WO1998036710A1

WO1998036710A1 - An artificial tendon, a method for preparing the same and application thereof

Info

Publication number: WO1998036710A1
Application number: PCT/CN1998/000019
Authority: WO
Inventors: Qidi Cao
Original assignee: Nan Fang Hospital
Priority date: 1997-02-21
Filing date: 1998-02-18
Publication date: 1998-08-27
Also published as: AU5980398A; CN1203106A; CN1138573C

Abstract

This invention relates to an artificial tendon implantable into the body comprising human hairs and wrapped with biomembranes or biocompatible non-biomembranes. The hairs forming the tendon have been treated for urging it to change into tendinous substance. While the artificial tendon is absorbed and change into human self-tendon, it can be used as the tendon on the affected region effectively. Ultimately, the artificial tendon according to this invention may change into human self-tendon completely, therefor it has overcome the drawbacks of the human tendon replacement in the art.

Description

Artificial tendon, preparation method and application thereof

The invention relates to an artificial tendon which can be implanted in a human body instead of a human autologous tendon.

Background technique

From 1935 to 1959, Teneff and Fanda Bunell studied "allogous tendon" and found that there was a necrotic stage after experiments, which only served as a scaffold and had a rejection reaction. Since 1977, Jenkens has developed a "carbon fiber tendon", which has been widely used in foreign countries and China. Carbon fiber is not a protein and there is no rejection in the human body. However, after further tests, it is found that it is still carbon fiber in the human body after 18 months. Broken, only the outer membrane of connective tissue is formed, not tendonized. By 1980, Dai Kerong of China replaced the tendon with silicone. Although the silicone tendon is non-adhesive and easy to slide, the joint cannot be integrated into the body, is not absorbed by the body, is easy to fold, and becomes a foreign body once infected. In 1988, China's Huang Fengming replaced the tendon with human hair. Its tensile stress is not easy to decay, but it cannot be absorbed by the body. It cannot become a tendon of the body. Once infected, it becomes a foreign body. It adheres to tissues and can only be used for large Achilles tendons. Dynamic tendons should not be used for flexion and extension of the hands and feet.

The object of the present invention is to provide an artificial fitness which can be completely transformed into a human body's autologous tendon, and a preparation method and application thereof.

Summary of the Invention

The invention is realized as follows: The artificial tendon body (1) is formed by bundling together two or more human hairs that have undergone a tendonization step, and the surface of the tendon body (1) is formed by the human placental membrane (2). Wrapping, the tendon body (1) and the placental membrane (2) together form an artificial tendon. Two or more (for example, three) human hairs with different steps of tendonization, after implantation in the human body, have a stepwise change in the time of being absorbed and re-tendonized by the human body, that is, the first type of human hair is in the absorbed and During the process of forming the autologous tendon, the role of the tendon is diminished → disappeared-reconstructed; at this time, the second and third human hairs are in an unchanged state, thus effectively acting as tendons; when the second human hair is When entering the above changes, the first type of human hair is already forming its own tendon; the third type of human hair is still in an unchanged state; thus the first and third types of human hair perform the role of tendon together; when the third type of human hair When entering the above-mentioned state of change; the first type of human hair has been completely absorbed and turned into the human's own tendon, and the second type of human hair has entered the process of being absorbed and formed into the human's own tendon. Thus, the first and second types of human hair are transformed into The autologous tendon performs the role of a tendon. In the end, all three human hairs were completely absorbed and completely transformed into human tendons. ^Two or more types of human hair can be mixed together to be woven into a rope or bonded into a rope with a degradable medical glue. The placenta membrane ( ² ) outside the tendon body (1) is a membrane layer of the fetal surface that is peeled from the human placenta; it can be wrapped on the surface of the tendon body (1) with a degradable absorption suture, or it can be degraded and absorbed. The medical glue adheres the placenta membrane (2) to the surface of the tendon body (1). The function of the placenta membrane (2) is to separate the tendon body (1) from the surrounding tissues, so that the tendon body (1) does not adhere and fuse with the surrounding tissues during the process of being absorbed → autotenous.

The tendonization step treatment method of the present invention is as follows: the human hair is degreased, washed, and treated with R + OH_ drug, the total temperature range of which is 7 ° C ~ 40 ° C; the span of one step treatment is 5. C ~ 15 ° C; its total concentration range is 0.005 ~ 10%,-one step processing span is 0.005 to 4.5%; its processing time is more than 2 hours, and one step processing span is more than 1 hour; some of the above processing The human hair is put into an oxidant for treatment; the human hair treated as above is washed and fixed in an anti-rejection drug, and finally washed and sterilized by autoclaving. Among them, in R + OH ′ drugs, R represents an organic or inorganic atomic group and may also represent a monovalent metal; for example, K + or Na ⁺ . Among them, the parameter range of step processing is a better range. Anti-rejection drugs can be conventional special drugs such as R- (CHO) n drugs; the oxidizing agent can be ROOH (R can be an organic atomic group, can also refer to zinc, sodium, potassium, lithium). In addition, the steps of each step processing may be hierarchical or non-hierarchical.

The manufacturing method of the placental membrane (2) of the present invention is: The placental membrane (2) has a concentration of 0.005 to 1. / R-NH ₃ OH drug treatment, in 7 ~ 40. After soaking for 3 to 60 minutes under C conditions, the layers of the human placenta were separated, and after being cleaned with physiological saline ^{5 to} 20 times, for more than 30 minutes, the placental membrane was removed (2).

The preservation solution of the placental membrane (2) of the present invention contains two drugs, ArG-R and R-OH, whose concentration in water is 0.005 to 95%, and the storage temperature is 4 ° C. C ~ 35. c.

The artificial tendon implantation method of the present invention is: after sterilizing and removing the tendon body (1), immersing it in physiological salt 15 minutes to 2 hours in water, take the placenta membrane (2) out of the sterile ampoule and soak it in heavy saline for 15-30 minutes; wrap the treated placental membrane (2) on the surface of the treated tendon body (1) For positioning and fixation, an artificial tendon is formed; the two ends of the artificial tendon are connected with the stump of the tendon in the affected part. The function of physiological saline immersion is to eliminate the influence of the preservation solution on the human body and make the moistening of the tendon body (G) and the placental membrane (2) meet the physiological requirements of implantation.

The implantation method of the present invention may also adopt a method of fixing both ends of the artificial tendon and the starting and stopping points of the tendon of the affected part through a bone hole.

In the present invention, the tendon body (U) can also be wrapped with the autologous membrane (2) of the patient's body, such as myometrium, aponeurosis, pleura, peritoneum, etc., so as to form an artificial tendon together.

The membrane covering the tendon body (1) of the present invention may also be a non-biofilm. Because of the biological membrane of the living body, except for the patient's own membrane and the fetal mask of the placenta, the remaining biological allogeneic membranes, due to the rejection of the biological immune system of the patient's body; cannot be used as the tendon body (1) wrapping membrane of artificial tendons; and Non-biofilms, such as non-toxic food packaging plastic films, as the wrapping film of the tendon body (1) do not cause rejection reactions; therefore, it can be used instead of the placental film.

The non-biofilm covering the tendon body (1) of the present invention uses a degradable film made of starch as a main raw material. Because the above plastic film cannot be degraded, it will stay in the human body for a long time, which will adversely affect the tendon tissue of the human body from artificial tendon to autologous tendon, or affect the normal function of the body, or cause discomfort to the patient. Therefore, the biodegradable film, for example: as a 60 to 70% starch, with ³⁰ to 40% of biodegradable plastics component made bagging film effect tendon (1) of wrapping film may cause plant workers tendons After the insertion, the tendon body (1) is completely absorbed and transformed into the autologous tendon, and the wrapped film gradually degrades and disappears. In this way, the tendon body (1) is protected from being damaged before the tendon body (1) is fully autologized. Adhesion and fusion with the surrounding tissues, and after the tendon body (1) is autologized, the membrane (2) is gradually degraded and disappeared, thereby completely eliminating various defects caused by the membrane (2) that cannot be autologized. Overview of the drawings

FIG. 1 is a schematic structural diagram of an artificial tendon according to the present invention.

Because the present invention uses ^two or more types of human hair and placenta that have undergone tendonization step treatment The membrane is made into an artificial tendon; therefore, in the process of the artificial tendon being absorbed and transformed into the human autogenous tendon, more than two types of human hairs appear in order in the time of the weakening-disappearing-reconstructing change of the tendon effect. Complementary effects of step changes; In the process of completely transforming an artificial tendon into a human autogenous tendon, the tendon function of the affected part of the patient remains intact. Therefore, the medical purpose of implanting artificial tendon to replace the original autogenous tendon of the human body is achieved.

Preferred embodiment of the invention

Example 1

See Figure 1. After degreasing the human hair bundle with chloroform, wash it with distilled water; then divide the human hair into three equal parts and immerse them separately with the shaojian solution; the first treatment: temperature 5. C, concentration 0.005%, treatment time 3 hours; second treatment: temperature 10 匸, concentration 0.01%, treatment time 6 hours; third treatment: temperature 15 ° C, concentration 0.15%, treatment time 8 hours. Put the human hair treated with the third kind above into a 5% potassium peroxide solution and soak it for ² hours at normal temperature; then wash the human hair treated with the three types with steamed water and put it into the glutaraldehyde solution The medium was vesicles for ⁸ hours. Finally, the three human hairs treated in this way were uniformly taken out and woven into a tendon cord (1). )use. The tendon cord (1) is penetrated into the tendon sheath (3), washed with distilled water, and then sterilized under high temperature and high pressure for routine sterilization and aseptically sealed. Place the fresh human placenta of a healthy person in an Ammonia solution with a concentration of 0.001% and soak it for ²⁰ minutes at room temperature. After separating the layers of the body placenta, wash them with preservative-containing physiological saline 20 times for 30 minutes. Then remove the fetus The placenta membrane (2) is reserved.

Above placental membranes (2) are not available for immediate use Preservation Solution follows: Solution ingredients: 0.00 ^5% chlorine guanidine alkyl aromatic hydrocarbon group, 6 ² .75% Erguotou, balance water.

When the affected part of the human body needs to be implanted, the tendon cord (1) and the placental membrane (2) with the tendon sheath (3) are taken out, immersed in physiological saline for 30 minutes and taken out, and the placental membrane (2) is removed. Wrapped around the tendon cord (1) of the tendon sheath (3), sutured from the outside with a suture ( ⁴ ) to form an artificial tendon, and the two ends of the artificial tendon are connected to the stump of the flexor tendon of the patient's finger.

Example 2 The human hair used for the tendon body (1) is uniformly mixed after the tendonization step treatment. When it is needed for implantation, it is bonded or bundled with degradable medical glue to form the tendon body (1), and then the placental membrane (2) Adopt the above medical glue to the surface of the tendon body (1); make an artificial tendon, and fix the two ends of the artificial tendon through the bone holes at the starting and ending points of the flexor tendon of the patient. The rest is the same as in Example ¹ .

Example 3

The placental membrane (2) is replaced with a degradable plastic film (2) made of ⁷⁰ % gelatin and 30% degradable plastic components, and the rest are the same as in Example 1.

Industrial applicability

The artificial tendon can be produced by manual or mechanized batch production and stored at room temperature aseptically for use in medical surgery.

Claims

Rights request

1. An artificial tendon that can be implanted in a human body, characterized in that: the artificial tendon body (1) is formed by bundling together ^two or more human hairs that have undergone a tendonization step, and the tendon body (1) consists of The human placental membrane (2) covers its surface, and the tendon body (1) and the placental membrane (2) together form an artificial tendon.

2. The artificial tendon implantable into the human body according to claim 1, characterized in that: the placental membrane (2) surrounding the tendon body (1) is made of human hair that has been subjected to a tendonization treatment and can be finally absorbed. Suture (4) sutures it.

3- The artificial tendon that can be implanted into the human body according to claim 1, characterized in that: a tendon sheath (3) of a human hair undergoing a tendonization treatment is placed between the tendon body (1) and the placental membrane (2). The tendon body (1) is sleeved in it.

4- The artificial tendon that can be implanted into the human body according to claim 1 or 3, characterized in that: the tendon body (1) has two or more human hair-promoting step treatment methods: after degreasing the human hair Washing and treatment with R + OH 'drug, the total temperature range is 7 ° C ~ 40' C;-the step of the step treatment is 5 ° C ~ 15 ° C; the total concentration range is 0.005 ~ 10%, — One step treatment span is 0.005 to 4.5%; its treatment time is more than 2 hours, and one step treatment spans more than 1 hour; Put part of the human hair treated above into oxidant; Wash the human hair treated as above It is then fixed in anti-rejection drugs, and finally washed and autoclaved.

According to claim ^4, wherein the body of the implantable artificial tendons, characterized in that: placental membrane ⁽²⁾ by the concentration of 0.005 to 1% R-NH ₃ OH drug treatment, in the condition of 7 ~ 40 ° C After soaking for 3 to 60 minutes, the layers of the human placenta are separated, and after being cleaned with physiological beneficial water for 5 to 20 times, for more than 30 minutes, the placental membrane is removed (2).

6. The placenta membrane preservation solution capable of being implanted into an artificial tendon of a human body according to claim 5, characterized in that the preservation solution of the placenta membrane (2) contains: ArG-R, R-OH two drugs, which are in water The concentration is 0.005 ~ 95%, and the storage temperature is 4. c ~ 35. c „

7. An implantable artificial tendon implantable method according to claim 5, wherein The method consists of: sterilizing and removing the tendon body (1), immersing it in physiological saline for 15 minutes to ² hours, removing the placental membrane (2) from a sterile ampoule and soaking it in physiological saline for I ^{5 to} 30 minutes; The placental membrane (2) is wrapped on the surface of the treated tendon body (1) for positioning and fixing to form an artificial tendon; the two ends of the artificial tendon are connected with the stump of the tendon in the affected part.

8. The method for implanting an artificial tendon that can be implanted into a human body according to claim ⁷ , characterized in that: both ends of the artificial tendon and the tendon starting and stopping point of the affected part are fixed through a bone hole.

The artificial tendon according to claim 1 or ³ , characterized in that the tendon body (1) is wrapped by a human body's own membrane (2), and the tendon body (1) and the autologous membrane (2) form an artificial tendon together.

The artificial tendon according to claim 1 or ³ , characterized in that the tendon body (1) is wrapped by a non-biofilm (2), and the tendon body (1) and the membrane (2) together form an artificial tendon.

11. The artificial tendon according to claim 10, characterized in that the non-biofilm (2) is a degradable film.