WO2017113626A1 - 输送系统及管腔支架系统 - Google Patents

输送系统及管腔支架系统 Download PDF

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Publication number
WO2017113626A1
WO2017113626A1 PCT/CN2016/085718 CN2016085718W WO2017113626A1 WO 2017113626 A1 WO2017113626 A1 WO 2017113626A1 CN 2016085718 W CN2016085718 W CN 2016085718W WO 2017113626 A1 WO2017113626 A1 WO 2017113626A1
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WO
WIPO (PCT)
Prior art keywords
lumen
carrier
anchor
insertion portion
limiting
Prior art date
Application number
PCT/CN2016/085718
Other languages
English (en)
French (fr)
Inventor
张军强
王刚
关成梅
Original Assignee
先健科技(深圳)有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 先健科技(深圳)有限公司 filed Critical 先健科技(深圳)有限公司
Priority to ES16880434T priority Critical patent/ES2831718T3/es
Priority to EP16880434.2A priority patent/EP3398568B1/en
Priority to US16/063,270 priority patent/US10799379B2/en
Priority to PL16880434T priority patent/PL3398568T3/pl
Publication of WO2017113626A1 publication Critical patent/WO2017113626A1/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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A61F2/9661—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod the proximal portion of the stent or stent-graft is released first
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
    • 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
    • A61F2/9522—Means for mounting a stent or stent-graft onto or into a placement instrument
    • 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
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A61F2002/9665—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod with additional retaining means

Definitions

  • the invention relates to the technical field of medical instruments, in particular to a delivery system and a lumen support system.
  • the aorta of the human body is divided into the ascending aorta, the aortic arch, the descending thoracic aorta, and the abdominal aorta. Due to various pathological changes, such as inflammation, ulcers, etc., it may cause damage to the intima or blood vessel wall of the aorta, and under the combined action of blood flow impact, diseases such as aneurysms are prone to occur. Once the aneurysm ruptures, a large amount of blood will flow out of the blood vessels, and the patient's blood circulation is insufficient, causing shock or death.
  • aneurysm diseases For the treatment of aneurysm diseases, it is commonly divided into surgical treatment and medical treatment.
  • the current treatment is based on surgical treatment.
  • Traditional surgical treatment ie, open surgery
  • the aneurysm lesions are removed after the extracorporeal blood circulation is established, and the artificial blood vessels are used to connect the blood vessels to achieve normal circulation of the arterial blood.
  • the traditional surgery for the treatment of aneurysm disease is high in risk and traumatic to the human body, it will cause great physical trauma to the elderly and infirm, and it takes a long time to recover after surgery.
  • Aortic lumen stent refers to the artificial lumen corresponding to the size of the lumen.
  • the procedure is as follows: first compress the lumen stent into the sheath of the delivery system; secondly, puncture the vessel at the position of the femoral or radial artery, using the guide wire The orbit is established; then, the delivery system loaded with the lumen stent is transported through the radial artery-abdominal aorta-thoracic aorta-aortic arch-ascending aorta to the designated site of the lesion; then, the lumen stent is released and deployed to the artery
  • the wall of the tumor tube, the membrane of the lumen stent isolates the blood flow from the lesion, thereby eliminating the impact of blood flow on the aneurysm wall of the lesion, establishing a channel for normal blood circulation; finally, withdrawing the guide wire and the delivery system, completing the pair Interventional treatment of aneurysms and arterial dissection.
  • connection with a portion Due to the high blood pressure and strong impact force in the aortic blood vessels, during the release of the lumen stent, the blood impacts the lumen stent, and there is a risk of displacement of the lumen stent. Therefore, in recent years, a connection with a portion has appeared.
  • the delivery system can easily hook the lumen stent that has been released, especially the connection portion of the lumen stent, resulting in displacement of the lumen stent, or even Failure of interventional surgery increases the risk of surgery for the patient.
  • the present invention provides a delivery system for delivering a lumen stent, the delivery system comprising a fixation anchor and a cylindrical and proximally open fixation cap, the fixation anchor comprising a hollow insertion portion and a connection to the insertion portion
  • the portion of the insertion portion is recessed toward the inside of the insertion portion to form a plurality of positioning grooves extending through the proximal end surface of the insertion portion, and a partition is formed between each adjacent two of the positioning grooves
  • the abutting portion includes a hollow carrier and a plurality of first limiting members disposed on a side of the carrier, and a distal end of each of the first limiting members corresponds to one of the positioning slots Providing an opening side of the abutting portion, a distal end surface of the plurality of first limiting members, a distal end surface of the carrier, and a proximal end surface of the partition member are coplanar; when the fixing anchor and the fixing cap are When closed, the insertion portion is
  • the abutting portion further includes a plurality of second limiting members, the number of the plurality of second limiting members being equal to the number of the plurality of first limiting members, the plurality of The second limiting member and the plurality of first limiting members are alternately arranged on the side of the carrier, each of the second limiting members is disposed corresponding to one of the spacers, and each of the The distal end surface of the second limiting member abuts against the proximal end surface of the corresponding spacer.
  • the width of the partition in the circumferential direction of the insertion portion is greater than the width of the second stopper corresponding to the partition in the circumferential direction of the abutting portion.
  • a cross section of each of the first and second stop members away from the surface of the carrier is perpendicular to a longitudinal centerline of the anchor.
  • the shapes are all arc segments, and the diameter of the arc segments is equal to the outer diameter of the proximal end of the fixed cap.
  • the longitudinal direction of the first limiting member and the second limiting member are both parallel to a longitudinal center line of the fixed anchor, and the first limiting member and the second portion
  • the proximal end of the limiting member extends toward the proximal end of the carrier, and the lengths of the first limiting member and the second limiting member are both smaller than the axial length of the carrier, each of the A proximal end outer surface of a limiting member and the second limiting member has a tapered smooth transition with a proximal outer surface of the carrier.
  • a side of the positioning groove in a direction along a longitudinal center line of the insertion portion and away from the abutting portion is a closed side.
  • the delivery system further includes an inner core tube, a tip disposed at a distal end of the inner core tube, an outer core sleeved outside the inner core tube and axially movable relative to the inner core tube a fixing cap disposed at a proximal end of the tip and surrounding the inner core tube, the fixing anchor being disposed at a distal end of the outer core tube and surrounding the outer core tube; The fixed anchor is adjacent to the tip.
  • the proximal end of the carrier extends to the outer core tube and the proximal outer surface of the carrier has a tapered transition with the outer surface of the outer core tube.
  • the present invention also provides a lumen stent system comprising a lumen stent and a delivery system as described in any of the above, the lumen stent comprising a bare stent, the bare stent comprising a corrugated annulus and a plurality of a connecting portion of the corrugated ring, when the fixing anchor and the fixing cap are closed, the connecting portion of the bracket is received in the positioning groove, and each of the partitions is adjacent to the corresponding partition
  • One of the first limiting member, the fixing cap and the carrier body form an small hole in a plane in which the proximal end surface of the fixing cap is located, and the small hole is along the fixed anchor circumferential direction
  • the width is less than the width of the end of the connecting portion along the circumferential direction of the lumen support.
  • the plurality of first limiting members are both locked with the crest portion of the corrugated ring.
  • the connecting portion is a U-shaped open-loop structure that is open at one side, the corrugated ring is broken at a crest portion, and both ends of the open side of the connecting portion are respectively connected to the corrugated ring The two ends of the opening portion of the insertion portion are connected; the positioning groove of the insertion portion is further provided with an axial backward movement limiting member, and the axial backward movement limiting member is perpendicular to each of the positioning grooves Between the sides of the insertion portion in the circumferential direction, there are gaps protruding from the groove of the positioning groove parallel to the circumferential direction of the insertion portion; the connecting portion is received in the positioning groove, and The connecting portion is engaged with the axial backward shifting member.
  • the axial rearward retaining member extends along the longitudinal centerline of the fixed anchor toward the first limiting member and is coupled to the first limiting member.
  • the connecting portion is provided with a barb.
  • the distal end surface of the first limiting member, the distal end surface of the carrier body and the proximal end surface of the partition member are coplanar, and therefore, when the fixing anchor and the fixing cap are closed, the fixing cap and the fixing anchor are fixed.
  • the first limiting member, the carrier and the partition on the abutting end face divide the end surface of the fixing cap into a plurality of small holes, thereby preventing the delivery of the released lumen bracket when the delivery system is withdrawn.
  • FIG. 1 is a schematic structural view of a lumen stent of a lumen stent system according to an embodiment of the present invention.
  • Fig. 2 is a partially enlarged schematic view showing a portion A in Fig. 1.
  • FIG. 3 is a schematic structural view of a delivery system of a lumen support system according to an embodiment of the present invention.
  • FIG. 4 is a schematic structural view of the fixed anchor and the outer core tube of FIG. 3.
  • Figure 5 is a cross-sectional view of the fixed anchor and the outer core tube of Figure 4 taken along the line B-B.
  • FIG. 6 is a schematic view showing the cooperation of the fixing cap, the fixing anchor and the connecting portion according to an embodiment of the invention.
  • FIG. 7 is a schematic view of a state of a lumen support system according to an embodiment of the present invention, in which a lumen stent is housed in a delivery system.
  • FIG. 8 is a schematic view showing a state of a lumen stent system according to an embodiment of the present invention, in which the lumen stent is in a semi-release state.
  • FIG. 9 is a schematic view showing a state of a lumen stent system according to an embodiment of the present invention, in which the lumen stent is in a fully released state.
  • FIG. 10 is a schematic diagram of a state of a lumen support system according to an embodiment of the present invention, in which the delivery system is in a retracted state.
  • Figure 11 is a schematic view of the cooperation of the fixed cap and the fixed anchor of Figure 10.
  • Figure 12 is a left side view of the cooperation of the fixed cap and the fixed anchor of Figure 11;
  • FIG. 13 is a schematic structural view of a connecting portion of a lumen stent of a lumen stent system according to another embodiment of the present invention.
  • FIG. 14 is a schematic view showing the cooperation of the connecting portion of FIG. 13 and the fixing anchor and the fixing cap according to another embodiment of the present invention.
  • FIG. 15 is a schematic view showing the cooperation of the connecting portion of FIG. 13 and the fixing anchor and the fixing cap according to another embodiment of the present invention.
  • the lumen stent system of the present invention includes a lumen stent and a delivery system for delivering the lumen stent.
  • the delivery system can implant the lumen stent into the lumen to form a new body fluid channel, such as a new blood flow channel after implantation into a blood vessel.
  • a lumen stent 100 according to an embodiment of the present invention includes a tubular stent graft 110 and a bare stent 120.
  • the lumen stent 100 has self-expanding properties.
  • the stent graft 110 includes a plurality of corrugated loops 111 composed of at least one braided wire, and a coating 112 covering the plurality of corrugated loops 111 for fixing the plurality of corrugated loops.
  • the material of the film 112 may be a polyester or e-PTFE material.
  • the braided wire may be stainless steel wire or nickel titanium wire, or may be other biological material braided wire.
  • Each of the waveform loops 111 may include a plurality of waveform units in a V-shape, a Z-shape, or other shapes.
  • the bare bracket 120 includes a plurality of sheet-like connecting portions 121. At least one barb 122 may be disposed on one of the connecting portions 121. One end of the barb 122 is disposed at an end of the connecting portion 121 away from the stent graft 110, and the other end of the barb 122 is a suspended end, and the hanging end of the barb 122 extends toward the stent graft 110 and is suspended.
  • the barbs 122 are substantially V-shaped with the connecting portion 121 where they are located. After the lumen stent 100 is fully released, the barbs 122 can penetrate the vessel wall to cause the lumen stent 100 to develop an anti-displacement capability upon completion of the release.
  • the bare stent 120 can generally also include a bare stent segment that connects the connecting portion 121 and the stent graft 110.
  • the bare stent segment includes one or more turns of a wave structure interconnected.
  • the bare bracket 120 can be designed to grow in two short forms.
  • the short bare stent includes one or two turns of a wave structure between the connecting portion 121 and the stent graft 110, and the elongated bare stent includes at least two turns between the connecting portion 121 and the stent graft 110. Waveform structure.
  • the bare stent 120 is a long bare stent, and includes a first wave structure 123 connected to the connecting portion 121 and a plurality of second wave structures 124 between the first wave structure 123 and the film stent 110. Each peak portion of the first waveform structure 123 is connected to a connection portion 121.
  • the wave density of the first waveform structure 123 is smaller than the wave density of the second waveform structure 124, and the wave height is greater than the wave height of the second waveform structure 124.
  • the number of turns of the undulating structure connecting the connecting portion 121 and the stent graft 110 may be one or two turns. It can also be understood that, in the adjacent two-turn waveform structure, the vertical distance between the peak and the trough of one waveform structure, that is, the wave height may be greater than or equal to the wave height of the other waveform structure.
  • the bare stent 120 can be cut by laser, and of course, can be woven like the stent graft 110.
  • the delivery system 200 of the embodiment of the present invention includes an inner core tube 210 , an outer core tube 220 that is disposed outside the inner core tube 210 and axially movable relative to the inner core tube 210 , and is disposed outside the outer core tube 220 and A sheath tube 230 for housing the lumen stent 100.
  • one end of the delivery system 200 near the operator is generally referred to as the proximal end, and the end remote from the operator is referred to as the distal end.
  • An annular cavity is formed between the distal end of the sheath tube 230 of the delivery system 200 and the outer core tube 220. During the delivery process, the radially compressed lumen stent 100 is received in the annular cavity.
  • the delivery system 200 also includes a hollow end 240 at the distal end of the inner core tube 210.
  • the proximal end of the tip 240 is fixed integrally with the distal end of the inner core tube 210, and the lumen of the end 240 is in communication with the lumen of the inner core tube 210 to serve as a guidewire channel. More specifically, the proximal end of the tip 240 is integrally formed with the distal end of the inner core tube 210.
  • delivery system 200 also includes a push tube 250 positioned between outer core tube 220 and sheath tube 230.
  • the push tube 250 is coaxial with the outer core tube 220 and is fixed in one body.
  • the delivery system 200 also includes a fixation cap 260 disposed at the proximal end of the tip 240 and surrounding the inner core tube 210.
  • the fixing cap 260 is a cylindrical structure with open ends, and the side surface thereof is a cylindrical surface.
  • One end of the fixing cap 260 is fixedly connected with the proximal end of the end 240 and the two are smoothly transitioned, so that the fixing cap 260 and other components can be avoided.
  • the other end is an open end for accommodating the connecting portion 121 of the lumen holder 100 and the barb 122 when the lumen holder 100 is loaded into the delivery system 200.
  • the delivery system 200 further includes a hollow anchor 270.
  • the fixing anchor 270 is disposed outside the distal end of the outer core tube 220 and surrounds the outer core tube 220.
  • the proximal end of the fixing anchor 270 is integrally fixed with the distal end of the outer core tube 220, and the inner cavity of the anchor 270 and the tube of the outer core tube 220 are fixed.
  • the cavities are in communication such that the anchors 270 and the outer core tube 220 fit together outside the inner core tube 210 and are axially movable relative to the inner core tube 210.
  • the anchor anchor 270 is used to axially secure the lumen stent 100 and cooperates with the fixation cap 260 for radially constraining the barbs 122.
  • the anchor 270 includes a hollow insertion portion 271 at the distal end and abutment portion 273 at the proximal end and connected to the insertion portion 271.
  • the insertion portion 271 has a substantially hollow cylindrical structure with an outer diameter slightly smaller than the inner diameter of the fixing cap 260, that is, the insertion portion 271 can be clearance-fitted with the fixing cap 260 so that the insertion portion 271 can be smoothly inserted into the fixing cap 260.
  • the insertion portion 271 is inserted into the fixing cap 260 and cooperates with the fixing cap 260 to radially restrain the connection portion 121 of the lumen holder 100 and the barbs 122.
  • a part of the side surface of the insertion portion 271 is recessed toward the inside of the insertion portion 271 to form a plurality of positioning grooves 2711 penetrating the proximal end surface of the insertion portion 271.
  • the positioning groove 2711 is for accommodating the connecting portion 121 of the lumen bracket 100, and a partition member 2713 is formed between each adjacent two positioning grooves 2711.
  • the side of the positioning groove 2711 along the longitudinal center line of the insertion portion 271 and adjacent to the abutting portion 273 is the opening side, and the side of the positioning groove 2711 in the direction of the longitudinal center line of the insertion portion 271 and away from the abutting portion 273 To close the side.
  • the shape of the positioning groove 2711 is slightly larger than the shape of the connecting portion 121 so that the connecting portion 121 is inserted from the opening side of the positioning groove 2711 and is integrally received in the positioning groove 2711.
  • the plurality of positioning grooves 2711 are evenly arranged on the side surface of the insertion portion 271.
  • the shape of the positioning groove 2711 is substantially the same as the shape of the connecting portion 121. It can be understood that the shape of the positioning groove 2711 may be different from the shape of the connecting portion 121, and only the length of the positioning groove 2711 extending along the longitudinal center line direction of the insertion portion 271 is slightly larger than the length of the connecting portion 121 to ensure the connecting portion 121. It can be completely accommodated in the positioning groove 2711.
  • the positioning groove 2711 and the fixing cap 260 collectively radially restrain the connecting portion 121 and the barb 122.
  • the effect is such that the dangling end of the barb 122 remains in the collapsed state.
  • the closed side of the positioning groove 2711 can abut the end of the connecting portion 121 away from the stent graft 110, thereby preventing the lumen stent 100 from moving forward axially (axially moving forward, that is, toward the distal direction of the delivery system 200)
  • the two adjacent partitions 2713 separate the adjacent connecting portions 121 to prevent the adjacent connecting portions 121 from interfering with each other.
  • the abutting portion 273 includes a hollow carrier 2731, a plurality of elongated first limiting members 2733 disposed on a side surface of the carrier 2731, and a plurality of second limiting members 2735.
  • the carrier 2731 is coupled to the insertion portion 271, and the lumen of the carrier 2731 is in communication with the lumen of the outer core tube 220.
  • the abutting portion 273 and the insertion portion 271 are integrally formed. It can be understood that the abutting portion 273 can also be connected to the insertion portion 271 by welding, bonding, or the like.
  • the number of the plurality of first limiting members 2733 is equal to the number of the plurality of second limiting members 2735, and the plurality of first limiting members 2733 and the plurality of second limiting members 2735 are alternately arranged on the side of the carrier body 2731. There is a second limiting member 2735 between each adjacent two first limiting members 2733.
  • the structure of the first limiting member 2733 is substantially the same as the structure of the second limiting member 2735.
  • the two end portions are alternately disposed on the distal side surface of the carrier body 2731, and the distal end faces of the two end faces are opposite to the distal end surface of the carrier body 2731.
  • the proximal end faces of the partitions 2713 are coplanar.
  • the cross-sectional shape of the distal end of the surface of each of the first limiting member 2733 and the second limiting member 2735 remote from the carrier 2731 is a circle in a cross section perpendicular to the longitudinal center line of the outer core tube 220.
  • the diameter of the arc segment of the first limiting member 2733 is the outer diameter of the distal end of the first limiting member 2733, and the diameter of the circular arc segment of the second limiting member 2735 is the second limiting member 2735.
  • the distal outer diameter of both ends is equal to the proximal outer diameter of the fixed cap 260.
  • the distal end faces of the first limiting member 2733 and the second limiting member 2735 can abut the proximal end surface of the fixing cap 260, so the lumen bracket 100 is in the fixing cap 260 and
  • the fixing anchor 270 can ensure its axial and radial restraint under the joint action; and the surface of each of the first limiting member 2733 and the second limiting member 2735 away from the carrier 2731 is included
  • the cross-sectional shape of the longitudinal center line of the core tube 220 is a curve, so that the fixed cap 260 smoothly transitions with the first limiting member 2733 and the second limiting member 2735, so that the fixing cap 260 and the fixing anchor 270 are prevented from being withdrawn.
  • the fistula stent 100 is removed from the extracorporeal process.
  • the longitudinal direction of the first limiting member 2733 and the second limiting member 2735 are both parallel to the longitudinal center line of the outer core tube 220, and the vicinity of each of the first limiting member 2733 and the second limiting member 2735 The ends all extend toward the proximal end of the carrier 2731.
  • the lengths of the first limiting member 2733 and the second limiting member 2735 are both smaller than the axial length of the carrier 2731.
  • the distance from the surface of the distal end of each of the first limiting member 2733 and the second limiting member 2735 away from the carrier 2731 to the longitudinal centerline of the outer core tube 220 is greater than or equal to the corresponding limiting member.
  • the proximal end of the carrier 2731 extends to the outer core tube 220, and the proximal end of the first limiting member 2733 and the second limiting member 2735, the proximal end of the carrier 2731, and the outer core tube 220 are externally
  • the surface presents a tapered smooth transition so that the proximal end of the abutment portion 273 has a substantially smooth tapered profile, which prevents the anchoring anchor 270 from abutting the portion 273 of the lumen stent 100 during withdrawal from the body, thereby improving the surgical procedure. safety.
  • the plurality of first limiting members 2733 are equally spaced on the outer surface of the carrier body 2731 along the circumferential direction of the carrier body 2731, and the distal end of each of the first limiting members 2733 corresponds to the opening of one positioning groove 2711 of the insertion portion 271.
  • the side arrangement, that is, the number of the plurality of first limiting members 2733 is equal to the number of the plurality of positioning grooves 2711, and is the number of the connecting portions 121 of the lumen holder 100.
  • the first limiting member 2733 can be caught in a crest portion of the first wave structure 123 of the lumen holder 100 to prevent the lumen bracket 100 from being fully released before the axis is deployed. Moving backwards (axial rearward movement, ie towards the proximal direction of the delivery system 200).
  • the plurality of second limiting members 2735 are equally spaced on the outer surface of the carrier body 2731 along the circumferential direction of the carrier body 2731, and each of the two adjacent second limiting members 2735 has a first limiting member 2733 therebetween. .
  • the distal end of each of the second limiting members 2735 is disposed corresponding to the proximal end of a partitioning member 2713 of the insertion portion 271, and the distal end surface of the second limiting member 2735 is coplanar with the proximal end surface of the partitioning member 2713.
  • each positioning groove 2711 in the circumferential direction of the insertion portion 271 is greater than the width of the first limiting member 2733 corresponding to the corresponding positioning groove 2711 in the circumferential direction of the abutting portion 273, and is smaller than the first limiting member 2733
  • the positioning groove 2711 and the first limiting member 2733 corresponding thereto and the two second limiting members 2735 adjacent to the left and right of the corresponding first limiting member 2733 together form a substantially U-shaped groove.
  • the transparent cap 260 is transparently processed
  • the bare stent 120 of the lumen stent 100 is assembled into the anchor 270, and the connecting portion 121 is received in the insertion portion 271.
  • the positioning groove 2711 is inserted into the fixing cap 260 together with the insertion portion 271, and the adjacent two partition members 2713 separate the adjacent connecting portions 121 from each other to prevent the adjacent connecting portions 121 from interfering with each other; and the connecting portion 121
  • the peak portion of the connected first wave structure 123 is stuck in the first limiting member 2733, and the adjacent two second limiting members 2735 separate the adjacent two peak portions of the first wave structure 123 to prevent phase
  • the two peak portions of the adjacent ones interfere with each other; at the same time, the first limiting member 2733 between the adjacent two second limiting members 2735 separates the two sides of one peak portion to prevent the two sides of the same peak portion from interfering with each other. .
  • the entire lumen stent 100 is radially compressed and placed into the annular cavity formed by the outer core tube 220 of the delivery system 200 and the sheath tube 230, as shown in FIG. 7 (to clearly illustrate the internal structure, in the figure
  • the sheath tube 230 is treated transparently).
  • the distal end of the sheath tube 230 is close to or even in contact with the proximal end of the tip 240; the fixed cap 260, the inner core tube 210, the fixed anchor 270, the outer core tube 220, and the push tube 250 are all located in the sheath tube 230. .
  • the insertion portion 271 of the fixing anchor 270 is inserted into the fixing cap 260 together with the connecting portion 121 received in the positioning groove 2711, and the first limiting member 2733 of the fixing anchor 270 is embedded in the peak portion of the first wave structure 122.
  • the second limiting member 2735 separates two adjacent peak portions.
  • the stent graft 110 of the lumen stent 100 is located outside of the outer core tube. Using a radial artery incision puncture, a guidewire (not shown) is introduced and the distal end of the guidewire is delivered to the lesion site to establish a delivery track. The delivery system 200 along with the lumen support 100 located therein is pushed along the guidewire to the lesion site.
  • the fixation cap 260 remains relatively stationary so that the lumen stent 100, in conjunction with the two, ensures axial and radial restraint so that the lumen stent 100 does not displace relative to the delivery system 200 until it reaches a predetermined location of the lesion.
  • the sheath 230 When the lumen stent 100 reaches the lesion site, the sheath 230 is pulled proximally, the sheath 230 is withdrawn and slowly moved away from the tip 240. Due to the action of the fixation cap 260 and the anchor 270, the bare stent 120 of the lumen stent 100 Still in a closed state, not released. When the sheath tube 230 is retracted and the outer core tube 220 is slowly exposed, the stent graft 110 of the lumen stent 100 is released step by step due to the disappearance of the binding force of the sheath tube 230.
  • the catheter stent 100 tends to have an axial backward movement during the retraction of the sheath tube 230.
  • the fixation anchor 270 of the delivery system 200 restricts the lumen support 100 from moving back, the fixation cap 260, the fixation anchor 270, and the lumen support 100 remain relatively stationary, even if the stent graft 110 of the lumen stent 100 is released.
  • the bare stent 120 of the lumen stent 100 is also always in a collapsed state without being opened in advance, thereby avoiding the risk of displacement of the lumen stent 100 due to early opening.
  • the inner core tube 210 is pushed distally, and the inner core tube 210 drives the tip 240 and the fixed cap 260 to move axially forward, thereby causing the head of the barb 122 of the lumen stent 100.
  • Slowly pull out of the fixed cap 260 Due to the friction between the fixed cap 260 and the barbs 122 of the lumen stent 100, the lumen stent 100 produces a tendency to move axially forward with the tip 240 under the frictional force.
  • the closed side of the positioning groove 2711 of the insertion portion 271 of the anchor 270 abuts the end of the side spur support structure 121 away from the stent graft 110, the axial advancement of the lumen stent 100 can be restricted, thereby avoiding the lumen stent 100. The risk of shifting as the tip 240 moves occurs.
  • the inner core tube 210 is pulled to drive the end 240 and the fixed cap 260 to move axially backward, so that the fixing cap 260 and the fixing anchor 270 are closed, that is, the insertion portion 271 of the fixing anchor 270 is inserted into the fixing cap 260.
  • the entire delivery system 200 and guidewire are continued to be pulled back until the delivery system 200 and the guidewire are withdrawn from the body.
  • the side surface of the fixing cap 260 smoothly transitions with the outer surfaces of the first limiting member 2733 and the second limiting member 2735, and the proximal end of the abutting portion 273 of the fixing anchor 270 is a smooth tapered contour.
  • the possibility of scratching of the outer surface of the anchoring anchor 270 and the fixed cap 260 and the lumen stent 100 during the withdrawal of the entire delivery system 200 can be reduced.
  • the side of the fixing cap 260 is together with the plurality of partitioning members 2713, the plurality of first limiting members 2733 and the carrier body 2731 at the proximal end of the fixing cap 260.
  • a plurality of small holes 280 are formed in the plane on which the end faces are located, and each of the small holes 280 is formed by a partition member 2713 and a first stopper 2733 adjacent thereto, a side surface of the fixing cap 260, and a carrier 2731.
  • the first limiting member 2733, the carrier 2731 and the spacer 2713 divide the proximal end surface of the fixing cap 260 into a plurality of small holes 280, thereby avoiding the hooking of the lumen stent 100 that has been released when the delivery system 200 is withdrawn.
  • the first limiting member 2733 also has a certain width in the circumferential direction along the resisting portion 273, so each small hole 280 is along The width in the circumferential direction of the abutting portion 273 is smaller than half the width of the positioning groove 2711 in the circumferential direction of the insertion portion 271.
  • the width of each of the small holes 280 in the circumferential direction of the abutting portion 273 is smaller than the width of the end portion of the connecting portion 121 in the circumferential direction of the lumen stent 100, and is much smaller than the first wave structure 123 in the bare stent 120 of the lumen stent 100.
  • the barbs 122 may not be disposed on the connecting portion 121 of the lumen bracket 100.
  • the connecting portion 121 can also have other structures. Referring to FIG. 13, the connecting portion is different from the above embodiment in that the first wave structure 123a is disconnected at the peak portion, and the connecting portion 121a is a U that is open at one side. In the open-loop type structure, both ends of the opening side of the connecting portion 121a are respectively connected to both ends of the disconnection of the first wave structure 123a, so that the peak portion of the first wave structure 123a communicates with the connecting portion 121a. Barbs may also be provided on the connecting portion 121a.
  • the structure of the anchor anchor can also be changed according to actual needs according to the structural change of the connecting portion.
  • the structure of the connecting portion is as shown by the connecting portion 121a in FIG. 13, the structure of the anchoring anchor is substantially the same as that of the anchoring anchor 270, except that the structure of the inserting portion 271a is inserted in the above embodiment.
  • the structure of the portion 271 is slightly different.
  • the positioning groove 2711a of the insertion portion 271a is further provided with an axial rearward retaining member 2715a, and each of the axial rearward retaining member 2715a and the positioning groove 2711a is perpendicular to the circumferential side of the insertion portion 271.
  • the axial rearward retaining member 2715a extends along and is connected to the first limiting member 2733a of the abutting portion along the longitudinal centerline of the fixed anchor.
  • the connecting portion 121a cannot be held by the first limiting member 2733a to prevent the axial back movement of the lumen bracket, and the axial direction can be set in the positioning groove 2711a.
  • the position limiting member 2715a is moved backward to hold the connecting portion 121a on the axial rearward retaining member 2715a, thereby achieving the purpose of preventing the axial back movement of the lumen bracket.
  • the axial rearward retaining member may also not be connected to the first limiting member of the abutting portion.
  • the axial rearward retaining member 2715b is a square protruding from the bottom of the positioning groove 2711a.
  • Each of the axial rearward retaining member 2715b and the positioning groove 2711a is perpendicular to the circumferential side of the insertion portion 271.
  • the connecting portion 121b can still be accommodated in the positioning groove 2711b and held in the axial rearward retaining member 2715b to prevent the lumen bracket from moving back axially.
  • the axial rearward retaining member can also be other shapes, and is not limited to the above listed shapes. Only the axial rearward movement limiting member can be matched with the connecting portion to achieve the purpose of preventing the axial back movement of the lumen bracket.

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Abstract

一种输送系统（200），用于输送管腔支架（100），输送系统（200）包括固定锚（270）和呈筒状且近端开口的固定帽（260），固定锚（270）包括中空的插入部（271）和与插入部（271）连接的抵持部（273），插入部（271）的部分侧面向插入部（271）内部凹陷形成多个贯穿插入部（271）的近端端面的定位槽（2711），每相邻两个所述定位槽（2711）之间形成一个分隔件（2713），抵持部（273）包括承载体（2731）及多个设于承载体（2731）侧面的第一限位件（2733），每个第一限位件（2733）的远端对应一个定位槽（2711）的靠近该抵持部（273）的开口侧设置，多个第一限位件（2733）的远端端面、承载体（2731）的远端端面及分隔件（2713）的近端端面共面；当固定锚（270）与固定帽（260）合拢时，插入部（271）插入固定帽（260）中，第一限位件（2733）的远端端面抵持固定帽（260）的近端端面。还涉及一种管腔支架系统。在撤出输送系统（200）时，输送系统（200）能够顺利、安全地撤出体外。

Description

输送系统及管腔支架系统
【技术领域】
本发明涉及医疗器械技术领域，尤其涉及一种输送系统及管腔支架系统。
【背景技术】
人体的主动脉分为升主动脉、主动脉弓、胸降主动脉和腹主动脉。由于各种病理改变，如炎症、溃疡等会造成主动脉血管内膜或血管壁的损伤，在血流冲击力的共同作用下，容易发生动脉瘤等疾病。动脉瘤一旦破裂，大量血液将会流出血管，病人血液循环的血量不足，造成人体休克或死亡。
对于动脉瘤疾病的治疗方法，常见的分为手术治疗和药物治疗。目前治疗方式以手术治疗为主。传统手术治疗（即开刀手术）为在建立体外血液循环后，将动脉瘤病变血管进行切除，再利用人造血管连接血管，实现动脉血液的正常循环的治疗方式。由于采用传统手术治疗动脉瘤疾病的方式手术风险高、对人创伤较大，故，对老年、体弱人群，将会造成很大身体创伤，且术后需要较长的时间恢复。
90年代以来，利用介入治疗方式治疗主动脉心血管疾病成为一种新的治疗方法。随着介入技术的不断发展，采用管腔支架治疗主动脉瘤和动脉夹层疾病的优势日显突出。主动脉管腔支架是指与管腔大小相适应的人工管腔，使用过程如下：先将管腔支架压缩进输送系统的鞘管内；其次，在股动脉或髂动脉位置穿刺血管，利用导丝建立轨道；接着，将装载有管腔支架的输送系统经髂动脉—腹主动脉—胸主动脉—主动脉弓—升主动脉输送到病变指定位置；然后，释放管腔支架，使其展开紧贴动脉瘤管壁，管腔支架的覆膜将血流和病变部位隔绝，从而消除血流对病变部位动脉瘤壁的冲击，建立血液正常循环的通道；最后，撤出导丝和输送系统，完成对动脉瘤和动脉夹层的介入治疗。
由于主动脉血管内血液血流压力大、冲击力强，在管腔支架释放过程中，血液冲击管腔支架，存在管腔支架移位的风险，故，近年来，出现一种带连接部的管腔支架，在该管腔支架释放过程中，连接部在输送系统中始终固定，所以管腔支架释放过程中不会产生移位，直至连接部从输送系统中脱离，管腔支架释放完成。
然而目前带连接部的管腔支架在释放完成后，撤出输送系统时，输送系统易勾挂已经释放的管腔支架，尤其是管腔支架的连接部，导致管腔支架移位，甚至导致介入手术失败，增加病患的手术风险。
【发明内容】
基于此，有必要提供一种当带连接部的管腔支架释放完成后，可以安全、顺利地撤出输送系统的管腔支架系统。
本发明提供一种输送系统，用于输送管腔支架，所述输送系统包括固定锚和呈筒状且近端开口的固定帽，所述固定锚包括中空的插入部和与所述插入部连接的抵持部，所述插入部的部分侧面向所述插入部内部凹陷形成多个贯穿所述插入部的近端端面的定位槽，每相邻两个所述定位槽之间形成一个分隔件，所述抵持部包括中空的承载体及多个设于所述承载体侧面的第一限位件，每个所述第一限位件的远端对应一个所述定位槽的靠近所述抵持部的开口侧设置，所述多个第一限位件的远端端面、所述承载体的远端端面及所述分隔件的近端端面共面；当所述固定锚与固定帽合拢时，所述插入部插入所述固定帽中，所述第一限位件的远端端面抵持所述固定帽的近端端面。
在其中一个实施例中，所述抵持部还包括多个第二限位件，所述多个第二限位件的数量与所述多个第一限位件的数量相等，所述多个第二限位件和所述多个第一限位件交替排布于所述承载体的侧面上，每个所述第二限位件对应一个所述分隔件设置，且每个所述第二限位件的远端端面与相应的所述分隔件的近端端面抵接。
在其中一个实施例中，所述分隔件沿所述插入部周向上的宽度大于与所述分隔件相对应的所述第二限位件沿所述抵持部周向上的宽度。
在其中一个实施例中，每个所述第一限位件和每个所述第二限位件的远离所述承载体的表面的远端在垂直于所述固定锚的纵向中心线的截面形状均为圆弧段，所述圆弧段的直径均等于所述固定帽的近端外径。
在其中一个实施例中，所述第一限位件和所述第二限位件的长度方向均平行于所述固定锚的纵向中心线，且所述第一限位件和所述第二限位件的近端均向所述承载体的近端延伸，所述第一限位件和所述第二限位件的长度均小于所述承载体的轴向长度，每个所述第一限位件和所述第二限位件的近端外表面与所述承载体的近端外表面呈锥形平滑过渡。
在其中一个实施例中，所述定位槽的沿所述插入部的纵向中心线的方向且远离所述抵持部的一侧为封闭侧。
在其中一个实施例中，所述输送系统还包括内芯管、设于内芯管远端的端头、套在所述内芯管外且可相对所述内芯管轴向移动的外芯管，所述固定帽设置在所述端头的近端且环绕所述内芯管，所述固定锚设置在所述外芯管远端且环绕所述外芯管；所述固定帽较所述固定锚靠近所述端头。
在其中一个实施例中，所述承载体的近端延伸至所述外芯管，且所述承载体的近端外表面与所述外芯管的外表面呈锥形过渡。
本发明还提供一种管腔支架系统，包括管腔支架和如上述任一项中所述的输送系统，所述管腔支架包括裸支架，所述裸支架包括波形环状物以及多个与所述波形环状物相连的连接部，当所述固定锚与固定帽合拢时，所述支架的连接部收容于所述定位槽中，所述每个分隔件、与相应的分隔件相邻的一个所述第一限位件、所述固定帽以及所述承载体在所述固定帽的近端端面所处的平面上形成一个小孔，所述小孔沿所述固定锚周向上的宽度小于所述连接部的端部沿所述管腔支架周向上的宽度。
在其中一个实施例中，当所述固定锚与固定帽合拢时，所述多个第一限位件均与所述波形环状物的波峰部卡持。
在其中一个实施例中，所述连接部为一侧开口的U型开环结构，所述波形环状物在波峰部断开，所述连接部的开口侧的两端分别与所述波形环状物的断开处的两端连接；所述插入部的所述定位槽中还设有轴向后移限位件，所述轴向后移限位件与所述定位槽的每个垂直于所述插入部周向的侧边之间均存在间隔且凸出于所述定位槽的平行于所述插入部周向的槽底；所述连接部收容于所述定位槽中，且所述连接部与所述轴向后移限位件卡持。
在其中一个实施例中，所述轴向后移限位件沿所述固定锚的纵向中心线向所述第一限位件延伸且与所述第一限位件连接。
在其中一个实施例中，所述连接部上设置有倒刺。
本发明的输送系统中，第一限位件的远端端面、承载体的远端端面及分隔件的近端端面共面，因此，当固定锚与固定帽合拢时，在固定帽与固定锚抵持的端面上第一限位件、承载体和分隔件将固定帽的该端面分成多个小孔，从而避免输送系统撤出时勾挂已经释放的管腔支架。
【附图说明】
图1为本发明一实施例的管腔支架系统的管腔支架的结构示意图。
图2为图1中的A处的局部放大示意图。
图3为本发明一实施例的管腔支架系统的输送系统的结构示意图。
图4为图3中的固定锚和外芯管的结构示意图。
图5为图4中的固定锚和外芯管沿B-B方向的剖面示意图。
图6为本发明一实施例的固定帽、固定锚与连接部的配合示意图。
图7为本发明一实施例的管腔支架系统的一状态示意图，此时管腔支架收容在输送系统内。
图8为本发明一实施例的管腔支架系统的一状态示意图，此时管腔支架处于半释放状态。
图9为本发明一实施例的管腔支架系统的一状态示意图，此时管腔支架处于全释放状态。
图10为本发明一实施例的管腔支架系统的一状态示意图，此时输送系统处于后撤状态。
图11为图10中固定帽与固定锚的配合示意图。
图12为图11中固定帽与固定锚的配合示意图的左示图。
图13为本发明另一实施例的管腔支架系统的管腔支架的连接部的结构示意图。
图14为图13中的连接部与本发明另一实施例的固定锚、固定帽的配合示意图。
图15为图13中的连接部与本发明另一实施例的固定锚、固定帽的配合示意图。
【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。
除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本发明。本文所使用的术语“及／或”包括一个或多个相关的所列项目的任意的和所有的组合。
本发明的管腔支架系统包括管腔支架和用于输送所述管腔支架的输送系统。所述输送系统可以将所述管腔支架植入管腔，以形成新的体液通道，如植入血管后该管腔支架则可成为新的血流通道。
请参阅图1和图2，本发明一实施例的管腔支架100，包括管状的覆膜支架110和裸支架120，管腔支架100具有自膨胀特性。
覆膜支架110包括由至少一根编织丝构成的多个波形环状物111，以及覆盖在多个波形环状物111上的用于固定该多个波形环状物的覆膜112。覆膜112的材料可以采用涤纶或e-PTFE材料。所述编织丝可以为不锈钢丝或镍钛丝，亦可以是其他生物材料编织丝。每个波形环状物111可包括多个呈V型、Z型或其他形状的波形单元。
裸支架120包括多个片状的连接部121。一个连接部121上可以设置至少一个倒刺122。倒刺122的一端设于连接部121远离覆膜支架110的端部，倒刺122的另一端为悬空端，且倒刺122的悬空端朝向靠近覆膜支架110的方向延伸并悬空。倒刺122与与其所在的连接部121组成大致V形。管腔支架100完全释放后，其倒刺122可刺入血管壁，以使管腔支架100在释放完成后产生抗移位能力。
除了连接部121外，裸支架120一般还可以包括连接连接部121和覆膜支架110的裸支架段。所述裸支架段包括一圈或多圈相互连接的波形结构。根据实际情况，裸支架120可以设计成长短两种形式。一般来讲，短裸支架包括位于连接部121和覆膜支架110之间的一圈或两圈的波形结构，而长裸支架包括位于连接部121和覆膜支架110之间至少两圈以上的波形结构。本实施例中，裸支架120为长裸支架，其包括与连接部121相连的第一波形结构123及多圈位于第一波形结构123与覆膜支架110之间的第二波形结构124。第一波形结构123的每个波峰部与一个连接部121相连，第一波形结构123的波密度小于第二波形结构124的波密度，且波高大于第二波形结构124的波高。
可以理解的是，其他实施例中，连接连接部121和覆膜支架110的波形结构的圈数也可以为一圈或者两圈。还可以理解的是，相邻两圈波形结构中，一个波形结构的波峰与波谷之间的垂直距离即波高可以大于或者等于另一个波形结构的波高。
裸支架120可以由激光切割而成，当然，也可以跟覆膜支架110一样编织而成。
请参阅图3，本发明一实施例的输送系统200包括内芯管210、套在内芯管210外且可相对内芯管210轴向移动的外芯管220、套在外芯管220外且用于收容管腔支架100的鞘管230。
在介入医学领域中，通常把输送系统200靠近操作者的一端称为近端，而其远离操作者的一端称为远端。
在输送系统200的鞘管230的远端和外芯管220之间形成一个环形腔体。输送过程中，径向压缩后的管腔支架100收容于该环形腔体内。
在本实施例中，输送系统200还包括中空的端头240，端头240位于内芯管210的远端。端头240的近端与内芯管210的远端固定为一体，且端头240的内腔与内芯管210的管腔相连通，以作为导丝通道。更具体地，端头240的近端与内芯管210的远端熔固为一体。
在本实施例中，输送系统200还包括位于外芯管220和鞘管230之间的推管250。推管250与外芯管220共轴，且固定为一体。
输送系统200还包括设置在端头240的近端且环绕内芯管210的固定帽260。固定帽260为两端开口的圆筒结构，其侧表面为圆柱面，固定帽260的一端与端头240的近端固定连接且两者光滑过渡，这样可以避免固定帽260与别的部件之间的刮擦；其另一端为开口端，用于在管腔支架100装入输送系统200时，收容管腔支架100的连接部121和倒刺122。
结合图1-3参见图4-5，输送系统200还包括中空的固定锚270。固定锚270设置在外芯管220远端外侧且环绕外芯管220，固定锚270的近端与外芯管220的远端固定为一体，且固定锚270的内腔与外芯管220的管腔相连通，以使固定锚270和外芯管220一起套在内芯管210外且可相对内芯管210轴向移动。固定锚270用于轴向固定管腔支架100，且与固定帽260配合，用于径向约束倒刺122。
在本实施例中，固定锚270包括位于远端的中空的插入部271以及位于近端且与插入部271连接的抵持部273。
插入部271大致呈中空圆柱形结构，其外径略小于固定帽260的内径，即插入部271可以与固定帽260间隙配合，以使插入部271可以顺利地插入固定帽260中。插入部271插入固定帽260中，且与固定帽260配合，对管腔支架100的连接部121和倒刺122进行径向约束。
插入部271的部分侧面向插入部271内部凹陷形成多个贯穿插入部271的近端端面的定位槽2711。定位槽2711用于容纳管腔支架100的连接部121，每相邻两个定位槽2711之间形成一个分隔件2713。定位槽2711的沿插入部271的纵向中心线的方向且靠近抵持部273的一侧为开口侧，定位槽2711的沿插入部271的纵向中心线的方向且远离抵持部273的一侧为封闭侧。定位槽2711的形状尺寸略大于连接部121的形状尺寸，以便于连接部121从定位槽2711的开口侧插入且整体容纳于定位槽2711中。
本实施例中，多个定位槽2711在插入部271的侧表面上均匀排布。定位槽2711的形状与连接部121的形状大致相同。可以理解，定位槽2711的形状也可以与连接部121的形状不相同，只需定位槽2711沿插入部271的纵向中心线方向延伸的长度比连接部121的长度稍大，以确保连接部121能够完全容纳于定位槽2711中即可。
当管腔支架100的连接部121容纳于定位槽2711，且固定锚270的插入部271插入固定帽260时，定位槽2711和固定帽260共同对连接部121和倒刺122起到径向约束的作用，从而使倒刺122的悬空端保持在收拢状态。同时，定位槽2711的封闭侧可以抵持连接部121的远离覆膜支架110的端部，从而防止管腔支架100轴向前移（轴向前移即朝向输送系统200远端方向的移动）；同时相邻的两个分隔件2713将相邻的连接部121隔开，防止相邻的连接部121相互干扰。
抵持部273包括中空的承载体2731、设于承载体2731侧表面上的多个长条形的第一限位件2733及多个第二限位件2735。
承载体2731与插入部271相连接，且承载体2731的管腔与外芯管220的管腔相连通。本实施例中，抵持部273和插入部271一体成型。可以理解，抵持部273还可以与插入部271通过焊接、粘接等方式连接。
多个第一限位件2733的数量与多个第二限位件2735的数量相等，且多个第一限位件2733和多个第二限位件2735交替排布于承载体2731的侧面上,即每相邻两个第一限位件2733之间均有一个第二限位件2735。
第一限位件2733的结构与第二限位件2735的结构大致相同，两者交替设于承载体2731的远端侧面上，且两者的远端端面均与承载体2731的远端端面、分隔件2713的近端端面共面。
第一限位件2733和第二限位件2735中的每个限位件的远离承载体2731的表面的远端在垂直于外芯管220的纵向中心线的截面上的截面形状均为圆弧段，第一限位件2733的圆弧段的直径即为第一限位件2733的远端外径，第二限位件2735的圆弧段的直径即为第二限位件2735的远端外径，该两者的远端外径均等于固定帽260的近端外径。从而当插入部271插入固定帽260时，第一限位件2733和第二限位件2735的远端端面均可抵持固定帽260的近端端面，所以管腔支架100在固定帽260和固定锚270的共同作用下可以保证其轴向和径向约束；且第一限位件2733和第二限位件2735中的每个限位件的远离所述承载体2731的表面在包括外芯管220的纵向中心线的截面上的截面形状均为曲线，如此，固定帽260与第一限位件2733和第二限位件2735平滑过渡，避免了固定帽260和固定锚270在撤出体外的过程中剐蹭管腔支架100。
第一限位件2733和第二限位件2735的长度方向均平行于外芯管220的纵向中心线，且第一限位件2733和第二限位件2735中每个限位件的近端均向承载体2731的近端延伸。第一限位件2733和第二限位件2735的长度均小于承载体2731的轴向长度。第一限位件2733和第二限位件2735中的每个限位件的远端的远离承载体2731的表面至外芯管220的纵向中心线的距离均大于或等于相应的限位件的近端的远离承载体2731的表面至外芯管220的纵向中心线的距离，第一限位件2733和第二限位件2735中每个限位件的近端均延伸至承载体2731的近端，承载体2731的近端延伸至外芯管220，且第一限位件2733和第二限位件2735的近端、承载体2731的近端以及外芯管220三者的外表面呈现锥形平滑过渡，从而使抵持部273的近端具有大致光滑的锥形轮廓，避免了固定锚270在撤出体外的过程中抵持部273剐蹭管腔支架100，提高了手术的安全性。
多个第一限位件2733沿承载体2731的周向等间隔分布在承载体2731的外表面上，且每一个第一限位件2733的远端对应插入部271的一个定位槽2711的开口侧设置，即多个第一限位件2733的数量与多个定位槽2711的数量相等，均为管腔支架100的连接部121的数量。
从而当连接部121容纳于定位槽2711时，第一限位件2733可卡在管腔支架100的第一波形结构123的一个波峰部中，以防止管腔支架100在其完全释放展开之前轴向后移（轴向后移即朝向输送系统200近端方向的移动）。
多个第二限位件2735沿承载体2731的周向等间隔分布在承载体2731的外表面上，且每相邻两个第二限位件2735之间均有一个第一限位件2733。每一个第二限位件2735的远端均对应插入部271的一个分隔件2713的近端设置，且第二限位件2735的远端端面与分隔件2713的近端端面共面。
每个定位槽2711沿插入部271周向上的宽度大于与相应的定位槽2711相对应的第一限位件2733沿抵持部273周向上的宽度，且小于与该第一限位件2733左右相邻的两个第二限位件2735之间沿抵持部273周向上的距离。即分隔件2713沿插入部271周向上的宽度大于与相应的分隔件2713相对应的第二限位件2735沿抵持部273周向上的宽度。定位槽2711与与其相对应的第一限位件2733、与相应的第一限位件2733左右相邻的两个第二限位件2735共同组成一个大致为U形的槽。
请同时参阅图6（为清楚地示意内部结构，图中对固定帽260作透明处理），将管腔支架100的裸支架120组装入固定锚270的过程中，连接部121容纳于插入部271的定位槽2711中，且与插入部271一起插入固定帽260，相邻的两个分隔件2713将相邻的连接部121相互隔开，防止相邻的连接部121相互干扰；与连接部121连接的第一波形结构123的波峰部卡在第一限位件2733，相邻的两个第二限位件2735将该第一波形结构123的相邻的两个波峰部隔开，防止相邻的两个波峰部相互干扰；同时相邻的两个第二限位件2735之间的第一限位件2733将一个波峰部的两侧隔开，防止同一个波峰部的两侧相互干扰。
以下结合附图对本发明的管腔支架系统的工作过程作进一步的阐述。
首先，将整个管腔支架100径向压缩后置入输送系统200的外芯管220和鞘管230所形成的环形腔体中，如图7所示（为清楚地示意内部结构，图中对鞘管230作透明处理）。此时鞘管230的远端与端头240的近端相靠近，甚至相接触；固定帽260、内芯管210、固定锚270、外芯管220以及推管250均为位于鞘管230内。固定锚270的插入部271带着容纳于定位槽2711中的连接部121和倒刺122一起插入固定帽260中，固定锚270的第一限位件2733嵌在第一波形结构122的波峰部中，第二限位件2735将相邻两个波峰部隔开。管腔支架100的覆膜支架110位于外芯管的外侧。利用髂动脉切口穿刺，导入导丝（未示出）并将导丝的远端输送到病变位置，建立输送轨道。沿导丝将输送系统200以及位于其内的管腔支架100一起推送到病变位置。
在管腔支架100输送和定位过程中，由于固定锚270的第一限位件1733和第二限位件2735的远端端面和固定帽260的近端端面对齐且抵持，固定锚270和固定帽260保持相对静止，故管腔支架100在两者共同作用下可以保证其轴向和径向的约束，从而使管腔支架100在到达病变预定位置之前相对输送系统200不发生位移。
当管腔支架100到达病变位置时，向近端拉动鞘管230，鞘管230后撤并慢慢远离端头240，由于固定帽260和固定锚270的作用，管腔支架100的裸支架120还是处于收拢状态，并不释放。当鞘管230后撤慢慢露出外芯管220时，管腔支架100的覆膜支架110由于鞘管230的约束力消失而一步步释放。同时该过程中由于鞘管230和管腔支架100存在一定的摩擦力，因而鞘管230后撤过程中会使管腔支架100有轴向后移的倾向。但是由于输送系统200的固定锚270限制管腔支架100后移，从而使固定帽260、固定锚270和管腔支架100三者保持相对静止，即使在管腔支架100的覆膜支架110释放的过程中，管腔支架100的裸支架120也始终处于收拢状态，而不会提前打开，从而避免管腔支架100因提前打开而造成移位的风险。当管腔支架100的覆膜支架110完全释放时，如图8所示。
为了进一步使管腔支架100完全释放，推动内芯管210朝远端移动，内芯管210带动端头240以及固定帽260轴向前移，从而使管腔支架100的倒刺122的头部慢慢从固定帽260中脱出。由于固定帽260与管腔支架100的倒刺122之间存在一定的摩擦力，使得管腔支架100在该摩擦力的作用下产生随端头240轴向前移的倾向。但是由于固定锚270的插入部271的定位槽2711的封闭侧抵持侧刺支撑结构121的远离覆膜支架110的端部，可以限制管腔支架100轴向前移，进而避免管腔支架100随着端头240的移动而产生移位的风险发生。
当管腔支架100的连接部121从固定帽260中完全脱出时，管腔支架100的连接部121的径向约束力消失，管腔支架100在自身径向膨胀力作用下，连接部121也从固定锚270的定位槽2711中脱离，此时管腔支架100与输送系统200完全分离并展开贴附到管腔壁上。至此，整个管腔支架100完成释放，释放完成后如图9所示。
最后，如图10所示，拉动内芯管210带动端头240和固定帽260轴向后移，使固定帽260与固定锚270合拢，即固定锚270的插入部271插入固定帽260中，继续向后拉动整个输送系统200和导丝，直到输送系统200和导丝撤出体外。
请同时参阅图11，由于固定帽260的侧面与第一限位件2733和第二限位件2735的外表面平滑过渡，且固定锚270的抵持部273的近端为光滑的锥形轮廓，因此，在整个输送系统200撤回过程中能减少固定锚270和固定帽260的外表面与管腔支架100产生刮擦的可能。
请参阅图12，在撤回过程中固定帽260与固定锚270合拢后，固定帽260的侧面与多个分隔件2713、多个第一限位件2733和承载体2731一起在固定帽260近端端面所处的平面上形成多个小孔280，每个小孔280均由一个分隔件2713和与其相邻的一个第一限位件2733、固定帽260的侧面以及承载体2731共同形成。因为第一限位件2733、承载体2731和分隔件2713将固定帽260的近端端面分成多个小孔280，从而避免了输送系统200撤出时勾挂已经释放的管腔支架100。进一步地，由于每个定位槽2711的形状尺寸均略大于连接部121的形状尺寸，而第一限位件2733在沿抵持部273周向上也具有一定宽度，因此，每个小孔280沿抵持部273周向上的宽度小于定位槽2711沿插入部271周向上的宽度的一半。所以，每个小孔280沿抵持部273周向上的宽度小于连接部121的端部沿管腔支架100周向上的宽度，且远小于管腔支架100的裸支架120中第一波形结构123和第二波形结构124的波峰部沿管腔支架100周向上的宽度，以及覆膜支架110中波形环状物111的波峰部沿管腔支架100周向上的宽度，从而连接部121的端部和上述这些波峰部均不可能插进或卡进小孔280中，进一步使得整个输送系统200在管腔支架100释放完成后能够顺利、安全地撤出体外。
可以理解，管腔支架100的连接部121上也可以不设置倒刺122。还可以理解的是，连接部121还可以为其他结构，请参阅图13，连接部与上述实施例不同的是，第一波形结构123a在波峰部断开，连接部121a为一侧开口的U型开环结构，连接部121a的开口侧的两端分别与第一波形结构123a的断开处的两端连接，从而第一波形结构123a的波峰部与连接部121a连通。连接部121a上也可以设置倒刺。
可以理解，根据连接部的结构变化，固定锚的结构也可根据实际需要相应的变化。请参阅图14，当连接部的结构如图13中连接部121a所示时，固定锚的结构与固定锚270的结构大致相同，区别之处在于，插入部271a的结构与上述实施例中插入部271的结构略有不同。具体地，插入部271a的定位槽2711a中还设有轴向后移限位件2715a，轴向后移限位件2715a与定位槽2711a的每个垂直于插入部271周向的侧边之间均存在一定间隔且凸出于定位槽2711a平行于插入部271周向的槽底，轴向后移限位件2715a可随插入部271a一起插入固定帽中。本实施例中，轴向后移限位件2715a沿固定锚的纵向中心线向抵持部的第一限位件2733a延伸且与其连接。将管腔支架装载入输送系统中时，管腔支架的连接部121a容纳于定位槽2711a中，且连接部121a卡持于轴向后移限位件2715a上。
由此，即使连接部121a与第一波形结构123a连通相连，连接部121a无法卡持于第一限位件2733a以实现阻止管腔支架轴向后移，可以通过在定位槽2711a中设置轴向后移限位件2715a，使连接部121a卡持在轴向后移限位件2715a上，同样实现阻止管腔支架轴向后移的目的。
可以理解，轴向后移限位件也可以不与抵持部的第一限位件连接。请参阅图15，轴向后移限位件2715b为凸设于定位槽2711a槽底的方块，轴向后移限位件2715b与定位槽2711a的每个垂直于插入部271周向的侧边之间以及轴向后移限位件2715b与第一限位件2733b之间均存在一定距离。连接部121b依然可以容纳于定位槽2711b中，且卡持于轴向后移限位件2715b中，以防止管腔支架轴向后移。
可以理解，轴向后移限位件还可以为其他形状，不限于以上列举形状。只需要轴向后移限位件可以配合连接部，实现阻止管腔支架轴向后移的目的即可。
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 (13)

  1. 一种输送系统，用于输送管腔支架，所述输送系统包括固定锚和呈筒状且近端开口的固定帽，其特征在于，所述固定锚包括中空的插入部和与所述插入部连接的抵持部，所述插入部的部分侧面向所述插入部内部凹陷形成多个贯穿所述插入部的近端端面的定位槽，每相邻两个所述定位槽之间形成一个分隔件，所述抵持部包括中空的承载体及多个设于所述承载体侧面的第一限位件，每个所述第一限位件的远端对应一个所述定位槽的靠近所述抵持部的开口侧设置，所述多个第一限位件的远端端面、所述承载体的远端端面及所述分隔件的近端端面共面；当所述固定锚与固定帽合拢时，所述插入部插入所述固定帽中，所述第一限位件的远端端面抵持所述固定帽的近端端面。
  2. 根据权利要求1所述的输送系统，其特征在于，所述抵持部还包括多个第二限位件，所述多个第二限位件的数量与所述多个第一限位件的数量相等，所述多个第二限位件和所述多个第一限位件交替排布于所述承载体的侧面上，每个所述第二限位件对应一个所述分隔件设置，且每个所述第二限位件的远端端面与相应的所述分隔件的近端端面抵接。
  3. 根据权利要求2所述的输送系统，其特征在于，所述分隔件沿所述插入部周向上的宽度大于与所述分隔件相对应的所述第二限位件沿所述抵持部周向上的宽度。
  4. 根据权利要求1所述的输送系统，其特征在于，每个所述第一限位件和每个所述第二限位件的远离所述承载体的表面的远端在垂直于所述固定锚的纵向中心线的截面形状均为圆弧段，所述圆弧段的直径均等于所述固定帽的近端外径。
  5. 根据权利要求1所述的输送系统，其特征在于，所述第一限位件和所述第二限位件的长度方向均平行于所述固定锚的纵向中心线，且所述第一限位件和所述第二限位件的近端均向所述承载体的近端延伸，所述第一限位件和所述第二限位件的长度均小于所述承载体的轴向长度，每个所述第一限位件和所述第二限位件的近端外表面与所述承载体的近端外表面呈锥形平滑过渡。
  6. 根据权利要求1所述的输送系统，其特征在于，所述定位槽的沿所述插入部的纵向中心线的方向且远离所述抵持部的一侧为封闭侧。
  7. 根据权利要求1所述的输送系统，其特征在于，所述输送系统还包括内芯管、设于内芯管远端的端头、套在所述内芯管外且可相对所述内芯管轴向移动的外芯管，所述固定帽设置在所述端头的近端且环绕所述内芯管，所述固定锚设置在所述外芯管远端且环绕所述外芯管；所述固定帽较所述固定锚靠近所述端头。
  8. 根据权利要求1所述的输送系统，其特征在于，所述承载体的近端延伸至所述外芯管，且所述承载体的近端外表面与所述外芯管的外表面呈锥形过渡。
  9. 一种管腔支架系统，包括管腔支架和如权利要求1-8任一项中所述的输送系统，所述管腔支架包括裸支架，所述裸支架包括波形环状物以及多个与所述波形环状物相连的连接部，其特征在于，当所述固定锚与固定帽合拢时，所述支架的连接部收容于所述定位槽中，所述每个分隔件、与相应的分隔件相邻的一个所述第一限位件、所述固定帽以及所述承载体在所述固定帽的近端端面所处的平面上形成一个小孔，所述小孔沿所述固定锚周向上的宽度小于所述连接部的端部沿所述管腔支架周向上的宽度。
  10. 根据权利要求9所述的管腔支架系统，其特征在于，当所述固定锚与固定帽合拢时，所述多个第一限位件均与所述波形环状物的波峰部卡持。
  11. 根据权利要求9所述的管腔支架系统，其特征在于，所述连接部为一侧开口的U型开环结构，所述波形环状物在波峰部断开，所述连接部的开口侧的两端分别与所述波形环状物的断开处的两端连接；所述插入部的所述定位槽中还设有轴向后移限位件，所述轴向后移限位件与所述定位槽的每个垂直于所述插入部周向的侧边之间均存在间隔且凸出于所述定位槽的平行于所述插入部周向的槽底；所述连接部收容于所述定位槽中，且所述连接部与所述轴向后移限位件卡持。
  12. 根据权利要求11所述的管腔支架系统，其特征在于，所述轴向后移限位件沿所述固定锚的纵向中心线向所述第一限位件延伸且与所述第一限位件连接。
  13. 根据权利要求9所述的管腔支架系统，其特征在于，所述连接部上设置有倒刺。
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