CN116439879A

CN116439879A - Medical implantation sheath and preparation method thereof

Info

Publication number: CN116439879A
Application number: CN202310696613.2A
Authority: CN
Inventors: 李若云; 吕晓洁; 尹佳龙; 李凌晨; 蒋冠森
Original assignee: Hangzhou Rejoin Mastin Medical Device Co ltd
Current assignee: Hangzhou Rejoin Mastin Medical Device Co ltd
Priority date: 2023-06-13
Filing date: 2023-06-13
Publication date: 2023-07-18

Abstract

The invention relates to a medical implantation sheath and a preparation method thereof, wherein the medical implantation sheath is provided with a first end and a second end which are axially far away from each other, and the medical implantation sheath comprises: the nail sheath is enclosed to form an insertion channel, and the radial dimension of the insertion channel gradually decreases from the first end to the second end; wherein, the nail sheath is a braiding piece, the stiffness of the nail sheath is larger than or equal to 30 mN.m, and the nail sheath can be elastically abutted against the inner peripheral wall of the bone canal, so that the medical implantation sheath can be implanted in the bone canal in advance. The medical implant sheath formed by braiding is made of flexible materials and has rigid characteristics, so that the medical implant sheath can be implanted into a bone canal in advance, sterility of the medical implant sheath is ensured when the medical implant sheath is implanted into the bone canal, the use mode of the medical implant sheath accords with the use habit of a doctor, and the acceptance degree of the doctor to the medical implant sheath is improved; the braided medical implant sheath has elasticity, so that the medical implant sheath can be matched with the interface screw with the difference in size.

Description

Medical implantation sheath and preparation method thereof

Technical Field

The invention relates to the technical field of medical instruments, in particular to a medical implantation sheath and a preparation method of the medical implantation sheath.

Background

In order to reduce the damage to tendons and bone tracts caused in the process of implanting the interface screw, and enhance the fixation strength of the interface screw in the bone tracts, the interface screw is usually matched with an implantation sheath for use, the implantation sheath is mounted in the bone tracts in advance, and then the interface screw is mounted on the implantation sheath; however, the traditional manufacturing process of the implantation sheath is injection molding, the implantation sheath with corresponding size is required to be matched by the interface screws with different sizes, the adaptability of the medical implantation sheath is low, the implantation sheath on the market has the characteristics of high hardness and high brittleness, and the implantation sheath is easy to crack in the implantation process, so that the operation process is influenced.

The implant sheath is prepared by braiding in patent CN112494174 a. The preparation process comprises the following steps: weaving the mesh fabric by using a weaving line, and cutting the mesh fabric into component pieces with mutually connected tail ends; and a second step of: connecting the component pieces by using a braided wire, and forming an implantation sheath with a retractable suture end; and a third step of: the interface screw is placed into the implant sheath and then the implant sheath is tightened so that the interface screw is integrally mounted with the implant sheath into the bone tunnel.

Although the woven implant sheath provided in the patent can overcome the defect that the injection molding implant sheath is easy to crack, the defect is also obvious: 1. when in use, the braiding type implantation sheath is arranged on the interface screw in vitro, then the interface screw and the implantation sheath are implanted into the bone canal together, and the operation steps are redundant before the implantation of the bone canal, so that the sterility of the product is easily damaged; 2. when the medical implant sheath is implanted, the medical implant sheath is extruded by the interface screw and the bone canal, and the knitting texture on the surface of the medical implant sheath can increase friction with the bone canal, so that the integral implantation is difficult; 3. in the prior art, a doctor firstly installs the medical implantation sheath into a bone canal, and then implants an interface screw, and the use mode of the braided implantation sheath is contrary to the operation habit of the doctor, so the applicability is low.

Disclosure of Invention

Based on this, it is necessary to provide a medical implant sheath and a method for manufacturing the medical implant sheath.

The application provides a medical implant sheath having a first end and a second end axially remote from each other, the medical implant sheath comprising:

a tack sheath circumscribing an insertion channel, the insertion channel having a radial dimension that gradually decreases from the first end to the second end;

wherein the nail sheath is a braiding piece, the stiffness of the nail sheath is larger than or equal to 30 mN.m, and the nail sheath can be elastically abutted against the inner peripheral wall of the bone canal, so that the medical implantation sheath can be implanted in the bone canal in advance.

The medical implant sheath is made of flexible materials and has rigid characteristics, so that the medical implant sheath can be implanted into a bone canal in advance, sterility of the medical implant sheath is ensured when the medical implant sheath is implanted into the bone canal, the use mode of the medical implant sheath accords with the use habit of a doctor, and the acceptance degree of the doctor to the medical implant sheath is improved; the braided medical implant sheath has elasticity, so that the medical implant sheath can be matched with the interface screw with the difference in size, and the suitability of the medical implant sheath is improved.

In one embodiment, the sheath includes at least one flap body circumscribing the insertion channel, the flap body being woven from one of the braided wires.

By the arrangement, the knitting time of the nail sheath is shortened, the manufacturing efficiency of the medical implantation sheath is improved, and the production cost of the medical implantation sheath is reduced; the number of joints generated by braiding the sheath is reduced, the probability of loosening or breaking the joints is reduced or avoided, and the stability of the medical implantation sheath is improved.

In one embodiment, the stiffness of the braided wire is greater than 0.5 mN.m, the diameter of the braided wire is 0.15mm to 1.3mm, the number of warp-wise stitches of the braided lines is more than or equal to 7/cm, and the number of weft-wise lines of the braided lines is more than or equal to 7/cm.

When the stiffness of the knitting yarn is larger than 0.5 mN.m, the requirements of the stiffness of the valve body can be met through knitting; the number and the spacing of the knitting wires on the unit area of the valve body in the radial direction and the weft direction can meet the knitting requirements of the valve body such as the required stiffness, and the like, the stability of the valve body knitted and formed by the knitting wires is improved, the uncomfortable feeling of a patient caused by the implantation of the medical implantation sheath is reduced or avoided, and a doctor is convenient to install the medical implantation sheath into the bone canal of the patient in advance.

In one embodiment, the braided wire is a surgical suture.

So set up, the biological fusion nature of operation suture line is good, avoids braided wire to make the patient appear rejection reaction at the postoperative, improves patient's postoperative quality of life.

In one embodiment, the surgical suture is an absorbable material and/or a non-absorbable material, and the surgical suture is a levorotatory lactide polymer, a copolymer of levorotatory lactide and dextrorotatory lactide, or a copolymer of levorotatory/dextrorotatory lactide and glycolide.

The surgical suture is low in price, high in strength and small in rejection reaction of patients, the production cost of the medical implantation sheath is reduced, and the universality of the medical implantation sheath is improved.

In one embodiment, the medical implant sheath further comprises a bottom ring, the bottom ring being an internally hollow ring shape, the bottom ring being located at the second end; the bottom ring is the knitting starting point of the nail sheath.

The bottom ring is arranged in such a way that the air pressure in the bone canal after the medical implantation sheath is implanted is kept balanced, so that the difference value of the air pressure at the two sides of the second end in the bone canal after the medical implantation sheath is installed is avoided, and the stability of the medical implantation sheath installed in the bone canal is improved; the hollow bottom ring in the interior provides an avoidance space for the installation of the interface screw, so that the screw head of the interface screw is prevented from wearing the bottom ring when the interface screw is installed, and the stiffness and stability of the medical implantation sheath are improved; the medical implant sheath is convenient to weave, the medical implant sheath is indirectly connected through the bottom ring, the weaving cost of the medical implant sheath is reduced, the distance between the nail sheaths is controllable, and the stability of the bottom ring and the nail sheaths is improved, so that the stability of the medical implant sheath is improved.

In one embodiment, the medical implant sheath has a fixation strength within the bone tunnel of not less than 1KN.

The interface screw is installed in the bone canal through the medical implantation sheath, so that the stability of the interface screw after the installation is finished is improved, and the stability of the tendon fixed by the interface screw in the bone canal is improved.

The application also provides a preparation method of the medical implant sheath, which is based on the medical implant sheath and comprises the following steps:

step S1, preparing the braided wire, and braiding the braided wire into the first intermediate;

s2, adjusting the shape of the first intermediate body so that at least two first intermediate bodies enclose to form the insertion channel, wherein the first intermediate body is provided with the first end and the second end which are axially far away from each other, and the radial dimension of the insertion channel is gradually reduced from the first end to the second end;

step S3, heating the first intermediate to the melting temperature of the braided wire, and adjusting the temperature to the crystallization temperature of the braided wire to harden and shape the braided wire after melting and bonding;

and S4, obtaining the medical implant sheath with the stiffness of the nail sheath being greater than or equal to 30 mN.m, wherein the nail sheath can be elastically abutted against the inner peripheral wall of the bone canal, and the nail sheath can be pre-implanted into the bone canal as the medical implant sheath.

The medical implant sheath is made of flexible materials and has rigid characteristics, so that the medical implant sheath can be implanted into a bone canal in advance, sterility of the medical implant sheath when being implanted into the bone canal is ensured, the use mode of the medical implant sheath accords with the use habit of a doctor, and the acceptance of the doctor to the medical implant sheath is improved; the medical implantation sheath can be solidified and shaped after being melted, so that the stability of the medical implantation sheath can be improved, and the surface of the medical implantation sheath can be smooth after being melted, so that the medical implantation sheath can be smoothly installed into a bone canal, and the installation time of the medical implantation sheath is shortened.

In one embodiment, the step S1 includes:

step S10, preparing the braided wire, and braiding the braided wire into the first intermediate, wherein the first intermediate comprises at least two valve bodies;

the step S2 includes:

step S21, placing the first intermediate into a containing groove of a first die, placing a second die into the middle of at least two valve bodies, and pressing the first intermediate onto the peripheral wall of the containing groove by using the second die, so that the at least two valve bodies are enclosed to form the insertion channel, wherein the first intermediate is provided with a first end and a second end which are axially far away from each other, and the radial dimension of the insertion channel is gradually reduced from the first end to the second end;

the step S4 includes:

and S40, obtaining the medical implantation sheath with the stiffness of the valve body being greater than or equal to 30 mN.m, wherein the nail sheath can be elastically abutted against the inner peripheral wall of the bone canal through the valve body, so that the medical implantation sheath can be implanted in the bone canal in advance.

The arrangement is convenient for the medical implantation sheath to be implanted into the bone canal in advance, and shortens the installation time of the medical implantation sheath, thereby shortening the overall time consumption of the operation; the medical implantation sheath is formed by extrusion by matching the first die and the second die, so that the surface of the valve body is smoother, abrasion of the surface of the valve body or the surface of the bottom ring to bone tracts and/or tendons during installation is avoided, and the stability and applicability of the medical implantation sheath are improved; promote the growth and healing of the postoperative bone canal after operation.

In one embodiment, the step S3 includes:

step S31, heating the first intermediate to the melting temperature of the braided wire, wherein the melting temperature is 160-220 ℃ and the heating time is 1-5 min; adjusting the temperature to the crystallization temperature of the braided wire, wherein the crystallization temperature is 90-130 ℃, and the heating time is 0.5-2 h; cooling to room temperature, and hardening and shaping the braided wire after fusion bonding.

The medical implant sheath has the advantages that the stiffness of the medical implant sheath after fusion hardening molding is improved, a doctor is convenient to install the medical implant sheath in the bone canal in advance, the fusion temperature and the crystallization temperature of the braided wire are far higher than the in-vivo temperature of a patient no matter what medical treatment is accepted, the stability of the medical implant sheath in the bone canal is improved, the time required for preparing the medical implant sheath is short, the production efficiency of the medical implant sheath is improved, and the production cost of the medical implant sheath is reduced.

Drawings

FIG. 1 is a schematic view of a medical implant sheath according to an embodiment of the present invention;

FIG. 2 is a flow chart illustrating the cooperation of the medical implant sheath and the second mold;

FIG. 3 is a block diagram of the fabrication of a first mold, a second mold, and a medical implant sheath;

FIG. 4 is a diagram of the weave architecture of the valve body;

FIG. 5 is a diagram of the structure of the knitting at another step in the valve body knitting process;

FIG. 6 is a diagram of the structure of the knitting at another step in the process of knitting the valve body;

FIG. 7 is a diagram of the structure of the knitting at another step in the valve body knitting process;

fig. 8 is a diagram of the structure of the knitting at another step in the process of knitting the valve body.

Reference numerals:

100. a medical implant sheath; 10. a first end; 20. a second end; 30. a valve body; 31. braiding wires; 40. a bottom ring; 60. a first mold; 61. a receiving groove; 70. a second mold; 1. an insertion channel; 201. a first braided wire; 202. a second braided wire; 203. a first knitted loop; 204. a first layer of woven structure; 205. a second layer of knitted loops; 206. an empty braiding ring; 207. an nth layer braiding ring; 208. braiding a wire at the tail end; 209. an n-th layer of empty braiding rings; 210. a first ending braid; 211. a second ending braid; 212. a connecting ring; 90. and (5) nailing the sheath.

Detailed Description

In order that the above objects, features and advantages of the invention will be readily understood, a more particular description of the invention will be rendered by reference to the appended drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. The present invention may be embodied in many other forms than described herein and similarly modified by those skilled in the art without departing from the spirit of the invention, whereby the invention is not limited to the specific embodiments disclosed below.

In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings are merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the device or element being referred to must have a specific orientation, be configured and operated in a specific orientation, and therefore should not be construed as limiting the present invention.

Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include at least one such feature. In the description of the present invention, the meaning of "plurality" means at least two, for example, two, three, etc., unless specifically defined otherwise.

In the present invention, unless explicitly specified and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; either directly or indirectly, through intermediaries, or both, may be in communication with each other or in interaction with each other, unless expressly defined otherwise. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.

In the present invention, unless expressly stated or limited otherwise, a first feature "up" or "down" a second feature may be the first and second features in direct contact, or the first and second features in indirect contact via an intervening medium. Moreover, a first feature "above," "over" and "on" a second feature may be a first feature directly above or obliquely above the second feature, or simply indicate that the first feature is higher in level than the second feature. The first feature being "under", "below" and "beneath" the second feature may be the first feature being directly under or obliquely below the second feature, or simply indicating that the first feature is less level than the second feature.

It will be understood that when an element is referred to as being "fixed" or "disposed" on another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like are used herein for illustrative purposes only and are not meant to be the only embodiment.

Referring now to fig. 1, fig. 1 is a schematic view illustrating a medical implant sheath 100 according to an embodiment of the present invention.

Referring to fig. 2 to 3, the present application provides a medical implant sheath 100, the medical implant sheath 100 having a first end 10 and a second end 20 axially distant from each other, the medical implant sheath 100 comprising:

the nail sheaths 90 are enclosed to form an insertion channel 1, and the radial dimension of the insertion channel 1 gradually decreases from the first end 10 to the second end 20;

wherein, the nail sheath 90 is a braiding part, the stiffness of the nail sheath 90 is larger than or equal to 30 mN.m, and the nail sheath 90 can be elastically abutted against the inner peripheral wall of the bone canal, so that the medical implant sheath 100 can be implanted in the bone canal in advance.

The medical implant sheath 100 formed by braiding is made of a flexible material and has a rigid characteristic, so that the medical implant sheath 100 can be implanted into a bone canal in advance, sterility of the medical implant sheath 100 is ensured when the medical implant sheath 100 is implanted into the bone canal, the use mode of the medical implant sheath 100 accords with the use habit of a doctor, and the acceptance of the medical implant sheath 100 by the doctor is improved; the braided medical implant sheath 100 has elasticity, so that the medical implant sheath 100 can be adapted to interface screws with differences in size, and the adaptability of the medical implant sheath is improved.

It should be noted that "stiffness" in the present application refers to the ability of the petals 30 to resist radial loads without deformation.

Stiffness may be obtained in the following manner: a load was applied to the vertically clamped specimen 5cm from the jig, and a bending moment required for bending the specimen to 15℃from the center line of the specimen by a width of 3.81mm was observed.

Referring to fig. 1-3, in one embodiment, the sheath 90 includes at least one valve body 30, the valve body 30 enclosing an insertion channel 1, the valve body 30 being woven from a single woven wire 31.

By the arrangement, the knitting time of the nail sheath 90 is shortened, the manufacturing efficiency of the medical implant sheath 100 is improved, and the production cost of the medical implant sheath 100 is reduced; the number of joints generated by braiding the sheath 90 is reduced, the probability of loosening or breaking the joints is reduced or avoided, and the stability of the medical implant sheath 100 is improved.

Referring to fig. 1 to 3, in one embodiment, the sheath 90 includes at least two petals 30, at least two petals 30 are enclosed to form an insertion channel 1, and each petal 30 is woven from a single woven wire 31.

The shape of the insertion channel 1 formed by enclosing at least two valve bodies 30 is adjusted according to the shape of the bone canal, so that the medical implantation sheath 100 is convenient to install, and the installation time of the medical implantation sheath 100 is shortened; the number of joints of the nail sheath 90 is small, the probability of joint loosening is reduced, the comfort of the medical implant sheath 100 is improved, and the stability of the medical implant sheath 100 is improved; the at least two petals 30 provide the medical implant sheath 100 with an expanding clearance to facilitate the medical implant sheath 100 to accommodate different sized interface screws.

In one embodiment, the tack sheath 90 includes at least two petals 30, with a space between at least two petals 30 to facilitate placement of each petal 30 into a mold for thermosetting molding.

Alternatively, the stiffness of the braided wire 31 is implemented to be greater than 0.5 mN.m in the present embodiment, and in other embodiments of the present application, the stiffness of the braided wire 31 may be implemented to be equal to or less than 0.5 mN.m as long as the braiding and installation of the medical implant sheath 100 are facilitated.

Alternatively, in the present embodiment, the tack sheath 90 is implemented to include at least two petals 30, and in other embodiments of the present application the tack sheath 90 may be implemented to include one petal 30, so long as the medical implant sheath 100 is pre-installed within the bone canal.

Alternatively, in the present embodiment, the knitting method of the valve body 30 and/or the bottom ring 40 is implemented as a plain knitting, and in other embodiments of the present application, the knitting method of the valve body 30 and/or the bottom ring 40 may be implemented as a knitting method such as a twill knitting, a closed-weave knitting, and/or a twisting knitting method, so long as the knitting and the installation of the medical implant sheath 100 are facilitated.

Optionally, in this embodiment, the veins of the valve body 30 and/or the bottom ring 40 are implemented as square plain weave, and in other embodiments of the present application, the veins of the valve body 30 and/or the bottom ring 40 may be implemented as rectangular twill, diamond plain weave, etc., so long as the braiding and installation of the medical implant sheath 100 are facilitated.

It is understood that the above-described knitting lines and knitting patterns may be adaptively combined, so long as the medical implant sheath 100 formed by knitting can be pre-installed in the bone tunnel and has a certain fixing strength.

Referring to fig. 1 to 3, in one embodiment, the stiffness of the knitting yarn 31 is greater than 0.5mn·m, the diameter of the knitting yarn 31 is 0.15mm to 1.3mm, the number of warp stitches of the knitted texture is equal to or greater than 7/cm, and the number of weft stitches of the knitted texture is equal to or greater than 7/cm.

When the stiffness of the braided wire 31 is larger than 0.5mn·m, the stiffness requirement of the flap body 30 can be satisfied by braiding; the number and the spacing of the knitting wires 31 in the radial direction and the weft direction on the unit area of the valve body 30 can meet the knitting requirements of the valve body 30 such as the required stiffness, and the like, the stability of the valve body 30 knitted by the knitting wires 31 is improved, the uncomfortable feeling of a patient caused by the implantation of the medical implantation sheath 100 is reduced or avoided, and the medical implantation sheath 100 is convenient for a doctor to install the medical implantation sheath 100 into the bone canal of the patient in advance.

Alternatively, the diameter of the braided wire 31 is implemented as 0.15mm to 1.3mm in the present embodiment, and in other embodiments of the present application, the diameter of the braided wire 31 may be implemented as less than 0.15mm or more than 1.3mm, as long as the flap 30 braided by the braided wire 31 can be pre-installed in the bone canal of the patient and has a certain fixing strength.

Optionally, in this embodiment, the number of warp stitches of the post-weaving texture is greater than or equal to 7/cm, the number of weft stitches of the post-weaving texture is greater than or equal to 7/cm, and in other embodiments of the present application, the number of warp stitches of the post-weaving texture is less than 7/cm, and the number of weft stitches of the post-weaving texture is less than 7/cm, as long as the flap 30 formed by weaving the woven wire 31 can be pre-installed in the bone canal of the patient.

Referring to fig. 1 to 8, in one embodiment, the braided wire 31 is a surgical suture.

So set up, the biological fusion nature of operation suture line is good, avoids braided wire 31 to make the patient appear rejection reaction at the postoperative, improves patient's postoperative quality of life.

Referring to fig. 1 to 8, in one embodiment, the surgical suture is made of absorbable and/or non-absorbable material, and the surgical suture is made of a poly (l-lactide), a copolymer of l-lactide and d-lactide, or a copolymer of l/d-lactide and glycolide.

The arrangement has the advantages of low price, high strength and small rejection reaction of patients of the surgical suture, reduces the production cost of the medical implantation sheath 100, and improves the universality of the medical implantation sheath 100.

Alternatively, the surgical suture made of absorbable material in this embodiment is implemented as a levorotatory lactide polymer, a copolymer of levorotatory lactide and dextrorotatory lactide, or a copolymer of levorotatory/dextrorotatory lactide and glycolide. In other embodiments of the present application, the surgical suture may be implemented as a surgical suture such as a catgut or a purely natural collagen suture, as long as the surgical suture for braiding the medical implant sheath 100 can be pre-installed in the bone canal of the patient.

Referring to fig. 1-3, in one embodiment, the medical implant sheath 100 further comprises a bottom ring 40, the bottom ring 40 being a hollow-interior ring, the bottom ring 40 being located at the second end 20; the bottom ring 40 is the braiding origin of the spike sheath 90. So arranged, the bottom ring 40 keeps the air pressure in the bone canal after the medical implant sheath 100 is implanted to be balanced, so that the difference between the air pressures at two sides of the second end 20 in the bone canal after the medical implant sheath 100 is installed is avoided, and the stability of the medical implant sheath 100 installed in the bone canal is improved; the hollow bottom ring 40 provides avoidance space for the installation of the interface screw, so that the screw head of the interface screw is prevented from wearing the bottom ring 40 during the installation of the interface screw, and the stiffness and stability of the medical implant sheath 100 are improved; the braiding of the nail sheath 90 is facilitated, the nail sheath 90 of the medical implant sheath 100 is indirectly connected through the bottom ring 40, the braiding cost of the medical implant sheath 100 is reduced, the distance between the nail sheaths 90 is controllable, and the stability of the bottom ring 40 and the nail sheath 90 is improved, so that the stability of the medical implant sheath 100 is improved.

Alternatively, in the present embodiment, the bottom ring 40 is implemented at the second end 20, and in other embodiments of the present application, the bottom ring 40 may be implemented at the first end 10, so long as the stability of the medical implant sheath 100 after installation can be improved.

Alternatively, in the present embodiment, the bottom ring 40 is implemented as a ring shape having a hollow interior, and in other embodiments of the present application, the interior of the bottom ring 40 may be implemented as a mesh fabric, so as to provide a buffer when the interface screw is installed, and improve the installation accuracy of the interface screw, so long as the stability of the medical implant sheath 100 after installation can be improved.

Alternatively, in the present embodiment, the bottom ring 40 is implemented as a knitting start point of the sheath 90, and in other embodiments of the present application, the knitting start point of the sheath 90 may be implemented as any point, and after the knitted sheaths 90 are arranged according to a desired arrangement, the sheath 90 is threaded between the sheaths to form the bottom ring 40, so long as the stiffness and stability of the medical implant sheath 100 can be pre-installed in the bone canal.

It will be appreciated that the medical implant sheath 100 is implemented as a braid-formed and no obvious ends of the braided wire 31 are exposed in the present embodiment, but that the medical implant sheath 100 may be implemented with the ends of the braided wire 31 exposed in other embodiments of the present application.

Alternatively, in the present embodiment, the number of the nail sheaths 90 is two, and in other embodiments of the present application, the number of the nail sheaths 90 may be one or more than two, so long as the stiffness and stability of the medical implant sheath 100 can be pre-installed in the bone tunnel.

Alternatively, in the present embodiment, the bottom ring 40 is implemented as a knitting start point of the nail sheath 90 to perform knitting of the medical implant sheath 100 in steps, and in other embodiments of the present application, knitting of the medical implant sheath 100 may be implemented as a knitting of an integrally formed 3D knitting technology, so long as the stiffness and stability of the medical implant sheath 100 can be pre-installed in the bone canal.

Referring to fig. 1-3, in one embodiment, the medical implant sheath 100 has a fixation strength within the bone tunnel of not less than 1KN.

With this arrangement, the interface screw is installed in the bone canal through the medical implant sheath 100, so that the stability of the interface screw after the installation is completed is improved, and the stability of the tendon fixed by the interface screw in the bone canal is improved.

The fixing strength means a force required to pull out the medical implant sheath 100 together with the interface screw after the medical implant sheath 100 is mounted in the bone tunnel.

Alternatively, in the present embodiment, the fixation strength of the medical implant sheath 100 in the bone tunnel is implemented to be not less than 1KN, and in other embodiments of the present application, the fixation strength of the medical implant sheath 100 in the bone tunnel may be implemented to be less than 1KN as long as the interface screw can be stably mounted in the bone tunnel.

Referring to fig. 1 to 8, the present application further provides a method for preparing a medical implant sheath 100, wherein the method for preparing the medical implant sheath 100 is based on the medical implant sheath 100, and includes the following steps:

step S1, preparing braided wires 31, and braiding the braided wires 31 into a first intermediate;

step S2, adjusting the shape of the first intermediate body so that at least two first intermediate bodies enclose to form an insertion channel 1, wherein the first intermediate body is provided with a first end 10 and a second end 20 which are axially far away from each other, and the radial dimension of the insertion channel 1 is gradually reduced from the first end 10 to the second end 20;

step S3, heating the first intermediate to the melting temperature of the braided wire 31, and adjusting the temperature to the crystallization temperature of the braided wire 31 to harden and shape the braided wire 31 after fusion bonding;

step S4, obtaining the medical implant sheath 100 with the stiffness of the nail sheath 90 being greater than or equal to 30 mN.m, wherein the valve body 30 can be elastically abutted against the inner peripheral wall of the bone canal, so that the medical implant sheath 100 can be implanted in the bone canal in advance.

The medical implant sheath 100 formed by braiding is made of a flexible material and has a rigid characteristic, the medical implant sheath 100 has high stability, so that the medical implant sheath 100 can be implanted into a bone canal in advance, the sterility of the medical implant sheath 100 when being implanted into the bone canal is ensured, the use mode of the medical implant sheath 100 accords with the use habit of a doctor, and the acceptance of the doctor to the medical implant sheath 100 is improved; the medical implant sheath 100 is melted and hardened to form the medical implant sheath 100, so that the stability of the medical implant sheath 100 can be improved, and the surface of the medical implant sheath 100 can be smooth due to the melting, so that the medical implant sheath 100 can be smoothly installed into a bone canal, and the installation time of the medical implant sheath 100 is shortened.

It will be appreciated that in this embodiment the radial dimension of the insertion channel 1 decreases gradually from the first end 10 towards the second end 20; when the medical implant sheath 100 is installed, the second end 20 provided with the bottom ring 40 is advanced into the bone canal, and the second end 20 can guide the first end 10 into the bone canal, facilitating the second end 20 into the bone canal.

Referring to fig. 4-8, in one embodiment,

the step S1 comprises the following steps:

step S10, preparing braided wires 31, and braiding the braided wires 31 into a first intermediate, wherein the first intermediate comprises at least two valve bodies 30;

the step S2 comprises the following steps:

step S20, adjusting the shape of a first intermediate body to enable a plurality of petals 30 to be enclosed to form an insertion channel 1, wherein the first intermediate body is provided with a first end 10 and a second end 20 which are axially far away from each other, and the radial dimension of the insertion channel 1 is gradually reduced from the first end 10 to the second end 20;

in step S21, the first intermediate is placed in the accommodating groove 61 of the first mold 60, the second mold 70 is placed between the at least two petals 30, and the first intermediate is pressed onto the peripheral wall of the accommodating groove 61 by the second mold 70, so that the at least two petals 30 are enclosed to form the insertion channel 1, the first intermediate has a first end 10 and a second end 20 that are axially far away from each other, and the radial dimension of the insertion channel 1 gradually decreases from the first end 10 to the second end 20.

The step S4 includes:

step S40, obtaining the medical implant sheath 100 with the stiffness of the valve body 30 being greater than or equal to 30 mN.m, wherein the nail sheath 90 can elastically abut against the inner peripheral wall of the bone canal through the valve body 30, so that the medical implant sheath 100 can be implanted in the bone canal in advance.

The arrangement is convenient for the medical implant sheath 100 to be implanted into the bone canal in advance, and shortens the installation time of the medical implant sheath 100, thereby shortening the overall time consumption of the operation; the first die 60 and the second die 70 are matched to enable the medical implantation sheath 100 to be shaped through extrusion, and the surface of the valve body 30 is smoother, so that abrasion to bone tracts and/or tendons is avoided when the surface of the valve body 30 or the surface of the bottom ring 40 is installed, and the stability and applicability of the medical implantation sheath 100 are improved; promote the growth and healing of the postoperative bone canal after operation.

Alternatively, in the present embodiment, one step in shaping the medical implant sheath 100 is performed by pressing the first mold 60 and the second mold 70 together, and the second mold 70 is implemented as a solid body, and in other embodiments of the present application, the medical implant sheath 100 may be shaped by only the first mold 60 or by the air pressure difference and the cooperation between the first molds 60, as long as the stability of the medical implant sheath 100 after shaping is high.

Alternatively, in the present embodiment, the second mold 70 is implemented as a solid body of a fixed shape, and in other embodiments of the present application, the second mold 70 may be implemented as a conformal mold member in which the filling with the fluid is implemented, as long as the stability after the molding of the medical implant sheath 100 is high.

It should be understood that in this embodiment, the medical implant sheath 100 is integrally and uniformly shaped, the deformation degree of each part of the medical implant sheath 100 is different in the installation and use processes, and the required stiffness of each part of the medical implant sheath 100 is different.

It should be understood that, in the present embodiment, the medical implant sheath 100 is formed by knitting one type of knitting wire 31, and in other embodiments of the present application, the bottom ring 40 and the valve body 30 of the medical implant sheath 100 may be formed by knitting a knitting wire 31 made of different materials, so long as the medical implant sheath 100 can be pre-installed in the bone canal and the abrasion to the bone canal and/or tendon is small.

Referring to fig. 4 to 8, in one embodiment, step S3 includes:

step S31, heating the first intermediate to the melting temperature of the braided wire 31, wherein the melting temperature is 160-220 ℃, and the heating time is 1-5 min; then the temperature is adjusted to the crystallization temperature of the braided wire 31, the crystallization temperature is 90 ℃ to 130 ℃, and the heating time is 0.5h to 2h; cooling to room temperature, so that the braided wire 31 is hardened and shaped after fusion bonding.

The stiffness of the medical implant sheath 100 after fusion hardening molding is improved, so that a doctor can install the medical implant sheath 100 in the bone canal in advance, the fusion temperature and crystallization temperature of the braided wire 31 are far higher than the in-vivo temperature of a patient no matter what medical treatment is accepted, the stability of the medical implant sheath 100 in the bone canal is improved, the time required for preparing the medical implant sheath 100 is short, the production efficiency of the medical implant sheath 100 is improved, and the production cost of the medical implant sheath 100 is reduced.

Alternatively, the melting temperature of the braided wire 31 is implemented at 160 ℃ to 220 ℃ and the heating period is implemented at 1min to 5min in the present embodiment; in other embodiments of the present application, the melting temperature of the braided wire 31 may be implemented to be less than 160 ℃ or more than 220 ℃, and the heating period may be implemented to be less than 1min or more than 5min, as long as the production and use of the medical implant sheath 100 are facilitated.

It is understood that in the present embodiment, when the stiffness of the braided primary intermediate is 30mn·m or more, the primary intermediate may also be implemented without melt hardening shaping, as long as the braided medical implant sheath 100 is capable of having a stiffness that enables it to be installed in the bone tunnel in advance. Alternatively, in the present embodiment, the crystallization temperature of the braided wire 31 is implemented at 90 ℃ to 130 ℃, and the heating period is implemented at 0.5h to 2h; in other embodiments of the present application, the crystallization temperature of the braided wire 31 may also be implemented to be less than 90 ℃ or greater than 130 ℃, and the heating period may also be implemented to be less than 0.5h or greater than 2h; so long as the manufacture and use of the medical implant sheath 100 is facilitated.

It will be appreciated that in this embodiment the first intermediate body has a first end 10 and a second end 20 axially remote from each other, wherein the axial direction is implemented as the alpha direction, as shown in fig. 1.

It will be appreciated that in this embodiment the radial dimension of the insertion channel 1 tapers from the first end 10 to the second end 20, wherein the radial direction is embodied as beta-direction, as shown in fig. 1.

It will be appreciated that in the present embodiment the radial dimension of the insertion channel 1 decreases gradually from the first end 10 to the second end 20, and in other embodiments of the present application the radial dimension of the insertion channel 1 may be implemented as the same as the first end 10 and the second end 20, as long as the use of the medical implant sheath 100 is facilitated.

Referring to fig. 1 to 8, in the embodiment, the medical implant sheath 100 of the present invention adopts a method of forming a super-hydrophobic polymer-based material surface, the method comprises determining a structural shape of a desired surface, determining a weaving mode of a silk screen template, and providing a super-hydrophobic surface with various shapes and grain options, such as square plain weave, rectangular twill weave, diamond plain weave, etc.; and then constructing the surface micron-sized silk screen template by weaving methods such as plain weaving, twill weaving, close-weave weaving and twisting weaving.

The present application provides a method of braiding a valve body 30, the first step being with reference to fig. 4: taking two knitting wires 31 for knitting the left flap body 30 and the right flap body 30 respectively, winding a first knitting wire 201 on a second knitting wire 202 to form a plurality of first knitting rings 203, forming a first layer knitting structure 204 by the plurality of first knitting rings 203, wherein the first layer knitting structures 204 of the two flap bodies 30 respectively occupy half of the bottom ring 40;

please refer to fig. 5 for the second step: the tail end of the first braided wire 201 sequentially bypasses the first layer of braided structure 204, tightens the first braided ring 203, sequentially forms the second layer of braided ring 205, and does not bypass the second braided wire 202 when the second layer of braided ring 205 is formed, so that the whole first braided wire 201 is kept on the same side of the second braided wire 202; after the last second layer knitting loop 205 of the second layer is completed, an additional empty knitting loop 206 is added to make the number of the second layer knitting loops 205 be +1 of the number of the first layer knitting structure 204; and so on to complete the third layer, the fourth layer, etc.;

for the third step, please refer to fig. 6: ending the knitting behavior after finishing the n-th layer of knitting turns 207, wherein the tail end knitting wires 208 respectively pass through the n-th layer of empty knitting turns 209 and the n-th layer of knitting turns 207 to form a first ending knitting turn 210, and the tail end of the right first knitting wire 201 passes through the right n-th layer of knitting turns 207 to form a second ending knitting turn 211;

fourth step please refer to fig. 7: the tail end of the first braided wire 201 sequentially forms a third ending braided loop, a fourth ending braided loop and the like on the nth layer of braided loops 207; forming a locking braid by passing the second ending braid 211 through the first ending braid 210 to lock the first ending braid 210; then sequentially passing the ending braiding ring n through the locking braiding ring n-1 until the last braiding ring forms a locking braiding ring;

fifth, referring to fig. 8, the tail end of the first braided wire 201 is locked after passing through the connecting ring 212, and then the tail end of the first braided wire 201 is pressed and sheared by passing through any braiding structure, so that braiding is completed;

repeating the above steps to complete the braiding of the other valve body 30, and finally forming the medical implant sheath 100 shown in fig. 1;

since the left and right petals 30 and 30 are knitted using one knitting wire 31, respectively, there is no hardened shear structure, and thus the knitting structure has high stability.

It will be appreciated that the above-described braiding method is merely exemplary, and that other braiding methods may be used to braid the medical implant sheath 100 of the present invention, and is not limited thereto.

The technical features of the above embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The foregoing examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.

Claims

1. A medical implant sheath, wherein the medical implant sheath has a first end and a second end axially spaced apart from each other, the medical implant sheath comprising:

2. The medical implant sheath of claim 1, wherein the staple sheath comprises at least one flap body circumscribing the insertion channel, the flap body being woven from one of the braided wires.

3. The medical implant sheath according to claim 1 or claim 2, wherein the braided wire has a stiffness of more than 0.5 mN-m, the braided wire has a diameter of 0.15mm to 1.3mm, the number of warp stitches of the braided pattern is not less than 7/cm, and the number of weft stitches of the braided pattern is not less than 7/cm.

4. A medical implant sheath according to claim 3, wherein the braided wire is a surgical suture.

5. The medical implant sheath of claim 4, wherein the surgical suture is an absorbable material and/or a non-absorbable material, and the surgical suture is a levorotatory lactide polymer, a copolymer of levorotatory lactide and dextrorotatory lactide, or a copolymer of levorotatory/dextrorotatory lactide and glycolide.

6. The medical implant sheath of claim 4, further comprising a bottom ring, the bottom ring being an internally hollow ring-shaped, the bottom ring being located at the second end; the bottom ring is the knitting starting point of the nail sheath.

7. The medical implant sheath of claim 1, wherein the medical implant sheath has a fixation strength within the bone tunnel of not less than 1KN.

8. A method for preparing a medical implant sheath, characterized in that the method for preparing a medical implant sheath is based on the medical implant sheath according to any one of claims 1 to 7, comprising the steps of:

step S1, preparing the braided wire, and braiding the braided wire into a first intermediate;

s2, adjusting the shape of the first intermediate body so that the first intermediate body surrounds the insertion channel, wherein the first intermediate body is provided with the first end and the second end which are axially far away from each other, and the radial dimension of the insertion channel gradually decreases from the first end to the second end;

and S4, obtaining a nail sheath with the stiffness of the nail sheath being greater than or equal to 30 mN.m, wherein the nail sheath can be elastically abutted against the inner peripheral wall of a bone canal, and the nail sheath serving as the medical implantation sheath can be implanted in the bone canal in advance.

9. The method for preparing a medical implant sheath according to claim 8, wherein,

the step S1 includes:

the step S2 includes:

the step S4 includes:

10. The method of preparing a medical implant sheath according to claim 9, wherein the step S3 comprises: