CN110339464B - Balloon catheter with metal sheath and processing method of metal sheath - Google Patents

Abstract

The balloon catheter with the metal sheath and the processing method of the metal sheath comprise a balloon outer tube, a balloon bag body, the metal sheath and an ultra-soft head end, wherein the outer tube connecting end and the head end connecting end are respectively arranged at two ends of the balloon bag body, the outer tube connecting end is connected with the balloon outer tube, the head end connecting end is connected with the ultra-soft head end, the metal sheath comprises a metal sheath fixing end and a metal sheath free end, a metal protection wire is connected between the metal sheath fixing end and the metal sheath free end, and the metal protection wire is arranged outside the balloon bag body. When the balloon catheter is expanded, the metal sheath is attached to the surface of the hardened plaque, and the plaque can be cut to reduce the deformation and movement of the large plaque. In addition, the metal sheath may weaken the circumferential shear effect of the balloon on plaque when the polymer surface of the balloon is expanded and deformed, thereby reducing the incidence of interlayer. The processing method of the metal sheath is simple and easy.

Description

Balloon catheter with metal sheath and processing method of metal sheath

technical field

The invention relates to the technical field of medical devices, in particular to a balloon catheter with a metal sheath and a processing method of the metal sheath.

Background technique

Atherosclerosis is the main culprit of vascular occlusive disease in humans. According to statistics, there are 44 million patients with photoperipheral arterial occlusive disease in my country, with an incidence rate of 0.6% in people aged 45-54, 2.5% in people aged 55-64, and 8.8 in people aged 65-74. %. The incidence of lower extremity arterial occlusion in people over 70 years old is as high as 15-20%.

Percutaneous transluminal angioplasty (PTA) is the endovascular treatment of choice for the treatment of atherosclerotic plaques. PTA is accomplished by inflating a balloon that is directed to the lining of the blood vessel in the atherosclerotic lesion. Radial pressure is applied to redistribute the plaque and restore blood flow to the lesion.

However, simple balloon dilation, due to the sliding of the balloon surface along the circumferential surface and the excessive expansion of the balloon during expansion, can easily lead to tearing of the endothelium at the lesion site, resulting in dissection. The rate of dissection due to balloon dilatation is as high as 20-50%. Once the dissection is formed, stents have to be implanted for salvage clinically, which brings a great burden to both the operator and the patient.

Therefore, it is necessary to provide a balloon catheter with a metal sheath and a processing method of the metal sheath. The diameter of the metal sheath increases with the change of the diameter of the balloon when the balloon is expanded, and the metal sheath adheres to the The surface of the vascular lesion is between the vascular endothelium and the surface of the balloon, which can solve the problem of tearing the endothelium to form a dissection due to the deformation of the balloon when the balloon dilates the vascular lesion.

SUMMARY OF THE INVENTION

In view of this, the purpose of the present invention is to provide a balloon catheter with a metal sheath and a processing method of the metal sheath, so as to solve the problem that the existing ordinary balloon is prone to dissection during the expansion process.

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

A balloon catheter with a metal sheath, comprising a balloon outer tube, a balloon body, a metal sheath and an ultra-soft head end, the two ends of the balloon body are respectively an outer tube connection end and a head end connection The outer tube connecting end is connected with the balloon outer tube, the head end connecting end is connected with the super soft head end, the metal sheath includes a metal sheath fixed end and a metal sheath free end, the metal sheath A metal protection wire is connected between the fixed end of the sleeve and the free end of the metal sheath, and the metal protection wire is arranged outside the balloon body.

Preferably, the metal sheath fixing end is sleeved on the outer wall of the balloon outer tube where the connection end of the outer tube is connected with the balloon outer tube, and is bonded and fixed with the balloon outer tube, and the metal sheath is freely sleeved On the outer wall of the head connecting end, the inner diameter of the free end of the metal sheath is larger than the outer diameter of the head connecting end.

Further, the shape of the metal protection wire is spiral. The gap between the spiral metal protection wires depends on the length and diameter of the balloon body, and the metal protection wire overlaps with the expansion part of the balloon body. When the balloon body is expanded, the metal sheath follows the balloon body. The diameter of the helical metal protective wire increases due to the expansion of the body, and the free end of the metal sheath of the metal sheath rotates around it outside the connecting end of the head end, so as to ensure that the helical metal protective wire is free from the expansion of the balloon body. expansion.

The processing method of the metal sheath of the above-mentioned balloon catheter with metal sheath, the processing method is: preparing a metal tube, the metal sheath fixed end and the metal sheath free end are reserved at both ends of the metal tube, and the metal tube is reserved. The middle of the tube is a metal protective wire, and the middle of the metal tube is laser-cut into a spiral shape, and then subjected to surface cleaning, electrochemical polishing, and 500-degree heat treatment to shape.

Another processing method for the metal sheath of the above-mentioned balloon catheter with metal sheath, the processing method is: preparing a metal tube, cutting the fixed end of the metal sheath and the free end of the metal sheath from the metal tube, winding a spiral The two ends of the metal wire are welded between the fixed end of the metal sheath and the free end of the metal sheath, and then surface cleaning, electrochemical polishing, and 500-degree heat treatment are performed to shape.

Preferably, the fixed end of the metal sheath is sleeved on the outer wall of the connecting end of the head end, and the free end of the metal sheath is sleeved on the outer wall of the outer tube of the balloon at the connection between the connection end of the outer tube and the outer tube 1 of the balloon, The inner diameter of the free end of the metal sheath is larger than the outer diameter of the balloon outer tube.

Further, the metal protection wire is a straight line parallel to the direction of the balloon body. The gap between the straight metal protection wires depends on the length and diameter of the balloon body. The metal protection wire overlaps with the expansion part of the balloon body. When the balloon body is expanded, the metal sheath follows the balloon body. As the body expands and expands, the gap of the linear metal protection wire becomes larger, the length of the linear metal protection wire becomes shorter, and the free end of the metal sheath of the metal sheath moves forward outside the outer tube of the balloon to ensure the linear metal protection. The silk expands with the expansion of the balloon body.

Preferably, the material of the metal sheath is 316L stainless steel, cobalt-chromium alloy or nickel-titanium alloy.

The processing method of the metal sheath of the above-mentioned balloon catheter with metal sheath, the processing method is: preparing a metal tube, the metal sheath fixed end and the metal sheath free end are reserved at both ends of the metal tube, and the metal tube is reserved. The middle part of the metal tube is a metal protective wire, and the middle part of the metal tube is laser-cut into a straight line, and then surface cleaning, electrochemical polishing, and 500-degree heat treatment are carried out.

Another processing method of the metal sheath of the above-mentioned balloon catheter with metal sheath, the processing method is: preparing a metal tube, cutting the fixed end of the metal sheath and the free end of the metal sheath from the metal tube, and preparing a straight line The metal wire is welded in parallel between the fixed end of the metal sheath and the free end of the metal sheath, and then subjected to surface cleaning, electrochemical polishing, and 500-degree heat treatment to shape.

The beneficial effects of the present invention are as follows:

A balloon catheter with a metal sheath and a processing method of the metal sheath of the present invention adopt the above technical solutions. When the balloon catheter is expanded, the metal sheath is adhered to the surface of the hardened plaque, and the plaque can be cut. Reduced deformation movement of large patches. In addition, when the polymer surface of the balloon is expanded and deformed, the metal sheath can weaken the circumferential shearing effect of the balloon on the plaque, thereby reducing the incidence of dissection. The processing method of the metal sheath is simple and easy.

The above description is only an overview of the technical solutions of the present invention, in order to be able to more clearly understand the technical means of the present invention and to implement according to the content of the description, and to make the above and other purposes, technical features and advantages of the present invention more understandable, One or more preferred embodiments are listed below and described in detail with reference to the accompanying drawings.

Description of drawings

One or more embodiments are exemplified by the pictures in the corresponding drawings, and these exemplifications do not constitute limitations of the embodiments, and elements with the same reference numerals in the drawings are denoted as similar elements, Unless otherwise stated, the figures in the accompanying drawings do not constitute a scale limitation.

FIG. 1 shows a schematic structural diagram of a helical metal sheath of a balloon catheter with a metal sheath according to the present invention.

FIG. 2 shows a schematic structural diagram of a linear metal sheath of a balloon catheter with a metal sheath according to the present invention.

Description of main reference signs:

1- Balloon outer tube, 2- Balloon body, 3- Metal sheath, 4- Super soft head end, 5- Metal sheath fixed end, 6- Metal sheath free end.

Detailed ways

The specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings, but it should be understood that the protection scope of the present invention is not limited by the specific embodiments.

Unless expressly stated otherwise, throughout the specification and claims, the term "comprising" or its conjugations such as "comprising" or "comprising" and the like will be understood to include the stated elements or components, and Other elements or other components are not excluded.

In this document, for convenience of description, spatially relative terms, such as "below", "below", "under", "above", "above", "over", etc., may be used to describe one element or feature with respect to another Relationship of elements or features in the drawings. It is to be understood that spatially relative terms are intended to encompass different orientations of items in use or operation in addition to the orientation depicted in the figures. For example, if the item in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" the elements or features. Thus, the exemplary term "below" can encompass both an orientation of below and above. Items may also have other orientations (rotated 90 degrees or other orientations) and the spatially relative terms used herein should be interpreted accordingly.

Example 1

As shown in Figure 1, a balloon catheter with a metal sheath includes a balloon outer tube 1, a balloon body 2, a metal sheath 3 and an ultra-soft tip 4. The two parts of the balloon body 2 The ends are respectively the outer tube connection end and the head end connection end, the outer tube connection end is connected with the balloon outer tube 1, the head end connection end is connected with the super soft head end 4, and the metal sheath 3 includes a metal sheath. The sleeve fixed end 5 and the metal sheath free end 6 are connected with a metal protection wire, which is arranged outside the balloon body 2 .

The metal sheath fixed end 5 is sleeved on the outer wall of the balloon outer tube 1 where the outer tube connecting end and the balloon outer tube 1 are connected, and is bonded and fixed with the balloon outer tube 1, and the free end of the metal sheath is 6 is sleeved on the outer wall of the connecting end of the head end, and the inner diameter of the free end 6 of the metal sheath is larger than the outer diameter of the connecting end of the head end. The shape of the metal protection wire is helical. The gap between the helical metal protection wires depends on the length and diameter of the balloon body 2 , and the metal protection wires overlap with the expanded part of the balloon body 2 .

During use, when the balloon body 2 is expanded, the metal sheath 3 expands with the expansion of the balloon body 2, the diameter of the spiral metal protection wire becomes larger, and the free end 6 of the metal sheath of the metal sheath 3 is at the head. The end connecting end rotates around it to ensure that the helical metal protection wire expands with the expansion of the balloon body 2 . After the operation is completed, the balloon body 2 is retracted, the metal sheath 3 is retracted with the retraction of the balloon body 2, the diameter of the spiral metal protection wire becomes smaller, and the free end 6 of the metal sheath of the metal sheath 3 is retracted. Rotate around the head-end connecting end to ensure that the helical metal protection wire retracts with the retraction of the balloon body 2 .

The metal sheath 3 is made of 316L stainless steel, cobalt-chromium alloy or nickel-titanium alloy.

The processing method of the metal sheath of the above-mentioned balloon catheter with metal sheath, the processing method is: preparing a metal tube, the metal sheath fixed end 5 and the metal sheath free end 6 are reserved at both ends of the metal tube, and the metal sheath is reserved. The middle part of the metal tube is a metal protective wire, and the middle part of the metal tube is laser cut into a spiral shape, and then subjected to surface cleaning, electrochemical polishing, and 500-degree heat treatment to shape.

Another processing method of the metal sheath of the above-mentioned balloon catheter with metal sheath, the processing method is: preparing a metal tube, cutting the metal sheath fixed end 5 and the metal sheath free end 6 from the metal tube, and wrapping around the metal sheath. The spiral metal wire is made and shaped, the two ends of the metal wire are welded between the fixed end 5 of the metal sheath and the free end 6 of the metal sheath, and then surface cleaning, electrochemical polishing, and 500-degree heat treatment are carried out to shape.

Example 2

As shown in Figure 2, a balloon catheter with a metal sheath includes a balloon outer tube 1, a balloon body 2, a metal sheath 3 and a supersoft tip 4. The two parts of the balloon body 2 The ends are respectively the outer tube connection end and the head end connection end, the outer tube connection end is connected with the balloon outer tube 1, the head end connection end is connected with the super soft head end 4, and the metal sheath 3 includes a metal sheath. The sleeve fixed end 5 and the metal sheath free end 6 are connected with a metal protection wire, which is arranged outside the balloon body 2 .

The metal sheath fixed end 5 is sleeved on the outer wall of the head end connecting end, and the metal sheath free end 6 is sleeved on the outer wall of the balloon outer tube 1 where the outer tube connecting end and the balloon outer tube 1 are connected, The inner diameter of the free end 6 of the metal sheath is larger than the outer diameter of the balloon outer tube 1 . The metal protection wire is a straight line parallel to the direction of the balloon body 2 . The gap between the straight metal protection wires depends on the length and diameter of the balloon body 2 , and the metal protection wires overlap with the expanded part of the balloon body 2 .

In use, when the balloon body 2 is expanded, the metal sheath 3 expands with the expansion of the balloon body 2, the gap of the linear metal protection wire becomes larger, the length of the linear metal protection wire becomes shorter, and the metal sheath The free end 6 of the metal sheath of 3 moves forward outside the balloon outer tube 1 to ensure that the linear metal protection wire expands with the expansion of the balloon body 2 . After the operation is completed, the balloon body 2 is retracted, the metal sheath 3 is retracted with the retraction of the balloon body 2, the length of the linear metal protection wire becomes longer, and the free end 6 of the metal sheath of the metal sheath 3 is retracted. Move backward outside the balloon outer tube 1 to ensure that the helical metal protection wire retracts with the retraction of the balloon body 2 .

The metal sheath 3 is made of 316L stainless steel, cobalt-chromium alloy or nickel-titanium alloy.

The processing method of the metal sheath of the above-mentioned balloon catheter with metal sheath, the processing method is: preparing a metal tube, the metal sheath fixed end 5 and the metal sheath free end 6 are reserved at both ends of the metal tube, and the metal sheath is reserved. The middle part of the metal tube is a metal protective wire. The middle part of the metal tube is laser cut into a straight line, and then surface cleaning, electrochemical polishing, and 500-degree heat treatment are carried out.

Another processing method for the metal sheath of the above-mentioned balloon catheter with metal sheath, the processing method is: preparing a metal tube, cutting the metal sheath fixed end 5 and the metal sheath free end 6 from the metal tube, preparing Straight metal wires are welded in parallel between the fixed end 5 of the metal sheath and the free end 6 of the metal sheath, and then subjected to surface cleaning, electrochemical polishing, and 500-degree heat treatment to shape.

The foregoing descriptions of specific exemplary embodiments of the present invention have been presented for purposes of illustration and description. These descriptions are not intended to limit the invention to the precise form disclosed, and obviously many changes and modifications are possible in light of the above teachings. The exemplary embodiments were chosen and described for the purpose of explaining certain principles of the invention and their practical applications, to thereby enable others skilled in the art to make and utilize various exemplary embodiments and various different aspects of the invention. Choose and change. Any simple modifications, equivalent changes and modifications made to the above-described exemplary embodiments should fall within the protection scope of the present invention.

Claims (4)

1. The method for processing the metal sheath of the balloon catheter with the metal sheath comprises a balloon outer tube (1), a balloon bag body (2), the metal sheath (3) and an ultra-soft head end (4), wherein the two ends of the balloon bag body (2) are respectively an outer tube connecting end and a head end connecting end, the outer tube connecting end is connected with the balloon outer tube (1), the head end connecting end is connected with the ultra-soft head end (4), the metal sheath (3) comprises a metal sheath fixing end (5) and a metal sheath free end (6), a metal protection wire is connected between the metal sheath fixing end (5) and the metal sheath free end (6), the metal protection wire is arranged outside the balloon bag body (2), and the metal protection wire is in a spiral shape; the metal sheath fixed end (5) is sleeved on the outer wall of the balloon outer tube (1) at the joint of the outer tube connecting end and the balloon outer tube (1) and is fixedly bonded with the balloon outer tube (1), the metal sheath free end (6) is sleeved on the outer wall of the head end connecting end, and the inner diameter of the metal sheath free end (6) is larger than the outer diameter of the head end connecting end; the metal sheath (3) is made of 316L stainless steel, cobalt-chromium alloy or nickel-titanium alloy;

the method is characterized in that the processing method of the metal sheath (3) comprises the following steps: preparing a metal pipe, reserving a metal sheath fixed end (5) and a metal sheath free end (6) at two ends of the metal pipe, wherein a metal protection wire is arranged in the middle of the metal pipe, the middle of the metal pipe is cut into a spiral shape by laser, and then surface cleaning, electrochemical polishing and 500-degree heat treatment setting are carried out.

2. The method for processing the metal sheath of the balloon catheter with the metal sheath according to the claim 1, wherein the other processing method of the metal sheath (3) is as follows: preparing a metal pipe, cutting a metal sheath fixed end (5) and a metal sheath free end (6) from the metal pipe, winding and shaping a spiral metal wire, welding two ends of the metal wire between the metal sheath fixed end (5) and the metal sheath free end (6), and then carrying out surface cleaning, electrochemical polishing and 500-degree heat treatment shaping.

3. A metal sheath processing method of a balloon catheter with a metal sheath comprises a balloon outer tube (1), a balloon bag body (2), the metal sheath (3) and an ultra-soft head end (4), wherein the two ends of the balloon bag body (2) are respectively an outer tube connecting end and a head end connecting end, the outer tube connecting end is connected with the balloon outer tube (1), the head end connecting end is connected with the ultra-soft head end (4), the metal sheath (3) comprises a metal sheath fixing end (5) and a metal sheath free end (6), a metal protection wire is connected between the metal sheath fixing end (5) and the metal sheath free end (6), the metal protection wire is arranged outside the balloon bag body (2), and the metal protection wire is in a linear shape parallel to the direction of the balloon bag body (2); the metal sheath fixed end (5) is sleeved on the outer wall of the head end connecting end, the metal sheath free end (6) is sleeved on the outer wall of the balloon outer tube (1) at the connecting position of the outer tube connecting end and the balloon outer tube (1) and is fixedly bonded with the balloon outer tube (1), and the inner diameter of the metal sheath free end (6) is larger than the outer diameter of the balloon outer tube (1); the metal sheath (3) is made of 316L stainless steel, cobalt-chromium alloy or nickel-titanium alloy;

the method is characterized in that the processing method of the metal sheath (3) comprises the following steps: preparing a metal pipe, reserving a metal sheath fixed end (5) and a metal sheath free end (6) at two ends of the metal pipe, cutting the middle part of the metal pipe into a linear shape by laser, and then carrying out surface cleaning, electrochemical polishing and 500-degree heat treatment setting.

4. The method for processing the metal sheath of the balloon catheter with the metal sheath according to the claim 3, wherein the other processing method of the metal sheath (3) is as follows: preparing a metal pipe, cutting the fixed end (5) and the free end (6) of the metal sheath from the metal pipe, preparing linear metal wires, welding the linear metal wires between the fixed end (5) and the free end (6) of the metal sheath in parallel, and then carrying out surface cleaning, electrochemical polishing and 500-degree heat treatment setting.

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