WO2018161959A1 - 一种取栓器系统 - Google Patents

一种取栓器系统 Download PDF

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Publication number
WO2018161959A1
WO2018161959A1 PCT/CN2018/078570 CN2018078570W WO2018161959A1 WO 2018161959 A1 WO2018161959 A1 WO 2018161959A1 CN 2018078570 W CN2018078570 W CN 2018078570W WO 2018161959 A1 WO2018161959 A1 WO 2018161959A1
Authority
WO
WIPO (PCT)
Prior art keywords
bracket
bolt
developing
stent
distal end
Prior art date
Application number
PCT/CN2018/078570
Other languages
English (en)
French (fr)
Inventor
王国辉
王震
吴健平
薛宗玉
Original Assignee
上海心玮医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN201710142837.3A external-priority patent/CN106859729A/zh
Priority claimed from CN201710198720.7A external-priority patent/CN106963451A/zh
Priority claimed from CN201710575843.8A external-priority patent/CN109247969B/zh
Application filed by 上海心玮医疗科技有限公司 filed Critical 上海心玮医疗科技有限公司
Priority to US16/492,762 priority Critical patent/US11583302B2/en
Publication of WO2018161959A1 publication Critical patent/WO2018161959A1/zh

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/0084Material properties low friction
    • A61B2017/00845Material properties low friction of moving parts with respect to each other
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/0084Material properties low friction
    • A61B2017/00849Material properties low friction with respect to tissue, e.g. hollow organs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00867Material properties shape memory effect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2215Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having an open distal end

Definitions

  • the invention belongs to the field of medical instruments, and in particular relates to a thrombectomy system.
  • Stroke is currently one of the most common diseases in the world, and its characteristics are: high morbidity, high prevalence, and high disability.
  • the annual incidence of urban cerebrovascular disease in China is 219/100,000, and that in rural areas is 185/100,000, and it is still rising year by year.
  • the prevalence of cerebrovascular disease increased from 5.9 to 9.7 from 1998 to 2008.
  • About three-quarters of patients with surviving cerebrovascular disease have different levels of incapacity. It has been reported that 80% of stroke patients have varying degrees of physical dysfunction, and 43.7% of them cannot take care of themselves.
  • Intravenous rt-PA thrombolysis is currently the only acute treatment for cerebral infarction confirmed by evidence-based medicine.
  • intravenous thrombolysis has a long treatment period, and it has great damage to ischemic brain tissue, and is associated with bleeding risk.
  • the recanalization rate is very low; the recanalization rate of basilar artery thrombolysis is only about 30%, and the lesion at the end of carotid artery dissolves.
  • the occlusion rate is only 6%, and the total carotid artery thrombolysis is only about 27% recanalization rate.
  • the time window for intravenous thrombolysis is only about 4 hours. It can be seen from the above that cerebral artery occlusion alone is not enough for intravenous thrombolysis, and simple intravenous thrombolysis may not be sufficient to meet the actual clinical needs.
  • a thrombectomy device is a medical tool for treating blood clots in a blood vessel.
  • the thrombectomy device enters the embolization position through the microcatheter system, and after release, the thrombus at the embolization position can be grasped, and then recovered through the microcatheter to take out the thrombus.
  • the existing thrombectomy device is mainly for thicker blood vessels and cannot enter the thinner cerebral artery.
  • the design of the plug stent itself is improperly designed, it is easy to cause irreversible damage to the blood vessel, leading to other complications such as restenosis and rupture of the blood vessel; in addition, it is easy to occur in the process of thrombus grabbing, which is time consuming and has low recanalization rate. If it takes a long time, it will cause the ischemia time to be too long and it will cause irreversible damage to the brain. Poor development of the thrombectomy stent can also lead to problems such as excessive thrombectomy time, thrombus detachment, and poor thrombolysis. All of these are the problems that the thrombectomy device must be applied to treat stroke caused by cerebral thrombosis.
  • a bolting stent system including a bolting stent, which has a roll shape; the plug stent has an open-loop structure in cross section.
  • the outer diameter of the plug holder varies with the degree of curling of the bolt holder.
  • the open-loop cylindrical roll design facilitates the adjustment of the tightness of the crimp as needed to adjust the outer diameter of the plug holder to accommodate different blood vessel sizes and to accommodate different support forces. When the blood vessels are small, the curl is increased and the outer diameter becomes smaller; and vice versa.
  • the suitable supporting force is beneficial to improve the fusion of the thrombectomy stent and the thrombus without damaging the blood vessel and increasing the grasping ability of the thrombus.
  • the supporting force here refers to the tension of the plug holder for the inner wall of the blood vessel at the working site.
  • the distal end and the proximal end of the bolt-out stent are both open.
  • the middle segment of the thrombectomy stent is often fused with the thrombus, and the middle segment of the stent is often deformed so that the outer diameter of the segment is reduced. If the distal end and/or the proximal end of the thrombectomy stent are closed, the outer diameter of the entire thrombectomy stent is reduced when the thrombus is taken. When the thrombus is taken, the thrombus is easily resisted from the vessel wall by the resistance of the vessel wall. Fall off.
  • the distal end and the proximal end of the bolt-taking bracket are both open, the outer diameter of the middle section (the plug-out part) of the bolt-out bracket is reduced, and the outer diameter of the two ends of the bolt-out bracket is larger than the middle part, and the bracket is dumbbell-shaped.
  • the thrombus is not easily detached from the stent when the plug is taken. Therefore, the thrombus fusion and grasping ability of the thrombectomy stent with the open ends is obviously better than that of the thrombectomy stent with one end and both ends closed.
  • the cross section of the proximal end of the bolt removing bracket is reduced to a dot shape.
  • the distal end of the plug holder has a C-shaped cross section.
  • the proximal end of the bolt receiving bracket has a C-shaped cross section.
  • the bolting bracket includes a plurality of identical or different grid cells.
  • the grid cells are connected to each other in a mesh shape.
  • the mesh is larger in the middle than the mesh on both sides, and the support force is stronger, and the thrombus can be better embedded.
  • the shape of the grid unit includes one or more of a graph composed of an arc, a polygon, and a graph composed of an arc and a straight line.
  • the shape of the grid unit includes one or more of a circle, an ellipse, a quadrangle, a triangle, a diamond, and a trapezoid.
  • the shape of the grid unit includes a pattern of a plurality of arcs.
  • the bolt receiving bracket has a first state and a second state; in the second state, the shape of the mesh unit is changed such that the outer diameter of the middle portion of the bolt removing bracket is smaller than the outer diameters of the two ends thereof.
  • the shape of the mesh unit is stable.
  • the width of the mesh wire of the mesh unit is 0.05 to 0.16 mm; and the size of the mesh unit is 3 to 5 mm.
  • the width of the grid wire of the grid unit is 0.07 to 0.14 mm.
  • the size of the grid unit is 3.6 ⁇ 4.5mm.
  • the width and thickness of the grid wire of the grid unit, as well as the size of the grid unit, together with the cylindrical coiled open-loop structure of the bolting bracket, determine the supporting force of the bolting bracket on the working part, but the cylinder roll is opened.
  • the ring structure can facilitate adjustment of the support force.
  • the thickness of the mesh wire of the mesh unit in the present invention is as shown in the prior art.
  • the thrombectomy stents are designed with different outer diameters and lengths to accommodate different diameters of cerebrovascular vessels and thrombus of different lengths.
  • the end of the mesh unit of the distal end of the bolt-out stent is provided with a developing element.
  • the developing element is used to position the thrombectomy stent in the blood vessel during surgery.
  • the end of the mesh unit of the distal end of the bolt-out stent is provided with a developing element extending along the distal end of the bolt-out bracket.
  • the number of developing elements at the end of the grid unit at the distal end of the bolt removing bracket is 2-8.
  • the raised developing element facilitates the insertion of the stud stent through the thrombus site.
  • the material of the plug holder includes a memory alloy. Further, the material of the plug holder includes a nickel-titanium alloy and/or a cobalt-based alloy.
  • the bolt removing bracket system further includes a pushing rod; the distal end of the bolt removing bracket is provided with a developing member; the proximal end of the bolt removing bracket is connected with the distal end of the pushing rod, and the developing member is disposed at the joint.
  • the developing element adopts a precious metal developing point and has strong developability, which can help the operator to determine the position of the bolting bracket during the operation.
  • the developing element at the junction of the proximal end of the bolting bracket and the distal end of the push rod is a developing ring; the developing ring is sleeved outside the joint.
  • the attachment of the proximal end of the bolt holder to the distal end of the push rod includes a welding, socket, link or adhesive fixed connection.
  • the welding comprises silver welding and/or gold welding.
  • the manner in which the proximal end of the bolt-out bracket is coupled to the distal end of the push rod includes welding, socketing, or linking, and then fixing the adhesive with a glue.
  • the adhesive includes UV glue and/or epoxy glue.
  • the material of the push rod includes a nickel titanium alloy. Therefore, it has good flexibility and resilience, and is convenient for pushing the stent system in the rugged blood vessel.
  • distal end of the push rod is configured to be tapered to facilitate smooth transition when connected to the proximal end of the bolt holder.
  • the outer surface of the push rod is coated with a polymer material having a low coefficient of friction. It helps to reduce the friction of the push rod and provides high push performance.
  • Polymer materials having a low coefficient of friction include PTFE (polytetrafluoroethylene) and/or PET (polybutylene terephthalate plastic).
  • the bolt removing stent system further comprises an introduction sheath;
  • the introduction sheath is a double tube, the inner tube material comprises PTFE or/and HDPE (high density polyethylene), and the outer tube material comprises nylon and/or Pebax (nylon). Elastomer).
  • the purpose of the introducer sheath is to introduce the thrombectomy stent into the microcatheter along with the push rod.
  • the microcatheter is a surgical accessory.
  • distal inner wall of the inner tube is configured to have a rounded transition smooth.
  • proximal end of the introducer sheath is provided with a handle.
  • the invention is directed to the deficiencies of the prior art, in particular, the design problem of the developing element on the bolting bracket, and also provides a bolt removing device, comprising a bolt removing bracket, and the developing bolt is provided on the bolt removing bracket.
  • the shape of the developing member can be set as needed, and may be, for example, a line shape, a ring shape, a mesh shape, and/or a dot shape.
  • the distal end and the proximal end of the bolt removing bracket are provided with a developing element.
  • the distal end refers to the end that is remote from the operator (such as a doctor);
  • the proximal end refers to the end that is close to the operator (such as a doctor).
  • the plug receiving bracket has a roll shape; the cross section of the plug mounting bracket is an open loop structure.
  • the outer diameter of the plug holder varies with the degree of curling of the bolt holder.
  • the open-loop roll design facilitates the tightening of the crimp as needed to adjust the outer diameter of the plug to accommodate different vessel sizes and to accommodate different support forces. When the blood vessels are small, the curl is increased and the outer diameter becomes smaller; and vice versa.
  • the suitable supporting force is beneficial to improve the fusion of the thrombectomy stent and the thrombus without damaging the blood vessel and increasing the grasping ability of the thrombus.
  • the supporting force here refers to the tension of the plug holder for the inner wall of the blood vessel at the working site.
  • the number of developing elements is ⁇ 2, and the developing elements are evenly distributed around the roll-shaped circumference of the plug holder.
  • the number of developing elements is ⁇ 3.
  • the number of developing elements on the distal end of the plug holder is ⁇ 2 (preferably ⁇ 3), and the developing elements on the distal end of the plug holder are evenly distributed on the distal end of the bolt removing bracket;
  • the number of developing elements on the proximal end of the stent is > 2 (preferably > 3) and the developing elements on the proximal end of the bolting stent are evenly distributed over the proximal end of the bolting stent.
  • the plug holder is in the form of a roll; the cross section of the plug holder is an open loop structure; and the number of the developing elements on the distal end of the plug holder is ⁇ 2 (preferably ⁇ 3),
  • the developing element on the distal end of the bolt-out stent is evenly distributed around the circumference of the bobbin-shaped bracket around the bobbin-shaped stent; the number of developing elements on the proximal end of the bolt-out stent is ⁇ 2 (preferably ⁇ 3), the developing element on the proximal end of the bolt-out stent is evenly distributed around the roll-shaped circumference of the bolt holder on the proximal end of the bolt-out bracket.
  • the middle portion of the bolt removing bracket is provided with a developing member.
  • the midsection of the thrombectomy stent of the present invention refers to the segment between the distal end and the proximal end of the thrombectomy stent.
  • the number of developing elements on the distal end of the plug holder is ⁇ 2 (preferably ⁇ 3), and the developing elements on the distal end of the plug holder are evenly distributed on the distal end of the bolt removing bracket;
  • the number of developing elements on the proximal end of the stent is ⁇ 2 (preferably ⁇ 3), and the developing element on the proximal end of the bolting bracket is evenly distributed on the proximal end of the bolt removing bracket;
  • the number of developing elements is ⁇ 2 (preferably ⁇ 3), and the developing elements on the middle portion of the plug holder are evenly distributed on the middle portion of the bolt removing bracket.
  • the plug holder is in the form of a roll; the cross section of the plug holder is an open loop structure; and the number of the developing elements on the distal end of the plug holder is ⁇ 2 (preferably ⁇ 3),
  • the developing element on the distal end of the bolt-out stent is evenly distributed around the circumference of the bobbin-shaped bracket around the bobbin-shaped stent;
  • the number of developing elements on the proximal end of the bolt-out stent is ⁇ 2 (preferably ⁇ 3), the developing element on the proximal end of the bolting bracket is evenly distributed around the roll-shaped circumference of the plug bracket on the proximal end of the bolt-out bracket;
  • the number of developing elements on the middle section of the bolt-out bracket is ⁇ 2 (preferably ⁇ 3), the developing element on the middle section of the bolt-out stent is evenly distributed around the roll-shaped circumference of the bolt holder on the middle section of the bolt-out bracket.
  • the developing element comprises a development line in the form of a line.
  • one end of the developing line is disposed on the distal end or the distal end surface of the bolt removing bracket, and the other end is disposed on the proximal end or the proximal end surface of the bolt removing bracket.
  • the number of developing lines is ⁇ 3, and the developing line is evenly arranged on the bolt removing bracket.
  • the plug receiving bracket is in the form of a roll; the cross section of the plug mounting bracket is an open loop structure; the number of developing lines is ⁇ 3, and the developing line extends along the axial direction of the bolt removing bracket, surrounding the bolt removing bracket The roll-like circumference is evenly arranged on the bolt-out bracket.
  • the plug holder is in the form of a roll; the cross section of the plug holder is an open loop structure; the plug holder is in the form of a roll; and the development line extends in a circumferential direction of the roll of the plug holder.
  • the plug-out bracket is in the form of a roll; the cross-section of the plug-out bracket is an open-loop structure; the development line extends both in the axial direction of the plug-out bracket and along the rolled circumference of the bolt-out bracket. The direction extends back and forth.
  • the number of developing lines is ⁇ 3, and the developing line is evenly arranged on the bobbin holder around the roll-shaped circumference of the bolt removing bracket.
  • the developing element is disposed by spraying the coating plug, applying the developing material, and mounting the developing component to the plug bracket by winding, snapping, perforating, welding or bonding. kind.
  • the body of the thrombectomy stent is covered with a developing material.
  • Covering the developing material includes spraying and painting the developing material onto the bolt removing bracket.
  • the developing element includes a web of web development; the web is located at the most distal end of the plug holder and closes the distal opening of the plug holder.
  • the distal end of the bolt receiving bracket is in an open state.
  • the middle segment of the thrombectomy stent is often fused with the thrombus, and the middle segment of the stent is often deformed so that the outer diameter of the segment is reduced. If the distal end of the thrombectomy stent is closed, the outer diameter of the middle segment and the distal end of the thrombectomy stent are reduced when the thrombus is taken. When the thrombus is taken, the thrombus is easily detached from the thrombectomy stent due to the resistance of the blood vessel wall.
  • the distal end of the bolt-taking bracket is in an open state, the outer diameter of the middle portion (the bolting portion) of the bolt-taking bracket is reduced, and the outer diameter of the two ends of the bolt-taking bracket is larger than the middle portion, and the bolt-shaped bracket is dumbbell-shaped, especially
  • the distal diameter of the distal end of the bolt-taking stent is larger than the outer diameter of the middle portion of the bolt-taking stent, and the thrombus is not easily detached from the stent when the plug is taken. Therefore, the thrombus fusion and grasping ability of the thrombectomy stent in the distal open state is obviously better than that of the distally closed thrombectomy stent.
  • the proximal end of the bolt receiving bracket is in an open state.
  • the outer diameter of the proximal end is larger than the outer diameter of the middle portion of the bolt-taking stent, and the thrombus is not easily detached from the proximal end.
  • the cross section of the proximal end of the bolt removing bracket is reduced to a dot shape.
  • the distal end of the plug holder has a C-shaped cross section.
  • the proximal end of the bolt receiving bracket has a C-shaped cross section.
  • the bolting bracket includes a plurality of identical or different grid cells.
  • the grid cells are connected to each other in a mesh shape.
  • the developing element comprises a web of developing web; the developing web is located at the most distal end of the plug holder, and the distal opening of the plug holder is closed; the mesh size of the developing web is smaller than the grid size of the grid unit. Therefore, during the thrombectomy process, both the position of the distal end of the thrombectomy stent and the thrombus dropped during the thrombectomy can be captured.
  • the shape of the grid unit includes one or more of a graph composed of an arc, a polygon, and a graph composed of an arc and a straight line.
  • the shape of the grid unit includes one or more of a circle, an ellipse, a quadrangle, a triangle, a diamond, and a trapezoid.
  • the shape of the grid unit includes a pattern of a plurality of arcs.
  • a plurality of grid cells are sequentially arranged in rows, and grid cells of two adjacent rows are misaligned.
  • the rows are parallel to the axial direction of the bolt-out bracket. That is, in a direction perpendicular to the axial direction of the bolt removing bracket, one of the adjacent two rows, the grid unit of one row faces the gap of two grid cells adjacent to the other row.
  • the grid unit is enclosed by four adjacent grid units.
  • the grid unit includes a first grid unit and a second grid unit; the first grid unit is enclosed by four adjacent second grid units; the second grid unit is composed of adjacent 4 The first grid unit is enclosed.
  • the grid unit includes a first grid unit and a second grid unit; the plurality of first grid units are sequentially arranged in a first grid unit row parallel to the axial direction of the bolt removing bracket; the plurality of second grids The cells are sequentially arranged in a row of second grid cells parallel to the axial direction of the bolt-out bracket; the rows of the first grid cells and the rows of the second grid cells are alternately arranged in the axial direction of the bolt-out bracket, perpendicular to the bolts The brackets are misaligned in the axial direction.
  • the arrangement manner is: the singular behavior of the bolting bracket is the first grid unit row, the double number is the second grid unit row; or the double number is the first grid unit row, and the singular behavior is the second grid unit row;
  • the first grid unit aligns the gaps of the adjacent two second grid cells
  • the second grid unit aligns the gaps between the adjacent two first grid cells.
  • the width of the mesh wire of the mesh unit is 0.05 to 0.16 mm; the size of the connection point between the mesh cells is 0.25 to 0.45 mm.
  • the width of the grid wire of the grid unit is 0.07 to 0.14 mm.
  • the bolt receiving bracket has a first state and a second state; in the second state, the shape of the mesh unit changes. For example, after the change, the outer diameter of the middle portion of the bolt-out bracket is smaller than the outer diameter of the two ends.
  • the shape of the mesh unit is stable.
  • the size of the grid unit is 3 to 5 mm.
  • the size of the grid unit is 3.6 to 4.5 mm.
  • the width and thickness of the grid wire of the grid unit, as well as the size and arrangement of the grid unit, together with the open loop structure of the bobbin bracket, determine the supporting force of the bolting bracket on the working part, and the reel
  • the open-loop structure can facilitate the adjustment of the supporting force.
  • the thickness of the mesh wire of the mesh unit in the present invention is as shown in the prior art.
  • the thrombectomy stents are designed with different outer diameters and lengths to accommodate different diameters of cerebrovascular vessels and thrombus of different lengths.
  • the distal end of the bolt removing bracket is provided with a developing element.
  • the developing element is used to position the thrombectomy stent in the blood vessel during surgery.
  • the number of developing elements at the end of the grid unit at the distal end of the bolt removing bracket is 2-8.
  • the material of the plug holder includes a memory alloy. Further, the material of the plug holder includes a nickel-titanium alloy and/or a cobalt-based alloy.
  • the ejector further includes a push rod; the proximal end of the bolster bracket is coupled to the distal end of the push rod, and a developing member is disposed at the joint.
  • the developing element adopts a precious metal developing point and has strong developability, which can help the operator to determine the position of the bolting bracket during the operation.
  • the developing element at the junction of the proximal end of the bolting bracket and the distal end of the push rod is a developing ring; the developing ring is sleeved outside the joint.
  • the attachment of the proximal end of the bolt holder to the distal end of the push rod includes a welding, socket, link or adhesive fixed connection.
  • the welding comprises silver welding and/or gold welding.
  • the manner in which the proximal end of the bolt-out bracket is coupled to the distal end of the push rod includes welding, socketing, or linking, and then fixing the adhesive with a glue.
  • the adhesive includes UV glue and/or epoxy glue.
  • the material of the push rod includes a nickel titanium alloy. Thereby having good flexibility and resilience, it is convenient for the pusher to push in the rugged blood vessels.
  • distal end of the push rod is configured to be tapered to facilitate smooth transition when connected to the proximal end of the bolt holder.
  • the outer surface of the push rod is coated with a polymer material having a low coefficient of friction. It helps to reduce the friction of the push rod and provides high push performance.
  • Low-coefficient polymeric materials include polytetrafluoroethylene (PTFE) and/or poly(p-benzoic acid) (PET) plastics.
  • the plucking device further comprises an introduction sheath;
  • the introduction sheath is a double tube, the material of the inner tube comprises PTFE or/and high density polyethylene (HDPE), and the material of the outer tube comprises nylon and/or Pebax.
  • Pebax is a nylon elastomer.
  • the purpose of the introducer sheath is to introduce the thrombectomy stent into the microcatheter along with the push rod.
  • the microcatheter is a surgical accessory.
  • distal inner wall of the inner tube is configured to have a rounded transition smooth.
  • proximal end of the introducer sheath is provided with a handle.
  • the inventors also provide a thrombectomy system comprising a bolt removing bracket, a pushing rod and a catching member; the proximal end of the bolt removing bracket is connected with the pushing rod, the pushing rod is connected with the catching member; and the catching member is arranged to be receivable Stitch bracket.
  • the distal end refers to the end that is remote from the operator (such as a doctor); the proximal end refers to the end that is close to the operator (such as a doctor).
  • the catching member includes a first end and a second end; the first end is coupled to the proximal end of the plug bracket or the push rod; the second end is provided with an opening; the opening is configured for feeding the plug bracket and the push rod Pass through.
  • the first end is fixedly connected to the proximal end of the bolt holder or the push rod in a sleeved manner.
  • the catching member has a first state and a second state; in the first state, the bolting bracket is located outside the capturing member; and in the second state, the bolting bracket is disposed in the capturing member.
  • the transition from the first state to the second state is set to: extend the first end of the distal end of the microcatheter and the plug-up bracket to pull back the plug bracket through the push rod and retract the first end into the microcatheter, and wear
  • the second end is located in the microcatheter such that the first end is located at the proximal end of the capturing member and the second end is located at the distal end of the capturing member, so that the bolt receiving bracket is sleeved in the capturing member.
  • the microcatheter is a surgical accessory that is used for the surgical procedure of the thrombectomy system.
  • the resistance or/and the friction force of the microcatheter to the catching member makes the second end retracting speed smaller than the retracting speed of the first end, thereby
  • the bolt holder and the first end are capable of passing through the second end.
  • the second end of the capture member is retracted within the microcatheter, the outer surface of the capture member being in contact with the inner surface of the microcatheter, the microcatheter limiting the natural stretch of the capture member.
  • the first end is located at the distal end of the capturing member, and the second end is located at the proximal end of the capturing member; the transition from the first state to the second state causes the capturing member to be turned inside out and back and forth.
  • the opening on the second end tends to close.
  • the tendency to close is advantageous to prevent the thrombus on the plug receiving bracket from being detached from the opening of the second end.
  • the catching member is knitted in such a manner that the opening on the second end thereof tends to open in the first state; when in the second state, that is, after the inner and outer flaps of the catching member are turned over, the opening on the second end thereof tends to close. It tends to open in the first state, which is beneficial to generate greater friction with the microcatheter, and facilitates the transition from the first state to the second state, and the plug holder and the first end easily pass through the second end to complete the capture. The storage of the plug holder.
  • the catching member is a flexible structure.
  • the catching member is made of a metal and/or a polymer material.
  • the catching member is woven from a wire or a polymer material.
  • the wire is a memory alloy such as a nickel titanium alloy.
  • the capturing member is in the shape of a long tube and is self-expanding.
  • the length of the catching member is greater than the length of the bolt-out bracket.
  • the catheter is a surgical procedure that is used in the surgical procedure of the thrombectomy system for guiding the microcatheter and the thrombectomy stent within the microcatheter to a corresponding location in the blood vessel.
  • the bolt-out bracket comprises a plurality of identical or different grid cells; the catching member has a mesh structure, and the mesh size is smaller than the mesh size of the mesh unit.
  • the grid cells are connected to each other in a mesh shape.
  • the shape of the grid unit includes one or more of a graph composed of an arc, a polygon, and a graph composed of an arc and a straight line.
  • the shape of the mesh unit includes one or more of a circle, an ellipse, a quadrangle, a triangle, a diamond, and a trapezoid.
  • the shape of the grid unit includes a pattern composed of a plurality of arcs.
  • a plurality of grid cells are sequentially arranged in rows, and grid cells of two adjacent rows are misaligned.
  • the rows are parallel to the axial direction of the bolt removal bracket. That is, in a direction perpendicular to the axial direction of the bolt removing bracket, one of the adjacent two rows, the grid unit of one row faces the gap of two grid cells adjacent to the other row.
  • the grid unit is enclosed by four adjacent grid units.
  • the grid unit comprises a first grid unit and a second grid unit; the first grid unit is enclosed by four adjacent second grid units; the second grid unit is composed of adjacent 4 The first grid unit is enclosed.
  • the grid unit includes a first grid unit and a second grid unit; the plurality of first grid units are sequentially arranged in a first grid unit row parallel to the axial direction of the bolt removing bracket; the plurality of second grids The cells are sequentially arranged in a row of second grid cells parallel to the axial direction of the bolt-out bracket; the rows of the first grid cells and the rows of the second grid cells are alternately arranged in the axial direction of the bolt-out bracket, perpendicular to the bolts The brackets are misaligned in the axial direction.
  • the arrangement manner is: the singular behavior of the bolting bracket is the first grid unit row, the double number is the second grid unit row; or the double number is the first grid unit row, and the singular behavior is the second grid unit row;
  • the first grid unit aligns the gaps of the adjacent two second grid cells
  • the second grid unit aligns the gaps between the adjacent two first grid cells.
  • the mesh is larger in the middle than the meshes on both sides, and the support force is stronger, and the mesh can be better embedded in the thrombus.
  • the width of the mesh wire of the mesh unit is 0.05 to 0.16 mm; and the size of the connection point between the mesh cells is 0.25 to 0.45 mm.
  • the width of the grid wire of the grid unit is 0.07 to 0.14 mm.
  • the bolt receiving bracket has an unfolded state and a contracted state; the unfolded state includes a third state and a fourth state; and in the fourth state, the mesh unit is subjected to an external force and the shape is changed.
  • the outer diameter of the middle portion of the bolt-out bracket is smaller than the outer diameter of the two ends.
  • the unfolded state refers to a state in which the plug stent is released into the blood vessel without externally sheathing the microcatheter and/or into the sheath;
  • the contracted state refers to a state in which the plug stent is recovered into the microcatheter and/or introduced into the sheath.
  • the shape of the mesh unit is stable.
  • the size of the grid unit is 3 to 5 mm.
  • the size of the grid unit is 3.6 to 4.5 mm.
  • the width and thickness of the grid wire of the grid unit, as well as the size and arrangement of the grid unit, together with the open loop structure of the bobbin bracket, determine the supporting force of the bolting bracket on the working part, and the reel
  • the open-loop structure can facilitate the adjustment of the supporting force.
  • the thickness of the mesh wire of the mesh unit in the present invention is as shown in the prior art.
  • the thrombectomy stents are designed with different outer diameters and lengths to accommodate different diameters of cerebrovascular vessels and thrombus of different lengths.
  • the plug receiving bracket has a roll shape; the cross section of the plug mounting bracket is an open loop structure.
  • the outer diameter of the plug holder varies with the degree of curling of the bolt holder.
  • the open-loop roll design facilitates the tightening of the crimp as needed to adjust the outer diameter of the plug to accommodate different vessel sizes and to accommodate different support forces. When the blood vessels are small, the curl is increased and the outer diameter becomes smaller; and vice versa.
  • the suitable supporting force is beneficial to improve the fusion of the thrombectomy stent and the thrombus without damaging the blood vessel and increasing the grasping ability of the thrombus.
  • the supporting force here refers to the tension of the plug holder for the inner wall of the blood vessel at the working site.
  • a developing member is disposed on the bolt removing bracket.
  • the shape of the developing member can be set as needed, and may be, for example, a line shape, a ring shape, a mesh shape, and/or a dot shape.
  • the developing element is used to position the thrombectomy stent in the blood vessel during surgery. Further, the developing member adopts a noble metal developing point and has strong developability.
  • the number of developing elements is ⁇ 2, and the developing elements are evenly distributed around the roll-shaped circumference of the plug holder.
  • the number of developing elements is ⁇ 3.
  • the distal end and the proximal end of the bolt removing bracket are provided with a developing element.
  • the number of developing elements on the distal end of the plug holder is ⁇ 2, and the developing element on the distal end of the plug holder is evenly distributed on the distal end of the bolt removing bracket; the developing element on the proximal end of the bolt holder is taken The number of the ⁇ 2, the developing elements on the proximal end of the bolting stent are evenly distributed on the proximal end of the bolt removing bracket.
  • the number of developing elements on the distal end of the plug holder is ⁇ 2, and the developing element on the distal end of the plug holder is evenly distributed around the circumference of the bobbin holder around the roll-shaped circumference of the plug holder;
  • the number of developing elements on the proximal end of the bolting bracket is ⁇ 2, and the developing element on the proximal end of the bolting bracket is evenly distributed around the rolled circumference of the bolt bracket on the proximal end of the bolt removing bracket.
  • the middle portion of the plug holder is provided with a developing member.
  • the midsection of the thrombectomy stent of the present invention refers to the segment between the distal end and the proximal end of the thrombectomy stent.
  • the number of developing elements on the distal end of the plug holder is ⁇ 2, and the developing element on the distal end of the plug holder is evenly distributed on the distal end of the bolt removing bracket; the developing element on the proximal end of the bolt holder is taken
  • the number of the developing elements on the proximal end of the bolting bracket is evenly distributed on the proximal end of the bolt removing bracket; the number of developing elements on the middle section of the bolting bracket is ⁇ 2, and the developing on the middle section of the bolting bracket The components are evenly distributed over the middle section of the bolt-out bracket.
  • the number of developing elements on the distal end of the plug holder is ⁇ 2, and the developing element on the distal end of the plug holder is evenly distributed around the circumference of the bobbin holder around the roll-shaped circumference of the plug holder;
  • the number of developing elements on the proximal end of the bolting bracket is ⁇ 2, and the developing element on the proximal end of the bolting bracket is evenly distributed around the rounded circumference of the bolt bracket on the proximal end of the bolt removing bracket;
  • the number of developing elements on the middle section is ⁇ 2, and the developing element on the middle section of the bolting bracket is evenly distributed around the winding circumference of the plug bracket on the middle section of the bolt removing bracket.
  • the developing member includes a developing line in a line shape.
  • one end of the developing line is disposed on the distal end or the distal end surface of the bolt removing bracket, and the other end is disposed on the proximal end or the proximal end surface of the bolt removing bracket.
  • the number of developing lines is ⁇ 3, and the developing line is evenly arranged on the bolt removing bracket.
  • the plug holder is in the form of a roll; the cross section of the plug holder is an open loop structure; the number of development lines is ⁇ 3, the development line extends along the axial direction of the plug holder, and the roll around the plug holder The circumference is evenly arranged on the bolt-out bracket.
  • the developing line extends in the circumferential direction of the roll of the plug holder.
  • the developing line extends both in the axial direction of the bolt removing bracket and in the circumferential direction of the roll of the bolt removing bracket.
  • the number of developing lines is ⁇ 3, and the developing line is evenly arranged on the bobbin holder around the roll-shaped circumference of the plug holder.
  • the developing element is disposed by spraying the coating plug, applying the developing material, and mounting the developing component to the plug bracket by winding, snapping, perforating, welding or bonding. kind.
  • the body of the plug holder is covered with a developing material.
  • the developing member includes a web of developing web; the developing web is located at the most distal end of the plug holder, and the distal opening of the plug holder is closed.
  • the bolt-out bracket includes a plurality of grid elements of the same or different; the mesh size of the development grid is smaller than the grid size of the grid unit. Therefore, during the thrombectomy process, both the position of the distal end of the thrombectomy stent and the thrombus dropped during the thrombectomy can be captured.
  • the distal end of the bolt receiving bracket is in an open state.
  • the middle segment of the thrombectomy stent is often fused with the thrombus, and the middle segment of the stent is often deformed so that the outer diameter of the segment is reduced. If the distal end of the thrombectomy stent is closed, the outer diameter of the middle segment and the distal end of the thrombectomy stent are reduced when the thrombus is taken. When the thrombus is taken, the thrombus is easily detached from the thrombectomy stent due to the resistance of the blood vessel wall.
  • the distal end of the bolt-taking bracket is in an open state, the outer diameter of the middle portion (the bolting portion) of the bolt-taking bracket is reduced, and the outer diameter of the two ends of the bolt-taking bracket is larger than the middle portion, and the bolt-shaped bracket is dumbbell-shaped, especially
  • the distal diameter of the distal end of the bolt-taking stent is larger than the outer diameter of the middle portion of the bolt-taking stent, and the thrombus is not easily detached from the stent when the plug is taken. Therefore, the thrombus fusion and grasping ability of the thrombectomy stent in the distal open state is obviously better than that of the distally closed thrombectomy stent.
  • the proximal end of the bolt receiving bracket is in an open state.
  • the outer diameter of the proximal end is larger than the outer diameter of the middle portion of the bolt-taking stent, and the thrombus is not easily detached from the proximal end.
  • the closer to the most distal end of the thrombectomy stent the smaller the circumference of the cross section of the distal end of the thrombectomy stent. It facilitates the curling of the distal end of the stent to a finer state, thereby extending into a thinner blood vessel, thereby expanding the scope of application of the bolting stent.
  • the cross section of the proximal end of the bolt holder is reduced to a dot shape.
  • the distal end of the plug holder has a C-shaped cross section.
  • the proximal end of the plug holder has a C-shaped cross section.
  • the material of the plug holder includes a memory alloy.
  • the material of the bolt-out bracket comprises a nickel-titanium alloy and/or a cobalt-based alloy.
  • the proximal end of the bolt receiving bracket is coupled to the distal end of the push rod, and a developing member is disposed at the joint.
  • the developing element at the junction of the proximal end of the bolt receiving bracket and the distal end of the pushing rod is a developing ring; the developing ring is sleeved outside the joint.
  • connection of the proximal end of the bolt-out bracket to the distal end of the push rod includes a welding, socket, link or adhesive fixed connection.
  • connection between the proximal end of the bolt holder and the distal end of the push rod includes welding, socketing or linking, and then fixing the connection with the glue.
  • the adhesive includes UV glue and/or epoxy glue.
  • the material of the push rod includes a nickel titanium alloy. Thereby having good flexibility and resilience, it is convenient for the pusher to push in the rugged blood vessels.
  • distal end of the push rod is tapered to provide a smooth transition when connected to the proximal end of the bolt holder.
  • the outer surface of the push rod is coated with a polymer material having a low coefficient of friction. It helps to reduce the friction of the push rod and provides high push performance.
  • Low-coefficient polymeric materials include polytetrafluoroethylene (PTFE) and/or poly(p-benzoic acid) (PET) plastics.
  • the introduction sheath is further included; the introduction sheath is a double tube, the material of the inner tube includes PTFE and/or HDPE, and the material of the outer tube includes nylon and/or other polymer materials (such as Pebax).
  • the purpose of the introducer sheath is to introduce the thrombectomy stent into the microcatheter along with the push rod.
  • distal inner wall of the inner tube is configured to have a rounded transition smooth.
  • proximal end of the introducer sheath is provided with a handle.
  • Benefits include:
  • the catching member can effectively capture the thrombus dropped during the thrombectomy process.
  • the transition between the first state and the second state of the catching member facilitates the release or nesting operation of the bolt removing bracket from the capturing member in a simple, convenient, and repeatable manner.
  • the catching member When the catching member completely inserts the plugging bracket into the inside, the opening of the catching member is closed, which is more favorable for preventing the thrombus on the plugging bracket from falling.
  • the catching member adopts a mesh structure of a small mesh or a mesh-like structure of a mesh.
  • Adding ⁇ 3 development lines on the bolt-taking bracket can accurately display the expansion state of the bolt-trapping stent during the bolting and the specific position of the bolt-taking stent, so as to judge the fusion of the stent-bolster and the blood vessel, which is convenient for the doctor to judge. , surgical operation and reduce the operation time.
  • the plug stent is sprayed with gold, platinum and other developing materials, so that the thrombectomy stent can be fully developed, which can accurately display the expansion state of the thrombectomy stent during the thrombectomy and the specific position of the thrombectomy stent to determine the fusion of the thrombectomy stent and the blood vessel.
  • the situation is convenient for the doctor's judgment, surgical operation and reducing the operation time.
  • Adding a developing net at the distal end of the bolt removing bracket can not only show the position of the bolt removing bracket but also capture the thrombus dropped when the bolt is taken, especially the mesh size of the developing net is smaller than that of the grid unit of the bolting bracket. When the size is.
  • the special bolting bracket cutting design ensures the flexibility of the bolting bracket and has a good thrombus grasping ability.
  • the bolting bracket and the push rod have good flexibility and elasticity, and can pass freely in the microcatheter and the multi-bend blood vessel.
  • the side wall of the bolting bracket must be rounded, thereby reducing the probability of damage to the blood vessel during the operation.
  • the structure of the bolt-opening bracket is open-loop, which makes the stent have good flexibility and can pass through the tortuous blood vessels and reach the treatment site smoothly.
  • FIG. 1 is a schematic structural view of a thrombectomy system according to the present invention.
  • Figure 2 is a schematic structural view of the A-A cross section of Figure 1;
  • Figure 3 is a schematic structural view of the plug-out bracket of Figure 2 in another state
  • 4A is a schematic structural view of a plucking device system in a first state
  • 4B is a schematic structural view of a plucker system during a transition from a first state to a second state
  • 4C is a schematic structural view of the extractor system in the second state
  • Figure 5 is a schematic view showing a preferred structure of the bolt removing bracket designed by the present invention.
  • 6-11 are schematic structural views of several specific embodiments of the design and distribution of the developing member
  • Figure 16 is a cutting pattern of the bolt removing bracket
  • Figure 17 is a bolting bracket cutting pattern 2
  • Figure 18 is a bolting bracket cutting pattern three
  • Figure 19 is a bolting bracket cutting pattern four
  • Figure 20 is a bolting bracket cutting pattern five
  • Figure 21 is a bolting bracket cutting pattern six
  • Figure 22 is a bolting bracket cutting pattern seven
  • FIG. 23 is a schematic diagram of a link between a thrombus stent and a push rod in a specific embodiment
  • Figure 24 is a schematic view showing the socket of the thrombus stent and the push rod in another embodiment
  • Figure 25 is a schematic view showing the structure of the introducer sheath
  • Figure 26 is a partially enlarged schematic view showing the portion B of Figure 24;
  • Figure 1 illustrates a specific embodiment of the thrombectomy system of the present invention.
  • the plucking device system includes a bolt removing bracket 1, a developing ring 2, a pushing rod 3, an introduction sheath 4, and a catching member 5.
  • the proximal end of the bolt removing bracket 1 is connected to the distal end of the push rod 3, and a developing ring 2 (which is the first one of the developing elements 21) is provided at the joint.
  • the push rod 3 is connected to the introduction sheath 4.
  • the distal end of the bolt receiving bracket 1 is provided with a developing member 21.
  • the distal end and the proximal end of the bolt-out stent 1 are both open.
  • the proximal end of the bolt-out stent 1 is also connected to the catching member 5.
  • the catching member 5 has a first state and a second state.
  • 4A shows the case in the first state, the catching member 5 is sleeved outside the push rod 3, and the end connected to the bolt removing bracket 1 is the first end 51 of the catching member 5, at the far side of the catching member 5. The other end is the second end 52 of the catching member 5 at the proximal end of the catching member 5.
  • Fig. 4B shows the transition of the catching member 5 from the first state to the second state;
  • Fig. 4C shows the situation in the second state.
  • the state transition is to insert the plugging bracket 1 after the completion of the bolting operation into the capturing member 5 to prevent the thrombus from falling off.
  • the microcatheter 6 needs to be withdrawn and the blood vessel 7 is withdrawn along with the microcatheter 6.
  • the bolt receiving bracket 1 has an unfolded state and a contracted state.
  • the unfolded state refers to a state in which the plug stent is released into the blood vessel without externally sheathing the microcatheter and/or into the sheath;
  • the contracted state refers to a state in which the plug stent is recovered into the microcatheter and/or introduced into the sheath.
  • the unfolded state further includes a third state and a fourth state; in the fourth state, the mesh unit of the bolting bracket 1 is subjected to an external force, and the shape is changed, for example, the middle section of the bolting stent is inserted into the thrombus during the bolting process.
  • the outer diameter is reduced to form a narrow shape in the middle and a wide width at both ends.
  • the plug holder 1 is naturally stretched and has a stable shape.
  • the second end 52 In the first state, the second end 52 is in the microcatheter 6, the push rod 3 passes through the opening 521 in the second end 52; the plug holder 1 and the first end 51 are outside the microcatheter 6.
  • the bolt receiving bracket 1 is in an unfolded state.
  • the pin holder 1 and the first end 51 are pulled back through the push rod 3 into the microcatheter 6.
  • the second end 52 remains stationary or the retraction speed is lower than the retraction speed of the first end 51 and the bolt receiving bracket 1, so that the first end 51 and the take-up
  • the bolt bracket 1 passes through the second end 52.
  • the first end 51 is transformed from the distal end of the capture member 5 to the proximal end of the capture member 5, while the second end 52 is transformed from the proximal end of the capture member 5 to the distal end of the capture member 5.
  • the catching member 5 is reversed inside and outside, and the front and rear are replaced, so that the bolt removing bracket 1 is sleeved in the catching member 5, and the transition from the first state to the second state is realized.
  • the capture member 5 is a capture net that is woven from a memory alloy wire and braided such that in the first state, the opening 521 of the second end 52 tends to open, thereby interacting with the microcatheter 6 The contact is more tight, and the two sides will generate more friction when moving relative to each other; in the second state, the catching member 5 is turned inside out and outside, and the opening 521 of the second end 52 tends to close (as shown in FIG. 4C). Thereby, the thrombus on the bolt removing bracket 1 housed by the catching member 5 is less likely to fall off.
  • the flipping mode is that the operator (such as a doctor) holds the capture net 5, pushes the push rod 3 forward to the capture net 5 to completely flip, and completes the transition from the second state to the first state.
  • the catching member 5 is made of a metal and/or a polymer material.
  • the catching member 5 may be a meshing net in a mesh structure or a bag-like structure without a mesh.
  • the reticular structure can facilitate the flow of blood without clogging the blood flow.
  • it is a catching net, its mesh size is smaller than the mesh size of the grid unit of the bolting bracket, or the mesh of the capturing net is small enough to prevent most of the thrombus from falling off.
  • FIG. 1 The A-A cross section of Fig. 1 is as shown in Fig. 2, and it can be seen that the cross section of the bolt removing bracket 1 is an open loop. It can be seen in conjunction with Figure 1 that the bolt-out stent 1 is in the form of a roll. Adjusting the degree of curling of the bolt removing bracket 1 can change the outer diameter of the bolt removing bracket 1, for example, after increasing the degree of curling, the outer diameter of the bolt removing bracket 1 becomes small, as shown in FIG. vice versa.
  • the mesh hole in the middle of the bolt-taking bracket is larger than the mesh holes on both sides, and the supporting force of the middle mesh hole is stronger, so that the middle mesh hole of the bolt-taking bracket can be better embedded.
  • the thrombus at the same time, when cutting the thrombus, it has a better cutting effect.
  • the distal end and the proximal end of the bolt-out stent 1 are provided with a developing member 21, as shown in FIG.
  • a developing member 21 there are three developing elements 21 at the distal end which are evenly distributed over the circumference of the rolled structure of the plug holder 1.
  • evenly distributed on the circumference of the rolled structure of the bolt removing bracket 1 means that the distance between the two sides on the circumference is the same or similar.
  • the developing member 21 located at the proximal end has one or more, and when plural, it is evenly distributed on the circumference of the rolled structure of the plug holder 1.
  • the number of the developing members 21 located at the distal end and the proximal end is not limited to that shown in Fig. 6, and may be one or more.
  • the distal end, the middle section and the proximal end of the bolt removing bracket 1 are provided with a developing member 21, as shown in FIG.
  • a developing member 21 there are three developing elements 21 at the distal end which are evenly distributed over the circumference of the rolled structure of the plug holder 1.
  • the developing member 21 located in the middle portion has one or more, and when it is plural, it is evenly distributed on the circumference of the rolled structure of the bolt removing bracket 1.
  • the developing member 21 located at the proximal end has one or more, and when plural, it is evenly distributed on the circumference of the rolled structure of the plug holder 1.
  • the number of the developing members 21 located at the distal end, the middle portion, and the proximal end is not limited to that shown in Fig. 6, and may be one or more.
  • the developing member includes the developing line 22.
  • One end of the developing line 22 is disposed on the distal end of the bolt removing bracket 1, and the other end is disposed on the proximal end surface of the bolt removing bracket 1, as shown in FIG.
  • the developing line 22 extends in a wave shape along the circumferential direction of the bobbin of the bolt removing bracket 1 while extending in the axial direction of the bolt removing bracket 1.
  • the number of development lines 22 may be one or more. When there are a plurality of strips, they are evenly distributed on the circumference of the rolled structure of the plug holder 1.
  • the developing member includes the developing line 22.
  • One end of the developing line 22 is disposed on the distal end of the bolt removing bracket 1, and the other end is disposed on the proximal end of the bolt removing bracket 1, and does not reach the proximal end surface, as shown in FIG.
  • the developing line 22 extends in a wave shape along the circumferential direction of the bobbin of the bolt removing bracket 1 while extending in the axial direction of the bolt removing bracket 1.
  • the number of development lines 22 may be one or more. When there are a plurality of strips, they are evenly distributed on the circumference of the rolled structure of the plug holder 1.
  • the developing member includes a developing line.
  • One end of the developing line is disposed on the distal end of the bolt removing bracket, and the other end is disposed on the proximal end of the bolt removing bracket.
  • the developing line is in a straight line extending along the axial direction of the bolt removing bracket.
  • the number of development lines may be one or more. When there are a plurality of strips, they are evenly distributed on the circumference of the rolled structure of the plug holder.
  • the developing member includes a developing line.
  • the developing line extends in the circumferential direction of the roll of the plug holder.
  • the number of development lines is plural.
  • the distal end, the middle section and the proximal end of the bolt-out stent are provided with a development line.
  • the developing member includes a developing line.
  • the number of development lines is one.
  • the developing line extends back and forth along the circumferential direction of the bobbin of the bolt removing bracket while extending along the axial direction of the bolt removing bracket.
  • One end of the developing line is disposed on the distal end of the bolt removing bracket, and the other end is disposed on the proximal end of the bolt removing bracket.
  • the plug holder 1 is sprayed or coated with a developing material, as shown in FIG.
  • the proximal end of the bolt removing bracket 1 is provided with a developing member 21, and the distal end is provided with a developing screen 23, as shown in FIG.
  • the developing web 23 is one of the developing elements 21.
  • the developing screen 23 is located at the farthest end of the bolt removing bracket, and closes the distal opening of the bolt removing bracket 1.
  • the mesh size of the developing web 23 is smaller than the mesh size of the grid unit of the plug holder 1.
  • the developing member 21 located at the proximal end has one or more, and when plural, it is evenly distributed on the circumference of the rolled structure of the plug holder 1.
  • the developing member 21 is disposed on the bolt removing bracket 1 in a wound manner as shown in FIG.
  • the developing member 21 located at the proximal end of the bolt removing bracket 1 is wound on the bolt removing bracket 1.
  • the plug holder 1 is provided with an attachment member 30, and the developing member 21 is mounted on the attachment member 30, as shown in Figs.
  • the installation method can be perforation (as shown in Figure 13) or buckle (as shown in Figure 14).
  • the mounting means in this embodiment may be for the developing member 21 located at any position, preferably for the developing member 21 at the proximal end of the plug holder 1.
  • the developing member 21 is attached to the bolt removing bracket 1 in a wound manner, or the developing member 21 is annularly sleeved on the bolt removing bracket 1, as shown in FIG.
  • the mounting means in this embodiment may be for the developing member 21 located at any position, preferably for the developing member 21 at the distal end of the plug holder 1.
  • the bolt-out bracket 1 comprises a plurality of identical grid units 11 connected to each other.
  • the grid unit 11 is elliptical.
  • the bolt-out bracket 1 includes a plurality of grid units 11 connected to each other.
  • the grid unit 11 is a triangle.
  • the bolt-out bracket 1 includes a plurality of grid units 11 connected to each other.
  • the grid unit 11 is a quadrangle.
  • the grid cells are elliptical.
  • the bolt-out bracket 1 includes a plurality of grid units 11 connected to each other.
  • the distal end of the bolt-out stent 1 is provided with six developing elements 21 extending along the distal end of the bolt-out stent.
  • the bolt receiving bracket 1 is provided with one proximal end 12.
  • the bolt-out bracket 1 includes a plurality of grid units 11 connected to each other.
  • the bolt receiving bracket 1 is provided with two proximal ends 12.
  • the cutting pattern of the bolt removing bracket is as shown in FIG. 21.
  • the bolt-out bracket 1 includes a plurality of grid units 11 connected to each other.
  • the distal end of the bolt-out stent 1 is provided with three developing elements 21 extending along the distal end of the bolt-out stent.
  • the bolt receiving bracket 1 is provided with two proximal ends 12.
  • the bolt-out bracket 1 includes a plurality of grid units 11 connected to each other.
  • the plurality of grid cells 11 are sequentially arranged in a row parallel to the axial direction of the bolt removing bracket 1, and the grid cells 11 in the singular row and the double row are misaligned.
  • the distal end of the bolt-out stent 1 is provided with three developing elements 21 extending along the distal end of the bolt-out stent.
  • the bolt receiving bracket 1 is provided with one proximal end 12.
  • the bolt-out bracket includes a plurality of grid units connected to each other.
  • a grid cell is a graph composed of arcs.
  • the end portions of the most distal grid unit of the bolt-out bracket are provided with developing elements, and there are four in total, but not limited to four.
  • the grid unit includes a first grid unit and a second grid unit.
  • the plurality of first grid cells are sequentially arranged in a row of first grid cells parallel to the axial direction of the bolt removing bracket; the plurality of second grid cells are sequentially arranged in a second grid unit parallel to the axial direction of the bolt removing bracket Row.
  • the first grid cell row and the second grid cell row are alternately arranged in the axial direction, and are arranged in a direction perpendicular to the axial direction, that is, the singular behavior of the plug bracket is the first grid unit row, and the double number behavior is the second network.
  • a unit cell row; or a double number acts as a first grid cell row, the singular acts as a second grid cell row; and in a direction perpendicular to the axial direction of the bolting bracket, the first grid unit aligns the adjacent two grids
  • the gap of the cell, the second grid cell aligns the gap between two adjacent first grid cells.
  • the first grid unit is enclosed by four adjacent second grid units; the second grid unit is enclosed by four adjacent first grid units.
  • the grid wire of the grid unit includes a first grid wire and a second grid wire.
  • the width of the first grid wire is 0.07 mm; the width of the second grid wire is 0.16 mm.
  • the grid unit includes a first grid unit and a second grid unit.
  • the size of the bolting bracket is fully expanded into a plane according to the circumference of the cross-section, that is, the size of the cutting frame of the bolting bracket is: the width of the first grid unit (perpendicular to the axial direction of the bolting bracket, and the axial direction of the bolting bracket refers to The axial direction of the distal end and the proximal end of the thrombectomy stent is 4.55 mm, and the length (parallel to the axial direction of the bolt removal bracket) is 3.95 mm.
  • the width of the second grid unit (perpendicular to the axial direction of the bolt-out bracket) is 4.36 mm and the length (parallel to the axial direction of the bolt-out bracket) is 4.97 mm.
  • the width of the joint point in the axial direction of the bolt removing bracket (perpendicular to the axial direction of the bolt removing bracket) is 0.25 mm, and the length (parallel to the axial direction of the bolt removing bracket) is 0.45 mm.
  • the width of the joint in the direction intersecting the axial direction of the bolt-out bracket is 0.38 mm, and the length (parallel to the axial direction of the bolt-out bracket) It is 4.2mm.
  • the mesh wire of the mesh unit includes a first mesh wire, a second mesh wire, and a third mesh wire.
  • the width of the first mesh wire is 0.07 mm; the width of the second mesh wire is 0.16 mm, and the width of the third mesh wire is 0.10 mm.
  • the grid unit includes a first grid unit, a second grid unit, and a third grid unit.
  • the type of the mesh wire and the mesh unit is not limited to one type, two types, or three types.
  • connection manner of the thrombus stent 1 and the push rod 3 is a link
  • the developing ring 2 is sleeved outside the joint
  • UV glue and/or epoxy is coated in the developing ring 2.
  • the resin glue further secures the connection of the thrombus stent 1 to the push rod 3.
  • connection manner of the thrombus stent 1 and the push rod 3 is sleeved, and the developing ring 2 is sleeved outside the joint.
  • Figure 25 shows a specific embodiment of the introducer sheath of the present invention.
  • the introduction sheath is a double tube, the material of the inner tube 42 comprises PTFE, and the material of the outer tube 43 comprises nylon and/or Pebax.
  • the purpose of the introducer sheath is to introduce the thrombectomy stent into the microcatheter along with the push rod.
  • the microcatheter is a surgical accessory.
  • a proximal end of the introducer sheath is provided with a handle 44.
  • Fig. 26 shows a partially enlarged structure of the portion B in Fig. 25. As shown in Figure 26, the distal inner wall 421 of the inner tube 42 is configured to have a rounded transition smooth.
  • a 0.014 inch nerve-guidewire eg, Synchro® or Transend® guidewire
  • a 0.014 inch nerve-guidewire is placed into the vessel and thrombus site to connect the hemostasis valve to the microcatheter.
  • the distal end of the microcatheter is then delivered to the distal end of the thrombus 10 mm if vascular conditions permit.
  • the guide wire is removed from the microcatheter.
  • the introducer sheath Insert the introducer sheath into the hemostatic valve halfway and gently tighten.
  • the sheath was introduced back into the sheath with physiological saline until the saline flowed out from the proximal end of the introducer sheath.
  • Loosen the hemostatic valve feed the introducer sheath into the microcatheter interface, and tighten the hemostatic valve.
  • Operate the push rod in the introducer sheath to push the bolt stop in the introducer sheath.
  • the distal end of the bolt-out stent includes a head end and a distal tapered section, the head end is 4 mm long, and the distal tapered section is 6 mm long.
  • the microcatheter is withdrawn to completely release the thrombectomy stent.
  • the catching member is in the first state
  • the bolting bracket is in the fourth state
  • the middle portion of the bolting bracket is in contact with the thrombus
  • the thrombus generates a force on the mesh unit of the segment
  • the grid unit is compressed, and the shape thereof changes.
  • the outer diameter of the middle section of the bolt-out bracket is made smaller than the outer diameter of the two ends.
  • the push rod is pulled so that the catching member is in the second state, the plug holder and the catching member are both located in the microcatheter, and then the plug holder, the catching member, and the pushing device are pushed.
  • the rod and microcatheter are pulled together as a whole. Post processing. Complete the bolting operation.
  • the mesh unit is stable in shape.

Abstract

一种取栓支架系统,包括取栓支架(1),取栓支架(1)呈卷筒状,取栓支架(1)的横截面为开环结构。一种取栓器,包括取栓支架(1),取栓支架(1)上设置有显影元件(21),能够准确显示取栓支架(1)在取栓时的膨胀状态和取栓支架(1)具体位置从而判断取栓支架(1)与血管(7)融合情况。一种取栓器系统,包括取栓支架(1)、推送杆(3)和取栓支架(1)的近端与推送杆(3)连接,取栓支架(1)的近端或者推送杆(3)与捕捉件(5)连接;捕捉件(5)被设置为能够收纳取栓支架(1)。捕捉件(5)能有效捕捉取栓过程中掉落的血栓。

Description

一种取栓器系统
技术领域
本发明属于医疗器械领域,尤其是涉及一种取栓器系统。
背景技术
脑卒中目前为世界上的常见病之一,其具有的特点为:高发病率、高患病率、高致残率。我国城市脑血管病的年发病率为219/10万,农村的为185/10万,而且还在逐年上升。自1998年至2008年脑血管病的患病率由5.9‰上升至9.7‰。在存活的脑血管病患者中,约有四分之三不同程度的丧失劳动能力,有报道称80%的脑卒中患者有不同程度的肢体功能障碍,其中43.7%的患者生活不能自理。静脉注射rt-PA溶栓是目前唯一被循证医学证实有效的脑梗死急性期治疗方法。但是静脉注射溶栓的治疗时间长,对缺血的脑组织损伤大,并伴有出血风险,再通率非常低;基底动脉溶栓的再通率只有30%左右,颈动脉末端的病变溶栓只有6%的再通率,颈总动脉溶栓只有27%左右的再通率。而且静脉注射溶栓的时间窗只有4小时左右。由以上可见,脑动脉闭塞单用静脉溶栓是远远不够的,单纯的静脉溶栓可能不足以使满足实际的临床需求。
取栓器是一种用于治疗由于抓取血管中的血栓的医疗工具。取栓器通过微导管系统进入栓塞位置,释放后可以抓捕栓塞位置的血栓,然后后通过微导管回收,将血栓取出。然而,现有的取栓器主要针对较粗的血管,无法进入较细的脑动脉血管。且取栓支架本身若设计不当,容易对血管造成不可逆的损伤,导致再狭窄、血管破裂等其他并发症;此外还容易出现在血栓抓取过程中血栓脱落,耗时,血管再通率低。若耗时久,则会导致缺血时间过长容易对大脑产生不可逆的损伤。取栓支架的显影情况不佳,也会导致取栓时间过长、血栓脱落、溶栓效果不佳等问题。以上这些都是取栓器要应用于治疗脑血栓引起的脑卒中所必须面对的问题。
发明内容
针对现有技术的不足,本发明者们研究获得了一种取栓支架系统,包括取栓支架,取栓支架呈卷筒状;取栓支架的横截面为开环结构。取栓支架的外径大小随取栓支架的卷曲程度而改变。开环的圆筒卷状设计有利于取栓支架根据需要调节卷曲的松紧度,从而调整其外径大小,以适应不同血管大小,以及适应不同支撑力的需要。当血管小时,提高卷曲度,外径变小;反之亦然。适合的支撑力,有利于提高取栓支架与血栓的融合性的同时又不损伤血管,增加血栓的抓取能力。这里的支撑力是指取栓支架对于作业部位血管内壁的张力。
进一步地,取栓支架的远端和近端均为开口状态。在取栓的过程中,往往利用取栓支架的中段与血栓进行融合,此时取栓支架的中段往往会变形使得该段的外径缩小。若取栓支架的远端和/或近端呈封闭状态,那么取栓时整个取栓支架的外径均被缩小了,取栓时,血栓因受到血管壁的阻力很容易从取栓支架上脱落。若取栓支架的远端和近端均为开口状态,则取栓支架的中段(取栓部位)外径缩小,而取栓支架两端的外径则大于中间部位,此时支架呈哑铃状,取栓时血栓不易从支架上脱落。因此,两端开口状态的取栓支架其血栓融合、抓取能力即取栓效果会明显好于一端和两端闭合状态的取栓支架。
进一步地,越靠近取栓支架的最远端,取栓支架的远端的横截面的周长越小。
进一步地,越靠近取栓支架的最近端,取栓支架的近端的横截面的周长越小。
进一步地,取栓支架的最近端的横截面缩小为点状。
进一步地,取栓支架的远端的横截面呈C字形。
进一步地,取栓支架的近端的横截面呈C字形。
进一步地,取栓支架包括多个相同或不同的网格单元。
进一步地,网格单元彼此相连呈网状。
在一个具体实施方式中,中间为网孔比两边网孔更大,并且支撑力更强,可以更好的嵌入血栓中
在一个具体实施方式中,网格单元的形状包括弧线构成的图形、多边形和弧线与直线构成的图形中的一种或者多种。
在另一个具体实施方式中,网格单元的形状包括圆形、椭圆形、四边形、三角形、菱形和梯形中的一种或者多种。
在又一个具体实施方式中,网格单元的形状包括多条弧线构成的图形。
进一步地,取栓支架具有第一状态和第二状态;在第二状态下,网格单元的形状变化,使得取栓支架的中段的外径小于其两端的外径。
进一步地,在第一状态下,网格单元的形状稳定。
进一步地,在第一状态下,网格单元的网格丝的宽度是0.05~0.16mm;网格单元的大小是3~5mm。优选地,网格单元的网格丝的宽度是0.07~0.14mm。网格单元的大小是3.6~4.5mm。网格单元的网格丝的宽度、厚度,以及网格单元的大小,连同取栓支架的圆筒卷状开环结构一起决定了取栓支架对作业部位的支撑力,但圆筒卷状开环结构能够便于该支撑力的调节。本发明中网格单元的网格丝的厚度采用现有技术中所显示的。取栓支架设计有不同的外径和长度,用以适应不同直径的脑血管和不同长度的血栓。
进一步地,取栓支架的远端的网格单元的端部设置有显影元件。显影元件用以定位手术时取栓支架在血管中位置。
进一步地,取栓支架的远端的网格单元的端部设置有沿取栓支架的远端延伸的显影元件。优选地,位于取栓支架的远端的网格单元的端部的显影元件的数量是2-8个。优选地,为4个。凸起的显影元件有利于取栓支架穿过血栓部位。
进一步地,取栓支架的材质包括记忆合金。进一步地,取栓支架的材质包括镍钛合金和/或钴基合金。
进一步地取栓支架系统还包括推送杆;取栓支架的远端上设置有显影元件;取栓支架的近端与推送杆的远端连接,并在该连接处设置有显影元件。进一步地,显影元件采用贵金属显影点,有较强的显影性,可以帮助术者在术中确定取栓支架的位置。
在一个具体实施方式中,取栓支架的近端与推送杆的远端连接处的显影元件是显影环;显影环套设在该连接处外。
在另一个具体实施方式中,取栓支架的近端与推送杆的远端的连接方式包括焊接、套接、链接或粘胶固定连接。优选地,焊接包括银焊和/或金焊。
在又一个具体实施方式中,取栓支架的近端与推送杆的远端的连接方式包括先焊接、套接或链接,再用粘胶固定连接。
进一步地,粘胶包括UV胶和/或环氧树脂胶。
进一步地,推送杆的材料包括镍钛合金。从而具有良好的柔韧性和回弹性,便于取栓支架系统在崎岖血管中的推送。
进一步地,推送杆的远端被设置为锥度台阶状,以便与取栓支架的近端连接时过渡顺畅。
进一步地,推送杆的外表面包覆有低摩擦系数的高分子材料。有利于减少推送杆的摩擦力,提供较高的推送性能。低摩擦系数的高分子材料包括PTFE(聚四氟乙烯)和/或PET(聚对苯甲酸已二醇酯塑料)。
进一步地,取栓支架系统还包括导入鞘;导入鞘为双层管,内层管的材料包括PTFE或/和HDPE(高密度聚乙烯),外层管的材料包括尼龙和/或Pebax(尼龙弹性体)。导入鞘的作用是将取栓支架连同推送杆导入到微导管中。微导管为一种手术附件。
进一步地,内层管的远端内壁被设置为圆角过渡顺滑。
进一步地,导入鞘的近端设置有手柄。
本发明针对现有技术的不足,尤其是取栓支架上显影元件的设计问题,还提供了一种取栓器,包括取栓支架,取栓支架上设置有显影元件。显影元件的形状可以根据需要进行设定,比如可以是线状、环状、网状和/或点状。
进一步地,取栓支架的远端和近端均设置有显影元件。在本发明中远端指远离操作者(比如医生)的那一端;近端指靠近操作者(比如医生)的那一端。
进一步地,取栓支架呈卷筒状;取栓支架的横截面为开环结构。取栓支架的外径大小随取栓支架的卷曲程度而改变。开环的卷筒状设计有利于取栓支架根据需要调节卷曲的松紧度,从而调整其外径大小,以适应不同血管大小,以及适应不同支撑力的需要。当血管小时,提高卷曲度,外径变小;反之亦然。适合的支撑力,有利于提高取栓支架与血栓的融合性的同时又不损伤血管,增加血栓的抓取能力。这里的支撑力是指取栓支架对于作业部位血管内壁的张力。
进一步地,显影元件的数量为≥2个,显影元件绕取栓支架的卷筒状的圆周均匀分布。
优选地,显影元件的数量为≥3个。
进一步地,取栓支架的远端上的显影元件的数量≥2个(优选地为≥3个),取栓支架的远端上的显影元件均匀分布在取栓支架的远端上;取栓支架的近端上的显影元件的数量≥2个(优选地为≥3个),取栓支架的近端上的显影元件均匀分布在取栓支架的近端上。
在一个具体实施方式中,取栓支架呈卷筒状;取栓支架的横截面为开环结构;取栓支架的远端上的显影元件的数量≥2个(优选地为≥3个),取栓支架的远端上的显影元件绕取栓支架的卷筒状的圆周均匀分布在取栓支架的远端上;取栓支架的近端上的显影元件的数量≥2个(优选地为≥3个),取栓支架的近端上的显影元件绕取栓支架的卷筒状的圆周均匀分布在取栓支架的近端上。
进一步地,取栓支架的中段设置有显影元件。本发明中取栓支架的中段指位于取栓支架的远端和近端之间的区段。
进一步地,取栓支架的远端上的显影元件的数量≥2个(优选地为≥3个),取栓支架的远端上的显影元件均匀分布在取栓支架的远端上;取栓支架的近端上的显影元件的数量≥2个(优选地为≥3个),取栓支架的近端上的显影元件均匀分布在取栓支架的近端上;取栓支架的中段上的显影元件的数量≥2个(优选地为≥3个),取栓支架的中段上的显影元件均匀分布在取栓支架的中段上。
在一个具体实施方式中,取栓支架呈卷筒状;取栓支架的横截面为开环结构;取栓支架的远端上的显影元件的数量≥2个(优选地为≥3个),取栓支架的远端上的显影元件绕取栓支架的卷筒状的圆周均匀分布在取栓支架的远端上;取栓支架的近端上的显影元件的数量≥2个(优选地为≥3个),取栓支架的近端上的显影元件绕取栓支架的卷筒状的圆周均匀分布在取栓支架的近端上;取栓支架的中段上的显影元件的数量≥2个(优选地为≥3个),取栓支架的中段上的显影元件绕取栓支架的卷筒状的圆周均匀分布在取栓支架的中段上。
在另一个具体实施方式中,显影元件包括呈线状的显影线。
进一步地,显影线的一端设置在取栓支架的远端或远端面,另一端设置在取栓支架的近端或近端面。
进一步地,显影线的数量是≥3条,显影线均匀地排布在取栓支架上。
在一个具体实施方式中,取栓支架呈卷筒状;取栓支架的横截面为开环结构;显影线的数量是≥3条,显影线沿取栓支架的轴向延伸,围绕取栓支架的卷筒状的圆周均匀地排布在取栓支架上。
在另一个具体实施方式中,取栓支架呈卷筒状;取栓支架的横截面为开环结构;取栓支架呈卷筒状;显影线沿取栓支架的卷筒状的圆周方向延伸。
在又一个具体实施方式中,取栓支架呈卷筒状;取栓支架的横截面为开环结构;显影线既沿取栓支架的轴向延伸,又沿取栓支架的卷筒状的圆周方向来回延伸。
进一步地,显影线的数量是≥3条,显影线围绕取栓支架的卷筒状的圆周均匀地排布在取栓支架上。
进一步地,显影元件的设置方式包括向取栓支架喷涂、涂刷显影材料,以及通过缠绕、卡扣、穿孔、焊接或粘接的方式将显影元件安装到取栓支架上中的一种或者多种。
在一个具体实施方式中,取栓支架的全身覆盖有显影材料。覆盖有显影材料包括向所述取栓支架喷涂、涂刷显影材料。
在另一个具体实施方式中,显影元件包括呈网状的显影网;显影网位于取栓支架的最远端,将取栓支架的远端开口封闭。
进一步地,取栓支架的远端为开口状态。在取栓的过程中,往往利用取栓支架的中段与血栓进行融合,此时取栓支架的中段往往会变形使得该段的外径缩小。若取栓支架的远端呈封闭状态,那么取栓时取栓支架中段和远端的外径均被缩小了,取栓时,血栓因受到血管壁的阻力很容易从取栓支架上脱落。若取栓支架的远端为开口状态,则取栓支架的中段(取栓部位)外径缩小,而取栓支架两端的外径则大于中间部位,此时取栓支架呈哑铃状,尤其是取栓支架的远端外径大于取栓支架的中段外径,取栓时血栓不易从支架上脱落。因此,远端开口状态的取栓支架其血栓融合、抓取能力即取栓效果会明显好于远端闭合状态的取栓支架。
进一步地,取栓支架的近端为开口状态。使得在取栓时,近端外径大于取栓支架的中段外径,血栓不易从近端脱落。
进一步地,越靠近取栓支架的最远端,取栓支架的远端的横截面的周长越小。有利于取栓支架的远端卷曲成更细的状态,从而伸入到更细的血管,因此扩大了取栓支架的适用范围。
进一步地,越靠近取栓支架的最近端,取栓支架的近端的横截面的周长越小。有利于取栓支架更好的收拢到导入鞘中。
进一步地,取栓支架的最近端的横截面缩小为点状。
进一步地,取栓支架的远端的横截面呈C字形。
进一步地,取栓支架的近端的横截面呈C字形。
进一步地,取栓支架包括多个相同或不同的网格单元。
进一步地,网格单元彼此相连呈网状。
进一步地,显影元件包括呈网状的显影网;显影网位于取栓支架的最远端,将取栓支架的远端开口封闭;显影网的网格尺寸比网格单元的网格尺寸小。从而在取栓过程中,既能显示取栓支架远端的位置,又能捕获取栓时掉落的血栓。
在一个具体实施方式中,网格单元的形状包括弧线构成的图形、多边形和弧线与直线构成的图形中的一种或者多种。
在另一个具体实施方式中,网格单元的形状包括圆形、椭圆形、四边形、三角形、菱形和梯形中的一种或者多种。
在又一个具体实施方式中,网格单元的形状包括多条弧线构成的图形。
进一步地,多个网格单元依次排列成行,且相邻两行的网格单元错位排列。优选地,所述行与取栓支架的轴向平行。即,在垂直于取栓支架轴向的方向上,相邻两行中,一行的网格单元对着另一行相邻两个网格单元的空隙。这样的设计,使得取栓支架更易压缩,更能适应细小血管,也更容易收入导入鞘中。
进一步地,网格单元由相邻的4个网格单元围合而成。
进一步地,网格单元包括第一网格单元和第二网格单元;第一网格单元由相邻的4个第二网格单元围合而成;第二网格单元由相邻的4个第一网格单元围合而成。
进一步地,网格单元包括第一网格单元和第二网格单元;多个第一网格单元依次排列成与取栓支架的轴向平行的第一网格单元行;多个第二网格单元依次排列成与取栓支架的轴向平行的第二网格单元行;第一网格单元行与第二网格单元行在取栓支架的轴向上交替排列,在垂直于取栓支架的轴向上错位排列。其排列方式即:取栓支架的单数行为第一网格单元行,双数行为第二网格单元行;或者双数行为第一网格单元行,单数行为第二网格单元行;并且在垂直于取栓支架轴向的方向上,第一网格单元对齐相邻两个第二网格单元的空隙,第二网格单元对齐相邻两个第一网格单元的空隙。这样的排列方式,有利于取栓支架的各区段以及其横截面的一周上的网格丝分布均匀,从而能够提供均匀的支撑力,取栓效果更好。
进一步地,网格单元的网格丝的宽度是0.05~0.16mm;网格单元之间的连接点的尺寸是0.25~0.45mm。优选地,网格单元的网格丝的宽度是0.07~0.14mm。
进一步地,取栓支架具有第一状态和第二状态;在第二状态下,网格单元的形状变化。比如,变化后使得取栓支架的中段的外径小于其两端的外径。
进一步地,在第一状态下,网格单元的形状稳定。
进一步地,在第一状态下,网格单元的大小是3~5mm。优选地,网格单元的大小是3.6~4.5mm。网格单元的网格丝的宽度、厚度,以及网格单元的大小和排布,连同取栓支架的卷筒状的开环结构一起决定了取栓支架对作业部位的支撑力,且卷筒状的开环结构能够便于该支撑力的调节。本发明中网格单元的网格丝的厚度采用现有技术中所显示的。取栓支架设计有不同的外径和长度,用以适应不同直径的脑血管和不同长度的血栓。
进一步地,取栓支架的远端设置有显影元件。显影元件用以定位手术时取栓支架在血管中位置。优选地,位于取栓支架的远端的网格单元的端部的显影元件的数量是2-8个。优选地,为4个。
进一步地,取栓支架的材质包括记忆合金。进一步地,取栓支架的材质包括镍钛合金和/或钴基合金。
进一步地取栓器还包括推送杆;取栓支架的近端与推送杆的远端连接,并在该连接处设置有显影元件。进一步地,显影元件采用贵金属显影点,有较强的显影性,可以帮助术者在术中确定取栓支架的位置。
在一个具体实施方式中,取栓支架的近端与推送杆的远端连接处的显影元件是显影环;显影环套设在该连接处外。
在另一个具体实施方式中,取栓支架的近端与推送杆的远端的连接方式包括焊接、套接、链接或粘胶固定连接。优选地,焊接包括银焊和/或金焊。
在又一个具体实施方式中,取栓支架的近端与推送杆的远端的连接方式包括先焊接、套接或链接,再用粘胶固定连接。
进一步地,粘胶包括UV胶和/或环氧树脂胶。
进一步地,推送杆的材料包括镍钛合金。从而具有良好的柔韧性和回弹性,便于取栓器在崎岖血管中的推送。
进一步地,推送杆的远端被设置为锥度台阶状,以便与取栓支架的近端连接时过渡顺畅。
进一步地,推送杆的外表面包覆有低摩擦系数的高分子材料。有利于减少推送杆的摩擦力,提供较高的推送性能。低摩擦系数的高分子材料包括聚四佛乙烯(PTFE)和/或聚对苯甲酸已二醇酯(PET)塑料。
进一步地,取栓器还包括导入鞘;导入鞘为双层管,内层管的材料包括PTFE或/和高密度聚乙烯(HDPE),外层管的材料包括尼龙和/或Pebax。Pebax为尼龙弹性体。导入鞘的作用是将取栓支架连同推送杆导入到微导管中。微导管为一种手术附件。
进一步地,内层管的远端内壁被设置为圆角过渡顺滑。
进一步地,导入鞘的近端设置有手柄。
本发明者还提供了一种取栓器系统,包括取栓支架、推送杆和捕捉件;取栓支架的近端与推送杆连接,推送杆与捕捉件连接;捕捉件被设置为能够收纳取栓支架。在本发明中远端指远离操作者(比如医生)的那一端;近端指靠近操作者(比如医生)的那一端。
进一步地,捕捉件包括第一端和第二端;第一端与取栓支架的近端或者推送杆连接;第二端上设置有开口;开口被设置为用于供取栓支架和推送杆穿过。
作为优选,第一端以套设在外的方式与取栓支架的近端或者推送杆固定连接。
进一步地,捕捉件具有第一状态和第二状态;在第一状态下,取栓支架位于捕捉件外;在第二状态下,取栓支架被设置在捕捉件内。
进一步地,第一状态到第二状态的转变被设置为:伸出微导管远端的第一端和取栓支架通过推送杆回拉取栓支架和第一端回撤进入微导管,且穿过位于微导管内的第二端,使得第一端位于捕捉件的近端,而第二端位于捕捉件的远端,实现取栓支架被套设在捕捉件内。微导管为一种手术附件被用于取栓器系统的手术操作。
其中,推送杆回拉取栓支架和第一端进入微导管的过程中,微导管对捕捉件的阻力或/和摩擦力使得第二端的回撤速度小于第一端的回撤速度,从而使得取栓支架和第一端能够穿过第二端。捕捉件的第二端收缩在微导管内,捕捉件的外表面与微导管的内表面接触,微导管限制了捕捉件的自然舒展。当推送杆回拉伸出微导管的取栓支架及捕捉件的第一端时,微导管对捕捉件的阻力或/和摩擦力,阻碍捕捉件第二端的回撤运动,从而使得取栓支架和第一端能穿过第二端,实现捕捉件对取栓支架的收纳。
作为优选,在第一状态下,第一端位于捕捉件的远端,第二端位于捕捉件的近端;第一状态到第二状态的转变使得捕捉件发生里外翻转、前后置换。
进一步地,在第二状态下,第二端上的开口趋于合拢。趋于合拢有利于避免收纳在内的取栓支架上的血栓从第二端的开口处脱落。优选地,捕捉件的编织方式使得其第二端上的开口在第一状态下趋于打开;当在第二状态下时,即捕捉件内外翻转之后,其第二端上的开口又趋于合拢。在第一状态下趋于打开,有利于与微导管产生更大的摩擦力,有利于从第一状态转变为第二状态时,取栓支架及第一端容易穿过第二端,完成捕捉器对取栓支架的收纳。
进一步地,捕捉件为柔性结构。
进一步地,捕捉件由金属和/或高分子材料制成。作为优选,捕捉件由金属丝或者高分子材料丝编织而成。优选地,该金属丝为记忆合金,比如镍钛合金。
作为优选,捕捉件呈长筒袜状,具有自膨性。
进一步地,捕捉件的长度大于取栓支架的长度。
进一步地,在第二状态下,被捕捉件包裹的取栓支架及捕捉件被进一步的拉入导管。该导管是一种手术附件被用于取栓器系统的手术操作,其作用是用于引导微导管和微导管内的取栓支架进入血管的相应位置处。
进一步地,取栓支架包括多个相同或不同的网格单元;捕捉件呈网状结构,其网格尺寸比网格单元的网格尺寸小。
进一步地,网格单元彼此相连呈网状。
进一步地,网格单元的形状包括弧线构成的图形、多边形和弧线与直线构成的图形中的一种或者多种。
进一步地,网格单元的形状包括圆形、椭圆形、四边形、三角形、菱形和梯形中的一种或者多种。
进一步地,网格单元的形状包括多条弧线构成的图形。
进一步地,多个网格单元依次排列成行,且相邻两行的网格单元错位排列。优选地,行与取栓支架的轴向平行。即,在垂直于取栓支架轴向的方向上,相邻两行中,一行的网格单元对着另一行相邻两个网格单元的空隙。这样的设计,使得取栓支架更易压缩,更能适应细小血管,也更容易收入导入鞘中。
进一步地,网格单元由相邻的4个网格单元围合而成。
作为优选,网格单元包括第一网格单元和第二网格单元;第一网格单元由相邻的4个第二网格单元围合而成;第二网格单元由相邻的4个第一网格单元围合而成。
进一步地,网格单元包括第一网格单元和第二网格单元;多个第一网格单元依次排列成与取栓支架的轴向平行的第一网格单元行;多个第二网格单元依次排列成与取栓支架的轴向平行的第二网格单元行;第一网格单元行与第二网格单元行在取栓支架的轴向上交替排列,在垂直于取栓支架的轴向上错位排列。其排列方式即:取栓支架的单数行为第一网格单元行,双数行为第二网格单元行;或者双数行为第一网格单元行,单数行为第二网格单元行;并且在垂直于取栓支架轴向的方向上,第一网格单元对齐相邻两个第二网格单元的空隙,第二网格单元对齐相邻两个第一网格单元的空隙。这样的排列方式,有利于取栓支架的各区段以及其横截面的一周上的网格丝分布均匀,从而能够提供均匀的支撑力,取栓效果更好。
进一步地,中间为网孔比两边网孔更大,并且支撑力更强,可以更好的嵌入血栓中
作为优选,网格单元的网格丝的宽度是0.05~0.16mm;网格单元之间的连接点的尺寸是0.25~0.45mm。优选地,网格单元的网格丝的宽度是0.07~0.14mm。
进一步地,取栓支架具有展开状态和紧缩状态;展开状态包括第三状态和第四状态;在第四状态下,网格单元受外力作用,形状变化。比如,变化后使得取栓支架的中段的外径小于其两端的外径。展开状态指取栓支架被释放到血管中,其外没有套设微导管和/或导入鞘时的状态;紧缩状态指取栓支架被回收到微导管和/或导入鞘中时的状态。
进一步地,在第三状态下,网格单元的形状稳定。
进一步地,在第三状态下,网格单元的大小是3~5mm。优选地,网格单元的大小是3.6~4.5mm。网格单元的网格丝的宽度、厚度,以及网格单元的大小和排布,连同取栓支架的卷筒状的开环结构一起决定了取栓支架对作业部位的支撑力,且卷筒状的开环结构能够便于该支撑力的调节。本发明中网格单元的网格丝的厚度采用现有技术中所显示的。取栓支架设计有不同的外径和长度,用以适应不同直径的脑血管和不同长度的血栓。
进一步地,取栓支架呈卷筒状;取栓支架的横截面为开环结构。取栓支架的外径大小随取栓支架的卷曲程度而改变。开环的卷筒状设计有利于取栓支架根据需要调节卷曲的松紧度,从而调整其外径大小,以适应不同血管大小,以及适应不同支撑力的需要。当血管小时,提高卷曲度,外径变小;反之亦然。适合的支撑力,有利于提高取栓支架与血栓的融合性的同时又不损伤血管,增加血栓的抓取能力。这里的支撑力是指取栓支架对于作业部位血管内壁的张力。
进一步地,取栓支架上设置有显影元件。显影元件的形状可以根据需要进行设定,比如可以是线状、环状、网状和/或点状。显影元件用以定位手术时取栓支架在血管中位置。进一步地,显影元件采用贵金属显影点,有较强的显影性。
作为优选,显影元件的数量为≥2个,显影元件绕取栓支架的卷筒状的圆周均匀分布。
作为优选,显影元件的数量为≥3个。
进一步地,取栓支架的远端和近端均设置有显影元件。
进一步地,取栓支架的远端上的显影元件的数量≥2个,取栓支架的远端上的显影元件均匀分布在取栓支架的远端上;取栓支架的近端上的显影元件的数量≥2个,取栓支架的近端上的显影元件均匀分布在取栓支架的近端上。
作为优选,取栓支架的远端上的显影元件的数量≥2个,取栓支架的远端上的显影元件绕取栓支架的卷筒状的圆周均匀分布在取栓支架的远端上;取栓支架的近端上的显影元件的数量≥2个,取栓支架的近端上的显影元件绕取栓支架的卷筒状的圆周均匀分布在取栓支架的近端上。
作为优选,取栓支架的中段设置有显影元件。本发明中取栓支架的中段指位于取栓支架的远端和近端之间的区段。
进一步地,取栓支架的远端上的显影元件的数量≥2个,取栓支架的远端上的显影元件均匀分布在取栓支架的远端上;取栓支架的近端上的显影元件的数量≥2个,取栓支架的近端上的显影元件均匀分布在取栓支架的近端上;取栓支架的中段上的显影元件的数量≥2个,取栓支架的中段上的显影元件均匀分布在取栓支架的中段上。
作为优选,取栓支架的远端上的显影元件的数量≥2个,取栓支架的远端上的显影元件绕取栓支架的卷筒状的圆周均匀分布在取栓支架的远端上;取栓支架的近端上的显影元件的数量≥2个,取栓支架的近端上的显影元件绕取栓支架的卷筒状的圆周均匀分布在取栓支架的近端上;取栓支架的中段上的显影元件的数量≥2个,取栓支架的中段上的显影元件绕取栓支架的卷筒状的圆周均匀分布在取栓支架的中段上。
进一步地,显影元件包括呈线状的显影线。
进一步地,显影线的一端设置在取栓支架的远端或远端面,另一端设置在取栓支架的近端或近端面。
进一步地,显影线的数量是≥3条,显影线均匀地排布在取栓支架上。
作为优选,取栓支架呈卷筒状;取栓支架的横截面为开环结构;显影线的数量是≥3条,显影线沿取栓支架的轴向延伸,围绕取栓支架的卷筒状的圆周均匀地排布在取栓支架上。
进一步地,显影线沿取栓支架的卷筒状的圆周方向延伸。
进一步地,显影线既沿取栓支架的轴向延伸,又沿取栓支架的卷筒状的圆周方向来回延伸。
作为优选,显影线的数量是≥3条,显影线围绕取栓支架的卷筒状的圆周均匀地排布在取栓支架上。
进一步地,显影元件的设置方式包括向取栓支架喷涂、涂刷显影材料,以及通过缠绕、卡扣、穿孔、焊接或粘接的方式将显影元件安装到取栓支架上中的一种或者多种。
进一步地,取栓支架的全身覆盖有显影材料。
进一步地,显影元件包括呈网状的显影网;显影网位于取栓支架的最远端,将取栓支架的远端开口封闭。
进一步地,取栓支架包括多个相同或不同的网格单元;显影网的网格尺寸比网格单元的网格尺寸小。从而在取栓过程中,既能显示取栓支架远端的位置,又能捕获取栓时掉落的血栓。
进一步地,取栓支架的远端为开口状态。在取栓的过程中,往往利用取栓支架的中段与血栓进行融合,此时取栓支架的中段往往会变形使得该段的外径缩小。若取栓支架的远端呈封闭状态,那么取栓时取栓支架中段和远端的外径均被缩小了,取栓时,血栓因受到血管壁的阻力很容易从取栓支架上脱落。若取栓支架的远端为开口状态,则取栓支架的中段(取栓部位)外径缩小,而取栓支架两端的外径则大于中间部位,此时取栓支架呈哑铃状,尤其是取栓支架的远端外径大于取栓支架的中段外径,取栓时血栓不易从支架上脱落。因此,远端开口状态的取栓支架其血栓融合、抓取能力即取栓效果会明显好于远端闭合状态的取栓支架。
进一步地,取栓支架的近端为开口状态。使得在取栓时,近端外径大于取栓支架的中段外径,血栓不易从近端脱落。
作为优选,越靠近取栓支架的最远端,取栓支架的远端的横截面的周长越小。有利于取栓支架的远端卷曲成更细的状态,从而伸入到更细的血管,因此扩大了取栓支架的适用范围。
作为优选,越靠近取栓支架的最近端,取栓支架的近端的横截面的周长越小。有利于取栓支架更好的收拢到导入鞘和微导管中。
作为优选,取栓支架的最近端的横截面缩小为点状。
作为优选,取栓支架的远端的横截面呈C字形。
作为优选,取栓支架的近端的横截面呈C字形。
进一步地,取栓支架的材质包括记忆合金。优选地,取栓支架的材质包括镍钛合金和/或钴基合金。
进一步地,取栓支架的近端与推送杆的远端连接,并在该连接处设置有显影元件。
进一步地,取栓支架的近端与推送杆的远端连接处的显影元件是显影环;显影环套设在该连接处外。
进一步地,取栓支架的近端与推送杆的远端的连接方式包括焊接、套接、链接或粘胶固定连接。
作为优选,取栓支架的近端与推送杆的远端的连接方式包括先焊接、套接或链接,再用粘胶固定连接。
进一步地,粘胶包括UV胶和/或环氧树脂胶。
进一步地,推送杆的材料包括镍钛合金。从而具有良好的柔韧性和回弹性,便于取栓器在崎岖血管中的推送。
进一步地,推送杆的远端被设置为锥度状,以便与取栓支架的近端连接时过渡顺畅。
进一步地,推送杆的外表面包覆有低摩擦系数的高分子材料。有利于减少推送杆的摩擦力,提供较高的推送性能。低摩擦系数的高分子材料包括聚四佛乙烯(PTFE)和/或聚对苯甲酸已二醇酯(PET)塑料。
进一步地,还包括导入鞘;导入鞘为双层管,内层管的材料包括PTFE和/或HDPE,外层管的材料包括尼龙和/或其他高分子材料(比如Pebax)。导入鞘的作用是将取栓支架连同推送杆导入到微导管中。
进一步地,内层管的远端内壁被设置为圆角过渡顺滑。
进一步地,导入鞘的近端设置有手柄。
有益效果包括:
1、捕捉件能有效捕捉取栓过程中掉落的血栓。捕捉件第一状态和第二状态之间的转变,简单、便捷、可重复地实现了取栓支架从捕捉件中释放或套入操作。
2、当捕捉件完全将取栓支架装入其内后,捕捉件的开口合拢,更有利于防止取栓支架上的血栓掉落。尤其是捕捉件采用较小的网眼的网状结构或者无网眼的袋状结构。
3、在取栓支架的有效长度上(即取栓支架的近端到远端)增加显影元件的数量,便于医生手术时准确判断取栓支架的位置。
4、在取栓支架上增加≥3条的显影线,能够准确显示取栓支架在取栓时的膨胀状态和取栓支架具体位置,从而判断取栓支架与血管融合的情况,便于医生的判断、手术操作及减少手术时间。
5、取栓支架全身喷涂黄金、铂金等显影材料,从而让取栓支架能够全身显影,能够准确显示取栓支架在取栓时的膨胀状态和取栓支架具体位置从而判断取栓支架与血管融合情况,便于医生的判断、手术操作及减少手术时间。
6、在取栓支架的远端增加显影网,既能显示取栓支架的位置又能捕获取栓时掉落的血栓,尤其是显影网的网格尺寸小于取栓支架网格单元的网格尺寸时。
7、特殊的取栓支架切割设计,保证取栓支架柔韧性的同时又具有适合的很好的血栓抓取能力。
8、特殊的取栓支架切割设计,可以有效的附着血栓避免取栓过程中血栓从取栓支架上脱落.
9、取栓支架和推送杆具有良好的柔韧性和弹性,可以在微导管和多弯的血管中自由穿行。
10、当取栓支架的网格单元为弧线围成的图形时,取栓支架的侧壁必定为圆角,因此可以降低在术中损伤血管的概率。
11、取栓支架为开环的结构设计,使得支架具有很好的柔韧性,能够穿过曲折的血管,顺利到达治疗部位。
附图说明
图1是本发明所涉及的一种取栓器系统的结构示意图;
图2是图1中A-A截面的结构示意图;
图3是图2中的取栓支架另一状态时的结构示意图;
图4A是在第一状态下取栓器系统的结构示意图;
图4B是在第一状态向第二状态转变过程中取栓器系统的结构示意图;
图4C是在第二状态下取栓器系统的结构示意图;
图5是本发明设计的取栓支架一种优选的结构示意图;
图6-11是关于显影元件设计与分布的几种具体实施方式的结构示意图;
图12-15是关于显影元件设置方式的几种具体实施方式的结构示意图;
图16是取栓支架切割图案一;
图17是取栓支架切割图案二;
图18是取栓支架切割图案三;
图19是取栓支架切割图案四;
图20是取栓支架切割图案五;
图21是取栓支架切割图案六;
图22是取栓支架切割图案七;
图23是一种具体实施方式中血栓支架与推送杆的链接示意图;
图24是另一种具体实施方式中血栓支架与推送杆的套接示意图;
图25是导入鞘的结构示意图;
图26是图24中B部局部放大结构示意图;
具体实施方式
下面结合附图与具体实施例对本发明做进一步的描述,本发明的保护内容不局限于以下实施例。在不背离发明构思的精神和范围下,本领域技术人员能够想到的变化和优点都被包括在本发明中,并且以所附的权利要求书为保护范围。
实施例1
图1示出了本发明涉及的取栓器系统的一个具体实施例。在本实施例中,取栓器系统包括取栓支架1、显影环2、推送杆3、导入鞘4和捕捉件5。取栓支架1的近端与推送杆3的远端连接,在连接处上设置有显影环2(属于显影元件21中的第一种)。推送杆3与导入鞘4连接。取栓支架1的远端设置有显影元件21。取栓支架1的远端和近端均为开口状态。取栓支架1的近端还与捕捉件5连接。
捕捉件5具有第一状态和第二状态。图4A中示出的是第一状态下的情况,捕捉件5套设在推送杆3外,与取栓支架1连接的那一端为捕捉件5的第一端51,处于捕捉件5的远端;另一端为捕捉件5的第二端52,处于捕捉件5的近端。图4B示出了捕捉件5从第一状态向第二状态转变;图4C示出了第二状态下的情况。
结合图4A、4B和4C以便更直观的了解第一状态向第二状态转变过程:首先该状态转变是为了将取栓工作完成后的取栓支架1套入捕捉件5,避免血栓脱落。具体是,取栓支架1完成取栓工作后,需要回撤进入微导管6,随微导管6一同撤离血管7。取栓支架1具有展开状态和紧缩状态。展开状态指取栓支架被释放到血管中,其外没有套设微导管和/或导入鞘时的状态;紧缩状态指取栓支架被回收到微导管和/或导入鞘中时的状态。展开状态又包括第三状态和第四状态;在第四状态下,取栓支架1的网格单元受外力作用,形状变化,比如,取栓过程中取栓支架的中段因插入血栓中而使得其外径变小,形成中间窄,两端宽的形态。在第三状态下,取栓支架1自然舒展,形状稳定。
在第一状态下,第二端52处于微导管6内,推送杆3穿过第二端52上的开口521;取栓支架1和第一端51处于微导管6外。取栓支架1为展开状态。通过推送杆3回拉取栓支架1和第一端51进入微导管6。同时由于第二端52与微导管6内壁的摩擦力,使得第二端52保持不动或者回撤速度小于第一端51和取栓支架1的回撤速度,从而使得第一端51和取栓支架1穿过第二端52。第一端51由捕捉件5的远端转变为捕捉件5的近端,而第二端52则由捕捉件5的近端转变为捕捉件5的远端。此时,捕捉件5发生里外翻转、前后置换,导致取栓支架1被套设在捕捉件5内,实现了第一状态向第二状态的转变。
在一个具体实施例中,捕捉件5为捕捉网,其采用记忆合金丝编织而成,而且编织方式使得在第一状态下时,第二端52的开口521趋于打开,从而与微导管6的接触更紧密,两者相对运动时会产生更大的摩擦力;在第二状态下时,捕捉件5发生内外翻转,第二端52的开口521趋于合拢(如图4C所示),从而使得被捕捉件5收纳的取栓支架1上的血栓更不容易脱落。
当进行再次取栓的时候,需要将捕捉网5在体外翻转后再重新从微导管6进入体内。翻转方式为操作者(比如医生)手持捕捉网5,往前推动推送杆3至捕捉网5完全翻转,完成从第二状态向第一状态的转变。
捕捉件5由金属和/或高分子材料制成。捕捉件5可以是呈网状结构的捕捉网,也可以是没有网眼的袋状结构。网状结构可以利于血流流过,不堵塞血流。当其为捕捉网时,其网眼尺寸小于取栓支架的网格单元的网格尺寸,或者说捕捉网的网眼小到能阻止大部分血栓脱落。
图1的A-A截面如图2所示,可以看到取栓支架1的横截面为开环。结合图1可以看出取栓支架1呈卷筒状。调节取栓支架1的卷曲程度能够使得取栓支架1的外径发生改变,比如提高卷曲程度后,取栓支架1的外径变小,如图3所示。反之,亦然。
实施例2
在本实施例中,如图5所示,取栓支架中间的网孔比两边网孔更大,并且中间网孔的支撑力更强,这样可以利用取栓支架的中间网孔更好的嵌入血栓中,同时在切割血栓时,具有更好的切割效果。
实施例3
本实施例中,取栓支架1的远端和近端均设置有显影元件21,如图6所示。位于远端的显影元件21有3个,其在取栓支架1的卷筒状结构的圆周上均匀分布。本发明中,在取栓支架1的卷筒状结构的圆周上均匀分布的意思是两两间在圆周上的距离相同或相近。位于近端的显影元件21有1个或多个,当为多个时,其在取栓支架1的卷筒状结构的圆周上均匀分布。位于远端和近端的显影元件21的数量不限于图6所示,均可以为1个或多个。
实施例4
本实施例中,取栓支架1的远端、中段和近端均设置有显影元件21,如图7所示。位于远端的显影元件21有3个,其在取栓支架1的卷筒状结构的圆周上均匀分布。位于中段的显影元件21有1个或多个,当为多个时,其在取栓支架1的卷筒状结构的圆周上均匀分布。位于近端的显影元件21有1个或多个,当为多个时,其在取栓支架1的卷筒状结构的圆周上均匀分布。位于远端、中段和近端的显影元件21的数量不限于图6所示,均可以为1个或多个。
实施例5
本实施例中,显影元件包括显影线22。显影线22的一端设置在取栓支架1的远端上,另一端设置在取栓支架1的近端面上,如图8所示。显影线22呈波浪状沿取栓支架1的卷筒状的圆周方向来回延伸,同时又沿着取栓支架1的轴向延伸。显影线22的数量可以是一条或多条。当为多条时,其在取栓支架1的卷筒状结构的圆周上均匀分布。
实施例6
本实施例中,显影元件包括显影线22。显影线22的一端设置在取栓支架1的远端上,另一端设置在取栓支架1的近端上,未抵达近端面,如图9所示。显影线22呈波浪状沿取栓支架1的卷筒状的圆周方向来回延伸,同时又沿着取栓支架1的轴向延伸。显影线22的数量可以是一条或多条。当为多条时,其在取栓支架1的卷筒状结构的圆周上均匀分布。
实施例7
本实施例中,显影元件包括显影线。显影线的一端设置在取栓支架的远端上,另一端设置在取栓支架的近端上。显影线呈直线,沿着取栓支架的轴向延伸。显影线的数量可以是一条或多条。当为多条时,其在取栓支架的卷筒状结构的圆周上均匀分布。
实施例8
本实施例中,显影元件包括显影线。显影线沿取栓支架的卷筒状的圆周方向延伸。显影线的数量是多条。取栓支架的远端、中段和近端均设置有显影线。
实施例9
本实施例中,显影元件包括显影线。显影线的数量是1条。显影线沿取栓支架的卷筒状的圆周方向来回延伸,同时又沿着取栓支架的轴向延伸。显影线的一端设置在取栓支架的远端上,另一端设置在取栓支架的近端上。
实施例10
本实施例中,取栓支架1全身喷涂或者涂刷显影材料,如图10所示。
实施例11
本实施例中,取栓支架1的近端设置有显影元件21,远端设置有显影网23,如图11所示。显影网23是显影元件21中的一种。显影网23位于取栓支架的最远端,将取栓支架1的远端开口封闭。显影网23的网格尺寸小于取栓支架1的网格单元的网格尺寸。位于近端的显影元件21有1个或多个,当为多个时,其在取栓支架1的卷筒状结构的圆周上均匀分布。
实施例12
本实施例中,显影元件21以缠绕的方式设置在取栓支架1上,如图12所示。比如,位于取栓支架1近端的显影元件21以缠绕的方式设置在取栓支架1上。
实施例13
本实施例中,取栓支架1上设置有附着元件30,显影元件21安装在附着元件30上,如图13和14所示。安装方式可以是穿孔(如图13所示)或者卡扣(如图14所示)。本实施例中的安装方式可以是针对位于任何位置的显影元件21,优选针对取栓支架1近端的显影元件21。
实施例14
本实施例中,显影元件21以缠绕的方式安装在取栓支架1上,或者显影元件21为环状套设在取栓支架1上,如图15所示。本实施例中的安装方式可以是针对位于任何位置的显影元件21,优选针对取栓支架1远端的显影元件21。
实施例15
本实施例中,取栓支架切割图案如图16所示。取栓支架1包括多个相同的彼此相连的网格单元11。网格单元11为椭圆形。
实施例16
本实施例中,取栓支架切割图案如图17所示。取栓支架1包括多个彼此相连的网格单元11。网格单元11为三角形。
实施例17
本实施例中,取栓支架切割图案如图18所示。取栓支架1包括多个彼此相连的网格单元11。网格单元11为四边形。
实施例18
在本实施例中,网格单元为椭圆形。
实施例18.1
本实施例中,取栓支架切割图案如图19所示。取栓支架1包括多个彼此相连的网格单元11。取栓支架1的远端设置有6个沿取栓支架的远端延伸的显影元件21。取栓支架1设置有1个最近端12。
实施例18.2
本实施例中,取栓支架切割图案如图20所示。取栓支架1包括多个彼此相连的网格单元11。取栓支架1设置有2个最近端12。
实施例18.3
本实施例中,取栓支架切割图案如图21所示。取栓支架1包括多个彼此相连的网格单元11。取栓支架1的远端设置有3个沿取栓支架的远端延伸的显影元件21。取栓支架1设置有2个最近端12。
实施例18.4
本实施例中,取栓支架切割图案如图22所示。取栓支架1包括多个彼此相连的网格单元11。多个网格单元11依次排列成与取栓支架1的轴向平行的行,且单数行和双数行中的网格单元11错位排列。取栓支架1的远端设置有3个沿取栓支架的远端延伸的显影元件21。取栓支架1设置有1个最近端12。
实施例19
本实施例中,取栓支架包括多个彼此相连的网格单元。网格单元为由弧线构成的图形。取栓支架的最远端的网格单元的端部均设置有显影元件,这里共为4个,但不拘于4个。网格单元包括第一网格单元和第二网格单元。多个第一网格单元依次排列成与取栓支架的轴向平行的第一网格单元行;多个第二网格单元依次排列成与取栓支架的轴向平行的第二网格单元行。第一网格单元行与第二网格单元行在轴向上交替排列,在垂直于轴向上错位排列,即:取栓支架的单数行为第一网格单元行,双数行为第二网格单元行;或者双数行为第一网格单元行,单数行为第二网格单元行;并且在垂直于取栓支架轴向的方向上,第一网格单元对齐相邻两个第二网格单元的空隙,第二网格单元对齐相邻两个第一网格单元的空隙。这样的排列方式,有利于取栓支架的各区段以及其横截面的一周上的网格丝分布均匀,从而能够提供均匀的支撑力,取栓效果更好。
第一网格单元由相邻的4个第二网格单元围合而成;第二网格单元由相邻的4个第一网格单元围合而成。
实施例20
实施例20.1
在本实施例中,网格单元的网格丝包括第一网格丝和第二网格丝。第一网格丝的宽度是0.07mm;第二网格丝的宽度是0.16mm。网格单元包括第一网格单元和第二网格单元。
在取栓支架按照横截面周长完全展开成平面的尺寸,即取栓支架切割图尺寸为:第一网格单元的宽度(与取栓支架的轴向垂直,取栓支架的轴向是指贯穿取栓支架的远端和近端的轴线方向)是4.55mm,长度(与取栓支架的轴向平行)是3.95mm。第二网格单元的宽度(与取栓支架的轴向垂直)是4.36mm,长度(与取栓支架的轴向平行)是4.97mm。
第一网格单元之间,在取栓支架轴向上的连接点的宽度(与取栓支架的轴向垂直)是0.25mm,长度(与取栓支架的轴向平行)是0.45mm。
第一网格单元之间,在与取栓支架轴向相交的方向上的连接点的宽度(与取栓支架的轴向相交)是0.38mm,长度(与取栓支架的轴向接近平行)是4.2mm。
取栓支架展开为一个平面时,其宽度(与取栓支架的轴向垂直)是20.15mm,长度(与取栓支架1的轴向平行)是38mm。
实施例20.2
在本实施例中,网格单元的网格丝包括第一网格丝、第二网格丝和第三网格丝。第一网格丝的宽度是0.07mm;第二网格丝的宽度是0.16mm,第三网格丝的宽度是0.10mm。网格单元包括第一网格单元、第二网格单元和第三网格单元。
网格丝和网格单元的种类不限于1种、2种或者3种。
以上实施例20.1和20.2所列的数值为帮助理解本发明,并不是把本发明限定在这些数值中。实际应用中可以根据血栓情况、血管情况设计不同的尺寸大小,以满足取栓的需要,并不限于上述数值。
实施例21
如图23所示,本实施例中,血栓支架1与推送杆3的连接方式是链接,显影环2套设在该连接处外,且在显影环2内涂布UV胶和/或环氧树脂胶以进一步固定血栓支架1与推送杆3的连接。
实施例22
如图24所示,本实施例中,血栓支架1与推送杆3的连接方式是套接,显影环2套设在该连接处外。
实施例23
图25示出了本发明涉及的导入鞘的一个具体实施例。导入鞘为双层管,内层管42的材料包括PTFE,外层管43的材料包括尼龙和/或Pebax。导入鞘的作用是将取栓支架连同推送杆导入到微导管中。微导管为一种手术附件。导入鞘的近端设置有手柄44。图26示出了图25中B部局部放大后的结构。如图26所示,内层管42的远端内壁421被设置为圆角过渡顺滑。
实施例24
工作时,使用传统的导管技术,用0.014英寸的神经-导丝(例如:Synchro®或Transend®导丝)进入血管和血栓位置,将止血阀连接到微导管。
然后若血管条件允许,将微导管远端送到血栓远端10mm处。将导丝从微导管中移除。
将导入鞘插入止血阀一半处,轻轻收紧。用生理盐水回冲导入鞘,直至生理盐水从导入鞘近端流出。松开止血阀,将导入鞘送入微导管接口处,拧紧止血阀。操作位于导入鞘中的推送杆,推动位于导入鞘中的取栓支架。当大约送入一半长度的取栓支架进入微导管时,取下导入鞘,继续推送取栓支架,直至取栓支架远端完全露出微导管。在本实施例中,取栓支架的远端包括头端和远端锥形段,头端长4mm,远端锥形段长6mm。
回撤微导管从而完全释放取栓支架。此时,捕捉件处于第一状态,取栓支架处于第四状态,取栓支架的中段与血栓接触,血栓对该段的网格单元产生作用力,网格单元被压缩,其形状发生改变,使得取栓支架的中段的外径小于其两端的外径。
等待一段时间(约5分钟),使得血栓充分融合嵌入到取栓支架中,取栓支架的中段的外径慢慢恢复至原状或接近原状。
然后,可以做一些阻断近端血流的常规操作后,拉动推送杆,使得捕捉件处于第二状态,取栓支架和捕捉件均位于微导管内,然后将取栓支架、捕捉件、推送杆和微导管作为一个整体一起缓慢拉出。后处理。完成取栓操作。
取栓支架在导入鞘时,其卷曲程度大,使得取栓支架的外径足够小才能装入导入鞘中。当其从导入鞘中释放出来,其外径变大。在未有外力作用于取栓支架时,其处于第三状态,如图1所示,网格单元形状稳定。
以上详细描述了本发明的较佳具体实施例。应当理解,本领域的普通技术无需创造性劳动就可以根据本发明的构思作出诸多修改和变化。因此,凡本技术领域中技术人员依本发明的构思在现有技术的基础上通过逻辑分析、推理或者有限的实验可以得到的技术方案,皆应在由权利要求书所确定的保护范围内。

Claims (136)

  1. 一种取栓支架系统,特征在于,包括取栓支架,所述取栓支架呈卷筒状;所述取栓支架的横截面为开环结构。
  2. 如权利要求1所述的取栓支架系统,其特征在于,所述取栓支架的远端和近端均为开口状态。
  3. 如权利要求1所述的取栓支架系统,其特征在于,越靠近所述取栓支架的最远端,所述取栓支架的远端的横截面的周长越小。
  4. 如权利要求1所述的取栓支架系统,其特征在于,越靠近所述取栓支架的最近端,所述取栓支架的近端的横截面的周长越小。
  5. 如权利要求4所述的取栓支架系统,其特征在于,所述取栓支架的最近端的横截面缩小为点状。
  6. 如权利要求1所述的取栓支架系统,其特征在于,所述取栓支架的远端的横截面呈C字形。
  7. 如权利要求1所述的取栓支架系统,其特征在于,所述取栓支架的近端的横截面呈C字形。
  8. 如权利要求1所述的取栓支架系统,其特征在于,所述取栓支架包括多个相同或不同的网格单元。
  9. 如权利要求8所述的取栓支架系统,其特征在于,所述网格单元彼此相连呈网状。
  10. 如权利要求8所述的取栓支架系统,其特征在于,所述取栓支架中间的网格单元的孔径大于两端网格单元的孔径。
  11. 如权利要求8所述的取栓支架系统,其特征在于,所述取栓支架中间网格单元的支撑力强于两端网格单元的支撑力。
  12. 如权利要求8所述的取栓支架系统,其特征在于,所述网格单元的形状包括弧线构成的图形、多边形和弧线与直线构成的图形中的一种或者多种。
  13. 如权利要求8所述的取栓支架系统,其特征在于,所述网格单元的形状包括圆形、椭圆形、四边形、三角形、菱形和梯形中的一种或者多种。
  14. 如权利要求8所述的取栓支架系统,其特征在于,所述网格单元的形状包括多条弧线构成的图形。
  15. 如权利要求8所述的取栓支架系统,其特征在于,所述取栓支架具有第一状态和第二状态;在所述第二状态下,所述网格单元的形状变化,使得所述取栓支架的中段的外径小于其两端的外径。
  16. 如权利要求15所述的取栓支架系统,其特征在于,在所述第一状态下,所述网格单元的形状稳定。
  17. 如权利要求16所述的取栓支架系统,其特征在于,在所述第一状态下,所述网格单元的网格丝的宽度是0.05~0.16mm,所述网格单元的大小是3~5mm。
  18. 如权利要求8所述的取栓支架系统,其特征在于,所述取栓支架的最远端的所述网格单元的端部设置有显影元件。
  19. 如权利要求8所述的取栓支架系统,其特征在于,所述取栓支架的最远端的所述网格单元的端部设置有沿所述取栓支架的远端延伸的显影元件。
  20. 如权利要求1所述的取栓支架系统,其特征在于,所述取栓支架的材质包括记忆合金。
  21. 如权利要求1所述的取栓支架系统,其特征在于,还包括推送杆;所述取栓支架的远端上设置有显影元件;所述取栓支架的近端与所述推送杆的远端连接,并在该连接处设置有显影元件。
  22. 如权利要求21所述的取栓支架系统,其特征在于,所述取栓支架的近端与所述推送杆的远端连接处的所述显影元件是显影环;所述显影环套设在该连接处外。
  23. 如权利要求21所述的取栓支架系统,其特征在于,所述取栓支架的近端与所述推送杆的远端的连接方式包括焊接、套接、链接或粘胶固定连接。
  24. 如权利要求21所述的取栓支架系统,其特征在于,所述取栓支架的近端与所述推送杆的远端的连接方式包括先焊接、套接或链接,再用粘胶固定连接。
  25. 如权利要求23或24所述的取栓支架系统,其特征在于,所述粘胶包括UV胶和/或环氧树脂胶。
  26. 如权利要求21所述的取栓支架系统,其特征在于,所述推送杆的材料包括镍钛合金。
  27. 如权利要求21所述的取栓支架系统,其特征在于,所述推送杆的远端被设置为锥度台阶状,以便与所述取栓支架的近端连接时过渡顺畅。
  28. 如权利要求21所述的取栓支架系统,其特征在于,所述推送杆的外表面包覆有低摩擦系数的高分子材料。
  29. 如权利要求21所述的取栓支架系统,其特征在于,还包括导入鞘;所述导入鞘为双层管,内层管的材料包括PTFE和/或HDPE,外层管的材料包括尼龙和/或Pebax。
  30. 如权利要求29所述的取栓支架系统,其特征在于,所述内层管的远端内壁被设置为圆角过渡顺滑。
  31. 如权利要求29所述的取栓支架系统,其特征在于,所述导入鞘的近端设置有手柄。
  32. 一种取栓器,其特征在于,包括取栓支架,所述取栓支架上设置有显影元件。
  33. 如权利要求32所述的取栓器,其特征在于,所述取栓支架的远端和近端均设置有所述显影元件。
  34. 如权利要求32或33所述的取栓器,其特征在于,所述取栓支架呈卷筒状;所述取栓支架的横截面为开环结构。
  35. 如权利要求34所述的取栓器,其特征在于,所述显影元件的数量为≥2个,所述显影元件绕所述取栓支架的卷筒状的圆周均匀分布。
  36. 如权利要求35所述的取栓器,其特征在于,所述显影元件的数量为≥3个。
  37. 如权利要求33所述的取栓器,其特征在于,所述取栓支架的远端上的显影元件的数量≥2个,所述取栓支架的远端上的显影元件均匀分布在所述取栓支架的远端上;所述取栓支架的近端上的显影元件的数量≥2个,所述取栓支架的近端上的显影元件均匀分布在所述取栓支架的近端上。
  38. 如权利要求33所述的取栓器,其特征在于,所述取栓支架呈卷筒状;所述取栓支架的横截面为开环结构;所述取栓支架的远端上的显影元件的数量≥2个,所述取栓支架的远端上的显影元件绕所述取栓支架的卷筒状的圆周均匀分布在所述取栓支架的远端上;所述取栓支架的近端上的显影元件的数量≥2个,所述取栓支架的近端上的显影元件绕所述取栓支架的卷筒状的圆周均匀分布在所述取栓支架的近端上。
  39. 如权利要求33所述的取栓器,其特征在于,所述取栓支架的中段设置有所述显影元件。
  40. 如权利要求39所述的取栓器,其特征在于,所述取栓支架的远端上的显影元件的数量≥2个,所述取栓支架的远端上的显影元件均匀分布在所述取栓支架的远端上;所述取栓支架的近端上的显影元件的数量≥2个,所述取栓支架的近端上的显影元件均匀分布在所述取栓支架的近端上;所述取栓支架的中段上的显影元件的数量≥2个,所述取栓支架的中段上的显影元件均匀分布在所述取栓支架的中段上。
  41. 如权利要求39所述的取栓器,其特征在于,所述取栓支架呈卷筒状;所述取栓支架的横截面为开环结构;所述取栓支架的远端上的显影元件的数量≥2个,所述取栓支架的远端上的显影元件绕所述取栓支架的卷筒状的圆周均匀分布在所述取栓支架的远端上;所述取栓支架的近端上的显影元件的数量≥2个,所述取栓支架的近端上的显影元件绕所述取栓支架的卷筒状的圆周均匀分布在所述取栓支架的近端上;所述取栓支架的中段上的显影元件的数量≥2个,所述取栓支架的中段上的显影元件绕所述取栓支架的卷筒状的圆周均匀分布在所述取栓支架的中段上。
  42. 如权利要求32所述的取栓器,其特征在于,所述显影元件包括呈线状的显影线。
  43. 如权利要求42所述的取栓器,其特征在于,所述显影线的一端设置在所述取栓支架的远端或远端面,另一端设置在所述取栓支架的近端或近端面。
  44. 如权利要求42所述的取栓器,其特征在于,所述显影线的数量是≥3条,所述显影线均匀地排布在所述取栓支架上。
  45. 如权利要求42所述的取栓器,其特征在于,所述取栓支架呈卷筒状;所述取栓支架的横截面为开环结构;所述显影线的数量是≥3条,所述显影线沿所述取栓支架的轴向延伸,围绕所述取栓支架的卷筒状的圆周均匀地排布在所述取栓支架上。
  46. 如权利要求42所述的取栓器,其特征在于,所述取栓支架呈卷筒状;所述取栓支架的横截面为开环结构;所述取栓支架呈卷筒状;所述显影线沿所述取栓支架的卷筒状的圆周方向延伸。
  47. 如权利要求42所述的取栓器,其特征在于,所述取栓支架呈卷筒状;所述取栓支架的横截面为开环结构;所述显影线既沿所述取栓支架的轴向延伸,又沿所述取栓支架的卷筒状的圆周方向来回延伸。
  48. 如权利要求47所述的取栓器,其特征在于,所述显影线的数量是≥3条,所述显影线围绕所述取栓支架的卷筒状的圆周均匀地排布在所述取栓支架上。
  49. 如权利要求32所述的取栓器,其特征在于,所述显影元件的设置方式包括向所述取栓支架喷涂、涂刷显影材料,以及通过缠绕、卡扣、穿孔、焊接或粘接的方式将所述显影元件安装到所述取栓支架上中的一种或者多种。
  50. 如权利要求32所述的取栓器,其特征在于,所述取栓支架的全身覆盖有显影材料。
  51. 如权利要求32所述的取栓器,其特征在于,所述显影元件包括呈网状的显影网;所述显影网位于所述取栓支架的最远端,将所述取栓支架的远端开口封闭。
  52. 如权利要求32所述的取栓器,其特征在于,所述取栓支架的远端为开口状态。
  53. 如权利要求32所述的取栓器,其特征在于,所述取栓支架的近端为开口状态。
  54. 如权利要求32所述的取栓器,其特征在于,越靠近所述取栓支架的最远端,所述取栓支架的远端的横截面的周长越小。
  55. 如权利要求32所述的取栓器,其特征在于,越靠近所述取栓支架的最近端,所述取栓支架的近端的横截面的周长越小。
  56. 如权利要求55所述的取栓器,其特征在于,所述取栓支架的最近端的横截面缩小为点状。
  57. 如权利要求32所述的取栓器,其特征在于,所述取栓支架的远端的横截面呈C字形。
  58. 如权利要求32所述的取栓器,其特征在于,所述取栓支架的近端的横截面呈C字形。
  59. 如权利要求32所述的取栓器,其特征在于,所述取栓支架包括多个相同或不同的网格单元。
  60. 如权利要求59所述的取栓器,其特征在于,所述网格单元彼此相连呈网状。
  61. 如权利要求60所述的取栓器,其特征在于,所述显影元件包括呈网状的显影网;所述显影网位于所述取栓支架的最远端,将所述取栓支架的远端开口封闭;所述显影网的网格尺寸比所述网格单元的网格尺寸小。
  62. 如权利要求59所述的取栓器,其特征在于,所述网格单元的形状包括弧线构成的图形、多边形和弧线与直线构成的图形中的一种或者多种。
  63. 如权利要求59所述的取栓器,其特征在于,所述网格单元的形状包括圆形、椭圆形、四边形、三角形、菱形和梯形中的一种或者多种。
  64. 如权利要求59所述的取栓器,其特征在于,所述网格单元的形状包括多条弧线构成的图形。
  65. 如权利要求59所述的取栓器,其特征在于,多个所述网格单元依次排列成行,且相邻两行的所述网格单元错位排列。
  66. 如权利要求65所述的取栓器,其特征在于,所述行与所述取栓支架的轴向平行。
  67. 如权利要求59所述的取栓器,其特征在于,所述网格单元由相邻的4个所述网格单元围合而成。
  68. 如权利要求59所述的取栓器,其特征在于,所述网格单元包括第一网格单元和第二网格单元;所述第一网格单元由相邻的4个所述第二网格单元围合而成;所述第二网格单元由相邻的4个所述第一网格单元围合而成。
  69. 如权利要求59所述的取栓器,其特征在于,所述网格单元包括第一网格单元和第二网格单元;多个所述第一网格单元依次排列成与所述取栓支架的轴向平行的第一网格单元行;多个所述第二网格单元依次排列成与所述取栓支架的轴向平行的第二网格单元行;所述第一网格单元行与所述第二网格单元行在所述取栓支架的轴向上交替排列,在垂直于所述取栓支架的轴向上错位排列。
  70. 如权利要求59所述的取栓器,其特征在于,所述网格单元的网格丝的宽度是0.05~0.16mm;所述网格单元之间的连接点的尺寸是0.25~0.45mm。
  71. 如权利要求59所述的取栓器,其特征在于,所述取栓支架具有第一状态和第二状态;在所述第二状态下,所述网格单元的形状变化。
  72. 如权利要求71所述的取栓器,其特征在于,在所述第一状态下,所述网格单元的形状稳定。
  73. 如权利要求71所述的取栓器,其特征在于,在所述第一状态下,所述网格单元的大小是3~5mm。
  74. 如权利要求32所述的取栓器,其特征在于,所述取栓支架的材质包括记忆合金。
  75. 如权利要求32所述的取栓器,其特征在于,还包括推送杆;所述取栓支架的近端与所述推送杆的远端连接,并在该连接处设置有显影元件。
  76. 如权利要求75所述的取栓器,其特征在于,所述取栓支架的近端与所述推送杆的远端连接处的所述显影元件是显影环;所述显影环套设在该连接处外。
  77. 如权利要求75所述的取栓器,其特征在于,所述取栓支架的近端与所述推送杆的远端的连接方式包括焊接、套接、链接或粘胶固定连接。
  78. 如权利要求75所述的取栓器,其特征在于,所述取栓支架的近端与所述推送杆的远端的连接方式包括先焊接、套接或链接,再用粘胶固定连接。
  79. 如权利要求77或78所述的取栓器,其特征在于,所述粘胶包括UV胶和/或环氧树脂胶。
  80. 如权利要求75所述的取栓器,其特征在于,所述推送杆的材料包括镍钛合金。
  81. 如权利要求75所述的取栓器,其特征在于,所述推送杆的远端被设置为锥度台阶状,以便与所述取栓支架的近端连接时过渡顺畅。
  82. 如权利要求75所述的取栓器,其特征在于,所述推送杆的外表面包覆有低摩擦系数的高分子材料。
  83. 如权利要求32所述的取栓器,其特征在于,还包括导入鞘;所述导入鞘为双层管,内层管的材料包括PTFE和/或HDPE,外层管的材料包括尼龙和/或Pebax。
  84. 如权利要求83所述的取栓器,其特征在于,所述内层管的远端内壁被设置为圆角过渡顺滑。
  85. 如权利要求83所述的取栓器,其特征在于,所述导入鞘的近端设置有手柄。
  86. 一种取栓器系统,其特征在于,包括取栓支架、推送杆和捕捉件;所述取栓支架的近端与所述推送杆连接,所述取栓支架的近端或者所述推送杆与所述捕捉件连接;所述捕捉件被设置为能够收纳所述取栓支架。
  87. 如权利要求86所述的取栓器系统,其特征在于,所述捕捉件包括第一端和第二端;所述第一端与所述取栓支架的近端或者所述推送杆连接;所述第二端上设置有开口;所述开口被设置为用于供所述取栓支架和所述推送杆穿过。
  88. 如权利要求87所述的取栓器系统,其特征在于,所述第一端以套设在外的方式或焊接、胶水粘接、机械连接等方式与所述取栓支架的近端或者所述推送杆固定连接。
  89. 如权利要求87所述的取栓器系统,其特征在于,所述捕捉件具有第一状态和第二状态;在所述第一状态下,所述取栓支架位于所述捕捉件外;在所述第二状态下,所述取栓支架被设置在所述捕捉件内。
  90. 如权利要求89所述的取栓器系统,其特征在于,所述第一状态到所述第二状态的转变被设置为:伸出微导管远端的所述第一端和所述取栓支架通过所述推送杆回拉所述取栓支架和所述第一端回撤进入所述微导管,且穿过位于所述微导管内的所述第二端,使得所述第一端位于所述捕捉件的近端,而所述第二端位于所述捕捉件的远端,实现所述取栓支架被套设在所述捕捉件内。
  91. 如权利要求90所述的取栓器系统,其特征在于,所述推送杆回拉所述取栓支架和所述第一端进入所述微导管的过程中,所述微导管对捕捉件的阻力或/和摩擦力,使得所述第二端的回撤速度小于所述第一端的回撤速度,从而使得所述取栓支架和所述第一端能够穿过所述第二端。
  92. 如权利要求90所述的取栓器系统,其特征在于,在所述第一状态下,所述第一端位于所述捕捉件的远端,所述第二端位于所述捕捉件的近端;所述第一状态到所述第二状态的转变使得所述捕捉件发生里外翻转、前后置换。
  93. 如权利要求90所述的取栓器系统,其特征在于,在所述第二状态下,所述第二端上的所述开口趋于合拢。
  94. 如权利要求90所述的取栓器系统,其特征在于,所述捕捉件的编织方式使得所述第二端上的开口在所述第一状态下趋于打开;当在所述第二状态下时,即所述捕捉件内外翻转之后,所述第二端上的开口又趋于合拢。
  95. 如权利要求86所述的取栓器系统,其特征在于,所述捕捉件为柔性结构。
  96. 如权利要求86所述的取栓器系统,其特征在于,所述捕捉件由金属和/或高分子材料制成。
  97. 如权利要求86所述的取栓器系统,其特征在于,所述捕捉件呈长筒袜状,具有自膨性。
  98. 如权利要求86所述的取栓器系统,其特征在于,所述捕捉件的长度大于所述取栓支架的长度。
  99. 如权利要求86所述的取栓器系统,其特征在于,所述取栓支架包括多个相同或不同的网格单元;所述捕捉件呈网状结构,其网格尺寸比所述网格单元的网格尺寸小。
  100. 如权利要求99所述的取栓器系统,其特征在于,所述网格单元的形状包括弧线构成的图形、多边形和弧线与直线构成的图形中的一种或者多种。
  101. 如权利要求99所述的取栓器系统,其特征在于,多个所述网格单元依次排列成行,且相邻两行的所述网格单元错位排列。
  102. 如权利要求99所述的取栓器系统,其特征在于,所述网格单元包括第一网格单元和第二网格单元;多个所述第一网格单元依次排列成与所述取栓支架的轴向平行的第一网格单元行;多个所述第二网格单元依次排列成与所述取栓支架的轴向平行的第二网格单元行;所述第一网格单元行与所述第二网格单元行在所述取栓支架的轴向上交替排列,在垂直于所述取栓支架的轴向上错位排列。
  103. 如权利要求99所述的取栓器系统,其特征在于,所述网格单元的网格丝的宽度是0.05~0.16mm;所述网格单元之间的连接点的尺寸是0.25~0.45mm。
  104. 如权利要求99所述的取栓器系统,其特征在于,所述取栓支架具有展开状态和紧缩状态;所述展开状态包括第三状态和第四状态;在所述第四状态下,所述网格单元受外力作用,形状变化。
  105. 如权利要求104所述的取栓器系统,其特征在于,在所述第三状态下,所述网格单元的形状稳定。
  106. 如权利要求104所述的取栓器系统,其特征在于,在所述第三状态下,所述网格单元的大小是3~5mm。
  107. 如权利要求86所述的取栓器系统,其特征在于,所述取栓支架呈卷筒状;所述取栓支架的横截面为开环结构。
  108. 如权利要求107所述的取栓器系统,其特征在于,所述取栓支架上设置有显影元件。
  109. 如权利要求108所述的取栓器系统,其特征在于,所述显影元件的数量为≥2个,所述显影元件绕所述取栓支架的卷筒状的圆周均匀分布。
  110. 如权利要求108所述的取栓器系统,其特征在于,所述取栓支架的远端和近端均设置有所述显影元件。
  111. 如权利要求110所述的取栓器系统,其特征在于,所述取栓支架的远端上的显影元件的数量≥2个,所述取栓支架的远端上的显影元件绕所述取栓支架的卷筒状的圆周均匀分布在所述取栓支架的远端上;所述取栓支架的近端上的显影元件的数量≥2个,所述取栓支架的近端上的显影元件绕所述取栓支架的卷筒状的圆周均匀分布在所述取栓支架的近端上。
  112. 如权利要求110所述的取栓器系统,其特征在于,所述取栓支架的中段设置有所述显影元件。
  113. 如权利要求112所述的取栓器系统,其特征在于,所述取栓支架的远端上的显影元件的数量≥2个,所述取栓支架的远端上的显影元件绕所述取栓支架的卷筒状的圆周均匀分布在所述取栓支架的远端上;所述取栓支架的近端上的显影元件的数量≥2个,所述取栓支架的近端上的显影元件绕所述取栓支架的卷筒状的圆周均匀分布在所述取栓支架的近端上;所述取栓支架的中段上的显影元件的数量≥2个,所述取栓支架的中段上的显影元件绕所述取栓支架的卷筒状的圆周均匀分布在所述取栓支架的中段上。
  114. 如权利要求108所述的取栓器系统,其特征在于,所述显影元件包括呈线状的显影线。
  115. 如权利要求114所述的取栓器系统,其特征在于,所述显影线的一端设置在所述取栓支架的远端或远端面,另一端设置在所述取栓支架的近端或近端面。
  116. 如权利要求114所述的取栓器系统,其特征在于,所述显影线的数量是≥3条,所述显影线均匀地排布在所述取栓支架上。
  117. 如权利要求108所述的取栓器系统,其特征在于,所述显影元件的设置方式包括向所述取栓支架喷涂、涂刷显影材料,以及通过缠绕、卡扣、穿孔、焊接或粘接的方式将所述显影元件安装到所述取栓支架上中的一种或者多种。
  118. 如权利要求108所述的取栓器系统,其特征在于,所述取栓支架的全身覆盖有显影材料。
  119. 如权利要求108所述的取栓器系统,其特征在于,所述显影元件包括呈网状的显影网;所述显影网位于所述取栓支架的最远端,将所述取栓支架的远端开口封闭。
  120. 如权利要求119所述的取栓器系统,其特征在于,所述取栓支架包括多个相同或不同的网格单元;所述显影网的网格尺寸比所述网格单元的网格尺寸小。
  121. 如权利要求108所述的取栓器系统,其特征在于,所述取栓支架的远端为开口状态。
  122. 如权利要求108所述的取栓器系统,其特征在于,所述取栓支架的近端为开口状态。
  123. 如权利要求86所述的取栓器系统,其特征在于,越靠近所述取栓支架的最远端,所述取栓支架的远端的横截面的周长越小。
  124. 如权利要求86所述的取栓器系统,其特征在于,越靠近所述取栓支架的最近端,所述取栓支架的近端的横截面的周长越小。
  125. 如权利要求86所述的取栓器系统,其特征在于,所述取栓支架的材质包括记忆合金。
  126. 如权利要求86所述的取栓器系统,其特征在于,所述取栓支架的近端与所述推送杆的远端连接,并在该连接处设置有显影元件。
  127. 如权利要求126所述的取栓器系统,其特征在于,所述取栓支架的近端与所述推送杆的远端连接处的所述显影元件是显影环;所述显影环套设在该连接处外。
  128. 如权利要求126所述的取栓器系统,其特征在于,所述取栓支架的近端与所述推送杆的远端的连接方式包括焊接、套接、链接或粘胶固定连接。
  129. 如权利要求126所述的取栓器系统,其特征在于,所述取栓支架的近端与所述推送杆的远端的连接方式包括先焊接、套接或链接,再用粘胶固定连接。
  130. 如权利要求128或129所述的取栓器系统,其特征在于,所述粘胶包括UV胶和/或环氧树脂胶。
  131. 如权利要求86所述的取栓器系统,其特征在于,所述推送杆的材料包括镍钛合金。
  132. 如权利要求86所述的取栓器系统,其特征在于,所述推送杆的远端被设置为锥度台阶状,以便与所述取栓支架的近端连接时过渡顺畅。
  133. 如权利要求86所述的取栓器系统,其特征在于,所述推送杆的外表面包覆有低摩擦系数的高分子材料。
  134. 如权利要求86所述的取栓器系统,其特征在于,还包括导入鞘;所述导入鞘为双层管,内层管的材料包括PTFE和/或HDPE,外层管的材料包括尼龙和/或其他高分子材料。
  135. 如权利要求134所述的取栓器系统,其特征在于,所述内层管的远端内壁被设置为圆角过渡顺滑。
  136. 如权利要求134所述的取栓器系统,其特征在于,所述导入鞘的近端设置有手柄。
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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109464175A (zh) * 2018-12-21 2019-03-15 北京久事神康医疗科技有限公司 血栓取出装置及其使用方法
CN114469468A (zh) * 2022-01-20 2022-05-13 上海心玮医疗科技股份有限公司 一种可调节支架的限位装置
CN115068162A (zh) * 2022-07-19 2022-09-20 深圳佰特微医疗科技有限公司 血栓清除装置及血栓清除系统

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7606190B2 (en) 2002-10-18 2009-10-20 Kineto Wireless, Inc. Apparatus and messages for interworking between unlicensed access network and GPRS network for data services
US7953423B2 (en) 2002-10-18 2011-05-31 Kineto Wireless, Inc. Messaging in an unlicensed mobile access telecommunications system
KR20070044072A (ko) 2002-10-18 2007-04-26 키네토 와이어리즈 인코포레이션 비인가 무선 통신 시스템을 이용한 인가 무선 통신시스템의 커버리지 영역 확장 장치 및 방법
EP2309809B1 (en) 2004-05-14 2015-03-11 Kineto Wireless, Inc. Messaging in an unlicensed mobile access telecommunications system
CN113598884B (zh) * 2021-08-06 2022-11-25 内蒙古工业大学 一种碎栓组件及血管血栓处理装置
CN113598881B (zh) * 2021-09-07 2023-12-29 艾柯医疗器械(北京)股份有限公司 血管内异物移除装置及组件
CN114098904A (zh) * 2021-11-10 2022-03-01 北京泰杰伟业科技有限公司 一种血栓收集装置
CN114010260B (zh) * 2021-11-16 2023-08-18 陈宏涛 一种血管内切割支架
CN114191154A (zh) * 2022-02-18 2022-03-18 天津市环湖医院 一种一体式渐变直径的取栓支架
CN115153755A (zh) * 2022-06-17 2022-10-11 上海玮琅医疗科技有限公司 一种血栓捕获支架及制作方法
CN115530927B (zh) * 2022-12-02 2023-04-07 北京久事神康医疗科技有限公司 取栓支架及输送系统

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006116636A1 (en) * 2005-04-28 2006-11-02 The Cleveland Clinic Foundation Stent with integrated filter
US20070112372A1 (en) * 2005-11-17 2007-05-17 Stephen Sosnowski Biodegradable vascular filter
CN103841905A (zh) * 2011-05-23 2014-06-04 拉撒路效应公司 取出系统及其使用方法
CN104586469A (zh) * 2013-11-01 2015-05-06 上海理工大学 局部循环式血栓取除器
CN105662534A (zh) * 2016-01-06 2016-06-15 赵烜 一种带有刺状结构的血管取栓装置及其血栓治疗仪
CN105726088A (zh) * 2016-04-27 2016-07-06 湖南瑞康通科技发展有限公司 一种血栓取出装置
CN106859729A (zh) * 2017-03-10 2017-06-20 上海心玮医疗科技有限公司 一种取栓支架系统
CN106963451A (zh) * 2017-03-29 2017-07-21 上海心玮医疗科技有限公司 一种取栓器

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5855600A (en) * 1997-08-01 1999-01-05 Inflow Dynamics Inc. Flexible implantable stent with composite design
US6096072A (en) * 1999-01-26 2000-08-01 Uni-Cath Inc. Self-exchange stent with effective supporting ability
US20070288054A1 (en) * 2006-06-13 2007-12-13 Tanaka Don A Vascular thrombectomby apparatus and method of use
US8066757B2 (en) * 2007-10-17 2011-11-29 Mindframe, Inc. Blood flow restoration and thrombus management methods
DE102008038195A1 (de) * 2008-08-19 2010-02-25 Phenox Gmbh Vorrichtung zur Eröffnung okkludierter Blutgefäße
US8357178B2 (en) * 2009-07-08 2013-01-22 Concentric Medical, Inc. Vascular and bodily duct treatment devices and methods
US10383644B2 (en) * 2013-10-17 2019-08-20 Covidien Lp Mechanical thrombectomy with proximal occlusion
AU2015211058A1 (en) * 2014-01-29 2016-08-11 Concentric Medical, Inc. Vascular and bodily duct treatment devices and methods
EP3352688B1 (en) * 2015-09-21 2020-02-19 Stryker Corporation Embolectomy devices
CN105354811A (zh) 2015-10-30 2016-02-24 北京自动化控制设备研究所 一种地面用多线三维激光雷达点云数据的滤波方法
US20170119408A1 (en) * 2015-10-31 2017-05-04 Neurovasc Technologies, Inc. Embolus Removal Device with Blood Flow Restriction and Related Methods
US10052185B2 (en) * 2016-02-12 2018-08-21 Covidien Lp Vascular device marker attachment
US10709464B2 (en) * 2017-05-12 2020-07-14 Covidien Lp Retrieval of material from vessel lumens
US10092309B1 (en) * 2018-02-02 2018-10-09 Highway 1 Medical, Inc. Devices for retrieving an obstruction in a bodily duct of a patient

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006116636A1 (en) * 2005-04-28 2006-11-02 The Cleveland Clinic Foundation Stent with integrated filter
US20070112372A1 (en) * 2005-11-17 2007-05-17 Stephen Sosnowski Biodegradable vascular filter
CN103841905A (zh) * 2011-05-23 2014-06-04 拉撒路效应公司 取出系统及其使用方法
CN104586469A (zh) * 2013-11-01 2015-05-06 上海理工大学 局部循环式血栓取除器
CN105662534A (zh) * 2016-01-06 2016-06-15 赵烜 一种带有刺状结构的血管取栓装置及其血栓治疗仪
CN105726088A (zh) * 2016-04-27 2016-07-06 湖南瑞康通科技发展有限公司 一种血栓取出装置
CN106859729A (zh) * 2017-03-10 2017-06-20 上海心玮医疗科技有限公司 一种取栓支架系统
CN106963451A (zh) * 2017-03-29 2017-07-21 上海心玮医疗科技有限公司 一种取栓器

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109464175A (zh) * 2018-12-21 2019-03-15 北京久事神康医疗科技有限公司 血栓取出装置及其使用方法
CN109464175B (zh) * 2018-12-21 2023-10-20 北京久事神康医疗科技有限公司 血栓取出装置及其使用方法
CN114469468A (zh) * 2022-01-20 2022-05-13 上海心玮医疗科技股份有限公司 一种可调节支架的限位装置
CN115068162A (zh) * 2022-07-19 2022-09-20 深圳佰特微医疗科技有限公司 血栓清除装置及血栓清除系统
CN115068162B (zh) * 2022-07-19 2023-07-18 深圳佰特微医疗科技有限公司 血栓清除装置及血栓清除系统

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