CN104841007A - Medical suture line and preparation method thereof - Google Patents
Medical suture line and preparation method thereof Download PDFInfo
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- CN104841007A CN104841007A CN201510315358.8A CN201510315358A CN104841007A CN 104841007 A CN104841007 A CN 104841007A CN 201510315358 A CN201510315358 A CN 201510315358A CN 104841007 A CN104841007 A CN 104841007A
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Abstract
The invention provides a preparation method of a medical suture line. The preparation method of the medical suture line comprises the following steps: step 1, contacting freshly extracted animal muscle tendon with a treating fluid 1 at 30-40 DEG C for 1-2 h to obtain a muscle tendon raw material 1; step 2, contacting the muscle tendon raw material 1 with a treating fluid 2 at 30-40 DEG C for 1-2 h to obtain a muscle tendon raw material 2; step 3, contacting the muscle tendon raw material 2 with a treating fluid 3 at 15-30 DEG C for 0.5-1 h to obtain a muscle tendon raw material 3; step 4, contacting the muscle tendon raw material 3 with O3 at 15-30 DEG C for 0.5-1 h to obtain a muscle tendon raw material 4; step 5, contacting the muscle tendon raw material 4 with medicinal alcohol at 15-30 DEG C for 20-30 h for curing so as to obtain a muscle tendon raw material 5, wherein the components of the treating fluid 1 are pepsase and/or acetic acid; the components of the treating fluid 2 are trypsase and/or NaCO3; and the components of the treating fluid 3 are NaClO and/or NaOH. The medical suture line prepared by using the method has the advantages of high intensity, high absorption effect, low lethality and high safety.
Description
Technical field
The present invention relates to medical material manufacture field, be specifically related to a kind of suture and preparation method thereof.
Background technology
Suture is a kind of thread like material sewed up for body operation, experienced by: silk thread, catgut, chemosynthesis line, pure-natural collagen stitching thread from its development history of material development; From absorbability, experienced by: non-absorbing stitching thread and absorbable suture; Natural stitching thread and artificial stitching thread two kinds is divided into according to raw-material source.
The animal tendon suture utilizing animal tendon materials to prepare is a kind of absorbable suture of pure natural, take from animal tendon tissue, there is many characteristics of collagen protein material, compare with other stitching thread have good absorbing effect, pulling force strong, promote the exclusive functions such as wound healing, be thus widely used in medical sutures process.
Due to the particularity of application, the following characteristic requirements of suture demand fulfillment: 1. can keep enough intensity in wound healing process, also should extend to adapt to wound edema, and is retracted into original length with wound retraction; 2. after wound healing, it again can degraded and absorbed voluntarily, no longer leaves foreign body; 3. do not produce inflammation; 4. nonirritant and carcinogenecity; 5. be easy to the process such as dyeing, sterilizing, sterilization; 6. can form knot securely; 7. easy to make, cheap, can produce in a large number.
Existing medical animal Tendon Suture is eliminated after the reasons such as not good and inactivation of virus effect is bad usually can cause the inflammatory reaction of patient, relevant disease and final wound healing due to immunogenicity and is produced cicatrix and subcutaneous lump.Therefore be necessary the preparation method that a kind of new suture is provided, thus obtain the animal Tendon Suture that intensity is good, safety is high.
Summary of the invention
The object of the invention is to overcome the defect existed in prior art, the suture preparation method of the suture that a kind of intensity is good, safety is high being provided and preparing by the method.
The invention provides a kind of preparation method of suture, comprise the following steps:
Step one: at 30-40 DEG C, freshly extd animal tendon is contacted 1-2h with treatment fluid 1 and obtain tendon raw material 1; Step 2: at 30-40 DEG C, described tendon raw material 1 is contacted 1-2h with treatment fluid 2 and obtain tendon raw material 2; Step 3: at 15-30 DEG C, described tendon raw material 2 is contacted 0.5-1h with treatment fluid 3 and obtain tendon raw material 3; Step 4: by described tendon raw material 3 and O at 15-30 DEG C
3contact 0.5-1h obtains tendon raw material 4; Step 5: described tendon raw material 4 is contacted 20-30h at 15-30 DEG C with medical alcohol and be cured and obtain tendon raw material 5;
Wherein, the constituent of described treatment fluid 1 is pepsin and/or acetic acid; The constituent of described treatment fluid 2 is trypsin and/or NaCO
3; The constituent of described treatment fluid 3 is NaClO and/or NaOH.
Wherein, the object of step one and step 2 is that animal tendon in order to make and its hetero-organization depart from, and obtains highly purified animal tendon.The object of step 3 and step 4 is immunogenicity in order to remove animal tendon and deactivation and the removal carrying out virus.The object of step 5 is to be cured animal tendon.
In preferred situation, containing pepsin and acetic acid in described treatment fluid 1; Containing trypsin and NaCO in described treatment fluid 2
3; Containing NaClO and NaOH in described treatment fluid 3.
Optionally, in described treatment fluid 1, pepsic concentration is 0.3-2.5 % by weight; The concentration of acetic acid is 0.1-0.6mol/L.
Preferably, when containing pepsin and acetic acid in described treatment fluid 1, pepsic concentration is 0.6-1.8%; The concentration of acetic acid is 0.45-0.55mol/L; PH is 2-3.
Optionally, in described treatment fluid 2, tryptic concentration is 0.3-2.0 % by weight; NaCO
3concentration be 0.15-0.65mol/L.
Preferably, when containing trypsin and NaCO in described treatment fluid 2
3time, tryptic concentration is 0.5-1.5%; NaCO
3concentration be 0.45-0.55mol/L; PH is 9-10.
Optionally, in described treatment fluid 3, the concentration of NaClO is 0.01-10 % by weight; The concentration of NaOH is 0.05-0.15mol/L.
Preferably, when containing NaClO and NaOH in described treatment fluid 3, the concentration of NaClO is 0.01-8 % by weight; The concentration of NaOH is 0.08-0.12mol/L; PH is 12-14.
Optionally, described method is also included in 100,000 grades of cleaning shops, temperature is 18-28 DEG C, humidity is under the condition of 45-65%, and air-dry for described tendon raw material 5 and polishing are obtained suture.
Optionally, described method is also included in and adopts the Co60 of 20-25KGy dosage to carry out irradiation sterilization to described suture.Wherein, described method utilizes pure water to carry out rinsing 3-5 time to tendon raw material after being also included in step one, two, three, four and five, removes residual treatment fluid and O
3composition;
Optionally, described animal tendon is the long-tail mammals such as coypu ail tendo, cattle ail tendo, cauda equina tendon.Preferably, described animal tendon is coypu ail tendo.
Wherein, in method provided by the present invention, the mode of the contact of animal tendon and treatment fluid 1-3 is for be soaked in treatment fluid 1-3 by described animal tendon, and the present invention has no particular limits, as long as guarantee submergence tendon raw material for the amount of soaking the treatment fluid 1-3 used.
Wherein, in step 3, tendon raw material 3 and O
3during contact, O
3concentration be 0.3-0.6mg/L, air pressure during process is 0.3-0.6MPa.
Present invention also offers the suture utilizing method of the present invention to prepare.
Method operating process provided by the present invention is easy, and the suture utilizing the method to prepare has that intensity is high, good absorbing effect, mortality are low, safety is high, without the advantage of cicatrization.
Accompanying drawing explanation
Fig. 1 is zoopery tissue resorption slice map group.Wherein, A is animal tendon suture group absorbing state, and B is that chemosynthesis line is combined into situation, and a is the 4th day, and b is the 10th day, and c is the 18th day.
Fig. 2 is zoopery tissue collagen fibroplasia figure group.Wherein, A is animal tendon suture group, and B is chemosynthesis line group, and a is the 8th day, and b is the 10th day.
Fig. 3 is zoopery tissue inflammation reaction figure group.Wherein, A is animal tendon suture group, and B is chemosynthesis line group.
Fig. 4 is zoopery tissue resorption slice map group.Wherein, A is animal tendon suture group absorbing state, and B is that chemosynthesis line is combined into situation, and a is the 10th day, and b is the 12nd day
Detailed description of the invention
Below will the present invention is described in detail by detailed description of the invention.It will be appreciated that providing of following examples is only object in order to play explanation, being not used to limit scope of the present invention.Those skilled in the art, when not deviating from aim of the present invention and spirit, can carry out various amendment and replacement to the present invention.
Embodiment 1-5
Suture 1-5 is prepared in constituent according to the treatment fluid 1-3 provided in table 1.
First extract coypu ail tendo and clean up; Freshly extd tendon is soaked in 1.5h in treatment fluid 1 at 35 DEG C and obtains tendon raw material 1; Tendon raw material 1 is soaked in 1.5h in treatment fluid 2 at 35 DEG C and obtains tendon raw material 2; Tendon raw material 2 is soaked in 45min in treatment fluid 3 at 25 DEG C and obtains tendon raw material 3; By tendon raw material 3 (content 0.45mg/L, air pressure is 0.1MPa) O at 25 DEG C
3contact 45min obtains tendon raw material 4; Tendon raw material 4 is soaked in 24h in medical alcohol at 25 DEG C and is cured acquisition tendon raw material 5; In 100,000 grades of cleaning shops, temperature is 18-28 DEG C, humidity is under the condition of 45-65%, carries out air-dry, polishing typing, band medical suture needle and packaging to tendon raw material 5; Under the Co60 radiation condition being finally 20-25KGy at dosage, sterilizing obtains suture 1-5.
Table 1
Embodiment 6
Adopt the method identical with embodiment 1 to prepare suture, difference is only, in treatment fluid 1, does not add acetate component, obtains suture 6.
Embodiment 7
Adopt the method identical with embodiment 1 to prepare suture, difference is only, in treatment fluid 2, does not add NaCO
3composition, obtains suture 7.
Embodiment 8
Adopt the method identical with embodiment 1 to prepare suture, difference is only, in treatment fluid 3, does not add NaOH composition, obtains suture 8.
Test case 1
Test case 1 is for illustration of the tensile strength of the stitching thread 1-8 obtained in embodiment 1-8: adopt stitching thread tension tester to detect the tensile strength of suture 1-8, test intensity results is as shown in table 2 below, following data are all the tensile strength of 3-0, and test quantity is 300.
Table 2
| Sequence number | Stitching thread | Tensile strength |
| 1 | Stitching thread 1 | 21.3±0.7 |
| 2 | Stitching thread 2 | 22.1±0.8 |
| 3 | Stitching thread 3 | 23.7±1.3 |
| 4 | Stitching thread 4 | 20.2±2.4 |
| 5 | Stitching thread 5 | 19.7±1.8 |
| 6 | Stitching thread 6 | 22.6±2.7 |
| 7 | Stitching thread 7 | 23.1±1.2 |
| 8 | Stitching thread 8 | 22.4±1.3 |
Can be learnt by above Data Data, the tensile strength of stitching thread 3 is maximum, and above data all meet the industry standard of suture 3-0.Resist from anti-intensity, stitching thread 1-8 all can be used for making stitching thread.
Test case 2
Test case 2 is for illustration of the absorbing state of the stitching thread 3 obtained in embodiment 3: experimental group stitching thread 3 pairs of White Rabbit myometrial sutures, matched group adopts stitching thread (the PGA suture of chemosynthesis, purchased from Nantong Hua Likang Medical Devices Co., Ltd.) equally the otch of White Rabbit is sewed up, then get stitching thread in animal body the 4th, 10,18 day time otch sample do HE stained and in the sutural absorbing state of the basis of microscopic observation of x10, assimilation effect is shown in Fig. 1.As can be seen from assimilation effect figure, stitching thread 3 (animal tendon suture group) absorbed completely at the 18th day, and matched group (chemosynthesis line group) absorbing state is undesirable.
Test case 3
Test case 3 is for illustration of the collagen fiber hyperplasia situation of the stitching thread 3 obtained in embodiment 3: experimental group stitching thread 3 is to the White Rabbit back that implants, matched group adopts stitching thread (the PGA suture of chemosynthesis, purchased from Nantong Hua Likang Medical Devices Co., Ltd.) implant White Rabbit back equally, then get stitching thread in animal body 8,10 days time otch sample do VG stained and in the basis of microscopic observation collagen fiber hyperplasia situation of x10.Collagen Proliferation situation is shown in Fig. 2.As can be seen from Figure 2: experimental group (animal tendon suture group) has collagen fiber hyperplasia on the 8th day and invades suture inside, within the 10th day, do not observe collagen fiber hyperplasia situation is because stitching thread has been degraded and absorbed, in-vivo tissue cell cannot continue to produce collagen fiber hyperplasia around suture; Matched group (chemosynthesis line group) all can observe obvious collagen fiber hyperplasia situation at the 8th, 10 day, because the stitching thread of chemosynthesis is not obviously absorbed so just can continue to produce collagen fiber hyperplasia around stitching thread, along with the prolongation of soak time, excessive collagen fiber hyperplasia will cause the generation of cicatrix and subcutaneous lump.
Test case 4
Test case 4 is for illustration of the inflammatory reaction situation of the stitching thread 3 obtained in embodiment 3: experimental group stitching thread 3 pairs of White Rabbit myometrial sutures, matched group adopts stitching thread (the PGA suture of chemosynthesis, purchased from Nantong Hua Likang Medical Devices Co., Ltd.) equally the otch of White Rabbit is sewed up, then get stitching thread in animal body the 10th day time otch sample do HE stained and in the sutural inflammatory reaction situation of the basis of microscopic observation of x10, inflammatory reaction effect is shown in Fig. 3.As can be seen from the figure, experimental group (animal tendon suture group) can not observe stitching thread and without obvious inflammatory cell infiltration, i.e. NIP reaction; And matched group (chemosynthesis group) partially absorbs and inflammatory cell infiltration is obvious, namely there is obvious inflammatory reaction.
Test case 5
Test case 5 is for illustration of the TNF-alpha levels change of the stitching thread 3 obtained in embodiment 3: experimental group stitching thread 3 pairs of White Rabbit myometrial sutures, matched group adopts stitching thread (the PGA suture of chemosynthesis, purchased from Nantong Hua Likang Medical Devices Co., Ltd.) equally the otch of White Rabbit is sewed up, then stitching thread in animal body the 10th is got, otch sample when 12 days, SABC SABC method is adopted to cut into slices and at the basis of microscopic observation stitching thread staining conditions of x40, Bresalier sxemiquantitative formula is adopted to judge coloration result thus judge TNF-alpha levels, TNF-α time variations sees the following form:
Table 3
| Group | 10th day | 12nd day |
| Animal tendon suture group | —* | —* |
| PGA line group | 1.12±0.34 | 1.18±0.31 |
* represent and compare P < 0.05 with PGA suture group, "-" represents does not observe result
Statistical analysis: there were significant differences for both TNF-α of Post operation the 10th day, the 12nd day: animal Tendon Suture group does not observe TNF-α and PGA line group has TNF-α, this may with whether absorb completely relevant, namely PGA line does not absorb and causes the infiltration of inflammatory cell and make the existence of TNF-α and have the trend of increase, and sections observation design sketch is shown in Fig. 4.
Although above the present invention is described in detail with a general description of the specific embodiments, on basis of the present invention, can make some modifications or improvements it, this will be apparent to those skilled in the art.Therefore, these modifications or improvements without departing from theon the basis of the spirit of the present invention, all belong to the scope of protection of present invention.
Claims (10)
1. a preparation method for suture, is characterized in that, comprises the following steps:
Step one: at 30-40 DEG C, freshly extd animal tendon is contacted 1-2h with treatment fluid 1 and obtain tendon raw material 1;
Step 2: at 30-40 DEG C, described tendon raw material 1 is contacted 1-2h with treatment fluid 2 and obtain tendon raw material 2;
Step 3: at 15-30 DEG C, described tendon raw material 2 is contacted 0.5-1h with treatment fluid 3 and obtain tendon raw material 3;
Step 4: by described tendon raw material 3 and O at 15-30 DEG C
3contact 0.5-1h obtains tendon raw material 4;
Step 5: described tendon raw material 4 is contacted 20-30h at 15-30 DEG C with medical alcohol and be cured and obtain tendon raw material 5;
Wherein, the constituent of described treatment fluid 1 is pepsin and/or acetic acid; The constituent of described treatment fluid 2 is trypsin and/or NaCO
3; The constituent of described treatment fluid 3 is NaClO and/or NaOH.
2. preparation method according to claim 1, is characterized in that, in described treatment fluid 1, pepsic concentration is 0.3-2.5 % by weight; The concentration of acetic acid is 0.1-0.6mol/L.
3. preparation method according to claim 1 and 2, is characterized in that, in described treatment fluid 2, tryptic concentration is 0.3-2.0 % by weight; NaCO
3concentration be 0.15-0.65mol/L.
4. preparation method according to claim 3, is characterized in that, in described treatment fluid 3, the concentration of NaClO is 0.01-10 % by weight; The concentration of NaOH is 0.05-0.15mol/L.
5. according to the preparation method in claim 1,2 and 4 described in any one, it is characterized in that, described method is also included in 100,000 grades of cleaning shops, under the condition of temperature 18-28 DEG C, humidity 45-65%, air-dry for described tendon raw material 5 and polishing are obtained suture.
6. the preparation method according to claim 4 or 5, is characterized in that, described animal tendon is coypu ail tendo, cattle ail tendo or cauda equina tendon.
7. preparation method according to claim 6, is characterized in that, described animal tendon is coypu ail tendo.
8. preparation method according to claim 7, is characterized in that, O
3air pressure during process is 0.1MPa, and concentration is 0.3-0.6mg/L.
9. preparation method according to claim 8, is characterized in that, the Co60 that described method also comprises employing 20-25KGy dosage carries out irradiation sterilization to described suture.
10. utilize the suture that the method in claim 1-9 described in any one prepares.
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| CN201510315358.8A CN104841007B (en) | 2015-06-10 | 2015-06-10 | A kind of suture and its preparation method |
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|---|---|---|---|
| CN201510315358.8A CN104841007B (en) | 2015-06-10 | 2015-06-10 | A kind of suture and its preparation method |
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| CN104841007B CN104841007B (en) | 2016-06-01 |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4488911A (en) * | 1975-10-22 | 1984-12-18 | Luck Edward E | Non-antigenic collagen and articles of manufacture |
| CN1262959A (en) * | 2000-03-01 | 2000-08-16 | 郑思华 | Preparation method of coypu collagen operating suture |
| CN1879898A (en) * | 2006-04-29 | 2006-12-20 | 双城市北龙生物技术开发有限公司 | Production method of absorbable suture of mammal nerve fiber |
| CN101085373A (en) * | 2006-06-09 | 2007-12-12 | 湖南然原医用高科技蛋白线有限公司 | Method for producing nutria tendon tissue medical suture and straining device for the same |
-
2015
- 2015-06-10 CN CN201510315358.8A patent/CN104841007B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4488911A (en) * | 1975-10-22 | 1984-12-18 | Luck Edward E | Non-antigenic collagen and articles of manufacture |
| CN1262959A (en) * | 2000-03-01 | 2000-08-16 | 郑思华 | Preparation method of coypu collagen operating suture |
| CN1879898A (en) * | 2006-04-29 | 2006-12-20 | 双城市北龙生物技术开发有限公司 | Production method of absorbable suture of mammal nerve fiber |
| CN101085373A (en) * | 2006-06-09 | 2007-12-12 | 湖南然原医用高科技蛋白线有限公司 | Method for producing nutria tendon tissue medical suture and straining device for the same |
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| CN104841007B (en) | 2016-06-01 |
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