CN210433516U - Tissue repair sleeve - Google Patents
Tissue repair sleeve Download PDFInfo
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- CN210433516U CN210433516U CN201920303908.8U CN201920303908U CN210433516U CN 210433516 U CN210433516 U CN 210433516U CN 201920303908 U CN201920303908 U CN 201920303908U CN 210433516 U CN210433516 U CN 210433516U
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Abstract
The utility model relates to a tissue repair sleeve, which is composed of polymer electrospun fiber, and the inner diameters of a first end 1 and a second end 2 of the tissue repair sleeve are different; the polymer is a biodegradable polymer, and the tissue repair sleeve can be highly matched with the near and far ends of tendon tissues such as a broken achilles tendon and the like, so that tissue adhesion is avoided, and the tissue repair effect is promoted.
Description
Technical Field
The utility model relates to a biomedical materials technical field especially relates to a tissue repair sleeve pipe.
Background
Injuries to tendons include acute injuries to skeletal muscles such as contusions, tears, ischemia, strains, and complete ruptures. These injuries can cause severe pain and can incapacitate affected persons, hamper their ability to work or even participate in normal daily activities.
Among them, the rupture of the achilles tendon is the tendon injury with the highest incidence rate, which is mostly caused by sports injury and is a common disease in orthopedics. The treatment method comprises conservative treatment and surgical treatment. After conservative treatment, the incidence of re-rupture of the Achilles tendon is high, and plantarflexion and weakness easily occur, thus seriously affecting the function of a patient. The traditional incision operation is to use a tissue repair sleeve to suture the broken achilles tendon end to reliably fix the achilles tendon, but the technology is not mature enough, and the tissue repair sleeve is completely matched with the near and far ends of the achilles tendon tissue, so that the achilles tendon is adhered in the repair process, and the achilles tendon is delayed to be healed.
CN206285127U discloses magnesium base metal tendon repair sleeve pipe relates to the medical instrument field, tendon repair sleeve pipe's main part is cylindrical or oblate cylinder shape, porous structure has in the main part, the main part is configured to the cover and establishes on the tendon, and pass through porous structure with the tendon adopts the stylolite to fix. Magnesium base metal tendon repair sleeve pipe can wrap around damaging cracked tendon, sews up the tendon broken ends on the sleeve pipe with magnesium base metal silk thread to rebuild together, possess antibiotic, sew up firmly, degradation time is moderate, promotes characteristics such as tendon tissue repair, but the sleeve pipe is difficult to agree with completely, causes the tissue adhesion easily, is unfavorable for the restoration of tissue.
CN106264633A discloses an absorbable Achilles tendon fracture jointer, which is an elliptical tube structure, wherein the wall of the elliptical tube is provided with an opening, and the wall of the elliptical tube is provided with a nail hole. The utility model can avoid the adoption of various complex suture operations in the clinical achilles tendon combination operation, and can complete the operation only by inserting the broken ends of the two achilles tendons into the elliptical tube and then nailing the two achilles tendon into the fixing nail or using the utility model to wrap the fixing nail after the two open-close ends are clamped or making the columnar body extending from the tube wall penetrate into the achilles tendon and then clamping the two open-close ends, the structure is simple and reasonable, the operation is easy, can greatly shorten the operation time, the elliptical tube, the cylindrical body and the fixing nail are made of degradable and shapeable absorbing materials, the broken end of the achilles tendon is easy to be accurately aligned and can ensure the firm fixation after the alignment, the normal healing after the operation of the broken end is convenient, the secondary operation to a patient can be avoided, the pain of the patient caused by the secondary operation is reduced, meanwhile, the physical consumption of an operator is effectively reduced, but the adapter is not easy to be completely fit with the two ends of the broken achilles tendon, and the effect of tissue repair is reduced.
Therefore, the development of a tissue repair sleeve with high contact ratio at the near end and the far end, which is suitable for tendon tissues such as broken achilles tendon, is urgently needed in the field, so that tissue adhesion is avoided, and the tissue repair effect is promoted.
Disclosure of Invention
Not enough to prior art, the utility model aims to provide a tissue repair sleeve pipe, tissue repair sleeve pipe can highly agree with the nearly far end of tendon tissue such as cracked achilles tendon, avoids the tissue adhesion, promotes the tissue repair effect.
To achieve the purpose, the utility model adopts the following technical proposal:
in a first aspect, the present invention provides a tissue repair sleeve, which is composed of a biodegradable polymer electrospun fiber, and the inner diameter of the first end 1 of the tissue repair sleeve is different from the inner diameter of the second end 2 of the tissue repair sleeve.
Tissue repair sleeve pipe be one kind and can be used to restore cracked tendon tissue's medical instrument, when the tissue breaks, utilize the sleeve pipe to sew up cracked both ends end to end, histiocyte grows in the intraductal, realizes tendon tissue's restoration.
Different with ruptured nerve, ruptured tendon tissue both ends diameter is often different, especially the achilles tendon, from top to bottom tapering, when there is apparent difference or needs many parties to sew up at this kind of both ends tendon diameter, the utility model provides a can simplify the operation step through the tissue repair sleeve pipe of difference in both ends, reduce the damage that the great tension of in-process production brought, the experimental result is more accurate, at tissue regeneration's in-process, the tissue repair sleeve pipe that the both ends internal diameter is different is high with the degree of agreeing with of rupture both ends tissue, sews up the restoration that is favorable to the effect ware and the reply of function, has still avoided the tissue adhesion, has simplified the operation process, has adapted to the change of pathophysiology structure, does benefit to the histiocyte growth, promotes the restoration of tissue.
The tissue repair sleeve has the appearance shown in figure 1.
Preferably, the ratio of the inner diameter of the first end 1 and the inner diameter of the second end 2 of the tissue repair sleeve is 2:1 to 10:1, such as 3:1, 4:1, 5:1, 6:1, 7:1, 8:1 or 9:1, etc.
The utility model discloses in, set up first end internal diameter and second end internal diameter according to above-mentioned proportion scope, better with the degree of agreeing with at cracked achilles tendon both ends, sew up with traditional tendon and compare, have following advantage: (1) both ends can be sewn with little tension. (2) The tendon stump gap is very small. The gap does not influence tendon regeneration, and the accuracy of tendon regeneration selection is improved. (3) The sleeve surrounds the outside of the tendon. After the tendon is injured, local tissues swell and fill gaps, so that escape of regenerated fibers of the tendon can be reduced, and generation of scars can be reduced. The tissue repair sleeve with specific inner diameter ratio can play a better tissue repair effect when applied to the tendon with the defective tendon diameter difference of 2:1-10: 1.
Preferably, the tissue repair sleeve has a wall thickness of 0.1-0.3mm, such as 0.12mm, 0.15mm, 0.20mm, 0.25mm, or 0.28mm, etc.
Preferably, the tissue repair sleeve has a length > 1.5cm, such as 1.6cm, 1.7cm, 1.8cm, 1.9cm, 2.0cm, 2.5cm, 3.0cm, 3.5cm or 4.0cm etc., preferably 2-3 cm.
Preferably, the polymer includes any one of polylactic acid, polycaprolactone, polylactic acid-glycolic acid copolymer, polyurethane, and lactide-caprolactone copolymer.
Preferably, the biodegradable polymer electrospun fiber has a diameter of 1.5-2.5 μm, such as 1.6 μm, 1.7 μm, 1.8 μm, 1.9 μm, 2.0 μm, 2.1 μm, 2.2 μm, 2.3 μm, or 2.4 μm, and the like.
Compared with the prior art, the utility model discloses following technological effect has:
the utility model provides an operation step can be simplified through the tissue repair sleeve pipe of difference in both ends, reduce the damage that the great tension of in-process production brought, the experimental result is more accurate, at the in-process of tissue regeneration, the different tissue repair sleeve pipe of both ends internal diameter is high with the degree of agreeing with of fracture both ends tissue, sew up the restoration that is favorable to the effector and the reply of function, still avoided the tissue adhesion, simplified the operation process, adapted to the change of pathophysiology structure, do benefit to the histocyte and grow, promote the restoration of tissue.
Drawings
FIG. 1 is a schematic view of a tissue repair sleeve provided by the present invention;
wherein 1-a first end of the tissue repair sleeve, and 2-a second end of the tissue repair sleeve.
Detailed Description
To facilitate understanding of the present invention, the present invention has the following embodiments. It should be understood by those skilled in the art that the described embodiments are merely provided to assist in understanding the present invention and should not be construed as specifically limiting the present invention.
Example 1
The utility model provides a tissue repair sleeve, its concrete preparation method is as follows:
(1) mixing polylactic acid-glycolic acid copolymer (M)w280000) and lactide-caprolactone copolymer (M)w260000) was dissolved in hexafluoroisopropanol to obtain an electrospinning dope containing 10% by mass of a polylactic acid-glycolic acid copolymer and 20% by mass of a lactide-caprolactone copolymer.
(2) Injecting the electrospinning raw liquid into an injector, injecting the electrospinning raw liquid at the speed of 2 mL/h under the action of a propulsion pump of electrospinning equipment, carrying out electrospinning under the loading voltage of 16kV, receiving the polylactic acid-glycolic acid copolymer and the lactide-caprolactone copolymer blended electrospinning filament (the diameter is 2 mu m) obtained by electrospinning at the rotating speed of 1200 r/h by using a circular truncated cone-shaped metal rotating receiving disc (the diameters of two ends are 0.5mm and 1.5mm respectively, and the length is 2.5cm) to obtain a tissue repair sleeve, and placing the tissue repair sleeve in a vacuum drying oven for drying for 40h to obtain the tissue repair sleeve (the inner diameter of a first end is 1.5mm, the inner diameter of a second end is 0.5mm, and the ratio is 3:1) with the wall thickness of 0.2mm and the length of 2.5 cm.
Example 2
The difference from example 1 is that polylactic acid-glycolic acid copolymer (Mw: 280000) is replaced with polylactic acid (Mw: 260000).
Example 3
The difference from example 1 is that the lactide-caprolactone copolymer (Mw 260000) was replaced with polycaprolactone (Mw 280000).
Example 4
The difference from example 1 is that the diameters of both ends of the metal rotary receiving disk in the shape of a truncated cone are 0.2mm and 2mm, respectively, and the ratio of the inner diameter of the first end to the inner diameter of the second end of the resulting tissue repair cannula is 10: 1.
Example 5
The difference from example 1 is that the diameters of both ends of the metal rotary receiving disk in the shape of a truncated cone are 0.5mm and 1mm, respectively, and the ratio of the inner diameter of the first end to the inner diameter of the second end of the resulting tissue repair cannula is 2: 1.
Example 6
The difference from example 1 is that the diameters of both ends of the metal rotary receiving disk in the shape of a truncated cone are 0.2mm and 2.2mm, respectively, and the ratio of the inner diameter of the first end to the inner diameter of the second end of the obtained tissue repair cannula is 11: 1.
Example 7
The difference from example 1 is that the diameters of both ends of the metal rotary receiving disk in the shape of a truncated cone are 1mm and 1mm respectively, and the ratio of the inner diameter of the first end to the inner diameter of the second end of the obtained tissue repair sleeve is 1: 1.
Example 8
The difference from example 1 is that an electrospinning dope containing 8% by mass of a polylactic acid-glycolic acid copolymer and 18% by mass of a lactide-caprolactone copolymer was obtained in step (1), and the electrospun fiber obtained in step (2) had a diameter of 1.5 μm.
Example 9
The difference from example 1 is that an electrospinning dope containing 12% by mass of a polylactic acid-glycolic acid copolymer and 25% by mass of a lactide-caprolactone copolymer was obtained in step (1), and the electrospun fiber obtained in step (2) had a diameter of 2.5 μm.
Example 10
The utility model provides a tissue repair sleeve, its concrete preparation method is as follows:
(1) mixing polylactic acid-glycolic acid copolymer (M)w200000) and lactide-caprolactone copolymer (M)w260000) was dissolved in hexafluoroisopropanol to obtain an electrospinning dope containing 10% by mass of a polylactic acid-glycolic acid copolymer and 20% by mass of a lactide-caprolactone copolymer.
(2) Injecting the electrospinning raw liquid into an injector, injecting the electrospinning raw liquid at a speed of 1 mL/h under the action of a propulsion pump of electrospinning equipment, carrying out electrospinning under a loading voltage of 10kV, receiving the polylactic acid-glycolic acid copolymer and the lactide-caprolactone copolymer blended electrospinning filament (the diameter is 2.1 mu m) obtained by electrospinning at a rotating speed of 2000r/h by using a circular truncated cone-shaped metal rotating receiving disc (the diameters of two ends are 0.2mm and 2mm, and the length is 2cm) to obtain a tissue repair sleeve, and placing the tissue repair sleeve in a vacuum drying oven for drying for 36h to obtain the tissue repair sleeve (the inner diameter of the first end is 2mm, the inner diameter of the second end is 0.2mm, and the proportion is 10:1) with the wall thickness of 0.1mm and the length of 2 cm.
Example 11
The utility model provides a tissue repair sleeve, its concrete preparation method is as follows:
(1) mixing polylactic acid-glycolic acid copolymer (M)w300000) and lactide-caprolactone copolymer (M)w260000) was dissolved in hexafluoroisopropanol to obtain an electrospinning dope containing 10% by mass of a polylactic acid-glycolic acid copolymer and 20% by mass of a lactide-caprolactone copolymer.
(2) Injecting the electrospinning raw liquid into an injector, injecting the electrospinning raw liquid at the speed of 3 mL/h under the action of a propulsion pump of electrospinning equipment, carrying out electrospinning under the loading voltage of 20kV, receiving the polylactic acid-glycolic acid copolymer and the lactide-caprolactone copolymer blended electrospinning filament (the diameter is 2 mu m) obtained by electrospinning at the rotating speed of 700r/h by using a circular truncated cone-shaped metal rotating receiving disc (the diameters of two ends are 0.5mm and 1mm respectively, and the length is 3cm) to obtain a tissue repair sleeve, and drying the tissue repair sleeve in a vacuum drying box for 48h to obtain the tissue repair sleeve (the inner diameter of a first end is 1mm, the inner diameter of a second end is 0.5mm, and the proportion is 2:1) with the wall thickness of 0.3mm and the length of 3 cm.
Comparative example 1
The difference from example 1 is that the inner diameters of two sections of the obtained tissue repair cannula were 1.5mm by replacing a truncated cone-shaped metal rotating receiving disk (the diameters of both ends were 0.5mm and 1.5mm, respectively, and the length was 2.5cm) with a cylindrical metal rotating receiving disk (the diameter was 1.5mm, and the length was 2.5 cm).
And (3) performance testing:
(1) and (3) testing the degradation speed:
the fiber membranes obtained in the examples and comparative examples were prepared into several sample strips, the original mass of each sample strip was weighed by an analytical balance, 3 pieces of the sample strips were placed in a phosphate buffer solution with a pH of 7.40, 12 pieces were divided, degradation was performed in a constant temperature incubator at 37 ℃, and after the complete decomposition of the sample, the degradation time was recorded.
(2) Animal experiments:
exposing achilles tendon of anesthetized SD rat, excising 7mm to make 10 mm tissue defect formed by tissue retraction, transplanting into tissue repair cannula prepared in this example and comparative example, suturing both proximal and distal ends, setting control group: no tissue repair cannula is transplanted, direct end-to-end suturing, testing recovery of rat after 12 weeks after operation, self-made rat foot walking box channel length 50cm, width 15cm, one rat box placed at end of channel, length 20cm, width 15cm. and height 15cm, one side door opened, continuous recording paper (20cm width) placed at bottom of box, experimental rat double rear foot carbon dipping ink, placing into proximal inlet of walking box, rat leaving 4-5 toes on each side during far end crawling, selecting experimental side foot (E) and normal side foot (N) footprints, measuring 3 variables, ① foot print length (podagreength, PL longest distance of foot print, i.e. distance from ② to toe (wihbirth foot print), measuring distance of foot print length (⑧) from 3 variables, calculating distance of foot print, connecting line from 3 to 351 st line of sflndex, 5, calculating distance of sflndex, and connecting line of sff-toe, measuring function, line, and connecting line of sflndex, calculating distance of sff-1, 5, and connecting line of sff-toe-distance of sf7-index (2) of sff-index).
SFI＝-38.3(EPL-NPL)/NPL+109.5(ETW-NTW)+13.3(EIT-NIT)/NIT-8.8
Wherein, the sciatic nerve functional index SFI is normal when the value is 0 and the value is complete injury when the value is 100.
Where E begins with data for the experimental side foot, N begins with data for the normal side foot, e.g., EPL represents the foot print length of the experimental side foot, NPL represents the foot print length of the normal side foot, and so on.
The results of the performance tests are shown in table 1.
TABLE 1
As can be seen from Table 1, the tissue repair sleeve provided by the utility model is excellent in the repair effect on tendon tissue, the repair grade of the rat is above-48 in 12 weeks, and can reach-15 (basically recover to be normal), and the repair effect of the tissue repair sleeve with the same inner diameter at both ends provided by the comparative example 1 is poor, and the repair grade of-86 can be reached only in 12 weeks. According to the above data, the utility model provides a tissue repair sleeve pipe that both ends internal diameter is different is very showing to the repairing effect of tissue, this is because the tissue repair sleeve pipe that both ends internal diameter is different is high with the degree of agreeing with of fracture both ends tissue, reduces the damage that the in-process produced great tension and brings, sews up the restoration that is favorable to the effector and the reply of function, has avoided the tissue adhesion, has simplified the operation process, has adapted to the change of pathophysiology structure, does benefit to the tissue cell growth to promote the restoration of tissue.
It is understood from comparison of examples 1 and 4 to 7 that the tissue repair sleeve has a better repair effect when a specific ratio of the inner diameters of both ends is selected to be 2:1 to 10:1 (examples 1, 4 and 5), and that the inner diameters of both ends of the tissue repair sleeve are set at the above specific ratio to have a better fit with both ends of the broken achilles tendon, thereby further improving the repair effect.
The applicant states that the present invention is illustrated by the above embodiments, but the present invention is not limited to the above detailed process equipment and process flow, i.e. the present invention is not meant to be implemented by relying on the above detailed process equipment and process flow. It should be clear to those skilled in the art that any improvement of the present invention, to the equivalent replacement of each raw material of the present invention, the addition of auxiliary components, the selection of specific modes, etc., all fall within the protection scope and disclosure scope of the present invention.
Claims (7)
1. A tissue repair sleeve, characterized in that the tissue repair sleeve is composed of electrospun filaments of a biodegradable polymer and the inner diameter of the first end (1) of the tissue repair sleeve is different from the inner diameter of the second end (2) of the tissue repair sleeve.
2. The tissue repair sleeve according to claim 1, wherein the ratio of the inner diameter of the first end (1) to the inner diameter of the second end (2) of the tissue repair sleeve is 2:1-10: 1.
3. The tissue repair sleeve of claim 1 wherein the tissue repair sleeve has a wall thickness of 0.1-0.3 mm.
4. The tissue repair cannula of claim 1, wherein the tissue repair cannula has a length > 1.5 cm.
5. The tissue repair cannula of claim 4, wherein the tissue repair cannula has a length of 2-3 cm.
6. The tissue repair cannula of claim 1, wherein the polymer comprises any one of polylactic acid, polycaprolactone, polylactic-co-glycolic acid, polyurethane, and lactide-co-caprolactone.
7. The tissue repair sleeve of claim 1 wherein the biodegradable polymer electrospun fiber filaments have a diameter of 1.5-2.5 μm.
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| CN201920303908.8U CN210433516U (en) | 2019-03-11 | 2019-03-11 | Tissue repair sleeve |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109758197A (en) * | 2019-03-11 | 2019-05-17 | 宁波光远致信生物科技有限公司 | A kind of tissue repair casing and its preparation method and application |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109758197A (en) * | 2019-03-11 | 2019-05-17 | 宁波光远致信生物科技有限公司 | A kind of tissue repair casing and its preparation method and application |
| CN109758197B (en) * | 2019-03-11 | 2024-02-20 | 宁波光远致信生物科技有限公司 | Tissue repair sleeve and preparation method and application thereof |
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