CN114983645B - Hierarchical self-expansion bifurcation stent and implantation method thereof - Google Patents
Hierarchical self-expansion bifurcation stent and implantation method thereof Download PDFInfo
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- 238000002513 implantation Methods 0.000 title description 10
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- 229910001000 nickel titanium Inorganic materials 0.000 claims description 9
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- 230000000996 additive effect Effects 0.000 claims description 4
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2002/825—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having longitudinal struts
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
- A61F2002/9155—Adjacent bands being connected to each other
- A61F2002/91575—Adjacent bands being connected to each other connected peak to trough
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0061—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof swellable
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Physics & Mathematics (AREA)
- Vascular Medicine (AREA)
- Optics & Photonics (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
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Abstract
The invention discloses a hierarchical self-expansion bifurcation stent, which comprises a main stent and a bifurcation stent, wherein the bifurcation stent is positioned on the main stent and forms an inclined angle with the main stent; the phase transition temperature of the main support is smaller than that of the branch support, so that the main support and the branch support are unfolded in a grading manner; the branch bracket meets specific conditions, is of a variable-diameter spiral structure and is formed by spirally rising a plurality of support rings in an end-to-end connection manner; each supporting ring comprises a plurality of supporting units and a plurality of first connecting rods, and the connected supporting units are connected through the first connecting rods; each supporting unit consists of two second connecting rods with equal length and an arc-shaped ring connected with the two second connecting rods. The vascular stent can bear large axial and radial deformation under small stress, so that the integrated stent can be in a straight structure similar to a traditional single-channel vascular stent after compression assembly, and the stent can be suitable for vessels with any diameter.
Description
Technical Field
The invention relates to the field of innovative medical instruments, in particular to a grading self-expanding bifurcated intravascular stent and an implantation method thereof.
Background
Cardiovascular disease is one of the major diseases that threatens human health and safety. Atherosclerosis (commonly known as vascular stenosis), a relatively common pathological feature in cardiovascular disease, refers to the accumulation of lipid substances on the inner wall of arterial blood vessels or the growth of tumors, thereby causing the arterial blood vessels to narrow. Atherosclerosis can severely affect blood circulation and supply. Atherosclerosis usually occurs in coronary arteries, cerebral arteries, aorta and renal arteries. The cause of the occurrence of small-diameter arteries such as coronary arteries and cerebral arteries is mainly the accumulation of lipid substances in the wall of blood vessels, while the cause of the occurrence of large-diameter arteries such as the aorta is usually the occurrence of substances such as aneurysms. At present, the treatment is mainly carried out by implanting a vascular stent into the corresponding diseased vessel. Atherosclerosis, which occurs in bifurcated vessels, is a more complex type of lesion than atherosclerosis, which occurs in single-channel arterial vessels, and is one of the challenges that is urgently needed to overcome at this stage.
The existing method for treating the bifurcated atherosclerosis mainly comprises two ways of implanting two single-channel vascular stents or implanting a customized bifurcated integrated stent. For larger diameter bifurcated arteries (such as the abdominal aorta), treatment is typically performed by implanting custom-made bifurcated integral stents. This treatment requires that the branch vessel of the bifurcated artery have a relatively large diameter, that both branches of the bifurcated artery be perforated, and that a guidewire be introduced to guide both branches of the integrated stent. For smaller diameter bifurcated arteries (e.g., bifurcated coronary and cerebral arteries), because the vessel diameters are small and because these arteries are typically located inside the organ, it is difficult to perform a perforation operation, and thus it is generally desirable to implant two single-pass stents for treatment. Treatment with a double stent implantation requires destruction of the stent structure of the first stent, affecting the stability of the stent use; meanwhile, after the double brackets are implanted, the joint of the two brackets may affect the circulation of blood, resulting in the consequences of insufficient blood supply and the like.
Disclosure of Invention
Aiming at the defects of the prior art, the invention provides a grading self-expanding bifurcation stent and an implantation method thereof, the stent can be implanted into a body through a guide wire and is simultaneously applicable to large-diameter arteries and small-diameter arteries, thereby providing a new treatment mode for cardiovascular diseases such as atherosclerosis and the like.
The aim of the invention is achieved by the following technical measures:
The hierarchical self-expansion bifurcation stent comprises a main stent and a branch stent, wherein the branch stent is positioned on the main stent and forms an inclined angle with the main stent;
The main support and the branch support are respectively made of nickel-titanium alloy materials with different nickel-titanium proportions, so that the phase transition temperature of the main support is lower than that of the branch support, and the main support and the branch support are unfolded in a grading manner;
The branch bracket is of a variable-diameter spiral structure and consists of a plurality of support rings which are connected end to end and spirally ascend; each supporting ring comprises a plurality of supporting units and a plurality of first connecting rods, and the connected supporting units are connected through the first connecting rods; each supporting unit consists of two equal-length second connecting rods and an arc-shaped ring connected with the two second connecting rods; the diameter D of a circular ring formed by the projection of each supporting ring on the horizontal plane is equal; the sum of the gaps at the bottom end of the second connecting rod of each supporting unit of the upper layer of supporting ring is larger than the sum of all supporting gaps of the lower layer of supporting ring, so that the branch bracket can be in a variable-diameter spiral structure after being radially compressed;
the parameters of the branch bracket meet the following conditions:
D' The upper layer -D' The next layer ≥2d (1.4)
Wherein D is the diameter of a circular ring corresponding to the projection of each support ring on a horizontal plane before compression; d' X is the diameter of the ring corresponding to the compressed supporting ring, and L is the projection length of the expansion structure of each supporting ring on the horizontal plane; l X is the length of the deployed structure of each support ring; θ is the angle between each support ring and the horizontal line, i.e. the helix angle; For the included angle of the two second connecting rods in the supporting units, X n is the number of the supporting units in each supporting ring, t is the width of the connecting rods, d is the thickness of the connecting rods, and H is the overall height of the supporting units.
Further, the helix angle θ of the support ring at the bottommost layer of the branch stent is 0 degrees.
Further, the length L X of the deployed configuration of each support ring is equal.
Further, the main support and the branch support are of an integrated structure, and additive manufacturing of the support is realized on the basis of manufacturing nickel-titanium alloy through a selective laser melting technology.
Further, the main support consists of a plurality of sine wave support rings, which are only subjected to radial large deformations.
An implantation method of a graded self-expanding bifurcated stent, the method comprising the following steps:
s1: simultaneously radially and axially compressing the branch stent of the graded self-expanding branch vascular stent to form a scroll structure, and radially compressing the main stent to form a straight structure of the whole graded self-expanding branch vascular stent;
S2: after implanting the graded self-expanding bifurcated vascular stent with a straight structure into a corresponding lesion vessel through a guide wire, heating a designated part to a first temperature to gradually expand the main stent; in the process of expanding the main support, the position and the posture of the support are adjusted in a rotating support mode, so that the branch support is accurately aligned to a branch vessel;
S3: and continuing to heat the appointed position to a second temperature to expand the branch stent, thereby completing the implantation of the graded self-expansion branch vascular stent.
The beneficial effects of the invention are as follows:
(1) The graded self-expanding bifurcated vascular stent can be compressed into a straight stent when being assembled and compressed, can be implanted through one-time transmission under the guidance of a guide wire, and is suitable for blood vessels with any diameter.
(2) The branch stent of the grading self-expansion branch vascular stent is of a variable-diameter spiral structure and can be compressed into a scroll structure, so that the stent is prevented from being damaged, and the stability of the stent is ensured to be good.
Drawings
FIG. 1 is a schematic illustration of a hierarchical self-expanding bifurcated stent structure and its compression to form a straight stent.
Fig. 2 is an expanded view of a branched stent of the hierarchical self-expanding branched stent.
Fig. 3 is a schematic diagram of the compression process of the branch stent of the hierarchical self-expanding bifurcated stent.
Fig. 4 is a workflow diagram of a hierarchical self-expanding bifurcated stent implantation method.
Detailed Description
The objects and effects of the present invention will become more apparent from the following detailed description of the preferred embodiments and the accompanying drawings, it being understood that the specific embodiments described herein are merely illustrative of the invention and not limiting thereof.
As shown in fig. 1, the hierarchical self-expanding bifurcated stent of the present invention comprises a main stent and a bifurcated stent. The main support is similar to the traditional design and only needs to bear radial large deformation. The main stent illustrated in fig. 1 is a sinusoidal stent. The axial direction of the branch bracket and the axial direction of the main bracket form a certain inclination angle.
As shown in fig. 2 and 3, the branch bracket is of a variable-diameter spiral structure and consists of a plurality of support rings which are connected end to end and spirally ascend; each supporting ring comprises a plurality of supporting units and a plurality of first connecting rods, and the connected supporting units are connected through the first connecting rods; each supporting unit consists of two equal-length second connecting rods and an arc-shaped ring connected with the two second connecting rods; the width of the second connecting rod is t, the thickness of the second connecting rod (the radial dimension of each supporting unit) is d, the overall height of each supporting unit is H, and the distance between the two second connecting rods in each supporting unit and the connecting end of the first connecting rod is a supporting gap S. The included angle between each support ring and the horizontal line after being unfolded is a helix angle theta.
When the branch bracket is designed, the requirements are satisfied: the diameter D of a circular ring formed by the projection of each supporting ring on the horizontal plane is equal; the sum of the supporting gaps S of each supporting unit of the supporting ring of the upper layer is larger than the sum of all supporting gaps of the supporting ring of the lower layer, so that the branched bracket can be formed into a variable-diameter spiral structure after being radially compressed. Meanwhile, parameters of the branch bracket also need to satisfy: the diameter of the corresponding circular ring of each supporting ring is the same, and can be calculated by the formula 1.1; meanwhile, the length L x of each support ring after being unfolded is the same, and can be calculated by the formula 1.2; after radial compression is carried out on the branch bracket, the branch bracket forms a variable-diameter screw mechanism, as shown in figure 3, and the diameter of each supporting ring after radial compression can be calculated by using 1.3; in order to ensure that the branch support can finally form a scroll structure, the diameter of the corresponding ring after radial compression of the upper layer of support ring is at least larger than the diameter of the corresponding ring after radial compression of the lower layer of support ring by two second connecting rod thicknesses, and 1.4 needs to be satisfied; the diameter of each supporting ring after radial compression is required to satisfy 1.5
D' The upper layer -D' The next layer ≥2d (1.4)
Wherein D is the diameter of a circular ring corresponding to the projection of each support ring on a horizontal plane before compression; d' X is the diameter of the ring corresponding to the compressed supporting ring, and L is the projection length of the expansion structure of each supporting ring on the horizontal plane; l X is the length of the deployed structure of each support ring; θ is the angle between each support ring and the horizontal line, i.e. the helix angle; X n is the number of the supporting units in each supporting ring for the included angle of the two second connecting rods in the supporting units.
The branch stent can bear large axial and radial deformation under small stress, so that the integrated stent can be in a straight structure similar to a traditional single-channel vascular stent after compression assembly. I.e. can be guided into the corresponding diseased vessel by a guide wire.
In addition, in order to achieve good fixation of the branch stent on the main stent, the helix angle θ of the support ring of the nearest layer of the branch stent from the main stent, i.e., the support ring of the bottommost layer, is 0 degrees.
For ease of additive manufacturing, the length L X of the deployed structure of each support ring is set to be equal.
Meanwhile, the main support and the branch support respectively use nickel-titanium alloy materials with different nickel-titanium proportions, so that the phase transition temperatures of the branch support and the main support are different, and the phase transition temperature of the main support is smaller than that of the branch support, so that the function of grading and expanding the graded self-expanding bifurcated vascular support is realized, as shown in fig. 4.
The hierarchical self-expanding bifurcated stent provided by the invention has a complex structure and has the requirement of personalized customization in clinic, and is difficult to process by utilizing traditional laser cutting. The selective laser melting technology can realize the rapid customization of metal parts with complex shapes, so the invention realizes the additive manufacturing of the bracket on the basis of manufacturing the nickel-titanium alloy by adopting the selective laser melting technology, and carries out post-treatment operations such as heat treatment, sand blasting, electrolytic polishing and the like on the manufactured sample so as to meet the clinical requirements.
Figure 4 shows a workflow diagram of a method of implanting a hierarchical self-expanding bifurcated stent. The implantation method of the graded self-expansion bifurcated intravascular stent comprises the following steps:
s1: simultaneously radially and axially compressing the branch stent of the graded self-expanding branch vascular stent to form a scroll structure, and radially compressing the main stent to form a straight structure of the whole graded self-expanding branch vascular stent;
S2: as shown in fig. 4 (a), after implanting the hierarchical self-expanding bifurcated stent of a straight structure into a corresponding lesion vessel through a guide wire, a designated site is heated to a first temperature a using a non-contact electromagnetic induction heating apparatus. In the heating process, the main support is gradually unfolded; as shown in fig. 4 (b), the main stent is unfolded, the pose is adjusted by rotating the stent (the head of the guide wire is connected with the partial region of the hierarchical self-expanding bifurcated vascular stent, so that the rotating guide wire can rotate the integrated stent), the main stent is unfolded, and the bifurcated stent can be accurately aligned with the branched vessel, as shown in fig. 4 (c).
S3: as shown in fig. 4 (d), the stent graft is deployed by heating to the second temperature B using a non-contact electromagnetic induction heating apparatus, thereby completing the implantation of the hierarchical self-expanding bifurcated stent graft.
It will be appreciated by persons skilled in the art that the foregoing description is a preferred embodiment of the invention, and is not intended to limit the invention, but rather to limit the invention to the specific embodiments described, and that modifications may be made to the technical solutions described in the foregoing embodiments, or equivalents may be substituted for elements thereof, for the purposes of those skilled in the art. Modifications, equivalents, and alternatives falling within the spirit and principles of the invention are intended to be included within the scope of the invention.
Claims (5)
1. The grading self-expansion bifurcation stent is characterized by comprising a main stent and a branch stent, wherein the branch stent is positioned on the main stent and forms an inclined angle with the main stent;
The main support and the branch support are respectively made of nickel-titanium alloy materials with different nickel-titanium proportions, so that the phase transition temperature of the main support is lower than that of the branch support, and the main support and the branch support are unfolded in a grading manner;
The branch bracket is of a variable-diameter spiral structure and consists of a plurality of support rings which are connected end to end and spirally ascend; each supporting ring comprises a plurality of supporting units and a plurality of first connecting rods, and the connected supporting units are connected through the first connecting rods; each supporting unit consists of two equal-length second connecting rods and an arc-shaped ring connected with the two second connecting rods; the diameter D of a circular ring formed by the projection of each supporting ring on the horizontal plane is equal; the sum of the gaps at the bottom end of the second connecting rod of each supporting unit of the upper layer of supporting ring is larger than the sum of all supporting gaps of the lower layer of supporting ring, so that the branch support is radially compressed to form a variable-diameter spiral structure;
the parameters of the branch bracket meet the following conditions:
（1.1）
（1.2）
（1.3）
（1.4）
（1.5）
Wherein D is the diameter of a circular ring corresponding to the projection of each support ring on a horizontal plane before compression; The diameter of the ring corresponding to the compressed supporting ring is L, and the projection length of the expansion structure of each supporting ring on the horizontal plane is L; l X is the length of the deployed structure of each support ring; θ is the angle between each support ring and the horizontal line, i.e. the helix angle; for the angle between the two second connecting rods in the supporting unit, The number of the supporting units in each supporting ring is t, the width of the connecting rod is t, the thickness of the connecting rod is d, and the overall height of the supporting units is H.
2. The hierarchical self-expanding bifurcated stent of claim 1, wherein the helix angle θ of the bottommost support ring of the bifurcated stent is 0 degrees.
3. The hierarchical self-expanding bifurcated stent of claim 1, wherein the length L X of the deployed structure of each support ring is equal.
4. The hierarchical self-expanding bifurcated stent of claim 1, wherein the main stent and the bifurcated stent are of an integrated structure, and wherein additive fabrication of the stent is achieved on the basis of fabrication of nickel-titanium alloy by selective laser melting techniques.
5. The hierarchical self-expanding bifurcated stent of claim 1, wherein the main stent is comprised of a plurality of sine wave support rings that are subject to only large radial deformations.
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|---|---|---|---|---|
| CN109730803A (en) * | 2019-01-10 | 2019-05-10 | 西安交通大学 | Rapid fabrication of metal 4D printing for self-expanding bifurcated vascular stents |
| CN110234297A (en) * | 2017-02-01 | 2019-09-13 | 恩朵罗杰克斯股份有限公司 | The stent graft system and method that can longitudinally extend |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CA2335333C (en) * | 1998-06-19 | 2009-05-05 | Endologix, Inc. | Self expanding bifurcated endovascular prosthesis |
| US7731741B2 (en) * | 2005-09-08 | 2010-06-08 | Boston Scientific Scimed, Inc. | Inflatable bifurcation stent |
| CN206852682U (en) * | 2016-12-28 | 2018-01-09 | 先健科技(深圳)有限公司 | Intraluminal stent |
| CN112438828A (en) * | 2020-12-04 | 2021-03-05 | 柳克祥 | Blood vessel support with branch |
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| CN110234297A (en) * | 2017-02-01 | 2019-09-13 | 恩朵罗杰克斯股份有限公司 | The stent graft system and method that can longitudinally extend |
| CN109730803A (en) * | 2019-01-10 | 2019-05-10 | 西安交通大学 | Rapid fabrication of metal 4D printing for self-expanding bifurcated vascular stents |
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