WO2018232772A1 - 可降解可收回4d打印线型有机人体支架及其使用方法 - Google Patents

可降解可收回4d打印线型有机人体支架及其使用方法 Download PDF

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Publication number
WO2018232772A1
WO2018232772A1 PCT/CN2017/090766 CN2017090766W WO2018232772A1 WO 2018232772 A1 WO2018232772 A1 WO 2018232772A1 CN 2017090766 W CN2017090766 W CN 2017090766W WO 2018232772 A1 WO2018232772 A1 WO 2018232772A1
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Prior art keywords
human body
spiral
support
mounting ring
body bracket
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PCT/CN2017/090766
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English (en)
French (fr)
Inventor
于永臣
孙继泽
程楷
刘缵森
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青岛容商天下网络有限公司
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Publication of WO2018232772A1 publication Critical patent/WO2018232772A1/zh

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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
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/041—Mixtures of macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08—Materials for coatings
    • A61L31/10—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148—Materials at least partially resorbable by the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9528—Instruments specially adapted for placement or removal of stents or stent-grafts for retrieval of stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/252—Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/42—Anti-thrombotic agents, anticoagulants, anti-platelet agents

Definitions

  • the invention relates to the technical field of human body brackets, in particular to a degradable and retractable 4D printing line type organic human body bracket and a using method thereof.
  • cardiovascular disease there are more than 270 million people with cardiovascular and cerebrovascular diseases in China.
  • the number of deaths caused by cardiovascular and cerebrovascular diseases is close to 40% of the total number of deaths in the country. It has become the number one killer of Chinese health.
  • the main cause of cardiovascular disease is excess fat and calcium deposits on the blood vessel wall to thicken it, causing blood vessels to narrow or block, resulting in difficulty in blood circulation, resulting in angina, myocardial infarction and death.
  • the main means of combating cardiovascular disease is the interventional treatment of percutaneous puncture to insert a special stent into the lesion for diagnosis and treatment: the principle is to implant the stent into the narrowed blood vessel, thereby producing the inner wall. A constant radial pressure forces the deposits attached to the vessel wall to concentrate and support it to keep the blood vessels clear.
  • the first generation can be said that the balloon is dilated, and the blocked blood vessel can be propped up with the balloon; however, due to the rapid collapse, the re-stenosis occurs, and some patients develop acute vascular occlusion.
  • the second generation appeared in the 1990s, doctors used stainless steel mesh stents. Although this technique avoids acute occlusion and partial restenosis, the appearance of metallic foreign bodies accelerates the growth of scar tissue and occurs again. Narrowness can even completely block the coronary arteries; at the beginning of this century, doctors applied drugs to the "naked" stents and implanted them in the body.
  • the present invention is directed to a degradable retractable 4D printed linear organic human body stent and method of use thereof. To this end, the present invention provides the following technical solutions:
  • the present invention provides a human body bracket, comprising: a spiral portion and a mounting ring; wherein the mounting ring is disposed at least at one end of the spiral portion, and the mounting ring is provided with a fixing hole; the spiral portion includes a plurality of spirals connected in sequence unit.
  • each of the spiral units includes a circumferential unit and a plurality of support units; the shape of the support unit is an arched ridge parallel to the axial direction of the human body support; and the shape of the circumferential unit is a spiral shape.
  • the number of support units on each spiral unit is an even number; the support units are evenly distributed on the circumferential unit, and the directions of adjacent two support units are opposite.
  • the number of support units on each spiral unit is four, and the interval angle between adjacent two support units is 90 degrees.
  • the number of support units on each spiral unit is six, and the interval angle between adjacent two support units is 60 degrees.
  • one end of the spiral portion is provided with a mounting ring, the other end is provided with a protrusion, and the protrusion is in the shape of a drop.
  • the drop-like projections allow the body mount to avoid puncturing the blood vessels during use.
  • the shape of the axis of the support unit comprises a sinusoidal waveform, an arc, a U or a parabola.
  • a chamfer is provided between the mounting ring and the spiral portion; a chamfer is provided between the support unit and the circumferential unit.
  • the mounting ring is formed by a support unit that is closed with the circumferential unit.
  • the mounting ring is formed by the end of the helix being thickened and provided with holes.
  • the amplitude of the thickening is between 1 and 5 times the diameter of the spiral;
  • the mounting ring of the present invention is not limited to the mounting ring in the conventional sense, any hole in the middle and can realize the installation of the present invention.
  • a ring structure of the ring effect is possible.
  • the human scaffold of the present invention can be used for the support of blood vessels, pancreatic ducts, bile ducts, intestines, ureters, esophagus or nasal cavities.
  • each component of the human body support includes a skeleton portion, a functional protein membrane, and a chitosan membrane; a surface layer of the skeleton portion covers the functional protein membrane, and a surface layer of the functional protein membrane covers the chitosan membrane
  • the skeleton portion is prepared by using L-polylactic acid, D-polylactic acid and carboxymethyl chitosan.
  • human body bracket provided by the present invention can also be used in combination with other devices or devices.
  • the present invention provides a method for using a human body bracket.
  • the method includes the following steps: S101: inserting a catheter wearing a hook-shaped guide wire into the human body support; wherein the hook guide wire includes a rod portion and a hook portion connected to one end of the rod portion, the shape of the rod portion is a wire shape, the shape of the hook portion is a spiral shape, and the axial line of the rod portion coincides with the spiral axis line of the hook portion; S102: the hook portion is The free end is buckled into the mounting ring of the human body bracket, and the rod portion of the hook-shaped guide wire is rotated in the spiral direction of the hook portion, so that the hook portion completely passes through the mounting ring, and the mounting ring is sleeved at the joint of the rod portion and the hook portion; S103: Pulling the rod to drive the human body bracket away from the blood vessel wall, and then the straight human body bracket enters the catheter; S104: After the human body bracket is
  • the human body support provided by the present invention is used for supporting a blood vessel when in a first state, that is, a use state; when it is in a second state, that is, when removed, it is stretched into a linear structure; in other words, compared with a conventional human body support,
  • the invention provides a linear organic human body support.
  • the diameter of the hook portion of the hook-shaped guide wire is smaller than the diameter of the inner wall of the catheter. Specifically, the diameter of the hook portion of the hook-shaped guide wire is 0.5 to 0.7 times the diameter of the fixing hole of the mounting ring.
  • the installation method is the same as that of the conventional catheter and guidewire balloon expansion; specifically: (1) puncture with a special needle in the large blood vessel of the arm or thigh; the pinhole is during the operation The only body surface wound; (2) the needle is placed along the needle, at which point the needle can be withdrawn, leaving the guidewire in the blood vessel; (3) the catheter is placed along the guidewire, and the guidewire guides the catheter into the heart. Coronary artery; (4) put the balloon wrapped around the human body stent along the catheter; (5) inflate the balloon, the balloon expands The body stent is deformed to support; (6) the balloon, catheter and guide wire are withdrawn.
  • the human body stent provided by the invention can achieve the effect of fixing in the blood vessel without damaging the blood vessel and without adding the auxiliary fixing device; and can be conveniently taken out, and has wide application value.
  • the human body support provided by the invention does not stimulate the blood vessel wall, and effectively reduces the suffering of the patient.
  • the human body scaffold of the present invention is easy to take out and prepared by using a degradable material, so that when implanted into a recipient blood vessel: First, for a patient who finds that the position of the human body scaffold is inappropriate within two weeks after the operation, It can be conveniently taken out again; within two weeks after the implantation of the human stent provided by the present invention, the tissue-based cells have not been fused with the human body support, and if the position of the human stent is found to be improper, it can be easily taken out; second, for long-term support And without any discomfort, because the human body bracket of the invention is prepared by using a degradable material, the human body implant implanted in the body can be slowly degraded, thereby eliminating the pain of surgical bypass after the patient has a second stenosis.
  • the human body scaffold of the present invention is prepared by using polylactic acid and chitosan, because both polylactic acid and chitosan have good human compatibility and no rejection reaction occurs; chitosan, polylactic acid and protein are all It can be decomposed or degraded in the body, thus eliminating the pain of the patient's secondary stenosis.
  • the functional protein can play a role in ablation of the thrombus and is human-friendly; the deformation of the 4D printed material is not the opposite of the wire.
  • the blood vessel wall produces stimulation; therefore, the human body stent provided by the present invention has wide application value.
  • the human stent provided by the present invention mechanically supports the narrow coronary artery during the specific use, and releases the drug to prevent restenosis; and the blocked blood vessel is supported by the stent for 6 months, the human body The more force can help restore the elasticity of the blood vessels, after which the stent slowly degrades until it is completely absorbed by the tissue, and the vascular structure and function completely return to the natural state.
  • the coronary artery on the heart acts as a high-risk zone of the thrombus.
  • the common coronary vascular stent is misplaced or displaced in the course of surgery, it can only be rescued by thoracotomy. Therefore, the present invention provides a human body stent that is pierced by a large needle in the arm or thigh by a special needle, ie
  • the utility model can realize the safe removal of the human body bracket and has wide application value.
  • FIG. 1 is a schematic structural view of a spiral unit of a human body bracket according to an embodiment of the present invention
  • FIG. 2 is a schematic structural view of a human body bracket according to an embodiment of the present invention.
  • FIG. 3 is a schematic structural view of a human body bracket according to an embodiment of the present invention.
  • FIG. 4 is a schematic structural view of a hook-shaped guide wire according to an embodiment of the present invention.
  • FIG. 5 is a schematic structural view of a human body bracket removing process according to an embodiment of the present invention.
  • FIG. 6 is a schematic structural view of a human body bracket according to an embodiment of the present invention.
  • Figure 7 is a full cross-sectional view showing the human body bracket during use in the embodiment of the present invention.
  • Figure 8 is a partial cross-sectional view showing the human body bracket during use in the embodiment of the present invention.
  • test materials used in the following examples were purchased from conventional reagent stores.
  • the present invention provides a human body support, as shown in FIG. 2 and FIG. 3, comprising: a spiral portion 9 and a mounting ring 3; wherein the mounting ring 3 is disposed at least at one end of the spiral portion 9, and the mounting ring 3 is provided with a fixing hole 4; the spiral portion 9 includes a plurality of spiral units connected in series.
  • the arrangement of the mounting ring 3 and the fixing hole 4 can facilitate the implantation and removal of the human body frame during subsequent use, thereby effectively reducing the suffering of the patient.
  • FIG. 2 is a schematic view of the structure of the human body bracket with the mounting ring 3 at both ends, so that the human body bracket can be performed from both directions during the installation process.
  • each spiral unit includes a circumferential unit 1 and a plurality of support units 2; the shape of the support unit 2 is an arched ridge parallel to the axial direction of the human body support; the shape of the circumferential unit 1 is Spiral.
  • the human body stent can achieve the effect of being fixed in the blood vessel without damaging the blood vessel and without increasing the accessory fixing device.
  • the number of support units 2 on each spiral unit is an even number; the support units 2 are evenly distributed on the circumferential unit 1, and the directions of adjacent two support units 2 are opposite.
  • one end of the spiral portion 9 is provided with a mounting ring 3, the other end is provided with a protrusion 5, and the protrusion 5 is in the shape of a drop; as shown in FIG. 3, the existence of the drop-like protrusion 5 The puncture of the blood vessel of the human body bracket during the installation process is avoided.
  • the shape of the axis of the support unit 2 includes a sinusoidal waveform, an arc, a U shape, or a parabola shape.
  • a chamfer is provided between the mounting ring 3 and the helical portion 9; a chamfer is provided between the support unit 2 and the circumferential unit 1.
  • the chamfering setting can be effectively reduced, and the stress concentration during the use of the human body bracket can be reduced, and the strength of the human body bracket can be enhanced.
  • the mounting ring 3 is formed by the closure of a support unit 2 and the circumferential unit 1.
  • the mounting ring 3 is formed by the end of the spiral portion 9 being thickened and provided with holes.
  • the invention provides a human body support, as shown in FIG. 2, comprising: a spiral portion 9, a mounting ring 3 and water a drop-shaped projection 5; wherein the mounting ring 3 is disposed at one end of the spiral portion 9, and the mounting ring 3 is provided with a fixing hole 4; the teardrop-shaped projection 5 is disposed at the other end of the spiral portion 9; the spiral portion 9 includes a plurality of spiral units connected in series, each spiral unit comprising a spiral circumferential unit 1 and 4 support units 2, that is, the number of support units 2 on each spiral unit is 4, and the interval between adjacent two support units 2
  • the angle of the support unit 2 is an arched ridge parallel to the axial direction of the human body support, and the directions of the adjacent two support units 2 are opposite, and the shape of the axial line of the support unit 2 is a sinusoidal waveform.
  • the present invention provides a human body support, as shown in FIG. 3, comprising: a spiral portion 9 and a mounting ring 3; wherein the mounting ring 3 is disposed at both ends of the spiral portion 9, and the mounting ring 3 is provided with a fixing hole 4;
  • the portion 9 includes a plurality of spiral units connected in series, each spiral unit including a spiral circumferential unit 1 and 6 support units 2, that is, the number of support units 2 on each spiral unit is six, and two adjacent support units
  • the spacing angle of 2 is 60 degrees
  • the shape of the supporting unit 2 is an arched ridge parallel to the axial direction of the human body bracket, and the directions of the adjacent two supporting units 2 are opposite, and the shape of the axial line of the supporting unit 2 is a sinusoidal waveform.
  • the present invention provides a human body support, as shown in FIG. 6, comprising: a spiral portion 9 and a mounting ring 3; wherein the mounting ring 3 is disposed at two ends of the spiral portion 9, and the mounting ring 3 is provided with a fixing hole 4, and
  • the mounting ring in this embodiment is formed by closing a support unit 2 and the circumferential unit 1.
  • the spiral portion 9 includes a plurality of spiral units connected in series, each spiral unit including a spiral circumferential unit 1 and six support units 2, that is, the number of the support units 2 on each spiral unit is six, and two adjacent supports
  • the spacing angle of the unit 2 is 60 degrees
  • the shape of the supporting unit 2 is an arched ridge parallel to the axial direction of the human body bracket, and the directions of the adjacent two supporting units 2 are opposite
  • the shape of the axial line of the supporting unit 2 is a sinusoidal waveform.
  • Figure 7 is a full cross-sectional view showing the human body support during use in the embodiment of the present invention
  • Figure 8 is a partial cross-sectional view showing the human body support during use in the embodiment of the present invention.
  • the present invention specifically designs the use method of the human body support:
  • the mounting method of the human body bracket of the present invention is the same as that of the conventional catheter 8 and the catheter balloon expansion; specifically: (1) using a special needle to puncture the large blood vessel of the arm or the thigh; the pinhole is The only body surface wound during the operation; (2) the guide wire is placed along the needle, and the needle can be withdrawn, thereby keeping the guide wire in the blood vessel; (3) placing the guide wire 8 along the guide wire, guiding the guide wire
  • the catheter 8 enters the coronary artery on the heart; (4) the balloon wrapped around the human stent is placed along the catheter 8; (5) the balloon is inflated, the balloon is expanded to deform the body stent; (6) the ball is withdrawn The capsule, catheter 8 and guide wire.
  • FIG. 4 is a schematic structural view of a hook-shaped guide wire used in the removal process
  • FIG. 5 is a human body support removal. Schematic diagram of the process:
  • the left side view of the guide wire (c) is a front view of the hook guide wire;
  • the hook guide wire includes a rod portion 6 and a hook portion 7 connected to one end of the rod portion 6,
  • the shape of the rod portion 6 is a wire shape, and the hook portion
  • the shape of 7 is a spiral shape, and the axial line of the rod portion 6 coincides with the spiral axis line of the hook portion 7;
  • the diameter of the hook portion 7 is smaller than the diameter of the inner wall of the catheter 8, and the diameter of the hook in the hook-shaped guide wire is the mounting ring 3
  • the fixing hole 4 is 0.5 to 0.7 times the diameter.
  • each component is prepared using a degradable material.
  • each component of the human body support comprises a skeleton portion, a functional protein membrane and a chitosan membrane; a surface layer of the skeleton portion is covered with a functional protein membrane, a surface layer of the functional protein membrane is covered with a chitosan membrane; and a skeleton portion is a polylactic acid.
  • D-polylactic acid and carboxymethyl chitosan are prepared. Made of this material and has this hair
  • the human body scaffold with a clear structure is systematically evaluated for its efficacy by functional tests:
  • the upper platelet-rich plasma was taken, and the sample was soaked in the platelet solution at 37 ° C for 1 hour, and then taken out, rinsed with physiological saline solution, fixed with 2.5% glutaraldehyde fixative, and then fixed. Dehydrated by alcohol series, dealcoholized with isoamyl acetate, sprayed with silver after critical point drying, and observed platelet morphology under scanning electron microscope.
  • the human body stent provided by the present invention has excellent blood compatibility.
  • the anti-extrusion performance of the human stent was measured. Specifically, a human body stent of 3.0 mm under the nominal pressure of the present invention is loaded on the balloon dilatation catheter 8 and stabilized in a water bath at 37 ° C ⁇ 1 ° C for more than 30 s, and then filled to a nominal diameter of 3.0 mm, respectively, and the ball is withdrawn. The balloon dilatation catheter 8 places the released human body bracket between the upper and lower parallel plates of the tensile machine.
  • the length of the parallel plate ensures that the length of the test body bracket is exceeded, and the human body bracket is compressed at a constant speed to 50% deformation (1.5 mm), and then Continue to compress until the human body stent reaches the maximum allowable displacement. At this point, stop the experiment and record the data, as shown in Table 1.
  • the human body scaffold provided by the invention is used in the clinical treatment process, specifically, 100 patients with coronary heart disease aged 18-60 years old are enrolled, and each patient has an angiographic stenosis degree of more than 70%, or accompanied by severe angina or For myocardial infarction, etc., a stent needs to be implanted. Each patient was divided into two groups, and the human stents of Example 1 and Example 2 were respectively tested; then, the trial of the human stent was evaluated by return visit 2 weeks and 1 year after the implantation, and the specific data is shown in Table 2.
  • Excellent the patient has no discomfort after implantation, and there is no feeling of traction; good: the patient has moderate discomfort, such as stretch, hernia, etc.; invalid: the patient still has symptoms such as difficulty breathing and chest pain.
  • the human body bracket provided by the invention can achieve the effect of being fixed in the blood vessel without damaging the blood vessel and without adding the auxiliary fixing device; and can be conveniently taken out, and has wide application value; moreover, the human body bracket provided by the invention is It does not cause irritation to the blood vessel wall during use, and is convenient to take out, effectively reducing the suffering of the patient.
  • the meaning of "a plurality” is two or more unless specifically and specifically defined.
  • the terms “installation”, “connected”, “connected”, “fixed” and the like shall be understood broadly, and may be either a fixed connection or a detachable connection, unless explicitly stated and defined otherwise. , or integrated; can be mechanical connection, or can be electrical connection; can be directly connected, or can be indirectly connected through an intermediate medium, can be the internal communication of two elements or the interaction of two elements.
  • the specific meanings of the above terms in the present invention can be understood on a case-by-case basis.
  • first and second are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated.
  • features defining “first” and “second” may include one or more of the features either explicitly or implicitly.
  • the meaning of "a plurality” is two or more unless specifically and specifically defined.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Surgery (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Chemical & Material Sciences (AREA)
  • Prostheses (AREA)
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Abstract

一种可降解可收回4D打印线型人体支架及其使用方法，该人体支架包括螺旋部（9）和安装环（3），其中安装环（3）至少设置于螺旋部（9）的一端，且安装环（3）上设有固定孔（4）。所述螺旋部（9）包括数个依次连接的螺旋单元，每个螺旋单元包括圆周单元（1）和数个支撑单元（2），其中支撑单元（2）的形状是与人体支架轴向平行的拱形隆起，圆周单元（1）的形状为螺旋形。该人体支架能够在不损坏血管和不增加附属固定装置的情况下固定在血管中，且能够在短期内方便取出，长期使用过程中不会对血管壁产生刺激，可以有效降解。

Description

可降解可收回4D打印线型有机人体支架及其使用方法 技术领域
本发明涉及人体支架技术领域，具体涉及一种可降解可收回4D打印线型有机人体支架及其使用方法。
背景技术
根据《中国卫生统计提要》的数据显示：目前我国心脑血管疾病患者已经超过2.7亿人，心脑血管疾病导致死亡人数已接近全国死亡总人数的40％，已然成为国人健康的“头号杀手”。心血管疾病的主要病因是多余脂肪类物质及钙在血管壁沉积使之变厚，造成血管变窄或堵塞而造成血液流通困难，进而产生心绞痛、心肌梗塞直至死亡。截至目前，对抗心血管疾病的主要手段是采用经皮穿刺途径将特制的支架插入病变区进行诊断和治疗的介入治疗法：其原理是将支架植入已经变窄了的血管，从而对内壁产生一个持续的径向压力，迫使依附在血管壁上的沉积物浓缩并支撑其而使血管畅通。
对于血管支架，人们进行了诸多研究：第一代可谓球囊扩张，它将堵塞的血管用球囊撑起即可；但由于很快会发生塌陷，出现再次狭窄，部分病人会发生急性血管闭塞；第二代出现在上世纪九十年代，医生用的是不锈钢网状支架，这项技术虽然避免了血管急性闭塞和部分再狭窄，但金属异物的出现会加速疤痕组织的生长，并发生再狭窄甚至会完全堵塞冠状动脉；本世纪初，有医生在“裸”支架上涂上药物再植入体内，新一代药物洗脱支架大大降低了再狭窄，但是药物支架表面涂层的组织不相容性会产生局部炎症刺激，从而诱发生成血栓。中国专利200820006963.2公开了一种由导管和自动弹开式支架源构成的管状血管支架，且一旦植入，无法在短期内方便地取出。此外，除了血管支架，在肠道支架、胆管支架等人体支架领域也面临着同样的难题。基于此，研发一 款新型的血管支架尤为重要。
发明内容
针对现有技术中的缺陷，本发明旨在提供一种可降解可收回4D打印线型有机人体支架及其使用方法。为此，本发明提供如下技术方案：
第一方面，本发明提供一种人体支架，包括：螺旋部和安装环；其中，安装环至少设置于螺旋部的一端，且安装环上设有固定孔；螺旋部包括数个依次连接的螺旋单元。
在本发明的一个实施例中，每个螺旋单元包括圆周单元和数个支撑单元；支撑单元的形状是与人体支架轴向平行的拱形隆起；圆周单元的形状为螺旋形。
在本发明的一个实施例中，每个螺旋单元上支撑单元的数量为偶数；支撑单元均匀地分布在圆周单元上，且相邻两个支撑单元的方向相反。
在本发明的一个实施例中，每个螺旋单元上支撑单元的数量为4个，且相邻两个支撑单元的间隔角度是90度。
在本发明的一个实施例中，每个螺旋单元上支撑单元的数量为6个，且相邻两个支撑单元的间隔角度是60度。
在本发明的一个实施例中，所述螺旋部的一端设置有安装环，另一端设置有凸起，且所述凸起呈水滴状。水滴状凸起的设置可以使人体支架在使用过程中避免刺破血管。
在本发明的一个实施例中，支撑单元的轴心线的形状包括正弦波形、弧形、U形或抛物线形。
在本发明的一个实施例中，安装环与螺旋部之间设有倒角；支撑单元与圆周单元之间设有倒角。
在本发明的一个实施例中，安装环是由一个支撑单元与圆周单元闭合后形成的。
在本发明的一个实施例中，安装环是螺旋部的端部加粗并设孔形成的。具 体地，加粗的幅度处于螺旋部直径的1～5倍之间都是可以的；此外，本发明的安装环并不仅限于传统意义上的安装环，任何中间有孔且能实现本发明安装环效果的环状结构都是可以的。本发明的人体支架可以用于血管、胰腺管、胆管、肠道、输尿管、食管或鼻腔的支撑。
在本发明的一个实施例中，人体支架的各部件均采用可降解材料制备而成。具体地，人体支架的各部件包括骨架部、功能蛋白膜和壳聚糖膜；所述骨架部的表层覆盖着所述功能蛋白膜，所述功能蛋白膜的表层覆盖着所述壳聚糖膜；所述骨架部是采用左旋聚乳酸、右旋聚乳酸和羧甲基壳聚糖制备而成。
需要说明的是，本发明提供的人体支架也可以与其他装置或设备配合使用。
第二方面，本发明提供一种人体支架的使用方法，人体支架在移除时，包括如下步骤：S101：将穿有钩状导丝的导管插入到人体支架处；其中，钩状导丝包括杆部和连接于杆部一端的钩部，杆部的形状是丝形，钩部的形状是螺旋形，杆部的轴心线与钩部的螺旋轴心线重合；S102：将钩部的自由端扣入人体支架的安装环中，沿钩部的螺旋方向旋转钩状导丝的杆部，使得钩部完全穿过安装环，且安装环套设在杆部与钩部的连接处；S103：拉动杆部以带动人体支架脱离血管壁，之后被拉直的人体支架进入导管；S104：当人体支架通过导管移除体外后，移除导管。本发明提供的人体支架处于第一状态即使用状态时，用于支撑血管；当其处于第二状态即移除时，被拉伸成直线型结构；换句话说，与传统人体支架相比，本发明提供的是一种线型有机人体支架。
在本发明的一个实施例中，钩状导丝中钩部的直径小于导管内壁的直径，具体地，钩状导丝中钩部的直径是安装环的固定孔直径的0.5～0.7倍。
本发明人体支架在使用过程中，其安装方法与传统的导管、导丝球囊扩张安装相同；具体地：(1)用专用针在手臂或大腿的大血管穿刺；该针孔为手术过程中唯一的体表伤口；(2)顺着针放入导丝，此时针便可以退出，从而留着导丝在血管里；(3)顺着导丝放入导管，导丝引导导管进入心脏上的冠状动脉；(4)顺着导管放入包裹着人体支架的球囊；(5)给球囊充气，球囊扩张使人 体支架变形撑起来；(6)撤出球囊、导管和导丝。
本发明提供的上述技术方案具有以下优点：
(1)申请人经过大量实验发现：本发明提供的人体支架能够在不损坏血管、不增加附属固定装置的情况下，达到固定在血管中的效果；并能够方便地取出，具有广泛的应用价值；此外，本发明提供的人体支架不会对血管壁产生刺激，有效减少了患者的痛苦。
(2)本发明的人体支架易于取出且采用降解材料制备而成，从而使其在植入受体血管时：其一、对于手术后两周内复查发现人体支架位置不合适的患者来说，可以很方便的再次取出；本发明提供的人体支架植入后两周内，基于组织细胞还没有与人体支架融合，如果发现人体支架的位置不当，可以方便地取出；其二、对于需要长期支撑且无任何不适的患者，因为本发明的人体支架采用可降解材料制备而成，因此，植入体内的人体支架可以缓慢降解，从而免去了患者二次狭窄后手术搭桥的痛苦。
(3)本发明的人体支架采用聚乳酸和壳聚糖制备而成，因为聚乳酸和壳聚糖均具有良好的人体相容性，不会发生排斥反应；壳聚糖、聚乳酸、蛋白质均可在体内分解或降解，从而免去了患者二次狭窄手术搭桥的痛苦；此外，功能性蛋白质能够起到消融血栓的作用，具有人体友好性；4D打印材料的变形比金属丝的不会对血管壁产生刺激；因此，本发明提供的人体支架具有广泛的应用价值。
(4)本发明提供的人体支架在具体使用过程中，会对狭窄的冠状动脉血管进行机械性支撑，同时释放药物，防止再狭窄；且堵塞的血管在经支架支撑6个月后，人体自愈力就能帮助恢复血管的弹性，之后支架缓慢降解直至完全被组织吸收，血管结构及功能完全恢复至自然状态。
(5)众所周知，心脏上的冠状动脉作为血栓的高发地带，手术过程中普通冠脉血管支架一旦放错或者发生位置偏移，就只能通过开胸手术进行挽救；因此，采用本发明提供的人体支架，通过专用针在手臂或大腿的大血管穿刺，即 可实现人体支架的安全移除，具有广泛的应用价值。
本发明的附加方面和优点将在下面的描述中部分给出，部分将从下面的描述中变得明显，或通过本发明的实践了解到。
附图说明
图1为本发明实施例中人体支架的一个螺旋单元的结构示意图；
图2为本发明实施例中人体支架的结构示意图；
图3为本发明实施例中人体支架的结构示意图；
图4为本发明实施例中钩状导丝的结构示意图；
图5为本发明实施例中人体支架移除过程的结构示意图；
图6为本发明实施例中人体支架的结构示意图；
图7为本发明实施例中人体支架在使用过程中的全剖视图；
图8为本发明实施例中人体支架在使用过程中的局部剖视图；
图中：
1、圆周单元；2、支撑单元；3、安装环；4、固定孔；5、凸起；
6、杆部；7、钩部；8、导管；9、螺旋部。
具体实施方式
下面将对本发明技术方案的实施例进行详细的描述。以下实施例仅用于更加清楚的说明本发明的技术方案，因此只作为实例，而不能以此来限制本发明的保护范围。
下述实施例中的实验方法，如无特殊说明，均为常规方法。
下述实施例中所用的试验材料，如无特殊说明，均为自常规试剂商店购买得到的。
以下实施例中的定量试验，均设置三次重复实验，数据为三次重复实验的平均值或平均值±标准差。
本发明提供一种人体支架，如图2和图3所示，包括：螺旋部9和安装环3；其中，安装环3至少设置于螺旋部9的一端，且安装环3上设有固定孔4；螺旋部9包括数个依次连接的螺旋单元。安装环3及固定孔4的设置，可以使人体支架在后续使用过程中方便的植入与移除，从而有效减少患者的痛苦。具体地，图2为两端均为安装环3的人体支架结构示意图，从而使得人体支架在安装过程中，从两个方向均可进行。
在一个实施例中，如图1所示，每个螺旋单元包括圆周单元1和数个支撑单元2；支撑单元2的形状是与人体支架轴向平行的拱形隆起；圆周单元1的形状为螺旋形。从而使人体支架能够在不损坏血管、不增加附属固定装置的情况下，达到固定在血管中的效果。
在一个实施例中，每个螺旋单元上支撑单元2的数量为偶数；支撑单元2均匀地分布在圆周单元1上，且相邻两个支撑单元2的方向相反。
在一个实施例中，所述螺旋部9的一端设置有安装环3，另一端设置有凸起5，且所述凸起5呈水滴状；如图3所示，水滴状凸起5的存在避免了人体支架在安装过程中对血管的刺破。
在一个实施例中，支撑单元2的轴心线的形状包括正弦波形、弧形、U形或抛物线形。
在一个实施例中，安装环3与螺旋部9之间设有倒角；支撑单元2与圆周单元1之间设有倒角。倒角的设置可以有效减小还可以起到减小人体支架使用过程中的应力集中现象，且能加强人体支架的强度。
在一个实施例中，安装环3是由一个支撑单元2与圆周单元1闭合后形成的。
在一个实施例中，所述安装环3是螺旋部9的端部加粗并设孔形成的。
下面结合具体实施方式进行说明：
实施例一
本发明提供一种人体支架，如图2所示，包括：螺旋部9、安装环3和水 滴形的凸起5；其中，安装环3设置于螺旋部9的一端，且安装环3上设有固定孔4；水滴形的凸起5设置于螺旋部9的另一端；螺旋部9包括数个依次连接的螺旋单元，每个螺旋单元包括螺旋形的圆周单元1和4个支撑单元2，即每个螺旋单元上支撑单元2的数量为4个，相邻两个支撑单元2的间隔角度为90度，支撑单元2的形状是与人体支架轴向平行的拱形隆起，且相邻两个支撑单元2的方向相反，支撑单元2轴心线的形状为正弦波形。
实施例二
本发明提供一种人体支架，如图3所示，包括：螺旋部9和安装环3；其中，安装环3设置于螺旋部9的两端，且安装环3上设有固定孔4；螺旋部9包括数个依次连接的螺旋单元，每个螺旋单元包括螺旋形的圆周单元1和6个支撑单元2，即每个螺旋单元上支撑单元2的数量为6个，相邻两个支撑单元2的间隔角度为60度，支撑单元2的形状是与人体支架轴向平行的拱形隆起，且相邻两个支撑单元2的方向相反，支撑单元2轴心线的形状为正弦波形。
实施例三
本发明提供一种人体支架，如图6所示，包括：螺旋部9和安装环3；其中，安装环3设置于螺旋部9的两端，且安装环3上设有固定孔4，且本实施例中的安装环由一个支撑单元2与圆周单元1闭合后形成。螺旋部9包括数个依次连接的螺旋单元，每个螺旋单元包括螺旋形的圆周单元1和6个支撑单元2，即每个螺旋单元上支撑单元2的数量为6个，相邻两个支撑单元2的间隔角度为60度，支撑单元2的形状是与人体支架轴向平行的拱形隆起，且相邻两个支撑单元2的方向相反，支撑单元2轴心线的形状为正弦波形。图7为本发明实施例中人体支架在使用过程中的全剖视图；图8为本发明实施例中人体支架在使用过程中的局部剖视图。
实施例四
针对本发明提供的人体支架，本发明专门设计了该人体支架的使用方法：
具体地，本发明人体支架使用时的安装方法与传统的导管8、导丝球囊扩张的安装方法相同；具体地：(1)用专用针在手臂或大腿的大血管穿刺；该针孔为手术过程中唯一的体表伤口；(2)顺着针放入导丝，此时针便可以退出，从而留着导丝在血管里；(3)顺着导丝放入导管8，导丝引导导管8进入心脏上的冠状动脉；(4)顺着导管8放入包裹着人体支架的球囊；(5)给球囊充气，球囊扩张使人体支架变形撑起来；(6)撤出球囊、导管8和导丝。
此外，本发明的人体支架在移除时，包括如下步骤，具体如图4和图5所示，图4为移除过程中所用的钩状导丝的结构示意图，图5为人体支架移除过程的结构示意图：
S101：将穿有钩状导丝的导管8插入到人体支架处；其中，钩状导丝的如图4所示，其中，(a)为钩状导丝的立体示意图，(b)为钩状导丝的左视图，(c)为钩状导丝的主视图；钩状导丝包括杆部6和连接于杆部6一端的钩部7，杆部6的形状是丝形，钩部7的形状是螺旋形，杆部6的轴心线与钩部7的螺旋轴心线重合；钩部7的直径小于导管8内壁的直径，且钩状导丝中钩的直径是安装环3的固定孔4直径的0.5～0.7倍。S102：如图5所示，将钩部7的自由端扣入人体支架的安装环3中，沿钩部7的螺旋方向旋转钩状导丝的杆部6，使得钩部7完全穿过安装环3，且安装环3套设在杆部6与钩部7的连接处。S103：拉动杆部6以带动人体支架脱离血管壁，之后被拉直的人体支架进入导管8。S104：当人体支架通过导管8移除体外后，移除导管8。从而对于手术后两周内复查发现人体支架位置不合适的患者来说，可以很方便的再次取出。
另外，对于本发明的人体支架，各部件均采用可降解材料制备而成。具体地，人体支架的各部件包括骨架部、功能蛋白膜和壳聚糖膜；骨架部的表层覆盖着功能蛋白膜，功能蛋白膜的表层覆盖着壳聚糖膜；骨架部是采用左旋聚乳酸、右旋聚乳酸和羧甲基壳聚糖制备而成。对于由此材料制备而成且具有本发 明结构的人体支架，通过功能学试验来系统评价其功效：
一、血小板粘附试验
众所周知，生物医药材料与血液接触时，会引起血小板粘附、变形和聚集等一系列变化，从而使材料表面形成血栓；测试血小板在材料表面的粘附城度是评价医用材料血液相容性的重要手段。根据“梁栋科：血管内支架的加工及其力学性能的分析与评价”中记载的方法进行实验。
具体地，将新鲜抗凝人血离心10min后，取上部富血小板血浆，将试样浸泡入37℃的血小板液中1h后取出，经生理盐水液漂洗，2.5％戊二醛固定液固定，再由酒精系列脱水、乙酸异戊酯脱醇，经临界点干燥后喷银，在扫描电镜下观察血小板形态。
实验发现：本发明人体支架表面粘附的血小板数量很少，且粘附的血小板为圆盘状且没有伪足，血小板变形很小。由此说明，本发明提供的人体支架具有优异的血液相容性。
二、本发明人体支架径向力学性能测试
根据“万敏：人体支架物理力学性能实验研究”中记载的方法，测定人体支架的抗挤压性能。具体地，将本发明的公称压力下3.0mm的人体支架装载在球囊扩张导管8上，在37℃±1℃的水浴中稳定30s以上，然后分别充盈至公称直径3.0mm后，撤出球囊扩张导管8，将释放后的人体支架放置在拉力机的上下两平行平板之间，平行平板长度确保超过测试人体支架的长度，匀速压缩人体支架至50％的变形量(1.5mm)，然后继续压缩直至人体支架达到最大允许的位移量，此时停止实验，记录数据，如表1所示。
表1 本发明人体支架径向力学性能数据列表
Figure PCTCN2017090766-appb-000001
三、临床试验
将本发明提供的人体支架用于临床治疗过程中，具体地，征集年龄18～60岁的冠心病患者100名，各患者的血管造影狭窄程度均在70％以上，或者伴随有严重的心绞痛或心肌梗死等，需要植入支架。将各患者均分为2组，分别试用实施例一和实施例二的人体支架；之后在植入之后2周和1年时通过回访评估人体支架的试用情况，具体数据如表2所示。
判断标准：
优异：植入后患者无不适症状，且无牵引等感觉；良好：患者出现适度不适，如牵张、憋气等；无效：患者依旧出现呼吸困难、胸痛等症状。
表2 本发明人体支架临床试验数据列表
Figure PCTCN2017090766-appb-000002
当然，除了实施例一和实施例二列举的情况，人体支架结构的其他参数设置等也是可以的。
本发明提供的人体支架能够在不损坏血管、不增加附属固定装置的情况下，达到固定在血管中的效果；并能够方便地取出，具有广泛的应用价值；此外，本发明提供的人体支架在使用过程中不会对血管壁产生刺激，且方便取出，有效减少了患者的痛苦。
在本发明的描述中，需要理解的是，术语“中心”、“纵向”、“横向”、“轴向”、“径向”、“周向”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。
在本发明的描述中，“多个”的含义是两个以上，除非另有明确具体的限定。在本发明中，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”、“固定”等术语应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或成一体；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通或两个元件的相互作用关系。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本发明中的具体含义。
在本发明的描述中，需要理解的是，术语“第一”、“第二”仅用于描述目的，而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此，限定有“第一”、“第二”的特征可以明示或者隐含地包括一个或者更多个该特征。在本发明的描述中，“多个”的含义是两个以上，除非另有明确具体的限定。
在本说明书的描述中，参考术语“一个实施例”、“一些实施例”、“示例”、“具体示例”、或“一些示例”等的描述意指结合该实施例或示例描述的具体特征、结构、材料或者特点包含于本发明的至少一个实施例或示例中。在本说明书中，对上述术语的示意性表述不必须针对的是相同的实施例或示例。而且，描述的具体特征、结构、材料或者特点可以在任一个或多个实施例或示例中以合适的方式结合。此外，在不相互矛盾的情况下，本领域的技术人员可以将本说明书中描述的不同实施例或示例以及不同实施例或示例的特征进行结合和组合。
尽管上面已经示出和描述了本发明的实施例，可以理解的是，上述实施例是示例性的，不能理解为对本发明的限制，本领域的普通技术人员在本发明的范围内可以对上述实施例进行变化、修改、替换和变型。

Claims (13)

  1. 一种人体支架，其中，包括：螺旋部和安装环；
    其中，所述安装环至少设置于所述螺旋部的一端，且所述安装环上设有固定孔；所述螺旋部包括数个依次连接的螺旋单元。
  2. 根据权利要求1所述的人体支架，其中：
    每个所述螺旋单元包括圆周单元和数个支撑单元；所述支撑单元的形状是与所述人体支架轴向平行的拱形隆起；所述圆周单元的形状为螺旋形。
  3. 根据权利要求2所述的人体支架，其中：
    每个所述螺旋单元上支撑单元的数量为偶数；所述支撑单元均匀地分布在所述圆周单元上，且相邻两个所述支撑单元的方向相反。
  4. 根据权利要求3所述的人体支架，其中：
    每个所述螺旋单元上支撑单元的数量为4个，且相邻两个所述支撑单元的间隔角度是90度；或，每个所述螺旋单元上支撑单元的数量为6个，且相邻两个所述支撑单元的间隔角度是60度。
  5. 根据权利要求3所述的人体支架，其中：
    所述螺旋部的一端设置有安装环，另一端设置有凸起，且所述凸起呈水滴状。
  6. 根据权利要求2～5任一项所述的人体支架，其中：
    所述支撑单元的轴心线的形状包括正弦波形、弧形、U形或抛物线形。
  7. 根据权利要求6所述的人体支架，其中：
    所述安装环与所述螺旋部之间设有倒角；所述支撑单元与所述圆周单元之间设有倒角。
  8. 根据权利要求7所述的人体支架，其中：
    所述人体支架的各部件均采用可降解材料制备而成。
  9. 根据权利要求1～5任一项所述的人体支架，其中：
    所述人体支架用于血管、胰腺管、胆管、肠道、输尿管、食管或鼻腔的支 撑。
  10. 根据权利要求1～5任一项所述的人体支架，其中：
    所述安装环是由一个支撑单元与圆周单元闭合后形成的。
  11. 根据权利要求1～5任一项所述的人体支架，其中：
    所述安装环是螺旋部的端部加粗并设孔形成的。
  12. 权利要求1～11任一项所述人体支架的使用方法，其中：所述人体支架在移除时，包括如下步骤：
    S101：将穿有钩状导丝的导管插入到人体支架处；其中，所述钩状导丝包括杆部和连接于所述杆部一端的钩部，所述杆部的形状是丝形，所述钩部的形状是螺旋形，所述杆部的轴心线与所述钩部的螺旋轴心线重合；
    S102：将所述钩部的自由端扣入所述人体支架的安装环中，沿所述钩部的螺旋方向旋转所述钩状导丝的杆部，使得所述钩部完全穿过所述安装环，且所述安装环套设在所述杆部与钩部的连接处；
    S103：拉动所述杆部以带动所述人体支架脱离血管壁，之后被拉直的所述人体支架进入所述导管；
    S104：当所述人体支架通过导管移除体外后，移除导管。
  13. 根据权利要求12所述的人体支架的使用方法，其中：
    所述钩状导丝中所述钩部的直径小于所述导管内壁的直径。
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CN108969165B (zh) * 2018-06-13 2020-08-07 哈尔滨工业大学 一种4d打印形状记忆聚合物复合材料气管支架及其制备方法
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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5591230A (en) * 1994-09-07 1997-01-07 Global Therapeutics, Inc. Radially expandable stent
US20020133223A1 (en) * 2001-03-09 2002-09-19 Vito Raymond P. Intravascular device and method for axially stretching blood vessels
WO2005016185A1 (de) * 2003-08-14 2005-02-24 Strecker Ernst P Mäanderstent
US20050131515A1 (en) * 2003-12-16 2005-06-16 Cully Edward H. Removable stent-graft
US20080097573A1 (en) * 2001-03-28 2008-04-24 Boston Scientific Scimed, Inc. Expandable Coil Stent
US7942917B2 (en) * 2009-04-17 2011-05-17 Medtronic Vascular, Inc. Hollow helical stent system
CN103841929A (zh) * 2011-09-28 2014-06-04 伊西康公司 负压肠吻合术保护器械

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3868956A (en) * 1972-06-05 1975-03-04 Ralph J Alfidi Vessel implantable appliance and method of implanting it
AU5025096A (en) * 1995-02-27 1996-09-18 Instent Inc. Hollow stent
CN2695012Y (zh) * 2004-04-02 2005-04-27 北京美中双和医疗器械有限公司 一种网格型血管支架
US7766960B2 (en) * 2004-04-30 2010-08-03 Novostent Corporation Delivery catheter that controls foreshortening of ribbon-type prostheses and methods of making and use
GB0621048D0 (en) * 2006-10-23 2006-11-29 Anson Medical Ltd Helical stent graft
US8182890B2 (en) * 2007-01-19 2012-05-22 Elixir Medical Corporation Biodegradable endoprostheses and methods for their fabrication
US9149376B2 (en) * 2008-10-06 2015-10-06 Cordis Corporation Reconstrainable stent delivery system
CN104116578B (zh) * 2014-07-18 2016-01-20 西安交通大学 一种4d打印成型人工血管支架的方法

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5591230A (en) * 1994-09-07 1997-01-07 Global Therapeutics, Inc. Radially expandable stent
US20020133223A1 (en) * 2001-03-09 2002-09-19 Vito Raymond P. Intravascular device and method for axially stretching blood vessels
US20080097573A1 (en) * 2001-03-28 2008-04-24 Boston Scientific Scimed, Inc. Expandable Coil Stent
WO2005016185A1 (de) * 2003-08-14 2005-02-24 Strecker Ernst P Mäanderstent
US20050131515A1 (en) * 2003-12-16 2005-06-16 Cully Edward H. Removable stent-graft
US7942917B2 (en) * 2009-04-17 2011-05-17 Medtronic Vascular, Inc. Hollow helical stent system
CN103841929A (zh) * 2011-09-28 2014-06-04 伊西康公司 负压肠吻合术保护器械

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