CN113877042B

CN113877042B - Medical balloon, balloon catheter and medical device

Info

Publication number: CN113877042B
Application number: CN202111128664.2A
Authority: CN
Inventors: 胡景就; 黄君仪; 张志军
Original assignee: Guangdong Bomai Medical Technology Co Ltd
Current assignee: Guangdong Bomai Medical Technology Co Ltd
Priority date: 2021-09-26
Filing date: 2021-09-26
Publication date: 2023-07-11
Anticipated expiration: 2041-09-26
Also published as: CN113877042A

Abstract

The invention relates to the technical field of medical instruments, and provides a medical balloon, a balloon catheter and a medical device. According to the medical balloon provided by the invention, the plurality of expansion rings are sleeved outside the balloon body in sequence, when the medical balloon enters a lesion area at a bent blood vessel, the plurality of expansion rings at the inner side of the bent part are sequentially clung together under the influence of the bent blood vessel, so that a flat plane is formed, the V-shaped crease occurring when the balloon body is singly used is completely eliminated, and the lesion area can be smoothly opened; meanwhile, the performance of the medical balloon is not restricted by the original performance of the balloon body by superposition of the two materials of the balloon body and the expansion ring, so that the medical balloon has higher rated pressure and lower compliance.

Description

Medical balloon, balloon catheter and medical device

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to a medical balloon, a balloon catheter and a medical device.

Background

Balloon catheters are widely used for the expansion of stenotic lesions in blood vessels, or for the implantation and expansion of stents. When the balloon catheter is used, a guide wire is firstly introduced into the tip of the balloon and passes through the guide catheter from the proximal end to the vascular opening, then the guide wire passes through the stenosis, and the balloon enters the lesion along with the guide wire. After entering the lesion, the mixed solution of the developer and the normal saline (1:1) is injected into the saccule, so that the saccule is filled, and the effect of expanding the lesion is achieved.

The method has the defects that if the lesion occurs at a bent blood vessel, and the lesion is heavy and complex in stenosis degree, a plurality of V-shaped folds are generated at the bent part after the balloon is expanded by using low pressure during operation, so that the complete opening of the lesion is not facilitated. At present, clinical operators can only use higher expansion pressure to further reduce the influence of V-shaped folds, but can not fully expand the V-shaped folds; meanwhile, in the process of further improving the expansion pressure, the saccule can generate a slipping phenomenon, so that the pain operation risk of a patient is increased. It can be seen that the balloon catheters on the market currently have the defects that the lesions cannot be completely opened and high-pressure expansion is required when the balloon catheters are used for treating artificial or autologous arteriovenous fistula or other bending lesions, and the actual requirements of bending lesions and patients cannot be met.

Disclosure of Invention

The invention aims to provide a medical balloon to solve the technical problem that a plurality of V-shaped folds are generated at a bent part after the balloon is expanded when a vascular lesion is bent in the prior art, so that the lesion cannot be completely opened.

In order to achieve the above object, according to a first aspect of the present invention, a technical scheme is as follows: the utility model provides a medical balloon, including sacculus body and cover locate the outside a plurality of expansion rings of sacculus body, a plurality of the expansion ring is followed the length direction of sacculus body sets gradually, this internal pressure relief chamber that fills of sacculus is equipped with.

Further, the balloon body comprises a connecting portion and a working portion with a circular cross section, the connecting portion is arranged at two ends of the working portion, the connecting portion and the inside of the working portion jointly form the inflation and pressure relief cavity, and a plurality of inflation rings are sleeved on the working portion along the length direction of the balloon body.

Further, in the length direction of the balloon body, the plurality of expansion rings are sequentially distributed on the whole working portion, and a preset gap is reserved between the adjacent expansion rings.

Further, the preset gap is equal to or smaller than the width of the expansion ring along the length direction of the balloon body.

Further, the expansion ring is made of a high polymer material.

In a second aspect, the present invention also provides a balloon catheter comprising a luer connector, a catheter assembly and a medical balloon as claimed in any one of claims 1 to 5, the catheter assembly connecting the luer connector and the balloon body of the medical balloon respectively.

Further, the catheter assembly comprises an inner tube and an outer tube, the inner tube is arranged in the outer tube, the medical balloon is sleeved at the distal end of the outer wall of the inner tube, and the proximal end of the medical balloon is connected with the distal end of the outer tube.

Further, the luer connector is of a Y-shaped structure and comprises a connector main body and a side branch connector, wherein the connector main body is communicated with the proximal end of the inner tube, and the side branch connector is connected to the side wall of the connector main body and is communicated with the outer tube.

Further, the balloon catheter further comprises a developing ring, wherein the developing ring is positioned in the medical balloon and is arranged on the outer side of the inner tube.

In a third aspect, the present invention also provides a medical device comprising a pressure pump, a guidewire for passing through the balloon catheter and guiding the balloon catheter into a lesion, and a balloon catheter according to any one of claims 5 to 9, the pressure pump being connected to the balloon catheter.

Compared with the prior art, the medical balloon provided by the invention has the advantages that the plurality of expansion rings are sleeved outside the balloon body in sequence, when the medical balloon enters the lesion area at the bent blood vessel, the plurality of expansion rings at the inner side of the bent part are clung together in sequence under the influence of the bent blood vessel, so that a flat plane is formed, the V-shaped crease appearing when the balloon body is independently used is completely eliminated, the lesion area can be smoothly opened, the expansion pressure is reduced, the pain of a patient is relieved, and the operation risk and the operation cost are reduced; meanwhile, the performance of the medical balloon is not restricted by the original performance of the balloon body by superposition of the two materials of the balloon body and the expansion ring, so that the medical balloon has higher rated pressure and lower compliance.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings that are needed in the embodiments or the description of the prior art will be briefly described below, it being obvious that the drawings in the following description are only some embodiments of the present invention, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

Fig. 1 is a schematic structural view of a medical balloon according to an embodiment of the present invention;

FIG. 2 is a schematic structural view of an expansion ring according to an embodiment of the present invention;

fig. 3 is a schematic structural diagram of a balloon catheter according to an embodiment of the present invention.

Wherein, each reference sign in the figure:

1-a medical balloon; 11-a balloon body; 111-filling the pressure relief cavity; 112-a linking moiety; 114-a working part; 12-an expansion loop; 2-balloon catheter; a 21-catheter assembly; 211-an inner tube; 212-an outer tube; a 22-luer fitting; 221-a connector body; 222-side branch joint.

Detailed Description

In order to make the technical problems, technical schemes and beneficial effects to be solved more clear, the invention is further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the invention.

It will be understood that when an element is referred to as being "mounted" or "disposed" on another element, it can be directly on the other element or be indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly or indirectly connected to the other element. The terms "length," "width," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like are used for convenience of description based on the orientation or positional relationship shown in the drawings, and are not meant to indicate or imply that the devices or elements being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus should not be construed as limiting the application, but rather should be construed to have a particular meaning for the terms given above, as would be understood by those of ordinary skill in the art in view of the specific circumstances.

It should be understood that the terms "comprises" and/or "comprising," when used in this specification and the appended claims, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.

Reference in the specification to "one embodiment" or "some embodiments" or the like means that a particular feature, structure, or characteristic described in connection with the embodiment is included in one or more embodiments of the application. Thus, appearances of the phrases "in one embodiment," "in some embodiments," "in other embodiments," and the like in the specification are not necessarily all referring to the same embodiment, but mean "one or more but not all embodiments" unless expressly specified otherwise. The terms "comprising," "including," "having," and variations thereof mean "including but not limited to," unless expressly specified otherwise.

Referring to fig. 1 and 2, a description will be given of a medical balloon 1 provided by the present invention, where the medical balloon 1 includes a balloon body 11 and a plurality of inflation rings 12 sleeved outside the balloon body 11, the plurality of inflation rings 12 are sequentially arranged along the length direction of the balloon body 11, and an inflation and pressure relief cavity 111 is provided in the balloon body 11. When the medical balloon 1 enters a lesion area at a bent blood vessel, a mixed solution of a developer and normal saline (1:1) is injected into the inflation and pressure relief cavity 111 in the balloon body 11, so that the balloon body 11 is inflated, the inflation rings 12 sleeved on the inner side of the bent part and arranged outside the balloon body 11 are sequentially clung together under the influence of the bent blood vessel, a flat plane is formed, V-shaped folds which are generated when the balloon body 11 is singly used are completely eliminated, and the lesion area can be smoothly opened without using high expansion pressure.

Compared with the prior art, the medical balloon 1 provided by the invention has the advantages that the plurality of expansion rings 12 are sleeved outside the balloon body 11 in sequence, when the medical balloon 1 enters a lesion area at a bent blood vessel, the plurality of expansion rings 12 at the inner side of the bent part are sequentially clung together under the influence of the bent blood vessel to form a flat plane, the V-shaped crease occurring when the balloon body 11 is singly used is completely eliminated, the lesion area can be smoothly opened, the expansion pressure is reduced, the pain of a patient is relieved, and the operation risk and the operation cost are reduced; meanwhile, the performance of the medical balloon 1 is not constrained by the original performance of the balloon body 11 by the superposition of the two materials of the balloon body 11 and the expansion ring 12, so that the medical balloon 1 has higher rated pressure and lower compliance.

In one embodiment, the balloon body 11 includes a connection portion 112 and a working portion 114 having a circular cross section, the connection portion 112 is disposed at two ends of the working portion 114, the connection portion 112 and the interior of the working portion 114 together form an inflation and pressure relief cavity 111, and the plurality of inflation rings 12 are sleeved on the working portion 114 along the length direction of the balloon body 11. In practice, the working portion 114 is used to house the expansion loop 12, and the connecting portion 112 may be used to connect to the outside. In specific applications, the expansion ring 12 may be sleeved on the working portion 114 in various manners, for example, may be adhered by an adhesive, or may be sintered on the working portion 114 of the balloon body 11 by a laser or a heat treatment, and may be selected and set by a person skilled in the art according to actual needs.

In an embodiment, in the length direction of the balloon body 11, the plurality of inflation rings 12 sequentially fill the entire working portion 114, and a preset gap is left between adjacent inflation rings 12. In this way, in a curved blood vessel, the expansion ring 12 can completely cover the working part 114, the expansion ring 12 can be sequentially attached according to the bending degree of the blood vessel, the larger the bending degree of the blood vessel is, the more tightly the expansion ring 12 at the inner side of the bending part is attached, so that a complete curved surface can be formed, and the occurrence of V-shaped folds is avoided.

In one embodiment, the preset gap is equal to or less than the width of the inflation ring 12 along the length of the balloon body 11. In particular, if the preset gap between the adjacent inflation rings 12 is too large, the adjacent inflation rings 12 cannot be sequentially abutted in the curved vessel, so that a complete curve cannot be formed, and therefore the preset gap between the adjacent inflation rings 12 needs to be set to be equal to or smaller than the width of the inflation ring 12 in the length direction of the balloon body 11.

In one embodiment, the expansion ring 12 is made of a polymeric material. Specifically, the inflation ring 12 may be made of polyamide, or may be made of a material having a certain elasticity, such as polyether block amide, thermoplastic polyurethane, or the like, so long as the inflation ring 12 has a certain elasticity and can expand and contract together with the balloon body 11, and those skilled in the art can select the inflation ring according to actual needs. The specific shape of the expansion ring 12 is not limited, and the expansion ring 12 may be set into various shapes according to different clinical requirements, for example, may be a regular ring or a ring with bumps.

The invention also provides a balloon catheter 2, referring to fig. 3 in combination, comprising a luer connector 22, a catheter assembly 21 and the medical balloon 1 as described above, wherein the catheter assembly 21 is respectively connected with the luer connector 22 and the balloon body 11 of the medical balloon 1. The balloon catheter 2 provided by the embodiment of the present invention has the medical balloon 1 provided by any one of the embodiments, so that the medical balloon 1 provided by any one of the embodiments has all the beneficial effects, and is not described in detail herein. In practice, saline may be injected into catheter assembly 21 and medical balloon 1 through luer fitting 22. The luer connector 22 can switch 4 infusion bags without plugging and unplugging infusion needles of a patient, and the luer connector 22 also allows a plurality of mutually compatible fluids to be managed by using the same pipeline, so that wounds on the patient can be reduced. In particular applications, the catheter assembly 21 may be of an inner and outer tubular configuration, or may be of a dual or multi-lumen tubular configuration, as may be selected by one of skill in the art based on actual needs.

Compared with the prior art, the balloon catheter 2 provided by the invention has the advantages that the plurality of expansion rings 12 are sleeved outside the balloon body 11 in sequence, when the medical balloon 1 enters a lesion area at a bent blood vessel, liquid or gas is injected into the catheter assembly 21 through the luer connector 22, so that the expansion rings 12 and the balloon body 11 are expanded together, the plurality of expansion rings 12 at the inner side of the bent part are clung together in sequence under the influence of the bent blood vessel to form a flat plane, the V-shaped crease appearing when the balloon body 11 is independently used is completely eliminated, the lesion area can be smoothly opened, the expansion pressure is reduced, the pain of a patient is relieved, and the operation risk and the operation cost are reduced; meanwhile, the performance of the medical balloon 1 is not constrained by the original performance of the balloon body 11 by the superposition of the two materials of the balloon body 11 and the expansion ring 12, so that the medical balloon 1 has higher rated pressure and lower compliance.

In one embodiment, the catheter assembly 21 comprises an inner tube 211 and an outer tube 212, the inner tube 211 is disposed in the outer tube 212, the medical balloon 1 is sleeved on the distal end of the outer wall of the inner tube 211, and the proximal end of the medical balloon 1 is connected with the distal end of the outer tube 212. In particular, distal refers to the end distal from the operator, i.e., the free end, and proximal refers to the end proximal to the operator. In use, saline may be injected into the medical balloon 1 through the proximal end of the outer tube 212.

In one embodiment, luer 22 is a Y-shaped structure comprising a connector body 221 and a side branch connector 222, connector body 221 communicating with the proximal end of inner tube 211, side branch connector 222 being connected to the side wall of connector body 221 and communicating with outer tube 212. In practice, physiological saline may be injected into the connector body 221 of the luer connector 22 at the proximal end of the balloon catheter 2 by using a syringe, and the lumen of the inner tube 211 may be flushed; the side branch fitting 222 may be used in connection with an inflation pressure pump by which a liquid medium is injected into the outer tube 212 so that the medical balloon 1 is inflated.

In one embodiment, balloon catheter 2 further includes a visualization ring (not shown) positioned within medical balloon 1 and outside of inner tube 211. In the specific application, the position of the developing ring can be displayed through the corresponding instrument, so that operators can know the position of the medical balloon 1, and the operators can conveniently perform corresponding operation.

The present invention also provides a medical device comprising a pressure pump (not shown), a guide wire (not shown) for passing through the balloon catheter 2 and guiding the balloon catheter 2 into a lesion area, and a balloon catheter 2 as described above, the pressure pump being connected to the balloon catheter 2. Specifically, the guidewire includes opposite first and second ends, the first end of the guidewire extending from the balloon body 11 into the balloon catheter 2 and out of the catheter assembly 21, the second end of the guidewire extending from the balloon body 11, and the pressure pump being connected to the catheter assembly 21. The medical device provided by the embodiment of the present invention has the balloon catheter 2 provided by any one of the embodiments, so that the medical device has all the beneficial effects of the balloon catheter 2 provided by any one of the embodiments, which are not described in detail herein. In particular embodiments, a first end of the guidewire enters balloon catheter 2 from second balloon taper 113 and protrudes from connector body 221, and a second end of the guidewire protrudes from second balloon taper 113, with the pressure pump connected to side branch connector 222. In a specific application of the medical device, the method can comprise the following steps:

(1) Using a syringe to inject saline into the connector body 221 of the luer connector 22 at the proximal end of the balloon catheter 2, the lumen of the inner tube 211 can be flushed by the saline since the connector body 221 communicates with the proximal end of the inner tube 211;

(2) Percutaneous puncture implanting a second end of the guidewire within the lumen of the patient and positioning the balloon catheter 2 along the track established by the guidewire into the patient at a location of severely curved lesions;

(3) Injecting a liquid medium into a side branch joint 222 of a luer joint 22 at the proximal end of the balloon catheter 2 by a pressure pump, and conveying the liquid medium into the inflation and pressure relief cavity 111 of the balloon body 11 of the medical balloon 1 through the outer tube 212 because the side branch joint 222 is communicated with the outer tube 212, expanding the balloon body 11 to a nominal diameter by the liquid medium, opening a severely bending lesion position under the action of a plurality of expansion rings 12, and contracting the balloon body 11 by a pressure pump negative pressure;

(4) Using a syringe to inject contrast medium into the joint body 221, since the joint body 221 communicates with the proximal end of the inner tube 211, the contrast medium can be injected into the blood vessel of the patient through the inner tube 211, and the blood flow condition at the severely curved lesion site can be observed by radioscopy;

(5) After the routine treatment or diagnosis is completed on the patient according to the condition of the step (4), the balloon catheter 2 and the guide wire are withdrawn from the patient body, and the whole operation process is completed.

Compared with the prior art, the medical device provided by the invention has the advantages that the balloon catheter 2 is guided to enter a lesion area through the guide wire, the balloon catheter 2 is injected with liquid or gas through the pressure pump, so that the expansion ring 12 and the balloon body 11 are expanded together, when the medical balloon 1 enters the lesion area at the bent blood vessel, the catheter assembly 21 is injected with liquid or gas through the luer connector 22, so that the expansion ring 12 and the balloon body 11 are expanded together, a plurality of expansion rings 12 at the inner side of the bent part are sequentially clung together under the influence of the bent blood vessel to form a flat plane, the V-shaped crease occurring when the balloon body 11 is singly used is completely eliminated, the lesion area can be smoothly opened, the expansion pressure is reduced, the pain of a patient is relieved, and the operation risk and the operation cost are reduced; meanwhile, the performance of the medical balloon 1 is not constrained by the original performance of the balloon body 11 by the superposition of the two materials of the balloon body 11 and the expansion ring 12, so that the medical balloon 1 has higher rated pressure and lower compliance.

It should be understood that the sequence number of each step in the foregoing embodiment does not mean that the execution sequence of each process should be determined by the function and the internal logic of each process, and should not limit the implementation process of the embodiment of the present application in any way.

The foregoing description of the preferred embodiments of the invention is not intended to be limiting, but rather is intended to cover all modifications, equivalents, and alternatives falling within the spirit and principles of the invention.

Claims

1. The medical balloon is characterized by comprising a balloon body and a plurality of elastic expansion rings sleeved outside the balloon body, wherein the expansion rings are sequentially arranged along the length direction of the balloon body, and an inflation and pressure relief cavity is formed in the balloon body;

the balloon body includes a connecting portion and a working portion having a circular cross-section;

in the length direction of the balloon body, a plurality of expansion rings are sequentially distributed on the whole working part, and preset gaps are reserved between adjacent expansion rings;

the preset gap is equal to or smaller than the width of the expansion ring along the length direction of the balloon body.

2. The medical balloon of claim 1, wherein the connecting portions are disposed at two ends of the working portion, the connecting portions and the interior of the working portion together form the inflation and pressure relief cavity, and the plurality of inflation loops are disposed around the working portion along the length of the balloon body.

3. The medical balloon of claim 1 or 2, wherein the inflation ring is made of a polymeric material.

4. A balloon catheter comprising a luer fitting, a catheter assembly and the medical balloon of any one of claims 1 to 3, the catheter assembly being connected to the luer fitting and the balloon body of the medical balloon, respectively.

5. The balloon catheter of claim 4, wherein the catheter assembly comprises an inner tube and an outer tube, the inner tube disposed within the outer tube, the medical balloon being disposed over a distal end of the outer wall of the inner tube, a proximal end of the medical balloon being connected to a distal end of the outer tube.

6. The balloon catheter of claim 5, wherein the luer fitting is a Y-shaped structure comprising a fitting body that communicates with the proximal end of the inner tube and a side branch fitting that is connected to a sidewall of the fitting body and communicates with the outer tube.

7. The balloon catheter of claim 5, further comprising a visualization ring positioned within the medical balloon and outside of the inner tube.

8. A medical device comprising a pressure pump, a guidewire and a balloon catheter according to any one of claims 4 to 7, the guidewire being for passing through the balloon catheter and guiding the balloon catheter into a lesion, the pressure pump being connected to the balloon catheter.