TWM507742U - The guided nerve conduit - Google Patents

Description

Guided nerve junction catheter

The design of the case is related to the repair and joining of the nerves. In detail, it is a biodegradable and biocompatible nerve-conducting catheter containing a guiding nerve bundle catheter and There are many permeability holes in the catheter. The permeability pores can improve the metabolic rate during nerve repair, reduce the chance of infection after surgery, and increase the ability of nerve repair and regeneration. The nerves that help repair can be accurate and fast. Regeneration and repair.

According to clinical statistics, it is known that the repair of medical and physiological diseases is difficult for patients with nerve damage to repair or easy to operate. Many patients suffer from long-term problems due to nerve injury or damage, especially affecting patients. The quality of life, even in severe cases, can lead to life-long illness, serious people may be disabled for life or death, so the related neurological diseases are increasing every year in the world, because the repair of nerve damage is relatively Difficulties, especially those caused by accidents, traumas and car accidents, may cause serious nerve injury or damage due to carelessness, resulting in an increase in personal medical expenses and national medical costs. Affect the quality of life of the individual.

In cases of nerve injury or damage, it is easier to cure with peripheral nerve defects. The most common and adopted method is to perform autologous nerve transplantation because autologous transplantation will not be more likely. The problem of rejection of the bed, but the nerve part for autologous nerve transplantation is extremely limited, and it is very inconvenient, and the source is not extensive, which may cause functional deficiency of the nerve supply site, and is limited to a small distance nerve defect can be applied. Too large a nerve defect requires finding a suitable medical material as a material for nerve bonding or repair, such as an allogeneic nerve graft, a vein replacement graft, or a biodegradable catheter. The use of a biodegradable and biocompatible guiding nerve junction catheter as a scaffold can assist in the regeneration and repair of damaged nerves, and can be clinically improved and newly developed into an autologous nerve graft. A nerve scaffold or a cemented catheter provides an excellent design for the beneficial physiological environment and association of neural tissue regeneration.

Currently, the material of the nerve conduit is selected from autologously transplanted tissues, blood vessels, collagen, synthetic polymers and high molecular polymers, including polylactic acid (PLA), polyglycolic acid (PGA) and collagen (Collagen). Wait. Among them, collagen and gelatin (Gelatin) are the main components of the extracellular matrix, which promote cell adhesion and enhance cell proliferation without cellular or biological toxicity. They have also been shown to be involved in other tissue repair or It is widely used in biomedical materials for burns, wounds and trauma. Therefore, the development of a new combined structure to enhance nerve regeneration has become one of the new research directions, and provides considerable mechanical strength to support axonal growth of nerve endings, but autologous graft materials are time-sensitive and have Restrictively, the time left in the original living environment should not be too long, and the artificial materials should be transformed into the most popular clinical research and development. The nerve conduits must have good biocompatibility and better mechanical strength, and hope to find out. The most suitable nerve conduit material and structure in clinical practice. Because of the inappropriate nerve conduit material and structure, only partial nerve repair can be provided, thus losing the golden period of nerve repair, or inflammatory reaction always occurs during the nerve repair process, and the inflammatory reaction will make the newborn tissue grow poorly. If there is an inflammatory reaction in the body during the period, it may cause the nerve growth to be oppressed or caused by Inflammation leads to long-term complications, which can lead to poor regeneration and even lead to failure of the entire transplant process.

Nerve injury or damage is generally not easy to cure. The current research pays special attention to the field of regenerative medicine. Many studies have made some improvements to the nerve repair catheter. The most common one is to make a suitable environment or the most appropriate. The conjugate structure is provided for use by the patient, and clinically or scientifically, Schwann's stem cells, Schwann cells, Tremella polysaccharides, adipose tissue stem cells, or other conditions that contribute to axonal regeneration are also added during the injured nerve repair phase. In addition to the environment, some animal experiment models have been used academically instead. The main purpose is to promote the regeneration or repair of nerves. Another purpose is to make neurons form, so that it is easier to repair damaged nerves. .

Referring to the anatomical map of the anatomy textbook in Figure 1, it is known that the characteristics of nerve tissue are important in the body system, and can regulate the operation of cells in individual systems and organs in the body. Neurons are composed of neurons (Neuron cells) and nerves. Made up of gelatinous cells (Neuroglia). Neurons are responsible for the main functions of the entire nervous system. Neuronal cells are composed of three parts, including cell bodies, dendrites, and axons. Therefore, in the process of peripheral nerve defects, the regeneration of neuronal cells and glial cells can restore the function of the nervous system. The content of glial cells in peripheral nerves is Schwann Cell and Satellite Cell. As the main reason, the main purpose of Schwann cells is to assist in the regeneration and repair after injury, so providing injured nerve regeneration is to regenerate new nerve tissue, especially neuronal cells and glial cells.

Referring to Fig. 2, the Chinese Patent No. M451975 "Application of a nerve junction catheter for the repair of peripheral nerve repair", hereinafter referred to as an EGT nerve catheter, discloses a nerve junction catheter for cutting peripheral nerve repair, the EGT The nerve conduit includes a tube The body 10 has a channel 11 extending through the ends of the tubular body 10; the appearance of the EGT nerve conduit from the general finished product is close to the ivory white or the original color (white or yellow) of the material. The inner diameter of the EGT nerve conduit tube is about 1.2~1.3mm, and the wall thickness is about 0.3mm. The longitudinal section shows that the inner wall surface of the nerve conduit is flat and dense, and the flat inner wall will help The transmission of nerve growth factor and the growth of nerve axons are conducive to the regeneration and repair of the defect nerve.

Although the EGT nerve catheter disclosed in the prior art can be applied to the repair of the peripheral nerve by a general patient or a user, the flat inner wall cannot provide the axon climbing, and the primary nerve tissue cannot be well supported. And protection, it is easy for the peripheral nerves with 2 to 3 bundles to have high-efficiency repair rate, which may slow the nerve regeneration rate, or it may be more likely to produce inflammation during the regeneration process, because abnormal inflammation will occur. Causes physiological damage and affects the rate of repair. The following is a specific statement of the shortcomings of the conventional EGT nerve catheter:

1. The wall of the inner layer of the EGT nerve conduit that is too flat can not provide a good growth environment for neurons, nerve cells, dendrites, axons, etc. required for regenerative nerves.

2. A single-layer EGT nerve catheter is prone to deformation or bending of the external structure, which may affect the subsequent growth of nerve regeneration.

3. There is no sealed environment with proper substance exchange, and material exchange and transfer are not easy.

4. If an inflammatory response is likely to occur in an in vivo infection, adversely implanted nerve regeneration and failure of the current surgery.

With the increasing emphasis on medical quality, Hypothesis is no longer just about the need to provide simple structural recovery, but also emphasizes functional recovery. Therefore, it requires a more meticulous and medical quality compound medical material. And the function of the known nerve conduit is only Improve the function of the truncated peripheral nerve repair, perhaps the repair rate of the repair function is not high, the clinical is more and more demanding to repair the functional quality improvement, the conventional simple nerve repair function will not meet the market development needs, if special To improve the above factors affecting the repair rate, or to provide a stable and appropriate structure for the area of nerve damage, in conjunction with the original market will put some additive cofactors or additives, such as adding Schwann stem cells, Wang's cells, Tremella polysaccharides, adipose tissue stem cells, etc., will have a double or double effect, and can enhance the competitiveness of the clinical market.

The main purpose of this case is to provide a biodegradable and biocompatible guiding nerve junction catheter, including: an outer tubular body, and a three-layer inner nerve bundle catheter structure, the overall structure is correct Guide the nerve regeneration of the injured tissue, and promote nerve regeneration along the inner nerve bundle catheter, smoothing the nerve repair. The most important feature of this guided nerve junction catheter is that it contains three inner nerve bundle catheter structures. In the body of vertebrates, the general peripheral nerve is a three-beam type of nerve bundle, and the entire three-beam type nerve is wrapped by a nerve-coated membrane. When the nerves at both ends are sutured, the guided nerve-engaging catheter is In the process of nerve regeneration, the injured tissue nerve can be correctly guided, and the nerve regeneration can be along the inner nerve bundle catheter. The structure of the guided nerve junction catheter body can be maintained stably and has excellent mechanical strength. The inner nerve bundle is maintained. The tube wall of the catheter is provided with a plurality of transparent holes, which can increase the exchange rate of physiological substances, nutrients and wastes, maintain a fixed permeability, and reduce the chance of inflammation. Hereinafter, the catheter is designed as a guided nerve junction catheter (hereinafter referred to as the case) GNT).

The main purpose of this catheter structure is to provide a wide range of neurologically impaired diseases. One can use this design to use this guided neural junction catheter (GNT) to induce the direction of nerve regeneration and correctly guide nerve tissue regeneration, to stabilize the nerve conduit structure, maintain a fixed rate of degradation, and not affect mechanical strength. It is also possible to add a variety of material cells to support the regeneration of neurons and axons, especially the inner layer of the nerve bundle catheter design and the permeable multiple pores, which is the most lacking structural design of the general nerve conduit.

The biodegradable and biocompatible guiding nerve junction catheter (GNT) has the structural features, and the number of inner nerve bundle catheters can be adjusted according to the number of damaged nerve bundles. The pores allow nutrients, metabolic waste, electrolytes, and physiological substances to be exchanged. In addition, the pore structure of the wall of the nerve junction catheter (GNT) can be adjusted in time with the neurological characteristics of the damaged part. The number allows the damaged nerve to grow normally in the inner bundle of the nerve bundle catheter structure.

1‧‧‧Guided nerve junction catheter

11‧‧‧ Guided neural junction catheter access

12‧‧‧ Guided nerve junction catheter wall

2‧‧‧Neuroscope

21‧‧‧Anatomy of the nerve bundle catheter

22‧‧‧through hole of the nerve bundle catheter

3‧‧‧Neural suture zone

The first figure is a structural diagram of the composition of normal nerves.

The second figure is a stereoscopic view of a known nerve catheter.

The third figure shows the stereoscopic appearance of the guided nerve junction catheter GNT.

Figure 4 is a side view of the guided nerve graft catheter GNT.

Figure 5 is a cross-sectional view of the guided nerve junction catheter GNT.

Selection of guided nerve junction catheter (GNT) materials

Biodegradable and biocompatible materials such as polyacetic acid (PLA), gelatin powder (Gelatin), collagen (Collagen), geniposide (Genipin), polyglycolic acid (PGA), or Choose only biodegradable, choose Only materials with biocompatibility and other properties can be selected as the material of the guided nerve junction catheter 1 (GNT). The material preparation process must pay attention to the quality assurance and sterilization of the catheter production process.

Preparation of guided nerve junction catheter (GNT) material

The guided nerve junction catheter 1 (GNT) can be divided into two major structures to illustrate. First, a biodegradable and biocompatible material is selected as the body 1 (GNT) of the guided nerve junction catheter. As long as the above mentioned or general biomedical materials can be made into a guided nerve junction catheter 1 (GNT), the material is first dissolved into a solution, dried to make a film of a certain thickness, and the film is cut into suitable for use. The size, shape, and the like are then shaped into a circular cylindrical shape by using an auxiliary tool, and joined into a hollow tubular body by a bio-bonding agent. The second is the portion of the nerve bundle catheter 2 inside the guided nerve junction catheter, which is also made in a similar manner to biodegradable or biocompatible material to make the outer guiding nerve junction catheter 1 (GNT) is a smaller round tube. It is necessary to make three nerve bundle catheters. After shaping, wait for the steps of shaping, drying, cutting, modifying and sterilizing.

Hole preparation of guiding nerve bundle catheter (GNT)

When the inner circular tube-shaped nerve bundle catheter 2 is made into a film before the finished product, the through hole 22 can be made by the hole punching aid after the sterilization step, and the size of the through hole 22 is not more than 2 mm. According to the size of the inner layer of the nerve bundle catheter 2, 8 to 80 holes are prepared, and according to the size of the catheter body, the guiding nerve-conducting catheter 1 is connected to the outer layer by using a bio-adhesive agent. (GNT), after shaping, waiting for shaping, drying, cutting, modification, sterilization, etc., you can then prepare for the implant surgery. The integrally guided nerve engagement catheter 1 (GNT) (as shown in the third and fourth figures) has a single layer tubular body at its center and has a catheter passage 11 extending through the ends of the tubular body 1. The length of the guided nerve junction catheter 1 (GNT) (in cm or mm) is adjusted according to the nerve to be implanted or pre-engaged. The diameter of the guide nerve-conducting catheter 1 (GNT) is also based on the desired diameter. The size of the inserted or pre-engaged nerve (unit cm or mm) is adjusted, the thickness of the wall 12 is about 0.2~1.0 mm, and the thickness of the outer guiding nerve-conducting catheter 1 is at least equal to or larger than the inner layer of the nerve bundle catheter 2 The thickness.

The fourth panel depicts a side view of a Guided Neural Arterial Catheter 1 (GNT) centered at the channel 11 of the outer tubular guided nerve-engaging catheter catheter, and the inner canal wall 12 in contact with the outer guiding nerve-engaging catheter The two ends, as the nerve suture zone 3 of the fractured or damaged nerve junction, pass through the passage 21 of the nerve bundle catheter at both ends of the guided nerve junction catheter body 1 (GNT), and the wall of the nerve bundle catheter contains many The through hole 22 of the nerve bundle catheter, the entire side view shows the appearance of the nerve bundle catheter 2 and the guided nerve junction catheter 1 (GNT).

The fifth figure depicts a view of the transverse axis of the nerve bundle catheter 2 within the guided neural junction catheter 1 (GNT). The nerve bundle catheter 2 of the present application has been fixedly adhered to the guided nerve junction catheter 1 (GNT), and the size of the three bundles of nerve bundle catheters 2 can be visualized by the transverse axis of the guided nerve junction catheter 1 (GNT). The nerve bundle catheter 2 can guide, assist the newly born tissue, and continuously maintain the nerve junction to both ends. The individual function of each of the inner nerve bundle catheters 2 is to provide the nerve regeneration and the regeneration of nerve cells. Good insurance The size of the nerve bundle catheter 2 can also be made in accordance with the size of the nerve in the body. It is not necessary that the size of the three nerve bundle catheters 2 be the same, because the nerves to be joined to the nerve bundle catheter 2 are not necessarily the same. The size may also be 2 to 3 bundles of peripheral nerves. The nerve bundle catheter 2 mainly provides a suitable point of attachment and climbing point, so that the newly regenerated nerve can avoid secondary damage caused by nerves that are damaged or injured again. .

The main purpose of the implementation of this case is to guide the nerve growth of the guiding nerve junction catheter 1 (GNT) first sutured with the damaged nerve, and then through the regeneration of the nerve primary sprout, and then extend to the inner layer of the nerve bundle catheter 2, such The collocation can be used as a substrate and auxiliary for the growth of peripheral nerve or sciatic nerve tissue. It can be said that such a complete combined guided neural junction catheter 1 (GNT) structure is extremely beneficial for peripheral nerve repair, except for improving the simple single tube. The structure also increases the internal changes, allowing the nerve's broken ends to have attached areas that provide a smooth growth direction.

Characteristics of guided nerve junction catheter 1 (GNT)

The guided nerve junction catheter 1 (GNT) has an outer nerve suture zone 3, and a perforation hole 22 of the perforation of the perforation of the nerve cannula, which can provide a neuronal material exchange and independent guidance of three nerve bundle catheters 2 The material and the inner layer of the neurosynthesis catheter 1 (GNT) and the three nerve bundle catheters 2 are raw materials for the engineering materials or tissues of the biomedical materials, and can also be implanted on the inner wall of the nerve bundle catheter, and add some stem cells, Growth factors, promoting factors, and the like. Guided neurosynthesis catheter 1 (GNT) is more capable of assisting the growth of nerve regeneration than conventional neural catheters, and has better function and condition to maintain a good physiological condition.

in conclusion

The promotion of nerve regeneration by the inner bundle of the nerve bundle catheter 2 in this case comes from the concept of anatomy. It has good mechanical strength, can cope with the nerve joint treatment of transplant surgery, and provides nerve suture area 3 at both ends for suturing, which can strengthen and provide a nerve climbing point, which usually shrinks in a short time after nerve injury. Such a structure can provide that the nerve and the guided nerve junction catheter 1 (GNT) are engaged to allow the engaged nerve to maintain its original cylindrical shape in the implanted body, which can be known and destroyed without reference to the prior art. Or other external force and injury again, such guiding function of the guided nerve junction catheter 1 (GNT) can provide a protective circuit for the growth of new nerve fibers, allowing the injured nerve to simultaneously assist and strengthen the cell body, tree The growth of axons and axons. Because the main nerve of the common sciatic nerve is divided into two to three bundles, the channel 11 in the lumen of the guided nerve junction catheter is subdivided into three channels of the nerve bundle catheter, which can help guide the growth of nerve fibers and inhibit Cell body, dendrites, axons extend in an improper direction, and avoid individual nerves that do not stick to each other or produce too much regenerative tissue coating. For example, common coated tissue is the most common neuroma, neuroma Regenerative tissue such as this is easy to cause infection or inflammation in the implanted area. Clinical cases may lead to poor nerve regeneration or regeneration failure. In severe cases, there may be re-opening or debridement to remove neuroma. The regenerative organization has even more serious consequences. The channel 21 with three nerve bundle catheters in the lumen and the through hole 22 of the nerve bundle catheter have 8-80 small exchange holes, which can effectively exchange substances and facilitate the transmission of nerves. The communication between nutrition, oxygen and waste, the inner nerve bundle catheter 2 has more improved nerve regeneration than the previously known structure, and can effectively improve the axonal regeneration and repair of the damaged peripheral nerve, providing Another good choice for individuals with somatic nerve grafts.

The nerve bundle catheter 2 in this case helps the nerve regeneration in the nerve regeneration fiber after implantation. Before the formation of the tissue, the tissue will not cause clinical symptoms of severe swelling or deformation, and it is not easy to have an inflammatory reaction, so this case provides the best transplant environment for the recipient of the nerve. When the nerve is regenerated, the growth direction will grow along the guided nerve junction catheter 1 (GNT) and the nerve bundle catheter 2, and the entire catheter will be structurally degraded due to the circulation of the physiological environment, and will not remain implanted. Within the tissue, it can be gradually and completely decomposed by metabolism in the body, so the guided nerve junction catheter 1 of this case, in addition to providing sufficient space for nerve growth, also provides sufficient time for the nerve to expand.

In addition, it can be applied to other factors that assist nerve regeneration or other nerve cells that promote nerve regeneration to coat the inner wall of the nerve bundle catheter. The function of the catheter can be strengthened. For example, adding or culturing adipose stem cells, Xu Wangshi Stem cells, Schwann cells, and the like have a function of enhancing nerve growth in the guided neurosynthesis catheter 1 (GNT), providing as much assistance as possible in the repair of nerve tissue. The design of this case is to improve and enhance the deficiencies of the known neural tube structure, to consolidate the nascent tissue and protect the structure of the regenerative nerve, which can enhance the regeneration of peripheral nerves and provide correct guidance, reduce the incidence of inflammatory reactions, and avoid transplantation. The rejection rate, which reduces the failure rate during neurosynthesis, can greatly enhance the competitiveness of clinical and general nerve conduits, and even replace the general nerve conduits on the market.

1‧‧‧Guided nerve junction catheter

11‧‧‧ Guided neural junction catheter access

12‧‧‧ Guided nerve junction catheter wall

2‧‧‧Neuroscope

21‧‧‧Anatomy of the nerve bundle catheter

22‧‧‧through hole of the nerve bundle catheter

3‧‧‧Neural suture zone

Claims (4)

A guided nerve junction catheter comprising: an outer tubular body having a passageway extending through the ends of the tubular body; the passageway having three inner conduit structures, referred to as a nerve bundle conduit, the inner conduit containing The plurality of through holes, the inner tube diameter and the tube length are smaller than the outer tubular body, and the length difference between the outer tube body and the left and right tube ends of the inner tube is a suture area connecting the fracture nerves. The guide nerve junction catheter according to claim 1, wherein the inner nerve bundle catheter structure is a three-layer thin tube diameter, which can graft, protect and provide regenerative nerve extension, regeneration nerve metabolism and The role of structural maintenance. The guiding nerve engaging catheter according to claim 2, wherein the diameter of the three thin layers of the inner layer is called a nerve bundle catheter, wherein the nerve bundle catheter contains a plurality of transparent holes, and the plurality The number of through holes can be from 8 to 80, and the perforation of the nerve bundle catheter can provide the exchange of nutrients and waste for nerve regeneration. In the guided nerve junction catheter of the third aspect of the patent application, the area where the left and right ends of the inner nerve bundle catheter do not overlap with the guided nerve junction catheter is a nerve suture area, and the total length of the nerve suture area. Do not exceed the length of the nerve bundle catheter, where the sutured area of the sutured or pre-engaged injured nerve must be appropriate, not too close to the tubular body of the outermost guided nerve-engaging catheter, nor too far from the guided nerve The tubular body of the catheter is engaged, and the appropriate suture area provides a good success rate of grafting or transplantation of the nerve.