CN111135430B

CN111135430B - Balloon catheter

Info

Publication number: CN111135430B
Application number: CN201911204603.2A
Authority: CN
Inventors: 张�雄; 龙汉
Original assignee: Dongguan Xianjian Medical Co ltd
Current assignee: Dongguan Xianjian Medical Co ltd
Priority date: 2019-11-29
Filing date: 2019-11-29
Publication date: 2022-12-02
Anticipated expiration: 2039-11-29
Also published as: CN111135430A

Abstract

The invention discloses a balloon catheter, which comprises a balloon, an inner tube, an outer tube and a catheter seat, wherein the inner tube penetrates through the outer tube, the far end of the balloon is fixed on the inner tube, the near end of the balloon is fixed on the outer tube, a filling channel communicated with an inner cavity of the balloon is formed between the inner tube and the outer tube, the near end of the outer tube is fixed on the catheter seat, and a joint communicated with the filling channel is arranged on the catheter seat; the balloon catheter also comprises a handle structure, the inner tube penetrates through the catheter seat and is connected with the handle structure, and the handle structure enables the inner tube and the outer tube to move relatively in the axial direction. The invention has the beneficial effects that: because the inner tube and the outer tube of this application can take place along axial relative movement, when the sacculus inflation, the axial extension of sacculus can be complied with to the inner tube, avoids sacculus and inner tube to take place the bending, leads to "banana effect" to form.

Description

Balloon catheter

Technical Field

The invention relates to the field of medical instruments, in particular to a balloon catheter.

Background

The prior art often uses balloon catheters for interventional procedures, such as performing balloon dilatation or positioning stents in stenotic arteries. Referring to fig. 1, the balloon catheter includes a balloon 1, an inner tube 2, an outer tube 3 and a catheter hub 4, wherein a distal end of the balloon 1 is fixed on the inner tube 2, a proximal end of the balloon is fixed on the outer tube 3, and proximal ends of the inner tube 2 and the outer tube 3 are respectively fixedly connected with the catheter hub 4. The balloon 1 will not only expand radially, but also elongate axially during inflation in use. Because the inner tube 2 and the outer tube 3 are both fixed on the catheter seat 4, the inner tube 2 and the outer tube 3 cannot move relatively in the axial direction, please refer to fig. 2, when the balloon 1 extends axially, the balloon 1 and the inner tube 2 are easily bent, which is the phenomenon of 'banana effect', which causes the unpredictable shape of the balloon and may damage blood vessels or cause operation failure.

Disclosure of Invention

The present invention is directed to a balloon catheter, which overcomes the above-mentioned drawbacks of the prior art.

The technical scheme adopted by the invention for solving the technical problems is as follows:

providing a balloon catheter, which comprises a balloon, an inner tube, an outer tube and a catheter seat, wherein the inner tube penetrates through the outer tube, the far end of the balloon is fixed on the inner tube, the near end of the balloon is fixed on the outer tube, a filling channel communicated with an inner cavity of the balloon is formed between the inner tube and the outer tube, the near end of the outer tube is fixed on the catheter seat, and a joint communicated with the filling channel is arranged on the catheter seat; the balloon catheter also comprises a handle structure, the inner tube penetrates through the catheter seat and is connected with the handle structure, and the handle structure enables the inner tube and the outer tube to move relatively in the axial direction.

In the balloon catheter, the inner tube is provided with a bending section, and the catheter section where the bending section is located can be straightened under the stress.

In the balloon catheter of the present invention, the curved section is located inside the balloon.

In the balloon catheter of the present invention, the catheter hub is provided therein with a lumen channel penetrating in the axial direction, the inner tube penetrates through the lumen channel, and an elastic seal member is provided between the lumen channel and the inner tube.

In the balloon catheter according to the present invention, one end of the elastic sealing member is fixed to the inner wall of the lumen channel, and the other end of the elastic sealing member is fixed to the inner tube, and the fixing point of the elastic sealing member to the lumen channel is located on the proximal side of the intersection of the lumen of the joint and the lumen channel.

In the balloon catheter, the side wall of the catheter seat is provided with a through hole for injecting glue, the through hole is communicated with the lumen channel, and the elastic sealing element is bonded and connected with the inner wall of the lumen channel.

In the balloon catheter of the invention, the handle structure comprises a first handle, and the proximal end of the inner tube is connected with the first handle.

In the balloon catheter, the handle structure further comprises a second handle connected to the catheter seat, the inner tube passes through the second handle and is connected with the first handle, and the first handle is slidably inserted into the second handle.

In the balloon catheter, the handle structure further comprises an axial positioning structure, the axial positioning structure comprises a positioning part which is slidably sleeved on the first handle, a sliding groove which extends along the axial direction of the first handle, and at least two positioning grooves which extend along the circumferential direction of the first handle and are communicated with the sliding groove; the positioning piece is provided with a sliding block, and the sliding block is connected in the sliding groove or the positioning groove in a sliding mode.

In the balloon catheter, the end cover is arranged at the proximal end of the second handle, the distal end of the first handle is slidably inserted into the end cover, and the diameter of an excircle of the cross section of the end cover is larger than the diameter of an inscribed circle of the inner cavity of the positioning piece.

In conclusion, the balloon catheter provided by the invention has the following beneficial effects: because the inner tube and the outer tube of the utility model can move relatively along the axial direction, when the saccule expands, the inner tube can conform to the axial extension of the saccule, and the saccule and the inner tube are prevented from being bent, so that the banana effect is formed.

Drawings

The invention will be further described with reference to the accompanying drawings and examples, in which:

FIG. 1 is a schematic view of a prior art balloon catheter;

FIG. 2 is a schematic view of the balloon catheter of FIG. 1 with the balloon and inner tube in flexion;

FIG. 3 is a schematic view of a balloon catheter provided in accordance with one embodiment of the present invention;

FIG. 4 is a schematic view of a handle structure of the balloon catheter shown in FIG. 3;

FIG. 5 is a schematic view of an axial positioning feature of the handle structure shown in FIG. 4;

FIG. 6 is a schematic view of a positioning element of the axial stop arrangement of FIG. 5;

FIG. 7 is a schematic view of a catheter hub of the balloon catheter of FIG. 1;

fig. 8 is a schematic view of a balloon catheter provided in accordance with a second embodiment of the present invention;

fig. 9 is a schematic view of a balloon catheter provided in accordance with a third embodiment of the present invention.

Detailed Description

In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms than those specifically described herein, and it will be apparent to those skilled in the art that many more modifications are possible without departing from the spirit and scope of the invention.

It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "left," "right," and the like as used herein are for illustrative purposes only and do not represent the only embodiments.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

In the field of interventional medicine, it is generally defined that the end of the instrument proximal to the operator is the proximal end and the end distal to the operator is the distal end.

As shown in fig. 3, one embodiment of the present invention provides a balloon catheter 100 comprising a balloon 1, an inner tube 2, an outer tube 3, a catheter hub 4 and a handle structure 5. The inner tube 2, the outer tube 3 and the catheter holder 4 are respectively provided with a lumen channel which penetrates along the axial direction, and the inner tube 2 penetrates through the lumen channels of the outer tube 3 and the catheter holder 4. The far end of the saccule 1 is fixed on the inner tube 2, the near end of the saccule 1 is fixed on the outer tube 3, the near end of the outer tube 3 is fixed on the catheter seat 4, the near end of the inner tube 2 is connected with the handle structure 5, and the inner tube 2 and the outer tube 3 are relatively moved along the axial direction through the handle structure 5. Because the inner tube 2 and the outer tube 3 can move relatively along the axial direction, when the saccule 1 is expanded, the inner tube 2 can conform to the axial extension of the saccule 1, and the saccule 1 and the inner tube 2 are prevented from being bent to cause the formation of a banana effect.

Referring to fig. 3 and 4, the handle structure 5 includes a first handle 51 and a second handle 52 that are axially movable relative to each other. The second handle 52 is connected to the catheter holder 4, the second handle 52 is a hollow structure, the proximal end of the inner tube 2 passes through the second handle 52 and is fixedly connected with the first handle 51, and the first handle 51 moves to drive the inner tube 2 to move axially.

Wherein the second handle 52 comprises a second body 521 and a second pusher 522 connected thereto. The second body 521 is fixedly connected to the catheter hub 4 by a fastener 53, and the fastener 53 can detachably connect the second body 521 to the catheter hub 4 by screwing, buckling, etc. The second body 521 is a hollow structure, and the inner pipe 2 passes through the second body 521. The second pusher 522 may be an annular structure or other structure that facilitates pushing by an operator.

First handle 51 includes a first body 511 and a first pusher 512 connected thereto. The distal end of the first body 511 is movably inserted into the second body 521, and the first body 511 is fixedly connected to the proximal end of the inner tube 2. The first body 511 is a hollow structure, and a guide wire may pass through the first body 511. First pusher 512 may be an annular structure or other structure that facilitates pushing by an operator.

When the pushing device is used, an operator sleeves the index finger and the thumb of a single hand into the first pushing piece 512 and the second pushing piece 522 respectively, and the first body 511 and the second body 521 can move relatively along the axial direction through opening and closing of the index finger and the thumb of the single hand. Therefore, the handle structure 5 of the present embodiment is easy to use, and the inner tube 2 can be moved in the axial direction by one hand.

Referring to fig. 3, fig. 4 and fig. 5, the handle structure 5 further includes an axial positioning structure 54, and the axial positioning structure 54 includes a positioning member 541, a sliding groove 542 and at least two positioning grooves 543.

The sliding groove 542 extends along an axial direction of the first body 511, the positioning grooves 543 are distributed along a circumferential direction of the first body 511 and are communicated with the sliding groove 542, and the positioning element 541 is slidably connected to the first body 511.

Referring to fig. 6, a sliding block 5411 is disposed on the positioning element 541, and the sliding block 5411 is slidably connected to the sliding groove 542 or the positioning groove 543. The positioning element 541 is of an annular structure, and the slider 5411 is disposed on an inner wall of the positioning element 541 in a protruding manner. Preferably, the number of the sliding blocks 5411 is at least two, at least two sliding blocks 5411 are uniformly distributed along the circumferential direction, at least two sliding grooves 542 are also provided, and each sliding block 5411 is connected in the corresponding sliding groove 542. By providing at least two sliders 5411, the positioning element 541 and the first body 511 can be always in a concentric state, so that the sliders 5411 can move smoothly in the sliding grooves 542 or the positioning grooves 543, and the positioning element 541 cannot move difficultly due to an eccentricity problem.

In operation, the first handle 51 and the second handle 52 are moved relatively in the axial direction, and when the distal end of one positioning groove 543 of the first handle 51 is approximately aligned with the proximal end of the second handle 52, the positioning member 541 is moved in the axial direction, so that the sliding block 5411 slides in the sliding groove 542 until the positioning member 541 abuts against the proximal end of the second handle 52; subsequently, the positioning member 541 is rotated in the circumferential direction, so that the slider 5411 on the positioning member 541 is rotated from the sliding groove 542 into the positioning groove 543. Since the positioning element 541 abuts against the proximal end of the second handle 52 and the sliding block 5411 is located in the positioning groove 543 distributed along the circumferential direction, the first handle 51 cannot continue to move axially toward one side of the second handle 52, so that the first handle 51 is locked, and the first handle 51 and the inner tube 2 thereon are prevented from continuing to extend forward.

Preferably, the first body 511 is provided with a plurality of positioning grooves 543, and the plurality of positioning grooves 543 are uniformly distributed along the axial direction of the first body 511. Therefore, the distance of the relative movement between the first handle 51 and the second handle 52, and further the distance of the movement of the inner tube 2 in the body can be determined by the number of the moving positioning grooves 543.

Referring again to fig. 4, the proximal end of the second handle 52 is provided with an end cap 523, and the end cap 523 can be fixed to the proximal end of the second body 521 by snapping, screwing or other means. The end cover 523 is a hollow structure, the first body 511 is slidably inserted into the end cover 523, and an inner cavity contour of the end cover 523 matches with an outer contour of the distal end of the first body 511 to prevent the first handle 51 and the second handle 52 from moving relative to each other in a radial direction.

Moreover, the diameter of the circumscribed circle of the cross section of the end cover 523 is greater than the diameter of the inscribed circle of the inner cavity of the positioning element 541, so that the end cover 523 abuts against the positioning element 541 to prevent the positioning element 541 from continuously moving towards one side of the second body 521. Since the positioning element 541 needs to abut against the proximal end of the second handle 52 when the handle structure 5 is in use to prevent the first handle 51 from extending forward, the shape of the contour of the proximal end of the second body 521 does not affect the abutment between the positioning element 541 and the proximal end of the second body 521 by providing the end cover 523 at the proximal end of the second body 521, so as to appropriately reduce the machining accuracy of the second body 521.

Referring to fig. 7, a lumen channel passing through the catheter base 4 along the axial direction is provided in the catheter base 4, the outer tube 3 is fixed in the lumen channel, the inner tube 2 can movably pass through the inner cavity of the outer tube 3, and an filling channel 21 communicated with the inner cavity of the balloon 1 is formed between the inner tube 2 and the outer tube 3. The catheter seat 4 is provided with a joint 41, the joint 41 is used for filling and pressure relief of the balloon 1, and the joint 41 is of a hollow structure, and the inner cavity of the joint is communicated with the filling channel 21. The proximal end of the catheter hub 4 is provided with a catch 42, and the distal end of the second handle 52 is inserted into the catch 42.

Since the inner tube 2 extends through the lumen passage of the catheter hub 4 and is connected to the first handle 51, an elastic seal 43 is provided between the lumen passage of the catheter hub 4 and the inner tube 2 in order to prevent the liquid or gas filling the balloon 1 from leaking out of the proximal end of the catheter hub 4 through the lumen passage.

In the embodiment shown in fig. 7, outer tube 3 is fixed to the distal end of catheter hub 4, and resilient seal 43 is fixed at one end to the inner wall of catheter hub 4 and at the other end to inner tube 2. The point of attachment of the resilient seal 43 to the catheter hub 4 is proximal to the intersection of the lumen of the hub 41 and the lumen passage of the catheter hub 4, avoiding the resilient seal 43 obstructing communication of the lumen of the hub 41 with the filling passage 21.

Because the elastic sealing element 43 is located between the lumen channel of the catheter hub 4 and the inner tube 2, the liquid or gas filling the balloon 1 can be effectively prevented from leaking from the proximal end of the catheter hub 4, and the elastic sealing element 43 has good elasticity, when the inner tube 2 and the outer tube 3 move relatively, the elastic sealing element 43 can be elastically deformed, and the relative movement of the inner tube 2 and the outer tube 3 cannot be influenced.

The elastic sealing member 43 of the present application has elastic deformation capability, it can be compressed or extended under stress, and the elastic sealing member 43 can bear higher pressure, playing a role of sealing. The elastic seal member 43 may be composed of a polymer material having high elasticity, such as rubber or the like. The elastic sealing member 43 may also be made of a metal material with certain elasticity, such as an elastic sheet.

The side wall of the catheter holder 4 is provided with a through hole (not shown) which is communicated with the lumen channel in the catheter holder 4, and glue can be injected into the lumen channel of the catheter holder 4 through the through hole. During assembly, one end of the elastic sealing element 43 is fixed on the inner tube 2, and the modes of hot melt welding, glue bonding and the like can be adopted; the inner tube 2 with the attached resilient seal 43 is then placed within the lumen channel of the catheter hub 4; finally, glue is injected from the reserved through hole, so that the other end of the elastic sealing element 43 is fixed on the inner wall of the catheter hub 4. Since one end of the elastic sealing member 43 is fixed to the inner wall of the catheter hub 4 by dispensing and the other end is fixed to the inner tube 2, the elastic sealing member 43 does not shift randomly under high pressure, thereby ensuring the sealing property of the balloon catheter 100 under high pressure.

Although the elastic sealing member 43 is fixed at one end to the inner wall of the catheter hub 4 and at the other end to the inner tube 2 in the present embodiment, the elastic sealing member 43 may be fixed at one end to the outer tube 3 and at the other end to the inner tube 2 in other embodiments. At this time, the outer tube 3 extends to the proximal end side of the intersection of the inner cavity of the joint 41 and the lumen channel of the catheter hub 4, a through hole is formed in the outer tube 3, the through hole is respectively communicated with the filling channel 21 and the inner cavity of the joint 41, and the fixing point of the elastic sealing element 43 and the outer tube 3 is located on the proximal end side of the through hole, so that the elastic sealing element 43 is prevented from obstructing the communication between the inner cavity of the joint 41 and the filling channel 21.

Referring to fig. 3 again, the balloon catheter 100 further includes a visualization mark 6 disposed on the inner tube 2, and the visualization mark 6 can be clearly visualized under X-ray illumination for precise positioning during surgery. The development mark 6 has a substantially ring-shaped structure, and may be made of platinum, tantalum, iridium, or the like. Although in the embodiment shown in fig. 3, the visualization markers 6 are located inside the balloon 1 to facilitate the determination of the position of the balloon 1 during the procedure, in other embodiments, the visualization markers 6 may be located at other locations on the inner tube 2 as desired.

The sacculus 1 is the sacculus of being made by thermoplastic elastomer, because thermoplastic elastomer's material is softer, and the inflation ratio of material is great, not only can make the sacculus expand rapidly, is favorable to increasing the compliance of sacculus and the anchoring force between sacculus and the vascular wall moreover. In addition, the thermoplastic elastomer has better elasticity, so that the balloon has smaller outline size before expansion or after pressure relief, the balloon catheter 100 can conveniently pass through a severely bent part, and the balloon catheter 100 is not easy to cause vascular injury when being withdrawn.

The distal end of the inner tube 2 is made of a polymer material with good flexibility, such as TPU, TPE, PEBAX, etc., so that the distal end has good bending performance and can pass through a complicated bent blood vessel along with the guide wire.

As shown in fig. 8, the second embodiment of the present invention provides a balloon catheter 100, which has substantially the same structure as the first embodiment, except that a curved section 21 is disposed on the inner tube 2, the catheter section where the curved section 21 is located is preset to be curved, and the catheter section where the curved section 21 is located is stressed to be straightened. Preferably, the curved section 21 is located inside the balloon 1.

When the balloon 1 is inflated, the catheter section where the bending section 21 is located can conform to the axial elongation of the balloon 1, reducing the distance that the inner tube 2 needs to be adjusted, i.e. the distance that the inner tube 2 is adjusted by the handle structure 5, thereby reducing the time required for the operation.

As shown in FIG. 9, a third embodiment of the present invention provides a balloon catheter 100 which is substantially the same in construction as the first embodiment except for the handle structure 5.

Referring to fig. 9, the handle structure 5 only includes a first handle 51, the proximal end of the inner tube 2 passes through the catheter hub 4 and is fixedly connected to the first handle 51, and the first handle 51 moves to drive the inner tube 2 to move axially.

The first handle 51 includes a first body 511 and two first pushing members 512 connected to each other, and the two first pushing members 512 are respectively disposed at both sides of the first body 511. The first pushing member 512 may be a ring-shaped structure or other structure convenient for the operator to push. When in use, the index finger and the middle finger of a single hand are respectively sleeved into the two first pushing pieces 512 by an operator, and the axial movement of the inner tube 2 can be realized by the single hand.

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

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

Claims

1. A balloon catheter comprises a balloon, an inner tube, an outer tube and a catheter seat, wherein the inner tube penetrates through the outer tube, the far end of the balloon is fixed on the inner tube, the near end of the balloon is fixed on the outer tube, a filling channel communicated with an inner cavity of the balloon is formed between the inner tube and the outer tube, the near end of the outer tube is fixed on the catheter seat, and a connector communicated with the filling channel is arranged on the catheter seat; the balloon catheter is characterized by further comprising a handle structure, wherein the handle structure comprises a first handle and a second handle which can relatively move along the axial direction, the proximal end of the inner tube is connected with the first handle, the second handle is connected to the catheter base, the inner tube penetrates through the catheter base and the second handle and is connected with the first handle, and the first handle is slidably inserted into the second handle; the handle structure enables the inner tube and the outer tube to move relatively along the axial direction, when the saccule is expanded, the handle structure enables the inner tube to move along the direction far away from the near end of the handle structure, and the saccule and the inner tube are prevented from being bent.

2. A balloon catheter according to claim 1, wherein the inner tube is provided with a curved section, and the catheter section on which the curved section is located is straightened under force.

3. A balloon catheter according to claim 2, wherein said curved section is located inside said balloon.

4. A balloon catheter according to claim 1, wherein a lumen channel is provided in the catheter hub and extends therethrough in an axial direction, the inner tube extending through the lumen channel, and an elastic seal is provided between the lumen channel and the inner tube.

5. A balloon catheter according to claim 4, wherein one end of the elastic seal is fixed to an inner wall of the lumen channel and the other end of the elastic seal is fixed to the inner tube, and the fixing point of the elastic seal to the lumen channel is located on a proximal side of a junction of the inner lumen of the joint and the lumen channel.

6. A balloon catheter according to claim 5, wherein a through hole for injecting glue is formed in the side wall of the catheter holder, the through hole is communicated with the lumen channel, and the elastic sealing element is bonded with the inner wall of the lumen channel.

7. The balloon catheter according to claim 1, wherein the handle structure further comprises an axial positioning structure, the axial positioning structure comprising a positioning member slidably fitted over the first handle, a sliding groove extending in an axial direction of the first handle, and at least two positioning grooves extending in a circumferential direction of the first handle and communicating with the sliding groove; the positioning piece is provided with a sliding block, and the sliding block is connected in the sliding groove or the positioning groove in a sliding mode.

8. The balloon catheter of claim 7 wherein a proximal end of the second handle is provided with an end cap into which a distal end of the first handle is slidably inserted, the end cap having a cross-section with an outer circular diameter larger than an inner circular diameter of the inner lumen of the positioning member.