CN113398444A

CN113398444A - Shock wave medicine-carrying double-layer balloon catheter for cardiovascular stenosis

Info

Publication number: CN113398444A
Application number: CN202110683561.6A
Authority: CN
Inventors: 袁柳; 程增兵; 林林
Original assignee: Suzhou Zhonghui Medical Technology Co ltd
Current assignee: Suzhou Zhonghui Medical Technology Co ltd
Priority date: 2021-06-21
Filing date: 2021-06-21
Publication date: 2021-09-17

Abstract

The invention relates to a shock wave medicine-carrying double-layer balloon catheter for cardiovascular stenosis, which comprises a distal end, a balloon and a proximal end; the distal end is an extension of the balloon; the balloon is proximate the distal end; the balloon is a double-layer balloon; the proximal end is connected with a handle; regular small holes are formed in the surface of the outer layer balloon of the balloon; a liquid medicine control dose injection port is also arranged at the position of the end part of the near end; the inner catheter and the outer catheter are used for filling medicine mixed liquid between the inner balloon and the outer balloon to form an outer balloon medicine liquid cavity. The double-layer balloon structure can release liquid medicine to the narrow lesion part at the same time, and the operation process is simple; the liquid medicine control dose injection port can realize the control of the delivery dose of the liquid medicine; the small hole structure on the outer layer saccule greatly improves the uniformity and the timeliness of the liquid medicine release, realizes the smoothness of the angiostenosis lesion and achieves the purpose of keeping the smoothness for a long time.

Description

Shock wave medicine-carrying double-layer balloon catheter for cardiovascular stenosis

Technical Field

The invention relates to the technical field of medical instruments, in particular to a shock wave medicine-carrying double-layer balloon catheter for cardiovascular stenosis.

Technical Field

At present, cardiovascular stenosis lesions are complex and diverse in clinic, and the main treatment methods for severe calcification lesions comprise: common balloon high pressure dilation, cutting balloon dilation, rotational atherectomy, laser angioplasty, and the like. Among the more widely used are rotational atherectomy. But still has the obvious defects of complex operation, easy induction of spasm, slow blood flow or no re-flow and the like; the method has higher perforation risk, higher cost and higher requirements on the operation technique of operators for calcified angulated lesions.

The clinical application of drug-coated balloons (DCB) has become more widespread in recent years, and the main mechanism is to permeate paclitaxel into the artery wall to inhibit intimal hyperplasia. Compared with the common balloon, the ISR and target vascular intervention (TLR) rate after DCB treatment is obviously reduced. However, intimal or media calcification interferes with paclitaxel uptake and distribution, resulting in a reduction in DCB efficacy. Therefore, in clinic, doctors select various volume reduction techniques according to the pathological changes of patients, and then select a plurality of medicine balloons to transmit medicines according to the pathological changes, so that the long-term patency rate is maintained when the angiostenosis is effectively treated, but the operation is complex and the cost is high.

Chinese patent CN106178231A discloses a medical double-layer high pressure resistant balloon, wherein the balloon body is of a double-layer structure and comprises a hard layer positioned on an outer layer and a soft layer positioned on an inner layer; or the sacculus body is including being located the outer soft layer and being located the inlayer hard layer, through adopting the double-deck combined material preparation of soft or hard, when effectively having increased sacculus burst pressure for sacculus itself has certain flexibility, when using as cardiovascular sacculus pipe and periphery blood vessel sacculus pipe, can effectively strengthen the penetrability of sacculus. The invention provides a double-layer balloon, but due to differences in use scenes and application, the double-layer balloon is mainly used for increasing the compression capacity and the compression quality, and other pathological treatments are not disclosed and cannot achieve the effect.

Chinese patent CN110638516A discloses a guide wire guide double-layer balloon catheter for chemical ablation of blood vessels, the invention divides the inner cavity of the catheter into a guide wire guide channel, a balloon filling channel and a drug delivery channel which are mutually independent along the radial direction; one channel is used for guiding a guide wire, the other channel is used for filling a saccule, the third channel is communicated with an outer cavity formed between the inner saccule and the outer saccule after the inner saccule and the outer saccule are expanded, the outer saccule on the surface of the outer cavity is in a loose porous structure, micropores are uniformly and densely distributed on the outer saccule, after the saccule is expanded, a medicine is sent to the outer cavity through a medicine feeding channel, enters the surface of the saccule through the micropores and is contacted with the endothelium of a target blood vessel, and the wall of the target blood vessel is accurately damaged; compared with the traditional chemical destruction or thermal ablation mode, the scheme provided by the invention can greatly reduce normal blood components and reduce the dosage of the medicine, but the specific administration dosage control on the blood vessel is not specifically solved, the medicine enters the surface of the balloon through the micropores to be in contact with the endothelium of the target blood vessel to realize accurate destruction, and the micropores structurally realize accurate destruction of the target blood vessel wall: when the porous outer balloon releases the medicine, the medicine is released to the target vascular wall of the target and is applied to other peripheral vascular walls, so that the medicine dosage of other normal blood is reduced, and the total dosage is not determined during conveying.

In view of the above, how to overcome the limitations of the prior art, the balloon catheter can realize the delivery of controllable dosage and improve the uniformity and timeliness of the delivery and release of the liquid medicine in the use process, effectively treat the vascular stenosis, simplify the operation while maintaining the long-term patency rate, reduce the bearing time of the patient in the treatment process, and the like, and is an urgent matter to be solved and has important significance.

Disclosure of Invention

To the not enough of prior art, the application provides a shock wave medicine carrying double-layer balloon catheter for angiostenosis pathological changes. The double-layer balloon structure of the shock wave medicine-carrying double-layer balloon catheter can release liquid medicine at the narrow lesion part at the same time, and the operation process is simplified; the end part of the catheter at the near end is provided with a liquid medicine control dose injection port, so that the control of the delivery dose of the liquid medicine can be realized, and the small holes in the outer saccule can improve the uniformity and the timeliness of the liquid medicine release, so that the smoothness of the cardiovascular stenosis part can be efficiently realized, and even the smoothness can be maintained for a long time.

In order to achieve the above purpose, the present application provides the following technical solutions:

a shock wave medicine-carrying double-layer balloon catheter for cardiovascular stenosis comprises a distal end, a balloon and a proximal end.

The distal end is an extension of the balloon; the balloon is proximate the distal end; the proximal end is connected to a handle.

The sacculus is multilayer sacculus, is two-layer sacculus at least.

In one embodiment, the balloon is a double-layer balloon comprising an inner layer balloon and an outer layer balloon.

And an electrode pair capable of releasing energy is arranged in the inner-layer balloon.

Preferably, the outer balloon is a structure with regular small holes;

in one embodiment, the small hole size of the outer balloon 202 is set to be small in inner diameter and large in outer diameter of the inner hole of the balloon, so that uniform release of the liquid medicine to the vessel wall at the cardiovascular stenosis part is realized;

the size of the outer diameter of the small hole is 100-1000 nm.

Preferably, a medical fluid controlled dose injection port is further provided at the proximal end position.

The shock wave medicine-carrying double-layer balloon catheter further comprises an inner catheter and an outer catheter.

Preferably, the inner catheter and the inner balloon are connected by means of adhesion, heat welding or laser.

Preferably, the inner catheter is of a multi-cavity structure, one cavity is a guide wire guide cavity, and the other cavities are inner-layer balloon liquid cavities.

Preferably, the inner catheter is perforated at the inner balloon to facilitate pressurized perfusion of contrast fluid.

Preferably, the inner catheter and the outer catheter are used for filling medicine mixed liquid between the inner balloon and the outer balloon to form an outer balloon medicine liquid cavity.

Preferably, the drug infused in the liquid cavity of the inner balloon is paclitaxel, the paclitaxel is mixed with a biocompatible hydrophilic or hydrophobic solvent in a specific proportion, the solvent is one or more of sodium chloride or the like, and the concentration of the drug liquid is 10-20 umol/L.

The application has the following advantages and technical effects:

1) the invention discloses a shock wave medicine-carrying double-layer balloon catheter for cardiovascular stenosis, which can not only meet the function of medicine carrying, but also carry out medicine conveying on a plurality of different catheters such as a catheter for conveying medicine, a balloon catheter and the like when the cardiovascular stenosis is treated in the prior art, and the operation process is more complex; even if the sacculus can not realize evenly releasing the medicine under the action of the shock wave during medicine carrying and conveying. The balloon in the catheter is arranged into double layers or even multiple layers, and the double-layer balloon can be also provided with structures such as an electrode pair, a marking ring and the like; an outer balloon liquid medicine cavity is formed between the outer catheter and the inner catheter, so that medicine is further administered to a lesion part; the structure can realize that the liquid medicine passes through the regular aperture on the outer sacculus surface, realizes evenly releasing to the vascular wall, and can release the energy of the electrode in the sacculus simultaneously, makes the shock wave that discharges and produce can further promote the aperture release of liquid medicine from outer sacculus, realizes the medication of more efficient angiostenosis pathological change department, therefore can realize the long-term unobstructed of stenosis department.

2) According to the double-layer balloon structure, the small hole structures are regularly distributed on the outer surface of the outer balloon, so that the outer balloon is a porous balloon, and the size of each small hole structure is set to be large in outer diameter and small in inner diameter, so that liquid medicine can be uniformly released to a blood vessel wall at a cardiovascular stenosis part, and release of different dosage can be met; under the effect of seismic wave, combine the aperture structure, improved the degree of consistency and the ageing of liquid medicine when the release greatly, and then improved the liquid medicine and reached balanced effectual effect and accelerate the treatment process in the quantity, reduced patient's the bearing time at the treatment in-process.

3) In the invention, the end part of the catheter at the near end is provided with a liquid medicine control dose injection port, in the treatment of the stenotic lesion in the specific embodiment, a proper amount of liquid medicine is prepared in the medicine delivery injector in advance according to the judgment of the lesion, and the liquid medicine control dose injection port is filled into the liquid cavity of the inner layer balloon.

4) According to the invention, through the double-layer balloon structure, the liquid medicine conveyed in the balloon can be conveniently and effectively released to the vessel wall after the shock wave through the inner-layer balloon liquid cavity and the outer-layer balloon liquid cavity.

The foregoing is a summary of the present disclosure, and so that the present disclosure will be more clearly understood and appreciated, and the following detailed description will be given in conjunction with the accompanying drawings.

The above and other objects, advantages and features of the present application will become more apparent to those skilled in the art from the following detailed description of specific embodiments thereof, taken in conjunction with the accompanying drawings.

Drawings

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings needed to be used in the description of the embodiments or the prior art will be briefly introduced below, and it is obvious that the drawings in the following description are some embodiments of the present application, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts. Throughout the drawings, like elements or portions are generally identified by like reference numerals. In the drawings, elements or portions are not necessarily drawn to scale.

Fig. 1 is a schematic view of a shock wave drug-loaded double-layer balloon catheter for cardiovascular stenosis according to the present invention;

FIG. 2 is a schematic structural view of a double-layer balloon in the shock wave drug-loaded double-layer balloon catheter for cardiovascular stenosis disease according to the present invention;

FIG. 3 is a schematic view of section A-A of a dual layer balloon structure according to the present invention;

wherein the reference numerals are: 1. a distal end; 2. a balloon; 201. an inner balloon; 202. an outer balloon; 3. a proximal end; 4. an electrode pair; 5. a liquid controlled preparation amount injection port; 6. an inner conduit; 7. an outer catheter; 8. an outer balloon liquid medicine cavity; 9. a marker ring; 10. a guide wire chamber; 11. an inner balloon liquid chamber; 12. a handle; 13. an energy release button; 14. an energy generator; 15. a power source; 16. a parameter display screen; 17. and connecting the cable.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present application clearer, 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 some embodiments of the present application, but not all embodiments. In the following description, specific details such as specific configurations and components are provided only to help the embodiments of the present application be fully understood. Accordingly, it will be apparent to those skilled in the art that various changes and modifications may be made to the embodiments described herein without departing from the scope and spirit of the present application. In addition, descriptions of well-known functions and constructions are omitted in the embodiments for clarity and conciseness.

It should be appreciated that reference throughout this specification to "one embodiment" or "the embodiment" means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present application. Thus, the appearances of the phrase "one embodiment" or "the present embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

Further, the present application may repeat reference numerals and/or letters in the various examples. This repetition is for the purpose of simplicity and clarity and does not in itself dictate a relationship between the various embodiments and/or configurations discussed.

The term "and/or" herein is merely an association describing an associated object, meaning that three relationships may exist, e.g., a and/or B, may mean: a exists alone, B exists alone, and A and B exist at the same time, and the term "/and" is used herein to describe another association object relationship, which means that two relationships may exist, for example, A/and B, may mean: a alone, and both a and B alone, and further, the character "/" in this document generally means that the former and latter associated objects are in an "or" relationship.

The term "at least one" herein is merely an association relationship describing an associated object, and means that there may be three relationships, for example, at least one of a and B, may mean: a exists alone, A and B exist simultaneously, and B exists alone.

It is further noted that, herein, relational terms such as first and second, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion.

Example 1

This embodiment specifically introduces a kind of shock wave medicine carrying double-layer balloon catheter for cardiovascular stenosis pathological changes.

As shown in fig. 1, 2, and 3:

a shock wave medicine-carrying double-layer balloon catheter for cardiovascular stenosis comprises a distal end 1, a balloon 2 and a proximal end 3.

The distal end 1 is an extension of the balloon 2; the balloon 2 is positioned at the middle lower part between the distal end 1 and the proximal end 3; the proximal end 3 is connected with a handle 12;

the balloon 2 is a multilayer balloon, and at least comprises two layers of balloons;

optionally, the balloon is selected from a double-layer balloon comprising an inner balloon 201 and an outer balloon 202.

Further, an electrode pair 4 capable of releasing energy is arranged inside the inner layer balloon 201.

Further, the outer balloon 202 of the balloon is a structure with regular small holes; the size of the small hole of the outer balloon 202 is set to be small in the inner diameter of the inner hole of the balloon and large in the outer diameter of the inner hole of the balloon, so that liquid medicine can be uniformly released to the wall of a blood vessel at the position of the cardiovascular stenosis; the size of the outer diameter of the small hole is 100-1000 nm.

Further, a liquid medicine control dose injection port 5 is further arranged at the end position of the proximal end 3; the liquid medicine controlled dose injection port 5 can be connected to a drug delivery syringe and accurately control the amount of liquid medicine.

The shock wave medicine-carrying double-layer balloon catheter further comprises an inner catheter 6 and an outer catheter 7.

Optionally, the inner catheter 6 and the inner balloon 201 are connected by means of bonding, heat welding or laser.

The inner catheter 6 is of a multi-cavity structure, one cavity is used as a guide wire guide cavity 10, and the other cavities are used as contrast liquid perfusion cavities of the inner balloon, namely an inner balloon liquid cavity 11.

Further, the inner catheter 6 is perforated at the inner balloon 201 to facilitate pressurizing the perfusion contrast fluid.

Furthermore, the inner balloon liquid cavity 11 can uniformly release the liquid medicine in the inner balloon liquid cavity 11 after the electrode pair 4 inside the inner balloon 201 releases energy to shatter calcified lesions.

It is noted that the working pressure of the balloon shattering and calcification is 4atm, after a certain amount of liquid medicine is filled at 4atm after shattering, the inner balloon 201 is inflated to 6atm for expansion, and energy shock waves are released to accelerate the liquid medicine to be uniformly released to the vessel wall.

Wherein, the saccule at the lesion position of the long-section stenosis can move to shatter and calcify and release the liquid medicine.

The inner catheter 6 and the outer catheter 7 are used for filling the medicine mixed liquid between the inner balloon 201 and the outer balloon 202, namely, the outer balloon medicine liquid cavity 8 is formed.

Further, at least two marker rings 9 are arranged in the balloon for indicating the length.

Further, the drug mixture solution filled in the inner balloon liquid cavity 11 is anti-regenerative drug paclitaxel and its derivatives, rapamycin, temsirolimus, tacrolimus, everolimus, and the like.

Optionally, the drug is selected from paclitaxel, and mixed with biocompatible hydrophilic or hydrophobic solvent at a specific ratio, wherein the solvent is one or more of sodium chloride or other materials, and the concentration of the medicinal liquid is 10-20 μmol/L.

Example 2

This example illustrates a seismic-wave drug-loaded double-layer balloon catheter for cardiovascular stenosis based on example 1, which is used for recanalization treatment of M sites of the cardiovascular stenosis.

A shock wave medicine-carrying double-layer balloon catheter for cardiovascular stenosis diseases further comprises an energy release button 13, an energy generator 14, a power supply 15, a parameter display screen 16 and a connecting cable 17.

The energy release button 13 is positioned on the handle 12 and is used for controlling the energy release of the electrode pair; the energy generator 14 is a carrier platform of a power supply 15 and a parameter display screen 16; the connection cable 17 is used to connect the handle 12 and the energy generator 14.

In this embodiment, the main steps of the recanalization treatment of the M position of the angiostenosis lesion include the following steps:

step 1, determining that the balloon catheter reaches the far end of the M position of a target cardiovascular stenosis position through a guide wire in a guide wire cavity 10 by a parameter display screen 16;

step 2, preparing a proper amount of liquid medicine in the medicine delivery injector in advance, and filling the liquid medicine into the inner-layer balloon 201 through the liquid medicine controlled dose injection port 5 to fill the balloon;

step 3, the electrode pair 4 in the inner-layer balloon 201 releases energy by starting the energy release button 13, so that shock waves are generated by discharging, and plaque fragmentation and cracking at the far end of the M position of the cardiovascular stenosis part are realized;

step 4, injecting a certain amount of prepared paclitaxel injection into a drug liquid cavity of the outer balloon by using a drug delivery injector through a drug liquid control dose injection port 5 at the end position of the far end 1, passing through small holes in the surface of the outer balloon 201, realizing uniform release to the vessel wall, and when the dosage requirement of a lesion part is large, quickly releasing the required dosage through the small holes in the surface of the outer balloon 201;

step 5, when the liquid medicine is released in the step 4, the electrode pairs in the saccule can be released continuously, so that the shock wave generated by the discharge can further and quickly promote the release of the liquid medicine from the micropores on the outer saccule 202;

step 6, repeating the steps, and releasing the medicine once or for multiple times to complete the recanalization treatment of the distal stenosis at the M position;

and 7, at least two marking rings 9 are arranged in the balloon 2 and can be used for indicating the length, after the treatment of the position of the far M end of the cardiovascular stenosis is finished, the balloon can be moved to the position of the near-end lesion by an operator through the control handle 12 according to the treatment requirement and the data display on the parameter display screen 16, the process of delivering and releasing liquid medicine after shock wave is repeatedly realized, so that the recanalization treatment of the cardiovascular stenosis position or the positions of multiple stenosis positions is realized, and the aim of keeping the blood vessel of the far-stage lesion unblocked is fulfilled.

Example 3

On the basis of example 1 and example 2, the section A-A of the double-layer balloon structure on the shock wave medicine-carrying double-layer balloon catheter for cardiovascular stenosis lesion is additionally described.

As can be seen more clearly from the cross section a-a of the double-layer balloon structure in fig. 3, a plurality of small holes are uniformly distributed on the surface of the outer-layer balloon 202, and the outer-layer balloon 202 is a porous balloon; in this embodiment, the size of the small hole is different from the inside and outside, the small hole is in a circular truncated cone shape with a large outer diameter and a small inner diameter, the small hole structure plays a great role in enabling liquid medicine to be released uniformly to reach the wall of a blood vessel, and the medicine administration to the narrow lesion is more uniform and efficient, so that effective treatment is achieved. The inner catheter 6 is a multi-lumen catheter which comprises a guide wire cavity 10 and an inner balloon liquid cavity 11; when the catheter is used, the guide wire in the guide wire cavity 6 is drawn to reach the target angiostenosis lesion, and the intervention through the guide wire is the conventional technical means of the current interventional operation.

The double-layer balloon is more convenient and effective in structure, and can release liquid medicine to the vessel wall after shock wave through the inner-layer balloon liquid cavity and the outer-layer balloon liquid cavity. The aperture on the outer sacculus combines the effect of seismic wave, has improved the degree of consistency and the ageing of liquid medicine when the release greatly, and then has improved the liquid medicine and has reached balanced effectual effect and accelerate the treatment process in the quantity, reduces patient's the bearing time at the treatment in-process.

The above description is only a preferred embodiment of the present invention, and it is not intended to limit the scope of the present invention, and various modifications and changes may be made by those skilled in the art. Variations, modifications, substitutions, integrations and parameter changes of the embodiments may be made without departing from the principle and spirit of the invention, which may be within the spirit and principle of the invention, by conventional substitution or may realize the same function.

Claims

1. A shock wave medicine-carrying double-layer balloon catheter for cardiovascular stenosis is characterized by comprising a distal end (1), a balloon (2) and a proximal end (3);

the distal end (1) is an extension of the balloon (2); the balloon (2) is close to the distal end (1), and the balloon (2) is a double-layer balloon; the proximal end (3) is connected with a handle (12).

2. The shock wave drug-loaded double-layer balloon catheter for cardiovascular stenosis of claim 1, wherein the double-layer balloon comprises an inner balloon (201) and an outer balloon (202).

3. The shock wave drug-loaded double-layer balloon catheter for cardiovascular stenosis of claim 2, wherein the inner-layer balloon (201) is internally provided with an electrode pair (4) capable of releasing energy.

4. The shock wave drug-loaded double-layer balloon catheter for cardiovascular stenosis of claim 2, wherein the outer balloon (202) of the balloon is a structure with regular small holes.

5. The shock wave medicine-carrying double-layer balloon catheter for the cardiovascular stenosis of claim 4, wherein the small hole of the outer balloon (202) is set to be small in inner diameter and large in outer diameter of the inner hole of the balloon, so that liquid medicine is uniformly released to a blood vessel wall at the cardiovascular stenosis; the size of the outer diameter of the small hole is 100-1000 nm.

6. The shock wave drug-loaded double-layer balloon catheter for the cardiovascular stenosis of claim 1, wherein a drug liquid control dose injection port (5) is further arranged at the end position of the proximal end (3).

7. The shock-carrying double-layer balloon catheter for cardiovascular stenosis according to claim 2, further comprising an inner catheter (6) and an outer catheter (7);

the inner catheter (6) is connected with the inner layer balloon (201) in an adhesion, thermal welding or laser mode; the outer catheter (7) is arranged on the outer layer of the inner catheter (6), and the inner catheter (6) and the outer catheter (7) are used for filling medicine mixed liquid between the inner balloon (201) and the outer balloon (202) to form an outer balloon medicine liquid cavity (8).

8. The shock wave drug-loaded double-layer balloon catheter for cardiovascular stenosis according to claim 7, wherein the inner catheter (6) is perforated at the inner balloon (201) to facilitate pressurizing perfusion contrast fluid.

9. The shock wave drug-loaded double-layer balloon catheter for cardiovascular stenosis according to claim 7 or 8, wherein the inner catheter (6) is a multi-lumen structure, one lumen is a guide wire lumen (10), and the other lumen is an inner balloon liquid lumen (11).

10. The shock wave drug-loaded double-layer balloon catheter for cardiovascular stenosis of claim 9, wherein the drug mixture solution filled in the inner balloon fluid chamber (11) is paclitaxel as an anti-regeneration drug, and is mixed with a biocompatible hydrophilic or hydrophobic solvent in a specific ratio, the solvent is one or more of sodium chloride or other solvents, and the concentration of the drug solution is 10-20 μmol/L.