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CN115670751A - Tricuspid valve conveyor - Google Patents

Tricuspid valve conveyor Download PDF

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Publication number
CN115670751A
CN115670751A CN202211391790.1A CN202211391790A CN115670751A CN 115670751 A CN115670751 A CN 115670751A CN 202211391790 A CN202211391790 A CN 202211391790A CN 115670751 A CN115670751 A CN 115670751A
Authority
CN
China
Prior art keywords
bending
adjusting
bend
wire fixing
tricuspid valve
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
CN202211391790.1A
Other languages
Chinese (zh)
Inventor
吴意
黄文晞
耿肖肖
刘瑩
吴明明
陈大凯
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Koka Nantong Lifesciences Co Ltd
Original Assignee
Koka Nantong Lifesciences Co Ltd
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 Koka Nantong Lifesciences Co Ltd filed Critical Koka Nantong Lifesciences Co Ltd
Publication of CN115670751A publication Critical patent/CN115670751A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436Deployment by retracting a sheath
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation
    • A61F2/243Deployment by mechanical expansion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation
    • A61F2/2439Expansion controlled by filaments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/246Devices for obstructing a leak through a native valve in a closed condition
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466Delivery devices therefor
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Biomedical Technology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Mechanical Engineering (AREA)
  • Prostheses (AREA)

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to a tricuspid valve conveyor. A tricuspid valve delivery device comprising a bend-adjusting structure, the bend-adjusting structure comprising: the adjusting bent pipe can be bent; and the bending adjusting handle is communicated with the bending adjusting pipe and controls the bending degree of the bending adjusting pipe. The bending adjusting handle comprises a rotating part, a main rod, a stay wire fixing part, an inner moving part and at least one bending adjusting stay wire. In the bend adjusting structure, the original stay wire fixing ring is designed in a split mode, namely the stay wire fixing ring is disassembled into a stay wire fixing piece and an inner moving piece, the stay wire fixing piece can automatically move to the far end, a space is reserved for the movement of the bend adjusting stay wire, the bend adjusting pipe can achieve the purpose of automatically straightening, and the far end of the bend adjusting pipe is prevented from being manually straightened.

Description

Tricuspid valve conveyor
This application claims priority to chinese patent application 2021113240164, filed 2021, 11/10/month. The present application refers to the above-mentioned chinese patent application in its entirety.
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to a tricuspid valve conveyor.
Background
The tricuspid valve is located between the right atrium and right ventricle of human body, and is in the form of three valve leaflets connected with chordae tendineae in the ventricle for preventing the blood of the right ventricle from flowing back to the right atrium. Specifically, the tricuspid valve acts as a "one-way valve" to ensure that blood circulation must flow from the right atrium to the right ventricle and through a certain amount of flow. When the right ventricle contracts, the heart squeezes the blood in the chamber, which impacts the valve. The tricuspid valve closes and blood does not flow into the right atrium. However, when the tricuspid valve structure is damaged or the heart is damaged, the tricuspid valve regurgitation phenomenon is caused.
At present, the mode of treating tricuspid regurgitation through constriction mainly comprises two modes of surgical thoracotomy and medical minimally invasive surgery. Open surgical chest surgery discourages a large number of patients from receiving this form of treatment due to the large surgical trauma, high risk and long-term and expensive rehabilitation after surgery. And the medical minimally invasive surgery of the femoral transcatheter aortic valve treatment provides a novel treatment method with smaller trauma, less complications and quick postoperative rehabilitation for doctors.
During valve treatment, a tricuspid valve transfemoral valve prosthesis is used for implementation. The transfemoral valve prosthesis pinches the valve leaflets through its pinching structure, while the transfemoral valve prosthesis requires a transporter in cooperation with it to transport, control its form and release. For example, the bending adjusting pipe is bent by the bending adjusting structure in the conveyer, or the expanding sheath pipe is bent by the expanding structure, so that the conveying pipe in the conveying pipe is bent, and the purpose of conveying the tricuspid valve to the target position through the femoral valve prosthesis is achieved. In the original bending adjusting structure or expansion structure, when any one of the bending adjusting pipe or the expansion sheath pipe is bent or straightened, the other pipe cannot be automatically bent or straightened, and the normal work of the stay wire is influenced. There is therefore a need for a delivery device for a tricuspid transfemoral valve prosthesis that can follow the automatic bending or straightening of the bending or dilating sheath.
Disclosure of Invention
The invention aims to solve the technical problem that a conveyor which can automatically bend or straighten back along with a bend adjusting pipe or an expansion sheath pipe is lacked in the process of treating a tricuspid valve, and aims to provide a tricuspid valve conveyor.
A tricuspid valve delivery device comprising a bend-adjusting structure, the bend-adjusting structure comprising:
the adjusting bent pipe can be bent;
and the bending adjusting handle is communicated with the bending adjusting pipe and controls the bending degree of the bending adjusting pipe.
The bend-adjusting handle comprises:
the inner wall of the rotating part is provided with internal threads capable of driving the bending adjusting pull wire, and the outer wall of one end of the rotating part is sleeved with a bending adjusting knob;
a main rod arranged in the rotating part, the far end of the main rod is an open structure and the interior of the main rod is hollow,
the pull wire fixing piece is positioned in the rotating piece, sleeved outside the main rod and capable of axially moving along the main rod, and a pull wire fixing end is arranged on the pull wire fixing piece;
the internal movable piece is positioned in the rotating piece, is sleeved outside the main rod at the far end side of the stay wire fixing piece and can move axially along the main rod, an external thread of the internal movable piece is arranged on the outer surface of the internal movable piece, the external thread of the internal movable piece is in threaded connection with the internal thread of the rotating piece, and a stay wire transition hole for communicating the far end with the near end is axially arranged on the side wall of the internal movable piece;
one end of the bending adjusting pull wire is connected with the bending adjusting pipe, and the other end of the bending adjusting pull wire penetrates through the bending adjusting pipe, the rotating part, the main rod and the pull wire transition hole in sequence and then is connected with the fixed end of the pull wire;
when rotating the accent turn knob drives when rotating the piece and rotating, interior movable part is followed mobile jib axial displacement drives the mounting of acting as go-between and moves to the near-end when interior movable part moves to the near-end, and then drives the accent on the stiff end of acting as go-between and moves the line of acting as go-between to adjust the crookedness of transfer pipe, when interior movable part moves to the distal end, because the distal end of transfer pipe all has elastic, consequently the mounting of acting as go-between when having the distance with interior movable part, the mounting of acting as go-between moves to the distal end automatically, with the crookedness of adjusting the pipe.
Preferably, the fixing end of the pulling wire comprises:
the stay wire fixing hole is arranged on the outer wall of the stay wire fixing piece, and the axial direction of the stay wire fixing hole is parallel to the axial direction of the rotating piece;
and the pull wire fixing rod is inserted in the pull wire fixing hole and used for winding the bending adjusting pull wire.
Preferably, the inner moving piece is provided with avoidance grooves at the far end side and the near end side of the stay wire transition hole respectively.
As the preferred scheme, be provided with the notes gluey groove on the outer wall of mobile jib.
As a preferred scheme, the outer wall of the main rod is axially provided with a bending and rotation preventing strip or a bending and rotation preventing groove;
and the inner walls of the stay wire fixing part and the inner moving part are correspondingly provided with a bending and rotation preventing groove or a bending and rotation preventing strip.
Preferably, the outer wall of the rotating part is provided with a rotating part external thread;
the bend-adjusting handle further comprises:
the bending adjusting shell can contain the rotating part, the bending adjusting knob extends out of the near end or the far end, a shell sliding groove is formed in the side wall of the bending adjusting shell, and the shell sliding groove is formed in the axial direction of the rotating part;
a bend-adjusting limiting device comprises a limiting block, wherein a plurality of groups of spiral pushing blocks are arranged on the inner side of the limiting block, the spiral pushing blocks are meshed with external threads of the rotating piece, and the outer side of the limiting block is slidably mounted on the shell sliding groove.
Preferably, the spiral pushing block is a strip-shaped pushing block, or the middle part of the spiral pushing block is of a concave structure, so that the spiral pushing block is composed of two convex blocks.
As a preferable scheme, the outer surface of the limiting block is provided with a bending adjusting mark, and the bending adjusting mark can be one or a combination of a protrusion, a groove or a colored mark.
As the preferred scheme, a transparent outer cover is arranged on the bending adjusting shell, and the outer cover sealing cover is arranged on the outer side of the shell sliding groove.
Preferably, the expansion structure is the same as the bending structure.
A method of assembling a pull cord control device, comprising:
fixing the distal section of the inner tube inside a conveying shell through an inner clamp, inserting an outer tube into the conveying shell from the outside of the proximal end of the conveying shell, adjusting the inclination of the inner tube and sleeving the outer tube from the proximal side of the inner tube;
fixing the distal section of the inner tube inside the delivery casing so that the inner tube is stationary. The positive progress effects of the invention are as follows: the tricuspid valve conveyor has the following advantages:
1. in the bend adjusting structure, the original stay wire fixing ring is designed in a split mode, namely the stay wire fixing ring is disassembled into a stay wire fixing piece and an inner moving piece, the stay wire fixing piece can move automatically, a space is reserved for movement of a bend adjusting stay wire or an expansion stay wire, the bend adjusting pipe or the expansion sheath pipe can achieve the purpose of automatically straightening, and the remote end of the bend adjusting pipe or the expansion sheath pipe is prevented from being manually and forcibly straightened.
2. The design that the axis direction of the stay wire fixing hole is parallel to the axis direction of the rotating part can avoid the problem that the rotating part cannot normally rotate due to the interference of the end part of the stay wire fixing rod and the internal thread of the rotating part.
3. The avoidance groove can prevent the inner moving piece from extruding and bending the stay wire when the inner moving piece is tightly abutted to the stay wire fixing piece.
4. The side face of the main rod is provided with the glue injection hole, so that the problem of device pollution caused by the fact that the binder overflows when the pipe/sheath needs to be coated with the binder firstly and then assembled with the main rod is solved.
5. The positions of the near end and the far end of the limiting block can be determined through the length of the sliding groove of the shell, so that the rotation limit of the rotating part is limited, and the stroke of the bending-adjusting pull wire is controlled.
Drawings
FIG. 1 (a) is an exploded view of one configuration of the delivery and release structures of the present invention;
FIG. 1 (b) is another schematic angle view of FIG. 1 (a);
FIG. 1 (c) is a schematic view of the overall structure of the delivery and release structures of the present invention;
FIG. 2 (a) is a schematic view of a part of the structure of the conveying structure of the present invention;
FIG. 2 (b) is an exploded view of the structure of FIG. 2 (a);
FIG. 3 is an exploded view of a rotary control device according to the present invention;
FIG. 4 (a) is an exploded view of a portion of the release structure of the present invention;
FIG. 4 (b) is a cross-sectional view of FIG. 4 (a);
FIG. 4 (c) is a schematic structural view of the rotary sleeve of FIG. 4 (a);
FIG. 4 (d) is an exploded view of the connection between the core rod and the core rod retainer of the present invention;
FIG. 5 (a) is a schematic view of one connection of the bend-adjusting, loader, and expansion configurations of the present invention;
FIG. 5 (b) is a schematic diagram of an application of FIG. 5 (a);
FIG. 5 (c) is a schematic view of the structure of FIG. 5 (a) with the housing and the rotating member removed;
FIG. 6 (a) is an exploded view of a bend-adjusting structure of the present invention except for the bend-adjusting housing;
FIG. 6 (b) is an exploded view of a portion of the structure of FIG. 6 (a);
FIG. 6 (c) is an exploded view of a portion of the structure of the bend adjustment handle of the present invention;
FIG. 7 is a schematic view of a pull string holder of the present invention;
FIG. 8 (a) is a schematic structural diagram of a stopper according to the present invention;
fig. 8 (b) is another schematic structural diagram of the limiting block of the present invention.
Detailed Description
In order to make the technical means, the creation characteristics, the achievement purposes and the effects of the invention easy to understand, the invention is further described with the specific drawings.
In the present disclosure, when describing a tricuspid valve delivery device, "distal", "proximal", "distal", and "proximal" are used as terms of orientation that are conventional in the art of interventional medical devices, wherein "distal" and "distal" refer to the end or segment that is distal from the operator during a procedure, and "proximal" refer to the end or segment that is proximal to the operator during a procedure. "axial" refers to a direction parallel to the line joining the center of the distal end and the center of the proximal end of the medical device; "radial" refers to a direction perpendicular to the "axial" direction described above.
Referring to fig. 1 (a), 1 (b) and 5 (a), the tricuspid transporter of the present invention comprises, in order from the proximal end to the distal end, a release structure 100, a transport structure 200, a bend-adjusting structure 300 of the present invention, a loader structure 400 and an expansion structure 500 of the present invention.
The delivery structure 200 is provided with a delivery pipe 210, the bend-adjusting structure 300 is provided with a bend-adjusting pipe 310 with adjustable bending degree, the delivery pipe 210 penetrates through the bend-adjusting pipe 310 and extends out of the bend-adjusting pipe 310 to be detachably connected with the tricuspid valve transfemoral valve prosthesis, and the delivery structure 200 is used for delivering the tricuspid valve transfemoral valve prosthesis to a target position. The loader structure 400 is used to load the tricuspid valve transfemoral valve prosthesis and the supply elbow 310 therethrough. The expandable structure 500 has an expandable sheath 510 with an adjustable degree of flexion, the expandable sheath 510 allowing the adjustable bend 310 to pass through.
In some embodiments, referring to fig. 1 (a) -2 (b), the delivery structure 200 further comprises a delivery handle 220, the delivery handle 220 comprising a delivery housing and a pull-wire control device.
The distal end of the delivery housing is connected to the proximal end of the delivery tube 210. A delivery end 2211 is preferably removably disposed at the distal end of the delivery housing. The conveying shell is preferably composed of a conveying upper shell 221a and a conveying lower shell 221b which are connected.
The stay wire control devices can slide on the conveying shell along the axial direction of the conveying pipe 210, preferably, the number of the stay wire control devices is the same as that of the clamping pieces of the tricuspid valve transfemoral valve repair device, each stay wire control device is respectively connected with one corresponding clamping piece, and the stay wire control devices are used for controlling the clamping pieces to open and close.
The pull wire control device includes an inner tube 222, an outer tube 223, and a delivery pull wire. The distal section of the inner tube 222 is secured inside the delivery housing. Preferably, the distal section of the inner tube 222 is fixed to the inside of the upper conveying casing 221 a. The distal end of the outer tube 223 extends through the proximal end of the delivery housing and fits over the inner tube 222. Preferably, the distal end of the outer tube 223 extends through the proximal end of the upper delivery sheath 221 a. The proximal end of the outer tube 223 is located outside the delivery housing, the outer tube 223 being axially slidably connected to at least the middle and proximal sections of the inner tube 222, the outer tube 223 being axially slidably connected to the proximal end of the delivery housing. The distal end of the delivery pull wire extends axially along the inside of the outer tube 223, the inside of the inner tube 222 and the inside of the delivery tube 210 in sequence and is detachably connected with the clip of the tricuspid valve transfemoral valve prosthesis, and the proximal end of the delivery pull wire is connected with the proximal end of the outer tube 223. When the conveying pull wire needs to be pulled back or conveyed, the outer tube 223 outside the conveying shell is driven to axially slide along the proximal end of the conveying shell and the outer wall of the inner tube 222, and the conveying pull wire at the proximal end of the outer tube 223 is driven to move along with the conveying pull wire. Under the sliding fit of the outer tube 223 and the inner tube 222, the pulling and pushing control conveying pull line is smoother and more reliable, and is more accurate and reliable when a clamping piece for the tricuspid valve transfemoral valve repair device is opened and closed.
Specifically, when in use, one end of the delivery pull wire is connected to the proximal end of the outer tube 223, and the other end of the delivery pull wire axially extends to the tricuspid valve repair device along the inside of the outer tube 223, the inside of the inner tube 222 and the inside of the delivery tube 210, and extends back to the proximal end of the outer tube 223 after being detachably connected with the clip of the tricuspid valve repair device, so that the delivery pull wire forms a U-shaped structure. When the conveying stay wire is connected with the clamping piece of the tricuspid valve transfemoral valve prosthesis, the clamping piece is provided with a stay wire through hole, and the conveying stay wire bypasses the stay wire through hole to realize detachable connection with the clamping piece. When it is desired to separate the delivery construct 200 from the tricuspid valve transfemoral prosthesis, the delivery pull-wire is released and one end of the delivery pull-wire is continuously pulled until the entire pull-wire is pulled out.
In some embodiments, the proximal end of the delivery casing is provided with an outer bore 2212, and the outer tube 223 extends through the proximal end of the delivery casing through the outer bore 2212 and slides within the outer bore 2212 in the axial direction. Preferably, referring to fig. 1 (a), 1 (b) and 2 (b), an outer casing hole 2212 is provided at the proximal end of the upper conveying casing 221a, and the number of the outer casing holes 2212 is the same as or not less than the number of the wire control devices, so that each outer tube 223 penetrates the proximal end of the upper conveying casing 221a through its corresponding independent outer casing hole 2212. The outer tube 223 is slidable in the outer tube axial direction within the outer fitting hole 2212.
In some embodiments, referring to fig. 1 (a) to fig. 2 (b), the distal end of the outer tube 223 is provided with a damping ring 224, and the damping ring 224 is sleeved outside the inner tube 222 and attached to the inner tube 222.
The damping ring 224 is usually made of an elastic material, and the damping ring 224 is tightly attached to the inner tube 222, so that a certain force is required to push the outer tube 223 to generate damping, and the problem that the control accuracy is affected due to a large amount of displacement of the outer tube 223 when slightly stressed is solved. Meanwhile, the damping ring 224 can also control the positioning of the outer tube 223, after the outer tube 223 moves to the target position, the external operating force is removed, and the outer tube 223 can maintain a stable position relation with the inner tube 222 under the action of the damping ring 224. While the damping ring 224 also prevents the distal end of the outer tube 223 from sliding out of the interior of the delivery housing.
In some embodiments, the outer surface of the inner tube 222 is a non-slip layer. The anti-slip layer may be obtained by sanding the outer surface of the inner tube 222, so that the outer surface of the inner tube 222 is relatively unsmooth or uneven, thereby increasing the damping force generated between the damping ring 224 and the inner tube 222.
In some embodiments, referring to fig. 2 (a) and 2 (b), the distal section of the inner tube 222 is connected to the interior of the delivery housing by an inner clamp 225, and the distal section of the inner tube 222 can be angularly rocked between the inner clamp 225 and the delivery housing. Preferably, the distal section of the inner tube 222 is connected to the interior of the upper delivery sheath 221a by an inner clamp 225.
The present invention achieves the connection of the distal section of the inner tube 222 to the delivery housing by means of the inner clamp 225, rather than a direct hard connection of the two, because: the processing precision of the conveying shell can be greatly reduced, especially the corresponding relation between the fixing positions of the outer installation hole and the inner tube 222, if the inner tube cannot be slightly adjusted, but the processing precision of the conveying shell is insufficient or internal stress deformation occurs, after the inner tube 222 and the outer tube 223 are installed, the sliding of the inner tube 222 relative to the outer tube 223 may be limited, for example, the sliding is not smooth or cannot be performed. The present invention ensures that the inner tube 222 can be adjusted to keep smooth sliding with the outer tube 223 during assembly by the way that the inner tube 222 can obliquely rock relative to the fixed position, and after the adjustment of the inner tube 222 is completed, the far end or far end of the inner tube 222 adopts flexible ways such as gluing, etc. to realize the direct hard fixation of the far end of the inner tube 222 and the conveying shell, i.e. the inner tube 222 is fixed at two points at the time, so that the inner tube 222 and the outer tube 223 form a stable state.
Based on the above, the invention also provides an assembly method of the stay wire control device, which comprises the following specific steps:
the distal end of the inner tube 222 is fixed inside the transport case by the inner clamp 225, the outer tube 223 is inserted into the transport case from the outside of the proximal end of the transport case, and the inclination of the inner tube 222 is adjusted to fit the outer tube 223 to the proximal end of the inner tube 222. The distal section of the inner tube 222 is secured inside the delivery housing such that the inner tube 222 is stationary.
Specifically, the distal end of the inner tube 222 is fixed inside the upper conveying casing 221a by the inner clamp 225, the outer tube 223 is inserted into the upper conveying casing 221a from the outer casing hole 2212 at the proximal end of the upper conveying casing 221a, the inclination of the inner tube 222 is adjusted, and the outer tube 223 is fitted to the proximal end of the inner tube 222, and when the outer tube 223 and the inner tube 222 are smoothly slid, it is considered that the adjustment of the inner tube 222 is completed. The distal section of the inner tube 222 is fixed inside the upper delivery casing 221a by gluing so that the inner tube 222 is fixed.
In some embodiments, the inner clamp 225 may be a clamping mechanism that can clamp and allow some angular play of the inner tube 222 as in the prior art, and the inner clamp 225 of the present invention may be designed as follows:
referring to fig. 2 (b), the inner clamp 225 includes a clamp base 2251 and a clamp top 2252. The top surface of the clamping base 2251 has a lower semi-cylindrical groove. The bottom surface of the clamping top block 2252 has an upper semi-cylindrical groove, the clamping top block 2252 is connected to the clamping base 2251, the upper semi-cylindrical groove and the lower semi-cylindrical groove form a cylindrical groove for accommodating the inner tube 222, and the outer diameter of the cylindrical groove is slightly larger than or equal to the outer diameter of the inner tube 222, which can be adjusted by controlling the clamping degree between the clamping base 2251 and the clamping top block 2252, for example, the clamping top block 2252 presses the clamping base 2251 tightly, or the clamping top block 2252 only contacts the clamping base 2251, the clamping base 2251 and the clamping top block 2252 are made of materials with certain elastic deformation, and are deformed by applying a certain force, so that the outer diameter of the cylindrical groove can be changed to some extent. As shown in fig. 2 (b), the clamp seats 2251 of the plurality of inner clamps 225 may be integrally formed and each have a separate lower semi-cylindrical groove. Clamping top 2252 is detachably connected to clamping base 2251, for example, screw holes are formed in clamping top 2252 and clamping base 2251, and the two are connected by screws.
In some embodiments, referring to fig. 1 (a) to 2 (b), the pull wire control device further includes a pushing block 226, the pushing block 226 is disposed at the proximal end of the outer tube 223, and the pushing block 226 drives the outer tube 223 to slide in the axial direction.
In some embodiments, the pull wire control device further comprises a pushing slide 2261, the pushing slide 2261 is fixed at the proximal side of the delivery housing, and a pushing slide 2262 is axially disposed on the pushing slide 2261. Preferably, the pushing slide 2261 is fixed on the outer wall of the proximal end of the lower delivery casing 221b, and the pushing slide 2262 may extend to the proximal end of the lower delivery casing 221b, so that the corresponding slide groove is also disposed on the proximal end surface of the lower delivery casing 221 b.
The pushing block 226 is provided with a guiding block 2263, and the guiding block 2263 is slidably connected with the pushing sliding groove 2262. When the pushing block 226 needs to move in the axial direction, the pushing sliding groove 2262 provides a guiding function for the pushing block 226, so that the pushing process of the pushing block 226 is more stable and reliable.
In some embodiments, referring to fig. 1 (a) to 2 (b), the pulling wire control device further includes an actuating block 227, the actuating block 227 is disposed on the pushing block 226, and an anti-pushing clip 2271 is disposed inside the actuating block 227. The actuating block 227 is rotatably mounted on the pusher block 226, both of which may be of a clip-like configuration.
The proximal end of the delivery housing is correspondingly provided with a detent 2213, and the detent 2213 is detachably snap-connected with an anti-push card 2271. Specifically, the lower conveying housing 221b may be provided with a corresponding latching recess 2213. When the card recess 2213 is connected with the anti-pushing clamp 2271 in a clamping manner, the pushing block 226 cannot move along the axial direction of the outer tube 223, the length of the conveying pull wire is locked, when the conveying pull wire needs to be pulled or conveyed, the starting block 227 is pressed, the card recess 2213 is separated from the anti-pushing clamp 2271, the pushing block can move, and the pushing block 226 slides axially to pull or convey the conveying pull wire. The design of bayonet 2213 abandons the original convex structure to prevent injury to the operator's hand.
In some embodiments, referring to fig. 1 (a) -2 (b), the pull wire control device further comprises a rotational control device 228, the rotational control device 228 is disposed at the proximal end of the outer tube 223, and the rotational control device 228 is fixed to the proximal end of the delivery pull wire. The delivery pull wire is secured by a rotation control device 228. The rotation control device 228 can realize rotation, so that the pull wire control device realizes the purposes of push-pull and rotation dual control, and the control precision of conveying pull wires is increased.
In some embodiments, when the pull wire control device is provided with a pushing block 226, the proximal end of the outer tube 223 is fixedly provided with a rotation control device 228 through the pushing block 226, and the delivery pull wire penetrates through the pushing block 226 and is fixed with the rotation control device 228.
In some embodiments, referring to fig. 3, the rotational control device 228 includes an outer ring body 2281 and an inner ring body 2282. The outer ring body 2281 is a cylindrical structure with an open structure at least on the top surface and a hollow interior so as to accommodate the inner ring body 2282, and an outer through hole 2283 communicating the inside and the outside is arranged on the outer wall of the outer ring body 2281. The inner ring 2282 is rotatably disposed within the outer ring 2281, and the outer wall of the inner ring 2282 is spaced from the inner wall of the outer ring 2281 to accommodate a delivery pull wire. The proximal end of the delivery pull wire passes through the outer perforation 2283 and is wound and connected with the outer wall of the inner ring body 2282.
According to the invention, by rotating the inner ring body 2282, the conveying pull wire can be wound or loosened on the outer wall of the inner ring body 2282, namely, a gap between the inner ring body 2282 and the outer ring body 2281, so that the recovery or conveying of the conveying pull wire is realized. So that the conveying structure 200 can realize push-pull and rotation dual regulation and control, and the regulation and control precision of the conveying stay wire is increased. For example, if the push-pull push block 226 is too large in amplitude, precise control of the delivery pull wire can be achieved by slightly rotating the inner ring body 2282.
In some embodiments, referring to fig. 3, the diameters of the upper and lower ends of the inner ring 2282 are larger than the diameter of the middle portion, the outer walls of the upper and lower ends of the inner ring 2282 are attached to the inner wall of the outer ring 2281, and the middle outer wall of the inner ring 2282 is wound with a delivery pull wire. Due to the design, a certain gap is formed between the outer wall of the middle of the inner ring body 2282 and the inner wall of the outer ring body 2281, the outer walls of the upper end and the lower end of the inner ring body 2282 are relatively close to the inner wall of the outer ring body 2281, and the inner ring body 2282 has certain damping effect when rotating relative to the outer ring body 2281. Such a fitting relationship is known in the art, such as an interference fit or a transition fit, and will not be described herein.
In some embodiments, referring to fig. 3, the inner ring 2282 is an internally hollow cylindrical structure, and an inner aperture 2284 is disposed on an outer wall of the inner ring 2282 to communicate the inside and outside. The proximal end of the delivery pull wire is threaded through one of the outer perforations 2283 and one of the inner perforations 2284 in sequence and then extends out of the other outer perforation 2283 corresponding to the inner perforation 2284. Therefore, as shown in fig. 3, the outer ring 2281 has two outer perforations 2283 corresponding to the two ends of the inner perforation 2284 penetrated by the inner ring 2282. The outer perforation 2283 and the inner perforation 2284 are designed to form a pull line channel inside and outside the rotary control device 228, so that the large-amplitude pull adjustment of the conveying pull line can be directly realized. Such large-amplitude stay wire adjustment often occurs before the device enters a human body, and the conveying stay wire is convenient to assemble and adjust. The length of the stay wire is reserved and fixedly conveyed, after the adjustment is completed, the inner ring body 2282 is rotated, the parts on the two sides of the outer ring body 2281 are conveyed to the stay wire to enter the space between the outer ring body 2281 and the inner ring body 2282, and the stay wire is conveyed to be wound on the inner ring body 2282 to be fixed. Generally, the fixing can be performed by rotating the fixing member two or more times. However, it is not intended to be limited to the description herein, as the gap between the inner ring 2282 and the outer ring 2281 may be different for different devices, and as the delivery wires may be different in thickness for different devices, the number of reliable fixed turns is often different, but according to the actual requirement, the number of fixed turns of the delivery wires can be determined without creative work, but is usually fixed by one or more turns, because it is necessary to reserve a reverse rotation margin for the fixation of the delivery wires in case of not confirming whether the operator will rotate the inner ring 2282 reversely, of course, the rotary control device 228 is usually used for fine adjustment, so the inner ring 2282 is moved by a relatively small amount, and here, for special cases, for example: if the operator needs to rotate the inner ring 2282 in a large number of opposite directions, the operator can be assured to rotate the inner ring 2282 in a large number of opposite directions by a large number of excessive rotations during the fixed wire feeding.
In some embodiments, the inner aperture 2284 is positioned inside the outer aperture 2283 such that the inner aperture 2284 is positioned in relation to the outer aperture 2283 to allow the delivery pull wire to more smoothly pass through the outer aperture 2283 and the inner aperture 2284 in sequence.
In some embodiments, referring to fig. 3, an operating end 2285 is disposed at an upper end of the inner ring body 2282, and the inner ring body 2282 is rotated by the operating end 2285. The operator can directly rotate the inner ring body 2282 through the operating end 2285. As shown in fig. 3, the operating end 2285 is a pull wire operating handle. The operating end 2285 may also be a face slot, for example, shaped to correspond to the insertion of a flathead screwdriver, which an operator may directly rotate the inner ring 2282 through the face slot. The manipulation end 2285 may also be a protrusion of a terminal surface, for example, a shape corresponding to the shape of the screw driver inserted into the screw driver, and the operator may directly insert the protrusion of the terminal surface through the screw driver to rotate the inner ring 2282, thereby facilitating the manipulation of the inner ring 2282.
In some embodiments, referring to fig. 1 (a) through 2 (b), the distal end of delivery handle 220 is provided with a transition piece 229, and delivery handle 220 is connected to the proximal end of delivery tube 210 by transition piece 229. The transition piece 229 is provided with a plurality of threading holes 2291, and the number of the threading holes 2291 is not less than the number of the delivery pulling wires passing through the delivery handle 220, for example, when one delivery pulling wire passes through the delivery handle 220 for a plurality of times, the number of the threading holes is calculated according to the number of the passing times. The length of threading aperture 2291 is axial to delivery handle 220, and threading aperture 2291 communicates the proximal and distal ends of transition piece 229. The proximal end of the delivery pull wire passes through the threading aperture 2291 and into the interior of the delivery handle 220. Set up threading hole 2291 on transition piece 229, can realize that every carries to act as go-between and independently get into conveyer pipe 210 through respective corresponding threading hole 2291 for every carries to act as go-between and does not take place to interfere with each other, prevents to carry to act as go-between and takes place the winding problem.
In some embodiments, a transition conduit is disposed between threading aperture 2291 and inner tube 222, the distal end of the transition conduit communicates with corresponding threading aperture 2291, the proximal end of the transition conduit communicates with corresponding inner tube 222, and threading aperture 2291, transition conduit and inner tube 222 form a threading channel inside delivery handle 220. When there are a plurality of delivery pull wires passing through the same inner tube 222, the proximal ends of the transition line tubes where the delivery pull wires pass through the same inner tube 222 are commonly connected to the distal ends of the corresponding inner tubes 222. Through the design of transition spool, can realize that every transport is acted as go-between and independently gets into inner tube 222 through the transition spool that corresponds separately, carry not to act as go-between and do not take place to interfere with each other, prevent to carry and take place the winding problem between acting as go-between.
In some embodiments, fig. 1 (a), 1 (b), 4 (a), and 4 (b), the release structure 100 is removably attachable to a tricuspid transfemoral valve prosthesis, the release structure 100 controlling attachment or detachment of the delivery structure 200 to the tricuspid transfemoral valve prosthesis. The release structure 100 includes a central core rod 110, a release control end 120, and a prosthetic control assembly.
The distal end of the middle core rod 110 passes through the delivery pipe 210 and then is detachably connected with the tricuspid valve transfemoral valve prosthesis, the proximal end of the middle core rod 110 is provided with a release control end 120, and the middle core rod 110 is connected with or separated from the tricuspid valve transfemoral valve prosthesis through the release control end 120. Preferably, the release control end 120 may be a release knob fixed to the proximal end of the central core rod 110, and the central core rod 110 is rotated by rotating the release knob to detachably connect or disconnect the tricuspid valve to or from the femoral valve prosthesis.
The prosthesis control assembly is used for controlling the working form of the tricuspid valve transfemoral valve prosthesis. The working states of the tricuspid valve transfemoral valve prosthesis mainly include an opening state, an umbrella opening state and a closing state, for example: chinese patent: in a valve repair fixture (publication number: CN 111449805A), the three states of the repair fixture, the tricuspid valve conveyor comprises but is not limited to the repair fixture of the kind, the valve repair fixture can be suitable for various medical devices needing to be controlled and conveyed by pulling wires, the various states are realized by pushing or pulling back the tricuspid valve through a femoral valve repair device by a central core rod 110, and a repair device control assembly can realize pushing or pulling back of the central core rod 110. The prosthesis control assembly includes a rotating sleeve 131, a threaded tube 132, a central mandrel holder 133 and a push nut 134.
The proximal and distal ends of the rotating sleeve 131 are open, the rotating sleeve 131 is hollow, and the rotating sleeve 131 is attached to the delivery housing. When the rotary casing 131 is provided on the delivery casing, it is preferable that a plurality of auxiliary guides, such as the first guide 1311, the second guide 1312, etc. of fig. 4 (c), are provided on the rotary casing 131, and the push block 226 may be supported on the rotary casing 131 to be moved in the axial direction by the auxiliary guides. The outer wall of the rotating sleeve 131 is circumferentially provided with a pin locking groove 1314. As shown in fig. 4 (c), a third guiding element 1313 may be further disposed on the rotating sleeve 131, and the third guiding element 1313 is used for fixing the rotating sleeve 131 to the conveying shell to prevent the rotating sleeve 131 from moving axially or rotating.
The proximal end and the distal end of the threaded tube 132 are open structures, the interior of the threaded tube 132 is hollow, the threaded tube 132 is at least partially located inside the rotating sleeve 131, external threads are arranged on the outer wall of the threaded tube 132, the proximal end of the threaded tube 132 extends out of the rotating sleeve 131 and is detachably connected with the central core rod fixing member 133, and the proximal end and the distal end can be connected in a threaded manner.
The central rod fixing element 133 is rotatably connected to the central rod 110 and drives the central rod 110 to move axially. When the threaded pipe 132 drives the middle core rod fixing piece 133 to move along the axial direction, the middle core rod 110 is further driven to move along the axial direction, and finally the working state of the tricuspid valve transfemoral valve repair device is controlled.
The proximal end of the push nut 134 is threadedly coupled to the external thread of the threaded tube 132, and in particular, the proximal end of the push nut 134 is preferably internally threaded on the inner wall thereof, and threadedly coupled to the external thread of the threaded tube 132 via the internal thread. The distal end of the pushing nut 134 can move along the circumferential direction of the rotating sleeve 131, specifically, a pin mounting hole 1341 is dug in the distal end of the pushing nut 134 along the radial direction, and the pushing nut 134 sequentially passes through the pin mounting hole 1341 and the pin clamping slot 1314 through the pushing pin 1342 to be connected with the rotating sleeve 131, so that the pushing nut 134 can move along the circumferential direction of the rotating sleeve 131. As shown in fig. 4 (a), four pin mounting holes 1341 are provided along the circumferential direction of the push nut 134, and the push nut 134 is rotatably connected to the rotary sleeve 131 by four push pins 1342, respectively.
The distal end of the middle core rod 110 sequentially passes through the middle core rod fixing piece 133, the threaded pipe 132 and the delivery pipe 210 and then is connected with the tricuspid valve transfemoral valve prosthesis, when the push nut 134 is rotated, the threaded pipe 132 can axially extend out or extend into the rotating sleeve 131 to drive the middle core rod fixing piece 133 because the rotating sleeve 131 is not moved, and further the middle core rod 110 is driven to be pushed or pulled back to the distal end, so that the working state of the tricuspid valve transfemoral valve prosthesis is controlled.
In some embodiments, the central core rod holder 133 may be configured to limit the central core rod 110 from moving axially relative to the threaded tube 132, but may be rotated such that the central core rod 110 may be removably attached to or detached from the tricuspid transfemoral valve prosthesis by releasing the control end 120, i.e., the central core rod 110 may not move axially on its own independent of the central core rod holder 133 or the threaded tube 132. Therefore, the connection between the central core rod 110 and the central core rod holder 133 of the present invention can be realized in such a way that the central core rod holder 133 allows the central core rod 110 to rotate and restricts the central core rod 110 from moving axially:
a positioning block receiving cavity is formed in the center core rod fixing member 133. A positioning block 111 is arranged at the proximal section of the middle core rod 110, and the positioning block 111 is rotatably limited in the positioning block accommodating cavity. That is, the positioning block 111 can rotate in the positioning block accommodating cavity, but the positioning block 111 cannot move axially from the positioning block accommodating cavity under the cooperation of the central rod fixing member 133 and the threaded pipe 132, so that the central rod 110 cannot move axially along the central rod fixing member 133 or the threaded pipe 132, but can rotate under the action of the release control end 120.
In some embodiments, the proximal section of the central core rod is further provided with a spacer 112, and the spacer 112 is attached to the proximal side or the distal side of the positioning block 111. The axial length of the positioning block accommodating cavity of the central core rod fixing piece 133 is greater than the axial length of the positioning block 111, and the axial length of the positioning block accommodating cavity of the central core rod fixing piece 133 is less than the total axial length of the positioning block 111 and the gasket 112. Since the positioning block 111 cannot be pressed too tightly between the center core rod fixing member 133 and the threaded pipe 132, it is difficult to rotate the center core rod 110. Therefore, in order to prevent the axial shake of the central core rod 110 caused by the positioning block 111 not being pressed, a gasket 112, such as a silicone gasket (ring), is disposed on the distal end side or the proximal end side of the positioning block 111, and the axial length of the positioning block accommodating cavity reserved for the positioning block 111 in the central core rod fixing member 133 is slightly smaller than the total axial length of the positioning block 111 and the gasket 112, but larger than the axial length of the positioning block 111, so that after the central core rod fixing member 133 is fixed to the threaded pipe 132, the positioning block 111 is pressed by the gasket 112 and cannot shake axially, and under the action of the gasket 112, the positioning block 111 cannot be pressed excessively, so that the central core rod 110 rotates under the action of the release control end 120.
In some embodiments, referring to fig. 4 (a), a rotation limiting groove 1321 is formed on the outer wall of the threaded pipe 132, and the length direction of the rotation limiting groove 1321 is the axial direction of the threaded pipe 132. Referring to fig. 4 (a) and 4 (c), a rotation limiting block 1315 is disposed on the inner wall of the rotary sleeve 131, and the rotation limiting block 1315 is located in the rotation limiting slot 1321 and is slidably connected to the rotation limiting slot 1321. The cooperating arrangement of rotation limiting slot 1321 and rotation limiting block 1315 limits rotation of threaded tube 132 within rotary sleeve 131, thereby allowing threaded tube 132 to move axially along rotary sleeve 131 under the action of push nut 134.
In some embodiments, referring to fig. 5 (a) to 6 (c), the bend adjusting structure 300 includes a bend adjusting pipe 310 and a bend adjusting handle 320, the bend adjusting pipe 310 can be bent, the bend adjusting pipe 310 can be penetrated by the conveying pipe 210, and the conveying pipe 210 in the bend adjusting pipe 310 and the central core rod in the conveying pipe 210 are bent together when the bend adjusting pipe is bent. The bend-adjusting handle 320 is communicated with the bend-adjusting pipe 310, and the bend-adjusting handle 320 controls the bending degree of the bend-adjusting pipe 310. Referring to fig. 6 (a) and 6 (b), the bending adjustment handle 320 includes a rotating member 321, a main lever 322, a wire fixing member 323, an inner moving member 324, and at least one bending adjustment wire.
The near-end and the distal end of rotating piece 321 are open structure, and the inside cavity of rotating piece 321, the inner wall of rotating piece 321 are provided with the rotating piece internal thread that can drive the accent and bend the acting as go-between, and the one end outer wall cover of rotating piece 321 is equipped with accent curved knob 3211, rotates and transfers curved knob 3211, and rotating piece 321 follows the rotation.
The main rod 322 is disposed in the rotating member 321, and a distal end of the main rod 322 has an open structure and is hollow. Preferably, as shown in fig. 6 (b), a gap 3223 for passing the delivery wire is provided at the distal end of the main rod 322.
The wire fixing part 323 is a ring structure, the wire fixing part 323 is located in the rotating part 321, the wire fixing part 323 is sleeved outside the main rod 322 and can move axially along the main rod 322, and a wire fixing end is arranged on the wire fixing part 323.
The inner moving member 324 is a ring structure, the inner moving member 324 is located in the rotating member 321, the inner moving member 324 is sleeved outside the main rod 322 and can move axially along the main rod 322, and the inner moving member 324 is located at the distal end side of the wire pulling fixing member 323. The outer surface of the inner moving piece 324 is provided with an inner moving piece external thread, the inner moving piece external thread is in threaded connection with the rotating piece internal thread, and a pull wire transition hole 3241 communicating the far end and the near end is axially arranged on the side wall of the inner moving piece 324.
The far end of the bending-adjusting pull wire is connected with the bending-adjusting pipe 310, and the near end of the bending-adjusting pull wire sequentially passes through the bending-adjusting pipe 310, the rotating part 321, the main rod 322 and the pull wire transition hole 3241 and then is connected with the fixed end of the pull wire.
When the turning knob 3211 is rotated to drive the turning member 321 to rotate, the inner moving member 324 moves axially along the main rod 322, and when the inner moving member 324 moves proximally, the pulling wire fixing member 323 is driven to move proximally, thereby driving the turning pulling wire at the fixed end of the pulling wire to move, so as to adjust the curvature of the turning pipe 310, and when the inner moving member 324 moves distally, because the distal end of the turning pipe 310 is elastic, when the pulling wire fixing member 323 has a distance from the inner moving member 324, the pulling wire fixing member 323 automatically rebounds and straightens at the distal end of the turning pipe 310, so that the pulling wire fixing member 323 automatically moves distally under the driving of the turning pulling wire, thereby straightening the turning pipe 310 by bending.
If the wire fixing member 323 and the inner moving member 324 are designed as an integral structure, there is a certain defect in actual use, therefore, the wire fixing member 323 and the inner moving member 324 are designed as separate bodies, and the expanding handle 520 of the expanding structure 500 preferably adopts the same structure as the bending handle 320 of the bending structure 300. The reason for the split design of the pull wire fixing part 323 and the inner moving part 324 is as follows:
referring to fig. 1 (a), 1 (b) and 5 (a), in the tricuspid valve delivery device, the use of the dilating sheath is not a single structure, but a plurality of structures which need to be fitted to each other are required, i.e., the tricuspid valve delivery device includes, but is not limited to, the release structure 100, the delivery structure 200, the bend adjusting structure 300, the loader structure 400 and the dilating structure 500 in the present invention. The interior of the dilating sheath 510 in the dilating structure 500 passes through the bending regulating tube 310 of the bending regulating structure 300, and the interior of the bending regulating tube 310 of the bending regulating structure 300 passes through the delivery tube 210 of the delivery structure 200.
Referring to fig. 5 (b) and 5 (c), when the tricuspid valve delivery device enters the human body, the operative bending adjusting structure is composed of the bending adjusting structure 300 and the dilating structure 500, so that the two structures are actually cooperative and restrained with each other, for example, when the dilating sheath 510 is actively bent, the inner moving part 524 of the dilating structure 500 pushes the pull wire fixing part 523 backward to drive the dilating pull wire to bend the distal end of the dilating sheath 510, and at the same time, the inner moving part will drive the bending adjusting tube 310 to bend. However, at this time, the bend adjusting pipe 310 is passively bent, and at this time, the bend at the distal end of the bend adjusting pipe 310 pushes the bend adjusting pull wire to move backward to a certain extent, and assuming that the inner moving member 324 and the pull wire fixing member 323 are of an integrated structure, at this time, because the inner moving member 324 is fixed by the rotating member 321 and cannot move freely due to the threaded connection relationship between the inner moving member 324 and the rotating member 321, the pull wire fixing member 323 cannot move, and the pull wire at this time cannot obtain a backward movement space, which may cause the bend of the bend adjusting pipe 310, increase the bending difficulty of the expanding sheath tube 510, thereby increasing the pulling force of the expanding pull wire, possibly causing the break of the expanding pull wire, or causing the bend adjusting bend pull wire to bend due to no backward movement space, thereby affecting the bend adjusting action of the bend adjusting pipe 310. According to the invention, the pull wire fixing part 323 and the inner moving part 324 are designed in a split manner, the pull wire fixing part 323 can automatically move backwards (towards the near end), so that a space is reserved for the backward movement of the bending-adjusting pull wire, the bending difficulty of the expansion sheath 510 is reduced, and the bending-adjusting pull wire is prevented from being bent. Similarly, the distal end of the dilating sheath 510 will be passively bent when the bending adjustment catheter 310 is actively bent, and therefore it is preferable that the inside of the dilating handle 520 has the same internal structure as the bending adjustment handle 320.
The distal ends of the deployment tube 310 and the dilating sheath 510 are typically flexible so that they self-straighten when the respective pull-wires are removed from tension. Therefore, the split design of the pull wire fixing member and the inner moving member also prevents the distal ends of the curved tube 310 and the dilating sheath 510 from being manually forced back straight. If one of the distal ends of the adjustable bending tube 310 and the expandable sheath 510 is in a bent state, the other one is forced to be straightened, and straightening difficulty can be caused under the stop of the bent tube body, or the pull wire which is not operated to be straightened is forced to be pushed without moving backward to cause bending, so that normal functions are affected. And the risk of manual forced straightening is avoided by adopting a split structure.
In some embodiments, referring to fig. 7, the wire fixing end includes a wire fixing hole 3231 and a wire fixing rod 3232, the wire fixing hole 3231 is disposed on an outer wall of the wire fixing member, and an axial direction of the wire fixing hole 3231 is parallel to an axial direction of the rotation member 321. The design that the axial direction of the stay wire fixing hole 3231 is parallel to the axial direction of the rotating member can avoid the problem that the rotating member 321 cannot normally rotate due to the interference between the end part of the stay wire fixing hole 3232 and the internal thread of the rotating member. The pulling wire fixing rod 3232 is inserted into the pulling wire fixing hole 3231, and when the bending-adjusting pulling wire needs to be fixed, the bending-adjusting pulling wire is wound and fixed on the pulling wire fixing rod 3232.
In some embodiments, referring to fig. 6 (a) and 6 (b), the inner movable member 324 is provided with an escape groove 3242 on each of a distal side and a proximal side of the wire transition hole 3241. The escape slot 3242 prevents the risk of pinching the bend stay wire when the inner movable member abuts the stay wire securing member.
In some embodiments, referring to fig. 6 (a) and 6 (b), a glue injection groove 3221 is disposed on the outer wall of the main rod 322. The side surface of the main rod 322 is provided with the glue injection hole, so that the problem of device pollution caused by the overflow of the adhesive when the pipe/sheath needs to be coated with the adhesive firstly and then assembled with the main rod 322 is solved.
In some embodiments, the outer wall of the main rod 322 is provided with a bending-proof strip or a bending-proof slot along the axial direction. The inner walls of the pull wire fixing part 323 and the inner moving part 324 are correspondingly provided with a bending and rotation preventing groove or a bending and rotation preventing strip. As shown in fig. 6 (b), the outer wall of the main rod 322 is axially provided with a bending-prevention bar 3222, the inner wall of the pull wire fixing member 323 is correspondingly provided with a bending-prevention groove 3233, and the inner wall of the inner movable member 324 is correspondingly provided with a bending-prevention groove 3243.
In some embodiments, referring to fig. 6 (c), the outer wall of the rotating member 321 is provided with rotating member external threads 3212. The bending adjustment handle 320 further comprises a bending adjustment housing 325 and a bending adjustment limiting device.
The bending adjusting housing 325 can accommodate the rotating member 321, a bending adjusting knob 3211 extends from a proximal end or a distal end of the bending adjusting housing 325, a housing sliding groove 3251 is disposed on a side wall of the bending adjusting housing 325, and the housing sliding groove 3251 is disposed along an axial direction of the rotating member 321. As shown in fig. 5 (a) to 6 (a), a bend adjustment end cap 3252 is detachably provided at the distal end of the bend adjustment housing 325.
The bending adjusting limiting device comprises a limiting block 3261, a plurality of groups of spiral pushing blocks 3262 are arranged on the inner side of the limiting block 3261, the spiral pushing blocks 3262 are meshed with the external threads 3212 of the rotating piece, and the outer side of the limiting block 3261 is slidably mounted on the sliding groove 3251 of the shell.
Usually, the bending stay wire is reserved with a certain length to be convenient for assembling with the stay wire fixing part 323, so the requirement on the assembling precision is extremely high. In order to accommodate errors in the assembly process of the bending adjusting stay wire, the sliding section of the stay wire fixing part 323 and the inner moving part 324 sleeved on the main rod 322 is relatively long, so that the length error when the bending adjusting stay wire is fixed is accommodated, and the problem of difficult control of the movement stroke length of the bending adjusting stay wire is indirectly caused. In order to solve the problem, the bending regulating limiting device is additionally arranged in the bending regulating device, and the bending regulating stay wire is prevented from controlling the corresponding bending regulating pipe 310 to be bent too much, so that the far end of the bending regulating pipe 310 cannot be straightened normally. The length of the housing slide slot 3251 determines the position of the distal and proximal ends of the stop block 3261, thereby limiting the rotational limits of the rotational member 321 and thus controlling the travel of the bend adjusting wires. In practical use, the rotating member 321 can be assembled after the bending adjustment of the wire and the fixing of the wire fixing member 323 are completed, the rotating member 321 is debugged, so that the inner moving member 324 is in a proper position, then the limiting block 3261 is placed at a corresponding position of the sliding groove, and the spiral pushing block 3262 is meshed with the external thread 3212 of the rotating member, thereby realizing the control of the wire pulling stroke.
In some embodiments, the pusher block 3262 is an elongated pusher block. Referring to fig. 8 (a), two screw pushing blocks 3262 parallel to each other are provided inside the stopper 3261.
In some embodiments, the pusher block 3262 is concave in the middle, such that the pusher block 3262 is comprised of two convex blocks. Referring to fig. 8 (b), two sets of screw pushing blocks 3262 are disposed inside the limiting block 3261, and each set of screw pushing block 3262 has two protruding blocks. The spiral push block 3262 with a concave structure can greatly reduce the processing precision and increase the meshing smoothness of the spiral push block and the external thread 3212 of the rotating part.
In some embodiments, the outer surface of the stop block 3261 is provided with a bending adjustment mark 3263, and the bending adjustment mark 3263 may be one or more of a protrusion, a groove, or a colored mark. Referring to fig. 6 (c), the bend adjustment mark 3263 is a protrusion having a length direction perpendicular to a length direction of the bend adjustment housing 325. An operator can determine different positions of the limiting block 3261 in the shell sliding groove 3251 according to the bending adjusting mark 3263, and the state of the bending adjusting pipe 310 is displayed.
In some embodiments, the bend adjusting housing 325 is provided with a see-through cover 3253, and the cover 3253 is sealed to the outside of the housing slide groove 3251. The outer cover 3253 can be made of, for example, a colorless and transparent acrylic plate, glass, or the like. The outer cover 3253 seals the housing slide groove 3251, so that the bending handle 320 forms a relatively closed space, and prevents contamination inside the bending handle 320.
The foregoing shows and describes the general principles, essential features, and advantages of the invention. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, which are given by way of illustration of the principles of the present invention, but that various changes and modifications may be made without departing from the spirit and scope of the invention, and such changes and modifications are within the scope of the invention as claimed. The scope of the invention is defined by the appended claims and equivalents thereof.

Claims (11)

1. A tricuspid valve delivery apparatus comprising a bend-adjusting structure, wherein the bend-adjusting structure comprises:
the adjusting bent pipe can be bent;
the bending adjusting handle is communicated with the bending adjusting pipe and controls the bending degree of the bending adjusting pipe;
the bend-adjusting handle comprises:
the inner wall of the rotating part is provided with internal threads capable of driving the bending adjusting pull wire, and the outer wall of one end of the rotating part is sleeved with a bending adjusting knob;
a main rod arranged in the rotating part, the far end of the main rod is an open structure and the interior of the main rod is hollow,
the pull wire fixing piece is positioned in the rotating piece, sleeved outside the main rod and capable of axially moving along the main rod, and a pull wire fixing end is arranged on the pull wire fixing piece;
the internal movable piece is positioned in the rotating piece, is sleeved outside the main rod at the far end side of the stay wire fixing piece and can move axially along the main rod, an external thread of the internal movable piece is arranged on the outer surface of the internal movable piece, the external thread of the internal movable piece is in threaded connection with the internal thread of the rotating piece, and a stay wire transition hole for communicating the far end with the near end is axially arranged on the side wall of the internal movable piece;
and one end of the at least one bending adjusting pull wire is connected with the bending adjusting pipe, and the other end of the at least one bending adjusting pull wire sequentially penetrates through the bending adjusting pipe, the rotating part, the main rod and the pull wire transition hole and then is connected with the pull wire fixing end.
2. The tricuspid valve conveyor according to claim 1, wherein the pull wire fixing end comprises:
the stay wire fixing hole is arranged on the outer wall of the stay wire fixing piece, and the axial direction of the stay wire fixing hole is parallel to the axial direction of the rotating piece;
and the pull wire fixing rod is inserted in the pull wire fixing hole and used for winding the bending adjusting pull wire.
3. The tricuspid valve conveyor according to claim 1, wherein the inner moving member is provided with an avoidance groove on each of a distal side and a proximal side of the wire transition hole.
4. The tricuspid valve conveyor according to claim 1, wherein the outer wall of the main rod is provided with a glue injection groove.
5. The tricuspid valve conveyor according to claim 1, wherein the outer wall of the main rod is provided with a bending and rotation prevention strip or a bending and rotation prevention groove along the axial direction;
and the inner walls of the stay wire fixing piece and the inner moving piece are correspondingly provided with bending-adjusting and rotation-preventing grooves or bending-adjusting and rotation-preventing strips.
6. The tricuspid valve conveyor according to claim 1, wherein the outer wall of the rotating member is provided with an external thread of the rotating member;
the bend adjusting handle further comprises:
the bending adjusting shell can contain the rotating part, the bending adjusting knob extends out of the near end or the far end, a shell sliding groove is formed in the side wall of the bending adjusting shell, and the shell sliding groove is formed in the axial direction of the rotating part;
a bend-adjusting limiting device comprises a limiting block, wherein a plurality of groups of spiral pushing blocks are arranged on the inner side of the limiting block, the spiral pushing blocks are meshed with external threads of the rotating piece, and the outer side of the limiting block is slidably mounted on the shell sliding groove.
7. The tricuspid valve conveyor according to claim 6, wherein the spiral push block is an elongated push block;
or the middle part of the spiral push block is of a concave structure, so that the spiral push block consists of two convex blocks.
8. The tricuspid valve conveyor according to claim 6, wherein the outer surface of the stopper is provided with bend adjustment markings.
9. The tricuspid valve conveyor according to claim 8, wherein the bend adjustment markings are one or more combinations of raised, recessed or colored markings.
10. The tricuspid valve conveyor according to claim 6, wherein a see-through outer cover is provided on the bend adjusting housing, and the outer cover sealing cover is provided outside the housing sliding groove.
11. The tricuspid valve delivery apparatus according to any one of claims 1 to 10, wherein the tricuspid valve delivery apparatus further comprises an expansion structure comprising an expansion sheath and an expansion handle, the bending adjustment tube being bendable, the expansion handle being of the same construction as the bending adjustment handle.
CN202211391790.1A 2021-11-10 2022-11-08 Tricuspid valve conveyor Pending CN115670751A (en)

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CN202211391790.1A Pending CN115670751A (en) 2021-11-10 2022-11-08 Tricuspid valve conveyor
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CN115670752A (en) 2023-02-03

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