WO2019154123A1 - 介入瓣膜装载装置 - Google Patents

介入瓣膜装载装置 Download PDF

Info

Publication number
WO2019154123A1
WO2019154123A1 PCT/CN2019/073154 CN2019073154W WO2019154123A1 WO 2019154123 A1 WO2019154123 A1 WO 2019154123A1 CN 2019073154 W CN2019073154 W CN 2019073154W WO 2019154123 A1 WO2019154123 A1 WO 2019154123A1
Authority
WO
WIPO (PCT)
Prior art keywords
sleeve
small
grip ring
pressure grip
handle
Prior art date
Application number
PCT/CN2019/073154
Other languages
English (en)
French (fr)
Inventor
周庆亮
可大年
孟坚
Original Assignee
北京迈迪顶峰医疗科技有限公司
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
Application filed by 北京迈迪顶峰医疗科技有限公司 filed Critical 北京迈迪顶峰医疗科技有限公司
Publication of WO2019154123A1 publication Critical patent/WO2019154123A1/zh

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9522—Means for mounting a stent or stent-graft onto or into a placement instrument
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2439—Expansion controlled by filaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0067—Three-dimensional shapes conical

Definitions

  • the present invention relates to the field of medical devices, and more particularly to an interventional valve loading device.
  • the normal valve ensures smooth flow of blood in one direction and effectively pumps the blood out of the chamber without reflow.
  • endocarditis causes lesions in the valve that impair the function of the valve.
  • Stenosis and reflux are common valvular diseases.
  • valve loading device is disclosed, which is a combination of a plurality of wedge blocks.
  • the regular polygonal columnar space enclosed by the outer circumference is synchronously moved to the axis by each wedge block to realize the compression and expansion of the regular polygonal columnar space.
  • an external pressure applying device Due to the addition of an external pressure applying device, the structure of the device is complicated and the manufacturing cost is high.
  • the size of the device is large, which makes it impossible to use a simple cooling method (such as a flat plate with an ice-water mixture) to perform a martensitic transformation treatment on the nickel-titanium memory alloy stent, so that the stent becomes soft after being cooled at a low temperature. Recompression, such as compressing the stent under the austenite phase, will produce several times the radial support force, which has the risk of breaking the stent of the artificial valve device.
  • Another type of loading device has a relatively simple structure and low manufacturing cost, and is provided as a disposable consumable, which reduces the risk of cross-infection of patients, but its cumbersome operation steps cannot reduce the operation time of the operation.
  • the authorization announcement number is CN 102805676
  • the authorization announcement date is June 17, 2015
  • the patent name is "compression device of artificial valve replacement device”, which discloses a device with a clamping structure, and each clamp unit is sequentially connected.
  • a zooming channel when the artificial valve device is placed in the zoom channel, the external force is used to cause each of the jaw units to simultaneously gather toward the center of the zoom channel to achieve the purpose of compressing the artificial valve device.
  • the structure is relatively simple, since it is not equipped with an effective structure for implementing an external force, the operator can only rely on the grip force of the hand to compress the artificial valve device. Due to the high recovery of the shape memory alloy, the operator needs to continuously hold the compression device to complete the operation.
  • the technical problem to be solved by the present invention is to provide a interventional valve loading device which is not only simple in structure, low in production cost, and can be provided as a disposable use consumable, and is simple in operation, can greatly shorten the valve loading time, thereby shortening the overall operation. time.
  • the interventional valve loading device of the present invention comprises a pre-shrinking sleeve, a connecting claw member and a catheter sleeve, the pre-shrinking sleeve is in the shape of a bell mouth, and the connecting claw member comprises a handle, a connecting wire and a fastening sleeve, and the connecting wire is fixed On the handle, the connecting wire is opened outward along the axial direction of the handle, and the connecting wire is sleeved with the fastening sleeve, and the catheter sleeve comprises a pre-tightening sleeve and a pressure gripping member.
  • the pre-tightening sleeve is in the shape of a bell mouth with a small opening at one end of the large mouth, and the pressure gripping member is connected with the small end of the pre-tightening sleeve, and the pressure gripping member is made of an elastic material.
  • the invention relates to a valve loading device, wherein the pre-shrinking sleeve comprises a small port, a circular arc segment, a beveled segment and a large port, the small port is connected to one end of the circular arc segment, and the other end of the circular arc segment Connected to one end of the oblique section, the other end of the oblique section is connected to the large port, and the circular arc section smoothly transitions with the small port and the oblique section, respectively.
  • the present invention relates to a valve loading device, wherein the handle comprises a connecting handle and a connecting end, the connecting handle and the connecting end are cylindrical in shape, and one end of the connecting handle is screwed to one end of the connecting end Fixedly, the outer circumferential surface of the other end of the connecting handle is provided with a circumferentially disposed anti-slip groove.
  • the invention relates to a valve loading device, wherein an outer circumferential surface of the connecting head end is provided with an axially arranged strip-shaped groove, one end of the connecting wire is located in the strip-shaped groove, and the outer circumference of the connecting head end
  • the side sleeve is provided with a fixed tube that fixes one end of the connecting wire in the strip groove.
  • the present invention relates to the valve loading device, wherein the strip-shaped groove is provided with a circular hole perpendicular to the longitudinal direction of the strip-shaped groove, and one end of the connecting wire located in the strip-shaped groove is provided to cooperate with the circular hole.
  • An elbow, the first elbow is located in the circular hole, the first elbow is connected to the straight rod, and the straight rod and the first elbow are a portion of the connecting wire located in the strip groove,
  • the straight rod is connected to a diagonal rod, and the end of the diagonal rod is provided with a second elbow for connecting the valve stent.
  • the present invention relates to a valve loading device, wherein the angle between the diagonal rod and the straight rod is 120° to 150°, and the second curved portion is perpendicular to the oblique rod.
  • the present invention relates to the valve loading device, wherein the strip groove and the connecting wire are each set to three, and the three strip grooves are uniformly arranged circumferentially along the outer circumferential surface of the joint end.
  • the present invention relates to a valve loading device, wherein the small end of the pretensioning sleeve is provided with a fixing groove, the pressure gripping member comprises a pressure grip ring, the pressure grip ring is an open ring, and both ends of the pressure grip ring
  • the two sides of the pressure grip ring are respectively provided with a small handle, and the pressure grip ring is fixed in the fixing groove by a fixing pin, and the pressure grip ring is coaxially arranged with the small end of the pretensioning sleeve.
  • the present invention relates to the valve loading device, wherein the outer side of the small end of the pretensioning sleeve is provided with a protrusion, the protrusion is a small rectangular barb structure, and the pressure gripping member comprises a pressure grip ring, and the pressure grip ring is An open ring, the two ends of the pressure grip ring are superposed on each other, and the two ends of the pressure grip ring are respectively provided with a small handle, and the outer end of the pressure grip ring passes through a small handle disposed on the inner end.
  • a fixing sleeve is connected to the pressure grip ring, and an inner wall of the fixing sleeve is provided with a groove matching with the barb structure, and the fixing sleeve is fixed to the seat through the groove and the barb structure
  • the crimping ring, the fixing sleeve and the small end of the pre-tightening sleeve are arranged coaxially.
  • the present invention relates to the valve loading device, wherein the outer side of the small end of the pretensioning sleeve is provided with a protrusion, the protrusion is a small rectangular barb structure, and the pressure gripping member comprises a pressure grip ring, and the pressure grip ring is An open ring, the two ends of the crimping ring are superposed on each other, and a small handle is disposed at each end of the crimping ring, and a sliding groove is disposed on an inner side of the outer end of the pressing ring, the pressure An inner end of the grip ring is located in the sliding slot and is slidable along the sliding slot.
  • the pressing sleeve is connected with a fixing sleeve.
  • the inner wall of the fixing sleeve is provided with the barb structure. a groove, the fixing sleeve is fixed on the small end of the pre-tightening sleeve by the groove and the barb structure, and the small end of the pressure grip ring, the fixing sleeve and the pre-tightening sleeve are coaxially arranged When the two small handles are close to each other, the inner diameter of the pressure grip ring becomes small.
  • the present invention relates to the valve loading device, wherein the outer end of the small end of the pretensioning sleeve is provided with a circumferentially arranged notch, the pressure grip ring is an open circular ring, and the two ends of the pressure grip ring are superposed on each other, each end
  • Each of the heads is connected with a small handle, the small handle is perpendicular to the plane of the pressure grip ring, the pressure grip ring is fixedly mounted in the slot, and the pressure grip ring is the same as the small mouth end of the pretension sleeve
  • the shaft is arranged such that when the two small handles are close to each other, the inner diameter of the pressure grip ring becomes small.
  • the interventional valve loading device of the present invention differs from the prior art in that the present invention can be connected to the valve by connecting the head end of the connecting wire on the claw member and the fastening sleeve, and pre-compression of the valve is achieved by the cooperation of the pre-shrinking sleeve.
  • the handle connecting the claw member is taken out from the large port of the pre-shrinking sleeve into the small port, and the connecting wire fixed on the handle pulls the valve out from the large port of the pre-shrinking sleeve into the small port to complete the pre-compression of the valve, and then
  • the handle of the connecting claw member passes through the catheter sleeve, and the handle is pulled to pass the valve through the catheter sleeve, and when the pre-tightening sleeve in the catheter sleeve is passed through (from the large end of the pre-tightening sleeve into the small opening end), the catheter sleeve further compresses the valve, and then
  • the valve is crimped to the loading size using a catheter sleeve mid-pressure grip while the valve is loaded onto the delivery system.
  • Figure 1 is a schematic view showing the structure of a pre-shrinking sleeve in the present invention
  • Figure 2 is a schematic view showing the structure of the connecting claw member in the present invention.
  • Figure 3 is a cross-sectional view of Figure 2;
  • Figure 4 is a schematic view showing the structure of the connecting handle of the connecting claw member of the present invention.
  • Figure 5 is a schematic view showing the structure of the joint head of the connecting claw member in the present invention.
  • Figure 6 is a schematic view showing the structure of the end face of the connecting end of the connecting claw member in the present invention.
  • Figure 7 is a schematic view showing the structure of the connecting wire connecting the claw members in the present invention.
  • Figure 8 is a schematic view showing the structure of a fixing pipe connecting the claw members in the present invention.
  • Figure 9 is a schematic view showing the structure of a first catheter sleeve of the present invention.
  • Figure 10 is a schematic view showing the structure of a pre-tightening sleeve of the first catheter sleeve of the present invention.
  • Figure 11 is a schematic view showing the end face structure of the pretensioning sleeve of the first type of catheter sleeve of the present invention.
  • Figure 12 is a schematic view showing the structure of the crimping member of the first catheter sleeve of the present invention.
  • Figure 13 is a three-dimensional structural view of the crimping member of the first catheter sleeve of the present invention.
  • Figure 14 is a schematic view showing the structure of a second type of catheter sheath of the present invention.
  • Figure 15 is a schematic view showing the structure of a pre-tightening sleeve of a second type of catheter sleeve of the present invention.
  • Figure 16 is a three-dimensional structural schematic view of a pre-tightening sleeve of a second catheter sleeve of the present invention.
  • Figure 17 is a schematic view showing the structure of a crimping member of a second type of catheter sheath of the present invention.
  • Figure 18 is a three-dimensional structural view of a crimping member of a second catheter sleeve of the present invention.
  • Figure 19 is a schematic view showing another structure of the crimping member of the second catheter sleeve of the present invention.
  • Figure 20 is a schematic view showing another three-dimensional structure of the crimping member of the second catheter sleeve of the present invention.
  • Figure 21 is a schematic view showing the structure of a third type of catheter sheath of the present invention.
  • Figure 22 is a schematic view showing the structure of a crimping member of a third type of catheter sheath of the present invention.
  • Figure 23 is a schematic view showing the structure of a pretensioning sleeve of a third type of catheter sheath of the present invention.
  • the present invention relates to a valve loading device comprising a pre-shrinking sleeve 100, a connecting claw member 200 and a catheter sleeve, and the pre-shrinking sleeve 100 has a bell mouth shape.
  • the connecting claw member 200 includes a handle, a connecting wire 204 and a fastening sleeve 205.
  • the handle includes a connecting handle 201 and a connecting end 202.
  • the connecting wire 204 is fixedly disposed on the handle, specifically fixed on the connecting end 202 of the handle.
  • the connecting wire 204 is outwardly opened along the axial direction of the handle, and the connecting wire 204 is sleeved with a fastening sleeve 205.
  • the catheter sleeve comprises a pre-tightening sleeve and a pressure gripping member, and the pre-tightening sleeve is a bell mouth shape with one end and a large opening at one end.
  • the pressing part is connected with the small end of the pre-tightening sleeve, and the pressing part is made of an elastic material, and the elastic material is a polymer material, a nickel-titanium alloy or other elastic metal, so that the pressing part can automatically bounce off after the pressure-grip deformation is generated. .
  • the diameter of the small end of the pre-tightening sleeve is 6 mm to 8 mm.
  • the present invention is an interventional valve loading device, wherein the pre-shrinking sleeve 100 includes a small port 101, a circular arc segment 102, a beveled portion 103, and a large port 104, and the small port 101 is connected to one end of the circular arc segment 102, and is rounded.
  • the other end of the arc segment 102 is connected to one end of the bevel segment 103, and the other end of the bevel segment 103 is connected to the large port 104, and the arc segment 102 smoothly transitions with the small port 101 and the bevel segment 103, respectively.
  • the small port 101 of the pre-shrinking sleeve 100 has a diameter of 8 mm to 15 mm.
  • the pre-shrinking sleeve 100 is composed of a small port 101, a circular arc segment 102, a oblique side segment 103 and a large port 104.
  • the present invention is an interventional valve loading device wherein the handle includes a coupling handle 201 and a connector head end 202, and the connector handle 201 and the connector head end 202 are cylindrical in shape.
  • One end of the connecting handle 201 is screwed and fixed to one end of the connecting end 202, that is, the end surface of one end of the connecting handle 201 is provided with a threaded hole, and one end of the connecting end end 202 is provided with a thread matched with the threaded hole, and the connecting handle 201 and the connecting body are connected.
  • the head end 202 is secured by a threaded bore and a threaded connection.
  • the outer circumferential surface of the other end of the connecting handle 201 is provided with a circumferentially disposed non-slip groove.
  • the outer circumferential surface of the connecting head end 202 is provided with an axially arranged strip-shaped groove, one end of the connecting wire 204 is located in the strip-shaped groove, and the outer circumferential side of the connecting head end 202 is provided with a fixing tube 203, and the fixing tube 203 will One end of the connecting wire 204 is fixed in the strip groove.
  • the present invention relates to a valve loading device, wherein a circular hole perpendicular to a longitudinal direction of the strip groove is disposed in the strip groove, and one end of the connecting wire 204 located in the strip groove is provided with the round hole.
  • the first elbow is located in the circular hole, the first elbow is connected with the straight rod, the straight rod and the first elbow are the portion of the connecting wire 204 located in the strip groove, and the straight rod is connected with a diagonal rod,
  • the end of the diagonal rod is provided with a second elbow for connecting the valve support.
  • the connecting wire 204 is connected to the connecting hole of the valve through the second elbow, and the connecting wire 204 can be prevented from being detached from the valve by the tightening sleeve 205.
  • the invention relates to the valve loading device, wherein the angle between the diagonal rod and the straight rod is 120°-150°, the second elbow is perpendicular to the diagonal rod, and the outer circumferential surface of the connecting handle 201 is provided with a circumferentially arranged anti-slip groove. As shown in Fig. 3, the number of non-slip grooves is set to three, which prevents the worker from slipping when pulling the connecting handle 201 to load the valve.
  • the connecting wire 204 (please refer to FIG. 7) has a diameter of 1 mm and has a first elbow at one end.
  • the first elbow has a length of 2 mm and is fixedly connected with the circular hole of the connecting end 202.
  • the first elbow is connected with the straight rod.
  • the length is L2;
  • the other end of the connecting wire 204 forms a second elbow for connecting the valve support, the second elbow is connected with a diagonal rod, the length of the diagonal rod is L1, and the angle between the second elbow and the oblique rod is 90 °, the oblique rod and the straight rod have an angle of 150°;
  • the fixed tube 203 please refer to FIG. 8), the connecting wire 204 is fixed on the connecting end 202 (refer to FIG. 3);
  • the fastening sleeve 205 is medical A silicone rubber tube, the fastening sleeve 205 is free to move over the connecting wire 204 for securing the connecting wire 204 and the valve support.
  • the present invention relates to the valve loading device, wherein the strip groove and the connecting wire 204 are each set to three, and the three strip grooves are uniformly arranged circumferentially along the outer circumferential surface of the joint end 202.
  • the strip groove and the connecting wire 204 can also be non-uniformly mounted to the joint end 202.
  • the connecting wire 204 is flared outwardly by 30 to 60 degrees in the axial direction of the handle to form a taper.
  • the angle at which the connecting wire 204 is flared outward in the axial direction of the handle is complementary to the angle formed by the diagonal rod and the straight rod of the connecting wire 204.
  • the strip groove has a depth of 1.2 mm, and the length of the strip groove is half the length of the joint end 202.
  • the end of the strip groove is provided with a circular hole perpendicular to the length of the groove for fixing the wire 204.
  • the present invention is an interventional valve loading device, wherein the small end of the pretensioning sleeve 302 is provided with a fixing groove 3022, and the pressing member 301 includes a pressure grip ring 3012 and a pressure grip ring 3012. The two ends of the pressure grip ring 3012 are superposed on each other. The two ends of the pressure grip ring 3012 are respectively provided with a small handle 3011.
  • the pressure grip ring 3012 is fixed in the fixing groove 3022 by the fixing pin 3013, and the pressure grip ring 3012 is The small end of the pretensioning sleeve 302 is coaxially arranged, and when the two small handles 3011 are close to each other, the inner diameter of the pressure grip ring 3012 becomes small.
  • a non-slip rib is provided on the small handle 3011 to prevent slippage when the small handle 3011 is pressed.
  • the catheter sheath 300 shown in Figure 9 is used for the loading of the valve, including the crimping member 301 and the pretensioning sleeve 302.
  • the pre-tightening sleeve 302 (please refer to FIG. 10) is shaped like a bell mouth.
  • One end of the straight section 3021 is connected to the circular arc section 3023 and smoothly transitions, and the other end of the straight section 3021 forms a small opening end 3026 for final compression of the valve;
  • the circular arc segment 3023 is connected to one end of the inclined surface 3024 and smoothly transitions;
  • the inclined surface 3024 forms an angle with the straight segment 3021, and the other end of the inclined surface 3024 forms a large end 3025 as an entry end before the valve is compressed;
  • the fixing groove 3022 and the straight segment 3021 The fixing is fixed (refer to FIG. 11), and the fixing groove 3022 is used for fixing the crimping member 301. Pressing member 301 (refer to FIG.
  • the middle crimping ring 3012 is an open ring, which can be used for valve crimping, and the small handle 3011 is connected to both ends of the crimping ring 3012 to form a certain angle; the crimping ring The two ends of the 3012 are superposed on each other.
  • the pressure grip ring 3012 is curled, so that the valve is in a crimped state;
  • the fixing pin 3013 is perpendicular to the plane of the pressure grip ring 3012 (please refer to FIG. 13), and fixed.
  • the pin 3013 is fixedly coupled to the fixing groove 3022 such that the crimping member 301 and the pre-tightening sleeve 302 are fixed to form the catheter sheath 300.
  • the present invention is an interventional valve loading device, wherein the outer side of the small end of the pretensioning sleeve 402 is provided with a protrusion 4022 which is a small rectangular barb structure and a crimping force.
  • the member 401 includes a crimping ring 4012.
  • the crimping ring 4012 is an open circular ring.
  • the two ends of the crimping ring 4012 are superposed on each other.
  • the two ends of the crimping ring 4012 are respectively provided with a small handle 4011.
  • the outer end of the crimping ring 4012 is worn.
  • a small handle 4011 is disposed on the inner end, and a fixed sleeve 4013 is connected to the pressure grip ring 4012.
  • the inner wall of the fixing sleeve 4013 is provided with a groove matching the barb structure, and the fixing sleeve 4013 passes through the groove and The barb structure is fixed on the small end of the pretensioning sleeve 402.
  • the crimping ring 4012, the fixing sleeve 4013 and the small end of the pretensioning sleeve 402 are coaxially arranged. When the two small handles 4011 are close to each other, the crimping ring 4012 is The inner diameter becomes smaller.
  • the outer end of the crimping member 401 passes through the small handle 4011 on the inner end, and plays a role of motion guiding when the two small handles 4011 are close to each other, thereby preventing misalignment of the two small handles 4011 during the crimping process.
  • the catheter sheath 400 shown in FIG. 14 includes a crimping member 401 and a pretensioning sleeve 402.
  • the straight section 4021 of the pre-tightening sleeve 402 (please refer to FIG. 15) is connected with the inclined surface 4023 to form an angle.
  • the straight section 4021 forms a small-mouth end, and the inclined surface 4023 forms a large-mouth end;
  • the protrusion 4022 is located on the cylindrical surface of the straight section 4021, and is symmetric.
  • the protrusion 4022 is a small rectangular barb structure for fixing the crimping member 401.
  • the crimping member 401 includes a crimping ring 4012.
  • the crimping ring 4012 is an open circular ring structure.
  • the two small handles 4011 form an angle for the valve crimping; one end of the crimping ring 4012 is from the other end.
  • the middle of the small handle 4011 passes through for guiding the crimping ring 4012;
  • the fixing sleeve 4013 is connected to the bottom end of the crimping ring 4012, and the cylindrical portion of the fixing sleeve 4013 has a groove, and the convex portion of the pre-tightening sleeve 402
  • the 4022 is fixedly coupled such that the crimping member 401 is fixedly coupled to the pretensioning sleeve 402 to form the catheter sheath 400.
  • the present invention is an interventional valve loading device, wherein the outer side of the small end of the pretensioning sleeve 402 is provided with a protrusion 4022, and the protrusion 4022 is a small rectangular barb structure, and the crimping member 403 includes
  • the pressure grip ring 4032 is an open ring, and the two ends of the pressure grip ring 4032 are superposed on each other.
  • the two ends of the pressure grip ring 4032 are respectively provided with a small handle 4031, and the inner side of the outer end of the pressure grip ring 4032 is provided.
  • the sliding groove 4033 is provided, and the inner end of the pressure grip ring 4032 is located in the sliding slot 4033 and can slide along the sliding slot 4033.
  • the pressing sleeve 4032 is connected with a fixing sleeve 4013, and the inner wall of the fixing sleeve 4013 is provided with
  • the spur structure is matched with the groove, and the fixing sleeve 4013 is fixed on the small end of the pre-tightening sleeve 402 through the groove and the barb structure, and the small end of the pressing ring 4032, the fixing sleeve 4013 and the pre-tightening sleeve 402 are coaxially arranged.
  • the crimping member 403 shown in Figs. 19 and 20 is fitted and fixed with the pretensioning sleeve 402 to form a catheter sheath of another configuration.
  • the pressure grip member 403 forms a certain angle between the two small handles 4031 to facilitate the valve grip; the pressure grip member 403 is cylindrical, and when the angle between the two small handles 4031 is reduced, the valve is in a grip state. .
  • the present invention is an interventional valve loading device, wherein the outer side of the small end of the pretensioning sleeve 502 is provided with a circumferentially disposed notch 5022, and the crimping ring 5012 is an open circular ring.
  • the ends of the crimping ring 5012 are superimposed on each other, and each end is connected with a small handle 5011.
  • the small handle 5011 is perpendicular to the plane of the crimping ring 5012.
  • the crimping ring 5012 is fixedly mounted in the notch 5022, and the crimping ring 5012 is pressed. Coaxially disposed with the small end of the pre-tightening sleeve 502, when the two small handles 5011 are close to each other, the inner diameter of the pressure grip ring 5012 becomes small.
  • the catheter sheath 500 shown in FIG. 21 includes a crimping member 501 and a pretensioning sleeve 502.
  • the crimping member 501 is made of a metal material.
  • Two small handles 5011 of the crimping member 501 (please refer to FIG. 22) are respectively located at two ends of the pressing member 501, and form a bending structure, and the small handle 5011 is perpendicular to the plane of the pressing ring 5012;
  • the pre-tightening sleeve 502 please refer to FIG.
  • a semi-annular notch 5022 is formed between the small-mouth end 5021 and the inclined surface 5023 for fixing the crimping member 501; one end of the inclined surface 5023 is connected with the small-mouth end 5021, and the other end is formed with a large-mouth end.
  • the pretensioning sleeve 502 is formed into a bell mouth shape.
  • the crimping members shown in Figs. 12, 18, and 20 have an open-loop overlapping structure, and the crimping members shown in Fig. 22 have a spiral overlapping structure.
  • the invention can be connected to the valve by connecting the head end of the connecting wire on the claw member and the fastening sleeve, and the pre-compression of the valve is realized by the cooperation of the pre-shrinking sleeve, that is, the handle connecting the claw member from the large port of the pre-shrinking sleeve
  • the small port is ejected, and the connecting wire fixed on the handle pulls the valve out from the large port of the pre-shrinking sleeve into the small port to complete the pre-compression of the valve, and then passes the handle of the connecting claw member through the catheter sleeve, and pulls the handle to pass the valve
  • the catheter sleeve is passed through the pre-tightening sleeve in the catheter sheath (from the large end of the pre-tightening sleeve into the small opening), the catheter sleeve is further compressed by the catheter sleeve, and then the valve sleeve is crimped to the
  • the invention not only has the advantages of simple structure, low production cost, and can be provided as a disposable use consumable, and the simple operation can greatly shorten the valve loading time and shorten the overall operation time.
  • the interventional valve loading device of the embodiment of the invention can be connected to the valve by connecting the head end of the connecting wire on the claw member and the fastening sleeve, and the pre-compression of the valve is realized under the cooperation of the pre-shrinking sleeve, that is, the handle of the connecting claw member is connected From the large port of the pre-shrinking sleeve into the small port, the connecting wire fixed on the handle pulls the valve out from the large port of the pre-shrinking sleeve into the small port, completes the pre-compression of the valve, and then passes the handle of the connecting claw member through the catheter
  • the sleeve is pulled to pass the valve through the catheter sheath, and the catheter sleeve is further compressed by the catheter sleeve, and then the valve sleeve is crimped to the loading size using the catheter sleeve crimping member, and the valve is loaded to the valve.
  • the invention has the advantages of simple structure, low manufacturing cost

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

一种介入瓣膜装载装置，其包括预缩套（100）、连接爪件（200）和导管套（300），预缩套（100）呈喇叭口状，连接爪件（200）包括手柄、连接丝（204）和紧固套（205），连接丝（204）固定设在手柄上，连接丝（204）沿着手柄的轴向向外张开，连接丝（204）上套设有紧固套（205），导管套（300）包括预紧套（302）和压握件（301），预紧套（302）为一端大口一端小口的喇叭口状，压握件（301）与预紧套（302）的小口端（3026）连接，压握件（301）由弹性材料制成。介入瓣膜装载装置不仅结构简单、制作成本较低、可作为一次性使用耗材提供，而且操作简单，可大大缩短瓣膜装载时间，从而缩短整体手术时间。

Description

介入瓣膜装载装置
本发明是要求由申请人提出的，申请日为2018年02月06日，申请号为CN201810116307.6，名称为“介入瓣膜装载装置”的申请的优先权。以上申请的全部内容通过整体引用结合于此。
技术领域
本发明涉及医疗器械领域，特别是涉及一种介入瓣膜装载装置。
发明背景
正常的瓣膜可保障血液单向顺畅流动，能有效将腔室的血液泵出而不回流。很多种疾病，如风湿性心脏病，心内膜炎引起瓣膜的病变使瓣膜的功能受到损害，狭窄和返流是常见的瓣膜性疾病。
传统的外科瓣膜置换手术要行开胸术，要建立体外循环使心脏停跳，需要大量的人力配合，对术者的要求极高，手术极为复杂。由于手术需要体外循环技术支持，给病人带来的创伤较大，对于高龄患者和较多合并症患者，死亡率和并发症很高。近年来，经皮介入瓣膜的发展为患者带来一种安全性更高的替代疗法。
目前常用的介入瓣膜根据其释放方式主要分为球扩式和自膨式。因为介入瓣膜结构设计复杂，借助瓣膜装载装置能方便快速的将瓣膜装载在输送器上。但是目前已有的一些装载装置结构复杂，虽然操作简单，但制造成本偏高，每次使用后需要重新清洁和灭菌以便重复利用，重复灭菌使用会增加患者器械感染的风险。如在国内专利授权公告号为CN 101257863，授权公告日为2011年5月11日，专利名称为“修复性瓣膜卷曲装置”中公开了一种瓣膜装载装置，是利用多个楔形块组合成一个外周封闭的正多边形柱状空间，通过每个楔形块同步向轴心平动，实现正多边形柱状空间压缩和扩张。由于其增加了外部施压装置，使该装置结构复杂，制造成本高。而且，该装置外廓尺寸较大，导致无法使用简易的冷却方式(如装有冰水混合物的平盘)对镍钛记忆合金支架进行马氏体相变处理，使支架 在低温下变柔软后再压缩，如让支架在奥氏体相下被压缩，将产生数倍的径向支撑力，这有使得人造瓣膜装置支架断裂的风险。
另一类装载装置结构相对简单，制造成本低，做为一次性耗品提供，降低了患者交叉感染的风险，但是其繁琐的操作步骤无法降低手术的操作时间。如授权公告号为CN 102805676，授权公告日为2015年6月17日，专利名称为“人造瓣膜置换装置的压缩装置”中公开了一种钳夹结构的装置，各钳夹单元依次相连围成一个缩放通道，当人造瓣膜装置放置在缩放通道内时，通过外力使得各钳夹单元同时向缩放通道中心收拢，达到压缩人造瓣膜装置的目的。其结构虽然相对简单，但是因其并没有配备实施外力的有效结构，操作者只能依靠手的握持力将人造瓣膜装置压缩。由于形状记忆合金的恢复性强，使得操作者需持续大力紧握此压缩装置才能完成操作。
发明内容
本发明要解决的技术问题是提供一种介入瓣膜装载装置，该装置不仅结构简单、制作成本较低、可作为一次性使用耗材提供，而且操作简单，可大大缩短瓣膜装载时间，从而缩短整体手术时间。
本发明介入瓣膜装载装置，包括预缩套、连接爪件和导管套，所述预缩套呈喇叭口状，所述连接爪件包括手柄、连接丝和紧固套，所述连接丝固定设在所述手柄上，所述连接丝沿着所述手柄的轴向向外张开，所述连接丝上套设有所述紧固套，所述导管套包括预紧套和压握件，所述预紧套为一端大口一端小口的喇叭口状，所述压握件与所述预紧套的小口端连接，所述压握件由弹性材料制成。
本发明介入瓣膜装载装置，其中所述预缩套包括小端口、圆弧段、斜边段和大端口，所述小端口与所述圆弧段的一端相连，所述圆弧段的另一端与所述斜边段的一端相连，所述斜边段的另一端与所述大端口相连，所述圆弧段分别与小端口和斜边段平滑过渡。
本发明介入瓣膜装载装置，其中所述手柄包括连接柄和连接头端，所述连接柄和所述连接头端的形状均为圆柱形，所述连接柄的一端与所述连接头端的一端 螺纹连接固定，所述连接柄另一端外圆周面上设有周向布置的防滑凹槽。
本发明介入瓣膜装载装置，其中所述连接头端的外圆周面上设有轴向布置的条形凹槽，所述连接丝的一端位于所述条形凹槽内，所述连接头端的外圆周侧套装有一固定管，所述固定管将所述连接丝的一端固定于所述条形凹槽内。
本发明介入瓣膜装载装置，其中所述条形凹槽内设有垂直于条形凹槽长度方向的圆孔，位于条形凹槽内的连接丝一端设有与所述圆孔相配合第一弯头，所述第一弯头位于所述圆孔内，所述第一弯头连接一直杆，所述直杆和第一弯头为所述连接丝位于条形凹槽内的部分，所述直杆连接一斜杆，所述斜杆的端头设有第二弯头，所述第二弯头用于连接瓣膜支架。
本发明介入瓣膜装载装置，其中所述斜杆与所述直杆的夹角为120°～150°，所述第二弯头垂直于所述斜杆。
本发明介入瓣膜装载装置，其中所述条形凹槽和所述连接丝均设为3个，3个所述条形凹槽沿所述连接头端的外圆周面周向均匀布置。
本发明介入瓣膜装载装置，其中所述预紧套的小口端设有固定槽，所述压握件包括压握环，所述压握环为开口圆环，所述压握环的两端头相互叠加，所述压握环的两端各设有一小手柄，所述压握环通过固定销固定于所述固定槽内，所述压握环与所述预紧套的小口端同轴布置，当两个小手柄相互靠拢时，压握环的内径变小。
本发明介入瓣膜装载装置，其中所述预紧套的小口端的外侧设有凸起，所述凸起为小长方形的倒刺结构，所述压握件包括压握环，所述压握环为开口圆环，所述压握环的两端头相互叠加，所述压握环的两端各设有一小手柄，所述压握环的外侧一端穿过设置于内侧一端上的小手柄，所述压握环上连接有固定套筒，所述固定套筒的内壁上设有与所述倒刺结构相配合的凹槽，所述固定套筒通过所述凹槽和倒刺结构固定于所述预紧套的小口端上，所述压握环、固定套筒和预紧套的小口端同轴布置，当两个小手柄相互靠拢时，压握环的内径变小。
本发明介入瓣膜装载装置，其中所述预紧套的小口端的外侧设有凸起，所述凸起为小长方形的倒刺结构，所述压握件包括压握环，所述压握环为开口圆环， 所述压握环的两端头相互叠加，所述压握环的两端各设有一小手柄，所述压握环的外侧一端的内侧面上设有滑槽，所述压握环的内侧一端位于所述滑槽内并能够沿着滑槽滑动，所述压握环上连接有固定套筒，所述固定套筒的内壁上设有与所述倒刺结构相配合的凹槽，所述固定套筒通过所述凹槽和倒刺结构固定于所述预紧套的小口端上，所述压握环、固定套筒和预紧套的小口端同轴布置，当两个小手柄相互靠拢时，压握环的内径变小。
本发明介入瓣膜装载装置，其中所述预紧套的小口端外侧开设有周向布置的槽口，所述压握环为开口圆环，所述压握环的两端头相互叠加，每一端头各连接有一小手柄，所述小手柄垂直于所述压握环所在的平面，所述压握环固定安装于所述槽口内，所述压握环与所述预紧套的小口端同轴布置，当两个小手柄相互靠拢时，压握环的内径变小。
本发明介入瓣膜装载装置与现有技术不同之处在于本发明通过连接爪件上的连接丝的头端和紧固套可以连接到瓣膜上，在预缩套的配合下实现对瓣膜的预先压缩，即将连接爪件的手柄从预缩套的大端口进小端口出，同时固定在手柄上的连接丝拉动瓣膜从预缩套的大端口进小端口出，完成对瓣膜的预压缩，接着将连接爪件的手柄通过导管套，拉动手柄使瓣膜通过导管套，通过导管套中的预紧套时(从预紧套的大口端进小口端出)，导管套对瓣膜实现进一步的压缩，然后使用导管套中压握件将瓣膜压握到装载尺寸，同时将瓣膜装载到输送系统上。由此可见，本发明结构简单，制作成本低，操作简单，可大大缩短瓣膜装载时间，从而缩短整体手术时间。
下面结合附图对本发明作进一步说明。
附图简要说明
图1是本发明中的预缩套的结构示意图；
图2是本发明中的连接爪件的结构示意图；
图3为图2的剖视图；
图4是本发明中连接爪件的连接柄结构示意图；
图5是本发明中连接爪件的连接头端结构示意图；
图6是本发明中连接爪件的连接头端端面结构示意图；
图7是本发明中连接爪件的连接丝结构示意图；
图8是本发明中连接爪件的固定管结构示意图；
图9是本发明的第一种导管套结构示意图；
图10是本发明的第一种导管套的预紧套结构示意图；
图11是本发明的第一种导管套的预紧套的端面结构示意图；
图12是本发明的第一种导管套的压握件结构示意图；
图13是本发明的第一种导管套的压握件三维结构示意图；
图14是本发明的第二种导管套结构示意图；
图15是本发明的第二种导管套的预紧套结构示意图；
图16是本发明的第二种导管套的预紧套的三维结构示意图；
图17是本发明的第二种导管套的压握件结构示意图；
图18是本发明的第二种导管套的压握件三维结构示意图；
图19是本发明的第二种导管套的压握件另一种结构示意图；
图20是本发明的第二种导管套的压握件另一种三维结构示意图；
图21是本发明的第三种导管套结构示意图；
图22是本发明的第三种导管套的压握件结构示意图；
图23是本发明的第三种导管套的预紧套的结构示意图。
实施本发明的方式
如图1所示，并结合图2、3、9、14、21所示，本发明介入瓣膜装载装置，包括预缩套100、连接爪件200和导管套，预缩套100呈喇叭口状，连接爪件200包括手柄、连接丝204和紧固套205，手柄包括连接柄201和连接头端202，连接丝204固定设在手柄上，具体为固定设在手柄的连接头端202上，连接丝204沿着手柄的轴向向外张开，连接丝204上套设有紧固套205，导管套包括预紧套和压握件，预紧套为一端大口一端小口的喇叭口状，压握件与预紧套的 小口端连接，压握件由弹性材料制成，弹性材料为高分子材料、镍钛合金或其他弹性金属，使压握件在产生压握变形后可自动弹开。预紧套小口端的直径尺寸为6㎜～8㎜。
如图1所示，本发明介入瓣膜装载装置，其中预缩套100包括小端口101、圆弧段102、斜边段103和大端口104，小端口101与圆弧段102的一端相连，圆弧段102的另一端与斜边段103的一端相连，斜边段103的另一端与大端口104相连，圆弧段102分别与小端口101和斜边段103平滑过渡。预缩套100的小端口101直径尺寸为8㎜～15㎜。预缩套100由小端口101、圆弧段102、斜边段103和大端口104组成喇叭口结构。
如图3所示，并结合图4-8所示，本发明介入瓣膜装载装置，其中手柄包括连接柄201和连接头端202，连接柄201和连接头端202的形状均为圆柱形。连接柄201的一端与连接头端202的一端螺纹连接固定，即连接柄201一端的端面设有螺纹孔，连接头端202的一端外侧设有与螺纹孔相配合的螺纹，连接柄201和连接头端202通过螺纹孔和螺纹连接固定。连接柄201另一端外圆周面上设有周向布置的防滑凹槽。连接头端202的外圆周面上设有轴向布置的条形凹槽，连接丝204的一端位于条形凹槽内，连接头端202的外圆周侧套装有一固定管203，固定管203将连接丝204的一端固定于条形凹槽内。
如图7所示，本发明介入瓣膜装载装置，其中条形凹槽内设有垂直于条形凹槽长度方向的圆孔，位于条形凹槽内的连接丝204一端设有与圆孔相配合第一弯头，第一弯头位于圆孔内，第一弯头连接一直杆，直杆和第一弯头为连接丝204位于条形凹槽内的部分，直杆连接一斜杆，斜杆的端头设有第二弯头，第二弯头用于连接瓣膜支架。连接丝204通过第二弯头连接到瓣膜的连接孔中，通过紧固套205可以防止连接丝204与瓣膜脱离。
本发明介入瓣膜装载装置，其中斜杆与直杆的夹角为120°～150°，第二弯头垂直于斜杆，连接柄201的外圆周面上设有周向布置的防滑凹槽，如图3所示，防滑凹槽的数量设为3个，防止工作人员在拉动连接柄201以装载瓣膜时发生滑脱。
连接丝204(请参照图7)，直径为1㎜，一端有第一弯头，第一弯头的长度为2㎜，与连接头端202的圆孔固定连接，第一弯头连接一直杆，长度为L2；连接丝204的另一端形成第二弯头，用于连接瓣膜支架，第二弯头连接一斜杆，斜杆长度为L1，第二弯头与斜杆的夹角为90°，斜杆与直杆存在夹角，角度为150°；固定管203(请参照图8)，将连接丝204固定于连接头端202上(请参照图3)；紧固套205为医用硅橡胶管，紧固套205在连接丝204上能自由移动，用于固定连接丝204和瓣膜支架。
本发明介入瓣膜装载装置，其中条形凹槽和连接丝204均设为3个，3个条形凹槽沿连接头端202的外圆周面周向均匀布置。当然，条形凹槽和连接丝204也可以非均匀地安装到连接头端202上。连接丝204沿着手柄的轴向方向向外张开30°～60°，形成锥形。连接丝204沿着手柄轴向向外张开的角度与连接丝204的斜杆、直杆所呈的夹角互为补角。
条形凹槽的深度为1.2㎜，条形凹槽的长度为连接头端202长度的一半，条形凹槽的终点设有垂直于凹槽长度方向的圆孔，用于固定连接丝204。
如图9所示，并结合图10-13所示，本发明介入瓣膜装载装置，其中预紧套302的小口端设有固定槽3022，压握件301包括压握环3012，压握环3012为开口圆环，压握环3012的两端头相互叠加，压握环3012的两端各设有一小手柄3011，压握环3012通过固定销3013固定于固定槽3022内，压握环3012与预紧套302的小口端同轴布置，当两个小手柄3011相互靠拢时，压握环3012的内径变小。为了增大小手柄3011的摩擦力，在小手柄3011上设置防滑凸棱，防止在压握小手柄3011时发生滑脱。
图9所示的导管套300，用于瓣膜的装载，包括压握件301和预紧套302。预紧套302(请参照图10)，形状如喇叭口，直段3021的一端与圆弧段3023连接，且平滑过渡，直段3021的另一端形成小口端3026，用于瓣膜最后的压缩；圆弧段3023与斜面3024的一端连接，且平滑过渡；斜面3024与直段3021形成夹角，斜面3024的另一端形成大口端3025，作为瓣膜压缩前的进入端；固定槽3022与直段3021相连固定(请参照图11)，固定槽3022用于压握件 301的固定。压握件301(请参照图12)，中间的压握环3012为开口圆环，可用于瓣膜压握，小手柄3011连接于压握环3012的两端，形成一定的夹角；压握环3012的两端互相叠加，当两个小手柄3011相互靠拢时，压握环3012形成卷曲，使得瓣膜处于压握状态；固定销3013与压握环3012所在平面垂直(请参照图13)，固定销3013与固定槽3022固定连接，使得压握件301与预紧套302固定形成导管套300。
如图14所示，并结合图15-18所示，本发明介入瓣膜装载装置，其中预紧套402的小口端的外侧设有凸起4022，凸起4022为小长方形的倒刺结构，压握件401包括压握环4012，压握环4012为开口圆环，压握环4012的两端头相互叠加，压握环4012的两端各设有一小手柄4011，压握环4012的外侧一端穿过设置于内侧一端上的小手柄4011，压握环4012上连接有固定套筒4013，固定套筒4013的内壁上设有与倒刺结构相配合的凹槽，固定套筒4013通过凹槽和倒刺结构固定于预紧套402的小口端上，压握环4012、固定套筒4013和预紧套402的小口端同轴布置，当两个小手柄4011相互靠拢时，压握环4012的内径变小。压握件401的外侧一端穿过内侧一端上的小手柄4011后，在两个小手柄4011相互靠拢时起到运动导向的作用，可防止压握过程中两个小手柄4011发生错位。当然，为了增大小手柄4011的摩擦力，还可以在小手柄4011上设置防滑凸棱，防止在压握小手柄4011时发生滑脱。
图14所示的导管套400，包括压握件401和预紧套402。预紧套402(请参照图15)的直段4021与斜面4023连接，形成夹角，直段4021形成小口端，斜面4023形成大口端；凸起4022位于直段4021的圆柱面上，且对称布置，凸起4022为小长方形的倒刺结构，用于固定压握件401。请参照图17，压握件401包括压握环4012，压握环4012为开口圆环结构，两个小手柄4011形成一定的角度，用于瓣膜压握；压握环4012的一端从另一端的小手柄4011的中间穿过，用于压握环4012的导向；在压握环4012的底端连接固定套筒4013，固定套筒4013的圆柱内部有凹槽，与预紧套402的凸起4022固定连接，使得压握件401与预紧套402固定连接形成导管套400。
如图15、16、19、20所示，本发明介入瓣膜装载装置，其中预紧套402的小口端的外侧设有凸起4022，凸起4022为小长方形的倒刺结构，压握件403包括压握环4032，压握环4032为开口圆环，压握环4032的两端头相互叠加，压握环4032的两端各设有一小手柄4031，压握环4032的外侧一端的内侧面上设有滑槽4033，压握环4032的内侧一端位于滑槽4033内并能够沿着滑槽4033滑动，压握环4032上连接有固定套筒4013，固定套筒4013的内壁上设有与倒刺结构相配合的凹槽，固定套筒4013通过凹槽和倒刺结构固定于预紧套402的小口端上，压握环4032、固定套筒4013和预紧套402的小口端同轴布置，当两个小手柄4031相互靠拢时，压握环4032的内径变小。压握件403的外侧一端的内侧面上的滑槽4033，当两个小手柄4031在相互靠拢时，压握件403的内侧一端沿着滑槽4033滑动，能够起到运动导向的作用，可防止压握过程中两个小手柄4031发生错位。当然，为了增大小手柄4031的摩擦力，还可以在小手柄4031上设置防滑凸棱，防止在压握小手柄4031时发生滑脱。
图19和图20所示的压握件403与预紧套402配合固定，形成另一结构的导管套。压握件403，两个小手柄4031之间形成一定的角度，便于瓣膜压握；压握件403为圆筒状，当两个小手柄4031之间的角度减小时，使瓣膜处于压握状态。
如图21所示，并结合图22、23所示，本发明介入瓣膜装载装置，其中预紧套502的小口端外侧开设有周向布置的槽口5022，压握环5012为开口圆环，压握环5012的两端头相互叠加，每一端头各连接有一小手柄5011，小手柄5011垂直于压握环5012所在的平面，压握环5012固定安装于槽口5022内，压握环5012与预紧套502的小口端同轴布置，当两个小手柄5011相互靠拢时，压握环5012的内径变小。
图21所示的导管套500包括压握件501和预紧套502。压握件501为金属材料制作而成。压握件501(请参照图22)的两个小手柄5011分别位于压握件501的两端，并形成一种折弯结构，小手柄5011与压握环5012所在平面垂直；当处于压握件501两端的小手柄5011靠近时，压握环5012直径变小， 使得瓣膜处于压握状态。预紧套502(请参照图23)，小口端5021与斜面5023之间形成半圆环状槽口5022，用于固定压握件501；斜面5023一端与小口端5021连接，另一端形成大口端，使得预紧套502形成喇叭口形状。
图12、18、20所示的压握件为开环重叠结构，图22所示的压握件为螺旋重叠结构。
本发明通过连接爪件上的连接丝的头端和紧固套可以连接到瓣膜上，在预缩套的配合下实现对瓣膜的预先压缩，即将连接爪件的手柄从预缩套的大端口进小端口出，同时固定在手柄上的连接丝拉动瓣膜从预缩套的大端口进小端口出，完成对瓣膜的预压缩，接着将连接爪件的手柄通过导管套，拉动手柄使瓣膜通过导管套，通过导管套中的预紧套时(从预紧套的大口端进小口端出)，导管套对瓣膜实现进一步的压缩，然后使用导管套中压握件将瓣膜压握到装载尺寸，同时将瓣膜装载到输送系统上。由此可见，本发明结构简单，制作成本低，操作简单，可大大缩短瓣膜装载时间，从而缩短整体手术时间。
本发明不仅结构简单，制作成本较低，可作为一次性使用耗材提供，而且操作简单可大大缩短瓣膜装载时间从而缩短整体手术时间。
以上所述的实施例仅仅是对本发明的优选实施方式进行描述，并非对本发明的范围进行限定，在不脱离本发明设计精神的前提下，本领域普通技术人员对本发明的技术方案作出的各种变形和改进，均应落入本发明权利要求书确定的保护范围内。
工业实用性
本发明实施例的介入瓣膜装载装置通过连接爪件上的连接丝的头端和紧固套可以连接到瓣膜上，在预缩套的配合下实现对瓣膜的预先压缩，即将连接爪件的手柄从预缩套的大端口进小端口出，同时固定在手柄上的连接丝拉动瓣膜从预缩套的大端口进小端口出，完成对瓣膜的预压缩，接着将连接爪件的手柄通过导管套，拉动手柄使瓣膜通过导管套，通过导管套中的预紧套时，导管套对瓣膜实现进一步的压缩，然后使用导管套中压握件将瓣膜压握到装载尺 寸，同时将瓣膜装载到输送系统上。本发明结构简单，制作成本低，操作简单，可大大缩短瓣膜装载时间，从而缩短整体手术时间。本发明实施例的介入瓣膜装载装置能够批量生产制造。

Claims (11)

  1. 一种介入瓣膜装载装置，其特征在于：包括预缩套、连接爪件和导管套，所述预缩套呈喇叭口状，所述连接爪件包括手柄、连接丝和紧固套，所述连接丝固定设在所述手柄上，所述连接丝沿着所述手柄的轴向向外张开，所述连接丝上套设有所述紧固套，所述导管套包括预紧套和压握件，所述预紧套为一端大口一端小口的喇叭口状，所述压握件与所述预紧套的小口端连接，所述压握件由弹性材料制成。
  2. 根据权利要求1所述的介入瓣膜装载装置，其特征在于：所述预缩套包括小端口、圆弧段、斜边段和大端口，所述小端口与所述圆弧段的一端相连，所述圆弧段的另一端与所述斜边段的一端相连，所述斜边段的另一端与所述大端口相连，所述圆弧段分别与所述小端口和所述斜边段平滑过渡。
  3. 根据权利要求1所述的介入瓣膜装载装置，其特征在于：所述手柄包括连接柄和连接头端，所述连接柄和所述连接头端的形状均为圆柱形，所述连接柄的一端与所述连接头端的一端螺纹连接固定，所述连接柄另一端外圆周面上设有周向布置的防滑凹槽。
  4. 根据权利要求3所述的介入瓣膜装载装置，其特征在于：所述连接头端的外圆周面上设有轴向布置的条形凹槽，所述连接丝的一端位于所述条形凹槽内，所述连接头端的外圆周侧套装有一固定管，所述固定管将所述连接丝的一端固定于所述条形凹槽内。
  5. 根据权利要求4所述的介入瓣膜装载装置，其特征在于：所述条形凹槽内设有垂直于条形凹槽长度方向的圆孔，位于所述条形凹槽内的连接丝一端设有与所述圆孔相配合的第一弯头，所述第一弯头位于所述圆孔内，所述第一弯头连接一直杆，所述直杆和所述第一弯头为所述连接丝位于条形凹槽内的部分，所述直杆连接一斜杆，所述斜杆的端头设有第二弯头，所述第二弯头用于连接瓣膜支架。
  6. 根据权利要求5所述的介入瓣膜装载装置，其特征在于：所述斜杆与 所述直杆的夹角为120°～150°，所述第二弯头垂直于所述斜杆。
  7. 根据权利要求5所述的介入瓣膜装载装置，其特征在于：所述条形凹槽和所述连接丝均设为3个，3个所述条形凹槽沿所述连接头端的外圆周面周向均匀布置。
  8. 根据权利要求1所述的介入瓣膜装载装置，其特征在于：所述预紧套的小口端设有固定槽，所述压握件包括压握环，所述压握环为开口圆环，所述压握环的两端头相互叠加，所述压握环的两端各设有一小手柄，所述压握环通过固定销固定于所述固定槽内，所述压握环与所述预紧套的小口端同轴布置，当两个所述小手柄相互靠拢时，所述压握环的内径变小。
  9. 根据权利要求1所述的介入瓣膜装载装置，其特征在于：所述预紧套的小口端的外侧设有凸起，所述凸起为小长方形的倒刺结构，所述压握件包括压握环，所述压握环为开口圆环，所述压握环的两端头相互叠加，所述压握环的两端各设有一小手柄，所述压握环的外侧一端穿过设置于内侧一端上的所述小手柄，所述压握环上连接有固定套筒，所述固定套筒的内壁上设有与所述倒刺结构相配合的凹槽，所述固定套筒通过所述凹槽和所述倒刺结构固定于所述预紧套的小口端上，所述压握环、所述固定套筒和所述预紧套的小口端同轴布置，当两个所述小手柄相互靠拢时，所述压握环的内径变小。
  10. 根据权利要求1所述的介入瓣膜装载装置，其特征在于：所述预紧套的小口端的外侧设有凸起，所述凸起为小长方形的倒刺结构，所述压握件包括压握环，所述压握环为开口圆环，所述压握环的两端头相互叠加，所述压握环的两端各设有一小手柄，所述压握环的外侧一端的内侧面上设有滑槽，所述压握环的内侧一端位于所述滑槽内并能够沿着滑槽滑动，所述压握环上连接有固定套筒，所述固定套筒的内壁上设有与所述倒刺结构相配合的凹槽，所述固定套筒通过所述凹槽和所述倒刺结构固定于所述预紧套的小口端上，所述压握环、所述固定套筒和所述预紧套的小口端同轴布置，当两个所述小手柄相互靠拢时，所述压握环的内径变小。
  11. 根据权利要求1所述的介入瓣膜装载装置，其特征在于：所述预紧套 的小口端外侧开设有周向布置的槽口，所述压握环为开口圆环，所述压握环的两端头相互叠加，每一端头各连接有一小手柄，所述小手柄垂直于所述压握环所在的平面，所述压握环固定安装于所述槽口内，所述压握环与所述预紧套的小口端同轴布置，当两个所述小手柄相互靠拢时，所述压握环的内径变小。
PCT/CN2019/073154 2018-02-06 2019-01-25 介入瓣膜装载装置 WO2019154123A1 (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201810116307.6A CN108309511A (zh) 2018-02-06 2018-02-06 介入瓣膜装载装置
CN201810116307.6 2018-02-06

Publications (1)

Publication Number Publication Date
WO2019154123A1 true WO2019154123A1 (zh) 2019-08-15

Family

ID=62903622

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2019/073154 WO2019154123A1 (zh) 2018-02-06 2019-01-25 介入瓣膜装载装置

Country Status (2)

Country Link
CN (1) CN108309511A (zh)
WO (1) WO2019154123A1 (zh)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022266164A1 (en) * 2021-06-16 2022-12-22 Boston Scientific Scimed, Inc. Medical device loading tool

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108309511A (zh) * 2018-02-06 2018-07-24 北京迈迪顶峰医疗科技有限公司 介入瓣膜装载装置
CN110251273B (zh) * 2019-05-23 2022-09-13 沛嘉医疗科技(苏州)有限公司 一种经导管输送瓣膜预装载系统装置
CN117323065B (zh) * 2023-11-14 2024-02-23 南京鼓楼医院 一种瓣膜压缩装置

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101460115A (zh) * 2006-04-10 2009-06-17 可沃弗有限公司 用于将假体装载到最低程度侵入的输送系统的系统和方法
WO2010121076A2 (en) * 2009-04-15 2010-10-21 Cardiaq Valve Technologies, Inc. Vascular implant and delivery system
WO2012106491A1 (en) * 2011-02-02 2012-08-09 St. Jude Medical, Inc. System and method for loading a collapsile heart valve into a delivery device
US20140331475A1 (en) * 2013-05-13 2014-11-13 Medtronic Vascular Galway Devices and methods for crimping a medical device
CN104586542A (zh) * 2013-10-31 2015-05-06 上海微创医疗器械（集团）有限公司 一种将植入体装载到输送系统中的装置和方法
CN105287052A (zh) * 2011-02-25 2016-02-03 爱德华兹生命科学公司 人工心脏瓣膜递送装置
CN106214288A (zh) * 2012-05-30 2016-12-14 内奥瓦斯克迪亚拉公司 用于向递送系统上装载假体的方法和设备
CN108309511A (zh) * 2018-02-06 2018-07-24 北京迈迪顶峰医疗科技有限公司 介入瓣膜装载装置

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100292779A1 (en) * 2009-05-15 2010-11-18 Helmut Straubinger Device for compressing a stent and a system as well as a method for loading a stent into a medical delivery system
US8245733B2 (en) * 2009-11-12 2012-08-21 E I Du Pont De Nemours And Company Clip for a pipe or duct
KR101416271B1 (ko) * 2013-02-07 2014-08-13 주식회사 피케이에프씨 호스 고정용 클램프
CN204942841U (zh) * 2015-07-20 2016-01-06 佛山市顺德区金海田机械有限公司 闭形弹性卡环箍
CN107157621A (zh) * 2016-09-23 2017-09-15 杭州启明医疗器械有限公司 一种可回收及重复定位介入器械的输送系统
CN208808750U (zh) * 2018-02-06 2019-05-03 北京迈迪顶峰医疗科技有限公司 介入瓣膜装载装置

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101460115A (zh) * 2006-04-10 2009-06-17 可沃弗有限公司 用于将假体装载到最低程度侵入的输送系统的系统和方法
WO2010121076A2 (en) * 2009-04-15 2010-10-21 Cardiaq Valve Technologies, Inc. Vascular implant and delivery system
WO2012106491A1 (en) * 2011-02-02 2012-08-09 St. Jude Medical, Inc. System and method for loading a collapsile heart valve into a delivery device
CN105287052A (zh) * 2011-02-25 2016-02-03 爱德华兹生命科学公司 人工心脏瓣膜递送装置
CN106214288A (zh) * 2012-05-30 2016-12-14 内奥瓦斯克迪亚拉公司 用于向递送系统上装载假体的方法和设备
US20140331475A1 (en) * 2013-05-13 2014-11-13 Medtronic Vascular Galway Devices and methods for crimping a medical device
CN104586542A (zh) * 2013-10-31 2015-05-06 上海微创医疗器械（集团）有限公司 一种将植入体装载到输送系统中的装置和方法
CN108309511A (zh) * 2018-02-06 2018-07-24 北京迈迪顶峰医疗科技有限公司 介入瓣膜装载装置

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022266164A1 (en) * 2021-06-16 2022-12-22 Boston Scientific Scimed, Inc. Medical device loading tool

Also Published As

Publication number Publication date
CN108309511A (zh) 2018-07-24

Similar Documents

Publication Publication Date Title
WO2019154123A1 (zh) 介入瓣膜装载装置
KR101797575B1 (ko) 전달 시스템 내에 임플란트를 로드시키는 장치 및 방법
CN111419327B (zh) 端部执行器械
WO2017066987A1 (zh) 结扎装置
WO2018227592A1 (zh) 结扎装置、解锁方法、及结扎器械
EP3915520B1 (en) Implant loading tool, compression device and loading system
JPH0460676B2 (zh)
CN103930051A (zh) 一种活组织结扎装置
KR101026933B1 (ko) 혈관 문합 장치
US20210022746A1 (en) System, device and method for treatment of hemorrhoids
WO2022095725A1 (zh) 一种止血夹
JP5337081B2 (ja) 人工心臓ポンプの血管接続装置およびこれを備えた人工心臓ポンプ
CN107212914A (zh) 一种医用手柄及取石网篮系统
CN107874903A (zh) 用于人造视网膜用钉的手术持针器
CN214104517U (zh) 一种止血夹
CN208640801U (zh) 可脱卸夹子装置
US10420562B2 (en) Banding device for treating hemorrhoids and reloading device
CN104815381A (zh) 导管夹具
CN209827106U (zh) 植入物的装载工具、压缩装置及装载系统
WO2023020410A1 (zh) 一种医用装置
CN214595939U (zh) 一种止血夹
WO2019119218A1 (zh) 用于人造视网膜用钉的手术持针器
US11083558B2 (en) Catcher
US11439384B2 (en) Suture lock device
CN106963438A (zh) 具有可伸展套筒的装载单元

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 19751993

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 19751993

Country of ref document: EP

Kind code of ref document: A1