WO2008033766A2

WO2008033766A2 - Self-suturing anchor device

Info

Publication number: WO2008033766A2
Application number: PCT/US2007/078028
Authority: WO
Inventors: Fred P. Lampropoulos; Arlin Dale Nelson; Brian Stevens; Greg Mcarthur; William Padilla
Original assignee: Merit Medical Systems, Inc.
Priority date: 2006-09-14
Filing date: 2007-09-10
Publication date: 2008-03-20
Also published as: WO2008033766A3

Abstract

A catheter anchor device for use with a catheter includes an adhesive layer configured to be secured to the skin of the patient proximate the catheter insertion site, a stationary base secured to the adhesive layer, a rotatable ring coupled to the stationary base and circumscribing the stationary base such that the rotatable outer ring can be rotated by the user relative to the stationary base, a first suture including a loop portion and first and second ends, the loop portion looping around a catheter when the anchor device is in place relative to the catheter insertion site, a suture retention assembly maintaining the position of the sutures to minimize disruption of the sutures before deployment of the sutures, and a pull handle including first and second separable pull tabs, the pull handle being coupled to the first and second ends of the first suture, the pull handle being configured such that actuation of the pull handle actuates first suture to secure the catheter relative to the rotatable ring.

Description

SELF-SUTURING ANCHOR DEVICE

BACKGROUND OF THE INVENTION

1. The Field of the Invention

[001] Exemplary embodiments of the present invention relate to the field of catheters, and, more particularly, to a self-suturing anchor device for use with a catheter.

2. Background and Relevant Art

[002] Catheters play an important role in the treatment and care of patients in modern medicine. In particular, catheters provide relatively unobtrusive access to remote portions of a patient's body, allowing desired procedures or treatments to be performed. A wide variety of generalized and specialized catheters have been developed and refined for particular uses. For example, angioplasty catheters have been adapted to provide a safe and effective conduit for the delivery of a stent and/or balloon to a narrowing or loading blockage in a patient's artery or vein. Drainage catheters are configured to be inserted into a cavity surrounding a patient's kidney, liver, or other organ to drain excess fluid or infection from the cavity. [003] In addition, a number of devices and implements have been developed for use with catheters, to facilitate their effectiveness, or to overcome inherent difficulties associated with their use. For example, catheters that are designed to remain placed in a patient for long periods of time, such as for ongoing care or treatment of the patient, present a number of difficulties. Such catheters must be secured to the patient in a manner that minimizes movement of the catheter that could harm the patient or otherwise interrupt proper functioning of the catheter.

[004] Accordingly, one approach in the prior art has been to suture the catheter directly to the patient's skin. However, when a patient repositions himself/herself in bed, the catheter may pull at the suture site or bend the catheter. Another approach is to inflate a balloon associated with the distal end of the catheter inside the patient. However, at times an incoherent patient may attempt to withdraw or otherwise remove the catheter. This can cause injury to the catheter insertion site, or can interfere with proper operation of the catheter. [005] In view of these and other problems in the art, a number of devices have been developed to secure a catheter in a manner that minimizes movement of the catheter, or minimizes interference with its proper operation. Typically, such devices include an adhesive layer to be secured to the patient with a small bore for accommodating the catheter and an adhesive strip to secure the catheter relative to the adhesive layer. Devices such as these are useful because they can be employed by a practitioner to secure the desired positioning of the catheter. Such devices, however, can be undesirable due at least in part to the fact that they typically cover or otherwise obstruct the catheter insertion site. This can make it difficult to identify infections, drainage, or other complications that may occur at the catheter insertion site. Furthermore, the devices can also obstruct cleaning of the insertion site, such that the site can only be cleaned by removing the anchor devices. Additionally, conventional anchor devices typically utilize a clip, or other securement member which typically is rigid or has a high profile when utilized to secure the catheter. As a result, the securement device can be uncomfortable if pressed against the patient by a chair, bed, or other object.

BRIEF SUMMARY OF SOME EMBODIMENTS OF THE INVENTION [006] The present invention is directed to a catheter securement device that automatically secures the catheter without requiring the practitioner to manually suture the catheter to the self-suturing anchor device. According to one embodiment, the catheter securement device includes a center aperture defined in a rotatable ring. The catheter extends through the aperture when the catheter securement device is deployed. One or more sutures are disposed about the center aperture. As a result, when the catheter securement device is in place, the suture or sutures are located around the catheter. According to one example, the first suture is looped around the catheter and includes a knot tied therein.

[007] The catheter securement device may be secured to the patient with an adhesive. The adhesive allows a practitioner to rapidly locate the catheter securement device on the patient near the catheter insertion location. With the catheter securement device in place, a first securement is realized by pulling on the ends of a first suture. Pulling on the ends of the sutures draws the knot in the first suture into contact with the catheter, thereby securing the catheter. A pull handle is provided to further facilitate the rapid deployment of the first knot in the first suture. According to one example, the pull handle includes two separable portions, each of which has one end of the suture secured thereto. After the first knot is secured, the separable portions may be separated and a second knot tied in the first suture. [008] The self-suturing anchor device has a securement mechanism that is adapted to be actuated by the user to automatically secure the catheter in a quick and efficient manner. In one embodiment, a rotatable ring is provided in connection with the self-suturing anchor device to automatically secure the catheter, At least one suture thread extends from the bottom of the rotatable ring. When a user pulls the suture in a rearward direction, a loop portion of the suture is freed from the rotatable ring and initially engages a portion of the catheter associated with the bottom of the rotatable ring. The user can then rotate the rotatable ring in one or both of a clock-wise or a counter clock-wise direction to deploy one or more additional suture. Rotation of the rotatable ring tensions the additional suture to automatically secure the portion of the catheter positioned centrally within the rotatable ring. Once the additional suture has been secured, the first suture can be tightened and tied to further secure the catheter.

[009] The rotatable ring is utilized in connection with a ratchet mechanism. The ratchet mechanism allows movement of the rotatable ring in a first direction while preventing movement of the rotatable ring in the opposite direction. As a result, the rotational position of the rotatable ring is secured against movement in a rearward direction. When the user rotates the rotatable ring to deploy, secure, and/or tighten the sutures relative to the catheter, inadvertent movement of the rotatable ring does not result in loosening of the sutures. Additionally, where the tension on the sutures decreases due to factors such as the natural loosening of the fibers of the suture, the user can easily ratchet the rotatable ring an additional amount to return the sutures to a desired degree of tensioning.

[010] The ratchet mechanism includes rotatable ratchet members. The rotatable ratchet members pivot or flex allowing for movement of the portion of the rotatable ratchet member having teeth. Additionally, in one example a ratchet member engagement spring is provided which maintains contact between the teeth of the rotatable ratchet member and teeth of the ratchet ring. The ratchet member engagement spring can flex or undergo other deformation to allow for sliding of the teeth of the rotatable ratchet member over the teeth of the ratchet ring during rotation of the rotatable ring.

[011] In one embodiment, an O-ring is provided to maintain the position of the sutures beneath the rotatable ring. The O-ring is configured to be positioned between the rotatable outer ring and base. Maintaining the position of the sutures minimizes disruption of the sutures before deployment of the sutures. In another embodiment, the base of the anchor device comprises a single molded member. The single molded member is formed utilizing first and second mold members. The base includes an undercut. As a result, the first mold member and the second mold member are formed to provide the undercut during the molding of the base.

[012] In one embodiment, a suture retention assembly is provided to maintain the position of the sutures beneath the rotatable ring. The suture retention assembly includes a retention element, such as a flat washer and a bias element, such as a wave spring. The suture retention assembly is configured to be positioned between the rotatable ring and the base. Maintaining the position of the sutures minimizes disruption of the sutures before deployment. [013] According to one embodiment of the present invention, a method of assembling the catheter anchor device is provided. Loading of the sutures is facilitated by mounting the base of the anchor device on a loading block. A suture-loading cylinder is positioned through the center bore of the catheter anchor device and the center aperture. The suture-loading cylinder is utilized to provide a quick and effective mechanism for forming the loop configurations of the first suture, the second suture, and the third suture and for loading the sutures in the base. According to another embodiment of the present invention, one or more components of the catheter anchor device are welded to facilitate assembly of the catheter anchor device. For example, a plurality of pins of the rotatable outer ring are configured to be welded to securement bores of the bearing members. A plurality of access bores are provided in connection with the base of the anchor device such that a welding tool can be inserted through the access bores of the catheter anchor device to weld the pins of the rotatable outer ring to the securement bores of the bearing member. These and other aspects will become more fully apparent from the following description and appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[014] In order to describe the manner in which the above recited and other advantages and features of the invention can be obtained, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof, which are illustrated in the appended drawings. Understanding that these drawings depict only typical embodiments of the invention and are not therefore to be considered to be limiting of its scope, the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[015] Figure 1 is a top view of the catheter anchor device illustrating deployment of a first suture;

[016] Figure 2 is a top view of the catheter anchor device illustrating deployment of a second suture relative to the catheter;

[017] Figure 3 is a top view of a catheter anchor device illustrating securement of the catheter subsequent to deployment of the sutures;

[018] Figure 4 is a top view of an example anchor device that includes a pull handle; [019] Figure 5 illustrates the deployment of the loop portion of the first suture; [020] Figure 6 illustrates the first and second ends of the first suture tied to the portion of catheter corresponding with extension saddle;

[021] Figure 7 illustrates the pull tabs being removed from the first suture; [022] Figure 8A illustrates a pull handle that includes first and second pull tabs; [023] Figure 8B illustrates the pull tabs separated;

[024] Figure 8C illustrates sutures secured to a pull handle with first and second pull tabs;

[025] Figure 8D illustrates the first and second pull tabs separated and the sutures freed;

[026] Figure 9 is an exploded view of the catheter anchor device illustrating the components of the catheter anchor device including an O-ring and rotatable ratchet members;

[027] Figures 1OA and 1OB are perspective views of the base of the catheter anchor device illustrating molding of the base utilizing first and second mold members;

[028] Figure 1 1 is an exploded view of the catheter anchor device illustrating components of the catheter anchor device that facilitate assembly of the catheter anchor device utilizing welding of one or more portions of the catheter anchor device;

[029] Figures 12A and 12B are perspective views of the base of the catheter anchor device illustrating loading of the sutures during assembly of the catheter anchor device; and

[030] Figures 13A and 13B are component views illustrating the ratchet mechanism including operation of a rotatable ratchet member relative to the ratchet ring.

[031] Figure 14 is a top view of the catheter anchor device illustrating deployment of a first suture according to one example;

[032] Figure 15 is a top view of the catheter anchor device illustrating deployment of a second suture relative to the catheter according to one example;

[033] Figure 16 is a top view of a catheter anchor device illustrating securement of the catheter subsequent to deployment of the sutures according to one example;

[034] Figure 17 is an exploded view of the catheter anchor device illustrating the components of the catheter anchor device including a suture retention assembly and rotatable ratchet members according to one example;

[035] Figures 18A and 18B are perspective views of the base of the catheter anchor device illustrating molding of a base utilizing first and second mold members according to one example;

[036] Figure 19 is an exploded view of the catheter anchor device illustrating components of the catheter anchor device that facilitate assembly of the catheter anchor device according to one example;

[037] Figures 2OA and 2OB are perspective views of the base of the catheter anchor device, illustrating loading of the sutures and a suture retention assembly during assembly of the catheter anchor device according to one example; [038] Figures 21 A and 2 IB are component views illustrating the ratchet mechanism including operation of a rotatable ratchet member relative to the ratchet ring according to one example; and

[039] Figures 23A and 23B are component views illustrating a ratchet mechanism that includes an integral ratchet and bearing member, including operation of a rotatable ratchet member relative to the ratchet ring according to one example.

DETAILED DESCRIPTION OF SOME EXAMPLE EMBODIMENTS [040] The present invention is directed to a catheter securement device that enables securement of a catheter without requiring the practitioner to manually suture the catheter to the self-suturing anchor device. According to one embodiment, the catheter securement device includes a center aperture defined in a rotatable ring. The catheter extends through the aperture when the catheter securement device is deployed. One or more sutures are disposed about the center aperture. As a result, when the catheter securement device is in place, the suture or sutures are located around the catheter. According to one example, the first suture is looped around the catheter and includes a knot tied therein.

[041] The catheter securement device may be secured to the patient with an adhesive. The adhesive allows a practitioner to rapidly locate the catheter securement device on the patient near the catheter insertion location. With the catheter securement device in place, a first securement is realized by pulling on the ends of a first suture. Pulling on the ends of the sutures draws the knot in the first suture into contact with the catheter, thereby securing the catheter to the catheter securement device. A pull handle is provided to further facilitate the rapid deployment of the first knot in the first suture. The pull handle is an example of a structural implementation of a means for tensioning a suture. According to one example, the pull handle includes two separable portions, each of which has one end of the suture secured thereto.

[042] The self-suturing anchor device has a securement mechanism that is adapted to be actuated by the user to automatically further secure the catheter in a quick and efficient manner. The rotatable ring is used in connection with a ratchet mechanism. The ratchet mechanism allows movement of the rolatable ring in a first direction while controlling movement of the rotatable ring in the opposite direction. As a result, the rotational position of the rotatable ring is secured. The ratchet mechanism includes rotatable ratchet members. The rotatable ratchet members pivot allowing for slight movement of the portion of the rotatable ratchet member having the teeth. Additionally, in one example a ratchet member engagement spring is provided which maintains contact between the teeth of the rotatable ratchet member and the teeth of the ratchet ring. The ratchet member engagement spring can flex or undergo other deformation to allow for sliding of the teeth of the rotatable ratchet member over the teeth of the ratchet ring during rotation of the rotatable ring. [043] Figure 1 is a perspective view of anchor device 10 according to one embodiment of the present invention. Anchor device 10 is utilized to secure a catheter relative to a patient while allowing access to a catheter insertion site for observation and care of the catheter insertion site. Anchor device 10 provides a simple and effective mechanism for securing a catheter by automatically deploying one or more sutures to secure the catheter. In the illustrated embodiment, anchor device 10 comprises an adhesive sheet 12, rotatable ring 14, and a center aperture 16. A catheter 18 is shown being utilized in connection with anchor device 10. Catheter 18 has been inserted into the patient at a catheter insertion site 26. [044] Anchor device 10 has been placed over catheter 18 such that catheter 18 is threaded through the middle of center aperture 16. Catheter insertion site 26 is positioned approximately in the middle of center aperture 16 such that rotatable ring 14 is positioned and centered about catheter insertion site 26. Adhesive sheet 12 has an adhesive backing that securely fastens anchor device 10 to the patient before and after deployment of the sutures of anchor device 10. Rotatable ring 14 is utilized to automatically deploy one or a plurality of sutures for securement of catheter 18.

[045] Center aperture 16 is configured to allow access to catheter 18 at the catheter insertion site 26. By providing access to catheter insertion site 26, a practitioner can observe the condition of catheter insertion site 26 and provide treatment and care of catheter insertion site 26 as needed. This can be important in the event of injury, infection, drainage, or other disruptions of catheter insertion site 26. The ability to care for catheter insertion site 26 can be quite helpful, particularly where catheter 18 is utilized in a gastric or similar setting where regular care and treatment of the catheter insertion site is necessary to maintain the health of the patient and proper operation of catheter 18.

[046] In the embodiment illustrated in Figure 1 , a first suture 20, which is utilized to secure catheter 18, is shown being partially deployed. First suture 20 comprises a first end 20a, a second end 20b, and a loop portion 20c. A user grasps a pull handle connected to each of the first end 20a and second end 20b. Exemplary pull handles will be discussed in more detail below. The user then retracts first end 20a and second end 20b with the pull handle in a rearward fashion to draw the loop portion 20c of the first suture 20 from under the rotatable ring 14 and to partially deploy the loops of the loop portion 20c of first suture 20. In the illustrated embodiment, the loop portion 20c of first suture 20 is a double loop forming a clove hitch-type securement knot. At this point of the deployment process, a user actuates rotatable ring 14. After actuating the rotatable ring 14, the user then continues to retract first and second ends 20a, b. As the user retracts first end 20a and second end 20b, loop portion 20c continues to tighten about catheter 18 at a position adjacent rotatable ring 14. The configuration of first suture 20 provides a simple, quick, and effective mechanism for securing a portion of catheter 18 relative to rotatable ring 14. In a matter of seconds, first suture 20 can be freed from beneath the rotatable ring 14. A second suture 21 (Figure 2) may then be deployed by actuating rotatable ring 14. In one example, preliminarily freeing the loop portion 20c of the first suture 20 allows the rotatable ring 14 to be rotated with less torque, thereby facilitating deployment of the second suture 21. After the second suture 21 is fully deployed and securely fastened about catheter 18, first end 20a and second end 20b can retracted to secure the loop portion 20c adjacent the bottom of rotatable ring 14. Next, the ends 20a, b may then be tied about the portion of catheter 18 adjacent the extension saddle 44. By providing two points of securement, first suture 20 minimizes twisting and/or pulling of catheter 18 that could result in injury of the patient tissue at catheter insertion site 26. [047] As will be appreciated by those skilled in the art, a variety of types and configurations of anchor devices can be utilized without departing from the scope and spirit of the present invention. For example, in one embodiment, only a first suture is utilized to secure the catheter. In another embodiment, string is used in the place of conventional suture material. In yet another embodiment, the suture is comprised of a monofilament material, woven silk thread, or other known or conventional string, wire, and/or suture materials. [048] Figure 2 is a top view of anchor device 10 illustrating a user actuating rotatable ring 14 of anchor device 10, according to one embodiment of the present invention. In the illustrated embodiment, anchor device 10 includes a second suture 21 with a first portion 22 and a second portion 24, both of which are housed beneath rotatable ring 14 prior to actuation of rotatable ring 14. Once the loop portion 20c of first suture 20 is freed from beneath the rotatable ring 14, a user begins to rotate rotatable ring 14 to deploy first portion 22 and second portion 24 of second suture 21. As the user rotates rotatable ring 14, first portion 22 and second portion 24 automatically deploy from beneath rotatable ring 14 and begin to loop about the portion of catheter 18 adjacent catheter insertion site 26. In the illustrated embodiment, the ends of first portion 22 and second portion 24 of second suture 21 are actuated from opposite sides of rotatable ring 14 such that both first portion 22 and second portion 24 of second suture 21 anchor catheter 18 from opposite sides of the catheter insertion site 26. As a result, two lateral securement positions are provided on each side of catheter 18 to minimize unintentional movement of catheter 18 at catheter insertion site 26. Securement of catheter 18 at catheter insertion site 26 will be discussed in more detail with respect to Figure 3. The loops of first portion 22 and second portion 24 of second suture 21 are formed using a double or triple knot configuration to provide a slip resistant knot when secured to catheter 18. The ability of the loop portion to secure catheter 18 will be discussed in more detail with respect to Figure 3.

[049] As will be appreciated by those skilled in the art, a variety of types and configurations of anchor device 10 can be utilized without departing from the scope and spirit of the present invention. For example, multiple sutures can be provided in connection with deployment of the rotatable ring rather than a single suture. In another embodiment, more than two sutures are provided in connection with deployment of rotatable ring 14. In yet another embodiment, a plurality of rotatable rings are provided with each rotatable ring deploying one or more sutures to secure catheter 18 in subsequent steps of actuation during use of the anchor device. [050] Figure 3 is a top perspective view of anchor device 10 subsequent to deployment of rotatable ring 14 and securement of first suture 20. In the illustrated embodiment, catheter 18 is secured by the first and second portions 22, 24 of the second suture 21, subsequent to actuation of rotatable ring 14. Once second suture 21 has been deployed, the first suture 20 may be further secured by retracting the first and second ends 20a, b to tighten loop portion 20c. The first and second ends 20a, b may then be tied adjacent extension saddle 44. Extension saddle 44 provides a desired degree of displacement between the points of securement provided by suture 20 relative to catheter 18. The displacement provided between the points of securement of first suture 20 is sufficient to substantially minimize kinking, twisting, or other manipulation of catheter 18 that could result in damage to the patient tissue at catheter insertion site 26 resulting from movement of catheter 18. Additionally, extension saddle 44 provides a groove that accommodates catheter 18 to minimize kinking, pinching, or other pressure on catheter 18 from the transition over the top of rotatable ring 14.

[051] The portion of catheter 18 positioned adjacent catheter insertion site 26 is secured by second suture 21. Particularly, one part of first portion 22 is positioned on the left side of rotatable ring 14, while another part of first portion 22 is secured adjacent the right side of rotatable ring 14. Similarly, one part of second portion 24 is secured adjacent the left side of rotatable ring 14, while another part of second portion 24 is secured adjacent the right side of rotatable ring 14. Additionally, the first portion 22 and second portion 24 on the left side of rotatable ring 14 are positioned at a displacement between five and 65 degrees or more relative to one another to provide securement of catheter 18 and thereby minimize movement of catheter 18 during use of the anchor device 10. Similarly, the first portion 22 and second portion 24 on the right side of rotatable ring 14 are positioned at an angle of between five and 65 degrees or more relative to one another to minimize movement of catheter 18 which could result in injury at catheter insertion site 26. As a result, a total of four separate points of securement are provided at the portion of catheter 18 adjacent catheter insertion site 26 to minimize both lateral and forward and rearward movement of catheter 18 during usage of catheter anchor device 10. This provides a safe and reliable securement of catheter 18 during usage while also providing access to the catheter insertion site for cleaning and care of the catheter and/or patient tissue at catheter insertion site 26. In the illustrated embodiment, a plurality of scallops 42 are shown on rotatable ring 14. Scallops 42 facilitate gripping of rotatable ring during actuation of rotatable ring as shown in Figure 2. Scallops 42 comprise a concave depression in the outward surface of rotatable ring 14. By providing a concave depression in the outward surface of rotatable ring 14, scallops 42 provide gripping members that minimize any potential abrasion to the patient or practitioner utilizing anchor device 10. [052] The configuration of anchor device 10 and rotatable ring 14 allow for quick, simple, and effective securement of catheter 18 subsequent to placement of catheter 18 in a patient. This not only shortens the length of the catheter securement procedure and thus the entire catheter placement procedure, but also is sufficiently simple such that an assisting nurse or other caretaker can secure catheter 18 while the physician attends to other aspects of the procedure being performed. This is not only more efficient from the standpoint of operating room economics, but can also be quite helpful in time-sensitive procedures such as in a trauma setting or emergency situation.

[053] Figure 4 is a top view of an example embodiment of an anchor device 10 that includes a pull handle 50. Pull handle 50 facilitates the rapid deployment of first suture 20 to secure loop portion 20c to catheter 18 and the rotatable ring 14. As will be evident from the disclosure herein, the various disclosed embodiments of a pull handle are example structural implementations of a means for tensioning a suture. The scope of the invention is not, however, limited to the disclosed structural implementations. Rather, any other structure(s) of comparable functionality are considered to fall within the scope of the invention. [054] In the illustrated example, pull handle 50 includes first and second separable members, such as pull tabs 52a, b. Pull tabs 52a, b each have respective openings 53a, b defined therein. The ends 20a, b of first suture 20 are shown as being looped through the openings 53a, b and secured to pull tabs 52a, b. As a result, each end 20a, b of the first suture 20 is secured to a corresponding separable tab 52a, b. Pull tabs 52a, b are initially coupled together. In particular, according to the example shown, pull handle 50 is initially a single piece of material with two separable portions. In the illustrated example, pull handle 50 includes a line of perforations 54 disposed between the pull tabs 52a, b. However, the scope of the invention is not so limited. More generally, any portion of material that can be separated into at least two parts can be used for the pull handle 50.

[055] Figure 5 illustrates the deployment of the loop portion 20c of first suture 20. In order to operate the illustrated example device, a practitioner deploys the loop portion 20c by first grasping the pull tabs 52a, b as shown. At this point, the loop portion 20c is surrounding catheter 18, in a similar manner as illustrated in Figure 1. The practitioner then draws the pull handle 50 away from the rotatable ring 14. Drawing pull handle 50 away from rotatable ring 14 draws the loop portion 20c from underneath the rotatable ring 14. Additionally, after second suture (Figure 3) is deployed, the pull handle 50 may also be retracted to draw the first and second ends 20a, b of the first suture 20 more tightly about catheter 18 at a position adjacent rotatable ring 14.

[056] To aid in the operation of pull handle 50, one or both of pull tabs 52a, b may include ergonomic features. For example, each of the example pull tabs 52a, b includes a gripping edge 56a, b that has a generally arcuate profile. A generally arcuate profile may be more comfortable for a practitioner to grasp when deploying the loop portion 20c. Further, the generally arcuate profiles shown mean that the pull tabs 52a, b are wider on the outer portions of the pull tabs 52a, b than in the center. The generally wider outer portions may reduce the possibility that a practitioner's grip will slip while pulling on pull handle 50. Further, the pull tabs 52a, b may be shaped such that pull handle 50 is substantially symmetrical. Symmetry of pull handle 50 may allow for use of the pull handle 50 with either hand. [057] Turning now to Figure 6, when loop portion 20c is freed from beneath the rotatable ring 14, the rotatable ring 14 may be actuated to deploy second suture 21. Once second suture 21 is fully deployed, first end 20a and second end 20b can then be tied about the portion of catheter 18 located proximate the extension saddle 44. In particular, as previously introduced, pull handle 50 includes separable pull tabs 52a, b or other portions that may otherwise be separated into at least two pieces. Once the loop portion 20c is freed and second suture 21 is deployed, the pull handle 50 may be retracted to tighten loop portion 20c about the catheter 18 at a location proximate the rotatable ring 14. The pull tabs 52a, b are then separated. Next, each puli tab 52a, b may be manipulated independently to tie the second knot in the first suture 20 to fully secure the first suture 20, such as a knot near the portion of the catheter 18 located proximate with the extension saddle 44. In the illustrated embodiment, the pull handle 50 may be formed of a material capable of being manually torn along the perforation line 54a, b. Suitable materials may include, without limitation, pulp products such as high-density paper or fiber board.

[058] Figure 7 illustrates the pull tabs 52a, b being removed from the first suture 20. As introduced, the pull tabs 52a, b may be separated to facilitate tying of the second knot. It may be desirable to remove the pull tabs 52a, b and/or reduce the length of the first and second ends 20a, b that extend beyond the extension saddle 44. The pull tabs 52a, b may provide a convenient handle relative to bare suture ends thereby allowing a practitioner to quickly shorten the lengths of the first and second ends 20a, b while 'removing the pull tabs 52a, b. According to the illustrated example, scissors or another cutting tool may be used to cut the first and second ends 20a, b. While one configuration of pull handle 50 has been disclosed, those of skill in the art will appreciate any number of configurations are possible. Another example configuration is disclosed in Figures 8 A to 8B.

[059] Figure 8A illustrates a pull handle 80 that includes first and second pull tabs 82a, 82b. For ease of reference, the first pull tab 82a will be discussed as being located on the left hand side. Each pull tab 82a, b includes apertures 84-87 formed therein. The apertures 84-87 are sized to allow a practitioner to grasp the pull handle 80 by passing her fingers therethrough. The pull handle 80 then may be actuated as discussed above to secure a loop portion 20c (Figure 1) of a first suture 20 to a catheter. Once the loop portion 20c is thus secured, the pull tabs 82a, b may be separated.

[060] Figure 8B illustrates the pull tabs 82a, b separated. According to the illustrated embodiment, the pull tabs 82a, b have interlocking structure(s) formed thereon that are configured to mate with corresponding structure(s) on the other pull tab. This configuration allows for re-use of the handle 80. Such a configuration may provide a relatively secure coupling of the pull tabs 82a, b while also providing for convenient and rapid separation of the pull tabs 82a, b and/or release of the sutures 20, 21. According to one example, the pull tabs 82a, b may be formed of a durable material, such as a plastic material. Further, the pull tabs 82a, b may be formed using any suitable process or processes, such as molding processes.

[061] According to one example, the interlocking structures formed on the pull tabs 82a, b include recesses 88 and posts 90. The posts 90 are pressed into the recesses 88 to thereby couple the pull tabs 82a, b together. While posts and recesses are described, any interlocking arrangement may also be used. [062] Figure 8C and 8D illustrate another example in which first and second ends 20a, b of the suture 20 are secured between the pull tabs 82a, b. In particular, as previously discussed, the pull tabs 82a, b are coupled together using an interlocking structures. The first and second ends 20a, b may be located between the interlocking structures, such as before the puli tabs 82a, b are coupled together. In particular, in one example the first and second ends 20; b of the sutures are placed adjacent the posts 88 before the posts 90 are coupled to the recesses 88. Locating the first and second ends 20a, b between pull tabs 82a, b secures the first and second ends 20; b to the pull tabs 82a, b.

[063] Figure 8D illustrates the pull tabs 82; b separated from each other. Separating the first and second pull tabs 82; b frees the first and second ends 20a, b of the first suture 20. After the first and second ends 20; b are freed, they may be tied directly, thereby eliminating the need to further free the first and second ends 20a, b from the pull tabs, such as by cutting. [064] Figure 9 is an exploded view of rotatable ring 14 of anchor device 10 depicting a ratchet mechanism. In the illustrated embodiment, rotatable outer ring 130 and bearing members 134a, b are shown separated from base 132. A plurality of pin members are positioned beneath rotatable outer rings. The pin members are configured to be positioned in bearing members 134a, b to secure bearing members 134a, b to rotatable outer ring 130. [065] Bearing members 134a, b are configured to be positioned between rotatable outer ring 130 and base 132. Bearing members 134a, b contact base 132 beneath ratchet ring 136 such that bearing members 134a, b do no contact the teeth of ratchet ring 136. Similarly, bearing members 134a, b contact rotatable outer ring 130 beneath rotatable ratchet members 138a, b such that bearing members 134a, b do not contact the teeth of rotatable ratchet members 138a, b. As a result, bearing members 134a, b do not interfere with the cooperative engagement between ratchet members 38a, b and ratchet ring 136.

[066] A lip on each of bearing members 134a, b extends inwardly beneath ratchet ring 136. When rotatable outer ring 130 is secured to bearing members 134a, b, the lateral positioning of bearing members 134a, b secures both bearing members 134a, b and rotatable outer ring 130 to base 132. Additionally, the positioning of bearing members 134a, b maintains ratchet members 138a, b in cooperative engagement with ratchet ring 136. In the illustrated embodiment, bearing members 134a, b include a securement member for securing the first and second portions 22, 24 of the second suture 21 during rotation of bearing members 134a, b.

[067] As will be appreciated by those skilled in the art, a variety of types and configurations of bearing members can be utilized without departing from the scope and spirit of the present invention. For example, in one embodiment a circular bearing member is utilized in place of two bearing member segments. In another embodiment, one or more bearing members are integrally coupled to the rotatable outer ring. In yet another embodiment one or more bearing members are integrally coupled to the ratchet members. In another embodiment, the bearing members are positioned above the ratchet ring. In yet another embodiment, a liquid bearing mechanism is utilized. In another embodiment, a roller bearing mechanism is utilized. [068] In the embodiment illustrated in Figure 9, the path of sutures 20, 21 relative to sutures storage channel 140 previous to deployment is depicted. Sutures 20, 21 are looped such that they are positioned inside suture storage channel 140. As a result, when the practitioner secures the anchor device to the patient, the practitioner does not need to manage the positioning of sutures 20, 21. Suture storage channel 140 in combination with O-ring 128 also maintains the particular desired loop formation of sutures 20, 21 ensuring proper operation and/or deployment of sutures 20, 21.

[069] In the embodiment illustrated in Figure 9, first suture channels 152a, b are positioned through base 132 and exit at extension saddle 44. First suture 20 is configured to be positioned through first suture channels 152a, b such that the ends of first suture 20a, b extend from extension saddle 44. The extension of the ends of first suture 20a, b from the extension saddle 44 allows a user to grasp the ends of first suture 20a, b to actuate first suture 20.

[070] Second suture channels 154a₅ b and third suture channels 156a, b are positioned through ratchet ring 136 and base 132. Bearing member suture channels 158a, b and 160a, b are positioned through bearing members 134a, b. More particularly, the second suture 21 is looped to form the first and second portions 22, 24 that intersect at loop portion 21a. The loop portion 21a of the second suture 21 is secured to the exterior of bearing member 134a. Next, the first and second portions 22, 24 of the second suture 21 are passed through bearing member 134a, then through the ratchet ring 136 and base 132. Loops are then formed in the first and second portions 22, 24 of second suture 21 as described below with reference to Figures 12A and 12 B. After the loops are formed in the first and second portions 22, 24, the first and second portions 22, 24 are passed through bearing member 134b. In particular, a first end 22a of first portion 22 is threaded first through bearing member channel 160a in bearing member 134a and through third suture channel 156a. The first portion 22 of second suture 21 is then looped as desired. The first end 22a of the first portion 22 is then passed through the second suture channel 154a in ratchet ring 136 and base 132 and through bearing member channel 158a. Similarly, a first end 24a of the second portion 24 is threaded first through bearing member channel 160b in bearing member 134a and then through third suture channel 156b. The second portion 24 of second suture 21 is then looped as desired. The first end 24a of the second portion 24 is then threaded through second suture channel 154b in ratchet ring 136 and base 132 and finally through bearing member channel 158b. The first ends 22a, 24a of the first and second portions 22, 24 of the second suture are then secured to the exterior of bearing member 134b.

[071] With continuing reference to Figure 9, base 132 and ratchet ring 134 are stationary relative to the rotatable outer ring 130. As a result, second suture channel 154a, b and third suture channel 156a, b remain stationary during operation of rotatable ring 14. Bearing members 134a, b rotate in connection with rotatable outer ring 130. As a result, bearing member suture channels 158a, b and 160a, b rotate in connection with rotation of rotatable outer ring 130 and bearing member 134a, b. When bearing members 134a, b rotate in a clockwise direction, the ends 22a and 24a of the second suture 21 are drawn around the outside diameter of base 132 beneath ratchet ring 136. As a result, the length of first and second portions 22 and 24 of the second suture 21 inside suture storage channel 140 is shortened. As the length of first and second portions 22 and 24 inside suture storage channel 140 is shortened, the loops of sutures 22 and 24 become smaller such that they can no longer fit in suture storage channel 140. This results in automatic deployment of the second suture 21 from suture storage channel 140.

[072] Rotatable ratchet members 138a, b engage the teeth of ratchet ring 136 to minimize counterclockwise movement of rotatable ring 14 that would result in loosening of the second suture. During rotation of rotatable outer ring 130, bearing members 134a, b and rotatable ratchet members 138a, b are rotated in a clockwise direction about base 132 and in particular ratchet ring 136. Rotatable ratchet members 138a, b engage the teeth of ratchet ring 136 as rotatable ratchet members are advanced 138a, b in the clockwise direction. When a user discontinues rotation of rotatable outer ring, rotatable ratchet members 138a, b engage the teeth of ratchet ring 136 minimizing movement of rotatable outer ring in a counterclockwise direction that would otherwise loosen first portion 22 and second portion 24, [073] As illustrated in Figure 9, rotatable ratchet member 138a is positioned between bearing member 134a and rotatable outer ring 130. A pivot pin is positioned on the bottom surface of each of the rotatable ratchet members 138a, b. The pivot pins are is positioned in rotation bores of the corresponding bearing members 134a, b to pivotally couple rotatable ratchet member 134a to bearing member 134a. Rotatable outer ring 130 contacts the upper surface of rotatable ratchet member 138a to maintain contact between the pivot pins and the rotation bores.

[074] The end of rotatable ratchet members 138a, b positioned opposite the pivot point provided by the pivot pin of rotatable ratchet member 138a, b and the bore of bearing members 134a,b include a spring member and a plurality of teeth. The plurality of teeth engage the teeth of ratchet ring 136 to minimize movement of rotatable outer ring 130 and bearing members 134a,b in a counterclockwise direction. This spring is provided by the cutaway portion in the head of rotatable ratchet members 138a,b and the resilient nature from the material from which the heads of rotatable ratchet members 138a,b are constructed. Rotatable ratchet members 138a, b will be discussed in more detail with reference to Figures 13A and l3B.

[0751 In the embodiment illustrated in Figure 9, an O-ring 128 is also illustrated. O-ring 128 is configured to be sandwiched between rotatable outer ring 130 and base 132 to maintain the position of first suture 20, first portion 22 and second portion 24 of the second suture 21 beneath rotatable ring 14. By maintaining the position of first suture 20, first portion 22, and second portion 24, disruption of the sutures before deployment of the sutures is minimized and reliable and proper operating of anchor device 10 is maintained. As a result, O-ring 128 provides a simple and reliable mechanism for storing first suture 20, first portion 22, and second portion 24 beneath rotatable ring 14 during storage of anchor device 10, during securement of adhesive sheet 12 to the patient, or other aspects of the securement procedure performed before actuation of sutures 20, 21. A backup ring 173 is also provided between the O-ring 128 and rotatable outer ring 130. The backup ring 173 isolates the rotation of the rotatable outer ring 130 and the O-ring 128 to reduce torque and friction. [076] Figure 1OA and 1OB are perspective views of base 132 during molding of base 132. In the illustrated embodiment, base 132 comprises a single molded member formed utilizing first and second mold members 146 and 148. Base 132 comprises a ratchet ring 136 and an extension saddle 44. In the illustrated embodiment, base 132 includes an undercut 139 positioned between ratchet ring 136 and base flange 137. Undercut 139 substantially complicates the molding of base 132. As a result, first mold member 146 and second mold member 148 are utilized to provide the undercut during the molding of base 132. For the sake of clarity, the other mold members utilized to form base 132 have not been illustrated to more clearly depict operation of first mold member 146 and second mold member 148. [077] In the illustrated embodiment, first mold member 146 comprises mold member interfaces 147a, b, an inner circumference 150, and a gripping handle 153. Second mold member 148 comprises mold member interfaces 149a, b, an inner circumference 151, and gripping handle 155. During molding, mold member interfaces 147a, b of first moid member contact mold member interfaces 149a, b of second mold member 148. Inner circumference 150 of first mold member 146 and inner circumference 151 of second mold member 148 form the undercut 139 positioned between ratchet ring 136 and base flange 137. Inner circumference 150 and inner circumference 151 define the inner boundary of undercut 139. The top portion of first mold member 146 and second mold member 148 define the upper lateral surface extending from the innermost horizontal surface of uppercut 139 (not shown) to the edge of ratchet ring 136. The bottom of first mold member 146 and second mold member 148 form the lower horizontal surface which extends from the inner vertical surface of undercut 139 (not shown) and extends outward to be coextensive with base flange 137. [078] In one embodiment, the surfaces of undercut 139 are slightly flared or tapered to allow for proper releasing of first mold member 146 and second mold member 148 such that when a user grasps gripping handles 153 and gripping handle 155 to pull first mold member 146 and second mold member 148 in a rearward direction, first mold member and second mold member 146, 148, automatically release and can easily be slid from undercut 39. In this manner, base 132 can be molded in single member ensuring continuity of surfaces and reliable and proper operation of the components of base 132 during use of anchor device 10. [079] As will be appreciated by those skilled in the art, a variety of types and configurations of mechanism can be utilized to mold base 132 in a unitary fashion without departing from the scope and spirit of the present invention. For example, first and second mold members which are configured to be automatically retracted by an automated molding apparatus or other machinery can be utilized. In another embodiment, a single mold member which is hinged, bendable, meltable or otherwise manipulable to remove the mold member from undercut 139 is utilized. In another embodiment, mold members having different form, size, and/or surfaces can be utilized. In another embodiment, more than two mold members are utilized to form the undercut and/or other portions of the base during molding. [080] Figure 11 is a bottom exploded view illustrating the manner in which the components of anchor device 10 are secured during assembly. In the illustrated embodiment, rotatable outer ring 130, rotatable ratchet member 138a, bearing member 134a, and base 132 are depicted. Bearing member 134a is configured to be sandwiched between rotatable outer ring 130 and base 132. Rotatable ratchet member 138a is configured to be positioned between bearing member 134a and rotatable outer ring 130. Bearing member 134a is configured to be attached directly to rotatable outer ring 130 while being slidable relative to base 132. Pins 164a-c are positioned on the underside of rotatable outer ring 130 engage securement bores 166a-d of bearing member 134a, b. Contact between bearing member 134a and base 132 maintains contact between securement bores 166a-d and pins 164a-d. In the illustrated embodiment, pins 164a, b are configured to be welded to securement bores 166a, b to couple bearing member 134a to rotatable outer ring 130 subsequent to assembly of rotatable outer ring and base 132. Pins 164c, d are configured to be welded to securement bores 166c, d to integrally couple bearing member 134b to rotatable outer ring 130 subsequent to assembly of rotatable outer ring and base 132. A plurality of access bores 168a-d are provided in connection with base 132 such that the welding tool can be inserted through access bores 168a-d to weld pins 164a-d to securement bores 166a-d of bearing members 134a, b. [081] Rotatable ratchet member 138a is positioned between bearing member 134a and rotatable outer ring 130. In the illustrated embodiment, a pivot pin is positioned on the upper surface of bearing member 134a. The pivot pin is positioned in rotation bore 165 to pivotally couple rotatable ratchet member 134a to bearing member 134a. Rotatable outer ring 130 contacts the upper surface of rotatable ratchet member 138a to maintain contact between the pivot pins and rotation bore 165. Additionally, the outer horizontal portion of the rotatable outer ring which extends downward adjacent rotatable ratchet member 138a contains lateral movement of the free end of rotatable ratchet member 138a to ensure proper operation and contact between the teeth of rotatable ratchet member 138a and the teeth of ratchet ring 136 (illustrated in Figures 1OA and 10B).

[082] As will be appreciated by those skilled in the art, a variety of types and configurations of mechanisms for securing the components of the rotatable ring can be utilized without departing from the scope and spirit of the present invention. For example, in one embodiment, the bearing member is configured to be welded to the rotatable outer ring previous to assembly with the base. In another embodiment, a snap fitting is provided between the bearing member and the rotatable outer ring. In another embodiment, a continuous bearing member is integrated with the base 132 while the rotatable ratchet member is secured independently to the rotatable outer ring. In yet another embodiment, a surface is provided on the bearing member to maintain proper operation of the rotatable ratchet member.

[083] Figures 12A and 12B illustrate loading of the sutures utilized with anchor device 10, according to one embodiment of the present invention. In particular, as seen in Figure 12A, base 132 of anchor device 10 is mounted on a loading block 170. The anchor device 10 is positioned over the center bore 171 of loading block 170. First suture 20 is partially loaded into the base 132. More specifically, the ends 2Oa₅ b of first suture 20 are threaded from the interior of the ratchet ring 136 through the base 132 to extend beyond the extension saddle 44, The loop portion 20c of first suture 20 is looped about the perimeter of the base 132. The first and second ends 20a, b may be threaded through the extension saddle 44 either before or after the base 132 is mounted to a loading block 170. Thereafter, the second suture 21 may be loaded.

[084] As illustrated in Figure 12B, a suture loading cylinder 172 is positioned through center bore 171 (Figure 12A) such that the wall of the suture loading cylinder 172 is positioned adjacent the inner portion of ratchet ring 136. Suture loading cylinder 172 is utilized to provide a quick and effective mechanism for forming the loop configurations of first suture 20 and second suture 21 and for loading the sutures 20, 21 in base 132. A sleeve 175, also referred to as a suture expander, may also be placed over the suture loading cylinder 172 adjacent the suture loading channel 140. The sleeve 175 may help ensure the loops of the first and second sutures 20, 21 are located within the suture storage channel 140 during loading.

[085] In the illustrated embodiment, the loops of second suture 21 are being formed around suture loading cylinder 172. First suture 20 has previously been threaded through base 132. Initially, the second suture 21 is doubled over to form the first and second portions 22, 24 (Figure 12A) that are connected by a loop portion. More particularly, as illustrated in Figure 9, the first end 22a of first portion 22 is threaded first through bearing member channel 160a in bearing member 134a and through third suture channel 156a in the ratchet ring 136 and base 132. A first end 24a of the second portion 24 is threaded first through bearing member channel 160b in bearing member 134a and through third suture channel 156b in the ratchet ring 136 and base 132. Returning to Figure 12B, after the first ends 22a, 24a, of the first and second portions 22, 24 of the second suture 21 have been threaded through the ratchet ring 136 and base 132, loops are formed in the first and second portions 22, 24. One loop is substantially formed by wrapping the length of first portion 22 about suture loading cylinder 172 in a manner so as to produce the desired loop configuration in the first portion 22 of the second suture 21. The second portion 24 is also wrapped to form the desired loop configuration. Once the loops have been formed in the first and second portion 22, 24, the ends 22a, 24a of the second suture 21 are threaded through the ratchet ring 136 and base 132 and then the bearing member 134b and secured.

[086] As the loops of first and second portions 22, 24 are drawn tight and the loop portion 21a is secured relative to bearing members 134a and base 132, the loops of the first and second portions 22, 24 of the second suture 21 are automatically drawn down such that the loops are loaded within ratchet ring 136 in the desired position for deployment. Once second suture 21 has been loaded into the base 132, additional loops or knots may be formed in the first suture 20 using the suture loading cylinder 172. The first suture 20 may then be drawn tight such that the first suture 20 is drawn into the suture storage channel 140. As will be appreciated by those skilled in the art, similar steps, acts, and processes are utilized to load first suture 20 and second portion 24. The discussion of the formation of loops in the second suture and the loading of second suture 21 in base 132 is discussed for illustrative purposes and should in no way be considered to be limiting in nature.

[087] Once first and second sutures 20 and 21 have been properly loaded in base 132, O- ring 128 is positioned over the top of suture loading cylinder 172. O-ring 128 is lowered along the length of suture loading cylinder 172 until the O-ring 128 is positioned along the inner circumference of ratchet ring 136, effectively maintaining the position of first suture 20, first portion 22, and second portion 24 in their desired position within base 132. Once O-ring 128 has been properly positioned within base 132, a backup ring 173 is lowered along the length of suture loading cylinder 172 until the backup ring 173 is positioned on top of the O- ring 128.

[088] After the O-ring 128 and backup ring 173 have been positioned, the suture loading cylinder 172 is withdrawn and rotatable outer ring 130 is lowered into engagement with base 132 as discussed with respect to Figure 11. The proper steps can then be taken to couple rotatable outer ring 130 to bearing member 134a, b as discussed with respect to Figure 1 1. The backup ring 173 isolates the rotation of the rotatable outer ring 130 and the O-ring 128 to reduce torque and friction. The backup ring 173 may be formed of a material having a relatively low coefficient of friction, such as a durable plastic or polytetrafluoroethylene (PTFE). Further, when positioned as described above, the O-ring 128 and the backup ring 173 are located between the rotatable outer ring 130 and the base 132. In the illustrated example, the backup ring 173 is located between the O-ring 128 and the rotatable outer ring 130. In this position, as the rotatable outer ring 130 rotates, the rotatable outer ring 130 is in contact with the backup ring 173. Thus rotation of the rotatable outer ring 130 is not hindered by the O-ring 128. Further, the relatively low friction of the backup ring 173 reduces friction between the O-ring 128 and the backup ring 173. While the backup ring 173 is described as being positioned before the suture loading cylinder 172 is withdrawn, the backup ring 173 may alternatively be positioned over the O-ring 128 after the suture loading cylinder 172 is withdrawn. [089] As will further be appreciated by those skilled in the art, a variety of types and configurations of mechanism for loading the sutures in the base can be utilized without departing from the scope and the spirit of the present invention. For example, in one embodiment, a loading block and suture loading cylinder are utilized to manually load the sutures in the anchor device. In another embodiment, the loading block and suture loading cylinder are utilized with automated processes to load the suture into the base or other component of the anchor device.

[090] Figures 13A and 13B illustrate rotatable ratchet member 138b in operation with respect to ratchet ring 136. While rotatable ratchet member 138b is shown for illustrative purposes, it will be understood by those skilled in the art that operation of rotatable ratchet member 138b also is exemplary of rotatable ratchet member 138a (see Figure 9.) In the illustrated embodiment, rotatable ratchet member 138b is rotatably coupled to bearing member 134b utilizing pivot pin 169 and rotation bore 165 of rotatable ratchet member 134b. Rotatable ratchet member 138ab engages the teeth of ratchet ring 136 to minimize counterclockwise movement of rotatable ring 14 that would result in loosening of second suture 21. Rotatable ratchet member 138b is secured to bearing member 134b by pivot pin 169 located between the upper surface of bearing member 134b and the bottom surface of rotatable outer ring 130 (see Figure 9). Pivot pin 169 is positioned in the rotation bore 165 of rotalable ratchet member 138b such that rotatable ratchet member 138b can pivot about pivot pin 169.

[091] The rotatable ratchet member 138b is held in place relative to bearing member 134b by being sandwiched between bearing member 134b and rotatable outer ring 130 (see Figure 4). Thus, during rotation of rotatable outer ring 130 (see Figure 4), bearing member 134b and rotatable ratchet member 138b are rotated in a clockwise direction about ratchet ring 136. Rotatable ratchet member 138b engages the teeth of ratchet ring 136 as rotatable ratchet member is advanced 138b in the clockwise direction. When a user discontinues rotation of the rotatable outer ring, rotatable ratchet member 138b engages the teeth of ratchet ring 136 minimizing movement of rotatable outer ring 130 in a counterclockwise direction that would otherwise loosen the sutures.

[092] The end of rotatable ratchet member 138b positioned opposite the rotation bore 165 and pivot pin includes a ratchet member engagement spring 178 and rotatable ratchet member teeth 176. Rotatable ratchet member teeth 176 engage the ratchet ring teeth 174 to minimize movement of the rotatable outer ring and bearing member 134b in counterclockwise direction. Ratchet member engagement spring 178 is provided by the cutaway portion in the head of rotatable ratchet member 138b. The nature of the material from which the head of rotatable ratchet member 138b is constructed provides sufficient resilience to undergo deformation while maintaining contact between rotatable ratchet member teeth 176 and ratchet ring teeth 174.

[093] As the rotatable ratchet member teeth 176 slide over ratchet ring teeth 174, ratchet member engagement spring 178 flexes slightly to maintain contact between rotatable ratchet member teeth 176 and ratchet ring teeth 174. This is caused by the ramp-like configuration of rotatable ratchet member teeth 176 and ratchet ring teeth 174. When the rotatable ratchet member teeth 176 pass over the outer most ridge of ratchet ring teeth 174 such that they engage new teeth, ratchet member engagement spring 178 forces the rotatable ratchet member teeth 176 toward the center of the anchor device 10, thus maintaining engagement with ratchet ring teeth 174.

[094] As will be appreciated by those skilled in the art, a variety of types and configurations of rotatable ratchet members can be utilized without departing from the scope and spirit of the present invention. For example, in one embodiment, the rotatable ratchet members prevent rotation of a rotatable ring in a clockwise direction. In another embodiment, the rotatable ratchet members prevent backward movement of a nonrotational actuation member. In another embodiment, a secondary spring separate from the body of the rotatable ratchet member provides the spring movement of all or part of the rotatable ratchet member. [095] Figure 14 is a top view of an anchor device 210 according to one example. Anchor device 210 is utilized to secure a catheter relative to a patient while allowing access to a catheter insertion site for observation and care of the catheter insertion site. Anchor device 210 provides a simple and effective mechanism for securing a catheter by automatically deploying one or more sutures to secure the catheter. In the illustrated embodiment, anchor device 210 comprises an adhesive sheet 212, rotatable ring 214, and a center aperture 216. A catheter 218 is shown being utilized in connection with anchor device 210. Catheter 218 has been inserted into the patient at a catheter insertion site 226. [096] Anchor device 210 has been placed over catheter 218 such that catheter 218 is threaded through the middle of center aperture 216. Catheter insertion site 226 is positioned approximately in the middle of center aperture 216 such that rotatable ring 214 is positioned and centered about catheter insertion site 226. Adhesive sheet 212 has an adhesive backing which securely fastens anchor device 210 to the patient's skin before and after deployment of the sutures of anchor device 210. Rotatable ring 214 is utilized to automatically deploy one or more sutures for securement of catheter 218. [097] Center aperture 216 is configured to allow access to catheter 218 at the catheter insertion site 226. By providing access to catheter insertion site 226, a practitioner can observe the condition of the catheter insertion site 226 and provide treatment and care of the catheter insertion site 226 as needed. This can be important in the event of injury, infection, drainage, or other disruptions of catheter insertion site 226. The ability to care for catheter insertion site 226 can be quiet helpful, particularly where catheter 218 is utilized in a gastric or similar setting where regular care and treatment of the catheter insertion site 226 is necessary to maintain the health of the patient and proper operation of catheter 218. [098] In the illustrated embodiment, a first suture 220, which is utilized to secure catheter 218, is shown being partially deployed. First suture 220 comprises a first end 220a, a second end 220b, and a loop portion 220c. A user grasps first end 220a and second end 220b. The user then retracts first end 220a and second end 220b in a rearward fashion to draw the loop portion 220c of the first suture 220 from under the rotatable ring 214 and to partially deploy the loops of the loop portion 220c of first suture 220. In the illustrated embodiment, the loop portion 220c of first suture 220 is a double loop forming a clove hitch- type securement knot. A second suture 221 (Figure 2) may then be deployed. The second suture 221 is deployed by rotating rotatable ring 214. In one example, preliminarily freeing the loop portion 220c of the first suture 220 allows the rotatable ring 214 to be rotated with less torque, thereby facilitating deployment of the second suture 221. Additionally, initially freeing the first suture 220 before actuating rotatable ring 214 may also reduce the likelihood that the first suture 220 and the second suture 221 will become tangled as the second suture 221 is deployed. After the second suture 221 is fully deployed and securely fastened about catheter 218, first end 220a and second end 220b can retracted to secure the loop portion 220c adjacent the bottom of rotatable ring 214. Next, the ends 220a, b may then be tied about the portion of catheter 218 adjacent the extension saddle 244. This provides two different points of securement of catheter 218 by the first suture 220 relative to anchor device 210. By providing two points of securement, first suture 220 minimizes twisting and/or pulling of catheter 218 that could result in injury of the patient tissue at catheter insertion site 226. [099] In addition to minimizing twisting and/or pulling of the catheter 218, the anchor device 210 may be configured to minimize discomfort of the anchor device 210 when the patient moves or bends. For example, according to one embodiment, the adhesive sheet 212 extends a sufficient distance beyond the extension saddle 244 to provide cushioning or protection for the patient with respect to the extension saddle 244. [0100] As will be appreciated by those skilled in the art, a variety of types and configurations of anchor devices can be utilized without departing from the scope and spirit of the present invention. For example, in one embodiment, only a first suture is utilized to secure the catheter. In another embodiment, the suture is comprised of braided nylon, monofilament material, woven silk thread, or other known or conventional string, wire, and/or other suture materials.

[0101] Figure 15 is a top view of anchor device 210 illustrating a user actuating rotatable ring 214 of anchor device 210, according to one embodiment. In the illustrated embodiment, anchor device 210 includes a second suture 221 with a first portion 222 and a second portion 224, which are housed beneath rotatable ring 214 prior to actuation of rotatable ring 214. In particular, Figure 4 illustrates the first suture 220 in position beneath a retention element 402. Deploying the first suture 220 frees the first suture 220 from beneath the retention element 402. Once the loop portion (220c, Figure 2) of first suture 220 is freed from the suture storage channel 240, a user begins to rotate rotatable ring 214 to deploy second suture 221. As the user rotates rotatable ring 214, the second suture 221 automatically deploys and begins to loop about the portion of catheter 218 adjacent catheter insertion site 226. Returning to the embodiment illustrated in Figure 15, the ends of first portion 222 and second portion 224 of the second suture 221 are actuated from opposite sides of rotatable ring 214 such that both first portion 222 and second portion 224 anchor catheter 218 from opposite sides of the catheter insertion site 226. As a result, two lateral securement positions are provided on each side of catheter 218 to minimize movement of catheter 218 at catheter insertion site 226. Securement of catheter 218 at catheter insertion site 226 will be discussed in more detail with respect to Figure 16. The loops of first portion 222 and second portion 224 are formed using a double or triple knot configuration to provide a slip resistant knot when secured to catheter 218.

[0102] As will be appreciated by those skilled in the art, a variety of types and configurations of anchor device 210 can be utilized without departing from the scope and spirit of the present invention. For example, multiple sutures can be provided in connection with deployment of the rotatable ring rather than a single suture. In another embodiment, more than two sutures are provided in connection with actuation of rotatable ring 214. In yet another embodiment, a plurality of rotatable rings are provided with each rotatable ring deploying one or more sutures to secure catheter 218 in subsequent steps of actuation during use of the anchor device. [0103] Figure 16 is a top view of anchor device 210 subsequent to actuation of rotatable ring 214 and securement of first suture 220. In the illustrated embodiment, catheter 218 is secured by the first and second portions 222, 224 of the second suture 221, subsequent to actuation of rotatable ring 214. Once second suture 221 has been deployed, the first suture 220 may be further secured by retracting the ends 220a, b of the first suture 220 to tighten loop portion 220c. The first and second ends 220a, b of first suture 220 are then tied adjacent extension saddle 244. Extension saddle 244 provides a desired degree of displacement between the points of securement provided by suture 220 relative to catheter 218. The displacement provided between the points of securement of first suture 220 is sufficient to substantially minimize kinking, twisting, or other manipulation of catheter 218 that could result in damage to the patient tissue at catheter insertion site 226 resulting from movement of catheter 218. Additionally, extension saddle 244 provides a groove which accommodates catheter 218 to minimize kinking, pinching, or other pressure on catheter 218 from the transition over the top of rotatable ring 214.

[0104] The portion of catheter 218 positioned adjacent catheter insertion site 226 is secured by the first and second portions 222, 224 of the second suture 221. A part of the first portion 222 is positioned on the left side of rotatable ring 214, while another part of the first portion 222 is secured adjacent the right side of rotatable ring 214. One part of second portion 224 is secured adjacent the left side of rotatable ring 214, while another part of second portion 224 is secured adjacent the right side of rotatable ring 214. As a result, a total of four separate points of securement are provided at the portion of catheter 218 adjacent catheter insertion site 226 to minimize both lateral and forward and rearward movement of catheter 218 during usage of catheter anchor device 210. This provides a safe and reliable securement of catheter 218 during usage while also providing access to the catheter insertion site 226 for cleaning and care of the catheter and/or patient tissue at the catheter insertion site 226. In the illustrated embodiment, a plurality of scallops 242 is shown on rotatable ring 214. Scallops 242 facilitate gripping of rotatable ring during actuation of rotatable ring as shown in Figure 15. Scallops 242 comprise a concave depression in the outward surface of rotatable ring 214. By providing a concave depression in the outward surface of rotatable ring 214, scallops 242 provide gripping members which minimize any potential abrasion to the patient or practitioner utilizing anchor device 210.

[0105] The configuration of anchor device 210 and rotatable ring 214 allow for quick, simple, and effective securement of catheter 218 subsequent to placement of catheter 218 in a patient. This not only shortens the length of the catheter securement procedure and, thus, the entire catheter placement procedure, but also is sufficiently simple such that an assisting nurse or other caretaker can secure catheter 218 while the physician attends to other aspects of the procedure being performed. This is not only more efficient from the standpoint of operating room economics, but can also be quite helpful in time sensitive procedures such as in a trauma setting or emergency situation.

[0106] Figure 17 is an exploded view of rotatable ring 214 of anchor device 210 depicting a ratchet mechanism. In the illustrated embodiment, rotatable outer ring 230 and bearing members 234a, b are shown separated from base 232. Multiple pin members 264a-d (more clearly shown in Figure 19) are configured and arranged to be positioned in bearing members 234a, b to secure bearing members 234a, b to rotatable outer ring 230. [0107] In the embodiment illustrated in Figure 17, the disposition of sutures 220 and 221 relative to suture storage channel 240 prior to deployment is depicted. Particularly, sutures 220 and 221 are looped such that they are positioned inside suture storage channel 240. As a result, when the practitioner secures the anchor device 210 to the patient, the practitioner does not need to manage the positioning of sutures 220 and 221. Suture storage channel 240 in combination with a suture retention assembly 400 also maintains the particular desired loop formation of sutures 220 and 221 ensuring proper operation and/or deployment of sutures 220 and 221. The example suture retention assembly 400 helps maintain the sutures in position within the suture storage channel 240 during storage by covering at least a portion of the suture storage channel 240 to thereby reduce the likelihood of the sutures 220 and 221 leaving the suture storage channel 240 before the sutures 220 and 221 are deployed. [0108] In general, this example of the suture retention assembly 400 includes a retention element and a bias element. The retention element is an example of a structural implementation of a means for retaining the sutures within the suture storage channel 240. According to one example, the retention element comprises structure for covering at least a portion of the suture storage channel 240 to retain the sutures 220 and 221 within the suture storage channel 240. According to one example, the bias element is an example of a structural implementation of a means for biasing the retention element into a position where the retention element retains the sutures 220 and 221 within the suture channel 240. In one embodiment, the bias element comprises structure for helping maintain the retention element in contact with the suture channel 240, such that the retention element covers at least a portion of the suture channel. Further, the bias element may further server to urge the rotatable outer ring 214 away from the base 232. Particular examples of a retention element and a bias element will now be discussed in more detail. [0109] In the example illustrated in Figure 17, the retention element is a flat washer 402 and the bias element is a wave spring 404. The flat washer 402 and the wave spring 404 are positioned between the rotatable ring 230 and the suture storage channel 240. As will be discussed in more detail, in this example the wave spring 404 retains the sutures 220 and 221 within the suture storage channel 240 by covering at least a portion of the suture storage channel 240. In particular, the flat washer 402 is placed between wave spring 404 and the suture storage channel 240, while the wave spring 404 is placed between the flat washer 402 and the rotatable outer ring 230. The flat washer 402 may be sized such that a portion of the flat washer 402 is configured to rest on an inner lip of the suture storage channel 240. The flat washer 402 is further sized to cover a sufficient portion of the suture storage channel such that the sutures 220 and 221 are retained within the suture storage channel 240 until the sutures 220 and 221 are deployed. The inner lip of the suture storage channel may be relatively wide or flat to thereby provide a relatively flat surface on which the flat washer 402 sits to thereby increase contact between the flat washer 402 and the suture storage channel 240. Increasing the contact between the flat washer 402 and the suture storage channel 240 facilitates retention of the sutures 220 and 221 in the suture storage channel 240 to help ensure that the sutures 220 and 221 will remain in the particular desired loop formations. [0110] With continuing reference to Figure 17, the wave spring 404 provides a resilient biasing force against the flat washer 402 to help further ensure the flat washer 402 remains in contact with the suture storage channel 240. In particular, as previously discussed, the wave spring 404 and the flat washer 402 may be positioned between the suture storage channel 240 and the rotatable ring 230. When the flat washer 402 and wave spring 404 are thus positioned, and the rotatable ring 230 is coupled to the base 232, the wave spring 404 will be compressed. The compression causes the wave spring 404 to exert a biasing force on the flat washer 402, as previously discussed. The biasing force may help maintain the flat washer 402 in contact with the suture storage channel 240 and thereby help ensure the sutures 220 and 221 will remain in the particular desired loop formations. Retaining the sutures 220 and 221 in the desired loop formations may help ensure proper operation and/or deployment. [0111] In addition, such a configuration may reduce the friction of the rotatable outer ring 230 relative to base 232 and the suture storage channel 240 in particular. For example, the rotatable outer ring 230, the wave spring 404, the flat washer 402 and/or the suture storage channel 240 may each be formed of materials with low coefficients of friction, such as plastic materials. As a result, the frictional forces between one or more of these components as the rotatable outer ring 230 rotates relative the base 232 may be relatively low. Further, bearing members 234a, b likewise facilitate rotation of the rotatable outer ring 230. [0112] Specifically, with continued reference to the example illustrated in Figure 17, the bearing members 234a, b are configured to be positioned between rotatable outer ring 230 and base 232. Bearing members 234a, b contact base 232 beneath ratchet ring 236 such that bearing members 234a, b do not contact the teeth of ratchet ring 236. Similarly, bearing members 234a, b contact rotatable outer ring 230 beneath rotatable ratchet members 238a, b such that bearing members 234a, b do not contact the teeth of rotatable ratchet members 238a, b. As a result, bearing members 234a, b do not interfere with the cooperative engagement between ratchet members 238a, b and ratchet ring 236.

[0113] A lip on each of bearing members 234a, b extends inwardly beneath ratchet ring 236. When rotatable outer ring 230 is secured to bearing members 234a, b, the lateral positioning of bearing members 34a, b secures both bearing members 234a, b and rotatable outer ring 230 to base 232. Additionally, the positioning of bearing members 234a, b maintains ratchet members 238a, b in cooperative engagement with ratchet ring 236. In the illustrated embodiment, bearing members 234a, b include a securement member for securing the suture 221 during rotation of bearing members 234a, b.

[0114] As will be appreciated by those skilled in the art, a variety of types and configurations of bearing members can be utilized without departing from the scope and spirit of the present invention. For example, in one embodiment a circular bearing member is utilized in place of two bearing member segments. In another embodiment, one or more bearing members are integrally coupled to the rotatable outer ring. Tn yet another embodiment one or more bearing members are integrally coupled to the ratchet members. In another embodiment, the bearing members are positioned above the ratchet ring. In yet another embodiment, a liquid bearing mechanism is utilized. In another embodiment, a roller bearing mechanism is utilized. [0115] In the embodiment illustrated in Figure 17, first suture channels 252a, b are positioned through base 232 and exit at extension saddle 244. First suture 220 is configured to be positioned through first suture channels 252a, b such that the ends of first suture 220a, b extend from extension saddle 244. The extension of the ends of first suture 220a, b from the extension saddle 244 allows a user to grasp the ends of first suture 220a, b to actuate first suture 220.

[0116] Second suture channels 254a, b and third suture channels 256a, b are positioned through ratchet ring 236 and base 232. Bearing member suture channels 258a, b and 260a, b are positioned through bearing members 234a, b. The second suture 221 is looped to form the first and second portions 222, 224 that intersect at loop portion 221a. The loop portion 221a of the second suture is secured to the exterior of bearing member 234a. Next, the first and second portions 222, 224 of the second suture 221 are passed through bearing member 234a, then through the ratchet ring 236 and base 232. Next, the first and second portions 222, 224 have loops with knots formed therein, as discussed in more detail with reference to Figures 2OA and 2OB. Once the loops and knots have been formed in the first and second portions 222, 224 of second suture 221, the first and second portions 222, 224 are passed through bearing member 234b. In particular, a first end 222a of first portion 222 is threaded first through bearing member channel 260a in bearing member. 234a and through third suture channel 256a in ratchet ring 236 and base 232. The first end 222a of first portion 222 is then looped as desired and passed through second suture channel 254a in ratchet ring 236 and base 232. The first end 222a is then passed through bearing member channel 258a. A first end 224a of the second portion 224 is threaded first through bearing member channel 260b in bearing member 234b and through third suture channel 256b. The first end 224a of second portion 224 is then looped as desired and then passed through second suture channel 254b in ratchet ring 236 and base 232. Finally, the first end 224a of second portion 224 is threaded through bearing member channel 258b. The first ends 222a, 224a of the first and second portions 222, 224 of the second suture are then secured to the exterior of bearing member 234b.

[0117] Base 232 and ratchet ring 236 are stationary relative to the rotatable outer ring 230. As a result, second suture channels 254a, b and third suture channels 256a, b remain stationary during operation of rotatable ring 214. Bearing members 234a, b rotate in connection with rotatable outer ring 230. As a result, bearing member suture channels 258a, b and 260a, b rotate in connection with rotation of rotatable outer ring 230 and bearing member 234a, b.

[0118] When bearing members 234a, b rotate in a clockwise direction, the ends of second suture 221 are drawn around the outside diameter of base 232 beneath ratchet ring 236. As a result, the length of first suture 221 inside suture storage channel 240 is shortened. As the length of second sutures 221 inside suture storage channel 240 is shortened, the loops of suture 221 become smaller such that they can no longer fit in suture storage channel 240. This causes the suture 221 to be drawn over the inner lip of the suture storage channel 240. As the suture 221 is drawn over the inner lip of the suture storage channel 240, the suture 221 overcomes the biasing force the wave spring 404 applies to the flat washer 402. This results in automatic deployment of the loops from suture storage channel 240. [0119] With continued reference to Figure 17, rotatable ratchet members 238a, b engage the teeth of ratchet ring 236 to minimize counter clock-wise movement of rotatable ring 214 that would result in loosening of the suture 221. In one example, during rotation of rotatable outer ring 230, bearing members 234a, b and rotatable ratchet members 238a, b are rotated in a clock-wise direction about base 232 and ratchet ring 236 in particular. Rotatable ratchet members 238a, b engage the teeth of ratchet ring 236 as rotatable ratchet members 238a, b are advanced in the clock-wise direction. When a user discontinues rotation of rotatable outer ring 230, rotatable ratchet members 238a, b engage the teeth of ratchet ring 236 minimizing movement of rotatable outer ring 230 in a counter clock-wise direction that would otherwise loosen second suture 221.

[0120] Rotatable ratchet member 238a is positioned between bearing member 234a and rotatable outer ring 230. A pivot pin is positioned on the bottom surface of each of the rotatable ratchet members 238a, b. The pivot pins are positioned in rotation bores of the corresponding bearing members 234a, b to pivotally couple rotatable ratchet member 238a to bearing member 234a. In one example, rotatable outer ring 230 contacts the upper surface of rotatable ratchet member 238a to maintain contact between the pivot pins and the rotation bores.

[0121] The end of rotatable ratchet members 238a, b, positioned opposite the pivot point provided by the pivot pin of rotatable ratchet member 238a, b and the bore of bearing members 234a, b, includes a spring member and a plurality of teeth. The plurality of teeth engage the teeth of ratchet ring 236 to minimize movement of rotatable outer ring 230 and bearing members 234a, b in a counter clock-wise direction. This spring is provided by the cutaway portion in the head of rotatable ratchet members 238a, b and the resilient nature from the material from which the heads of rotatable ratchet members 238a, b are constructed. [0122] The suture retention assembly 400 may also help position the bearing members 234a, b relative to the base 232. As previously discussed, the flat washer 402 and the wave spring 404 are located between the suture storage channel 240 and the rotatable outer ring 230. The sutures storage channel 240 may be connected to or be part of the base 232. Further, when the rotatable outer ring 230 is coupled to the base 232, the wave spring 404 is compressed. In addition to exerting a force on the flat washer 402, the wave spring 404 also exerts a force against the rotatable outer ring 230. With reference to the example illustrated in Figure 17, this force urges the rotatable outer ring 230 away from the base 232.

[0123] The lip on each of the bearing members 234a, b extends beneath the ratchet ring 236. The lip prevents the bearing members 234a, b and rotatable outer ring 230 from disengaging from the base 232. In particular, the lip engages the ratchet ring 236 as the rotatable outer ring 230 and bearing members 234a, b are urged away from the base 232 by the wave spring 404. Accordingly, the suture retention assembly 400 helps maintain the position of the sutures 220 and 221 within the suture storage channel 240. By maintaining the position of first suture 220 and second suture 221, disruption of the sutures before deployment of the sutures is minimized, and reliable and proper operating of anchor device 210 is maintained. As a result, the suture retention assembly 400 provides a simple and reliable mechanism for storing first suture 220 and second suture 221 beneath rotatable ring 214 during storage of anchor device 210 until such time as the sutures 220 and 221 are required to be retracted from the suture storage channel 240.

[0124] Figure 18A and 18B are perspective views of base 232 during molding of base 232. In the illustrated embodiment, base 232 comprises a single molded member formed utilizing first and second mold members 246 and 248. Base 232 comprises a ratchet ring 236 and an extension saddle 244. In the illustrated embodiment, base 232 includes an undercut 239 positioned between ratchet ring 236 and base flange 237. Undercut 239 substantially complicates the molding of base 232. As a result, first mold member 246 and second mold member 248 are utilized to provide the undercut 239 during the molding of base 232. For the sake of clarity, the other mold members utilized to form base 232 have not been illustrated to more clearly depict operation of first mold member 246 and second mold member 248. [0125] In the illustrated embodiment, first mold member 246 comprises mold member interfaces 247a, b, an inner circumference 250, and a gripping handle 253. Second mold member 248 comprises mold member interfaces 249a, b, an inner circumference 251, and gripping handle 255. During molding, mold member interfaces 247a, b of first mold member 246 contact mold member interfaces 249a_; b of second mold member 248. Inner circumference 250 of first mold member 246 and inner circumference 251 of second mold member 248 form the undercut 239 positioned between ratchet ring 236 and base flange 237. Inner circumference 250 and inner circumference 251 define the inner boundary of undercut 239. The top portion of first mold member 46 and second mold member 248 define the upper lateral surface extending from the innermost horizontal surface of undercut 239 (not shown) to the edge of ratchet ring 236. The bottom of first mold member 246 and second mold member 248 form the lower horizontal surface which extends from the inner vertical surface of undercut 239 (not shown) and extends outwardly to be coextensive with base flange 237. [0126] In one embodiment, the surfaces of undercut 239 are slightly flared or tapered to allow for proper releasing of first mold member 246 and second mold member 248 such that when gripping handles 253 and gripping handle 255 are used to pull the first mold member 246 and second mold member 248 apart, first mold member and second mold member 246, 248, automatically release and can easily be slid from undercut 239. In this manner, base 232 can be molded in single member ensuring continuity of surfaces and reliable and proper operation of the components of base 232 during use of anchor device 210. [0127] As will be appreciated by those skilled in the art, a variety of types and configurations of mechanisms can be utilized to mold base 232 in a unitary fashion without departing from the scope and spirit of the present invention. For example, first and second mold members which are configured to be automatically retracted by an automated molding apparatus or other machinery can be utilized. In another embodiment, a single mold member which is hinged, bendable, meltable or otherwise manipulable to remove the mold member from undercut 239 is utilized, In another embodiment, mold members having different form, size, and/or surfaces can be utilized. In another embodiment, more than two mold members are utilized to form the undercut and/or other portions of the base during molding. [0128] Figure 19 is a bottom exploded view illustrating the manner in which the components of anchor device 210 are secured during assembly. In the illustrated embodiment, rotatable outer ring 230, rotatable ratchet member 238a, bearing member 234a, and base 232 are depicted. Bearing members 234a, b are configured to be sandwiched between rotatable outer ring 230 and base 232. Rotatable ratchet members 238a, b are configured to be positioned between bearing members 234a, b and rotatable outer ring 230. Bearing members 234a, b are configured to be attached directly to rotatable outer ring 230 while being slidable relative to base 232. Pins 264a-d are positioned on the underside of rotatable outer ring 230 engage securement bores 266a-d of bearing members 234a, b. Bearing members 234a, b and base 232 maintain contact between securement bores 266a-d and pins 264a-d. In the illustrated embodiment, pins 264a, b are configured to be snapped to or otherwise pressed or swaged into engagement with securement bores 266a, b to couple bearing member 234a to rotatable outer ring 230 subsequent to assembly of rotatable outer ring 230 and base 232. Pins 264c, d are configured to be snapped or otherwise secured to securement bores 266c, d to integrally couple bearing member 234b to rotatable outer ring 230 subsequent to assembly of rotatable outer ring 230 and base 232. In one example, the pins are formed with enlarged heads. The enlarged heads provide a rivet function in that when pressed through bearing members 234a, b, the heads lock the rotatable outer ring to the bearing members 234a, b. In addition, ultrasound or thermal deformation may be used to lock the pins 264c, d into the base 232. A plurality of access bores 268a-d are provided in connection with base 232 such that the welding tool can be inserted through access bores 268a-d to weld pins 264a-d to securement bores 266a-d of bearing members 234a, b.

[0129] Rotatable ratchet members 238a, b are positioned, respectively, between bearing members 234a, b and rotatable outer ring 230. In the illustrated embodiment, the pivot pins 269 are positioned on the upper surface of bearing members 234a, b. The pivot pin 269 is positioned in rotation bores 265 to pivotally couple rotatable ratchet members 238a, b to bearing members 234a, b. Rotatable outer ring 230 contacts the upper surface of rotatable ratchet members 238a, b to maintain contact between the pivot pins 269 and rotation bores 265. Additionally, the outer horizontal portion of the rotatable outer ring 230, which extends downward adjacent rotatable ratchet members 238a, b, allows lateral movement of the free end of rotatable ratchet members 238a, b to ensure proper operation and contact between the teeth of rotatable ratchet members 238a, b and the teeth of ratchet ring 236 (illustrated in Figures 18A and 18B). In one example, the components discussed above may be positioned relative to each other and then snapped into place. Such a configuration may increase the manufacturability of the anchor device 210.

[0130] As will be appreciated by those skilled in the art, a variety of types and configurations of mechanisms for securing the components of the rotatable ring can be utilized without departing from the scope and spirit of the present invention. For example, in one embodiment, the bearing member is configured to be snapped to the rotatable outer ring before assembly with the base. In another embodiment, a snap fitting is provided between the bearing member and the rotatable outer ring. In another embodiment, a continuous bearing member is integrated with the base 32 while the rotatable ratchet member is secured independently to the rotatable outer ring. In yet another embodiment, a surface is provided on the bearing member to maintain proper operation of the rotatable ratchet member. [0131] Figures 2OA and 2OB illustrate loading of the sutures utilized with anchor device, according to one embodiment of the .present invention. In particular, as seen in Figure 2OA, base 232 of anchor device 210 is mounted on a loading block 270. The anchor device 210 is positioned over the center bore 271 of loading block 270. First suture 220 is partially loaded into the base 232. More specifically, the ends 220a, b of first suture 220 are threaded from the interior of the ratchet ring 236 through the base 232 to extend beyond the extension saddle 244. The loop portion 220c of first suture 220 is looped about the perimeter of the base 232. The ends 220a, b of the first suture 220 may be threaded through the extension saddle 244 either before or after the base 232 is mounted to a loading block 270. Thereafter, the second suture 221 may be loaded. [0132] As illustrated in Figure 2OB, a suture loading cylinder 272 is positioned through center bore 271 (Figure 20A) such that the wall of the suture loading cylinder 272 is positioned adjacent the inner portion of ratchet ring 236. Suture loading cylinder 272 is utilized to provide a quick and effective mechanism for forming the loop configurations of first suture 220 and second suture 221 and for loading the sutures 220, 221 in base 232. [0133] In the illustrated embodiment, the loops of second suture 221 are being formed around suture loading cylinder 272. First suture 220 has previously been located about the perimeter of base 232. Initially, the second suture 221 is doubled over to form the first and second portions 222, 224 that are connected by a loop portion 221a. More particularly, as illustrated in Figure. 17, the first end 222a of first portion 222 is threaded first through bearing member channel 260a in bearing member 234a and through third suture channel 256a in the ratchet ring 236 and base 232. A first end 224a of the second portion 224 is threaded first through bearing member channel 260b in bearing member 234a and through third suture channel 256b in the ratchet ring 236 and base 232. Returning to Figure 20B, after the first ends 222a, 224a, of the first and second portions 222, 224 of the second suture 221 have been threaded through the ratchet ring 236 and base 232, loops are formed in the first second portions 222, 224. One loop is substantially formed by wrapping the length of first portion 222 about suture loading cylinder 272 in a manner so as to produce the desired loop configuration in the first portion 222 of the second suture 221. The second portion 224 is also wrapped to form the desired loop configuration. Once the loops have been formed in the first and second portion 222, 224, the ends 222a, 224a of the second suture 221 are threaded through the ratchet ring 236 and base 232 and then the bearing member 234b and secured. [0134] As the loops of first and second portions 222, 224 are drawn tight and the loop portion 221a is secured relative to bearing members 234a and base 232, the loops of the first and second portions 222, 224 of the second suture 221 are automatically drawn down such that both the first and second portions 222, 224 are loaded within ratchet ring 236 in the desired position for deployment. Once second suture 221 has been loaded into the base 232, additional loops or knots may be formed in the first suture 220 using the suture loading cylinder 272. The first suture 220 may then be drawn tight such that the first suture 220 is drawn into the suture storage channel 240. As will be appreciated by those skilled in the art, similar steps, acts, and processes are utilized to load first suture 220 and second portion 224. The discussion of the formation of loops in the second suture and the loading of second suture 221 in base 232 is for illustrative purposes and should in no way be considered to be limiting in nature. [0135] Once first suture 220 and second suture 221 have been properly loaded in storage channel 240, the flat washer 402 is positioned over the top of suture loading cylinder 272. The flat washer 402 is lowered along the length of suture loading cylinder 272 until the flat washer 402 is positioned along the inner circumference of ratchet ring 236, effectively maintaining the position of first suture 220 and second suture 221 in their desired position within storage channel 240. Next, the wave spring 404 is lowered along the length of the suture loading cylinder 272 until the wave spring 404 is positioned on the flat washer 402. Once the flat washer 402 and wave spring 404 have been properly positioned within base 232, suture loading cylinder 272 is withdrawn and rotatable outer ring 230 is lowered into engagement with base 232 as discussed with respect to Figure 19. The proper steps can then be taken to couple rotatable outer ring 230 to bearing members 234a, b as discussed with respect to Figure 19.

[0136] As will be appreciated by those skilled in the art, a variety of types and configurations of mechanisms for loading the sutures in the suture storage channel can be utilized without departing from the scope and the spirit of the present invention. For example, in one embodiment, a loading block and suture loading cylinder are utilized to manually load the sutures in the anchor device. In another embodiment, the loading block and suture loading cylinder are utilized with automated processes to load the sutures into the base or other component of the anchor device.

[0137] Figures 21A and 21B illustrate rotatable ratchet member 238b in operation with respect to ratchet ring 236. While rotatable ratchet member 238b is shown for illustrative purposes, it will be understood by those skilled in the art that operation of rotatable ratchet member 238b also is exemplary of rotatable ratchet member 238a (see Figure 17.) In the illustrated embodiment, rotatable ratchet member 238b is rotatably coupled to bearing member 234b utilizing pivot pin 269 and rotation bore 265 of rotatable ratchet member 238b. Rotatable ratchet member 238b engages the teeth of ratchet ring 236 to minimize counterclockwise movement of rotatable ring 214 that would result in loosening of the second suture 221 (not shown). Rotatable ratchet member 238b is secured to bearing member 234b by pivot pin 269 located between the upper surface of bearing member 234b and the bottom surface of rotatable outer ring 230 (see Figure 17). Pivot pin 269 is positioned in the rotation bore 265 of rotatable ratchet member 238b such that rotatable ratchet member 238b can pivot about pivot pin 269.

[0138] The rotatable ratchet member 238b is held in place relative to bearing member 234b by being sandwiched between bearing member 234b and rotatable outer ring 230 (see Figure 17). Thus, during rotation of rotatable outer ring 230 (see Figure 17), bearing member 234b and rotatable ratchet member 238b are rotated in a clock-wise direction about ratchet ring 236. Rotatable ratchet member 238b engages the teeth of ratchet ring 236 as rotatable ratchet member 238b is advanced in the clock-wise direction. When a user discontinues rotation of the rotatable outer ring 230, rotatable ratchet member 238b engages the teeth of ratchet ring 236 minimizing movement of rotatable outer ring 230 in a counter clock-wise direction that would otherwise loosen the sutures.

[0139] The end of rolatable ratchet member 238b positioned opposite the rotation bore 265 and pivot pin 269 includes a ratchet member engagement spring 278 and rotatable ratchet member teeth 276, Rotatable ratchet member teeth 276 engage the ratchet ring teeth 274 to minimize movement of the rotatable outer ring 230 and bearing member 234b in a counter clock-wise direction. Ratchet member engagement spring 278 is provided by the cutaway portion in the head of rotatable ratchet member 238b. The nature of the material from which the head of rotatable ratchet member 238b is constructed provides sufficient resilience to undergo deformation while maintaining contact between rotatable ratchet member teeth 276 and ratchet ring teeth 274.

[0140] As the rotatable ratchet member teeth 276 slide over ratchet ring teeth 274, ratchet member engagement spring 278 flexes slightly to maintain contact between rotatable ratchet member teeth 276 and ratchet ring teeth 274. This is caused by the ramp-like configuration of rotatable ratchet member teeth 276 and ratchet ring teeth 274. When the rotatable ratchet member teeth 276 pass over the outer most ridge of ratchet ring teeth 274 such that they engage new teeth, ratchet member engagement spring 278 forces the rotatable ratchet member teeth 276 toward the center of the anchor device 210, thus maintaining engagement with ratchet ring teeth 274. As previously introduced, according to one embodiment, the rotatable ratchet members 238a, b may be integral with the bearing members 234a, b. [0141] Figures 22A and 22B illustrate an integral ratchet and bearing member 290 engaged with a ratchet ring 236. As illustrated in Figured 22A, the integral ratchet and bearing member 290 includes a bearing member portion 292 and a ratchet portion 294. In one embodiment, the ratchet portion 294 is integrally formed with the bearing member 292, such that the bearing member portion 292 and the ratchet portion 294 are a single piece. The ratchet portion 294 includes ratchet teeth 296. Ratchet teeth 296 engage the ratchet ring teeth 274 to minimize movement of the ratchet and bearing member 290 in a counter clock-wise direction. The material from which the ratchet 21 1 portion 294 is constructed provides sufficient resilience to undergo deflection while maintaining contact between ratchet teeth 296 and ratchet ring teeth 274.

[0142] For example, in the configuration illustrated in Figure 22A, the ratchet portion 294 is partially deflected. In particular, in the absence of contact with the ratchet ring 236, the portion of the ratchet portion 294 that includes ratchet teeth 296 would be closer to the center of the anchor device 210. Positioning the ratchet portion 294 relative to the ratchet ring 236 results in the partial deflection of the ratchet portion 294. The partial deflection of the ratchet portion 294 provides a biasing force that helps maintain the contact between ratchet teeth 296 and ratchet ring teeth 274 as shown in Figure 22A. The ratchet portion 294 is also configured to be further deflected, as illustrated in Figure 22B.

[0143] As the ratchet teeth 296 slide over ratchet ring teeth 274, the ratchet portion 294 is further deflected. As the ratchet portion 294 is further deflected, the tendency of the ratchet portion 294 to move toward an undeflected position helps maintain contact between rotatable ratchet teeth 296 and ratchet ring teeth 274. When the ratchet teeth 296 pass over the outermost ridge of ratchet ring teeth 274 such that the ratchet teeth 296 engage new ratchet ring teeth 274, the tendency of the ratchet portion 294 to return to an undeflected position forces the ratchet teeth 296 toward the center of the anchor device 210, thus maintaining engagement with ratchet ring teeth 274.

[0144] As will be appreciated by those skilled in the art, a variety of types and configurations of rotatable ratchet members can be utilized without departing from the scope and spirit of the present invention. For example, in one embodiment, the rotatable ratchet members prevent rotation of a rotatable ring in a clock-wise direction. In another embodiment, the rotatable ratchet members prevent backward movement of a nonrotational actuation member. In another embodiment, a secondary spring separate from the body of the rotatable ratchet member provides the spring movement of all or part of the rotatable ratchet member. [0145] The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims

CLAIMS What is claimed is:

1. A catheter anchor device, the catheter anchor device comprising: an adhesive element configured to be secured to the skin of the patient proximate a catheter insertion site; a stationary base secured to the adhesive element; a rotatable ring coupled to the stationary base such that the rotatable outer ring can be rotated by a user relative to the stationary base; a first suture coupled to the rotatable ring, the first suture including a loop portion and first and second ends, the loop portion extending about a catheter when the anchor device is in place relative to the catheter insertion site; and a pull handle including first and second separable portions, and the pull handle being coupled to the first and second ends of the first suture, the pull handle being configured to selectively tension the first suture.

2. The catheter anchor device of claim 1, wherein the first and second ends of the first suture are coupled to the first and second separable portions respectively.

3. The catheter anchor device of claim 2, wherein the pull handle includes perforations defining a boundary between the first and second separable portions.

4. The catheter anchor device of claim 1, wherein each separable portion includes a generally arcuate gripping portion.

5. The catheter anchor device of claim 1, wherein the pull handle comprises a plastic material.

6. The catheter anchor device of claim 1, wherein the first and second pull separable portions include respective interlocking features such that coupling the first and second separable portions can be detached from each other.

7. The catheter anchor device of claim 6, wherein the first and second separable portions can be selectively reattached to each other.

8. The catheter anchor device of claim 1, wherein the first and second separable portions comprise at least first and second pull tabs.

9. The catheter anchor device of claim 1 , further comprising additional sutures coupled to the rotatable ring such that a predetermined rotation of the rotatable ring corresponds with a tensioning of the one or more sutures about the catheter.

10. The catheter anchor device of claim 7, wherein a portion of each of the sutures is stored in a suture storage channel previous to tensioning of the sutures.

11. The catheter anchor device of claim 7, wherein the suture storage channel is positioned in the stationary base.

12. The catheter anchor device of claim 7, wherein the suture storage channel is positioned in the rotatable ring.

13. The catheter anchor device of claim 7, wherein the suture storage channel comprises a flexible flange.

14. The catheter anchor device of claim 12, further comprising an O-ring, wherein the O-ring secures the sutures in the suture storage channel in cooperation with the flexible flange.

15. The catheter anchor device of claim 14, further comprising a backup ring, the backup ring being interposed between the rotatable ring and the O-ring.

16. The catheter anchor device of claim 1, wherein each pull tab has at least one aperture defined therein sized to accommodate at least a portion of a finger of a user.

17. The anchor device of claim 1, wherein the pull handle is substantially symmetrical about a predetermined axis.

18. A catheter anchor device, the catheter anchor device comprising:

a base; a rotatable ring coupled to the base and arranged for movement relative to the base; and a first suture and additional sutures coupled to the rotatable ring, the first suture including a loop portion and first and second ends, the loop portion looping around a catheter when the anchor device is in place relative to a catheter insertion site, the first suture being arranged relative to the base and catheter such that a predetermined rotation of the rotatable ring corresponds with a relative increase in tension of the first suture about the catheter; means for tensioning a suture, the means serving to enable tensioning of at least one suture about the catheter; and a ratchet mechanism operably disposed with respect to the rotatable ring, the ratchet mechanism comprising a rotatable ratchet member which maintains cooperative engagement of the components of the ratchet mechanism such that the rotatable ring is rotatable in a first direction and is not rotatable in a second direction.

19. The catheter anchor device of claim 18, wherein the means for tensioning a suture comprises a pull handle.

20. The catheter anchor device of claim 19, wherein the pull handle comprises first and second separable portions.

21. The catheter anchor device of claim 20, wherein the separable portions are coupled respectively to the first and second ends of the first suture

22. The catheter anchor device of claim 19, wherein the pull handle is formed from at least one of paper or plastic.

23. The catheter anchor device of claim 18, further comprising an adhesive element attached to the base.

24. A catheter anchor device for use with a catheter, the anchor device comprising: an adhesive layer configured to be secured to the skin of the patient proximate the catheter insertion site that allows access to the catheter insertion site and permits a practitioner to view and clean the catheter insertion site; a stationary base secured to the adhesive layer; a rotatable ring circumscribing the stationary base such that the rotatable outer ring can be rotated by the user relative to the stationary base; one or more sutures coupled to the rotatable ring such that actuation of the rotatable ring actuates the one or more sutures to secure the catheter relative to the rotatable ring; and a suture retention assembly disposed between the sutures and the rotatable ring, the suture retention assembly including a retention element and a bias element.

25. The catheter anchor device of claim 24, wherein the sutures are stored in a suture storage channel previous to deployment of the sutures.

26. The catheter anchor device of claim 25, wherein the suture storage channel is positioned in the stationary base.

27. The catheter anchor device of claim 25, wherein the suture storage channel is positioned in the rotatable ring.

28. The catheter anchor device of claim 25, wherein the suture storage channel comprises a flexible flange.

29. The catheter anchor device of claim 28, wherein the suture retention assembly secures the sutures in the suture storage channel in cooperation with the flexible flange.

30. The catheter anchor device of claim 24, wherein retention element comprises a flat washer.

31. The catheter anchor device of claim 24, wherein the bias element comprises a wave spring.

32. The catheter anchor device of claim 25, wherein the retention element covers at least a portion of the suture storage channel during storage of the one or more sutures.

33. The catheter anchor device of claim 24, further comprising: a ratchet ring coupled to the stationary base; and at least one rotatable ratchet member coupled to the rotatable ring, wherein the bias element urges the rotatable ratchet member into engagement with the ratchet ring.

34. The catheter anchor device of claim 33, further comprising at least one bearing member coupled to the rotatable ring and wherein the rotatable ratchet member is integrally formed with the bearing member.

35. The catheter anchor device of claim 34, wherein the rotatable ratchet member is configured to be deflected to bias the rotatable ratchet member into engagement with the ratchet ring.

36. A catheter anchor device for use with a catheter, the anchor device comprising: a stationary base secured to the patient; a rotatable ring circumscribing the stationary base such that the rotatable outer ring can be rotated by the user relative to the stationary base; one or more sutures coupled to the rotatable ring such that actuation of the rotatable ring actuates the one or more sutures to secure the catheter relative to the rotatable ring; a ratchet mechanism utilized in connection with the rotatable ring, the ratchet mechanism comprising a rotatable ratchet member which maintains cooperative engagement of the components of the ratchet mechanism allowing movement of the rotatable ring in a first direction while securing the rotational position of the rotatable ring against movement in a second direction; means for retaining the one or more sutures in a desired location relative to the base; and means for biasing, the means for biasing cooperating with the means for retaining to aid in retention of the one or more sutures in a desired location relative to the base.

37. The catheter anchor device of claim 36, wherein the rotatable ratchet member comprises a spring.

38. The catheter anchor device of claim 36, wherein the rotatable ratchet member comprises a resilient component

39. The catheter anchor device of claim 36, wherein the rotatable ratchet member includes a pivot point at one end and one or more teeth at the opposing end.

40. The catheter anchor device of claim 39, wherein the ratchet mechanism comprises one or more stationary teeth and wherein the teeth of the rotatable ratchet member pass over the stationary teeth during movement of the rotatable ring.

41. The catheter anchor device, of claim 40, wherein the rotatable ratchet member allows biasing of one or more components of the ratchet mechanism allowing the one or more teeth of the rotatable ratchet mechanism to pass over the stationary teeth while maintaining contact between the one or more teeth of the rotatable ratchet mechanism and the stationary teeth.

42. The catheter anchor device of claim 41, wherein the rotatable ratchet member comprises a pivot point which allows for movement of the one or more teeth of the rotatable ratchet mechanism allowing passage of the one or more teeth of the rotatable ratchet mechanism over the stationary teeth.

43. The catheter anchor device of claim 41, wherein a rotatable ratchet member engagement spring is positioned adjacent the one or more teeth of the rotatable ratchet mechanism to maintain contact between the one or more teeth of the rotatable ratchet mechanism and the stationary teeth.

44. The catheter anchor device of claim 43, wherein the rotatable ratchet member engagement spring comprises a resilient component of the head of the rotatable ratchet member which deforms as the teeth of the rotatable ratchet member pass over the stationary teeth.

45. The catheter anchor device of claim 36, wherein the means for biasing experts a force on the rotatable outer ring in a direction away from the stationary base.