WO2018011664A1

WO2018011664A1 - Asymmetric stapler heads and applications thereof

Info

Publication number: WO2018011664A1
Application number: PCT/IB2017/053965
Authority: WO
Inventors: Simon Robinson; Avraham Rami Lore; Ronny Winshtein
Original assignee: Stepwise Ltd
Priority date: 2016-07-12
Filing date: 2017-06-30
Publication date: 2018-01-18

Abstract

Surgical staplers and stapler heads for use in laparoscopic surgeries and related medical applications. Disclosed are various embodiments of asymmetric surgical stapler heads and applications thereof. Exemplary embodiments include, among several features, at least one of a particularly structured and functional: tissue cutting mechanism; stapler head jaw surface that stretches across the stapler head blade; and stapler head jaws strengthening mechanism that selectively provides additional support, strengthening, or/and power, to the asymmetric surgical stapler head jaws.

Description

ASYMMETRIC STAPLER HEADS AND APPLICATIONS THEREOF

RELATED APPLICATION

This application claims the benefit of priority under 35 USC 119(e) of U.S. Provisional Patent

Application No. 62/361 ,006, filed July 12, 2016, entitled "Asymmetric Stapler Heads", the contents of which are incorporated herein by reference in their entirety.

FIELD OF THE INVENTION

The present invention, in some embodiments thereof, relates to laparoscopic surgical instrumentation, and more particularly, but not exclusively, to surgical staplers and stapler heads configured for use in laparoscopic surgeries and related medical applications.

BACKGROUND OF THE INVENTION

There is a growing trend towards designing surgical tools with smallest possible diameters while maintaining, or possibly also improving, functionality for surgical practice. In cases of minimally invasively introduced laparoscopic tools, smaller diameters may contribute to smaller incisions or cuts made to the skin and soft tissues underneath. In cases of natural orifice (e.g., oral) introduction of endoscopic tools, smaller diameters may contribute to the possibility or/and ease to add more tools or other, larger, tools in parallel, via the natural orifice.

In past years this trend also encompasses design efforts of surgical staplers, including disposable or reusable linear staplers and endo cutter staplers. Endoscopic surgical staplers are commonly introduced through laparoscopic ports being 12 mm or more in diameter, so there is a need to provide smaller designs introducible through natural orifices or through laparoscopic ports being 8 mm or less, or even about 6 mm or less, in diameter. Some prior art teachings focus on different ways of configuring staples (e.g., as relating to staple size dimensions), and applying staples (e.g., by attaching staples to and through tissue walls), which enable staplers to have smaller overall sizes. Such prior art teachings are found for example in U.S. Patent Nos. 8,556,935; 8,403,956; and 8,365,973, the disclosures of which are fully incorporated herein by reference.

Additional exemplary prior art teachings are as follows.

PCT International Patent Application Publication No. WO 2015/140730, by the same applicant of the present invention, includes teachings about convertible surgical tissue staplers having small sizes and high suitability for introduction and delivery through small surgical incisions or cuts, natural orifices, or laparoscopic ports, followed by deployment to full operational configurations. Also disclosed therein are methods of surgically fastening or/and cutting tissue inside a body, for example, using a linear tissue stapler, and of deploying a linear tissue stapler to operational form.

PCT International Patent Application Publication No. WO 2016/042475, by the same applicant of the present invention, includes teachings about tissue staplers and stapler heads for surgically fastening and cutting a bodily tissue or/and organ. Also disclosed therein are methods for surgically fastening and cutting a bodily tissue or/and organ.

In spite of these and other teachings in the field and art of the invention, there is need for developing and implementing new or/and improved surgical staplers and stapler heads configured for use in laparoscopic surgeries.

SUMMARY OF THE INVENTION

The present invention, in some embodiments thereof, relates to laparoscopic surgical instrumentation, and more particularly, but not exclusively, to surgical staplers and stapler heads configured for use in laparoscopic surgeries and related medical applications. Disclosed are various exemplary embodiments of asymmetric surgical stapler heads and applications thereof. Exemplary embodiments include, among several features, at least one of a particularly structured and functional: tissue cutting mechanism; stapler head jaw surface that stretches across the stapler head blade; and stapler head jaws strengthening mechanism that selectively provides additional support, strengthening, or/and power, to the asymmetric surgical stapler head jaws.

According to an aspect of some embodiments of the present invention, there is provided an asymmetric surgical stapler head, comprising: a first jaw pivotally connected and opposing to a second jaw with a jaws closing mechanism configured to facilitate closing of the first jaw against the second jaw, for holding a tissue therebetween; and a tissue cutting mechanism comprising a blade, a pusher connected to the blade and configured to selectively push the blade distally along the asymmetric stapler head for cutting the tissue when held between the first and second jaws, and a lateral extension having an oblique contact surface emerging from the pusher or the blade; wherein the first jaw includes a first slot and the second jaw includes a second slot extending parallel to and juxtaposing the first slot, such that, when the first jaw is closed against the second jaw, the blade is slidable in and along both of the first and second slots; and wherein the first slot is laterally opened to a recessed channel configured as a support track having an oblique sliding surface sized and angled to mate with, and provide support to, the oblique contact surface, so as to allow the blade to slide along, and be suspended from, the oblique sliding surface. According to some embodiments of the invention, the second slot is opened at both sides to a transverse track sized and shaped to allow passing therethrough of a blade fixating member located opposite the lateral extension and extending from both sides of the blade.

According to some embodiments of the invention, the lateral extension in the tissue cutting mechanism includes a hooked projection being angled backwards and forming an acute angle with a blade lateral surface of the blade.

According to some embodiments of the invention, the lateral extension and the blade fixating member are configured to force the first and second jaws to move apart a maximal distance therebetween, thereby facilitating grasping of the tissue between the first and second jaws.

According to some embodiments of the invention, the oblique contact surface has a contact area for supporting a maximal force generatable by the lateral extension and the blade fixating member at the grasping. According to some embodiments of the invention, the oblique contact surface has a contact area in a range of between 5 mm² and 25 mm². According to some embodiments of the invention, the oblique contact surface has a width in a range of between 0.1 mm and 0.5 mm.

According to some embodiments of the invention, one of the first and second jaws is configured for dispensing staples and another of the first and second jaws includes an anvil configured for bending the staples when the staples are compressed against the anvil.

According to some embodiments of the invention, the first and second slots extend off-center relative to, and along a length of, the asymmetric surgical stapler head, thereby dividing the asymmetric stapler head into a first, narrow, section and a second, wide, section.

According to some embodiments of the invention, the first section has a width equal to or less than 3 mm.

According to an aspect of some embodiments of the present invention, there is provided an asymmetric surgical stapler head, comprising: a blade, and a first jaw pivotally connected and opposing to a second jaw with a jaws closing mechanism configured to facilitate closing of the first jaw against the second jaw, for holding a tissue therebetween; wherein the first jaw includes a first slot and the second jaw includes a second slot extending parallel to and juxtaposing the first slot, such that, when the first jaw is closed against the second jaw, the blade is slidable in and along both of the first and second slots; and wherein the second jaw includes a first sloped surface stretching across the blade, the blade is configured and arranged to pass through the first sloped surface whereby, when sliding over the tissue held between the first and second jaws, the blade cuts the tissue along a cutting line that projects over the first sloped surface.

According to some embodiments of the invention, the first sloped surface forms a slope angle with lower portions of the first and second tissue contact surfaces, the slope angle being equal to or less than 45 °. According to some embodiments of the invention, the first sloped surface has a width in a range of between about 0.1 mm and about 2 mm.

According to some embodiments of the invention, the second jaw further includes: a first longitudinal section having a first tissue contact surface extending between the second slot and a closer side of the second jaw; and a second longitudinal section having a second tissue contact surface extending between the second slot and a farther side of the second jaw; wherein one of the first and second tissue contact surfaces is elevated relative to other one of the first and second tissue contact surfaces, and the first sloped surface connects the first tissue contact surface to the second tissue contact surface.

According to some embodiments of the invention, the first sloped surface extends from a first side of the second jaw to a corner point located across the blade, and the second jaw includes a second sloped surface extending between a second side of the second jaw to the corner point.

According to some embodiments of the invention, the intersection between the first sloped surface and the second sloped surface forms an angle equal to or greater than 90 °.

According to some embodiments of the invention, the first jaw includes a first tissue contact surface and a second tissue contact surface, wherein, when the first jaw is closed against the second jaw, the first tissue contact surface extends above and parallel to the first sloped surface and the second tissue contact surface extends above and parallel to the second sloped surface.

According to an aspect of some embodiments of the present invention, there is provided an asymmetric surgical stapler head, comprising: a first jaw, a second jaw, and a loose pivot connection configured for connecting between the first and second jaws; a jaws closing mechanism configured to facilitate closing of the first jaw against the second jaw, for compressing a tissue therebetween; and a jaws strengthening mechanism configured to selectively provide mechanical advantage in producing a compression force between the first and second jaws, when the first jaw is closed against the second jaw.

According to some embodiments of the invention, the asymmetric surgical stapler head is transformable between a delivery configuration, wherein the second jaw is provided distally to the first jaw, to an operational configuration, wherein the first jaw juxtaposes and opposes the second jaw and is pivotally movable relative thereto.

According to some embodiments of the invention, the jaws strengthening mechanism includes a push-rod, and a push-rod driver operatively connected to the push-rod and configured to selectively drive the push-rod, to thereby engage and push, via an acute angle, a distal portion of one of the first and second jaws, so as to increase the compression force between the first and second jaws.

According to some embodiments of the invention, the first and second jaws are asymmetrically shaped in cross sections thereof, wherein the push-rod is arranged for engaging the jaw distal portion at a pre-defined off-centered location, for diminishing torsion stresses when producing the compression force.

According to some embodiments of the invention, the jaws strengthening mechanism includes a clamp, and a clamp driver operatively connected to the clamp and configured to selectively drive the clamp, to thereby engage and compress around the first and second jaws, so as to increase the compression force between the first and second jaws.

All technical or/and scientific words, terms, or/and phrases, used herein have the same or similar meaning as commonly understood by one of ordinary skill in the art to which the invention pertains, unless otherwise specifically defined or stated herein. Exemplary embodiments of methods (steps, procedures), apparatuses (devices, systems, components thereof), equipment, and materials, illustratively described herein are exemplary and illustrative only and are not intended to be necessarily limiting. Although methods, apparatuses, equipment, and materials, equivalent or similar to those described herein can be used in practicing or/and testing embodiments of the invention, exemplary methods, apparatuses, equipment, and materials, are illustratively described below. In case of conflict, the patent specification, including definitions, will control.

Implementation of some embodiments of the invention can involve performing or completing selected tasks manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of some embodiments of the invention, several selected tasks could be implemented by hardware, by software, by firmware, or a combination thereof, using an operating system.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

Some embodiments of the present invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative description of some embodiments of the present invention. In this regard, the description taken together with the accompanying drawings make apparent to those skilled in the art how some embodiments of the present invention may be practiced.

In the drawings:

FIGs. 1A and 1 B schematically illustrate different views of an exemplary surgical stapler having an asymmetric surgical stapler head, according to some embodiments of the invention;

FIGs. 2A and 2B schematically illustrate cross sectional front views of an exemplary asymmetric surgical stapler head configured for being equipped with a tissue cutting mechanism, wherein FIG. 2A shows the asymmetric surgical stapler head without the tissue cutting mechanism and FIG. 2B shows the asymmetric surgical stapler head with the tissue cutting mechanism, according to some embodiments of the invention;

FIGs. 3A and 3B schematically illustrate a perspective view (FIG. 3A) and a cross-sectional front view (FIG. 3B) of an exemplary asymmetric surgical stapler head, according to some embodiments of the invention;

FIGs. 4A - 4C schematically illustrate different views of an exemplary tissue cutting mechanism included in the asymmetric surgical stapler head shown in FIGs. 3A and 3B, according to some embodiments of the invention;

FIG. 4D schematically illustrates a cross-sectional front view of another exemplary asymmetric surgical stapler head, according to some embodiments of the invention;

FIGs. 5A - 5D schematically illustrate cross-sectional transverse and front views of an exemplary asymmetric surgical stapler head including an exemplary jaws strengthening mechanism, according to some embodiments of the invention;

FIGs. 6A and 6B schematically illustrate cross-sectional transverse and front views of an exemplary asymmetric surgical stapler head including another embodiment of the exemplary jaws strengthening mechanism, according to some embodiments of the invention;

FIGs. 7A - 7C schematically illustrate cross-sectional front and transverse views of an exemplary asymmetric surgical stapler head including another exemplary jaws strengthening mechanism, according to some embodiments of the invention; and

FIGs. 8A and 8B schematically illustrate cross-sectional transverse views of a first variation (FIG.

8A) and a second variation (FIG. 8B) of the exemplary asymmetric surgical stapler head shown in FIGs. 7A - 7C, according to some embodiments of the invention.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

Some exemplary embodiments of the herein disclosed asymmetric surgical stapler heads include a tissue cutting mechanism having a blade that is slidable between rows of staples. Such exemplary embodiments include stapler heads that are asymmetric in the sense that the blade is set to pass between staples rows which are differentiated (in each side of the blade) by at least one of staples size and number of staple rows. Asymmetric surgical stapler heads designed for the purpose of size minimization may be associated with design limitations which can affect strength and stability of the stapler head, in general, and of some components thereof, in particular. At least some exemplary embodiments of the present disclosure address and provide possible means and solutions for improving upon or/and overcoming these and other limitations.

In exemplary embodiments, the surgical tissue staplers and stapler heads of the present invention are particularly minimal in cross-sectional dimensions, thus, providing for introduction thereof into the body in a minimally invasive manner.

In exemplary embodiments, some particular minimal cross-sectional dimensions of the herein disclosed surgical tissue staplers and stapler heads are provided by the convertible properties of the surgical tissue heads or/and with the asymmetrical structure of the surgical tissue head, being suitably configured for allowing delivery thereof via the above-mentioned passage.

Herein disclosed exemplary embodiments of the present invention are illustratively described in the context of exemplary laparoscopic surgical procedures, for ease of description and understanding. The present invention is not limited to the specifically described devices and methods, and may be adapted to various clinical applications without departing from the overall scope of the invention. For example, devices and related methods including concepts described herein may be used for other surgical procedures such as, but not limited to: single-port laparoscopy, endoscopy, and NOTES ("Natural Orifice Translumenal Endoscopic Surgery") assisted endoscopic or laparoscopic surgeries.

The term "surgical stapler", as used herein, in a non-limiting manner, refers to a medical device which is used to place surgical fasteners.

The terms "surgical fastener", "tissue fastener", "surgical staples" or "tissue staples", as used herein, in a non-limiting manner, are interchangeable and refer to any pronged artifact that can pierce through tissue layers for fixating or bonding them together. A surgical fastener may include one leg or a plurality of legs, possibly linked one with the other via a leg bridge; each leg is pronged at its end and sized to pass through a plurality of soft tissue layers. Surgical fasteners or staples types include, but are not limited to, those that are elastic and capable to bounce from a stressed configuration (e.g., by stretching or compressing its legs open or close) to a nominal less stressed configuration during deployment, those that are rigid enough in order to preclude deformation during deployment, or those that are plastically deformable during deployment, as in the case of surgical tissue staples, where the legs are forced to bend to a fixedly deformed closed configuration, and are commonly used to close wounds or openings in place of sutures. Surgical staplers may be designed for open surgeries or for endoscopic or laparoscopic surgeries, may or may not include tissue cutting means, and may be disposable or reusable. Surgical staplers are optionally loaded with disposable cartridges containing the fasteners (e.g., staples). The stapler line may be straight, curved, or circular.

A surgical stapler, as other types of staples, typically includes two opposing jaws that are pivotally movable relative to each other: a first jaw, commonly referred to as a "stapling jaw", which houses staples or/and cartridges thereof, and optionally, includes means to push staples to protrude towards the opposing, second, jaw; and a second jaw, commonly referred to as an "anvil jaw", which has a number of recesses or grooves corresponding in number and position to the staples in the "stapling jaw". Upon grasping and compressing a tissue with (between) the jaws, each staple appropriately penetrates through the tissue with each of its two pronged legs which are then inwardly bent as they press against the corresponding anvil recesses of the anvil jaw.

The terms "linear tissue stapler", "linear stapler", and "surgical linear stapler", as used herein, in a non-limiting manner, refer to a surgical stapler loaded with two or more staggered straight rows of staples, commonly used in abdominal surgery, thoracic surgery, gynecology, and pediatric surgery. Linear tissue staplers may be reusable or disposable, with distinctive designs for open surgeries and for endoscopic surgeries.

The terms "endocutter", "endo-cutter", "endo cutter stapler" and "cutting stapler", as used herein, in a non-limiting manner, refer to a linear stapler with a blade provided between staples rows used for resection and transection of organs or tissues. Common cutting staplers are loaded with two groups of staple rows (each with a single row, or double or triple staggered rows, or more, or any combination thereof) and simultaneously cuts and divides tissue between the two groups of rows in parallel to closing cut tissue ends with staples.

The present invention, in exemplary embodiments thereof, relates to surgical fastener appliers, and in particular, to surgical (linear) cutting staplers. The stapler head is asymmetric in the sense that quantity, type, size or/and distribution of tissue fasteners (e.g., staples) is different (i.e., asymmetric) on two sides of the blade and elongated channel (e.g., in a form of a '2+1 ', or '3+1 ', or '3+2' type).

In exemplary embodiments, the surgical stapler head readily incorporates or/and is configured to include a first stapling jaw portion/side and a second stapling jaw portion/side. In some embodiments, the second stapling jaw portion is configured to apply tissue fasteners in similar size and quantity as in large endo cutter staplers, and a first stapling jaw portion/side configured to apply tissue fasteners in much smaller size or/and quantity, thereby decreasing substantially the cross-sectional dimension of the surgical stapler head in corresponding side of the surgical stapler head relative to longitudinal channel. In exemplary embodiments, the surgical stapler head is asymmetric in the sense that at least the rows of tissue fasteners adjacent to each side of the longitudinal channel are different (i.e., asymmetric) one from the other with respect to type or/and size of staples.

In surgical procedures involving withdrawal of cut tissues, each of tissue remaining within the body, and tissue removed from the body, may be treated in a different manner. Specifically, for tissue remaining within the body, it is necessary that the cut end be fastened and sealed in a manner that eliminates untightened spaces, yet loose enough to exclude over-compression and necrosis. For the removed tissue part, it is believed that the cut end may be fastened in a much less strict manner in terms of untightened spaces, that allows further compression of the tissue to a minimal thickness, hence, even a single row with smaller staples may be used.

Exemplary embodiments of the surgical tissue stapler and asymmetric surgical stapler head of the present invention, include a (linear, cutting) surgical stapler head, having: a stapling jaw configured to include a first stapling jaw portion and a second stapling jaw portion being relatively positioned so as to be oppositely separated from each other by a longitudinal channel extending therebetween, the longitudinal channel is sized and configured for allowing a blade having a sharp edge to travel therealong; and an anvil jaw positionable to oppose the stapling jaw; wherein the first stapling jaw portion includes a first row of tissue fasteners of a first staple size or/and type adjacent to a first side of the longitudinal channel, and the second stapling jaw portion includes a second row of tissue fasteners of a second staple size or/and type adjacent to a second side of the longitudinal channel.

I n some exemplary embodiments, the second stapling jaw portion has a plurality of rows of tissue fasteners including the second row of tissue fasteners of the second staple size or/and type. According to some embodiments, a plurality of rows of tissue fasteners is two rows or three rows. First and second stapling jaw portions are optionally different one from the other with respect to at least the staples size or/and type of the rows adjacent to each side of the longitudinal channel. Namely, at least the single row immediately adjacent one side of the longitudinal channel is different than the other single row immediately adjacent the other side of the longitudinal channel, such that each of these two rows includes a different size/type of tissue fasteners.

According to some exemplary embodiments, first and second stapling jaw portions are different one from the other with respect the entire size or/and type of staples. In some exemplary embodiments, the second stapling jaw portion has a number of rows of tissue fasteners which is greater by at least one, than the number of rows of the first stapling jaw portion. In some exemplary embodiments, the second stapling jaw portion has a number of rows of tissue fasteners which is greater by one or two than the number of rows of the first stapling jaw portion. In some exemplary embodiments, the second stapling jaw portion has two rows of tissue fasteners of the second staple size or/and type and the first stapling jaw portion has one row of tissue fasteners of a first staple size or/and type. I n some exemplary embodiments, the second stapling jaw portion has three rows of tissue fasteners of the second staple size or/and type and the first stapling jaw portion has one row of tissue fasteners of a first staple size or/and type. In some exemplary embodiments, the second stapling jaw portion has three rows of tissue fasteners of the second staple size or/and type and the first stapling jaw portion has two rows of tissue fasteners of a first staple size or/and type.

Exemplary embodiments of the herein disclosed invention include various technical features, characteristics, and aspects, which are novel and inventive compared to prior art teachings in the relevant field and art of the invention. Moreover, such exemplary embodiments may address, and provide solutions to, various technical limitations or problems associated with prior art teachings.

For example, at least some exemplary embodiments of the herein disclosed invention include a particularly structured and functional (operational) tissue cutting mechanism, for cutting tissue. In some known surgical stapler heads, the installed tissue cutting mechanism is configured with a cutting element including a blade set to run or slide in between rows of staples, while being mechanically supported at both its ends by the upper and lower stapler head jaws. In some such embodiments, this arrangement is also configured for tightening the grip of the jaws to the cut tissue. Accordingly, the tissue cutting mechanism is sufficiently strong, rigid, and configured for accurate function. In a miniature sized or/and asymmetric stapler head, the preceding may be considered a technical problem that requires a structural solution. Namely, first, size limitation does not allow use of known means (elements, components or/and portions) to support the cutting element or/and to tighten jaws grip; second, the asymmetric arrangement of the stapler head further limits the size and construction of the tissue cutting mechanism since the cutting element is located close to the stapler head side, and not in the middle of the stapler head side as known in regular (symmetric) stapler heads; and third, the asymmetric arrangement of the stapler head provides structural imbalance which puts further constraints on design considerations.

In another example, at least some exemplary embodiments of the herein disclosed invention include a particularly structured and functional (operational) jaw having a sloped surface that stretches across the blade of the asymmetric surgical stapler head. Asymmetric stapler heads, configured to operate small staples on one side of the blade and large (regular sized) staples on the other side of the blade, have anvil jaws with portions of different heights relative to the stapling jaw, such that the anvil portion in front of the small staples is relatively closer than the anvil portion in front of the large staples. Such arrangement creates an abutment with a sharp change in height in front of the blade which runs between the small and large staples rows, such that the tissue can be twisted or/and stretched inclined to the blade, which can improve tissue cutting efficacy. In another example, at least some exemplary embodiments of the herein disclosed invention include a particularly structured and functional (operational) jaws strengthening mechanism, that is configured to selectively provide additional support, strengthening, or/and power, to the asymmetric surgical stapler head jaws, so as to increase grasping and force magnitude applied to tissue held by the jaws. In some embodiments, the jaws strengthening mechanism is configured to selectively (e.g., automatically via a machine process, or manually via human interface) provide (add) mechanical advantage in producing a compression force between the jaws, optionally, if / when the jaws are closed against each other.

For purposes of further understanding exemplary embodiments of the present invention, in the following illustrative description thereof, reference is made to the figures. Throughout the following description and accompanying drawings, same reference numbers refer to same components, elements, or features. It is to be understood that the invention is not necessarily limited in its application to particular details of construction or/and arrangement of the exemplary devices or/and components thereof, or to any particular sequential ordering of exemplary method steps or procedures, set forth in the following illustrative description. The invention is capable of other exemplary embodiments or of being practiced or carried out in various ways.

Reference is made to FIGs. 1A and 1 B which schematically illustrate different views of an exemplary surgical stapler 10 (in a form of a linear cutting stapler) having an asymmetric surgical stapler head 1. Stapler 10 includes an elongated shaft 11 whose distal end is connected to a surgical stapler head 1 and whose proximal end is connected to a handle assembly 13 that has an arm actuator 14.

Asymmetric surgical stapler head 1 includes a stapling jaw 2 and an anvil jaw 3 that are juxtapositionally arranged and opposed to each other, one above the other, which form an operational surgical stapler head such that the maximal stapler cross-sectional dimension is greater than or equal to a minimal inner diameter 4. In exemplary embodiments, minimal inner diameter 4 may be about 8 mm or less; optionally, about 6 mm or less; optionally, about 4 mm or less; or higher, or lower, or an intermediate size. In exemplary embodiments, Asymmetric stapler head 1 maximal cross-sectional dimension in the deployment configuration may be a maximal height, a maximal width or/and a maximal diameter, and is, optionally, equal to or greater than about 5 mm; optionally, equal to or greater than about 7 mm; optionally, equal to or greater than about 8 mm; optionally, equal to or greater than about 12 mm; or higher, or lower, or an intermediate value.

Stapling jaw 2 is configured to include a first stapling jaw portion 'A' and a second stapling jaw portion 'Β', being relatively positioned so as to be oppositely separated from each other by a longitudinal channel 7 extending therebetween. First stapling jaw portion A includes a first (single) row of tissue fasteners, and second stapling jaw portion B includes a second row (or of one or more rows) of tissue fasteners.

First stapling jaw portion A includes a first row of tissue fasteners of a first staple size or/and type and is positioned adjacent to a first side of longitudinal channel 7. Second stapling jaw portion B includes a second row of tissue fasteners of a second staple size or/and type, and is positioned adjacent to a second side of the longitudinal channel 7. As shown in FIGs. 1A and 1 B, stapling jaw 2 includes a drive member 5 in the form of a slidable cover provided with a blade 6 having a sharp edge. Drive member 5 is configured to travel along longitudinal channel 7 extending between the separated opposing stapling jaw portions A and B of stapling jaw 2.

As an example, first stapling jaw portion A contains a single row of small tissue fasteners or staples 8 and second stapling jaw portion B contains three staggered rows of large tissue fasteners or staples 9, although different arrangements of rows in both stapling jaw portions A and B are possible. In some embodiments, the tissue fasteners of the second row of tissue fasteners have a second size or/and type of tissue fasteners. In some embodiments, the second size or/and type of tissue fasteners have a minimal leg length being greater than about 3 mm. In some embodiments, the tissue fasteners of the first row of tissue fasteners have a first size or/and type of tissue fasteners. In some embodiments, the first size or/and type of tissue fasteners have a maximal leg length being less than about 3 mm.

A minimal leg size of the large tissue fasteners or staples 9 legs is, optionally, greater than 3 mm in length, optionally, about 3.5 mm, or optionally, about 3.8 mm, or optionally, about 4.1 mm. A maximal leg size of the small tissue fasteners or staples 8 legs is, optionally, smaller than 3 mm in length, optionally, about 2.5 mm, or optionally, about 2 mm. Optionally, additionally, or alternatively, a minimal leg size of large tissue staples 9 legs is, optionally, equal to or greater than 1.5 mm, optionally, equal to or greater than 2 mm, in length, whereas a maximal leg size of small tissue staples 8 legs is, optionally, smaller by at least 0.2 mm, optionally, by at least 0.5 mm, optionally, by at least 1 mm, optionally, by at least 1.5 mm, than the minimal leg size of large tissue staples 9.

Drive member 5 includes a number of runners (for example, runners 225 shown in FIG. 4B), where each runner is slidable along a corresponding grooved route provided along a length of the corresponding stapling jaw portions, A or B. The runner of stapling jaw for first portion A is optionally shorter in height or/and held lower than runners of stapling jaw portion B, corresponding to size and level of the packed small tissue staples 8 (in first stapling jaw portion A) with respect to those of packed large tissue staples 9 (in second stapling jaw portion B). Each row of tissue fasteners includes a number of grooved slots, and each grooved slot houses a staple pusher, such that upon sliding of the sliding runners distally through the grooved routes, each of the staple pushers moves vertically in the corresponding grooved slot, so as to press the corresponding tissue staple towards a corresponding depression in anvil jaw 3. Anvil jaw 3 is also shaped accordingly, asymmetrically, such that the contact surface in front of stapling jaw portion B is leveled lower than the contact surface in front of stapling jaw portion A.

FIGs. 2A and 2B schematically illustrate cross sectional front views of an exemplary asymmetric surgical stapler head 100, configured for being equipped with a tissue cutting mechanism, for example, tissue cutting mechanism 101. FIG. 2A shows exemplary asymmetric surgical stapler head 100 without the herein disclosed tissue cutting mechanism 101 , and FIG. 2B shows exemplary asymmetric surgical stapler head 100 with the herein disclosed tissue cutting mechanism 101. Optionally, asymmetric surgical stapler head 100 is similar in function or/and structure to asymmetric surgical stapler head 1 , and may be provided as part of a surgical stapler, such as linear tissue stapler 10 (FIGs. 1A and 1 B).

Asymmetric surgical stapler head 100 includes a first jaw 102 pivotally connected and opposing to a second jaw 103. In exemplary embodiments, asymmetric surgical stapler head 100 includes a jaws closing mechanism, which includes, for example, arm actuator 14 shown in FIG. 1A, configured to facilitate closing of first jaw 102 against second jaw 103, for holding a tissue, for example, tissue T, therebetween. In FIG. 2B, an exemplary tissue is generally represented by the dashed line shape enclosing the letter "T". Such general representation of an exemplary tissue (i.e., tissue T), being an exemplary work piece (work object) of the herein disclosed invention, is equally applicable to each exemplary embodiment of the present invention. In some embodiments, one of first and second jaws 102 and 103 is configured for dispensing staples and the other of first and second jaws 102 and 103 includes an anvil configured for bending staples when the staples are compressed against the anvil.

Tissue cutting mechanism 101 includes a blade 104, a pusher (for example, pusher 220 shown in FIG. 4A) operatively connected to blade 104 and configured to selectively push blade 104 distally along asymmetric surgical stapler head 100 for cutting the tissue T when held between first and second jaws 102 and 103. Tissue cutting mechanism 101 further includes a lateral extension, for example, lateral extension 105, having an oblique contact surface, for example, oblique contact surface 106, emerging from the pusher or from blade 104. In exemplary embodiments, lateral extension 105 includes a hooked projection, for example, hooked projection 120, angled backwards and forming an acute angle, for example, acute angle 122, with a blade lateral surface 113 of blade 104. In some embodiments, most or all parts and members of asymmetric surgical stapler head 100, or of tissue cutting mechanism 101 itself, are made of metal, or polymers, or any combination thereof. In some such embodiments, blade 104 or/and lateral extension 105 are made of metal alloy. In some embodiments, staples cartridges applicable for installation in asymmetric surgical stapler head 100 are made of plastic material.

First jaw 102 includes a first (vertical) slot 107. Second jaw 103 includes a second (vertical) slot 108 extending parallel to and juxtaposing first slot 107, such that, when first jaw 102 is closed against second jaw 103, blade 104 is slidable in and along both first and second slots 107 and 108. First and second slots 107 and 108 extend off-centered relative to and along a length of asymmetric surgical stapler head 100, thereby dividing the stapler head into a narrow, first section A and a wide, second section B. Optionally, first section A is 5 mm or less wide, optionally, 3 mm or less, optionally, about 2.4 mm.

First slot 107 is laterally opened to a (horizontal) recessed channel 109 configured as a support track having an oblique sliding surface, for example, oblique sliding surface 110, sized and angled to mate with, and provide support to, oblique contact surface 106, so as to allow blade 104 to slide along, and be suspended from, oblique contact surface 106. Second slot 108 is opened at both sides to a (horizontal) transverse track 111 that is sized and shaped to allow passing therethrough of blade fixating member 112 located opposite lateral extension 105 and extending from both sides of blade 104.

In some embodiments, lateral extension 105 and blade fixating member 112 are formed, sized, arranged, and configured to force jaws 102 and 103 to move apart with a maximal distance therebetween, thereby facilitating grasping of tissue T between jaws 102 and 103 in a manner required for adequate stapling or/and cutting tissue T. In such embodiments, and in efforts for minimizing size of stapler head, a minimally required contact area or/and width of oblique contact surface 106, or ranges thereof, is chosen, still sufficient for facilitating or supporting such force and stresses distributable between lateral extension 105 and blade fixating member 112.

In some embodiments, oblique contact surface 106 has a contact area in a range of between 1 mm² and 50 mm²; optionally, between 5 mm² and 25 mm²; or/and a width in a range of between 0.1 and 1 mm; optionally, between about 0.2 mm and about 0.3 mm; optionally, 0.26 mm. Optionally, contact area of oblique contact surface 106 is a multiplication of a fixed width and a variable length derived from size of the staples cartridge in use; for example: for a 30 mm length cartridge the contact area is about 7.8 mm²; for a 45 mm length cartridge the contact area is about 11.7 mm²; for a 50 mm length cartridge the contact area is about 13 mm²; for a 55 mm length cartridge the contact area is about 14.3 mm²; for a 60 mm length cartridge the contact area is about 15.6 mm².

In some embodiments, second jaw 103 includes, within first section A, a first tissue contact surface 114 extending between second slot 108 and a closer side 115 of second jaw 103. Second jaw 103 may further include, within second section B, a second tissue contact surface 116 extending between second slot 108 and a farther side 117 of second jaw 103. In exemplary embodiments, one of first and second tissue contact surfaces 114 and 116 is elevated (i.e., higher) relative to the other. For example, as shown in FIGs. 2A and 2B, first tissue contact surface 114 is elevated (higher) relative to second tissue contact surface 116. A sloped surface 118 connects between first and second tissue contact surfaces 114 and 116, whereby, when blade 104 slides over tissue T held between first and second jaws, 102 and 103, respectively, blade 104 cuts tissue T along a cutting line (i.e., a virtual line representing an actual physical path taken by blade 104 while cutting the tissue) that projects over sloped surface 118. This way, tangling or misalignment of tissue T, due to height differences and close proximity between first and second tissue contact surfaces 114 and 116, is diminished or avoided, and a more accurate incision can be achieved due to improved tissue positioning or/and distribution. In exemplary embodiments, sloped surface 118 forms a slope angle 124 with lower of first and second tissue contact surfaces 114 and 116, being 45 ⁰ or less, optionally 30 ⁰ or less. Sloped surface 118 is optionally between about 0.1 mm and about 2 mm in width.

Reference is now made to FIGs. 3A and 3B, which schematically illustrate a perspective view (FIG. 3A) and a cross-sectional front view (FIG. 3B) of an exemplary asymmetric surgical stapler head 200, being an exemplary variation of asymmetric surgical stapler head 100 (FIGs. 2A and 2B), and to FIGs. 4A - 4C, which schematically illustrate different views of an exemplary tissue cutting mechanism 201 included in asymmetric surgical stapler head 200. Exemplary asymmetric surgical stapler head 200 may be similar in function or/and structure to previously described asymmetric surgical stapler heads 1 and 100, and is optionally provided as part of a surgical stapler, such as linear tissue stapler 10 (FIGs. 1A and l B).

Asymmetric surgical stapler head 200 is connected to a tissue stapler shaft 225, and includes a first jaw 202 pivotally connected (via a pivot 226) and opposing to a second jaw 203. In exemplary embodiments, asymmetric surgical stapler head 200 includes a jaws closing mechanism, which includes, for example, arm actuator 14 shown in FIG. 1A, configured to facilitate closing of first jaw 202 against second jaw 203, for holding a tissue (for example, tissue T) therebetween. First jaw 202 is configured for dispensing staples, and second jaw 203 includes an anvil 219 configured for bending staples when the staples are compressed against anvil 219.

Tissue cutting mechanism 201 includes a blade 204, a pusher 220 connected to blade 204 and configured to selectively push blade 204 distally along asymmetric surgical stapler head 200 for cutting the tissue when held between first and second jaws 202 and 203. Tissue cutting mechanism 201 further includes a lateral extension, for example, lateral extension 205, having an oblique contact surface, for example, oblique contact surface 206, emerging from pusher 220. Lateral extension 205 includes a hooked projection, for example, hooked projection 221 , angled backwards and forming an acute angle, for example, acute angle 222, with a blade lateral surface 213 of blade 204.

In exemplary embodiments, a (longitudinally and horizontally extended) transverse track 211 is sized and shaped to allow passing therethrough of a blade fixating member 212 opposing lateral extension 205 and extending from both sides of blade 204. Blade 204 is slidable in and along at least one slot (e.g., slot 107 or/and slot 108 of FIGs. 2A and 2B) which extends off-centered relative to and along a length of asymmetric surgical stapler head 200, thereby dividing the stapler head into a narrow section and a wide section (for example, similar to narrow, first section A, and wide, second section B, shown in FIGs. 2A and 2B). Each slot (e.g., slot 107 or/and 108) is opened at both sides thereof to transverse track 211.

In some embodiments, lateral extension 205 and blade fixating member 212 are formed, sized, arranged and configured to force jaws 202 and 203 to move apart with a maximal distance therebetween, thereby facilitating grasping of tissue between the jaws 202 and 203 in a manner required for adequate stapling or/and cutting of the tissue. In such embodiments, and in efforts for minimizing size of stapler head, a minimal contact area or/and width of oblique contact surface 206, or ranges thereof, is chosen, still sufficient for facilitating or supporting such force and stresses distributable between lateral extension 205 and blade fixating member 212. In some embodiments, oblique contact surface 206 has a contact area in a range of between 1 mm² and 50 mm²; optionally, between 5 mm² and 25 mm²; or/and a width in a range of between 0.1 and 1 mm; optionally, between about 0.2 mm and about 0.3 mm; optionally, 0.26 mm. In exemplary embodiments, oblique contact surface 206 is supported by, suspended from, and slidable on, a mating oblique sliding surface, for example, oblique sliding surface 210, which is similar to that shown in FIGs. 2A and 2B wherein oblique contact surface 106 is supported by, suspended from, and slidable on, mating oblique sliding surface 110.

FIG. 4D schematically illustrates a cross-sectional front view of another exemplary asymmetric surgical stapler head 200', being a variation of asymmetric surgical stapler head 200. Exemplary asymmetric stapler head 200' may be similar in function or/and structure to previously described asymmetric surgical stapler heads 1, 100, and 200, and is optionally provided as part of a surgical stapler, such as linear tissue stapler 10 (FIGs. 1A and 1 B).

Asymmetric surgical stapler head 200' is connected to a tissue stapler shaft (for example, tissue stapler shaft 225 [FIG. 4B]), and includes a first jaw 202' pivotally connected (via a pivot, for example, pivot 226 [FIG. 3A]) and opposing to a second jaw 203'. In exemplary embodiments, asymmetric surgical stapler head 200' includes a jaws closing mechanism (for example, arm actuator 14 [FIG. 1A]) configured to facilitate closing of first jaw 202' against second jaw 203', for holding a tissue (for example, tissue T) therebetween. First jaw 202' is configured for dispensing staples, and second jaw 203' includes an anvil (for example, anvil 219 [FIG. 3B]) configured for bending staples when the staples are compressed against the anvil.

Tissue cutting mechanism 201 ' includes a blade 204', a pusher (for example, pusher 220 [FIGs. 3B, 4A]) connected to blade 204' and configured to selectively push blade 204' distally along asymmetric surgical stapler head 200' for cutting the tissue when held between first and second jaws 202' and 203'. In exemplary embodiments, second jaw 203' includes a first sloped surface 205' stretching across blade 204', wherein blade 204' is configured and arranged to pass through first sloped surface 205', whereby, when blade 204' slides over tissue held between first and second jaws 202' and 203', respectively, blade 204' cuts the tissue along a cutting line (i.e., a virtual line representing a path taken by blade 204' while cutting the tissue) that projects over first sloped surface 205'. In some embodiments, first sloped surface 205' extends from a first side of second jaw 203' to an intersection line 209' located across blade 204'. Second jaw 203' also includes a second sloped surface 206' extending from a second side of second jaw 203' to intersection line 209'. In some embodiments, intersection line 209' between first sloped surface 205' and second sloped surface 206' forms an angle, for example, angle 211 ', being equal to or greater than 90 °; optionally, between 120 ⁰ and 150 °; optionally, about 130 °.

In some embodiments, first jaw 202' includes a first tissue contact surface 207' and a second tissue contact surface 208', wherein, when first jaw 202' is closed against second jaw 203', first tissue contact surface 207' extends above and parallel to first sloped surface 205' and second tissue contact surface 208' extends above and parallel to second sloped surface 206'. This way, tangling or misalignment of the tissue, due to height differences of stapling lines on both sides of blade 204', is diminished or avoided, and a more accurate incision can be achieved due to improved tissue positioning or distribution. In exemplary embodiments, first sloped surface 205' has a width of about 1.8 mm, and a first slope angle 213' of about 43 °. In exemplary embodiments, second sloped surface 206' has a width of about 4.5 mm, and a second slope angle 215' of about 8 °. In exemplary embodiments, first tissue contact surface 207' has a width of about 1.1 mm, and a slope angle 217' of about 43 °. In exemplary embodiments, second tissue contact surface 208' has a width of about 3.5 mm, and a slope angle 219' of about 8 °.

FIGs. 5A - 5D schematically illustrate cross-sectional transverse and front views of an exemplary asymmetric surgical stapler head 300 including an exemplary jaws strengthening mechanism. Exemplary asymmetric stapler head 300 may be similar in function or/and structure to previously described asymmetric surgical stapler heads 1, 100, and 200, and is optionally provided as part of a surgical stapler, such as linear tissue stapler 10 (FIGs. 1A and 1 B).

Asymmetric surgical stapler head 300 includes a first jaw 301 , a second jaw 302, and a jaws closing mechanism, for example, arm actuator 14 shown in FIG. 1A, configured to facilitate closing of first jaw 301 against second jaw 302, for compressing a tissue (for example, tissue T) therebetween.

Asymmetric surgical stapler head 300 further includes a connection, for example, connection 303, configured for connecting between first and second jaws 301 and 302. In exemplary embodiments, connection 303 is a loose pivot connection 303, configured for connection, via a loose pivot, between first and second jaws 301 and 302.

The term "loose pivot (or jaws) connection" refers to a type of connection between jaws 301 and 302 that is designed such that the force generated by, or transmitted to, the jaws, for facilitating partial or full actuation (activation) of the jaws (e.g., closing, clamping, grasping, etc.), is insufficient (intentionally or unintentionally) for required or preferred outcome of such jaws actuation. For example, as in the case of tissue stapling or/and cutting, the loose pivot connection 303 of asymmetric surgical stapler head 300 may only transfer or/and generate a maximal jaws closing force that may be sufficient to substantially bring jaws 301 and 302 together, but may not be sufficient to press a tissue into a form or/and shape for easing or facilitating stapling or/and cutting thereof with stapler head 300. In some embodiments, the use of a loose pivot (jaws) connection, such as loose pivot connection 303, is a result of, or a precondition for, functionality of a transformable stapler head that can be changed in between forms, in which jaws 301 and 302 can be (pivotally) shifted relative to each other, thereby avoiding constraints which may be present using a standard (e.g., more rigid in relevant axes) type of connection between jaws 301 and 302. In some embodiments, asymmetric surgical stapler head 300 is transformable between a delivery configuration, wherein second jaw 302 is provided distally to first jaw 301 , to an operational configuration, wherein firstjaw 301 is juxtaposing and opposing second jaw 302 and is pivotally movable relative thereto.

In exemplary embodiments, for example, as relating to exemplary asymmetric surgical stapler head 300, the connection, for example, connection 303, or loose pivot connection 303, that connects between first and second jaws 301 and 302, is structurally made or formed via various possible ways using various possible materials of construction, so as to provide the above illustratively described (loose pivoting type) functionality and operation of first and second jaws 301 and 302, in particular, and of asymmetric surgical stapler head 300, in general. For example, the connection is made or formed by directly connecting (attaching) proximal ends of first and second jaws 301 and 302 to each other. For example, the connection is made or formed by using a joint with high degree of freedom, or an adhesive / adhesive-type material that facilitates connection (attachment) of first and second jaws 301 and 302 directly to each other. For example, the connection is made or formed by using one or more connecting (connector) members or/and elements to which are connected (attached) each of first and second jaws 301 and 302, thereby providing a connection (attachment) interface between first and second jaws 301 and 302. Preceding illustrative description of the connection, for example, connection 303, or loose pivot connection 303, in addition to being applicable to exemplary asymmetric surgical stapler head 300, is equally applicable to the other herein disclosed exemplary embodiments of the asymmetric surgical stapler head, for example, exemplary asymmetric stapler heads 1 , 100, 200, 200', 400, 400', and 400".

In exemplary embodiments, asymmetric surgical stapler head 300 includes a jaws strengthening mechanism 304 that is configured to selectively provide additional support, strengthening or/and power to increase grasping and force magnitude applied to the tissue by both jaws. In some embodiments, jaws strengthening mechanism 304 is configured to selectively (e.g., automatically via a machine process, or manually via human interface) provide (add) mechanical advantage in producing a compression force between first and second jaws 301 and 302, optionally, if / when they are closed against each other. In exemplary embodiments, jaws strengthening mechanism 304 includes a push-rod 305, and a push-rod driver 306 (also referred to as rod delivery mechanism 306) operatively connected to push-rod 305 and configured to selectively drive push-rod 305, to thereby engage and push a distal portion 307 of one (or more) of first and second jaws 301 and 302, so as to increase the compression force producible therebetween. In exemplary embodiments, asymmetric surgical stapler head 300 is configured with jaws strengthening mechanism 304 such that push-rod 305 engages distal portion 307 via an acute angle, for example, acute angle 309, as shown in FIG. 5B.

In exemplary embodiments, alternatively, or additionally, to strengthening and providing (adding) mechanical advantage to tissue grasping by the stapler head jaws, jaws strengthening mechanism 304 also stabilizes the jaws and increases overall rigidity.

FIG. 5A shows a cross-sectional transverse view of asymmetric surgical stapler head 300 in which push-rod 305 is disposed distally to asymmetric surgical stapler head 300, optionally, mostly within push-rod driver (rod delivery mechanism) 306, in a way that does not interfere, for example, with function or maneuverability of asymmetric surgical stapler head 300, or with deformation / transformation thereof. FIG. 5B shows an exemplary embodiment wherein push-rod 305 engages and pushes distal portion 307 of second jaw 302 towards first jaw 301 , thereby increasing grasping force between first and second jaws 301 and 302. FIG. 5C shows a cross-sectional front view of exemplary asymmetric surgical stapler head 300, wherein the area of engagement of push-rod 305 with distal portion 307 is located at the middle of second jaw 302. In alternative exemplary embodiments, jaws strengthening mechanism 304 may be configured also for diminishing undesired internal stresses originating due to asymmetry of asymmetric surgical stapler head 300. FIG. 5D shows a cross-sectional front view of exemplary asymmetric surgical stapler head 300, wherein push-rod 305 is arranged for engaging jaw distal portion 307 at a predefined off-centered location, for diminishing torsional (i.e., twisting or turning) stresses when producing a compression force.

FIGs. 6A and 6B schematically illustrate cross-sectional transverse and front views, respectively, of exemplary asymmetric surgical stapler head 300 including another embodiment of exemplary jaws strengthening mechanism 304. Exemplary asymmetric surgical stapler head 300 may be similar in function or/and structure to previously described asymmetric surgical stapler heads 1 , 100, and 200, and is optionally provided as part of a surgical stapler, such as linear tissue stapler 10 (FIGs. 1 A and 1 B).

In exemplary embodiments, asymmetric surgical stapler head 300 includes jaws strengthening mechanism 304' that is configured to selectively provide additional support, strengthening or/and power to increase grasping and force magnitude applied to the tissue (for example, tissue T) by both jaws. In some embodiments, jaws strengthening mechanism 304' is configured to selectively (e.g., automatically via a machine process, or manually via human interface) provide (add) mechanical advantage in producing a compression force between first and second jaws 301 and 302, optionally, if / when they are closed against each other.

In exemplary embodiments, exemplary strengthening mechanism 304' includes a plurality of, for example, two, push-rods 305, and a corresponding plurality of, for example, two, push-rod drivers 306 (also referred to as rod delivery mechanisms 306) operatively connected to push-rods 305 and configured to selectively drive push-rods 305, to thereby engage and push corresponding distal portions 307 of first and second jaws 301 and 302, so as to increase the compression force producible therebetween. In exemplary embodiments, each push-rod 305 is configured for engaging a different target area around distal end of first jaw 301 or second jaw 302. In the exemplary embodiment shown in FIGs. 6A and 6B, a first push-rod 305 engages a distal portion of first jaw 301 and a second push-rod 305 engages a distal portion of second jaw 302. In exemplary embodiments, asymmetric surgical stapler head 300 is configured with jaws strengthening mechanism 304' such that push-rods 305 engage corresponding first and second jaw distal portions 307 via acute angles, for example, acute angle 309, as shown in FIG. 6A.

In exemplary embodiments, alternatively, or additionally, to strengthening and providing (adding) mechanical advantage to tissue grasping by the stapler head jaws, jaws strengthening mechanism 304' also stabilizes the jaws and increases overall rigidity thereof.

FIGs. 7A - 7C schematically illustrate cross-sectional front and transverse views of an exemplary asymmetric surgical stapler head 400 including another exemplary jaws strengthening mechanism. Exemplary asymmetric surgical stapler head 400 may be similar in function or/and structure to previously described asymmetric surgical stapler heads 1 , 100, 200, and 300, and is optionally provided as part of a surgical stapler, such as linear tissue stapler 10 (FIGs. 1A and 1 B).

Asymmetric surgical stapler head 400 includes a first jaw 401 , a second jaw 402, and a (radial) jaws strengthening mechanism 403. In some embodiments, jaws strengthening mechanism 403 includes a clamp 404 and a clamp driver 405 (also referred to as clamp delivery mechanism 405 operatively connected to clamp 404 and configured to selectively drive clamp 404, to thereby engage and compress around first and second jaws 401 and 402, so as to increase the compression force producible therebetween upon tissue (for example, tissue T). FIG. 7A shows a cross-sectional front view of asymmetric surgical stapler head 400 with jaws 401 and 402 in a loose state, when jaws strengthening mechanism 403 is inactive (indicated schematically with greater inner periphery 406). FIG. 7B shows a cross-sectional front view, and FIG. 7C shows a cross-sectional side view, of asymmetric surgical stapler head 400 with jaws 401 and 402 when constrained with jaws strengthening mechanism 403 (indicated schematically with smaller inner periphery 406'). In exemplary embodiments, alternatively, or additionally, to strengthening and providing (adding) mechanical advantage to tissue grasping by the stapler head jaws, jaws strengthening mechanism 403 also stabilizes the jaws and increases overall rigidity thereof.

FIGs. 8A and 8B schematically illustrate cross-sectional transverse views of a first variation 400' (FIG. 8A) and a second variation 400" (FIG. 8B) of the exemplary asymmetric surgical stapler head 400 described above and shown in FIGs. 7A - 7C. Each of exemplary asymmetric surgical stapler heads 400' and 400" may be similar in function or/and structure to previously described asymmetric surgical stapler heads 1 , 100, 200, 300, and 400, and is optionally provided as part of a surgical stapler, such as linear tissue stapler 10 (FIGs. 1A and 1 B).

As shown in FIG. 8A, exemplary asymmetric surgical stapler head 400', including jaws strengthening mechanism 403, has a sliding clamp mechanism that includes a clamp sliding member 407 and a clamp inner member 408. In exemplary embodiments, clamp sliding member 407 is configured to slidably engage, then revolve and compress, clamp inner member 408, so as to strengthen gripping by jaws 401 and 402 upon tissue (for example, tissue T), to diminish asymmetry related inner stresses, and to constrict the jaws into a tightened grasping form (for example, as shown in FIGs. 7B and 7C).

As shown in FIG. 8B, exemplary asymmetric surgical stapler head 400", including jaws strengthening mechanism 403, has a threading clamp mechanism that includes a clamp bolting member 409 and a clamp inner member 410. In exemplary embodiments, clamp bolting member 409 is configured to threadably engage, then revolve and compress, clamp inner member 410, so as to strengthen gripping by jaws 401 and 402, to diminish asymmetry related inner stresses, and to constrict the jaws into a tightened grasping form (as shown in FIGs. 7B and 7C for example).

Each of the following terms written in singular grammatical form: 'a', 'an', and 'the', as used herein, means 'at least one', or One or more'. Use of the phrase One or more' herein does not alter this intended meaning of 'a', 'an', or 'the'. Accordingly, the terms 'a', 'an', and 'the', as used herein, may also refer to, and encompass, a plurality of the stated entity or object, unless otherwise specifically defined or stated herein, or, unless the context clearly dictates otherwise. For example, the phrases: 'a unit', 'a device', 'an assembly', 'a mechanism', 'a component', 'an element', and 'a step or procedure', as used herein, may also refer to, and encompass, a plurality of units, a plurality of devices, a plurality of assemblies, a plurality of mechanisms, a plurality of components, a plurality of elements, and, a plurality of steps or procedures, respectively.

Each of the following terms: 'includes', 'including', 'has', 'having', 'comprises', and 'comprising', and, their linguistic / grammatical variants, derivatives, or/and conjugates, as used herein, means 'including, but not limited to', and is to be taken as specifying the stated component(s), feature(s), characteristic(s), parameter(s), integer(s), or step(s), and does not preclude addition of one or more additional component(s), feature(s), characteristic(s), parameter(s), integer(s), step(s), or groups thereof. Each of these terms is considered equivalent in meaning to the phrase 'consisting essentially of.

The term 'method', as used herein, refers to a single step, procedure, manner, means, or/and technique, or a sequence, set, or group of two or more steps, procedures, manners, means, or/and techniques, for accomplishing or achieving a given task or action. Any such herein disclosed method, in a non-limiting manner, may include one or more steps, procedures, manners, means, or/and techniques, that are known or readily developed from one or more steps, procedures, manners, means, or/and techniques, previously taught about by practitioners in the relevant field(s) and art(s) of the herein disclosed invention. In any such herein disclosed method, in a non-limiting manner, the stated or presented sequential order Of one or more steps, procedures, manners, means, or/and techniques, is not limited to that specifically stated or presented sequential order, for accomplishing or achieving a given task or action, unless otherwise specifically defined or stated herein, or, unless the context clearly dictates otherwise. Accordingly, in any such herein disclosed method, in a non-limiting manner, there may exist one or more alternative sequential orders of the same steps, procedures, manners, means, or/and techniques, for accomplishing or achieving a same given task or action, while maintaining same or similar meaning and scope of the herein disclosed invention.

Throughout this disclosure, a numerical value of a parameter, feature, characteristic, object, or dimension, may be stated or described in terms of a numerical range format. Such a numerical range format, as used herein, illustrates implementation of some exemplary embodiments of the invention, and does not inflexibly limit the scope of the exemplary embodiments of the invention. Accordingly, a stated or described numerical range also refers to, and encompasses, all possible sub-ranges and individual numerical values (where a numerical value may be expressed as a whole, integral, or fractional number) within that stated or described numerical range. For example, a stated or described numerical range 'from 1 to 6' also refers to, and encompasses, all possible sub-ranges, such as 'from 1 to 3', 'from 1 to 4', 'from 1 to 5', 'from 2 to 4', 'from 2 to 6', 'from 3 to 6', etc., and individual numerical values, such as Ί', Ί .3', '2', '2.8', '3', '3.5', '4', '4.6', '5', '5.2', and '6', within the stated or described numerical range of 'from 1 to 6'. This applies regardless of the numerical breadth, extent, or size, of the stated or described numerical range.

Moreover, for stating or describing a numerical range, the phrase 'in a range of between about a first numerical value and about a second numerical value', is considered equivalent to, and meaning the same as, the phrase 'in a range of from about a first numerical value to about a second numerical value', and, thus, the two equivalently meaning phrases may be used interchangeably. For example, for stating or describing the numerical range of room temperature, the phrase 'room temperature refers to a temperature in a range of between about 20 °C and about 25 °C, and is considered equivalent to, and meaning the same as, the phrase 'room temperature refers to a temperature in a range of from about 20 °C to about 25 °C.

The term 'about', as used herein, refers to ± 10 % of the stated numerical value.

It is to be fully understood that certain aspects, characteristics, and features, of the invention, which are, for clarity, illustratively described and presented in the context or format of a plurality of separate embodiments, may also be illustratively described and presented in any suitable combination or sub-combination in the context or format of a single embodiment. Conversely, various aspects, characteristics, and features, of the invention which are illustratively described and presented in combination or sub-combination in the context or format of a single embodiment, may also be illustratively described and presented in the context or format of a plurality of separate embodiments.

Although the invention has been illustratively described and presented by way of specific exemplary embodiments, and examples thereof, it is evident that many alternatives, modifications, or/and variations, thereof, will be apparent to those skilled in the art. Accordingly, it is intended that all such alternatives, modifications, or/and variations, are encompassed by the scope of the appended claims.

All publications, patents, and or/and patent applications, cited or referred to in this disclosure are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent, or/and patent application, was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this specification shall not be construed or understood as an admission that such reference represents or corresponds to prior art of the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting.

Claims

WHAT IS CLAIMED IS:

1. An asymmetric surgical stapler head, comprising:

a first jaw pivotally connected and opposing to a second jaw with a jaws closing mechanism configured to facilitate closing of said first jaw against said second jaw, for holding a tissue therebetween; and

a tissue cutting mechanism comprising a blade, a pusher connected to said blade and configured to selectively push said blade distally along the asymmetric stapler head for cutting said tissue when held between said first and second jaws, and a lateral extension having an oblique contact surface emerging from said pusher or said blade;

wherein said first jaw includes a first slot and said second jaw includes a second slot extending parallel to and juxtaposing said first slot, such that, when said first jaw is closed against said second jaw, said blade is slidable in and along both of said first and second slots; and

wherein said first slot is laterally opened to a recessed channel configured as a support track having an oblique sliding surface sized and angled to mate with, and provide support to, said oblique contact surface, so as to allow said blade to slide along, and be suspended from, said oblique sliding surface.

2. The asymmetric surgical stapler head according to claim 1 , wherein said second slot is opened at both sides to a transverse track sized and shaped to allow passing therethrough of a blade fixating member located opposite said lateral extension and extending from both sides of said blade.

3. The asymmetric surgical stapler head according to claim 1 , wherein said lateral extension in said tissue cutting mechanism includes a hooked projection being angled backwards and forming an acute angle with a blade lateral surface of said blade.

4. The asymmetric surgical stapler head according to claim 2, wherein said lateral extension and said blade fixating member are configured to force said first and second jaws to move apart a maximal distance therebetween, thereby facilitating grasping of said tissue between said first and second jaws.

5. The asymmetric surgical stapler head according to claim 2, wherein said oblique contact surface has a contact area for supporting a maximal force generatable by said lateral extension and said blade fixating member at said grasping.

6. The asymmetric surgical stapler head according to claim 1 , wherein said oblique contact surface has a contact area in a range of between 5 mm² and 25 mm².

7. The asymmetric surgical stapler head according to claim 1 , wherein said oblique contact surface has a width in a range of between 0.1 mm and 0.5 mm.

8. The asymmetric surgical stapler head according to claim 1 , wherein one of said first and second jaws is configured for dispensing staples and another of said first and second jaws includes an anvil configured for bending said staples when said staples are compressed against said anvil.

9. The asymmetric surgical stapler head according to claim 8, wherein said first and second slots extend off-center relative to, and along a length of, the asymmetric surgical stapler head, thereby dividing said asymmetric stapler head into a first, narrow, section and a second, wide, section.

10. The asymmetric surgical stapler head according to claim 9, wherein said first section has a width equal to or less than 3 mm.

11. An asymmetric surgical stapler head, comprising:

a blade, and a first jaw pivotally connected and opposing to a second jaw with a jaws closing mechanism configured to facilitate closing of said first jaw against said second jaw, for holding a tissue therebetween;

wherein said second jaw includes a first sloped surface stretching across said blade, said blade is configured and arranged to pass through said first sloped surface whereby, when sliding over said tissue held between said first and second jaws, said blade cuts said tissue along a cutting line that projects over said first sloped surface.

12. The asymmetric surgical stapler head according to claim 11 , wherein said first sloped surface forms a slope angle with lower portions of said first and second tissue contact surfaces, said slope angle being equal to or less than 45 °.

13. The asymmetric surgical stapler head according to claim 11 , wherein said first sloped surface has a width in a range of between about 0.1 mm and about 2 mm.

14. The asymmetric surgical stapler head according to claim 11 , wherein said second jaw further includes:

a first longitudinal section having a first tissue contact surface extending between said second slot and a closer side of said second jaw; and

a second longitudinal section having a second tissue contact surface extending between said second slot and a farther side of said second jaw;

wherein one of said first and second tissue contact surfaces is elevated relative to other one of said first and second tissue contact surfaces, and said first sloped surface connects said first tissue contact surface to said second tissue contact surface.

15. The asymmetric surgical stapler head according to claim 11 , wherein said first sloped surface extends from a first side of said second jaw to a corner point located across said blade, and said second jaw includes a second sloped surface extending between a second side of said second jaw to said corner point.

16. The asymmetric surgical stapler head according to claim 15, wherein intersection between said first sloped surface and said second sloped surface forms an angle being equal to or greater than 90 °.

17. The asymmetric surgical stapler head according to claim 15, wherein said first jaw includes a first tissue contact surface and a second tissue contact surface, wherein, when said first jaw is closed against said second jaw, said first tissue contact surface extends above and parallel to said first sloped surface and said second tissue contact surface extends above and parallel to said second sloped surface.

18. An asymmetric surgical stapler head, comprising:

a first jaw, a second jaw, and a loose pivot connection configured for connecting between said first and second jaws;

a jaws closing mechanism configured to facilitate closing of said first jaw against said second jaw, for compressing a tissue therebetween; and

a jaws strengthening mechanism configured to selectively provide mechanical advantage in producing a compression force between said first and second jaws, when said first jaw is closed against said second jaw.

19. The asymmetric surgical stapler head according to claim 18, being transformable between a delivery configuration, wherein said second jaw is provided distally to said first jaw, to an operational configuration, wherein said first jaw juxtaposes and opposes said second jaw and is pivotally movable relative thereto.

20. The asymmetric surgical stapler head according to claim 18, wherein said jaws strengthening mechanism includes a push-rod, and a push-rod driver operatively connected to said push-rod and configured to selectively drive said push-rod, to thereby engage and push, via an acute angle, a distal portion of one of said first and second jaws, so as to increase said compression force between said first and second jaws.

21. The asymmetric surgical stapler head according to claim 20, wherein said first and second jaws are asymmetrically shaped in cross sections thereof, wherein said push-rod is arranged for engaging said jaw distal portion at a pre-defined off-centered location, for diminishing torsion stresses when producing said compression force.

22. The asymmetric surgical stapler head according to claim 18, wherein said jaws strengthening mechanism includes a clamp, and a clamp driver operatively connected to said clamp and configured to selectively drive said clamp, to thereby engage and compress around said first and second jaws, so as to increase said compression force between said first and second jaws.