WO2020191806A1

WO2020191806A1 - Balloon catheter

Info

Publication number: WO2020191806A1
Application number: PCT/CN2019/081522
Authority: WO
Inventors: 汪郁卉; 李午阳; 徐勇
Original assignee: 深圳市擎源医疗器械有限公司
Priority date: 2019-03-27
Filing date: 2019-04-04
Publication date: 2020-10-01
Also published as: CN109966627A

Abstract

Provided is a balloon catheter (100), comprising a balloon (30), a catheter (40), and an air inflation apparatus (50); one end of the catheter (40) is in communication with the balloon (30); the air inflation apparatus (50) is mounted on the other end of the catheter (40) and is in communication with the catheter (40); the air inflation apparatus (50) can inflate the balloon (30) by means of a guide member (20) and the catheter (40). If the air inflation apparatus (50) does not inflate the balloon (30), the balloon (30) has a smaller volume and can be inserted into the base of the skull of the patient; after the air inflation apparatus (50) inflates the balloon (30), the balloon (30) expands and becomes larger, and performs the function of supporting the artificial dura mater or hemostatic gel.

Description

Balloon catheter

Technical field

The present invention relates to the technical field of medical devices, in particular to a balloon catheter.

Background technique

Pituitary tumors and craniopharyngiomas are common intracranial tumors, and their treatment is mainly surgical removal of the tumor. Because transsphenoidal resection does not require craniotomy and uses the nasal septum as the surgical channel, it has the advantages of little impact on brain tissue and endocrine function, less trauma, and fewer complications, which has become the first choice for surgical resection of tumors. Cerebrospinal fluid leakage caused by bone defect in the skull base after the operation is the most common complication of the operation and can lead to intracranial infection. At present, artificial dura mater or hemostatic gel is usually used clinically to repair the skull base defect caused by the operation and prevent the leakage of cerebrospinal fluid after the operation. When using the above methods to repair skull base defects, the lack of effective physical support often results in failure of the repair, and a second operation is required to repair it.

Summary of the invention

The main technical problem solved by the present invention is that when the skull base is repaired after transnasal sphenoid resection, the lack of effective physical support of the artificial dura mater or hemostatic gel will cause the repair to fail.

A technical solution adopted by the present invention is to provide a balloon catheter that can be used for skull base repair after transnasal resection surgery, including:

Balloon

A catheter, one end of which is in communication with the balloon;

An inflation device is installed at the other end of the catheter and communicates with the catheter, and the inflation device can inflate the balloon through the guide and the catheter.

In some embodiments, the catheter includes a tube body and a reinforcement part embedded in the tube wall of the tube body, the reinforcement part is a semi-rigid metal wire, and the reinforcement part is embedded in the tube body. Inside the wall of the tube.

In some embodiments, the catheter includes a tube body and a reinforcement part, the reinforcement part is embedded in the tube wall of the tube body, the reinforcement part is a circular tube-shaped mesh, and the reinforcement part is evenly embedded in the Inside the tube wall of the tube body.

In some embodiments, the balloon catheter further includes a guide, and the balloon is sleeved on the guide and communicates with the guide, and the guide communicates with one end of the catheter.

In some embodiments, one end of the guide member is semi-spherical or conical, and the other end is in communication with one end of the catheter; the side wall of the guide member is provided with an air outlet, and the balloon is sleeved on the The outer side wall of the guide member, and communicates with the guide member through the air outlet hole.

In some embodiments, the inflator indicates that the balloon is used to inflate the balloon, and the pressure in the balloon can be known through changes in the size, hardness, or thickness of the inflator.

In some embodiments, the inflation device is provided with a scale, and the pressure in the balloon is obtained by reading the scale.

In some embodiments, the balloon catheter further includes a valve installed on the inflation device.

In some embodiments, the valve is a one-way valve.

In some embodiments, the balloon catheter further includes a fixing clip installed on the catheter for fixing the catheter.

The beneficial effect of the embodiment of the present invention is: different from the state of the prior art, the balloon catheter in the embodiment of the present invention includes a balloon, a catheter, and an inflation device, and one end of the catheter is connected to the balloon; the inflation device It is installed at the other end of the catheter and communicated with the catheter, and the inflation device can inflate the balloon through the guide and the catheter. Through the above method, when the inflator is not inflated into the balloon, the balloon has a small volume and can be inserted into the base of the patient's skull; after the inflator is inflated into the balloon, the balloon expands and becomes larger. Support the role of artificial dura mater or hemostatic gel.

Description of the drawings

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

2 is a longitudinal cross-sectional view of the catheter in the balloon catheter in one of the embodiments of the present invention;

3 is a transverse cross-sectional view of the catheter in the balloon catheter in one of the embodiments of the present invention;

4 is a longitudinal sectional view of a catheter in a balloon catheter according to another embodiment of the present invention;

5 is a transverse cross-sectional view of a catheter in a balloon catheter according to another embodiment of the present invention;

Figure 6 is a perspective view of a locking device in a balloon catheter according to an embodiment of the present invention;

Fig. 7 is an exploded view of the locking device in the balloon catheter of the embodiment of the present invention.

detailed description

In order to facilitate the understanding of the present invention, the present invention will be described in more detail below with reference to the drawings and specific embodiments. It should be noted that when an element is expressed as being "fixed to" another element, it can be directly on the other element, or there can be one or more elements in between. When an element is said to be "connected" to another element, it can be directly connected to the other element, or there may be one or more intervening elements in between. The terms "vertical", "horizontal", "left", "right" and similar expressions used in this specification are for illustrative purposes only.

Unless otherwise defined, all technical and scientific terms used in this specification have the same meaning as commonly understood by those skilled in the technical field of the present invention. The terms used in the specification of the present invention in this specification are only for the purpose of describing specific embodiments, and are not used to limit the present invention. The term "and/or" as used in this specification includes any and all combinations of one or more related listed items.

The present invention provides a balloon catheter that can be used for repairing the skull base after transnasal resection surgery. Please refer to FIG. 1. The balloon catheter 100 provided by the embodiment of the present invention includes: a guide 20, a balloon 30, and a catheter 40. Inflator 50 and one-way valve 60. The balloon 30 is sleeved on the outside of the guide 20 and communicates with the guide 20. The guide 20 communicates with one end of the catheter 40, and the other end of the catheter 40 is connected to the inflator. The device 50, the valve 60 is installed on the inflation device 50.

The balloon catheter 100 in the embodiment of the present invention mainly includes a balloon 30, a catheter 40, and an inflation device 50. One end of the catheter 40 is in communication with the balloon 30; the inflation device 50 is installed at the other end of the catheter 40 , And communicate with the catheter 40, the inflation device 50 can inflate the balloon 30 through the guide 20 and the catheter 40. In the above manner, when the inflation device 50 is not inflated into the balloon 30, the balloon 30 has a small volume and can be inserted into the base of the patient's skull; after the inflation device 50 inflates the balloon 30, the balloon 30 The swelling becomes larger, and it plays the role of supporting the artificial dura mater or hemostatic gel.

Specifically, in the embodiment of the present invention, the guide member 20 may be made of plastic such as silica gel or PVC. The guide member 20 has a circular tube shape, one end of which is semi-spherical or conical, and the other end is in communication with one end of the pipe 40. The side wall of the guide member 20 is provided with an air outlet hole (not shown in the figure), and the balloon 30 is sleeved on the outer side wall of the guide member 20 and communicates with the guide member 20 through the air outlet hole.

The balloon 30 is an elastomer made of thermoplastic materials such as nylon or TPE. The balloon 30 is a hollow sphere and is adhered to the outer side wall of the guide 20. The balloon 30 communicates with the guide 20 through the air outlet.

The pipe 40 includes a pipe body 41 and a reinforcing part 42. The pipe body 41 is a hose made of thermoplastic materials such as PVC, PE, PA, or Pebax. The reinforcing portion 42 is embedded in the tube wall of the tube body 41 to enhance the rigidity of the tube body 41.

In one of the embodiments, as shown in FIGS. 2 and 3, the reinforcing portion 42 is a semi-rigid metal wire, the reinforcing portion 42 is embedded in the pipe wall of the pipe body 41, and the reinforcing portion 42 is connected to The geometric center lines of the tube body 41 are arranged in parallel. The reinforcing portion 42 can increase the rigidity of the tube body 41, thereby making the catheter 40 semi-rigid. This structure facilitates smooth insertion of the catheter 40 along the patient's bronchus, and due to the semi-rigid nature of the catheter 40, the balloon catheter 100 can be changed with the shape of the bronchus during the process of being inserted into the patient's bronchus.

It is understandable that, in another embodiment, the reinforcing portion 42 includes a plurality of semi-rigid metal wires, and the reinforcing portion 42 is evenly embedded in the tube wall of the tube body 41, and the plurality of semi-rigid metal wires are It is parallel to the geometric centerline of the tube body 41. The reinforcing portion 42 can increase the rigidity of the tube body 41, thereby making the catheter 40 semi-rigid. This structure facilitates smooth insertion of the catheter 40 along the patient's bronchus, and due to the semi-rigid nature of the catheter 40, the balloon catheter 100 can be changed with the shape of the bronchus during the process of being inserted into the patient's bronchus. Further, because the reinforcing portion 42 is a circular tube-shaped mesh, the reinforcing portion 42 is evenly distributed on the tube wall of the tube body 41. During the process of inserting the balloon catheter 100 into the patient's bronchus, the force of the bronchial tube wall is more even, so as to avoid causing discomfort to the patient, such as tingling or squeezing.

In another embodiment, as shown in FIGS. 4 and 5, the reinforcing portion 42 is a circular tube-shaped mesh, and the reinforcing portion 42 is evenly embedded in the tube wall of the tube body 41. The reinforcing portion 42 can increase the rigidity of the tube body 41, thereby making the catheter 40 semi-rigid. This structure facilitates smooth insertion of the catheter 40 along the patient's bronchus, and due to the semi-rigid characteristics of the catheter 40, the catheter 40 can be changed with the shape of the bronchus during the process of being inserted into the patient's bronchus. Furthermore, since the reinforcing portion 42 is a circular tube-shaped mesh, the reinforcing portion 42 is evenly distributed on the tube wall of the tube body 41. During the process of inserting the balloon catheter 100 into the patient's bronchus, the force of the bronchial tube wall is more even, so as to avoid causing discomfort to the patient, such as tingling or squeezing.

If the catheter 40 does not have the reinforcing part 42, it is only the tube body 41. Although the tube body 41 is a hose made of thermoplastic materials such as nylon or TPE, the catheter 40 will follow the bronchus after the catheter 40 is inserted into the bronchus. When the shape is bent, uneven bending occurs. Specifically, the catheter 40 may be bent sharply at a certain point, resulting in sharp edges and corners due to the bending, which may easily cause a tingling sensation to the patient. Especially when the angle that needs to be bent is large, because the bending angle of the catheter 40 is too large, the pipe wall at the bend is severely deformed, which causes the pipe walls to fit each other and block the catheter 40, resulting in the need to inflate the balloon 30. When the inflator 50 cannot inflate the balloon 30 through the catheter 40; or when the balloon 30 needs to be removed, the balloon 30 cannot be removed due to its large volume because the gas in the balloon 30 cannot be released.

The inflator 50 may specifically be a syringe or an indicating balloon. In this embodiment, the inflator 50 is an indicator balloon, and the inflator 50 is installed at the other end of the catheter 40 and communicates with the balloon 30 through the catheter 40. The inflator 50 is used to inflate the balloon 30, and the pressure in the balloon 30 can be known through changes in the size, hardness, or thickness of the inflator 50. Of course, in other ways, a scale can also be provided on the inflator 50, and the pressure in the balloon 30 can be obtained by reading the scale.

One end of the inflator 50 is connected to the other end of the conduit 40, and the valve 60 is installed with the other end of the inflator 50. The valve 60 is a one-way valve used to deflate the balloon 30.

The following will briefly describe the use of the balloon catheter:

The patient needs skull base repair after transnasal sphenoid resection. First, artificial dura mater or hemostatic gel is placed into the patient's skull base defect, and then the guide 20 is inserted into the patient's bronchus. Since the front end of the guide 20 is semi-spherical or conical, it is advantageous to guide the balloon 30 and the catheter 40 to slide along the bronchus. After the balloon enters the skull base defect via the bronchus, adjust the specific position of the balloon. At this time, the balloon is inflated by the inflator 50, so that the volume of the balloon becomes larger and effective physical support is formed. Finally, the syringe or the inflator is disconnected, the one-way valve 60 is closed, the filled balloon 30 remains in the body, a part of the catheter 40 and the inflator 50, and the valve 60 is fixed on the skin surface.

In order to fix the part of the catheter 50 left on the patient's body on the patient's body, so as to prevent the patient from causing discomfort due to the shaking of the catheter 50. Please refer to FIG. 1 again. The balloon catheter 100 also includes a fixing clip 70 installed on the outer wall of the middle part of the catheter 40 to fix the catheter 40 on the skin surface. It is made of plastic such as PC, PE, or PP. Made of materials. The fixing clip 70 is installed on the catheter 40 and is located between the balloon 30 and the inflation device 50.

Since the balloon catheter 100 needs to be disconnected after the patient undergoes a transsphenoidal resection operation, the guide 20, the balloon 30 and the other part of the catheter 50 will be temporarily left in the patient's body. The disconnection of the catheter 50 needs to be sealed to prevent the air in the balloon 30 from flowing out and affect the supporting effect of the balloon 30. 6 and 7, the balloon catheter 100 further includes a locking device 80, the locking device 80 includes a clamping member 81 and a locking ring 82, the clamping member 81 includes a base 811, a clip The tightening portion 812 and the through hole 813, the base portion 811 is cylindrical, the clamping portion 812 is substantially V-shaped, one end of the clamping portion 812 is fixedly connected to one end of the base 811, the clamping portion The outer surface of 812 is a conical surface. The outer side surface of the base 811 and the outer side surface of the clamping portion 812 smoothly transition, and the outer side surface of the base portion 811 and the outer side surface of the clamping portion 812 are both provided with external threads. The through hole 813 penetrates the base 811 and the clamping portion 812 along the axis of the base 811. The pipe 40 passes through the locking device 80 through the through hole 813. The clamping portion 812 has two inner side surfaces, and the two inner side surfaces are opposite to each other, and are provided with a tooth-like structure, and the tooth-like structures of the two inner side surfaces can mesh with each other. The locking ring 82 is annular, the inner surface of the locking member 82 is provided with internal threads, and the locking ring 82 is sleeved on the base 811. Rotating the locking ring 82 can make the locking ring 82 move from the base 811 to the clamping portion 812 or from the clamping portion 812 to the base 811. When the base 811 moves to the clamping portion 812, when the locking ring 82 moves from the connecting end of the clamping portion 812 to the suspended end, the clamping portion 812 is gradually clamped. The two inner side surfaces of the clamping portion 812 are close to each other, and the tooth-like structures of the two inner side surfaces mesh with each other. When the clamping portion 812 is completely clamped, the catheter 40 is clamped by the clamping portion 812, and the catheter 40 is bent into a wave shape in the area clamped by the clamping portion 812, and is clamped. Hold into a flat shape. Since the clamped area of the duct 40 is bent into a wave shape, it can be more beneficial to prevent gas from passing through this area on the duct 40, thereby achieving a complete seal.

It should be noted that the description of the present invention and its accompanying drawings give preferred embodiments of the present invention, but the present invention can be implemented in many different forms and is not limited to the embodiments described in this specification. These embodiments are not intended as additional limitations on the content of the present invention, and the purpose of providing these embodiments is to make the understanding of the disclosure of the present invention more thorough and comprehensive. In addition, the above technical features continue to be combined with each other to form various embodiments not listed above, which are regarded as the scope of the description of the present invention; further, for those of ordinary skill in the art, improvements or changes can be made based on the above description. , And all these improvements and transformations should belong to the protection scope of the appended claims of the present invention.

Claims

A balloon catheter (100), characterized in that it comprises:

Balloon (30);

A catheter (40), one end of which is in communication with the balloon (30);

The inflation device (50) is installed at the other end of the catheter (40) and communicates with the catheter (40). The inflation device (50) can pass through the guide (20) and the catheter (40). ) Inflate the balloon (30).
The balloon catheter (100) according to claim 1, wherein:

The catheter (40) includes a tube body (41) and a reinforcement part (42), the reinforcement part (42) is embedded in the tube wall of the tube body (41); the reinforcement part (42) is a semi-rigid The metal wire, the reinforcing part (42) is embedded in the pipe wall of the pipe body (41).
The balloon catheter (100) according to claim 1, wherein:

The catheter (40) includes a tube body (41) and a reinforcement part (42), the reinforcement part (42) is embedded in the tube wall of the tube body (41); the reinforcement part (42) is a round tube shape The reinforcing part (42) is evenly embedded in the pipe wall of the pipe body (41).
The balloon catheter (100) according to claim 1, wherein:

The balloon catheter (100) further includes a guide (20), the balloon (30) is sleeved on the guide (20) and communicates with the guide (20), the guide (20) 20) Communicating with one end of the pipe (40).
The balloon catheter (100) according to claim 1, wherein:

One end of the guide piece (20) is semi-spherical or conical, and the other end is connected with one end of the catheter (40); the side wall of the guide piece (20) is provided with an air outlet, and the balloon (30) ) Is sleeved on the outer side wall of the guide member (20), and communicates with the guide member (20) through the air outlet.
The balloon catheter (100) according to claim 1, wherein:

The inflator (50) is used to indicate that the balloon is used to inflate the balloon (30), and the balloon (30) can be known by the change in size, hardness, or thickness of the inflator (50) Pressure within.
The balloon catheter (100) according to claim 6, characterized in that:

The inflation device (50) is provided with a scale, and the pressure in the balloon (30) is obtained by reading the scale.
The balloon catheter (100) according to claim 1, wherein:

The balloon catheter (100) further includes a valve (60), and the valve (60) is installed on the inflation device (50).
The balloon catheter (100) according to claim 8, wherein:

The valve (60) is a one-way valve.
The balloon catheter (100) according to claim 1, wherein:

The balloon catheter (100) further includes a fixing clip (80), and the fixing clip (80) is installed on the catheter (40) for fixing the catheter (40).