WO2023124638A1 - 一种带夹持导向功能的植入装置 - Google Patents

一种带夹持导向功能的植入装置 Download PDF

Info

Publication number
WO2023124638A1
WO2023124638A1 PCT/CN2022/132962 CN2022132962W WO2023124638A1 WO 2023124638 A1 WO2023124638 A1 WO 2023124638A1 CN 2022132962 W CN2022132962 W CN 2022132962W WO 2023124638 A1 WO2023124638 A1 WO 2023124638A1
Authority
WO
WIPO (PCT)
Prior art keywords
clamping
chuck
implant device
function according
distal end
Prior art date
Application number
PCT/CN2022/132962
Other languages
English (en)
French (fr)
Inventor
曾建锋
李阳
庄镇平
Original Assignee
杭州德晋医疗科技有限公司
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 杭州德晋医疗科技有限公司 filed Critical 杭州德晋医疗科技有限公司
Publication of WO2023124638A1 publication Critical patent/WO2023124638A1/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
    • A61F2/02—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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/122—Clamps or clips, e.g. for the umbilical cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • 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
    • 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
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2454—Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
    • A61F2/2457—Chordae tendineae prostheses
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • 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
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Definitions

  • the invention relates to the technical field of medical instruments, in particular to an implant device with a clamping and guiding function.
  • interventional surgery is becoming more and more common, which is characterized by opening a small operating window on the patient's body surface, and delivering catheter-like devices along the vascular channel to the predetermined treatment area.
  • the device achieves the purpose of treatment/repair by implanting corresponding implants (such as spacers, anchors, etc.) at the lesion.
  • Existing implant devices usually include implants and delivery systems. Take the artificial chord implantation device and the transatrial septal mitral valve artificial chord implantation as examples.
  • the implant includes a first An anchor, a second anchor on the papillary muscle or the ventricular wall, and an artificial chord attached between the spacer and the anchor.
  • control the delivery system to pass through the atrial septum and pass through the mitral valve to reach the papillary muscle, and then control the puncture needle at the far end of the delivery system to penetrate into the papillary muscle, push out the second anchor and make it anchor into the papillary muscle; then release the artificial chordae ;
  • the distal end of the delivery system is withdrawn, and then the first anchor is implanted on the surface of the valve leaflet, thereby completing the implantation of the artificial chordae and realizing the repair/treatment of the diseased mitral valve.
  • the present invention provides an implant device with a clamping and guiding function to solve the problems of insufficient anchoring accuracy and poor anchoring effect of the existing implant device.
  • an embodiment of the present invention provides an implant device with a clamping and guiding function, including:
  • a clamping assembly the clamping assembly includes a first clamping head and a second clamping head that can be relatively opened and closed for fixed-point clamping, and the first clamping head is provided with a guide channel;
  • the puncture component is movably accommodated in the lumen of the clamping component, and punctures tissue through the guide channel;
  • a push-pull component the push-pull component is movably accommodated in the lumen of the puncture component and abuts against the implant, for pushing the implant.
  • an implant device with a clamping and guiding function provided by the present invention has at least the following technical effects:
  • An implant device with clamping guide function provided by an embodiment of the present invention, by adding a clamping assembly including a first clamping head and a second clamping head, the first clamping head and the second clamping head can pinpoint the clamping target precisely
  • the tissue in the anchoring area can still be fine-tuned after the implant is released, and the puncture direction of the puncture component can be guided through the guide channel set on the first chuck, so that the puncture component can be accurately guided to the target anchoring area
  • FIG. 1 is a schematic structural view of the assembly of an implant device with a clamping guide and a guide device according to an embodiment of the present invention
  • FIG. 2 is a schematic structural view of the unfolded state of the clamping assembly of the implant device according to the embodiment of the present invention
  • Fig. 3 is a partial cross-sectional view of the clamping assembly of the implant device according to the embodiment of the present invention closed and accommodated in the guide device;
  • Fig. 4 is a partial cross-sectional view of the unfolded state of the clip assembly of the implant device according to the embodiment of the present invention.
  • FIG. 5 is a schematic exploded view of the structure of the clamping component, the puncture component, the implant and the push-pull component of the implant device according to the embodiment of the present invention
  • Fig. 6 is a schematic structural view of the clamping assembly in Fig. 5;
  • Fig. 7 is a schematic diagram of the separation of the first chuck and the second chuck of the clamping assembly in Fig. 5;
  • Fig. 8 is a sectional view of the puncture needle tube in Fig. 5;
  • Fig. 9 is a schematic structural view of the guiding device in Fig. 1;
  • FIGS 10 to 18 are schematic diagrams of the process of using the implant device for transcatheter mitral valve chordae repair according to the embodiment of the present invention, wherein:
  • Figure 10 is a schematic diagram of the implant device to be punctured
  • Fig. 11 is the schematic diagram that the clamping assembly of the implant device reaches the papillary muscle
  • Fig. 12 is a schematic diagram of the clamping assembly of the implant device being clamped on the papillary muscle
  • Figure 13 is a schematic diagram of the clamping component of the implant device being clamped on the papillary muscle and the puncture component piercing the papillary muscle;
  • Fig. 14 is a schematic diagram of pushing out the gasket from the push-pull tube of the implant device
  • Figure 15 is a schematic diagram of the retraction of the push-pull tube of the implant device
  • Fig. 16 is the schematic diagram that the spacer of implanting device is implanted in papillary muscle
  • Fig. 17 is a schematic diagram of the clamping assembly of the implant device being withdrawn from the body along the guiding sheath;
  • Fig. 18 is a schematic diagram of the valve leaflet implanted into the spacer and the suture pulled between the leaflet and the papillary muscle.
  • the terms “installation”, “connection”, “connection”, and “set on" should be understood in a broad sense, for example, it can be A fixed connection can also be a detachable connection or an integral connection; it can be a mechanical connection; it can be a direct connection or an indirect connection through an intermediary, and it can be an internal communication between two components.
  • the proximal end refers to the end closer to the operator, while the distal end refers to the end farther away from the operator;
  • the axial direction refers to the direction parallel to the line between the center of the distal end and the center of the proximal end of the medical device.
  • the radial direction refers to the direction along the diameter or radius
  • the radial direction and the axial direction are perpendicular to each other
  • the circumferential direction refers to the circumferential direction around the central axis.
  • the embodiment of the present invention discloses an implant device with a clamping and guiding function, which is used to accurately deliver the implant 3 to a predetermined position in the patient's body and realize anchoring.
  • the implant 3 may be an anchor, a screw, a heart valve clamp, an artificial chord, a ventricular volume reduction clip, and other devices used for the repair/treatment of heart valve diseases.
  • the implant 3 can be made of a material with shape memory function, has a deployed state (implanted state) in a natural state, can be stretched into a line shape and loaded into the inner cavity of the implant device during use.
  • the implant device with clamping and guiding function includes a clamping component 1 , a puncture component 2 , an implant 3 and a push-pull component 4 .
  • the clamping assembly 1 includes a first clamping head 11 and a second clamping head 12 that can be opened and closed relative to each other for fixed-point clamping.
  • the first clamping head 11 is provided with a guide channel 111. the inner cavity, and puncture the tissue through the guide channel 111, the implant 3 can be movably accommodated in the inner cavity of the puncture component 2, and the push-pull component 4 can be movably accommodated in the inner cavity of the puncture component 2 and abuts against the implant 3, For pushing the implant3.
  • the distal end of the clamping component 1 clamps the predetermined puncture point, and then the puncture component 2 punctures the predetermined puncture point along the guide channel 111 and the implant 3 Push out the lumen of the puncture component 2. Since the tissue is still clamped and fixed by the clamp component 1 at this time, you can continue to fine-tune the position of the implant 3. After confirming that the implant 3 is in the best position, loosen it. The clamped tissue is released, and the implant 3 is implanted in the desired target area at this time, and other components of the implant device are withdrawn, thereby completing the implantation of the implant 3 .
  • the first clamping head 11 and the second clamping head 12 can pinch the tissue in the target anchoring area precisely, and the position can still be fine-tuned after the implant 3 is released, And through the guide channel 111 provided on the first chuck 11, the puncture assembly 2 passes through to guide the puncture direction of the puncture assembly 2, so as to guide the puncture assembly 2 to the tissue of the target anchoring area accurately, avoiding the puncture needle In the case of slippery tissue surface, insufficient puncture depth or deviation of anchor position, etc., it can realize precise puncture and anchoring.
  • the guide Channel 111 is a channel with an angle change. Specifically, the guide channel 111 extends obliquely toward the distal end and toward the direction of the central axis of the first chuck 11 . Such setting enables the puncture assembly 2 to pass out along a certain trajectory under the guidance of the guide channel 111, not only can obtain a greater puncture depth and a better anchor point position, but also avoid tissue damage caused by the puncture assembly 2's direct puncture. damage.
  • the first chuck 11 and the second chuck 12 form a tissue accommodating space, and when the two chucks are closed, the tissue is fixed in the space.
  • the distal end of the guide passage 111 penetrates to the surface of the first chuck 11 facing the second chuck 12, and the distal end of the puncture assembly 2 penetrates between the first chuck 11 and the second chuck 12 through the guide passage 111.
  • the puncture assembly 2 will directly puncture the target area when passing through the guide channel 111, so that the puncture assembly 2 can be precisely Target regional tissues in a targeted manner.
  • the included angle between the entrance and exit of the guide channel 111 is ⁇ 1, in order to ensure that the puncture assembly 2 has a greater puncture depth and a better anchor point position as much as possible, and at the same time avoid damage to the surrounding area due to the long puncture stroke of the puncture assembly 2 Tissue, set 90° ⁇ 1 ⁇ 150°.
  • the included angle ⁇ 1 between the entrance and the exit of the guide channel 111 can be 90°, 100°, 110°, 120°, 130°, 140° and 150°, etc., which is not limited here, and this implementation
  • the angle ⁇ 1 between the entrance and exit of the guide channel 111 is preferably 120°.
  • the guide channel 111 is located at the middle section of the second chuck 12 to the second chuck The position of the far end of 12 changes in the above-mentioned included angle.
  • the unilateral clearance range between the guide channel 111 and the puncture assembly 2 is 0.1mm -0.5mm.
  • the unilateral gap between the guide channel 111 and the puncture assembly 2 can be 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, etc., which is not limited here.
  • the unilateral gap between components 2 is 0.1mm.
  • the proximal end between the first clamping head 11 and the second clamping head 12 is connected, and the distal end can be opened and closed, so that the clamping assembly 1 realizes the tissue adjustment through the relative movement between the first clamping head 11 and the second clamping head 12.
  • the clamping is fixed.
  • the first chuck 11 is a fixed chuck
  • the second chuck 12 is a movable chuck, that is, the proximal ends of the first chuck 11 and the second chuck 12 are adapted in shape and connected to each other
  • the distal end of the second clamping head 12 can expand or close relative to the distal end of the first clamping head 11 , and the tissue can be clamped by pressing the second clamping head 12 to the first clamping head 11 .
  • the first clamp 11 is a movable clamp
  • the second clamp 12 is a fixed clamp, that is, the tissue is clamped by pressing the first clamp 11 to the second clamp 12 .
  • the distal end of the first clamping head 11 moves toward the second clamping head 12
  • the direction of the distal end of the first chuck 112 is extended to form a first tooth 112
  • the distal end of the second chuck 12 extends toward the direction of the distal end of the first chuck 11 to form a second tooth 121.
  • the first teeth 112 and the second teeth Teeth 121 are used to grip tissue.
  • the number of the first teeth 112 is two, and the two first teeth 112 are arranged in parallel on the first chuck
  • the two first teeth 112 and the two second teeth 121 are staggered along the axial direction of the first chuck 11 and the second chuck 12, so that the first chuck 11 and the second After the chuck 12 is closed, the clamping surfaces of the first chuck 11 and the second chuck 12 are adapted to each other, so as to reduce the outer diameter of the clamping assembly 1 and facilitate transportation; and the first teeth 112 and the second The teeth 121 are staggered and embedded, which can firmly clamp sticky and slippery tissues, increase the clamping force, and prevent the tissues from slipping.
  • the side of the first tooth 112 near the proximal end of the first clamp 11 is configured as an arc
  • the side of the first tooth 112 near the proximal end of the first chuck 11 is configured as a concave arc.
  • the side of the second tooth 121 near the proximal end of the second chuck 12 is configured as an arc
  • the side of the second tooth 121 near the proximal end of the second chuck 12 is configured as a concave arc shape.
  • the first teeth 112 are close to the distal end of the first chuck 11
  • the side of the second tooth 121 near the distal end of the second chuck 12 is configured as a smooth arc.
  • the first chuck 11 and the second chuck 12 when the first chuck 11 and the second chuck 12 are closed, in order to allow the gap between the first teeth 112 and the second teeth 121 to allow the puncture assembly 2 to pass through, while ensuring that the first The first tooth 112 and the second tooth 121 firmly clamp the tissue without damaging the tissue.
  • the height h3 of the first tooth 112 and the second tooth 121 should satisfy: 0.2mm ⁇ h3 ⁇ 2.0mm
  • the two first teeth Both the distance between the teeth 112 and the distance h4 between the two second teeth 121 should satisfy: 0.5mm ⁇ h4 ⁇ 2.5mm.
  • h3 can be 0.2mm, 0.4mm, 0.6mm, 0.8mm, 1.0mm, 1.2mm, 1.4mm, 1.6mm, 1.8mm, 2.0mm, etc., and it is not limited here.
  • h3 is 1.2 mm for an example.
  • h4 may be 0.5 mm, 1.0 mm, 1.5 mm, 2.0 mm, 2.5 mm, etc., which is not limited here, and this embodiment takes h4 as 2.0 mm for example.
  • the heights of the first teeth 112 and the second teeth 121 are consistent, and the distance between the two first teeth 112 and the two The distance between the second teeth 121 should also be the same.
  • the second clamping head 12 in order to ensure that the clamping assembly 1 has sufficient stability and a sufficient contact area with the tissue during the clamping process, the second clamping head 12 includes a clamping portion 122 with a certain area, specifically, the second Both the proximal end and the distal end of the chuck 12 are closed structures, which diverge from the proximal end to the distal end, expand to a certain extent in the middle section, and then gradually converge toward the distal end, thereby forming a clamping portion 122 with a certain area.
  • the area of the clamping portion 122 first increases and then decreases, so that the second clamping head 12 has a certain clamping area, and the second clamping capacity can be improved.
  • the clamping effect after the head 12 and the first chuck 11 are closed.
  • the specific shape of the clamping portion 122 may be any regular or irregular shape such as circle, triangle, rhombus, rectangle, ellipse, polygon, or a combination of any of the aforementioned shapes.
  • a rhombus is adopted, and the two sides of the rhombus are designed with rounded corners. This is because the rhombus structure is easier to be compressed, and the resistance to retracting into the delivery device is smaller.
  • the clamping part 122 includes two support rods 1221 arranged at intervals. Along the direction from the proximal end to the distal end of the second chuck 12, the distance between the two support rods 1221 first increases and then decreases. The proximal end of the second chuck 12 diverges toward the distal end, expands to a maximum extent somewhere in the middle section, and then gradually converges toward the distal end of the second chuck 12 , thereby forming a clamping portion 122 with a certain area.
  • the clamping portion 122 is formed by the two supporting rods 1221 spaced apart, which increases the clamping area and does not affect the process of storing the second chuck 12 into the conveying system.
  • the clamping area of the clamping portion 122 is related to the spacing between the support rods 1221 on both sides. The larger the spacing, the greater the clamping area and clamping force, but at the same time, the second chuck 12 will be retracted to
  • the pulling force required to recover the second chuck 12 is also related to the included angle ⁇ between each support rod 1221 and the axial direction of the second chuck 12, the greater the included angle ⁇ Larger means that the larger the included angle between the clamping part 122 and the axial direction of the sheath tube, the larger the recovery pulling force required.
  • the distance between the two support rods 1221 is 7mm-8mm, and the clamp between the two support rods 1221 and the proximal end of the second chuck 12
  • the angle ⁇ should satisfy: 90° ⁇ 150°.
  • the distance between the two supporting rods 1221 may be 7 mm, 7.5 mm, 8 mm, etc., which is not limited here.
  • the included angle ⁇ between the two support rods 1221 and the proximal end of the second chuck 12 can be 90°, 100°, 110°, 120°, 130°, 140°, 150°, etc., which will not be discussed here. limited.
  • the rigid length of the clamping assembly 1 needs to be smaller than the radius of curvature of the passing blood vessel.
  • the transatrial septal intervention route is adopted.
  • the rigid length L of the clamping component 1 should be smaller than the radius of curvature of the transatrial septum catheter.
  • the clamping force of the clamping assembly 1 on the tissue is related to the effective depth of clamping.
  • the effective depth of clamping refers to: when the first clamping head 11 and the second clamping head 12 are closed, they are located at the same length of the two clamping heads. Theoretically, the axial dimension of the part, on the premise that the overall length of the clamping assembly 1 remains constant, the greater the effective depth, the stronger the clamping force. Since the clamping assembly 1 achieves clamping through the relative opening and closing of a pair of clamps, if the length of one of the clamps is greater than the length of the other, an excess length will be formed, which will affect the clamping assembly 1. effective depth and affect the conduction of force.
  • the second chuck 12 is a movable chuck
  • the first chuck 11 is a fixed chuck, that is, by pressing the second chuck 12 to the first chuck 11, the tissue can be tightened. Clamping fixed. Therefore, in order to increase the effective depth of clamping as much as possible and to ensure that the second chuck 12 is pressed against the first chuck 11 when the force is uniform, in the natural state of the relative expansion of the first chuck 11 and the second chuck 12 Next, the distal end of the first chuck 11 and the distal end of the second chuck 12 are aligned.
  • the second clamp 12 is expanded relative to the first clamp 11, therefore, in order to be in the natural state where the first clamp 11 and the second clamp 12 are relatively expanded, the distal end of the first clamp 11 and the second clamp The positions of the distal ends of the clips 12 can be aligned, so the length of the second clip 12 is greater than the length of the first clip 11 .
  • the rigid length L of the clamping assembly 1 should be smaller than the radius of curvature of the transatrial septum catheter, specifically, it should satisfy 5mm ⁇ L ⁇ 25mm. Therefore, the length range of the second chuck 12 and the first chuck 11 is 5-25mm. In this embodiment, the length of the second chuck 12 is 20 mm, and the length of the first chuck 11 is 15 mm.
  • the first clamp 11 is a movable clamp
  • the second clamp 12 is a fixed clamp, that is, the first clamp 11 is pressed to the second clamp 12 to achieve
  • the length of the first chuck 11 should be greater than the length of the second chuck 12 .
  • the vertical distance between the highest point of the arc of the first chuck 11 and the lowest point of the arc of the second chuck 12 is h1
  • the first chuck 11 The vertical distance between the highest point of the arc and the highest point of the arc of the second chuck 12 is h2.
  • h1 determines the maximum distance that can be clamped to the tissue. The larger the h1, the greater the thickness of the tissue that can be clamped, and the need for h2 to be as small as possible on the basis of satisfying the clamping distance of h1 , which in turn reduces tissue damage or hooks the chords.
  • h1 can be 8mm, 9mm, 10mm, 11mm, 12mm, 13mm , 14mm or 15mm, etc.
  • the proximal end of the first chuck 11 is provided with one of the groove 123 and the boss 113
  • the proximal end of the second chuck 12 is provided with one of the groove 123 and the boss 113.
  • the groove 123 and the boss 113 are matched in shape and connected to each other. The matching connection between the groove 123 and the protrusion can limit the relative movement between the second chuck 12 and the first chuck 11, and ensure that the first chuck 11 and the second chuck 12 do not have mutual circumferential rotation and axial displacement. Prevent the occurrence of unstable clamping or insufficient clamping force.
  • the proximal end of the first chuck 11 is provided with a groove 123, and the proximal end of the second chuck 12 is provided with a boss 113; in other embodiments, the proximal end of the first chuck 11 is A boss 113 is provided and a groove 123 is provided at the proximal end of the second chuck 12 .
  • the first chuck 11 is provided with a boss 113 and the second chuck 12 is provided with a groove 123 for example.
  • the groove 123 is in clearance fit with the boss 113, and the groove 123 and the boss 113
  • the unilateral clearance range is 0.05mm ⁇ B2 ⁇ 0.1mm.
  • the unilateral gap B2 between the groove 123 and the boss 113 can be 0.05mm, 0.06mm, 0.07mm, 0.08mm, 0.09mm, 0.1mm, etc., which is not limited here.
  • the unilateral gap B2 between 123 and boss 113 is 0.05 mm for example.
  • the groove 123 The matching depth range with the boss 113 is 0.5mm-2mm.
  • the matching depth between the groove 123 and the boss 113 can be 0.5mm, 1.0mm, 1.5mm, 2.0mm, etc., which is not limited here.
  • the depth between the groove 123 and the boss 113 is The mating depth is 1.5mm for example.
  • the outer diameter of the proximal end of the second chuck 12 is equal to the outer diameter of the proximal end of the first chuck 11, so as to avoid the appearance of steps at the position of the outer diameter difference, and avoid damage to the steps when the clamping assembly 1 is stored in the delivery system. delivery system while avoiding blood accumulation at steps to form thrombus. It can be understood that, in other optional implementation manners, a design manner in which the outer diameters of the first chuck 11 and the second chuck 12 are not equal may also be adopted, which is not limited here.
  • the first collet 11 is a fixed collet made of rigid material or material with shape memory function
  • the second collet 12 is a movable collet made of material with shape memory function.
  • the second clamping head 12 can be pre-set to expand relative to the first clamping head 11 in a natural state, so that the first clamping head 11 and the second clamping head 12 can clamp the tissue in the target anchoring area.
  • the clamping portion 122 of the second clamping head 12 can be loaded into the delivery system in the shape of a synthetic strand after being pressed.
  • the material of the second chuck 12 is a material with a shape memory function, and nickel-titanium alloy is used in this embodiment.
  • the nickel-titanium alloy tube is cut by laser, and then it is heated and shaped, so that it can maintain a specific shape and has superelasticity.
  • the clamping area is used to clamp the tissue;
  • the first chuck 11 is made of rigid materials to provide better support force during the clamping process and avoid the overall swing of the clamping component 1, such as 304 stainless steel, 316 stainless steel, titanium alloy, tantalum, ABS or PC, etc.
  • tantalum is preferred, which has good imaging properties under ultrasound, and can display the relative position of the clamping component 1 and the tissue.
  • the clamping assembly 1 further includes a flexible sheath 14, the first chuck 11 and the second chuck 12 are coaxially fitted and connected to the distal end of the flexible sheath 14, and the puncture assembly 2 is movably mounted on the flexible sheath 14.
  • the lumen of the flexible sheath tube 14 communicates with the guide channel 111
  • the puncture assembly 2 penetrates into the guide channel 111 through the lumen of the flexible sheath tube 14 and enters the tissue containing space.
  • the first chuck 11 is fixedly arranged on the distal end of the flexible sheath 14
  • the second chuck 12 is movably arranged on the distal end of the flexible sheath 14 .
  • the flexible sheath 14 is a hollow flexible tube with a certain length, and the puncture assembly 2 can move through the lumen of the flexible sheath 14 .
  • Commonly used forms of the flexible sheath 14 are metal cutting tubes, multi-layer composite tubes, and the like.
  • the flexible sheath 14 is a stainless steel cut tube, it can be connected with the first chuck 11 and/or the second chuck 12 by means of welding, bonding, etc.; when the flexible sheath 14 is a multilayer composite pipe, the multilayer composite
  • the tube usually has a three-layer structure, which is an inner membrane (PTFE material), a braided mesh (made of stainless steel wire or tungsten wire) and an outer membrane (PEBAX material) from the inside to the outside.
  • the flexible sheath 14 and the first The clamping head 11 and/or the second clamping head 12 may be connected by means of glue bonding or hot melting.
  • the flexible sheath 14 uses a multi-layer composite tube body.
  • the clamping assembly 1 further includes a clamp connector 13, the clamp connector 13 is connected to the distal end of the flexible sheath 14, and the first clamp 11 and the second clamp 12 are connected to the clamp connector 13 The distal end of the first chuck 11 and the second chuck 12 and the connection between the flexible sheath 14 are realized.
  • the chuck connector 13 is a hollow pipe body, which can be made of metal materials such as stainless steel, or high-molecular materials such as ABS.
  • the chuck connector 13 can be connected to the first chuck 11, the second chuck 12 and the flexible sheath 14 by means of welding, bonding, integral molding, melting, interference fit, etc., which are not limited here .
  • the puncture assembly 2 includes a hollow puncture needle tube 21 , and the puncture needle tube 21 is movably mounted in the lumen of the flexible sheath 14 for accommodating and passing the implant 3 and the push-pull assembly 4 .
  • the puncture needle tube 21 passes through the inner cavity of the flexible sheath tube 14 and the guide channel 111 of the first chuck 11 sequentially, along a certain The arcuate trajectory exits to pierce tissue located in the tissue-receiving space.
  • the distal end of the puncture needle tube 21 is a sharp point, and the puncture needle tube 21 should have certain flexibility and rigidity at the same time, and its rigidity is greater than that of the tissue intima in the body, so as to puncture the tissue.
  • the puncture needle tube 21 For the tube body with a certain axial length and cross-sectional area such as the puncture needle tube 21, it is usually required to have a certain degree of flexibility and support, so that it can pass through curved blood vessels smoothly, and can not bend when puncturing tissue. fold or slip.
  • the moment of inertia I value of the section is a geometric parameter to measure the bending resistance of the section. The smaller the I value, the stronger the flexibility of the tube body, the smaller the bending radius that can be achieved, and the stronger the adaptability to the vascular path.
  • the puncture needle tube 21 is a hollow structure, and its cross-section is a hollow circle.
  • the tube of the puncture needle tube 21 The smaller the diameter, the smaller the moment of inertia I, the smaller the bending radius of the puncture needle tube 21, and the stronger the adaptability to the blood vessel path, but at the same time, the support and puncture force of the tube will be correspondingly reduced.
  • the outer diameter of the puncture needle tube 21 ranges from 0.5 mm to 2.0 mm, and the inner diameter range of the puncture needle tube 21 ranges from 0.2 mm to 1.8 mm.
  • the outer diameter range of the puncture needle tube can be 0.5mm, 1.0mm, 1.5mm, 2.0mm, 2.5mm, etc.
  • the inner diameter of the puncture needle tube 21 can be 0.2mm, 0.4mm, 0.6mm, 0.8mm, 1.0mm, 1.2mm , 1.4mm, 1.6mm, 1.8mm, etc., which are not limited here.
  • the outer diameter of the puncture needle tube 21 is preferably 1.0mm, and the inner diameter of the puncture needle tube 21 is 0.8mm.
  • the commonly used tubing types of the puncture needle tube 21 include PEEK tube, PI tube, PA tube, metal cutting tube, heat-treated nickel-titanium alloy tube, etc.
  • the material of the puncture needle tube 21 is preferably a PEEK tube, which can withstand high temperature The bottom has plasticity, thus, through pre-high-temperature shaping treatment, the part of the puncture needle tube 21 near the distal end has a shape similar to that of the guide channel 111, so that the needle can be passed through the guide channel 111 more compliantly.
  • the puncture needle tube is ejected along the movement trajectory limited by the guide channel 111, which can form a certain needle exit angle, so as to avoid excessively long puncture stroke and damage to surrounding tissues.
  • the needle exit angle is the same as the included angle ⁇ 1 between the entrance and exit of the guide channel 111 , ranging from 90° to 150°, and is 120° in this embodiment.
  • the push-pull assembly 4 includes a push-pull tube 41, the push-pull tube is movably accommodated in the lumen of the puncture needle tube 21, and is movably connected with the implant 3, so as to push the implant 3 out of the puncture needle tube 21 of the inner cavity.
  • the puncture needle tube 21 punctures the tissue, its inner cavity is guided by the guide channel 111 and obstructed by the tissue, and the inner cavity has a certain curvature, and the curvature may be irregular, so the push-pull tube 21 should be both soft and rigid to facilitate smooth passage. Puncture the lumen of the needle tube 21.
  • the push-pull tube 21 can be a hollow or solid tube or rod, such as PEEK tube, PI tube, PA tube, metal cutting tube, heat-treated nickel-titanium alloy tube, etc., and can be further preferably PI tube.
  • the implant 3 is used to be fixed on the papillary muscle of the left ventricle.
  • the implant 3 includes a spacer 31 and a suture 32 with a certain length connected to the spacer 31.
  • the spacer 31 is in frictional contact or clearance fit with the inner wall of the puncture needle tube 21, so that the spacer 31 can It is fixed in the lumen of the puncture needle tube 21, and is pushed by the push-pull tube 31 to pass through the lumen of the puncture needle tube 21.
  • the proximal end of the gasket 31 is provided with a locking position or at least one through hole, and the suture 32 is folded in half and hung on the locking position or connected to the through hole, so that the sewing The wire 32 is connected to the spacer 31 .
  • the spacer 31 in the initial state, can be stretched into a line shape or compressed into a smaller shape, and loaded into the lumen of the hollow puncture needle tube 21, and its proximal end abuts against the push-pull tube 41; the implant 3 and the push-pull tube 41 are delivered to the predetermined implantation site; the operator pushes the implant 3 out of the puncture needle tube 21 through the push-pull tube 41, and the implant 3 is released and resumes its natural unfolded state.
  • the outer diameter of the gasket 31 ranges from 0.5-0.75mm, and the length of the gasket 31 ranges from 4-9mm.
  • the outer diameter of gasket 31 can be 0.5mm, 0.55mm, 0.6mm, 0.65mm, 0.7mm, 0.75mm, etc.
  • the length of gasket 31 can be 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, etc. No limit.
  • a gasket 31 with an outer diameter of 0.75 mm and a length of 9 mm is preferably used, that is, the gasket 31 is a short hollow tube.
  • the gasket 31 is made of flexible and rigid materials, including but not limited to PEEK, PI, PA, stainless steel or nickel-titanium alloy.
  • nickel-titanium alloy is preferred, and the nickel-titanium alloy that has been heat-treated and quenched and tempered can have certain softness and certain rigidity.
  • the suture 32 is selected from biocompatible medical thread, such as at least one selected from PET, e-PTFE, and UHMWPE (ultra-high molecular weight polyethylene).
  • biocompatible medical thread such as at least one selected from PET, e-PTFE, and UHMWPE (ultra-high molecular weight polyethylene).
  • UHMWPE ultra-high molecular weight polyethylene
  • 3-0 gauge ultra-high molecular weight polyethylene sutures are used, which have higher biocompatibility properties and form-forming features that reduce the chance of post-implantation thrombosis.
  • the implant device with clamping and guiding functions further includes a handle 6, which is connected to the proximal end of the flexible sheath 14, including The housing and a plurality of control parts arranged in the housing, each control part is respectively connected to the proximal end of the clamping assembly 1, the proximal end of the puncture assembly 2 and the proximal end of the push-pull assembly 4, for controlling the clamping assembly 1.
  • Axial movement or circumferential rotation of the puncture assembly 2 and the push-pull assembly 4 .
  • the flexible sheath 14 is an adjustable bendable sheath
  • the handle 6 can also be provided with a bending control member to adjust the bending angle of the distal end of the flexible sheath 14, so that the flexible sheath 14 is easy to reach the target. anchor area.
  • the implant device with clamping and guiding function of the present application can also cooperate with the guide device 5 as a transcatheter interventional therapy system.
  • the guiding device 5 includes a guiding sheath and a guiding handle located at the distal end of the guiding sheath.
  • the implanting device is movably accommodated in the guiding sheath.
  • the guiding sheath is usually a hollow tube with a certain length and a bending function, and the distal end can be shaped and/or bent.
  • the guide sheath reaches the predetermined treatment site in the patient along the guide wire path, and then the guide handle is used to bend or rotate the guide sheath to make the distal end of the guide device 5 more Accurately target tissue to create an in vitro-in vivo channel.
  • the introducing device 5 and the guiding sheath can use existing adjustable curved sheaths, plastic sheaths, etc., which will not be repeated here.
  • the implant device can be pre-installed in the guide sheath and enter the body together with the guide sheath, or the guide sheath can be sent into the body first, and after adjusting the position of the distal end of the guide sheath, Then the distal end of the implantation device is passed through the proximal end of the guide sheath, and slowly pushed until the distal end of the implantation device reaches a predetermined position.
  • the first chuck 11 and the second chuck 12 themselves have a certain tension.
  • the second chuck 12 is far away from the first chuck 11.
  • the ends are far away from each other to form a certain opening distance, which is greater than the diameter of the papillary muscle.
  • the movable second clip 12 is squeezed by the distal opening of the guiding sheath, and the distal end of the second clip 12 approaches the distal end of the first clip 11, thereby shortening the distance between the second clip 12 and the first clip.
  • the suture 32 connected to the implant 3 is pulled outside the body to realize the fine adjustment of the position of the implant 3, so that the implant 3 can be adjusted from a position coaxial with the puncture needle tube 21 to It is perpendicular to the position of the puncture needle tube 21, so as to be attached to the surface of the tissue as an anchor.
  • the clamping assembly 1 first enters the body along the guide sheath in a closed state, and then withdraws the guide sheath or pushes the flexible sheath 14 after reaching the target area. , so that the clamping assembly 1 is released into the unfolded state. At this time, the distal ends of the second chuck 12 and the first chuck 11 are in the unfolded state. Adjust the clamping assembly 1 to the vicinity of the tissue to be clamped to ensure that the guiding device 5 end does not move, and the flexible sheath 1 is withdrawn, so that the clamping assembly 1 is pressed by the distal end of the guiding sheath and gradually closed. At this time, the second chuck 12 is pressed by the distal end of the guiding sheath, The first clamping head 11 generates clamping force to achieve clamping of the target area.
  • Step 1 As shown in Figure 10, both the implant 3 and the push-pull assembly 4 are accommodated in the inner cavity of the puncture assembly 2, and the puncture assembly 2 is inserted into the flexible sheath tube 14, and the flexible sheath tube 14 and the The clamping assembly 1 at the distal end is worn in the guiding sheath of the guiding device 5, and the guiding device 5 reaches the left atrium along the guide wire and the atrial septal puncture device (not shown in the figure). At this time, the clamping component 1 is closed state;
  • Step 2 As shown in Figure 11, keep the position of the distal end of the guiding sheath unchanged, and push the flexible sheath 14 to the distal end until the clamping assembly 1 protrudes from the distal end of the guiding sheath and is in a natural expansion state;
  • Step 3 As shown in Figure 12, push the flexible sheath 14 so that the clamping assembly 1 reaches the top of the papillary muscle, adjust the position of the distal end of the flexible sheath 14 and the clamping assembly 1, and make the first chuck 11 face the heart membrane wall, the second chuck 12 faces the heart chamber, and continues to push the flexible sheath 14 so that the clamping assembly 1 covers the top of the papillary muscle to the greatest extent; the flexible sheath 14 is withdrawn to turn the clamping assembly 1 into a closed state, realizing Apply force to the papillary muscle;
  • Step 4 As shown in Figure 13, make the puncture needle tube 21 protrude along the guide channel 111 of the first chuck 11 and puncture the papillary muscle until it penetrates the papillary muscle clamped in the tissue containing space; confirm with medical imaging equipment Whether the puncture is achieved at the expected position, if the puncture point is accurate, proceed to the next step; if the puncture point error is large, repeat the steps of clamping and/or puncturing;
  • the fifth step is to push the push-pull tube 41 to the distal end, so that the gasket 31 protrudes from the distal end of the puncture needle tube 21, and further adjust the position and state of the gasket 31 precisely by pulling the suture 32, and finally make the The gasket 31 is perpendicular to the axial direction of the push-pull tube 41;
  • Step 6 as shown in Figure 15 and Figure 16, withdraw the push-pull tube 41 and the puncture needle tube 21 to complete the implantation of the spacer 31 in the papillary muscle;
  • Step 7 As shown in Figure 17, the effect of puncture and implantation can be observed in real time through medical imaging equipment. After confirming that the expected effect is achieved, the guiding sheath is withdrawn and the clamping component 1 is released to restore the clamping component 1 to its natural state. In the unfolded state, no force is exerted on the papillary muscle, and then continue to withdraw the implant device to the top of the valve leaflet, then withdraw the implant device, and lead the suture 32 out of the body;
  • Step 8 As shown in Figure 18, implant one or more sutures 32 with spacers 31 at the anterior leaflet and/or posterior leaflet of the mitral valve, and implant the sutures 32 and the sutures 32 in the papillary muscle
  • the sutures 32 implanted on the leaflets are connected to adjust the tension between the mitral valve leaflets and the papillary muscles until the mitral valve regurgitation disappears or is reduced to the slightest state, and the two sets of sutures 32 are fixed and the excess parts are cut off , withdraw all instruments, and complete the artificial chord implantation process.
  • the process of implanting sutures and spacers in the anterior leaflet and/or posterior leaflet of the mitral valve can be performed by using the implanting device with clamping and guiding functions of the present application, or by using the existing The technique of chorda tendon implantation device is carried out, and this application is not limited.
  • the implant device of the present application can also be used in other transcatheter interventional operations, such as annuloplasty and valve edge-to-edge repair, as long as the tissue at the target area is clamped by the clamping assembly 1 first, For example, clamp any parts of the valve ring tissue, the leaflets of the mitral valve/tricuspid valve, the free wall of the ventricle, etc., and then puncture the tissue and implant the implant.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Cardiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Surgery (AREA)
  • Public Health (AREA)
  • Vascular Medicine (AREA)
  • Transplantation (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Pathology (AREA)
  • Reproductive Health (AREA)
  • Surgical Instruments (AREA)
  • Prostheses (AREA)

Abstract

一种带夹持导向功能的植入装置，包括夹持组件（1）、穿刺组件（2）、植入物（3）以及推拉组件(4)，夹持组件（1）包括可相对开合以定点夹持的第一夹头(11)和第二夹头(12)，第一夹头(11)设有导向通道(111)，穿刺组件（2）可活动地容纳在夹持组件（1）的内腔，并经由导向通道(111)穿刺组织，植入物（3）可活动地容纳于穿刺组件（2）的内腔，推拉组件(4)可活动地容纳于穿刺组件（2）的内腔且与植入物（3）抵接，用于推送植入物（3）。第一夹头(11)和第二夹头(12)可以夹持于目标锚定区域的组织，可避免因无夹持功能而出现的打滑、穿刺深度不足或锚定位置偏移等情况。并且，第一夹头(11)上设有导向通道(111)可将穿刺针精准导致目标锚定区域的组织，可获得较大的穿刺深度和较好的锚点位置。

Description

一种带夹持导向功能的植入装置
本申请要求于2021年12月31日提交至中国专利局、申请号为2021116757505、申请名称为“一种带夹持导向功能的植入装置”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本发明涉及医疗器械技术领域，涉及一种带夹持导向功能的植入装置。
背景技术
随着医疗技术的发展，介入式手术的使用日益普遍，其特点是通过在患者体表开设较小的操作窗口，将导管类器械沿着血管通道送达预定的治疗区域。通常情况下，器械通过在病灶处植入相应的植入物(如垫片、锚钉等)以达到治疗/修复的目的。
现有的植入装置通常包括植入物和输送系统，以人工腱索植入装置及经房间隔的二尖瓣人工腱索植入术为例，植入物包括位于瓣叶上的第一锚定件、位于乳头肌或心室壁上的第二锚定件、及连接于垫片和锚定件之间的人工腱索。首先控制输送系统经房间隔、穿过二尖瓣到达乳头肌，再控制输送系统远端的穿刺针头扎进乳头肌，推出第二锚定件并使其锚进乳头肌；然后释放人工腱索；后撤输送系统远端，再将第一锚定件植入在瓣叶表面，从而完成人工腱索的植入，实现对病变二尖瓣的修复/治疗。
然而，在将锚定件植入乳头肌组织的过程中，由于输送系统远端没有夹持功能，而且向远端推送植入物所需的推送力比较大，容易出现将穿刺针反推出穿刺点、穿刺针在组织表面打滑的风险，从而影响植入装置的锚定精度及锚定效果。
发明内容
为了克服上述现有技术所述的至少一种缺陷，本发明提供一种带夹持导向功能的植入装置，以解决现有植入装置的锚定精度不足和锚定效果较差的问题。
为解决上述问题，本发明实施例提供一种带夹持导向功能的植入装置，包括：
夹持组件，所述夹持组件包括可相对开合以定点夹持的第一夹头和第二夹头，所述第一夹头设有导向通道；
穿刺组件，所述穿刺组件可活动地容纳在所述夹持组件的内腔，并经由所述导向通道穿刺组织；
植入物，所述植入物可活动地容纳于所述穿刺组件的内腔；以及
推拉组件，所述推拉组件可活动地容纳于所述穿刺组件的内腔且与所述植入物抵接，用于推送所述植入物。
综上所述，本发明提供的一种带夹持导向功能的植入装置，与现有技术相比，至少具有如下技术效果：
本发明实施例提供的一种带夹持导向功能的植入装置，通过增加包括第一夹头和第二夹头的夹持组件，第一夹头和第二夹头可以精确定点夹持目标锚定区域的组织，并且在植入物释放后仍然可以微调位置，并通过第一夹头上设置的导向通道，对穿刺组件的穿刺方向进行导向，可以将穿刺组件精准导向至目标锚定区域的组织，避免穿刺针在组织表面打滑、穿刺深度不足或锚定位置偏移等情况，以实现精确定点穿刺及锚定。
附图说明
图1为本发明实施例的带夹持导向的植入装置与导引装置组装的结构示意图；
图2为本发明实施例的植入装置的夹持组件展开状态的结构示意图；
图3为本发明实施例的植入装置的夹持组件闭合收容于导引装置内的局部剖视图；
图4为本发明实施例的植入装置的夹持组件展开状态的局部剖视图；
图5为本发明实施例的植入装置的夹持组件、穿刺组件、植入物及推拉组件的结构分解示意图；
图6为图5中的夹持组件的结构示意图；
图7为图5中的夹持组件的第一夹头和第二夹头分离的结构示意图；
图8为图5中的穿刺针管的剖视图；
图9为图1中的导引装置的结构示意图；
图10至图18为本发明实施例的植入装置用于经导管二尖瓣腱索修复的使用过程示意图，其中：
图10为植入装置待穿刺的示意图；
图11为植入装置的夹持组件达到乳头肌的示意图；
图12为植入装置的夹持组件夹持于乳头肌的示意图；
图13为植入装置的夹持组件夹持于乳头肌且穿刺组件穿刺于乳头肌的示意图；
图14为植入装置的推拉管推出垫片的示意图；
图15为植入装置的推拉管后撤的示意图；
图16为植入装置的垫片植入在乳头肌的示意图；
图17为植入装置的夹持组件沿着导引鞘管撤出体内的示意图；
图18为瓣叶植入垫片、缝线牵拉在瓣叶和乳头肌之间的示意图。
其中，附图标记含义如下：
1、夹持组件；11、第一夹头；111、导向通道；112、第一齿牙；113、凸台；12、第二夹头；121、第二齿牙；122、夹持部；1221、支撑杆；123、凹槽；13、夹头连接件；14、柔性鞘管；2、穿刺组件；21、穿刺针管；3、植入物；31、垫片；32、缝线；4、推拉组件；41、推拉管；5、导引装置；6、手柄。
具体实施方式
为了更好地理解和实施，下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述。
在本发明的描述中，需要说明的是，术语“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。
除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在限制本发明。
在本发明的描述中，需要说明的是，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”、“设置在……上”应做广义理解，例如，可以是固定连接，也可以是可拆卸地连接，或者一体地连接；可以是机械连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通。在介入医疗器械领域，近端是指距离操作者较近的一端，而远端是指距离操作者较远的一端；轴向是指平行于医疗器械远端中心和近端中心连线的方向，径向是指沿直径 或半径的方向，径向与轴向相互垂直，周向是指绕中心轴线的圆周方向。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本发明中的具体含义。
参阅图1至图8，本发明实施例公开了一种带夹持导向功能的植入装置，用于精确定点地将植入物3输送至患者体内的预定位置并实现锚定。植入物3可以是锚钉、螺旋钉、心脏瓣膜夹钳、人工腱索、心室减容夹等用于心脏瓣膜疾病修复/治疗的器械。植入物3可由具有形状记忆功能的材料制成，具有自然状态下的展开状态(植入状态)，使用时可以拉伸成线条状并被装载至植入装置的内腔中。
带夹持导向功能的植入装置包括夹持组件1、穿刺组件2、植入物3及推拉组件4。夹持组件1包括可相对开合以定点夹持的第一夹头11和第二夹头12，第一夹头11设有导向通道111，穿刺组件2可活动地容纳在夹持组件1的内腔，并经由导向通道111穿刺组织，植入物3可活动地容纳于穿刺组件2的内腔，推拉组件4可活动地容纳于穿刺组件2的内腔且与植入物3抵接，用于推送植入物3。当植入装置的远端到达目标锚定区域后，夹持组件1的远端对预定穿刺点进行夹持，再将穿刺组件2沿导向通道111对预定穿刺点进行穿刺并将植入物3推出穿刺组件2的内腔，由于此时组织仍被夹持组件1夹持及固定，因此可继续对植入物3的位置进行微调，确认植入物3位于最佳的位置后，再松开夹持的组织，此时植入物3植入在理想的目标区域，撤出植入装置的其他组件，从而完成植入物3的植入。
本方案的带夹持导向功能的植入装置，由于第一夹头11和第二夹头12可以精确定点夹持目标锚定区域的组织，并且在植入物3释放后仍然可以微调位置，并通过第一夹头11上设置的导向通道111，供穿刺组件2穿过，以对穿刺组件2的穿刺方向进行导向，从而将穿刺组件2精准导向至目标锚定区域的组织，避免穿刺针在组织表面打滑、穿刺深度不足或锚定位置偏移等情况，以实现精确定点穿刺及锚定。
一些实施例中，考虑到穿刺点距离组织表面应有一定的穿刺深度，以提高植入物3植入后的锚定力，同时为避免穿刺组件2径直穿刺而刺伤或刺穿心脏，导向通道111为具有角度变化的通道。具体地，导向通道111朝远端同时朝第一夹头11的中轴线的方向倾斜延伸。如此设置，使得穿刺组件2在导向通道111的 引导下沿着一定的运动轨迹穿出，不仅可以获得较大的穿刺深度和较好的锚点位置，还可避免穿刺组件2径直穿刺导致的组织损伤。
第一夹头11和第二夹头12形成组织容纳空间，当两个夹头闭合后，组织被固定于该空间内。导向通道111的远端贯通至第一夹头11朝向第二夹头12的表面，穿刺组件2的远端经由导向通道111穿入第一夹头11与第二夹头12之间，此时由于组织被牢固地夹持于第一夹头11与第二夹头12之间的组织容纳空间，穿刺组件2由导向通道111穿出时会直接刺入目标区域，从而使得穿刺组件2可以精准定点地靶向目标区域组织。
导向通道111的入口处与出口处之间的夹角为α1，为了保证穿刺组件2尽量具有较大的穿刺深度和较好的锚点位置，同时避免穿刺组件2的穿刺行程过长而损伤周围组织，设定90°≤α1≤150°。其中，导向通道111的入口处与出口处之间的夹角α1可以为90°、100°、110°、120°、130°、140°以及150°等，在此不对其进行限定，本实施例优选采用导向通道111的入口处与出口处之间的夹角α1为120°。
考虑到导向通道111的入口处与出口处之间的夹角较大，也即导向通道111的角度变化较小，优选地，导向通道111的位于第二夹头12的中段至第二夹头12的远端的位置发生上述夹角的变化。
更进一步地，为了保证穿刺组件2能够在导向通道111中顺畅地通过，同时限制穿刺组件2在导向通道111中的运动轨迹，导向通道111与穿刺组件2之间的单边间隙范围为0.1mm-0.5mm。其中，导向通道111与穿刺组件2之间的单边间隙可以为0.1mm、0.2mm、0.3mm、0.4mm、0.5mm等，在此不对其进行限定，本实施例优选采用导向通道111与穿刺组件2之间的单边间隙为0.1mm。
第一夹头11和第二夹头12之间的近端相连，远端可以开合，使得夹持组件1通过第一夹头11和第二夹头12之间的相对运动来实现对组织的夹持固定。本实施例中，第一夹头11为固定夹头，第二夹头12为活动夹头，即，第一夹头11的和第二夹头12的近端形状相适配且互相连接，第二夹头12的远端可相对第一夹头11的远端展开或靠拢，通过将第二夹头12压向第一夹头11来夹持组织。在另一些实施例中，第一夹头11为活动夹头，第二夹头12为固定夹头，即通过将第一夹头11压向第二夹头12来夹持组织。
由于组织表面的黏滑特性，以及处于不断的运动状态，一些实施例中，为了在夹持过程中增大对组织的夹持力，第一夹头11的远端沿朝向第二夹头12的远端的方向延伸形成第一齿牙112，第二夹头12的远端沿朝向第一夹头11的远端的方向延伸形成第二齿牙121，第一齿牙112和第二齿牙121用于夹持组织。
进一步地，为了进一步提高第一夹头11和第二夹头12之间的夹持力，第一齿牙112的数量为两个，两个第一齿牙112平行并列设置在第一夹头11的远端的相对两侧，第二齿牙121的数量为两个，两个第二齿牙121平行并列设置在第二夹头12的远端的相对两侧，通过两个第一齿牙112和两个第二齿牙121配合夹持组织。在其中一些实施例中，两个第一齿牙112和两个第二齿牙121沿着第一夹头11和第二夹头12的轴向交错设置，使得第一夹头11和第二夹头12闭合后，第一夹头11和第二夹头12面对彼此的夹持面相适配，以减小夹持组件1的外径，利于输送；并且第一齿牙112和第二齿牙121交错嵌设，可以牢固地卡住黏滑的组织，增加夹持力，防止组织滑脱。
一些实施例中，为了避免第一夹头11和第二夹头12在工作过程中钩挂天然腱索，第一齿牙112靠近第一夹头11的近端的侧边被构造成弧形，具体地，第一齿牙112靠近第一夹头11的近端的侧边被构造成内凹的弧形。其弧形角度为α2，α2＞90°，其中，α2可以为90°、100°、110°、120°、130°、140°、150°等，本实施例优选α2＝150°，
同理，第二齿牙121靠近第二夹头12的近端的侧边被构造成弧形，第二齿牙121靠近第二夹头12的近端的侧边被构造成内凹的弧形。其弧形角度为α3，α3＞90°，其中，α3可以为90°、100°、110°、120°、130°、140°、150°等，本实施例优选α3＝150°。
一些实施例中，为避免第一齿牙112和第二齿牙121的末端在相对开合或夹持的过程中损伤组织，优选地，第一齿牙112靠近第一夹头11的远端的侧边被构造成圆滑的弧形，第二齿牙121靠近第二夹头12的远端的侧边被构造成圆滑的弧形。
参见图4，一些实施例中，当第一夹头11和第二夹头12闭合后，为了使得第一齿牙112和第二齿牙121之间的空隙允许穿刺组件2通过，同时保证第一齿牙112和第二齿牙121对组织夹持牢靠且不损伤组织，第一齿牙112和第二齿牙 121的高度h3均应满足：0.2mm≤h3≤2.0mm，两第一齿牙112的间距和两第二齿牙121的间距h4均应满足：0.5mm≤h4≤2.5mm。其中，h3可以为0.2mm、0.4mm、0.6mm、0.8mm、1.0mm、1.2mm、1.4mm、1.6mm、1.8mm、2.0mm等，在此不对其进行限定，本实施例以h3为1.2mm进行示例。其中h4可以为0.5mm、1.0mm、1.5mm、2.0mm、2.5mm等，在此不对其进行限定，本实施例以h4为2.0mm进行示例。可以理解的是，为了保证第一夹头11和第二夹头12的夹持面相适配，第一齿牙112和第二齿牙121的高度一致，两第一齿牙112的间距和两第二齿牙121的间距也应相同。
一些实施例中，为了使得夹持组件1在夹持过程中有足够的稳定性以及与组织有足够的接触面积，第二夹头12包括具有一定面积的夹持部122，具体地，第二夹头12的近端和远端均为闭合结构，由近端向远端发散，在中段某处达到最大程度展开，然后再向远端逐渐汇聚，从而形成具有一定面积的夹持部122。即，沿第二夹头12的近端至远端的方向上，夹持部122的面积先增大后减小，从而使得第二夹头12具备一定的夹持面积，能提高第二夹头12与第一夹头11闭合后的夹持效果。
其中，夹持部122的具体形状可以是圆形、三角形、菱形、矩形、椭圆形、多边形等任意规则或不规则形状或前述任意形状的组合。本实施例采用菱形，且菱形的两侧部为倒圆角设计，这是由于菱形结构更易被压缩，回撤至输送装置内的阻力更小。
具体地，夹持部122包括间隔设置的两支撑杆1221，沿第二夹头12的近端至远端方向上，两支撑杆1221的间距先增大后减小，两支撑杆1221先由第二夹头12的近端向远端发散，在中段某处达到最大程度展开，然后再向第二夹头12的远端逐渐汇聚，从而形成具有一定面积的夹持部122。采用两支撑杆1221间隔设置形成夹持部122的设计方式，在增加夹持面积的同时，不影响第二夹头12的收容至输送系统的过程。
可以理解的是，夹持部122的夹持面积与两侧支撑杆1221的间距有关，间距越大，夹持面积及夹持力越大，但同时会增加第二夹头12被后撤至收容于输送系统中所需的拉力；此外，回收第二夹头12所需的拉力也与每根支撑杆1221与第二夹头12的轴向之间的夹角δ有关，夹角δ越大，说明夹持部122与鞘管 轴向之间的夹角越大，所需的回收拉力越大。因此，为了在增加夹持面积的同时，不影响第二夹头12的收容，两支撑杆1221的间距范围为7mm-8mm，两支撑杆1221与第二夹头12的近端之间的夹角δ应满足：90°≤δ≤150°。其中，两支撑杆1221之间的间距可以为7mm、7.5mm以及8mm等等，在此不对其进行限定。其中，两支撑杆1221与第二夹头12的近端之间的夹角δ可以为90°、100°、110°、120°、130°、140°、150°等，在此不对其进行限定。
一些实施例中，为了保证夹持组件1在弯曲的血管中的通过性，夹持组件1的刚性长度需要小于所经过血管的曲率半径。本实施例中，采用经房间隔的介入路径，为了便于夹持组件1经导管顺利到达左心房，夹持组件1的刚性长度L应小于经房间隔的导管曲率半径，结合现有技术中常用的经房间隔导管尺寸，设置5mm≤L≤25mm，优选，L＝22mm。
夹持组件1对组织的夹持力与夹持的有效深度有关，本申请中，夹持的有效深度指：第一夹头11和第二夹头12闭合时位于两个夹头共同长度的部分的轴向尺寸，理论上，在夹持组件1的整体长度不变的前提下，有效深度越大，夹持力越强。由于夹持组件1通过一对夹头的相对开合来实现夹持，若其中一个夹头长度大于另一个夹头的长度，就会形成一段多余长度，这段多余长度会影响夹持组件1的有效深度并影响力的传导。如前所述，本实施例中，第二夹头12为活动夹头，第一夹头11为固定夹头，即通过将第二夹头12压向第一夹头11来实现对组织的夹持固定。因此，为尽量增加夹持的有效深度及保证第二夹头12被压向第一夹头11贴靠时的受力均匀，在第一夹头11和第二夹头12相对展开的自然状态下，第一夹头11的远端和第二夹头12的远端的位置平齐。
进一步地，第二夹头12相对于第一夹头11展开，因此，为了在第一夹头11和第二夹头12相对展开的自然状态下，第一夹头11的远端和第二夹头12的远端的位置能够平齐，因此第二夹头12的长度大于第一夹头11的长度。如前所述，夹持组件1的刚性长度L应小于经房间隔的导管曲率半径，具体应满足5mm≤L≤25mm，因此，第二夹头12与第一夹头11的长度范围均为5-25mm。本实施例中，第二夹头12长度为20mm，第一夹头11长度为15mm。可以理解的是，在另一些实施例中，第一夹头11为活动夹头，而第二夹头12为固定夹头，即通过将第一夹头11压向第二夹头12来实现对组织的夹持固定，则为了保证在第一夹 头11和第二夹头12相对展开的自然状态下，第一夹头11的远端和第二夹头12的远端的位置平齐，第一夹头11的长度应大于第二夹头12的长度。
一些实施例中，在夹头组件1的展开状态下，第一夹头11的圆弧最高处与第二夹头12的圆弧最低处之间的垂直距离为h1，第一夹头11的圆弧最高处与第二夹头12的圆弧最高处之间的垂直距离为h2。其中，在夹持使用过程，h1决定了对组织所能夹持的最大距离，h1越大，能夹持的组织厚度越大，而h2在满足h1的夹持距离的基础上的需要尽量小，继而降低对组织的损伤或者钩挂腱索。在本实例中，以对乳头肌夹持为例，8mm≤h1≤15mm，这样基本能实现对所有乳头肌的厚度进行夹持，其中，h1可以为8mm、9mm、10mm、11mm、12mm、13mm、14mm或15mm等，在本实例中优选h1＝10mm；而为保证第二夹头12具有足够的刚性实现夹持动作，9mm≤h2≤17mm，其中，h2可以为9mm、10mm、11mm、12mm、13mm、14mm、15mm、16mm或17mm等，在本实例中优选h2＝12.5mm。
一些实施例中，第一夹头11的近端设有凹槽123和凸台113二者中的其中一个，第二夹头12的近端设有凹槽123和凸台113二者中的另一个，凹槽123和凸台113形状相适配且互相连接。凹槽123和凸起的配合连接可以限制第二夹头12与第一夹头11的相对运动，确保第一夹头11和第二夹头12彼此不发生相互周向旋转和轴向位移，防止出现夹持不稳或者夹持力度不够的情况。在一些实施例中，第一夹头11的近端设有凹槽123，且第二夹头12的近端设有凸台113；在另一些实施例中，第一夹头11的近端设有凸台113且第二夹头12的近端设有凹槽123，本实施例以第一夹头11设有凸台113，第二夹头12设有凹槽123进行示例。
进一步地，为了保证第一夹头11和第二夹头12配合顺畅，既能相对开合又不发生晃动或摇摆，凹槽123与凸台113间隙配合，且凹槽123与凸台113的单边间隙范围为0.05mm≤B2≤0.1mm。其中，凹槽123与凸台113之间的单边间隙B2可以为0.05mm、0.06mm、0.07mm、0.08mm、0.09mm、0.1mm等，在此不对其进行限定，本实施例以凹槽123与凸台113的单边间隙B2为0.05mm进行示例。
进一步地，为了保证第一夹头11上的凸台113和第二夹头12上的凹槽123配合牢靠同时不影响第一夹头11和第二夹头12的顺畅开合，凹槽123和凸台113之间的配合深度范围为0.5mm-2mm。其中，凹槽123与凸台113之间的配合 深度可以为0.5mm、1.0mm、1.5mm、2.0mm等，在此不对其进行限定，本实施例以凹槽123与凸台113之间的配合深度为1.5mm进行示例。
优选地，第二夹头12的近端外径与第一夹头11近端外径相等，从而避免在外径差的位置出现台阶，避免夹持组件1收容至输送系统的过程中该台阶损伤输送系统，同时避免血液积聚在台阶处形成血栓。可以理解的是，在其他可选的实施方式，还可以采用第一夹头11和第二夹头12的外径不相等的设计方式，在此不对其进行限定。
一些实施例中，第一夹头11为固定夹头，由刚性材料或具有形状记忆功能的材料制成，第二夹头12为活动夹头，由具有形状记忆功能的材料制成。如此设置，可以预先将第二夹头12设置成在自然状态下可以相对于第一夹头11展开，以使得第一夹头11和第二夹头12可以夹持目标锚定区域的组织。并且，第二夹头12的夹持部122可以受压后对合成线条状被装载至输送系统中。
可选地，第二夹头12材质为具有形状记忆功能的材料，本实施例采用镍钛合金。先将镍钛合金管材通过激光切割，制备为前述的形状再经过加热定型，从而能维持特定形状且具有超弹性，既能受压被收容在鞘管中输送，也能展开后通过一定的夹持面积来夹持组织；第一夹头11使用刚性材料制作，以在夹持过程中提供较好的支撑力，避免夹持组件1整体摆动，如304不锈钢、316不锈钢、钛合金、钽、ABS或PC等，本实施例优先选用钽，其在超声下具有良好的显影特性，可以显示夹持组件1与组织的相对位置。
一些实施例中，夹持组件1还包括柔性鞘管14，第一夹头11与第二夹头12同轴配合连接于柔性鞘管14的远端，穿刺组件2可活动地穿装于柔性鞘管14中，柔性鞘管14的内腔与导向通道111相连通，穿刺组件2经由柔性鞘管14的内腔穿入导向通道111，并进入组织容纳空间。其中，第一夹头11固定设于柔性鞘管14的远端，第二夹头12活动设于柔性鞘管14的远端。
柔性鞘管14为具有一定长度的中空柔性管体，穿刺组件2可活动地穿过柔性鞘管14的内腔。柔性鞘管14常用的形式为金属切割管、多层复合管等。当柔性鞘管14为不锈钢切割管时，与第一夹头11和/或第二夹头12可采用焊接、粘接等方式连接；当柔性鞘管14为多层复合管时，多层复合管通常为三层结构，由里到外分别为内膜(PTFE材料)、编织网(不锈钢丝或钨丝编织而成)以及 外膜(PEBAX材料)，此时柔性鞘管14与与第一夹头11和/或第二夹头12可采用胶水粘接或热熔等方式连接。本实施例中柔性鞘管14使用多层复合管体。
一些实施例中，夹持组件1还包括夹头连接件13，夹头连接件13连接于柔性鞘管14的远端，第一夹头11与第二夹头12连接于夹头连接件13的远端，从而实现第一夹头11和第二夹头12以及柔性鞘管14之间的连接。
进一步地，夹头连接件13为中空结构的管体，可以采用不锈钢等金属材料制作，也可以采用ABS等高分子材料制作。夹头连接件13与第一夹头11、第二夹头12和柔性鞘管14之间可以分别通过焊接、粘接、一体成型、熔融、过盈配合等方式连接，在此不对其进行限定。
一些实施例中，穿刺组件2包括中空的穿刺针管21，穿刺针管21可活动地穿装于柔性鞘管14的内腔中，用于容纳并通过植入物3和推拉组件4。当收容有穿刺针管21的柔性鞘管14通过弯曲的血管输送，并到达目标区域后，穿刺针管21依次经由柔性鞘管14的内腔及第一夹头11的导向通道111，沿着一定的弧线轨迹穿出，以穿刺位于组织容纳空间中的组织。
进一步地，穿刺针管21的远端为尖端，穿刺针管21应同时具有一定的柔性及刚性，其刚性大于体内组织内膜，以便于穿刺组织。
对于穿刺针管21这类具有一定轴向长度及截面积的管体，通常要求其具备一定的柔顺性及支撑性，从而既能在弯曲的血管中顺利通过，又能在穿刺组织时不发生弯折或打滑。截面的惯性矩I值是衡量截面抗弯能力的一个几何参数，I值越小，管体的柔顺性就越强，能达到的弯曲半径就越小，对血管路径的适应性越强。如前所述，穿刺针管21为中空结构，其截面呈空心圆形，通过空心圆截面惯性矩I的公式：I＝π(D^4-d^4)/64可知，穿刺针管21的管径越小，惯性矩I越小，穿刺针管21的弯曲半径越小，对血管路径的适应性越强，但是与此同时，管材的支撑性及穿刺力会相应降低。本实施例中，为了同时保证穿刺针管21在血管中的通过性及对组织的穿刺力，穿刺针管21的外径范围为0.5mm-2.0mm，穿刺针管21的内径范围为0.2mm-1.8mm。其中，穿刺针管的外径范围可以为0.5mm、1.0mm、1.5mm、2.0mm、2.5mm等，穿刺针管21的内径可以为0.2mm、0.4mm、0.6mm、0.8mm、1.0mm、1.2mm、1.4mm、1.6mm、1.8mm等，在此不对其进行限定，本实施例优选穿刺针管21的外径为1.0mm，穿刺针管21的内径为0.8mm。
可选地，穿刺针管21的常用管材类型有PEEK管、PI管、PA管、金属切割管，热处理过的镍钛合金管等，本实施例中，穿刺针管21材质优选PEEK管，其在高温下具有可塑性，由此，通过预先高温塑形处理，使穿刺针管21靠近远端的部分具备与导向通道111相近的形状，能更顺应地通过导向通道111出针。穿刺针管沿着导向通道111限制的运动轨迹出针，可形成一定的出针角度，避免穿刺行程过长，损伤周围组织。其中，出针角度与导向通道111的入口处与出口处之间的夹角α1相同，范围为90°-150°，本实施例中为120°。
一些实施例中，推拉组件4包括推拉管41，推拉管可活动地容纳在穿刺针管21的内腔，并与植入物3之间可活动连接，从而将植入物3推送出穿刺针管21的内腔。由于穿刺针管21在穿刺组织后，其内腔经过导向通道111的导向及组织阻碍，内腔具有一定的曲率，且曲率可能不规则，因此推拉管21应兼具软性及刚性以便于顺利经过穿刺针管21的内腔。推拉管21可以是中空或实心的管体或杆体，如PEEK管、PI管、PA管、金属切割管、热处理过的镍钛合金管等，可进一步优选PI管。
本实施例中，植入物3用于固定在左心室乳头肌上。具体地，植入物3包括垫片31和与垫片31相连的具有一定长度的缝线32，垫片31与穿刺针管21的内壁之间摩擦接触或间隙配合，以使得垫片31既可以固定在穿刺针管21的内腔中，并被推拉管31推送从穿刺针管21的内腔中穿行。
进一步地，为了实现垫片31和缝线32的连接固定，垫片31的近端设有卡位或者至少一个通孔，缝线32对折后悬挂于卡位或者连接于通孔，从而将缝线32连接于垫片31。具体地，在初始状态下，垫片31可以拉伸成线条状或者压缩成较小形态，并被装载至中空的穿刺针管21的内腔中，其近端抵接推拉管41；植入物3和推拉管41被输送到预定的植入位点；操作者通过推拉管41将植入物3自穿刺针管21中推出，植入物3释放并恢复自然展开状态。
更进一步地，尽管垫片31的外径越大，长度越长，其在组织内的锚定力就越大，但由于垫片31需要经过穿刺针管21完成穿刺后的弯曲内腔和第一夹头11的导向通道111，而尺寸过大的垫片31的通过性较差，因此，垫片31的外径范围为0.5-0.75mm，垫片31的长度范围为4-9mm。其中，垫片31的外径可以为0.5mm、0.55mm、0.6mm、0.65mm、0.7mm、0.75mm等，垫片31的长度可以为4mm、 5mm、6mm、7mm、8mm、9mm等，具体不做限定。本实施例优选采用外径为0.75mm、长度为9mm的垫片31，即，垫片31为一中空的短圆管。
可选地，为了垫片31能够顺利通过导向通道111，垫片31由兼具柔性及刚性的材料制成，包括但不限于PEEK、PI、PA、不锈钢或镍钛合金。本实施例优选镍钛合金，经过热处理和调质处理的镍钛合金，可具有一定的柔软性和一定的刚性。
可选地，缝线32选用符合生物相容性的医用丝线，例如选自PET、e-PTFE、UHMWPE(超高分子量聚乙烯)中的至少一种。本实例使用3-0规格超高分子量聚乙烯缝线，其生物相容特性更高，同时其成形特征也可降低植入后血栓形成的几率。
在其中一些实施例中，为了便于操作者的握持和在体外远程控制前述各组件，带夹持导向功能的植入装置还包括手柄6，手柄6连接于柔性鞘管14的近端，包括壳体和设置于壳体中的多个控制件，每个控制件分别对应连接至夹持组件1的近端、穿刺组件2的近端及推拉组件4的近端，用于控制夹持组件1、穿刺组件2及推拉组件4的轴向运动或周向旋转。在其中一些实施例中，柔性鞘管14是可调弯鞘管，则手柄6上还可以设置调弯控制件，从而调整柔性鞘管14远端的弯曲角度，使得柔性鞘管14易于到达目标锚定区域。
同时参见图1及图9，一些实施例中，本申请的带夹持导向功能的植入装置还可以和导引装置5共同配合，作为一种经导管介入治疗系统。导引装置5包括导引鞘管及位于导引鞘管远端的导引手柄。植入装置可活动地容纳于导引鞘管内。导引鞘管通常是具有一定长度并具有调弯功能的中空管体，远端可以进行塑形和/或调弯。在手术过程中，先将导引鞘管沿着导丝路径到达患者体内的预定治疗部位，再通过导引手柄对对导引鞘管的调弯或旋转操作，使导引装置5远端更准确地指向组织，从而建立体外-体内的通道。导引装置5及导引鞘管可以使用现有的可调弯鞘管、塑形鞘管等，在此不再赘述。可以理解的是，植入装置可以预先穿装在导引鞘管内和导引鞘管共同进入体内，也可以先将导引鞘管送入体内，调整好导引鞘管远端的位置后，再将植入装置的远端经由导引鞘管的近端穿入，并缓慢推送直至植入装置的远端到达预定位置。
以下对本申请的植入装置的植入原理及过程进行详细的说明：
在夹头组件1初始的自然展开状态下，第一夹头11、第二夹头12本身具有一定的张力，当没有外力压迫迫使其产生形变，第二夹头12与第一夹头11远端之间相互远离，形成一定的张开距离，其张开距离大于乳头肌直径。当第二夹头12和第一夹头11接近需要夹持的组织后，保持夹持组件1的位置不动，控制导引鞘管往远端运动以挤压夹持组件1，此时可活动的第二夹头12在导引鞘管的远端开口挤压下，第二夹头12的远端向第一夹头11的远端靠近，从而缩短第二夹头12与第一夹头11之间的距离，而原先处于夹持组件1之间的组织被牢靠地被夹持，然后再推动穿刺组件2的穿刺针管21经过柔性鞘管14内腔及导向通道111穿出进行穿刺、再通过推送组件4的推送管41将植入物3经由穿刺针管21推出，使得植入物3释放即可。
当植入物3被释放后，在体外扯动与植入物3连接的缝线32，实现植入物3的位置微调，使植入物3能从与穿刺针管21同轴的位置调整至垂直于穿刺针管21的位置，从而作为锚定件贴靠在组织表面。
进一步地，为了便于器械经导管引进体内，实际使用过程中，夹持组件1首先以闭合状态沿着导引鞘管进入体内，到达目标区域后再后撤导引鞘管或推动柔性鞘管14，使得夹持组件1释放成展开状态，此时第二夹头12和第一夹头11远端处于展开状态，将夹持组件1调整至需要夹持的组织附近，保证导引装置5远端不动，后撤柔性鞘管1，使夹持组件1被导引鞘管的远端压迫并逐渐闭合，此时第二夹头12在导引鞘管的远端的挤压下，与第一夹头11产生夹持力，实现对目标区域的夹持。
请一并参阅图10至图18，以下通过二尖瓣腱索修复为例，阐述本申请的一种带夹持导向功能的植入装置的使用过程：
第一步：如图10所示，将植入物3及推拉组件4均收容在穿刺组件2的内腔中，穿刺组件2穿装在柔性鞘管14中，柔性鞘管14及设于其远端的夹持组件1穿装在导引装置5的导引鞘管内，导引装置5沿着导丝及房间隔穿刺装置(图未示出)到达左心房，此时夹持组件1为闭合状态；
第二步：如图11所示，保持导引鞘管的远端位置不变，向远端推送柔性鞘管14，直至夹持组件1自导引鞘管的远端伸出并处于自然展开状态；
第三步：如图12所示，推动柔性鞘管14，使夹持组件1到达乳头肌顶部， 调整柔性鞘管14远端及夹持组件1的位置，使第一夹头11朝向心脏内膜壁，第二夹头12朝向心脏腔室，继续推动柔性鞘管14，使夹持组件1最大程度覆盖乳头肌顶部；后撤柔性鞘管14，使夹持组件1转为闭合状态，实现对乳头肌施力夹持；
第四步：如图13所示，使穿刺针管21沿着第一夹头11的导向通道111伸出并穿刺乳头肌，直至贯穿夹持在组织容纳空间内的乳头肌；通过医学影像设备确认是否实现对预期位置的穿刺，如果穿刺点准确，进行下一步；如果穿刺点误差较大，可重复夹持和/或穿刺的步骤；
第五步，如图14所示，向远端推送推拉管41，使垫片31自穿刺针管21的远端伸出，通过拉扯缝线32，进一步精确调整垫片31位置和状态，最后使得垫片31与推拉管41的轴向垂直；
第六步，如图15及图16所示，后撤推拉管41和穿刺针管21，完成垫片31在乳头肌的植入；
第七步：如图17所示，可通过医学影像设备对穿刺和植入效果实时观察，确认实现预期效果之后，后撤导引鞘管，释放夹持组件1，使夹持组件1恢复自然展开状态，不再对乳头肌施力，然后继续后撤植入装置至瓣叶上方，然后撤出植入装置，并将缝线32引出至体外；
第八步：如图18所示，在二尖瓣前叶和/或后叶植入一根或多根带有垫片31的缝线32，并将植入在乳头肌的缝线32和植入在瓣叶上的缝线32连接，以调整二尖瓣瓣叶与乳头肌的张力，直至二尖瓣反流消失或减轻至最轻微的状态，固定两组缝线32并切断多余部分，撤出所有器械，完成人工腱索植入过程。
可以理解的是，第八步中，在二尖瓣前叶和/或后叶植入缝线和垫片的过程可以利用本申请的带夹持导向功能的植入装置进行，也可以利用现有技术的腱索植入装置进行，本申请不做限定。
可以理解的是，本申请的植入装置也可以用于其他经导管介入手术，例如，瓣环成形术、瓣膜缘对缘修复术，只要先利用夹持组件1夹持目标区域处的组织，例如，夹持瓣环组织的任意几处，二尖瓣/三尖瓣的瓣叶，心室游离壁等部位，再穿刺组织并植入植入物即可。
本发明方案所公开的技术手段不仅限于上述实施方式所公开的技术手段，还 包括由以上技术特征任意组合所组成的技术方案。应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也视为本发明的保护范围。

Claims (30)

  1. 一种带夹持导向功能的植入装置，夹持组件，所述夹持组件包括可相对开合以定点夹持的第一夹头和第二夹头，所述第一夹头设有导向通道；
    穿刺组件，所述穿刺组件可活动地容纳在所述夹持组件的内腔，并经由所述导向通道穿刺组织；
    植入物，所述植入物可活动地容纳于所述穿刺组件的内腔；以及
    推拉组件，所述推拉组件可活动地容纳于所述穿刺组件的内腔且与所述植入物抵接，用于推送所述植入物。
  2. 根据权利要求1所述的带夹持导向功能的植入装置，其特征在于，所述导向通道朝远端同时朝所述第一夹头的中轴线的方向倾斜延伸。
  3. 根据权利要求1所述的带夹持导向功能的植入装置，其特征在于，所述导向通道的远端贯通至第一夹头朝向所述第二夹头的表面，所述穿刺组件的远端经由所述导向通道穿入所述第一夹头与所述第二夹头之间。
  4. 根据权利要求1所述的带夹持导向功能的植入装置，其特征在于，所述导向通道与所述穿刺组件之间的单边间隙范围为0.1mm-0.5mm。
  5. 根据权利要求1所述的带夹持导向功能的植入装置，其特征在于，所述导向通道的入口处与出口处之间的夹角为α1，90°≤α1≤150°。
  6. 根据权利要求1所述的带夹持导向功能的植入装置，其特征在于，所述夹持组件还包括柔性鞘管，所述第一夹头与所述第二夹头同轴配合连接于所述柔性鞘管的远端，所述穿刺组件可活动地穿装于所述柔性鞘管中，所述柔性鞘管的内腔与所述导向通道相连通。
  7. 根据权利要求6所述的带夹持导向功能的植入装置，其特征在于，所述第一夹头固定设于所述柔性鞘管的远端，所述第二夹头活动设于所述柔性鞘管的远端，所述第一夹头的和所述第二夹头的近端形状相适配且互相连接，所述第二夹头的远端可相对所述第一夹头的远端展开或靠拢以夹持组织。
  8. 根据权利要求7所述的带夹持导向功能的植入装置，其特征在于，所述第一夹头由刚性材料或具有形状记忆功能的材料制成，所述第二夹头由具有形状记忆功能的材料制成。
  9. 根据权利要求8所述的带夹持导向功能的植入装置，其特征在于，在所述第二夹头的展开状态下，所述第一夹头的圆弧最高处与所述第二夹头的圆弧最低处之间的垂直距离为h1，8mm≤h1≤15mm，所述第一夹头的圆弧最高处与所述第二夹头的圆弧最高处之间的垂直距离为h2，9mm≤h3≤17mm。
  10. 根据权利要求6所述的带夹持导向功能的植入装置，其特征在于，所述第一夹头的远端沿朝向所述第二夹头的远端的方向延伸形成第一齿牙，所述第二夹头的远端沿朝向所述第一夹头的远端的方向延伸形成第二齿牙，所述第一齿牙和所述第二齿牙用于夹持组织。
  11. 根据权利要求10所述的带夹持导向功能的植入装置，其特征在于，所述第一齿牙靠近所述第一夹头的近端的侧边被构造成弧形，其弧形角度为α2，α2＞90°；
    所述第二齿牙靠近所述第二夹头的近端的侧边被构造成弧形，其再为α3，α3＞90°。
  12. 根据权利要求11所述的带夹持导向功能的植入装置，其特征在于，
    所述第一齿牙靠近所述第一夹头的远端的侧边被构造成圆弧形；
    所述第二齿牙靠近所述第二夹头的远端的侧边被构造成圆弧形。
  13. 根据权利要求10所述的带夹持导向功能的植入装置，其特征在于，所述第一齿牙的数量为两个，两个所述第一齿牙平行并列设置在所述第一夹头的远端的相对两侧，所述第二齿牙的数量为两个，两个所述第二齿牙平行并列设置在所述第二夹头的远端的相对两侧。
  14. 根据权利要求13所述的带夹持导向功能的植入装置，其特征在于，所述第一齿牙和所述第二齿牙的高度h3均满足：0.2mm≤h3≤2.0mm；
    相邻两所述第一齿牙的间距和两所述第二齿牙的间距h4均满足：0.5mm≤h4≤2.5mm。
  15. 根据权利要求1所述的带夹持导向功能的植入装置，其特征在于，所述第二夹头包括夹持部，沿所述第二夹头的近端至远端的方向上，所述夹持部的夹持面积先增大后减小。
  16. 根据权利要求15所述的带夹持导向功能的植入装置，其特征在于，所述夹持部包括间隔设置的两支撑杆，沿所述第二夹头的近端至远端方向上，所述两支撑杆的间距先增大后减小。
  17. 根据权利要求16所述的带夹持导向功能的植入装置，其特征在于，所述两支撑杆的间距范围为7mm-8mm，所述两支撑杆与所述第二夹头的近端之间的夹角为δ，90°≤δ≤150°。
  18. 根据权利要求6所述的带夹持导向功能的植入装置，其特征在于，所述夹持组件的刚性长度范围为L，5mm≤L≤25mm。
  19. 根据权利要求18所述的带夹持导向功能的植入装置，其特征在于，在所述第一夹头和所述第二夹头相对展开的自然状态下，所述第一夹头的远端和所述第二夹头的远端的位置平齐。
  20. 根据权利要求6所述的带夹持导向功能的植入装置，其特征在于，在所述第一夹头和所述第二夹头闭合后，所述第一夹头和所述第二夹头的远端外径之和小于所述柔性鞘管的内径。
  21. 根据权利要求6所述的带夹持导向功能的植入装置，其特征在于，所述第一夹头的近端设有凹槽和凸台二者中的其中一个，所述第二夹头的近端设有凹槽和凸台二者中的另一个，所述凹槽和凸台形状相适配且互相连接。
  22. 根据权利要求21所述的带夹持导向功能的植入装置，其特征在于，所述凹槽与 所述凸台间隙配合，所述凹槽与所述凸台之间的单边间隙范围为0.05mm-0.1mm；
    所述凹槽和所述凸台之间的配合深度范围为0.5mm-2mm。
  23. 根据权利要求6所述的带夹持导向功能的植入装置，其特征在于，所述夹持组件还包括夹头连接件，所述夹头连接件连接于所述柔性鞘管的远端，所述第一夹头与所述第二夹头连接于所述夹头连接件的远端。
  24. 根据权利要求1所述的带夹持导向功能的植入装置，其特征在于，所述穿刺组件包括中空的穿刺针管，所述穿刺针管的外径范围为0.5mm-2.0mm，所述穿刺针管的内径范围为0.2mm-1.8mm。
  25. 根据权利要求1所述的带夹持导向功能的植入装置，其特征在于，所述植入物包括垫片和与所述垫片相连的具有一定长度的缝线，所述垫片与所述穿刺针管的内壁之间摩擦接触或间隙配合。
  26. 根据权利要求25所述的带夹持导向功能的植入装置，其特征在于，所述垫片的近端设有卡位或者至少一个通孔，所述缝线对折后悬挂于所述卡位或者连接于所述通孔。
  27. 根据权利要求25所述的带夹持导向功能的植入装置，其特征在于，所述垫片的外径范围为0.5mm-0.75mm，所述垫片的长度范围为4mm-9mm。
  28. 根据权利要求25所述的带夹持导向功能的植入装置，其特征在于，所述垫片由兼具柔性及刚性的材料制成，包括但不限于PEEK、PI、PA、不锈钢或镍钛合金。
  29. 根据权利要求25所述的带夹持导向功能的植入装置，其特征在于，所述缝线选自PET、e-PTFE、UHMWPE中的至少一种。
  30. 根据权利要求1～29任一项所述的带夹持导向功能的植入装置，其特征在于，还包括手柄，所述手柄设于所述夹持组件的近端。
PCT/CN2022/132962 2021-12-31 2022-11-18 一种带夹持导向功能的植入装置 WO2023124638A1 (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202111675750.5 2021-12-31
CN202111675750.5A CN116407350A (zh) 2021-12-31 2021-12-31 一种带夹持导向功能的植入装置

Publications (1)

Publication Number Publication Date
WO2023124638A1 true WO2023124638A1 (zh) 2023-07-06

Family

ID=86997511

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2022/132962 WO2023124638A1 (zh) 2021-12-31 2022-11-18 一种带夹持导向功能的植入装置

Country Status (2)

Country Link
CN (1) CN116407350A (zh)
WO (1) WO2023124638A1 (zh)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004019816A2 (en) * 2002-08-29 2004-03-11 Md3 Technologies Llc Implantable devices for controlling the internal circumference of an anatomic orifice or lumen
US20070066863A1 (en) * 2005-08-31 2007-03-22 Medtronic Vascular, Inc. Device for treating mitral valve regurgitation
CN102164548A (zh) * 2008-11-06 2011-08-24 奥林巴斯医疗株式会社 缝合器及缝合系统
US20140214152A1 (en) * 2013-01-31 2014-07-31 St. Jude Medical, Inc. Method and device for heart valve repair
CN106999174A (zh) * 2014-07-17 2017-08-01 核心医疗股份公司 用于心瓣修复的医疗设备及方法

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004019816A2 (en) * 2002-08-29 2004-03-11 Md3 Technologies Llc Implantable devices for controlling the internal circumference of an anatomic orifice or lumen
US20070066863A1 (en) * 2005-08-31 2007-03-22 Medtronic Vascular, Inc. Device for treating mitral valve regurgitation
CN102164548A (zh) * 2008-11-06 2011-08-24 奥林巴斯医疗株式会社 缝合器及缝合系统
US20140214152A1 (en) * 2013-01-31 2014-07-31 St. Jude Medical, Inc. Method and device for heart valve repair
CN106999174A (zh) * 2014-07-17 2017-08-01 核心医疗股份公司 用于心瓣修复的医疗设备及方法

Also Published As

Publication number Publication date
CN116407350A (zh) 2023-07-11

Similar Documents

Publication Publication Date Title
JP6688325B2 (ja) 結紮クリップ
KR102400789B1 (ko) 심실 내에 배치하기 위한 심장 판막 수리 기구 및 심장 판막 수리 기구를 이식하기 위한 전달 시스템
US20210038866A1 (en) Anchor instrumentation and methods
CN113040978A (zh) 经导管锚钉植入装置及经导管锚钉植入系统
CN212630823U (zh) 可调弯的缝合线锁结装置
WO2023029724A1 (zh) 经导管缩环系统及其应用
CN110575210A (zh) 可调节的缝合线锁结装置
CN114424972A (zh) 一种自适应导引装置以及经导管治疗系统
CN209186798U (zh) 可调节的缝合线锁结装置
WO2019218930A1 (zh) 瓣膜夹合器及瓣膜夹合系统
CN212490011U (zh) 经导管途径的瓣膜缝线器械及其穿刺针
WO2021082821A1 (zh) 可探测瓣膜夹持状态的瓣膜夹合器及瓣膜夹合系统
WO2023124638A1 (zh) 一种带夹持导向功能的植入装置
CN113116423B (zh) 可导向的瓣膜缝线器及瓣膜缝线系统
CN212490016U (zh) 前推释放型缝合线锁结装置
US20230210664A1 (en) Valve clamping device with locking mechanism and valve repair system
CN113892986A (zh) 可调弯的缝合线锁结装置
CN113491547A (zh) 前推释放型缝合线锁结装置
CN211934428U (zh) 经导管锚钉植入装置及经导管锚钉植入系统
WO2022037084A1 (zh) 组织夹持件及瓣膜夹合装置
US11986180B2 (en) Adjustable suture locking apparatus
CN113116424A (zh) 经导管途径的瓣膜缝线器械及其穿刺针
CN113040843A (zh) 拉力驱动式锁结装置
CN217091029U (zh) 输送器组件
WO2024032743A1 (zh) 瓣膜夹合系统

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: 22913896

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE