Hemostatic balloon catheter system

Abstract

The present invention relates to a hemostatic balloon catheter system, comprising a first tube, a second tube, a balloon, and a support member, wherein a lumen is formed between the first and second tubes; the balloon is eccentrically arranged at the distal end of the second tube and forms a channel with two open ends between the balloon and the distal end, the balloon having a balloon cavity connected to the lumen and a plurality of drug injection paths on its upper surface; the support member is arranged in the channel and has a supporting state of arching outward and an initial state of resetting inward, when the support member is in the supporting state, the support member drives the balloon to arch outward, one end of the support member is movably arranged on the second tube and can slide controllably relative to the second tube so that the support member can switch between the initial state and the supporting state. The system drives the balloon to arch outward through the support member, so that the balloon can contact the damaged part of the blood vessel, and can achieve precise penetration of the drug, while ensuring the normal circulation of blood during the hemostasis process, reducing the risk of postoperative complications.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a hemostatic sac catheter system. Background Art

[0002] Existing vascular interventional treatment devices, such as balloon dilatation catheters and stents, typically achieve their therapeutic purpose by directly dilating blood vessels. However, during vascular rupture or postoperative hemostasis, the hemostatic function of traditional catheters is relatively limited, especially when drug release and pressure cannot be controlled, which can easily cause incomplete hemostasis or secondary damage. In addition, existing catheters may affect blood flow during the hemostasis process, leading to blood clot formation and increasing the risk of postoperative complications. Therefore, the development of a catheter that can accurately control pressure and drug release during hemostasis and ensure normal blood flow is of great clinical significance. Summary of the Invention

[0003] The purpose of the present invention is to provide a hemostatic balloon catheter system, which can accurately control pressure and drug release during the hemostatic process and ensure normal blood flow.

[0004] In order to achieve the above object, the technical solution adopted by the present invention is:

[0005] A hemostatic balloon catheter system, comprising:

[0006] a first pipe fitting;

[0007] a second tube, the second tube being sleeved on the outside of the first tube and forming a tubular cavity with a closed distal end between the second tube and the first tube;

[0008] a sac, the sac being eccentrically disposed at the distal end of the second tube and forming a channel with both distal and proximal ends open therebetween, the sac having a sac cavity communicating with the tube lumen and having a plurality of injection paths on its upper surface connecting the sac cavity with the outside;

[0009] A support member is arranged in the channel and has a supporting state of arching outward and an initial state of resetting inward. When the support member is in the supporting state, the support member drives the bag to arch outward and allows blood to pass through the channel. One end of the support member is movably arranged on the second tube member and can slide controllably relative to the second tube member to enable the support member to switch between the initial state and the supporting state.

[0010] Preferably, the capsule body includes an inner capsule wall and an outer capsule wall connected to the second tube at both ends. The outer capsule wall is located outside the inner capsule wall and forms the capsule cavity between it and the inner capsule wall. A through groove for connecting the capsule cavity and the tube cavity is provided on the second tube between the inner capsule wall and the outer capsule wall.

[0011] Preferably, the outer capsule wall has a permeable area located on the upper side and non-permeable areas located on both sides of the permeable area, and the drug injection path is arranged on the permeable area.

[0012] Preferably, the permeation area includes a first permeation layer and a second permeation layer sequentially arranged from the inside out, the first permeation layer is a gel membrane layer formed by cross-linking a polymer and having pores, and the second permeation layer is a polymer membrane layer with a plurality of micropores formed thereon.

[0013] Further preferably, the micropore diameter of the second permeable layer is larger than the pore diameter of the first permeable layer.

[0014] Preferably, the impermeable region is an impermeable polymer film layer.

[0015] Preferably, the outer capsule wall is an impermeable polymer film layer.

[0016] In some embodiments, the gel film layer is polyvinyl alcohol.

[0017] In some embodiments, the polymer film layer is polyurethane.

[0018] Preferably, the vertical cross-section of the capsule is arc-shaped.

[0019] Preferably, the support member has a mesh structure.

[0020] Preferably, the support member is made of metal or a metal alloy.

[0021] In some embodiments, the support member is made of nickel-titanium alloy.

[0022] Preferably, the proximal end and the distal end of the support member extend out of the capsule respectively, the distal end of the support member is fixed, and the proximal end is movable.

[0023] Preferably, the support member has a larger width in the middle and smaller widths at both ends.

[0024] Preferably, the hemostatic sac catheter system also includes a driving mechanism configured to drive the support member to move, the driving mechanism including a shell connected to the proximal end of the second tube member, a transmission member movably arranged between the shell and the second tube member and distally connected to one end of the support member, and a driving assembly arranged on the shell and configured to control the movement of the transmission member. Controlled by the driving assembly, the transmission member can cause the support member to slide relative to the second tube member.

[0025] In some embodiments, the transmission member includes a third tube member and a fourth tube member that are sleeved on the outside of the second tube member, the third tube member is connected to the support member, the fourth tube member is located at the proximal end of the third tube member and is spirally connected to the outer shell, and is controlled by the drive assembly. The fourth tube member can rotate around the axis and slide along its axial direction with the third tube member.

[0026] In some embodiments, the drive assembly includes a drive wheel threadedly connected to the transmission member, a rod member connected to the drive wheel at one end, an operating part rotatably provided on the housing, and a transmission wheel group provided between the operating part and the rod member. The operating part is rotated, and the operating part drives the transmission wheel group to rotate with the rod member, thereby driving the drive wheel to move with the transmission member.

[0027] Due to the application of the above technical solution, the present invention has the following advantages compared with the prior art:

[0028] The hemostatic sac catheter system of the present invention drives the sac to arch outward through the support member, so that the sac can contact the damaged part of the blood vessel. The contact pressure between the sac and the damaged part of the blood vessel can be adjusted by further controlling the degree of outward arching of the support member. By injecting drugs into the lumen, the drugs can flow into the sac cavity and flow out to the damaged part of the blood vessel through the injection path, thereby achieving precise penetration of the drugs. At the same time, the hemostatic sac catheter system can ensure the normal circulation of blood during the hemostasis process, achieve a rapid and effective hemostatic effect without affecting blood flow, and reduce the risk of postoperative complications. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.

[0030] Figure 1 This is a schematic structural diagram of the hemostatic balloon catheter system of Example 1;

[0031] Figure 2 This is a schematic structural diagram of the distal end portion of the hemostatic balloon catheter system of Example 1;

[0032] Figure 3 This is a structural exploded view of the distal end portion of the hemostatic balloon catheter system of Example 1;

[0033] Figure 4 is a cross-sectional view of the distal end portion of the hemostatic balloon catheter system of Example 1;

[0034] Figure 5 This is a schematic structural diagram of the capsule of Example 1;

[0035] Figure 6 is a top view of the capsule of Example 1;

[0036] Figure 7 for Figure 6 Sectional view of the AA plane;

[0037] Figure 8 This is a schematic structural diagram of the capsule of Example 1 from another angle;

[0038] Figure 9 for Figure 8 Cross-sectional view of the middle BB surface;

[0039] Figure 10 This is an exploded view of the structure of the capsule of Example 1;

[0040] Figure 11 This is a schematic structural diagram of the support member of Example 1;

[0041] Figure 12 is a top view of the support member of Example 1;

[0042] Figure 13 This is a structural schematic diagram of the support member of Example 1 from another angle;

[0043] Figure 14 This is a schematic structural diagram of the proximal portion of the hemostatic balloon catheter system of Example 1;

[0044] Figure 15 is a cross-sectional view of the proximal portion of the hemostatic balloon catheter system of Example 1;

[0045] Figure 16 This is a physical picture of the distal end portion of the hemostatic balloon catheter system of Example 1;

[0046] Wherein: 1, catheter; 11, first pipe; 12, second pipe; 121, through groove; 13, lumen; 14, fixed end;

[0047] 2. Capsule body; 21. Inner capsule wall; 22. Outer capsule wall; 221. Permeable region; 2211. First permeable layer; 2212. Second permeable layer; 2213. Micropores; 222. Non-permeable region; 23. Capsule cavity;

[0048] 3. Channel;

[0049] 4. Support member; 41. Support body; 42. Distal support ring; 43. Proximal support ring;

[0050] 5. Driving mechanism; 51. Housing; 511. Drug injection cavity; 512. Guide wire cavity; 52. Third pipe; 53. Fourth pipe; 54. Driving wheel; 55. Rod; 56. First gear; 57. Second gear; 58. Operating unit. DETAILED DESCRIPTION

[0051] Hereinafter, only certain exemplary embodiments are briefly described. As will be appreciated by those skilled in the art, the described embodiments may be modified in various ways without departing from the spirit or scope of the embodiments of the present invention. Therefore, the drawings and description are to be regarded as illustrative in nature and not restrictive.

[0052] In describing the embodiments of the present invention, it should be understood that the terms "distal" and "proximal" and other terms indicating positions or relationships are defined based on the orientation of the hemostatic balloon catheter system during use, with the side closest to the operator being the proximal end and the side away from the operator being the distal end. These terms are used solely for the purpose of facilitating the description of the embodiments of the present invention and simplifying the description. They do not indicate or imply that the devices or components referred to must have, be constructed, or operate in a specific orientation, and are therefore not to be construed as limiting the embodiments of the present invention.

[0053] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be understood to indicate or imply relative importance or implicitly specify the number of the technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of the embodiments of the present invention, "plurality" means two or more, unless otherwise specifically defined.

[0054] In the embodiments of the present invention, unless otherwise expressly specified or limited, a first feature being "above" or "below" a second feature may include the first and second features being in direct contact, or may include the first and second features being in contact not directly but through another feature between them. Moreover, a first feature being "above," "above," and "above" a second feature includes the first feature being directly above and obliquely above the second feature, or simply indicates that the first feature is higher in level than the second feature. A first feature being "below," "below," and "below" a second feature includes the first feature being directly below and obliquely below the second feature, or simply indicates that the first feature is lower in level than the second feature.

[0055] The disclosure below provides many different embodiments or examples for implementing different structures of the embodiments of the present invention. In order to simplify the disclosure of the embodiments of the present invention, the components and configurations of specific examples are described below. Of course, these are merely examples and are not intended to limit the embodiments of the present invention. In addition, the embodiments of the present invention may repeat reference numerals and / or reference letters in different examples. Such repetition is for the purpose of simplicity and clarity and does not in itself indicate the relationship between the various embodiments and / or configurations discussed.

[0056] The embodiments of the present invention are described in detail below with reference to the accompanying drawings.

[0057] Example 1

[0058] A hemostatic balloon catheter system, such as Figures 1 to 16 As shown, it includes a catheter 1, a balloon 2 and a support 4.

[0059] The catheter 1 comprises an elongated first tubular member 11 and a second tubular member 12. The second tubular member 12 is sleeved around the first tubular member 11 and is preferably coaxial with the first tubular member 11. A lumen 13 is formed between the second tubular member 12 and the first tubular member 11. The distal end of the lumen 13 is sealed, and the proximal end has an injection port through which a hemostatic drug can be injected into the lumen 13. Such drugs, such as tranexamic acid (TXA), can inhibit fibrinolysis and help stabilize blood clots at sites of vascular injury.

[0060] See also Figures 1 to 3 The capsule 2 is eccentrically arranged at the distal end of the second tube 12 and forms a channel 3 with the distal end of the second tube 12. The distal and proximal ends of the channel 3 are open, thereby allowing blood to pass through without affecting the normal flow of blood. Preferably, the cross-section of the capsule 2 in the vertical direction is arc-shaped and its two ends are respectively connected to the two sides of the distal end of the second tube 12, and the capsule 2 has a certain length in the horizontal direction. The capsule 2 has a capsule cavity 23 connected to the lumen 13. The upper surface of the capsule 2 is provided with a plurality of injection paths connecting the capsule cavity 23 with the outside world, and the lower surface is not provided with an injection path, so that the drug only flows out from the upper surface and acts on the damaged part of the blood vessel in contact with it, without leaking from the lower surface, and the drug delivery is more accurate.

[0061] Specifically, see Figures 4 to 10 The capsule body 2 includes an inner capsule wall 21, an outer capsule wall 22, and a capsule cavity 23 formed between the inner capsule wall 21 and the outer capsule wall 22. In order to achieve the connection between the capsule cavity 23 and the tubular cavity 13, a through groove 121 connecting the two can be opened on the second tube member 12 between the inner capsule wall 21 and the outer capsule wall 22. The outer capsule wall 22 is located on the outside of the inner capsule wall 21 and has an injection path thereon, while the inner capsule wall 21 does not have an injection path to prevent drug leakage. The injection path can be composed of micropores 2213 opened on the outer capsule wall 22 and / or pores formed on the outer capsule wall 22. As a preferred example, a large number of micropores 2213 can be formed by punching holes in a polymer film; by controlling the degree of cross-linking of the polymer, a film with pores can be formed, and the drug can seep out through the pores.

[0062] In this embodiment, the outer capsule wall 22 includes a permeable region 221 located on the upper side and non-permeable regions 222 located on either side of the permeable region 221. The drug injection path is provided on the permeable region 221. Specifically, the permeable region 221 comprises a first permeable layer 2211 and a second permeable layer 2212, arranged sequentially from the inside out. The first permeable layer 2211 is a porous gel membrane layer formed by cross-linking a polymer, preferably a polyvinyl alcohol (PVA) hydrogel membrane. The second permeable layer 2212 is a polymer membrane layer with a plurality of micropores 2213, preferably a polyurethane (PU) membrane layer. The micropores 2213 in the second permeable layer 2212 have a larger pore size than those in the first permeable layer 2211, ensuring that the drug can penetrate the permeable region 221 via a concentration gradient. The outer capsule wall 22 is prepared by forming a thin and flexible capsule wall structure through a blow molding process. After a large number of micropores 2213 are formed in the capsule wall where the permeable region 221 is located, a PVA hydrogel membrane is coated on the inside to form the outer capsule wall 22. The inner capsule wall 21 is preferably an impermeable polymer film, such as a PU film layer.

[0063] Since the capsule 2 is flexible, has little supporting force and is difficult to adhere to the blood vessel wall, it is difficult to accurately deliver the drug from the capsule 2 to the damaged blood vessel. The inventors set a support member 4 between the capsule 2 and the second tube 12. The support member 4 supports the capsule 2, which enables the capsule 2 to adhere to the damaged blood vessel and achieves accurate drug delivery of the capsule 2. Specifically, the support member 4 is set in the channel 3 and has a supporting state of arching outward and an initial state of resetting inward. When the support member 4 is in the supporting state, the support member 4 drives the capsule 2 to arch outward and allows blood to pass through the channel 3. One end of the support member 4 is movably set on the second tube 12 and can slide controllably relative to the second tube 12 so that the support member 4 can switch between the initial state and the supporting state.

[0064] Further, see Figures 11 to 13The support member 4 comprises a support body 41 and distal support rings 42 and proximal support rings 43 located on either side of the support body 41. The support body 41 has a mesh structure that allows blood to pass through during hemostasis and filters blood clots caused by vascular damage, preventing blood flow obstruction. Preferably, the support body 41 is wide in the middle and narrow at both ends. Each end extends beyond the capsule 2 and connects to the distal support ring 42 and proximal support ring 43, respectively. The distal support ring 42 and proximal support ring 43 are movably mounted on the outside of the second tubular member 12. When one of the support rings approaches the other, the support body 41 arches upward and drives the capsule 2 to arch upward. By adjusting the height of the arch, the contact area and contact pressure between the capsule 2 and the vessel wall can be adjusted. The support body 41 is made of metal or a metal alloy, preferably nickel-titanium alloy. Nickel-titanium alloy has strength, toughness, and developability, making it suitable for supporting the capsule 2 when shape memory function is not required. The material of the distal support ring 42 and the proximal support ring 43 is the same as that of the support body 41 or can also be a conventional material in the art, which is not limited in this application.

[0065] The hemostatic balloon catheter system further comprises a driving mechanism 5 configured to drive the support member 4 to move. Figure 14 and Figure 15 As shown, the drive mechanism 5 includes a housing 51, a transmission member, and a drive assembly. The housing 51 is connected to the proximal end of the second tubular member 12 and is provided with a drug injection channel 511 communicating with the tubular cavity 13 and a guidewire channel 512 communicating with the first tubular member 11. The transmission member is movably disposed between the housing 51 and the second tubular member 12, with its proximal end connected to the housing 51 and its distal end connected to the proximal support ring 43 of the support member 4. Controlled by the drive assembly, the transmission member can slide with the proximal support ring 43 relative to the second tubular member 12, at which point the distal support ring 42 abuts against the fixed end 14 connected to the distal end of the second tubular member 12, and the support body 41 tends to arch outward.

[0066] Furthermore, the transmission member includes a third tube member 52 and a fourth tube member 53 that are sleeved on the outside of the second tube member 12. The third tube member 52 is connected to the proximal support ring 43 of the support member 4. The fourth tube member 53 is located at the proximal end of the third tube member 52 and is screwed to the housing 51. Controlled by the drive assembly, the fourth tube member 53 can rotate about the axis and slide along the axial direction of the third tube member 52. The drive assembly includes a drive wheel 54 threadedly connected to the fourth tube member 53, a rod member 55 with one end connected to the drive wheel 54, an operating portion 58 rotatably disposed on the housing 51, and a transmission wheel assembly disposed between the operating portion 58 and the rod member 55. The transmission wheel assembly includes a first gear 56 fixedly connected to the other end of the rod member 55 and a second gear 57 meshed between the operating portion 58 and the first gear 56. The second gear 57 has a plurality of gears disposed around the outer circumference of the first gear 56. Rotate the operating part 58, and the operating part 58 drives the second gear 57 to rotate with the first gear 56. The first gear 56 rotates and drives the rod 55 and the driving wheel 54 to rotate. The driving wheel 54 rotates to drive the fourth rod 55 to rotate and drives the third rod 55 to slide along the axial direction of the fourth rod 55, thereby switching the support member 4 from the initial state to the supporting state or from the supporting state to the initial state.

[0067] Working principle:

[0068] The distal end of the hemostatic balloon catheter system is placed at the target position, and then the operating part 58 is rotated. The operating part 58 drives the second gear 57 to rotate with the first gear 56, the rod 55 and the driving wheel 54. When the driving wheel 54 rotates, it drives the fourth tube 53 to rotate and slides the third tube 52 toward the distal end, thereby driving the proximal end of the support member 4 (i.e., the proximal support ring 43) to slide toward the distal end. The support body 41 has a tendency to arch outward and switches from the initial state to the supporting state. The support member 4 drives the balloon 2 to arch outward and align with the damaged blood vessel at the target position. The sliding distance of the proximal end of the support member 4 can be controlled by rotating the operating portion 58, thereby being able to adjust the contact area and contact pressure between the capsule 2 and the damaged blood vessel. After the adjustment is completed, the drug is introduced into the lumen 13 through the drug injection cavity 511, and the drug flows into the capsule cavity 23 through the lumen 13, and enters the damaged blood vessel through the drug injection path of the penetration area 221, thereby playing a role in hemostasis and drug treatment. At the same time, the mesh main structure of the support member 4 allows blood to filter blood clots caused by blood vessel damage during the hemostasis process to prevent blood flow obstruction.

[0069] After hemostasis is completed, the operating portion 58 is rotated in the reverse direction to switch the support member 4 from the supporting state to the initial state of inward reset, and the catheter 1 can be withdrawn.

[0070] The above embodiments are intended only to illustrate the technical concepts and features of the present invention. Their purpose is to enable those skilled in the art to understand the contents of the present invention and implement them accordingly. They are not intended to limit the scope of protection of the present invention. Any equivalent changes or modifications made in accordance with the spirit of the present invention are intended to be covered by the scope of protection of the present invention.

Claims

1. A hemostatic balloon catheter system, characterized in that: The hemostatic balloon catheter system comprises: a first pipe member (11); a second tube (12), the second tube (12) being sleeved on the outside of the first tube (11) and forming a distally closed tube cavity (13) between the second tube (12) and the first tube (11); A sac (2), the sac (2) being eccentrically arranged at the distal end of the second tube (12) and forming a channel (3) with both distal and proximal ends open between the sac and the distal end of the second tube (12), the sac (2) having a sac cavity (23) communicating with the tube cavity (13) and having a plurality of injection paths on its upper surface for connecting the sac cavity (23) with the outside; A support member (4) is provided in the channel (3) and has a supporting state of arching outward and an initial state of resetting inward. When the support member (4) is in the supporting state, the support member (4) drives the sac (2) to arch outward and allows blood to pass through the channel (3). One end of the support member (4) is movably provided on the second tube member (12) and controllably slides relative to the second tube member (12) so that the support member (4) can switch between the initial state and the supporting state.

2. The hemostatic balloon catheter system according to claim 1, characterized in that: The sac body (2) comprises an inner sac wall (21) and an outer sac wall (22) connected to the second tube member (12) at both ends; the outer sac wall (22) is located outside the inner sac wall (21) and forms the sac cavity (23) between the outer sac wall (22) and the inner sac wall (21); and a through groove (121) for connecting the sac cavity (23) with the tube cavity (13) is provided on the second tube member (12) between the inner sac wall (21) and the outer sac wall (22).

3. The hemostatic balloon catheter system according to claim 2, characterized in that: The outer capsule wall (22) has a permeable area (221) located on the upper side and non-permeable areas (222) located on both sides of the permeable area (221), and the drug injection path is arranged on the permeable area (221).

4. The hemostatic balloon catheter system according to claim 3, characterized in that: The permeable region (221) comprises a first permeable layer (2211) and a second permeable layer (2212) arranged sequentially from the inside out, wherein the first permeable layer (2211) is a gel membrane layer formed by cross-linking a polymer and having pores, and the second permeable layer (2212) is a polymer membrane layer with a plurality of micropores (2213) formed thereon; The impermeable region (222) is an impermeable polymer film layer.

5. The hemostatic balloon catheter system according to claim 2, characterized in that: The outer capsule wall (22) is an impermeable polymer film layer.

6. The hemostatic balloon catheter system according to claim 1, characterized in that: The cross section of the capsule (2) in the vertical direction is arc-shaped.

7. The hemostatic balloon catheter system according to claim 1, characterized in that: The support member (4) has a mesh structure; And / or, the support member (4) is made of metal or metal alloy.

8. The hemostatic balloon catheter system according to claim 1, characterized in that: The proximal end and the distal end of the support member (4) respectively extend out of the capsule (2); the distal end of the support member (4) is fixed, and the proximal end is movable.

9. The hemostatic balloon catheter system according to claim 1, characterized in that: The support member (4) has a large width in the middle and small widths at both ends.

10. The hemostatic balloon catheter system according to claim 1, characterized in that: The hemostatic sac catheter system also includes a driving mechanism (5) configured to drive the support member (4) to move, and the driving mechanism (5) includes a shell (51) connected to the proximal end of the second tube member (12), a transmission member movably arranged between the shell (51) and the second tube member (12) and distally connected to one end of the support member (4), and a driving component arranged on the shell (51) and configured to control the movement of the transmission member. Under the control of the driving component, the transmission member can slide with the support member (4) relative to the second tube member (12).

11. The hemostatic balloon catheter system according to claim 10, characterized in that: The transmission member includes a third tube member (52) and a fourth tube member (53) which are sleeved on the outside of the second tube member (12); the third tube member (52) is connected to the support member (4); the fourth tube member (53) is located at the proximal end of the third tube member (52) and is spirally connected to the outer shell (51). Controlled by the drive assembly, the fourth tube member (53) can rotate around the axis and slide along the axial direction of the third tube member (52).

12. The hemostatic balloon catheter system according to claim 10, characterized in that: The driving assembly comprises a driving wheel (54) threadedly connected to a transmission member, a rod (55) one end of which is connected to the driving wheel (54), an operating portion (58) rotatably arranged on the housing (51), and a transmission wheel set arranged between the operating portion (58) and the rod (55). When the operating portion (58) is rotated, the operating portion (58) drives the transmission wheel set to rotate with the rod (55), thereby driving the driving wheel (54) to move with the transmission member.

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