Balloon catheter and interventional medical device

Abstract

The application provides a balloon catheter and an interventional medical device, which comprises a balloon connecting tube and an inflatable balloon, the inflatable balloon comprises a first part, an intermediate part and a second part arranged along the axial direction of the balloon connecting tube in sequence, the balloon connecting tube is a hollow structure, the section of the balloon connecting tube located inside the inflatable balloon comprises a first section, an intermediate section and a second section arranged in sequence, at least one communication hole is arranged on the intermediate section, the communication hole is a strip-shaped hole, and at least one of the at least one communication hole extends to at least the first joint between the intermediate section and the first section and / or the second joint between the intermediate section and the second section. The position of the communication hole is arranged to control the deflation process of the inflatable balloon, so that the inflatable balloon is deflated to the balloon connecting tube uniformly at all positions when the inflatable balloon is recovered, and the inflatable balloon can be basically shrunk to the folding state before use, so that the operation can be smoothly performed.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a balloon catheter and an interventional medical device. BACKGROUND

[0002] The heart is an important organ of the human body, which provides power for blood circulation of the human body. The aortic valve inside the heart controls the direction of blood flow, and plays a crucial role in ensuring sufficient blood flow through the cardiovascular system. Aortic valve stenosis can easily lead to poor blood flow, causing pain to patients and even endangering their lives. At present, the main treatment methods for aortic valve stenosis include expansion through a balloon connecting tube or implantation of an artificial valve stent through a catheter to replace the diseased native aortic valve and perform functions.

[0003] Both of the above treatment methods require the use of an inflatable balloon, and after treatment, the inflatable balloon needs to be withdrawn from the body. However, the inflatable balloon used at present is difficult to recover to the state before inflation after inflation, that is, the folding memory of the inflatable balloon is poor. This situation can lead to prolonged surgery time, increase the safety of the surgery, and in severe cases, the corresponding instruments need to be removed by surgery, further increasing the risk of surgery and the pain of patients. SUMMARY

[0004] Based on the above situation, the main purpose of the present application is to provide a balloon catheter and an interventional medical device to solve the problem of poor folding memory of the inflatable balloon in the prior art.

[0005] To achieve the above-mentioned purpose, the technical scheme adopted by the present application is as follows:

[0006] A balloon catheter for an interventional medical device, comprising a balloon connecting tube, an inner tube and an inflatable balloon, the inner tube being sleeved in the balloon connecting tube; the inflatable balloon is arranged at the distal end region of the balloon connecting tube, and its two ends are respectively sealedly connected with the balloon connecting tube, the inflatable balloon comprises a first part, a middle part and a second part arranged in sequence along the axial direction of the balloon connecting tube, and the inflatable balloon has an unfolded state and a folded state, in the unfolded state, the first part and the second part are in a conical structure, and the middle part is in a columnar structure;

[0007] The balloon connecting tube is a hollow structure, and the section inside the inflatable balloon includes a first section, a middle section and a second section arranged in sequence, in the radial direction of the balloon connecting tube, the first section corresponds to the first part, the middle section corresponds to the middle part, and the second section corresponds to the second part;

[0008] The intermediate section is provided with at least one through hole which penetrates the sidewall of the balloon connecting tube and is a strip-shaped hole extending along the axial direction of the balloon connecting tube,

[0009] At least one of the at least one through hole extends to at least one of the first joint between the intermediate section and the first section and the second joint between the intermediate section and the second section.

[0010] Preferably, at least one of the at least one through hole is a first hole, and both ends of the first hole extend to the first joint and the second joint respectively.

[0011] Preferably, the intermediate section is provided with a plurality of first holes, and the length of each first hole is equal to the length of the intermediate section.

[0012] Preferably, at least one of the at least one through hole is a second hole; the second hole is provided at at least one of the first joint and the second joint, one end of the second hole is located at the joint where the second hole is provided, and the other end of the second hole is spaced apart from the other joint.

[0013] Preferably, the intermediate section is provided with a plurality of through holes, at least part of the plurality of through holes are second holes, and the plurality of second holes form at least one hole group, in the same hole group, the plurality of second holes are located at the same position in the circumferential direction and are spaced apart in the axial direction, and two of the second holes are located at the first joint and the second joint respectively.

[0014] Preferably, each hole group includes two second holes.

[0015] Preferably, a plurality of intermediate sections are provided with a plurality of hole groups, and the plurality of hole groups are uniformly distributed along the circumferential direction of the intermediate section.

[0016] Preferably, a first flow guide groove is further provided on the outer wall of the intermediate section, the first flow guide groove extends along the axial direction, and two adjacent second holes in the same hole group are connected through the first flow guide groove.

[0017] Preferably, the intermediate section is provided with a plurality of through holes in the circumferential direction;

[0018] A second flow guide groove is further provided on the outer wall of the intermediate section, the second flow guide groove extends in the circumferential direction, and two adjacent through holes in the circumferential direction are connected through the second flow guide groove.

[0019] Preferably, the intermediate section is provided with the through holes at 2-8 positions in the circumferential direction, the size of the through holes in the circumferential direction is 0.1-0.7 mm, and the greater the number of through holes in the circumferential direction, the smaller the size of the through holes.

[0020] Preferably, the communication hole comprises at least one of an elliptical hole and a waist-shaped hole.

[0021] The present application also relates to an interventional medical device comprising the foregoing balloon catheter.

[0022]

Advantages

[0023] The balloon catheter of the present application can control the deflation process of the inflatable balloon by setting the position of the communication hole. Specifically, the communication hole is arranged at at least one end of the middle section of the balloon connecting tube corresponding to the inflatable balloon, i.e. at at least one end of the maximum outer diameter section in the expanded state of the inflatable balloon. In this way, the inner part of the balloon connecting tube can communicate with the space inside the inflatable balloon at at least one end of the middle section, respectively. When the inflation medium inside the inflatable balloon is just being extracted, the suction force can directly act on the middle section of the inflatable balloon or the junction of the middle section with the first section and the second section, so that the three sections of the inflatable balloon can all be deflated towards the balloon connecting tube, and the three sections are uniformly deflated, thereby avoiding that the first section and the second section are preferentially deflated to block the passage of the inflation medium during the deflation process, improving the smooth progress of the entire inflatable balloon recovery and improving the safety of the operation. Moreover, since the communication hole of the present application is a strip-shaped hole, even if the first section and the second section preferentially contact the balloon connecting tube, the communication hole will not be blocked. Therefore, the medium can flow smoothly during the entire recovery process, and the folded state before use can be achieved.

[0024] Other advantages of the present application will be described in the specific embodiments by introducing specific technical features and technical solutions, and those skilled in the art should be able to understand the beneficial technical effects brought by the technical features and technical solutions through the introduction of the technical features and technical solutions. BRIEF DESCRIPTION OF DRAWINGS

[0025] The preferred embodiments of the balloon catheter of the present application will be described below with reference to the accompanying drawings. In the drawings:

[0026] Figure 1 is a structural schematic view of a preferred embodiment of the inflatable balloon part of the balloon catheter of the present application;

[0027] Figure 2 is a structural schematic view of a second preferred embodiment of the inflatable balloon part of the balloon catheter of the present application;

[0028] Figure 3 is a structural schematic view of a third preferred embodiment of the inflatable balloon part of the balloon catheter of the present application;

[0029] Figure 4 is a partial sectional view of the balloon connecting tube along its axial direction;

[0030] Figure 5 a cross-sectional view of the balloon connection tube along its radial direction;

[0031] Figure 6 a structure schematic view of a preferred embodiment of the balloon catheter.

[0032] In the figure, 1, balloon connection tube; 2, inflatable balloon; 3, three-way tailstock; 4, stress diffusion tube; 5, inner tube;

[0033] 11, first section; 12, intermediate section; 13, second section; 14, first joint; 15, second joint; 21, first part; 22, intermediate part; 23, second part;

[0034] 121, first hole; 122, second hole; 123, first flow guide groove; 124, second flow guide groove. DETAILED DESCRIPTION

[0035] The present application is described in the following based on examples, but the present application is not limited to these examples only. In the following detailed description of the present application, some specific details are described in detail in order to avoid obscuring the essence of the present application, and well-known methods, processes, procedures, elements are not described in detail.

[0036] In addition, those of ordinary skill in the art will understand that the drawings provided herein are for illustrative purposes only and are not necessarily drawn to scale.

[0037] Unless the context clearly requires otherwise, throughout the description and the claims, the words "comprise", "comprising", and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is to say, in the sense of "including, but not limited to".

[0038] In the description of the present application, it should be understood that the terms "first", "second" and the like are used only for the purpose of description and cannot be understood as indicating or implying relative importance. In addition, in the description of the present application, unless otherwise stated, the meaning of "multiple" is two or more.

[0039] It should be noted that in the description of the present application, "proximal end", "distal end", "distal end portion", "proximal end portion", "near", "far" are described in the state of the interventional medical device during normal operation during surgery, and are relative to the operator. The proximal end refers to the end close to the operator, and the distal end refers to the end away from the operator. For the same component, if part of it extends into the patient's body, the end extending into the patient's body is the distal end portion, and the end located outside the body close to the operator is the proximal end. For reference, see Figure 1 and Figure 6The above description is only for the convenience of description and does not limit the scope of the present application.

[0040] Referring to Figures 1-6 The present application provides a balloon catheter for interventional medical devices, comprising a balloon connecting tube 1 and an inflatable balloon 2, the inflatable balloon 2 is arranged at the distal end region of the balloon connecting tube 1, and the two ends thereof are respectively sealedly connected (including direct connection and indirect connection) with the balloon connecting tube 1, the inflatable balloon 2 comprises a first part 21, an intermediate part 22 and a second part 23 arranged in sequence along the axial direction of the balloon connecting tube 1, and the inflatable balloon 2 has an unfolded state and a folded state, in the unfolded state, the first part 21 and the second part 23 are in a conical structure, and the diameter of each of the first part 21 and the second part 23 gradually decreases from the end close to the intermediate part 22 to the end away from the intermediate part 22, for example, when the first part 21 is located at the proximal end side of the intermediate part 22 and the second part 23 is located at the distal end side of the intermediate part 22, the diameter of the first part 21 gradually decreases from the distal end to the proximal end, and the diameter of the second part 23 gradually increases, and the intermediate part 22 is basically in a cylindrical structure, that is, in the unfolded state, the diameter of the intermediate part 22 is basically equal at different positions.

[0041] The balloon connecting tube 1 is a hollow structure, and an inner tube 5 is sleeved in the balloon connecting tube 1, the inner tube 5 is provided with a space for a guide wire to pass through, and the space between the balloon connecting tube 1 and the inner tube 5 is provided for the flow of inflation medium, and at the distal end, the space between the balloon connecting tube 1 and the inner tube 5 is closed. The section of the balloon connecting tube 1 located inside the inflatable balloon 2 comprises a first section 11, an intermediate section 12 and a second section 13 arranged in sequence, and in the radial direction of the balloon connecting tube 1, the first section 11 corresponds to the first part 21, the intermediate section 12 corresponds to the intermediate part 22, and the second section 13 corresponds to the second part 23, that is, when the inflatable balloon 2 is in the unfolded state, the first part 21 is basically wrapped outside the first section 11, the intermediate part 22 is basically wrapped outside the intermediate section 12, and the second part 23 is basically wrapped outside the second section 13.

[0042] In some embodiments, the through hole is arranged on the section of the first section 11 or the second section 13 away from the middle section 12, or arranged on the middle section of the first section 11 or the second section 13, so that the inflation medium entering the middle pipeline of the balloon connection tube 1 enters the inflatable balloon 2 through the through hole, and the inflatable balloon 2 is unfolded. However, when the inflatable balloon 2 needs to be folded, the suction force directly acts on the first part 21 and the second part 23 with a small space when the inflation medium is extracted through the through hole, causing the two parts to be in contact with the balloon connection tube 1 first, which hinders the suction passage of the inflation medium, and even may block the through hole, so that part of the medium in the inflatable balloon 2 cannot be extracted, causing the inflatable balloon 2 to fail to return to the folded state before use, so that the entire balloon catheter is difficult to return to the delivery catheter, affecting the smooth progress of the operation.

[0043] To solve the above problems, in the present application, the middle section 12 is provided with a through hole, specifically, referring to Figure 1 、 Figure 2 The middle section 12 is provided with at least one through hole (such as the first hole 121 and the second hole 122), and the through hole penetrates the side wall of the balloon connection tube 1, and the central pipeline of the balloon connection tube 1 communicates with the inflatable balloon 2 through the through hole. The through hole can be a strip-shaped hole extending along the axial direction of the balloon connection tube 1, and the strip-shaped hole refers to the maximum size in the axial direction of the balloon connection tube 1 being greater than the maximum size in the circumferential direction of the balloon connection tube 1.

[0044] At least one of the at least one communication hole extends to at least one of the first joint 14 between the intermediate section 12 and the first section 11 and / or the second joint 15 between the intermediate section 12 and the second section 13. That is, the number of communication holes in the intermediate section 12 can be one, two, three or more. In the embodiment in which the number of communication holes is one, the communication hole extends to at least one of the first joint 14 and / or the second joint 15. In the embodiment in which the number of communication holes is two or more, all of the communication holes can extend to at least one of the first joint 14 and / or the second joint 15, or only some of the communication holes can extend to at least one of the first joint 14 and / or the second joint 15. For the communication hole that extends to at least one of the first joint 14 and / or the second joint 15, the communication hole can extend to at least one of the first joint 14, the second joint 15 or both. Specifically, for each communication hole, the end closer to or in the first section 11 is referred to as the first end (proximal end of the communication hole), and the other end is referred to as the second end (distal end of the communication hole). For the communication hole that extends to at least the first joint 14, the first end of the communication hole extends to at least the first joint 14, i.e. the first end of the communication hole can extend to only the first joint 14 (i.e. the first end is located at the first joint 14), or the first end of the communication hole can extend beyond the first joint 14 to the proximal end of the first section 21 (i.e. the first end extends beyond the first joint 14 to the proximal end of the first section 21, and there is usually a gap between the first end and the proximal end of the first section 21). Similarly, for the communication hole that extends to at least the second joint 15, the second end of the communication hole extends to at least the second joint 15, i.e. the second end of the communication hole can extend to only the second joint 15 (i.e. the second end is located at the second joint 15), or the second end of the communication hole can extend beyond the second joint 15 to the distal end of the second section 23 (i.e. the second end extends beyond the second joint 15 to the distal end of the second section 23, and there is usually a gap between the second end and the distal end of the second section 23).

[0045] For the various arrangements of the communication holes described above, the communication holes can be arranged in one of the first joint 14 and the second joint 15, e.g. the first joint 14 has a communication hole (the first end of the communication hole extends to at least the first joint 14, and the second end is located proximally of the second joint 15), and the second joint 15 has no communication hole. Alternatively, the second joint 15 has a communication hole (the second end of the communication hole extends to at least the second joint 15, and the first end is located distally of the first joint 14), and the first joint 14 has no communication hole. Alternatively, both the first joint 14 and the second joint 15 have a communication hole. The communication holes in the first joint 14 and the second joint 15 can be the same hole (as described in detail below with reference to FIG. 6), or different holes (as described in detail below with reference to FIG. 7). Figure 1 Figure 2 ​The communication holes are distributed at least at one of the two joints, and regardless of which of the three aforementioned embodiments, the communication holes are able to cover at least one of the two joints.

[0046] The balloon catheter of the present application, the communication holes are distributed at least at one end of the balloon connecting tube 1 corresponding to the middle part 22 of the inflatable balloon 2, so that the inner part of the balloon connecting tube 1 can communicate with the space inside the inflatable balloon 2 at least at one end of the middle section 12, when the inflation medium inside the inflatable balloon 2 is just beginning to be extracted, especially in the embodiment that the communication holes are distributed at both joints, the suction force can directly act on the middle part 22 of the inflatable balloon 2 or the junction of the middle part 22 and the first part 21 and the second part 23, so that the three parts of the inflatable balloon 2 can all be recessed to the balloon connecting tube 1, and the three parts can be uniformly recessed, thereby avoiding that the first part 21 and the second part 23 preferentially recessed to block the passage of the inflation medium during the recessing process, and the communication holes are not wrapped by the first part 21 and the second part 23 during the entire folding process of the inflatable balloon 2, thus ensuring the smooth progress of the entire inflatable balloon 2 recovery and improving the safety of the operation; and even if the first part 21 and the second part 23 preferentially contact the balloon connecting tube 1, the communication holes will not be blocked, so that the medium can flow smoothly during the entire recovery process, thereby achieving the folding state before use, and the smooth progress of the operation will not be affected. It can be seen that the special position of the communication holes can control the recessing process of the inflatable balloon 2, so that the entire recovery process of the inflatable balloon 2 can be carried out smoothly.

[0047] In the present application, the middle section 12 at least ensures that the first joint 14 and the second joint 15 (i.e. the end region of the middle section 12) have communication holes, of course, the communication holes can also be located at positions other than the first joint 14 and the second joint 15, for example, on the middle region of the middle section 12.

[0048] And the communication holes of the present application are strip-shaped holes, so that the length of the communication holes in the axial direction is relatively long, and even if the first part 21 and the second part 23 preferentially contact the balloon connecting tube 1 during the contraction process of the inflatable balloon 2, at most only the part of the communication holes close to the first section 11 or the second section 13 will be blocked, therefore, the communication holes will not be completely blocked, thereby better ensuring that the inflatable balloon 2 can recover to the folding state before use.

[0049] Meanwhile, when multiple connecting holes are provided in the intermediate section 12, in the first embodiment, the multiple connecting holes can be distributed in multiple positions around the balloon connecting tube 1; for example, multiple connecting holes are provided at the first connection 14, and these connecting holes are spaced apart along the circumference of the balloon connecting tube 1, so that the first connection 14 can draw in expandable media at multiple positions in the circumference; in the second embodiment, connecting holes are provided at multiple positions in the axial direction of the intermediate section, for example, a connecting hole is provided at the first connection 14, and a connecting hole is also provided at the second connection 15 (e.g. Figure 2 (As shown); In the third embodiment, multiple connecting holes are distributed both circumferentially and axially along the balloon connecting tube 1. For example, multiple connecting holes are provided at the first junction 14, and these connecting holes are spaced apart circumferentially along the balloon connecting tube 1. Multiple connecting holes are also provided at the second junction 15, and these connecting holes are spaced apart circumferentially along the balloon connecting tube 1. Multiple connecting holes are provided on the intermediate section 12. In particular, in the embodiment where the connecting holes are distributed at multiple locations circumferentially, multiple connecting holes allow the inflatable balloon 2 to fold as evenly as possible circumferentially and to gradually shrink basically according to the creases of the original state. Therefore, it is possible to better shrink the balloon to the initial folded state, which is conducive to the withdrawal of the delivery catheter and to better ensure the smooth progress of the interventional surgery. In addition, during the process of withdrawing the expansion medium, even if some connecting holes are blocked, other adjacent connecting holes can ensure that the expansion medium can be withdrawn, further ensuring that the inflatable balloon 2 can return to the folded state before use.

[0050] Among them, the connecting hole can extend through the entire length of the intermediate section 12 in the axial direction, or even longer, or it can only extend through a part of the section. That is to say, the former is longer than the latter. For ease of description, the longer strip hole is referred to as the first hole 121 and the shorter strip hole is referred to as the second hole 122.

[0051] Among them, see Figure 1 The first hole 121 extends at least to the first junction and the second junction 15 in the axial direction at both ends. That is, the length of the first hole 121 can be equal to the length of the middle section 12, or the length of the first hole 121 can be greater than the length of the middle section 12. That is, the two ends of the first hole 121 extend to the first section 11 and the second section 13, respectively. The two ends of the first hole 121 extend out of the two ends of the middle section 12 and reach the first section 11 and the second section 13, thereby increasing the speed of the expansion medium flow and improving the efficiency of the inflatable balloon 2 during recovery.

[0052] In the embodiment where all the communication holes are the first holes 121, each of the communication holes on the intermediate section 12 can be the first hole 121, i.e., the intermediate section 12 is provided with the first hole 121 at each position in the circumferential direction, and specifically, the number of the first holes 121 can be one, two, three or more, and when the number of the first holes 121 is two or more, the first holes 121 can be equidistantly arranged in the circumferential direction of the intermediate section 12. In this embodiment, the length of each first hole 121 can be equal or not equal, and the size in the circumferential direction can be equal or not equal, and preferably, the length of each first hole 121 is equal to the length of the intermediate section 12, and the size in the circumferential direction of each first hole 121 is equal.

[0053] When the communication hole is the second hole 122, the number of the second holes 122 can be one, two, three or more, and regardless of the number of the second holes 122, the second holes can be arranged at the first joint 14 or the second joint 15, and when the number of the second holes 122 is two or more, the second holes at the same position in the axial direction (e.g., the first joint 14 or the second joint 15) can be spaced apart in the circumferential direction; in the embodiment where the number of the second holes 122 is two or more, the second holes 122 can be arranged at the first joint 14 and the second joint 15 at the same time, and of course, the second holes 122 can be arranged on the intermediate region of the intermediate section 12, and of course, when there are multiple second holes 122 at the same position in the axial direction, the second holes 122 can be spaced apart in the circumferential direction.

[0054] In the embodiment where the intermediate section 12 is provided with multiple second holes 122, the second holes 122 can all form a hole group (see below) or all form a non-hole group (see below); or part of the second holes 122 form a hole group and part of the second holes 122 are arranged in a non-hole group manner.

[0055] In the hole group manner, for the same hole group, multiple second holes 122 are included, the multiple second holes 122 are at the same position in the circumferential direction and are spaced apart in the axial direction, and two of the multiple second holes 122 are located at the first joint 14 and the second joint 15, respectively, and each of the second holes 122 in the same hole group is located on the same generatrix (for example, the intermediate section 12 is a cylindrical structure) of the intermediate section 12 and is spaced apart from each other (i.e., not directly communicated), and when a hole group includes only two second holes 122, the two second holes 122 are located at the first joint 14 and the second joint 15, respectively, and when a hole group includes three or more second holes 122, the three or more second holes 122 are located at the same position in the circumferential direction and are spaced apart in the axial direction, and two of the three or more second holes 122 are located at the first joint 14 and the second joint 15, respectively, and the other one or more second holes 122 are located on the intermediate region of the intermediate section 12. Figure 2As shown, one second hole 122 is located at the first joint 14, and another second hole 122 is located at the second joint 15; when there are more than three second holes 122 in a hole group, two of the second holes 122 are located at the first joint 14 and the second joint 15 respectively, and the other second holes 122 are located between the first joint 14 and the second joint 15. Among them, one end of the second hole 122 located at the first joint 14 is located near the middle region of the middle section 12, and the other end can be stopped at the first joint 14 or continue to extend to the first section 11; similarly, the second hole 122 located at the second joint 15 can also be similarly arranged, that is, one end is located near the middle region of the middle section 12, and the other end can be stopped at the second joint 15 or continue to extend to the second section 13. By adopting the hole group mode, the opening length of the middle section 12 in the axial direction can be reduced, thereby improving the strength of the balloon connecting pipe 1, and when the balloon connecting pipe 1 is driven, the torque can be well transmitted to the inflatable balloon 2.

[0056] In the non-hole group mode, a plurality of second holes 122 are not arranged in the above-mentioned hole group mode, for example, only one second hole 122 can be arranged at a position in the circumferential direction of the middle section 12, and the second hole 122 can be located at the first joint 14, the second joint 15, or the middle region of the middle section 12 in the axial direction; for another example, two or more second holes 122 can be arranged at a position in the circumferential direction of the middle section 12, but these second holes 122 are arranged in the region close to the first joint 14 (not arranged at the second joint 15), the region close to the second joint 15 (not arranged at the first joint 14), or the middle region of the middle section 12 in the axial direction, or two of the three positions, but not at the same time arranged at the first joint 14 and the second joint 15.

[0057] In the embodiment in which all the plurality of communication holes are second holes 122, the plurality of second holes 122 can all form the above-mentioned hole group mode, at this time, the plurality of communication holes on the middle section 12 are all arranged in the hole group mode, that is, the middle section 12 is provided with a plurality of hole groups in the circumferential direction, and these hole groups can be uniformly distributed in the circumferential direction; the plurality of communication holes on the middle section 12 can also be all arranged in the above-mentioned non-hole group mode; or, the plurality of communication holes on the middle section 12 can also be partially arranged in the hole group mode and partially arranged in the non-hole group mode.

[0058] In other embodiments, only part of the through holes are the second holes 122, while the rest of the through holes can be the first holes 121, that is, the through holes on the intermediate section 12 are either the first holes 121 or the second holes 122, that is, part of the through holes are the first holes 121, and part of the through holes are the second holes 122. The second holes 122 can form one hole group, or can form multiple hole groups, or all of them are non-hole groups, or part of them are hole groups and part of them are non-hole groups. That is, part of the through holes on the intermediate section 12 are the first holes 121, and the rest of them are hole groups, or part of the through holes are the first holes 121, and the rest of them are non-hole groups, or part of the through holes are the first holes 121, part of them are hole groups, and the rest of them are non-hole groups.

[0059] It should be noted that in the embodiments in which multiple hole groups are formed, the number of second holes 122 in each hole group can be equal or not equal, for example, all hole groups can include two second holes 122, or part of the hole groups can include two second holes 122, and the rest of the hole groups can include three or more second holes 122. The lengths of the second holes 122 in the same hole group can be equal or not equal, and the lengths of the second holes 122 in different hole groups can also be equal or not equal, that is, the sizes of the second holes 122 in different hole groups can be independently set, and the sizes of the second holes 122 in the same hole group can also be independently set. In addition, the through holes at two circumferentially adjacent positions can be axially offset from each other.

[0060] In the above embodiments, the distribution positions of the multiple through holes in the circumferential direction of the intermediate section 12 can be two, three or more. When the number is large, the diameter of the balloon connecting tube 1 is small, which can affect its strength and in turn affect the transmission of torque. In a preferred embodiment of the present application, the intermediate section 12 is provided with through holes at 2-8 positions in the circumferential direction, for example, at 2, 3, 4, 5, 6, 7 or 8 positions in the circumferential direction, to improve the efficiency of the inflatable balloon 2 being compressed. Further, the number of positions of the through holes in the circumferential direction can be determined according to the number of petals of the inflatable balloon 2 in the folded state, and preferably, the through holes are provided at 4-6 positions.

[0061] The size of each through hole in the circumferential direction can be 0.1-0.7 mm, and the larger the number of through holes in the circumferential direction, the smaller the size, so as to ensure that the intermediate section 12 has sufficient strength. For example, when the through holes are provided at two positions in the circumferential direction, the size of each through hole in the circumferential direction can be 0.7 mm; for example, when the through holes are provided at 6-8 positions in the circumferential direction, the size of each through hole in the circumferential direction can be 0.1-0.2 mm.

[0062] The length of each communication hole can be 0.1-43 mm. Specifically, the length can be determined according to the number of communication holes at the same circumferential position. For example, when only one communication hole is arranged at a circumferential position, such as the first hole 121, the length can be relatively long, such as 43 mm. For another example, when multiple communication holes are arranged at a circumferential position, the length of each communication hole can be relatively small. For example, when two second holes 122 are arranged, the length of each communication hole can be 10-15 mm.

[0063] Specifically, the communication hole includes at least one of an elliptical hole, a waist-shaped hole, or a rectangular hole. The specific shape is not limited, as long as the length in the axial direction is greater than the length in the circumferential direction.

[0064] In the embodiment in which multiple communication holes are arranged at the same circumferential position of the intermediate section 12, such as the embodiment in which the intermediate section 12 is provided with a hole group, see Figure 3 and Figure 4 Preferably, the first flow guide groove 123 is further arranged on the outer wall of the intermediate section 12 and extends in the axial direction. The two adjacent second holes 122 in the same hole group are communicated through the first flow guide groove 123. The first flow guide groove 123 does not penetrate the side wall of the balloon connection tube 1, i.e., it can be formed by inwardly recessing the outer wall of the intermediate section 12, and the opening of the first flow guide groove 123 faces outward, so that the inflation medium in the inflatable balloon 2 can directly enter the first flow guide groove 123 from the opening. The two adjacent second holes 122 in the axial direction are communicated through the first flow guide groove 123, so that when the inflatable balloon 2 is deflated, even if part of the second hole 122 is blocked by the folded part of the inflatable balloon 2, the inflation medium can be extracted through the first flow guide groove 123 connected to the second hole 122, thereby better ensuring that the inflatable balloon 2 is uniformly deflated. It should be noted that in the non-hole group mode or other embodiments, as long as the two adjacent communication holes at the same circumferential position are also communicated through the first flow guide groove 123.

[0065] In another embodiment, see Figure 5 A second flow guide groove 124 is further arranged on the outer wall of the intermediate section 12 and extends in the circumferential direction. The two adjacent communication holes in the circumferential direction are communicated through the second flow guide groove 124. The second flow guide groove 124 can also enhance the extraction effect of the inflation medium by the communication hole, and ensure that the inflatable balloon 2 can reach the folded state before use.

[0066] It should be noted that the intermediate section 12 can be provided with only the first flow guide groove 123, only the second flow guide groove 124, or both the first flow guide groove 123 and the second flow guide groove 124.

[0067] The communication hole, the first flow guide groove 123 and the second flow guide groove 124 can be formed by laser engraving or other processing methods.

[0068] It should be noted that, although the first part 21 is described as being on the proximal side of the middle part 22 and the second part 23 is described as being on the distal side of the middle part 22, the first part 21 can also be on the distal side of the middle part 22 and the second part 23 can be on the proximal side of the middle part 22, and correspondingly, the first segment 11 can be on the distal side of the middle segment 12 and the second segment 13 can be on the proximal side of the middle segment 12. In addition, although the terms such as diameter and radial direction are used in many places, the corresponding components in the present application are not limited to being circular or cylindrical.

[0069] With reference to the foregoing description, Figure 6 The balloon catheter further comprises a three-way tail seat 3 and a stress dispersion tube 4, and the proximal end of the balloon connecting tube 1 and the inner tube 5 are connected to the three-way tail seat 3 through the stress dispersion tube 4. Specifically, the three-way tail seat 3, the inner tube 5 and the connecting tube 1 can be connected by glue or welding. By adding the stress dispersion tube 4, the stress generated by rotating the balloon catheter can be buffered by the stress dispersion tube 4, so as to ensure that the balloon catheter does not affect the function of the catheter in actual use. Further, the part of the inner tube 5 on which the inflatable balloon 2 is connected has a developing structure, so as to facilitate the operator to position the inflatable balloon 2.

[0070] The present application also provides an interventional medical device, which can be an interventional medical device for expanding plaque (embolus) through the balloon connecting tube 1, such as directly expanding the blood vessel through the inflatable balloon 2, or rotating and grinding the plaque in the blood vessel by adding a rotating and grinding structure at the inflatable balloon 2; the medical device can also be an interventional medical device for delivering an artificial stent (such as a heart valve) through the balloon connecting tube 1, and the device comprises the balloon catheter of any one of the foregoing embodiments.

[0071] The inner tube 5 is arranged in the balloon connecting tube 1, and the present application controls the deflation process of the inflatable balloon 2 through the position of the communication hole, so as to avoid the situation that the communication hole is blocked during the extraction of the inflation medium, and ensure that the inflatable balloon 2 can return to the folded state before use.

[0072] It should be noted that the "circumferential direction" mentioned above refers to the circumferential direction of the balloon connecting tube 1 (i.e. the middle segment 12), and the "axial direction" refers to the axial direction of the balloon connecting tube 1 (i.e. the middle segment 12); the plurality of communication holes at the same position in the circumferential direction means that the centers of these communication holes are coincident in the axial projection of the balloon connecting tube 1, i.e. all located at the same position of the projection circumference, such as Figure 2The two second holes 122 shown in the middle are two communicating holes at the same circumferential position; communicating holes at the same axial position means that the centers of the communicating holes are located at the same point if they are projected onto the axis of the balloon connecting tube 1, for example Figure 4 The two second holes 122 at the leftmost end belong to two communicating holes at the same axial position, and the two second holes 122 at the rightmost end belong to two communicating holes at the same axial position, but the communicating holes at the leftmost end and the rightmost end are obviously not at the same axial position.

[0073] Those skilled in the art can understand that the above-mentioned preferred schemes can be freely combined and superimposed without conflict.

[0074] It should be understood that the above embodiments are only exemplary and not limiting, and various obvious or equivalent modifications or replacements of the above details can be made by those skilled in the art without departing from the essential principles of the present application, and all shall be included in the scope of the claims of the present application.

Claims

1. A balloon catheter for use in an interventional medical device, characterized by, The balloon catheter comprises a balloon connecting tube, an inner tube and an inflatable balloon, the inner tube is sleeved in the balloon connecting tube; the inflatable balloon is arranged at the distal end region of the balloon connecting tube, and the two ends of the inflatable balloon are respectively in sealed connection with the balloon connecting tube; the inflatable balloon comprises a first part, an intermediate part and a second part arranged in sequence along the axial direction of the balloon connecting tube; the inflatable balloon has an unfolded state and a folded state; in the unfolded state, the first part and the second part are in a conical structure, and the intermediate part is in a columnar structure; The balloon connecting tube is a hollow structure, and the section of the balloon connecting tube located inside the inflatable balloon comprises a first section, an intermediate section and a second section arranged in sequence; in the radial direction of the balloon connecting tube, the first section corresponds to the first part, the intermediate section corresponds to the intermediate part, and the second section corresponds to the second part; The intermediate section is provided with at least one communication hole, the communication hole penetrates the side wall of the balloon connecting tube, and is a strip-shaped hole extending along the axial direction of the balloon connecting tube, At least one of the at least one communication hole is a first hole, and the two ends of the first hole extend to at least the first joint between the intermediate section and the first section and the second joint between the intermediate section and the second section respectively; the length of the first hole is equal to the length of the intermediate section.

2. The balloon catheter of claim 1, wherein, The intermediate section is provided with a plurality of first holes.

3. The balloon catheter of claim 2, wherein, At least one of the at least one communication hole is a second hole; the second hole is arranged at at least one of the first joint and the second joint, one end of the second hole is located at the joint where the second hole is located, and the other end of the second hole is spaced apart from the other joint.

4. The balloon catheter of claim 3, wherein, The intermediate section is provided with a plurality of communication holes, at least part of the plurality of communication holes are second holes, and the plurality of second holes form at least one hole group; in the same hole group, the plurality of second holes are located at the same position in the circumferential direction and are arranged at intervals in the axial direction, and two of the second holes are located at the first joint and the second joint respectively.

5. The balloon catheter of claim 4, wherein, Each hole group comprises two second holes.

6. The balloon catheter of claim 4, wherein, The intermediate section is provided with a plurality of hole groups, and the plurality of hole groups are uniformly distributed along the circumferential direction of the intermediate section.

7. The balloon catheter of claim 4, wherein, A first flow guide groove is further arranged on the outer wall of the intermediate section, and the first flow guide groove extends along the axial direction; adjacent two second holes in the same hole group are communicated through the first flow guide groove.

8. The balloon catheter of any of claims 1-7, wherein, The intermediate section is provided with a plurality of communication holes in the circumferential direction; A second flow guide groove is further arranged on the outer wall of the intermediate section, and the second flow guide groove extends in the circumferential direction; adjacent two communication holes in the circumferential direction are communicated through the second flow guide groove.

9. The balloon catheter of any of claims 1-7, wherein, The intermediate section is provided with the communication holes at 2-8 positions in the circumferential direction, the size of the communication holes in the circumferential direction is 0.1-0.7 mm, and the greater the number of the communication holes in the circumferential direction, the smaller the size.

10. The balloon catheter of any of claims 1-9, wherein, The communication hole comprises at least one of an elliptical hole and a waist-shaped hole.

11. An interventional medical device, characterized by The balloon catheter comprises the balloon catheter according to any one of claims 1-10.

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