Balloon catheter with metal sheath and processing method of metal sheath
Technical Field
The invention relates to the technical field of medical instruments, in particular to a balloon catheter with a metal sheath and a processing method of the metal sheath.
Background
Atherosclerosis is the major culprit of vascular obstructive disease in humans. According to statistics, 4400 million patients with peripheral arterial occlusive disease in China exist, the morbidity of 45-54 years old people is 0.6%, the morbidity of 55-64 years old people is 2.5%, and the morbidity of 65-74 years old people is 8.8%. The incidence rate of lower limb artery occlusion in people over 70 years old is 15-20%.
Percutaneous Transluminal Angioplasty (PTA) is the preferred intravascular treatment for atherosclerotic plaque by inflating a balloon which applies radial pressure to the inner wall of the blood vessel in the atherosclerotic lesion to redistribute the plaque and restore blood flow to the lesion.
However, in the case of pure balloon expansion, due to the sliding of the balloon surface along the circumferential surface and the over-expansion of the balloon during expansion, the endothelium of the lesion site is easily torn, and an interlayer is formed. The proportion of the interlayer caused by the vascular balloon dilatation is as high as 20-50%. Once the dissection is formed, the stent has to be implanted for clinical repair, which brings great burden to both the operator and the patient.
Therefore, it is desirable to provide a balloon catheter with a metal sheath and a processing method of the metal sheath, wherein the diameter of the metal sheath is increased along with the change of the diameter of the balloon during balloon expansion, and the metal sheath is attached to the surface of the vascular lesion after expansion and is between the vascular endothelium and the surface of the balloon, so that the problem that the inner endothelium is torn to form an interlayer due to the deformation of the balloon during the expansion of the vascular lesion by the balloon can be solved.
Disclosure of Invention
In view of this, the present invention aims to provide a balloon catheter with a metal sheath and a processing method of the metal sheath, which solve the problem that the conventional common balloon is easy to cause interlayer in the expansion process.
In order to solve the technical problems, the invention adopts the following technical scheme:
the utility model provides a take metal sheath's sacculus pipe, includes sacculus outer tube, sacculus utricule, metal sheath and super flexible head end, the both ends of sacculus utricule are outer tube connection end and head end link respectively, outer tube connection end and sacculus outer tube connection, the head end link is connected with super flexible head end, metal sheath includes metal sheath stiff end and metal sheath free end, be connected with the metal protection silk between metal sheath stiff end and the metal sheath free end, the metal protection silk sets up the outside at the sacculus utricule.
Preferably, the fixed end of the metal sheath is sleeved on the outer wall of the balloon outer tube at the joint of the outer tube connecting end and the balloon outer tube and is fixedly bonded with the balloon outer tube, the free end of the metal sheath is sleeved on the outer wall of the head end connecting end, and the inner diameter of the free end of the metal sheath is larger than the outer diameter of the head end connecting end.
Further, the shape of the metal protection wire is a spiral type. The clearance between the spiral type metal protection wire is decided according to the length and the diameter of the balloon sac body, the metal protection wire is overlapped with the expansion part of the balloon sac body, when the balloon sac body is expanded, the metal sheath expands along with the expansion of the balloon sac body, the diameter of the spiral type metal protection wire is enlarged, the free end of the metal sheath rotates around the metal sheath at the end connecting end, and the spiral type metal protection wire is ensured to expand along with the expansion of the balloon sac body.
The processing method of the metal sheath of the balloon catheter with the metal sheath comprises the following steps: preparing a metal tube, reserving a metal sheath fixed end and a metal sheath free end at two ends of the metal tube, wherein a metal protection wire is arranged in the middle of the metal tube, the middle of the metal tube is cut into a spiral shape by laser, and then surface cleaning, electrochemical polishing and 500-degree heat treatment setting are carried out.
Another processing method of the metal sheath of the balloon catheter with the metal sheath comprises the following steps: preparing a metal pipe, cutting a fixed end of a metal sheath and a free end of the metal sheath from the metal pipe, winding and shaping a spiral metal wire, welding two ends of the metal wire between the fixed end of the metal sheath and the free end of the metal sheath, and then carrying out surface cleaning, electrochemical polishing and 500-degree heat treatment shaping.
Preferably, the fixed end of the metal sheath is sleeved on the outer wall of the head end connecting end, the free end of the metal sheath is sleeved on the outer wall of the balloon outer tube 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, and 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 in a linear shape parallel to the balloon body direction. The clearance between the linear type metal protection wire is decided according to the length and the diameter of the sacculus utricule, the metal protection wire overlaps with the sacculus utricule expansion part, when the sacculus utricule expands, the metal sheath expands along with the expansion of the sacculus utricule, the clearance grow of linear type metal protection wire, the length of linear type metal protection wire shortens, the metal sheath free end of metal sheath moves forward outside the sacculus outer tube to guarantee that the linear type metal protection wire expands along with the expansion of the sacculus utricule.
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 balloon catheter with the metal sheath comprises the following steps: preparing a metal tube, reserving a metal sheath fixed end and a metal sheath free end at two ends of the metal tube, wherein a metal protection wire is arranged in the middle of the metal tube, laser cutting the middle of the metal tube into a linear shape, and then carrying out surface cleaning, electrochemical polishing and 500-degree heat treatment setting.
Another processing method of the metal sheath of the balloon catheter with the metal sheath comprises the following steps: preparing a metal pipe, cutting the fixed end and the free end of the metal sheath from the metal pipe, preparing linear metal wires, welding the linear metal wires between the fixed end and the free end of the metal sheath in parallel, and then carrying out surface cleaning, electrochemical polishing and 500-degree heat treatment setting.
The invention has the following beneficial effects:
according to the balloon catheter with the metal sheath and the processing method of the metal sheath, due to the adoption of the technical scheme, when the balloon catheter is expanded, the metal sheath is attached to the surface of a hardened plaque, the plaque can be cut, and the deformation and movement of a large plaque are reduced. 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.
The foregoing description is only an overview of the technical solutions of the present invention, and in order to make the technical means of the present invention more clearly understood and to make the technical means implementable in accordance with the contents of the description, and to make the above and other objects, technical features, and advantages of the present invention more comprehensible, one or more preferred embodiments are described below in detail with reference to the accompanying drawings.
Drawings
One or more embodiments are illustrated by way of example in the accompanying drawings, which correspond to the figures in which like reference numerals refer to similar elements and which are not to scale unless otherwise specified.
Fig. 1 shows a schematic structural view of a helical metal sheath of a balloon catheter with a metal sheath according to the present invention.
Fig. 2 shows a schematic structural view of a linear metal sheath of a balloon catheter with a metal sheath according to the present invention.
Description of the main reference numerals:
1-balloon outer tube, 2-balloon body, 3-metal sheath, 4-super soft end, 5-metal sheath fixed end and 6-metal sheath free end.
Detailed Description
The following detailed description of the present invention is provided in conjunction with the accompanying drawings, but it should be understood that the scope of the present invention is not limited to the specific embodiments.
Throughout the specification and claims, unless explicitly stated otherwise, the word "comprise", or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated element or component but not the exclusion of any other element or component.
Spatially relative terms, such as "below," "lower," "upper," "above," "upper," and the like, may be used herein for ease of description to describe one element or feature's relationship to another element or feature in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the object in use or operation in addition to the orientation depicted in the figures. For example, if the items in the figures are 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. The article may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative terms used herein should be interpreted accordingly.
Example 1
As shown in fig. 1, a balloon catheter with a metal sheath comprises a balloon outer tube 1, a balloon bag body 2, a 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 fixed end 5 and a metal sheath free end 6, a metal protection wire is connected between the metal sheath fixed end 5 and the metal sheath free end 6, and the metal protection wire is arranged outside the balloon bag body 2.
The metal sheath fixed end 5 sleeves 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 sleeves 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 shape of the metal protection wire is spiral. The gaps between the spiral metal protective wires depend on the length and the diameter of the balloon body 2, and the metal protective wires are overlapped with the expansion part of the balloon body 2.
When the spiral metal protective wire is used, when the balloon body 2 is expanded, the metal protective sleeve 3 is expanded along with the expansion of the balloon body 2, the diameter of the spiral metal protective wire is increased, and the free end 6 of the metal protective sleeve 3 rotates around the head end connecting end outside the head end connecting end, so that the spiral metal protective wire is ensured to be expanded along with the expansion of the balloon body 2. After the operation is finished, the balloon body 2 retracts, the metal sheath 3 retracts along with the retraction of the balloon body 2, the diameter of the spiral metal protection wire is reduced, and the metal sheath free end 6 of the metal sheath 3 rotates around the metal sheath free end outside the head end connecting end to ensure that the spiral metal protection wire retracts along 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 balloon catheter with the metal sheath 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 spiral shape by laser, and then carrying out surface cleaning, electrochemical polishing and 500-degree heat treatment setting.
Another processing method of the metal sheath of the balloon catheter with the metal sheath comprises the following steps: 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.
Example 2
As shown in fig. 2, a balloon catheter with a metal sheath comprises a balloon outer tube 1, a balloon bag body 2, a 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 fixed end 5 and a metal sheath free end 6, a metal protection wire is connected between the metal sheath fixed end 5 and the metal sheath free end 6, and the metal protection wire is arranged outside the balloon bag body 2.
The outer wall of the sacculus outer tube 1 at the joint of the outer tube connecting end and the sacculus outer tube 1 is sleeved with the metal sheath fixed end 5, the outer wall of the sacculus outer tube 1 at the joint of the outer tube connecting end and the sacculus outer tube 1 is sleeved with the metal sheath free end 6, the outer wall of the sacculus outer tube 1 is bonded and fixed with the sacculus outer tube 1, and the inner diameter of the metal sheath free end 6 is larger than the outer diameter of the sacculus outer tube 1. The metal protection wire is in a linear shape parallel to the balloon body 2. The clearance between the linear metal protective wires depends on the length and the diameter of the balloon body 2, and the metal protective wires are overlapped with the expansion part of the balloon body 2.
When the balloon is used, when the balloon body 2 is expanded, the metal sheath 3 is expanded along with the expansion of the balloon body 2, the gap of the linear metal protection wire is enlarged, the length of the linear metal protection wire is shortened, and the free end 6 of the metal sheath 3 moves forwards outside the balloon outer tube 1 to ensure that the linear metal protection wire is expanded along with the expansion of the balloon body 2. After the operation is finished, the balloon body 2 retracts, the metal sheath 3 retracts along with the retraction of the balloon body 2, the length of the linear metal protection wire is lengthened, and the free end 6 of the metal sheath 3 moves backwards outside the balloon outer tube 1 so as to ensure that the spiral metal protection wire retracts along 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 balloon catheter with the metal sheath 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.
Another processing method of the metal sheath of the balloon catheter with the metal sheath comprises the following steps: 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.
The foregoing descriptions of specific exemplary embodiments of the present invention have been presented for purposes of illustration and description. It is not intended to limit the invention to the precise form disclosed, and obviously many modifications and variations are possible in light of the above teaching. The exemplary embodiments were chosen and described in order to explain certain principles of the invention and its practical application to enable one skilled in the art to make and use various exemplary embodiments of the invention and various alternatives and modifications as are suited to the particular use contemplated. Any simple modifications, equivalent changes and modifications made to the above exemplary embodiments shall fall within the scope of the present invention.