WO2023246277A1

WO2023246277A1 - Ventricular assist apparatus and method for manufacturing same

Info

Publication number: WO2023246277A1
Application number: PCT/CN2023/090093
Authority: WO
Inventors: 叶文雄; 杨云骢; 刘曦; 杨夏燕; 虞奇峰
Original assignee: 上海焕擎医疗科技有限公司
Priority date: 2022-06-23
Filing date: 2023-04-23
Publication date: 2023-12-28
Also published as: CN117298411A

Abstract

Provided is a ventricular assist apparatus and a method for manufacturing same. The ventricular assist apparatus comprises: an axial flow pump body (20) and a pigtail pipe body (10) provided at a distal end of the axial flow pump body (20). The pigtail pipe body (10) comprises a bending part (11) located at a distal end and a supporting part (12) located at a proximal end. At least part of a distal end of the bending part (11) is a bent pipe in a natural state, and the bending part (11) can be roughly straightened under the action of an external force. The at least part of the distal end of the bending part (11) is a variable-diameter section. The material of the bending part (11) has a first hardness. The supporting part (12) is of a straight pipe structure in a natural state, and the material of the supporting part (12) has a second hardness greater than the first hardness. By means of dividing the pigtail pipe into the supporting part (12) and the bending part (11) and making the hardness of the supporting part (12) greater than that of the bending part (11), the pigtail pipe has good resilience while maintaining good support performance, so that the supporting part (12) can prevent a product from attaching to a wall and an inflow opening (30) from being blocked, and the bending part (11) can quickly rebound to a pigtail shape after crossing a valve and withdrawing a guide wire, thereby preventing a ventricular wall from being scratched.

Description

A ventricular assist device and a method for manufacturing the ventricular assist device

Technical field

The present invention relates to the technical field of medical devices, and in particular to a ventricular assist device and a manufacturing method of the ventricular assist device.

Background technique

The percutaneous ventricular assist device is a newer type of medical device compared to traditional ventricular assist devices or cardiac blood pumps. Its main advantage is that it does not require thoracotomy for implantation and can be implanted through minimally invasive methods such as femoral artery puncture or incision. heart, greatly reducing surgical risks. This advantage allows it to be used to maintain vital signs in patients with severe heart failure, or to assist in high-risk PCI (percutaneous coronary intervention) surgery to reduce surgical risks. However, during the operation of the percutaneous ventricular assist device, its distal end is placed in the left ventricle after crossing the valve, and the proximal end is in the aorta, and its position will gradually shift over time after operation. , in order to avoid damage to the ventricular wall during operation and implantation, a pigtail tube is used as the distal end of the device. In order to prevent the inflow chamber from sticking to the ventricular wall during the operation of the device and affecting the performance of the product, the pigtail tube needs to have good support; after the device is implanted and the guide wire is withdrawn, the pigtail tube should rebound quickly to avoid scratching the ventricle. wall, so the pigtail tube needs to have good resilience. Existing pig tail tubes are generally made of thermoplastic polyurethane. Although pig tail tubes with lower hardness have better resilience and can rebound to the original pig tail shape within a few seconds, they have poor support and may cause problems during surgery. Risk of the inflow chamber sticking against the ventricular wall, causing blockage of the flow path. The pigtail tube with higher hardness has better support in the straight section, but its rebound elasticity is poor. After the guide wire is withdrawn, the curved end cannot rebound from the straight tube state to the pigtail curved state in time, and the head end is easily scratched. room wall.

In view of this, there is an urgent need to improve existing ventricular assist devices so that the pigtail tube has good support and good resilience.

Contents of the invention

The invention discloses a ventricular assist device and a method for making the ventricular assist device, which are used to solve the problem in the prior art that the pigtail tube of the ventricular assist device cannot have both support and resilience.

In order to solve the above problems, the present invention adopts the following technical solutions:

A ventricular assist device is provided, including an axial flow pump body and a pigtail tube body disposed at the distal end of the axial flow pump body;

The pigtail tube body includes a bending portion located at the distal end and a supporting portion located at the proximal end;

At least part of the section at the distal end of the bent part is a bent pipe in a natural state, and the bent part can be substantially straightened under the action of external force; at least part of the section at the distal end of the bent part is a variable diameter section, and the variable diameter section The outer diameter of the diameter section gradually decreases by 4% to 30% from the proximal end to the distal end; the material of the bending part has the first hardness;

The support part has a straight tube structure in a natural state, and the material of the support part has a second hardness greater than the first hardness.

In the above solution, the support part is a straight pipe with an equal diameter and an outer diameter of 2 to 3 mm.

In the above solution, the proximal end of the bending part is the same as the outer diameter of the supporting part.

In the above solution, the outer diameter of the variable diameter section gradually decreases by 10% from the proximal end to the distal end.

In the above solution, the first hardness ranges from 50D to 60D, and the second hardness ranges from 60D to 70D.

In the above solution, the bending part and the supporting part are both made of thermoplastic polyurethane.

In the above solution, it is characterized in that the bending part and the supporting part are connected by welding or bonding, and the connection position is a connection surface.

In the above solution, the connection surface between the support part and the bending part is a non-vertical connection surface.

In the above solution, the non-vertical connection surface includes a chamfered connection surface. .

In the above solution, the bending part and the supporting part are an integral structure, and supporting parts are provided in at least some sections of the supporting part, and the supporting parts are used to increase the overall hardness of the supporting part.

In the above solution, the support member is a spiral and braided tubular structure, or an integrally formed tubular structure.

In the above solution, the bending part and the supporting part are made of thermoplastic polyurethane with the same hardness.

The present invention also provides a method for manufacturing a ventricular assist device according to any one of the above solutions, including:

providing a thermoplastic polyurethane having a first hardness and a second hardness respectively, wherein the second hardness is greater than the first hardness;

Extruding and shaping the thermoplastic polyurethane of the first hardness and the thermoplastic polyurethane of the second hardness respectively;

Cut the thermoplastic polyurethane of the first hardness and the thermoplastic polyurethane of the second hardness into a bending part and a supporting part;

Bonding or welding the bending part and the supporting part;

The bending part and the supporting part are connected to form a pigtail tube body.

In the above solution, the fracture force that the interface of the pigtail tube body can withstand is greater than 50N.

In the above solution, the welding includes:

Cover the bending part and the support part with heat-shrinkable tubes respectively, and heat the connection surface between the bending part and the support part using a high temperature of 100°C to 300°C;

Stop heating and allow to cool.

In the above scheme, it also includes:

Provide a casing, one end of which is provided with an inlet;

The pigtail tube body is plugged into one end provided with the inlet;

The axial flow pump body is at least partially inserted into the other end of the casing to form an outflow chamber.

The technical solution adopted by the present invention can achieve the following beneficial effects:

The pigtail tube of the ventricular assist device is divided into a support part and a bending part, and the support part is harder than the bending part, so that the pigtail tube maintains good support and has good resilience. The support part can prevent the product from sticking to the wall and flowing into the inlet. The adverse consequences caused by blockage, and the curved portion can quickly rebound to a pigtail shape after crossing the valve and withdrawing the guidewire, thereby preventing scratching of the ventricular wall; at least part of the distal area of the curved portion is a variable-diameter section, and the variable-diameter section The outer diameter of the segment gradually decreases from the proximal end to the distal end, making the curved portion smoother when passing through the hemostatic valve and implanting, and the distal end is tapered to enhance resilience. When the axial flow pump operates, liquid flows in from the inlet, thereby forming a negative pressure. Due to the good support of the support part, the inlet is prevented from sticking to the wall, so it does not affect the performance of the axial flow pump, thus avoiding the risk of blockage of the flow channel. Improved safety of use of cardiac assist devices.

Description of the drawings

In order to explain the technical solutions of the embodiments of the present invention more clearly, the accompanying drawings needed to be used in the description of the embodiments will be briefly introduced below, which constitute a part of the present invention. The schematic embodiments of the present invention and their explanations explain the present invention. , does not constitute an improper limitation of the present invention. In the attached picture:

Figure 1 is a schematic diagram of the overall structure of the ventricular assist device disclosed in Embodiment 1 of the present invention;

Figure 2 is a schematic diagram of the overall structure of the pigtail tube of the ventricular assist device disclosed in Embodiment 1 of the present invention;

Figure 3 is a cross-sectional view of the pigtail tube of the ventricular assist device disclosed in Embodiment 2 of the present invention.

Specifically include the following reference signs:
Pigtail tube body-10; bending part-11; support part-12; support part-13; axial flow pump body-20; inlet-30; casing-40.

Detailed ways

In order to make the purpose, technical solutions and advantages of the present invention more clear, the technical solutions of the present invention will be clearly and completely described below with reference to specific embodiments of the present invention and corresponding drawings. Obviously, the described embodiments are only some of the embodiments of the present invention, but not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts fall within the scope of protection of the present invention.

Example 1

As shown in Figures 1 and 2, the ventricular assist device provided by the present invention includes an axial flow pump body 20 and a pigtail tube body 10 located at the distal end of the axial flow pump body 20; the pigtail tube body 10 includes a The bending part 11 and the supporting part 12 located at the proximal end.

At least part of the distal section of the bent part 11 is a bent pipe in the natural state, and the bent part 11 can be substantially straightened under the action of external force; at least part of the distal section of the bent part 11 is a variable diameter section, and the outer diameter of the variable diameter section It gradually decreases by 4% to 30% from the proximal end to the distal end; the material of the curved portion 11 has a first hardness; the support portion 12 has a straight tube structure in its natural state, and the material of the support portion 12 has a second hardness greater than the first hardness. .

The present invention divides the pigtail tube body 10 of the ventricular assist device into a support part 12 and a bending part 11, and the support part 12 is harder than the bending part 11, so that the pigtail tube body 10 maintains good support and has good resilience. The support part 12 can prevent adverse consequences caused by product wall adhesion and inlet blockage, and the bending part 11 can quickly rebound to a pigtail shape after crossing the valve and withdrawing the guidewire, thereby preventing scratches on the ventricular wall; the bending part 11 At least part of the distal end is a variable-diameter section, and the outer diameter of the variable-diameter section gradually decreases from the proximal end to the distal end, making the curved portion 11 smoother when passing through the hemostatic valve and implanting, and the distal end gradually becomes thinner to enhance the return. elasticity. The axial flow pump body 20 operates, causing liquid to flow in from the inlet 30, thereby forming a negative pressure. Since the support part 12 has good support, the inlet 30 is prevented from sticking to the wall, so it will not affect the performance of the axial flow pump body 20, so it is avoided. Reduces the risk of flow channel blockage. Improved safety of use of cardiac assist devices.

The support part 12 is a straight pipe with an equal diameter and an outer diameter of 2 to 3 mm. Preferably, the outer diameter of one end of the bent portion 11 close to the supporting portion 12 is the same as the outer diameter of the supporting portion 12 .

Preferably in this embodiment, the outer diameter of the variable diameter section gradually decreases by 10% from the proximal end to the distal end. The curved portion 11 is smoother when passing through the hemostatic valve and implanted, and the distal end is gradually tapered to enhance resilience without being too thin.

Preferably in this embodiment, the first hardness is 50D-60D, and the second hardness is 60D-70D.

Preferably in this embodiment, the bending portion 11 and the supporting portion 12 of the pigtail tube body 10 are made of thermoplastic polyurethane. It has the characteristics of high strength, high toughness and wear resistance, and is widely used in the medical industry.

Preferably in this embodiment, the bending part 11 and the supporting part 12 are connected by welding or bonding, and the connection position is the connection surface. The thermoplastic polyurethane of the bending part 11 has a first hardness, and the thermoplastic polyurethane of the support part 12 has a second hardness. The bending part 11 and the supporting part 12 are manufactured separately and then connected and formed.

Preferably in this embodiment, the connection surface between the support part 12 and the bending part 11 is a non-vertical connection surface, and the support part 12 and the bending part 11 are connected by welding.

Preferably in this embodiment, the non-vertical connection surface includes a chamfered connection surface. The chamfered connection surface increases the contact area of the connection surface during welding and increases the welding area between the bending part 11 and the supporting part 12 . Improved tear resistance of the connection surface.

When the blood pump is withdrawn from the human body, the pig tail tube body 10 will bear part of the tensile force due to friction with the blood vessel wall. Therefore, the bending portion 11 and the supporting portion 12 need to be tightly welded. The pig tail tube body 10 in the present invention is epoxy-coated. Ethane high temperature sterilization After aging treatment, a destructive tensile test was conducted on it using a tensile machine, and the measured breaking force was greater than 50N, which is sufficient to meet the requirements.

Specifically, when making the pigtail tube body 10, thermoplastic polyurethane granules of different hardnesses are first extruded and shaped after heat treatment. After cutting, put on a heat shrink tube of appropriate size, and use equipment to align the interface of the two hardness tubes with a high temperature of 100°C to 300°C for heating. Stop heating after a period of time and cool down. After welding, its surface quality can be seen under a 50x microscope without obvious scratches, so it will not damage blood cells.

Example 2

As shown in FIG. 3 , what is different from Embodiment 1 is that in this embodiment, the bending part 11 and the supporting part 12 are an integral structure, and the supporting part 12 is provided with a supporting member 13 in at least some sections inside it. The support member 13 is used to increase the overall hardness of the support portion 12 .

Specifically, the support member 13 is a spiral and braided tubular structure or an integrally formed tubular structure, which can increase the supportability of the support portion 12. The support member 13 can be made of metal or other materials with high hardness, which can further strengthen the support. To support the supportability of the portion 12, preferably, the support member 13 has a third hardness that is not less than the second hardness.

In this embodiment, the bending part 11 and the supporting part 12 are made of thermoplastic polyurethane with the same hardness. Preferably, both the bending part 11 and the supporting part 12 have the first hardness.

In this embodiment, the bending part 11 and the supporting part 12 adopt an integrated structure to facilitate production without the need for welding. Therefore, the pigtail tube body 10 has strong tear resistance and improves production efficiency. The supporting part 13 can be made of a wide range of materials. The hardness of the support part 12 has a wide selection range.

Example 3

The present invention also provides a method for manufacturing the ventricular assist device in Embodiment 1, which is shown in conjunction with Figures 1 and 2, including:

Cut the thermoplastic polyurethane of the first hardness and the thermoplastic polyurethane of the second hardness to form the bending part 11 and the supporting part 12;

Bond or weld the bending part 11 and the supporting part 12;

The bending part 11 and the supporting part 12 are connected to form the pigtail pipe body.

Preferably in this embodiment, the bending part 11 and the supporting part 12 are connected by welding, including:

Put the bending part 11 and the support part 13 on the heat shrink tube respectively, align the connection surface of the bending part 11 and the support part 12 and heat it at a high temperature of 100°C to 300°C;

Stop heating and allow to cool.

Preferably in this embodiment, the interface of the pigtail tube body can withstand a breaking force greater than 50N. Withdrawal due to blood pump In the human body, the pig tail tube body 10 will bear part of the tensile force due to friction with the blood vessel wall, so the bending part 11 and the supporting part 12 need to be tightly welded. The pig tail tube body 10 in the present invention has been sterilized by high temperature with ethylene oxide and After aging treatment, a tensile machine was used to conduct a destructive tensile test, and the measured breaking force was greater than 50N, which can meet the requirements.

Preferably in this embodiment, the connecting surface of the bending part 11 and the supporting part 12 is smooth enough. After welding, the surface of the connecting surface of the bending part 11 and the supporting part 12 can have no obvious scratches under a 50x microscope, so it is suitable for Blood cells are not damaged.

The manufacturing method of the ventricular assist device provided by the present invention also includes:

A casing 40 is provided, and one end of the casing 40 is provided with an inlet 30;

The pigtail tube body 10 is plugged into one end provided with the inlet 30;

The axial flow pump body 20 is at least partially inserted into the other end of the sleeve 40 to form an outflow chamber.

The present invention divides the pigtail tube of the ventricular assist device into a support part and a bending part, and the support part is harder than the bending part, so that the pigtail tube maintains good support and has good resilience, and the support part can prevent the product from sticking to the wall and The adverse consequences caused by blockage of the inlet, and the curved portion can quickly rebound to a pigtail shape after crossing the valve and withdrawing the guidewire, thereby preventing scratching of the ventricular wall; at least part of the distal area of the curved portion is a variable diameter section, The outer diameter of the variable-diameter section gradually decreases from the proximal end to the distal end, making the curved portion smoother when passing through the hemostatic valve and implanting, and the distal end is gradually tapered to enhance resilience. When the axial flow pump operates, liquid flows in from the inlet, thereby forming a negative pressure. Due to the good support of the support part, the inlet is prevented from sticking to the wall, so it does not affect the performance of the axial flow pump, thus avoiding the risk of blockage of the flow channel. Improved safety of use of cardiac assist devices.

The embodiments of the present invention have been described above in conjunction with the accompanying drawings. However, the present invention is not limited to the above-mentioned specific implementations. The above-mentioned specific implementations are only illustrative and not restrictive. Those of ordinary skill in the art will Under the inspiration of the present invention, many forms can be made without departing from the spirit of the present invention and the scope protected by the claims, all of which fall within the protection of the present invention.

Claims

A ventricular assist device, characterized by comprising an axial flow pump body and a pigtail tube body disposed at the distal end of the axial flow pump body;

The pigtail tube body includes a bending portion located at the distal end and a supporting portion located at the proximal end;

At least part of the section at the distal end of the bent part is a bent pipe in a natural state, and the bent part can be substantially straightened under the action of external force; at least part of the section at the distal end of the bent part is a variable diameter section, and the variable diameter section The outer diameter of the diameter section gradually decreases by 4% to 30% from the proximal end to the distal end; the material of the bending part has the first hardness;

The support part has a straight tube structure in a natural state, and the material of the support part has a second hardness greater than the first hardness.
The ventricular assist device according to claim 1, wherein the support part is a straight tube with an outer diameter of 2 to 3 mm.
The ventricular assist device according to claim 1, wherein the proximal end of the bending portion is the same as the outer diameter of the supporting portion.
The ventricular assist device according to claim 1, wherein the outer diameter of the variable diameter section gradually decreases by 10% from the proximal end to the distal end.
The ventricular assist device according to claim 1, wherein the first hardness ranges from 50D to 60D, and the second hardness ranges from 60D to 70D.
The ventricular assist device according to claim 1, wherein the bending part and the supporting part are made of thermoplastic polyurethane.
The ventricular assist device according to any one of claims 1 to 6, wherein the bending part and the supporting part are connected by welding or bonding, and the connection position is a connection surface.
The ventricular assist device according to claim 7, wherein the connection surface between the support part and the bending part is a non-vertical connection surface.
The ventricular assist device according to claim 8, wherein the non-vertical connection surface includes a chamfered connection surface.
The ventricular assist device according to claim 1, characterized in that the bending part and the supporting part are an integral structure, and at least some sections of the supporting part are provided with supporting parts, and the supporting parts are used to increase the The overall stiffness of the support.
The ventricular assist device according to claim 10, wherein the support member is a spiral and braided tubular structure, or an integrally formed tubular structure.
The ventricular assist device according to claim 10, wherein the bending part and the supporting part are made of thermoplastic polyurethane with the same hardness.
A method for manufacturing a ventricular assist device according to any one of claims 1 to 9, characterized in that it includes:

providing a thermoplastic polyurethane having a first hardness and a second hardness respectively, wherein the second hardness is greater than the first hardness;

Extruding and shaping the thermoplastic polyurethane of the first hardness and the thermoplastic polyurethane of the second hardness respectively;

Cut the thermoplastic polyurethane of the first hardness and the thermoplastic polyurethane of the second hardness into a bending part and a supporting part;

Bonding or welding the bending part and the supporting part;

The bending part and the supporting part are connected to form a pigtail tube body.
The method of manufacturing a ventricular assist device according to claim 13, wherein the interface of the pigtail tube body can withstand a breaking force greater than 50N.
The method of manufacturing a ventricular assist device according to claim 13, wherein the welding includes:

Cover the bending part and the support part with heat-shrinkable tubes respectively, and heat the connection surface between the bending part and the support part using a high temperature of 100°C to 300°C;

Stop heating and allow to cool.
The method for manufacturing a ventricular assist device according to claim 13, further comprising:

Provide a casing, one end of which is provided with an inlet;

The pigtail tube body is plugged into one end provided with the inlet;

The axial flow pump body is at least partially inserted into the other end of the casing to form an outflow chamber.