CN113876475A - Degradable magnesium alloy stent - Google Patents

Degradable magnesium alloy stent Download PDF

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Publication number
CN113876475A
CN113876475A CN202010550112.XA CN202010550112A CN113876475A CN 113876475 A CN113876475 A CN 113876475A CN 202010550112 A CN202010550112 A CN 202010550112A CN 113876475 A CN113876475 A CN 113876475A
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CN
China
Prior art keywords
section
body support
main body
magnesium alloy
peak
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Granted
Application number
CN202010550112.XA
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Chinese (zh)
Other versions
CN113876475B (en
Inventor
周文选
吕轲
左伟
尚磊
李涛
林森
梁栋科
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shanghai Pumi Medical Instrument Co ltd
Shanghai Kindly Medical Instruments Co ltd
Original Assignee
Shanghai Pumi Medical Instrument Co ltd
Shanghai Kindly Medical Instruments Co ltd
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Priority to CN202010550112.XA priority Critical patent/CN113876475B/en
Publication of CN113876475A publication Critical patent/CN113876475A/en
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Publication of CN113876475B publication Critical patent/CN113876475B/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958Inflatable balloons for placing stents or stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00011Metals or alloys
    • A61F2310/00035Other metals or alloys
    • A61F2310/00041Magnesium or Mg-based alloys

Abstract

The invention provides a degradable magnesium alloy stent, which belongs to the technical field of medical appliances and comprises the following components: the main body support rings are arranged at intervals, each main body support ring is of an annular structure, and every two adjacent main body support rings are connected through a plurality of connectors; the main body support ring is formed by sequentially connecting a plurality of wave crest sections and wave trough sections, the wave crest sections and the wave trough sections are connected through transition sections, at least part of the wave crest sections (3) are of a structure with at least two arc vertexes, and the section width of the wave trough sections is larger than the average section width of the main body support ring. According to the structure with the plurality of arc-shaped peaks of the peak section, the deformation allowance of the peak section is increased; the section of the wave trough section is widened, so that the structural strength of the wave trough section is improved; in the radial expansion process, the concentrated stress and deformation can be dispersed by the arc-shaped peak structure and the cross section widening design, the degradation rate difference between the peak section, the trough section and the transition section is reduced, and the failure of the integral stent caused by the fact that the peak section and the trough section are degraded before the transition section is avoided.

Description

Degradable magnesium alloy stent
Technical Field
The invention relates to the technical field of medical instruments, in particular to a degradable magnesium alloy stent.
Background
With the development of modern medical technology and the increasing perfection of medical equipment, coronary stent implantation is becoming a main means of interventional cardiovascular therapy. The magnesium alloy stent not only can provide the high support strength of the metal stent, but also can be absorbed by a human body after 6-12 months, thereby avoiding the long-term foreign matter stimulation to the vascular wall, reducing the restenosis rate of the blood vessel and showing huge advantages and potentials.
The stent in the closed state is placed on a balloon at the distal end of a balloon catheter, and is conveyed to a lesion or stenosis portion through an artery of a patient along a guide wire previously inserted into the artery; expanding the balloon catheter to make the balloon drive the stent to expand, wherein the expanded stent supports the artery wall and keeps the stenosis part in an open state; and after the support is fixed, removing the balloon catheter.
At present, a support ring of a support is of a quasi-sinusoidal structure, stress concentration easily occurs at wave crests and wave troughs of the support in an expansion process, and pitting corrosion occurs at the stress concentration part first to lose bearing capacity.
Disclosure of Invention
Therefore, the technical problem to be solved by the present invention is to overcome the defect that the magnesium alloy stent in the prior art is prone to stress concentration, so as to provide a magnesium alloy stent capable of reducing stress concentration.
In order to solve the above technical problems, the present invention provides a degradable magnesium alloy stent, comprising:
the device comprises a plurality of main body support rings arranged at intervals, wherein each main body support ring is of an annular structure, and two adjacent main body support rings are connected through a plurality of connectors;
the main part support ring is connected gradually through a plurality of crest sections and trough section and constitutes, the crest section with connect through the changeover portion between the trough section, at least part the crest section is for having the structure on two at least arc summits, the cross-sectional width of trough section is greater than the average cross-sectional width of main part support ring.
Preferably, the cross-sectional width of the peak section is greater than the average cross-sectional width of the body support ring.
Preferably, at least one end of the connecting body is connected with the transition section of the main body supporting ring.
Preferably, both ends of the connecting body are connected with the transition section of the main body support ring.
Preferably, one end of the connecting body is connected with the transition section of the main body support ring, and the other end of the connecting body is connected with the vertex position of the wave trough section.
Preferably, each of the peak sections has two arc-shaped apexes.
Preferably, the crest segment has two structures: the first structure is a structure with one arc vertex, the second structure is a structure with two arc vertices, and the wave peak sections of the two structures are alternately arranged.
Preferably, the wave crests of two adjacent main body support rings are opposite to the wave crests, or the wave crests of two adjacent main body support rings are opposite to the wave troughs.
Preferably, mirror symmetry is adopted between two adjacent main body support rings.
Preferably, the method further comprises the following steps:
and the X-ray developing sheet is connected to the transition section or the connecting body.
The technical scheme of the invention has the following advantages:
1. according to the degradable magnesium alloy stent provided by the invention, the deformation allowance of the wave crest section is increased due to the structure of the plurality of arc vertexes of the wave crest section; the section of the wave trough section is widened, so that the structural strength of the wave trough section is improved; in the radial expansion process of the main body support ring, the arc-shaped peak structure and the cross section widening design can disperse concentrated stress and deformation, so that the structural strength of the peak section and the trough section is enhanced, the degradation rate difference between the peak section, the trough section and the transition section is reduced, the peak section, the trough section and the transition section are degraded as far as possible synchronously, and the failure of the integral support caused by the fact that the peak section and the trough section are degraded before the transition section is avoided.
2. According to the degradable magnesium alloy stent provided by the invention, the section width of the peak section is larger than the average section width of the main body support, so that the structural strength of the peak section is increased.
3. According to the degradable magnesium alloy support provided by the invention, in the radial expansion process of the main body support ring, the stress and deformation borne by the transition section are smaller, so that at least one end of the connector is connected with the transition section of the main body support ring, and the integral structural strength of the support is increased.
4. According to the degradable magnesium alloy support provided by the invention, the two adjacent main body support rings are arranged in a mirror symmetry manner, namely the wave crests of the main body support rings are opposite to the wave crests, so that the deformation allowance of the whole support is increased, and the damage degree of the deformation of the whole support in the expansion process is reduced.
5. The degradable magnesium alloy bracket provided by the invention is convenient for tracking the position of the bracket through X rays due to the arrangement of the X-ray developing film.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.
Fig. 1 is a schematic unfolded three-dimensional structure diagram of a degradable magnesium alloy stent provided in a first embodiment of the invention.
Fig. 2 is a front view of fig. 1.
Fig. 3 is a second schematic deployment view of the degradable magnesium alloy stent provided in the first embodiment of the invention.
Fig. 4 is a schematic structural diagram of the first body unit.
Fig. 5 is a first schematic deployment view of a degradable magnesium alloy stent provided in a second embodiment of the invention.
Fig. 6 is a second schematic deployment view of a degradable magnesium alloy stent provided in a second embodiment of the invention.
Fig. 7 is a schematic structural view of the second body unit.
Description of reference numerals:
1. a main body support ring; 2. a linker; 3. a peak band; 4. a wave trough section; 5. an X-ray developing sheet; 6. an arc vertex structure; 7. a transition section; 8. a half arc segment; 9. a first body unit; 10. a second body unit.
Detailed Description
The technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are some, but not all embodiments of the present invention. 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.
In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present invention.
In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.
In addition, the technical features involved in the different embodiments of the present invention described below may be combined with each other as long as they do not conflict with each other.
Example 1
The degradable magnesium alloy stent provided by the embodiment comprises a plurality of main body support rings 1 and a connector 2.
As shown in fig. 1 and 2, the main body support ring 1 in an undeployed state is an annular structure and is formed by sequentially connecting a plurality of first main body units 9, the main body support ring 1 has a plurality of peak sections 3 and valley sections 4, and the peak sections 3 and the valley sections 4 are sequentially connected; the main body support rings 1 are transitionally connected into a tubular degradable magnesium alloy bracket through the connecting body 2, and the adjacent two main body support rings 1 are in mirror symmetry, namely the wave crests of the adjacent two main body support rings 1 are opposite to the wave crests; the connector 2 is of a straight line or curve structure suitable for bending, and two ends of the connector 2 are connected with the transition section 7 of the main body support ring 1. Be equipped with X-ray development piece 5 on the main part support ring 1, X-ray development piece 5 is connected the midpoint department of changeover portion 7 is convenient for track the position of support through X ray.
As an alternative embodiment, as shown in FIG. 3, the X-ray film 5 is attached at the midpoint of the connecting body 2 to facilitate tracking of the position of the stent by X-ray.
As shown in fig. 4, the first body unit 9 includes two arc-shaped apex structures 6, a transition section 7, and a half-arc section 8; the two arc-shaped peak structures 6 are positioned in the middle of the first main body unit 9, the two arc-shaped peak structures 6 form a peak section 3 of the main body support ring 1, and the arc-shaped peak structures 6 increase the deformation allowance of the peak section 3; the section width of the wave crest section 3 is larger than the average section width of the main body support ring 1, so that the deformation resistance of the wave crest section 3 is increased. The number of the half arc sections 8 is two, and the two half arc sections are respectively connected to the left side and the right side of the arc vertex structure 6 through the transition sections 7; two adjacent first main body units 9 are connected through the half-arc sections 8, and the two adjacent half-arc sections 8 are in transition connection to form the trough sections 4 of the main body support ring 1; the cross-sectional width of the wave-trough section 4 is greater than the average cross-sectional width of the body support ring 1, increasing the strength of the wave-trough section 4 against deformation. The transition section 7 is of a curve structure, and the deformation allowance of the transition section 7 is increased. The design of the first main body unit reduces the degradation rate difference between the crest section 3, the trough section 4 and the transition section 7, so that the crest section 3, the trough section 4 and the transition section 7 are degraded as synchronously as possible, and the failure of the integral support caused by the fact that the crest section 3 and the trough section 4 are degraded before the transition section 7 is avoided.
Example 2
The degradable magnesium alloy stent provided in this embodiment is similar to that of embodiment 1, except that, as shown in fig. 5 and 6, the main body support ring 1 is formed by alternately connecting the first main body unit 9 and the second main body unit 10, so that the peak sections 3 assume two structures, one is a structure having one arc apex, and the other is a structure having two arc apexes, and the peak sections 3 of the two structures are alternately arranged.
As shown in fig. 7, the second body unit 10 includes: an arc apex structure 6, a transition section 7 and a half-arc section 8; the arc-shaped peak structure 6 is located in the middle of the second main body unit 10 and forms the peak section 3 of the main body support ring 1, and the section width of the peak section 3 is greater than the average section width of the main body support ring 1, so that the deformation resistance of the peak section 3 is increased. The number of the half arc sections 8 is two, and the two half arc sections are respectively connected to the left side and the right side of the arc vertex structure 6 through the transition sections 7; the second main body unit 10 and the first main body unit 9 are connected through the half-arc section 8 and form a wave trough section 4 of the main body support ring 1; the cross-sectional width of the wave-trough section 4 is greater than the average cross-sectional width of the body support ring 1, increasing the strength of the wave-trough section 4 against deformation.
As an alternative embodiment, the adjacent main body support rings 1 are opposite to each other in peak and trough, and are transitionally connected by a connecting body 2, and both ends of the connecting body 2 are connected with the transition section 7 of the main body support ring 1.
As another alternative embodiment, the wave crests and wave troughs of adjacent main body support rings 1 are opposite and are connected in a transition way through a connecting body 2; one end of the connector 2 is connected with the transition section 7 of the main body support ring 1, and the other end of the connector 2 is connected with the peak position of the wave trough section 4.
It should be understood that the above examples are only for clarity of illustration and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. And obvious variations or modifications therefrom are within the scope of the invention.

Claims (10)

1. The degradable magnesium alloy support is characterized by comprising a plurality of main body support rings (1) which are arranged at intervals, wherein the main body support rings (1) are of annular structures, and two adjacent main body support rings (1) are connected through a plurality of connectors (2);
the main part support ring (1) connects gradually through a plurality of crest segments (3) and trough segment (4) and constitutes, crest segment (3) with connect through changeover portion (7) between trough segment (4), at least part crest segment (3) are for having the structure on two at least arc summits, the cross-sectional width of trough segment (4) is greater than the average cross-sectional width of main part support ring (1).
2. The degradable magnesium alloy stent of claim 1, wherein the cross-sectional width of the peak section (3) is larger than the average cross-sectional width of the body support ring (1).
3. The degradable magnesium alloy stent according to claim 1 or 2, wherein at least one end of the connector (2) is connected with the transition section (7) of the body support ring (1).
4. The degradable magnesium alloy stent as claimed in claim 3, wherein both ends of the connecting body (2) are connected with the transition section (7) of the main body support ring (1).
5. The degradable magnesium alloy stent as claimed in claim 3, wherein one end of the connector (2) is connected with the transition section (7) of the main body support ring (1), and the other end of the connector (2) is connected with the peak position of the wave trough section (4).
6. The degradable magnesium alloy stent according to any one of claims 1 to 5, wherein each of the peak sections (3) has two arc-shaped vertexes.
7. The degradable magnesium alloy stent according to any one of claims 1 to 5, wherein the peak section (3) has two structures: one is a structure with one arc vertex, the other is a structure with two arc vertices, and the wave peak sections (3) of the two structures are alternately arranged.
8. A degradable magnesium alloy stent according to claim 6 or 7, wherein the wave crests of two adjacent body support rings (1) are opposite to the wave crests, or the wave crests of two adjacent body support rings (1) are opposite to the wave troughs.
9. The degradable magnesium alloy stent as claimed in claim 8, wherein mirror symmetry is adopted between two adjacent body support rings (1).
10. The degradable magnesium alloy stent of claim 9, further comprising:
and the X-ray developing sheet (5) is connected to the transition section (7) or connected to the connecting body (2).
CN202010550112.XA 2020-06-16 2020-06-16 Degradable magnesium alloy bracket Active CN113876475B (en)

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CN113876475B CN113876475B (en) 2024-03-19

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Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1989007199A1 (en) * 1988-02-05 1989-08-10 Debiopharm Sa Pump
US20020010504A1 (en) * 1996-02-14 2002-01-24 Eckhard Alt Tubular stent with oval struts
WO2002034163A2 (en) * 2000-10-16 2002-05-02 Smart Therapeutics, Inc. Neurovascular stent
US20070010869A1 (en) * 2005-07-11 2007-01-11 Nipro Corporation Flexible stent with excellent expandability and trackability
CN201840555U (en) * 2010-03-10 2011-05-25 谢建 Vessel stent being beneficial to being pressed and held
EP2583597A1 (en) * 2011-10-18 2013-04-24 Ernest Buck Flame-proof grilled goods holder
US20150039075A1 (en) * 2013-08-01 2015-02-05 Abbott Cardiovascular Systems Inc. Variable stiffness stent
CN106726037A (en) * 2017-01-04 2017-05-31 北京航空航天大学 A kind of PLA base intravascular stent that can uniformly degrade
CN106859821A (en) * 2017-03-15 2017-06-20 大连理工大学 A kind of biodegradable polymer intravascular stent of injection moulding
CN107596454A (en) * 2017-10-18 2018-01-19 苏州恒瑞迪生医疗科技有限公司 A kind of absorbable vascular endoprostheses and preparation method thereof
WO2019042201A1 (en) * 2017-08-28 2019-03-07 先健科技(深圳)有限公司 Covered stent
CN111001951A (en) * 2019-12-26 2020-04-14 上海百心安生物技术有限公司 Vascular stent structure beneficial to wall adhesion and processing device and method thereof

Patent Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1989007199A1 (en) * 1988-02-05 1989-08-10 Debiopharm Sa Pump
US20020010504A1 (en) * 1996-02-14 2002-01-24 Eckhard Alt Tubular stent with oval struts
WO2002034163A2 (en) * 2000-10-16 2002-05-02 Smart Therapeutics, Inc. Neurovascular stent
US20070010869A1 (en) * 2005-07-11 2007-01-11 Nipro Corporation Flexible stent with excellent expandability and trackability
CN201840555U (en) * 2010-03-10 2011-05-25 谢建 Vessel stent being beneficial to being pressed and held
EP2583597A1 (en) * 2011-10-18 2013-04-24 Ernest Buck Flame-proof grilled goods holder
US20150039075A1 (en) * 2013-08-01 2015-02-05 Abbott Cardiovascular Systems Inc. Variable stiffness stent
CN106726037A (en) * 2017-01-04 2017-05-31 北京航空航天大学 A kind of PLA base intravascular stent that can uniformly degrade
CN106859821A (en) * 2017-03-15 2017-06-20 大连理工大学 A kind of biodegradable polymer intravascular stent of injection moulding
WO2019042201A1 (en) * 2017-08-28 2019-03-07 先健科技(深圳)有限公司 Covered stent
CN107596454A (en) * 2017-10-18 2018-01-19 苏州恒瑞迪生医疗科技有限公司 A kind of absorbable vascular endoprostheses and preparation method thereof
CN111001951A (en) * 2019-12-26 2020-04-14 上海百心安生物技术有限公司 Vascular stent structure beneficial to wall adhesion and processing device and method thereof

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