WO2023029956A1 - 植入物递送手柄、植入物系统、递送系统及其使用方法 - Google Patents

植入物递送手柄、植入物系统、递送系统及其使用方法 Download PDF

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Publication number
WO2023029956A1
WO2023029956A1 PCT/CN2022/112376 CN2022112376W WO2023029956A1 WO 2023029956 A1 WO2023029956 A1 WO 2023029956A1 CN 2022112376 W CN2022112376 W CN 2022112376W WO 2023029956 A1 WO2023029956 A1 WO 2023029956A1
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WO
WIPO (PCT)
Prior art keywords
inner tube
sealing member
proximal end
distal end
gear
Prior art date
Application number
PCT/CN2022/112376
Other languages
English (en)
French (fr)
Inventor
张伟
徐浩然
魏勇强
赵婧
Original Assignee
上海臻亿医疗科技有限公司
江苏臻亿医疗科技有限公司
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 上海臻亿医疗科技有限公司, 江苏臻亿医疗科技有限公司 filed Critical 上海臻亿医疗科技有限公司
Priority to US18/278,238 priority Critical patent/US20240122707A1/en
Priority to EP22863096.8A priority patent/EP4282382A1/en
Publication of WO2023029956A1 publication Critical patent/WO2023029956A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—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
    • 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
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082—Catheter tip comprising a tool
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0113—Mechanical advancing means, e.g. catheter dispensers
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
    • A61F2250/001—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting a diameter
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0069—Sealing means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0063—Catheters; Hollow probes characterised by structural features having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/0177—Introducing, guiding, advancing, emplacing or holding catheters having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/0186—Catheters with fixed wires, i.e. so called "non-over-the-wire catheters"

Definitions

  • the invention relates to the technical field of medical devices, in particular to an implant delivery handle, an implant system, a delivery system and a use method thereof.
  • the heart has four chambers, the left atrium and left ventricle are on the left side of the heart, and the right atrium and right ventricle are on the right side of the heart.
  • the atrium and ventricle form the ventricular inflow tract
  • the left ventricle and the aorta form the left ventricular outflow tract
  • the right ventricle and the pulmonary artery form the right ventricular outflow tract.
  • the hemodynamics of the heart change and the heart functions abnormally. These abnormalities are called valvular heart disease.
  • valvular heart disease With the development of social economy and the aging of the population, the incidence of valvular heart disease has increased significantly. Studies have shown that the incidence of valvular heart disease in the elderly population over 75 years old is as high as 13.3%. At present, traditional surgical treatment is still the first choice for patients with severe valvular disease, but for patients who are elderly, complicated with multiple organ diseases, have a history of thoracotomy, and have poor heart function, the risk of traditional surgery is high and death The rate is high, and some patients do not even have the chance of surgery.
  • Interventional valve implantation is a brand-new minimally invasive valve replacement technology developed internationally in recent years. Valves, so that the patient's heart function is improved. This technology can treat valvular diseases without thoracotomy and heart beating, eliminating the huge trauma caused by previous surgical thoracotomy and cardiac arrest.
  • the structure of the human heart is very complex, especially the structure of the mitral valve is more complex than that of the aortic valve, the shape of the valve ring is irregular, and the multiple tendons in the ventricular chamber seriously interfere with the implantation and positioning of the interventional valve.
  • transcatheter valve replacement surgery including transcatheter aortic valve replacement surgery TAVI, transcatheter mitral valve replacement surgery TMVR, etc.
  • TAVI transcatheter aortic valve replacement surgery
  • TMVR transcatheter mitral valve replacement surgery
  • the transmission rate of the delivery system affects the operation time. At the same time, when the delivery system, especially the delivery catheter, is poorly sealed, it will cause problems such as blood loss and gas leakage, which increases the risk during the operation.
  • One of the objectives of the present invention is to provide an implant delivery handle, an implant system, a delivery system and a method of use thereof, which can improve the transmission efficiency of the delivery system and shorten the operation time.
  • Another purpose of the present invention is to improve the sealing performance of the catheter assembly, so as to reduce the leakage of blood and gas, and reduce the risk during the operation.
  • the present invention provides an implant delivery handle, which includes two delivery systems arranged along the axial direction of the first inner tube, the delivery system at the distal end is connected to the proximal end of the first inner tube, The delivery system at the proximal end is connected to the proximal end of the second inner tube, characterized in that,
  • the transmission system includes a lead screw, an inner tube connector, an outer gear and an inner gear, the outer gear is rotatably connected to the inner gear, and is used to drive the inner gear to rotate, and the lead screw is connected through the inner tube
  • the screw is connected to the first inner tube or the second inner tube, and the screw is also connected to the inner gear and rotates with the inner gear to drive the first inner tube or the second inner tube to move axially ;
  • the transmission ratio of the external gear and the internal gear is greater than 1.
  • the external gear is sleeved on the outer side of the internal gear, and the external gear and the internal gear are meshedly connected.
  • the inner tube connector at the distal end is connected to the proximal outer wall of the first inner tube, and is sleeved on the outer side of the second inner tube, and is also used to seal the first inner tube from the proximal end. the gap between the inner tube and the second inner tube; and
  • the inner tube connector at the proximal end is connected to the proximal outer wall of the second inner tube, and is sheathed on the outside of the guide wire tube, and is also used to seal the gap between the second inner tube and the guide wire tube from the proximal end. the gap between.
  • the inner tube connector located at the distal end includes a first seal, a second seal and a third seal sleeved on the outside of the second inner tube, and the proximal end of the first inner tube is fit and fixed Within the distal end of the first seal, the second seal is resiliently sandwiched between the proximal end of the first seal and the distal end of the third seal, and When the sealing member and the third sealing member jointly squeeze the second sealing member, the second sealing member is attached to the outer wall of the second inner tube to seal the proximal end of the first inner tube and the second inner tube. the gap between the second inner tubes; and
  • the inner tube connector at the proximal end includes a fourth sealing element, a fifth sealing element and a sixth sealing element sleeved on the outside of the guide wire tube, and the proximal end of the second inner tube is fit and fixed on the first sealing element.
  • the fifth sealing element is elastically clamped between the proximal end of the fourth sealing element and the distal end of the sixth sealing element, and between the fourth sealing element and the sixth sealing element.
  • the material of the second sealing member and the fifth sealing member includes a polymer material, and the Shore hardness A of the second sealing member and the fifth sealing member is 35HA-55HA.
  • first sealing element, the second sealing element and the third sealing element are all tubular structures, the second sealing element is arranged in the proximal end of the first sealing element, and the third sealing element The distal end is arranged in the proximal end of the first sealing element, and cooperates with the first sealing element to press the second sealing element, so that the inner diameter of the second sealing element shrinks and is aligned with the second sealing element. Fit setting between inner tubes;
  • the inner diameters of the first sealing member, the second sealing member and the third sealing member are all greater than or equal to the outer diameter of the second inner tube, and the inner diameter of the proximal end of the first sealing member is larger than the inner diameter of the distal end, so
  • the value of the outer diameter of the second sealing member is between the inner diameter of the distal end and the inner diameter of the proximal end of the first sealing member
  • the value of the outer diameter of the distal end of the third sealing member is between that of the second sealing member between the inner diameter of the distal end and the inner diameter of the proximal end of the first seal.
  • the fourth sealing element, the fifth sealing element and the sixth sealing element are all tubular structures, the fifth sealing element is arranged in the proximal end of the fourth sealing element, and the sixth sealing element The distal end is disposed in the proximal end of the fourth sealing element, and cooperates with the fourth sealing element to squeeze the fifth sealing element, so that the inner diameter of the fifth sealing element is reduced and is compatible with the guide wire Fitting settings between tubes;
  • the inner diameters of the fourth sealing member, the fifth sealing member and the sixth sealing member are all greater than or equal to the outer diameter of the guide wire tube, the proximal inner diameter of the fourth sealing member is larger than the distal inner diameter, and the The value of the outer diameter of the fifth sealing member is between the inner diameter of the distal end and the inner diameter of the proximal end of the fourth sealing member, and the value of the outer diameter of the distal end of the sixth sealing member is between that of the fifth sealing member. between the inner diameter of the distal end and the inner diameter of the proximal end of the fourth sealing member.
  • the lead screw and the internal gear are coaxially arranged and rotated coaxially, the lead screw has external threads, the inner tube connector has internal threads, and the inner tube connector is threaded on On the lead screw, the inner tube connector is used to drive the first inner tube or the second inner tube to move axially when the lead screw rotates along the thread.
  • the present invention provides an implant system, including the implant delivery handle, and a catheter assembly, the catheter assembly includes a first inner tube, a second inner tube and a The wire guide tube, the implant delivery handle drives the first inner tube and the second inner tube to move axially.
  • the present invention provides a delivery system, comprising the implant delivery handle, a first inner tube, a second inner tube, a guide wire tube, a tapered head and a fixing head, and the fixing head is arranged on the The distal end of the second inner tube and the guide wire tube, the tapered head is arranged on the distal end of the first inner tube, and the implant is compressed and arranged in the distal end of the first inner tube , and located between the conical head and the fixed head, the implant delivery handle drives the first inner tube and the second inner tube to move axially, so as to realize loading, delivery and release of the implant.
  • the present invention provides a method of using a delivery system, including the implant delivery system, the method of using includes:
  • the present invention has the following beneficial effects:
  • the present invention provides an implant delivery handle, implant system, delivery system and usage method thereof.
  • the delivery system of the implant delivery handle includes a lead screw, an inner tube connector, an external gear and an internal gear.
  • the external gear The internal gear is rotatably connected and used to drive the internal gear to rotate, the screw is connected to the first inner tube or the second inner tube through the inner tube connector, and the screw is also connected to the inner tube gear, and rotate with the internal gear to drive the first inner tube or the second inner tube to move axially; wherein, the transmission ratio of the external gear and the internal gear is greater than 1, so that the external gear and the internal gear form
  • the planetary gear, the combination of the planetary gear and the lead screw improves the transmission rate of the implant delivery system, shortens the operation time, and reduces the residence time of the instrument in the patient's body, thereby reducing the risk of accidents during the operation.
  • the present invention also connects the proximal outer wall of the first inner tube through the inner tube connector located at the distal end, and is sleeved on the outside of the second inner tube, and is also used to seal the first inner tube from the proximal end.
  • the gap between the inner tube and the second inner tube; and the inner tube connector at the proximal end connects the proximal outer wall of the second inner tube, and is sleeved on the outside of the guide wire tube, and is also used for The end seals the gap between the second inner tube and the wire guide tube, so that the proximal end of the catheter assembly has good sealing performance.
  • the present invention has the advantages of simple structure, high safety and low cost.
  • FIG. 1 is a schematic three-dimensional structure diagram of an implant delivery system according to an embodiment of the present invention
  • FIGS. 2a-2b are partial schematic diagrams of an implant delivery system according to an embodiment of the present invention.
  • Fig. 3 is a partial schematic diagram of an implant delivery handle according to an embodiment of the present invention.
  • FIGS. 4a-4b are schematic structural views of a first transmission assembly according to an embodiment of the present invention.
  • FIG. 5a-5b are schematic structural views of a first linkage assembly according to an embodiment of the present invention.
  • 6a-6f are structural schematic diagrams of the components of the first linkage assembly according to an embodiment of the present invention.
  • FIGS. 7a-7c are structural schematic diagrams during the sealing process of the first linkage assembly according to an embodiment of the present invention.
  • the core idea of the present invention is to provide an implant delivery handle, including two delivery systems arranged along the axial direction of the first inner tube, the delivery system at the distal end is connected to the proximal end of the first inner tube, the delivery system at the proximal end connects the proximal end of the second inner tube,
  • the transmission system includes a lead screw, an inner tube connector, an outer gear and an inner gear, the outer gear is rotatably connected to the inner gear, and is used to drive the inner gear to rotate, and the lead screw is connected through the inner tube
  • the screw is connected to the first inner tube or the second inner tube, and the screw is also connected to the inner gear and rotates with the inner gear to drive the first inner tube or the second inner tube to move axially ;
  • the transmission ratio of the external gear and the internal gear is greater than 1.
  • the present invention provides an implant delivery system, which includes the implant delivery handle, and includes a catheter assembly, the catheter assembly includes a first inner tube, a second inner tube, and a The wire guide tube, the implant delivery handle drives the first inner tube and the second inner tube to move axially.
  • the present invention provides an implant system, comprising the implant delivery handle, a first inner tube, a second inner tube, a guide wire tube, a tapered head and a fixing head, and the fixing head is arranged on the The distal end of the second inner tube and the guide wire tube, the tapered head is arranged on the distal end of the first inner tube, and the implant is compressed and arranged in the distal end of the first inner tube , and located between the conical head and the fixed head, the implant delivery handle drives the first inner tube and the second inner tube to move axially, so as to realize loading, delivery and release of the implant.
  • the present invention provides a method of using an implant delivery system, including the implant delivery system, the method of using comprising:
  • distal end and proximal end all refer to the relative orientation, relative position, and direction of elements or actions relative to each other from the perspective of a doctor using the medical device, although “distal end”, “proximal end” “end” is not limiting, but “proximal” generally refers to the end of the medical device that is near the operator during normal operation, and “distal” generally refers to the end near the patient's heart.
  • the structures of the first transmission assembly and the second transmission assembly are generally the same, and the difference may only lie in subtleties, for example, the first transmission assembly is provided with a first through hole for passing through the first inner tube, and the second transmission assembly The wire guide tube fixing member for fixing the wire guide tube is arranged on the top, and these differences do not affect the actual functions of the first transmission assembly and the second transmission assembly.
  • the structures of the first linkage assembly and the second linkage assembly are generally the same, and the difference may only lie in subtleties, such as the axial lengths of the first lead screw and the second lead screw, and the length of the first inner tube connector.
  • FIG. 1 is a schematic perspective view of the three-dimensional structure of an implant delivery system in this embodiment.
  • 2a-2b are partial schematic diagrams of an implant delivery system of this embodiment.
  • Fig. 3 is a partial schematic diagram of an implant delivery handle in this embodiment.
  • the present embodiment provides an implant delivery system including a catheter assembly and an implant delivery handle, and the implant delivery handle drives the first inner tube and the second inner tube to perform axial sports.
  • the catheter assembly includes a first inner tube 11, a second inner tube 12, and a guide wire tube 13 that are sequentially sleeved from outside to inside, that is, the first inner tube 11 is sleeved on the outside of the second inner tube 12, The second inner tube 12 is sleeved on the outer side of the wire guide tube 13 .
  • a guide wire is arranged in the guide wire tube 13 .
  • the distal end of the catheter assembly also includes a tapered head and a fixed head, and the fixed head is arranged on the distal end of the second inner tube 12, so that the six degrees of freedom of the fixed head are all restricted, which Used to fix the implant 7.
  • the conical head is detachably arranged at the distal end of the first inner tube 11, the implant 7 is located at the distal end of the second inner tube 12, and is compressed and arranged on the first inner tube 11.
  • the tube at the distal end of the tube 11 is confined between the conical head and the fixed head before being released.
  • the implant 7 is, for example, an artificial heart valve.
  • the implant delivery handle includes a housing 3, a first transmission system, a second transmission system, a first linkage assembly 5 and a second connecting member, and the first transmission system and the second transmission system move from the distal end to the proximal end Set in turn.
  • the proximal end of the first transmission system is penetrated in the housing 3, and the distal end of the first transmission system is exposed outside the distal end of the housing 3; the distal end of the second transmission system is penetrated In the housing 3, the proximal end of the second transmission system is exposed outside the proximal end of the housing 3, and the first linkage assembly 5 connects the distal end of the housing 3 and the first transmission system,
  • the second connecting piece connects the proximal end of the housing 3 and the second transmission system.
  • the proximal end of the first inner tube 11 is fixed on the first transmission system, and the first transmission system drives the first inner tube 11 to move axially; the proximal end of the second inner tube 12 and the proximal end of the guide wire tube 13 pass through the first transmission system axially and are fixed on the second transmission system, and the second transmission system drives the second inner tube 12 to move axially .
  • the first transmission system includes a first transmission assembly 2 and a first linkage assembly 5 arranged in sequence from the distal end to the proximal end
  • the second transmission system includes a second transmission assembly 4 arranged in sequence from the proximal end to the distal end and the second linkage assembly 6,
  • the housing 3 is located between the first transmission assembly 2 and the second transmission assembly 4
  • the first linkage assembly 5 and the second linkage assembly 6 are both arranged on the housing 3
  • the first linkage component 5 is located at the distal end of the housing 3
  • the second linkage component 6 is located at the proximal end of the housing 3.
  • the first connecting piece connects the casing 3 and the first transmission system
  • the second connecting piece connects the casing 3 and the second transmission assembly 4 .
  • the proximal end of the first inner tube 11 passes through the first transmission assembly 2 and is fixed on the first linkage assembly 5, and the proximal end of the second inner tube 12 extends out of the first inner tube 11 and fixed on the second linkage assembly 6 after passing through the first linkage assembly 5, the proximal end of the guide wire tube 13 stretches out from the proximal end of the second inner tube 12 and After passing through the second linkage assembly 6, it is fixed on the second transmission assembly 4.
  • the first transmission assembly 2 includes a first handwheel, a first external gear 21 and a first internal gear 22 which are sequentially socketed from the outside to the inside, the first The hand wheel is fixed on the outside of the first external gear 21, the first external gear 21 and the first internal gear 22 form a planetary gear, the first external gear 21 and the first internal gear 22 are connected in transmission, further , the first external gear 21 and the first internal gear 22 are meshedly connected.
  • the first hand wheel is turned, the first external gear 21 and the first internal gear 22 rotate synchronously (for example, synchronously rotate counterclockwise or clockwise), so as to drive the first inner tube 11 in the axial direction back and forth movement.
  • the first linkage assembly 5 includes a first inner tube connector 51 and a first screw 52, the first inner tube connector 51 is sleeved on the first screw 52, and the first inner tube The distal end of the tube connector 51 protrudes from the first lead screw 52 and connects to the first internal gear 22 .
  • the proximal end of the first inner tube 11 passes through the first external gear 21 and is fixed on the distal end of the first inner tube connector 51, and the proximal end of the second inner tube 12 extends out of the first inner tube 12.
  • the proximal end of the tube 11 passes through the first inner tube connector 51 and is fixed on the second linkage assembly 6, and the first inner tube 11 and the second inner tube 12 are arranged parallel to the first lead screw 52 .
  • the first handwheel drives the first external gear 21 and the first internal gear 22 to rotate synchronously, the first internal gear 22 rotates coaxially with the first lead screw 52, and drives the first inner tube 11 to rotate axially. sports.
  • the first external gear 21 is a cylindrical structure with one end open, the opening of the first external gear 21 is set towards the proximal end, the first internal gear 22 is arranged in the first external gear 21, and is connected with the first external gear 21.
  • the bottom wall of the first external gear 21 is arranged in parallel.
  • the transmission ratio of the first external gear 21 and the first internal gear 22 is m:n greater than 1, for example when the When the transmission ratio between the first external gear 21 and the first internal gear 22 is 3, the first external gear 21 can rotate one turn, while the first internal gear 22 can rotate three turns.
  • the transmission ratio between the first external gear 21 and the first internal gear 22 is also large, so that the first inner tube 11 has high transmission efficiency, thereby shortening the operation time. Time can reduce the residence time of the device in the patient's body, thereby reducing the risk of surgical accidents.
  • the bottom wall of the first external gear 21 is provided with a first through hole (not shown in the figure), the first inner tube 11 passes through the first external gear 21 through the first through hole, and The diameter of the first through hole is larger than the outer diameter of the first inner tube 11 , so that the first inner tube 11 can move axially in the first through hole.
  • the first inner tube connecting member 51 includes a first portion 511 , a second portion 513 and a first fixing member 512 disposed along the transverse direction, and the first fixing member 512 connects the first portion 511 and the second portion 513 .
  • the first part 511 is a tubular structure, and the first part 511 is sheathed on the outside of the first screw 52.
  • the inner wall of the first part 511 has internal threads, and the first screw
  • the outer wall of the rod 52 has an external thread matched with the internal thread, the first part 511 is screwed on the first lead screw 52, and when the first lead screw 52 rotates, the first lead screw 52 One part 511 drives the second part 513 to move axially.
  • the first fixing member 512 has two first guide columns on opposite sides of the second portion 513, the housing 3 has two first guide grooves arranged in the axial direction, and the first guide columns
  • the guide post is disposed in the first guide groove, so that when the first lead screw 52 rotates, the second portion 513 moves axially under the guidance of the first guide groove.
  • the second part 513 has a first lumen axially penetrated, and the proximal end of the first inner tube 11 passes through the first through hole and is fixed on the distal end of the first lumen, so that the The first inner tube 11 moves axially under the drive of the first part 511; after the proximal end of the second inner tube 12 protrudes from the proximal end of the first inner tube 11 and passes through the first lumen, It is fixed on the second linkage assembly 6.
  • the second part 513 includes a first seal 513a, a second seal 513b and a third seal 513c, the proximal end of the first seal 513a is fixed on the outside of the third seal 513c, and the The second seal 513b is interposed between the first seal 513a and the third seal 513c.
  • the proximal end of the first inner tube 11 is fixed in the distal end of the first sealing member 513a, and the second inner tube 12 protrudes from the proximal end of the first inner tube 11 and passes through the first inner tube 11
  • a sealing member 513a, a second sealing member 513b and a third sealing member 513c, the second sealing member 513b seals between the second inner tube 12 and the first inner cavity (that is, the second inner tube 12 and the first inner cavity between the tubes 11) to seal the gap.
  • the first sealing member 513a is a tubular structure, and the first sealing member 513a includes a first distal end portion 5131, a first transition portion 5132 and a first The proximal portion 5133, the first distal portion 5131 and the first proximal portion 5133 are equal-diameter segments (that is, the outer diameter of the first distal portion 5131 is equal in diameter, and the inner diameter is equal in diameter; the first proximal portion The outer diameter of the part 5133 is equal to the inner diameter), the first transition part 5132 is a diameter-changing section, the outer diameter and inner diameter of the first distal end part 5131 are the smallest, and the first distal end part 5131 The inner diameter is larger than the outer diameter of the first inner tube 11 , so that the proximal end of the first inner tube 11 can be fixed on the distal inner wall of the first distal portion 5131 .
  • Both the outer diameter and inner diameter of the first proximal portion 5133 are the largest, and the outer diameter and inner diameter of the first transition portion 5132 are gradually reduced from the proximal end to the distal end.
  • the outer peripheral surface of the proximal end of the first proximal portion 5133 has external threads.
  • FIGS. 6c-6d are schematic structural views of the second sealing member of this embodiment.
  • the second sealing member 513b is usually made of a soft material (ie elastic material), specifically polymer materials such as silica gel/tpu/pebax, and the Shore hardness of the second sealing member 513b A is usually 35HA to 55HA.
  • the second seal 513b includes a second proximal portion 5134 and a second distal portion 5135 from the proximal end to the distal end, the second proximal portion 5134 is an isometric section, and the second distal portion 5135 is In the variable diameter section, the inner diameter and outer diameter of the distal end of the second distal end portion 5135 are the smallest, and the outer diameter of the distal end of the second distal end portion 5135 is greater than or equal to the inner diameter of the first distal end portion 5131, and smaller than the inner diameter of the first proximal portion 5133, so that the second seal 513b can be disposed in the first proximal portion 5133 and the first transition portion 5132, and the second proximal portion 5134 is close to the proximal end set up.
  • the second sealing member 513b has a first inner space passing through the second sealing member 513b in the axial direction, and the first inner space includes a first segment, a second segment and a
  • the third section, the radial sections of the first section, the second section and the third section are all circular, the first section and the third section are equal-diameter sections, and the second section is a variable-diameter section , the diameter of the first segment is the largest.
  • the diameter of the third section is the smallest and larger than the outer diameter of the second inner tube, so that the second inner tube can pass through the second sealing member 513b, and the diameter of the second section is from approximately tapered distally.
  • the third sealing member 513c includes a third proximal portion 5136 and a third distal portion 5137 from the proximal end to the distal end, and the third proximal portion 5136 and the third distal portion 5137 are equal-diameter sections, and the outer diameter of the third proximal portion 5136 is greater than the outer diameter of the third distal portion 5137, the inner diameter of the third proximal portion 5136 and the third distal portion 5137
  • the inner diameters are the same, and the inner diameter of the third sealing member 513c is larger than the outer diameter of the second inner tube, so that the second inner tube can pass through the third sealing member 513c.
  • the distal end surface of the third proximal portion 5136 has an annular first groove 5138 arranged axially, the surface of the first groove 5138 near the proximal end is a bottom wall, and the first groove 5138
  • the sidewall close to the axis is the inner sidewall
  • the sidewall away from the axis of the first groove 5138 is the outer sidewall
  • the distance from the inner sidewall to the axis is the same as the outer diameter of the third distal end part 5137, so
  • the outer wall has internal threads matching the external threads on the outer peripheral surface of the first proximal portion 5133 .
  • the first proximal portion 5133 is screwed into the first groove 5138
  • the third distal portion 5137 is located in the first proximal portion 5133, and is screwed into the first seal 513a.
  • the third sealing member 513c presses the second sealing member 513b from the proximal end, so as to sandwich the second sealing member 513b between the first sealing member 513a and the third sealing member 513c.
  • the outer diameter of the third distal portion 5137 is larger than the inner diameter of the second distal portion 5135 and smaller than the inner diameter of the first proximal portion 5133, so that the first sealing member 513a and the third sealing member 513c can sandwich the second sealing member 513b between the two, and make the second sealing member 513b elastically deform in the radial direction, so as to reduce the inner diameter of the second distal end portion 5135 of the second sealing member 513b until it Elastic extrusion occurs between the first inner tube 11 and the second inner tube 12, so as to seal the gap between the first inner tube 11 and the second inner tube 12, avoid the occurrence of air leakage/liquid leakage, etc., and greatly improve the operation efficiency. security.
  • the sealing process of the second part 513 is as follows.
  • the positioning reference line 0 is when the first sealing member 513a, the second sealing member 513b and the third sealing member 513c are in the initial state, the third sealing member The position of the distal end face of the member 513c.
  • the first sealing member 513a, the second sealing member 513b and the third sealing member 513c are all in the initial state, at this time, the inner diameter of the second distal end portion 5135 is L0, and L0 is larger than the second inner tube 12, the axial length of the second sealing member 513b is H0, and the axial distance between the third sealing member 513c and the positioning datum line 0 is 0; then, as shown in Figure 7b, the position of the first sealing member 513a is kept unchanged, the third sealing member 513c is preliminarily tightened.
  • the third sealing member 513c moves upward in the axial direction, the third sealing member 513c squeezes the second sealing member 513b, and the second sealing member 513b undergoes elastic deformation.
  • the inner diameter of the second distal end portion 5135 is reduced to L1, L1 is still larger than the outer diameter of the second inner tube 12, the axial length of the second sealing member 513b is reduced to H1, and the third sealing member 513c and the positioning reference line 0
  • the axial distance is increased to A1; finally, as shown in Figure 7c, continue to keep the position of the first sealing member 513a unchanged, and further tighten the third sealing member 513c, at this time, the third sealing member 513c continues to move upward in the axial direction , the third sealing member 513c further squeezes the second sealing member 513b, the second sealing member 513b further elastically deforms and generates a pressing force with the outer wall of the second inner tube 12, the inner diameter of the second distal end portion 5135 Continue to decrease to L2, L2 is equal to
  • the hardness of the second sealing member 513b, the inner diameter of the second transition section, the axial length of the second sealing member 513b and the axial distance between the third sealing member 513c and the positioning reference line 0 can be determined according to the The outer diameter of the second inner tube is designed.
  • the second transmission assembly 4 includes a second handwheel, a second external gear 41 and a second internal gear 42 that are sequentially socketed from outside to inside, and the second handwheel is fixed on the second
  • the outer side of the external gear 41, the second external gear 41 and the second internal gear 42 are planetary gears, the second external gear 41 and the second internal gear 42 are connected in transmission, further, the second external gear 41 and the second The internal gear 42 is meshedly connected.
  • the second external gear 41 and the second internal gear 42 rotate synchronously (for example, synchronously rotate counterclockwise or clockwise), so as to drive the second inner tube 12 to move back and forth in the axial direction.
  • the second linkage assembly 6 includes a second inner tube connector 61 and a second screw 62, and the second inner tube connector 61 is sleeved on the second screw 62 , and the proximal end of the second inner tube connector 61 protrudes from the second lead screw 62 to connect with the second internal gear 42 .
  • the proximal end of the second inner tube 12 passes through the first linkage assembly 5 and is fixed on the second inner tube connector 61, and the second inner tube 12 is arranged parallel to the second lead screw 62, so The proximal end of the guide wire tube 13 protrudes from the proximal end of the second inner tube 12 and is fixed on the second external gear 41 after passing through the second inner tube connector 61 .
  • the second hand wheel drives the second external gear 41 and the second internal gear 42 to rotate synchronously, the second internal gear 42 rotates coaxially with the second lead screw 62, and drives the second inner tube 12 to move axially. sports.
  • the second external gear 41 is a cylindrical structure with one end open, the opening of the second external gear 41 is set towards the proximal end, the second internal gear 42 is arranged in the second external gear 41, and is connected with the second external gear 41.
  • the bottom wall of the second external gear 41 is arranged in parallel.
  • the second lead screw 62 passes through the bottom wall of the second external gear 41 and is connected with the second internal gear 42 located in the second external gear 41, so that the second internal gear 42 drives the first Two leading screws 62 rotate.
  • the transmission ratio of the second external gear 41 and the second internal gear 42 is M:N, and when M:N The larger the ratio, the larger the transmission ratio between the second external gear 41 and the second internal gear 42, so that the second inner tube 12 has high transmission efficiency, thereby shortening the operation time and reducing the number of instruments in the patient's body. The residence time, thereby reducing the risk of surgical accidents.
  • the values of M and m may be the same or different, and the same values of N and n may be the same or different, which are designed according to actual requirements.
  • the bottom wall of the second external gear 41 is connected with a guide wire tube fixing part 43, and the guide wire tube fixing part 43 penetrates the bottom wall of the second external gear 41 in the axial direction, And it is used to fix the proximal end of the guide wire tube 13 .
  • the proximal end of the second external gear 41 has a ratchet cover, and the ratchet cover is arranged at the opening of the second external gear 41 to protect the internal environment of the second external gear 41 .
  • the second inner pipe connector 61 includes a third part, a fourth part and a second fixing part (not shown) arranged in the transverse direction, and the second fixing part is located between the third part and the fourth part , and connect the third part and the fourth part.
  • the third part is a tubular structure, and the third part is sleeved on the outside of the second lead screw 62.
  • the inner wall of the third part has internal threads
  • the second lead screw 62 has internal threads.
  • the outer wall has an external thread matched with the internal thread, the third part is screwed on the second lead screw 62, and when the second lead screw 62 rotates, the third part drives the The fourth part described above carries out axial movement.
  • the second fixing member has two second guide columns on opposite sides of the fourth part, the housing 3 has two second guide grooves arranged in the axial direction, and the second guide columns It is arranged in the second guide groove, so that when the second lead screw 62 rotates, the fourth part moves axially under the guidance of the second guide groove.
  • the fourth part has a second lumen axially penetrated, and the proximal end of the second inner tube 12 passes through the first lumen and is fixed on the distal end of the second lumen, so that the first inner tube 12
  • the two inner tubes 12 move axially under the driving of the third part; the proximal end of the guide wire tube 13 protrudes from the proximal end of the second inner tube 12 and passes through the second inner cavity, and is fixed on the On the guide wire tube fixing part 43.
  • the fourth part includes a fourth seal, a fifth seal and a sixth seal, the proximal end of the fourth seal is fixed on the outside of the sixth seal, and the fifth seal is interposed Between the fourth and sixth seals.
  • the proximal end of the second inner tube 12 is fixed in the distal end of the fourth sealing member, and the proximal end of the guide wire tube 13 protrudes from the proximal end of the second inner tube 12 and passes through the
  • the fourth sealing member, the fifth sealing member and the sixth sealing member are fixed on the guide wire tube fixing member 43 afterward, and the fifth sealing member seals between the guide wire tube 13 and the second inner chamber (guide wire The gap between the pipe 13 and the second inner pipe 12) is sealed.
  • the fourth sealing member is a tubular structure, and the fourth sealing member includes a first distal portion, a first transition portion, and a first proximal portion in sequence from the distal end to the proximal end, and the first distal portion and the first proximal portion
  • the first proximal portion is an equal-diameter section (that is, the outer diameter of the first distal portion is equal to the same diameter, and the inner diameter is equal to the diameter; the outer diameter of the first proximal portion is equal to the same diameter, and the inner diameter is equal to the diameter), and the first The transition portion is a variable diameter section, the outer diameter and the inner diameter of the first distal end portion are the smallest, and the inner diameter of the first distal end portion is larger than the outer diameter of the guide wire tube 13, and the first proximal end portion Both the outer diameter and the inner diameter of the first transition part are the largest, and the outer diameter and the inner diameter of the first transition part gradually decrease from the proximal end to the distal end.
  • the fifth sealing member is usually made of soft material, specifically polymer materials such as silica gel/tpu/pebax, and the Shore hardness A of the fifth sealing member is generally 35HA-55HA.
  • the fifth sealing member includes a second proximal portion and a second distal portion from the proximal end to the distal end, the second proximal portion is an equal diameter section, and the second distal end is a variable diameter section, so The inner diameter and the outer diameter of the distal end of the second distal end portion are the smallest, and the outer diameter of the distal end of the second distal end portion is greater than or equal to the inner diameter of the first distal end portion, and smaller than that of the first proximal end portion The inner diameter is such that the fifth seal can be disposed in the first proximal portion and the first transition portion, and the second proximal portion is disposed proximally.
  • the fifth sealing member has an axial penetration through the second internal space
  • the second internal space includes a first section, a second section and a third section in sequence from the proximal end to the distal end in the axial direction, and the first section
  • the radial sections of the first section, the second section and the third section of the second internal space are all circular, the first section and the third section of the second internal space are all equal-diameter sections, and the second internal space
  • the second section of the second internal space is a variable diameter section, the first section of the second internal space has the largest diameter, and the third section of the second internal space has the smallest diameter and is larger than the outer diameter of the guide wire tube.
  • the diameter of the second section of the second internal space gradually decreases from the proximal end to the distal end.
  • the sixth sealing member includes a third proximal end portion and a third distal end portion from the proximal end to the distal end, the third proximal end portion and the third distal end portion of the sixth sealing member are equal-diameter sections, and
  • the outer diameter of the third proximal end portion of the sixth sealing member is greater than the outer diameter of the third distal end portion of the sixth sealing member, and the inner diameter of the third proximal end portion of the sixth sealing member is the same as that of the sixth sealing member.
  • the inner diameters of the third distal end portions of the sixth sealing member are the same, and the inner diameter of the sixth sealing member is larger than the outer diameter of the wire guide tube.
  • the distal end surface of the third proximal portion of the sixth sealing member has an annular second groove arranged in the axial direction, the surface of the second groove near the proximal end is a bottom wall, and the second groove
  • the sidewall of the groove close to the axis is the inner sidewall
  • the sidewall of the second groove away from the axis is the outer sidewall
  • the distance between the inner sidewall of the second groove and the axis is equal to that of the third groove of the sixth seal.
  • the outer diameters of the distal parts are the same, and the outer side wall of the second groove has an inner thread matching the outer thread on the outer peripheral surface of the first proximal part of the fourth sealing member.
  • the first proximal end of the fourth seal is threaded in the second groove, the third distal end of the sixth seal is located in the first proximal end of the fourth seal, And when the fourth seal is screwed into the second groove, the sixth seal squeezes the fifth seal from the proximal end, so that the fifth seal is sandwiched between the fourth seal and the sixth seal. Between the parts, avoiding the occurrence of air/liquid leakage, etc., greatly improving the safety of the operation.
  • the outer diameter of the third distal end portion of the sixth sealing member is greater than the inner diameter of the second distal end portion of the fifth sealing member, and smaller than the inner diameter of the first proximal end portion of the fourth sealing member, so that The fourth sealing member and the sixth sealing member may interpose the fifth sealing member therebetween, and make the fifth sealing member elastically deform in the radial direction, so as to reduce the second distance of the fifth sealing member.
  • the inner diameter of the end part is elastically squeezed between it and the guide wire tube 13 , so as to achieve the effect of sealing the gap between the guide wire tube 13 and the second inner tube 12 .
  • the sealing process of the fourth part is the same as that of the second part.
  • connection method of the implant delivery handle in this embodiment is: after the proximal end of the first inner tube 11 passes through the first through hole, it is fixed on the distal end of the first sealing member 513a of the first inner tube connecting member 51 Inside, the proximal end of the second inner tube stretches out of the first inner tube and is fixed in the distal end of the fourth sealing member of the second inner tube connector 61 after passing through the first inner cavity.
  • the sealing member 513c and the first sealing member 513a squeeze the second sealing member 513b between them by tightening, so that the second sealing member 513b is deformed and generates a pressing force with the outer wall of the second inner tube, so that the second inner tube
  • the gap between the proximal outer wall of the tube 12 and the first inner tube 11 is sealed; the guide wire tube 13 stretches out from the proximal end of the second inner tube 12, and is fixed on the second outer tube after passing through the second inner cavity.
  • the sixth seal and the fourth seal squeeze the fifth seal located between them by tightening, so that the fifth seal deforms and contacts with the guide wire tube 13
  • the outer wall of the guide wire tube 13 generates a compressive force to seal the gap between the proximal outer wall of the guide wire tube 13 and the second inner tube 12 .
  • the distal end of the first lead screw 52 passes through the first part 511 of the first inner tube connector 51 and is connected to the first internal gear 22, and when the first handwheel rotates, the first internal gear 22 is connected to the first internal gear 22.
  • the first external gear 21 rotates at the same time, and the first lead screw 52 is threadedly rotated with the first internal gear 22 to drive the first inner tube 11 fixed on the second part 513 of the first inner tube connector 51 Axial movement;
  • the proximal end of the second lead screw 62 passes through the third part of the second inner tube connector 61 and connects the second internal gear 42, and when the second handwheel rotates, the second internal gear 42 Rotate simultaneously with the second external gear 41 , and the second lead screw 62 is threadedly rotated with the second internal gear 42 to drive the second inner tube fixed on the fourth part of the second inner tube connector 61 12 for axial movement.
  • first internal gear 22 and the first external gear 21 are planetary gears
  • second internal gear 42 and the second external gear 41 are planetary gears
  • they have the characteristics of high load and large transmission ratio, and can cope with various working conditions.
  • the handle especially when a large transmission ratio is required, thus obtains high transmission efficiency.
  • a method of using the implant delivery system including: firstly put the implant delivery handle and the catheter assembly Install according to the above description to complete the installation of the implant delivery system; then, simultaneously turn the first handwheel and the second handwheel towards the first direction, through the first external gear 21 and the first internal gear 22 and the first wire
  • the transmission of the rod 52 makes the first inner tube 11 retract in the axial direction, and through the transmission of the second external gear 41, the second internal gear 42 and the second lead screw 62, the second internal tube 12 retreats in the axial direction simultaneously; then , while turning the first handwheel and the second handwheel in the opposite direction of the first direction, through the transmission of the first external gear 21, the first internal gear 22 and the first lead screw 52, the first inner tube 11 is axially Advance, through the transmission of the second external gear 41 and the second internal gear 42 and the second lead screw 62, the second inner tube 12 advances in the axial direction at the same time, at
  • the present invention provides an implant delivery handle, an implant system, a delivery system and a method of use thereof.
  • the implant delivery handle uses a planetary gear structure combined with a screw drive, so that the implant delivery handle has a " The "high load + large transmission ratio" structure improves the transmission rate of the implant delivery system, shortens the operation time, and reduces the residence time of the device in the patient's body, thereby reducing the risk of accidents in the operation; the sealing of the delivery catheter On the one hand, the sealing design of the first connecting piece and the second inner pipe connecting piece is different from the traditional sealing.
  • the structure of the present invention is simple and safe, and the simple structure can greatly save costs in both design and processing costs.

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Abstract

一种植入物递送手柄、植入物系统及、递送系统及其使用方法，植入物递送手柄的传送系统包括丝杠、内管连接件、外齿轮和内齿轮，外齿轮可转动连接内齿轮，并用于带动内齿轮转动，丝杠通过内管连接件连接第一内管（11）或第二内管（12），丝杠还连接内齿轮，并随内齿轮转动，以带动第一内管（11）或第二内管（12）进行轴向运动；其中，外齿轮和内齿轮的传动比大于1，使得外齿轮和内齿轮组成行星轮，行星轮与丝杠的结合，提高了植入物递送系统的传动速率，缩短了手术的时间，减少了器械在患者体内的滞留时间，从而降低手术发生意外的风险。

Description

植入物递送手柄、植入物系统、递送系统及其使用方法 技术领域
本发明涉及医疗器械技术领域，特别涉及一种植入物递送手柄、植入物系统及、递送系统及其使用方法。
背景技术
心脏含有四个心腔，左心房与左心室位于心脏左侧，右心房与右心室位于心脏右侧。心房与心室间形成心室流入道，左心室与主动脉形成左室流出道，右心室与肺动脉形成右室流出道。在室流入道和室流出道处存在有“单向阀”功能的心脏瓣膜，以保证心腔内血液的正常流动。当心脏瓣膜出现问题时，心脏血液动力学发生改变，心脏功能出现异常，这些异常称为瓣膜性心脏病。
随着社会经济的发展以及人口的老龄化，瓣膜性心脏病的发病率明显增加，研究表明75岁以上的老年人群瓣膜性心脏病发病率高达13.3％。目前，采用传统外科手术治疗仍是重度瓣膜病变患者的首选治疗手段，但是对于高龄、合并多器官疾病、有开胸手术史以及心功能较差的患者来说，传统外科手术的风险大、死亡率高，部分患者甚至没有手术的机会。
介入瓣膜置入术是国际近年来研发的一种全新的微创伤瓣膜置换技术，其原理是瓣膜假体被装载到递送系统内，通过经导管的方式输送到人体内，替代功能退化的原瓣膜，使病人心脏功能得到改善。这项技术，可以在不开胸、心脏不停跳的情况下治疗瓣膜疾病，免去了以前外科开胸术、心脏停跳对病人造成的巨大创伤。
人体心脏结构非常复杂，特别是二尖瓣结构比主动脉瓣更复杂，瓣环形状不规则，心室腔多根腱索严重干扰介入瓣膜的植入和定位。对于经导管瓣膜置换手术(包括经导管主动脉置换手术TAVI、经导管二尖瓣置换手术TMVR等)而言，递送系统的安全有效操作是手术成功的关键因素之一。这就要求递送系统能够实现安全精确的操作，尤其要求递送系统传动效率及密封性。递送系统的传动率影响手术时间，同时递送系统尤其是递送导管的密封性差时，会造成血液减少以及气体的泄露等问题，增加了手术过程中的风险。
发明内容
本发明的目的之一在于，提供一种植入物递送手柄、植入物系统、递送系统及其使用方法，可以提高递送系统传动效率，缩短了手术时间。
本发明的另一目的在于，可以提高导管组件的密封性，以减少血液和气体的泄露，减少手术过程中的风险。
为了解决上述问题，本发明提供一种植入物递送手柄，包括沿第一内管的轴向设置的两个传送系统，位于远端的所述传送系统连接所述第一内管的近端，位于近端的所述传送系统连接第二内管的近端，其特征在于，
所述传送系统包括丝杠、内管连接件、外齿轮和内齿轮，所述外齿轮可转动连接所述内齿轮，并用于带动所述内齿轮转动，所述丝杠通过所述内管连接件连接所述第一内管或第二内管，所述丝杠还连接所述内齿轮，并随所述内齿轮转动，以带动所述第一内管或第二内管进行轴向运动；其中，所述外齿轮和内齿轮的传动比大于1。
可选的，所述外齿轮套设在所述内齿轮的外侧，且所述外齿轮和内齿轮啮合连接。
可选的，位于远端的所述内管连接件连接所述第一内管的近端外壁，并套设在所述第二内管的外侧，还用于从近端密封所述第一内管与第二内管之间的间隙；以及
位于近端的所述内管连接件连接所述第二内管的近端外壁，并套设在导丝管的外侧，还用于从近端密封所述第二内管与导丝管之间的间隙。
进一步的，位于远端的所述内管连接件包括套设在第二内管外侧的第一密封件、第二密封件和第三密封件，所述第一内管的近端贴合固定在所述第一密封件的远端内，所述第二密封件弹性夹设在所述第一密封件的近端和所述第三密封件的远端之间，并在所述第一密封件和第三密封件共同挤压所述第二密封件时，所述第二密封件贴合设置在所述第二内管的外壁上，以密封所述第一内管的近端与第二内管之间的间隙；以及
位于近端的所述内管连接件包括套设在导丝管外侧的第四密封件、第五密封件和第六密封件，所述第二内管的近端贴合固定在所述第四密封件的远 端内，所述第五密封件弹性夹设在所述第四密封件的近端和所述第六密封件的远端之间，并在所述第四密封件和第六密封件共同挤压所述第五密封件时，所述第五密封件贴合设置在所述导丝管的外壁上，以密封所述第二内管的近端与导丝管之间的间隙。
进一步的，所述第二密封件和第五密封件的材料包括高分子材料，且所述第二密封件和第五密封件的邵氏硬度A为35HA～55HA。
进一步的，所述第一密封件、第二密封件和第三密封件均为管状结构，所述第二密封件设置在所述第一密封件的近端内，所述第三密封件的远端设置在所述第一密封件的近端内，并与所述第一密封件配合挤压所述第二密封件，以使得所述第二密封件的内径缩小并与所述第二内管之间贴合设置；
其中，所述第一密封件、第二密封件和第三密封件的内径均大于或等于所述第二内管的外径，所述第一密封件的近端内径大于远端内径，所述第二密封件的外径的取值在所述第一密封件的远端内径和近端内径之间，所述第三密封件的远端外径的取值在所述第二密封件的远端内径与所述第一密封件的近端内径之间。
进一步的，所述第四密封件、第五密封件和第六密封件均为管状结构，所述第五密封件设置在所述第四密封件的近端内，所述第六密封件的远端设置在所述第四密封件的近端内，并与所述第四密封件配合挤压所述第五密封件，以使得所述第五密封件的内径缩小并与所述导丝管之间贴合设置；
其中，所述第四密封件、第五密封件和第六密封件的内径均大于或等于所述导丝管的外径，所述第四密封件的近端内径大于远端内径，所述第五密封件的外径的取值在所述第四密封件的远端内径和近端内径之间，所述第六密封件的远端外径的取值在所述第五密封件的远端内径与所述第四密封件的近端内径之间。
可选的，所述丝杠和所述内齿轮同轴设置，并进行同轴转动，所述丝杠具有外螺纹，所述内管连接件具有内螺纹，所述内管连接件螺纹连接在所述丝杠上，所述内管连接件用于在所述丝杠沿螺纹转动时，带动所述第一内管或第二内管进行轴向运动。
另一方面，本发明提供一种植入物系统，包括所述的植入物递送手柄， 以及包括导管组件，所述导管组件包括由外向内依次套接的第一内管、第二内管和导丝管，所述植入物递送手柄带动所述第一内管和第二内管进行轴向运动。
再一方面，本发明提供一种递送系统，包括所述的植入物递送手柄、第一内管、第二内管、导丝管、锥形头和固定头，所述固定头设置在所述第二内管及导丝管的远端端部，所述锥形头设置在所述第一内管的远端端部，植入物压缩设置在所述第一内管的远端内，且位于所述锥形头和固定头中间，所述植入物递送手柄带动所述第一内管和第二内管进行轴向运动，以实现植入物的装载、输送和释放。
又一方面，本发明提供一种递送系统的使用方法，包括所述的植入物递送系统，所述使用方法包括：
沿第一方向转动外齿轮，内齿轮与所述外齿轮同时转动，丝杠随所述内齿轮转动，内管连接件在所述丝杠转动时带动所述第一内管或第二内管沿轴向前进；以及
沿第一方向的反方向转动外齿轮，所述内齿轮与所述外齿轮同时转动，所述丝杠随所述内齿轮转动，所述内管连接件在所述丝杠转动时带动所述第一内管或第二内管沿轴向后退。
与现有技术相比，本发明具有以下有益效果：
本发明提供一种植入物递送手柄、植入物系统及、递送系统及其使用方法，植入物递送手柄的传送系统包括丝杠、内管连接件、外齿轮和内齿轮，所述外齿轮可转动连接所述内齿轮，并用于带动所述内齿轮转动，所述丝杠通过所述内管连接件连接所述第一内管或第二内管，所述丝杠还连接所述内齿轮，并随所述内齿轮转动，以带动所述第一内管或第二内管进行轴向运动；其中，所述外齿轮和内齿轮的传动比大于1，使得外齿轮和内齿轮组成行星轮，行星轮与丝杠的结合，提高了植入物递送系统的传动速率，缩短了手术的时间，减少了器械在患者体内的滞留时间，从而降低手术发生意外的风险。
本发明还通过位于远端的所述内管连接件连接所述第一内管的近端外壁，并套设在所述第二内管的外侧，还用于从近端密封所述第一内管与第二内管之间的间隙；以及位于近端的所述内管连接件连接所述第二内管的近端 外壁，并套设在导丝管的外侧，还用于从近端密封所述第二内管与导丝管之间的间隙，使得导管组件的近端密封性能好。另外，本发明的结构简单、安全性高以及成本低等优点。
附图说明
图1为本发明一实施例的一种植入物递送系统的立体结构示意图；
图2a-2b为本发明一实施例的一种植入物递送系统的局部示意图；
图3为本发明一实施例的一种植入物递送手柄的局部示意图；
图4a-4b为本发明一实施例的第一传动组件的结构示意图；
图5a-5b为本发明一实施例的第一连动组件的结构示意图；
图6a-6f为本发明一实施例的第一连动组件的各部件的结构示意图；
图7a-7c为本发明一实施例的第一连动组件的密封过程中的结构示意图；
附图标记说明：
11-第一内管；12-第二内管；13-导丝管；2-第一传动组件；21-第一外齿轮；22-第一内齿轮；3-外壳；4-第二传动组件；41-第二外齿轮；42-第二内齿轮；43-导丝管固定件；5-第一连动组件；51-第一内管连接件；511-第一部；512-第一固定件；513-第二部；513a-第一密封件；513b-第二密封件；513c-第三密封件；5131-第一远端部；5132-第一过渡部；5133-第一近端部；5134-第二近端部；5135-第二远端部；5136-第三近端部；5137-第三远端部；5138-第一凹槽；52-第一丝杠；6-第二连动组件；61-第二内管连接件；62-第二丝杠；
7-植入物。
具体实施方式
本发明的核心思想在于，提供一种植入物递送手柄，包括沿第一内管的轴向设置的两个传送系统，位于远端的所述传送系统连接所述第一内管的近端，位于近端的所述传送系统连接第二内管的近端，
所述传送系统包括丝杠、内管连接件、外齿轮和内齿轮，所述外齿轮可转动连接所述内齿轮，并用于带动所述内齿轮转动，所述丝杠通过所述内管连接件连接所述第一内管或第二内管，所述丝杠还连接所述内齿轮，并随所 述内齿轮转动，以带动所述第一内管或第二内管进行轴向运动；其中，所述外齿轮和内齿轮的传动比大于1。
另一方面，本发明提供一种植入物递送系统，包括所述植入物递送手柄，以及包括导管组件，所述导管组件包括由外向内依次套接的第一内管、第二内管和导丝管，所述植入物递送手柄带动所述第一内管和第二内管进行轴向运动。
再一方面，本发明提供一种植入物系统，包括所述植入物递送手柄、第一内管、第二内管、导丝管、锥形头和固定头，所述固定头设置在所述第二内管及导丝管的远端端部，所述锥形头设置在所述第一内管的远端端部，植入物压缩设置在所述第一内管的远端内，且位于所述锥形头和固定头中间，所述植入物递送手柄带动所述第一内管和第二内管进行轴向运动，以实现植入物的装载、输送和释放。
又一方面，本发明提供一种植入物递送系统的使用方法，包括所述植入物递送系统，所述使用方法包括：
沿第一方向转动外齿轮，内齿轮与所述外齿轮同时转动，丝杠随所述内齿轮转动，内管连接件在所述丝杠转动时带动所述第一内管或第二内管沿轴向前进；以及
沿第一方向的反方向转动外齿轮，所述内齿轮与所述外齿轮同时转动，所述丝杠随所述内齿轮转动，所述内管连接件在所述丝杠转动时带动所述第一内管或第二内管沿轴向后退。
以下将对本发明的一种植入物递送手柄、植入物系统及、递送系统及其使用方法作进一步的详细描述。下面将参照附图对本发明进行更详细的描述，其中表示了本发明的优选实施例，应该理解本领域技术人员可以修改在此描述的本发明而仍然实现本发明的有利效果。因此，下列描述应当被理解为对于本领域技术人员的广泛知道，而并不作为对本发明的限制。
为了清楚，不描述实际实施例的全部特征。在下列描述中，不详细描述公知的功能和结构，因为它们会使本发明由于不必要的细节而混乱。应当认为在任何实际实施例的开发中，必须做出大量实施细节以实现开发者的特定目标，例如按照有关系统或有关商业的限制，由一个实施例改变为另一个实 施例。另外，应当认为这种开发工作可能是复杂和耗费时间的，但是对于本领域技术人员来说仅仅是常规工作。
为使本发明的目的、特征更明显易懂，下面结合附图对本发明的具体实施方式作进一步的说明。需说明的是，附图均采用非常简化的形式且均使用非精准的比率，仅用以方便、明晰地辅助说明本发明实施例的目的。本文中，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外。本文所使用的术语“内”、“外”、以及类似的表述只是为了说明的目的，并不表示是唯一的实施方式。本文中，术语“远端”、“近端”均是从使用该医疗器械的医生的角度来看相对于彼此的元件或动作的相对方位、相对位置、方向，尽管“远端”、“近端”并非是限制性的，但是“近端”通常是指该医疗器械在正常操作过程中靠近操作者的一端，“远端”通常是指靠近患者的心脏的一端。
另外，由于第一传动组件和第二传动组件的结构大体相同，且区别可能仅在于细微处，例如第一传动组件上设置用于穿设第一内管的第一通孔，第二传动组件上设置固定导丝管的导丝管固定件，而这些差异并不影响第一传动组件和第二传动组件的实际功能。同样的，第一连动组件和第二连动组件的结构也大体相同，且区别可能仅在于细微处，例如第一丝杠和第二丝杠的轴向长度，第一内管连接件的第一部的各零部件与第二内管连接件的第三部的各零部件的尺寸上的差异，而这些差异并不影响第一连动组件和第二连动组件的实际功能。因此，为了简单、明了，说明书附图仅对以下实施例中的第一传动组件进行了详细标识，且以下具体实施例方式中的具体内容中第一传动组件和第二传动组件更为详尽。
图1为本实施例的一种植入物递送系统的立体结构示意图。图2a-2b为本实施例的一种植入物递送系统的局部示意图。图3为本实施例的一种植入物递送手柄的局部示意图。如图1-3所示，本实施例提供一种植入物递送系统包括导管组件和植入物递送手柄，所述植入物递送手柄带动所述第一内管和第二内管进行轴向运动。
所述导管组件包括由外向内依次套接的第一内管11、第二内管12和导丝管13，即所述第一内管11套设在所述第二内管12的外侧，所述第二内管12套接在所述导丝管13的外侧。其中，所述导丝管13内设置有导丝。
所述导管组件的远端还包括锥形头和固定头，所述固定头设置在所述第二内管12的远端端部，使得所述固定头的六个自由度均被限制，其用以固定植入物7。所述锥形头可拆卸的设置在所述第一内管11的远端端部，所述植入物7位于所述第二内管12的远端，且压缩设置在所述第一内管11远端的管内，并在未释放前被限制在所述锥形头和所述固定头之间。所述植入物7例如是人工心脏瓣膜。
所述植入物递送手柄包括外壳3、第一传动系统、第二传动系统、第一连动组件5和第二连接件，所述第一传动系统和第二传动系统由远端向近端依次设置。所述第一传动系统的近端穿设在所述外壳3中，所述第一传动系统的远端暴露在所述外壳3的远端的外侧；所述第二传动系统的远端穿设在所述外壳3中，所述第二传动系统的近端暴露在所述外壳3的近端的外侧，所述第一连动组件5连接所述外壳3的远端和第一传动系统，所述第二连接件连接所述外壳3的近端和第二传动系统。所述第一内管11的近端固定在所述第一传动系统上，且所述第一传动系统带动所述第一内管11进行轴向运动；所述第二内管12的近端和导丝管13的近端均沿轴向穿过所述第一传动系统后固定在所述第二传动系统上，且所述第二传动系统带动所述第二内管12进行轴向运动。
所述第一传动系统包括由远端向近端依次设置的第一传动组件2和第一连动组件5，所述第二传动系统包括由近端向远端依次设置的第二传动组件4和第二连动组件6，所述外壳3位于第一传动组件2和第二传动组件4之间，所述第一连动组件5和所述第二连动组件6均设置在所述外壳3内，且所述第一连动组件5位于所述外壳3的远端，所述第二连动组件6位于所述外壳3的近端。所述第一连接件连接所述外壳3与第一传动系统，所述第二连接件连接所述外壳3与第二传动组件4。
所述第一内管11的近端穿过所述第一传动组件2后固定在所述第一连动组件5上，所述第二内管12的近端伸出所述第一内管11的近端并穿过所述第一连动组件5后固定在所述第二连动组件6上，所述导丝管13的近端伸出所述第二内管12的近端并穿过所述第二连动组件6后固定在所述第二传动组件4上。所述第一连动组件5在所述第一传动组件2转动时，带动所述第一 内管11进行轴向运动；所述第二连动组件6在所述第二传动组件4转动时带动所述第二内管12进行轴向运动。
图4a-4b为本实施例的第一传动组件的结构示意图。如图4a-4b所示，同时请参阅图3，所述第一传动组件2包括由外向内依次套接的第一手轮、第一外齿轮21和第一内齿轮22，所述第一手轮固定在所述第一外齿轮21的外侧，所述第一外齿轮21和第一内齿轮22组成为行星轮，所述第一外齿轮21和第一内齿轮22传动连接，进一步的，所述第一外齿轮21和第一内齿轮22啮合连接。转动所述第一手轮时，所述第一外齿轮21和所述第一内齿轮22同步转动(例如同步逆时针转动或顺时针转动)，以带动所述第一内管11在轴向往返运动。
所述第一连动组件5包括第一内管连接件51和第一丝杠52，所述第一内管连接件51套设在所述第一丝杠52上，且所述第一内管连接件51的远端伸出所述第一丝杠52后连接所述第一内齿轮22。所述第一内管11的近端穿过第一外齿轮21后固定在所述第一内管连接件51的远端，所述第二内管12的近端伸出所述第一内管11的近端并穿过所述第一内管连接件51后固定在第二连动组件6上，所述第一内管11以及第二内管12均与第一丝杠52平行设置。所述第一手轮带动第一外齿轮21和第一内齿轮22同步转动，所述第一内齿轮22与第一丝杠52同轴转动，并带动所述第一内管11进行轴向运动。
所述第一外齿轮21为一端开口的筒状结构，所述第一外齿轮21的开口朝向近端设置，所述第一内齿轮22设置在所述第一外齿轮21中，且与所述第一外齿轮21的底壁平行设置。所述第一外齿轮21的内侧壁上具有m个槽，所述第一内齿轮22的外壁上具有n个齿，且m＞n，由于第一外齿轮21和第一内齿轮22的啮合连接，使得第一外齿轮21和第一内齿轮22的模数相同，因此，所述第一外齿轮21与所述第一内齿轮22的传动比为m：n大于1，例如当所述第一外齿轮21与所述第一内齿轮22的传动比为3时，所述第一外齿轮21可以转动一圈，而所述第一内齿轮22则可以转动三圈。同理，当m：n的比值越大则所述第一外齿轮21与所述第一内齿轮22的传动比也越大，使得第一内管11具有高传动效率，从而缩短了手术的时间，能够减少器械在患者体内的滞留时间，从而降低手术意外的风险。
所述第一外齿轮21的底壁上设置有第一通孔(图中未示出)，所述第一内管11通过所述第一通孔穿过所述第一外齿轮21，且所述第一通孔的直径大于所述第一内管11的外径，使得所述第一内管11可以在第一通孔中进行轴向运动。
所述第一内管连接件51包括沿横向设置的第一部511、第二部513和第一固定件512，所述第一固定件512连接所述第一部511和第二部513。
所述第一部511为管状结构，所述第一部511套设在所述第一丝杠52的外侧，详细的，所述第一部511的内壁上具有内螺纹，所述第一丝杠52的外壁上具有与所述内螺纹相匹配的外螺纹，所述第一部511螺纹连接在所述第一丝杠52上，并在所述第一丝杠52转动时，所述第一部511带动所述第二部513进行轴向运动。
所述第一固定件512在所述第二部513相对的两侧具有两个第一导引柱，所述外壳3具有沿轴向设置的两个第一导引槽，所述第一导引柱设置在所述第一导引槽中，以在所述第一丝杠52转动时，所述第二部513在第一导引槽的引导下沿轴向移动。
所述第二部513具有沿轴向贯通的第一内腔，所述第一内管11的近端穿过第一通孔后固定在所述第一内腔的远端，以使得所述第一内管11在第一部511的带动下轴向运动；所述第二内管12的近端伸出所述第一内管11的近端并穿过所述第一内腔后，固定在第二连动组件6上。
所述第二部513包括第一密封件513a、第二密封件513b和第三密封件513c，所述第一密封件513a的近端固定在所述第三密封件513c的外侧，且所述第二密封件513b夹设在第一密封件513a和第三密封件513c之间。所述第一内管11的近端固定在所述第一密封件513a的远端内，所述第二内管12伸出所述第一内管11的近端，并穿过所述第一密封件513a、第二密封件513b和第三密封件513c，所述第二密封件513b将所述第二内管12与第一内腔之间(即第二内管12和第一内管11之间)的间隙密封。
图6a-6b为本实施例的第一密封件的结构示意图。如图6a-6b所示，所述第一密封件513a为管状结构，且所述第一密封件513a由远端向近端依次包括第一远端部5131、第一过渡部5132和第一近端部5133，所述第一远端部5131 和第一近端部5133为等径段(即所述第一远端部5131的外径等径，内径等径；所述第一近端部5133的外径等径，内径等径)，所述第一过渡部5132是变径段，所述第一远端部5131的外径和内径均最小，所述第一远端部5131的内径大于所述第一内管11的外径，使得所述第一内管11的近端可以固定在所述第一远端部5131的远端内壁上。所述第一近端部5133的外径和内径均最大，所述第一过渡部5132的外径和内径均从近端向远端逐渐减小。所述第一近端部5133的近端端部外周面上具有外螺纹。
图6c-6d为本实施例的第二密封件的结构示意图。如图6c-6d所示，所述第二密封件513b通常采用软质材料(即弹性材料)，具体可以为硅胶/tpu/pebax等高分子材料，所述第二密封件513b的邵氏硬度A通常为35HA～55HA。所述第二密封件513b由近端向远端包括第二近端部5134和第二远端部5135，所述第二近端部5134为等径段，所述第二远端部5135为变径段，所述第二远端部5135的远端的内径及外径均最小，且所述第二远端部5135的远端的外径大于或等于第一远端部5131的内径，且小于第一近端部5133的内径，使得所述第二密封件513b可以设置在所述第一近端部5133和第一过渡部5132中，且所述第二近端部5134靠近近端设置。
所述第二密封件513b具有沿轴向贯通所述第二密封件513b的第一内部空间，所述第一内部空间沿轴向由近端向远端依次包括第一段、第二段和第三段，所述第一段、第二段和第三段的径向截面均为圆形，所述第一段和第三段均为等径段，所述第二段为变径段，所述第一段的直径最大。所述第三段的直径最小，且大于所述第二内管的外径，使得所述第二内管可以穿设在所述第二密封件513b中，所述第二段的直径由近端向远端逐渐减小。
图6e-6f为本实施例的第三密封件的结构示意图。如图6e-6f所示，所述第三密封件513c由近端向远端包括第三近端部5136和第三远端部5137，所述第三近端部5136和第三远端部5137均为等径段，且所述第三近端部5136的外径大于所述第三远端部5137的外径，所述第三近端部5136的内径和第三远端部5137的内径相同，所述第三密封件513c的内径大于第二内管的外径，使得所述第二内管可以穿设在所述第三密封件513c中。所述第三近端部5136的远端端面上具有沿轴向设置的环形的第一凹槽5138，所述第一凹槽 5138靠近近端的表面为底壁，所述第一凹槽5138靠近轴线的侧壁为内侧壁，所述第一凹槽5138远离轴线的侧壁为外侧壁，所述内侧壁距离所述轴线的距离与所述第三远端部5137的外径相同，所述外侧壁上具有与所述第一近端部5133外周面上的外螺纹相匹配的内螺纹。所述第一近端部5133螺纹连接在所述第一凹槽5138中，所述第三远端部5137位于所述第一近端部5133中，且在第一密封件513a拧入第一凹槽5138中时，第三密封件513c从近端挤压所述第二密封件513b，以将所述第二密封件513b夹设在第一密封件513a和第三密封件513c之间。
其中，所述第三远端部5137的外径大于所述第二远端部5135的内径，且小于第一近端部5133的内径，以使得所述第一密封件513a和第三密封件513c可以将所述第二密封件513b夹设在二者之间，并使得第二密封件513b沿径向发生弹性形变，以缩小第二密封件513b的第二远端部5135的内径直至其与第二内管12之间发生弹性挤压，从而达到密封第一内管11和第二内管12之间的间隙的作用，避免了漏气/漏液等情况的发生，极大提高手术的安全性。
所述第二部513的密封过程如下，为了使得表述更为清晰，定位基准0线为第一密封件513a、第二密封件513b和第三密封件513c在初始状态时，所述第三密封件513c的远端端面所在位置。如图7a所示，首先，第一密封件513a、第二密封件513b和第三密封件513c均位于初始状态，此时，第二远端部5135的内径为L0，L0大于第二内管12的外径，第二密封件513b的轴向长度为H0，第三密封件513c与定位基准线0的轴向间距为0；接着，如图7b所示，保持第一密封件513a的位置不变，初步拧紧第三密封件513c，此时，第三密封件513c沿轴向上移，第三密封件513c对第二密封件513b进行了挤压，第二密封件513b发生弹性形变，且第二远端部5135的内径变小为L1，L1依然大于第二内管12的外径，第二密封件513b的轴向长度缩小为H1，第三密封件513c与定位基准线0的轴向间距增大为A1；最后，如图7c所示，继续保持第一密封件513a的位置不变，进一步拧紧第三密封件513c，此时，第三密封件513c沿轴向继续上移，第三密封件513c对第二密封件513b进一步的挤压，第二密封件513b进一步发生弹性形变并与第二内管12的外壁之 间产生挤压力，第二远端部5135的内径继续变小为L2，L2等于第二内管12的外径，第二密封件513b的轴向长度继续缩小为H2，第三密封件513c与定位基准线0的轴向间距继续增大为A2，以实现第二内管12与第一内腔之间的密封。在本实施例中，所述第二密封件513b的硬度、第二过渡段的内径、第二密封件513b的轴向长度以及第三密封件513c与定位基准线0的轴向间距可以根据针对第二内管的外径进行设计。
如图3所示，所述第二传动组件4包括由外向内依次套接的第二手轮、第二外齿轮41和第二内齿轮42，所述第二手轮固定在所述第二外齿轮41的外侧，第二外齿轮41和第二内齿轮42为行星轮，所述第二外齿轮41和第二内齿轮42传动连接，进一步的，所述第二外齿轮41和第二内齿轮42啮合连接。所述第二外齿轮41和所述第二内齿轮42同步转动(例如同步逆时针转动或顺时针转动)，以带动所述第二内管12在轴向往返运动。
如图2b、图3所示，所述第二连动组件6包括第二内管连接件61和第二丝杠62，所述第二内管连接件61套设在所述第二丝杠62上，且所述第二内管连接件61的近端伸出所述第二丝杠62后连接所述第二内齿轮42。所述第二内管12的近端穿过第一连动组件5后固定在所述第二内管连接件61上，且所述第二内管12与第二丝杠62平行设置，所述导丝管13的近端伸出所述第二内管12的近端并穿过第二内管连接件61后固定在所述第二外齿轮41上。所述第二手轮带动第二外齿轮41和第二内齿轮42同步转动，所述第二内齿轮42与第二丝杠62同轴转动，并带动所述第二内管12进行轴向运动。
所述第二外齿轮41为一端开口的筒状结构，所述第二外齿轮41的开口朝向近端设置，所述第二内齿轮42设置在所述第二外齿轮41中，且与所述第二外齿轮41的底壁平行设置。所述第二丝杠62贯通所述第二外齿轮41的底壁后与位于所述第二外齿轮41内的第二内齿轮42连接，以使得所述第二内齿轮42带动所述第二丝杠62转动。
所述第二外齿轮41的内侧壁上具有M个槽，所述第二内齿轮42的外壁上具有N个齿，且M＞N，由于第二外齿轮41和第二内齿轮42的啮合连接，使得第二外齿轮41和第二内齿轮42的模数相同，因此，所述第二外齿轮41与所述第二内齿轮42的传动比为M：N，且当M：N的比值越大则所述第二 外齿轮41与所述第二内齿轮42的传动比也越大，使得第二内管12具有高传动效率，从而缩短了手术的时间，能够减少器械在患者体内的滞留时间，从而降低手术意外的风险。其中，M与m的取值可以相同，也可以不同，同样的N与n的取值可以相同，也可以不同，具体根据实际需求进行设计。
请参阅图1和3，所述第二外齿轮41的底壁上连接一导丝管固定件43，所述导丝管固定件43沿轴向贯通所述第二外齿轮41的底壁，并用于固定所述导丝管13的近端。所述第二外齿轮41的近端具有一棘轮盖，所述棘轮盖盖设在所述第二外齿轮41的开口处，以保护所述第二外齿轮41的内部环境。
所述第二内管连接件61包括沿横向设置的第三部、第四部和第二固定件(未图示)，所述第二固定件位于所述第三部和第四部之间，且连接所述第三部和第四部。
所述第三部为管状结构，所述第三部套设在所述第二丝杠62的外侧，详细的，所述第三部的内壁上具有内螺纹，所述第二丝杠62的外壁上具有与所述内螺纹相匹配的外螺纹，所述第三部螺纹连接在所述第二丝杠62上，并在所述第二丝杠62转动时，所述第三部带动所述第四部进行轴向运动。
所述第二固定件在所述第四部相对的两侧具有两个第二导引柱，所述外壳3具有沿轴向设置的两个第二导引槽，所述第二导引柱设置在所述第二导引槽中，以在所述第二丝杠62转动时，所述第四部在第二导引槽的引导下沿轴向移动。
所述第四部具有沿轴向贯通的第二内腔，所述第二内管12的近端穿过第一内腔后固定在所述第二内腔的远端，以使得所述第二内管12在第三部的带动下轴向运动；所述导丝管13的近端伸出所述第二内管12的近端并穿过所述第二内腔后，固定在所述导丝管固定件43上。
所述第四部包括第四密封件、第五密封件和第六密封件，所述第四密封件的近端固定在所述第六密封件的外侧，且所述第五密封件夹设在第四密封件和第六密封件之间。所述第二内管12的近端固定在所述第四密封件的远端内，所述导丝管13的近端伸出所述第二内管12的近端，并穿过所述第四密封件、第五密封件和第六密封件后固定在所述导丝管固定件43上，所述第五密封件将所述导丝管13与第二内腔之间(导丝管13和第二内管12之间)的 间隙密封。
所述第四密封件为管状结构，且所述第四密封件由远端向近端依次包括第一远端部、第一过渡部和第一近端部，所述第一远端部和第一近端部为等径段(即所述第一远端部的外径等径，内径等径；所述第一近端部的外径等径，内径等径)，所述第一过渡部是变径段，所述第一远端部的外径和内径均最小，且所述第一远端部的内径大于所述导丝管13的外径，所述第一近端部的外径和内径均最大，所述第一过渡部的外径和内径均从近端向远端逐渐减小。所述第一近端部的近端端部外周面上具有外螺纹。
所述第五密封件通常采用软质材料，具体可以为硅胶/tpu/pebax等高分子材料，所述第五密封件的邵氏硬度A通常为35HA～55HA。所述第五密封件由近端向远端包括第二近端部和第二远端部，所述第二近端部为等径段，所述第二远端部为变径段，所述第二远端部的远端的内径及外径均最小，且所述第二远端部的远端的外径大于或等于第一远端部的内径，且小于第一近端部的内径，使得所述第五密封件可以设置在所述第一近端部和第一过渡部中，且所述第二近端部靠近近端设置。
所述第五密封件具有沿轴向贯通所述第二内部空间，所述第二内部空间沿轴向由近端向远端依次包括第一段、第二段和第三段，所述第二内部空间的第一段、第二段和第三段的径向截面均为圆形，所述第二内部空间的第一段和第三段均为等径段，所述第二内部空间的第二段为变径段，所述第二内部空间的第一段的直径最大，所述第二内部空间的第三段的直径最小，且大于所述导丝管的外径，所述第二内部空间的第二段的直径由近端向远端逐渐减小。
所述第六密封件由近端向远端包括第三近端部和第三远端部，所述第六密封件的第三近端部和第三远端部均为等径段，且所述第六密封件的第三近端部的外径大于所述第六密封件的第三远端部的外径，所述第六密封件的第三近端部的内径和第六密封件的第三远端部的内径相同，且所述第六密封件的内径大于导丝管的外径。所述第六密封件的第三近端部的远端端面上具有沿轴向设置的环形的第二凹槽，所述第二凹槽靠近近端的表面为底壁，所述第二凹槽靠近轴线的侧壁为内侧壁，所述第二凹槽远离轴线的侧壁为外侧壁， 所述第二凹槽的内侧壁距离所述轴线的距离与所述第六密封件的第三远端部的外径相同，所述第二凹槽的外侧壁上具有与所述第四密封件的第一近端部外周面上的外螺纹相匹配的内螺纹。所述第四密封件的第一近端部螺纹连接在所述第二凹槽中，所述第六密封件的第三远端部位于所述第四密封件的第一近端部中，且在第四密封件拧入第二凹槽中时，第六密封件从近端挤压所述第五密封件，以将所述第五密封件夹设在第四密封件和第六密封件之间，避免了漏气/漏液等情况的发生，极大提高手术的安全性。
其中，所述第六密封件的第三远端部的外径大于所述第五密封件的第二远端部的内径，且小于第四密封件的第一近端部的内径，以使得所述第四密封件和第六密封件可以将所述第五密封件夹设在二者之间，并使得第五密封件沿径向发生弹性形变，以缩小第五密封件的第二远端部的内径直至其与导丝管13之间发生弹性挤压，从而达到密封导丝管13和第二内管12之间的间隙的作用。其中，所述第四部的密封过程与第二部的密封过程相同。
本实施例的植入物递送手柄的连接方式为：第一内管11的近端穿过第一通孔后，固定在所述第一内管连接件51的第一密封件513a的远端内，所述第二内管的近端伸出所述第一内管并穿过第一内腔后固定在第二内管连接件61的第四密封件的远端内，所述第三密封件513c和第一密封件513a通过拧紧挤压二者之间的第二密封件513b，使得第二密封件513b发生形变并与第二内管的外壁产生挤压力，以将第二内管12的近端外壁与第一内管11之间的间隙密封；所述导丝管13伸出所述第二内管12的近端，并穿出第二内腔后固定在第二外齿轮41的导丝管固定件43上，所述第六密封件和第四密封件通过拧紧挤压位于二者之间的第五密封件，使得第五密封件发生形变并与导丝管13的外壁产生挤压力，以将导丝管13的近端外壁与第二内管12之间的间隙密封。
第一丝杠52的远端穿过第一内管连接件51的第一部511后连接第一内齿轮22，并在第一手轮的转动时，所述第一内齿轮22与所述第一外齿轮21同时转动，且所述第一丝杠52随着第一内齿轮22螺纹转动，以带动固定在第一内管连接件51的第二部513上的第一内管11进行轴向运动；第二丝杠62的近端穿过第二内管连接件61的第三部后连接第二内齿轮42，并在第二 手轮的转动时，所述第二内齿轮42与所述第二外齿轮41同时转动，且所述第二丝杠62随着第二内齿轮42螺纹转动，以带动固定在第二内管连接件61的第四部上的第二内管12进行轴向运动。由于第一内齿轮22和第一外齿轮21为行星轮，第二内齿轮42和第二外齿轮41为行星轮，从而具有了高载荷、大传动比的特点，能够应对各种工况的手柄，尤其需要大传动比的情况，从而获取了稿的传动效率。
请参阅图1-3，本实施例提供的一种植入物递送系统的使用方法，以选用两步释放的植入物为例，所述使用方法包括：首先将植入物递送手柄与导管组件根据上述描述进行安装，以完成植入物递送系统的安装；接着，同时朝向第一方向转动第一手轮和第二手轮，通过第一外齿轮21和第一内齿轮22与第一丝杠52的传动，使得第一内管11沿轴向后退，通过第二外齿轮41和第二内齿轮42与第二丝杠62的传动，使得第二内管12沿轴向同时后退；接着，同时朝向第一方向的反方向转动第一手轮和第二手轮，通过第一外齿轮21和第一内齿轮22与第一丝杠52的传动，使得第一内管11沿轴向前进，通过第二外齿轮41和第二内齿轮42与第二丝杠62的传动，使得第二内管12沿轴向同时前进，此时，植入物7安装在递送管中；然后，将植入物递送系统按照指定路径行进，并将植入物输送至预设位置处；接着，同时朝向第一方向或第一方向的反向转动第一手轮和第二手轮，使得第一内管11和第二内管12沿轴向运动以完成所述植入物7释放。
综上所述，本发明提供一种植入物递送手柄、植入物系统、递送系统及其使用方法，植入物递送手柄使用行星齿轮结构结合丝杠传动，使得植入物递送手柄为具有“高载荷+大传动比”的结构，提高了植入物递送系统的传动速率，缩短了手术的时间，减少了器械在患者体内的滞留时间，从而降低手术发生意外的风险；在递送导管的密封方面，第一连接件和第二内管连接件的密封设计不同于传统的密封，本发明的结构简单，安全性高，该简单的结构无论是设计还是加工费用都能够较大的节约成本。
此外，需要说明的是，除非特别说明或者指出，否则说明书中的术语“第一”和“第二”仅仅用于区分说明书中的各个组件、元素、步骤等，而不是用于表示各个组件、元素、步骤之间的逻辑关系或者顺序关系等。
可以理解的是，虽然本发明已以较佳实施例披露如上，然而上述实施例并非用以限定本发明。对于任何熟悉本领域的技术人员而言，在不脱离本发明技术方案范围情况下，都可利用上述揭示的技术内容对本发明技术方案作出许多可能的变动和修饰，或修改为等同变化的等效实施例。因此，凡是未脱离本发明技术方案的内容，依据本发明的技术实质对以上实施例所做的任何简单修改、等同变化及修饰，均仍属于本发明技术方案保护的范围内。

Claims (11)

  1. 一种植入物递送手柄，其特征在于，包括沿第一内管的轴向设置的两个传送系统，位于远端的所述传送系统连接所述第一内管的近端，位于近端的所述传送系统连接第二内管的近端，其特征在于，
    每个所述传送系统包括丝杠、内管连接件、外齿轮和内齿轮，所述外齿轮可转动连接所述内齿轮，并用于带动所述内齿轮转动，所述丝杠通过所述内管连接件连接所述第一内管或第二内管，所述丝杠还连接所述内齿轮，并随所述内齿轮转动，以带动所述第一内管或第二内管进行轴向运动；其中，所述外齿轮和内齿轮的传动比大于1。
  2. 如权利要求1所述的植入物递送手柄，其特征在于，所述外齿轮套设在所述内齿轮的外侧，且所述外齿轮和内齿轮啮合连接。
  3. 如权利要求1所述的植入物递送手柄，其特征在于，
    位于远端的所述内管连接件连接所述第一内管的近端外壁，并套设在所述第二内管的外侧，还用于从近端密封所述第一内管与第二内管之间的间隙；以及
    位于近端的所述内管连接件连接所述第二内管的近端外壁，并套设在导管组件的导丝管的外侧，还用于从近端密封所述第二内管与导丝管之间的间隙。
  4. 如权利要求1所述的植入物递送手柄，其特征在于，
    位于远端的所述内管连接件包括套设在所述第二内管外侧的第一密封件、第二密封件和第三密封件，所述第一内管的近端贴合固定在所述第一密封件的远端内，所述第二密封件弹性夹设在所述第一密封件的近端和所述第三密封件的远端之间，并在所述第一密封件和所述第三密封件共同挤压所述第二密封件时，所述第二密封件贴合设置在所述第二内管的外壁上，以密封所述第一内管的近端与所述第二内管之间的间隙；以及
    位于近端的所述内管连接件包括套设在导管组件的导丝管外侧的第四密封件、第五密封件和第六密封件，所述第二内管的近端贴合固定在所述第四密封件的远端内，所述第五密封件弹性夹设在所述第四密封件的近端和所述 第六密封件的远端之间，并在所述第四密封件和所述第六密封件共同挤压所述第五密封件时，所述第五密封件贴合设置在所述导丝管的外壁上，以密封所述第二内管的近端与所述导丝管之间的间隙。
  5. 如权利要求4所述的植入物递送手柄，其特征在于，所述第二密封件和所述第五密封件的材料包括高分子材料，且所述第二密封件和所述第五密封件的邵氏硬度A为35HA～55HA。
  6. 如权利要求4所述的植入物递送手柄，其特征在于，
    所述第一密封件、所述第二密封件和所述第三密封件均为管状结构，所述第二密封件设置在所述第一密封件的近端内，所述第三密封件的远端设置在所述第一密封件的近端内，并与所述第一密封件配合挤压所述第二密封件，以使得所述第二密封件的内径缩小并与所述第二内管之间贴合设置；
    其中，所述第一密封件、所述第二密封件和所述第三密封件的内径均大于或等于所述第二内管的外径，所述第一密封件的近端内径大于远端内径，所述第二密封件的外径的取值在所述第一密封件的远端内径和近端内径之间，所述第三密封件的远端外径的取值在所述第二密封件的远端内径与所述第一密封件的近端内径之间。
  7. 如权利要求4所述的植入物递送手柄，其特征在于，
    所述第四密封件、所述第五密封件和所述第六密封件均为管状结构，所述第五密封件设置在所述第四密封件的近端内，所述第六密封件的远端设置在所述第四密封件的近端内，并与所述第四密封件配合挤压所述第五密封件，以使得所述第五密封件的内径缩小并与所述导丝管之间贴合设置；
    其中，所述第四密封件、所述第五密封件和所述第六密封件的内径均大于或等于所述导丝管的外径，所述第四密封件的近端内径大于远端内径，所述第五密封件的外径的取值在所述第四密封件的远端内径和近端内径之间，所述第六密封件的远端外径的取值在所述第五密封件的远端内径与所述第四密封件的近端内径之间。
  8. 如权利要求1所述的植入物递送手柄，其特征在于，所述丝杠和所述内齿轮同轴设置，所述丝杠具有外螺纹，所述内管连接件具有内螺纹，所述内管连接件与所述丝杠通过螺纹连接，所述内管连接件在所述丝杠沿螺纹转 动时，带动所述第一内管或第二内管进行轴向运动。
  9. 一种植入物递送系统，其特征在于，包括如权利要求1～8中任一项所述的植入物递送手柄，以及包括导管组件，所述导管组件包括由外向内依次套接的第一内管、第二内管和导丝管，所述植入物递送手柄带动所述第一内管和所述第二内管进行轴向运动。
  10. 一种植入物系统，其特征在于，包括如权利要求1～8中任一项所述的植入物递送手柄、第一内管、第二内管、导丝管、锥形头和固定头，所述固定头设置在所述第二内管及所述导丝管的远端端部，所述锥形头设置在所述第一内管的远端端部，植入物压缩设置在所述第一内管的远端内，且位于所述锥形头和所述固定头中间，所述植入物递送手柄带动所述第一内管和所述第二内管进行轴向运动，以实现植入物的装载、输送和释放。
  11. 一种植入物递送系统的使用方法，包括如权利要求9所述的植入物递送系统，其特征在于，所述使用方法包括：
    沿第一方向转动外齿轮，内齿轮与所述外齿轮同时转动，丝杠随所述内齿轮转动，内管连接件在所述丝杠转动时带动所述第一内管或第二内管沿轴向前进；以及
    沿第一方向的反方向转动外齿轮，所述内齿轮与所述外齿轮同时转动，所述丝杠随所述内齿轮转动，所述内管连接件在所述丝杠转动时带动所述第一内管或第二内管沿轴向后退。
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