CN115252219A

CN115252219A - Adjustable pre-plastic balloon catheter

Info

Publication number: CN115252219A
Application number: CN202111114442.5A
Authority: CN
Inventors: 刘春杰; 台运莉; 荣慧; 王皓
Original assignee: Shanghai Haofeng Medical Technology Co ltd
Current assignee: Shanghai Haofeng Medical Technology Co ltd
Priority date: 2021-09-23
Filing date: 2021-09-23
Publication date: 2022-11-01

Abstract

The invention belongs to the technical field of medical instruments, particularly relates to the field of A61F2/24, and particularly relates to an adjustable pre-plastic balloon catheter. The invention provides an adjustable pre-plastic balloon catheter which comprises an inner tube, wherein the inner tube is made of nickel-titanium memory alloy and is pre-molded to form a human anatomical shape; the outer pipe and the inner pipe are coaxially arranged, and the inner pipe axially moves in the inner cavity of the outer pipe; the balloon is arranged at the far ends of the inner tube and the outer tube, the outer side near end of the balloon is fixedly connected with the far end of the outer tube, and the inner side far end of the balloon is fixedly connected with the far end of the inner tube. According to the invention, the middle part of the balloon is set to be the inner arc shape with the thin middle part and the thick two ends, so that the balloon can be accurately positioned in a blood vessel, the automatic position locking can be carried out in the blood vessel through the balloon structure with the concave middle part, and the slippage problem of the balloon is solved.

Description

Adjustable pre-plastic balloon catheter

Technical Field

The invention belongs to the technical field of medical instruments, particularly relates to the field of A61F2/24, and particularly relates to an adjustable pre-plastic balloon catheter.

Background

Different from the traditional surgical operation, the minimally invasive interventional medical technology has the advantages of small wound, simple and convenient operation, small pain of a patient, quick recovery and the like, and has application and remarkable effect on the problem of heart valve regurgitation. During minimally invasive interventional procedures for heart valves, it is common to deliver catheters from the femoral artery or vein with replacement valves or to implant valve repair devices. The balloon catheter is indispensable as an auxiliary instrument.

Currently, the international mainstream minimally invasive interventional catheters usually adopt coaxial or fast exchange type straight tube balloon catheters. There are mainly the following problems: the artificial blood vessel can not be suitable for the anatomical structure of a human body, and kinks are generated in the advancing process of the blood vessel, so that the internal stress is too large, and the product is broken; difficulty in pushing in the human body; scraping with blood vessels to cause blood vessel injury; the balloon is easy to slip off at the pathological part, and the positioning is inaccurate, so that the tissue is damaged; the saccule drives the guide wire in the slipping process, and the guide wire punctures tissues; the balloon is not filled in the center, which causes insufficient expansion and the like.

Disclosure of Invention

In view of the above problems, the present invention provides an adjustable pre-plastic balloon catheter comprising

The inner tube is made of nickel-titanium memory alloy and is pre-molded to form a human anatomical shape;

the outer pipe and the inner pipe are coaxially arranged, and the inner pipe axially moves in the inner cavity of the outer pipe;

the balloon is arranged at the far ends of the inner tube and the outer tube, the outer side near end of the balloon is fixedly connected with the far end of the outer tube, and the inner side far end of the balloon is fixedly connected with the far end of the inner tube.

As a preferred technical solution, the balloon comprises a proximal end portion, an intermediate portion and a distal end portion in sequence from the proximal end to the distal end.

Preferably, the wall thickness of the intermediate portion is thinner at the intermediate location and thicker at the proximal and distal locations.

As a preferable technical solution, the middle part of the balloon is provided with a tubular structure with a smaller cross-sectional radius at the middle position and a larger cross-sectional radius at the two end positions in the axial direction; the balloon has a cross-sectional radius that tapers from the proximal end to the intermediate position and a cross-sectional radius that increases from the intermediate position to the distal end.

As a preferred technical scheme, the balloon is coated with a heparin coating on the outer surface of the middle section in the axial direction of the balloon.

As a preferable technical solution, the balloon is provided with a pit at a surface of a middle position in an axial direction thereof.

As a preferred technical solution, the proximal end of the balloon is provided with a trumpet-shaped structure with an increasing cross-sectional radius from the near side to the far side; the maximum cross-sectional radius of the proximal end portion is equal to the radius of the proximal maximum cross-section of the intermediate portion; the proximal end has a minimum cross-sectional radius equal to the outer tube radius.

As a preferred technical solution, the distal end of the balloon is provided with a trumpet-shaped structure with a decreasing cross-sectional radius from the near side to the far side; the maximum cross-sectional radius of the distal end portion is equal to the radius of the distal maximum cross-section of the intermediate portion; the distal end of the distal end part is provided with a tip which is in a dome-shaped conical structure.

As a preferable technical scheme, a part of the inner tube located inside the balloon is wrapped with a developing tube, and the developing tube is mixed and extruded by a plurality of materials and then is hot-melted on the inner tube.

As a preferred technical scheme, the developing tube is made of a mixed material of a high polymer material, barium sulfate and bismuth trioxide.

As a preferable technical scheme, the outer tube is a polymer woven bend adjusting tube containing metal wires, and the bend adjusting direction of the outer tube and the plane formed by the inner tube pre-shaping structure are in an adjustable range of 0-90 degrees.

Has the advantages that: the invention provides an adjustable pre-plastic balloon catheter which is used as an implanted medical apparatus, enters valve rings under the matching of a guide wire, and is used for mitral regurgitation or other cardiovascular diseases in a mode of coating medicines on a balloon or pressing and holding a prosthetic valve; the balloon inflation device comprises an inner tube supported by memory alloy which is pre-shaped in vitro, the shape of the inner tube conforms to the structure of a human body, the inner tube does not influence the structure of the human body in the process of functioning, a guide wire is not needed to provide supporting force in the process of balloon inflation, and the pre-shaped inner tube can provide the supporting force.

In the invention, the outer surface of the middle section of the saccule in the axial direction is coated with a heparin coating. The heparin coating prevents the surface of the balloon from clotting blood, so that thrombus blockage is caused, and adverse effects are generated.

According to the invention, the middle part of the balloon is set to be in the shape of an inner circular arc with a thin middle part and thick two ends, so that the balloon can be accurately positioned in a blood vessel, the balloon structure with a concave middle part can be used for automatically locking the position in the blood vessel, and the problem of the slippage of the balloon is solved.

Furthermore, a pit structure is arranged on the surface of the middle part of the balloon, so that on one hand, the friction force between the balloon and human tissues is further increased through the pit structure, and the positioning accuracy and stability are increased; on the other hand, the pit structure also provides a good landing point for heparin, avoids the heparin coating from falling off because of friction, and can better guarantee the anticoagulation effect of the heparin coating.

According to the invention, the axial position is adjusted by utilizing the pre-shaping structure of the inner pipe, the radial position is adjusted by the bending adjusting function of the outer pipe, the bending adjusting center is filled with the balloon, the same force of the balloon expansion to all directions of the blood vessel is ensured, the deflection of the balloon pile expanding process is ensured, and the stress damage caused by uneven compression to the blood vessel is avoided.

The developing tube abandons the commonly used noble metal developing material, is formed by mixing and extruding macromolecules and BaSo4 or Bi2O3, and then is hot-melted on the balloon inner tube, so that the metal developing ring and the macromolecule balloon are prevented from causing contact damage.

Drawings

FIG. 1 is a schematic structural view of an adjustable pre-plastic balloon catheter provided in the present invention;

FIG. 2 is an enlarged schematic view of the balloon;

FIGS. 3-7 are schematic views illustrating the operation of the present invention;

wherein, 1-inner tube, 11-developing tube, 2-outer tube, 3-sacculus, 31-near end, 32-middle part, 33-far end, 34-tip and 4-guide wire.

Detailed Description

An adjustable pre-plastic balloon catheter, comprising

The inner tube 1 is made of nickel-titanium memory alloy, and the inner tube 1 is pre-molded to form a human anatomical shape;

the outer tube 2 is coaxially arranged with the inner tube 1, and the inner tube 1 axially moves in the inner cavity of the outer tube 2;

the balloon 3 is arranged at the far ends of the inner tube 1 and the outer tube 2, the outer near end of the balloon 3 is fixedly connected with the far end of the outer tube 2, and the inner far end of the balloon 3 is fixedly connected with the far end of the inner tube 1.

In some preferred embodiments, the balloon 3 comprises, in order from the proximal end to the distal end, a proximal end 31, an intermediate portion 32, and a distal end 33.

In some preferred embodiments, the wall thickness of the intermediate portion 32 is thinner at the intermediate location and thicker at the proximal and distal locations. The shape of bag sets up to thin both ends in the middle thick, and the wall thickness of sacculus sets up to behind the thin both ends in the middle to be the whole form of waist when filling the in-process assurance atress, the intermediate part is linear type sacculus structure when reaching service pressure, accomplishes the linear type expansion to the blood vessel.

In some preferred embodiments, the middle portion 32 of the balloon 3 is provided as a tubular structure having a smaller cross-sectional radius at the middle position and a larger cross-sectional radius at the both end positions in the axial direction; the cross-sectional radius of the balloon 3 is gradually reduced from the proximal end to the middle position, and the cross-sectional radius of the balloon 3 is gradually increased from the middle position to the distal end.

In some preferred embodiments, the balloon 3 is coated with a heparin coating on the outer surface of the middle section in the axial direction thereof. The surface of the balloon is prevented from coagulation by coating a heparin coating, so that the smooth passing of the balloon in a blood vessel is ensured, the position is kept stable at a target working position, and adverse effects caused by coagulation effects are avoided; meanwhile, the heparin coating is arranged at the middle position of the balloon, namely, the heparin coating can be prevented from being rubbed and falling off at the thinner position in the advancing process.

In some preferred embodiments, the balloon 3 is provided with a dimple at a surface at a central position in the axial direction thereof. The positioning stability of the saccule is improved through the pit structure or other structures for increasing the friction force, and the saccule is prevented from moving and even falling off after being expanded.

In some preferred embodiments, the proximal end 31 of the balloon 3 is provided with a trumpet-like structure with an increasing cross-sectional radius from the proximal side to the distal side; the maximum section radius of the proximal end portion 31 is equal to the radius of the proximal maximum section of the intermediate portion 32; the smallest cross-sectional radius of the proximal end 31 is equal to the radius of the outer tube 2.

In some preferred embodiments, the distal end 33 of the balloon 3 is provided as a trumpet-like structure with a decreasing cross-sectional radius from proximal to distal; the maximum cross-sectional radius of the distal end portion 33 is equal to the radius of the distal maximum cross-section of the intermediate portion 32; the distal end of the distal end 33 is provided with a tip 34, the tip 34 being a rounded conical structure.

In some preferred embodiments, the part of the inner tube 1 located inside the balloon 3 is wrapped with a developing tube 11, and the developing tube 11 is mixed and extruded by several materials and then is hot-melted on the inner tube 1.

In some preferred embodiments, the developing tube 11 is made of a mixture of a polymer material, barium sulfate, and bismuth trioxide. The developing tube is made of polymer developing materials and avoids damaging the saccule.

In some preferred embodiments, the outer tube 2 is provided as a polymer woven bend adjusting tube containing metal wires, and the bend adjusting direction of the outer tube 2 is within an adjustable range of 0 to 90 degrees with respect to the plane formed by the pre-shaped structure of the inner tube 1. The axial position is adjusted through inner tube pre-shaping, and the radial position is adjusted through outer tube bending, so that the central filling expansion of the balloon at the lesion part is realized.

The working principle is as follows: the invention provides an adjustable pre-plastic balloon catheter which is used as an implanted medical apparatus, enters valve rings under the matching of a guide wire, and is used for mitral regurgitation or other cardiovascular diseases in a mode of coating medicines on a balloon or pressing and holding a prosthetic valve; the balloon inflation device comprises an inner tube supported by memory alloy which is pre-shaped in vitro, the shape of the inner tube conforms to the structure of a human body, the inner tube does not influence the structure of the human body in the process of functioning, a guide wire is not needed to provide supporting force in the process of balloon inflation, and the pre-shaped inner tube can provide the supporting force. As shown in fig. 3, the present invention enters the aortic arch with the assistance of a guidewire; as shown in FIG. 4, the present invention is advanced through complex body structures in the pre-shaped curve of the inner tube to the lesion; as shown in fig. 5, the invention enters the lesion site during the pre-shaped bending adjustment of the inner tube, and realizes the accurate positioning and position locking in the axial direction by the inner arc structure of the balloon and the developing tube inside the balloon, thereby preventing the falling off; as shown in fig. 6, the guide wire is withdrawn, and the balloon is radially positioned by the bending adjusting function of the outer tube, so as to ensure that the balloon is inflated at the central position of the blood vessel; as shown in fig. 7, the balloon is thin in the middle and thick at two ends, and the wall thickness of the balloon is thin in the middle, so that the whole waist shape is ensured during the filling process, and the middle part is of a linear balloon structure when the pressure is applied, thereby completing the linear expansion of the blood vessel.

Claims

1. An adjustable pre-plastic balloon catheter, which is characterized by comprising

The inner tube (1), the inner tube (1) adopts nickel titanium memory alloy to make, the inner tube (1) is preformed to form the human anatomy shape;

the outer pipe (2) and the inner pipe (1) are coaxially arranged, and the inner pipe (1) axially moves in the inner cavity of the outer pipe (2);

the balloon (3), the balloon (3) sets up the distal end of inner tube (1) and outer tube (2), the outside near-end of balloon (3) with outer tube (2) distal end fixed connection, the inboard distal end of balloon (3) with the distal end fixed connection of inner tube (1).

2. Adjustable pre-plastic balloon catheter according to claim 1, wherein the balloon (3) comprises, in order from proximal to distal, a proximal end (31), an intermediate portion (32), a distal end (33).

3. The adjustable pre-plastic balloon catheter as recited in claim 2, wherein the wall thickness of the intermediate portion (32) is thinner at the intermediate location and thicker at the proximal and distal locations.

4. Adjustable pre-plastic balloon catheter according to claim 1, characterized in that the middle section (32) of the balloon (3) is provided as a tubular structure with a smaller cross-sectional radius at the middle position and a larger cross-sectional radius at the two end positions in the axial direction; the cross section radius of the balloon (3) is gradually reduced from the proximal end to the middle position, and the cross section radius of the balloon (3) is gradually increased from the middle position to the distal end.

5. Adjustable pre-plastic balloon catheter according to claim 4, characterized in that the balloon (3) is coated with a heparin coating on its middle section in the axial direction.

6. Adjustable pre-plastic balloon catheter according to claim 4, characterized in that the balloon (3) is provided with a recess in its surface at a central position in the axial direction.

7. The adjustable pre-plastic balloon catheter as claimed in claim 4, characterized in that the proximal end (31) of the balloon (3) is provided with a trumpet-like structure with an increasing radius of section from the proximal side to the distal side; the maximum section radius of the proximal end portion (31) is equal to the radius of the proximal maximum section of the intermediate portion (32); the smallest cross-sectional radius of the proximal end (31) is equal to the outer tube (2) radius.

8. The adjustable pre-plastic balloon catheter as claimed in claim 4, characterized in that the distal end (33) of the balloon (3) is provided as a trumpet-like structure with a decreasing cross-sectional radius from proximal to distal; the maximum cross-sectional radius of the distal end portion (33) being equal to the radius of the distal maximum cross-section of the intermediate portion (32)

9. The adjustable pre-plastic balloon catheter as recited in claim 6, wherein a distal end of the distal end (33) is provided with a tip (34), the tip (34) being a domed, conical structure.

10. The adjustable pre-plastic balloon catheter as claimed in claim 1, characterized in that the part of the inner tube (1) inside the balloon (3) is wrapped with a visualization tube (11), and the visualization tube (11) is hot-melted onto the inner tube (1) after several materials are mixed and extruded.

11. The adjustable pre-plastic balloon catheter as claimed in claim 8, wherein the developing tube (11) is made of a mixed material of a polymer material, barium sulfate and bismuth trioxide.

12. The adjustable pre-plastic balloon catheter as claimed in claim 1, wherein the outer tube (2) is provided as a polymeric braided bend tube containing metal wires, and the bending direction of the outer tube (2) and the plane formed by the pre-shaped structure of the inner tube (1) are within an adjustable range of 0-90 degrees.