CN220124759U - Device for generating shock waves - Google Patents

Abstract

The utility model relates to a device for generating shock waves, which comprises an elongated member, a balloon and a shock wave generating assembly, wherein the shock wave generating assembly comprises a first lead, a second lead, an inner electrode and an outer electrode sheath of an insulating sheath, a first electrode hole is arranged on the insulating sheath, a second electrode hole is arranged on the outer electrode sheath, the positions and the shapes of the first electrode hole and the second motor hole are mutually matched, the inner electrode is positioned in the first electrode hole, and when the electric current is electrified, the current sequentially passes through the first electrode hole and the second motor hole to reach the outer electrode sheath and induce the shock waves; in particular, the second electrode hole has a profiled shape in order to more uniformly generate shock waves by the shock waves.

Description

Device for generating shock waves

Technical Field

The utility model relates to the field of medical instruments for interventional procedures, in particular to a shock wave generating device for medical treatment.

Background

Shock waves have a wide range of applications in the medical field, such as lithotripsy, treatment of lesions, etc. The existing shock wave generating device has certain limitations, such as difficult control of the intensity, range and direction of the generated shock wave, and poor treatment effect or damage to surrounding tissues may be caused. Therefore, there is a need to develop a more safe and efficient shock wave generating device.

Shock wave balloons are an innovative medical device, mainly used for the treatment of vascular calcifications, stones and other lesions. Vascular calcification refers to the pathophysiological process of abnormal deposition of minerals such as calcium, phosphorus and the like in the vascular wall, and the disease incidence is continuously increased along with the aging of population. Traditional methods of treatment include drug therapy, surgery, balloon dilation, and the like. However, these methods have certain limitations, such as the potential for adverse effects of drug treatment, the relatively traumatic nature of surgery, and the balloon dilation only works to dilate blood vessels and does not effectively disrupt calcified tissue. Accordingly, it is urgent to develop a new therapeutic device to solve the above-mentioned problems.

The principle of the shock wave balloon is based on the shock wave technology, and the pressure of a lesion part is relieved by generating high-energy shock waves to break calcified tissues and stones. Compared with the traditional treatment method, the shock wave saccule has the advantages of small wound, quick recovery, high safety and the like. In addition, the shock wave balloon can be used for adjusting the shock wave intensity so as to adapt to the requirements of different patients.

The shock wave saccule mainly comprises an elongated member, a saccule, an inner electrode, an outer electrode sheath and the like. The balloon encloses a portion of the elongate member, the interior of which may be filled with a conductive fluid. The inner electrode is positioned within the balloon and the outer electrode sheath is disposed around the balloon. By applying a voltage between the inner electrode and the outer electrode sheath, a current is caused to flow from the inner electrode to the outer electrode sheath in sequence, thereby generating a shock wave.

The development of shock wave balloons benefits from technological advances in multiple disciplinary fields, such as biomedical engineering, materials science, and electronics. At present, the shock wave balloon has shown good treatment effect in laboratory and clinical test, and is considered to be a novel treatment means with wide prospect. However, shock wave balloon technology is still in the development stage and some key problems need to be solved to achieve wide application.

In addition, the procedure of the shock wave balloon needs to be highly accurate to ensure that the balloon is accurately positioned to the lesion. Therefore, in combination with the existing imaging technologies (such as X-ray, ultrasound, etc.), implementing real-time navigation and monitoring is an important research direction.

Finally, the safety and effectiveness of shock wave balloons needs to be verified in more clinical trials. The efficacy of shock wave balloons in lesions of different types and severity was evaluated by comparison with conventional treatment methods to clarify their indications and advantages.

In a word, the shock wave saccule is used as a novel treatment device and has wide application prospect in the fields of vascular calcification and calculus treatment. With the progress and clinical verification of the related art, the shock wave balloon is expected to bring safer, more effective and more convenient treatment options for patients.

Disclosure of Invention

The utility model discloses a device for generating shock waves, and aims to solve the technical problems in the prior art.

The present utility model provides in one embodiment an apparatus for generating a shock wave, comprising an elongate member, a balloon, and a shock wave generating assembly;

the elongate member extends axially;

a balloon surrounding at least a portion of the elongate member, the balloon interior for filling with a conductive fluid;

the shock wave generating assembly comprises a first wire, a second wire, an inner electrode, an outer electrode sheath and an insulating sheath;

a first lead extending axially along the elongate member and connected to the inner electrode;

the inner electrode is positioned in the balloon and is arranged on the outer side surface of the slender component;

the insulating sheath is arranged on the periphery of the inner electrode in a surrounding manner and is provided with a first electrode hole capable of conducting electricity;

a second lead extending axially along the elongate member and connected to the outer electrode sheath;

the outer electrode sheath is arranged on the periphery of the insulating sheath in a surrounding mode, a second electrode hole is formed in the outer electrode sheath, and the shape and the position of the second electrode hole are matched with those of the first electrode hole;

a shockwave can be generated in the second electrode;

the second electrode hole is configured in a non-circular shape, and has a first extending direction and a second extending direction, and the length of the first extending direction is different from the length of the second extending direction.

As a preferable technical scheme, a plurality of shock wave generating assemblies are arranged in the balloon, each shock wave generating assembly is provided with a second electrode hole, and the second electrode holes and/or the first electrode holes in each shock wave generating assembly face different space directions respectively.

As a preferred solution, in the balloon at least part of the second electrode holes are oriented so as to cover part of the circumference and/or the whole circumference.

As a preferred solution, several adjacent shock wave generating assemblies are connected in parallel.

As a preferred solution, the second electrode aperture is configured as an oval, circular arc, trapezoid or other non-circular shape.

As a preferable technical scheme, the first extending direction is parallel to the length direction of the elongated member, and the second extending direction is perpendicular to the length direction of the elongated member;

alternatively, the first extension direction is perpendicular to the length direction of the elongated member, and the second extension direction is parallel to the length direction of the elongated member;

alternatively, the first direction of extension extends helically along the outer circumference of the elongate member.

As a preferable technical scheme, the shape of the first electrode hole is the same as that of the second electrode hole, and the opening size of the first electrode hole is smaller than that of the second electrode hole.

As a preferred solution, the elongated member comprises a flexible material for passing through tortuous or narrow spaces.

As a preferred solution, the elongate member is configured as a double-layered tubular, with the conductive fluid infused by the elongate member into the balloon.

As a preferable technical scheme, the voltage between the inner electrode and the outer electrode sheath is adjustable so as to realize the adjustment of the intensity of the shock wave.

The present utility model also provides, in another embodiment, an apparatus for generating a shock wave, comprising an elongate member, a balloon, and a shock wave generating assembly;

the elongate member extends axially;

a balloon surrounding at least a portion of the elongate member, the balloon interior for filling with a conductive fluid; the outer side of the balloon wall of the balloon is provided with a medicine carrying part and/or a medicine coating, and the medicine carrying part and/or the medicine coating are used for containing medicines;

the shock wave generating assembly comprises a first wire, a second wire, an inner electrode, an outer electrode sheath and an insulating sheath;

a first lead extending axially along the elongate member and connected to the inner electrode;

the inner electrode is positioned in the balloon and is arranged on the outer side surface of the slender component;

the insulating sheath is arranged on the periphery of the inner electrode in a surrounding manner and is provided with a first electrode hole capable of conducting electricity;

a second lead extending axially along the elongate member and connected to the outer electrode sheath;

the outer electrode sheath is arranged on the periphery of the insulating sheath in a surrounding mode, a second electrode hole is formed in the outer electrode sheath, and the shape and the position of the second electrode hole are matched with those of the first electrode hole;

the second electrode aperture is configured to: when the balloon is filled with a conductive fluid and a voltage is applied between the inner electrode and the outer electrode sheath, current flows from the inner electrode to the outer electrode sheath in sequence, generating a shock wave;

the second electrode hole is configured in a non-circular shape, and has a first extending direction and a second extending direction, and the length of the first extending direction is different from the length of the second extending direction.

The technical scheme adopted by the utility model can achieve the following beneficial effects:

by the device for generating the shock waves, the generated shock waves are controlled, so that the shock waves can be more accurately aligned with a treatment target, and damage to surrounding tissues is reduced. In the current shock wave device, the electrode holes are round holes, the holes for generating shock waves are small, the locally generated pressure is high, the local instantaneous pressure is generated, and the risk of balloon rupture is increased.

In one embodiment of the utility model, a plurality of shock wave generating assemblies are arranged in the balloon, the orientations of the second electrode holes in each shock wave generating assembly are different, and the sum of the orientations of the second electrode holes on at least part of adjacent shock wave generating assemblies can cover part of the circumference so as to ensure that the shock wave can cover a larger treatment area and enhance the treatment effect.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present utility model, the drawings required for the description of the embodiments are briefly described below to form a part of the present utility model, and the exemplary embodiments of the present utility model and the description thereof illustrate the present utility model and do not constitute undue limitations of the present utility model. In the drawings:

FIG. 1 is a schematic view showing the structure of an apparatus for generating shock waves in a preferred embodiment of example 1 of the present utility model;

FIG. 2 is a schematic view showing the structure of a shock wave generating assembly in a preferred embodiment of example 1 of the present utility model;

FIG. 3 is a schematic view showing the structure of a shock wave generating assembly according to another preferred embodiment of example 1 of the present utility model;

FIG. 4 is a schematic view showing the structure of a shock wave generating assembly according to another preferred embodiment of example 1 of the present utility model;

FIG. 5 is a schematic view showing the structure of an apparatus for generating shock waves in a preferred embodiment of example 2 of the present utility model;

FIG. 6 is a schematic structural view of an apparatus for generating shock waves in another preferred embodiment of example 2 of the present utility model;

FIG. 7 is a schematic view showing the structure of an apparatus for generating shock waves in another preferred embodiment of example 2 of the present utility model;

FIG. 8 is a schematic view of the apparatus for generating shock waves in a preferred embodiment of example 3 of the present utility model;

FIG. 9 is a schematic view showing the structure of an apparatus for generating shock waves in another preferred embodiment of example 3 of the present utility model;

fig. 10 is a schematic structural view of an apparatus for generating shock waves in another preferred embodiment of example 3 of the present utility model.

Reference numerals illustrate:

the device comprises an elongated member 100, an inner tube 110, an outer tube 120, a balloon 200, a drug delivery portion 210, a closure portion 220, a release element 230, a groove 240, a shock wave generating assembly 300, a first lead 310, a second lead 320, an inner electrode 330, an insulating sheath 340, a first electrode hole 341, an outer electrode sheath 350, a second electrode hole 351, a marker band 400, an indentation line 500, a tear line 600, and a tear port 610.

Detailed Description

In order to make the objects, technical solutions and advantages of the present utility model more apparent, the technical solutions of the present utility model will be clearly and completely described below with reference to specific embodiments of the present utility model and corresponding drawings. In the description of the present utility model, it should be noted that the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.

In the description of the present utility model, it should be noted that, unless explicitly specified and limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; the magnetic connection can be mechanical connection or magnetic connection; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present utility model will be understood in specific cases by those of ordinary skill in the art. In addition, in the description of the present utility model, the terms "first," "second," and the like are used merely to distinguish between descriptions and are not to be construed as indicating or implying relative importance.

It will be apparent that the described embodiments are only some, but not all, embodiments of the utility model. All other embodiments, which can be made by those skilled in the art based on the embodiments of the utility model without making any inventive effort, are intended to be within the scope of the utility model.

To solve the problems of the prior art, the present utility model provides an apparatus for generating a shock wave, comprising an elongated member 100, a balloon 200, and a shock wave generating assembly 300; wherein the elongated member 100 extends axially; balloon 200 encloses at least a portion of the area of elongate member 100, the interior of balloon 200 being filled with a conductive fluid; the shock wave generating assembly 300 includes a first wire 310, a second wire 320, an inner electrode 330, an outer electrode sheath 350, and an insulating sheath 340; a first lead 310 extends axially along the elongate member 100 and is connected to the inner electrode 330; an inner electrode 330 is positioned within balloon 200, inner electrode 330 being disposed on the outer side of elongate member 100; the insulating sheath 340 is disposed around the inner electrode 330, and the insulating sheath 340 has a first electrode hole 341 through which power can be supplied; a second lead 320 extends axially along the elongate member 100 and is connected to an outer electrode sheath 350; the outer electrode sheath 350 is arranged around the outer periphery of the insulating sheath 340, the outer electrode sheath 350 is provided with a second electrode hole 351, and the shape and the position of the second electrode hole 351 are matched with those of the first electrode hole 341; the second electrode hole 351 is configured to: when the balloon 200 is filled with a conductive fluid and a voltage is applied between the inner electrode 330 and the outer electrode sheath 350, current flows from the inner electrode 330 to the outer electrode sheath 350 in sequence, generating a shock wave; the second electrode hole 351 is configured in a non-circular shape, and the second electrode hole 351 has a first extending direction and a second extending direction, and the length of the first extending direction is different from the length of the second extending direction.

Example 1

At present, most of electrodes of the shock wave balloon are hole electrodes, and the direction and the size of shock waves generated by the electrodes are uncontrollable.

In view of the above, in a preferred embodiment of the present utility model, there is provided an apparatus for generating a shock wave, the apparatus having a structure including an elongated member 100, a balloon 200 and a shock wave generating assembly 300 as shown in fig. 1 to 4, wherein the balloon 200 encloses at least a partial region of the elongated member 100, the interior of the balloon 200 can be filled with a conductive fluid, and the shock wave generating assembly 300 is disposed within the balloon 200 and emits the shock wave radially outwardly.

Preferably, the elongate member 100 extends axially and is made of a flexible material to facilitate passage through tortuous or stenosed body lumens.

Preferably, the elongate member 100 is configured as a double-layered tubular, and the conductive fluid can be infused into the balloon 200 from a lumen between the double-layered tubular.

In a preferred embodiment, the elongate member 100 comprises an inner tube 110 and an outer tube 120 fixedly attached at a distal end and open at a proximal end with an annular channel therebetween, into which an electrically conductive fluid is infused proximally; balloon 200 is disposed at a portion of the distal end of outer tube 120 that is capable of filling or collapsing, and when infused with a conductive fluid, balloon 200 is capable of expanding and circumferentially squeezing the inside of the body lumen.

Preferably, the inner tube 110 of the elongated member 100 is used for delivering a guide wire to guide the delivery of the elongated member 100 in a blood vessel, and a guide wire outlet can be further provided at the side wall of the outer tube 120, the guide wire outlet being composed of the inner tube 110 and the outer tube 120 for guiding the guide wire to finally pass out therefrom in order to facilitate the delivery operation of the elongated member 100; preferably, a catheter hub may be further provided at the proximal end of the elongate member 100 from which the electrically conductive fluid may be infused.

In a preferred embodiment, saline is used as the conductive fluid to enhance the conductive properties of balloon 200, since the salt may increase the conductivity of the fluid, making it easier to deliver current.

In addition, the conductive fluid also has good biocompatibility and chemical stability to ensure that the balloon 200 does not react or fail during use. Therefore, when the conductive fluid is selected, factors such as irritation, cytotoxicity, solubility, stability and the like of human tissues are also considered, and necessary biocompatibility and toxicity tests are performed to ensure the safety and reliability of the fluid. Other conductive fluids may be selected for use in addition to the above-described saline, examples of which are not listed herein.

In a preferred embodiment, both balloon 200 and outer tube 120 may be made of nylon or polyether block amide PEBAX material, in order to ensure proper filling of balloon 200 after infusion with a conductive fluid, the thickness of the material at balloon 200 should be no greater than the thickness of outer tube 120; further, to ensure good pushability of the entire elongated member 100, the structural strength of the inner tube 110 is greater than that of the outer tube 120, alternatively the inner tube 110 may be configured as a multi-layer composite structure.

Specifically, since different patients have different physiological and pathological conditions, in order to ensure that the elongate member 100 can be delivered to the lesion site, the balloon 200 can be well fitted with the blood vessel at the lesion site to function, the dimensions of the elongate member 100 and the balloon 200 can be freely decided according to the actual situation of the patient, and will not be described herein.

In a preferred embodiment, the elongate member 100 is provided with marker bands 400 at both end positions of the balloon 200, and the marker bands 400 may be one or two for displaying the position of the balloon 200 in the human body.

In a preferred embodiment, the shock wave generating assembly 300 includes a first wire 310, a second wire 320, an inner electrode 330, an outer electrode, and an insulating sheath 340; the shock wave generating assembly 300 is disposed on the outer side of the inner tube 110, and when the conductive fluid is infused into the balloon 200, the shock wave generating device contacts the conductive fluid to release the shock wave.

Preferably, the first lead 310 extends axially of the elongate member 100 with a distal end connected to the inner electrode 330 and a proximal end extending axially to the proximal end of the elongate member 100 for electrical connection to the positive electrode; the inner electrode 330 is located inside the balloon 200 and is disposed on the outer sidewall of the inner tube 110; the insulating sheath 340 is disposed around the outer circumference of the inner electrode 330, the insulating sheath 340 is used for insulating the inner electrode 330 from the outer electrode sheath 350, specifically, a first electrode hole 341 is disposed on the insulating sheath 340, at least a portion of the inner electrode 330 and/or the first wire 310 is exposed in the first electrode hole 341, for conducting current; an outer electrode sheath 350 is looped around the outer circumference of the insulating sheath 340, and a second lead 320 is electrically connected to the outer electrode sheath 350, with the proximal end of the second lead 320 extending axially to the proximal end of the elongate member 100 and being capable of being electrically connected to the negative electrode.

In a preferred embodiment, the second electrode hole 351 is provided on the outer electrode sheath 350, the shape and position of the second electrode hole 351 correspond to those of the first electrode hole 341, and the opening size of the first electrode hole 341 is smaller than that of the second electrode hole 351, so as to ensure that the insulating sheath 340 can perform its insulating function, specifically, the second electrode hole 351 is configured to: when the balloon 200 is filled with a conductive fluid and a voltage is applied between the inner electrode 330 and the outer electrode sheath 350, current flows from the inner electrode 330 to the outer electrode sheath 350 in sequence, so that a shock wave is induced.

Preferably, the second electrode hole 351 has a special shape, including an oval, rectangle, circular arc, trapezoid or other non-circular shape, and configuring the second electrode hole 351 to be a non-circular special shape can enable the shock wave induced therefrom to be more specifically emitted to the target region, so as to improve the accuracy of treatment.

In particular, it may be difficult for the conventional circular electrode hole to completely cover a lesion area, resulting in poor treatment effect, while the non-circular second electrode hole 351 may better adapt to lesions of different shapes and sizes, thereby improving treatment accuracy. Further, the shape of the second electrode hole 351 can be customized according to the specific lesion morphology, so that the treatment can be more precisely applied to the lesion.

In addition, the non-circular second electrode hole 351 is designed to reduce the damage to normal tissue during the treatment process, and because the forms of normal tissue around the focus are different, when the treatment of the traditional circular electrode hole is performed, the normal tissue around the focus may be accidentally damaged, and additional damage is caused.

Furthermore, the non-circular second electrode hole 351 can also improve the safety and reliability of the treatment, and compared with the conventional circular electrode hole, the non-circular electrode hole can be used for fixing the electrode more stably, thereby reducing the risk of adverse events in the treatment process.

In a preferred embodiment, the ratio of the length to the width of the second electrode hole 351 having a special shape is greater than 2:1, specifically, the second electrode has a first extending direction and a second extending direction, specifically, the length direction is defined as a first extending direction, and the width direction is defined as a second extending direction; the length direction of the second electrode hole 351 may be configured to be parallel to the length direction of the elongated member 100, as in fig. 3, or the length direction of the second electrode hole 351 may be configured to be perpendicular to the length direction of the elongated member 100, as in fig. 2, or the length direction of the second electrode hole 351 may be configured to extend spirally along the outer circumference of the elongated member 100, as in fig. 4.

In a preferred embodiment, the second electrode hole 351 has a circular arc shape with a length direction perpendicular to the length direction of the elongated member 100, and further, the arc length of the second electrode hole 351 is greater than 1/3 of the circumference of the elongated member 100 in order to emit shock waves of a greater angle in the circumferential direction to expand the range of treatment.

In a preferred embodiment, the second electrode hole 351 is rectangular and has a length direction parallel to the length direction of the elongated member 100, and further, has a length direction freely decided according to the length of the outer electrode sheath 350 in order to emit a shock wave of a greater length in the axial direction to expand the treatment range.

In some alternative embodiments, at least two second electrode holes 351 may be distributed along the circumference of the outer electrode sheath 350, and in cooperation with the second electrode holes 351, the first electrode holes 341 are also formed at corresponding positions of the insulating sheath 340, and the second electrode holes 351 disposed adjacently in the circumferential direction may have the same shape or may have different shapes, so as to expand the treatment angle.

In this embodiment, in use, the above-mentioned apparatus for generating a shock wave is firstly filled with a conductive fluid in the balloon 200 so that a conductive path is formed between the inner electrode 330 on the inner side and the outer electrode sheath 350 on the outer side, and then a voltage is applied between the inner electrode 330 and the outer electrode sheath 350 through the first wire 310 and the second wire 320, so that a current flows from the inner electrode 330 to the outer electrode sheath 350 in sequence, a shock wave is generated, and in particular, the voltage between the inner electrode 330 and the outer electrode sheath 350 is adjustable, so as to achieve the adjustment of the strength of the shock wave.

Example 2

In this embodiment, a device for generating a shock wave is provided, and the features already included in embodiment 1 are naturally inherited in this embodiment, and will not be described again.

Referring to fig. 5-7, in a preferred embodiment, an apparatus for generating a shock wave comprises an elongated member 100, a balloon 200 and a shock wave generating assembly 300, wherein the balloon 200 encloses at least a partial area of the elongated member 100, the interior of the balloon 200 is capable of being filled with an electrically conductive fluid, the shock wave generating assembly 300 is arranged within the balloon 200 and emits the shock wave radially outwardly, preferably a plurality of axially arranged shock wave generating assemblies 300 are arranged in the balloon 200, each shock wave generating assembly 300 is provided with one second electrode aperture 351, from which the shock wave can be induced.

Preferably, axially adjacent shock wave generating assemblies 300 share the same second wire 320 within the balloon 200, and the inner electrode 330 in each shock wave generating assembly 300 is connected to a separate one of the first wires 310.

In a preferred embodiment, each shock wave generating assembly 300 in the balloon 200 may be disposed at equal intervals in the axial direction, or may be disposed at unequal intervals according to the actual shape/size of the lesion, so that the shock wave is distributed more uniformly, and the adaptability of the whole device is wider, and therefore, it is more preferable that the shock wave generating assemblies 300 in the balloon 200 are disposed at equal intervals in the axial direction.

In a preferred embodiment, in the balloon 200, the axial length of each shock wave generating assembly 300 is the same, the outer diameter of each shock wave generating assembly 300 is the same, and adjacent shock wave generating assemblies 300 are equidistantly spaced, at which time the overall device has better versatility.

In another preferred embodiment, in the balloon 200, the axial length and outer diameter of each shock wave generating assembly 300 may be varied, as may the spacing between adjacent shock wave generating assemblies 300, to specifically adapt to a more specific lesion shape. In this embodiment, although the length, the outer diameter, and the pitch of the shock wave generating assemblies 300 may be different in the super-balloon 200, the above-described several parameters of each shock wave generating assembly 300 are not necessarily different, that is, the length, the outer diameter, and the pitch of some shock wave generating assemblies 300 may be the same, the length, the outer diameter, and the pitch of other shock wave generating assemblies 300 may be different, the length, the outer diameter, and the pitch of some shock wave generating assemblies 300 may be different, and the length, the outer diameter, and the pitch of other shock wave generating assemblies 300 may be the same.

In a preferred embodiment, as shown in fig. 1, the second electrode holes 351 in each shock wave generating assembly 300 in the balloon 200 are all oriented in the same direction.

In a preferred embodiment, the second electrode holes 351 in each shock wave generating assembly 300 in the balloon 200 are respectively oriented in different spatial directions, and the sum of the orientations of the axially adjacent second electrode holes 351 can cover at least part of the circumference or all the circumference, so as to ensure that shock waves are generated in multiple directions as much as possible and ensure that the pressure in each direction is the same as much as possible.

As shown in fig. 5, the length direction of the second electrode holes 351 in each shock wave generating assembly 300 in the balloon 200 is perpendicular to the length direction of the elongated member 100, and the orientations of the plurality of second electrode holes 351 are rotated in sequence, preferably to cover the entire circumference.

As shown in fig. 6, the length direction of the second electrode holes 351 in each shock wave generating assembly 300 in the balloon 200 is parallel to the length direction of the elongated member 100, and the orientations of the plurality of second electrode holes 351 are rotated in sequence, preferably to be able to cover the entire circumference.

As shown in fig. 7, the length direction of the second electrode holes 351 in each shock wave generating assembly 300 in the balloon 200 is spirally extended, and the orientations of the plurality of second electrode holes 351 are sequentially rotated, preferably to cover the entire circumference.

Preferably, when the second electrode holes 351 in each shock wave generating assembly 300 are respectively oriented in different spatial directions, the second electrode holes 351 on different shock wave generating assemblies 300 may have different shapes/sizes, and may also have the same shape/size, and when the shapes/sizes of the second electrode holes 351 are the same, a more uniform pressure can be generated, and when the shapes/sizes of the second electrode holes 351 are different, the shape of the actual lesion can be more adapted, wherein the different shapes/sizes of the second electrode holes 351 may refer to the different shapes/sizes of the second electrode holes 351, and may also refer to the different shape/size of at least one second electrode hole 351 from the other second electrode holes 351.

Preferably, the second electrode holes 351 are configured to be non-circular regardless of whether the different second electrode holes 351 are oriented in the same direction or in different directions, and the specific shape configuration is the same as that of embodiment 1 described above, and will not be described here again.

Example 3

In this embodiment, a device for generating a shock wave is provided, and features already included in embodiment 1 or embodiment 2 described above are naturally inherited in this embodiment, and are not described in detail.

Referring to fig. 8 to 10, in a preferred embodiment, a drug loading part 210 is provided on the outer side of the balloon wall of the balloon 200, the drug loading part 210 is used for accommodating a drug, a sealing part 220 is provided on the outer side of the balloon wall of the balloon 200, the sealing part 220 at least covers the drug loading part 210 to prevent the drug from being lost during the delivery process, a release element 230 is provided on the outer side of the balloon wall of the balloon 200, the release element 230 is at least provided in a partial area of the drug loading part 210, the release element 230 can pierce the sealing part 220 radially outwards when the balloon 200 is filled, and finally cut open plaque and calcified lesion parts, on one hand, the drug in the drug loading part 210 is released, on the other hand, the drug can be better contacted with the inside of the lesion, and the therapeutic effect is enhanced.

Preferably, a partial region of the balloon wall is recessed radially inward to form a plurality of grooves 240, the plurality of grooves 240 constituting the drug-carrying portion 210, the drug-carrying portion 210 being for containing a drug.

In a preferred embodiment, the grooves 240 may be disposed in a matrix-like manner on the balloon wall; in a preferred embodiment, grooves 240 may be axially disposed in rows on the balloon wall; in another preferred embodiment, the grooves 240 may be staggered in a lattice pattern on the balloon wall; in some possible embodiments, the location and shape of the lesion may be observed in the imaging system prior to performing the interventional procedure, and then the grooves 240 in the balloon wall may be configured to follow the actual shape and location of the lesion.

Alternatively, the grooves 240 may be distributed over the entire balloon wall of the balloon 200, may be disposed in a concentrated manner in a certain section of the balloon wall, may be disposed in a dispersed manner in a plurality of sections of the balloon wall, or may be disposed in a dispersed manner in each groove 240, which is not shown here.

Preferably, since the specific size of the balloon 200 can be adjusted according to the actual physiological or pathological state of the patient, the specific size of the groove 240 can be freely adjusted according to the size of the balloon 200 or the lesion, which is not limited herein.

In a preferred embodiment, the drug contained within the recess 240 may be pasty or water-soluble and may be aspirin and clopidogrel (or ticagrelor), paclitaxel and iopromide, copolymers of paclitaxel and polylactic acid-glycolic acid, paclitaxel derivatives, rapamycin.

Preferably, the top of each groove 240 is provided with a sealing part 220, and the sealing parts 220 can be configured as a sealing film; preferably, a release element 230 is disposed in each recess 240, and the release element 230 is disposed at the bottom of each recess 240; preferably, release element 230 is capable of conforming to and adhering to groove 240 as balloon 200 collapses, and release element 230 is capable of protruding radially outward in a sharp configuration as balloon 200 fills.

Optionally, each groove 240 may correspond to one sealing portion 220, for example, a sealing film is attached to each groove 240; alternatively, a sealing film is covered outside the whole drug carrying part 210, that is, a complete and larger sealing film is attached outside the grooves 240.

In a preferred embodiment, the closure 220 is made of a degradable material, such as one or more of chitosan, polypropylene glycol glutarate, diisocyanate, polycarbonate fiber, modified polylactic acid, starch, and the like.

In a preferred embodiment, the release element 230 is a plurality of spikes, which act as the release element 230, capable of puncturing the closure 220 when the balloon 200 is inflated, so that the drug in the recess 240 can be released. Specifically, when balloon 200 is in the folded state, the spikes can be conformably disposed at the folds of balloon 200, similar to the spikes of a hedgehog in a calm state; when the balloon 200 is in the inflated state, the spikes stand radially outward, similar to the spikes of a hedgehog in the stimulated state, at which time the spikes can pierce the closure 220, exposing the drug, rotating the balloon 200, allowing the drug to uniformly spread on the inner wall of a calcified inner tube, and through rotating the balloon 200, the spikes can also cut plaque and calcified lesions, thereby effectively expanding the vessel wall. Meanwhile, the shock wave generating assembly 300 emits shock waves to break up calcified lesions, and the inner wall of the blood vessel can accelerate the absorption of the medicine under the action of the shock waves, so that the medicine utilization rate is improved.

In a preferred embodiment, the grooves 240 are arranged in a row along the axial direction, and the grooves 240 are arranged at folds after the balloon 200 is folded, at this time, the spikes are also arranged at the folds to reduce the diameter of the balloon 200 when folded, increase the trafficability of the balloon 200, and in this way, the damage to the balloon wall caused by the spikes when the balloon 200 is folded can be avoided, when the balloon 200 is inflated and expanded, the spikes rise along with them to pierce the sealing portion 220, and the drug contained in the grooves 240 is released.

Alternatively, the spikes are made of nylon, PE, pebax, PVC, PTFE, FEP or PET material and secured to the bottom of the recess 240 by an adhesive.

Preferably, the bottom area of the spike is smaller than the bottom area of the groove 240 to ensure that there is sufficient space in the groove 240 to hold the drug; preferably, in the inflated condition of balloon 200, the height of the spike is greater than the depth of groove 240 to ensure that the spike is able to puncture closure 220 to release the drug.

Preferably, an auxiliary release structure is further provided to prevent the release element 230 from being unable to puncture the closure 220 when the balloon 200 is inflated, resulting in the inability of the drug to be released.

In a preferred embodiment, as shown in fig. 9, the auxiliary release structure comprises a score line 500 provided on the sealing film, the score line 500 having a thickness that is less than the thickness of other areas of the sealing film.

In a preferred embodiment, when the sealing film covers the entire drug-carrying portion 210, an annular indentation line 500 is provided on the sealing film, the indentation line 500 may be formed by pressing with an indentation machine, so that the sealing film has a series of dotted indentations at positions corresponding to the grooves 240, the indentation line 500 is formed, the structural strength of the indentation line 500 is weak, and when the balloon 200 enters the focus and fills, the sealing film may be ruptured due to the inflation of the balloon 200 due to the small structural strength of the indentation line 500, so as to release the drug in the drug-carrying portion 210.

As shown in fig. 10, preferably, when the sealing film covers the entire drug delivery portion 210, the auxiliary release structure includes not only the score line 500 provided on the sealing film, but also a tear line 600, the tear line 600 being a linear structure, the distal end of the tear line 600 being connected to the score line 500, the proximal end of the tear line 600 extending axially to the proximal end of the elongated member 100.

In a preferred embodiment, when a plurality of score lines 500 are provided, one tear line 600 is provided for each score line 500.

In a preferred embodiment, the score lines 500 are disposed circumferentially of the drug delivery part 210, at which point the score lines 500 can open with radial expansion of the balloon 200 to release the drug in the drug delivery part 210, as the balloon 200 can expand radially.

In another preferred embodiment, the indentation line 500 is disposed along the axial direction of the drug-carrying portion 210, at this time, one end of the indentation line 500 is further provided with a tear line 600, so that the sealing portion 220 can be opened at any time without having to wait for the balloon 200 to expand, and when in operation, the drug in the drug-carrying portion 210 can be released only by retracting the tear line 600 proximally, and meanwhile, due to the presence of the tear line 600, the situation that the opening is difficult due to the excessive structural strength of the indentation line 500 can be effectively avoided.

In general, in the drug balloon provided with the shock wave generating assembly 300, the release of the drug is required after the calcified lesion is treated, and the above-mentioned release element 230 can open the sealing part 220 after the calcified lesion is released according to circumstances, so that the drug reaches the lesion to ensure that the drug fully plays a role.

The embodiments of the present utility model have been described above with reference to the accompanying drawings, but the present utility model is not limited to the above-described embodiments, which are merely illustrative and not restrictive, and many forms may be made by those having ordinary skill in the art without departing from the spirit of the present utility model and the scope of the claims, which are to be protected by the present utility model.

Claims (10)

1. An apparatus for generating a shock wave, comprising an elongate member, a balloon and a shock wave generating assembly;

the elongate member extends axially;

the balloon surrounding at least a partial region of the elongate member, the balloon interior for filling with a conductive fluid;

the shock wave generating assembly comprises a first wire, a second wire, an inner electrode, an outer electrode sheath and an insulating sheath;

the first lead extends along the axial direction of the slender component and is connected with the inner electrode;

the inner electrode is positioned in the balloon and is arranged on the outer side surface of the slender component;

the insulating sheath ring is arranged on the periphery of the inner electrode, and the insulating sheath is provided with a first electrode hole capable of conducting electricity;

the second lead extends axially along the elongated member and is connected with the outer electrode sheath;

the outer electrode sheath ring is arranged on the periphery of the insulating sheath, a second electrode hole is formed in the outer electrode sheath, and the shape and the position of the second electrode hole are matched with those of the first electrode hole;

a shockwave can be generated in the second electrode hole;

the second electrode hole is configured in a non-circular shape, the second electrode hole having a first extending direction and a second extending direction, the length of the first extending direction being different from the length of the second extending direction.

2. The device for generating shock waves according to claim 1, wherein a plurality of shock wave generating assemblies are arranged in the balloon, each shock wave generating assembly is provided with one second electrode hole, and the second electrode holes and/or the first electrode holes in each shock wave generating assembly are respectively oriented in different spatial directions.

3. Device for generating shock waves according to claim 2, characterized in that in the balloon at least part of the second electrode holes are oriented so as to cover part of the circumference and/or the whole circumference.

4. The apparatus for generating a shock wave according to claim 2, wherein adjacent ones of the shock wave generating assemblies are connected in parallel.

5. The apparatus for generating a shock wave according to claim 1, wherein the second electrode aperture is configured in an elliptical, circular arc, trapezoidal or other non-circular shape.

6. The apparatus for generating a shock wave according to any one of claims 1 to 5, wherein the first extension direction is parallel to the length direction of the elongated member, and the second extension direction is perpendicular to the length direction of the elongated member;

alternatively, the first extending direction is perpendicular to the longitudinal direction of the elongated member, and the second extending direction is parallel to the longitudinal direction of the elongated member;

alternatively, the first direction of extension extends helically along the outer circumference of the elongate member.

7. The apparatus for generating a shock wave according to claim 1, wherein the shape of the first electrode hole is the same as the shape of the second electrode hole, and an opening size of the first electrode hole is smaller than an opening size of the second electrode hole.

8. The apparatus for generating shock waves of claim 1, wherein the elongated member is configured as a double-layered tubular, conductive fluid being infused into the balloon by the elongated member.

9. The apparatus for generating a shock wave according to claim 1, wherein a voltage between the inner electrode and the outer electrode sheath is adjustable to achieve adjustment of the shock wave intensity.

10. An apparatus for generating a shock wave, comprising an elongate member, a balloon and a shock wave generating assembly;

the elongate member extends axially;

the balloon surrounding at least a partial region of the elongate member, the balloon interior for filling with a conductive fluid; the outer side of the balloon wall of the balloon is provided with a medicine carrying part and/or a medicine coating, and the medicine carrying part and/or the medicine coating are used for containing medicines;

the shock wave generating assembly comprises a first wire, a second wire, an inner electrode, an outer electrode sheath and an insulating sheath;

the first lead extends along the axial direction of the slender component and is connected with the inner electrode;

the inner electrode is positioned in the balloon and is arranged on the outer side surface of the slender component;

the insulating sheath ring is arranged on the periphery of the inner electrode, and the insulating sheath is provided with a first electrode hole capable of conducting electricity;

the second lead extends axially along the elongated member and is connected with the outer electrode sheath;

the outer electrode sheath ring is arranged on the periphery of the insulating sheath, a second electrode hole is formed in the outer electrode sheath, and the shape and the position of the second electrode hole are matched with those of the first electrode hole;

the second electrode aperture is configured to: when the balloon is filled with a conductive fluid and a voltage is applied between the inner electrode and the outer electrode sheath, current flows from the inner electrode to the outer electrode sheath in sequence, generating a shock wave;

the second electrode hole is configured in a non-circular shape, the second electrode hole having a first extending direction and a second extending direction, the length of the first extending direction being different from the length of the second extending direction.