CN217186588U - Conveying device and balloon assembly thereof - Google Patents

Abstract

The utility model relates to a conveyor and sacculus subassembly thereof, sacculus subassembly include the sacculus and be located the support frame of sacculus, and the sacculus is used for when filling to expand the prosthesis that its periphery was located to the cover, and the support frame has along the uplift portion of its circumference extension, and when the prosthesis pressure was held in the sacculus periphery, the uplift portion was used for carrying out the axial spacingly to the prosthesis, and the part level and smooth closure with the sacculus contact in the surface of uplift portion. The utility model discloses a conveyor and sacculus subassembly thereof, the support frame that is located the sacculus has along its axial extension's uplift portion to it is spacing to utilize the uplift portion to carry out the axial to pressing the false body of holding in the sacculus, thereby reduces the probability that axial aversion appears in the relative sacculus of false body, and in the surface of uplift portion with the partial level and smooth closure of sacculus contact, damage the sacculus when avoiding the uplift portion to carry out the axial spacing to the false body.

Description

Conveying device and balloon assembly thereof

Technical Field

The utility model relates to an intervene medical treatment technical field, especially relate to a conveyor and sacculus subassembly thereof.

Background

Transcatheter Aortic Valve Replacement (TAVR) has become one of the important methods for the treatment of valvular heart disease. Compared with the traditional surgical thoracotomy, transcatheter aortic valve replacement has the advantages of small wound, safety, obvious curative effect and the like.

Currently, the main valve prostheses used in transcatheter aortic valve replacement are self-expandable valve prostheses and balloon valve prostheses. Although the ball-expanded valve prosthesis can provide stable release force, the valve prosthesis is easy to shift relative to the balloon in the processes of conveying, expanding or releasing the valve prosthesis, so that the conveying, expanding and releasing accuracy of the valve prosthesis is poor, and the implantation success rate of the valve prosthesis is reduced. For example, in a state where the valve prosthesis is crimped on the balloon, the valve prosthesis may be axially displaced relative to the balloon during movement of the balloon to the release position, so that the valve prosthesis cannot be expanded well during subsequent inflation of the balloon. And because the valve prosthesis is axially displaced relative to the balloon, the situation that the release position is inaccurate is more likely to occur in the process of releasing the valve. For another example, in the case that the restraining effect of the valve prosthesis on the balloon is too large, during the process of injecting fluid into the balloon, the expansion degrees of the distal end and the proximal end of the balloon are difficult to coordinate, so that the valve is unevenly expanded and axially displaced relative to the balloon, and the accuracy of the release position is low, which interferes with the normal operation of the interventional operation.

SUMMERY OF THE UTILITY MODEL

Based on this, it is necessary to provide a balloon assembly and a delivery device including the balloon assembly, aiming at the problem that the prosthesis is easy to displace.

In one aspect, the utility model provides a balloon assembly, include the sacculus and be located support frame in the sacculus, the sacculus is used for when filling to expand the prosthesis that its periphery was located to the cover, the support frame has along its circumference extension's uplift portion, works as the prosthesis is pressed and is held during the sacculus periphery, the uplift portion is used for right the prosthesis carries out the axial spacing, just in the surface of uplift portion with the level and smooth closure of part of sacculus contact.

In one embodiment, the cage has two of the protuberances thereon for axially retaining the distal and proximal ends of the prosthesis, respectively.

In one embodiment, the scaffold comprises a distal end section, a middle section and a proximal end section which are connected in sequence, wherein the distal end of the distal end section is connected with the distal end of the balloon, the proximal end of the proximal end section is connected with the proximal end of the balloon, and the middle section can guide the filling medium injected into the balloon from the proximal end section to the distal end section.

In one embodiment, the scaffold is a tubular structure having mesh openings, and the mesh openings of the distal and proximal segments have a higher density than the mesh openings of the intermediate segment.

In one embodiment, the stent is a braided tubular structure comprising a plurality of wires that are surface coated with a layer of soft material.

In one embodiment, the middle section comprises a first section and a second section, the braid density of the wires in the first section is higher than the braid density of the wires in the second section, and the axial length of the first section is greater than or equal to half of the axial length of the middle section.

In one embodiment, the support frame is a hollow tubular structure, and hollow holes are formed in the distal end section and the proximal end section.

In one embodiment, at least one of the distal section and the proximal section is provided with the elevation.

In one embodiment, the balloon has a straight section and tapered portions at both ends of the straight section, the raised portion has a partial structure corresponding to the tapered portion of the balloon, and the position where the diameter of the raised portion is the largest corresponds to the straight section.

In one embodiment, the hollowed-out tubular structure has a hardness of less than 90A.

On the other hand, the utility model provides a conveying device, including inner tube, outer tube and as above-mentioned sacculus subassembly, the distal end of inner tube with the distal end of sacculus is connected, outer pipe box is located the inner tube, the outer tube with the near-end of sacculus is connected, the inner tube with form between the outer tube with the sufficient passageway that the sacculus is linked together, sufficient passageway be used for to the sacculus pours into sufficient medium into, makes the sacculus inflation is with the expansion prosthesis.

The utility model discloses a conveyor and sacculus subassembly thereof, sacculus subassembly include the sacculus and are located the support frame of sacculus, and this support frame has along its axial extension's uplift portion to it is spacing to utilize the uplift portion to carry out the axial to pressing the false body of holding in the sacculus, thereby it appears the probability that axial aversion to reduce the relative sacculus of false body, and in the surface of uplift portion with the smooth closure of the part of sacculus contact, damage the sacculus when avoiding the uplift portion to carry out the axial spacing to the false body.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required to be used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, drawings of other embodiments can be obtained according to the drawings without creative efforts.

FIG. 1 is a schematic diagram of a conveyor according to an embodiment;

FIG. 2 is a schematic illustration of the connection of a balloon assembly and a catheter assembly of one embodiment of the delivery device;

FIG. 3 is a schematic view of a scaffold in a balloon assembly of one embodiment of the delivery device;

FIG. 4 is a schematic view of a balloon assembly of one embodiment of a delivery device with a prosthesis loaded therein in a crimped configuration;

FIG. 5 is a schematic view of another embodiment of a scaffold in a balloon assembly of the delivery device;

fig. 6 is a schematic structural view of a scaffold in a balloon assembly of another embodiment of a delivery device.

The reference numbers illustrate: 100. a conveying device; 10. a balloon assembly; 11. a balloon; 11a, a straight section; 11b, a tapered portion; 12. a support frame; 121. a distal segment; 122. a middle section; 123. a proximal segment; 12a, a raised portion; 12b, hollowing out holes; 20. a catheter assembly; 21. an inner tube; 22. an outer tube; 23. a delivery sheath; 30. a handle; 40. a prosthesis.

Detailed Description

In order to facilitate understanding of the present invention, the present invention will be described more fully hereinafter with reference to the accompanying drawings. Preferred embodiments of the present invention are shown in the drawings. The invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

It should be noted that the terms "distal" and "proximal" are used as terms commonly used in the field of interventional medical devices, where "distal" refers to the end away from the operator during the operation, and "proximal" refers to the end close to the operator during the operation, for example, in the delivery device 100 shown in fig. 1, the left end of the balloon 11 is the distal end of the balloon 11, and the right end of the balloon 11 is the proximal end of the balloon 11.

In the embodiment of the utility model, the axial direction is parallel to the direction of the connection line of the far end center and the near end center of the medical instrument; radial refers to a direction perpendicular to the above-mentioned axial direction.

Referring to fig. 1, the present invention provides a delivery device 100 comprising a balloon assembly 10, a catheter assembly 20, and a handle 30, the balloon assembly 10 being located at the distal end of the catheter assembly 20, and the proximal end of the catheter assembly 20 being connected to the handle 30. The handle 30 injects an inflation medium through the catheter assembly 20 into the balloon assembly 10 to inflate the balloon assembly 10 to release the prosthesis 40 loaded on the balloon assembly 10 (see fig. 4). The prosthesis 40 may be a vascular stent or a valvular stent, but is not limited thereto. The inflation medium may be a liquid or a gas, so long as the balloon assembly 10 is inflated, causing the balloon assembly 10 to expand and dilate the prosthesis 40.

The inventor of the present invention has found through extensive research that when the prosthesis 40 is directly pressed on the balloon 11 of the balloon assembly 10, it often happens that the filling medium cannot pass through the region where the prosthesis 40 is pressed to reach the distal end of the balloon 11 during the expansion of the prosthesis 40, so that the proximal end of the balloon 11 is firstly expanded to push the prosthesis 40 to the distal end, thereby causing the prosthesis 40 to expand unevenly, and in severe cases, the prosthesis 40 cannot expand. But also the prosthesis 40 is displaced axially by the axial thrust of the balloon 11, increasing the inaccuracy of the release position. When severe calcification is encountered, the calcified lesion site exerts greater force on the valve prosthesis and balloon, further increasing the difficulty of accurate release. Taking the prosthesis 40 as a heart valve prosthesis as an example, during the release process, the risk of the heart valve prosthesis slipping into the ventricle is easily increased due to the axial displacement of the heart valve prosthesis caused by the balloon 11.

In the present invention, the accuracy of the release position is improved by modifying the balloon assembly 10. Specifically, as shown in fig. 2 and 3, the balloon assembly 10 includes a support frame 12 disposed within the balloon 11 in addition to the balloon 11. For ease of understanding, the portion of the scaffold 12 near the distal end will be referred to below as the "distal segment", the portion of the scaffold 12 near the proximal end will be referred to as the "proximal segment", and the portion connecting between the distal and proximal segments will be referred to as the "intermediate segment". Specifically, the scaffold 12 includes a distal segment 121, an intermediate segment 122 and a proximal segment 123 connected in sequence from the distal end to the proximal end, that is, the distal end of the distal segment 121 is connected to the distal end of the balloon 11, and the proximal end of the proximal segment 123 is connected to the proximal end of the balloon 11.

In some embodiments, intermediate section 122 is capable of directing the inflation medium injected into balloon 11 from proximal section 123 to distal section 121 such that balloon 11 is injected with the inflation medium at a location corresponding to each of distal section 121 and proximal section 123, thereby reducing the chance of axial displacement of prosthesis 40 relative to balloon 11 as balloon 11 expands prosthesis 40.

Of course, the chance of axial displacement of the prosthesis 40 relative to the balloon 11 may also be reduced by axially restraining the prosthesis 40. For example, in some embodiments, the scaffold 12 has a raised portion 12a extending circumferentially thereof, the raised portion 12a serving to axially restrain the prosthesis 40 when the prosthesis 40 is crimped about the balloon 11. It should be noted that the number of the raised portions 12a may be 1 or 2, and as shown in fig. 2, in the balloon assembly 10, the support frame 12 has 2 raised portions 12a, and the 2 raised portions 12a are spaced apart along the circumference of the support frame 12, so as to axially limit the distal end and the proximal end of the prosthesis 40. Understandably, in some embodiments, only the distal or proximal end of the prosthesis 40 needs to be axially restrained, and only 1 protrusion is required to be disposed at the corresponding position on the scaffold 12, and in some embodiments, 1 protrusion is disposed at the distal end for axial restraint.

It should be noted that there are various implementations of the intermediate section 122 being capable of directing the inflation medium injected into the balloon 11 from the proximal section 123 to the distal section 121.

For example, in one embodiment, the cage 12 is a tubular structure having mesh openings. Specifically, the mesh density of distal section 121 and proximal section 123 is higher than the mesh density of intermediate section 122, and it should be noted that the mesh density refers to the ratio of the mesh area per unit area. For example, the larger the proportion of the mesh area, i.e., the greater the mesh density, the easier the filling medium passes through within 1 unit area. Accordingly, the smaller the mesh density, the less easily the engorgement medium passes through. Therefore, when the mesh density of the distal section 121 and the proximal section 123 is higher than that of the middle section 122, the mesh of the distal section 121 and the proximal section 123 has a better liquid passing effect, i.e., the filling medium can smoothly pass through the mesh of the corresponding distal section 121 and the proximal section 123.

When it is desired to expand prosthesis 40 by inflating balloon 11, filling medium is injected into balloon 11 through catheter assembly 20, and a portion of fluid enters intermediate section 122 from proximal section 123, because of the lower mesh density of intermediate section 122, the filling medium will flow along intermediate section 122 to distal section 121, so that both the proximal and distal ends of balloon 11 have filling medium, and thus both ends of balloon 11 fill simultaneously, and prosthesis 40 is uniformly expanded. Because the positions of the balloon 11 corresponding to the proximal section 123 and the distal section 121 can be filled simultaneously, when the proximal side of the balloon 11 is prevented from being filled, the balloon 11 can generate an axial force to the prosthesis 40 to displace towards the distal end, in other words, through the balloon assembly 10 of the present invention, the probability of the prosthesis 40 to displace axially relative to the balloon 11 can be effectively reduced, so as to improve the accuracy of the release position of the prosthesis 40.

In some embodiments, distal section 121 and proximal section 123 each have a ridge 12a of greater diameter than intermediate section 122, thereby creating an axial stop effect with the greater diameter of ridge 12 a. The diameter of the ridge 12a is larger than the crimped diameter of the prosthesis 40 (inner diameter in the crimped state of the prosthesis 40), and preferably, the maximum diameter of the ridge 12a is larger than the crimped diameter of the prosthesis 40 and is less than or equal to 1.3 times the crimped diameter of the prosthesis 40. As shown in fig. 4, before expansion of the prosthesis 40, the prosthesis 40 is axially restrained between the raised portion 12a of the distal segment 121 and the raised portion 12a of the proximal segment 123, and then no axial displacement occurs. Further, the raised parts 12a at the two ends can achieve a good axial limiting effect on the prosthesis 40, so that even if the balloon 11 is not expanded, the balloon 11 is not in close contact with the prosthesis 40 and cannot limit the displacement of the prosthesis 40, the axial limiting of the raised parts 12a at the two ends on the prosthesis 40 can well prevent the displacement of the prosthesis 40 relative to the balloon 11, so as to improve the safety during the delivery process and further improve the accuracy of the release position of the prosthesis 40.

The balloon 11 has a straight section 11a and tapered sections 11b at both ends of the straight section 11a, and when the scaffold 12 is disposed in the balloon 11, the raised section 12a preferably corresponds to the straight section 11a of the balloon 11. Of course, in some embodiments, the raised portion 12a may also be a partial structure corresponding to the tapered portion 11b of the balloon 11, as long as the position where the diameter of the raised portion 12a is the largest corresponds to the straight section 11 a.

The portion of the outer surface of the raised portion 12a that contacts the balloon 11 is smoothly closed, where smoothly closing a surface means that a line connecting any three points on the surface along the surface is a curved line. In this way, the portion of the outer surface of the bulge portion 12a that contacts the balloon 11 does not form a sharp apex, and when the prosthesis 40 crimped to the balloon 11 is axially restrained by the bulge portion 12a, even if the balloon 11 covers the bulge portion 12a, the bulge portion 12a is not damaged.

In some embodiments, the maximum diameter of the raised part 12a is the most easily contacted with the balloon 11, and the outer contour of the raised part 12a defined by the maximum diameter of the raised part 12a is smoothly closed, which is beneficial to reduce the damage to the balloon 11. Note that the outer ring contour is smoothly closed, which means that, after the outer ring contour is formed by a line connecting points where the diameter of the bulge portion 12a is maximum, the outer ring contour is a smooth curve, and for example, the outer ring contour is circular, elliptical, or formed by an arc shape, so that a sharp peak is not formed, and when the prosthesis 40 pressed against the balloon 11 is axially restrained by the bulge portion 12a, even if the balloon 11 covers the bulge portion 12a, the bulge portion 12a is not damaged.

In some embodiments, the middle section 122 of the scaffold 12 is woven in a high density structure along half or more of its axial direction, thereby increasing the flow guiding effect of the middle section 122. The high-density woven structure is a structure in which the weaving density is higher than that of other positions, and it is understood that the higher the weaving density is, the denser the weaving yarn is. The scaffold 12 may be compressed in both the axial and radial directions to facilitate assembly, for example, the scaffold 12 may be a cage-like structure woven from wires such that the scaffold 12 may be crimped in both the axial and radial directions to facilitate assembly with the balloon 11 to the catheter assembly 20.

For ease of understanding, the tube section corresponding to the high-density weave structure will be referred to as a "first tube section M" and the tube section having a lower relative weave density will be referred to as a "second tube section" hereinafter, as shown in fig. 2. In particular, the intermediate section 122 comprises a first section M and a second section M connected to each other, the braiding density of the wires located in the first section M being higher than the braiding density of the wires located in said second section. The middle section 122 of the support frame 12 adopts a high-density braided structure along half or more of the axial direction thereof, that is, the axial length of the first tube section M corresponding to the high-density braided structure is greater than or equal to half of the axial length of the middle section 122. It should be noted that in some embodiments, there may be one or two second tube segments, for example, the proximal end and the distal end of the first tube segment M are provided with the second tube segments. The number and position of the second tube segments are not limited herein as long as the first tube segments M having a higher braid density occupy half or more of the axial length of the entire middle segment 122. Preferably, the first tube segments M are continuously disposed in the middle of the intermediate segment 122 to better form the fluid passage.

In some embodiments, the support frame 12 is a braided tubular structure, and specifically, the support frame 12 includes a plurality of wires that are integrally braided. The metal wire can be a stainless steel wire, a nickel titanium wire or the like, and preferably, the surface of the metal wire is coated with a soft material layer, wherein the hardness of the soft material layer is less than or equal to 72A, for example, the soft material layer is made of silica gel, terylene, polytetrafluoroethylene or the like. In some preferred embodiments, the material hardness of the soft material layer is less than or equal to 55A.

In the above embodiment, the soft material layer covers the metal wires, so that the metal wires and the balloon 11 are separated from each other, and further, the metal wires are prevented from directly contacting the balloon 11, which may cause damage to the balloon 11.

The metal wire can be round wire or flat wire with size range of 0.1-0.5 mm. In some embodiments, the scaffold 12 is braided from an even number of strands of wire, for example, the scaffold 12 includes 4 strands or more than 4 strands of wire. As mentioned above, the mesh density of the distal section 121 and the proximal section 123 is lower than that of the intermediate section 122, and in this embodiment, the scaffold 12 may be woven from the distal end to the proximal end or from the proximal end to the distal end by using wires, as long as the mesh density of the scaffold 12 corresponding to the intermediate section 122 is lower than that of the distal section 121 and the proximal section 123. Taking the uniform size of the individual meshes as an example, the greater the number of meshes per unit area, the greater the mesh density. For example, in the case that the mesh openings on the scaffold 12 are uniform in size, the distal end section 121 and the proximal end section 123 at both ends of the scaffold 12 may be provided with a large number of mesh openings, so that the mesh opening number of the intermediate section 122 is smaller than that of the distal end section 121 and the proximal end section 123, or the mesh openings of the intermediate section 122 are sparse and negligible, for example, the intermediate section 122 forms a compact structure without mesh openings. When the balloon 11 is injected with the filling medium, the fluid can enter the intermediate section 122 from the proximal section 123 and then flow from the intermediate section 122 to the distal section 121, and the arrangement of the meshes of the distal section 121 and the proximal section 123 enables the portions of the balloon 11 corresponding to the proximal section 123 and the distal section 121 to be filled simultaneously, so that the distal and proximal expansion effects on the prosthesis 40 during the expansion of the balloon 11 are consistent, the probability of axial displacement of the prosthesis 40 is reduced, and the accuracy of the release position is improved.

Accordingly, when the scaffold 12 is a braided tubular structure, the wires of the intermediate section 122 of the scaffold 12 can be tightly braided, and the wires of the distal section 121 and the proximal section 123 can be relatively sparsely braided, so that the mesh density of the intermediate section 12 is lower than that of the distal section 121 and the proximal section 123, which facilitates the simultaneous filling of the proximal section 123 and the proximal section 121 of the balloon 11, thereby reducing the probability of axial displacement of the prosthesis 40 and improving the accuracy of the release position.

When the frame 12 is woven with metal wires, the weave angle may be 15-75, such as 15, 20, 25, 35, 55, 65, or 75. The braiding angle refers to the angle between the wires that cross each other. In the embodiment, the weaving angle can be adjusted to adapt to the density of the mesh holes. The diameter of the straight section 11a may be 1.2mm to 3.0 mm.

It should be noted that the scaffold 12 may be of other structures than the tubular braided structure described above, as long as the scaffold 12 can guide the inflation medium on the proximal side of the balloon 11 to the distal side of the balloon 11.

For example, in other embodiments, the support frame 12 is a hollow tubular structure, and in this embodiment, as shown in fig. 5, the support frame 12 may also include a distal section 121, a middle section 122 and a proximal section 123 connected in sequence. The difference is that in this embodiment, the scaffold 12 is not a woven structure, and the middle section 122 may not be provided with mesh, and only the distal section 121 and the proximal section 123 of the tubular scaffold 12 are provided with hollow holes 12 b. The filling medium on the proximal side of the balloon 11 may flow from the proximal side 123 into the intermediate section 122 and along the intermediate section 122 to the distal section 121, and finally the filling medium may flow freely in the hollow holes 12b of the distal section 121 and the proximal section 123, so that the distal side of the balloon 11 may be injected with the filling medium simultaneously with the proximal side of the balloon 11, improving the stability of the expansion of the prosthesis 40 to ensure the accuracy of the release position of the prosthesis 40.

The hollow holes 12b may be formed in an integral injection molding process or may be formed by machining on the tubular main body structure.

The shape of the hollow hole 12b may be a diamond, a square, a circle or a special-shaped structure, for example, as shown in fig. 5, the shape of the hollow hole 12b is a regular hexagon, and as shown in fig. 6, the shape of the hollow hole 12b is an ellipse.

It should be noted that, in this embodiment, the distal end section 121 and the proximal end section 123 of the scaffold 12 may also be provided with a raised portion 12a having a larger diameter than the intermediate section 122, so as to facilitate the raised portion 12a to axially limit the prosthesis 40, and further reduce the probability of axial displacement of the prosthesis 40.

The support frame 12 may be formed by two separate parts, which are respectively disposed at two ends of the gripping area of the prosthesis 40, and the raised parts 12a at the two ends can be respectively utilized to achieve a good axial limiting effect on the prosthesis 40, so as to improve the accuracy of the release position.

In some embodiments, the scaffold 12 is a hollow tubular structure formed by a thermoplastic tube, wherein the hardness of the thermoplastic tube is less than 90A, preferably less than 70A, and more preferably 20A-70A, such as 20A, 35A, 50A, 65A or 70A, and the hardness of the thermoplastic tube is 20A-70A, which can make the scaffold 12 meet the limit requirement of the prosthesis 40 by using its raised portion 12a, and at the same time, the scaffold 12 has good flexibility as a whole to further protect the balloon 11 and prevent puncture of the balloon 11.

For example, the material of the support frame 12 may be a silicone or nylon elastomer (e.g., PEBAX, a nylon elastomer from ARKEMA, france), and the support frame 12 may also be integrally molded by injection molding, wherein the injection molding material is preferably a material with low hardness, such as silicone or nylon elastomer. The support frame 12 is not limited by the processing technology in the present application, and the hardness of the obtained hollowed tubular structure is less than 90A, preferably less than 70A, and more preferably 20A-70A. The forming method and material of the supporting frame 12 are not described herein.

It should be noted that the entire cage 12 need not be a braided structure or a thermoplastic tube, but only a portion of the structure may be a braided structure or a thermoplastic tube. For example, in some embodiments, the raised portion 12a is formed by weaving metal wires, or the raised portion 12a is formed by cutting a metal tube, or the raised portion 12a is formed by hollowing out a polymer tube.

Referring again to fig. 1, in some embodiments, catheter assembly 20 includes an inner tube 21 and an outer tube 22, a distal end of inner tube 21 is connected to a distal end of balloon 11, outer tube 22 is sleeved on inner tube 21, outer tube 22 is connected to a proximal end of balloon 11, and a filling channel is formed between inner tube 21 and outer tube 22, and is connected to balloon 11, so that filling medium is injected into balloon 11 through the filling channel to inflate balloon 11. Understandably, after the inner tube 21 passes through the scaffold 12, the distal end of the inner tube 21 is connected with the distal end of the balloon 11, and the scaffold 12 can prevent the balloon 11 from being pressed and held by the prosthesis 40 to be attached to the outer surface of the inner tube 21, so that a gap exists between the balloon 11 and the outer surface of the inner tube 21, and thus the middle section 122 of the scaffold 12 is effectively utilized to guide the filling medium injected into the proximal section 123 to the distal section 121, and the synchronous expansion of the distal end and the proximal end of the balloon 11 is realized. Further, there is a gap between the inner surface of the scaffold 12 and the outer surface of the inner tube 21 to take advantage of the gap between the inner surface of the scaffold 12 and the outer surface of the inner tube 21 to meet the need for the intermediate section 122 to direct the inflation medium injected into the proximal section 123 to the distal section 121. Preferably, the gap between the middle section 122 and the inner tube 21 is 0.2mm-2mm, so that when the prosthesis 40 is tightly wrapped around the balloon 11, the gap forms a fluid passage to allow the filling medium to flow to the distal section 121 more rapidly, thereby achieving good flow guiding effect.

It should be noted that the catheter assembly 20 may also include other tubes, such as a delivery sheath 23 for the delivery balloon assembly 10, and the delivery sheath 23 may be movably disposed on the outer tube 22.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

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

Claims (11)

1. A balloon assembly comprising a balloon for expanding a prosthesis fitted around its periphery when inflated and a scaffold within the balloon, the scaffold having a protuberance extending circumferentially thereof,

when the prosthesis is pressed and held on the periphery of the balloon, the raised part is used for axially limiting the prosthesis, and the part of the outer surface of the raised part, which is in contact with the balloon, is smoothly closed.

2. A balloon assembly according to claim 1 wherein the scaffold has two of said protuberances thereon for axially retaining the distal and proximal ends of the prosthesis, respectively.

3. The balloon assembly of claim 1, wherein the scaffold comprises a distal section, a middle section and a proximal section connected in sequence, wherein the distal end of the distal section is connected to the distal end of the balloon, and the proximal end of the proximal section is connected to the proximal end of the balloon, and wherein the middle section is capable of guiding the filling medium injected into the balloon from the proximal section to the distal section.

4. The balloon assembly of claim 3 wherein the scaffold is a tubular structure having mesh openings, the mesh density of the distal and proximal segments being higher than the mesh density of the intermediate segment.

5. A balloon assembly according to claim 4 wherein the scaffold is a braided tubular structure comprising a plurality of wires which are surface coated with a layer of soft material.

6. A balloon assembly according to claim 3 wherein the intermediate section comprises first and second tube sections connected to one another, the wires in the first tube section having a higher braid density than the wires in the second tube section, the first tube section having an axial length greater than or equal to half the axial length of the intermediate section.

7. The balloon assembly of claim 3, wherein the support frame is a hollowed tubular structure, and the distal section and the proximal section are provided with hollowed holes.

8. A balloon assembly according to claim 3 wherein at least one of the distal and proximal end sections is provided with said protuberance.

9. The balloon assembly of claim 8, wherein the balloon has a straight section and tapered portions at both ends of the straight section, the bump corresponding to the straight section of the balloon.

10. The balloon assembly of claim 7 wherein the openwork tubular structure has a durometer of less than 90A.

11. A delivery device comprising an inner tube, an outer tube and a balloon assembly according to any of claims 1-10, wherein a distal end of the inner tube is connected to a distal end of the balloon, the outer tube is disposed around the inner tube, the outer tube is connected to a proximal end of the balloon, and a filling passage is formed between the inner tube and the outer tube and is in communication with the balloon, the filling passage being adapted to inject a filling medium into the balloon to inflate the balloon to expand the prosthesis.

Images