WO2018045797A1 - 覆膜支架及其制备方法 - Google Patents

覆膜支架及其制备方法 Download PDF

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Publication number
WO2018045797A1
WO2018045797A1 PCT/CN2017/090595 CN2017090595W WO2018045797A1 WO 2018045797 A1 WO2018045797 A1 WO 2018045797A1 CN 2017090595 W CN2017090595 W CN 2017090595W WO 2018045797 A1 WO2018045797 A1 WO 2018045797A1
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WO
WIPO (PCT)
Prior art keywords
stent graft
film
section
suture
stent
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Application number
PCT/CN2017/090595
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English (en)
French (fr)
Inventor
肖本好
汪泽辉
Original Assignee
先健科技(深圳)有限公司
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Publication of WO2018045797A1 publication Critical patent/WO2018045797A1/zh

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Classifications

    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
    • 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
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes
    • A61F2240/002—Designing or making customized prostheses

Definitions

  • the invention relates to the technical field of interventional medical devices, in particular to a coated stent and a preparation method thereof.
  • the stent graft has been used to treat the aneurysm. Specifically, the radially compressed stent graft is loaded into the delivery system and released along the guide wire to the lesion site to release a new artery. The blood flow channel separated by the tumor and the blood flow. Thus, after the aneurysm loses blood flow, the expanded tumor wall shrinks under negative pressure and returns to the original form, thereby achieving the purpose of treating the aneurysm.
  • the vascular anatomy of different patients is quite different. In some patients, the length of the tumor may be long, and the difference between the neck and the neck of the tumor may be large. Therefore, the standardized stent graft is difficult to apply to each patient.
  • Combination stent grafts have emerged in the prior art for the treatment of conditions in which standard stent grafts are not suitable.
  • the combined stent graft can be randomly combined according to the patient's vascular anatomy and the length and shape of the tumor, and is a combination of at least two stent grafts, that is, a larger diameter stent graft is sleeved to another smaller diameter.
  • the inside of the stent graft achieves the connection of the two stent grafts by the friction generated by the overlapping portions of the two stent grafts.
  • the combined stent graft is implanted into the blood vessel, and under the scouring of the blood flow, displacement or even disconnection may occur, which not only fails to achieve treatment.
  • the present invention provides a stent graft comprising a body segment, the body segment comprising a membrane and a corrugated annulus disposed on the membrane, the stent graft further comprising a constriction connected to one end of the body segment
  • the mouth segment, the necking section comprising a film and no corrugated annulus, the smallest inner diameter of the necking section being smaller than the inner diameter of the end of the body section joined to the necking section.
  • the stent graft further includes a connecting section, the crimping section being connected between the main body section and the connecting section, wherein the narrow inner diameter of the narrowing section is smaller than the shrinkage The inner diameter of the end of the connecting section to which the segments are connected.
  • the constricted section is disposed at a distal end of the body segment, and the connecting section is disposed at a distal end of the constricted section.
  • the connecting section includes a film and a corrugated ring disposed on the film.
  • the connecting section includes the coating and no corrugated annulus is provided.
  • the stent graft is a lateral branch of an aortic stent or a bifurcation stent.
  • the constricted section includes at least one suture, one end of the suture enters the lumen of the constricted section through the membrane of the constricted section, and at least once The film of the constricted section passes through the lumen of the constricted section and is finally fixedly coupled to the other end of the suture.
  • the invention also provides a preparation method of a stent graft, comprising:
  • a stent graft preform comprising a body segment and a film segment, the body segment comprising a film and a bare stent disposed on the film, the film segment comprising a film And no waveform ring is set;
  • the number of sutures is one.
  • the suture has a diameter of from 0.15 mm to 0.3 mm.
  • the number of sutures is greater than or equal to two.
  • the suture has a diameter of from 0.1 mm to 0.15 mm.
  • the stent graft of the present invention comprises a constricted section which has a greater amount of compression to another stent graft in the combined stent graft, such that the constricted section and the further stent graft The static friction generated between them is large, so that the stent graft of the present invention has a higher joint strength when it is connected to the other stent graft.
  • Figure 1 is a schematic view showing the structure of a stent graft of the present invention.
  • FIG. 2 is a schematic view showing the structure of a stent graft of the present invention in combination with another stent graft.
  • 3(a) to 3(c) are schematic views showing the process of a method for preparing a stent graft.
  • 4(a) to 4(b) are schematic views showing the process of another preparation method of the stent graft.
  • Fig. 5 is a schematic view showing an application example of the stent graft of Fig. 1.
  • Fig. 6 is a schematic view showing another application example of the stent graft of Fig. 1.
  • blood flow is defined from the proximal end of the stent graft to the distal end of the stent graft.
  • the "film-covered stent” refers to a structure in which the surface of the bare stent is covered with a film
  • the bare stent refers to a stent that includes a plurality of corrugated rings along the longitudinal direction and each of the corrugated rings are spaced apart from each other.
  • the corrugated ring may be an open-loop structure, and the shape of the corrugated ring is cut from any position and laid flat on a plane, such as a sine wave, a Z-wave, etc.; the corrugated ring may also be The open-loop structure, and the shape of the corrugated ring flat on the plane is wavy, such as a sine wave, a Z-wave, or the like.
  • the stent graft 100 of the present invention comprises a coating 101 and a bare stent 102 disposed on the coating 101.
  • the film 101 may be made of a material such as polytetrafluoroethylene, polyester or rayon, and the bare frame 102 includes at least one corrugated ring.
  • the film 101 may be disposed on the inner surface, the outer surface, or the inner surface and the outer surface of the tubular structure composed of at least one corrugated ring of the bare stent 102; the bare stent 102 may be sutured by continuous winding along each corrugated ring
  • the method adheres to the film 101 or adheres to the film 101 by other means such as bonding or pressing.
  • the stent graft 100 includes a body section 200 that is connected through, a connecting section 300, and a necking section 400 disposed between the body section 200 and the connecting section 300.
  • the connecting section 300 is disposed at the distal end of the stent graft 100.
  • the main body section 200 and the connecting section 300 are both straight cylindrical structures, and the main body section 200 and the connecting section 300 each include a coating 101 and at least one corrugated ring. It can be understood that the body segment 200 and the connecting segment 300 can also be a tapered cylindrical structure, and the specific shape can be selected according to the shape of the blood vessel.
  • the necking section 400 is located between the distal end of the body section 200 and the proximal end of the connecting section 300, and the necking section 400 includes only the film 101.
  • the circumference of the constricted section 400 is recessed toward the central axis of the stent-graft 100, and cooperates with the main body section 200 and the connecting section 300 to form a waist-contracting structure having the constricted section 400 as a waist.
  • the constricted section 400 has a minimum inner diameter that is less than the inner diameter of the distal end of the body section 200 that is proximally coupled to the constricted section 400, and that is smaller than the connecting section 300 that is distally coupled to the constricted section 400. The inner diameter of the end.
  • the connecting stent graft 500 has a straight cylindrical structure, and the connecting stent graft 500 is used in combination with the stent graft 100 to form a combined stent graft.
  • the connecting stent graft 500 is combined with the stent graft 100, the proximal end of the connecting stent graft 500 is connected to the distal end of the stent graft 100, and specifically, the connecting stent graft 500 is inserted into the lumen of the stent graft 100.
  • the connecting stent graft 500 overlaps the distal end of the body segment 200 of the stent graft 100, that is, the distal end of the body segment 200 of the stent graft 100, the necking section 400, and the connecting section 300 are partially connected to each other.
  • the membrane stents 500 are overlapped.
  • the region where the stent graft 100 overlaps the connection stent graft 500 is defined as the anchoring region 600.
  • the outer diameter of the portion of the stent graft 500 located in the anchoring zone 600 is slightly larger than the stent graft.
  • the connection of the bracket 500 is described in the bracket 500.
  • the anchoring zone 600 of the stent graft 100 and the connection stent graft 500 includes a necking section 400, since the minimum inner diameter of the necking section 400 is smaller than the anchoring of the connecting stent graft 500.
  • the amount of compression of the stent 500 at the necking section 400 is greater than the amount of compression of the connecting stent graft 500 at the connecting section 300; and the amount of compression of the connecting stent graft 500 at the necking section 400 is greater than that of the connecting stent graft 500.
  • the amount of compression at the body segment 300 is large.
  • the "compression amount" of the present invention means a size in which the diameter of the connection stent graft 500 is compressed in the radial direction to be reduced. Therefore, under the premise that the anchoring zone 600 of the same length in the axial direction of the stent graft is compared with the prior art combined stent, the compression of the connecting stent graft 500 is caused by the narrowing section 400 of the anchoring zone 600. The larger the amount, that is, the positive pressure between the narrowing section 400 and the connecting stent graft 500 is larger, the static friction generated between the narrowing section 400 and the connecting stent graft 500 is also larger, and the narrowing section 400 can be connected by a hook.
  • the stent graft 500 so that the stent graft 100 with the necking region 400 of the anchoring zone 600 has a higher connection strength when connected to the connecting stent graft 500, prevents the two from falling off.
  • the two stent grafts of the combined stent graft include a corrugated ring in the overlapping region, and when the corrugated ring overlaps the corrugated ring, a gap is easily generated, resulting in blood flow in the Flow between the two stent grafts, and blood flow between the two stent grafts can enter between the stent graft and the vessel wall to form an endoleak.
  • the stent graft 100 includes the necking section 400 of the anchoring zone 600, and the necking section 400 includes only the film 101, excluding the corrugated ring, the necking section 400 can be connected with the stent graft.
  • the 500 fits better, i.e., reduces the gap between the constricted section 400 and the connecting stent graft 500 that overlaps the constricted section 400, thus flowing into the bloodstream between the body section 200 and the connecting stent graft 500. It is blocked at the constricted section 400 and eventually forms a thrombus at the junction of the constricted section 400 and the body section 200, thereby preventing blood flow from entering the endodontic space between the stent graft and the vessel wall.
  • the connecting segment 300 can also be disposed at the proximal end of the stent graft 100.
  • the body segment 200 is disposed at the distal end of the stent graft 100, and the crimping segment 400 is still disposed between the connecting segment 300 and the body segment 200.
  • the distal end of the connecting stent graft 500 is inserted into the stent graft 100 from the proximal end of the stent graft 100 until the distal end of the connecting stent graft 500 is anchored with the crimping section 400 of the stent graft 100.
  • the anchoring zone 600 includes a connecting section 300, a necking section 400, and a proximal end of the body section 200.
  • the connecting section 300 may also include only the film 101, and does not include any wavy ring. Since the connecting section 300 also includes only the covering film 101, at this time, internal leakage between the stent graft and the blood vessel wall can be further prevented.
  • the stent graft 100 can also include only the main body segment 200 and the constricted segment 400 connected to the main body segment 200, that is, the stent graft 100 does not include the connecting segment 300, and the constricted segment 400 can be disposed at the main body segment 200. Far or near end.
  • the stent graft 100 can be a single stent, such as an aortic stent; the stent graft 100 can also be part of a stent, for example, the stent graft 100 is a lateral branch of the fistula stent.
  • a stent graft preform 100a is provided.
  • the stent graft preform 100a includes a coating 101a and a bare stent 102a disposed on the coating 101a.
  • the stent graft preform 100a is a straight tubular or conical tubular structure, and the stent graft preform 100a includes a body segment 200a, a connecting segment 300a, and a film segment 401a between the body segment 200a and the connecting segment 300a.
  • the body segment 200a and the connecting segment 300a each include a film 101a and a bare bracket 102a.
  • the film section 401a includes only the film 101a.
  • the circumferential surface of the membrane segment 401a is provided with a plurality of suture holes 402a in the same plane direction perpendicular to the axis of the stent-graft preform 100a, and the number of the plurality of suture holes 402a is an even number.
  • the plurality of suture holes 402a are evenly spaced along the circumferential direction of the film segment 401a. It can be understood that the plurality of suture holes 402a may also be distributed at non-uniform intervals along the circumferential direction of the film segment 401a.
  • a continuous suture 403a is provided, the suture 403a having two free ends.
  • a free end of the suture 403a is passed from the outside of the stent-graft preform 100a through a suture hole 402a of the stent-graft preform 100a into the lumen of the stent-graft preform 100a; then, the suture 403a is inserted The free end passes through the adjacent suture hole 402a from the lumen of the stent-graft preform 100a and exits the stent-graft preform 100a; this is repeated until the free end of the suture 403a is prefabricated through the stent-graft All of the suture holes 402a of the piece 100a, and the two free ends of the suture 403a are ultimately located outside of the stent-graft preform 100a.
  • the two free ends of the suture 403a are tightened, so that the film segment 401a is formed at the portion where the suture 403a is pierced, and the two free ends of the suture 403a are fixed.
  • Shrink section 400a In this embodiment, the two free ends of the suture 403a are fixed by knotting. It can be understood that the two free ends of the suture 403a can also be fixed by bonding, heat fusion or binding.
  • the diameter of the suture 403a is preferably 0.15 mm-0.3 mm, thereby ensuring the restraining force of the constricted section 400a to connect the stent graft 500, that is, when the constricted section 400a overlaps with the connecting stent graft 500,
  • the suture 403a is not broken by the radial supporting force of the connecting stent graft 500; at the same time, when the necking section 400a overlaps the connecting stent graft 500, the suture 403a is opposite to the necking section 400a and the connecting film.
  • the effect of the gap of the bracket 500 is to ensure the ability of the neck portion 400a to prevent internal leakage.
  • the suture hole can also be omitted. In this case, the suture can be placed on the film of the constricted section through the penetration of the needle tip of the needle connected to the suture and the inner cavity of the constricted section. .
  • the method for preparing another stent graft comprises the following steps: First, a plurality of sutures 403b are provided, each suture 403b having two free ends; secondly, Passing one free end of each of the plurality of sutures 403b through the outer side of the film-coated section 401b of the stent-graft preform 100b through a suture hole 402b into the lumen of the stent-graft preform 100b; The free end of each suture 403b is passed through a suture hole 402b at least once through the inner side of the film segment 401b, and both free ends of the suture 403b are ultimately located outside the film segment 401b.
  • each suture 403b are tensioned so that the film segment 401b is formed at the portion where the plurality of sutures 403b are pierced, and the two of each suture 403b are fixed.
  • the free ends form a constriction 400b.
  • the constriction 400b is formed by using the plurality of sutures 403b
  • the connection stent graft 500 is inserted into the constriction 400b
  • the confinement force of the constriction 400b to the connection stent graft 500 is dispersed on the plurality of sutures 403b, and therefore, the suture 403b
  • the diameter of the suture 403a can be smaller than the diameter of the suture 403a, thereby better reducing the effect of the suture 403b on the gap between the constricted section 400b and the attachment stent graft 500.
  • the diameter of the suture 403b is preferably from 0.1 mm to 0.15 mm.
  • the shape of the constriction may not be limited to a circular shape, and may also be other shapes, such as a teardrop shape, and only need to be set according to actual needs, correspondingly
  • the position of the suture 403b can be sutured respectively, so that the stent graft having the constricted section can be better connected with the differently shaped connecting stent grafts to meet the needs of different blood vessel segments in the human body.
  • two or more sutures may be accommodated in each suture hole of the prepared stent graft, or one or some suture holes in the prepared stent graft.
  • the suture is not accommodated in the middle, and is not limited to this embodiment, and can be set according to actual needs. It can be understood that the neck portion 400 of the stent graft 100 is not limited to being prepared by the above-mentioned suture, and may be prepared by sticking, hot-melting or directly preparing a small-diameter film.
  • the stent graft 100 of the present invention can be used in any site where a combined stent graft is desired, such as a thoracic aorta, an abdominal aorta, or a bifurcation artery.
  • FIG. 5 is a schematic view showing the application of the combined stent graft formed by the stent graft 100 and the stent graft 500 of the present invention to the abdominal aorta vessel 10.
  • the stent graft 100 is delivered to the abdominal aorta vessel 10 through a small diameter delivery catheter (not shown) and released; then, the connected stent graft 500 is passed through a smaller diameter delivery catheter (Fig. Not shown) is inserted into the stent graft 100 from the distal end of the stent graft 100 and released.
  • the outer diameters of the stent graft 100 and the connecting stent graft 500 are larger than the inner diameter of the abdominal aorta vessel 10, and when the stent graft 100 and the connecting stent graft 500 are implanted into the abdominal aorta vessel 10, the membrane is covered.
  • the stent 100 and the connecting stent graft 500 are compressed to generate a radial supporting force with respect to the abdominal aorta vessel 10, and the stent graft 100 and the connecting stent graft 500 respectively generate static friction with the vessel wall of the abdominal aorta vessel 10 to cover
  • the membrane stent 100 and the connection stent graft 500 do not move with the abdominal aorta vessel 10, respectively.
  • the constricted section 400 radially compresses the overlapping portion of the connecting stent graft 500 with the constricted section 400, thereby increasing the stent graft 100 and the connecting stent graft 500.
  • the positive pressure between them increases the static friction and connection strength between the stent graft 100 and the connection stent graft 500.
  • FIG. 6 is a schematic view of a composite stent graft formed by a stent graft 100 and a stent graft 500 for use in a radial aneurysm 20.
  • the stent graft 100 is a lateral branch of the fistula stent 30.
  • the iliac bifurcated stent 30 is delivered to the iliac aneurysm 20 through a small diameter delivery catheter (not shown) and released, and the proximal end of the iliac bifurcation stent 30 is located in the iliac artery aorta 21, The distal end of the bifurcated stent 30 is located in the external iliac artery 22, and the lateral branch of the iliac bifurcation 30, that is, the stent graft 100, is located in the tumor cavity of the iliac aneurysm 20; then, the connecting stent graft 500 is passed through a smaller diameter.
  • a delivery catheter (not shown) is inserted into the stent graft 100 from the distal end of the stent graft 100 and released.
  • the proximal end of the stent graft 500 is located in the tumor lumen of the aneurysm 20, connecting the distal end of the stent graft 500.
  • the end is located in the internal iliac artery 23 of the iliac artery.
  • the outer diameter of the proximal end of the bifurcated stent 30 is larger than the inner diameter of the aortic blood vessel 21, and the outer diameter of the distal end of the bifurcated stent 30 is larger than the inner diameter of the extraordinary artery 22, and the stent graft 500 is connected.
  • the outer diameter of the distal end is larger than the inner diameter of the internal iliac artery 23, and therefore, the proximal end of the iliac bifurcation 30, the distal end, and the distal end of the sacral stent 500 are respectively sacral aorta 21 and iliac artery 22
  • the internal iliac artery 23 is compressed to generate a static friction force, and the sacral bifurcated stent 30 is prevented from moving relative to the iliac aorta vessel 21 and the iliac artery vasculature 22.
  • the connected stent graft 500 does not move relative to the internal iliac artery.
  • the connecting stent graft 500 and the stent graft 100 are connected in the tumor cavity; since the stent graft 100 includes the necking section 400 The constricted section 400 radially compresses the overlapping portion of the connecting stent graft 500 and the constricted section 400, thereby increasing the connection strength between the stent graft 100 and the connecting stent graft 500, and reducing the stent graft 100 and The possibility of detachment or displacement of the stent graft 500 in the tumor lumen.

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  • Health & Medical Sciences (AREA)
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  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • Prostheses (AREA)

Abstract

一种覆膜支架(100)包括主体段(200)，主体段(200)包括覆膜(101)和设置于覆膜(101)上的波形环状物。覆膜支架(100)还包括与主体段(200)一端连接的缩口段(400)。缩口段(400)包括覆膜且未设置波形环状物。缩口段(400)的最小内径小于与缩口段(400)连接的主体段(200)的端部的内径。该覆膜支架与另一覆膜支架连接时具有更高的连接强度。

Description

覆膜支架及其制备方法
【技术领域】
本发明涉及介入医疗器械技术领域，尤其涉及一种覆膜支架及其制备方法。
【背景技术】
随着高血压发病率的急剧上升，动脉相关疾病发病率显著上升。随着医学的发展，现已采用覆膜支架来治疗动脉瘤，具体地，将径向压缩后的覆膜支架装入输送系统，并沿导丝输送到病变位置后释放，形成新的将动脉瘤和血流隔开的血流通道，如此，动脉瘤在丧失了血流后，扩张状态的瘤壁受负压而收缩，恢复到原始形态，从而达到治疗动脉瘤的目的。
然而，不同患者的血管解剖形态差异较大，有的患者瘤体的长度可能很长，瘤体两端的瘤颈差别也可能较大，因此标准化的覆膜支架很难适用于每个患者。现有技术中出现了组合式覆膜支架，用于治疗标准化覆膜支架不能适用的病症。组合式覆膜支架可以根据患者的血管解剖形态和瘤体长度和形状随意组合，为至少两个覆膜支架的组合，即，将一个直径较大的覆膜支架套接在另一个直径较小的覆膜支架的内部，通过两个覆膜支架的重叠部分产生的摩擦力实现所述两个覆膜支架的连接。
然而，由于重叠部分产生的摩擦力所形成的连接强度较小，组合式覆膜支架植入血管后，在血流的冲刷下，会产生移位甚至断开连接的现象，不仅达不到治疗动脉瘤的目的，而且会危害人体生命。
【发明内容】
基于此，有必要提供一种能够增强组合式覆膜支架之间连接强度的覆膜支架及其制备方法。
本发明提供一种覆膜支架，包括主体段，所述主体段包括覆膜和设置于所述覆膜上的波形环状物，所述覆膜支架还包括与所述主体段一端连接的缩口段，所述缩口段包括覆膜且未设置波形环状物，所述缩口段的最小内径小于与所述缩口段连接的所述主体段的端部的内径。
在其中一个实施例中，所述覆膜支架还包括连接段，所述缩口段连接于所述主体段和所述连接段之间，所述缩口段的最小内径小于与所述缩口段连接的所述连接段的端部的内径。
在其中一个实施例中，所述缩口段设置于所述主体段的远端，所述连接段设置于所述缩口段的远端。
在其中一个实施例中，所述连接段包括覆膜和设置于覆膜上的波形环状物。
在其中一个实施例中，所述连接段包括所述覆膜且未设置波形环状物。
在其中一个实施例中，所述覆膜支架为主动脉血管支架或髂分叉支架的侧分支。
在其中一个实施例中，所述缩口段包括至少一根缝合线，所述缝合线的一端经所述缩口段的覆膜进入所述缩口段的内腔，再至少一次经所述缩口段的覆膜穿出所述缩口段的内腔，最后与所述缝合线的另一端固定连接在一起。
本发明还提供一种覆膜支架的制备方法，包括：
提供一覆膜支架预制件，所述覆膜支架预制件包括主体段和覆膜段，所述主体段包括覆膜和设置于所述覆膜上的裸支架，所述覆膜段包括覆膜且未设置波形环状物；
将至少一根缝合线的一端经所述覆膜段的覆膜进入所述覆膜段的内腔，再至少一次经所述覆膜段的覆膜穿出所述覆膜段的内腔，且所述缝合线的两个自由端最终均位于所述覆膜段的外部；
拉紧所述缝合线的两个自由端，使所述覆膜段在所述缝合线穿设的部位紧缩，并将所述缝合线的两个自由端固定在一起，形成所述缩口段。
在其中一个实施例中，所述缝合线的数量为一根。
在其中一个实施例中，所述缝合线的直径为0.15mm-0.3mm。
在其中一个实施例中，所述缝合线的数量大于或等于两根。
在其中一个实施例中，所述缝合线的直径为0.1mm-0.15mm。
本发明的覆膜支架由于包括缩口段，所述缩口段对组合式覆膜支架中的另一覆膜支架的压缩量较大，使所述缩口段和所述另一覆膜支架之间产生的静摩擦力较大，从而本发明的覆膜支架与所述另一覆膜支架连接时具有更高的连接强度。
【附图说明】
图1为本发明的覆膜支架的结构示意图。
图2为本发明的覆膜支架与另一覆膜支架组合使用时的结构示意图。
图3（a）-图3（c）为覆膜支架的一种制备方法的过程示意图。
图4（a）-图4（b）为覆膜支架的另一种制备方法的过程示意图。
图5为采用图1的覆膜支架的一种应用例的示意图。
图6为采用图1的覆膜支架的另一种应用例的示意图。
【具体实施方式】
为了使本发明的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本发明进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本发明，并不用于限定本发明。
在覆膜支架领域，将覆膜支架植入血管后，定义血流从覆膜支架的近端流向该覆膜支架的远端。
本申请中“覆膜支架”是指裸支架表面覆盖有薄膜后的结构，裸支架是指沿长度方向包括多个波形环状物且各波形环状物相互隔开设置的支架。波形环状物可以为开环结构，且将该波形环状物从任一处剪断后平铺于平面上的形状为波浪形，例如正弦波、Z型波等；波形环状物也可以为开环结构，且该波形环状物平铺于平面上的形状呈波浪形，例如正弦波、Z型波等。
请参阅图1，本发明的覆膜支架100包括覆膜101和设置于覆膜101上的裸支架102。覆膜101可采用聚四氟乙烯、聚酯或绦纶等材料制成，裸支架102包括至少一个波形环状物。覆膜101可以设置在裸支架102的至少一个波形环状物组成的管状结构的内表面、外表面，或者内表面和外表面；裸支架102可以通过沿各波形环状物连续绕线的缝合方式附着在覆膜101上，或者通过粘贴、压合等其他方式附着于覆膜101上。
覆膜支架100包括贯通连接的主体段200、连接段300和设置于主体段200与连接段300之间的缩口段400。连接段300设置于覆膜支架100的远端，主体段200和连接段300均为直筒状结构，且主体段200和连接段300均分别包括覆膜101和至少一个波形环状物。可以理解，主体段200和连接段300还可以为锥形筒状结构，具体形状可根据血管形状进行选择。
缩口段400位于主体段200的远端和连接段300的近端之间，缩口段400仅包括覆膜101。缩口段400的周面向覆膜支架100的中心轴线凹陷，与主体段200和连接段300配合形成以缩口段400为腰部的腰部收缩结构。缩口段400具有一最小内径，所述最小内径小于与缩口段400近端连接的主体段200远端的内径，且所述最小内径小于与缩口段400远端连接的连接段300近端的内径。
请参阅图2，连接覆膜支架500为直筒状结构，连接覆膜支架500用于与覆膜支架100组合，形成组合式覆膜支架。当连接覆膜支架500与覆膜支架100组合时，连接覆膜支架500的近端与覆膜支架100的远端连接，具体可以是连接覆膜支架500插入覆膜支架100的管腔内，直至连接覆膜支架500的近端与覆膜支架100的主体段200远端重叠，也就是说，覆膜支架100的主体段200远端、缩口段400和连接段300均与部分连接覆膜支架500重叠，此时，定义覆膜支架100与连接覆膜支架500重叠的区域为锚定区600。一般来说，为了使连接覆膜支架500与覆膜支架100能够在锚定区600进行连接，在自然膨胀状态下，连接覆膜支架500位于锚定区600部分的外径稍大于覆膜支架100的连接段300的内径和主体段200远端的内径，从而当连接覆膜支架500插入覆膜支架100后，在锚定区600，覆膜支架100限制连接覆膜支架500的自然膨胀，即在锚定区600，覆膜支架100对连接覆膜支架500进行压缩，使覆膜支架100和连接覆膜支架500在锚定区600产生静摩擦力，从而实现覆膜支架100与连接覆膜支架500的连接。
本发明中，不同于现有技术，覆膜支架100与连接覆膜支架500进行连接的锚定区600包括缩口段400，由于缩口段400的最小内径小于连接覆膜支架500的位于锚定区600部分的内径，当连接覆膜支架500插入覆膜支架100并在锚定区600处与覆膜支架100相连时，覆膜支架100压缩所述连接覆膜支架500，且连接覆膜支架500在缩口段400处的压缩量，比连接覆膜支架500在连接段300处的压缩量大；而且连接覆膜支架500在缩口段400处的压缩量，比连接覆膜支架500在主体段300处的压缩量大。需要指出的是，本发明的“压缩量”是指，连接覆膜支架500在径向方向上被压缩而产生的直径减小的尺寸。因此，在覆膜支架轴线方向上具有相同长度的锚定区600的前提下，与现有技术的组合式支架相比，因为锚定区600的缩口段400对连接覆膜支架500的压缩量较大，即缩口段400与连接覆膜支架500之间的正压力较大，缩口段400和连接覆膜支架500之间产生的静摩擦力也较大，缩口段400可以卡持连接覆膜支架500，从而锚定区600带有缩口段400的覆膜支架100与连接覆膜支架500连接时具有更高的连接强度，避免两者脱落。
而且，现有技术中，组合式覆膜支架的两个覆膜支架在重叠区域内均包括波形环状物，而波形环状物与波形环状物重叠时，容易产生间隙，导致血流在两个覆膜支架之间流动，且两个覆膜支架之间的血流可进入覆膜支架与血管壁之间，形成内漏。本发明中，由于覆膜支架100包括位于锚定区600的缩口段400，且缩口段400仅包括覆膜101，不包括波形环状物，因此缩口段400可以与连接覆膜支架500更好地贴合，即减少了缩口段400和与缩口段400重叠的连接覆膜支架500之间的间隙，如此，流进主体段200与连接覆膜支架500之间的血流在缩口段400处被阻断，并最终在缩口段400与主体段200的连接处形成血栓，从而防止了血流进入覆膜支架与血管壁之间形成内漏。
可以理解，连接段300还可以设置于覆膜支架100的近端，主体段200设置于覆膜支架100的远端，缩口段400仍然设置于连接段300和主体段200之间。连接覆膜支架500的远端从覆膜支架100的近端插入覆膜支架100，直至连接覆膜支架500的远端与覆膜支架100的缩口段400锚定，此时，锚定区600包括连接段300、缩口段400和主体段200近端。
可以理解，连接段300还可以仅包括覆膜101，不包括任何波形环状物。由于连接段300也仅包括覆膜101，此时，可进一步地防止覆膜支架与血管壁之间产生内漏。
可以理解，覆膜支架100还可以仅包括主体段200和与主体段200相连的缩口段400，即覆膜支架100不包括连接段300，此时缩口段400可以设于主体段200的远端或近端。
可以理解，覆膜支架100可以为单独的一个支架，例如主动脉血管支架；覆膜支架100还可以为一个支架的一部分，例如覆膜支架100为髂分叉支架的侧分支。
图3（a）至图3（c）示出了制备本发明覆膜支架100的一种方法。请参阅图3（a），提供一个覆膜支架预制件100a，覆膜支架预制件100a包括覆膜101a和设置于覆膜101a上的裸支架102a。覆膜支架预制件100a为直筒状或圆锥筒状结构，覆膜支架预制件100a包括主体段200a、连接段300a和位于主体段200a与连接段300a之间的覆膜段401a。主体段200a和连接段300a均包括覆膜101a和裸支架102a。覆膜段401a仅包括覆膜101a。覆膜段401a的周面在垂直于覆膜支架预制件100a轴线的同一个平面方向上开设有多个缝合孔402a，多个缝合孔402a的数量为偶数个。本发明中，所述多个缝合孔402a沿覆膜段401a的周向均匀间隔分布。可以理解，多个缝合孔402a沿覆膜段401a的周向也可以非均匀间隔分布。
请参阅图3（b），提供一根连续的缝合线403a，缝合线403a具有两个自由端。首先，将缝合线403a的一个自由端从覆膜支架预制件100a的外侧穿过覆膜支架预制件100a的一个缝合孔402a，进入覆膜支架预制件100a的内腔；然后，将缝合线403a的该自由端从覆膜支架预制件100a内腔穿过相邻的另一个缝合孔402a，穿出覆膜支架预制件100a；如此反复，直至缝合线403a的该自由端穿过覆膜支架预制件100a的全部缝合孔402a，且缝合线403a的两个自由端最终位于所述覆膜支架预制件100a的外侧。
请参阅图3（c），同时拉紧缝合线403a的两个自由端，使覆膜段401a在缝合线403a穿设的部位形成缩口，并固定缝合线403a的该两个自由端，形成缩口段400a。本实施例中，缝合线403a的两个自由端通过打结固定。可以理解，该缝合线403a的两个自由端还可以通过粘接、热熔或捆绑等方式进行固定。
本实施例中，缝合线403a的直径优选为0.15mm-0.3mm，从而保证了缩口段400a对连接覆膜支架500的限制力度，即在缩口段400a与连接覆膜支架500重叠时，缝合线403a不会因为连接覆膜支架500的径向支撑力而断裂；同时，还减小了缩口段400a与连接覆膜支架500重叠时，缝合线403a对缩口段400a与连接覆膜支架500的间隙的影响，即保证了缩口段400a防止内漏的能力。可以理解的是，缝合孔也可以省略不要，此时，可以通过与缝合线相连的针的针尖的穿入及穿出缩口段的内腔，将缝合线设置于缩口段的覆膜上。
可以理解，当所述多个缝合孔的数量大于或等于四个时，所述缝合线的数量也可以为多根。请参阅图4（a）和图4（b），制备另一种覆膜支架的方法包括以下步骤：首先，提供多根缝合线403b，每根缝合线403b均具有两个自由端；其次，将多根缝合线403b中的每根缝合线403b的一个自由端经覆膜支架预制件100b的覆膜段401b的外侧穿过一个缝合孔402b，进入覆膜支架预制件100b的内腔；再次，将每根缝合线403b的该自由端至少一次经覆膜段401b的内侧穿出一个缝合孔402b，且缝合线403b的两个自由端最终均位于覆膜段401b的外侧。
请参阅图4（b），拉紧每根缝合线403b的两个自由端，使覆膜段401b在多根缝合线403b穿设的部位形成缩口，并固定每根缝合线403b的该两个自由端，形成缩口400b。采用多根缝合线403b形成缩口400b时，当连接覆膜支架500插入缩口400b时，缩口400b对连接覆膜支架500的限制力分散在多根缝合线403b上，因此，缝合线403b的直径相比于缝合线403a的直径可以较小，从而更好地减小缝合线403b对缩口段400b与连接覆膜支架500的间隙的影响。本实施例中，缝合线403b的直径优选为0.1mm-0.15mm。而且，采用多根缝合线403b来制备所述缩口时，所述缩口的形状可以不限制为圆形，还可以为其他形状，如水滴形，只需根据实际需求来设定，在相应的位置分别采用缝合线403b进行缝合即可，如此，具有所述缩口段的覆膜支架可以与不同形状的连接覆膜支架更好的连接，以满足人体内不同血管段的需求。可以理解的是，其他实施例中，制备好的覆膜支架的每个缝合孔中也可以收容有两根或者更多根缝合线，或者制备好的覆膜支架中某个或者某些缝合孔中并未收容有缝合线，不限于本实施例，可根据实际需要来设定。可以理解，覆膜支架100的缩口段400不限于通过上述缝合线进行制备，还可以通过粘贴、热熔或直接制备小直径的覆膜等方式进行制备形成。
本发明的覆膜支架100可以使用于任何需求组合式覆膜支架的部位，如胸主动脉、腹主动脉、或髂分叉动脉处等。
图5为本发明的覆膜支架100和连接覆膜支架500形成的组合式覆膜支架应用于腹主动脉血管10中的示意图。使用时，首先，将覆膜支架100通过直径较小的输送导管（图未示）输送至腹主动脉血管10处并释放；然后，将连接覆膜支架500通过直径较小的输送导管（图未示）从覆膜支架100的远端插入覆膜支架100中并释放。本实施例中，覆膜支架100和连接覆膜支架500的外径均大于腹主动脉血管10的内径，当覆膜支架100和连接覆膜支架500植入腹主动脉血管10时，覆膜支架100和连接覆膜支架500被压缩以相对腹主动脉血管10产生径向支撑力，进而覆膜支架100和连接覆膜支架500分别与腹主动脉血管10的血管壁产生静摩擦力而使覆膜支架100和连接覆膜支架500分别与腹主动脉血管10不产生移动。同时，由于覆膜支架100包括缩口段400，缩口段400对连接覆膜支架500的与缩口段400重叠部分径向压缩，从而增大了覆膜支架100和连接覆膜支架500之间的正压力，进而增加了覆膜支架100和连接覆膜支架500之间的静摩擦力及连接强度。
图6为覆膜支架100和连接覆膜支架500形成的组合式覆膜支架应用于髂动脉瘤20中的示意图，本应用中，覆膜支架100为髂分叉支架30的侧分支。使用时，首先，将髂分叉支架30通过直径较小的输送导管（图未示）输送至髂动脉瘤20处并释放，髂分叉支架30的近端位于髂主动脉血管21中，髂分叉支架30的远端位于髂外动脉血管22中，髂分叉支架30的侧分支即覆膜支架100位于髂动脉瘤20的瘤腔中；然后，将连接覆膜支架500通过直径较小的输送导管（图未示）从覆膜支架100的远端插入覆膜支架100中并释放，连接覆膜支架500的近端位于髂动脉瘤20的瘤腔中，连接覆膜支架500的远端位于髂内动脉血管23中。本实施例中，髂分叉支架30的近端的外径大于髂主动脉血管21的内径，髂分叉支架30的远端的外径大于髂外动脉血管22的内径，连接覆膜支架500的远端的外径大于髂内动脉血管23的内径，因此，髂分叉支架30的近端、远端以及连接覆膜支架500的远端分别被髂主动脉血管21、髂外动脉血管22和髂内动脉血管23压缩以产生静摩擦力，保证髂分叉支架30相对髂主动脉血管21和髂外动脉血管22不产生移动，连接覆膜支架500相对髂内动脉血管23不产生移动。同时，由于连接覆膜支架500的近端的外径大于覆膜支架100远端的内径，连接覆膜支架500与覆膜支架100在瘤腔内连接；由于覆膜支架100包括缩口段400，缩口段400对连接覆膜支架500与缩口段400重叠部分径向压缩，从而增大了覆膜支架100和连接覆膜支架500之间的连接强度，减小了覆膜支架100和连接覆膜支架500在瘤腔中脱离或移位的可能。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (10)

  1. 一种覆膜支架，包括主体段，所述主体段包括覆膜和设置于所述覆膜上的波形环状物，其特征在于，所述覆膜支架还包括与所述主体段一端连接的缩口段，所述缩口段包括覆膜且未设置波形环状物，所述缩口段的最小内径小于与所述缩口段连接的所述主体段的端部的内径。
  2. 根据权利要求1所述的覆膜支架，其特征在于，所述覆膜支架还包括连接段，所述缩口段连接于所述主体段和所述连接段之间，所述缩口段的最小内径小于与所述缩口段连接的所述连接段的端部的内径。
  3. 根据权利要求2所述的覆膜支架，其特征在于，所述缩口段设置于所述主体段的远端，所述连接段设置于所述缩口段的远端。
  4. 根据权利要求2所述的覆膜支架，其特征在于，所述连接段包括覆膜和设置于覆膜上的波形环状物。
  5. 根据权利要求2所述的覆膜支架，其特征在于，所述连接段包括所述覆膜且未设置波形环状物。
  6. 根据权要求1至5任一项所述的覆膜支架，其特征在于，所述覆膜支架为主动脉血管支架或髂分叉支架的侧分支。
  7. 根据权利要求1至5任一项所述的覆膜支架，其特征在于，所述缩口段包括至少一根缝合线，所述缝合线的一端经所述缩口段的覆膜进入所述缩口段的内腔，再至少一次经所述缩口段的覆膜穿出所述缩口段的内腔，最后与所述缝合线的另一端固定连接在一起。
  8. 一种如权利要求1所述的覆膜支架的制备方法，包括：
    提供一覆膜支架预制件，所述覆膜支架预制件包括主体段和覆膜段，所述主体段包括覆膜和设置于所述覆膜上的裸支架，所述覆膜段包括覆膜且未设置波形环状物；
    将至少一根缝合线的一端经所述覆膜段的覆膜进入所述覆膜段的内腔，再至少一次经所述覆膜段的覆膜穿出所述覆膜段的内腔，且所述缝合线的两个自由端最终均位于所述覆膜段的外部；
    拉紧所述缝合线的两个自由端，使所述覆膜段在所述缝合线穿设的部位紧缩，并将所述缝合线的两个自由端固定在一起，形成所述缩口段。
  9. 根据权利要求8所述的覆膜支架的制备方法，其特征在于，所述缝合线的直径为0.15mm-0.3mm。
  10. 根据权利要求8所述的覆膜支架的制备方法，其特征在于，所述缝合线的直径为0.1mm-0.15mm。
PCT/CN2017/090595 2016-09-08 2017-06-28 覆膜支架及其制备方法 WO2018045797A1 (zh)

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