CN110522990B

CN110522990B - Double-balloon catheter

Info

Publication number: CN110522990B
Application number: CN201910961603.0A
Authority: CN
Inventors: 王森; 苏彦; 戴志豪; 宋睿; 周国磊
Original assignee: Shanghai Shenqi Medical Technology Co Ltd
Current assignee: Shanghai Shenqi Medical Technology Co Ltd
Priority date: 2019-10-11
Filing date: 2019-10-11
Publication date: 2020-12-22
Anticipated expiration: 2039-10-11
Also published as: CN110522990A

Abstract

The invention provides a double-balloon catheter which comprises a catheter body, wherein a medicine balloon and a cutting balloon are sequentially arranged in the direction from a near end to a far end in the far end direction of the catheter body, a guide wire catheter, an injection catheter and a pumping catheter are arranged in the catheter body, a guide wire with the outer diameter of 0.014 inch is arranged in the guide wire catheter, the injection catheter is communicated with the medicine balloon, and the pumping catheter is communicated with the cutting balloon; the medicine sacculus evenly is equipped with a plurality of micropores, cutting sacculus surface evenly is equipped with a plurality of cutting blades. The product can expand and dredge blood vessels, can cut the pathological change part, and can inject liquid medicine to the cut pathological change part.

Description

Double-balloon catheter

Technical Field

The invention belongs to the field of medical instruments, and particularly relates to a double-balloon catheter.

Background

Endovascular intervention has been for more than 40 years, and since 1977 human beings used a balloon dilatation catheter for the first time to perform coronary artery stenosis intervention, related medical instruments are continuously evolved, and balloon cutting is an intervention method developed on the basis of traditional balloon intracavity angioplasty. The cutting saccule mainly utilizes the saccule with a miniature blade to expand and cut atherosclerotic plaques on the inner wall of a blood vessel, and can generally achieve satisfactory effect on narrow blood vessels which cannot be expanded by the conventional saccule, such as calcified lesion and fibrotic lesion structures.

Although the cutting balloon can achieve good immediate effect in treating complex lesions, the injury of the blood vessel can still cause the intima to continue to proliferate, and cause restenosis. Therefore, the combined use of the cutting balloon and the medicine balloon in medicine can achieve good long-term effect. However, the combined use of the cutting balloon and the drug balloon requires two interventional operations, which results in long operation time and increased pain for the patient. In order to avoid the pain caused by two interventional operations, most of the existing cutting sacculus carries a medicine by a micro blade or the sacculus, so that the injury caused by the two interventional operations is avoided. For example, patent application No. 201710126716.X discloses a drug-loaded cutting balloon, which comprises a balloon body and a plurality of groups of cutting knife sets, wherein the balloon body is in a hollow oval sphere shape, the plurality of groups of cutting knife sets are arranged on the surface of the balloon body, each group of cutting knife sets comprises a plurality of cutting blades arranged on the same circumference, the cutting blades extend along the circumferential direction of the balloon body, and a plurality of drug-loaded areas are arranged on the balloon body and used for coating drugs. The utility model discloses an application number is 201620602788.8's utility model patent, discloses a medicine carrying cutting sacculus expansion pipe, including a sacculus and evenly set up a plurality of cutting blade at this sacculus surface, cutting blade sets up along the generating line of sacculus, and is located a plurality of cutting blade intervals on same generating line and sets up, and the surface that this cutting blade's symmetry set up is equipped with recess or concave point, packs in this recess or concave point, adheres to or coats the medicine. Both of the above patents are cutting balloons or blades carrying drugs, however, existing balloons can also carry liquid drugs, for example patent application No. 201080064442.2 discloses a double-layer balloon catheter system in which the outer balloon surface has micropores for the delivery of liquid drugs. However, the above three patents still have the following problems:

1. the existing cutting saccule carries drugs which are anti-proliferative active drugs, such as paclitaxel, rapamycin, Everomone, Zostamopsis and the like, and are attached to the surface of the cutting saccule or the surface of a blade in a crystallized state; when the cutting sacculus gets into the blood vessel of target pathological change, because the unevenness on cutting sacculus surface, the smoothness on blade surface makes the medicine be difficult to adhere to, often drops off at the partial part of the washing away of blood, at the in-process of cutting sacculus expansion and shrink, also can cause the medicine to run off in a large number, causes the medicine when reaching the pathological change position to remain a few to be difficult to reach treatment. Meanwhile, a large amount of medicines are not absorbed by pathological tissues but enter a human body in a solid particle form, so that local thrombus and microcirculation disturbance are easily caused, and clinical adverse events are increased. Therefore, even if the existing cutting saccule can expand and cut a diseased part, the carried medicine is easy to run off in the pushing process, so that not only can an ideal treatment effect not be achieved, but also more injuries are caused to patients.

2. Although the existing cutting saccule can also inject liquid medicine, the expansion and the cutting of the lesion part can not be considered, so that the absorption efficiency of the lesion part to the medicine is not high, and the treatment effect is difficult to achieve.

Disclosure of Invention

In order to overcome the defects of the prior art, the invention provides a double-balloon catheter, which solves the problem of how to cut, expand and dredge blood vessels of a narrow pathological change part, and can inject medicines simultaneously so as to improve the medicine absorption rate of the pathological change part.

The technical scheme adopted by the invention for solving the technical problems is as follows: a double-balloon catheter comprises a catheter body, wherein a medicine balloon and a cutting balloon are sequentially arranged on the catheter body from a near end to a far end, a guide wire catheter, an injection catheter and a pumping catheter are arranged inside the catheter body, a guide wire with the outer diameter of 0.014 inch is arranged in the guide wire catheter, the injection catheter is communicated with the medicine balloon, and the pumping catheter is communicated with the cutting balloon; the medicine sacculus surface evenly is equipped with a plurality of micropores that are used for discharging liquid medicine, cutting sacculus surface evenly is equipped with a plurality of cutting blades.

Preferably, the drug balloon and the cutting balloon are folded and wound on the catheter body by adopting a winding device.

Preferably, the cutting balloon is a non-compliant balloon made of one of nylon, polyester or polyolefin.

Preferably, the nominal cutting balloon pressure is 8atm, and the rated bursting pressure is 16 atm.

Preferably, the material of the drug balloon is polypropylene.

Preferably, the micropores are formed by biaxial stretching of the film, and the diameter of the micropores is 100-1000 nm.

Preferably, the liquid medicine is liquid in which liposome particles with the diameter of 50-100nm or nano microspheres with the diameter of 50-100nm are dissolved in PBS solution.

Preferably, the blade is made of one of stainless steel, functional plastics or ceramics.

Preferably, the blade is triangular or wedge-shaped.

The invention has the beneficial effects that:

1. the product is a double-balloon catheter, and the cutting balloon can be used for cutting and expanding the stenotic lesion part of the blood vessel to dredge the blood vessel; the medicine is injected to the lesion part by utilizing the micropores on the surface of the medicine saccule, and the medicine is injected into the medicine saccule by the pressure pump after the medicine saccule reaches the lesion part, so that the phenomenon that the medicine flows into a blood vessel due to the flushing of blood in the process of pushing the double-saccule catheter (the medicine is seriously lost due to the flushing of the blood in the process of pushing the existing saccule catheter) is avoided, the medicine can sufficiently reach the lesion part, and the treatment effect is better. Meanwhile, the granular medicine is prevented from flowing into blood vessels to cause local thrombus and microcirculation disturbance, the metabolic burden of a human body is increased, and more harm is brought to patients.

2. This product adopts cutting sacculus and medicine sacculus on a pipe body together, not only can utilize the cutting sacculus to expand, cut and dredge the blood vessel to the pathological change blood vessel, still can utilize the medicine sacculus, injects the medicine to the pathological change department after the cutting. The product has two functions simultaneously, and the treatment effect is effectively improved.

3. The micropores on the drug balloon are in a nanometer level, and the injected drugs are also in a nanometer level, so that the drugs can conveniently enter the cut and damaged vascular tissues, the absorption capacity of the diseased region to the drugs is effectively improved, and the treatment purpose is achieved.

Drawings

The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the principles of the invention and not to limit the invention. In the drawings:

FIG. 1 is a schematic structural view of a double-balloon catheter in accordance with one embodiment of the present invention;

FIG. 2 is a schematic structural view of a balloon-cutting lesion site according to the first embodiment;

FIG. 3 is a schematic structural diagram of a double-balloon catheter in the second embodiment;

FIG. 4 is a schematic cross-sectional view of the second embodiment of the cutting balloon in an expanded state;

FIG. 5 is a schematic cross-sectional view of the second embodiment of the cutting balloon in a deflated state;

FIG. 6 is a right side view of the cutting balloon according to the second embodiment;

FIG. 7 is a schematic front view of a cutting balloon according to a second embodiment of the present invention;

fig. 8 is a schematic cross-sectional view of a front view of the cutting balloon in the second embodiment.

Description of the drawings:

11: guide wire catheter	12: pumping catheter	13: injection catheter	14: medicine balloon
				15: micro-pores	16: first connecting port	17: cutting blade	18: second connecting port
19: cutting balloon	20, a catheter body	21: location of disease
				41 taking blade	42: uptake catheter	43: projection	44: fixing plate
61: first cutting blade

Detailed Description

Preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings. It should be understood that the detailed description and specific examples, while indicating the present invention, are given by way of illustration and explanation only, not limitation.

In the present invention, the terms "mounted," "connected," "fixed," and the like are used in a broad sense, and for example, "connected" may be a fixed connection, a detachable connection, or an integral connection. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

In the present invention, the practical directional terms such as "upper, lower, left, right" generally refer to upper, lower, left, right as shown in the drawings, unless otherwise specified; "inner and outer" refer to the inner and outer relative to the profile of the components themselves.

For convenience of description, the direction toward the operator during the operation is referred to as "near" and the direction away from the operator is referred to as "far" throughout this patent.

Example 1

Referring to fig. 1 to 2, embodiment 1 of the present invention provides a double-balloon catheter, including a catheter body 20, where the catheter body 20 is provided with a drug balloon 14 and a cutting balloon 19 in sequence from a proximal end to a distal end, and unlike the conventional balloons, both the drug balloon 14 and the cutting balloon 19 of the present invention are folded and wound on the catheter body by using a winding device, so as to effectively reduce the horizontal cross-sectional dimension of the balloons, thereby facilitating entry into tortuous or narrow blood vessels. This product adopts medicine sacculus 14 and the mode that cuts sacculus 19 combination together, not only can utilize cutting sacculus 14 to cut and expand the pathological change position, has still avoided at the in-process of propelling movement medicine sacculus 14, because of the washing away of blood leads to during the medicine flows into the blood vessel, effectively improves treatment.

Referring to fig. 1, a guide wire catheter 11, an injection catheter 13 and a pumping catheter 12 are arranged inside a catheter body 20, and a guide wire with an outer diameter of 0.014 inches is arranged inside the guide wire catheter 20, so that the propelling direction of the double-balloon catheter can be conveniently controlled; the injection catheter 13 is in communication with the drug balloon 14, and the aspiration catheter 12 is in communication with the cutting balloon 19; the medicine balloon 14 and the cutting balloon 19 can be controlled independently, the overall performance of the product can be effectively improved, and a good treatment effect can be achieved.

The surface of the medicine saccule 14 is uniformly provided with a plurality of micropores 15, the nano-scale liquid medicine can pass through the micropores 15, and the outer surface of the cutting saccule 19 is uniformly provided with a plurality of cutting blades 17. When the product is used, firstly, the cutting blade 17 on the cutting saccule 19 is utilized to cut a diseased part, then the medicine saccule 14 is pushed to the cutting part, and nano-scale liquid medicine enters the diseased part and the cutting injury part through the micropores 15; the product adopts nano-level liquid medicine, so that the medicine absorption capacity of the diseased part and the cutting injury part is greatly improved. Meanwhile, the medicine avoids the local thrombus and microcirculation disturbance caused by a large amount of medicine flowing into blood vessels, increases the metabolic burden of a human body and brings more harm to patients.

Furthermore, the cutting balloon 19 is a non-compliant balloon made of one of nylon, polyester or polyolefin, so that the expansion and contraction performance of the cutting balloon 19 is improved.

Further, the cutting balloon 19 may be cut into the lesion site at a nominal pressure of 8atm, and the cutting blade 17 may be cut into the lesion site at a nominal burst pressure of 16 atm.

Furthermore, the drug balloon 14 is made of polypropylene, so that the liquid drug can smoothly pass through the micropores 15.

Furthermore, the diameter of the micropores 15 is 100-1000nm, and the micropores are prepared by a film biaxial stretching process, so that the preparation process is simple and convenient; the liquid medicine which can pass through the micropores 15 is liquid which is formed by dissolving liposome particles or nano microspheres with the diameter of 50-100nm in PBS solution, so that the liquid medicine can smoothly pass through the micropores 15, and the absorption capacity of a lesion part to the liquid medicine is effectively improved.

Further, the material of the cutting blade 17 is one of stainless steel, functional plastic or ceramic, and different materials of the cutting blade 17 can be selected for different positions or degrees of lesion sites, for example, when a balloon catheter needs to enter a narrow or curved blood vessel, the cutting blade 17 made of the functional plastic can be selected; for a lesion site difficult to cut, a cutting blade 17 made of stainless steel may be selected.

Further, the cutting blade 17 is triangular or wedge-shaped, so that the cutting balloon 19 can cut the lesion site after being expanded.

In the implementation, the cutting saccule 19 in the double-saccule conduit is pushed to the lesion part according to the contrast result, the pressure pump is connected with the pumping conduit 12 and transmits the contrast liquid to enter the cutting saccule 19 from the second connecting port 18, because the pumping conduit 12 is communicated with the cutting saccule 19 through the second connecting port 18, when the pressure pump is used for conveying the contrast liquid, a closed space is formed between the pumping catheter 12 and the cutting saccule 19, the cutting saccule 19 is in an open state along with the gradual increase of the contrast liquid in the cutting saccule 19, the cutting blade 17 is vertically cut into a lesion 21 (shown in figure 2), the cutting state is kept for 30 seconds, then the cutting effect is observed through the contrast equipment (the cutting saccule 19 is filled with the contrast liquid, the cutting effect can be observed through the contrast equipment in vitro), and the cutting saccule 19 can be contracted and expanded for many times to cut according to the actual cutting condition. After cutting, the cutting saccule 19 is contracted (contrast liquid is sucked out through the pressure pump) and then the double-saccule catheter is continuously pushed, so that the medicine saccule 14 reaches a diseased region, the pressure pump is connected with the injection catheter and conveys liquid medicine, the liquid medicine enters the medicine saccule 14 through the first connecting port 16, the liquid medicine penetrates through the micropores 15 and enters the diseased region after cutting injury, the injection time is 30-60 seconds each time, and multiple injections can be performed according to the severity of the disease.

The product can expand and dredge blood vessels, can cut the pathological change part, and can inject liquid medicine to the cut pathological change part.

Example 2

Referring to fig. 3-8, a preferred embodiment 2 of the present invention provides a double-balloon catheter, which is different from embodiment 1 in that two sets of symmetrically arranged fixing plates 44 are further disposed in the cutting balloon 19, two sets of ingestion blades 41 fixedly connected to the fixing plates 44 are disposed on the outer surface of the cutting balloon 19, the cross-sectional shapes of the ingestion blades 41 are sickle-shaped, the blade edge ends of the two sets of ingestion blades 41 can approach each other along with the expansion of the cutting balloon until the two sets of ingestion blades are closed (as shown in fig. 4), a plurality of protrusions 43 are further disposed on the opposite surfaces of the ingestion blades 41, an ingestion catheter 42 is disposed in the catheter body 20, the distal end of the ingestion catheter 20 is communicated with an ingestion space formed between the two sets of ingestion blades 41, and the cutting balloon 19 and the ingestion catheter 41 are integrally formed.

In practice, the double-balloon catheter is pushed to enable the cutting balloon 19 to reach a lesion site, at this time, the two groups of ingestion blades 41 are in an open state (refer to fig. 5), then, a pressure pump is used for injecting a contrast solution into the cutting balloon 19 to expand the cutting balloon 19, so that the surface of the cutting balloon 19 is gradually enlarged to drive the two groups of ingestion blades 41 to be gradually closed to form a closed space (refer to fig. 4), during the closing process of the ingestion blades 41, the lesion site can be cut, so that a part of lesion tissue is cut off, the cut-off lesion tissue falls at the distal opening of the ingestion catheter 42, and then, the pressure pump is connected with the ingestion catheter 42 to perform suction, so that the cut-off lesion tissue enters the ingestion catheter 42. The diseased tissue within the uptake catheter 42 can then be removed for assay analysis. In this embodiment, the inner surface of the taking blade 41 is further provided with a plurality of protrusions 43, which facilitates the absorption of the stably cut-off lesion tissue and prevents the cut-off lesion tissue from being washed away by blood; in particular, the fixing plate 44 fixedly engaged with the taking-up blades 41 ensures that the two groups of taking-up blades 41 can perform relative movement (mutual cohesion cutting) according to the surface expansion of the cutting balloon 19 while ensuring the stability of the taking-up blades 41; in addition, the cutting balloon 19 and the intake catheter 42 are integrally formed, so that the phenomenon of mutual air leakage between the cutting balloon and the intake catheter is avoided.

In the embodiment, after the cutting balloon 19 is adopted to expand and cut the lesion part, the medicine balloon 14 is utilized to inject the medicine to the cut and damaged lesion part, and the product adopts the nano-scale liquid medicine, so that the absorption capacity of the lesion part to the medicine is effectively improved, and the treatment purpose is achieved.

In summary, the conventional intravascular interventional therapy usually requires pathological analysis of a diseased region, so as to diagnose the cause of disease according to the analysis result. However, the existing treatment methods usually require a surgical operation outside the body of the patient, remove the diseased region, and perform a pathological examination, which not only causes more harm to the patient, but also increases unnecessary operation risks. In the embodiment, the ingestion blade 41 on the cutting balloon 19 is used for cutting and ingesting the lesion part, so that more injuries to the patient caused by two operations are avoided, and meanwhile, the lesion part can be taken out for assay analysis, so that for the patient, the pain caused by the operation when pathological assay is needed is reduced; can more accurately understand the etiology for doctors, and effectively improve the later treatment effect.

The above embodiments are only preferred embodiments of the present invention, and it should be understood that the above embodiments are only for assisting understanding of the method and the core idea of the present invention, and are not intended to limit the scope of the present invention, and any modifications, equivalents and the like made within the spirit and principle of the present invention should be included in the scope of the present invention.

Claims

1. A double-balloon catheter comprises a catheter body and is characterized in that: the medical balloon and the cutting balloon are sequentially arranged on the catheter body from the near end to the far end, a guide wire catheter, an injection catheter and a pumping catheter are arranged in the catheter body, a guide wire with the outer diameter of 0.014 inch is arranged in the guide wire catheter, the injection catheter is communicated with the medical balloon, and the pumping catheter is communicated with the cutting balloon; the surface of the medicine saccule is uniformly provided with a plurality of micropores for discharging liquid medicine, and the outer surface of the cutting saccule is uniformly provided with a plurality of cutting blades; still be equipped with the fixed plate that two sets of symmetries set up in the cutting sacculus, this cutting sacculus surface be equipped with two sets of blades that absorb that the fixed plate links firmly, the shape of cross section that absorbs the blade is sickle-shaped, and two sets of cutting edge ends that absorb the blade can be close each other until the contact is closed along with the expansion of cutting sacculus, the opposite face that absorbs the blade still is equipped with a plurality of archs, this internal pipe that absorbs that is equipped with of pipe, the distal end that should absorb the pipe and two sets of space of absorbing that form between the blade are linked together, cutting sacculus and the pipe integrated into.

2. The dual balloon catheter of claim 1, wherein: the medicine sacculus and the cutting sacculus are folded and wound on the catheter body by adopting winding equipment.

3. The dual balloon catheter of claim 1, wherein: the cutting sacculus is a non-compliant sacculus and is made of one of nylon, polyester or polyolefin.

4. The dual balloon catheter of claim 1, wherein: the cutting balloon nominal pressure is 8atm, and the rated bursting pressure is 16 atm.

5. The dual balloon catheter of claim 1, wherein: the drug balloon is made of polypropylene.

6. The dual balloon catheter of claim 1, wherein: the micropores are made by biaxial stretching of the film, and the diameter of the micropores is 100-1000 nm.

7. The dual balloon catheter of claim 1, wherein: the liquid medicine which can pass through the micropores is liposome particles with the diameter of 50-100nm or liquid which is formed by dissolving nano microspheres with the diameter of 50-100nm in PBS solution.

8. The dual balloon catheter of claim 1, wherein: the blade is made of one of stainless steel, functional plastics or ceramics.

9. The dual balloon catheter of claim 1, wherein: the blade is triangular or wedge-shaped.