Balloon catheter

Abstract

The utility model relates to the field of interventional medical instruments, in particular to a balloon catheter which comprises a catheter part, a balloon and a catheter seat, and the catheter part comprises a first catheter part and a second catheter part; the first pipe fitting comprises an inner pipe body, an outer pipe body and a partition plate body, the inner pipe body and the outer pipe body are arranged in an inner-outer nested mode, and the partition plate body is divided into at least two independent special-shaped cavities between the inner pipe body and the outer pipe body to serve as a balloon filling cavity and a balloon filling cavity respectively. A perfusion hole communicated with the perfusion cavity to the outside is formed in the outer tube body, and a tube cavity of the second tube is communicated with an inner cavity of the inner tube body in a sealed mode to form a guide wire cavity penetrating through the catheter piece; pins at two ends of the balloon are hermetically fixed outside the catheter piece; the near end of the first pipe fitting is inserted into and fixed to the catheter base, and the guide wire cavity, the balloon filling cavity and the perfusion cavity are communicated with a guide wire inlet, a balloon filling opening and a perfusion opening of the catheter base respectively. Due to the structure of the balloon catheter, the guide wire does not need to be withdrawn before the contrast agent is infused, and the operation time is short.

Description

Technical Field

[0001] This application relates to the field of interventional medical devices, and particularly to a balloon catheter. Background Art

[0002] During an interventional operation, after the balloon catheter dilates the diseased blood vessel in place, it is often necessary to infuse a contrast agent into the blood vessel to confirm the effect after blood vessel dilation through angiography. However, before infusing the contrast agent, it is necessary to first withdraw the balloon catheter, and then infuse the contrast agent through a guiding catheter. Since this method involves exchange operation steps such as withdrawing the balloon catheter and inserting the guiding catheter, the operation time is prolonged.

[0003] To improve this problem, in related prior arts, the infusion of the contrast agent is realized in the balloon catheter to eliminate the operations of withdrawing the balloon catheter and inserting the guiding catheter. However, in such balloon catheter structures, in order to avoid interference between the contrast agent and the fluid medium used to fill the balloon, usually the guide wire lumen also serves as the infusion lumen for the contrast agent.

[0004] During angiography in the blood vessel, it is necessary to ensure the infusion rate of the contrast agent to avoid dilution of the contrast agent by the blood. However, the guide wire lumen itself has a small space, and the guide wire also occupies a certain space. Therefore, at least the guide wire needs to be withdrawn before infusing the contrast agent to create enough space in the guide wire lumen to ensure the infusion rate of the contrast agent.

[0005] Although this type of balloon catheter does not need to be withdrawn as a whole before angiography, still the withdrawal action of the guide wire cannot be eliminated, so there is still a problem of prolonged operation time. Utility Model Content

[0006] This application provides a balloon catheter, and the structure of this balloon catheter enables the guide wire not to be withdrawn before infusing the contrast agent, and the operation time is shorter.

[0007] To achieve the above object, the present application provides a balloon catheter, which includes a catheter member, a balloon, and a catheter hub, wherein: the catheter member includes a first pipe member and a second pipe member fixedly provided at the distal end of the first pipe member; the first pipe member includes an inner pipe body and an outer pipe body which are nested inside and outside, and a partition plate body connected between the inner pipe body and the outer pipe body, and the partition plate body circumferentially divides the annular region between the inner pipe body and the outer pipe body into at least two independent special-shaped cavities, respectively serving as a balloon inflation cavity and an irrigation cavity, and the special-shaped cavity serving as the irrigation cavity is blocked at the distal end of the first pipe member; an irrigation hole communicating the irrigation cavity to the outside is provided on the outer pipe body, and the lumen of the second pipe member is hermetically connected to the inner cavity of the inner pipe body to form a guide wire cavity penetrating the catheter member; the pins at both ends of the balloon are hermetically fixed outside the catheter member, and the balloon cavity formed therein communicates with the balloon inflation cavity; the proximal end of the first pipe member is inserted into and fixed to the catheter hub, and the guide wire cavity, the balloon inflation cavity, and the irrigation cavity are respectively communicated to the guide wire inlet, the balloon inflation port, and the irrigation port of the catheter hub.

[0008] According to some embodiments of the present application, the partition plate body is provided with three, and the three partition plate bodies are evenly arranged in the annular region along the circumferential direction, and a communication hole is provided on one of the partition plate bodies to communicate two adjacent special-shaped cavities and serve as the irrigation cavity, and another special-shaped cavity serves as the balloon inflation cavity.

[0009] According to some embodiments of the present application, the inner pipe body, the outer pipe body, and the partition plate body are integrally formed.

[0010] According to some embodiments of the present application, a transition pipe section is provided on the distal side of the first pipe member, the hardness of the transition pipe section is greater than that of the other pipe sections of the first pipe member, and the irrigation hole is provided on the transition pipe section.

[0011] According to some embodiments of the present application, the wall thickness of the transition pipe section is greater than that of the other pipe sections of the first pipe member, or the transition pipe section is separately provided from the other pipe sections of the first pipe member and fixed to each other, and the hardness of the pipe material of the transition pipe section is greater than that of the other pipe sections of the first pipe member.

[0012] According to some embodiments of the present application, the distance between the pin at the proximal end of the balloon and the sealed connection part of the catheter member and the irrigation hole is set to be 1 mm - 5 mm.

[0013] According to some embodiments of the present application, the pins at both ends of the balloon are respectively hermetically fixed outside the first pipe member and the second pipe member, and the balloon catheter further includes two radiopaque rings press-fitted and fixed on the outer periphery of the second pipe member.

[0014] According to some embodiments of the present application, the catheter seat includes a main seat body, and a first support body and a second support body arranged on the outer peripheral side of the main seat body, wherein: a main hole is formed in the main seat body and penetrates through the main seat body axially, the proximal end of the first pipe fitting is inserted and fixed from the far port of the main hole, and the near port of the main hole is set as the guide wire inlet; first through holes and second through holes penetrating through the first support body and the second support body are respectively formed in the first support body and the second support body; one end orifice of the first through hole communicates with the main hole, and the other end orifice is set as the perfusion port; and one end orifice of the second through hole communicates with the main hole, and the other end orifice is set as the balloon inflation port.

[0015] According to some embodiments of the present application, the first support body and the second support body are axially and circumferentially spaced and arranged at different positions of the main seat body.

[0016] According to some embodiments of the present application, the balloon catheter further includes a catheter reinforcing tube, the catheter reinforcing tube is sleeved outside the first pipe fitting, and its distal end is heat-shrunk or adhesively fixed on the outer peripheral wall of the first pipe fitting, and its proximal end is fixed on the main seat body.

[0017] The technical solutions provided by the embodiments of the present application may include the following beneficial effects:

[0018] In the first pipe fitting, through the inner pipe body, the outer pipe body and the partition plate body, the lumen in the inner pipe body can be used as the guide wire lumen, and the annular regions between the inner pipe bodies are further formed into mutually separated balloon inflation cavities and perfusion cavities through the partition plate body. In this way, the three cavities in the first pipe fitting are independent of each other and there is no sharing. Therefore, the contrast agent can enter the perfusion cavity through the perfusion port on the catheter seat and finally be output to the preset position through the perfusion holes. Before this infusion operation, it is not necessary to withdraw the entire balloon catheter or the guide wire. Therefore, the operation time is significantly shortened. Description of the Drawings

[0019] Figure 1 is a schematic diagram of the overall structure of the balloon catheter according to an embodiment of the present application;

[0020] Figure 2 is Figure 1 the sectional view of the balloon catheter shown in [reference number] along the A-A direction;

[0021] Figure 3 is a sectional view of the first pipe fitting at the opening of the perfusion hole;

[0022] Figure 4 is Figure 2 the enlarged view of part B of the sectional view shown in [reference number];

[0023] Figure 5 is Figure 2Enlarged view of part C of the sectional view shown;

[0024] Figure 6 is a schematic structural view of a catheter seat according to an embodiment of the present application.

[0025] Reference numerals: 100, catheter member; 11, first pipe member; 111, inner pipe body; 112, outer pipe body; 1121, perfusion hole; 113, partition plate body; 114, balloon inflation cavity; 115, perfusion cavity; 12, second pipe member; 13, guide wire cavity;

[0026] 200, balloon; 21, balloon chamber;

[0027] 300, catheter seat; 31, main seat body; 311, main pore; 312, guide wire inlet; 313, first glue injection hole; 314, second glue injection hole; 315, third glue injection hole; 32, first support body; 321, first support pore; 322, perfusion port; 33, second support body; 331, second support pore; 332, balloon inflation port;

[0028] 400, radiopaque ring; 500, catheter reinforcement tube. Detailed implementation manners

[0029] Here, the exemplary embodiments will be described in detail, and the examples are shown in the drawings. When the following description refers to the drawings, unless otherwise indicated, the same numbers in different drawings represent the same or similar elements. The manners described in the following exemplary embodiments do not represent all manners consistent with the present application, but are only the preferred embodiments of the present application. Those skilled in the art can make some changes or modifications to equivalent embodiments by using the above-disclosed technical content within the scope of the technical solution of the present application. However, any simple modification, equivalent change and modification made to the above embodiments based on the technical essence of the present application without departing from the content of the technical solution of the present application still fall within the scope of the technical solution of the present application.

[0030] In addition, in the description of the present application, the proximal end and the distal end are defined with reference to the position of the operator when using the balloon catheter. That is, the distal end refers to the end of the instrument or component that is relatively far from the operator, and the proximal end refers to the end of the instrument or component that is relatively close to the operator. In all the drawings of the present application, except Figure 3 In all other drawings, the right end side is the proximal end and the left end side is the distal end. The embodiments of the present application will be described in detail below with reference to the drawings.

[0031] As Figure 1As shown, a balloon catheter according to an embodiment of the present application includes a catheter member 100, a balloon 200, and a catheter hub 300. The pins at both ends of the balloon 200 are hermetically fixed outside the catheter member 100, and the proximal end of the catheter member 100 is inserted and fixed inside the catheter hub 300.

[0032] Based on Figure 1 in combination with Figure 2 and Figure 3 As shown, the catheter member 100 includes a first pipe member 11 and a second pipe member 12 fixed to the distal end of the first pipe member 11. Among them: the first pipe member 11 includes an inner tube body 111 and an outer tube body 112 that are nested inside and outside, and a partition plate body 113 connected between the inner tube body 111 and the outer tube body 112. The first pipe member 11 can be made of a polymer pipe material with better biocompatibility, such as PEBAX, PA, etc.

[0033] The annular region formed between the inner tube body 111 and the outer tube body 112 is circumferentially partitioned by the partition plate body 113 into at least two mutually different-shaped cavities, and the at least two different-shaped cavities are respectively used as a balloon inflation cavity 114 and a perfusion cavity 115. The balloon inflation cavity 114 communicates with the balloon chamber 21 inside the balloon 200 at the distal end of the first pipe member 11, so as to output the inflation medium for inflating the balloon 200 into the balloon chamber 21.

[0034] A perfusion hole 1121 communicating the perfusion cavity 115 to the outside is provided on the outer tube body 112, and the different-shaped cavity serving as the perfusion cavity 115 is blocked at the distal end of the first pipe member 11. In this way, the contrast agent in the perfusion cavity 115 will only be output to the outside of the first pipe member 11 through the perfusion hole 1121, and will not flow out from the distal end of the first pipe member 11 into the balloon chamber 21.

[0035] Based on Figure 3 in combination with Figure 4 As shown, in the state where the first pipe member 11 and the second pipe member 12 are connected, the inner cavity of the inner tube body 111 in the first pipe member 11 is hermetically communicated with the lumen of the second pipe member 12, so that a through wire cavity 13 is formed inside the entire catheter member 100. In this way, the guide wire can smoothly pass through the inside of the catheter member 100.

[0036] As Figure 4 shown, the pins at both ends of the balloon 200 are hermetically fixed outside the catheter member 100, and a balloon chamber 21 that is connected to the balloon inflation cavity 114 as mentioned above is formed inside. Further, in the illustrated embodiment, the pin at the proximal end of the balloon 200 is hermetically fixed to the outer peripheral side of the first pipe member 11, and the pin at its distal end is hermetically fixed to the outer peripheral side of the second pipe member 12.

[0037] Based on Figure 2 in combination with Figure 4As shown in , the balloon catheter further includes two developing rings 400 pressed and gripped on the outer circumference of the second tube 12 , and the spacing between the two developing rings 400 can be arranged at intervals according to the effective length of the balloon 200 .

[0038] The catheter seat 300 is provided with a guidewire inlet 312, an infusion port 322 and a balloon filling port 332, and the three ports are connected to the aforementioned guidewire cavity 13, the infusion cavity 115 and the balloon filling cavity 114. In this way, the guidewire passes through the guidewire inlet 312 into the balloon catheter and finally passes out from the distal end of the second tube 12; the expansion medium used to fill the balloon 200 flows into the balloon filling cavity 114 from the balloon filling port 332 and finally enters the balloon chamber 21; the contrast agent flows into the infusion cavity 115 from the infusion port 322 and finally flows out to the position in front of the balloon 200 through the infusion hole 1121, so as to achieve contrast in the blood vessel relatively close to the balloon 200, so that the operator can confirm the effect of the expansion of the diseased blood vessel where the balloon 200 is located through the image.

[0039] In the embodiment of the present application, the guidewire cavity 13 is formed inside the inner tube body 111 and the second tube 12, and the perfusion cavity 115 for accommodating the inflow of contrast agent is formed between the inner tube body 111 and the outer tube body 112. Therefore, the perfusion cavity 115 and the guidewire cavity 13 do not interfere with each other. After the balloon catheter is inserted into place to complete the expansion of the diseased blood vessel, neither the balloon catheter itself nor the guidewire in the guidewire cavity 13 need to be withdrawn, but the contrast agent can be directly injected into the blood vessel at a suitable speed through the perfusion cavity 115 and the perfusion hole 1121. The exchange action of extracting the guidewire or withdrawing the balloon catheter as a whole and replacing the guide catheter during the operation is avoided, so the overall time of the interventional surgery is shorter.

[0040] At the same time, when the contrast agent is discharged outward through the perfusion hole 1121, the balloon catheter does not need to be withdrawn or moved, and the position of the developing ring 400 and the distance between it and the perfusion hole 1121 can be accurately confirmed. Therefore, in this state, when perfusing the contrast agent into the blood vessel, the operator can use the developing ring 400 as a reference. Compared with the contrast agent injection scheme of withdrawing the balloon catheter as a whole and reinserting it into the guide catheter, the scheme in the present application can inject the contrast agent into the predetermined position more accurately.

[0041] like Figure 3 As shown in , in some embodiments, three partition plates 113 are provided, and the three partition plates 113 are evenly arranged in the annular region formed between the inner and outer tubes along the circumferential direction. In this way, the annular region is divided into three irregularly shaped cavities with approximately the same volume, one of which is used as the balloon filling cavity 114, and the other two irregularly shaped cavities are connected by opening holes on the partition plate 113, and the connected cavities are used as the perfusion cavity 115. In some embodiments, the inner tube 111, the outer tube 112 and the partition plate 113 are integrally formed.

[0042] The three circumferentially uniformly distributed partition bodies 113 make the cross-sectional shape of the first pipe fitting 11 tend to a centrosymmetric structure, which is beneficial to the manufacture of the first pipe fitting 11. For example, when integrally molding the inner pipe body 111, the outer pipe body 112 and the partition body 113 in the first pipe fitting 11 by means of injection molding or the like, the three circumferentially uniformly distributed partition bodies 113 can make the wall thicknesses of all parts of the whole pipe fitting tend to be uniform, so that the cooling rates at all parts inside the first pipe fitting 11 tend to be consistent, avoiding problems such as shrinkage holes and warping caused by too large wall thickness differences.

[0043] In addition, by connecting two of the special-shaped cavities through openings in the partition body 113 to form the perfusion cavity 115, the volume of the perfusion cavity 115 can be made large enough to ensure that the contrast agent can be output from the perfusion hole 1121 to a specified position in the blood vessel at a preset outflow rate.

[0044] At Figure 1 on the basis of combining Figure 3 as shown in

[0045] a perfusion hole 1121 communicating the perfusion cavity 115 to the outside is provided on the outer pipe body 112. The operation of opening the hole will inevitably cause a decrease in the local mechanical properties of the outer pipe body 112 and even the whole first pipe fitting 11. Therefore, the first pipe fitting 11 is prone to unexpected bending during transportation and use near the position where the perfusion hole 1121 is opened. To avoid this problem, a section of transition pipe section is provided at the distal end of the first pipe fitting 11, and the perfusion hole 1121 is opened on this transition pipe section, and the hardness of this transition pipe section is greater than that of the other pipe sections of the first pipe fitting 11.

[0046] In this way, by locally hardening the first pipe fitting 11, the influence of the opening of the perfusion hole 1121 on the local mechanical properties of the pipe fitting can be improved. In some embodiments, the local hardness of the first pipe fitting 11 can be increased by increasing the wall thickness of the transition pipe section or replacing the pipe material of the transition pipe section with a harder one and then connecting and fixing it to the other pipe sections of the first pipe fitting 11.

[0047] It can be understood that the transition pipe section provided on the first pipe fitting 11 does not necessarily clearly distinguish the boundary line between it and the other pipe sections of the first pipe fitting 11 from the appearance. For example, when manufacturing the first pipe fitting 11 by an injection molding process, it can be directly achieved by changing the injection molding material when molding the transition pipe section.

[0048] Further, in order to avoid the opening of the perfusion hole 1121 affecting the sealing performance of the balloon 200, the perfusion hole 1121 is opened at a position 1 mm - 5 mm away from the sealed connection part of the pin at the proximal end of the balloon 200 and the first pipe fitting 11.

[0049] As Figure 5 shown in the figure, the catheter seat 300 includes a main seat body 31, and a first support body 32 and a second support body 33 arranged on the outer peripheral side of the main seat body 31. Among them: a main hole 311 penetrating axially is opened on the main seat body 31. First branch holes 321 and second branch holes 331 are respectively opened on the first support body 32 and the second support body 33, and one end orifices of the first branch holes 321 and the second branch holes 331 are both communicated with the main hole 311, and the other end orifices of the two branch holes are respectively used as a perfusion port 322 and a balloon inflation port 332.

[0050] The first support body 32 and the second support body 33 are axially and circumferentially spaced and arranged at different positions of the main seat body 31. In the illustrated embodiment, the first support body 32 and the second support body 33 are circumferentially spaced about 180 degrees.

[0051] Combined with Figure 2 and Figure 5 shown in the figure, the balloon catheter further includes a catheter reinforcing tube 500, which is sleeved outside the catheter member 100, and its distal end is heat-shrunk or adhesively fixed on the outer peripheral wall of the first pipe fitting 11. The proximal end of the catheter reinforcing tube 500 is fixed on the main seat body 31. The arrangement of the catheter reinforcing tube 500 can reduce the stress concentration between the catheter member 100 and the catheter seat 300 and prevent the inner and outer catheters from being bent during packaging and use. In addition, the catheter reinforcing tube 500 can be made of a material with good biocompatibility such as polyolefin.

[0052] Combined with Figure 6 shown in the figure, in the direction from the distal end to the proximal end (i.e., Figure 6 the direction from left to right in the figure), first glue injection holes 313, second glue injection holes 314 and third glue injection holes 315 are successively opened on the main seat body 31. Among them: the first glue injection hole 313 is used for injecting glue to fix the first pipe fitting 11 and closing the gap of the balloon inflation cavity 114; the second glue injection hole 314 is used for fixing the first pipe fitting 11 and closing the gap between the balloon inflation cavity 114 and the perfusion cavity 115; the third glue injection hole 315 is used for injecting glue to fix the inner tube and closing the gap between the inner tube and the perfusion cavity 115. Correspondingly, the first pipe fitting 11 is opened at a position directly connected to the perfusion port 322 for communicating with the perfusion port 322; the first pipe fitting 11 is also provided with an opening at the position of the balloon inflation port 332 for communicating with the balloon inflation port 332.

Claims

1. A balloon catheter, characterized in that: The balloon catheter comprises a catheter component (100), a balloon (200) and a catheter seat (300), wherein: The catheter member (100) comprises a first pipe member (11) and a second pipe member (12) fixed to the distal end of the first pipe member (11); The first tube member (11) comprises an inner tube body (111) and an outer tube body (112) which are nested inside and outside, and a partition plate body (113) connected between the inner tube body (111) and the outer tube body (112), wherein the partition plate body (113) divides the annular region between the inner tube body (111) and the outer tube body (112) into at least two independent special-shaped cavities along the circumferential direction, respectively serving as a balloon filling cavity (114) and a perfusion cavity (115), and the special-shaped cavity serving as the perfusion cavity (115) is blocked at the distal end of the first tube member (11); The outer tube body (112) is provided with a perfusion hole (1121) connecting the perfusion cavity (115) to the outside, and the lumen of the second tube member (12) is sealed and connected to the inner cavity of the inner tube body (111) to form a guide wire cavity (13) passing through the catheter member (100); The pins at both ends of the balloon (200) are sealed and fixed outside the catheter (100), and the balloon chamber (21) formed therein is connected to the balloon filling chamber (114); The proximal end of the first tube (11) is inserted into and fixed to the catheter seat (300), and the guidewire cavity (13), the balloon filling cavity (114) and the perfusion cavity (115) are respectively connected to the guidewire inlet (312), the balloon filling port (332) and the perfusion port (322) of the catheter seat (300).

2. The balloon catheter according to claim 1, characterized in that: The number of the partition plate bodies (113) is three, and the three partition plate bodies (113) are evenly distributed in the annular area along the circumferential direction, and a connecting hole is opened on one of the partition plate bodies (113) to connect two adjacent special-shaped cavities and serve as the perfusion cavity (115), and the other special-shaped cavity serves as the balloon filling cavity (114).

3. The balloon catheter according to claim 1 or 2, characterized in that: The inner tube body (111), the outer tube body (112), and the partition plate body (113) are integrally formed.

4. The balloon catheter according to claim 1, characterized in that: A transition pipe section is provided on the distal end side of the first pipe member (11), the hardness of the transition pipe section is greater than the hardness of the remaining pipe sections of the first pipe member (11), and the perfusion hole (1121) is opened on the transition pipe section.

5. The balloon catheter according to claim 4, characterized in that: The wall thickness of the transition pipe section is greater than the wall thickness of the remaining pipe sections of the first pipe member (11), or, The transition pipe section and the remaining pipe sections of the first pipe fitting (11) are arranged separately and fixed to each other, and the pipe material hardness of the transition pipe section is greater than the pipe material hardness of the remaining pipe sections of the first pipe fitting (11).

6. The balloon catheter according to claim 1, characterized in that: The distance between the proximal tube pin of the balloon (200) and the sealed connection portion of the catheter member (100) and the perfusion hole (1121) is set to 1 mm-5 mm.

7. The balloon catheter according to claim 6, characterized in that: The pins at both ends of the balloon (200) are sealed and fixed to the outside of the first tube (11) and the second tube (12), respectively. The balloon catheter also includes two developing rings (400) that are fixed to the outer circumference of the second tube (12) by pressing and gripping.

8. The balloon catheter according to claim 1, characterized in that: The catheter seat (300) comprises a main seat body (31) and a first support seat body (32) and a second support seat body (33) arranged on the outer peripheral side of the main seat body (31), wherein: The main seat body (31) is provided with a main channel (311) which penetrates the main seat body (31) in the axial direction, the proximal end of the first pipe (11) is inserted and fixed from the distal end of the main channel (311), and the proximal end of the main channel (311) is set as the guide wire inlet (312); The first support body (32) and the second support body (33) are respectively provided with a first branch hole (321) and a second branch hole (331) penetrating the first support body (32) and the second support body (33); One end opening of the first branch channel (321) is connected to the main channel (311), and the other end opening is set as the injection port (322); and, One end opening of the second branch channel (331) is connected to the main channel (311), and the other end opening is configured as the balloon filling port (332).

9. The balloon catheter according to claim 8, characterized in that: The first support body (32) and the second support body (33) are arranged at different positions of the main support body (31) at intervals in the axial direction and the circumferential direction.

10. The balloon catheter according to claim 8, characterized in that: The balloon catheter also includes a catheter reinforcement tube (500), which is sleeved on the outside of the first tube (11), and its distal end is heat-shrunk or adhesively fixed to the outer wall of the first tube (11), and its proximal end is fixed to the main seat body (31).

Images