CN114699124B - Rapid tissue suture implant and preparation method thereof - Google Patents

Rapid tissue suture implant and preparation method thereof Download PDF

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Publication number
CN114699124B
CN114699124B CN202210631855.9A CN202210631855A CN114699124B CN 114699124 B CN114699124 B CN 114699124B CN 202210631855 A CN202210631855 A CN 202210631855A CN 114699124 B CN114699124 B CN 114699124B
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suture
implant
anchor
shaped
shaped structure
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CN114699124A (en
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董文兴
尹济琛
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Beijing Tianxing Medical Co ltd
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Beijing Tianxing Bomaidi Medical Equipment Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166Sutures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526Methods of manufacturing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0464Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors for soft tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A61B2017/0475Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery using sutures having a slip knot
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A61B2017/0477Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery with pre-tied sutures

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

The invention relates to the technical field of tissue repair, in particular to a rapid tissue suture implant and a preparation method thereof, wherein the rapid tissue suture implant comprises: the implant adopts special penetration and knot, and has the advantages of high suturing speed, strong adaptability, low iatrogenic damage, high fault tolerance rate and low cost.

Description

Rapid tissue suture implant and preparation method thereof
Technical Field
The application relates to the technical field of tissue repair, in particular to a rapid tissue suture implant and preparation and use methods thereof.
Background
In joint surgery and sports medicine, tear repair of knee joint menisci is one of the most common operations, menisci repair operations are developed to the present, various operation methods and instruments appear, traditional tissue suture uses a needle thread type suture method, namely a larger approach is opened to facilitate needle thread reciprocating suture operation, the half menisci suture is taken as an example, the suture process is complicated, the steps are multiple, requirements on suture technology and skill of doctors are high, and the training period of the operation type is long.
The traditional surgical suture technology has high difficulty and long period, and along with the continuous development of material science and biotechnology, the medical community improves suture instruments and technologies for the first time in the last 90 th century.
The first improvement is around: 1. prefabricating a suture structure; 2. the bio-friendly implant material is carried out at two points, aiming at shortening the operation time by a prefabricated suture line and solving the problem of tissue fixation by the bio-friendly material. The prefabricated suture line avoids complex knotting operation of doctors in the suture process, can directly close wounds by the prepared suture line, effectively reduces the size of the implant on the basis of further improving the suture strength by the aid of the bio-friendly material, reduces iatrogenic damage, and is characterized in that the special suture implant of the meniscus takes polyether-ether-ketone as an anchor point and takes the prefabricated suture line as a connecting structure to suture the meniscus. Homogeneous solid implants represented by polyetheretherketone can only suture specific tissues, because each organ and tissue has different requirements on the volume, contour and fixation performance of a fixed object, and the corresponding morphological characteristics are not unique.
With the innovation of implant design, surgical techniques are developing in a direction of 'faster, smaller and cheaper', the requirements of doctors for surgical quality are also improved, and various large medical companies begin to carry out second improvement on tissue repair and connection instruments, the second improvement is mainly based on biotechnology, partial micro-trauma, medical cost and stability are abandoned, and new expensive bioabsorbable materials are largely used, and the improvement cannot widely cover all patients before the material production technology has a great revolution.
Disclosure of Invention
The application aims to provide a rapid tissue suture implant and a preparation method thereof, which are mainly applied to the repair of meniscus soft tissue and can also be used for the suture of wounds, operation incisions, ligaments, muscle tissues, blood vessels and other organ tissues; the invention provides a universal suture implant capable of suturing most tissues after comprehensively considering cost, universality and reliability, and the purpose of rapid suture is realized in a minimally invasive surgery mode by fully utilizing a flexible mechanism technology.
The technical problem to be solved by the invention is realized by adopting the following technical scheme:
a rapid tissue suturing implant, the suturing implant comprising: the suture comprises a suture body and a sliding knot mechanism, wherein the sliding knot mechanism is divided into an S-shaped structure anchor and a T-shaped structure anchor, and the suture body connects the sliding knot mechanism in series.
As a preferred example, the number of the S-shaped structure anchors can be selected to be multiple, and the number of the T-shaped structure anchors is only one and is positioned at the rearmost part of the S-shaped structure anchors.
In a preferred embodiment, the suture thread of the S-shaped structural anchor is threaded into the sliding knot mechanism in an S-shape and is threaded from one end to the other end in an S-shape, the suture thread of the T-shaped structural anchor is threaded in a portal shape, and the middle section of the T-shaped structural anchor is locked by a thread ring.
In a preferred embodiment, the gate-type insertion manner above the T-shaped structural anchor is the same as the S-type insertion manner, and the middle loop is locked and fixed by knotting with a suture.
As a preferred example, the S-shaped structural anchor and the T-shaped structural anchor interpenetrate together to constitute an ST implant.
As a preferred example, the ST implant is received in a 304 puncture tube before implantation, and a 630 cylindrical elastic inner core is provided inside the puncture tube and behind the implant.
As a preferred example, the suture body is selected from a small diameter UHMWPE surgical suture; the slip knot mechanism selects a large diameter UHMWPE surgical suture.
As a preferred example, the slip knot mechanism is a hollow fabric sleeve.
In the method for preparing the rapid tissue suture implant, the suture line of the S-shaped structure anchor penetrates into the sliding knot mechanism in an S shape and penetrates from one end to the other end in an S shape; the suture line of the T-shaped structure anchor is inserted in a door shape, the middle section of the T-shaped structure anchor is locked by a wire ring, wherein the door-shaped insertion mode above the T-shaped structure anchor is the same as the S-shaped insertion mode, and the wire ring locking structure at the middle section is knotted and fixed by the suture line.
As a preferred example, the knotting is a common "dead knot".
As a preferred example, the S-shaped structural anchor and the T-shaped structural anchor interpenetrate together to constitute an ST implant.
As a preferred example, the ST implant is received in a 304 puncture tube before implantation, and a 630 cylindrical elastic inner core is provided inside the puncture tube and behind the implant.
The invention has the beneficial effects that:
1. the suture speed is high
The sliding knot mechanism of the implant is divided into an S-shaped structure anchor and a T-shaped structure anchor, the sliding knot mechanism is connected in series by the suture line body, and special insertion and knot buckling are adopted.
The structures of the anchor and the prefabricated wire section and the use mode of puncture suture shorten the suture time, so that doctors can avoid complicated knotting operation in the operation.
2. High adaptability
The implant is mainly applied to the repair of meniscus soft tissues, and can also be used for the suture of wounds, operation cuts, ligaments, muscle tissues, blood vessels and other organ tissues, and the locking wire loop structure can adapt to the suture of various tissues; the implant of the invention is completely made of ultra-high molecular weight polyethylene material, other implants generally use polyether-ether-ketone as an anchor, and the polyether-ether-ketone anchor implant can only suture meniscus.
3. Low iatrogenic damage
The implant with the fully flexible structure has no rigid structure, has small enough size, can reduce the diameter size of the puncture tool, and is suitable for arthroscopic operation.
4. High fault tolerance rate
If the operation is wrong, the fully flexible implant can be taken out by using the wire cutter and the probe hook and can not be detained in the human body.
5. Low cost
All parts of the implant are made of suture, and the manufacturing cost is low.
Drawings
In order to more clearly illustrate the detailed description of the present application or the technical solutions in the prior art, the drawings needed to be used in the detailed description of the present application or the prior art description will be briefly introduced below, and it is obvious that the drawings in the following description are some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative efforts.
FIG. 1 is a schematic perspective view of a rapid tissue suture implant provided in accordance with an embodiment of the present application;
FIG. 2 is a cross-sectional view of FIG. 1;
FIG. 3 is a perspective view of an S-shaped structural anchor of the present application;
FIG. 4 is a perspective view of a T-shaped structural anchor of the present application;
FIG. 5 is a schematic view of a process for preparing a loop-like dead knot of the anchoring nail having a T-shaped structure;
FIG. 6 is a schematic view of the implant and the insertion instrument engaged;
FIG. 7 is a schematic view of a step of using the implant;
fig. 8 is a schematic view of the expansion deformation of the sliding knot mechanism.
Reference numerals: 1-a suture body; a 2-S type structural anchor; a 3-T structural anchor; 4-an implant; 5-puncturing a tube; 6-inner core.
Detailed Description
The technical solutions of the present application will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are only some embodiments of the present application, but not all embodiments.
The components of the embodiments of the present application, generally described and illustrated in the figures herein, can be arranged and designed in a wide variety of different configurations. Thus, the following detailed description of the embodiments of the present application, presented in the accompanying drawings, is not intended to limit the scope of the claimed application, but is merely representative of selected embodiments of the application.
All other embodiments obtained by a person of ordinary skill in the art based on the embodiments in the present application without making any creative effort belong to the protection scope of the present application.
In the description of the present application, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, and do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present application. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.
In the description of the present application, it is to be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present application can be understood in a specific case by those of ordinary skill in the art.
A self-sealing balloon according to the present application is described below with reference to fig. 1-8.
The technical problem to be solved by the invention is realized by adopting the following technical scheme:
a rapid tissue suturing implant, the suturing implant 4 comprising: the suture comprises a suture body 1 and a sliding knot mechanism, wherein the sliding knot mechanism is divided into an S-shaped structural anchor 2 and a T-shaped structural anchor 3, and the suture body 1 connects the sliding knot mechanism in series.
As a preferred example, the number of S-shaped structural anchors 2 may be selected to be plural, and the number of T-shaped structural anchors 3 is only one and is located at the rearmost part of S-shaped structural anchors 2.
As a preferred example, the suture body 1 is selected from a small diameter UHMWPE surgical suture; the sliding knot mechanism selects a large diameter UHMWPE surgical suture.
As a preferred example, the slip knot mechanism is a hollow fabric sleeve with a head end hardened.
The suture line is used as a main body of the suture and can play a role of closing a wound through the sliding knot mechanism, the suture line connects the anchors in series structurally and forms a kinematic pair by crossing the anchors, and the kinematic pair controls the relative positions of the anchors through motion from the aspect of transmission.
The anchor is used as a fixing point of the suture action and can provide a fixed constraint in the tissue, the anchor is connected in series on the suture line in terms of the composition of the structure and exists in the structure in the form of a modular unit, and the anchor pushes the surrounding tissue to be squeezed towards the middle in terms of transmission, so that the suture is completed.
In the preparation method of the rapid tissue suture implant, the suture line of the S-shaped structure anchor 2 penetrates into the sliding knot mechanism in an S shape and penetrates from one end to the other end in an S shape; the suture line of the T-shaped structure anchor 3 is inserted in a door shape, the middle section of the T-shaped structure anchor is locked by a wire ring, wherein the door-shaped insertion mode above the T-shaped structure anchor is the same as the S-shaped insertion mode, and the wire ring locking structure at the middle section is knotted and fixed by the suture line.
As a preferred example, the knotting is a common "dead knot".
As a preferred example, the S-shaped structural anchor 2 and the T-shaped structural anchor 3 interpenetrate together to constitute an ST implant.
As shown in FIG. 7, the method of using the rapid tissue suture implant comprises the steps of:
1) identifying defective or incisional tissue;
2) inserting the puncture tube 5 into one end of the wound;
3) pushing the inner core 6, at which time the first S-shaped structural anchor is pushed out;
4) the puncture tube 5 is pulled out backwards, the first anchor is pulled and restrained, and the first anchor is coiled into a knot;
5) adjusting the position of the puncture tube 5 and aiming at the other end of the wound;
6) inserting the puncture tube 5 into a predetermined position;
7) pushing the inner core 6, and pushing out the T-shaped structure anchor at the moment;
8) the puncture tube 5 is pulled out backwards, and the T-shaped structure anchor is deformed in a tensile way;
9) pulling the suture backwards, the relative distance between the S-shaped structure anchor and the T-shaped structure anchor 3 is reduced, and the pressing wound shrinks towards the middle;
10) the wound is pressed and closed by the sliding knot mechanism;
11) cutting off the redundant suture line;
12) and finishing the sewing.
The ST implant is implanted and sutured by means of a specially-made auxiliary implantation instrument; when suturing a deep tissue, an arthroscopic technique is used for the operation, and when suturing a shallow skin tissue, a puncture suture is directly performed.
As shown in fig. 6, the ST implant is accommodated in the 304 puncture tube before implantation, in the puncture tube, behind the implant, there is a 630 cylindrical elastic core, which is used to eject the ST implant one by one when the implantation action is required, the number of the ST implant is equal to the number of the core ejecting actions required for the implantation action, the core stroke is short at the first needle of the suture action, the first S-shaped structure anchor 2 can be ejected, the stroke is slightly long at the second needle, the second S-shaped structure anchor 2 can be ejected, and the core stroke required for the implantation of the last T-shaped structure 3 is longest.
As shown in fig. 8, the mechanical behavior of the implant determines that the implant has special use effects and advantages, when the S-shaped structure anchor 2 or the T-shaped structure anchor 3 is stressed at both ends, the material gathers towards the middle, the length is shortened, but the diameter is increased (poisson effect), and at this time, the diameter of the anchor is larger than the pore channel, and the anchor is clamped at the outer side of the pore channel to complete the fixing function.
From the transmission point of view, each anchor belongs to a sliding pair, the size of a locking wire ring is determined by the position of the sliding pair T formed by the T-shaped structure anchor, the sliding pair T moves forwards, the wire ring becomes smaller, the sliding pair T moves backwards, the wire ring becomes larger, and the position of the wire ring and the anchor is adjusted by the sliding pair S formed by the S-shaped structure anchor.
Alternatively, the implantation tool can be replaced by a special implanter or a suture needle and a probe hook; there may be any number of S-shaped structural anchors, but only one T-shaped structural anchor, depending on the length of the suture wound; all parts of the implant can be made of absorbable suture, depending on the suture site.
Finally, it should be noted that: the above embodiments are only used to illustrate the technical solutions of the present application, and not to limit the same; although the present application has been described in detail with reference to the foregoing embodiments, it should be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present application.

Claims (9)

1. A rapid tissue suturing implant,
the suture implant (4) comprises: the suture comprises a suture body (1) and a sliding knot mechanism, wherein the sliding knot mechanism is divided into an S-shaped structural anchor (2) and a T-shaped structural anchor (3), and the suture body (1) connects the sliding knot mechanism in series; the number of the S-shaped structure anchors (2) can be selected to be multiple, the number of the T-shaped structure anchors (3) is only one, and the T-shaped structure is positioned at the rearmost part of the S-shaped structure anchors (2); the suture line of the S-shaped structure anchor (2) penetrates into the sliding knot mechanism in an S shape and penetrates from one end to the other end in an S shape, the suture line of the T-shaped structure anchor (3) penetrates in a portal shape, and the middle section of the T-shaped structure anchor is locked by a wire ring; the door-shaped penetrating mode above the T-shaped structure anchor (3) is the same as the S-shaped penetrating mode, and the wire ring at the middle section is locked and knotted and fixed by using a suture.
2. A rapid tissue suture implant according to claim 1, characterized in that said S-shaped structural anchors (2) and said T-shaped structural anchors (3) are interpenetrated to constitute an ST implant.
3. A rapid tissue suturing implant according to claim 2, wherein the ST implant is received in a 304 puncture tube (5) before implantation, inside the puncture tube, behind the implant, with a 630 cylindrical elastic inner core (6).
4. A rapid tissue suturing implant according to claim 1, characterized in that the suture body (1) is selected from a small diameter UHMWPE surgical suture; the slip knot mechanism selects a large diameter UHMWPE surgical suture.
5. The rapid tissue suturing implant of claim 1, wherein the sliding knot mechanism is a hollow fabric sleeve.
6. A method for preparing a rapid tissue suture implant according to claim 1, wherein the suture of the S-shaped structural anchor (2) is threaded into the sliding knot mechanism in an S-shape, and is threaded in an S-shape from one end to the other end; the suture line of the T-shaped structure anchor (3) is inserted in a door shape, the middle section of the T-shaped structure anchor is locked by a wire ring, wherein the door-shaped insertion mode above the T-shaped structure anchor is the same as the S-shaped insertion mode, and the wire ring locking structure of the middle section is knotted and fixed by the suture line.
7. The method of claim 6, wherein the knot is a conventional "dead knot".
8. The method for preparing according to claim 6, wherein the S-shaped structural anchors (2) and the T-shaped structural anchors (3) are interpenetrated to constitute ST implant.
9. The method of claim 8, wherein the ST implant is received in a 304 puncture tube (5) before implantation, and a 630 cylindrical resilient inner core (6) is provided inside the puncture tube and behind the implant.
CN202210631855.9A 2022-06-07 2022-06-07 Rapid tissue suture implant and preparation method thereof Active CN114699124B (en)

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CN115192103A (en) * 2022-08-11 2022-10-18 杭州锐健马斯汀医疗器材有限公司 Implant assembly, stapler and suturing method

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US6443963B1 (en) * 2000-07-26 2002-09-03 Orthopaedic Biosystems, Ltd. Apparatus and method for repairing or reattaching soft tissue
US8652172B2 (en) * 2006-02-03 2014-02-18 Biomet Sports Medicine, Llc Flexible anchors for tissue fixation
US8961538B2 (en) * 2008-03-04 2015-02-24 Arthrex, Inc. Method and system for meniscal repair using suture implant cinch construct
JP2015510790A (en) * 2012-03-07 2015-04-13 ボストン サイエンティフィック ニューロモデュレイション コーポレイション System and method for securing an implant to tissue
EP3082618B1 (en) * 2013-12-20 2021-10-06 ArthroCare Corporation All suture device for performing a knotless tissue repair
CN207707955U (en) * 2017-04-01 2018-08-10 德州健洁医疗器械有限公司 A kind of complete interior stitching devices of tissue repair
US10675015B2 (en) * 2017-07-12 2020-06-09 Ethicon, Inc. Systems, devices and methods for delivering transfascial suture implants for securing surgical mesh to tissue
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Address after: 102628 A018, floor 1, building 1, No. 25, Jinghai Second Road, Beijing Economic and Technological Development Zone, Daxing District, Beijing

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