CN111012557B

CN111012557B - Balloon catheter

Info

Publication number: CN111012557B
Application number: CN201911150140.6A
Authority: CN
Inventors: 房金锋; 龙汉; 张�雄
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2019-11-21
Filing date: 2019-11-21
Publication date: 2022-09-02
Anticipated expiration: 2039-11-21
Also published as: CN111012557A

Abstract

The invention discloses a balloon catheter, which comprises a catheter with an inner cavity, an expandable balloon arranged at the far end part of the catheter, a limiting part, a fixing part, a connecting part and a moving part, wherein the balloon is communicated with the inner cavity of the catheter; the movable piece can expand along with the saccule and move away from the center of the catheter, so that the included angle between the connecting piece and the catheter is increased. In the process of conveying the stent, the balloon catheter can limit the forward and backward displacement of the stent through the limiting part; in addition, when the balloon catheter releases the support in a balloon filling mode, the movable part can extend along the radial direction under the acting force of the balloon to limit the support, and the phenomenon that the support inclines and slides in the balloon filling process is avoided.

Description

Balloon catheter

Technical Field

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

Background

In recent years, interventional radiology has rapidly developed in many clinical fields with its obvious advantages of being minimally invasive, rapid, safe and effective, especially in the fields of cardiovascular, cerebrovascular, peripheral blood vessels and oncology, and is now the clinical three-major-pillar subject parallel to traditional internal medicine and surgery.

The stent is used as an important component of interventional radiology, and is mainly used for providing a supporting function for a narrow or blocked blood vessel or cavity, preventing tissues from retracting and reshaping. The absorbable drug-eluting coronary stent system consists of an absorbable drug-eluting coronary stent and a stent conveying system, and when the absorbable drug-eluting coronary stent system is used clinically, medical staff convey the stent to a lesion area through the stent conveying system to release the stent. Due to the complicated structure of the bent blood vessel in the human body, the stent may be displaced during the stent delivery process or the stent release process, which may result in poor operation or damage to the blood vessel.

Disclosure of Invention

The invention aims to provide a balloon catheter which can limit forward and backward displacement of a stent along a delivery direction in the process of delivering the stent and can prevent the stent from obliquely sliding in the process of balloon filling when the balloon catheter releases the stent.

In order to solve the problems, the end part of the balloon catheter is provided with a limiting part, and the balloon catheter can limit the forward and backward displacement of the stent through the limiting part in the process of delivering the stent; in addition, when the balloon catheter releases the support in the balloon filling mode, the moving part can extend along the radial direction under the acting force of the balloon, so that the support is limited, and the phenomenon of inclined sliding of the support in the balloon filling process is avoided.

The invention provides a balloon catheter, which comprises a catheter with an inner cavity and an expandable balloon arranged at the far end part of the catheter, wherein the balloon is communicated with the inner cavity of the catheter; the movable piece can expand along with the saccule and move away from the center of the catheter, so that the included angle between the connecting piece and the catheter is increased.

In one embodiment, the fixing member includes a fixing ring, and the fixing ring is fixedly disposed on the outer side of the catheter.

In one embodiment, the connecting member includes a plurality of connecting rods circumferentially distributed along the fixing ring, and the connecting rods are rigid rods.

In one embodiment, the moveable member comprises a ring-shaped structure made of an elastic or super-elastic material.

In one embodiment, the movable member includes a plurality of arcuate segments that are disposed around the outside of the balloon.

In one embodiment, the number of the limiting parts is two, the two limiting parts are respectively arranged at two ends of the balloon, and an area between the two movable parts on the balloon forms an installation area of the bracket.

In one embodiment, the limiting portion further includes at least one limiting member circumferentially distributed on the moving member, the limiting member is an arc-shaped structure, two ends of the limiting member are connected to the moving member, and the rest of the limiting member extends between the two ends of the limiting member.

In one embodiment, the limiting portion includes a plurality of limiting members, and the limiting members are arranged end to end along the circumferential direction of the moving member.

In one embodiment, the balloon catheter comprises a stent, the stent is installed on the outer side of the balloon, and the projection of the stent on the cross section perpendicular to the axial direction of the balloon falls within the projection of the limiting piece on the cross section.

In one embodiment, the connecting piece and the movable piece are tightly attached to the outer wall of the balloon.

Compared with the prior art, the invention has the following advantages and beneficial effects:

(1) the balloon catheter is provided with the limiting part at the end part of the balloon, and the balloon catheter can limit the forward and backward displacement of the stent through the limiting part in the process of conveying the stent;

(2) when the sacculus pipe released the support through the mode of filling the sacculus, the moving part can be along radially extending under the effort of sacculus with this to carry on spacingly to the support, avoids the support to appear the phenomenon that the slope slided in sacculus filling in-process.

Drawings

Various other advantages and benefits will become apparent to those of ordinary skill in the art upon reading the following detailed description of the preferred embodiments. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the invention. Also, like reference numerals are used to refer to like parts throughout the drawings. In the drawings:

FIG. 1 is a schematic structural view of a balloon catheter according to one embodiment of the present invention;

FIG. 2 is a partial schematic structural view of the balloon catheter of FIG. 1;

FIG. 3 is a schematic view of the balloon catheter of FIG. 2 in an expanded state;

FIG. 4 is an elevational view of the stop portion of one embodiment of the present invention in an unexpanded state;

FIG. 5 is a side view of the stop portion of FIG. 4 in an unexpanded state;

FIG. 6 is a front view of the spacing portion of FIG. 4 in an expanded state;

FIG. 7 is a side view of the spacing portion of FIG. 6 in an expanded state;

FIG. 8 is an elevational view of another embodiment of the spacing portion of the present invention in an unexpanded condition;

FIG. 9 is a side view of the stop portion of FIG. 8 in an unexpanded state;

FIG. 10 is a front view of the stop portion of FIG. 8 in an expanded state;

FIG. 11 is a side view of the stop portion of FIG. 10 in an expanded state.

Detailed Description

Exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the invention are shown in the drawings, it should be understood that the invention can be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.

It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only, and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" may be intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises," "comprising," "includes," "including," and "having" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order described or illustrated, unless specifically identified as an order of performance. It should also be understood that additional or alternative steps may be used.

For ease of description, spatially relative terms, such as "outer", "end", "circumferential", "radial", "medial", etc., may be used herein to describe one element or feature's relationship to another element or feature as illustrated in the figures. Such spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "over" the other elements or features. Thus, the example term "below … …" can include both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

In the field of interventional medical devices, one end of the interventional medical device operated by a user is generally referred to as an "operation end" or a "proximal end" of the interventional medical device, one end of the interventional medical device, which first extends into a human body, is referred to as an "implantation end" or a "distal end" of the interventional medical device, and the "operation end", "proximal end" and "implantation end" and "distal end" of any part of the interventional medical device are defined according to the principle. "axial" generally refers to the length of the interventional medical device as it is being delivered, and "radial" generally refers to the direction of the interventional medical device perpendicular to its "axial" direction, and defines both "axial" and "radial" directions for any component of the interventional medical device in accordance with this principle.

As shown in fig. 1, an embodiment of the present invention provides a balloon catheter 100, which includes a position-limiting portion 10, a balloon 20, a catheter 30, a guide wire 50, a catheter hub 60, and a stent (not shown in fig. 1) mounted on the outer side of the balloon 20.

Specifically, the catheter 30 has a lumen including a first lumen and a second lumen isolated from each other and both extending axially through the catheter 30. The balloon 20 is provided at the distal end of the catheter 30, and the balloon lumen is in communication with the catheter 30 lumen, in particular the first lumen. The balloon catheter 100 is capable of being inflated into the balloon 20 through the first lumen, the balloon 20 being configured to receive the stent 40 when the balloon 20 is in the deflated state, and the balloon 20 being configured to expand the stent 40 and release the stent 40 into body tissue, such as a blood vessel, in the expanded state when the balloon 20 is in the inflated state. The catheter 30 is further provided with an opening 31 for the guide wire 50 to pass through, the opening 31 is arranged near the proximal end of the balloon 20 and is communicated with the second inner cavity, the guide wire 50 passes through the opening 31 into the second inner cavity of the catheter 30 and extends out of the distal end of the catheter 30, and the guide wire 50 can play a role in guiding the balloon catheter 100 when the balloon catheter 100 is implanted into a human body. The catheter hub 60 is disposed at the proximal end of the balloon catheter 100, and is an operation end of the doctor, and the medical staff operates the balloon catheter 100 through the catheter hub 60 to deliver the stent 40 into the human tissue such as the blood vessel.

The position-limiting portion 10 includes a fixing member (described in detail below), a connecting member (described in detail below), and a movable member 102, the fixing member is sleeved on the end portion of the catheter 30 close to the balloon 20, one end of the connecting member is disposed on the fixing member and extends toward the balloon 20, the movable member 102 is disposed on the outer side of the balloon 20, the connecting member connects the fixing member and the movable member 102, and the connecting member is a rigid member, i.e., the connecting member is made of a rigid material, and the term "rigid member" is used herein to mean that the length of the connecting member does not change before and after the balloon is expanded. The moveable member 102 can expand with the balloon 20 and move away from the center of the catheter 30, such that the angle between the connector and the catheter 30 is increased and the connector length is unchanged. In some embodiments, moveable member 102 may be an annular structure made of an elastic or superelastic material. The diameter of moveable member 102 may vary accordingly under the application of an external force, such as by changing from a small diameter to a large diameter, and then returning to the small diameter again after the external force is removed. With the stent 40 mounted on the balloon catheter 100, the mobile member 102 abuts circumferentially against the end of the stent 40 and the mobile member 102 is able to expand radially during inflation of the balloon 20. As shown in fig. 2, the balloon catheter 100 of the present invention can restrict the forward and backward displacement of the stent 40 in the delivery direction by the stopper portion 10 in the process of delivering the stent 40. As shown in fig. 3, when the balloon catheter 100 releases the stent 40 by filling the balloon 20, the movable member 102 can be extended radially under the force of the balloon 20 to limit the stent 40, so as to avoid the stent 40 from tilting and sliding during the filling process of the balloon 20.

It will be appreciated that in other embodiments, the moveable member comprises a plurality of arcuate segments that are disposed around the outside of the balloon 20. When the balloon 20 is expanded, the plurality of arcuate segments also move away from the center of the catheter 30 as the balloon 20 expands, while the length of the connector is constant throughout.

Specifically, as shown in fig. 3, the movable element 102 may be made of a nickel-titanium wire with a larger wire diameter, and the movable element 102 may be contracted at a taper portion of the end portion of the balloon 20 and closely attached to the end edge of the stent 40, so that when the balloon 20 is expanded, the movable element 102 may abut against the end portion of the stent 40 to limit the forward and backward displacement of the stent 40. Further, in other embodiments, the number of the limiting portions 10 may also be two, that is, one limiting portion is respectively disposed at both ends of the balloon 20, specifically, the two movable members 102 in the two limiting portions 10 are respectively disposed at both ends of the balloon 20, an area on the balloon 20 located between the two movable members 102 forms an installation area of the stent 40, and the two movable members 102 limit both ends of the stent 40, so as to reduce a risk of displacement of the stent 40 during delivery and release of the stent 40 by the balloon catheter 100.

According to the embodiment of the present invention, further, the connecting member and the movable member 102 are tightly attached to the outer surface of the balloon, and during the filling process of the balloon 20, the tapered structure at the proximal end of the balloon 20 is filled first, so that the movable member 102 can be driven to extend at the first time, and the movable member 102 can limit the stent 40.

It should be noted that, the movable member 102 in the embodiment of the present invention mainly has a limiting function on the bracket 40, and the connecting member and the fixing member mainly have a supporting function on the movable member 102, so as to prevent the movable member 102 from moving forward and backward along the conveying direction under the driving of the bracket 40.

According to a preferred embodiment of the present invention, the fixing member may be in the form of a fixing ring 104, and the fixing ring 104 is fixed on the catheter 30 by forging, particularly near the proximal end or the distal end of the balloon 20, i.e. the fixing ring 104 does not move relative to the catheter 30. The connecting piece can be made of a plurality of connecting rods 103, and the connecting rods 103 are rigid rods which are difficult to bend. The fixed ring 104 provides sufficient supporting force for the movable member 102 through the plurality of connecting rods 103, and ensures the limiting effect of the movable member 102 on the bracket 40. Further, the diameter of the movable part 102 is greater than that of the fixed ring 104, and the two ends of the connecting rods 103 are respectively connected with the fixed ring 104 and the movable part 102, so that the connecting rods 103 can be rapidly opened in the filling process of the balloon 20, and the movable part is always supported, and the movable part is prevented from sliding down from the outer side of the balloon.

Referring to fig. 2, 4 and 5, when the operator pushes or retracts the balloon catheter 100, the movable member 102 is tightly attached to the end of the stent 40 when the balloon 20 is in an unexpanded state, and in the process of pushing or retracting the balloon catheter 100, a doctor applies a certain resistance to the stent 40 by blood or a blood vessel wall, the movable member 102 at the end of the stent 40 can limit the displacement or even the falling of the stent 40, and the fixing ring 104 is fixed on the catheter 30 by forging and pressing, so as to ensure that the movable member 102 cannot slide off the balloon 20.

Referring to fig. 3, 6, and 7, when the operator releases the stent 40, the balloon 20 gradually expands, the balloon 20 causes the stent 40 and the moveable member 102 to extend in a radial direction, and the moveable member 102 retracts slightly in an axial direction toward the stationary ring 104 while extending. Further, since the filling process of the balloon 20 is very rapid, the time for displacing the stent 40 is very short, and in this very short time, the movable member 102 does not move toward the fixed ring 104, the movable member 102 can limit the tendency for displacing the stent 40, after the balloon 20 is uniformly expanded, the expanding force of the stent 40 on the balloon 20 is relatively uniform, and the position-limiting portion 10 is separated from the stent 40 by slight retraction, so as to complete the position-limiting purpose of the stent 40.

In conclusion, the balloon catheter 100 of the present invention enables the absorbable drug stent 40 to accurately reach the lesion site during the clinical delivery process, and accurately releases the absorbable drug stent 40, thereby preventing the stent 40 from shifting during the delivery process or the release process to affect the treatment effect, and simultaneously preventing the stent 40 from shifting to cause vascular injury.

As shown in fig. 8 and 9, according to the preferred embodiment of the present invention, the position-limiting portion 10 further includes at least one position-limiting member 101 circumferentially distributed on the movable member 102. The limiting member 101 is an arc-shaped structure, two ends of the limiting member 101 are connected to the movable member 102, and the rest extends between two ends of the limiting member 101. Specifically, the limiting members 101 are nickel titanium wires, and the number of the limiting members is a plurality of nickel titanium wires, and the limiting members are arranged end to end along the circumferential direction of the movable member 102, and form a flower shape around the movable member 102. The distance between the two ends of the limiting part 101 can be changed along with the change of the movable part, namely, when the balloon is expanded, the diameter of the movable part is increased, and the circumference is increased, so that the distance between the two ends of the limiting part connected to the movable part is increased, correspondingly, the middle part of the limiting part is also closer to the movable part, namely, the arc radius of the limiting part is increased. At the instant the balloon catheter 100 releases the stent 40, the stop 101 may prevent the stent 40 from shifting due to the tilt angle caused by the non-uniform expansion of the balloon 20. Further, since the limiting member 101 can increase the limiting area of the limiting portion 10 to the bracket 40, the cross section of the movable member 102 can be set to be a circle with a smaller diameter, that is, the movable member can be set to be closer to the fixing ring.

As shown in fig. 8 and 9, when the balloon 20 is inflated, the movable element 102 is driven to expand synchronously with the bracket 40, the movable element 102 drives the middle part of the surrounding limiting element 101 to retract, the diameter of the movable element 102 is enlarged along with the expansion of the balloon 20, so that the distance between two adjacent connection points of the limiting element 101 on the movable element 102 is driven to be enlarged, and the whole limiting element 101 is close to the movable element 102. In the process, the length of the limiting member 101 is substantially unchanged, and since the connecting rod 103 is always kept in a straight state and the length is unchanged, and the position of the fixing ring 104 is fixed, the distance of the movable member 102 in the axial direction also gradually approaches the fixing ring 104 in the expansion process of the balloon 20. When the bracket is installed on the balloon, the height of the limiting piece can prevent the bracket from shifting, namely the projection of the bracket on the cross section perpendicular to the axial direction of the balloon falls in the projection of the limiting piece on the cross section. It is understood that in other embodiments, the projection of the stent 40 on the cross section perpendicular to the axial direction of the balloon 20 is beyond the projection of the limiting member 101 on the cross section, and the limiting member 101 can also block the displacement of the stent 40.

Further, the movable member 102 retracts slightly toward the fixing ring 104 while extending, and since the balloon 20 is inflated very quickly, the time for the stent 40 to displace is very short, and the limiting member 101 has not yet moved toward the fixing ring 104 in the very short time, the limiting member 101 can limit the tendency for the stent 40 to displace, after the balloon 20 expands uniformly, the stent 40 bears the expansion force of the balloon 20 relatively uniformly, and the limiting portion 10 is separated from the stent 40 by slight retraction, so that the purpose of limiting the stent 40 is achieved.

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 shall be subject to the appended claims.

Claims

1. A balloon catheter comprises a catheter with an inner cavity and an expandable balloon arranged at the far end part of the catheter, wherein the balloon is communicated with the inner cavity of the catheter; the movable piece can expand along with the saccule and move away from the center of the catheter, so that the included angle between the connecting piece and the catheter is increased.

2. A balloon catheter according to claim 1, wherein said fixing member includes a fixing ring, and said fixing ring is fixedly provided on the outside of said catheter.

3. The balloon catheter of claim 2, wherein the connector comprises a plurality of connecting rods circumferentially distributed along the retaining ring, and the connecting rods are rigid rods.

4. The balloon catheter of claim 1, wherein the movable member comprises a ring-shaped structure made of an elastic or superelastic material.

5. The balloon catheter of claim 1, wherein the movable member includes a plurality of arcuate segments that are disposed around an outside of the balloon.

6. The balloon catheter according to claim 1, wherein the number of the limiting portions is two, the two limiting portions are respectively provided at two ends of the balloon, and an area of the balloon between the two movable members forms an installation area of the stent.

7. The balloon catheter according to claim 1, wherein the limiting portion further comprises at least one limiting member circumferentially distributed on the movable member, the limiting member is an arc-shaped structure, two ends of the limiting member are connected to the movable member, and the rest of the limiting member extends between the two ends of the limiting member.

8. The balloon catheter according to claim 7, wherein the stopper portion includes a plurality of stoppers that are disposed end to end along the circumferential direction of the movable member.

9. A balloon catheter according to claim 7, comprising a stent mounted outside the balloon, the projection of the stent on a cross-section perpendicular to the axial direction of the balloon falling within the projection of the stop on said cross-section.

10. A balloon catheter according to any of claims 1-9, wherein the connecting member and the moveable member are snug against the outer wall of the balloon.