WO2022001151A1 - 支架系统 - Google Patents

支架系统 Download PDF

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Publication number
WO2022001151A1
WO2022001151A1 PCT/CN2021/078994 CN2021078994W WO2022001151A1 WO 2022001151 A1 WO2022001151 A1 WO 2022001151A1 CN 2021078994 W CN2021078994 W CN 2021078994W WO 2022001151 A1 WO2022001151 A1 WO 2022001151A1
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WO
WIPO (PCT)
Prior art keywords
stent
release control
graft
tube
coils
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Application number
PCT/CN2021/078994
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English (en)
French (fr)
Inventor
许慧珺
鹿洪杰
孔令娟
沙宇峰
刘梦钦
朱清
Original Assignee
上海微创心脉医疗科技(集团)股份有限公司
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Application filed by 上海微创心脉医疗科技(集团)股份有限公司 filed Critical 上海微创心脉医疗科技(集团)股份有限公司
Publication of WO2022001151A1 publication Critical patent/WO2022001151A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or 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
    • A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument

Definitions

  • the invention belongs to the technical field of medical devices, and particularly relates to a stent system.
  • stent-grafts A major advance in aortic surgery in recent years is the use of stent-grafts to treat aortic disease.
  • the mechanism of the stent-graft is to deliver the stent-graft into the lesion through a special delivery device, and then expand the stent-graft to achieve the purpose of isolating the tumor and blood.
  • the indications for the use of stent-grafts mainly include aortic dissection, true aortic aneurysm, aortic pseudoaneurysm, and aortic penetrating ulcers.
  • stent-graft can eliminate the risk of death caused by aneurysm rupture and hemorrhage or the compression of the aneurysm on surrounding tissues and organs, thereby greatly reducing the operative mortality and postoperative complications, reducing the surgical trauma, and facilitating the rapid recovery of patients.
  • stent grafts on the market include Valiant, Zenith, Relay, Gore, Hercules, Ankura, Aegis and the like. These stent-grafts are only suitable for the treatment of aortic aneurysms with a neck length of about 15 mm. For patients with thoracic aortic aneurysm or dissection involving the infrarenal abdominal aorta and the lateral iliac arteries and other complex dissection cases, only a single stent cannot completely isolate the aneurysm, and the therapeutic effect cannot be achieved. With the development of minimally invasive interventional technology, some stent grafts have appeared.
  • the stent-graft provided in the prior art, for example, including the short stent disclosed in the patent application CN110248620A, does not set the positioning of the stent-graft when it is released, which is prone to the problem of the stent-graft jumping forward or backward after the release, resulting in It is detached from the main stent and cannot isolate the tumor and blood.
  • the covered stent may cover the renal opening or other blood vessels, causing occlusion problems and serious consequences.
  • the purpose of the present invention is to provide a stent system, which can realize the precise release of the stent-graft in the body cavity, ensure the accuracy of the positioning of the stent-graft, and at the same time make the delivery operation simpler and more convenient.
  • the stent system includes a stent device and a delivery device
  • the stent device includes a stent-graft and a first release control mechanism
  • the first release control mechanism includes a plurality of confinement coils and a plurality of perforations
  • the plurality of confinement coils are axially spaced apart on the stent-graft
  • the plurality of perforations are arranged at the distal end of the stent-graft and are arranged at intervals along the circumference of the stent-graft;
  • the delivery device includes a handle assembly and a second release control mechanism;
  • the handle assembly includes an inner tube, an outer tube and a handle;
  • the inner tube is used for loading the stent device;
  • the outer tube is arranged outside the inner tube, and is used to cover the bracket device;
  • the second release control mechanism includes a release control member, and the first end of the release control member is used to pass through the plurality of through holes in sequence, and then further away from the far side of the bracket device. End to proximal end pass through a plurality of the restraining coils in sequence;
  • the second end of the release control member is connected with the handle, and the first end of the release control member is releasably arranged;
  • the first end of the release control member is sequentially drawn out from the plurality of restraint coils and the plurality of perforations to release the restraint of the release control member.
  • the first release control mechanism includes a plurality of confinement coil groups, and the plurality of confinement coil groups are axially spaced on the stent-graft; each confinement coil group includes two confinement coil groups.
  • the confinement coils are arranged in the circumferential direction of the membrane support, and two of the confinement coils are wound from a wire and are in an "8" shape.
  • a plurality of the confinement coil groups are arranged on the same side of the stent-graft, and the centers of the plurality of confinement coil groups are connected on a straight line and are parallel to the axis of the stent-graft.
  • the plurality of confinement coils are sewn on the corrugated rod of the stent-graft.
  • the first release control mechanism further includes a plurality of buffer coils, the plurality of buffer coils are sewn on the corrugated rod of the stent-graft and are arranged at intervals in the circumferential direction, and each of the buffer coils provides one of the perforations.
  • a plurality of the buffer coils are evenly arranged along the circumference of the stent-graft.
  • the covered stent includes a bare stent segment and a covered segment; the multiple restraint coils are all arranged on the covered segment.
  • the covered stent includes a bare stent segment and a covered segment; the length of the covered segment is 60mm-100mm.
  • the delivery device further includes a limiting mechanism disposed on the inner tube and located at the distal end of the stent device, and the limiting mechanism is used to limit the movement of the stent-graft to the distal end.
  • the limiting mechanism includes a jacking pipe and a reinforcing pipe; the distal end of the jacking pipe is connected with the proximal end of the reinforcing pipe, and the distal end of the reinforcing pipe is connected with the handle; the jacking pipe The proximal end is used to abut against the distal end of the stent device.
  • the distal end of the jacking pipe is thermally fused to the proximal end of the reinforcing pipe, or the distal end of the jacking pipe is threadedly connected to the proximal end of the reinforcing pipe.
  • the inner diameter of the top pipe is larger than the outer diameter of the reinforcing pipe, and the proximal end of the reinforcing pipe is inserted into the distal end of the top pipe to be connected.
  • the surface of the proximal end of the reinforcing tube is formed with lines.
  • the handle includes a pull ring connected to the second end of the release control member through a pull rod, the handle assembly further includes a conical head, and the first end of the release control member is connected to the second end of the release control member.
  • the tapered head can be disconnected;
  • the first end of the release control is separated from the tapered head and drawn out of the plurality of tethered coils and the plurality of perforations in turn.
  • the covered stent includes a bare stent segment and a covered segment; the stent device further includes a third release control mechanism for restraining the bare stent segment;
  • the third release control mechanism includes a restraining body and a plurality of through holes, the plurality of through holes are located in the bare section of the stent and are arranged at intervals along the circumference of the stent graft; the first end of the release control member is After passing through the plurality of restraining coils, it is releasably connected to one end of the restraining body, and the other end of the restraining body passes through the plurality of through holes in sequence and is fixedly connected to the inner tube.
  • the present invention has the following beneficial effects:
  • the stent graft will not move forward after the stent is released, the accuracy of releasing the stent graft by the delivery device is improved, and the stent graft will be released.
  • the positioning is accurate, so that the tumor body and blood flow can be effectively isolated, and the problem of normal organ openings or other blood vessels being blocked due to the displacement of the covered stent can be avoided, and the safety of the device is better.
  • the present invention removes the sleeve structure for restraining the stent, the structure is simpler, the release process is also simpler, the operation time can be effectively shortened, and the operation efficiency can be improved.
  • the stent system provided by the invention can prevent the problem of backward movement of the stent-graft after the release of the stent-graft through the limiting mechanism, and further improve the accuracy of releasing the stent-graft by the delivery device.
  • the limiting mechanism preferably resists the backward movement of the stent-graft through the jacking tube, and has a simple structure and convenient use.
  • the material of the top tube is a polymer material
  • the reinforcing tube connected to it is a metal material, so that the flexibility and pushability of the handle assembly can be ensured.
  • the connection process between the polymer jacking pipe and the metal reinforcing pipe needs to be carried out in an extremely limited space.
  • the jacking pipe and the reinforcing pipe are preferably connected by hot melt, which is stable and reliable. It can reduce the difficulty of connection.
  • FIG. 1 shows a schematic structural diagram of a conveying device in an embodiment of the present invention
  • FIG. 2 shows a schematic diagram of the delivery of the stent device in an embodiment of the present invention
  • FIG. 3 shows a schematic diagram of the relative positions of the stent device, the third release control mechanism and the inner tube in an embodiment of the present invention
  • FIG. 4 shows a schematic diagram of the connection structure of the outer tube and the rear handle in an embodiment of the present invention
  • Figure 5a shows a schematic structural diagram of a stent device in an embodiment of the present invention
  • Fig. 5b shows a schematic diagram of the connection between the release control member in the second release control mechanism and the plurality of restraint coils in the first release control mechanism according to an embodiment of the present invention, wherein each group of restraint coils includes two restraint coils;
  • Fig. 5c shows a schematic diagram of the connection between the release control member in the second release control mechanism and the multiple restraint coils in the first release control mechanism according to an embodiment of the present invention, wherein each group of restraint coils includes one restraint coil;
  • Fig. 6a shows the hot melt connection diagram of the top pipe in an embodiment of the present invention
  • Figure 6b shows a threaded connection diagram of a jack pipe in an embodiment of the present invention
  • FIG. 7 shows a schematic diagram of a distal end structure of a handle assembly in an embodiment of the present invention.
  • Figure 8 shows a plan assembly view of the control panel of the handle assembly in one embodiment of the present invention.
  • 10-stent device 11-film; 12-stent body; 121-proximal end of stent body; 122- distal end of stent body;
  • 20-delivery device 21-outer tube; 22-inner tube; 23-handle; 231-front handle; 232-rear handle; 233-locking structure; 234-handle tail; 2341-groove; 235-outer pipe connection 236-slider; 237-guide rod; 24-rear release assembly; 25-control disc; 251-release notch; 26-first pull ring; 27-cone head; 28-second pull ring; 281, 261-limiting protrusion; 282, 262-tie rod; 29-end cover;
  • 30 - release control mechanism 31 - tie coil; 311, 314 - first tie coil set; 312, 315 - second tie coil set; 313, 316 - third tie coil set; 32 - perforation; 33 - buffer coil; 34-release control;
  • distal generally refers to the end of the instrument that is operative close to the operator, and the term “proximal”, as opposed to “distal”, refers to the end of the instrument that acts away from the operator.
  • the term “length” generally refers to the distance along the axis of the member
  • “diameter” generally refers to the distance between two points located on the outer circumference of the member, and the line connecting the two points passes through and perpendicular to the axis of the member.
  • the proximal extension stent in order to restrain the proximal extension stent, the proximal extension stent is configured with a sleeve, the sleeve is placed in the outer tube, and the proximal extension stent is compressed and placed in the sleeve.
  • the outer tube is withdrawn, the Complete release of the cannula.
  • the proximal extension stent is still bound by the cannula, and the retraction of the cannula is controlled by releasing the guide wire to achieve the initial release of the proximal extension stent. In this way, the expansion of the proximal extension stent cannot be avoided.
  • the high force causes the problem of displacement of the proximal extension stent.
  • the core idea of the present invention is to provide a stent system, which aims to buffer the release tension of the stent-graft through the cooperation of the first release control mechanism and the second release control mechanism, so that the stent-graft will not move proximally after being released (that is, moving forward), optionally, in combination with the limit mechanism, the stent graft will not move to the distal end (that is, moving backward) after it is released, thereby improving the delivery device to release the film.
  • the accuracy of the stent enables the stent-graft to be positioned accurately, which can effectively isolate the tumor and blood flow, and can avoid the problem of normal organ openings or other blood vessels being blocked due to the displacement of the stent-graft, and the safety of the device is better.
  • the present invention removes the sleeve structure for restraining the stent, the structure is simpler, and the release process is simpler, which can effectively shorten the operation time and improve the operation efficiency.
  • an embodiment of the present invention provides a stent system, including a stent device 10 and a delivery device 20 .
  • the stent device 10 includes a stent-graft
  • the stent-graft includes a membrane 11 and a stent body 12
  • the membrane 11 covers the surface of the stent body 12 .
  • the covering film 11 may partially or completely cover the stent body 12 .
  • the covered stent 11 partially covers the stent body 12 to expose the proximal end 121 of the stent body 12.
  • the covered stent also includes a stent bare segment and a covered segment.
  • the bare section of the stent is the part not covered by the film 11
  • the film section is the part of the stent covered with the film 11 .
  • the present invention does not limit the connection method between the covering film 11 and the stent body 12 , and those skilled in the art can use the existing connection methods to realize the connection between the covering film 11 and the stent body 12 .
  • the stent system also includes a release control mechanism 30, which on the one hand is used to radially tighten the stent-graft, so as to reduce the outer diameter of the stent-graft for delivery;
  • the membrane stent has a problem of advancing forward after release.
  • the release control mechanism 30 includes a first release control mechanism and a second release control mechanism.
  • the bracket device 10 further includes the first release control mechanism.
  • the first release control mechanism includes a plurality of confinement coils 31 and a plurality of perforations 32, and the plurality of confinement coils 31 are axially spaced apart on the stent graft.
  • the plurality of restraint coils 31 are sutured on the outside of the stent-graft by medical sutures, mainly on the corrugated rod of the stent-graft, and the suture position on the corrugated rod is not limited, for example, it can be sutured on the wave crest of the corrugated rod. and the position between the troughs.
  • the distribution manner of the plurality of confinement coils 31 is not limited, as long as the plurality of confinement coils 31 are axially arranged from the distal end 122 to the proximal end 121 of the stent-graft.
  • the first release control mechanism includes a plurality of confinement coil sets, the plurality of confinement coil sets are axially spaced apart on the stent-graft, and each confinement coil set
  • the coil set consists of one confinement coil 31, that is, a plurality of confinement coils 31 are arranged at intervals along the axial direction of the stent-graft, for example, uniform or non-uniform arrangement. side, and the center line is in a straight line and parallel to the axis of the stent-graft, so as to reduce the release resistance and facilitate the smooth release of the stent-graft.
  • the plurality of restraint coils 31 are all arranged on the covered section of the stent-graft.
  • the first release control mechanism includes a plurality of confinement coil groups, and the plurality of confinement coil groups are arranged on the stent-graft along an axial interval, such as uniform or Unevenly arranged, and each of the confinement coil sets includes two confinement coils 31 arranged along the circumference of the stent-graft, and the two confinement coils 31 are wound from a wire and are in a "8" shape (or called butterfly shape), that is, the two confinement coils 31 in each confinement coil group are connected, optionally, multiple confinement coil groups are arranged on the same side of the stent graft, and the multiple confinement coil groups
  • the center line is in a straight line and parallel to the axis of the stent-graft, thereby reducing the release resistance, so that the stent-graft can be released smoothly.
  • the line connecting the centers of the plurality of confinement coil groups on a straight line means that the line connecting the suture points (ie the intersection points) of the two confinement coil groups 31 in the plurality of confinement coil groups is on a straight line.
  • the two confinement coils 31 in each confinement coil group may not be arranged along the circumference of the stent graft. Further, the multiple confinement coil sets are all arranged on the covered segment of the covered stent.
  • the present invention does not limit the number of confinement coils 31 , which needs to be set according to the length of the stent-graft itself.
  • at least two confinement coil groups are arranged along the axial direction of the stent-graft, or more confinement coil groups are arranged. .
  • a plurality of the perforations 32 are arranged at the distal end 122 of the stent graft and are arranged at intervals along the circumference of the stent graft, optionally, evenly arranged along the circumference.
  • the first release control mechanism further includes a plurality of buffer coils 33 (refer to FIG. 5a ), and at the distal end 122 of the stent-graft, a plurality of the buffer coils 33 are sutured on the wave rod of the stent-graft (eg, sutured on the corrugated rod of the stent-graft). on the wave crest) and are arranged at intervals along the circumferential direction, optionally, evenly arranged along the circumferential direction.
  • the perforation 32 can be provided through the buffer coil 33, and in this configuration, there is no need to make a hole on the wave rod at the distal end of the stent-graft, thereby avoiding reducing the strength of the stent-graft.
  • the present invention does not require the quantity of the buffer coils 33, and is specifically set according to actual use requirements.
  • the material of the suture for suturing the binding coil 31 and the buffer coil 33 is mainly a medical polymer material, optionally, an expanded polytetrafluoroethylene (ePTFE) material with better strength.
  • the delivery device 20 includes a handle assembly and the second release control mechanism.
  • the handle assembly includes an outer tube 21 , an inner tube 22 and a handle 23 .
  • the inner tube 22 is used for loading the stent device 10 , that is, the stent device 10 is mounted on the inner tube 22 .
  • the outer tube 21 is disposed outside the inner tube 22 and can move relative to the inner tube 22 and is used to cover the stent device 10 .
  • the handle 23 is connected with the distal end of the outer tube 21 and is used to control the forward movement and retraction of the outer tube 21 .
  • the second release control mechanism includes a release control member 34.
  • the first end of the release control member 34 passes through the plurality of buffer coils 33 of the distal end 122 in sequence, it is also used for the self-supporting device.
  • the distal end 122 to the proximal end 121 of the 10 pass through the plurality of restraint coils 31 in sequence, and finally, the first end of the release control member 34 is releasably connected to the relevant equipment, and the second end of the release control member 34 is connected to the handle 23 connect.
  • the stent graft can be radially tightened by pulling the release control member 34, and then the stent graft can be easily loaded into the delivery device 20 for delivery.
  • the delivery device 20 reaches the target position in the body, the outer tube 21 is withdrawn, After the stent device 10 is exposed, as long as the handle 23 is pulled, the first end of the release control member 34 can be pulled out from all the restraining coils 31 and all the perforations 32 in turn, thereby releasing the restraint of the release control member 34 on the stent-graft, The stent-graft is slowly expanded from the proximal end 121 to the distal end 122 .
  • This configuration not only achieves the purpose of radially tightening the stent graft, but also achieves the purpose of buffering the release tension of the stent graft, avoids the problem of post-release displacement of the stent graft due to excessive release tension, and improves the
  • the release accuracy of the stent-graft enables the stent-graft to be accurately positioned at the target position. Therefore, the present invention can accurately and quickly release the covered stent into the target diseased blood vessel, especially when used in conjunction with the main stent, it can effectively isolate the tumor and blood, so as to be suitable for more complicated cases, and the treatment effect is better.
  • the first end of the release control member 34 is inserted into the first restraint coil group 311 on the far left of FIG. 5b (that is, the restraint closest to the distal end 122 of the stent body).
  • the upper confinement coil 31 of the first confinement coil group 311 is passed through the upper confinement coil 31 of the first confinement coil group 311, and then along the outer surface of the stent-graft for half a circle, it is passed through the first confinement coil group 311.
  • the lower confinement coil 31 is then passed through the confinement coil 31, directly penetrates the upper confinement coil 31 of the second confinement coil group 312, and passes out, and then goes half a circle along the outer surface of the stent graft in the same way.
  • the binding coil 31 passes through the binding coil 31, and then directly penetrates the upper binding coil 31 of the third binding coil group 313 and then exits, and then the same In this way, along the outer surface of the stent-graft for half a circle, it penetrates into the lower confinement coil 31 of the third confinement coil group 313 and then passes through the confinement coil 31 .
  • the two confinement coils 31 in each group are first placed on the same side of the stent-graft, and then the two confinement coils 31 are tied together along the outer surface of the stent-graft by the release control 34, in this way throughout the entire stent-graft.
  • the stent-graft is bound by a plurality of binding coils 31 in the circumferential direction, and the purpose of reducing the outer diameter of the stent-graft can be achieved as long as the release control member 34 is tightened.
  • the first end of the release control member 34 extends toward the proximal end 121 of the stent-graft after passing through the plurality of confinement coils 31 and is optionally releasably connected to the conical head 27 in the delivery device 20 .
  • the distal end of the conical head 27 is provided with a slot, and the first end of the release control member 34 is releasably arranged in the slot.
  • binding coil set there are three binding coil sets located on the same side, and each binding coil set consists of only one binding coil 31 :
  • the first end of the release control member 34 is passed through the first restraint coil group 314 on the far left of FIG. 5c (ie, the restraint closest to the distal end 122 of the stent body).
  • the confinement coil 31 of the first confinement coil group 314 is then passed out, and then along the outer surface of the stent-graft, it is passed through the confinement coil 31 of the first confinement coil group 314 and then passed out, and then directly penetrated into the second confinement coil group.
  • the confinement coil 31 of 315 is passed out, and then goes around the outer surface of the stent-graft in the same way, and then passes through the confinement coil 31 of the second confinement coil group 315, and then passes through the third confinement directly.
  • the confinement coils 31 of the coil group 316 are then passed out, and in the same way, they are wound around the outer surface of the stent-graft, and then passed through the confinement coils 31 of the third confinement coil group 316 and passed out.
  • the delivery device 20 optionally further includes a limiting mechanism 40 , which is disposed on the inner tube 22 and located at the distal end of the stent device 10 , and is used to prevent the stent device 10 from releasing It moves backward to the distal end, thereby avoiding the problem of the stent graft being moved backward after being released, further improving the accuracy of releasing the stent graft by the delivery device 20, and making the positioning of the stent graft more accurate.
  • a limiting mechanism 40 which is disposed on the inner tube 22 and located at the distal end of the stent device 10 , and is used to prevent the stent device 10 from releasing It moves backward to the distal end, thereby avoiding the problem of the stent graft being moved backward after being released, further improving the accuracy of releasing the stent graft by the delivery device 20, and making the positioning of the stent graft more accurate.
  • the limiting mechanism 40 optionally includes a top tube 41 and a reinforcing tube 42, the proximal end of the top tube 41 is used to abut the distal end of the stent device 10, and the distal end of the top tube 41 is connected to the The proximal end of the reinforcing tube 42 is connected, and the distal end of the reinforcing tube 42 is connected with the handle 23 .
  • the material of the top tube 41 is a polymer material to ensure the bending performance of the handle assembly.
  • the material of the top pipe 41 includes but is not limited to high density polyethylene (HDPE).
  • the material of the reinforcing tube 42 is a metal material, so as to ensure the pushing performance of the handle assembly.
  • the material of the reinforcing tube 42 includes but is not limited to stainless steel, such as 304 stainless steel.
  • the proximal end of the reinforcing tube 42 is connected to the distal end of the top tube 41 by thermal fusion.
  • the reason for this structure is to consider that when the dimensions of the outer tube 21 and the inner tube 22 are fixed, the actual space reserved for the installation of the limiting mechanism 40 is very limited. Therefore, the connection process of the polymer jacking tube 41 needs to be extremely limited. At this time, in order to ensure the connection strength and connection stability of the jacking pipe 41 and the reinforcing pipe 42, optionally, the connection between the jacking pipe 41 and the reinforcing pipe 42 is realized by means of hot-melt connection.
  • the proximal surface of the reinforcing tube 42 can be laser-cut to form lines, so that the surface roughness of the reinforcing tube 42 can be improved after the laser cutting process, and then the top tube 41 is heated to melt and coat it.
  • the connection between the jacking pipe 41 and the reinforcing pipe 42 can be realized.
  • the temperature of heating the top pipe 41 should be higher than the melting point of the top pipe 41.
  • the melting point is 200°C
  • the heating temperature should be higher than 200°C.
  • the polymer material of the top pipe 41 infiltrates the cutting area of the reinforcing pipe 42, so that the connection between the two pipes is firmer and the reliability is better.
  • the present invention has no special requirements on the method of heating the top pipe 41.
  • the top pipe 41 can be heated by a hot air gun, and in other embodiments, the mold can be heated by a hot melt machine, so that the heat on the heating module can be heated. It is evenly conducted to the contact surface of the top pipe 41 and the reinforcing pipe 42, so that the polymer material of the top pipe 41 is infiltrated into the cutting area of the reinforcing pipe 42, so that the two pipes are firmly connected.
  • the length of the hot melt connection is set according to actual needs.
  • the top tube 41 can be fused to the corresponding laser cutting area on the reinforcing tube 42 .
  • the lines formed by laser cutting on the reinforcing tube 42 may be grid lines, spiral lines, or striped lines, etc., which are not limited in particular.
  • the proximal end of the reinforcing tube 42 may also be screwed with the distal end of the top tube 41 .
  • the proximal end of the reinforcing tube 42 has external threads
  • the distal end of the top tube 41 has internal threads
  • the proximal end of the reinforcing tube 42 has internal threads
  • the top tube 41 has internal threads.
  • the distal end has external threads.
  • the inner diameter of the top tube 41 is larger than the outer diameter of the reinforcing tube 42, so that the proximal end of the reinforcing tube 42 is inserted into the distal end of the top tube 41 for connection.
  • the top tube 41 with a larger outer diameter can be obtained, so as to increase its contact area with the distal end of the stent graft, and the limiting effect is better.
  • the inner diameter of the reinforcing tube 42 is larger than the outer diameter of the top tube 41 , so that the distal end of the top tube 41 is inserted into the proximal end of the reinforcing tube 42 for connection.
  • the delivery device 20 further includes a third release control mechanism for restraining the bare segment of the stent-graft.
  • the third release control mechanism includes a rear release assembly 24 (see FIG. 3 ) and a plurality of through holes (not labeled, ie, the mesh holes located at the proximal end 121 in FIG. 5 a ) located in the bare section of the stent.
  • the plurality of through holes are arranged at intervals along the circumference of the stent-graft
  • the rear release assembly 24 is arranged in the outer tube 21 and extends longitudinally and is passed through by the inner tube 22 . Specifically, as shown in FIG.
  • the bare stent segment at the proximal end 121 of the stent body 12 is provided with a plurality of through holes
  • the rear release assembly 24 includes a clamping claw and a rear end 122 in sequence from the proximal end 121 to the distal end 122 .
  • one end of the claw is detachably connected to the tapered head 27 after passing through the through hole on the bare section of the stent, and the other end is connected to the rear-release guide wire.
  • the post-release of the stent-graft can be achieved, that is, when the covered segment of the stent device 10 is deployed (ie, the release control mechanism 30 has completed the preliminary release of the stent-graft), the proximal end 121 of the stent device 10 (ie, The bare stent segment) is still bound by the rear release assembly 24, so that the position of the stent device 10 can be precisely adjusted, and the proximal stent bare segment is released after the position is finally determined, so that the stent device 10 is fully deployed. Therefore, the proximal end of the stent device 10 is restrained by passing through the through hole of the proximal stent bare segment of the stent device 10 through the claws.
  • the rear release assembly 24 is used in cooperation with the stent device 10 having a through hole in the bare section of the stent, and the rear release assembly 24 binds the proximal end of the stent device 10. For this reason, during the release operation, when the delivery device 20 reaches the target position in the body, the outer tube 21 is withdrawn, and the release control member 34 is first released from the restraint of the covered section of the stent-graft to achieve the initial release of the stent-graft, At this time, the proximal end 121 of the stent device 10 cannot be opened due to being bound by the rear release assembly 24. At this time, the stent device 10 can be slightly adjusted to achieve accurate positioning of the stent device 10.
  • the proximal stent bare segment of the stent device 10 can be released through the rear release assembly 24, so that the stent device 10 can be fully deployed.
  • the present invention does not limit the structure of the rear release assembly 24.
  • the proximal end 121 of the stent device 10 can also be bound by a restraining body, and the restraining body can be connected with the release control member 34, as long as Pulling the release control member 34 can realize the one-time release of the stent-graft, and at this time, there is no problem of multiple releases.
  • the third release control mechanism includes a restraining body (not shown) and a plurality of through holes (that is, mesh holes) located in the bare section of the stent, and the plurality of through holes are located along the stent graft. Circumferential spacing settings.
  • the first end of the release control member 34 is also used to be releasably connected to one end of the restraint body after passing through the plurality of restraint coils 31, and the other end of the restraint body passes through in sequence The plurality of through holes are then fixedly connected to the inner tube 22 .
  • the first end of the release control member 34 can be disengaged from one end of the restraining body as long as the handle 23 is pulled.
  • the release control member 34 is pulled out from the plurality of restraint coils 31 and the plurality of perforations 32 in sequence, so as to release the restraint of the release control member 34 and the restraint body, and realize the one-time release of the stent graft.
  • the one-time release the operation is simpler, and at the same time, the release accuracy of the stent can be ensured, which effectively saves the operation time and reduces the difficulty of the operation.
  • the constraining body is a PE wire.
  • the buffer coil 33 and the binding coil 31 can be made of PE wire.
  • the rear release assembly 24 also includes a guide member and a component defining an inner tube hole.
  • the jaws pass through the guides, and are guided and maintained in direction by the guides.
  • the function of the component defining the inner tube hole is to connect the claws with the rear-release guide wire to ensure that pulling the rear-release guide wire can drive the claws to move to the distal end.
  • the post-release guide wire is directly connected to the member defining the bore of the inner tube.
  • the inner tube hole allows the inner tube 22 to pass therethrough.
  • the jaws include a plurality of rods distributed along the circumferential direction.
  • the member defining the inner tube hole is connected or integrated with the plurality of rods.
  • the tapered head 27 is provided with a plurality of blind holes corresponding to the plurality of rod members along the circumferential direction, and the plurality of rod members are respectively inserted into the plurality of blind holes.
  • the guide member is provided with a plurality of axial through holes corresponding to the plurality of rod members in the circumferential direction, and the plurality of rod members respectively pass through the plurality of axial through holes.
  • the guides can guide and maintain the orientation of each rod of the jaws, avoid crossing or bending, and facilitate alignment and introduction of the rods of the jaws into the blind holes of the conical head 27 .
  • the handle 23 may include a front handle 231 and a rear handle 232 , the front handle 231 and the rear handle 232 are connected along the axial direction of the outer tube 21 , and the outer tube 21 and the rear handle 232 are realized by the locking structure 233 . Lock and release the relative movement between them to prevent misoperation by the operator. That is, the rear handle 232 controls the movement (including advancing and retreating) of the outer tube 21 .
  • the locking structure 233 is a switch located on the front handle 231 and close to one end of the rear handle 232 . When the switch moves toward the rear handle 232 , some of the switches are inserted into the corresponding locking grooves in the rear handle 232 . , the rotation of the rear handle 232 relative to the front handle 231 is restricted, and the relative movement between the outer tube 21 and the rear handle 232 is locked (closed) and released (opened).
  • the above switch is toggled to the open position, so that the front handle 231 and the rear handle 232 are separated, thereby keeping the front handle 231 stationary, and after rotating
  • the handle 232 is used to drive the outer tube 21 to withdraw, exposing the bracket device 10 that is still bound around the inner tube 22. Then, the control panel 25 on the rear handle 232 is rotated.
  • the control panel 25 When the control panel 25 is rotated to a certain position, the Pull the first pull ring 26 at the end 234 of the handle, and the release control member 34 is pulled by the first pull ring 26, so that the release control member 34 is separated from the plurality of restraint coils 31 and the plurality of buffer coils 33 in turn, so that the stent graft Open in sequence from the proximal end to the distal end.
  • the first pull ring 26 is pulled, the restraint of the proximal end of the stent graft by the third release control mechanism can be released, thereby realizing the one-time release of the stent device 10 to a predetermined position.
  • the release process of the stent device 10 includes initial release and full release.
  • the initial release is: when the first pull ring 26 is pulled, the first end of the release control member 34 is separated from each binding coil 31 and each buffer coil 33 in turn, thereby releasing the covered section and the distal end of the stent device 10. At this time, The proximal end of stent device 10 (ie, the bare stent segment) remains bound by rear release assembly 24 .
  • the rear release assembly 24 is retracted in the axial direction, thereby releasing the proximal end of the stent device 10. At this time, the stent device 10 is completely released.
  • the handle 23 further includes a first pull ring 26 and a second pull ring 28 .
  • One end of the first pull ring 26 is connected to the release control member 34 .
  • One end of the second pull ring 28 is connected to release the guide wire (not shown), and the assembly 24 is released after the guide wire is connected.
  • the handle 23 may also include only one pull ring, that is, the first pull ring 26, so as to realize the one-time release of the stent graft.
  • the handle assembly further includes a conical head 27, and the proximal end of the inner tube 22 is connected to the distal end of the conical head 27.
  • the first end of the release control member 24 is detachable from the conical head 27. ground connection.
  • the outer tube 21 is disposed outside the inner tube 22 and covers to the distal end of the tapered head 27 , that is, the tapered head 27 is exposed outside the outer tube 21 .
  • the handle assembly further includes a handle end 234 and a control disk 25 , and the handle end 234 is connected to the distal end of the rear handle 232 .
  • the control disk 25 is a ring structure, the control disk 25 is sleeved on the outside of the handle end 234, and is rotatably connected with it.
  • the handle assembly further includes an end cover 29 disposed at the distal end of the handle end 234 for restricting the movement of the control disk 25 along the axial direction of the outer tube 21 .
  • the handle tail end 234 is provided with two grooves 2341 with semicircular cross-sections along the axial direction of the outer tube 21 near the control disc 25 .
  • the rods 262 and 282 are respectively inserted into the two semicircular grooves 2341 through the holes on the end cover 29 .
  • Limiting bosses 261 and 281 are provided on one side of the bellows.
  • the inner diameter of the control disc 25 limits the movement of the limiting bosses 261 and 281 along the axial direction of the outer tube 21 . , so that the ring pull rod cannot be pulled out from the groove 2341.
  • the inner diameter of the control disc 25 is also provided with a release notch 251 that matches the shape of the limiting bosses 261 and 281. When the release notch 251 is rotated to the same position as one of the grooves 2341 , the pull-ring rods 262 and 282 can be pulled out from the groove 2341 and the release notch 251 at the same position.
  • an arrow is provided on the outer side of the handle end 234 , and two numbers “1” and “2” are provided on the peripheral side of the control panel 25 .
  • the pull-ring rod 262 of 26 can be pulled out from the semicircular groove 2341, thereby pulling the release control member 34 to realize the preliminary release of the bracket device 10; when the number "2" is aligned with the arrow, it means the release
  • the notch 251 is exactly at the same position as the semicircular groove 2341 where the pull ring rod 282 of the second pull ring 28 is located, and the pull ring rod 282 of the second pull ring 28 can be pulled from the semicircular groove 2341 Then, the guide wire is released after pulling, and the stent device 10 is completely released. With this configuration, release errors can be effectively avoided, and the release accuracy of the stent device 10 can be improved.
  • the handle assembly further includes an outer pipe connecting piece 235 , a sliding block 236 and a guide rod 237 .
  • the rear handle 232 and the slider 236 are threadedly connected, the slider 236 is slidably connected to a guide rod 237 , the guide rod 237 is axially parallel to the outer tube 21 , and the slider 236 is connected to the outer tube connector 235 .
  • the outer pipe connecting piece 235 is axially connected with the outer pipe 21 .
  • the slider 236 has an external thread, which is matched with the internal thread of the rear handle 232 . When the rear handle 232 is rotated, the slider 236 slides and drives the outer tube 21 to move, so as to realize the movement of the outer tube 21 toward the proximal end or the distal end.
  • the stent graft in the present invention can be used alone or in combination with the main stent, so as to solve the problem that the stent graft has a relatively large release tension and is prone to displacement during the release process.
  • the length of the covered section of the covered stent can be 60mm-100mm, more preferably 60mm-70mm.
  • the release control member 34 is a guide wire or other elongated member with certain flexibility.
  • the stent graft will not move forward after being released, which improves the release of the stent graft by the delivery device.
  • the accuracy of the stent graft can make the positioning of the covered device accurate, which can effectively isolate the tumor and blood flow, and can avoid the problem of normal organ openings or other blood vessels being blocked due to the displacement of the covered stent, and the safety of the device is better.
  • the present invention removes the sleeve structure for restraining the stent, the structure is simpler, and the release process is simpler, which can effectively shorten the operation time and improve the operation efficiency.

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Abstract

本发明涉及一种支架系统，支架系统包括支架装置和输送装置。支架装置包括覆膜支架和第一释放控制机构，第一释放控制机构包括多个束缚线圈和多个穿孔，多个束缚线圈沿轴向设置于覆膜支架上，多个穿孔设置于覆膜支架的远端并沿周向设置。输送装置包括手柄组件和第二释放控制机构。手柄组件包括内管、外管和手柄。第二释放控制机构包括释放控制件，释放控制件的第一端自远端至近端依次穿过多个穿孔和多个束缚线圈，第二端与手柄连接，第一端被可解脱地设置。在拉动手柄时，释放控制件的第一端从多个束缚线圈和多个穿孔中依次抽出，以解开释放控制件的束缚。本发明的优点是，能够实现覆膜支架的精准释放。

Description

支架系统 技术领域
本发明属于医疗器械技术领域，特别涉及一种支架系统。
背景技术
近年来主动脉外科手术的一大进展是利用覆膜支架治疗主动脉疾病。覆膜支架的机理是通过特制的输送装置将覆膜支架送入病变部位，然后使覆膜支架张开，达到隔绝瘤体与血液的目的。使用覆膜支架的适应症主要包括主动脉夹层、主动脉真性动脉瘤、主动脉假性动脉瘤、主动脉穿透性溃疡等。覆膜支架的应用可消除动脉瘤破裂大出血引起死亡的危险或瘤体对周围组织、器官的压迫，从而大大降低了手术死亡率以及术后并发症，减轻了手术创伤，有利于患者快速恢复。
目前市场上可用的覆膜支架例如有Valiant、Zenith、Relay、Gore、Hercules、Ankura、Aegis等。这些覆膜支架仅适合于治疗瘤颈长度为15mm左右的主动脉瘤。对于胸主动脉瘤或者夹层累及了肾下腹主动脉跟分侧髂动脉等复杂夹层病例的患者，仅使用单个支架无法完全隔离瘤体，达不到治疗效果。而随着微创伤介入技术的发展，出现了一些覆膜支架。对于锚定区不足，或者支架出现了移位或定位不准确的情况，通过覆膜支架和裸支架的配合使用仍然可以达到治疗效果，便于处理一些难度高病例，降低手术并发症，使腔内治疗更为安全和可靠。但是，现有技术提供的覆膜支架，例如包括专利申请CN110248620A所公开的短支架，在释放时未对覆膜支架做定位设置，容易出现释放后覆膜支架前跳或后移的问题，导致其与主体支架脱离，无法起到隔绝瘤体与血液的效果，更严重的可能导致覆膜支架覆盖肾开口或其他血管，引起闭塞问题，造成严重后果。
发明内容
本发明的目的是提供一种支架系统，能够实现覆膜支架在体腔内的精准释放，保证覆膜支架定位的准确性，同时使输送操作更为简单和方便。
为实现上述目的，所述支架系统包括支架装置和输送装置；
所述支架装置包括覆膜支架和第一释放控制机构，所述第一释放控制机构包括多个束缚线圈和多个穿孔；所述多个束缚线圈在所述覆膜支架上沿轴向间隔设置；所述多个穿孔设置于所述覆膜支架的远端并沿覆膜支架的周向间隔设置；
所述输送装置包括手柄组件和第二释放控制机构；所述手柄组件包括内管、外管和手柄；所述内管用于装载所述支架装置；所述外管设置于所述内管外，并用于覆盖所述支架装置；所述第二释放控制机构包括释放控制件，所述释放控制件的第一端用于依次穿过所述多个通孔后，进一步自所述支架装置的远端至近端依次穿过多个所述束缚线圈；所述释放控制件的第二端与所述手柄连接，所述释放控制件的第一端被可解脱地设置；
在拉动所述手柄时，所述释放控制件的第一端从多个所述束缚线圈和所述多个穿孔中依次抽出，以解开所述释放控制件的束缚。
可选地，所述第一释放控制机构包括多个束缚线圈组，多个所述束缚线圈组在所述覆膜支架上沿轴向间隔设置；每个所述束缚线圈组包括两个沿覆膜支架周向布置的束缚线圈，且两个所述束缚线圈由一根线材绕制而成并呈一“8”字形。
可选地，多个所述束缚线圈组设置在所述覆膜支架的同一侧，多个所述束缚线圈组的中心连线在一条直线上并与覆膜支架的轴线平行。
可选地，所述多个束缚线圈缝合在所述覆膜支架的波杆上。
可选地，所述第一释放控制机构还包括多个缓冲线圈，多个所述缓冲线圈缝合在所述覆膜支架的波杆上并沿周向间隔设置，且每个所述缓冲线圈提供一个所述穿孔。
可选地，多个所述缓冲线圈沿覆膜支架的周向均匀布置。
可选地，所述覆膜支架包括支架裸段和覆膜段；所述多个束缚线圈均设置在所述覆膜段上。
可选地，所述覆膜支架包括支架裸段和覆膜段；所述覆膜段的长度为60mm-100mm。
可选地，所述输送装置还包括限位机构，设置于所述内管上并位于所述支架装置的远端，所述限位机构用于限制所述覆膜支架向远端的移动。
可选地，所述限位机构包括顶管和加强管；所述顶管的远端与所述加强管的近端连接，所述加强管的远端与所述手柄连接；所述顶管的近端用于与所述支架装置的远端相抵靠。
可选地，所述顶管的远端与所述加强管的近端热熔连接，或者，所述顶管的远端与所述加强管的近端螺纹连接。
可选地，所述顶管的内径大于所述加强管的外径，所述加强管的近端插入所述顶管的远端相连接。
可选地，当所述顶管的远端与所述加强管的近端热熔连接时，所述加强管的近端表面形成有纹路。
可选地，所述手柄包括拉环，所述拉环通过拉杆与所述释放控制件的第二端连接，所述手柄组件还包括锥形头，所述释放控制件的第一端与所述锥形头可解脱连接；
当拉动所述拉环时，所述释放控制件的第一端与所述锥形头分离并依次从所述多个束缚线圈和所述多个穿孔中抽出。
可选地，所述覆膜支架包括支架裸段和覆膜段；所述支架装置还包括第三释放控制机构，用于束缚所述支架裸段；
所述第三释放控制机构包括一个约束体和多个通孔，所述多个通孔位于所述支架裸段并沿覆膜支架的周向间隔设置；所述释放控制件的第一端用于在穿过所述多个束缚线圈之后与所述约束体的一端可解脱地连接，所述约束体的另一端依次穿过所述多个通孔后与所述内管固定连接。
与现有技术相比，本发明具有以下有益效果：
本发明提供的支架系统通过第一释放控制机构与第二释放控制机构的配合，使得覆膜支架释放后不会出现前移的问题，提高了输送装置释放覆膜支架的精度，使覆膜装置定位准确，从而可有效隔绝瘤体与血流，并可避免因覆膜支架移位而导致正常器官开口或其他血管被封堵的问题，器械的安全性更好。与常规的释放方式相比，本发明去除了用于束缚支架的套管结构，结 构更为简单，释放过程也更简便，可有效缩短手术时间，提高手术效率。
本发明提供的支架系统通过限位机构能够防止覆膜支架释放后出现后移的问题，进一步提高输送装置释放覆膜支架的精度。所述限位机构优选通过顶管抵挡覆膜支架的后移，结构简单，使用方便。尤其地，顶管的材料为高分子材料，且与之连接的加强管为金属材料，以此配置可保证手柄组件的柔顺性和推送性。特别地，高分子顶管和金属加强管间的连接工艺需要在极其有限的空间内进行，为了保证两者的连接强度，顶管和加强管优选热熔连接，连接稳定和可靠性好，也可降低连接的难度。
附图说明
附图用于更好地理解本发明，不构成对本发明的不当限定。其中：
图1示出了本发明一实施例中输送装置的结构示意图；
图2示出了本发明一实施例中支架装置的输送示意图；
图3示出了本发明一实施例中支架装置、第三释放控制机构和内管的相对位置示意图；
图4示出了本发明一实施例中外管与后手柄的连接结构示意图；
图5a示出了本发明一实施例中支架装置的结构示意图；
图5b示出了本发明一实施例中第二释放控制机构中的释放控制件与第一释放控制机构中的多个束缚线圈的连接示意图，其中每组束缚线圈组包括两个束缚线圈；
图5c示出了本发明一实施例中第二释放控制机构中的释放控制件与第一释放控制机构中的多个束缚线圈的连接示意图，其中每组束缚线圈组包括一个束缚线圈；
图6a示出了本发明一实施例中顶管的热熔连接图；
图6b示出了本发明一实施例中顶管的螺纹连接图；
图7示出了本发明一实施例中手柄组件的远端结构示意图；
图8示出了本发明一实施例中手柄组件的控制盘的平面装配图。
其中：
10-支架装置；11-覆膜；12-支架本体；121-支架本体的近端；122-支架本体的远端；
20-输送装置；21-外管；22-内管；23-手柄；231-前手柄；232-后手柄；233-锁定结构；234-手柄尾端；2341-凹槽；235-外管连接件；236-滑块；237-导杆；24-后释放组件；25-控制盘；251-释放缺口；26-第一拉环；27-锥形头；28-第二拉环；281、261-限位凸起；282、262-拉杆；29-端盖；
30-释放控制机构；31-束缚线圈；311、314-第一个束缚线圈组；312、315-第二个束缚线圈组；313、316-第三个束缚线圈组；32-穿孔；33-缓冲线圈；34-释放控制件；
40-限位机构；41-顶管；42-加强管。
附图中相同或相似的附图标记代表相同或相似的部件。
具体实施方式
以下结合附图以及具体实施例对本发明作进一步详细说明。根据下面说明，本发明的优点和特征将更清楚。需说明的是，附图均采用非常简化的形式且均使用非精准的比例，仅用以方便、明晰地辅助说明本发明实施例的目的。
如在本说明书中所使用的，单数形式“一”、“一个”以及“该”包括复数对象，除非内容另外明确指出外。如在本说明书中所使用的，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外。如在本说明书中所使用的，术语“远端”通常是器械作用时靠近操作者的一端，“近端”与“远端”相反，是指器械作用时远离操作者的一端。如在本说明书中所使用的，术语“长度”通常是指沿构件的轴线方向的距离，“直径”通常是指位于构件外周上的两点间的距离，且该两点的连线穿过并垂直于构件的轴线。
在现有技术中，为束缚近端延伸支架，近端延伸支架配置有套管，套管置于外管内，近端延伸支架被压缩并置于套管内，当外管回撤后，可实现套管的完全释放，此状态下，近端延伸支架仍被套管束缚，再通过释放导丝控 制套管回收，实现近端延伸支架的初步释放，这样的方式，无法避免近端延伸支架因扩张力大导致近端延伸支架移位的问题。
本发明的核心思想在于提供一种支架系统，旨在通过第一释放控制机构和第二释放控制机构的配合缓冲覆膜支架的释放张力，使覆膜支架在释放后不会出现向近端移动(即前移)的问题，可选地，再配合限位机构，还可使覆膜支架在释放后也不会出现向远端移动(即后移)的问题，从而提高输送装置释放覆膜支架的精度，使覆膜支架准确定位，从而可有效隔绝瘤体与血流，并可避免因覆膜支架移位而导致正常器官开口或其他血管被封堵的问题，器械的安全性更好。与常规的释放方式相比，本发明去除了用于束缚支架的套管结构，结构更为简单，释放过程也更简便，可有效缩短手术时间，提高手术效率。
参阅图1至图3，并结合图5a所示，本发明实施例提供一种支架系统，包括支架装置10和输送装置20。所述支架装置10包括覆膜支架，所述覆膜支架包括覆膜11和支架本体12，所述覆膜11覆盖在支架本体12的表面。所述覆膜11可部分或全部覆盖支架本体12。本发明实施例中，所述覆膜11部分覆盖支架本体12，以暴露出支架本体12的近端121，此时，所述覆膜支架也即包括支架裸段和覆膜段。所述支架裸段即未被覆膜11所覆盖的部分，所述覆膜段即为覆盖了覆膜11的支架部分。本发明对覆膜11与支架本体12的连接方式不加限定，本领域技术人员可利用已有的连接方式实现覆膜11与支架本体12的连接。
所述支架系统还包括释放控制机构30，一方面用于径向收紧覆膜支架，便于缩小覆膜支架外径进行输送，另一方面用于缓冲覆膜支架释放时的扩张力，避免覆膜支架在释放后出现前移的问题。所述释放控制机构30包括第一释放控制机构和第二释放控制机构。且所述支架装置10还包括所述第一释放控制机构。所述第一释放控制机构包括多个束缚线圈31和多个穿孔32，多个束缚线圈31在覆膜支架上沿轴向间隔设置。进一步的，多个束缚线圈31通过医用缝合线缝合在覆膜支架的外部，主要缝合在覆膜支架的波杆上，且在波杆上的缝合位置不作限定，例如可缝合在波杆的波峰和波谷之间的位置。 多个束缚线圈31的分布方式不加限定，只要从覆膜支架的远端122至近端121沿轴向排布有多个束缚线圈31即可。
在一些实施例中，如图5c所示，所述第一释放控制机构包括多个束缚线圈组，多个所述束缚线圈组在所述覆膜支架上沿轴向间隔设置，且每个束缚线圈组由一个束缚线圈31组成，也即，多个束缚线圈31沿覆膜支架的轴向间隔排列，例如均匀或不均匀排列，可选的，多个束缚线圈31设置在覆膜支架的同一侧，且中心连线在一条直线上并与覆膜支架的轴线平行，以此降低释放阻力，便于顺利释放覆膜支架。进一步的，所述多个束缚线圈31均设置在覆膜支架的覆膜段上。
在另一些实施例中，如图5b所示，所述第一释放控制机构包括多个束缚线圈组，多个所述束缚线圈组在所述覆膜支架上沿轴向间隔设置，例如均匀或不均匀排列，且每个所述束缚线圈组包括两个沿覆膜支架周向布置的束缚线圈31，且两个所述束缚线圈31由一根线材绕制而成并呈一“8”字形(或称蝴蝶形)，也即，每个束缚线圈组中的两个束缚线圈31相连接，可选的，多个束缚线圈组设置在覆膜支架的同一侧，且多个束缚线圈组的中心连线在一条直线上并与覆膜支架的轴线平行，从而降低释放阻力，以便顺利释放覆膜支架。应理解，多个束缚线圈组的中心连线在一条直线上是指，多个束缚线圈组中的两个束缚线圈31的缝合点(即交点)的连线在一条直线上。与每个束缚线圈组中的单个束缚线圈31相比，通过在每个束缚线圈组中设置两个相互连接的束缚线圈31，一方面在释放时2个束缚线圈31会更牢固，另一方面可以减小释放阻力。在其他实施例中，每个所述束缚线圈组中的两个束缚线圈31也可不沿覆膜支架的周向布置。进一步的，所述多个束缚线圈组均设置在覆膜支架的覆膜段上。
本发明对束缚线圈31的数量不作限定，具体需要根据覆膜支架本身的长度来设定，通常的，至少沿覆膜支架的轴向布置两个束缚线圈组，或者布置更多个束缚线圈组。
多个所述穿孔32设置于覆膜支架的远端122并沿覆膜支架的周向间隔设置，可选地，沿周向均匀布置。所述第一释放控制机构还包括多个缓冲线圈 33(参阅图5a)，在覆膜支架的远端122处，多个所述缓冲线圈33缝合在覆膜支架的波杆上(例如缝合在波峰上)并沿周向间隔设置，可选地，沿周向均匀设置。如此，可通过缓冲线圈33提供穿孔32，这样配置，无需在覆膜支架远端的波杆上开孔，避免降低覆膜支架的强度。本发明对缓冲线圈33的数量没有要求，具体根据实际使用需求来设定。此外，缝合束缚线圈31和缓冲线圈33的缝线的材料主要是医用高分子材料，可选地，也可以是强度较好的膨体聚四氟乙烯(ePTFE)材料。
继续参阅图1，所述输送装置20包括手柄组件和所述第二释放控制机构。所述手柄组件包括外管21、内管22和手柄23。所述内管22用于装载支架装置10，即支架装置10安装在内管22上。所述外管21设置于内管22外并可相对于内管22运动，并用于覆盖支架装置10。所述手柄23与外管21的远端连接，并用于控制外管21的前移和后撤。
参阅图5a和图5b，所述第二释放控制机构包括释放控制件34，所述释放控制件34的第一端依次穿过远端122的多个缓冲线圈33后，还用于自支架装置10的远端122至近端121依次穿过多个束缚线圈31，最终，所述释放控制件34的第一端与相关设备可解脱地连接，而释放控制件34的第二端与手柄23连接。
在具体操作时，只要拉动释放控制件34即可径向收紧覆膜支架，进而可方便地装入输送装置20进行输送，且当输送装置20到达体内目标位置后，回撤外管21，暴露出支架装置10后，只要拉动手柄23，即可使释放控制件34的第一端从所有束缚线圈31和所有穿孔32中依次抽出，从而解开释放控制件34对覆膜支架的束缚，使得覆膜支架从近端121至远端122缓慢张开。如此配置，既达到了径向收紧覆膜支架的目的，又达到了缓冲覆膜支架的释放张力的目的，避免了覆膜支架因释放张力过大而出现释放后移位的问题，提高了覆膜支架的释放精度，使覆膜支架能够准确定位在目标位置。因此，本发明能使覆膜支架准确并快速的释放至靶病变血管中，尤其配合主体支架使用可有效隔绝瘤体与血液，以适用更多的复杂病例，治疗效果更好。
为了进一步解释说明，以下结合图5b和图5c，对释放控制件34的穿线 方式作更详细的说明。
首先以具有三个位于同一侧的束缚线圈组，以及每个束缚线圈组被构造成“8”字形为例：
如图5b所示，在穿过多个穿孔32后，将释放控制件34的第一端穿入图5b最左边的第一个束缚线圈组311(即最靠近支架本体远端122的一个束缚线圈组)的上面一个束缚线圈31后，从第一个束缚线圈组311的上面一个束缚线圈31穿出，然后沿着覆膜支架外表面半圈后再穿入第一个束缚线圈组311的下面一个束缚线圈31后由该束缚线圈31穿出，直接穿入第二个束缚线圈组312的上面一个束缚线圈31并穿出，然后又以同样的方式沿覆膜支架外表面半圈后再穿入第二个束缚线圈组312的下面一个束缚线圈31后由该束缚线圈31穿出，再直接穿入第三个束缚线圈组313的上面一个束缚线圈31后穿出，然后也以同样的方式沿覆膜支架外表面半圈后再穿入第三个束缚线圈组313的下面一个束缚线圈31后由该束缚线圈31穿出。应理解，首先将每组中的两个束缚线圈31设置在覆膜支架的同一侧，然后通过释放控制件34将两个束缚线圈31沿覆膜支架外表面束缚在一起，以此方式在整个覆膜支架周向上通过多个束缚线圈31进行束缚，进而只要拉紧释放控制件34，即可达到减小覆膜支架外径的目的。进一步的，所述释放控制件34的第一端在穿过多个束缚线圈31后向覆膜支架的近端121延伸并可选地与输送装置20中的锥形头27可解脱连接。例如锥形头27的远端设置有卡槽，所述释放控制件34的第一端可解脱地设置在所述卡槽中。
另外以具有三个位于同一侧的束缚线圈组，以及每个束缚线圈组仅由一个束缚线圈31为例：
如图5c所示，在穿过多个穿孔32后，将释放控制件34的第一端穿入图5c最左边的第一个束缚线圈组314(即最靠近支架本体远端122的一个束缚线圈组)的束缚线圈31后穿出，然后沿着覆膜支架外表面一圈后又穿入第一个束缚线圈组314的束缚线圈31再穿出，接着直接穿入第二个束缚线圈组315的束缚线圈31并穿出，然后又以同样的方式沿覆膜支架外表面一圈后再次穿入第二个束缚线圈组315的束缚线圈31后穿出，再直接穿入第三个束缚线圈 组316的束缚线圈31后穿出，又以同样的方式沿覆膜支架外表面绕一圈后再穿入第三个束缚线圈组316的束缚线圈31后穿出。
根据本发明的实施例，如图2所示，所述输送装置20可选地还包括限位机构40，设置于内管22上并位于支架装置10的远端，作用是防止支架装置10释放后向远端移动，由此避免覆膜支架在释放后出现后移的问题，进一步提高输送装置20释放覆膜支架的精度，使覆膜支架定位更准确。
参阅图6a，所述限位机构40可选地包括顶管41和加强管42，所述顶管41的近端用于抵住支架装置10的远端，所述顶管41的远端与加强管42的近端连接，所述加强管42的远端与手柄23连接。所述顶管41的材料为高分子材料，以保证手柄组件的弯曲性能。所述顶管41的材料包括但不限于高密度聚乙烯(HDPE)。可选地，所述加强管42的材料为金属材料，以此保证手柄组件的推送性能。所述加强管42的材料包括但不限于不锈钢，例如304不锈钢。
根据本发明的实施例，如图6a所示，可选地，所述加强管42的近端与顶管41的远端热熔连接。如此构造是因为考虑到，当外管21和内管22的尺寸固定后，实际为安装限位机构40所预留的空间很有限，因此，高分子的顶管41的连接工艺需要在极其有限空间内进行，此时，为保证顶管41和加强管42的连接强度和连接稳定性，可选地，采用热熔连接的方式实现顶管41和加强管42的连接，相比胶水连接，可有效的保证两者的连接强度，且稳定性也好。进一步的，可在实施时，先对加强管42的近端表面做激光切割处理而形成纹路，使加强管42在激光切割处理后表面粗糙度提高，然后，加热顶管41使其熔融包覆在加强管42的近端上，之后，冷却固化，即可实现顶管41和加强管42的连接。这里，加热顶管41的温度应高于顶管41的熔点，如顶管41的材料为HDPE时，熔点为200℃，加热温度应高于200℃。特别的，加热后，顶管41的高分子材料浸润到加强管42的切割区域，使两个管材的连接更牢固，可靠性更好。本发明对加热顶管41的方式没有特别的要求，例如在一些实施例中，可通过热风枪加热顶管41，另一些实施例中，可通过热熔机加热模具，使加热模块上的热量均匀传导至顶管41与加强管42的接触 表面，使顶管41的高分子材料浸润到加强管42的切割区域，使两个管材形成牢固连接。热熔连接的长度根据实际需要设定，例如根据不同覆膜支架的长度，可将顶管41熔融在加强管42上相应的激光切割区域。此外，加强管42上激光切割所形成的纹路可以是网格线、螺旋线或者条纹线等，具体不限。
根据本发明的实施例，如图6b所示，所述加强管42的近端也可与顶管41的远端螺纹连接。以此构造，方便调节顶管41与加强管42的连接部分的长度，以灵活地适应于不同长度的覆膜支架的限位需要。可选的，所述加强管42的近端具有外螺纹，所述顶管41的远端具有内螺纹，或者可替代的，所述加强管42的近端具有内螺纹，所述顶管41的远端具有外螺纹。
进一步的，所述顶管41的内径大于加强管42的外径，便于加强管42的近端插入顶管41的远端进行连接。以此构造，可获取外径较大的顶管41，以增大其与覆膜支架远端的接触面积，限位效果更好。可替代地，所述加强管42的内径大于顶管41的外径，便于顶管41的远端插入加强管42的近端进行连接。
进一步的，所述输送装置20还包括第三释放控制机构，用于束缚所述覆膜支架的支架裸段。在一些实施例中，所述第三释放控制机构包括后释放组件24(参阅图3)和位于支架裸段的多个通孔(未标注，也即图5a中位于近端121的网孔)，所述多个通孔沿覆膜支架的周向间隔布置，所述后释放组件24设置在外管21内纵向延伸并被内管22穿过。具体地，如图3所示，所述支架本体12的近端121的支架裸段设有多个通孔，所述后释放组件24从近端121到远端122按顺序包括卡爪和后释放导丝，所述卡爪的一端穿过支架裸段上的通孔后与锥形头27可分离地连接，另一端与所述后释放导丝相连接。以此构造，可实现覆膜支架的后释放，即：当支架装置10的覆膜段展开后(即释放控制机构30已完成覆膜支架的初步释放)，支架装置10的近端121(即支架裸段)仍然被后释放组件24束缚，这样可精确调整支架装置10的位置，待最终确定位置后再释放近端支架裸段，使支架装置10完全展开。由此，通过卡爪穿过支架装置10的近端支架裸段的通孔以束缚支架装置10的近端。从而，所述后释放组件24与支架裸段设通孔的支架装置10配合使用，所述 后释放组件24将支架装置10的近端束缚。为此，在释放操作时，当输送装置20到达体内目标位置后，回撤外管21，先解开释放控制件34对覆膜支架的覆膜段的束缚，实现覆膜支架的初释放，此时，支架装置10的近端121由于被后释放组件24束缚而无法弹开，此时，支架装置10可以稍作微调，以实现支架装置10的准确定位，当确认支架装置10的精确位置后，可以通过后释放组件24将支架装置10的近端支架裸段放开，从而使支架装置10完全展开。应知晓，本发明对后释放组件24的结构不加限定，除了上述描述的结构以外，还可通过约束体将支架装置10的近端121束缚，并将约束体与释放控制件34连接，只要拉动释放控制件34，即可实现覆膜支架的一次性释放，此时，并不存多次释放的问题。
在另一实施例中，所述第三释放控制机构包括一个约束体(未图示)和位于支架裸段的多个通孔(也即网孔)，所述多个通孔沿覆膜支架的周向间隔设置。此时，所述释放控制件34的第一端还用于在穿过所述多个束缚线圈31之后与所述约束体的一端可解脱地连接，且所述约束体的另一端依次穿过所述多个通孔后与所述内管22固定连接。实际操作时，也只要拉动手柄23，即可使释放控制件34的第一端与所述约束体的一端脱离，脱离后，所述约束体的一端依次从支架裸段的多个通孔中抽出，且所述释放控制件34的第一端依次从多个束缚线圈31和多个穿孔32中抽出，从而解开释放控制件34和约束体的束缚，实现覆膜支架的一次性释放。应理解，一次性释放，操作更简单，且同时还能够保证支架的释放精度，有效节约了手术时间，降低了手术难度。进一步的，所述约束体为PE线。进一步的，可由PE线制成所述缓冲线圈33和束缚线圈31。
进一步的，所述后释放组件24还包括导向件和限定内管孔的部件。所述卡爪穿过所述导向件，由所述导向件引导和保持方向。所述限定内管孔的部件的作用是将卡爪与后释放导丝相连接，确保拉动后释放导丝可以带动卡爪向远端移动。所述后释放导丝直接连接于限定内管孔的部件上。所述内管孔允许内管22穿过。所述卡爪包括沿周向分布的多根杆件。所述限定内管孔的部件与所述多根杆件相连接或者形成一体。所述锥形头27沿周向设有与所述 多根杆件相对应的多个盲孔，所述多根杆件分别插入所述多个盲孔内。进一步的，所述导向件设有沿周向与所述多根杆件相对应的多个轴向穿孔，所述多根杆件分别穿过所述多个轴向穿孔。以此构造，所述导向件能够引导和保持卡爪每一根杆件的方向，避免交叉或弯曲，并且便于将卡爪的多根杆件对准和引入锥形头27的盲孔中。
返回参阅图1，所述手柄23可包括前手柄231和后手柄232，所述前手柄231和后手柄232沿外管21的轴向连接，并通过锁定结构233实现外管21与后手柄232之间相对移动的锁定与释放，以防止操作人员的误操作。也即，所述后手柄232控制外管21的移动(包括前进和后撤)。本实施例中，所述锁定结构233为位于前手柄231上并靠近后手柄232一端的开关，所述开关向后手柄232移动时，部分所述开关插入后手柄232中对应的锁止槽内，限制后手柄232相对于前手柄231的旋转，实现外管21与后手柄232之间相对运动的锁定(关闭)和释放(打开)。
在一非限制性的操作中，当输送装置20被导入到体内预定位置后，将上述开关拨至打开位置，使前手柄231和后手柄232相分离，从而保持前手柄231不动，旋转后手柄232以驱动外管21回撤，暴露出仍被绑扎在内管22周围的支架装置10，然后，转动后手柄232上的控制盘25，当控制盘25转动至某一位置时，即可拉动手柄尾端234处的第一拉环26，由第一拉环26拉动释放控制件34，使释放控制件34依次从多个束缚线圈31和多个缓冲线圈33中脱离，使覆膜支架从近端到远端依次张开，可选的，拉动第一拉环26时可解除第三释放控制机构对覆膜支架近端的束缚，实现支架装置10的一次性释放到预定位置。
在其他实施例中，所述支架装置10的释放过程包括初释放和完全释放。初释放为：当拉动第一拉环26时，使释放控制件34的第一端依次脱离各个束缚线圈31和各个缓冲线圈33，从而释放支架装置10的覆膜段和远端，此时，支架装置10的近端(即支架裸段)仍然被后释放组件24所束缚。初释放后，当拉动手柄尾端234处的第二拉环28时，使后释放组件24沿轴向回撤，从而释放支架装置10的近端，此时，支架装置10的被完全释放。
参阅图1和图7，所述手柄23还包括第一拉环26和第二拉环28。所述第一拉环26的一端连接释放控制件34。所述第二拉环28的一端连接后释放导丝(未图示)，后释放导丝连接后释放组件24。在其他实施例中，所述手柄23也可仅包括一个拉环，即第一拉环26，实现覆膜支架的一次性释放。所述手柄组件还包括锥形头27，所述内管22的近端与锥形头27的远端连接，可选的，所述释放控制件24的第一端与锥形头27可解脱地连接。所述外管21设置在内管22外并覆盖至锥形头27的远端处，也即，锥形头27暴露在外管21外。
参阅图7和图8，并结合图1，所述手柄组件还包括手柄尾端234和控制盘25，所述手柄尾端234与后手柄232的远端相连。所述控制盘25为圆环结构，所述控制盘25套接于手柄尾端234的外侧，并与其转动连接。进一步的，所述手柄组件还包括端盖29，设置于手柄尾端234的远端，用于限制控制盘25沿外管21轴向的移动。所述手柄尾端234上靠近所述控制盘25处沿所述外管21的轴向设有两个横截面为半圆形的凹槽2341，所述第一、第二拉环的拉环杆262和282穿过所述端盖29上的孔分别插入所述两个半圆形的凹槽2341中，所述第一、第二拉环的拉环杆上远离所述控制盘25圆心的一侧均设有限位凸台261、281，在拔出所述拉环杆时，所述控制盘25的内径限制所述限位凸台261、281沿所述外管21轴向的移动，从而使所述拉环杆无法从所述凹槽2341中拔出，所述控制盘25的内径上还设有一与所述限位凸台261、281形状相匹配的释放缺口251，当所述释放缺口251旋转至与一个所述凹槽2341同一位置时，所述拉环杆262、282便能够从同一位置的所述凹槽2341和所述释放缺口251中拔出。
进一步的，所述手柄尾端234的外侧设有一个箭头，所述控制盘25的周侧设有两个数字“1”和“2”。转动控制盘25，当数字“1”与所述箭头对齐时，表示释放缺口251正好与第一拉环26中的拉环杆262所在的半圆形凹槽2341处于同一位置，第一拉环26的拉环杆262便可从所述半圆形凹槽2341中拉出，从而拉动释放控制件34，实现支架装置10的初步释放；当数字“2”与所述箭头对齐时，表示释放缺口251正好与第二拉环28中的拉环杆282所 在的半圆形凹槽2341处于同一位置，第二拉环28的拉环杆282便可从所述半圆形凹槽2341中拉出，从而拉动后释放导丝，实现支架装置10的完全释放。以此构造，能够有效地避免释放错误，提高支架装置10释放的精度。
参阅图4，所述手柄组件还包括外管连接件235、滑块236和导杆237。所述后手柄232与滑块236通过螺纹连接，所述滑块236与导杆237滑动连接，所述导杆237与外管21轴向平行设置，所述滑块236与外管连接件235连接，所述外管连接件235与外管21轴向连接。所述滑块236具有外螺纹，与后手柄232的内螺纹相配合。当旋转后手柄232时，滑块236滑动并带动外管21移动，实现外管21向近端或远端的移动。
应理解，本发明中的覆膜支架可以单独使用，也可以与主体支架配合使用，从而解决覆膜支架在释放过程中的释放张力比较大，较容易出现移位的问题。当与主体支架配合使用时，所述覆膜支架的覆膜段的长度可选为60mm-100mm，更优选为60mm-70mm。另外，可选地，所述释放控制件34为导丝或其他有一定柔性的细长构件。
综上，根据本发明实施例提供的技术方案，通过第一释放控制机构与第二释放控制机构的配合，使得覆膜支架释放后不会出现前移的问题，提高了输送装置释放覆膜支架的精度，使覆膜装置定位准确，从而可有效隔绝瘤体与血流，并可避免因覆膜支架移位而导致正常器官开口或其他血管被封堵的问题，器械的安全性更好。与常规的释放方式相比，本发明去除了用于束缚支架的套管结构，结构更为简单，释放过程也更简便，可有效缩短手术时间，提高手术效率。
本说明书中各个实施例采用递进的方式描述，每个实施例重点说明的都是与其他实施例的不同之处，各个实施例之间相同相似部分互相参见即可。
上述描述仅是对本发明较佳实施例的描述，并非对本发明范围的任何限定，本发明领域的普通技术人员根据上述揭示内容做的任何变更、修饰，均属于本发明的保护范围。

Claims (15)

  1. 一种支架系统，其特征在于，包括：
    支架装置，所述支架装置包括覆膜支架和第一释放控制机构；所述第一释放控制机构包括多个束缚线圈和多个穿孔；所述多个束缚线圈在所述覆膜支架上沿轴向间隔设置；所述多个穿孔设置于所述覆膜支架的远端并沿覆膜支架的周向间隔设置；以及
    输送装置，所述输送装置包括手柄组件和第二释放控制机构；所述手柄组件包括内管、外管和手柄；所述内管用于装载所述支架装置；所述外管设置于所述内管外，并用于覆盖所述支架装置；所述第二释放控制机构包括释放控制件，所述释放控制件的第一端用于依次穿过所述多个穿孔后，进一步自所述支架装置的远端至近端依次穿过所述多个束缚线圈；所述释放控制件的第二端与所述手柄连接，所述释放控制件的第一端被可解脱地设置；
    在拉动所述手柄时，所述释放控制件的第一端从所述多个束缚线圈和所述多个穿孔中依次抽出，以解开所述释放控制件的束缚。
  2. 根据权利要求1所述的支架系统，其特征在于，所述第一释放控制机构包括多个束缚线圈组，多个所述束缚线圈组在所述覆膜支架上沿轴向间隔设置；每个所述束缚线圈组包括两个沿覆膜支架周向布置的束缚线圈，且两个所述束缚线圈由一根线材绕制而成并呈一“8”字形。
  3. 根据权利要求2所述的支架系统，其特征在于，多个所述束缚线圈组设置在所述覆膜支架的同一侧，多个所述束缚线圈组的中心连线在一条直线上并与覆膜支架的轴线平行。
  4. 根据权利要求1-3中任一项所述的支架系统，其特征在于，所述多个束缚线圈缝合在所述覆膜支架的波杆上。
  5. 根据权利要求1-3中任一项所述的支架系统，其特征在于，所述第一释放控制机构还包括多个缓冲线圈，多个所述缓冲线圈缝合在所述覆膜支架的波杆上并沿周向间隔设置，且每个所述缓冲线圈提供一个所述穿孔。
  6. 根据权利要求5所述的支架系统，其特征在于，多个所述缓冲线圈沿 覆膜支架的周向均匀布置。
  7. 根据权利要求1-3中任一项所述的支架系统，其特征在于，所述覆膜支架包括支架裸段和覆膜段；所述多个束缚线圈均设置在所述覆膜段上。
  8. 根据权利要求1-3中任一项所述的支架系统，其特征在于，所述覆膜支架包括支架裸段和覆膜段；所述覆膜段的长度为60mm-100mm。
  9. 根据权利要求1所述的支架系统，其特征在于，还包括限位机构，设置于所述内管上并位于所述支架装置的远端，所述限位机构用于限制所述覆膜支架向远端的移动。
  10. 根据权利要求9所述的支架系统，其特征在于，所述限位机构包括顶管和加强管；所述顶管的远端与所述加强管的近端连接，所述加强管的远端与所述手柄连接；所述顶管的近端用于与所述支架装置的远端相抵靠。
  11. 根据权利要求10所述的支架系统，其特征在于，所述顶管的远端与所述加强管的近端热熔连接，或者，所述顶管的远端与所述加强管的近端螺纹连接。
  12. 根据权利要求11所述的支架系统，其特征在于，所述顶管的内径大于所述加强管的外径，所述加强管的近端插入所述顶管的远端。
  13. 根据权利要求10-12中任一项所述的支架系统，其特征在于，所述顶管的远端与所述加强管的近端热熔连接，所述加强管的近端表面形成有纹路。
  14. 根据权利要求1所述的支架系统，其特征在于，所述手柄包括拉环，所述拉环通过拉杆与所述释放控制件的第二端连接，所述手柄组件还包括锥形头，所述释放控制件的第一端与所述锥形头可解脱连接；
    当拉动所述拉环时，所述释放控制件的第一端与所述锥形头分离并依次从所述多个束缚线圈和所述多个穿孔中抽出。
  15. 根据权利要求1所述的支架系统，其特征在于，所述覆膜支架包括支架裸段和覆膜段；所述输送装置还包括第三释放控制机构，用于束缚所述支架裸段；
    所述第三释放控制机构包括一个约束体和多个通孔，所述多个通孔位于所述支架裸段并沿覆膜支架的周向间隔布置；所述释放控制件的第一端用于 在穿过所述多个束缚线圈之后与所述约束体的一端可解脱地连接，所述约束体的另一端依次穿过所述多个通孔后与所述内管固定连接。
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