CN113101022A

CN113101022A - Preparation method of specific in-vivo lumen implant

Info

Publication number: CN113101022A
Application number: CN202110600570.4A
Authority: CN
Inventors: 赵晓辉
Original assignee: Individual
Current assignee: Individual
Priority date: 2021-05-31
Filing date: 2021-05-31
Publication date: 2021-07-13

Abstract

The invention discloses a preparation method of a specific in-vivo lumen implant, which comprises the following steps: s1, selecting two single metal wires or polymer wire materials, or combining and twisting one metal wire and one polymer wire material, thereby forming the metal wires and/or the polymer wire materials which form the stent body; s2, selecting elastic metal wires and/or polymer wires with the diameter of 0.3-0.5mm, and tightly and spirally winding the elastic metal wires and/or polymer wires on a mold rod; s3, after the stent body is wound, taking out the die rod, and carrying out high-temperature friction on the inner wall of the stent by using a fine grinding wheel, or coating a polymer material on the inner wall of the stent to form a film; s4, cutting 2-4 pressure relief channels along the axial direction of the smooth inner wall by using a cutting tool on a machine tool, and performing scraping treatment or high-temperature pressing treatment on the outer wall of the stent, so that the outer surface of the metal wire and/or the polymer wire looks like a wrinkle integrally, and the stent has a link animal body surface bionic outer wall.

Description

Preparation method of specific in-vivo lumen implant

Technical Field

The invention relates to the technical field of in-vivo implants, in particular to a preparation method of a specific in-vivo lumen implant.

Background

A luminal-in-vivo graft prosthesis is a prosthesis for percutaneous implantation into a blood vessel or other similar luminal structural organ of a living body. These grafts may be biocompatible stents or prosthetic prostheses, typically, stent-graft prostheses typically include one or more radially compressible stents that are expandable within a body vessel at a diameter slightly larger than the body vessel, and have graft material on the inside or outside of the stent. When the stent-graft prosthesis is radially expanded in situ, the stent anchors the tubular graft material to the wall of the vessel or anatomical passageway. Thus, stent-graft prostheses are typically held in place by a mechanical fit and friction due to the reactive force provided by the radially-expanded stent against the vessel wall. When the stent is expanded, the graft material anchors against the inner wall of the body vessel. Thus, the graft material is held in place by friction between the stent and the body vessel.

Intraluminal grafts are used to treat aneurysms, dissections and transections. When the body lumen graft is implanted within an aneurysm vessel with the stent graft extending proximal and distal to the aneurysm, the stent graft acts as a bypass lumen allowing blood to flow through the graft material without flowing through the expanded portion of the aneurysm. Thus, the stent graft prosthesis isolates the aneurysm or other vascular abnormality from normal blood pressure, thereby reducing pressure on weakened vessel walls and reducing the likelihood of vessel rupture. The intraluminal grafts may have an open-mesh or closed-mesh configuration. In the open mesh configuration, the ends of the stent-graft prosthesis extend beyond the corresponding ends of the graft material and thus have portions that are not covered by the graft material. The uncovered portion typically allows blood to flow through the stent graft prosthesis during implantation. The uncovered portion of the open mesh configuration also provides a convenient location for a tip capture mechanism to be coupled to a delivery catheter. However, where the uncovered portions of the frame are tightly packed together by the end capture mechanisms, flow through the uncovered portions is not always desirable. In the closed-mesh configuration, the ends of the stent-graft prosthesis are covered or lined with graft material. Thus, the closed-mesh configuration leaves no exposed stent and is intended to reduce potential trauma between the stent-graft prosthesis and the vessel. For example, due to the delicate nature of vascular tissue, a stent graft prosthesis having a closed-mesh configuration may be selected to treat an aneurysm, dissection, or vessel transection. Thus, a closed-mesh configuration of the stent graft prosthesis is less traumatic to sensitive tissues and disease states. Closed mesh configurations stent graft prostheses provide convenience by maintaining the structural integrity of the delicate vascular tissue.

It is well known that intraluminal grafts are deployed by minimally invasive endoluminal delivery procedures to implant them within a vessel. However, existing stent grafts, whether bare metal stents, drug eluting stents, or biodegradable stents, have different degrees of vascular damage caused by expansion upon implantation and blood cannot flow through the stent graft prosthesis when the stent graft prosthesis is partially expanded against the vessel wall but the proximal end of the stent graft prosthesis is captured by the end capture mechanism. As a result, pulsatile blood pressure against the proximal or upstream end of the stent-graft prosthesis can cause the stent-graft prosthesis to move during deployment, thereby presenting challenges in accurately positioning, deploying, and stabilizing the stent-graft prosthesis. Thus, there is a need for a stent-graft prosthesis that ensures blood flow after deployment that is stable and does not shift, to improve positioning and deployment accuracy, and to maintain blood flow in the stent-graft prosthesis, and to increase the service life of the stent-graft prosthesis.

Disclosure of Invention

The invention aims to overcome the defects of the prior art and provides a preparation method of a specific in-vivo lumen implant, which comprises a prosthesis implanted into a human body vessel or other similar lumen structure organs through skin, such as a biocompatible stent or a bionic prosthesis such as a prosthesis vessel and the like, and the specific in-vivo lumen implant integrates a stent body, a specific stent inner wall, a spiral wire core and a link animal body surface bionic outer wall and takes an elastic metal wire or a polymer wire as a base material.

A method for preparing a specific intraluminal graft, comprising the steps of:

s1, selecting two single metal wires or polymer wire materials, or combining and twisting one metal wire and one polymer wire material, thereby forming the metal wires and/or the polymer wire materials which form the stent body;

s2, selecting elastic metal wires and/or polymer wires with the diameter of 0.3-0.5mm, and tightly and spirally winding the elastic metal wires and/or polymer wires on a mold rod;

s3, after the stent body is wound, taking out the die rod, and carrying out high-temperature friction on the inner wall of the stent by using a fine grinding wheel, or coating a polymer material on the inner wall of the stent to form a film;

s4, cutting 2-4 pressure relief channels along the axial direction of the smooth inner wall by using a cutting tool on a machine tool, and performing scraping treatment or high-temperature pressing treatment on the outer wall of the stent, so that the outer surface of the metal wire and/or the polymer wire looks like a wrinkle integrally, and the stent has a link animal body surface bionic outer wall.

In the step S2, no gap is left between each length of the metal wire and/or the polymer wire.

In step S3, the film substantially fills the space between the inner walls of adjacent segments of the stent, so that the inner walls of the stent are smooth and flat as a whole.

In step S4, the depth of the pressure relief channel is about 0.03 mm to about 0.06 mm.

The stent body can be completely or partially coated with a film or not coated with a film.

The stent is made of biocompatible materials, wherein the metal wires can have shape memory properties.

The invention discloses an implant of a lumen in vivo with a specific stent inner wall, which comprises a hollow stent body, wherein the stent body is formed by tightly winding elastic metal wires and/or polymer wires in a spiral shape and is provided with a through cavity, the metal wires and/or the polymer wires are in a bifilar structure and are twisted, the inner wall of the cavity of the stent body is subjected to high-temperature friction or film coating treatment, so that the inner wall is integrally smooth and flat, blood can be ensured to smoothly flow through the stent cavity, the smooth inner wall of the stent body is provided with one or more pressure relief channels extending from one end of the stent to the other end along the axial direction of the stent, the pressure of blood flow on the inner wall of the stent when a prosthesis is implanted into a blood vessel is dispersed or weakened, the cross section of the metal wires and/or the polymer wires is circular, and the outer wall of the stent is subjected to, therefore, the outer surfaces of the metal wires and/or the polymer wires forming the stent are integrally similar to fold shapes like the link animal body surface, so that the stent has the link animal body surface bionic outer wall, and the anchoring stability is ensured on the premise of not damaging the blood vessel wall.

The diameter d of the elastic metal wires and/or the polymer wire materials forming the stent body is 0.3-0.5mm, and the distance between the central points of the cross sections of the adjacent metal wires and/or the polymer wire materials is the same as the diameter d and is also 0.3-0.5 mm; the stent has an outer diameter of 6-18mm and a length of 40-90 mm after being unfolded.

Each of the two-strand structures forming the elastic metal wire and/or the polymer wire may be a single metal wire or polymer wire, or a combination of metal wires and polymer wires and twisted together.

The polymer wire forming the stent body is a high temperature resistant polymer material.

After the inner wall of the stent body is subjected to high-temperature friction treatment, the stent wall becomes thin, so that a metal wire and/or a polymer wire with a larger diameter are/is required to be adopted, and the proper wall thickness of the stent is ensured so as to have enough support property while the inner wall is ensured to be smooth and flat.

After the inner wall of the stent body is coated with the film, the stent wall can become thick, so that a metal wire or a polymer wire with a small diameter is required to be adopted, and the proper wall thickness of the stent is ensured to have enough support property while the inner wall is ensured to be smooth and flat.

The outer wall of the stent can be provided with a flat head bulge on each section of metal wires and/or polymer wires at the right half section so as to play a further role in anchoring.

The number of the pressure relief channels is 2-4, and each pressure relief channel is in smooth transition with the inner wall of the support.

When the specific in-vivo lumen implant is prepared, the specific in-vivo lumen implant is formed by tightly and spirally winding elastic metal wires and/or polymer wires with the diameter of 0.3-0.5mm on a mold rod, and no gap is left between each section of metal wire and/or polymer wire; after the support body is wound, taking out the mold rod, and carrying out high-temperature friction on the inner wall of the support by adopting a fine grinding wheel, or coating a polymer material on the inner wall of the support to form a film, wherein the film fully fills the vacant space between the inner walls of adjacent sections of the support, so that the inner wall of the support is integrally smooth and flat; and then, cutting 2-4 pressure relief channels with the depth of about 0.03-0.06mm by using a cutting tool on a machine tool along the axial direction of the smooth inner wall, and performing scraping treatment or high-temperature pressing treatment on the outer wall of the stent, so that the outer surface of the metal wire and/or the polymer wire integrally looks like a wrinkle, and the stent has a bionic outer wall on the surface of a link animal body.

Before the spiral winding, two single metal wires or polymer wires or one metal wire and one polymer wire are combined and twisted to form the metal wires and/or the polymer wires forming the stent body.

If the inner wall of the stent needs to be subjected to high-temperature friction treatment, the metal wire and/or the polymer wire with larger diameter is selected, and if the inner wall of the stent needs to be subjected to thin film coating treatment, the metal wire and/or the polymer wire with smaller diameter is selected, so that the inner wall is ensured to be smooth and flat, and meanwhile, the proper wall thickness of the stent is ensured so that the stent has enough support.

This application is through carrying out high temperature friction or film coating to the support inner wall and handling for the inner wall is whole smooth and level, thereby guaranteed that blood smoothly flows through the support cavity, the setting of pressure release passageway on its inner wall, the pressure of blood flow to the support inner wall when the blood vessel is implanted to the dispersion or weakened support graft false body, the bionical outer wall of link animal body surface of support, and the bellied setting of crew cut on the outer wall, make it guarantee the stability of anchor under the prerequisite that does not harm the vascular wall. The utility model provides an internal lumen supporting structure is more stable, implants safelyr, can enough guarantee that the blood flow is unobstructed, can avoid the appearance of restenosis again, and life is longer. In addition, in order to achieve the above purpose, the stent of the present application is more exquisite in material selection, and the metal wires and/or the polymer wires used therein are formed by cabling in a bifilar structure, thereby better achieving the above technical effects.

Drawings

FIG. 1 is a flow chart of a method of making a specific intraluminal graft of the present invention.

FIG. 2 is a schematic structural view of a specific intraluminal graft of the present invention.

FIG. 3 is a schematic view of the internal cavity structure of a specific intraluminal graft of the present invention.

FIG. 4 is a schematic diagram of the outer wall structure of a specific intraluminal implant of the present invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

Example 1

As shown in fig. 1, a method for preparing a specific intraluminal graft, the method comprising the steps of:

In the step S2, no gap is left between each length of the metal wire and/or the polymer wire. In the step S3, the film substantially fills the empty space between the inner walls of the adjacent segments of the stent, so that the inner walls of the stent are smooth and flat as a whole.

In step S4, the depth of the pressure relief channel is about 0.03 mm to about 0.06 mm. The stent body can be completely or partially coated with a film or not coated with a film. The stent is made of biocompatible materials, wherein the metal wires can have shape memory properties.

The specific in-vivo lumen implant comprises a hollow stent body 1, an elastic metal wire and/or a polymer wire material 2, a cavity 3 and a link animal body surface bionic outer wall 4, has a more stable structure, is safer to implant, can ensure smooth blood flow, avoids restenosis, and has obvious postoperative curative effect and long service life.

Example 2

As shown in fig. 2-4, the stent body 1 is formed by tightly winding an elastic metal wire and/or a polymer wire 2 in a spiral shape, and has a through cavity 3, the metal wire and/or the polymer wire 2 is formed by twisting a bifilar structure, the inner wall of the cavity 3 of the bracket body 1 is processed by high-temperature friction or film coating, thereby forming an integral smooth and flat inner wall, the smooth inner wall of the bracket is provided with one or more pressure relief channels extending from one end of the bracket to the other end along the axial direction of the bracket, the cross section of the metal wire and/or the polymer wire 2 is circular, the outer wall 4 of the bracket is subjected to scraping treatment or high-temperature pressing, therefore, the outer surface of the metal wire and/or the polymer wire 2 forming the stent is similar to wrinkle shape as the link animal body surface, and the stent has the link animal body surface bionic outer wall 4.

The diameter d of the elastic metal wire and/or the polymer wire 2 forming the stent body 1 is 0.3-0.5mm, and the distance between the central points of the cross sections of the adjacent metal wires and/or the polymer wires 2 is the same as the diameter d and is also 0.3-0.5 mm; the stent has an outer diameter of 6-18mm and a length of 40-90 mm after being unfolded.

Each of the two-strand structures forming the elastic metal wire and/or polymer wire 2 may be a single metal wire or polymer wire, or a combination of metal wires and polymer wires and twisted.

The polymer wires forming the stent body 1 are high temperature resistant polymer materials.

After the inner wall of the stent body 1 is subjected to high-temperature friction treatment, the stent wall becomes thin, so that a metal wire and/or a polymer wire 2 with a larger diameter is required to be adopted, and the proper wall thickness of the stent is ensured so as to have enough support property while the inner wall is ensured to be smooth and flat.

After the inner wall of the stent body 1 is coated with a thin film, the stent wall becomes thick, so that a metal wire or a polymer wire with a small diameter needs to be adopted, and the proper wall thickness of the stent is ensured so as to have enough support property while the inner wall is ensured to be smooth and flat.

The outer wall 4 of the stent can be provided with flat-head protrusions 6 on each section of metal wires and/or polymer wires 2 of the right half section 5 to play a role in further anchoring.

The stent body 1 can be completely or partially coated with a film or not coated with a film.

Example 3

When the specific in-vivo lumen implant is prepared, the elastic metal wire and/or the polymer wire material 2 with the diameter of 0.3-0.5mm is selected and tightly and spirally wound on a mold rod, and no gap is left between each section of the metal wire and/or the polymer wire material 2; after the support body 1 is wound, taking out the mold rod, and carrying out high-temperature friction on the inner wall of the support by adopting a fine grinding wheel, or coating a polymer material on the inner wall of the support to form a film, wherein the film fully fills the vacant space between the inner walls of adjacent sections of the support, so that the inner wall of the support is integrally smooth and flat; and then, cutting 2-4 pressure relief channels with the depth of about 0.03-0.06mm by using a cutting tool on a machine tool along the axial direction of the smooth inner wall, and performing scraping treatment or high-temperature pressing treatment on the outer wall 4 of the stent, so that the outer surface of the metal wire and/or the polymer wire 2 integrally looks like a wrinkle, and the stent has the bionic outer wall 4 of the body surface of the animal.

Before the spiral winding, two single metal wires or polymer wires or a combination of one metal wire and one polymer wire are selected and twisted to form the metal wire and/or polymer wire 2 which forms the stent body 1.

If the inner wall of the stent needs to be subjected to high-temperature friction treatment, the metal wire and/or the polymer wire 2 with larger diameter is selected, and if the inner wall of the stent needs to be subjected to thin film coating treatment, the metal wire and/or the polymer wire 2 with smaller diameter is selected, so that the inner wall is ensured to be smooth and flat, and meanwhile, the proper wall thickness of the stent is ensured so that the stent has enough support.

It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative embodiments, and that the present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. Any reference sign in a claim should not be construed as limiting the claim concerned.

Claims

1. A method for preparing a specific intraluminal graft, comprising the steps of:

2. The method for preparing a specific intraluminal graft according to claims 1 and 2, wherein, in the step S2, no gap is left between each length of the metal wires and/or the polymer wire material.

3. The method for preparing a specific intraluminal graft according to claims 1 and 2, wherein, in the step S3, the film substantially fills the empty space between the inner walls of adjacent segments of the stent, thereby making the inner walls of the stent smooth and flat as a whole.

4. The method of claim 1, wherein in step S4, the pressure relief channel has a depth of about 0.03 mm to about 0.06 mm.

5. The method for preparing a specific intraluminal graft according to claim 1, wherein the stent is coated with or without a membrane, either completely or partially, outside the body.

6. The method for preparing a specific intraluminal graft according to claim 1, wherein the scaffold is made of a biocompatible material, and wherein the wire has shape memory properties.