CN115569293A

CN115569293A - Shock wave balloon catheter device, shock wave balloon catheter system and control method thereof

Info

Publication number: CN115569293A
Application number: CN202211047084.5A
Authority: CN
Inventors: 季培红
Original assignee: Hangzhou Juzheng Medical Technology Co ltd
Current assignee: Hangzhou Juzheng Medical Technology Co ltd
Priority date: 2022-08-30
Filing date: 2022-08-30
Publication date: 2023-01-06

Abstract

The application discloses shock wave sacculus pipe device, shock wave sacculus pipe system and control method thereof, wherein, shock wave sacculus pipe device includes: a tube having opposite proximal and distal ends, at least a segment of the tube adjacent the distal end being a working segment, the tube providing at least a guidewire lumen and an infusion lumen; the balloon body is fixed on the periphery of the working section and is communicated with the perfusion cavity; and the electrode pair is positioned in the balloon body and is arranged close to the working section, and when the electrode pair discharges, the working section is driven to deform so as to push the guide wire in the guide wire cavity to move axially. The shock wave destroys the vascular occlusion and drives the guide wire to directly act on the vascular occlusion, thereby improving the working efficiency.

Description

Shock wave balloon catheter device, shock wave balloon catheter system and control method thereof

Technical Field

The application relates to the field of medical instruments, in particular to a shock wave balloon catheter device, a shock wave balloon catheter system and a control method thereof.

Background

In angioplasty, balloons are used to dilate vascular lesions to restore normal blood flow. During surgery, a catheter, typically carrying a balloon, is advanced over a guidewire into a blood vessel until the balloon is aligned with a lesion, and then the balloon is pressurized to destroy calcified plaque at the lesion.

In recent years, for endovascular calcified plaques, particularly heavily calcified plaques, us patent No.2009/0312768 discloses a balloon catheter system that provides a shock wave generator within the balloon, which may take the form of an electrode pair coupled to a high pressure source at the proximal end of the catheter. When a balloon is placed adjacent to a region of vein or artery calcification and a high voltage pulse is applied across the electrodes, a shock wave is formed that propagates through the fluid and strikes the balloon wall and the calcified region, and repeated pulses can destroy the calcified plaque without damaging the surrounding soft tissue.

On the basis of the above patent, chinese patent application publication No. CN112367934A discloses a balloon system for treating an occlusion in a body lumen with a shock wave, which has a thin profile structure and can open an occlusion section of a blood vessel, ureter, or the like to restore normal flow. But it relies on the expansion of the distal balloon to contact the vascular occlusion to function, with most of the shock wave acting around the balloon rather than at the front, resulting in inefficiencies.

Disclosure of Invention

Based on this, this application provides a shock wave sacculus device, and the shock wave destroys vascular occlusion and drives the seal wire direct action on vascular occlusion, has improved work efficiency.

A shock wave balloon catheter device comprising:

a tube having opposite proximal and distal ends, at least a segment of the tube adjacent the distal end being a working segment, the tube providing at least a guidewire lumen and an infusion lumen;

the balloon body is fixed on the periphery of the working section and is communicated with the perfusion cavity;

and the electrode pair is positioned in the balloon body and is arranged close to the working section, and when the electrode pair discharges, the working section is driven to deform so as to push the guide wire in the guide wire cavity to move axially.

Several alternatives are provided below, but not as an additional limitation to the above general solution, but merely as a further addition or preference, each alternative may be combined individually for the above general solution or between several alternatives without technical or logical contradictions.

Optionally, the body includes:

the first pipe fitting, the lumen is the guide wire lumen, the sacculus body is located at the periphery of the distal end part of the first pipe fitting, at least one section of the first pipe fitting located inside the sacculus body is the working section, and the working section is made of deformable materials;

the second pipe is arranged at the periphery of the first pipe and is in butt joint communication with the proximal end of the balloon body, the perfusion cavity comprises an injection cavity and a backflow cavity, and a radial gap between the first pipe and the second pipe is used as the backflow cavity;

a third tube arranged side-by-side with the first tube, the lumen of the third tube acting as the infusion lumen, and the distal end of the third tube opening into the balloon body at a location proximal to the distal end.

Optionally, the body still includes:

a fourth tube through which a lead wire connected to the positive electrode of the electrode pair extends proximally;

a fifth tube through which a lead wire connected to the negative electrode of the electrode pair extends proximally;

the fourth and fifth pipe elements are both within the second pipe element and arranged side-by-side with the first pipe element.

Optionally, the third, fourth and fifth tube members are arranged around the first tube member and fixed to the outer wall of the first tube member.

Optionally, the body is the multi-chamber pipe, and the body is inside including parallel arrangement at least:

the far end of the guide wire cavity is open and extends out of the far end of the balloon body;

the distal end of the injection cavity extends and is opened at a distal position in the balloon body;

the far end of the reflux cavity is arranged at the near end part in the balloon body, and the reflux cavity and the injection cavity form the perfusion cavity;

and the wires connected with the positive electrode and the negative electrode of the electrode pair extend to the proximal end of the tube body through the corresponding cable cavities.

Optionally, the working section is a section that extends continuously or a plurality of sections that are arranged at intervals, and the material of working section is at least one of nylon, pebax, TPU, PVC, silica gel, PU.

Optionally, the pair of electrodes is one or more pairs, and in the pair of electrodes, the negative electrode is closer to the distal end of the balloon body than the positive electrode.

Optionally, the distance between the positive electrode and the negative electrode of the same pair of electrode pairs is 0.5-5 mm, each working section is at least provided with a pair of electrode pairs correspondingly, the negative electrode of the same pair of electrode pairs is positioned on the working section, and the distance between the positive electrode and the nearest working section is less than 5mm in the axial direction of the tube body.

The application also provides a shock wave balloon catheter system, which comprises the shock wave balloon catheter device and a guide wire positioned in the guide wire cavity.

The application also provides a control method of the shock wave balloon catheter system, which comprises the following steps:

adjusting the axial relative position of the shock wave balloon catheter device and the guide wire to enable the distal end of the guide wire to extend out of the shock wave balloon catheter device;

and under the inflated state of the balloon body, the electrode pair is driven to discharge electricity, so that the guide wire generates relative motion along the axial direction relative to the balloon body.

The utility model provides a shock wave sacculus pipe device, set up the working section of one section deformability in the body, when the electrode pair discharges, transmission shock wave drive working section deformation, the seal wire of deformation extrusion seal wire intracavity through the working section promotes the seal wire along its axial to sacculus body distal end motion, the seal wire is terminal to vascular occlusion formation repeated instantaneous shock, shock wave itself also can cause the destruction to vascular occlusion, the stack seal wire is to the impact many times of vascular nasal obstruction simultaneously, can open vascular occlusion.

Drawings

FIG. 1 is a schematic view of a first embodiment of a shock wave balloon catheter device according to the present application (with the fourth and fifth tubular members omitted);

FIG. 2 is a schematic cross-sectional view of a tubular body of a first embodiment of a shock wave balloon catheter device according to the present application;

FIG. 3 is a schematic view of a second embodiment of a shock wave balloon catheter device according to the present application (with the cable lumen omitted);

FIG. 4 is a schematic cross-sectional view of a tubular body of a second embodiment of the shock wave balloon catheter device of the present application.

In the figure: 1. a balloon body; 2. a guide wire; 3. a first pipe member; 4. a second pipe member; 5. a third pipe member; 6. a positive electrode; 7. a negative electrode; 8. a working section; 9. a fourth pipe member; 10. a fifth pipe fitting; 11. a reflux cavity; 12. an injection chamber; 13. a guidewire lumen; 14. an injection chamber; 15. a reflux cavity; 16. a pipe body; 17. a cable cavity.

Detailed Description

The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all of the embodiments. All other embodiments obtained by a person of ordinary skill in the art based on the embodiments in the present application without making any creative effort belong to the protection scope of the present application.

For a better description and illustration of embodiments of the application, reference may be made to one or more of the drawings, but additional details or examples used in describing the drawings should not be construed as limiting the scope of any of the inventive concepts of the present application, the presently described embodiments, or the preferred versions.

It will be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. When a component is referred to as being "disposed on" another component, it can be directly on the other component or intervening components may also be present.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the description of the present application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

Referring to fig. 1 and 3, a shock wave balloon catheter device includes:

a tube 16 having opposite proximal and distal ends, at least a section of the tube 16 adjacent the distal end being a working section 8, the tube 16 providing at least a guidewire lumen 13 and an infusion lumen;

the balloon body 1 is fixed on the periphery of the working section 8 and is communicated with the perfusion cavity;

and the electrode pair is positioned in the balloon body 1 and is arranged close to the working section 8, and when the electrode pair discharges, the working section 8 is driven to deform so as to push the guide wire 2 in the guide wire cavity 13 to move axially.

The utility model provides a shock wave sacculus pipe device sets up one section deformable working segment 8 in body 16, when the electrode pair discharges, the transmission shock wave drive working segment 8 deformation, the seal wire 2 in extrusion seal wire chamber 13 through the deformation of working segment 8 and promote seal wire 2 along its axial to sacculus body 1 distal end motion, the electrode pair discharges according to predetermined frequency, then seal wire 2 will also follow its axial to sacculus body 1 distal end motion according to certain frequency, seal wire 2 distal end direct action is on the vascular occlusion, seal wire 2 will form repeated instantaneous impact to the vascular occlusion (including partial or whole material that blocks up the blood vessel, for example thrombus or plaque) along axial periodic motion, act on the vascular occlusion with the impact force, the damage of seal wire to the vascular occlusion's repeated impact stack shock wave, can open the vascular occlusion.

The far end of the guide wire 2 directly acts on the vascular occlusion, so that the destruction efficiency of the vascular occlusion is improved, and the balloon body 1 can more easily pass through the narrow area of the blood vessel.

The perfusion cavity is used for perfusing fluid into the balloon body 1, the fluid plays a role in inflating the balloon on one hand, and on the other hand, the fluid can absorb heat generated by discharge of the electrode pair, so that adverse effects on biological tissues caused by the discharge of the electrode pair are avoided.

1-2 developing rings can be arranged in the balloon body 1 to mark the position and the inflation state of the balloon.

Referring to fig. 1 and 2, the pipe body 16 includes:

the first pipe fitting 3, the lumen is a guide wire lumen 13, the balloon body 1 is positioned at the periphery of the distal part of the first pipe fitting 3, at least one section of the first pipe fitting 3 positioned in the balloon body 1 is a working section 8, and the working section 8 is made of deformable materials;

the second pipe fitting 4 is positioned at the periphery of the first pipe fitting 3 and is in butt joint communication with the near end of the balloon body 1, the perfusion cavity comprises an injection cavity 12 and a backflow cavity 11, and the radial gap between the first pipe fitting 3 and the second pipe fitting 4 is used as the backflow cavity 11;

a third tube 5, arranged alongside the first tube 3, the lumen of the third tube 5 acting as the infusion lumen 12, and the distal end of the third tube 5 opening into the balloon 1 adjacent to the distal end.

The cavity of infusing is including pouring into chamber 12 and backward flow chamber 11, pours into chamber 12 and backward flow chamber 11 and forms fluidic circulation circuit, and inside fluid entered the ball utricule 1 via pouring into chamber 12, flows out ball utricule 1 through backward flow chamber 11 simultaneously inside, and fluid is at the internal circulation of sacculus, had both inflated ball utricule 1, absorbs the heat when discharging to the electrode pair simultaneously.

The injection cavity 12 is close to the far end of the balloon body 1, and the return cavity 11 is close to the near end of the balloon body 1, so as to ensure the sufficiency of the fluid in the balloon body 1.

One section in the first pipe fitting 3 is a working section, the working section can be subjected to special heat treatment or chemical treatment on the integrally formed pipe fitting to form a deformable working section, the pipe fittings made of different materials can be sequentially inserted and fixed in an axial direction in an inserting mode, and the pipe fitting used as the working section is expected to be made of deformable materials.

Referring to fig. 1 and 2, the pipe 16 further includes:

a fourth tube 9 through which a lead wire connected to the positive electrode 6 of the electrode pair extends proximally;

a fifth tube member 10 through which a lead wire connected to the negative electrode 7 of the electrode pair extends proximally;

the fourth 9 and the fifth 10 pipe elements are both inside the second pipe element 4 and arranged side by side with the first pipe element 3.

Fourth pipe fitting 9 and fifth pipe fitting 10 are used for the line of walking of

anodal

6 and 7 wires of negative pole respectively to guarantee the safety of circuit use, when fourth pipe fitting 9 and fifth pipe fitting 10 do not possess, also can be with the periphery of wire snap-on in first pipe fitting 3, offer the recess that is used for the holding wire in the periphery of first pipe fitting 3.

Referring to fig. 1 and 2, the third pipe 5, the fourth pipe 9, and the fifth pipe 10 are arranged around the first pipe 3 and fixed to the outer wall of the first pipe 3.

Referring to fig. 3 and 4, tube 16 is a multi-lumen tube, and tube 16 includes at least:

a guidewire lumen 13, a distal end of the guidewire lumen 13 being open and extending out of the distal end of the balloon body 1;

an injection cavity 14, the distal end of the injection cavity 14 extends and is opened at the distal part in the balloon body 1;

the far end of the reflux cavity 15 is opened at the near end part in the balloon body 1, and the reflux cavity 15 and the injection cavity 14 form the perfusion cavity;

two cable lumens 17, and wires connected to the positive electrode 6 and the negative electrode 7 of the electrode pair extend proximally of the tube 16 through the respective cable lumens 17.

The injection chamber 14 is close to the distal end of the balloon body 1 and the return chamber 15 is close to the proximal end of the balloon body 1 to ensure the sufficiency of the fluid in the balloon body 1.

When the multi-cavity pipe is adopted as the pipe body, at least one section of the pipe body is made of deformable materials, the working section can be subjected to special heat treatment or chemical treatment on the integrally formed pipe fitting to form the deformable working section, the pipe fittings made of different materials can be sequentially spliced and fixed in the axial direction in a splicing mode, and the pipe fitting which is expected to serve as the working section is made of deformable materials.

The working section 8 is a section which extends continuously or a plurality of sections which are arranged at intervals, and the material of the working section 8 is at least one of nylon, pebax, TPU, PVC and silica gel.

The whole body of the tube body 16 needs to have a stable structure so as to support the balloon body 1, the working section 8 in the tube body 16 is made of deformable materials, the deformation of the tube body 16 needs to have a proper range, the tube body 16 can maintain the radial and axial structure and size under the state that the electrode pair does not discharge, and the working section 8 of the tube body 16 can be properly deformed to clamp the guide wire 2 under the state that the electrode pair discharges, so that the axial pushing of the guide wire 2 is realized.

The material of working segment 8 needs to have certain compliance, when the electrode pair discharges, can take place deformation, when the electrode pair does not discharge, can maintain relatively fixed form simultaneously. The elastic modulus of the material of the working section is less than or equal to 1.42GPa.

Referring to fig. 1 and 3, when the working section 8 is a continuously extending section, and the working section 8 is a plurality of sections arranged at intervals, each working section 8 is correspondingly provided with an electrode pair and a matched conducting wire, and the perfusion chambers in the tube body 16 can share one set.

The length of each working segment 8 (in figures 1 and 3) in the axial direction of the tubular body 16 is between 4 and 20mm.

Referring to fig. 1 and 3, the electrode pairs are one or more pairs, and in the same pair, the negative electrode 7 is closer to the far end of the balloon body 1 than the positive electrode 6.

Referring to fig. 1 and 3, the pair of electrodes is a pair of electrodes, and the negative electrode 7 is closer to the distal end of the balloon body 1 than the positive electrode 6 in the pair of electrodes, that is, the pair of electrodes ensures that the deformation of the working section 8 has directionality during discharging, so as to push the guide wire 2 to apply a force to the endovascular occlusion.

The electrode itself is made of conductive material, such as metal and alloy, and the conductive material can be selected from gold, silver, copper, aluminum, platinum, magnesium and other metals, and the alloy formed by more than two metals through various processes.

The electrode is not limited in configuration, and the positive electrode 6 is a coil, a dot, or a welded semicircular ring of 1 to 5 turns, and the negative electrode 7 is a dot, a coil, or a welded semicircular ring.

The lead wires connected with the electrodes are all wrapped by insulating layers, the positive electrode 6 and the negative electrode 7 are both provided with exposed areas for discharging, the surface area of the exposed area of the negative electrode 7 is 1/3 larger than that of the exposed area of the positive electrode 6, and the discharging voltage of the positive electrode 6 and the discharging voltage of the negative electrode 7 are 100-10000V. The non-exposed areas of the positive electrode 6 and the negative electrode 7 are coated with an insulating paste to maintain an insulating state.

The distance between the positive electrode and the negative electrode of the same pair of electrodes (D1 in figures 1 and 3) is 0.5-5 mm. Preferably, the distance between the positive electrode and the negative electrode of the same pair of electrodes is 1 to 3mm. More preferably, the distance between the positive and negative electrodes of the same pair of electrodes is 1 to 2mm.

Each working section 8 is at least correspondingly provided with a pair of electrodes, the negative electrode 7 of the same electrode pair is positioned on the working section 8, and the distance between the positive electrode 6 and the nearest working section 8 is less than 5mm in the axial direction of the tube body 16.

The distance between different electrode pairs along the axial direction of the tube body 16 is 0.5-20 cm, the distance between different electrode pairs is too close, which may cause mutual influence in the discharge process, and 1-5 pairs of electrodes can be arranged in each working section 8.

The negative pole 7 in every electrode pair is located working segment 8, and anodal 6 is not located working segment 8, but is located the position on the adjacent working segment 8, and when the electrode pair discharges the transmission impulse wave, the instantaneous current comes out from anodal 6 and gives 7 instantaneous impact forces of negative pole, and negative pole 7 is fixed in on working segment 8, and working segment 8 is out of shape under the effect of negative pole 7 to the distal end removal of centre gripping seal wire 2 to the sacculus body 1.

Each working segment 8 is provided with 1-5 electrode pairs, and each electrode pair can be arranged around the working segment 8.

The positive electrode 6 and the negative electrode 7 of each pair of electrodes can be arranged in parallel or in series according to actual needs, as long as the effect of the electrode pair on the working section 8 during discharging can be ensured.

Through setting up a plurality of working segments 8, every working segment 8 sets up a plurality of electrode pairs, and when the electrode pair discharged, the power that acts on seal wire 2 that produces when 8 deformations of working segment superposes at body 16 axials, more is favorable to promoting seal wire 2 to the distal end motion of sacculus body 1.

The distance between the electrode and the nearest working section 8 cannot be too far, which may cause deformation of the working section 8 when the electrode pair discharges, and further loses the function of pushing the guide wire 2.

The application also provides a shock wave balloon catheter system, which comprises the shock wave balloon catheter device and a guide wire 2 positioned in a guide wire cavity 13.

adjusting the axial relative position of the shock wave balloon catheter device and the guide wire 2 to ensure that the distal end of the guide wire 2 extends out of the shock wave balloon catheter device;

when the balloon body 1 is inflated, the driving electrode pair discharges electricity, so that the guide wire 2 generates relative motion along the axial direction relative to the balloon body 1.

When the distal end of the guide wire 2 is extended out of the shockwave balloon catheter device, the length (D3 in fig. 1 and 3) of the guide wire 2 extended out of the distal end of the balloon body 1 in the axial direction of the tube body 16 is 0.5 to 3mm. Preferably, the length of the guide wire 2 extending out of the distal end of the balloon body 1 is 1 to 3mm.

The length of the guide wire 2 extending out of the far end of the balloon body 1 is too long, and because the guide wire 2 is flexible, the impact force generated when the electrode pair discharges can be absorbed by the guide wire 2 and cannot be efficiently transmitted to the vascular occlusion; if the length of the guide wire 2 extending out of the distal end of the balloon body 1 is too short, the axial movement range of the guide wire 2 is limited, and the vascular occlusion cannot be effectively impacted.

In the process of using of shock wave sacculus pipe system, seal wire 2 extends out the proper length of sacculus body 1 distal end, seal wire 2 direct contact vascular occlusion, when the circular telegram was to discharge transmission shock wave, the instantaneous electric current was come out from anodal 6 and is given negative pole 7 an instantaneous impact force, negative pole 7 is fixed in on the working section 8 that can deform, make body 16 carry seal wire 2 to remove to sacculus body 1 distal end when pressing from both sides tight seal wire 2, seal wire 2 is with on the vascular occlusion with the impact force, carry out the multiple impact to the blood vessel, the shock wave also can cause the destruction effect to vascular occlusion simultaneously, vascular occlusion can be opened in the stack of two kinds of effects.

All possible combinations of the technical features of the above embodiments may not be described for the sake of brevity, but should be considered as within the scope of the present disclosure as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present application, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the concept of the present application, and these are all within the scope of protection of the present application. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. A shock wave balloon catheter device, comprising:

2. The shock wave balloon catheter device of claim 1, wherein the tube body comprises:

3. The shock wave balloon catheter device of claim 2, wherein the tube further comprises:

4. The shock wave balloon catheter device according to claim 3, wherein the third, fourth and fifth tube members are arranged around the first tube member and fixed to the outer wall of the first tube member.

5. The shock wave balloon catheter device according to claim 1, wherein the tube body is a multi-lumen tube comprising at least in parallel inside the tube body:

the distal end of the injection cavity extends and opens at a distal position in the balloon body;

6. A shock wave balloon catheter device according to any one of claims 1 to 5, wherein the working section is a continuously extending section or a plurality of spaced sections, and the material of the working section is at least one of nylon, pebax, TPU, PVC, silicone, PU.

7. A shock wave balloon catheter device according to any one of claims 1 to 5, wherein the pair of electrodes is one or more pairs of electrodes, the negative electrode being closer to the distal end of the balloon body than the positive electrode.

8. The shock wave balloon catheter device according to claim 7, wherein the distance between the positive and negative electrodes of the same electrode pair is 0.5-5 mm, at least one electrode pair is disposed in each working segment, the negative electrode of the same electrode pair is disposed on the working segment, and the distance between the positive electrode and the nearest working segment in the axial direction of the catheter body is less than 5mm.

9. A shock wave balloon catheter system comprising a shock wave balloon catheter device according to any one of claims 1 to 8 and a guide wire located within the guide wire lumen.

10. A method of controlling a shock wave balloon catheter system, comprising:

and under the inflation state of the balloon body, driving the electrode pair to discharge so as to enable the guide wire to generate relative motion along the axial direction relative to the balloon body.