CN213031623U

CN213031623U - Balloon component

Info

Publication number: CN213031623U
Application number: CN202021642528.6U
Authority: CN
Inventors: 丁海雁
Original assignee: Individual
Current assignee: Qiwei Medical Technology Shenzhen Co ltd
Priority date: 2020-08-10
Filing date: 2020-08-10
Publication date: 2021-04-23
Anticipated expiration: 2030-08-10

Abstract

The present application provides a balloon assembly, comprising: the balloon catheter comprises a balloon catheter and a balloon arranged on the balloon catheter, wherein the balloon is provided with a front end part and a rear end part in the longitudinal direction, the balloon is provided with a concave area in the middle in the longitudinal direction when being fully expanded, and a medicine composition layer is arranged on the outer surface of the concave area. The tip medicine coating sacculus that this application is disclosed combines current apparatus to handle the fistula, can realize that interatrial fistula is continuous open, prevents that interatrial fistula is just closed naturally in short-term, reaches the effect that reduces heart preload, treatment heart failure for a long time.

Description

Balloon component

Technical Field

The invention relates to the technical field of medical treatment, in particular to a balloon component for coating medicine on a part with a radial significant change.

Background

Interatrial septum fistulation is a well established technique in patients with advanced pediatric congenital heart disease, pulmonary hypertension. It is also applied to patients with diastolic dysfunction, heart failure and systolic dysfunction with continuous elevation of PCWP, and has a remarkable effect, but it is not formally developed clinically. The current research shows that the fistula can be naturally healed after 6 months no matter a stent is placed in the fistula or not after the interatrial fistula is made, so that the operation effect is greatly reduced. Therefore, how to avoid the natural closure of the fistula in a short period is the key to ensure the final treatment effect of the interatrial septum ostomy.

Disclosure of Invention

The heart medicine balloon is a new technology, and the medicine is uniformly distributed on the blood vessel wall by implanting the special balloon coated with paclitaxel, so as to inhibit the hyperplasia of the blood vessel endothelium and smooth muscle and prevent restenosis. The cardiac drug balloon can solve the problem of vascular stenosis without implanting a stent, and is an emerging treatment method. However, the existing drug balloons are designed for preventing the endothelial hyperplasia of coronary arteries and peripheral large blood vessels, and no balloon specially for healing the fistula, particularly the interatrial fistula with the thickness of only 2-3 mm is provided.

The application discloses give medicine and use sacculus subassembly combines current apparatus to handle the fistula, can realize that interatrial fistula is continuous open, solves the problem of interatrial fistula in short-term just closed naturally to reach the long-term purpose that reduces heart preload, treatment heart failure.

The technical scheme disclosed by the application comprises the following implementation modes:

embodiment 1, a balloon assembly, comprising: the balloon catheter comprises a balloon catheter and a balloon arranged on the balloon catheter, wherein the balloon is provided with a front end part and a rear end part in the longitudinal direction, and a medicine composition layer is arranged on the outer surface of at least one of the front end part and the rear end part.

Embodiment 2 the balloon assembly of embodiment 1, wherein only one of the front end portion and the rear end portion has a drug composition layer disposed on an outer surface thereof.

Embodiment 3 the balloon assembly of embodiment 1, wherein the balloon catheter has a guidewire through-hole and a pressurizing liquid channel, wherein the pressurizing liquid channel is in communication with the balloon interior.

Embodiment 4 the balloon assembly of embodiment 1, wherein the balloon is disposed at a front portion of the balloon catheter, the balloon front end being about 5 to 20mm from the balloon catheter front end.

Embodiment 5, the balloon assembly according to

embodiment

1 or 2, wherein the drug composition layer is disposed only on a portion having a radius greater than 2mm at the outer surface where the drug composition layer is disposed, and the drug composition layer is not disposed on the other outer surface of the balloon.

Embodiment 6 the balloon assembly of embodiment 1, wherein the longitudinal cut of the outer surface on which the drug composition layer is disposed has a concave arc shape, a circular arc shape, an elliptical arc shape, a parabolic shape, a straight line shape, a dog-leg shape, an irregular curved shape, or a combination of two or more thereof.

Embodiment 7 the balloon assembly of embodiment 1, wherein the drug composition layer comprises at least one of paclitaxel and rapamycin, and optionally a drug carrier.

Embodiment 8 the balloon assembly of any one of embodiments 1-7, wherein the balloon has a radial dimension when expanded of 6-25mm, e.g., 8 to 20mm, e.g., 10 to 20mm, e.g., 12 to 20mm, e.g., 14 to 20mm, e.g., 16 to 20mm, e.g., 18 to 20 mm.

Embodiment 9, the balloon assembly of any one of embodiments 1-7, wherein the balloon is a non-compliant balloon, a compliant balloon, or a semi-compliant balloon.

Embodiment 10, a medical device, in particular for percutaneous interatrial ostomy intervention, comprising a balloon assembly according to any of embodiments 1-9.

Embodiment 11, a balloon assembly, comprising: the balloon catheter comprises a balloon catheter and a balloon arranged on the balloon catheter, wherein the balloon is provided with a sunken area in the longitudinal middle part when being fully expanded, and a medicine composition layer is arranged on the outer surface of the sunken area.

Embodiment 12 the balloon assembly of embodiment 11, wherein the balloon catheter has a guidewire through hole and a pressurizing liquid channel, wherein the pressurizing liquid channel is in communication with the balloon interior.

Embodiment 13 the balloon assembly of embodiment 11, wherein the drug composition layer comprises at least one of paclitaxel and rapamycin, and optionally a drug carrier.

Embodiment 14 the balloon assembly of any one of embodiments 11-13, wherein the balloon has a radial dimension when expanded of 6-25mm, e.g., 8 to 20mm, e.g., 10 to 20mm, e.g., 12 to 20mm, e.g., 14 to 20mm, e.g., 16 to 20mm, e.g., 18 to 20 mm.

Embodiment 15 the balloon assembly of embodiment 14, wherein the recessed region has a minimum radial dimension of less than 6mm, such as less than or equal to 5 mm.

Embodiment 16 the balloon assembly of embodiment 15, wherein the drug composition layer is disposed on only a portion of the outer surface of the recessed region having a radius greater than 2mm, and the drug composition layer is not disposed on the other outer surface of the balloon.

The technical scheme disclosed by the application also comprises the following scheme:

scheme 1, a balloon assembly for administration, comprising: the balloon catheter comprises a balloon catheter and a balloon arranged on the catheter, wherein the longitudinal section of the balloon has a concave arc-shaped profile when the balloon is fully expanded. In some aspects, a pharmaceutical composition or a layer of a pharmaceutical composition is disposed on an outer surface of the region having the concave arc-like profile. The thickness of the layer of the pharmaceutical composition is from 1 micron to 100 microns, for example from 10 to 75 microns.

Scheme 2, the balloon assembly for administration of claim 1, wherein the concave arc-like profile is formed in at least one of a longitudinal front portion, a longitudinal rear portion, and a longitudinal middle portion of the balloon.

Scheme 3, the balloon assembly for administration according to scheme 1, wherein the balloon catheter has a guide wire through hole and a pressurizing liquid channel, wherein the pressurizing liquid channel communicates with the inside of the balloon.

Scheme 4, the balloon assembly for administration according to scheme 1, wherein the balloon is disposed at the front of the balloon catheter, and the distance from the front end of the balloon to the front end of the balloon catheter is about 5 to 20 mm.

The balloon assembly for drug administration according to claim 5 or 1, wherein the concave arc-like profile is formed at a longitudinal front portion and/or a longitudinal rear portion of the balloon, and the concave arc-like profile starts from a position radially close to the balloon catheter to end at a radially middle portion of the balloon.

Scheme 6, the balloon assembly for administration according to scheme 1, wherein the longitudinal dimension of the balloon is 2/3 or less (1/2 or less) of its radial dimension, such that when the balloon is folded, the area with the concave arc-shaped profile is mostly folded inside, thereby avoiding loss of the drug during pushing of the balloon assembly.

Scheme 7 the balloon assembly for administration according to scheme 1, wherein the drug composition layer contains at least one of paclitaxel and rapamycin, and optionally a drug carrier. The drug carrier comprises a hydrophilic drug carrier.

The balloon assembly for administration according to any one of claims 8 and 1 to 7, wherein the balloon assembly includes two balloons, the concave arc-shaped profile of one balloon is formed at a longitudinal front portion of the balloon, and the concave arc-shaped profile of the other balloon is formed at a longitudinal rear portion of the balloon.

Scheme 9, the balloon assembly for administration of any of schemes 1-8, wherein the balloon is a non-compliant balloon, a compliant balloon, or a semi-compliant balloon.

Scheme 10, a medical device, in particular for percutaneous interatrial ostomy intervention, comprising a balloon assembly according to any of schemes 1-9.

The technical scheme disclosed by the application also comprises the following examples:

example 1, a balloon assembly, comprising: the balloon catheter comprises a balloon catheter and a balloon arranged on the balloon catheter, wherein the outer surface of the balloon when the balloon is unfolded has at least one radial significant change part, and a medicine composition layer is arranged on at least one of the radial significant change parts.

Example 2 the balloon assembly of example 1, wherein only one of the radially varying portions is provided with the layer of the pharmaceutical composition.

Example 3 the balloon assembly of example 1, wherein the balloon catheter has a guidewire through-hole and a pressurized liquid channel, wherein the pressurized liquid channel is in communication with the balloon interior.

Example 4 the balloon assembly of example 1, wherein the balloon is disposed at a front of the balloon catheter, the balloon front end being about 5 to 20mm from the balloon catheter front end.

Example 5, the balloon assembly of example 1 or 2, wherein the drug composition layer is disposed only on areas having a radius greater than 2mm on the portion having the radial variation in which the drug composition layer is disposed, and the other outer surface of the balloon is not disposed with the drug composition layer.

Example 6 the balloon assembly of example 1, wherein the radially varying portion having the drug composition layer disposed thereon is a front end face, a rear end face, or a middle portion of the balloon, and a longitudinal section of the radially varying portion has a concave arc-shaped profile, a circular arc shape, an elliptical arc shape, a parabolic shape, a linear shape, a polygonal shape, an irregular curved shape, or a combination of two or more thereof.

Example 7 the balloon assembly of example 1, wherein the drug composition layer comprises at least one of paclitaxel and rapamycin, and optionally a drug carrier.

Example 8 the balloon assembly of any one of examples 1-7, wherein the balloon has a radial dimension when expanded of 6-25mm, e.g., 8 to 20mm, e.g., 10 to 20mm, e.g., 12 to 20mm, e.g., 14 to 20mm, e.g., 16 to 20mm, e.g., 18 to 20 mm.

Example 9, the balloon assembly of any one of examples 1-7, wherein the balloon is a non-compliant balloon, a compliant balloon, or a semi-compliant balloon.

Example 10, a medical device, in particular for percutaneous interatrial ostomy intervention, comprising the balloon assembly of any one of examples 1-9.

Example 11, a method of treating an interatrial septum fistula, comprising: contacting the radially altered portion of the balloon assembly of any one of examples 1-9, on which the layer of the pharmaceutical composition is disposed, with the interatrial fistula to administer the drug to the interatrial fistula and its periphery.

Example 12, a method of treating an interatrial septum fistula, comprising: contacting the portion of the balloon assembly of any one of examples 1-9 on which the radial variation of the drug composition layer is disposed with both sides of the interatrial fistula to administer the drug to the interatrial fistula and the peripheries of both sides thereof.

The technical scheme of this application combines current apparatus (for example cutting sacculus etc.) to handle the fistula, can realize dosing interatrial fistula and surrounding part, especially can make interatrial fistula continuously open, solves the problem that interatrial fistula is closed with regard to nature in short-term to reach the long-term purpose that reduces heart preload, treatment heart failure.

Drawings

To more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings of the embodiments will be briefly introduced below, and it is apparent that the drawings in the following description relate only to some embodiments of the present disclosure and are not limiting to the present disclosure.

FIG. 1 shows a schematic view of the balloon assembly of example 1;

FIG. 2 shows a schematic view of the front end portion of the balloon assembly of example 1 provided with a drug composition layer;

FIG. 3 shows a schematic view of the back end of the balloon assembly of example 2 provided with a drug composition layer;

FIG. 4 shows a schematic view of the front end portion of the balloon assembly of example 4 provided with a drug composition layer;

FIG. 5 shows a schematic view of the balloon assembly of example 5;

FIG. 6 shows a schematic view of the balloon assembly of example 6;

FIG. 7 shows a schematic view of the balloon assembly of example 7;

FIG. 8 shows a schematic view of the balloon assembly of example 8;

FIG. 9 shows a schematic view of the balloon assembly of example 9;

fig. 10 shows a schematic view of the balloon assembly of example 10;

fig. 11 shows a schematic view of the balloon assembly of example 11;

FIG. 12 shows a schematic view of the folding of the balloon assembly of example 11;

FIG. 13 shows a concave arc profile applicator schematic of the balloon assembly of example 11;

fig. 14 shows a schematic view of the balloon assembly of example 12;

FIG. 15 shows a schematic view of the folding of the balloon assembly of example 12;

fig. 16 shows a schematic view of the balloon assembly of example 14.

Reference numerals: 1-balloon catheter, 11-balloon catheter front end, 12-balloon catheter front portion, 13-guide wire through hole, 14-pressurizing liquid channel, 2-balloon, 21-balloon front end, 22-front end portion, 23-rear end portion, 241-longitudinal front portion, 242-longitudinal middle portion, 243-longitudinal rear portion, 25-concave arc profile, 251-position near balloon catheter, 252-radial middle portion, 26-concave region, 3-cannula, 4-drug composition layer.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present disclosure more apparent, the technical solutions of the embodiments of the present disclosure will be described clearly and completely with reference to the drawings of the embodiments of the present disclosure. It is to be understood that the described embodiments are only a few embodiments of the present disclosure, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the described embodiments of the disclosure without any inventive step, are within the scope of protection of the disclosure.

The following terms in this application have the specific meanings:

the direction along the catheter is defined herein as "longitudinal" and the direction perpendicular to the catheter is defined herein as "radial" and the balloon expands primarily in the radial direction.

In the present application, a portion which first reaches the region to be processed when used is defined as "front", and an orientation opposite to "front" is defined as "rear".

In this application, "end" and "section" and "end" are used to describe the balloon and various portions of the balloon catheter, where "end" refers to a defined end point or end surface, "section" is used to describe a range of regions, and "end" is used to describe a range of regions on the end surface.

For example, the "leading end" of a balloon catheter means that the balloon catheter first reaches the end point or end surface of the area to be treated when in operation, and the "leading end" of a balloon means that the balloon first reaches the end point or end surface of the area to be treated when in operation.

For example, the "front" of a balloon catheter refers to a range of the balloon catheter relative to the distal end of the operator, and the "longitudinal front", "longitudinal middle", and "longitudinal back" of the balloon refer to three regions of the balloon body ranging from the distal end to the proximal end relative to the operator in the direction of the balloon catheter, for example, the front refers to front 1/4, the back refers to back 1/4, and the middle refers between front 1/4 and back 1/4.

For example, the "leading end portion" of the balloon means that the balloon reaches the end face of the region to be treated first when it is operated, i.e., the region ranging from the leading end point of the balloon to the radially outermost end point of the balloon expansion. The "rear end portion" of the balloon means a portion opposite to the "front end portion", i.e., a region ranging from the radially outermost point of the balloon expansion to the balloon rear end point.

In the present application, each term has a meaning commonly understood in the art unless otherwise indicated or otherwise clearly understood from the context.

The application discloses a balloon component with a radially significant change part for applying medicine and a medical device comprising the same, wherein the radially significant change part refers to an area of an outer surface of the balloon, the size of which in the radial direction changes significantly along with the size in the longitudinal direction when the balloon is unfolded, for example, the change rate of the size in the radial direction along with the size change in the longitudinal direction is more than 0.1, more than 0.2, more than 0.3, more than 0.5, more than 0.6, more than 0.7, more than 0.8, more than 0.9, more than 1 and the like. The "significant radial variation" includes the front and rear end portions of the balloon, and the depressed region in the longitudinal middle of the balloon.

The application discloses a sacculus subassembly is scribbled to tip in one aspect, it includes: the balloon catheter comprises a balloon catheter and a balloon arranged on the balloon catheter, wherein the balloon is provided with a front end part and a rear end part in the longitudinal direction, and a medicine composition layer is arranged on the outer surface of at least one of the front end part and the rear end part. Therefore, when the end part is contacted with the interatrial fistula and the surrounding area, the medicine can directly act on the area to be treated, so that the medicine can be conveniently applied to the fistula, and a better treatment effect is achieved. The present application uses parameters common in the art for the length of the balloon catheter, which is typically 1.8F-2.0F in diameter, and in some cases may be selected in the range of 1.0F to 6.0F. The unit F here has the meaning generally understood by those skilled in the art, 1F means a catheter having a circumference of 1 mm, 1.8F means a catheter having a circumference of 1.8 mm, and 2.0F means a catheter having a circumference of 2.0 mm.

In some embodiments, a drug composition layer is disposed on an outer surface of only one of the front end portion and the rear end portion. When the balloon is expanded in the heart, the outer surface of only one end part is loaded with the drug, the end part loaded with the drug acts on the fistula, and compared with the arrangement of the drug composition layers on the outer surfaces of the two end parts, the arrangement can reduce the drug release amount to the maximum extent, so that the toxic and side effects are reduced.

In some embodiments, the balloon catheter has a guidewire through hole and a pressurizing liquid channel, wherein the pressurizing liquid channel is in communication with the balloon interior. The arrangement of the guide wire through hole can lead the balloon catheter to reach the selected area to be treated along the guide wire under the guide of the guide wire for treatment. The pressurizing liquid channel is used for injecting or extracting pressurizing liquid into or from the saccule, after the saccule reaches a target area, the pressurizing liquid is injected into the pressurizing liquid channel, the saccule is expanded under the action of hydraulic pressure, when the pressurizing liquid is extracted after administration treatment is finished, negative pressure is generated in the saccule, and the contraction and folding of the saccule are finished under the action of the negative pressure. Typically, for accurate positioning, markers (marker materials) are also provided inside the balloon, which are used to help an external device detect its position within the patient. In the present application, the selection of the balloon position marker is not particularly limited as long as the balloon position can be accurately positioned.

In some embodiments, the balloon is disposed at the front of the balloon catheter, and the distance from the front end of the balloon catheter is about 5 to 20 mm.

In some embodiments, the drug composition layer is disposed only on portions having a diameter greater than 2mm at the outer surface where the drug composition layer is disposed, and the drug composition layer is not disposed on other outer surfaces of the balloon. The "portion having a radius of more than 2 mm" as used herein refers to a specific outer surface area of the front end portion and/or the rear end portion, the perpendicular distance from any point in the specific outer surface area to the center line of the catheter being more than 2 mm. The drug composition layer is only arranged on the specific outer surface area, the specific outer surface area is overlapped with the drug administration area of the fistula to be treated and is in maximum contact with the drug administration area, the drug administration efficiency is improved, all the drugs act on the fistula, the minimal dose of drug application can be realized, and the toxicity generated by drug release in non-target areas is reduced. It should be understood that the above range for disposing the drug composition layer is not a limitation to the end coating range of the balloon disclosed in the present invention, and one skilled in the art can select a suitable range for disposing the drug composition layer according to actual needs, for example, a suitable end outer surface coating radius range according to the fistula diameter, for example, greater than 2.5mm, for example, greater than 3mm, for example, greater than 3.5mm, for example, greater than 4 mm. In interatrial fistulization intervention treatment, the fistula expansion diameter of the cutting balloon with the three fixed blades is about 5mm, the maximum fistula expansion diameter of other balloons can reach 12mm, and according to clinical treatment experience of congenital heart disease, the target size can be reached when the fistula diameter is about 5-8 mm, and the left atrial pressure can be effectively reduced.

The shape of the longitudinal section of the outer surface provided with the drug composition layer is not particularly limited, and in some embodiments, the longitudinal section of the outer surface provided with the drug composition layer has a concave arc-shaped profile, a circular arc shape, an elliptical arc shape, a parabolic shape, a linear shape, a polygonal shape, an irregular curved shape, or a combination of two or more thereof. In the present application, the term "longitudinal section" refers to a section along the direction of the catheter, and the term "concave arc" refers to an arc surface of the balloon opposite to the direction of expansion of the balloon when the balloon is expanded.

In some embodiments, the concave arc-like profile is formed in at least one of a longitudinal anterior portion, a longitudinal posterior portion, and a longitudinal middle portion of the balloon. Different arrangement modes of the concave arc-shaped profile can produce different treatment effects. In the case where the concave arc-shaped profile is formed at the longitudinal front portion of the balloon, the region provided with the drug composition layer can treat one face of the interatrial septum at the stoma, and can treat two faces of the interatrial septum at the stoma in cooperation with the balloon assembly in which the concave arc-shaped profile is formed at the longitudinal rear portion of the balloon. In the case where a concave arc-shaped contour is formed in the longitudinal middle of the balloon, the concave arc-shaped region corresponds to the stoma, and it is possible to treat both sides of the interatrial septum at the stoma at the same time.

In some embodiments, the concave arc profile is formed at a longitudinal anterior portion and/or a longitudinal posterior portion of the balloon, the concave arc profile beginning radially proximal to the balloon catheter and ending at a radially central portion of the balloon. By "proximate to the balloon catheter" in this application is meant in the range from the surface of the balloon catheter to a radial first distance from the centerline of the balloon catheter, the radial first distance being about 1.5mm to about 2.5 mm. When the concave arc-shaped profile is formed at the longitudinal front part of the balloon, the longitudinal distance from the position close to the balloon catheter to the front end of the balloon catheter is preferably not more than 20mm, and the longitudinal distance from the position close to the balloon catheter to the front end of the balloon is preferably 5mm to 20 mm. By "radially intermediate" is meant herein the region that is at a perpendicular distance from the centerline of the catheter when the balloon is fully expanded from 1/4 or greater to 3/4 or less of the specified range of balloon radii. In the present application, "balloon radius" refers to a perpendicular line perpendicular to the center line of the balloon catheter from the radially outermost end point of the expansion when the balloon is fully expanded, and the length of the perpendicular line is the balloon radius. It should be noted that the concave arc-shaped profile defines a range of the concave arc-shaped profile from a position radially close to the balloon catheter to a position ending at the radial middle part of the balloon, the range depends on a range of a drug administration target area, in interatrial fistula interventional therapy, a stoma expanding diameter of the balloon is about 5mm by using a three-side fixed blade cutting, and a maximum target size is reached when the stoma diameter reaches about 5-8 mm according to clinical treatment experience of congenital heart disease in combination with other balloons, and the left atrial pressure can be effectively reduced. However, the above dimensions are not limitations to the size of the balloon assembly disclosed in the present invention, and those skilled in the art can select an appropriate range of the concave arc-shaped profile according to actual needs, for example, an appropriate radial first distance according to the stoma diameter, and further an appropriate radial middle dimension according to the administration target area, thereby achieving the best administration effect.

In a preferred embodiment, the radial first distance is 2.5mm, and the radial middle part is 6.25mm or more, for example, 6.25mm to 10mm, from the center line of the balloon catheter, which is the preferred dimension for the present invention to achieve the optimal therapeutic effect, and is not limited by the disclosure of the present invention.

In some embodiments, the longitudinal dimension of the balloon is 2/3 or less (1/2 or less) of its corresponding radial dimension. In the present application, the distance between two end points in the longitudinal direction of a significant portion of the balloon is the longitudinal dimension when the balloon is fully expanded; the distance between two end points of the balloon in the radial direction is the radial dimension, and is usually twice the radius of the balloon. Significant portions as described herein refer to portions on the balloon having a radial distance greater than 1/4 balloon radius; and the distance between the two end points in the longitudinal direction of a significant portion of the balloon refers to the distance between the front end and the rear end of the portion of the balloon having a radial distance greater than 1/4 balloon radius. On the one hand, the size design enables the area with the concave arc-shaped profile to be mostly or completely folded into the inside when the balloon is folded, thereby avoiding the loss of the medicine due to dissolution in the pushing process of the balloon component. On the other hand, the balloon assembly disclosed by the application is mainly used for solving the technical problem of natural closure of the interatrial fistula, the area to be treated is a plane within a certain range around the fistula, and the size is designed to ensure that the balloon is flat in the longitudinal direction when the balloon is fully expanded, so that the balloon adapts to the internal space of the heart and generates a sufficient administration area. As a general arrangement of the invention, the longitudinal dimension of the balloon is typically 5mm to 16mm, for example 7.5mm to 13 mm. As a general arrangement of the invention, the radial dimension of the balloon is typically 10mm to 25mm, for example 15mm to 20 mm.

In some embodiments, the longitudinal cut of the outer surface provided with the layer of the pharmaceutical composition does not have a concave arc-shaped profile, e.g., the longitudinal cut of the outer surface provided with the layer of the pharmaceutical composition has a circular arc shape, an elliptical arc shape, a parabolic shape, a linear shape, a polygonal shape, an irregular curved shape, or a combination of two or more thereof. The arc shape, the elliptic arc shape and the parabola shape in the application all refer to a convex shape of the saccule which has the same expansion direction with the saccule when the saccule is expanded, and do not contain a concave arc shape. The different contour shapes of the longitudinal section of the outer surface of the drug composition layer can enable the end part of the balloon to generate different fitting effects with the fistula and the area around the fistula. One skilled in the art can select different balloons depending on the surface shape of the stoma and the area surrounding the stoma.

In some embodiments, the pharmaceutical composition layer comprises at least one of paclitaxel and rapamycin, and optionally a pharmaceutical carrier. The drug carrier preferably comprises a hydrophilic drug carrier and/or a hydrophobic drug carrier. In some embodiments, the hydrophilic drug carrier is at least one selected from the group consisting of iopamidol and iopromide. The existing drug-coated balloon (DCB) interventional therapy technology attaches drugs for inhibiting cell proliferation on the surface of the balloon, attaches the drug surface to the interatrial fistula and the periphery by expanding the balloon, and transmits the drugs to a target point so as to achieve the effect of inhibiting smooth muscle proliferation. Paclitaxel and rapamycin have the function of inhibiting cell proliferation, and are widely applied to the field of coronary artery and peripheral interventional therapy in clinic, the two drugs are lipophilic drugs, the lipophilic drugs paclitaxel and/or rapamycin and the hydrophilic drug carrier iopamidol and/or iopromide are randomly combined to form the drug composition layer, and the hydrophilic drug carrier can form a porous coating with a high contact surface between lipophilic drug molecules and a blood vessel wall, so that the dissolution and release of the lipophilic drug molecules are enhanced, and the drug delivery and the interaction between the lipophilic drug molecules and tissues can be changed. The drug composition is loaded on the surface of the front end part and/or the rear end part of the balloon component disclosed in the application from the surface as a balloon coating layer, after the balloon is expanded, the front end part and/or the rear end part loaded with the drug composition layer is completely contacted with an area to be treated, the target drug dose is uniformly and rapidly released, and clinical experience shows that the short contact time of only 30 seconds to 70 seconds is enough to inhibit cell proliferation and prevent peripheral endothelial crawl and fistula natural healing.

In some embodiments, the balloon has a radial dimension when expanded of 6-25mm, such as 8 to 20mm, such as 10 to 20mm, such as 12 to 20mm, such as 14 to 20mm, such as 16 to 20mm, such as 18 to 20 mm. In the present application, the distance between two end points in the radial direction during the balloon expansion is the radial dimension, the size of the radial dimension determines the size of the drug-loaded region, and those skilled in the art can select an appropriate radial dimension according to the range of the region to be treated around the fistula. In addition, the larger radial dimension ensures that the drug composition layer loaded at the end of the balloon is wrapped inside when the balloon is folded, thereby avoiding drug loss due to dissolution during the pushing process of the balloon assembly.

In some embodiments, the balloon is a non-compliant balloon, a compliant balloon, or a semi-compliant balloon. Compliance of the balloon as described herein refers to the characteristic of the balloon profile or volume change that occurs with each increase in atmospheric pressure (atm) when the balloon is inflated, and is an indicator of the ability of the balloon to stretch. Three different types of balloons employed in this application possess different characteristics: the balloon diameter of the compliant balloon increases with increasing pressure, the compliant balloon dispersing the inflation pressure; the non-compliant balloon means that no matter how much the diameter of the pressure balloon is added, the diameter of the pressure balloon keeps unchanged after reaching the specified size, the expansion pressure of the non-compliant balloon is intensively acted on a treatment part, and the non-compliant balloon has weak adaptability to blood vessels; the semi-compliant balloon has a wide working range, can flexibly control the size of the balloon, and is mainly used for pre-expansion. In practical application, a person skilled in the art can select different balloons according to actual needs to achieve the optimal technical effect. The materials and methods for making the balloon assembly are not particularly limited and may be selected by one skilled in the art according to actual needs.

Another aspect of the present application provides a medical device comprising a balloon assembly according to any of the other embodiments described herein. In particular, another aspect of the present application provides a medical device for percutaneous interatrial ostomy intervention comprising a balloon assembly according to any of the other embodiments described herein.

The application also discloses a balloon assembly, it includes: the balloon catheter comprises a balloon catheter and a balloon arranged on the balloon catheter, wherein the balloon is provided with a sunken area in the longitudinal middle part when being fully expanded, and a medicine composition layer is arranged on the outer surface of the sunken area. In this application, through setting up sunken region at vertical middle part, and be provided with the pharmaceutical composition layer on sunken region's the surface, thereby can pass through the sunken region of sacculus and the contact of fistula make the pharmaceutical composition layer direct action is in pending regional, is convenient for apply the medicine for the fistula, reaches better treatment effect.

In some embodiments, the balloon catheter of the balloon assembly has a guidewire through hole and a pressurizing liquid channel, wherein the pressurizing liquid channel is in communication with the balloon interior. The arrangement of the guide wire through hole can lead the balloon catheter to reach the selected area to be treated along the guide wire under the guide of the guide wire for treatment. The pressurizing liquid channel is used for injecting or extracting pressurizing liquid into or from the saccule, after the saccule reaches a target area, the pressurizing liquid is injected into the pressurizing liquid channel, the saccule is expanded under the action of hydraulic pressure, when the pressurizing liquid is extracted after administration treatment is finished, negative pressure is generated in the saccule, and the contraction and folding of the saccule are finished under the action of the negative pressure. Typically, for accurate positioning, markers (marker materials) are also provided inside the balloon, which are used to help an external device detect its position within the patient. In the present application, the selection of the balloon position marker is not particularly limited as long as the balloon position can be accurately positioned.

In some embodiments, the drug composition layer of the balloon component contains at least one of paclitaxel and rapamycin, and optionally a drug carrier. The drug carrier preferably comprises a hydrophilic drug carrier and/or a hydrophobic drug carrier. In some embodiments, the hydrophilic drug carrier is at least one selected from the group consisting of iopamidol and iopromide. The existing drug-coated balloon (DCB) interventional therapy technology attaches drugs for inhibiting cell proliferation on the surface of the balloon, attaches the drug surface to the interatrial fistula and the periphery by expanding the balloon, and transmits the drugs to a target point so as to achieve the effect of inhibiting smooth muscle proliferation. Paclitaxel and rapamycin have the function of inhibiting cell proliferation, and are widely applied to the field of coronary artery and peripheral interventional therapy in clinic, the two drugs are lipophilic drugs, the lipophilic drugs paclitaxel and/or rapamycin and the hydrophilic drug carrier iopamidol and/or iopromide are randomly combined to form the drug composition layer, and the hydrophilic drug carrier can form a porous coating with a high contact surface between lipophilic drug molecules and a blood vessel wall, so that the dissolution and release of the lipophilic drug molecules are enhanced, and the drug delivery and the interaction between the lipophilic drug molecules and tissues can be changed. The drug composition layer is loaded on the surface of the front end part and/or the rear end part of the balloon component disclosed in the application as a balloon coating, after the balloon is expanded, the front end part and/or the rear end part loaded with the drug composition layer is completely contacted with an area to be treated, the target drug dose is uniformly and rapidly released, and clinical experience shows that the short-time contact of only 30 seconds to 70 seconds is enough to inhibit cell proliferation and prevent peripheral endothelial crawl and fistula natural healing.

In some embodiments, the balloon of the balloon assembly for administration has a radial dimension when expanded of 6-25mm, such as 8 to 20mm, such as 10 to 20mm, such as 12 to 20mm, such as 14 to 20mm, such as 16 to 20mm, such as 18 to 20 mm.

In some embodiments, the minimum radial dimension of the recessed region of the balloon assembly for administration is less than 6mm, such as less than or equal to 5 mm. In the present application, the recessed area is loaded with the drug composition layer, and the minimum radial dimension thereof should not exceed the diameter of the fistula, and those skilled in the art can select a suitable radial dimension according to the diameter of the fistula to achieve the best administration effect.

In some embodiments, the drug composition layer is disposed on only a portion having a diameter greater than 2mm on the outer surface of the concave region of the balloon assembly for administration, and the drug composition layer is not disposed on the other outer surface of the balloon. The "portion with a radius greater than 2 mm" as used herein means that the longitudinal central portion has a specific outer surface area with a perpendicular distance from any point in the specific outer surface area to the centerline of the catheter greater than 2 mm. The drug composition layer is only arranged on the specific outer surface area, the specific outer surface area is overlapped with the drug administration area of the fistula to be treated and is in maximum contact with the drug administration area, the drug administration efficiency is improved, all the drugs act on the fistula, the minimal dose of drug application can be realized, and the toxicity generated by drug release in non-target areas is reduced. It should be understood that the above ranges for disposing the drug composition are not intended to limit the longitudinal central region of the balloon disclosed herein, and those skilled in the art can select a suitable range for disposing the drug composition layer according to actual needs, for example, a suitable range for disposing the drug composition layer according to the fistula diameter, such as a radius range of the outer surface of the concave region of the longitudinal central region, for example, greater than 2.5mm, for example, greater than 3mm, for example, greater than 3.5mm, for example, greater than 4 mm.

In the present application, the material and method for producing the balloon assembly are not particularly limited as long as specific operational requirements can be satisfied.

The balloon and balloon catheter may be made from polyamide (e.g., nylon 66, nylon 12, etc.), polyether amide block copolymers. The method of preparing the balloon catheter may employ various methods known in the art. The balloon may be formed by blow molding. A marker material, typically a platinum iridium alloy, is disposed at the catheter in the balloon. The balloon and the catheter can be bonded together by hot melting, or can be bonded by using a suitable adhesive.

The application also discloses a method of treating an interatrial fistula, comprising: make the sacculus on the sacculus subassembly of this application contact with interatrial fistula mouth to administer to interatrial fistula mouth and periphery. The position where the balloon is contacted with the fistula opening is the position on the balloon for applying the medicine.

In some embodiments, the method further comprises administering to both sides of the interatrial septum fistula. For example, the administration of drugs to both sides of the atrial septum is accomplished by a balloon assembly that is drug-coated on the anterior end and a balloon assembly that is drug-coated on the posterior end.

The ranges described above may be used alone or in combination. The present application can be more easily understood by the following examples.

Examples

Example 1 [ circular arc, distal end portion coating agent ]

As shown in fig. 1, the present application discloses an end-dosing balloon assembly comprising: the balloon catheter comprises a balloon catheter 1 and a balloon 2, wherein the balloon 2 is arranged at the front part 12 of the balloon catheter, and the distance between the front end 21 of the balloon and the front end 11 of the balloon catheter is 5 mm. The balloon 2 has a front end 22 and a rear end 23 in the longitudinal direction, and the longitudinal section of the outer surfaces of the front end 22 and the rear end 23 is circular arc-shaped. The balloon 2 has a radial dimension of 18mm when expanded, the balloon catheter 1 has a diameter of 1.8F, the balloon catheter 1 has a guide wire through hole 13 and a pressurizing liquid channel 14, wherein the pressurizing liquid channel 14 communicates with the inside of the balloon 2.

As shown in fig. 2, a drug composition layer 4 is disposed on an outer surface of the front end portion 22 of the balloon 2, and the drug composition layer 4 is paclitaxel and iopromide. The drug composition layer 4 forms a drug composition layer having a thickness of about 50 microns.

In treatment, a guidewire is first placed through the atrial septum, creating a fistula of appropriate size in the septum. Then, the end-coating balloon assembly is arranged on the fistula along a guide wire, after the front part 12 of the balloon catheter is pushed to the far end to reach a target area by utilizing a PTCA technology, pressurizing liquid is injected into the balloon 2 through a pressurizing liquid channel 14, the balloon 2 is fully expanded under the action of hydraulic pressure, the pressure in the balloon 2 is kept, the surface of the area of the front end part 22 of the balloon is fully contacted with one surface of the atrial septum of the fistula to be treated, the medicine is rapidly released to the contacted area, after a preset expansion time is reached, the pressurizing liquid is extracted, the balloon 2 is deflated, and the balloon assembly is withdrawn to finish the treatment.

Example 2 [ circular arc, rear end portion coating agent ]

Fig. 3 shows an end-coating balloon assembly disclosed in this embodiment, which has the same structure as that of embodiment 1, except that a drug composition layer 4 is disposed on the outer surface of the rear end 23 of the balloon 2.

In treatment, a guidewire is first placed through the atrial septum, creating a fistula of appropriate size in the atrial septum. Then, the end-coating balloon assembly is arranged on the fistula along a guide wire, the front part 12 of the balloon catheter is pushed to the far end by utilizing the PTCA technology and penetrates through the fistula to reach a target area, pressurizing liquid is injected into the balloon 2 through a pressurizing liquid channel 14, the balloon 2 is fully expanded under the action of hydraulic pressure, the pressure in the balloon 2 is kept, the outer surface of the rear end part 23 is fully contacted with one surface of the fistula to be treated and quickly releases the medicine to the target area, after a preset expansion time is reached, the pressurizing liquid is extracted, the balloon 2 is deflated, and the balloon assembly is withdrawn to finish the treatment.

Example 3 [ circular arc, both ends applying medicine, example 1 and example 2 in combination ]

The balloon component with drug applied at the end disclosed in this embodiment is a combination of two balloon components disclosed in

embodiments

1 and 2, wherein a drug composition layer 4 (i.e., the component in embodiment 1) is disposed on the outer surface of the front end portion 22 of the first balloon component, a drug composition layer 4 (i.e., the component in embodiment 2) is disposed on the outer surface of the rear end portion 23 of the second balloon component, and the drug composition layer 4 is paclitaxel, rapamycin, or iopamidol.

In the treatment, the front part 12 of the balloon catheter of the first balloon component is pushed to the far end to reach a target area which does not pass through the fistula orifice in the same way as in example 1, the surface of the area of the front end part 22 is fully contacted with one side of the interatrial septum at the fistula orifice to be treated, the first balloon component is withdrawn after the treatment is finished, then the front part 12 of the balloon catheter of the second balloon component is pushed to the far end to pass through the fistula orifice to reach the target area in the same way as in example 2, the surface of the area of the rear end part 23 is fully contacted with the other side of the interatrial septum at the fistula orifice to be treated, and the second balloon component is withdrawn after the treatment is finished. Thereby completing the sequential treatment of the two sides of the atrial septum at the fistula. It should be noted that the stoma itself can be provided with a medication at each treatment.

Example 4 [ circular arc, partial coating of chemical on tip ]

The end-coating balloon assembly disclosed in this example is shown in fig. 4, and has the same structure as that of example 1, except that the drug composition layer 4 is provided only on the outer surface of the distal end portion 22 at a portion having a radius greater than 3 mm.

The operation method of the balloon assembly disclosed in the embodiment is consistent with that in embodiment 1, the end coating area disclosed in the embodiment is overlapped with the administration area of the fistula to be treated and is in maximum contact with the administration area, so that the administration efficiency is improved, all the medicines act on the fistula, the coating with the minimum dosage can be realized, and the toxicity generated by medicine release in a non-target area is reduced.

Example 5 [ the longitudinal section of the front end is straight, the longitudinal section of the rear end is elliptical arc, and part of the front end is coated with a drug ]

The end portion drug applying balloon assembly disclosed in this embodiment is shown in fig. 5, and the structure thereof is substantially the same as that of embodiment 1, except that the longitudinal section of the outer surface of the front end portion 22 is linear, and the longitudinal section of the outer surface of the rear end portion 23 is elliptical. The layer of pharmaceutical composition (not shown in the figures) is only provided at the outer surface of the front end portion 22 at a portion with a radius larger than 3 mm.

The procedure in the treatment was in accordance with example 1.

Example 6 [ the longitudinal section of the front end is elliptical arc, the longitudinal section of the rear end is circular arc, and part of the front end is coated with a chemical ]

Fig. 6 shows an end-coating balloon assembly according to this embodiment, which is substantially the same as that of embodiment 1, except that the longitudinal section of the outer surface of the front end portion 22 is an elliptical arc, and the longitudinal section of the outer surface of the rear end portion 23 is an arc. The layer of pharmaceutical composition (not shown in the figures) is only provided at the outer surface of the rear end portion 23 at a portion with a radius larger than 3 mm.

The procedure in the treatment was in accordance with example 2.

Example 7 [ longitudinal sections of front and rear end portions are both in the shape of an elliptical arc ]

The end-coating balloon assembly disclosed in this example is shown in fig. 7, and has a structure substantially identical to that of example 1, except that the longitudinal sections of the outer surfaces of the front end portion 22 and the rear end portion 23 are both elliptical arcs.

The drug composition layer (not shown) may be disposed and treated in any manner of examples 1 to 4.

Example 8 [ combination of straight and circular arc-shaped longitudinal sections of front and rear end portions ]

The end-medicated balloon assembly disclosed in this embodiment is shown in fig. 8, and its structure is substantially the same as that of embodiment 1, except that the longitudinal sections of the outer surfaces of the front end portion 22 and the rear end portion 23 are both a combination of straight lines and circular arcs.

Example 9 [ longitudinal sections of front and rear end portions are both trapezoidal ]

The end portion drug applying balloon assembly disclosed in this embodiment is shown in fig. 9, and has a structure substantially identical to that of embodiment 1, except that the longitudinal sections of the outer surfaces of the front end portion 22 and the rear end portion 23 are trapezoidal.

Example 10 [ both longitudinal sections of front end portion and rear end portion are doglegged ]

The end-coating balloon assembly disclosed in this example is shown in fig. 10, and its structure is substantially the same as that of example 1, except that the longitudinal sections of the outer surfaces of the front end portion 22 and the rear end portion 23 are both zigzag.

Example 11 [ concave arc located at the longitudinal front of balloon ]

The balloon assembly for administration disclosed in this embodiment includes a balloon catheter 1 and a balloon 2, and fig. 11 shows the configuration of the balloon assembly when it is fully expanded, and the balloon 2 is disposed at a balloon catheter front portion 12. The diameter of the balloon catheter 1 is 1.8F, a guide wire through hole 13 and a pressurizing liquid channel 14 are arranged in the balloon catheter, and the pressurizing liquid channel 14 is communicated with the inside of the balloon 2. The balloon 2 comprises a longitudinal front portion 241, a longitudinal middle portion 242 and a longitudinal rear portion 243.

The balloon 2 has a longitudinal dimension of 10mm when fully expanded and a radial dimension of 15mm, and has a concave arc-like profile 25 in its longitudinal section at the longitudinal front portion 241. The concave arc profile 25 begins at a point 251 radially adjacent the balloon catheter and ends at a radially middle portion 252 of the balloon. The radial distance from the center line of the balloon catheter 1 to the balloon catheter approach 251 is 2mm, and the radial distance from the center line of the balloon catheter 1 to the radial middle 252 is 3.75mm [ here, the radial dimension is 15mm, and the balloon radius is 7.5mm ]. The longitudinal distance from the balloon catheter close position 251 to the front end of the balloon catheter is 20mm, and the longitudinal distance from the balloon catheter close position 251 to the front end of the balloon is 10 mm.

As shown in fig. 12, when folded, the balloon 2 is evacuated while being sheathed with the sleeve 3 having an inner diameter of 5mm from the back side of the region of the concave arc-like profile 25, so that the region of the concave arc-like profile 25 can be embedded in the folded balloon 2 and most of the region of the concave arc-like profile 25 is folded inside.

As shown in fig. 13, a drug composition layer 4 is disposed on the surface of the area of the concave arc-shaped contour 25, and the drug composition layer 4 is paclitaxel and iopromide. The layer of the pharmaceutical composition forms a layer 4 of the pharmaceutical composition having a thickness of about 50 microns. In treatment, a guidewire is first placed through the atrial septum and then a fistula of appropriate size is created in the septum. Then, the balloon assembly for drug administration is set on the stoma along a guide wire, after the balloon catheter front portion 12 is pushed to the distal end to reach a target area by using the PTCA technology, a pressurizing liquid is injected into the balloon 2 through the pressurizing liquid channel 14, the balloon 2 is sufficiently expanded under the hydraulic pressure, the pressure in the balloon 2 is maintained, the surface of the area of the concave arc-shaped profile 25 is sufficiently contacted with one surface of the interatrial septum of the stoma to be treated, the drug is rapidly released to the contacted area, after a predetermined expansion time, the pressurizing liquid is extracted, the balloon 2 is deflated, and the balloon assembly is withdrawn to complete the treatment.

Example 12 [ concave arc located at the longitudinal rear of balloon ]

Fig. 14 shows the structure of the balloon assembly in a fully expanded state under another embodiment, which comprises a balloon catheter 1 and a balloon 2, wherein the balloon 2 is arranged at the front part 12 of the balloon catheter. The diameter of the balloon catheter 1 is 1.8F, a guide wire through hole 13 and a pressurizing liquid channel 14 are arranged in the balloon catheter, and the pressurizing liquid channel 14 is communicated with the inside of the balloon 2. The balloon 2 comprises a longitudinal front portion 241, a longitudinal middle portion 242 and a longitudinal rear portion 243.

As shown in fig. 15, when folded, the balloon 2 is evacuated while being covered with the sleeve 3 having an inner diameter of 5mm from the back side of the region of the concave arc-like profile 25, so that the region of the concave arc-like profile 25 can be embedded in the folded balloon 2 and most of the region of the concave arc-like profile 25 is folded inside. The balloon 2 has a longitudinal dimension of 10mm when fully expanded and a radial dimension of 15mm, and has a concave arc-like profile 25 in its longitudinal section at the longitudinal rear portion 22. The concave arc profile 25 begins at a point 251 radially adjacent the balloon catheter and ends at a radially middle portion 252 of the balloon. The radial distance from the center line of the balloon catheter 1 to the balloon catheter approach 251 is 2mm, and the radial distance from the center line of the balloon catheter 1 to the radial middle 252 is 3.75mm [ here, the radial dimension is 15mm, and the balloon radius is 7.5mm ].

A layer of pharmaceutical composition 4 is provided on the surface of the area of said concave arc-shaped contour 25. The drug composition layer 4 is rapamycin and iopamidol. The layer of the pharmaceutical composition forms a layer 4 of the pharmaceutical composition having a thickness of about 50 microns. In treatment, a guidewire is first placed through the atrial septum and a fistula of appropriate size is created in the atrial septum. Then, the balloon assembly for drug administration is set on the stoma along a guide wire, the balloon catheter front portion 12 is pushed to the distal end by PTCA technology and reaches the target area through the stoma, a pressurizing liquid is injected into the balloon 2 through a pressurizing liquid passage 14, the balloon 2 is fully expanded under the action of hydraulic pressure, the pressure in the balloon 2 is maintained, the area surface of the concave arc-shaped profile 25 is fully contacted with one surface of the stoma to be treated and rapidly releases the drug to the target area, after a predetermined expansion time, the pressurizing liquid is extracted, the balloon 2 is deflated and the balloon assembly is withdrawn to complete the treatment.

Example 13 [ example 11 and example 12 in combination ]

The balloon assembly in example 3 of the present application is a combination of the two balloon assemblies disclosed in examples 11 and 12, wherein the first balloon assembly adopts the balloon having the longitudinal rear portion 243 with the concave arc profile 25 (i.e., the assembly of example 12), and the second balloon assembly adopts the balloon having the longitudinal front portion 241 with the concave arc profile 25 (i.e., the assembly of example 11). The surface of the area of the concave arc-shaped contour 25 is provided with a medicine composition layer 4, and the medicine composition layer 4 is paclitaxel, rapamycin and iopamidol.

In the treatment, the front part 12 of the balloon catheter of the first balloon component is pushed to the far end and passes through the fistula to reach the target area in the same way as in the example 12, so that the surface of the area of the concave arc-shaped profile 25 is fully contacted with one side of the interatrial septum at the fistula to be treated, and the first balloon component is withdrawn after the treatment is completed. Then, in the same manner as in example 11, the front portion 12 of the balloon catheter of the second balloon component is pushed to the far end to reach a target area which does not pass through the fistula, so that the area surface of the concave arc-shaped profile 25 is in full contact with the other surface of the atrial septum at the fistula to be treated, and the second balloon component is withdrawn after treatment is completed, thereby completing the sequential treatment of the two surfaces of the atrial septum at the fistula. It should be noted that the stoma itself can be provided with a medication at each treatment.

Example 14 [ with a depression in the longitudinal middle ]

Fig. 16 shows a configuration of the balloon assembly for administering a balloon according to the embodiment of the present application when it is sufficiently expanded, including the balloon catheter 1 and the balloon 2, the balloon 2 being disposed at the front portion 12 of the balloon catheter. The diameter of the balloon catheter 1 is 2.0F, a guide wire through hole 13 and a pressurizing liquid channel 14 are arranged in the balloon catheter, and the pressurizing liquid channel 14 is communicated with the inside of the balloon 2. The balloon 2 comprises a longitudinal front end portion 22, a longitudinal middle portion 242 and a rear end portion 23.

The balloon 2 is provided with a concave area 26 at the longitudinal section thereof in the longitudinal middle part 242, the outer surface of the concave area 26 is provided with a medicinal composition layer 4, and the medicinal composition layer 4 is paclitaxel, rapamycin, iopromide and iopamidol. In treatment, the front part 12 of the balloon catheter is pushed to a far-end target area by using a PTCA technology, the sunken area 26 is positioned at a fistula, then pressurizing liquid is injected into the balloon 2 through the pressurizing liquid channel 14, the balloon 2 is sufficiently expanded under the action of hydraulic pressure, the pressure in the balloon 2 is maintained, the surface of the sunken area 26 is sufficiently contacted with the fistula to be treated, medicine is rapidly released to the target area, after a preset expansion time, the pressurizing liquid is extracted, the balloon 2 is deflated, and the balloon assembly is withdrawn, thereby completing the treatment on the fistula.

The present application also includes the following:

embodiment 1, an end-on drug balloon assembly, comprising: a balloon catheter and a balloon disposed on the balloon catheter, the balloon having a front end and a rear end in a longitudinal direction, an outer surface of at least one of the front end and the rear end being provided with a pharmaceutical composition or a layer of a pharmaceutical composition, the layer of a pharmaceutical composition having a thickness of 1 to 100 microns, such as 10 to 75 microns.

Embodiment 2 the balloon assembly of embodiment 1, wherein the drug composition layer is disposed on an outer surface of only one of the leading end portion and the trailing end portion.

Embodiment 5, the balloon assembly according to

embodiment

1 or 2, wherein the drug composition layer is provided only on a portion having a radius greater than 2mm at the outer surface where the drug composition layer is provided, and the drug composition layer is not provided on the other outer surface of the balloon.

Embodiment 6 the balloon assembly of embodiment 1, wherein the longitudinal cut of the outer surface on which the drug composition layer is disposed does not have a concave arc-shaped profile, e.g., the longitudinal cut of the outer surface on which the drug composition layer is disposed has a circular arc shape, an elliptical arc shape, a parabolic shape, a linear shape, a polygonal shape, an irregular curved shape, or a combination of two or more thereof.

The above description is intended to be exemplary of the present disclosure, and not to limit the scope of the present disclosure, which is defined by the claims appended hereto.

Claims

1. A balloon assembly, comprising: the medical balloon comprises a balloon catheter and a balloon arranged on the balloon catheter, wherein the balloon is provided with a sunken area in the longitudinal middle part when being fully expanded, and a medicine composition layer is arranged on the outer surface of the sunken area, wherein the radial dimension of the balloon when being expanded is 6-25mm, and the minimum radial dimension of the sunken area is less than 6 mm.

2. A balloon assembly according to claim 1 wherein the radial dimension of the balloon when inflated is 8 to 20 mm.

3. The balloon assembly of claim 1 wherein the balloon has a radial dimension of 10 to 20mm when inflated.

4. The balloon assembly of claim 1 wherein the balloon has a radial dimension of 12 to 20mm when inflated.

5. A balloon assembly according to claim 1 wherein the radial dimension of the balloon when inflated is 14 to 20 mm.

6. The balloon assembly of claim 1 wherein the balloon has a radial dimension of 16 to 20mm when inflated.

7. The balloon assembly of claim 1 wherein the radial dimension of the balloon when inflated is 18 to 20 mm.

8. A balloon assembly according to claim 1 wherein the minimum radial dimension of the recessed region is 5mm or less.

9. The balloon assembly of claim 1 wherein the balloon catheter has a guidewire through hole and a pressurized liquid channel, wherein the pressurized liquid channel is in communication with the balloon interior.

10. The balloon assembly of claim 1, wherein the drug composition layer comprises one of paclitaxel and rapamycin, and a drug carrier.

11. The balloon assembly of claim 1, wherein the drug composition layer is disposed on only a portion of the outer surface of the recessed region having a radius greater than 2mm, and the other outer surface of the balloon is not disposed with the drug composition layer.