GB2614321A - Cardiac valve replacement prosthesis and threaded-needle fastening cardiac-apex pad - Google Patents

Cardiac valve replacement prosthesis and threaded-needle fastening cardiac-apex pad Download PDF

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Publication number
GB2614321A
GB2614321A GB2119096.2A GB202119096A GB2614321A GB 2614321 A GB2614321 A GB 2614321A GB 202119096 A GB202119096 A GB 202119096A GB 2614321 A GB2614321 A GB 2614321A
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United Kingdom
Prior art keywords
fixation
needle
cardiac
threaded
valve replacement
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Granted
Application number
GB2119096.2A
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GB202119096D0 (en
GB2614321B (en
Inventor
Jia Haitao
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Beijing Sinapex Medical Tech Co Ltd
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Beijing Sinapex Medical Tech Co Ltd
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Publication of GB202119096D0 publication Critical patent/GB202119096D0/en
Publication of GB2614321A publication Critical patent/GB2614321A/en
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Publication of GB2614321B publication Critical patent/GB2614321B/en
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Classifications

    • 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
    • A61F2/2478Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
    • A61F2/2481Devices outside the heart wall, e.g. bags, strips or bands
    • 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
    • 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
    • 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
    • A61F2/2409Support rings therefor, e.g. for connecting valves to tissue
    • 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
    • A61F2/2412Heart 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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • 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
    • A61F2/2412Heart 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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418Scaffolds therefor, e.g. support stents
    • 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
    • A61F2/2454Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
    • A61F2/2457Chordae tendineae prostheses
    • 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
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008Fixation appliances for connecting prostheses to the body
    • 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
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008Fixation appliances for connecting prostheses to the body
    • A61F2220/0016Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes

Landscapes

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

Abstract

A cardiac-apex pad for securing a cardiac valve replacement prosthesis via a tether (3, Fig. 1). The pad comprises a fixation needle 6 and an occlusion disk having a disk face 51 and a fixation block 52 and fixation peg 53 on the disk face. A tether bore 54 passes through the disk and fixation block for receipt of the tether via an optional hollow pillar 7. The fixation block has a fixation bore 55 perpendicular to and intersecting the tether bore. The fixation needle passes through the fixation bore to engage and fasten the tether and a head portion of the fixation needle engages the fixation block, being retained thereby. The needle may be of ultra-elastic material e.g., nickel-titanium alloy or nitinol and during prosthesis fitting is partially pre-inserted into the fixation bore to bend against the fixation post. Alternatively, the post may be resiliently located in the disk. Once the tether is properly located the needle is fully inserted and elastically recovers, locking against the post. A guide slot 56 in the post may assist. The needle may have a ring- or T-shaped head.

Description

CARDIAC VALVE REPLACEMENT PROSTHESISAND THREADED-NEEDLE FASTENING CARDIAC-APEX PAD
Field of the Invention
The present invention relates to the field of medical devices, and in particular, relates to a cardiac valve replacement prosthesis and a threaded-needle fastening cardiac-apex pad thereof.
Background of the Invention
Heart valve diseases of humans are serious heart diseases featured with high population incidence and high lethality rate. T here is currently no conservative treatment method like specific medicines. Surgical treatment schemes, such as surgical valve replacement or interventional-operation valve repair or replacement, are optimal solutions at present At present, the transapical valve repair or replacement surgery is a surgical method that combines the advantages of surgical and interventional operations and is gradually recognized in the medical field.
During the transapical valve repair or replacement surgery, the cardiac apex needs to be perforated at first then, devices and products are delivered to a lesion site via a formed hole; a repair or replacement prosthesis is then fixed accurately and firmly; and then, all the devices are withdrawn; and the cardiac apex is sutured finally. In general, the cardiac apex is only sutured without occlusion after the surgery.
However, since the heart is beating all the time and the intraventricular blood pressure is also very high, cardiac apex hemorrhage occurs as a very serious complication after the surgery. A patient would die once the cardiac apex hemorrhage occurs.
At present, many well-known medical device manufacturers in China and abroad have introduced products for interventional valve replacement wherein a Tendyne product from A bbott in the US is available for cardiac apex occlusion by using a cardiac-apex pad, which largely reduces the risk of cardiac apex hemorrhage and also greatly improves the postoperative survival rate of patients. As disclosed in the prior patent E P3845137A 1, an important component of the cardiac-apex pad in the Tendyne product is needle. When a tether is adjusted to a proper length, the tether needs to be threaded with the needle to firmly fix a stent portion to a valve annulus and simultaneously allow the cardiac-apex pad to firmly occlude the hole formed in the cardiac apex. However, the tether fastening structure of the cardiac-apex pad in the Tendyne product is complicated with an excess of parts that are very small with complex shapes, and individual parts are mutually restricted in size. T his structure is difficult to produce and very troublesome to assemble, which would accidentally lead to part missing, blocking, jamming and other convenience during operation. In the case of improper assembly, a medical accident would be caused on an operating table. This structure not only brings severe challenges to production and processing, but also has shortcomings in mechanics. For instance, if a protrusion in a bushing fails, the needle would be disengaged to easily lead to the problem of failure in a long-term using process. Meanwhile, due to the dimensional design of a firing pin therein, the diameter and height of a disk of the cardiac-apex pad have to be increased, which would greatly affect the use effect.
As can be seen from this, the current cardiac-apex pad for the cardiac valve replacement prosthesis as described above still has obvious disadvantages and shortcomings in terms of structure, method and use, and needs to be further improved. It has become an improvement goal in the current field how to create a new cardiac valve replacement prosthesis and a threaded-needle fastening cardiac-apex pad therefore to fix a tether by the cardiac-apex pad in a simpler and more convenient fashion with fewer structural components that are convenient to process and are firmer and more reliable.
Summary of the Invention
The technical problem to be solved by the present invention is to provide a threaded-needle fastening cardiac-apex pad for a cardiac valve replacement prosthesis, in order to fix a tether by the cardiac-apex pad in a simpler and more convenient fashion with fewer structural components that are convenient to process and are firmer and more reliable, thereby further increasing the postoperative survival rate of patients and overcoming the defects of the existing threaded-needle fastening cardiac-apex pad for the cardiac valve replacement prosthesis.
To solve the technical problem described above, the present invention provides a threaded-needle fastening cardiac-apex pad for a cardiac valve replacement prosthesis. The threaded-needle fastening cardiac apex includes an occlusion disk and a fixation needle, wherein the occlusion disk includes a disk face, a fixation block disposed on a lateral portion of the disk face, and a fixation peg disposed at the same side with the fixation block; the disk face and the fixation block are provided with interconnected center holes for threading a tether to connect inner and outer stents in the cardiac valve replacement prosthesis; the fixation block is provided with a fixation hole that is perpendicular to and connected with the center holes; the fixation needle is threaded into the fixation hole to fasten the tether; and the fixation peg coordinates with a tail portion of the fixation needle to fix the fixation needle.
As a further improvement a top portion of the fixation peg is provided with a guide slot for threading the fixation needle into the fixation hole; and the guide slot and a center axis of the fixation hole are located within the same vertical plane.
As a further improvement a top face of the fixation peg is 0.2-2 mm higher than a top portion of the fixation hole.
As a further improvement the guide slot is disposed as a cambered-surface longitudinal flat slot that inclines downwards from the top face of the fixation peg to the fixation hole.
As a further improvement the fixation needle has a thickness dimension of 0.5-2 mm, with a cross section shaped as a circle, a triangle, a square, an ellipse, a rhombus or a star.
As a further improvement the fixation peg is elastically and vertically disposable on the disk face.
As a further improvement the disk face is provided with a blind hole containing an elastic member inside; a bottom portion of the fixation peg is fixed inside the blind 10 hole; and the fixation peg moves up and down under the action of the elastic member.
As a further improvement the fixation needle includes a needle tip, a needle stem and a needle head; the needle head has an annular rod that is connected to a tail portion of the needle stem; and a cross-sectional shape of the fixation peg matches an inner annular structure of the annular rod.
As a further improvement the inner structure of the annular rod is shaped as a circle, a square, an ellipse or a triangle.
As a further improvement the fixation needle includes a needle tip, a needle stem and a needle head; the needle head has an annular rod that is connected to a tail portion of the needle stem; the top portion of the fixation peg is provided with a transverse clamping slot matching the annular rod; and a center axis of the transverse clamping slot is located on the same horizontal plane as the center axis of the fixation hole.
As a further improvement the fixation needle includes a needle tip, a needle stem and a needle head; the needle head has a vertical transverse rod that is connected to a tail portion of the needle stem; the top portion of the fixation peg is provided with a T-shaped clamping slot matching the annular head; and a center axis of the T-shaped clamping slot is located on the same horizontal plane as the center axis of the fixation hole.
As a further improvement the fixation needle is made of an ultra-elastic material of a nickel-titanium alloy or nitinol; and the occlusion disk is made of a material of PE, PEEK, PTFE, PET, PP or PVC.
As a further improvement the disk face is integrally molded with the fixation block and the fixation peg; a peripheral structure of the fixation block is rectangular, circular or D-shaped; and the fixation block is further provided with an installation insertion hole staggered from the fixation hole.
As another improvement of the present invention, the present invention further provides a cardiac valve replacement prosthesis, which includes the threaded-needle fastening cardiac-apex pad for the cardiac valve replacement prosthesis as defined above.
With such a design, the present invention at least has the following advantages: 1. According to the present invention, the process of threading the fixation needle and fastening the tether can be simplified by improving the structure of the fixation block in the occlusion disk and in combination with the improved arrangement of the fixation needle and the fixation peg, such that the fixation needle can be threaded more visually and conveniently; and the fixation needle can be fixed longitudinally, transversely and vertically in an all-round way in pre-installation and final installation states by virtue of the ultra-strong elastic property of the fixation needle and the coordination of the fixation needle and the fixation peg, thereby ensuring the stability and reliability of the fixation needle in short-term and long-term uses; 2. By setting the height of the fixation peg and the thickness of the fixation needle and arranging the cambered-surface longitudinal flat slot, the convenience and accuracy in pre-i nserting the fixation needle into the fixation hole are further improved, and the steadiness during the pre-i nstal lati on of the fixation needle is guaranteed; 3. Moreover, by improving the needle head of the fixation needle, the needle head is flexible to arrange in structure and convenient to process; and the fixation needle and the fixation peg or the clamping slot disposed thereon are installed in coordination, such that the fixation needle is fixed in an all-round way, thereby providing diverse fixations to meet different needs during operation; 4. Furthermore, the fixation peg is disposed as an elastic mobile structure, such that the threading and fixation of the fixation needle can be better facilitated to ensure the operation convenience during surgery; and 5. The threaded-needle fastening cardiac-apex pad for the cardiac valve replacement prosthesis according to the present invention has fewer parts and a simple structure and is convenient to produce and process, which greatly reduces the production cost; moreover, the cardiac-apex pad is convenient to assemble and has a low requirement for assembling environment and a low risk of contamination; and the cardiac-apex pad as an improved product will substitute the existing fastening structure of the cardiac-apex pad, showing a good market prospect.
Brief Description of the Drawings
Described above is only an outline of the technical solution of the present invention. For clearer understanding of the technical means of the present invention, the present invention will be further illustrated in detail below in conjunction with the accompanying drawings and the specific embodiments.
FIG. 1 is a schematic diagram of an overall structure of a cardiac valve replacement prosthesis according to the present invention; FIG. 2 is a schematic structural stereogram of a threaded-needle fastening cardiac-apex pad for a cardiac valve replacement prosthesis according to the present invention; FIG. 3 is a schematic structural top view of a threaded-needle fastening cardiac-apex pad for a cardiac valve replacement prosthesis according to the present invention; FIG. 4 is a schematic structural sectional view of a threaded-needle fastening cardiac-apex pad for a cardiac valve replacement prosthesis according to the present invention; FIG. 5 is a schematic structural sectional view of a threaded-needle fastening cardiac-apex pad for a cardiac valve replacement prosthesis (with a fixation needle removed) according to the present invention; FIG. 6 is an enlarged top view of a region A in FIG. 5; FIG. 7 is a schematic structural diagram of a cardiac valve replacement prosthesis according to the present invention; FIG. 8 is a schematic structural sectional view of a threaded-needle fastening cardiac-apex pad for a cardiac valve replacement prosthesis (with a fixation needle 25 removed) according to Embodiment 2 of the present invention; FIG. 9 is a schematic structural sectional view of a threaded-needle fastening cardiac-apex pad for a cardiac valve replacement prosthesis according to E mbodiment 3 of the present invention; FIG. 10 is a schematic structural sectional view of FIG. 9; FIG. 11 is a schematic structural sectional view of a threaded-needle fastening cardiac-apex pad for a cardiac valve replacement prosthesis (with a fixation needle removed) according to Embodiment 3 of the present invention; and FIG. 12 is a schematic structural sectional view of FIG. 11.
Detailed Description of the Invention
Based on the existing cardiac pad, the present invention makes an improvement by reducing the number of parts to simplify their production, processing and assembling; and the present invention shows better and more reliable effects in short-term and long-term fixation, greatly reduces the product cost and has a good market prospect The specific embodiments are as follows.
Embodiment 1 Referring to FIG. 1, a cardiac valve replacement prosthesis in this embodiment includes an outer stent 1, an inner stent 2, a tether 3 and a cardiac-apex pad 4. Here, the outer stent 1 and the inner stent 2 are connected and assembled in a plug-in way; the inner stent 2 and the tether 3 are connected and assembled in a manner of bucking compression plus suturing; and the cardiac-apex pad 4 is configured to fasten the tether 3 and occlude a sutured cardiac apex membrane at an outer side to achieve the effects of fixing the inner and outer stents and the tether and occluding the cardiac apex membrane.
Referring to FIGS. 2 to 7, the threaded-needle fastening cardiac-apex pad 4 for the cardiac valve replacement prosthesis in this embodiment includes an occlusion disk 5, a fixation needle 6 and a hollow pillar 7. Here, the occlusion disk 5 includes a disk face 51, a fixation block 52 disposed at a side of the disk face 51, and a fixation peg 53 disposed at the same side as the fixation block 52. The disk face 51 and the fixation block 52 are provided with interconnected center holes 54. The hollow pillar 7 is disposed on the other side of the disk face 51, and connected to an inlet end of the center hole of the disk face for guiding and threading the tether 3, which connects the inner and outer stents of the cardiac valve replacement prosthesis, into the center holes 54. The fixation block 52 is provided with a fixation hole 55 which is perpendicular to and connected with the center holes 54. The fixation needle 6 is threaded into the fixation hole 55 to fasten the tether 3; and the fixation peg 53 coordinates with a needle head at a tail portion of the fixation needle 6 to fix the fixation needle 6.
In this embodiment the fixation peg 53 may be shaped as a cylinder or a circular truncated cone. A top portion of the fixation peg 53 is provided with a guide slot 56 for threading the fixation needle 6 into the fixation hole 55. The guide slot 56 is located within the same vertical plane as a center axis of the fixation hole 55 for transversely guiding the fixation needle 6 to enter the fixation hole 55, which facilitates the smooth threading of the fixation needle into the fixation hole.
In a preferred embodiment, a top face of the fixation peg 53 is higher than the top of the fixation hole 55, for example, at a height difference H of 0.2-2 mm. In this way, when the fixation needle 6 enters the fixation hole 55 via the guide slot 56, it is necessary for the fixation needle 6 to undergo certain bending deformation due to the height difference so as to enter the fixation hole 55. As such, when the fixation needle 6 enters the fixation hole 55 but does not reach a final position, the fixation needle 6 is prevented from disengaged from the fixation hole 55 due to bending deformation resistance, such that the reliability of the fixation needle 6 can be ensured in a pre-installation state. The height setting of the fixation peg 53 is of particular importance. If the fixation peg 53 is configured too low, the bending strength of the fixation needle is insufficient, such that the steadiness of pre-installation cannot be ensured; and if the fixation peg 53 is configured too tall, the fixation peg 53 is difficult to install or even cannot be installed.
The guide slot 56 may also be disposed as a cambered-surface longitudinal flat slot that inclines downwards from the top face of the fixation peg 53 to the fixation hole 55. As shown in FIGS. Sand 6, the fixation needle 6 can be inserted and pre-fixed more easily.
In this embodiment, the fixation needle 6 includes a needle tip 61, a needle stem 62 and a needle head 63. The needle head 63 has an annular rod that is connected to a tail portion of the needle stem 62.A cross-sectional shape of the fixation peg 53 matches an inner annular structure of the annular rod, such that after the fixation needle 6 reaches a final insertion position, the annular rod can be sleeved and clamped on the pedphery of the fixation peg 53 to finally fix the fixation needle 6, thereby reliably fixing the fixation needle 6 longitudinally, transversely and vertically. T his not only ensures the short-term using effect but also ensures the long-term using effect of the fixation needle, showing strong steadiness without the risk of disengagement.
In this embodiment, the fixation needle 6 is made of an ultra-elastic material of a nickel-titanium alloy or nitinol, preferably the nickel-titanium alloy. With the ultra-elastic material, the bending deformation of the fixation needle 6 inserted into the fixation hole 55 can be realized; the pre-i nstal I ati on fixation of the fixation needle can be realized by virtue of resistance to the bending deformation; and after reaching a final insertion position, the fixation needle 6 may rebound to its original state to firmly fix the fixation needle at the final position.
Specifically, the inner structure of the annular rod of the fixation needle 6 may be shaped as a circle, a square, an ellipse, a triangle or other forms, as long as the annular rod is ensured to be accurately sleeved on the periphery of the fixation peg 53.
A cross-sectional shape of the fixation needle 6 may be shaped as a circle, or a triangle, a square, an ellipse, a rhombus, a star or other forms. The thickness dimension of the fixation needle 6 may be designed as required, which generally tends to be smaller than the dimension of the tether 3. Preferably, the thickness of the fixation needle 6 is in a range of 0.5-2 mm, more preferably 1 mm. If the fixation needle is too thin and soft without sufficient hardness, it tends to be disengaged during initial installation, leading to a surgical accident; and if the fixation needle is too thick and hard with high hardness, it is difficult to thread the needle, which increasing the difficulty in threading.
Moreover, in this embodiment the disk face 51 and the fixation block 52 may be in a split structure or an integrally molded structure. The fixation block 52 is further provided with an installation insertion hole 57 that is staggered from the fixation hole 55. A peripheral structure of the fixation block 52 may be disposed as a rectangular structure, or a circular or D-shaped structure, as long as the connection between the fixation block 52 and an external clamping delivery tool may be facilitated.
In this embodiment, the occlusion disk 5 is made of an implantation-level plastic material with the density of about 1 g/cm3, such as polyether ether ketone (PE E K), polyethylene (PE, including U H MW PE and XL PE), polytetrafluoroethylene (PT F E), polyethylene glycol terephthalate (PET), polypropylene (PP), polystyrene (PVC) and other materials, preferably PE. On one hand, the above materials have low structural density, light weight and ultra-strong elasticity, with properties that can better meet the requirement of the cardiac-apex pad. On the other hand, the above materials are readily available with the advantages of low cost thereby greatly reducing the production cost. However, the disk of the cardiac-apex pad in the existing Tenclyne product is made of PEEK, with a main reason lying in that its complex and small structure needs to keep sufficient strength, and other materials cannot meet its structural requirements. In this embodiment, due to different needle threading principle, the cardiac-apex pad is not highly dependent on the strength of the parts, such that the materials can be flexibly selected.
In addition, in this embodiment, the occlusion disk 5 has an easier and more convenient processing process, and may be generally processed by traditional machining equipment wherein two procedures are only needed by using a three-axis milling machine or carving machine. Therefore, the processing cost is low, and the product stability is better after mass production.
In the threaded-needle fastening cardiac-apex pad 4 for the cardiac valve replacement prosthesis according to this embodiment during an actual surgical procedure, the disk 5 and the fixation needle 6 are pre-assembled to ensure that the needle tip does not come out of the center holes 54 in which the tether 3 is threaded.
Otherwise, the tether 3 may not be adjusted during the surgery. T hen, after the tether 3 is adjusted to a proper length, the fixation needle 6 is continuously pushed in to pass through the tether 3; the needle head 63 is sleeved on the periphery of the fixation peg 53; the needle stem 62 bears a tension force produced by the tether 3, thereby fastening the tether 3 and simultaneously fix the occlusion disk 5 at a punctured mouth of the cardiac apex to occlude the punctured mouth of the cardiac apex.
Embodiment 2 This embodiment is different from Embodiment 1 described above in that as shown in FIG. 8, the fixation peg 53 is elastically and vertically disposable on the disk face 51, which is more conducive to the pre-installation and final positioning of the fixation needle 6.
Specifically, the disk face 51 is provided with a necked blind hole 59 containing an elastic member 58 therein. A bottom portion of the fixation peg 53 is fixed inside the necked blind hole 59, such that the fixation peg 53 may move up and down under the action of the elastic member and may also be prevented from disengagement.
In this way, for the threaded-needle fastening cardiac-apex pad 3 according to this embodiment, due to the combination of the ultra-elastic property of the fixation needle 6 per se and the elasticity of the elastic member, the fixation needle 6 when assembled is more easily inserted into the fixation hole 55 of the disk 5; and by virtue of the rebounding force of the elastic member, the fixation needle is steadier during pre-installation and is less likely to disengage.
Other parts of this embodiment are the same as those of the embodiment above, and will not be repeated in detail any more.
E mbodinnent 3 This embodiment is different from Embodiment 1 described above in that as shown in FIGS. 9 to 12, the top portion of the fixation peg 53 is further provided with a transverse clamping slot 60 that matches the annular rod of the needle head of the fixation needle 6; and a center axis of the transverse clamping slot 60 is on the same horizontal plane as the center axis of the fixation hole 55. The transverse clamping slot 60 is configured to clamp the annular rod of the needle head therein when the fixation needle 6 is continuously pushed into the fixation hole 55 to pass through the tether 3 to reach the final fixation position, thereby fixing the fixation needle longitudinally, transversely and vertically. Moreover, since the center axis of the transverse clamping slot 60 is on the same horizontal plane as the center axis of the fixation hole 55, the fixation needle 6 can be kept in a natural straight state without any bending resistance, such that the fixation needle 6 does not act in a long-term fatigue state and may present a long-lasting and steady puncturing and fastening effect.
Still, based on the design structure of this embodiment the needle head of the fixation needle 6 may also include a vertical transverse rod connected to the needle stem, i.e., forming a T-shaped fixation needle. In this way, the top portion of the fixation peg 53 is provided with the T-shaped clamping slot matching the vertical transverse rod. Likewise, the center axis of the T-shaped clamping slot is on the same horizontal plane as the center axis of the fixation hole, thereby fixing the fixation needle longitudinally, transversely and vertically.
In addition, the fixation peg 53 in this embodiment may also configured into a structure of movable fixation peg as in Embodiment 2, which similarly achieves the technical effects of facilitating installation and securing the pre-installation and final positioning of the fixation needle 6.
According to the present invention, the process of threading the fixation needle and fastening the tether is simplified by improving the structure of the disk and in combination with the improved arrangement of the fixation needle and the fixation peg, such that the tether can be fastened more visually and conveniently, and the fixation can be implemented longitudinally, transversely and vertically in an all-round way; moreover, the pre-installation and final state of the fixation needle can be secured by virtue of the ultra-strong elastic property of the fixation needle and the coordination of the fixation needle and the fixation peg, thereby ensuring the steadiness and reliability of the fixation needle in short-term and long-term uses.
In the description of the present invention, it should be noted that the terms such as 'up_, 'down_, 'front_, and 'back_ indicate directions or positional relations based on the directions or positional relations as shown in the accompanying drawings only for the convenience of describing the present invention and simplifying the description, instead of indicating or implying that a mentioned device or element must have a specific direction or must be constructed and operated in a specific direction. Therefore, these terms should not be construed as limiting the present invention.
In the description of the present invention, it should be noted that, unless otherwise expressly specified and defined, the terms " i nstal I", "connect", and "couple" should be understood in a broad sense. For example, a connection may be a fixation connection, a detachable connection or an integral connection; may be a mechanical connection or an electrical connection, may be a direct connection, or an indirect connection via an intermediate medium, or an internal connection between two elements. For those of ordinary skills in the art, the specific meanings of the above terms in the present invention can be understood in a specific context.
The above description only provides preferred embodiments of the present invention, and is not intended to limit the present invention in any form. Some simple alternations, equivalent variations or modifications made by those skilled in the art by using the technical content disclosed above shall fall within the protection scope of the present invention.

Claims (14)

  1. Claims 1. A threaded-needle fastening cardiac-apex pad for a cardiac valve replacement prosthesis, comprising an occlusion disk and a fixation needle, wherein the occlusion disk comprises a disk face, a fixation block disposed on a lateral portion of the disk face, and a fixation peg disposed at the same side with the fixation block; the disk face and the fixation block are provided with interconnected center holes for threading a tether to connect inner and outer stents in the cardiac valve replacement prosthesis; the fixation block is provided with a fixation hole that is perpendicular to and connected with the center holes; the fixation needle is threaded into the fixation hole to fasten the tether; and the fixation peg coordinates with a tail portion of the fixation needle to fix the fixation needle.
  2. 2. T he threaded-needle fastening cardiac-apex pad for the cardiac valve replacement prosthesis according to Claim 1, wherein a top portion of the fixation peg is provided with a guide slot for threading the fixation needle into the fixation hole; and the guide slot and a center is of the fixation hole are located within the same vertical plane.
  3. 3. T he threaded-needle fastening cardiac-apex pad for the cardiac valve replacement prosthesis according to Claim 2, wherein a top face of the fixation peg is 0.2-2 mm higher than a top portion of the fixation hole.
  4. 4. T he threaded-needle fastening cardiac-apex pad for the cardiac valve replacement prosthesis according to Claim 3, wherein the guide slot is disposed as a cambered-surface longitudinal flat slot that inclines downwards from the top face of the fixation peg to the fixation hole.
  5. 5. T he threaded-needle fastening cardiac-apex pad for the cardiac valve replacement prosthesis according to Claim 4, wherein the fixation needle has a thickness dimension of 0.5-2 mm, with a cross section shaped as a circle, a triangle, a square, an ellipse, a rhombus or a star.
  6. 6. T he threaded-needle fastening cardiac-apex pad for the cardiac valve replacement prosthesis according to Claim 4, wherein the fixation peg is elastically and vertically disposable on the disk face.
  7. 7. T he threaded-needle fastening cardiac-apex pad for the cardiac valve replacement prosthesis according to Claim 6, wherein the disk face is provided with a blind hole containing an elastic member inside; a bottom portion of the fixation peg is fixed inside the blind hole; and the fixation peg moves up and down under the action of the elastic member.
  8. 8. T he threaded-needle fastening cardiac-apex pad for the cardiac valve replacement prosthesis according to any one of Claims 1 to 7, wherein the fixation needle comprises a needle tip, a needle stem and a needle head; the needle head has an annular rod that is connected to a tail portion of the needle stem; and a cross-sectional shape of the fixation peg matches an inner annular structure of the annular rod.
  9. 9. T he threaded-needle fastening cardiac-apex pad for the cardiac valve replacement prosthesis according to Claim 8, wherein the inner structure of the annular rod is shaped as a circle, a square, an ellipse or a triangle.
  10. 10. T he threaded-needle fastening cardiac-apex pad for the cardiac valve replacement prosthesis according to any one of Claims 1 to 7, wherein the fixation needle comprises a needle tip, a needle stem and a needle head; the needle head has an annular rod that is connected to a tail portion of the needle stem; the top portion of the fixation peg is provided with a transverse clamping slot matching the annular rod; and a center axis of the transverse clamping slot is located on the same horizontal plane as the center axis of the fixation hole.
  11. 11.T he threaded-needle fastening cardiac-apex pad for the cardiac valve replacement prosthesis according to any one of Claims 1 to 7, wherein the fixation needle comprises a needle tip, a needle stem and a needle head; the needle head has a vertical transverse rod that is connected to a tail portion of the needle stem; the top portion of the fixation peg is provided with a T-shaped clamping slot matching the annular head; and a center axis of the T-shaped clamping slot is located on the same horizontal plane as the center axis of the fixation hole.
  12. 12. The threaded-needle fastening cardiac-apex pad for the cardiac valve replacement prosthesis according to Claim 1, wherein the fixation needle is made of an ultra-elastic material of a nickel-titanium alloy or nitinol; and the occlusion disk is made of a material of PE, PEEK, PTFE, PET, PP or PVC.
  13. 13.T he threaded-needle fastening cardiac-apex pad for the cardiac valve replacement prosthesis according to Claim 1, wherein the disk face is integrally molded with the fixation block and the fixation peg; a peripheral structure of the fixation block is rectangular, circular or D-shaped; and the fixation block is further provided with an installation insertion hole staggered from the fixation hole.
  14. 14.A cardiac valve replacement prosthesis, comprising the threaded-needle fastening cardiac-apex pad for the cardiac valve replacement prosthesis according to any one of Claims 1 to 13.
GB2119096.2A 2021-12-23 2021-12-29 Fastening pad for a cardiac vlave replacement prosthesis Active GB2614321B (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202111592596.5A CN114099077A (en) 2021-12-23 2021-12-23 Heart valve replacement prosthesis and puncture needle fastening apex cordis pad thereof

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GB202119096D0 GB202119096D0 (en) 2022-02-09
GB2614321A true GB2614321A (en) 2023-07-05
GB2614321B GB2614321B (en) 2024-05-15

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GB (1) GB2614321B (en)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150057705A1 (en) * 2013-08-01 2015-02-26 Tendyne Holdings, Inc. Pursestring Epicardial Pad Device
CN114176843A (en) * 2021-12-30 2022-03-15 北京心脉医疗科技有限公司 Heart valve replacement prosthesis and thread-fastened apical pad thereof
CN216221860U (en) * 2021-12-23 2022-04-08 北京心脉医疗科技有限公司 Heart valve replacement prosthesis and screw fastening apex cordis pad thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150057705A1 (en) * 2013-08-01 2015-02-26 Tendyne Holdings, Inc. Pursestring Epicardial Pad Device
CN216221860U (en) * 2021-12-23 2022-04-08 北京心脉医疗科技有限公司 Heart valve replacement prosthesis and screw fastening apex cordis pad thereof
CN114176843A (en) * 2021-12-30 2022-03-15 北京心脉医疗科技有限公司 Heart valve replacement prosthesis and thread-fastened apical pad thereof

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GB202119096D0 (en) 2022-02-09
GB2614321B (en) 2024-05-15

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