CN111016081B

CN111016081B - Mold and method for preparing multichannel nerve conduit

Info

Publication number: CN111016081B
Application number: CN201911294930.1A
Authority: CN
Inventors: 陈刚; 杨洪阳; 栗国贝; 孙冰冰
Original assignee: Beijing Tianxinfu Medical Appliance Co Ltd
Current assignee: Beijing Tianxinfu Medical Appliance Co Ltd
Priority date: 2019-12-16
Filing date: 2019-12-16
Publication date: 2021-12-14
Anticipated expiration: 2039-12-16
Also published as: CN111016081A

Abstract

The invention provides a mould for preparing a multichannel nerve conduit, which comprises a hollow pipe body; a first end cap is arranged at one end of the tube body and comprises a first cap body, and the first cap body is provided with a first blocking part protruding towards the interior of the tube body; the other end of the tube body is provided with a second end cap, the second end cap comprises a second cap body and a multi-needle cap, the second cap body is provided with a liquid injection port, and a second blocking part protruding towards the interior of the tube body is arranged at the liquid injection port; the multi-needle cap is mounted on the liquid injection port and is provided with a plurality of channel needles extending along the axial direction of the tube body. The application provides a multichannel nerve conduit mould, the simple easy combination of design, the edge is reserved partial length and is easily sewed up the adventitia, avoids disconnected end to expose, destroys reactions such as nerve repair internal environment and inflammation, but the body split into two halves, easily takes out, and all insert needles can once only be taken out to the many needle caps of fixed type, and the passageway is thin, avoids taking out the operation many times and destroys the passageway on every side.

Description

Mold and method for preparing multichannel nerve conduit

Technical Field

The invention relates to the technical field of medical instruments, in particular to a mold and a method for preparing a multichannel nerve conduit.

Background

Peripheral nerve defect is a common clinical sign, and when the distance of nerve defect is long and non-tension nerve end-end anastomosis cannot be realized by measures such as free nerve and the like, nerve transplantation treatment is usually required. However, allogeneic nerve transplantation faces the problem of immunological rejection, and autologous nerve transplantation has the defects of limited source, permanent absence of nerve dysfunction in a donor area and the like, so that the development of tissue engineering nerves as a substitute for nerve transplantation is an important research field for repairing nerve defects.

Three elements of tissue engineering are scaffolds, seed cells and factors. The biomaterial scaffold for constructing the tissue engineering nerve can be collectively called as an artificial nerve graft, the seed cells are mainly Schwann cells or cells with similar functions, and more used factors are neurotrophic factors.

The current research on stent materials by researchers mainly focuses on the selection and modification of materials and the structural design of the stent. The basic modes of the nerve scaffold include three types, namely a hollow single channel, built-in filler and a multi-channel. Although the traditional hollow single-channel catheter has positive effects on nerve regeneration and functional reconstruction, the traditional hollow single-channel catheter has some obvious defects that the tube diameter is too large and wrong guidance is easy to generate, and the like. The current design method of multichannel catheters and the influence on nerve regeneration are still in the basic research stage.

Application number 201310674367.7 provides a method for constructing a multichannel cavernous nerve conduit by two-time molding and a special mold, the method provided by the patent firstly prepares a single-channel conduit as an inner tube, inserts into an outer membrane cavity, injects a solution again, and performs secondary freeze drying to obtain the multichannel nerve conduit.

Application No. 201510270788.2 provides a method and mold for making a multichannel nerve conduit, which provides a mold comprising an outer tube and an inner tube with a fluid channel therein and a piston mold containing multiple channels, and introducing an active substance or cell co-culture fluid into the multiple channels while withdrawing the alloy wires at a later stage.

Application No. 201910312750.5 provides a multi-channel artificial nerve conduit and a method for preparing the same, wherein a conduit body simulates a natural nerve disruption learning channel and is prepared by a freeze-drying method, an outer conduit wall is prepared by an electrostatic spinning method, and the conduit body is adhered and compounded by an inner conduit component solution.

In addition, the method for preparing the multichannel nerve conduit is complex in forming and time-consuming, secondary freeze-drying involves rewetting of a sample subjected to primary freeze-drying, the original structure is inevitably damaged, and the double-layer structure is compounded and is easy to delaminate in the using process. In addition, the use of various chemical reagents and cross-linking agents inevitably has the problem of chemical residues, and the soaking removal also damages the structure of the finished product, so that the finished product is unstable.

Disclosure of Invention

In order to solve the above problems, the present invention aims to provide a mold which has a simple structural design and is convenient to use, and the multichannel nerve conduit is prepared by one-step molding in a freeze-drying process.

In one aspect, the present application provides a mold for preparing a multichannel nerve conduit, comprising: a hollow tube body; a first end cap is arranged at one end of the tube body and comprises a first cap body, and the first cap body is provided with a first blocking part protruding towards the interior of the tube body; a second end cap is mounted at the other end of the tube body and comprises a second cap body and a multi-needle cap, the second cap body is provided with a liquid injection port, and a second blocking part protruding towards the interior of the tube body is arranged at the liquid injection port; the multi-needle cap is mounted on the liquid injection port and is provided with a plurality of channel needles extending along the axial direction of the tube body.

The application provides a mould, can be directly when using in the tubulation solution injection tube body that is used for preparing the nerve pipe, install many needle caps in annotating the liquid mouth again, this moment a plurality of passageway needles insert the intraductal tubulation solution of intussuseption promptly, because the setting of a plurality of passageway needles, will solution together with the mould carries out the freeze-drying back, takes out many needle caps and demolishs the mould and can obtain the nerve pipe that has the multichannel. In addition, because the multi-needle cap is provided with the plurality of channel needles, the plurality of channel needles simultaneously enter the tube making solution and are taken out simultaneously after freeze-drying, the phenomenon that the surrounding channels are damaged by multiple taking-out operations is avoided, the time is saved, and the preparation efficiency is improved.

As a preferred embodiment, the length, diameter and arrangement on the multi-needle cap of the channel needle can be set according to the actual specification requirements of the multi-channel nerve conduit, such as the length, diameter and arrangement of the channel.

In a preferred embodiment, the first stopper and/or the second stopper are/is also protruded toward the inside of the tubular body in the axial direction of the tubular body. The first blocking portion and/or the second blocking portion can be tightly attached to the pipe wall of the pipe body without gaps, so that the first cap body and/or the second cap body can be more fixedly installed on the pipe body.

Further, a gap for forming the edge of the nerve conduit is formed between the first blocking part and/or the second blocking part and the tube wall of the tube body. By the arrangement, the prepared nerve conduit has a suture edge at the end, so that the nerve conduit is easier to suture the adventitia when used for repairing damaged peripheral nerves, and the reactions of exposing broken ends, damaging the internal environment of nerve repair, inflammation and the like are avoided.

In a preferred embodiment, the first blocking part and the second blocking part may be cylindrical, and in this case, an annular gap may be formed between the cylindrical blocking part and the tube wall to match the shape of the nerve conduit and form an end edge of the nerve conduit for suturing, and more preferably, the annular width of the annular gap is greater than 0.01mm and less than 1 mm.

Further, the first blocking part has a first length from one end close to the first cap body to one end far away from the first cap body, the second blocking part has a second length from one end close to the liquid injection port to one end far away from the liquid injection port, and the first length is equal to the second length.

Preferably, the first length and the second length are 1-5 mm. In one embodiment, when the first and second blocking portions are cylindrical, the first and second lengths may be understood as the distance between one circular end surface and the other circular end surface of the cylinder.

In a preferred embodiment, the first blocking portion has an end surface far from the first cap body, and when the multi-needle cap is mounted on the liquid injection port, the passage needle preferably contacts at least the end surface of the first blocking portion, that is, the length of the passage needle is not less than the length from the liquid injection port to the end surface.

Further, the first blocking part is provided with a needle hole matched with the channel needle, so that when the multi-needle cap is installed on the liquid injection port, the channel needle is located in the needle hole. So set up and to make the passageway needle position after the many needle caps of installation fixed, avoid because of its preparation failure that rocks and lead to.

In one embodiment, the first blocking portion may be a solid block, and the needle hole may be a blind hole matching the position and size of the passage needle.

In another embodiment, the first blocking portion may be hollow, in which case when the multi-needle cap is mounted, the passage needle may pass through a needle hole in an end face thereof remote from the first cap body into the hollow interior of the first blocking portion; or, the end face of the passage needle, which is far away from the first cap body, is made of flexible materials, and when the length of the passage needle is longer than the length from the liquid injection port to the end face, the passage needle can pierce the end face to enter the first blocking part, so that the effect of fixing the position of the passage needle is achieved.

Further, the second blocking portion is a hollow blocking tube, the liquid injection port is located in the central area of the second cap body, preferably, the blocking tube is communicated with the liquid injection port, and more preferably, the blocking tube has the same diameter as the liquid injection port. So set up, can be so that from annotating liquid mouthful department directly more convenient when adding system pipe solution in to the body, preferred, when pouring into system pipe solution in the body to this mould, add to keep off the pipe and keep away from annotating the one end of liquid mouthful can.

Further, the mould also comprises a liquid injection device arranged on the multi-needle cap, wherein the liquid injection device comprises a liquid injection conduit adjacent to the channel needle, a liquid storage chamber communicated with the liquid injection conduit, and a liquid pusher nested in the liquid storage chamber.

When the mold with the arrangement is used for preparing the nerve conduit, prepared tube making solution can be injected into the liquid storage chamber, and the liquid pusher is used for pushing the tube making solution in the liquid storage chamber to pass through the liquid injection conduit until the solution is injected into the conduit body. Preferably, the liquid pusher may be an electric push rod having a piston. So set up, can be so that when preparing the nerve conduit, need not this mould of dismouting, further improve the convenience, meanwhile, can also be more accurate quantitative injection tubulation solution.

Further, the second blocking part is a solid block, and the block is provided with a block through hole for matching and installing the channel needle.

Further, the pipe body is composed of two hollow semicylinders along the axial direction thereof. After the mould and tubulation solution freeze-drying simultaneously, open the nerve pipe that can take out the preparation with two hollow semicylinders, improved the convenience degree of demolising the mould from the nerve pipe greatly, it is preferred, two hollow semicylinders need not to consolidate in addition when assembling into the body and decide the piece, can realize assembling two hollow semicylinders fixed into hollow body through the installation of first end cap and second end cap.

Further, the inner diameter of the pipe body is 2-10 mm.

Further, the passage needle is at least partially cylindrical, the length of the cylindrical passage needle is not less than 2mm, and the diameter of the cylindrical passage needle is 0.2-1 mm.

Further, the material of the mould can be medical stainless steel or polytetrafluoroethylene, so that the mould is convenient to repeatedly use and is suitable for various solutions.

In another aspect, the present application also provides a method for preparing a multichannel nerve conduit in one step, comprising: the preparation was carried out using the above-described mould.

Further, the method may further comprise the step of freeze-drying the mold together with the tubing solution for preparing the nerve conduit.

Further, the method specifically comprises:

preparing a tubing solution, fixing the hollow tube body by using a first cap body and a second cap body, injecting the tubing solution into the tube body from an injection port, inserting a multi-needle cap, and freeze-drying.

In one embodiment, the method of making comprises:

s1, preparing a tube-making solution: mixing one or two of collagen and chitosan, and taking 1-10% acetic acid as a solvent to obtain a tubing solution with the mass concentration of 1-12%;

s2, assembling die: fixing two hollow semicylinders of the tube body at two ends by a first cap body and a second cap body respectively;

s3, injection solution: injecting the prepared tubing solution of the step S1 to the bottom of the second blocking part from the liquid injection port, and inserting a multi-needle cap until the bottom of the first blocking part;

s4, freeze drying: performing gradient freezing in liquid nitrogen, thawing, taking out the multi-needle cap, freeze-drying, removing the rest part of the mold, and taking out the nerve conduit sample;

s5, high-temperature vacuum fixation: the pressure is-0.09 MPa, the temperature is 105 +/-2 ℃, and the fixing time is 24 h;

and S6, sterilizing by using ethylene oxide.

Wherein the freeze drying comprises the following steps: gradient freezing: placing the mould in an elevator, lowering the mould at a speed of 10 r/min, adjusting the angle to 9 at a time interval of 1.5s, closing the elevator when the temperature is reduced to-60 ℃, maintaining the temperature at-80 ℃ to-60 ℃ for 40min, unfreezing the mould for 2h at a freezing chamber of-20 ℃ to-30 ℃, taking out the multi-needle cap, and freeze-drying the multi-needle cap, wherein the procedures are as follows:

the following beneficial effects can be brought through the application:

1. the mold for preparing the multichannel nerve conduit is simple in design, easy to combine and convenient to use, the length of the part reserved at the edge is easy to suture the nerve adventitia, and the exposure of the broken end, damage to the internal environment of nerve repair, inflammation and other reactions are avoided; the material is stainless steel or polytetrafluoroethylene material, can be used repeatedly and is suitable for various solutions; the tube body can be split into two parts and is easy to take out, all the insertion needles can be taken out of the fixed multi-needle cap at one time, the channel is thin, the phenomenon that the peripheral channel is damaged by multiple taking-out operations is avoided, and the time is saved.

2. The mold for preparing the multichannel nerve conduit can be suitable for a specific freeze drying process, is formed in one step, does not need secondary compounding, and avoids the damage of a structure or the generation of a layering phenomenon.

3. The application provides a mould for preparing multichannel nerve pipe can prepare and obtain directional porous and have multichannel nerve pipe, plays induction and promotion effect for nerve regeneration and function reconstruction, and edge design does benefit to on the one hand and sews up to because the hydrophilic characteristic of the material itself of selection will be attached with neural surface, seal the neural environment of restoreing, play the guard action.

4. The application provides a method for preparing a nerve conduit by using the mold, which uses the internationally recognized biodegradable material for nerve repair: collagen and chitosan, the solvent is single, easy to remove, does not use chemical cross-linking agent, and is nontoxic and harmless.

5. The method for preparing the nerve conduit by using the mold is prepared by adopting a one-step method, is simple in process and is easy for industrial production.

Drawings

The accompanying drawings, which are included to provide a further understanding of the application and are incorporated in and constitute a part of this application, illustrate embodiment(s) of the application and together with the description serve to explain the application and not to limit the application. In the drawings:

FIG. 1 is a schematic diagram of an embodiment of a multichannel nerve conduit mold prior to assembly;

FIG. 2 is a schematic assembled view of one embodiment of a multichannel nerve conduit mold;

FIG. 3 is a schematic assembled structural view of another embodiment of the multichannel nerve conduit mold;

FIG. 4 is a schematic assembled structural view of yet another embodiment of the multichannel nerve conduit mold;

FIG. 5 is a schematic view of a further embodiment of the multichannel nerve conduit mold prior to assembly;

in the figure: 1. a pipe body; 2. a first cap body; 21. a first blocking portion; 3. a second cap body; 31. a second blocking portion; 4. a multi-needle cap; 41. a fixed part; 42. a channel needle; 43. a hand-held portion; 5. a liquid injection device; 51. an infusion catheter; 52. a liquid storage chamber; 53. a liquid pusher.

Detailed Description

In order to more clearly explain the overall concept of the present invention, the following detailed description is given by way of example in conjunction with the accompanying drawings.

It should be noted that in the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention, however, the present invention may be practiced in other ways than those specifically described herein, and thus the scope of the present invention is not limited by the specific embodiments disclosed below.

In addition, in the description of the present invention, it is to be understood that the terms "center", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "axial", "radial", "circumferential", etc., indicate orientations and positional relationships based on those 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, are not to be construed as limiting the present invention.

In the present invention, unless otherwise expressly stated or limited, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can, for example, be fixedly connected, detachably connected, or integrally formed; either directly or indirectly through intervening media, either internally or in any other relationship. However, the direct connection means that the two bodies are not connected to each other by the intermediate structure but connected to each other by the connecting structure to form a whole. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

In the present invention, unless otherwise expressly stated or limited, the first feature "on" or "under" the second feature may be directly contacting the first and second features or indirectly contacting the first and second features through an intermediate. In the description herein, references to the description of the term "one embodiment," "some embodiments," "an example," "a specific example," or "some examples," etc., mean that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the invention. In this specification, the schematic representations of the terms used above are not necessarily intended to refer to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.

An embodiment of the application provides a mold which is simple in structural design and convenient to use, and can be used for preparing a multichannel nerve conduit in a one-step molding mode in a freeze drying process. Preferably, the material of the mould can be medical stainless steel or polytetrafluoroethylene with good acid and alkali resistance and strong stability so as to be convenient for repeated use and be suitable for various tube-making solutions.

As shown in fig. 1, the mold includes: hollow body 1, wherein body 1 has relative both ends, and wherein one end is used for installing first end cap, and the other end is used for installing the second end cap, and when first end cap and second end cap were the state after the complete assembly with body 1, the mould was whole to be inclosed cylinder to be applicable to the preparation cylindric nerve pipe, optional, the internal diameter of body 1 was 2-10mm, and length can be according to the specification setting of the nerve pipe that needs the preparation.

Preferably, constitute by two hollow semicylinders along its axis direction at above-mentioned body 1, figure 1 shows that hollow semicylinder is along its axial cross-section, so set up and make when mould and tubulation solution freeze-drying simultaneously after, open two hollow semicylinders and can take out the nerve pipe of preparation, improved the convenience degree of demolising the mould from the nerve pipe greatly, more preferably, two hollow semicylinders need not to consolidate in addition when assembling into the body, can realize fixing the hollow body 1 of assembling into with two hollow semicylinders through the fixing of first end cap and second end cap.

The first end cap comprises a first cap body 2, the first cap body 2 is provided with a first blocking portion 21 protruding towards the inside of the tube body 1, the second end cap comprises a second cap body 3, the second cap body 3 is provided with a liquid injection port, and a second blocking portion 31 protruding towards the inside of the tube body 1 is arranged at the liquid injection port.

The first stopper 21 and the second stopper 31 are protruded toward the inside of the tube body 1 along the axial direction of the tube body 1. The first blocking part 21 and/or the second blocking part 31 can be tightly attached to the tube wall of the tube body 1 without gaps, so that the first cap body 2 and/or the second cap body 3 can be more fixedly installed on the tube body 1, and in a preferred embodiment, a gap for forming the edge of the nerve conduit is formed between the first blocking part 21 and/or the second blocking part 31 and the tube wall of the tube body 1. Preferably, the first blocking portion 21 and the second blocking portion 31 may be cylindrical, and in this case, an annular gap may be formed between the cylindrical blocking portion and the tube wall of the tube body 1 to match the shape of the nerve conduit and form an end edge of the nerve conduit for suturing, and more preferably, the annular width of the annular gap is greater than 0.01mm and less than 1 mm.

In one embodiment, the first blocking portion 21 has a first length from its end close to the first cap body 2 to its end away from the first cap body 2, and the second blocking portion 31 has a second length from its end close to the pouring outlet to its end away from the pouring outlet, the first and second lengths being equal and preferably 1-2 mm. When the first blocking portion 21 and the second blocking portion 31 are both cylindrical, the first length and the second length can be understood as the distance from one circular end face of the cylinder to the other circular end face of the cylinder.

In the embodiment shown in fig. 1-4, the second blocking portion 31 is a hollow stopper tube, the liquid injection port is located in the central region of the second cap body 3, preferably, the stopper tube is through the liquid injection port, and more preferably, the stopper tube has the same diameter as the liquid injection port. So set up, can make from annotating liquid mouthful department directly more convenient when adding system pipe solution in to body 1, it is preferred, when pouring into system pipe solution in the body 1 to this mould, add to keeping off the tub bottom, its one end of keeping away from annotating the liquid mouth promptly can.

The second end cap further comprises a multi-needle cap 4 which is attachable to the pouring port of the second cap body 31. The multi-needle cap 4 comprises a fixing part 41 matched with the liquid injection port, and a plurality of channel needles 42 fixedly arranged on one side of the fixing part 41 and extending along the axial direction of the tube body 1, and a handheld part 43 is further arranged on the other side of the fixing part 41, wherein the handheld part 43 can be implemented in various ways, such as a ball, a hanging ring, a lifting handle and the like. When the multi-needle cap 4 is installed at the injection port, the channel needle 42 is located inside the tube body 1 for forming a plurality of channels in the multi-channel nerve conduit, and the hand-held portion 43 is located outside the tube body 1 for taking out the multi-needle cap 4 after preliminary freezing. Preferably, the access needle 42 is at least partially cylindrical, and the cylindrical access needle 42 has a length of not less than 2mm and a diameter of 0.2 to 1 mm.

In one embodiment, when the second blocking portion 31 is a hollow blocking tube, the shape and size of the fixing portion 41 may be variously implemented in order to more conveniently remove the multi-needle cap 4 after preliminary freezing, for example, the fixing portion 41 may partially extend out of the injection port, as shown in fig. 2; the fixing portion 41 may completely cover the pouring port, as shown in FIG. 3; the fixing portion 41 may be adapted to the diameter of the pouring outlet, as shown in FIG. 4.

The mould that the above-mentioned embodiment provided can directly pour into the tubulation solution that is used for preparing the nerve pipe into body 1 when using, again with many needle caps 4 installation in annotating the liquid mouth, and in the tubulation solution in body 1 was gone into in a plurality of passageway needles 42 plug-in this moment, because the setting of a plurality of passageway needles 42, after carrying out freeze-drying with the tubulation solution together with the mould, take out many needle caps 4 and demolish the mould and can obtain the nerve pipe that has the multichannel. In addition, since the multi-needle cap 4 has the plurality of passage needles 42, the plurality of passage needles 42 simultaneously enter the tubing solution and are simultaneously taken out after freeze-drying, thereby preventing the surrounding passages from being damaged by multiple taking-out operations, saving time and improving preparation efficiency.

Preferably, the above embodiment can also set the length and diameter of the channel needle 42 and the arrangement on the multi-needle cap 4 according to the actual specification requirements of the multi-channel nerve conduit, such as the length, diameter and arrangement of the channel.

The structure of the mold provided by the present application after installation is shown in fig. 2-4. Wherein, the first blocking part 21 is cylindrical and has a cylindrical end surface far away from the first cap body 2, when the multi-needle cap 4 is installed at the liquid injection port, the passage needle 42 preferably touches at least the cylindrical end surface of the first blocking part 21, that is, the length of the passage needle 42 is not less than the length from the liquid injection port to the cylindrical end surface. In the embodiment shown in FIG. 2, when the multi-needle cap 4 is mounted to the pouring outlet, the passage needle 42 thereof just touches the circular end face of the cylinder of the first stopper 21.

In other embodiments, the passage needle 42 may also extend beyond the circular end surface of the cylinder, so that the position of the passage needle is fixed after the multi-needle cap 4 is installed, and preparation failure caused by shaking is avoided.

In the embodiment shown in fig. 3, the first blocking portion 21 may be a hollow cylinder, and a needle hole matching the passage needle 42 is provided on the end surface of the first cap body 2, so that the passage needle 42 passes through or is located in the needle hole when the multi-needle cap 4 is mounted on the liquid injection port. When the multi-needle cap 4 is mounted, the passage needle 42 can enter the hollow interior of the first blocking portion 21 through a needle hole on the end face of the passage needle away from the first cap body 2; or, the end surface of the channel needle 42 far away from the first cap body 2 is made of flexible material, and when the length of the channel needle 42 is longer than the length from the liquid injection port to the end surface, the channel needle 42 can pierce the end surface and enter the first blocking portion 21, so as to fix the position of the channel needle 42.

In the embodiment shown in fig. 4, the first stop 21 may be a solid stop, and the needle hole may be a blind hole matching the position and size of the access needle 42.

Preferably, in the above embodiment, the needle hole should be sized to just receive the access needle 42 or have an interference fit with the access needle 42 to avoid loss of tubing solution into it.

The application also provides another embodiment of the mold, as shown in fig. 5, the mold further comprises a liquid injection device 5 arranged on the multi-needle cap 4.

The injection device 5 comprises an injection conduit 51 adjacent to the passage needle 42, a liquid storage chamber 52 communicated with the injection conduit 51, and a liquid pusher 53 nested in the liquid storage chamber 52. When the mold with the above arrangement is used for preparing the nerve conduit, the prepared tubing solution can be injected into the liquid storage chamber 52, and the pusher 53 is used for pushing the tubing solution in the liquid storage chamber 52 through the liquid injection conduit 51 until the tubing solution is injected into the tube body 1. Preferably, the plunger 53 may be an electric plunger having a piston. So set up, can be so that when preparing the nerve conduit, need not this mould of dismouting, further improve the convenience, meanwhile, can also be more accurate quantitative injection tubulation solution.

Preferably, in the mold with the injection device, the second blocking portion 31 is a solid block having a block through hole for matching placement of the channel needle 42.

On the other hand, another embodiment of the present application also provides a method for preparing a multichannel nerve conduit in one step by using the mold, which comprises the step of freeze-drying the mold together with a solution for preparing the nerve conduit, specifically as follows:

s2, assembling die: fixing two hollow semicylinders of the pipe body 1 at two ends by a first cap body 2 and a second cap body 3 respectively;

s3, injection solution: injecting the tubing solution prepared in step S1 to the bottom of the second barrier 21 from the injection port, and inserting the multi-needle cap 4 up to the bottom of the first barrier 31;

s4, freeze drying: performing gradient freezing in liquid nitrogen, thawing, taking out the multi-needle cap, freeze-drying, removing the rest part of the mold, and taking out the nerve conduit sample; wherein the freeze drying comprises the following steps: gradient freezing: placing the mould in an elevator, lowering the mould at a speed of 10 r/min, adjusting the angle to 9 at a time interval of 1.5s, closing the elevator when the temperature is reduced to-60 ℃, maintaining the temperature at-80 ℃ to-60 ℃ for 40min, unfreezing the mould for 2h at a freezing chamber of-20 ℃ to-30 ℃, taking out the multi-needle cap, and freeze-drying the multi-needle cap, wherein the procedures are as follows:

and S6, sterilizing by using ethylene oxide.

Experiments show that the method can be used for preparing and forming in one step to obtain the directional porous nerve conduit which is convenient to sew and has multiple channels, plays a role in inducing and promoting nerve regeneration and function reconstruction, has simple process and is easy for industrial production.

The above description is only an example of the present application and is not intended to limit the present application. Various modifications and changes may occur to those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application should be included in the scope of the claims of the present application.

Claims

1. A mold for preparing a multichannel nerve conduit, comprising:

a hollow tube body;

a first end cap is arranged at one end of the tube body and comprises a first cap body, and the first cap body is provided with a first blocking part protruding towards the interior of the tube body;

a second end cap is mounted at the other end of the tube body and comprises a second cap body and a multi-needle cap, the second cap body is provided with a liquid injection port, and a second blocking part protruding towards the interior of the tube body is arranged at the liquid injection port; the multi-needle cap is arranged at the liquid injection port and is provided with a plurality of channel needles extending along the axial direction of the tube body;

the tube body is provided with a tube wall, and gaps for forming suture edges of the nerve conduits are formed between the first blocking part and the tube wall of the tube body and between the second blocking part and the tube wall of the tube body;

the first blocking part and the second blocking part are cylindrical, circular ring-shaped gaps are formed between the cylindrical first blocking part and the pipe wall and between the cylindrical second blocking part and the pipe wall respectively, and the ring width of each circular ring-shaped gap is larger than 0.01mm and smaller than 1 mm.

2. The mold of claim 1, wherein the first blocking portion has a first length from an end thereof proximate to the first cap body to an end thereof distal from the first cap body, and wherein the second blocking portion has a second length from an end thereof proximate to the pour opening to an end thereof distal from the pour opening, the first length and the second length being equal.

3. The mold according to claim 1, wherein the first blocking portion is provided with a needle hole matching the passage needle so that the passage needle is located in the needle hole when the multi-needle cap is mounted to the liquid injection port.

4. The mold of claim 1, wherein the second blocking portion is a hollow blocking tube, the liquid injection port is disposed in a central region of the second cap body, and a diameter of the blocking tube is the same as a diameter of the liquid injection port.

5. The mold of claim 1, further comprising a filling device disposed on the multi-pin cap, the filling device comprising a filling conduit adjacent to the channel pin, a reservoir in communication with the filling conduit, and a pusher nested within the reservoir.

6. The mold of claim 5, wherein the second stop is a solid stop having a stop through-hole for mating mounting the access pin.

7. A mould according to any one of claims 1 to 6 wherein the tubular body is formed from two hollow semi-cylinders along its axis.

8. A method of preparing a multichannel nerve conduit comprising the step of performing a one-step preparation using the mold of any one of claims 1-7, comprising: the mold is freeze-dried together with the solution for preparing the nerve conduits.

9. The method according to claim 8, characterized in that the method comprises in particular: preparing a tubing solution, fixing the hollow tube body by using a first cap body and a second cap body, injecting the tubing solution into the tube body from an injection port, inserting a multi-needle cap, and freeze-drying.