Biomimetic tendon sheath and method of making

Abstract

The application discloses a kind of bionic tendon sheath and preparation method, spinning membrane forming process includes the following steps: step one, first, cylindrical sleeve is filled with gas, and a layer of cylindrical membrane is formed on the cylindrical sleeve (130), to form a side of the outer surface of the membrane;Step two, negative pressure suction is carried out to the cylindrical sleeve (130), so that the part of the cylindrical sleeve (130) between the side of the support sheet away from the shaft (110) has an arc greater than the diameter when it is inflated into a cylindrical surface;Step three, continue spinning operation, the rotating drum is changed to step-by-step rotation, so that the part of the cylindrical sleeve between the side of each support sheet receives drawing one by one, to form a thicker part, the concentration of hyaluronic acid in the part is 3-80%, to form the inside of the membrane;After the part between each support sheet forms thicker inside, the cylindrical sleeve is filled with gas again, and continuous rotation receives drawing, to form another outside surface of the membrane;Step four, after cutting, bionic tendon sheath is formed.The concentration of hyaluronic acid in the inside and outside of the formed membrane is different, and the inside is high and the outside is low, which is conducive to preventing and treating tendon adhesion while promoting tendon sliding and healing.

Description

TECHNICAL FIELD

[0001] The present application relates to a tendon sheath membrane for preventing tendon adhesion to tissue during tendon surgery, in particular to a hyaluronic acid membrane made by electrospinning. BACKGROUND

[0002] Tendon adhesion is a common clinical condition. Due to the lack of effective adhesion prevention measures, the treatment often falls into a vicious cycle of "adhesion-release-re-adhesion", which seriously affects the function of the patient's limbs. Placing an adhesion prevention membrane between the tendon and the surrounding tissue has a certain effect on reducing tendon adhesion, but they do not have the function of promoting tendon healing and sliding. In addition, due to material or structural reasons, wrapping the tendon can only play a physical barrier role, and the possible rejection and interference with tendon healing seriously affect the recovery of tendon function. This situation can be solved by making a hyaluronic acid membrane by electrospinning and combining a layer of fiber layer to wrap the tendon, which plays a role in lubricating and preventing tendon adhesion to the surrounding tissue.

[0003] Doctors have a relatively accurate estimate of the recovery time of the wound. Different wounds, patient age, physical condition, and especially some special patients, such as older patients, slow wound healing, and long-term patients, have different needs for the thickness and drug load of the tendon sheath membrane. However, the thickness, structure, and drug load of the existing membrane are fixed.

[0004] Prior art CN110368136B, this kind of in the double-layer membrane, additional free bag, additional increase the supply amount of hyaluronic acid, but the size, thickness and position of the free bag have a great influence on the absorption time. It is not conducive to accurately control the absorption time of the entire tendon sheath membrane and the drug supply. The free bag is curled and wrapped around the tendon, the position of the free bag, and the thickness of the entire membrane is increased, and the absorption time is prolonged. Moreover, in order to maintain the mechanical strength of the membrane and the free bag, the thickness of the membrane should be basically the same as the normal membrane thickness to complete the operation of pulling the free bag, which makes the thickness of the entire membrane too large and the drug penetration time too long. SUMMARY

[0005] The bionic tendon sheath membrane and the preparation method provided by the embodiments of the present application solve the problem of the thick membrane structure of the membrane in the prior art, which is not convenient for loading the required amount of drugs, and achieve the effect of conveniently wrapping the tendon and loading and adjusting the amount of drugs.

[0006] The bionic tendon sheath membrane and the preparation method provided by the embodiments of the present application solve the problem of the thick membrane structure of the membrane in the prior art, which is not convenient for loading the required amount of drugs, and achieve the effect of conveniently wrapping the tendon and loading and adjusting the amount of drugs.

[0007] In the electrospinning process, the drum is used to wind the drawn filaments to form a spinning film; the spinning film is spun in multiple times, and different concentrations of hyaluronic acid solution are used in the drawing process to form a concentration gradient inside and outside the spinning film; the outside surface is not loaded with hyaluronic acid, and the mass ratio concentration of the loaded hyaluronic acid inside can be 3-80% or vary in a gradient.

[0008] Further, the drum comprises a rotating shaft, a support sheet and a cylindrical sleeve;

[0009] The cross section of the support sheet is arc-shaped, the length direction of the support sheet is parallel to the axial direction of the rotating shaft, the support sheet protrudes towards the rotating shaft, and the two side edges of the support sheet away from the rotating shaft have the same distance from the rotating shaft;

[0010] The cylindrical sleeve is cylindrical and is sleeved outside the rotating shaft and the support sheet; the cylindrical sleeve is an elastic sleeve, and both ends of the cylindrical sleeve are fixedly and sealingly connected with the rotating shaft; after being filled with gas, the cylindrical sleeve is cylindrical, and the inner side surface of the cylindrical cylindrical sleeve contacts the two side edges of the support sheet away from the rotating shaft;

[0011] The cylindrical sleeve is provided with a gas valve for charging and discharging; after the cylindrical sleeve is subjected to negative pressure, the cylindrical sleeve can be attached to the support sheet.

[0012] Further, the spinning film forming process comprises the following steps:

[0013] Step one: first fill the cylindrical sleeve with gas to form a cylindrical film on the cylindrical sleeve, forming an outer side surface outside the film;

[0014] Step two: negative pressure suction is performed on the cylindrical sleeve, so that the part of the cylindrical sleeve between the side edges of the support sheet away from the rotating shaft has a larger curvature than the diameter when the cylindrical sleeve is inflated to a cylindrical surface;

[0015] Step three: continue the spinning operation, and the drum is changed to step-by-step rotation, so that the part of the cylindrical sleeve between the side edges of each support sheet receives the drawn filaments one by one to form a thicker part, and the concentration of hyaluronic acid in the thicker part is 50-70%, forming the inside of the film; after the part between each support sheet is formed into a thicker inside, the cylindrical sleeve is filled with gas again, and continuous rotation is performed to receive the drawn filaments to form another outer side surface of the film;

[0016] Step four: cut to form a biomimetic tendon sheath membrane.

[0017] Further, after step three is completed, the cylindrical sleeve is completely attached to the support sheet, and a continuous rotation of the drum is performed to stretch a multi-prism-shaped film at the stretching part between the side edges of the support sheet, which is separated from the previously formed film.

[0018] Further, the support sheets are four to eight in a group, and each group of support sheets is uniformly distributed along the same axial position of the rotating shaft;

[0019] There is a gap between two adjacent groups of support sheets.

[0020] Further, the support sheet is an elastic sheet;

[0021] The rotating shaft is hollow, and a coaxial pulling shaft is connected to the rotating shaft in a rotating manner, and the pulling shaft can be fixed relative to the rotating shaft through a locking device;

[0022] The two sides of the support sheet are fixed with pull lines, the pull lines pass through the rotating shaft into the cavity and are fixedly connected with the pulling shaft; the pulling shaft is rotated to change the arc of the opening of the support sheet;

[0023] In step three, the opening of the support sheet is maximized by rotating the pulling shaft, and after spinning into a film, the opening is reduced when the pull lines are loosened, and the film is spun again; finally, the pull lines are completely loosened and the film is spun again, so that a three-layer bag-shaped film can be formed.

[0024] A bionic tendon sheath, the outer side does not load hyaluronic acid, and the internal loaded hyaluronic acid mass ratio concentration is 3-80%.

[0025] Further, the film is quadrilateral, one side is open, and is bag-shaped.

[0026] Further, it further comprises a curling auxiliary layer, which comprises a pulling layer, one side of the pulling layer is adhered to a water-absorbing expansion layer, and the water-absorbing expansion layer is a high water-absorbing resin layer.

[0027] Further, the water-absorbing expansion layer away from the pulling layer side has uniformly distributed strip-shaped protrusions, and the length direction of the protrusions is parallel to the bag opening of the bag-shaped film.

[0028] One or more technical solutions provided in the embodiments of the application have at least the following technical effects or advantages: by dividing the spinning process into cylinder spinning and prism spinning, a bag-shaped film with one long side and one short side can be formed. The film naturally curls itself, which facilitates wrapping the tendon, and additional required drugs can be easily attached. BRIEF DESCRIPTION OF DRAWINGS

[0029] Figure 1 Structure diagram of the spinning drum, drainage tube and drawing wire;

[0030] Figure 2 Structure diagram of the spinning drum when the columnar sleeve is in a negative pressure state;

[0031] Figure 3 Structure diagram of the whole spinning drum;

[0032] Figure 4 Structure diagram of the spinning drum when the support sheets do not contact each other;

[0033] Figure 5 Structure diagram of the spinning drum when the support sheets have eight;

[0034] Figure 6 For Figure 5 Structure diagram of the middle column sleeve in negative pressure state;

[0035] Figure 7 Structure diagram of the rotating drum when the support pieces are not in contact with each other;

[0036] Figure 8 Combined diagram of pulling the front and back when the support pieces are elastic pieces;

[0037] Figure 9 Structure diagram of spinning the multi-layer composite bag-shaped film when the support pieces are elastic pieces;

[0038] Figure 10 Structure diagram of the cooperation of the pulling shaft, the pull wire, the rotating shaft and the support pieces;

[0039] Figure 11 Structure diagram of the bag-shaped film with the curling auxiliary layer;

[0040] Figure 12 For Figure 11 Structure diagram of the middle film winding the tendon;

[0041] Figure 13 For Figure 12 Structure diagram of the middle film naturally curling;

[0042] Figure 14 Structure diagram of the curling auxiliary layer;

[0043] Figure 15 Structure diagram of the curling auxiliary layer with the protruding part winding the tendon;

[0044] Figure 16 Structure diagram of the film with different concentrations inside and outside respectively;

[0045] Figure 17 Structure diagram of the film after being spun with different concentrations inside and outside respectively.

[0046] In the figure, the rotating drum 100, the rotating shaft 110, the pulling shaft 111, the pull wire 112, the support piece 120, the column sleeve 130; the drainage pipe 200, the pull wire 300, the spinning film 400, the pulling layer 500, the water-absorbing expansion layer 600, the protruding part 610. DETAILED DESCRIPTION

[0047] In order to facilitate the understanding of the present application, the present application will be described more fully below with reference to the accompanying drawings. The preferred embodiments of the present application are shown in the drawings. However, the present application can be realized in many different forms and is not limited to the embodiments described herein. On the contrary, these embodiments are provided so that the disclosure of the present application can be more thoroughly and completely understood.

[0048] It should be understood that when an element as a layer, region or plate is referred to as being "on" another element, it can be directly on the other element or intervening elements can also be present. In addition, it should be understood that when an element is referred to as being "connected" to or "coupled" to another element, it can be directly connected or coupled to the other element or intervening elements can be present. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0049] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0050] By dividing the spinning process into cylindrical spinning and prismatic spinning, a bag-shaped film with one long side and one short side can be formed. The film naturally curls by itself, making it easy to wrap around the tendon, and it is also convenient to add additional required drugs.

[0051] Example one

[0052] As Figures 1-7 shown, a method for preparing a bionic tendon sheath membrane includes the step of preparing a film from a hyaluronic acid solution by electrospinning process. The solution can use one of dichloromethane, N,N-dimethylformamide and hexafluoroisopropanol as solvent.

[0053] In the electrospinning process, a drum 100 is used to wind the wire 300;

[0054] The drum 100 includes a shaft 110, a support sheet 120 and a cylindrical sleeve 130;

[0055] The cross section of the support sheet 120 is arc-shaped, the length direction of the support sheet 120 is parallel to the axial direction of the shaft 110, the support sheet 120 protrudes towards the shaft 110, the middle line of the protruding surface is fixed on the shaft 110, and the distance between the two side edges of the support sheet 120 away from the shaft 110 and the shaft 110 is the same;

[0056] The cylindrical sleeve 130 is cylindrical and is sleeved outside the shaft 110 and the support sheet 120; the cylindrical sleeve 130 is an elastic sleeve, the two ends of which are fixedly and sealingly connected with the shaft 110; after being filled with gas, the cylindrical sleeve 130 is cylindrical, and the inner side surface of the cylindrical cylindrical sleeve 130 contacts the two side edges of the support sheet 120 away from the shaft 110;

[0057] The cylindrical sleeve 130 is provided with a gas valve for charging and discharging; after the cylindrical sleeve 130 is subjected to negative pressure, it is attached to the support sheet 120;

[0058] The spinning film forming process includes the following steps:

[0059] Step one, first fill the cylindrical sleeve with air, form a cylindrical film on the cylindrical sleeve 130, form an outer side of the film outside;

[0060] Step two, negative pressure suction is performed on the cylindrical sleeve 130, so that the part of the cylindrical sleeve 130 between the side edges of the support sheet away from the rotating shaft 110 has a larger arc than the diameter when it is expanded into a cylindrical surface;

[0061] Step three, continue the spinning operation, change the rotating drum to a step-by-step rotating drum, so that the part of the cylindrical sleeve between the side edges of each support sheet receives the drawn wire one by one, forms a thicker part, the concentration of hyaluronic acid in this part is 3-80% (different concentrations of the film can be selected according to the actual situation of the patient), forms the inside of the film; after the part between each support sheet forms a thicker inside, the cylindrical sleeve is filled with air again, and the continuous rotation receives the drawn wire to form another outer side of the film; the mass concentration of hyaluronic acid on the outer side is 30-50% or no hyaluronic acid is added.

[0062] Step four, cut to form a biomimetic tendon sheath membrane.

[0063] This formed film is a tightly bonded whole film. The amount of hyaluronic acid inside and outside is different, and the film is thick in the middle and thin on both sides, which is convenient for separation operation when wrapping the tendon. Figures 16-17 .

[0064] Example two

[0065] In order to facilitate the operation of the operation, on the basis of the tightly bonded whole film process, make improvements, after step three is completed, negative pressure suction is performed on the cylindrical sleeve 130, so that the cylindrical sleeve 130 adheres to the surface of the support sheet, at this time the cylindrical film deforms together with the cylindrical sleeve 130;

[0066] Continue the spinning operation, pull the multi-prism-shaped film between the side edges of the support sheet 120 away from the rotating shaft 110; the prism-shaped film is bonded with the cylindrical film at the corresponding positions of the support sheet side edges.

[0067] As shown in Figures 1-7 , the tendon sheath membrane formed in this way can be a bag-shaped film with one side longer than the other, and the thickness of each layer of film is very thin. On the one hand, this film is naturally curved, which is convenient for winding the tendon, on the other hand, this one-side-long one-side-short forms a drug containing space, after wrapping the tendon, additional drugs or growth factors can be injected between the two layers of film through the bag opening. After injection, the outer layer is long, and the drug extrusion is more conducive to the bending and positioning of the film. It can tightly fit the tendon and effectively release the drug.

[0068] The support pieces 120 are arranged in groups of four to eight, and each group of support pieces is evenly distributed along the same axial position of the rotating shaft 110.

[0069] There are gaps between two adjacent groups of support pieces 120.

[0070] As Figures 1-7 This is to facilitate cutting. By adjusting the size of the support pieces, bags of different sizes can be obtained.

[0071] The thickness of the film obtained in step three is less than that obtained in step one. The control of the spinning thickness is very simple, so the control of the thickness of the single-layer film is very beneficial to the selection of different patients. That is, the specifications of the tendon sheath membrane can be selected in a range.

[0072] In this way, the film thickness of the short side is thin, directly attached to the tendon, and the internal medicine can contact the wound faster.

[0073] Example three

[0074] The structure of the bag-shaped film can be further improved to form a closed space on the inner side, which can be filled with drugs and growth factors. Moreover, the multi-layer bag-shaped film can have different drug components between different layers, which is beneficial to the wound at different times. The spinning process is further improved compared to example one.

[0075] The support piece 120 is an elastic piece;

[0076] The rotating shaft 110 is hollow, and a coaxial pulling shaft 111 is connected to it, which can be fixed relative to the rotating shaft 110 by a locking device;

[0077] The support piece 120 is an elastic piece;

[0078] In step three, the opening of the support piece 120 is maximized by rotating the pulling shaft 111, and after spinning into a film, the opening is reduced when the pulling line 112 is loosened, and the film is spun again; Finally, the pulling line 112 is completely loosened and the film is spun again, so that a three-layer bag-shaped film can be formed.

[0079] As Figures 8-10 As shown, the bag formed by the innermost layer of the film can not have a bag opening, and before winding the tendon, a syringe can be used to inject medicine separately, which can form multiple layers of different component drugs. The release is convenient for the needs of different periods of wound healing. The pulling shaft 111 can be fixed coaxially with the rotating shaft by common methods such as threads, buckles, and latches.

[0080] Example 4

[0081] A biomimetic tendon sheath membrane is characterized by comprising two hyaluronic acid membranes, one side of which is shorter than the other, forming a pouch-like membrane with an opening on one side.

[0082] The outer side of the short face of the bag-shaped membrane has a hyaluronic acid membrane that is shorter than the short face.

[0083] It also includes a curling auxiliary layer, which includes a tension layer 500, and a water-absorbing and swelling layer 600 is adhered to one side of the tension layer 500. The water-absorbing and swelling layer 600 is a highly absorbent resin layer.

[0084] like Figures 11-15 As shown, during use, the curling aid layer is located inside the pouch membrane. After pushing the curling aid layer to insert the pouch membrane between the tendon and tissue, a hole is punctured on the inner side of the pouch membrane with a needle, and water or saline solution is injected into the inner side of the pouch membrane. The superabsorbent resin layer quickly absorbs water, and the 500mm tension layer restricts the flow, causing the front end of the pouch membrane to curl quickly, facilitating operation. Furthermore, because the membrane is very thin, doctors can wrap the tendon with multiple layers as needed. At this point, the side of the curling aid layer that has not absorbed water can be inserted into the pouch membrane, the pouch membrane can be punctured again, water can be injected, and the curling aid layer will again push the membrane to wrap around the tendon.

[0085] The water-absorbing and swelling layer 600 has uniformly distributed strip-shaped protrusions 610 on the side away from the tension layer 500, and the length direction of the protrusions 610 is parallel to the opening of the bag-shaped film.

[0086] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. For those skilled in the art, the present invention can have various modifications and variations. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A method for preparing a biomimetic tendon sheath, comprising the step of making a film from a hyaluronic acid solution by an electrospinning process, characterized in that, In the electrospinning process, the drum (100) is used to wind the drawn wire (300) to form a spinning film (400); the spinning film (400) is spun in multiple times, and different concentrations of hyaluronic acid solution are used in the wire drawing process to form a concentration gradient inside and outside the spinning film (400), and the outside surface is not loaded with hyaluronic acid, and the mass ratio concentration of the loaded hyaluronic acid in the inside is 3-80%; The drum (100) comprises a rotating shaft (110), a support sheet (120) and a cylindrical sleeve (130); The cross section of the support sheet (120) is arc-shaped, the length direction of the support sheet (120) is parallel to the axial direction of the rotating shaft (110), the support sheet (120) protrudes towards the rotating shaft (110), and the middle line of the protruding surface is fixed on the rotating shaft (110), so that the distance between the two side edges of the support sheet (120) away from the rotating shaft (110) and the rotating shaft (110) is the same; The cylindrical sleeve (130) is cylindrical and is sleeved outside the rotating shaft (110) and the support sheet (120); the cylindrical sleeve (130) is an elastic sleeve, and its two ends are fixedly and sealingly connected with the rotating shaft (110); after being filled with gas, the cylindrical sleeve (130) is cylindrical, and the inner surface of the cylindrical cylindrical sleeve (130) contacts the two side edges of the support sheet (120) away from the rotating shaft (110); The cylindrical sleeve (130) is provided with a gas valve for charging and discharging; after the cylindrical sleeve (130) is subjected to negative pressure, it can be attached to the support sheet (120); The spinning film forming process comprises the following steps: Step one: first fill the cylindrical sleeve with gas to form a cylindrical film on the cylindrical sleeve (130), forming one side of the outer surface of the film; Step two: negative pressure suction is performed on the cylindrical sleeve (130), so that the part of the cylindrical sleeve (130) between the side edges of the support sheet away from the rotating shaft (110) has a larger curvature than the diameter when the cylindrical sleeve is inflated to a cylindrical surface; Step three: continue the spinning operation, and the drum is changed to step-by-step rotation, so that the part of the cylindrical sleeve between the side edges of each support sheet receives the drawn wire one by one to form a thicker part, and the concentration of hyaluronic acid in the part is 3-80%, forming the inside of the film; after the part between each support sheet is formed into a thicker inside, the cylindrical sleeve is filled with gas again, and continuous rotation is performed to receive the drawn wire to form the other outer surface of the film; Step four: cut to form a biomimetic tendon sheath membrane.

2. The biomimetic tendon sheath membrane preparation method according to claim 1, characterized in that: After step three is completed, the cylindrical sleeve is completely adsorbed on the support sheet, and a multi-prism-shaped film is stretched between the side edges of the support sheet in continuous rotation, which is separated from the previously formed film.

3. The method of claim 2, wherein the method further comprises the step of: The support sheets (120) are four to eight in a group, and each group of support sheets is uniformly distributed at the same axial position of the rotating shaft (110); There are gaps between two adjacent groups of support sheets (120) in the multiple groups of support sheets (120).

4. The method of claim 2, wherein the biomimetic tendon sheath is prepared by the steps of: The support sheet (120) is an elastic sheet; The rotating shaft (110) is hollow, and a coaxial pulling shaft (111) is connected thereto; the pulling shaft (111) can be fixed relative to the rotating shaft (110) through a locking device; Two sides of the support sheet (120) are fixed with pull wires (112), the pull wires (112) pass through the rotating shaft (110) into the cavity and are fixedly connected with the pulling shaft (111); the pulling shaft (111) rotates, and the opening radian of the support sheet (120) can be changed; In step three, the opening of the support sheet (120) is maximized by rotating the pulling shaft (111), after spinning into a film, the opening is reduced when the pull wires (112) are loosened, and the film is spun again; finally, the pull wires (112) are completely loosened and the film is spun again, so that a three-layer bag-shaped film can be formed.

5. A biomimetic tendon sheath prepared using the method of claim 1, wherein, The outer side does not load hyaluronic acid, and the internal loading mass ratio concentration of hyaluronic acid is 3-80%.

6. The biomimetic tendon sheath of claim 5, wherein, The film is quadrilateral, and one side is open, in a bag shape.

7. The biomimetic tendon sheath of claim 6, wherein, It also includes a curling auxiliary layer, which includes a pulling layer (500), one side of the pulling layer (500) is adhered to a water-absorbing expansion layer (600), and the water-absorbing expansion layer (600) is a high water-absorbing resin layer.

8. The biomimetic tendon sheath according to claim 7, characterized in that The water-absorbing expansion layer (600) is provided with uniformly distributed strip-shaped protrusions (610) on the side away from the pulling layer (500), and the length direction of the protrusions (610) is parallel to the bag opening of the bag-shaped film.

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