WO2023005089A1 - 血流导向支架输送系统 - Google Patents

血流导向支架输送系统 Download PDF

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Publication number
WO2023005089A1
WO2023005089A1 PCT/CN2021/135306 CN2021135306W WO2023005089A1 WO 2023005089 A1 WO2023005089 A1 WO 2023005089A1 CN 2021135306 W CN2021135306 W CN 2021135306W WO 2023005089 A1 WO2023005089 A1 WO 2023005089A1
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WO
WIPO (PCT)
Prior art keywords
catheter
guide wire
delivery system
stent
distal end
Prior art date
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PCT/CN2021/135306
Other languages
English (en)
French (fr)
Inventor
贾晶
张捷捷
吴重草
胡天宙
刘振全
孙冰
Original Assignee
上海暖阳医疗器械有限公司
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.)
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Publication date
Priority claimed from CN202121760308.8U external-priority patent/CN215384918U/zh
Priority claimed from CN202121770600.8U external-priority patent/CN215384919U/zh
Priority claimed from CN202121761594.XU external-priority patent/CN215505037U/zh
Application filed by 上海暖阳医疗器械有限公司 filed Critical 上海暖阳医疗器械有限公司
Publication of WO2023005089A1 publication Critical patent/WO2023005089A1/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
    • A61F2/95—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

Definitions

  • Blood flow steering device is an emerging interventional treatment method for intracranial aneurysms in recent years. Its principle is to reconstruct the correct path of blood vessels at the aneurysm and restore the direction of blood flow.
  • the blood flow guiding device is generally used in conjunction with a self-expandable stent and a delivery device.
  • the self-expandable stent is delivered to the position of the intracranial aneurysm through a microcatheter and released, and then guides the blood flow to reduce blood entering the aneurysm and induce aneurysms.
  • the Chinese invention patent with application number CN202110093968.3 proposes a fixed and maintained structure for intravascular implants and a delivery system for intravascular implants. Fixation, retention and separation of implants during delivery.
  • the intravascular implant delivery system includes: a delivery tube, a guide wire running through the delivery tube, and a support connected to the guide wire.
  • the guide wire and the delivery tube remain relatively fixed, and the supporter is located at the head of the delivery tube and plays a role in fixing the implant; out, the implant is released.
  • the implant can be retracted to the adjusted position in the delivery tube through the guide wire and released again.
  • the distal end of the stent is a free end, which is not fixed with the guide wire, and there is no binding mechanism, which leads to easy shrinkage during assembly and other processes, and it is inconvenient to control the stent when it is released, and it is easy to damage the blood vessel.
  • the setting of the buckle section on the handle of the application is convenient for grasping and holding during the operation; it combines the split groove, V-shaped opening and hole, and when the vascular sheath exits the body, the outer sheath tube is easy to tear apart without effort The resistance is small, and the operation effect is improved.
  • the sheath tube of this structure is torn apart, it is manually torn by pulling the buckles on both sides. When tearing, excessive force is required, and it is difficult to control the force and tear length. If the system shakes, it is not conducive to the positioning of the blood flow guiding stent system, and it is easy to damage the inner wall of the blood vessel.
  • Chinese invention patent application CN104546243A discloses a one-handed vascular stent delivery system, which includes a catheter unit and a delivery unit.
  • the catheter unit is composed of an inner tube and an outer tube.
  • the delivery unit includes: a housing, an outer tube and a housing Connection, there is an adjustment mechanism in the housing, the inner tube is connected with the adjustment mechanism, the adjustment mechanism includes a guide rail, a slide button, a connecting pipe and a locking mechanism, the guide rail is set in the inner cavity of the housing, and the side wall of the guide rail is provided with a guide groove .
  • a sliding button is arranged on the top of the housing, and anti-slip lines are provided on the grip end; guide rails and pressure springs are arranged inside the housing.
  • the guide part under the slider can slide in the guide rail, and the compression spring is used to assist the reset of the slider; there is a locking seat between the housing and the slider, and the locking seat is provided for the guide wire to pass through.
  • the through hole passed through; the guide part at the lower end of the slide button is provided with a connecting tube, and the guide wire passes through the through hole of the locking seat and then penetrates into the connecting tube.
  • the purpose of the present invention is to solve the problems in the prior art, and propose a blood flow guiding stent delivery system.
  • An elastic support structure is provided at the far end of the dense mesh stent so that when the dense mesh stent is pushed to the far end, there is a force point at the far end. Walk forward to avoid accumulation of stent in catheter.
  • the present invention proposes a blood flow guiding stent delivery system, including a catheter, a guide wire, a convex part, and a dense mesh bracket; the guide wire can be movably arranged in the catheter; the convex part is fixed On the guide wire and near the proximal end of the dense mesh support, the protrusion can be controlled by the guide wire to move in the inner cavity of the distal end side of the catheter; the proximal end of the dense mesh support It is clamped between the convex part and the catheter, and the push of the dense mesh support is controlled by the guide wire; the distal end of the dense mesh support is supported and fixed by an elastic support structure, and the elastic support structure is fixed It is arranged on the guide wire, and also includes a sheath sleeved on the outside of the catheter, the sheath is slidably connected to the catheter, and the distal end of the dense mesh support is clamped on the elastic support structure between the sheath.
  • the handle includes a handle body and a release switch movably arranged on the handle body, the proximal end of the guide wire is connected to the release switch and the guide wire can be controlled by the release switch.
  • the wire moves relative to the lumen of the catheter.
  • the catheter includes a catheter body with a certain inner diameter, and a catheter head with an enlarged inner diameter located at the distal end of the catheter body, the inner diameter of the catheter head is slightly larger than the outer diameter of the protrusion, the The inner diameter of the main body of the catheter is smaller than the outer diameter of the convex part; at the initial stage of delivery of the dense mesh stent, the convex part is located at the head of the catheter and plays a role in fixing the dense mesh stent.
  • the guide wire is further provided with a limit block adjacent to the protrusion, the limit block is also located at the catheter head and is closer to the catheter body relative to the protrusion, the The maximum radial dimension of the stop block is larger than the inner diameter of the catheter body, so as to limit the tendency of the protrusion to move from the distal end toward the proximal end of the catheter.
  • the catheter is a non-integrated structure, including a spiral tube, a head sleeve connected to the distal end of the spiral tube, and a sleeve sleeved on the outside of the spiral tube.
  • the inner diameter is larger than the inner diameter of the helical tube, the head-end sleeve forms the catheter head, and the helical tube and the sleeve together form the catheter main body.
  • the proximal end of the catheter is provided with a plurality of catheter openings disposed therethrough.
  • radiographic imaging points are provided on the guide wire at positions corresponding to both ends of the dense mesh support.
  • a sheath tube is also included, the sheath tube includes a sheath tube body and a catheter disposed in the sheath tube body, the sheath tube body can slide axially relative to the catheter tube, and the sheath tube body is close to A notch is provided on the side of the end, the proximal end of the catheter extends out of the sheath tube body, and the extension part is provided with a sheath that can cooperate with the notch to expand the notch when the sheath tube body is withdrawn Tube push-off mechanism, the outer diameter of the sheath push-off mechanism is larger than the outer diameter of the catheter and the inner diameter of the sheath body, the sheath body has elasticity, and the gap can be automatically reset in a natural state.
  • a guide wire is provided inside the catheter, and a dense-mesh stent is provided at the distal end of the guide wire, and the dense-mesh stent is a self-expanding stent, and the movement of the sheath body relative to the stent can control the movement of the stent expansion and contraction.
  • the sheath tube body is made of PTFE, ePTFE, PET or DACRON polyester.
  • the distal end of the sheath push-off mechanism is provided with a tapered head whose diameter gradually expands from the distal end to the proximal end.
  • the side wall of the sheath tube body is provided with a tear mark connected to the notch, and the tear mark does not penetrate or partially penetrates the side wall of the sheath tube body.
  • the handle body includes a first shell and a second shell that engage with each other, and a release switch sandwiched between the first shell and the second shell is disposed in the second shell
  • the chute on the wall, the top of the release switch is exposed from the top of the handle body, the bottom of the release switch can slide in the chute, the bottom near end of the release switch is connected with a tension spring, the The bottom distal end of the release switch is provided with a guide wire groove for the guide wire to pass through, and the proximal end of the guide wire is fixedly connected to the bottom proximal end of the release switch;
  • Cover body a guide body arranged between the handle body and the cover body, the guide body has a through hole for the guide wire to pass through; and an expansion stress tube nested in the cover body at one end, and the The distal end of the cover body extends outwards, and the expansion stress tube has an outer diameter gradually decreasing from the proximal end to the distal end; wherein, through the sliding of the release switch along the length direction of
  • the length of the part of the expansion stress tube extending outward from the distal end of the cover body is greater than the length of the part of the expansion stress tube nested in the cover body.
  • the expansion stress tube is made of silicone.
  • the first housing and the second housing jointly form a slot for the release switch to slide, and a removable safety device is preset in the slot to prevent the release switch from slipping accidentally.
  • the guide body has a large end and a cylindrical portion, the guide body is clamped to the distal end portions of the first housing and the second housing through the large end, and the cylindrical portion is connected to the The distal end portions of the first shell and the second shell protrude outward, and are fixed to the hypotube outside the guide wire through the cylindrical portion.
  • the cylindrical part of the guide body has a slot, and the cylindrical part and the hypotube are fixed by applying glue at the slot.
  • the proximal end of the tension spring is fixed to the protrusion in the second housing, and the other end is fixed to the bottom proximal end of the release switch.
  • the proximal end of the guide wire is fixedly connected to the bottom proximal end of the release switch by dispensing glue.
  • the first shell and the second shell are connected through a buckle slot; the cover is screwed to the handle body.
  • anti-slip lines are provided on the bottom outer wall of the handle body opposite to the release switch.
  • the blood flow guiding stent delivery system is a delivery system for treating vascular lesions by establishing vascular access and delivering stents or other implants to the lesion.
  • the handle of the delivery system is used for the delivery of intravascular implants, which reduces the difficulty of the operation during the operation of the doctor, thereby improving the success rate of the operation.
  • an elastic support structure is provided at the distal end of the dense mesh support so that when the dense mesh support is pushed to the distal end, there is a force point at the distal end to move forward, so as to avoid the accumulation of the support in the catheter.
  • the structure is simple, the use is more convenient, and the production cost is lower.
  • the sheath body of the present application is elastic, and the notch can be automatically restored, so that after the sheath body is withdrawn, the catheter can be re-covered through the side notch, so that the notch can be pushed distally again and the stent can be shrunk into the sheath body.
  • a handle of a blood flow guiding stent delivery system by setting an expansion stress tube with one end nested in the cover body and the other end extending outward from the distal end of the cover body, the bending of the guide wire in this area is effectively avoided; further Specifically, a guide body for the guide wire to pass through is provided between the handle body and the cover body, the guide body not only realizes the guidance of the guide wire head end in the handle, but also realizes the fixed connection with the outer hypotube of the guide wire; Furthermore, the utility model also prevents accidental sliding of the switch by presetting a safety device at the far end of the switch. Easy to operate, high safety rate, high success rate.
  • Fig. 3 is a schematic structural view of the blood flow steering stent delivery system in the embodiment of Fig. 2 when it is located in a blood vessel.
  • FIG. 6 is an enlarged structural schematic diagram of part A in FIG. 1 .
  • Fig. 7 is a schematic structural diagram of the third embodiment.
  • Fig. 8 is a schematic diagram showing an enlarged structure of a part of a blood flow steering stent delivery system according to the present invention.
  • Fig. 9 is a schematic diagram of a sheath structure of a blood flow guiding stent delivery system according to the present invention.
  • Fig. 10 is a schematic structural diagram of Embodiment 5 of a blood flow steering stent delivery system according to the present invention.
  • Fig. 11 is a schematic diagram of the overall structure of the handle of the blood flow guiding stent delivery system provided according to a preferred embodiment of the present invention.
  • Fig. 12 is a schematic diagram of the internal structure of the handle shown in Fig. 11;
  • Fig. 13 is an exploded view of the handle shown in Fig. 11 .
  • Figure 1-7 is: 1-catheter, 2-guide wire, 3-convex part, 4-dense mesh support, 5-elastic support structure, 6-handle, 7-sheath, 8-limiting block, 11 -catheter opening, 21-radiography point, 61-handle body, 62-release switch, 101-catheter body, 102-catheter head, 103-spiral tube, 104-head end sleeve, 105-sleeve.
  • Figures 8-10 are: 1-sheath tube body, 2-catheter, 3-sheath tube pushing mechanism, 4-bracket, 5-guide wire, 11-notch, 12-tear mark, 31-taper head.
  • Figure 11-13 is: 1-handle body; 2-cover body; 3-expansion stress tube; 11-first shell; 12-second shell; 13-release switch; 14-anti-slip pattern; 15-slot ; 16-extension spring; 17-protrusion; 18-guide wire groove; 19-guide body.
  • first, second, third, etc. are only used for distinguishing descriptions, and should not be construed as indicating or implying relative importance. . Thus, a feature defined as “first” and “second” may explicitly or implicitly include one or more of these features.
  • “plurality” means two or more, unless otherwise specifically defined. "Several” means one or more than one, unless otherwise clearly and specifically defined.
  • the terms “installation”, “installation”, “connection” and “connection” should be understood in a broad sense, for example, it may be a fixed connection, It can also be a detachable connection or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediary, and it can be the internal communication of two components.
  • installation e.g., it may be a fixed connection, It can also be a detachable connection or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediary, and it can be the internal communication of two components.
  • the term “clinician” refers to a doctor, surgeon, nurse, or any other care provider, and may include support personnel.
  • proximal shall refer to the portion of the device or component thereof that is closer to the clinician and the term “distal” shall refer to the portion of the device or component thereof that is further from the clinician.
  • a blood flow guiding stent delivery system includes a catheter 1 , a guide wire 2 , a convex portion 3 , and a dense mesh stent 4 .
  • the guide wire 2 can be flexibly arranged in the catheter 1 .
  • the convex part 3 is fixed on the guide wire 2 and is arranged close to the proximal end of the dense mesh support 4 , and can be controlled by the guide wire 3 to move the convex part 3 in the lumen of the distal end side of the catheter 1 .
  • the proximal end of the dense-mesh stent 4 is clamped between the convex portion 3 and the catheter 1 , and the push of the dense-mesh stent 4 is controlled by the guide wire 1 .
  • the distal end of the dense mesh support 4 is supported and fixed by an elastic support structure 5 . It also includes a sheath tube 7 sleeved outside the catheter 1 . The sheath tube 7 is slidably connected with the catheter 1 . The distal end of the dense mesh stent 4 is clamped between the elastic support structure 5 and the sheath tube 7 .
  • the catheter 1 is a hypotube
  • the sheath 7 is a sheath/microcatheter.
  • the convex part 3 is located in the catheter 1, and the convex part 3 cooperates with the inner wall of the catheter 1 to clamp the proximal end of the dense mesh support 4, and the elastic support structure 5 is sleeved on it.
  • the outer sheath tube 7 cooperates to clamp the distal end of the dense mesh support 4; in the later stage of delivery of the dense mesh support 4, the dense mesh support 4 protrudes from the microcatheter, the binding force of the distal end of the dense mesh support 4 is lost, and the dense mesh support 4 The distal end is stretched to fit the inner wall of the blood vessel, and the push is continued, the convex part 3 is detached from the catheter 1, the binding force of the proximal end of the dense mesh stent 4 is lost, and the dense mesh stent 4 can be fully stretched to fit the inner wall of the blood vessel, realizing a self-expanding stent (that is, the release of the dense mesh stent) to treat the aneurysm.
  • a self-expanding stent that is, the release of the dense mesh stent
  • the dense-mesh stent 4 when the dense-mesh stent 4 is not fully deployed, the proximal end of the dense-mesh stent 4 is still connected to the convex part 3, and the dense-mesh stent 4 can be recovered into the catheter through the guide wire 2.
  • the elastic support structure 5 By setting the elastic support structure 5 at the distal end of the dense mesh support 4, when the dense mesh support 4 is pushed to the distal end, there is a force point at the distal end to move forward, so as to avoid accumulation of the support in the catheter.
  • Two connecting points of the elastic support structure 5 and the convex part 3 are set, double insurance, and the dense mesh support 4 at either end can be pulled back into the catheter through the guide wire 2 if the dense mesh support 4 is accidentally detached.
  • the elastic support structure 5 is directly arranged on the guide wire 2, so the structure is simple, the use is more convenient, and the production cost is lower.
  • the catheter 1 in this embodiment is a hypotube. And its flexibility gradually increases from the proximal end to the distal end.
  • the sheath 7 in this embodiment is a sheath/microcatheter.
  • a handle 6 is also included.
  • the handle 6 includes a handle body 61 and a release switch 62 movably arranged on the handle body 61 .
  • the proximal end of the catheter 1 is connected to the handle body 61 .
  • the proximal end of the guide wire 2 is connected to the release switch 62 and the relative movement of the guide wire 2 along the lumen of the catheter 1 can be controlled by the release switch 62 .
  • the handle 6 is provided to facilitate the control of the push of the guide wire 2, thereby controlling the push and release of the dense mesh support 4, and the movement of the guide wire 2 can be controlled by pushing and pulling the release switch 62.
  • the release switch 62 is not limited to this form, and any other suitable form can also be selected, as long as the delivery of the guide wire 3 can be achieved.
  • the dense mesh support is a braided support with 36 or 72 wires, braided by cobalt-chromium alloy wires and more than 8 developing wires, and the metal coverage is about 35%.
  • the overall diameter is basically unchanged
  • the cross-sections of the proximal end and the distal end of the stent are basically perpendicular to the axis of the stent
  • diamond-shaped meshes are formed between the braided wires, and the mesh density is uniform.
  • the catheter 1 includes a catheter body 101 with a certain inner diameter, and a catheter head 102 with an enlarged inner diameter located at the distal end of the catheter body 101 .
  • the inner diameter of the catheter head 102 is slightly larger than the outer diameter of the protrusion 3 .
  • the inner diameter of the catheter body 101 is smaller than the outer diameter of the protrusion 3 .
  • the convex part 3 is located at the catheter head 102 and plays a role in fixing the dense mesh stent 4 .
  • the catheter main body 101 is set as two parts with different inner diameters, which can cooperate with the convex part 3 to play a position-limiting role.
  • the convex part 3 can only move along the inner cavity of the catheter head 102 whose inner diameter is larger than that, and cannot slide to the catheter main body 101 Inside.
  • the catheter main body 101 and the catheter head 102 can be integrally formed, or can be a split structure connected by bonding, clamping, welding and the like.
  • the helical tube 103 and the head-end sleeve 104 can be two types of tubes of different sizes, the outer diameter of the distal end of the helical tube 103 is roughly equivalent to the inner diameter of the head-end sleeve 104, and the connecting part 106 overlaps a part or connects without overlapping.
  • the connecting part 106 overlaps a part or connects without overlapping.
  • the mouth of the distal end of the head sleeve 104 is tapered and arc-shaped, and there is no step at the mouth of the mouth; the cross section of the connecting part 106 is triangular, and the two sides are respectively on the side of the spiral tube 103 and the head sleeve 104.
  • the proximal section of the cross-section eliminates the step formed by the splicing of the two; the connecting part 106 is formed when the spiral tube 103 and the head-end sleeve 104 are welded or bonded, and its material can be the same as that of the spiral tube 103 and the head-end sleeve 104, or can be For other commonly used welding or bonding materials.
  • the sleeve 105 is made of a polymer material, and is tightly connected with the spiral tube 103 by bonding, heat sealing or integral molding;
  • the polymer material includes but is not limited to polyethylene, polyoxymethylene, polyurethane, polyester, polytetrafluoroethylene , fluorinated ethylene propylene copolymer, polyamide, polyimide or nylon, preferably polytetrafluoroethylene.
  • radiographic development points 21 are provided on the guide wire 2 corresponding to both ends of the dense mesh support 4 . It is convenient to confirm the position of the dense mesh support 4, and it is convenient to locate and release the dense mesh support 4.
  • the notch 71 has a length of 400 mm.
  • the distal end of the catheter ejection mechanism 9 is provided with a conical head whose diameter gradually expands from the distal end to the proximal end. And the cone head is fixed with glue.
  • the convex part 3 is located in the catheter 1, and the convex part 3 cooperates with the inner wall of the catheter 1
  • the proximal end of the dense mesh support 4 is clamped, and the elastic support structure 5 cooperates with the outer catheter to clamp the distal end of the dense mesh support 4; in the later stage of delivery of the dense mesh support 4, the dense mesh support 4 extends from the catheter , the binding force of the distal end of the dense mesh stent 4 is lost, the distal end of the dense mesh stent 4 is stretched to fit the inner wall of the blood vessel, and the push is continued, the convex part 3 is separated from the catheter 1, the binding force of the proximal end of the dense mesh stent 4 is lost, and the dense mesh The stent 4 can be fully stretched to fit the inner wall of the blood vessel, so as to realize the release of
  • the sheath tube in Embodiment 1 of the present invention includes a sheath tube body 1 and a catheter 2 disposed in the sheath tube body 1 .
  • the sheath body 1 is axially slidable relative to the catheter 2 .
  • a notch 11 is provided on the proximal side of the sheath tube body 1 .
  • the proximal end of the catheter 2 extends out of the sheath body 1 and the extended part is provided with a sheath opening mechanism 3 that can cooperate with the notch 11 to expand the notch 11 when the sheath body 1 is withdrawn.
  • the outer diameter of the sheath pushing mechanism 3 is larger than the outer diameter of the catheter 2 and the inner diameter of the sheath body 1 .
  • the sheath body 1 is elastic.
  • the gap 11 can be automatically reset under the natural state.
  • a notch 11 is provided at the proximal end of the sheath tube body 1, and a sheath tube push-off mechanism 3 matched with the notch 11 is provided.
  • the entire sheath tube body 1 completely covers the catheter 2; when the sheath tube body 1 When withdrawing to the proximal end, the sheath tube pushing mechanism 3 pushes back the gap at the proximal end of the sheath tube and releases the dense mesh stent without manual tearing by the doctor. The retraction of the sheath tube body 1 is more convenient.
  • a guide wire 5 is arranged inside the catheter 2 .
  • the distal end of the guide wire 5 is provided with a dense mesh support 4 .
  • the dense mesh support 4 is a self-expanding dense mesh support. The movement of the sheath body 1 relative to the dense-mesh stent 4 can control the expansion and contraction of the dense-mesh stent 4 .
  • the sheath body 1 is made of PTFE, ePTFE, PET or DACRON polyester. PTFE is preferred.
  • the distal end of the sheath ejection mechanism 3 is provided with a conical head 31 whose diameter gradually expands from the distal end to the proximal end.
  • the setting is convenient to cooperate with the sheath body 1 and the notch 11, and the tip of the cone head 31 is convenient to extend into the sheath body 1, and the distal end of the sheath body 1 is expanded through the tapered surface with gradually enlarged diameter, and the opening process is smoother and labor-saving .
  • the tear mark 12 can be a groove opened on the side wall of the sheath tube body 1, or it can be a crease formed by pressing, as long as the sheath tube body 1 is torn along the tear mark 12, the groove road does not penetrate the sheath
  • the side wall of the tube body 1 is arranged so that the tear mark 12 of the sheath tube body 1 is closed under normal conditions, and can be torn along the tear mark 12 when tearing, and the tearing process is smoother, avoiding distortion and tearing.
  • the whole sheath body 1 completely covers the catheter 2; when the sheath body 1 is withdrawn to the proximal end, the sheath The tube push-off mechanism 3 pushes back the gap at the proximal end of the sheath tube, and the tip of the cone head 31 is convenient to extend into the sheath tube body 1, and expands the distal end of the sheath tube body 1 through the tapered surface with gradually enlarged diameter, and releases the dense mesh
  • the stent does not need to be torn apart manually by the doctor.
  • the handle body 1 mainly includes: a first housing 11 , a second housing 12 , a release switch 13 , a tension spring 16 , and a guide body 19 .
  • a guide body 19 is also provided between the handle body 1 and the cover body 2. There is a through hole for the guide wire to pass through in the guide body 19.
  • the guide body 19 has a large end and a cylindrical portion. The guide body 19 passes through the large end. Clipped on the distal ends of the first housing 11 and the second housing 12, the cylindrical part protrudes outward from the distal ends of the first housing 11 and the second housing 12, and through the cylindrical part and the A hypotube (not shown) outside the guidewire is secured.
  • the length of the part of the expansion stress tube 3 extending outward from the distal end of the cover body 2 is greater than the length of the part nested in the cover body 2 .
  • the expansion stress tube 3 is made of silicone.
  • the first housing 11 and the second housing 12 jointly form a slot for the release switch 13 to slide, and a removable safety device is preset in the slot to prevent the release switch 13 from slipping accidentally.
  • the safety device is a detachable clip, which can be pulled out when the release switch needs to be toggled.
  • the cylindrical part of the guide body 19 has a slot, and the cylindrical part and the hypotube are fixed by applying glue at the slot.
  • extension spring 16 is fixed with the protrusion 17 in the second housing 11, and the other end is fixed with the near end of release switch 13.
  • the proximal end of the guide wire is fixedly connected to the bottom proximal end of the release switch 13 by dispensing glue.
  • Anti-slip lines 14 are provided on the outer wall of the bottom of the handle body 1 opposite to the release switch 13 to facilitate manual operation.
  • the periphery of the cover body 2 is provided with an anti-slip wall 21, and the cover body 2 needs to be rotated when it is connected with the handle body 1, and the anti-slip wall 21 prevents fingers from slipping during rotation.

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Abstract

一种血流导向支架输送系统，包括导管（1）、导丝（2）、凸部（3）、密网支架（4）；密网支架（4）的近端被夹持在凸部（3）与导管（1）之间，并通过导丝（2）控制密网支架（4）推送；密网支架（4）的远端通过弹性支撑结构（5）支撑固定，弹性支撑结构（5）固定设于导丝（2）上，且密网支架（4）的远端可被夹持在弹性支撑结构（5）和设于弹性支撑结构（5）外的鞘管（7）之间。通过将密网支架（4）远端设置弹性支撑结构（5）使得密网支架（4）向远端推送的时候远端有个受力点往前走，避免支架堆积在导管（1）内。设置弹性支撑结构（5）和凸部（3）两个连接点，双保险，任一端密网支架（4）意外脱离都能通过导丝（2）将密网支架（4）回拉回导管（1）内。结构简单，使用更方便，生产成本更低。

Description

一种血流导向支架输送系统 【技术领域】
本发明涉及血管治疗设备的技术领域，特别是血流导向支架输送系统的技术领域。
【背景技术】
动脉瘤是一种常见且危险性极高的血管疾病，目前针对其的治疗方式除手术外，血管内介入由于其微创、高效的优势正得到越来越多的关注和应用。血流导向装置是近几年新兴的颅内动脉瘤介入治疗方法，其原理为重建动脉瘤处血管的正确路径、恢复血流方向。血流导向装置一般是由自膨式支架与输送装置配合使用，通过微导管将自膨式支架输送至颅内动脉瘤的位置并释放，进而引导血液流向来减少血液进入瘤体，诱发瘤体形成血栓、降低其破裂风险。其中输送装置的输送效率和准确性极大地影响了手术的成功率，现有的输送系统偶见支架因受力不均发生变形或扭转，或因输送装置与支架之间的相互作用而发生勾丝等问题，有一定的失败率；而支架定位不准确时需要及时回撤进行二次释放，输送系统需要具有反复回撤和重新释放的功能，并保证此过程的安全性。
其中，申请号为CN202110093968.3的中国发明专利提出了一种血管内植入物固定保持结构和一种血管内植入物输送系统，血管内植入物固定保持结构用于在血管内植入物输送过程中进行植入物的固定、保持及分离动作。血管内植入物输送系统包括：输送管，贯穿输送管的导丝，及连接在导丝上的支持器。在输送初期，导丝与输送管保持相对固定，支持器位于输送管头部并对植入物起固定作用；在输送后期，导丝与输送管发生相对运动，支持器从输送管头部 伸出，植入物实现释放。当植入物伸出输送管远端长度不超过一定数值时，植入物可通过导丝回收至输送管内调整位置重新释放。但这种输送方式输送支架时，支架远端为自由端，不与导丝固定，也没有束缚的机构，导致装配等过程中易皱缩，支架在释放时也控制不便，易伤到血管。
现有技术中的鞘管是一种高分子管，可滑动地设置于导丝外，并将导丝远端的支架容纳在其远端内腔中，控制自膨胀支架的释放与回收。为了释放支架，需要将鞘管回撤。但是由于手柄的限制，需医生手动撕开才能后撤；然而，管状结构使其并不便于被手动撕开。
其中，申请号为CN209847254U的中国实用新型专利就提出了一种方便撕开的血管鞘外鞘管。包括鞘管、手柄、止血阀和三通管；止血阀设置于鞘管的末端；三通管设置于止血阀上，并与止血阀的中间相连通；手柄包括环扣段及连接段；连接段的中前段部位与环扣段相连接；环扣段另一侧面的前部设有开口；连接段内侧壁上设有相互对称的沿连接段延伸方向设置的裂槽；裂槽后端的连接段上设有V型开口；沿着裂槽走向的连接段上均匀设有裂洞。该申请手柄上环扣段的设置，方便在手术过程中抓握拿持使用；其结合裂槽、V型开口和孔洞，在血管鞘退出体内时，外鞘管的撕开不费劲，容易操作阻力小，提高手术效果。但这种结构的鞘管撕开时通过拉住两侧环扣手动撕开，撕开时需要过度用力，不易控制力度和撕开长度，易撕过头，且撕开时易使血流导向支架系统发生晃动，不仅不利于血流导向支架系统的定位，且易使血管内壁受损。
近年来，随着介入材料和技术的发展，通过建立血管通路输送支架或植入物，治疗血管病变显著提高了闭塞血管再通率，延长了治疗时间窗，显示了良好的应用前景。
中国发明专利申请CN104546243A公开了一种单手握持式的血管支架输送系统，其包括导管单元和输送单元，导管单元由内管和外管组成，输送单元包括： 壳体，外管与壳体连接，壳体内具有一调节机构，内管与调节机构相连，调节机构包括导向轨、滑钮、连接管和锁定机构，导向轨设置于壳体的内腔，导向轨的侧壁设有导向槽。壳体上方设有滑钮，握持端设有防滑纹；壳体内设有导向轨和压簧。向远端推动滑钮时，滑钮下方的导向部可以在导向轨中滑动，压簧用于辅助滑钮复位；壳体和滑钮之间设有锁定座，锁定座设有供导丝穿过的通孔；滑钮下端的导向部内设有连接管，导丝穿过锁定座的通孔后穿入连接管。
然而，该血管支架输送系统的缺陷在于，在输送过程中，位于壳体前端的导丝容易发生弯折，这给血管内植入物的输送带来不便，此外，该血管支架输送系统还存在支架意外释放的可能性。
【发明内容】
本发明的目的就是解决现有技术中的问题，提出一种血流导向支架输送系统，密网支架远端设置弹性支撑结构使得密网支架向远端推送的时候远端有个受力点往前走，避免支架堆积在导管内。
为实现上述目的，本发明提出了一种血流导向支架输送系统，包括导管、导丝、凸部、密网支架；所述导丝可活动设于所述导管内；所述凸部固定设于所述导丝上，且临近所述密网支架的近端设置，可通过所述导丝控制所述凸部在所述导管的远端侧内腔中移动；所述密网支架的近端被夹持在所述凸部与所述导管之间，并通过所述导丝控制所述密网支架推送；所述密网支架的远端通过弹性支撑结构支撑固定，所述弹性支撑结构固定设于所述导丝上，还包括套设于所述导管外的鞘管，所述鞘管与所述导管可滑动连接，所述密网支架的远端被夹持于所述弹性支撑结构与所述鞘管之间。
作为优选，还包括手柄，所述手柄包括手柄本体和可活动设于所述手柄本体上的释放开关，所述导丝近端与所述释放开关连接并可通过所述释放开关控制所述导丝沿所述导管内腔相对运动。
作为优选，所述的导管包括具有一定内径的导管主体，以及位于所述导管主体远端的、具有扩大内径的导管头部，所述导管头部内径略大于所述凸部外径，所述导管主体内径小于所述凸部外径；所述密网支架输送初期，所述凸部位于所述导管头部并对所述密网支架起固定作用。
作为优选，所述的导丝上还设有一个邻近所述凸部的限位块，所述限位块同样位于所述导管头部并相对所述凸部更靠近所述导管主体，所述限位块的最大径向尺寸大于所述导管主体的内径，以限制所述凸部自所述导管的远端朝向近端运动的趋势。
作为优选，所述的导管为非一体成型结构，包括螺旋管、与所述螺旋管远端连接的头端套筒、套设于所述螺旋管外侧的套管，所述头端套筒的内径大于所述螺旋管的内径，所述头端套筒构成所述导管头部，所述螺旋管与所述套管共同构成所述导管主体。
作为优选，所述的导管近端设有若干贯穿设置的导管开口。
作为优选，所述的导丝上与所述密网支架两端对应位置处均设有射线下显影点。
作为优选，还包括一鞘管，所述鞘管包括鞘管本体和设于所述鞘管本体内的导管，所述鞘管本体可相对于所述导管轴向滑动，所述鞘管本体近端侧面设有豁口，所述导管近端延伸至所述鞘管本体外且该延伸出部分设有可以与所述豁口配合的以在所述鞘管本体回撤时撑开所述豁口的鞘管顶开机构，所述鞘管顶开机构外径大于所述导管外径和所述鞘管本体内径，，所述鞘管本体具有弹性，所述豁口自然状态下可自动复位。
作为优选，所述导管内设有导丝，所述的导丝远端设有密网支架，所述密网支架为自膨支架，所述鞘管本体相对于支架的移动可控制所述支架的展开与收缩。
作为优选，所述的鞘管本体为PTFE、ePTFE、PET或DACRON聚酯制成。
作为优选，所述的鞘管顶开机构远端设有由远端至近端直径逐渐扩大的锥头。
作为优选，所述的鞘管本体侧壁设有与所述豁口连接的撕痕，所述撕痕不贯穿或部分贯穿所述鞘管本体侧壁设置。
作为优选，所述手柄本体，其包括相互卡接的第一壳体和第二壳体，夹置于第一壳体和第二壳体之间的释放开关，设置于所述第二壳体内壁上的滑槽，所述释放开关的顶部从手柄本体的上方露出，所述释放开关的底部可在所述滑槽内滑移，所述释放开关的底部近端与一拉簧连接，所述释放开关的底部远端设有供导丝穿过的导丝槽，所述导丝的近端与所述释放开关的底部近端固定连接；与所述手柄本体的远端连接的锥形盖体；设置于所述手柄本体和盖体之间的导向体，所述导向体具有供导丝穿过的通孔；以及一端嵌套于所述盖体内的扩张应力管，另一端从所述盖体的远端向外延伸，所述扩张应力管具有自近端向远端逐渐减小的外径；其中，通过所述释放开关沿手柄本体长度方向的滑移，可实现导丝的输送和撤回，进而实现血管内植入物的施放。
所述扩张应力管自所述盖体的远端向外延伸的部分的长度大于所述扩张应力管嵌套于所述盖体内的部分的长度。
优选地，所述扩张应力管由硅胶制成。
优选地，所述第一壳体和第二壳体共同形成供所述释放开关滑移的开槽，所述开槽处预设可移除的保险装置，以避免释放开关意外滑动。
优选地，所述导向体具有大头端和柱形部，所述导向体通过大头端卡接于所述第一壳体和第二壳体的远端端部，所述柱形部从所述第一壳体和第二壳体的远端端部向外伸出，并通过该柱形部与导丝外侧的海波管固定。
优选地，所述导向体的柱形部具有开槽，所述柱形部与所述海波管通过在 开槽处施加点胶固定。
优选地，所述拉簧的近端与所述第二壳体内的凸起固定，另一端与所述释放开关的底部近端固定。
优选地，所述导丝的近端与所述释放开关的底部近端通过点胶固定连接。
优选地，所述第一壳体和第二壳体通过卡扣卡槽相连；所述盖体与手柄本体之间螺纹连接。
优选地，所述手柄本体上与所述释放开关相对的底部外壁上设有防滑纹。
应当理解的是，血流导向支架输送系统是一种通过建立血管通路，向病变位置输送支架或其他植入物以实现对血管病变进行治疗的输送系统，本实用新型正是提供一种针对该输送系统的手柄，用于血管内植入物的施放，降低医生操作过程中手术难度，进而提高手术成功率。
本发明一种血流导向支架输送系统的有益效果：
1、本发明通过将密网支架远端设置弹性支撑结构使得密网支架向远端推送的时候远端有个受力点往前走，避免支架堆积在导管内。设置弹性支撑结构和凸部两个连接点，双保险，任一端密网支架意外脱离都能通过导丝将密网支架回拉回导管内。结构简单，使用更方便，生产成本更低。
2、将鞘管本体近端设置豁口，并设置与豁口配合的鞘管顶开机构，原始状态时，整根鞘管本体完整包覆导管；当鞘管本体向近端回撤时，鞘管顶开机构将鞘管近端的豁口顶开，并释放密网支架，无需医生手动撕开，力度控制更灵活，无需过度用力。鞘管本体回撤更方便。且本申请鞘管本体具有弹性，豁口能够自动复原，使得鞘管本体回撤后还能通过侧面豁口重新包覆导管，从而使豁口能够重新向远侧推进并将支架收缩到鞘管本体内。
3、一种血流导向支架输送系统的手柄，通过设置一端嵌套于盖体内、另一端从盖体远端向外延伸的扩张应力管，有效避免了导丝在该区域的弯折；进一步地，在手柄本体和盖体之间设置供导丝穿过的导向体，该导向体既实现了导丝头端在手柄内的导向，还实现了与导丝外侧海波管的固定连接；更进一步地，本实用新型还通过在开关远端预设保险装置，防止了开关的意外滑动。操作方便的、安全率高的、成功率高。
本发明的特征及优点将通过实施例结合附图进行详细说明。
【附图说明】
图1是本发明一种血流导向支架输送系统整体结构示意图。
图2是本发明一种血流导向支架输送系统实施例三结构示意图。
图3是图2实施例中血流导向支架输送系统位于血管内时的结构示意图。
图4是图2实施例中血流导向支架输送系统位于血管内弹性支撑结构松开时的结构示意图。
图5是图2实施例中血流导向支架输送系统位于血管内弹性支撑结构和凸部均松开时的结构示意图。
图6是图1中A部分放大后结构示意图。
图7是实施例三的结构示意图。
图8是本发明一种血流导向支架输送系统一部分放大后结构示意图。
图9是本发明一种血流导向支架输送系统的鞘管结构示意图。
图10是本发明一种血流导向支架输送系统实施例五结构示意图。
图11是根据本发明的一个优选实施例提供的血流导向支架输送系统的手柄的整体结构示意图。
图12是如图11所示手柄的内部结构示意图；
图13是如图11所示手柄的分解示意图。
其中，图1-7为：1-导管、2-导丝、3-凸部、4-密网支架、5-弹性支撑结构、6-手柄、7-鞘管、8-限位块、11-导管开口、21-射线下显影点、61-手柄本体、62-释放开关、101-导管主体、102-导管头部、103-螺旋管、104-头端套筒、105-套管。
图8-10为：1-鞘管本体、2-导管、3-鞘管顶开机构、4-支架、5-导丝、11-豁口、12-撕痕、31-锥头。
图11-13为：1-手柄本体；2-盖体；3-扩张应力管；11-第一壳体；12-第二壳体；13-释放开关；14-防滑纹；15-开槽；16-拉簧；17-凸起；18-导丝槽；19-导向体。
【具体实施方式】
为使本发明的目的、技术方案和优点更加清楚明了，下面通过附图及实施例，对本发明进行进一步详细说明。但是应该理解，此处所描述的具体实施例仅仅用以解释本发明，并不用于限制本发明的范围。此外，在以下说明中，省略了对公知结构和技术的描述，以避免不必要地混淆本发明的概念。
在本发明的描述中，需要说明的是，当元件被称为“固定于”或“设置于”另一个元件，它可以直接在另一个元件上或者间接在该另一个元件上。当一个元件被称为是“连接于”另一个元件，它可以是直接连接到另一个元件或间接连接至该另一个元件上。
在本发明的描述中，需要说明的是，术语“中心”、“长度”、“宽度”、“厚度”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，或者是该发明产品使用时惯常摆放的方位或位置关系，仅是为了便于描述本发明和简化描述，而不是指示或暗示所指的装置或 元件必须具有特定的方位，以特定的方位构造和操作，因此不能理解为对本发明的限制。此外，术语“第一”、“第二”、“第三”等仅用于区分描述，而不能理解为指示或暗示相对重要性。。由此，限定有“第一”、“第二”的特征可以明示或者隐含地包括一个或者更多个该特征。在本发明的描述中，“多个”的含义是两个或两个以上，除非另有明确具体的限定。“若干”的含义是一个或一个以上，除非另有明确具体的限定。
在本发明的描述中，还需要说明的是，除非另有明确的规定和限定，术语“设置”、“安装”、“相连”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本发明中的具体含义。
现在参考附图详细描述本公开的实施例。如本文所使用，术语“临床医生”是指医生、外科医生、护士或任何其它护理提供者，并且可以包括辅助人员。术语“近端”将指的是装置或其部件的更靠近临床医生的部分，术语“远端”将指的是装置或其部件的更远离临床医生的部分。
实施例一：
参阅图1-6，本发明一种血流导向支架输送系统，包括导管1、导丝2、凸部3、密网支架4。导丝2可活动设于导管1内。凸部3固定设于导丝2上，且临近密网支架4的近端设置，可通过导丝3控制凸部3在导管1的远端侧内腔中移动。密网支架4的近端被夹持在凸部3与导管1之间，并通过导丝1控制密网支架4推送。密网支架4的远端通过弹性支撑结构5支撑固定。还包括套设于导管1外的鞘管7。鞘管7与导管1可滑动连接。密网支架4的远端被夹持于弹性支撑结构5与鞘管7之间。本实施例中导管1为海波管，鞘管7为鞘管/ 微导管。根据该优选实施例，在密网支架4的输送初期，凸部3位于导管1中，凸部3与导管1内壁配合对密网支架4近端进行夹持，弹性支撑结构5与套在其外侧鞘管7配合对密网支架4远端进行夹持；在密网支架4的输送后期，密网支架4从微导管内伸出，密网支架4远端束缚力丧失，密网支架4远端撑开与血管内壁贴合，继续推送，凸部3从导管1内脱离，密网支架4近端束缚力丧失，密网支架4可以完全撑开与血管内壁贴合，实现自膨支架(即密网支架)的释放，对动脉瘤进行治疗。密网支架4释放过程中，当密网支架4未被完全施放，密网支架4近端与凸部3仍然连接在一起，密网支架4可通过导丝2被回收至导管内。通过将密网支架4远端设置弹性支撑结构5使得密网支架4向远端推送的时候远端有个受力点往前走，避免支架堆积在导管内。设置弹性支撑结构5和凸部3两个连接点，双保险，任一端密网支架4意外脱离都能通过导丝2将密网支架4回拉回导管内。本实施例将弹性支撑结构5直接设置在导丝2上，结构简单，使用更方便，生产成本更低。
根据该优选实施例，本实施例中导管1为海波管。且其柔性由近端向远端逐渐增加。
根据该优选实施例，本实施例中鞘管7为鞘管/微导管。
参阅图1，还包括手柄6。手柄6包括手柄本体61和可活动设于手柄本体61上的释放开关62。导管1近端与手柄本体61连接。导丝2近端与释放开关62连接并可通过释放开关62控制导丝2沿导管1内腔相对运动。设置手柄6便于控制导丝2的推送，从而控制密网支架4的推送和释放，通过推拉释放开关62即可控制导丝2移动。但是应当理解的是，释放开关62不仅限于此种形式，还可以选择其他任意适当的方式，只要能实现导丝3的递送即可。
根据该优选实施例，密网支架为36或72根丝编织支架，采用钴铬合金丝和8根以上的显影丝编织而成，金属覆盖率为35％左右。密网支架展开状态下 整体直径基本不变，支架近端和远端的截面与支架轴线基本垂直，编织丝之间形成菱形网孔，网孔密度均匀。
参阅图2，导管1包括具有一定内径的导管主体101，以及位于导管主体101远端的、具有扩大内径的导管头部102。导管头部102内径略大于述凸部3外径。导管主体101内径小于凸部3外径。密网支架4输送初期，凸部3位于导管头部102并对密网支架4起固定作用。将导管主体101设置为两个不同内径的部分，可以与凸部3配合，起到限位作用，凸部3只能沿内径大于他的导管头部102内腔活动，无法滑动至导管主体101内。本实施例中导管主体101和导管头部102可以为一体成型的结构也可以为通过粘接、卡接、焊接等方式连接的分体式结构。
参阅图2，导丝2上还设有一个邻近凸部3的限位块8。限位块8同样位于导管头部102并相对凸部3更靠近导管主体101。限位块8的最大径向尺寸大于导管主体101的内径，以限制凸部3自导管1的远端朝向近端运动的趋势。限位块8可以保护凸部3和与凸部3连接的密网支架4近端，防止由于导丝过渡回拉损坏凸部3造成密网支架4近端脱落。
实施例二：
参阅图2，在上一实施例的基础上。导管1为非一体成型结构，包括螺旋管103、与螺旋管103远端连接的头端套筒104、套设于螺旋管103外侧的套管105。头端套筒104的内径大于螺旋管103的内径。头端套筒104构成导管头部101。螺旋管103与套管105共同构成导管主体101。
优选地，螺旋管103和头端套筒104可以为不同尺寸的两种管子，螺旋管103远端外径与头端套筒104内径大致相当，通过连接部106重叠一部分或者不重叠地连接为一体。
优选地，头端套筒104远端筒口呈逐渐变细的锥形、弧形结构，筒口不产 生台阶；连接部106截面为三角形，两边分别在螺旋管103侧面以及所述头端套筒104的近端截面，消除二者拼接形成的台阶；连接部106为螺旋管103和头端套筒104焊接或粘接时形成，其材质可以与螺旋管103和头端套筒104相同，也可以为其他常用焊接或粘接材料。
优选地，螺旋管103为金属或高分子通过缠绕、编织或切割形成的螺旋结构，通过螺距、工艺的控制保证其柔顺性从近端到远端逐渐增加，优选为切割的不锈钢管。
优选地，套管105由高分子材质制成，与螺旋管103粘接、热合或一体成型，紧密连接；高分子材料包含但不限于聚乙烯、聚甲醛、聚氨酯、聚酯、聚四氟乙烯、氟化乙烯丙烯共聚物、聚酰胺、聚酰亚胺或尼龙，优选为聚四氟乙烯。
参阅图2导丝2上与所述密网支架4两端对应位置处均设有射线下显影点21。便于确认密网支架4位置，便于定位释放密网支架4。
实施例三：
参阅图6和图7。鞘管7近端侧面设有豁口71。导管1上靠近手柄本体61的一端设有可以与豁口71配合的以在鞘管7回撤时撑开豁口71的导管顶开机构9。鞘管7回撤时导管顶开机构9能够将鞘管7底部顶开，无需医生手动撕开，操作方便。
根据该优选实施例，豁口71长度为400mm。
根据该优选实施例，导管顶开机构9远端设有由远端至近端直径逐渐扩大的锥头。且该锥头设有点胶固定。
参阅图7，导管1近端设有若干贯穿设置的导管开口11。导管开口11可周向切割一周，也可切割出可流出生理盐水的若干个孔，实现生理盐水可通过导管1内流出即可。便于冲洗。
本发明工作过程：
本发明一种血流导向支架输送系统在工作过程中，在密网支架4的输送初期，导丝2与导管1保持相对固定，凸部3位于导管1中，凸部3与导管1内壁配合对密网支架4近端进行夹持，弹性支撑结构5与套在其外侧导管配合对密网支架4远端进行夹持；在密网支架4的输送后期，密网支架4从导管内伸出，密网支架4远端束缚力丧失，密网支架4远端撑开与血管内壁贴合，继续推送，凸部3从导管1内脱离，密网支架4近端束缚力丧失，密网支架4与可以完全撑开与血管内壁贴合，实现自膨支架4的释放，对动脉瘤进行治疗。
实施例四：
参阅图8和图9，本发明实施例一中的鞘管包括鞘管本体1和设于鞘管本体1内的导管2。鞘管本体1可相对于导管2轴向滑动。鞘管本体1近端侧面设有豁口11。导管2近端延伸至鞘管本体1外且该延伸出部分设有可以与豁口11配合的以在鞘管本体1回撤时撑开豁口11的鞘管顶开机构3。鞘管顶开机构3外径大于导管2外径和鞘管本体1内径。鞘管本体1具有弹性。豁口11自然状态下可自动复位。本实施例通过将鞘管本体1近端设置豁口11，并设置与豁口11配合的鞘管顶开机构3，原始状态时，整根鞘管本体1完整包覆导管2；当鞘管本体1向近端回撤时，鞘管顶开机构3将鞘管近端的豁口顶开，并释放密网支架，无需医生手动撕开。鞘管本体1回撤更方便。且本申请鞘管本体1具有弹性，豁口11能够自动复原，使得鞘管本体1回撤后还能通过侧面豁口11重新包覆导管2，从而使豁口11能够重新向远侧推进并将密网支架收缩到鞘管本体1内。
参阅图8和图9，导管2内设有导丝5。导丝5远端设有密网支架4。密网支架4为自膨密网支架。鞘管本体1相对于密网支架4的移动可控制密网支架4 的展开与收缩。
参阅图8和图9，鞘管本体1为PTFE、ePTFE、PET或DACRON聚酯制成。优选为PTFE。
参阅图8和图9，鞘管顶开机构3远端设有由远端至近端直径逐渐扩大的锥头31。设置便于与鞘管本体1、豁口11配合，锥头31尖端便于伸入鞘管本体1内，并通过直径逐渐扩大的锥面将鞘管本体1远端扩开，顶开过程更流畅、省力。
实施例五：
参阅图8、图9和图10，实施例四的基础上的鞘管本体1侧壁设有与豁口11连接的撕痕12。撕痕12不贯穿鞘管本体1侧壁设置。撕痕12可以为在鞘管本体1侧壁开设的槽路，也可以与压制出的折痕，只要实现鞘管本体1撕开时沿着撕痕12撕开即可，槽路不贯穿鞘管本体1侧壁设置，使得鞘管本体1的撕痕12在日常状态下为封闭的，当撕开时可以沿着撕痕12撕开，撕开过程更平滑，避免撕歪、撕断。
本发明工作过程：
本发明一种用于血流导向密网支架系统的鞘管在工作过程中，原始状态时，整根鞘管本体1完整包覆导管2；当鞘管本体1向近端回撤时，鞘管顶开机构3将鞘管近端的豁口顶开，锥头31尖端便于伸入鞘管本体1内，并通过直径逐渐扩大的锥面将鞘管本体1远端扩开，并释放密网支架，无需医生手动撕开。
实施例六：
如图11所示，实施例一中的手柄主要包括：手柄本体1，盖体2，扩张应力管3；其中，盖体2在手柄本体1的远端与其螺纹连接，扩张应力管3部分嵌套于盖体2的内部，部分自盖体2的远端伸出。
具体地，结合图12、图13所示，手柄本体1主要包括：第一壳体11，第二壳体12，释放开关13，拉簧16，导向体19。
其中，第一壳体11和第二壳体12通过卡扣卡槽相互卡接，释放开关13夹置于第一壳体11和第二壳体12之间形成的开槽中，第二壳体12的内壁上设有滑槽15，释放开关13的顶部从手柄本体1的上方露出，底部可在滑槽15内滑移，释放开关13的底部近端与一拉簧16连接，用于释放开关13的复位，释放开关13的底部远端设有供导丝穿过的导丝槽18，导丝的近端与释放开关13的底部近端固定连接。应当理解的是，释放开关13的滑移距离实际就相当于导丝能够前后移动的距离。
手柄本体1和盖体2之间还设有导向体19，该导向体19内具有供导丝穿过的通孔，该导向体19具有大头端和柱形部，该导向体19通过大头端卡接于第一壳体11和第二壳体12的远端端部，柱形部从第一壳体11和第二壳体12的远端向外伸出，并通过该柱形部与导丝外侧的海波管(图未示出)固定。
扩张应力管3的一端嵌套于盖体2内，另一端从盖体2的远端向外延伸，如图13所示，扩张应力管3具有自近端向远端逐渐减小的外径。
根据该优选实施例，扩张应力管3自盖体2的远端向外延伸的部分的长度大于嵌套于所述盖体2内的部分的长度。
优选地，该扩张应力管3由硅胶制成。
根据该优选实施例，第一壳体11和第二壳体12共同形成供释放开关13滑移的开槽，开槽处预设可移除的保险装置，以避免释放开关13意外滑动。可选地，该保险装置是一种可拆卸的卡子，需要拨动释放开关时拔掉卡子即可。
优选地，导向体19的柱形部具有开槽，所述柱形部与所述海波管通过在开槽处施加点胶固定。
拉簧16的近端与第二壳体11内的凸起17固定，另一端与释放开关13的 近端固定。
导丝的近端与释放开关13的底部近端通过点胶固定连接。
手柄本体1上与释放开关13相对的底部外壁上设有防滑纹14，以方便人手操作。
盖体2的外围设有防滑壁21，与手柄本体1连接时需旋转盖体2，防滑壁21防止旋转过程中手指打滑。
上述实施例是对本发明的说明，不是对本发明的限定，任何对本发明简单变换后的方案均属于本发明的保护范围。

Claims (19)

  1. 一种血流导向支架输送系统，包括：导管、导丝、凸部、密网支架,所述导丝可活动设于所述导管内,所述凸部固定设于所述导丝上，且临近所述密网支架的近端设置，可通过所述导丝控制所述凸部在所述导管的远端侧内腔中移动；所述密网支架的近端被夹持在所述凸部与所述导管之间，并通过所述导丝控制所述密网支架推送；其特征在于，所述弹性支撑结构固定设于所述导丝上，还包括套设于所述导管外的鞘管，所述鞘管与所述导管可滑动连接，所述密网支架的远端被夹持于所述弹性支撑结构与所述鞘管之间。
  2. 如权利要求1所述的一种血流导向支架输送系统，其特征在于：还包括手柄，所述手柄包括手柄本体和可活动设于所述手柄本体上的释放开关，所述导丝近端与所述释放开关连接并可通过所述释放开关控制所述导丝沿所述导管内腔相对运动。
  3. 如权利要求1所述的一种血流导向支架输送系统，其特征在于：所述的导管包括具有一定内径的导管主体，以及位于所述导管主体远端的、具有扩大内径的导管头部，所述导管头部内径略大于所述凸部外径，所述导管主体内径小于所述凸部外径；所述密网支架输送初期，所述凸部位于所述导管头部并对所述密网支架起固定作用。
  4. 如权利要求3所述的一种血流导向支架输送系统，其特征在于：所述的导丝上还设有一个邻近所述凸部的限位块，所述限位块同样位于所述导管头部并相对所述凸部更靠近所述导管主体，所述限位块的最大径向尺寸大于所述导管主体的内径，以限制所述凸部自所述导管的远端朝向近端运动的趋势。
  5. 如权利要求4所述的一种血流导向支架输送系统，其特征在于：所述的导管包括螺旋管、与所述螺旋管远端连接的头端套筒、套设于所述螺旋管外侧的套管，所述头端套筒的内径大于所述螺旋管的内径，所述头端套筒构成所述导管头部，所述螺旋管与所述套管共同构成所述导管主体。
  6. 如权利要求1所述的一种血流导向支架输送系统，其特征在于：所述的导管近端设有若干贯穿设置的导管开口；所述导丝上与所述密网支架两端对应位置处均设有射线下显影点。
  7. 如权利要求1所述的一种血流导向支架输送系统，其特征在于：包括一鞘管，所述鞘管包括鞘管本体和设于所述鞘管本体内的导管，所述鞘管本体可相对于所述导管轴向滑动，所述鞘管本体近端侧面设有豁口，所述导管近端延伸至所述鞘管本体外且该延伸出部分设有可以与所述豁口配合的以在所述鞘管本体回撤时撑开所述豁口的鞘管顶开机构，所述鞘管顶开机构外径大于所述导管外径和所述鞘管本体内径，所述鞘管本体具有弹性，所述豁口自然状态下可自动复位。
  8. 如权利要求7所述的一种血流导向支架输送系统，其特征在于：所述导管内设有导丝，所述的导丝远端设有密网支架，所述密网支架为自膨支架，所述鞘管本体相对于密网支架的移动可控制所述密网支架的展开与收缩。
  9. 如权利要求7所述的一种血流导向支架输送系统，其特征在于：所述的鞘管本体由PTFE、ePTFE、PET或DACRON聚酯制成。
  10. 如权利要求8所述的一种血流导向支架输送系统，其特征在于：所述的鞘管顶开机构远端设有由远端至近端直径逐渐扩大的锥头；所述的鞘管本体侧壁设有与所述豁口连接的撕痕，所述撕痕不贯穿或部分贯穿所述鞘管本体侧壁设置。
  11. 如权利要求2所述的一种血流导向支架输送系统，其特征在于：所述手柄本体，其包括相互卡接的第一壳体和第二壳体，夹置于第一壳体和第二壳体之间的释放开关，设置于所述第二壳体内壁上的滑槽，所述释放开关的顶部从手柄本体的上方露出，所述释放开关的底部可在所述滑槽内滑移，所述释放开关的底部近端与一拉簧连接，所述释放开关的底部远端设有供导丝穿过的 导丝槽，所述导丝的近端与所述释放开关的底部近端固定连接；与所述手柄本体的远端连接的锥形盖体；设置于所述手柄本体和盖体之间的导向体，所述导向体具有供导丝穿过的通孔；以及一端嵌套于所述盖体内的扩张应力管，另一端从所述盖体的远端向外延伸，所述扩张应力管具有自近端向远端逐渐减小的外径；其中，通过所述释放开关沿手柄本体长度方向的滑移，可实现导丝的输送和撤回，进而实现血管内植入物的施放。
  12. 如权利要求11所述的一种血流导向支架输送系统，其特征在于：所述扩张应力管自所述盖体的远端向外延伸的部分的长度大于所述扩张应力管嵌套于所述盖体内的部分的长度。
  13. 根据权利要求11所述的用于血管内植入物输送系统的手柄，其特征在于，所述扩张应力管由硅胶制成。
  14. 根据权利要求11所述的用于血管内植入物输送系统的手柄，其特征在于，所述第一壳体和第二壳体共同形成供所述释放开关滑移的开槽，所述开槽处预设可移除的保险装置，以避免所述释放开关意外滑动。
  15. 根据权利要求11所述的用于血管内植入物输送系统的手柄，其特征在于，所述导向体具有大头端和柱形部，所述导向体通过大头端卡接于所述第一壳体和第二壳体的远端端部，所述柱形部从所述第一壳体和第二壳体的远端端部向外伸出，并通过该柱形部与导丝外侧的海波管固定。
  16. 根据权利要求15所述的用于血管内植入物输送系统的手柄，其特征在于，所述导向体的柱形部具有开槽，所述柱形部与所述海波管通过在开槽处施加点胶固定。
  17. 根据权利要求11所述的用于血管内植入物输送系统的手柄，其特征在于，所述拉簧的近端与所述第二壳体内的凸起固定，另一端与所述释放开关的底部近端固定。
  18. 根据权利要求11所述的用于血管内植入物输送系统的手柄，其特征在于，所述导丝的近端与所述释放开关的底部近端通过点胶固定连接；所述手柄本体上与所述释放开关相对的底部外壁上设有防滑纹。
  19. 根据权利要求11所述的用于血管内植入物输送系统的手柄，其特征在于，所述第一壳体和第二壳体通过卡扣卡槽相连；所述盖体与手柄本体之间螺纹连接。
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