JP2011530322A - Medical device for use in surgical treatment of hyperproliferative disorders affecting the spinal cord - Google Patents

Abstract

  Described herein is a new treatment for hyperproliferative diseases that affect the spinal cord, including the use of biodegradable polymers to treat spinal cord tumor resection, i.e. to patch openings left by spinal cord tumor removal. Provide a method. In order to fill the area previously occupied by the tumor, a biocompatible polymeric material is made, for example, in the form of a tubular product configured to be inserted into the spinal column after surgical removal of the tumor. These protective products can also include drugs that stimulate spinal nerve regeneration, such as pharmaceuticals or donor neurons, such as human neural stem cells, thus restoring the patient's motor sensory function after spinal tumor surgery. You can also help.

Description

  This application is related to US Patent Application No. 60 / 794,986, filed April 25, 2006, and US Patent Application No. 11 / 789,538, filed April 25, 2007, the contents of which are incorporated by reference. Incorporated herein as is.

  This application relates generally to medical devices, and more specifically to medical devices for use in the surgical treatment of hyperproliferative diseases that affect the spinal cord.

  Hyperproliferative disorders of the spinal cord, including spinal and spinal tumors, include a wide variety of pathological diagnoses that vary significantly depending on the location and age of the patient. The spine and spinal cord can be affected by primary and metastatic tumors, expanding differential diagnosis and treatment options. Spinal cord tumors are often characterized based on their primary site (epidural, intradural extramedullary and intramedullary tumors). For example, spinal epidural metastasis (“SEM”) is a common complication of systemic cancer with an increasing incidence. Prostate cancer, breast cancer and lung cancer are the most common causative diseases.

  Metastasis usually occurs in the back of the vertebral body due to late invasion of the epidural space. The occurrence of metastatic epidural spinal cord compression (“MESCC”) and spinal cord metastases has become a more common clinical encounter as advanced systemic antineoplastic treatment modalities improve the survival of cancer patients. It is becoming.

  Historically, surgery for spinal cord metastases involved simple decompression laminectomy with simultaneous spinal cord stabilization. However, the results obtained in a retrospective case series indicate that this treatment offers little benefit to the patient. With the emergence of new patient-related selection practices along with new surgical techniques and improvements in postoperative care, it will play an important and useful role in the multidisciplinary care of cancer patients with spinal disease The ability of surgical therapy has improved significantly. Demand for suitable medical devices that can be used to patch spinal parenchymal openings left after tumor removal, more generally useful in surgical treatment of hyperproliferative diseases affecting the spinal cord Is continuing and not met.

  A hyperproliferative disease affecting the spinal cord, including the use of a biodegradable polymer to treat spinal cord tumor receiving, i.e. to patch the opening left by spinal cord tumor removal Provide new treatment methods. In order to fill the area previously occupied by the tumor, a biocompatible polymeric material is made, for example, in the form of a tubular product configured to be inserted into the spinal column after surgical removal of the tumor. These protective products help restore the patient's motor sensory function after spinal tumor surgery by including agents that stimulate spinal nerve regeneration, such as pharmaceuticals or donor neurons such as human neural stem cells You can also

  Thus, in one embodiment, a method of treating a hyperproliferative disease affecting the spinal cord comprises removing at least a portion of the tumor from the site of the animal or human spinal column and then in vivo in the animal or human spinal column. Implanting a polymeric biocompatible product that is biodegradable or bioabsorbable with a medical treatment of an animal or human subject in need thereof.

  In another embodiment, a method of medical treatment of an animal or human subject in need thereof includes removing at least a portion of a tumor from the site of an animal or human spinal column, and poly (lactic acid-co-glycolic acid) Forming a polymeric biocompatible material consisting essentially of a single scaffold product comprising, and thereafter, after surgical resection of the tumor, the polymeric biocompatible product at least partially surrounds the tumor site Implanting a polymeric biocompatible product in an animal or human spinal column adjacent (eg, at least partially surrounding) the site.

  In yet another embodiment, a medical treatment method for an animal or human subject in need thereof surgically exposes a surgical site to allow surgical access to the spinal column containing the tumor; Providing an implantation site for the polymeric biocompatible product by excising (eg, removing) at least a portion, implanting the polymeric biocompatible product in the implantation site, and then surgically treating the surgical site. And suturing.

  In yet a further embodiment, a method of medical treatment of an animal or human subject in need thereof surgically resects at least a portion of a tumor (eg, removes at least a portion of the tumor or surrounding tissue) from the spinal column. Later, instructing the health care professional to implant the polymeric biocompatible product into the spinal column of an animal or human subject.

  Additional features may be understood by reference to the accompanying figures, which should be construed in conjunction with the following detailed description and examples.

1 is one of the schematic views of an exemplary biodegradable protective tubular product inserted around a spinal cord injury site, such as a tumor site after surgical resection, according to an exemplary embodiment of the present invention. FIG. 1 is one of the schematic views of an exemplary biodegradable protective tubular product inserted around a spinal cord injury site, such as a tumor site after surgical resection, according to an exemplary embodiment of the present invention. FIG. FIG. 2 is a schematic diagram illustrating an exemplary method of manufacturing by electrodeposition of corrosive polypyrrole (“PPy”) to form a protective tubular product according to an exemplary embodiment of the present invention.

  Described herein are medical devices and methods that alleviate secondary damage of spinal cord injury, such as that associated with surgery to remove a spinal cord tumor, and promote recovery of the spinal cord injury. More specifically, certain embodiments of the present invention are directed to polymeric minitubes and other products that can be used for spinal tumor resection. In addition, other embodiments are directed to polymeric “fill-in” bands that can be used for spinal surgical treatment. For example, corrosive or biodegradable forms of biocompatible polymers are made for surgical implantation into the spinal cord after surgical removal of the spinal cord tumor.

Spinal cord tumors Hyperproliferative disorders that affect the spinal cord include spinal cord tumors, ie, cell proliferation in or around the spinal cord (benign or malignant neoplasm or mass). They occur within the spinal cord (intramedullary), within the meninges (membrane) covering the spinal cord (intramedullary dura mater), between the meninges and vertebrae (epidural), or spread from other sites Although obtained, most spinal cord tumors are epidural. Metastatic tumors often progress rapidly, but primary extramedullary tumors can progress slowly over weeks to years before clinically significant neuropathy occurs.

  Primary tumors originate from the spine, and secondary tumors arise from metastases from other sites, such as the lung, breast, prostate, kidney, or thyroid, but their precise etiology is generally unknown. Any type of tumor can occur in the spine, including lymphoma, leukemic tumor, myeloma and others. Some spinal cord tumors occur in the nerves of the spinal cord itself, but most often are ependymomas and other gliomas. Of the intradural types, many are extraspinal (extramedullary). Intradural tumors are mostly primary CNS tumors, and most epidural tumors are vertebral metastatic or primary bone tumors. The majority of tumor conditions affecting the spine are epidural metastases, and most primary spinal axis tumors are intradural. Of these, intradural extramedullary schwannoma and meningioma are the most common. Schwannoma and meningiomas are usually intradural but sometimes occur as epidural tumors. Other intradural extramedullary tumors include hemangiomas, chordomas, and epidermoid tumors. Intramedullary tumors often have the same cellular origin as brain tumors. Ependymoma, as well as astrocytoma, oligodendroglioma, ganglioglioma, medulloblastoma and hemangioblastoma generally occur as intramedullary tumors.

  The onset of symptoms is gradual, the first clinical symptoms are often asymmetric, and nonspecific motor paralysis is predominant. In fact, overt pain is often difficult to distinguish clinically from the usual musculoskeletal symptoms, which causes a delay in diagnosis. The level of dysfunction is determined by the affected muscle group. Proliferative tumors affect spinal cord cells, nerve roots, meninges, blood vessels and vertebrae (vertebrae) and are associated with ischemia caused by compression of the spinal cord or nerve roots, tumor infiltration into normal cells, or vascular occlusion Brings symptoms. Most primary spinal shaft tumors are not due to parenchymal invasion and result in symptoms and signs as a result of spinal cord and nerve root compression.

  Symptoms vary depending on the location, type, and general health of the tumor in the affected animal or human patient. Intramedullary tumors usually have more prominent symptoms and can span most of the body. Spastic weakness may be present with increased muscle tone and abnormal reflexes. The pain sensation of certain skin segments may be lost simultaneously with or independently of the loss of motor sensation. Common symptoms include back pain in the back or lower back, sensory abnormalities (illusional sensation), muscle weakness, contraction or spasm (fibrous bundle contraction), cold sensation in the lower limbs, cold sensation in the fingers or other areas. A feeling is included. Tumors that arise in the spinal cord (intradural intramedullary) tend to result in weakness, increased tension, usually in the form of convulsions, and sensory loss. Extramedullary lesions often cause symptoms of nerve root pain due to nerve root (lower motor neuron) compression, as well as long pathways due to spinal cord compression (upper motor neurons).

  Each tumor type is common in specific spinal cord regions (cervical, thoracic and lumbosacral spines), but spinal tumors as a group are distributed almost evenly along the spinal axis. A neurological examination can indicate the site of the tumor. The spinal cord tumor can be confirmed by radiological examination (X-ray, CT, MRI). CT scan) may be required. Similarly, cerebrospinal fluid (“CSF”) tests can reveal tumor cells. In particular, MRI is very important for the diagnosis, localization and characterization of spinal cord tumors. For vascular tumors (eg, hemangioblastoma), angiography can provide preoperative information regarding the visualization of the tumor blood supply. Regardless of which diagnostic medical imaging technique is used, the determination of the tumor site and its precise association with the spinal cord is important in surgical planning.

Surgery for spinal cord tumors Currently, radiation therapy and surgical resection are the only effective medical intervention available for spinal cord tumors. Radiation therapy can be used as an adjunct therapy for unresectable and incompletely resected neoplasms of the spine. Unfortunately, there are essentially no controlled clinical trials of chemotherapy for primary spinal axis tumors. In theory, an effective chemotherapy regimen for brain tumors can be assumed to be equally effective against histologically identical tumors in the spinal cord. However, current clinical experience is disappointing because primary spinal cord tumors and their intracranial counterparts do not respond to chemotherapy. Because of the lack of effective chemotherapy, surgery is most often required, especially to relieve pressure on the spinal cord.

  Corticosteroids such as dexamethasone can reduce inflammation and swelling and temporarily reduce symptoms. Corticosteroids can be administered before, during, and after spinal cord tumor surgery to help control spinal cord edema. Similarly, physical therapy and other interventions may be required to improve muscle strength and improve the ability to function independently in the event of permanent nerve loss. Surgical treatment therefore seeks to reduce or prevent neuropathy resulting from spinal cord compression.

  Some tumors can be completely removed by surgery, but in other cases it may only be medically acceptable to remove a portion of the tumor. Some spinal axis tumors, such as most benign intradural spinal cord neoplasms, can often be completely removed surgically. Of course, surgical tumor resection is more effective in early diagnosis and treatment, but neuropathy may persist after surgery. To alleviate the possibility of permanent disability, the new surgical treatment methods and materials described herein limit permanent damage to nerves, reduce disability due to nerve damage, and spinal cord Accelerate healing after tumor surgery.

  Various surgical techniques for resection of spinal cord tumors are known. A surgical microscope is essential for spinal cord tumor surgery, and intraoperative ultrasonography, carbon dioxide laser, and ultrasonic aspirator are effective in resection of spinal cord tumors. During surgery, the spinal cord is examined intact or with an open dura to find the maximum level of tumor invasion and to distinguish tumor cysts from solid tumor masses. In some cases, surgery can be interrupted if the tumor is found to be malignant or inoperable.

  Tumors that arise in the intradural extramedullary spinal compartment can be completely resected (eg, surgically removed) by laminectomy. In many cases, they readily separate from the spinal cord that has been replaced by the tumor but not infiltrated. Tumor extension outside the spinal cord can be removed by laterally spreading the exposure from the first laminectomy, but others can be done by separate surgery (thoracotomy, costatransversetomy or later) Peritoneal approach is required. The anterior cervical tumor can be removed using an anterior approach, using appropriate vertebral level corpectomy, followed by strut grafting after tumor resection.

  Intramedullary tumors are usually also approached by laminectomy. After the dural incision, a longitudinal spinal incision is usually performed at the midline or dorsal root entrance. The incision is a few millimeters deep to the tumor surface. The incision surface around the tumor is explored by microsurgery, gradually expanding around the surface of the tumor, and then removing the central tumor mass. Tumors without a clear incision plane often cannot be completely removed, but volume reduction can nevertheless provide long-term remission and is medically sufficient.

Spinal cord trauma from spinal surgery Despite surgeons' expertise and surgical skills, spinal cord tumor surgery has consistently caused injury to the spinal cord. For example, postoperative bleeding, fluid retention, and swelling may occur in or outside the spinal cord other than in the spinal canal. Pressure from surrounding bone and meninges can further damage the spinal cord. In addition, edema of the spinal cord itself may further promote secondary tissue loss. Primary mechanical damage associated with spinal surgery is the accumulation of excessive excitatory neurotransmitters; edema; electrolyte changes including increased intracellular calcium; free radicals, especially oxidant free radicals produced; and eicosanoid production Initiates a cascade of secondary injury mechanisms, including In a two-stage process, primary mechanical spinal cord injury results from tumor resection, which results from unintentional unavoidable trauma, pressure, injury or damage to the spinal column. Secondary damage is cellular and biochemical where cellular and molecular processes cause tissue destruction. Healing is promoted by blocking these secondary processes and spreading the pressure resulting from primary mechanical lesions as well as any spinal edema.

  Secondary pathological events caused by excitotoxicity, free radical formation and lack of neurotrophic support include glial scarring, myelin-related axonal growth inhibition, demyelination, and secondary cell death (eg, apoptosis) ) Is included. For example, oligodendrocyte death may continue after resection of the spinal cord tumor. Then, an environment that antagonizes axonal regeneration is formed. In addition to regenerative pathway disturbances, reflexia hyperexcitability and muscle spasms, there are further complications of, among other things, respiratory and bladder dysfunction. Over time, muscle mass can be lost as a result of loss of innervation and nonuse. The ultimate result of these spinal cord injuries is loss of function, the extent of which is determined by the severity of spinal surgery trauma, as well as by accidental secondary injury. Even when the loss of motor function is incomplete, common problems include poor posture, reduced walking speed, balance and gait abnormalities, and lack of adequate weight support.

  There is a need to provide improved devices and methods for preventing the process of causing secondary injury at the site of primary spinal tumor resection, or otherwise promoting post-operative healing. Furthermore, there is a need for devices and methods that alleviate or reduce the consequences of spinal cord tumor resection injury, including inter alia secondary tissue destruction, edema formation, and influx of inflammatory factors. Furthermore, new techniques are needed to protect the remaining tissue, promote intrinsic healing and repair, and reduce dysfunction resulting from spinal cord tumor removal.

Biocompatible polymer products for use in spinal cord tumor surgery The present specification relates to the use of biodegradable polymers for treating spinal cord tumor resection, i.e. for patching openings left after spinal cord tumor removal. New treatment methods for hyperproliferative diseases affecting the spinal cord are described. Create materials in the form of biocompatible polymer materials and products, for example tubular products configured to be inserted into the spinal column after surgical removal of the tumor from the spinal column, to fill the area previously occupied by the tumor To do.

  For example, corrosive or biodegradable or bioabsorbable forms of biocompatible polymers can be made into minitubes for surgical implantation at the spinal cord tumor site. Surgical implantation results in a target area that is encapsulated by the polymer so that the site from which the spinal cord tumor has been removed is completely encapsulated, thereby minimizing the secondary undesirable processes already described herein. is there. Shunting cysts filled with fluid reduces pressure rise in the spinal cord and reduces damage to nerve cells. By filling the gap formed by the cyst, the nerve cell regeneration pathway reaches the caudal side, and a functional synapse can be formed.

  The term “biodegradable” as used herein means any material that is degraded (usually gradually) by the body of an animal, eg, a primate mammal, after implantation. The term “bioabsorbable” as used herein is absorbed or reabsorbed by the body of an animal, eg, a primate mammal, after implantation, so that it is ultimately detected at the implantation site. Means a material or product that becomes impossible. The term “biodegradable” or “bioabsorbable” refers to any material that is biocompatible and biodegradable and / or bioabsorbable. Such materials can be formed into products suitable for implantation in animals and can be biodegraded or bioabsorbed by animals. Biodegradable or bioabsorbable products include, but are not limited to, biodegradable and bioabsorbable polymers. Examples of suitable polymers are described in Bezwada et al., Handbook of Biodegradable Polymers, “Poly (p-dioxanone) and its copolymers”, A. et al. J. et al. Edited by Domb et al., Hardwood Academic Publishers, The Netherlands, 29-61 (1997).

  Any number of medically useful substances can be incorporated into the products described herein, including minitubes and formable products. For example, the inner or outer surface of the minitube can be seeded with stem cells, such as mesenchymal or neural stem cells. Such cells can be deposited on the inner surface (the lumen in the case of a minitube) or the outer surface (s). Incorporating stem cells provides nutritional support or cell replacement at the site of injury. In addition, biocompatible and biodegradable polymer products, including minitubes, may additionally, alternatively or optionally, be pharmaceutical or biological such as anti-inflammatory compounds, growth factors and stem cells, among other agents. Active substances can be contained.

  Also described herein is a kit for surgically treating spinal cord injury. The kit may be, but is not limited to, a pre-cut polymer band or minitube product; one or more pieces of artificial dura; trimming tool; alignment tool; Any combination of components, devices and polymeric biocompatible materials or products, including one or more instructions for using the foregoing in the surgical procedures described herein; Can be included. The components of the kit can be packaged aseptically using sterilization techniques known in the relevant art.

Biocompatible Polymers Biocompatible polymers (including biodegradable and bioabsorbable polymers) for making minitubes, formable bandages or neuropatch products described herein are available in the art. Well known in the field. For example, the biocompatible polymer can be biodegradable (eg, PLGA). As used herein, “biodegradable” and “corrosive” are used interchangeably. Examples of biocompatible polymers that are biodegradable include, but are not limited to, polysaccharides, proteinaceous polymers, soluble derivatives of polysaccharides, soluble derivatives of proteinaceous polymers, polypeptides, polyesters, polyorthoesters. Biodegradable hydrophilic polymers such as Polysaccharides can include poly-1,4-glucans such as starch glycogen, amylose and amylopectin. Suitable biodegradable hydrophilic polymers include hydrolyzed amylopectin, hydroxyalkyl derivatives of hydrolyzed amylopectin, such as hydroxyethyl starch (“HES”), hydroxyethyl amylase, dialdehyde starch, and the like. Water-soluble derivatives of 1,4-glucan are included. Proteinaceous polymers and their soluble derivatives include gelled biodegradable synthetic polypeptides, elastin, alkylated collagen, alkylated elastin and the like. Biodegradable synthetic polypeptides include poly- (N-hydroxyalkyl) -L-asparagine, poly- (N-hydroxyalkyl) -L-glutamine, N-hydroxyalkyl-L-asparagine and N-hydroxyalkyl-L. -Copolymers of glutamine and other amino acids are included. Proposed amino acids include L-alanine, L-lysine, L-phenylalanine, L-leucine, L-valine, L-tyrosine and the like.

  The aforementioned biodegradable hydrophilic polymers are particularly suitable for the methods and compositions of the present invention because of their characteristically low human toxicity and substantially complete biodegradability. It will be appreciated that the particular polymer used can be any of a variety of biodegradable hydrophilic polymers that can be used.

  In yet another embodiment, the biodegradable or bioabsorbable polymer contains monomers of glycolide, lactide, dioxanone, caprolactone, trimethylene carbonate, ethylene glycol or lysine. The term “containing monomer” contemplates a polymer produced from or containing specific monomer unit (s). The polymer may be a homopolymer, a random or block copolymer containing any combination or blend of one or more such monomers, or a heteropolymer.

  For example, biodegradable or bioabsorbable polymers are bioabsorbable and biodegradable, such as polyglycolide (“PGA”) and its random copolymer poly (glycolide-co-lactide) (“PGA-co-PLA”). A linear aliphatic polyester can be contained. These polymers are approved for use in surgical applications, including medical sutures, by the US Food and Drug Administration ("FDA"). The advantage of these synthetic absorbent materials is that they are degraded by simple hydrolysis of the ester backbone in an aqueous environment such as body fluids. Degradation products, unlike cellulosic materials that the body cannot absorb, can eventually be metabolized to carbon dioxide and water, or excreted in the kidneys.

  The molecular weight (“MW”) of the polymer used in the products described herein can vary depending on the polymer used and the degradation rate desired to be achieved. In one embodiment, the average MW of the bandage polymer produced is from about 1,000 to about 50,000. In another embodiment, the average MW of the bandage polymer produced is from about 2,000 to about 30,000. In yet another embodiment, the average MW is about 20,000 to about 50,000 for PLGA and about 1,000 to about 3,000 for polylysine.

  One exemplary embodiment includes a biocompatible polymer that is a conductive material. This material allows conduction of intrinsic electrical activity from living neurons, thereby promoting cell survival. Any such material should be bioabsorbed in situ so that when it performs its function, it will naturally corrode. Ultimately, the three-dimensional scaffold creates a substrate that allows the cells to grow in vitro and then be implanted in vivo. For example, a hollow cylindrical scaffold (minitube) made of polypyrrole (“PPy”) meets all of these design requirements. An exemplary design schematic in situ is shown in FIG.

  Electrical signals in the form of action potentials are billions of cellular signaling means in the central nervous system. Numerous studies have shown that this electrical activity is necessary not only for communication, but also for normal development of the nervous system and densification of functional neural circuits. In the case of spinal surgery, cell-to-cell communication may be interrupted, and normal neural development mechanisms imply that electrical activity should be part of the restoration of functional connectivity. Yes. Such activity is important for the survival of existing cells and the incorporation of any transplanted cells (such as neural stem cells) into the working circuit.

  Thus, in one embodiment, single and double layer scaffolds, minitubes and other products are made from biomaterials that are conductive and can be naturally biodegraded or corroded in the body over a preselected period of time. To do. In one exemplary embodiment, the single scaffold, double scaffold or minitube product comprises a conductive biocompatible polymer, such as a polypyrrole polymer. Polyaniline, polyacetylene, poly-p-phenylene, poly-p-phenylene-vinylene, polythiophene, and hemosin are examples of other biocompatible polymers that are conductive and are described herein. Can be used in products and methods. Other corrosive conductive polymers are also well known. See, for example, Zelikin et al., “Erodible Conducting Polymers for Potential Biomedical Applications” Angew. Chem. Int. Ed. Engl. 41 (1), pages 141-44 (2002). Any of the aforementioned conductive polymers can be applied or coated onto a malleable or moldable product. The coated product can also be used as a bandage or nerve patch as described herein.

Tubular Polymeric Biocompatible Products “Minitubes” and “tubular products” are provided as cylindrical medical devices or as devices that can be formed into tubes as described more fully herein. The exemplary embodiments are directed to biocompatible polymer products and materials that can be made into such “minitubes” or “tubular products”. These products and materials can be used to promote post-operative healing of the spine and to treat the spine after the tumor has been removed from the spine. In one embodiment, one or more minitubes are placed at the site (site) where the tumor has been removed so that each hollow tube penetrates or surrounds the tumor site, preferably parallel to the longitudinal axis of the spinal cord. ) Insert into the spine around. For example, see FIG. The minitube can be inserted rostrally or caudally with respect to the tumor site by surgical incision. The minitube creates a new interface within the spinal cord parenchyma, relieves pressure sites and protects undamaged tissue. The pressure resulting from the compression force applied to the spinal cord can be determined by diffusing or redirecting the force from the original compressed site toward the surface of the minitube, and by applying compression energy to the biocompatible material of the minitube. It is alleviated by absorbing. In addition, by providing a structure (new interface) between the injury site and the surrounding tissue, inflammation in adjacent areas can be reduced, thereby leaving the remaining functionally related spinal cord tissue free from further trauma. it can.

  In another embodiment, the biocompatible polymeric conductive product can be made into a hollow minitube or tubular product having an inner surface, an outer surface and two opposing open ends. Such products, including minitubes, can be made in any geometry and size. For example, the size and shape of the product can vary depending on the age or size of the animal or human patient on which the product is to be used. The size and shape can also be configured to the size of the damage that remains after the tumor is surgically removed. A thin and elongated cylinder is one possible configuration, but other shapes such as elongated rectangular tubes, spheres, spiral structures and others are possible. For example, such a shape is hollow and has an open end.

  Depending on the appropriate medical judgment, further modifications in the configuration, such as the number, direction and shape of the product, may vary. For example, the product can be a rectangular sheet, or any other useful shape that can be rolled into a cylinder, and can be distributed along or around the site from which the tumor was removed. For example, the minitube may be smaller, the same size, or longer than the surgical lesion being treated. Further, the minitube may be longer than the length of the damaged site. In an alternative embodiment, the length of the surgically implanted product (eg, a minitube) is about 1.2 to about 3 times the length of the injury site or lesion that extends longitudinally along the spinal cord (or Furthermore, it is about 5 times to about 10 times. In yet another embodiment, the minitube protrudes to the caudal and rostral sides of the damaged site by a distance of about 1/4 to 1/2 of the length of the damaged site. In yet another embodiment, the minitube protrudes equally to the caudal and rostral sides of the injury site.

  When the polymeric biocompatible product is in the form of a minitube, its diameter (outer surface to outer surface, or “outer diameter”) can range from about 0.1 microns to about 10 millimeters, or several It may be as long as millimeters. For example, the overall diameter of the minitube (from the outer surface to the outer surface) can be from about 5 microns to about 200 microns, or in some embodiments a few millimeters. In other embodiments, the minitube diameter (outer to outer surface) is about 20 microns to about 200 microns, about 50 microns to about 175 microns, about 100 microns to about 200 microns, or about 150 microns to about 300. Micron. In another embodiment, the minitube has a diameter (outer surface to outer surface) of about 0.5 millimeters to about 20 millimeters. In still other embodiments, the minitube diameter (outer surface to outer surface) is about 1 millimeter to about 10 millimeters, about 1 millimeter to about 5 millimeters, and about 1 millimeter to about 3 millimeters. In other embodiments, the minitube can have a diameter of 1 centimeter or more depending on its intended use.

  Further, the diameter of the minitube (inner surface to inner surface, also known as “inner diameter”) may range from a few microns to a few millimeters. For example, the diameter (inner diameter) of the minitube may be from about 5 microns to about 200 microns. In other embodiments, the diameter (lumen) of the minitube is about 20 microns to about 200 microns, about 50 microns to 175 microns, about 100 microns to about 200 microns, and about 150 microns to about 300 microns, Good. In yet another embodiment, the minitube diameter (lumen) may be between about 0.5 millimeters and about 15 millimeters. In other embodiments, the diameter (lumen) of the minitube may be about 1 millimeter to about 10 millimeters, about 1 millimeter to about 5 millimeters, or about 1 millimeter to about 3 millimeters, or more. In other embodiments, the minitube can have a diameter of 1 centimeter or more depending on its intended use.

  Biodegradable or bioabsorbable polymeric tubular products can be formed by any means. In one embodiment, the product is formed by electrodepositing a conductive polymer onto a template conductive wire, where the polymer is applied by applying a reverse potential to the template conductive wire in a saline solution. , Removed from the conductive wire.

  An exemplary method used to make the polymeric minitube described herein is shown in FIG. For example, the pattern of the conductive template for electrodeposition of polypyrrole (“PPy”) controls the shape of the PPy scaffold that is created. By controlling the mold, polymer scaffolds can be manufactured in a variety of shapes and dimensions, ranging from fine lines to rectangular planar implants, among others. Tubular PPy scaffolds can be produced by plating PPy on conductive wires. For removal of the scaffold from the mold, a reversal potential is applied to the mold in saline solution. When applied with sufficient time and strength, the scaffold slides off the wire mold with a simple pull. This method frees the manufacturer from the need to use an organic solvent to etch the internal wire mold that would result in a polymer product that is not suitable for in vivo use. As mentioned above, polymer products including minitubes can be made to any medically desirable geometry and dimensions.

  For example, a spinal lesion that is 10 microns long (extending along the length of the spinal cord) and 3 microns deep has a length of 15 microns (or longer) and an overall diameter of 2.5 microns. It may require the use or insertion of a polymeric minitube having. The polymeric minitube is surgically inserted into the lesion so that the central portion of the lesion is enclosed by the tube. In this example, the tube would protrude approximately 2.5 microns from the caudal and rostral ends of the targeted disease change area, respectively.

Moldable polymeric biocompatible products Polymeric conductive products for use in the surgical procedures described herein are provided as formable, moldable, biocompatible polymeric materials or compositions. You can also. “Moldable” or “formable” is used interchangeably in this description. Advantageously, the polymeric material can be made as a putty. “Putty” means that the material has a dough-like consistency that is formable or moldable. Such materials are sufficiently and easily moldable and can be formed into a flexible three-dimensional structure or shape that is complementary to the target site to be treated.

  In yet another embodiment, the polymeric biocompatible material can be easily made into a formable or moldable bandage or nerve patch. For example, after removal of the spinal cord tumor, a bandage, putty or nerve patch is formed to complement the injury site by manual or mechanical means. The formed product is then embedded in the center of the lesion so that it fills the damaged site. The implanted product fills any gaps formed by spinal cord lesions, functions as an artificial pathway, promotes neuronal regrowth, reorganizes neurites, and helps form functional synapses. This new interface enables interaction between endogenous neurons (including neural stem cells when incorporated on the bandage) and a polymer-embedded environment without inhibitor molecules that promotes cell survival. Furthermore, by providing a structure (new interface) between the injury site and the surrounding tissue, inflammation in adjacent areas where the remaining functionally related spinal cord tissue can remain can be reduced.

  In one embodiment, a polymeric biocompatible bandage comprising a single polymeric scaffold having an inner surface and an outer surface can be easily made or formed into any shape and size. For example, the size and shape of the bandage can be changed to provide more effective mitigation. A thin and elongated strip is one exemplary configuration, but other shapes such as elongated rectangular strips, spheres, spiral structures, and others are possible. There may be various further modifications in the configuration, such as the number, orientation and shape of the straps to provide more effective mitigation. For example, the bandage can be rectangular or any other useful shape and can be distributed in or around the center (site) of spinal cord injury.

  In addition, the product can have a processed surface comprising a plurality of pores or microgrooves on its inner or outer surface. Such pores can have, for example, a diameter of about 0.5 microns to about 4 microns and a depth of at least about 0.5 microns. Further, the microgroove can have a width of, for example, about 0.5 microns to about 4 microns, as well as a depth of at least about 0.5 microns. Thus, the dimensions of the product and the dimensions and diameters of its pores and microgrooves vary with the spinal cord lesion being treated. The pores or microgrooves on the inner or outer surface can be seeded with one or more agents, such as human neural stem cells, to provide cell replacement or nutritional support. Alternatively, other agents such as therapeutic agents including anti-inflammatory agents and the like can be provided in addition or optionally. For example, the moldable product can act as a filler (i.e., fill the lesion) after implantation into the diseased area of the spinal cord. In another embodiment, the inner surface of the product is flush with the diseased spinal cord when it is implanted, i.e., in contact with the lesion.

  In another embodiment, polymeric “filled” bandages can be used for surgical treatment of spinal cord tumors. For example, a biocompatible polymer in corrosive or biodegradable form can be made for surgical implantation at a spinal cord tumor site. Implantation can be accomplished immediately by molding a bandage that conforms to the injury site so that the target area is encapsulated or filled with the formed polymer. The implant can completely enclose only the target area or central necrotic site, or the previously opened disease-change area can be filled with the formed polymer. Encapsulation of the central necrotic area minimizes secondary damage by inhibiting intercellular signaling by inflammatory cytokines. By filling the gap formed by the lesion, the regeneration pathway of nerve cells reaches the caudal side, and a functional synapse can be formed.

  In another embodiment, a biocompatible polymeric bandage comprising a single polymeric scaffold having an inner surface and an outer surface can be easily made / formed into any shape and size, and the formed bandage Can be made to any geometry and dimensions. The single polymer scaffold can include pores (eg, on a surface that contacts the lesion) for incorporating the drug, such as depositing neural stem cells, drugs, and the like.

  Optionally, a conductive, formable biocompatible polymeric material can be used to allow conduction of intrinsic electrical activity from living neurons and thereby promote cell survival. it can. All such materials should be bioabsorbed in situ so that when they perform their function, they naturally corrode. Ultimately, the three-dimensional scaffold creates a substrate that allows the cells to grow in vitro and then be implanted in vivo. For example, a bandage scaffold made of polypyrrole (“PPy”) meets all of these design requirements.

  The polymer bandage is not limited to conductive polymers such as PPy. The polymeric bandage can include one or more monomers such as, for example, glycolide, lactide, dioxanone, caprolactone, trimethylene carbonate, ethylene glycol, and lysine. In addition, the polymer bandage can include one or more biodegradable or bioabsorbable linear aliphatic polyesters, copolymer poly (glycolide-co-lactide), or biological tissue-derived materials. The material derived from living tissue is not limited to these, but may be neural stem cells or mesenchymal stem cells that can be used as a drug.

  As described above, minitubes, biocompatible and biodegradable polymer devices can contain drugs including pharmaceutically or biologically active substances such as anti-inflammatory compounds, growth factors and stem cells. As previously described, the polymer bandages are long pores or radial fines whose outer surface is axially oriented to axon guidance to allow fluid transport and inhibit scar tissue ingrowth. It can be made into a structure that is an outer scaffold with holes. The inner surface or inner scaffold can be porous and can be seeded with one or more agents for cell replacement or nutritional support, such as human neural stem cells. Thus, the fabricated and formed bandages can include two scaffolds (double scaffolds), stimulating healthy spinal cord structures via implants that optionally have polymer scaffolds seeded with neural stem cells. . The inner scaffold mimics gray matter and the outer part mimics white matter. The bandage can be easily designed to fit into various cavities.

  In another embodiment, a medical product suitable for implantation in an animal or human spinal cord is approximately equal to a block copolymer of poly (lactic acid-co-glycolic acid) and poly (lactic acid-co-glycolic acid) -polylysine ( For example, a 50:50) moldable biocompatible material comprising a blend. Poly (lactic acid-co-glycolic acid) is 75% poly (lactic acid-co-glycolic acid), and its average molecular weight (Mn) is about 40,000. The poly (lactic acid-co-glycolic acid) -polylysine block copolymer is a 25% poly (lactic acid-co-glycolic acid) -polylysine copolymer, and the average molecular weight (Mn) of the poly (lactic acid-co-glycolic acid) block Is about 30,000, and the average molecular weight (Mn) of the polylysine block is about 2,000. In an alternative embodiment, the product comprises a single block of poly (lactic-co-glycolic acid).

  Any of the aforementioned products can have an in vivo degradation rate of about 30 to 60 days (eg, 4 to 6 weeks), but the rate is within the range of appropriate medical judgment and is desired for therapeutic efficacy. Can be changed to bring a level. The product can further include an agent, such as a stem cell, associated with any of the polymeric materials. For example, stem cells can be seeded on the polymer, or more specifically in the pores on the polymer surface. Although any stem cell type can be used, neural stem cells and mesenchymal stem cells are particularly useful for the treatment of spinal cord tumors.

  In yet another exemplary embodiment, a method for treating a spinal cord wound resulting from tumor removal is disclosed, wherein the method adapts a polypyrrole double scaffold to a disease-change area of spinal cord injury and then the disease change. Filling the region with a biocompatible polypyrrole material. The inner surface or inner scaffold can be porous and can be seeded with one or more agents for cell replacement or nutritional support, such as human neural stem cells.

  Thus, such fabricated and formed bandages mimic a healthy spinal cord structure with an implant made of a polymer scaffold comprising two scaffolds, optionally seeded with neural stem cells. For example, the inner scaffold mimics the gray matter, and the outer scaffold (second scaffold) is a long strip oriented axially to axon guidance to allow fluid transport and inhibition of scar tissue ingrowth. Mimic white matter by having pores and radial voids. Such bandages can be easily designed to fit various cavities and provide a preselected degradation, corrosion or drug release profile.

  In one exemplary embodiment, polypyrrole has a degradation rate of about 30-60 days (eg, 4-6 weeks), although the rate can be varied to provide the desired level of therapeutic effectiveness. The material can further include stem cells in association with any of the polymeric materials. For example, stem cells can be seeded on the polymer, or more specifically in the pores on the polymer surface. Although any stem cell type can be used, for the treatment of spinal cord tumors, the stem cells advantageously comprise neural stem cells or mesenchymal stem cells.

Exemplary Embodiments The following exemplary non-limiting embodiments are provided for the benefit of the reader so that the scope and utility of the methods and devices disclosed herein may be better understood.

  For example, a method of treating a hyperproliferative disorder affecting the spinal cord removes at least a portion of the tumor from the site of the animal or human spine and then biodegradable or bioabsorbed in vivo into the animal or human spine. Medical treatment of an animal or human subject in need thereof, including the step of implanting a polymeric biocompatible product that is sexual.

  For example, the polymeric biocompatible product may be conductive. In one embodiment, the polymeric biocompatible product comprises a synthetic bioabsorbable polymer.

  In the methods herein, the implanting step is a polymeric step on the animal or human spinal column adjacent to the site such that, after surgical excision of the tumor, the polymeric biocompatible product at least partially surrounds the tumor site. Embedding a biocompatible product can be included.

  In one exemplary embodiment, the polymeric biocompatible product is substantially tubular. In another embodiment, the polymeric biocompatible product is a hollow tube. For example, the polymeric biocompatible product can form a tube having a diameter of about 0.1 microns to about 10 millimeters. The diameter may be from about 50 microns to about 175 microns. Similarly, the polymeric biocompatible product may be longer than the spinal cord tumor tissue. For example, the polymeric biocompatible product may be at least about 1.5 times longer than the site.

  In general, polymeric biocompatible products are completely and gradually resorbed after implantation. For example, the polymeric biocompatible product can have a degradation rate of about 30 to about 60 days (or about 4 weeks to about 6 weeks) in vivo.

  The polymeric biocompatible product comprises one or more polymers selected from the group consisting of polypyrrole polymer, polyaniline, polyacetylin, poly-p-phenylene, poly-p-phenylene-vinylene, polythiophene, hemosin and combinations thereof. be able to. For example, the one or more polymers can include polypyrrole. In another embodiment, the one or more polymers comprise one or more repeating monomers selected from the group consisting of glycolide, lactide, dioxanone, caprolactone, trimethylene carbonate, ethylene glycol, lysine and combinations thereof. Can do. In a further example, the one or more polymers can comprise a biodegradable or bioabsorbable linear aliphatic polyester such as polyglycolide or poly (glycolide-co-lactide).

  In yet another embodiment, the polymeric biocompatible product may consist essentially of a single scaffold of moldable biocompatible material comprising poly (lactic-co-glycolic acid). Further, the poly (lactic acid-co-glycolic acid) may be 75% poly (lactic acid-co-glycolic acid), and its average molecular weight (Mn) is from about 20,000 to about 50,000. In another embodiment, the polymeric biocompatible product consists essentially of an approximately 50:50 blend of poly (lactic acid-co-glycolic acid) and poly (lactic acid-co-glycolic acid) -polylysine block copolymers. Become. In yet a further embodiment, the poly (lactic acid-co-glycolic acid) -polylysine block copolymer is about 25% poly (lactic acid-co-glycolic acid) -polylysine copolymer, and the poly (lactic acid-co-glycolic acid) The block has an average molecular weight (Mn) of about 20,000 to about 50,000, and the polylysine block has an average molecular weight (Mn) of about 1,000 to about 3,000.

  The polymeric biocompatible product may be a moldable biocompatible polymeric material comprising a conductive polymer. For example, the conductive polymer can be selected from the group consisting of a polypyrrole polymer, polyaniline, polyacetylin, poly-p-phenylene, poly-p-phenylene-vinylene, polythiophene, hemosin and combinations thereof.

  The polymeric biocompatible product can also include one or more agents that are compatible with spinal nerve regeneration or healing. One or more agents that stimulate spinal column regeneration or healing help restore the motor or sensory function of the animal or human after spinal tumor surgery. In an exemplary configuration, the polymeric biocompatible product is a tube and the one or more agents are contained on the inner surface of the tube.

  The one or more agents that stimulate spinal regeneration or healing include one or more therapeutic agents. For example, the one or more therapeutic agents can include anti-inflammatory compounds, anti-cancer agents, antioxidant free radical scavengers, wound healing promoters, pain control agents, neuroplasticity enhancers, and anti-degenerative compounds. In addition, one or more agents that stimulate spinal nerve regeneration or healing are present on the surface of the polymeric conductive product. The agent or agents that stimulate spinal regeneration or healing can include one or more donor neurons, such as one or more human neural stem cells. For example, the one or more agents that stimulate spinal column regeneration or healing can include one or more mesenchymal stem cells.

  In another embodiment, a method of medical treatment of an animal or human subject in need thereof includes removing at least a portion of a tumor from the site of an animal or human spinal column, and poly (lactic acid-co-glycolic acid) Molding a polymeric biocompatible material consisting essentially of a single scaffold product comprising, and thereafter, after surgical resection of the tumor, such that the polymeric biocompatible product at least partially surrounds the tumor site Embedding a polymeric biocompatible product in an animal or human spinal column adjacent to the site of the spinal column. Stem cells may be associated with a polymeric biocompatible material.

  Also herein, for use in a surgical procedure to remove at least a portion of a tumor from an animal or human spinal column in one or more containers and one or more polymeric biocompatible products. A kit is provided for use in medical treatment of an animal or human subject in need thereof, including instructions for use. The kit can also include one or more pieces of artificial dura mater or one or more trimming tools.

  In yet another embodiment, a medical treatment method for an animal or human subject in need thereof surgically exposes a surgical site to allow surgical access to the spinal column containing the tumor; Providing an implantation site for the polymeric biocompatible product by ablating at least a portion, implanting the polymeric biocompatible product into the implantation site, and then surgically closing the surgical site; including.

  In yet a further embodiment, the method of medical treatment of an animal or human subject in need thereof comprises polymer biocompatibility with the spinal column of the animal or human subject after surgical removal of at least a portion of the tumor from the spinal column. Instructing medical personnel to embed the product.

(Example 1) Production of polypyrrole minitube (I)
A polypyrrole tube scaffold is created by electrodepositing corrosive PPy on platinum wire of diameter 250 μm at 100 μA for 30 minutes. For example, see FIG. After this step, reverse plating is performed at 3V for 5 minutes to allow removal of the scaffold. The example current, timing, voltage and other parameters are not intended to be limiting.

(Example 2) Production of PPy minitube (II)
A tube-like PPy scaffold was generated by plating PPy on a conductive wire mold. This technique can be scaled to produce scaffolds of any length, inner diameter and outer diameter. Furthermore, the surface roughness can be controlled by the electroplating temperature (see FIG. 2). Removal of the scaffold from the mold is performed by applying a negative potential in saline solution. Negative potentials cause electrochemical reduction and slightly increase the size of the scaffold. It can then be mechanically detached from the platinum wire mold with minimal force applied so as not to damage the material. This technique is an improvement over conventional etching of inner wires with unpleasant organics. For in vivo use, a PPy tube scaffold was created by electrodepositing corrosive PPy at 100 μA for 40 minutes on 250 μm diameter platinum wire. The scaffold can then be removed by reverse plating at 3V for 20 seconds. The resulting 10-15 mm long tube was cut into 3 mm long pieces for implantation.

Example 3 Production of a Single Scaffold A single scaffold consists of poly (lactic acid-co-glycolic acid) (PLGA) (75%, number average molecular weight Mn about 40,000) and poly (lactic acid-co-glycolic acid). ) -Made from a 50:50 blend of block copolymers of polylysine (25%, PLGA block Mn about 30,000, polylysine block Mn about 2000). The PLGA was selected to achieve a preselected degradation rate of about 30-60 days and a functionalized polymer was incorporated to make the site surface modifiable. Single scaffolds were manufactured using a salt leaching process. A 5% (wt / vol) solution of the polymer blend in chloroform was cast on a salt in the diameter range of 250-500 μm to evaporate the solvent. The salt was then leached in water to produce a single porous polymer layer, which can be seeded with stem cells or other agents.

Example 4 Fabrication of Dual Scaffolds Both inner and outer scaffolds were made from poly (lactic acid-co-glycolic acid) (PLGA) (75%, number average molecular weight Mn about 40,000) and poly (lactic acid-co -Glycolic acid)-made from a 50:50 blend of block copolymers of polylysine (25%, PLGA block Mn about 30,000, polylysine block Mn about 2000). PLGA was selected to achieve a degradation rate of about 30-60 days and a functionalized polymer was incorporated to make the site surface modifiable. The inner scaffold was manufactured using a salt leaching process. A 5% (wt / vol) solution of the polymer blend in chloroform was cast on a salt in the diameter range of 250-500 μm to evaporate the solvent. The salt was then leached in water. The oriented outer scaffold was made using a solid-liquid phase separation technique as follows. A 5% (wt / vol) solution of the polymer was filtered and poured into a silicone tube which was placed in the lower ethanol / dry ice bath at a rate of 2.6 × 10 ⁴ m / s. Once frozen, the dioxane was sublimed using an industry standard temperature controlled freeze dryer. The scaffold was then removed, trimmed, assembled and stored in a vacuum desiccator until use. The resulting product has an inner scaffold that mimics gray matter with a porous polymer layer that can be seeded with stem cells, the outer scaffold to allow fluid transport while inhibiting ingrowth of scar tissue , Imitating white matter with long pores and radial voids oriented axially in line with axon guidance.

Example 5: Seeding of mouse neural stem cells on polymer product Mouse NSCs (neural stem cells) were maintained in serum-containing medium. The scaffolds were soaked in 70% ethanol for 24 hours, rinsed 3 times with PBS, and seeded on an orbital shaker at 5 × 10 ⁵ cells / mL at 37 ° C. in a humidified 5% CO ₂ / air incubator. On the next day, the medium was changed, and the implant was further incubated for 4 days before being embedded.

Example 6: Seeding of human neural stem cells on polymer product Human HFB2050 cells and HFT0305 cells derived from HFB2050 ("hNSC") (Redmond et al., 2007) were first described as described above. Isolated from serum-containing primary dissociated monolayer cultures of the ventricular zone. In one exemplary embodiment, the following cell generation, maintenance and transplantation methods were used for hNSC transplantation. First, a stable serum-containing primary dissociated monolayer culture of the fetal ventricular zone was established. Promising media was then subjected to a 6-8 week continuous growth factor selection process based on growth parameters rather than markers. Cells that formed clusters that were larger than 10 cells in diameter and could not be easily disaggregated were excluded. Both adherent and non-adherent cells were included. Cells grown in serum were transferred to conditions containing EGF + bFGF but no serum. They were passaged once every 2 weeks. Cells that were successfully passaged were then grown in basal medium and bFGF alone. They were similarly passaged once every two weeks. Cells that were successfully passaged in bFGF were then transferred to EGF only. They were similarly passaged once every two weeks. Next, cells that were successfully passaged in EGF were transferred to bFGF again, and the same 2-week selection process was continued. Cells that were successfully passaged in bFGF were then transferred to bFGF + LIF.

  The medium, which was successfully passaged over the previous 6-8 weeks and continued to maintain stem-like growth after this selection process, was then subjected to functional screening in vitro and in vivo. In vitro, cells express undifferentiated markers (nestin, vimentin, sox2 and musashi), but should be able to express markers consistent with dopamine precursors upon induction. In vivo functional screening continues to use only cells with engraftment, migration and differentiation ability in vivo after implantation in the ventricle and cerebellum of newborn (P0) mice, respectively, olfactory bulb neurons or cerebellar granule neurons, respectively. Brought cells.

  Mice were euthanized 3-4 weeks later to determine if hNSCs resulted in neurons in the olfactory bulb, cortical glial cells and cerebellar granule neurons. Based on this screening protocol, cell lines were finally selected for further use. These systems were expanded and then aliquoted, frozen and stored as multiple vials of early passage hNSC for use in further experiments. The resulting human neural stem cells can be seeded on polymer products according to previous examples.

  While the invention has been described with reference to exemplary embodiments, those skilled in the art will recognize that various modifications can be made without departing from the scope, and that each element can be replaced by an equivalent. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope. Also, while the figures and description disclose exemplary embodiments and use specific terms, they are used in a general and descriptive sense only, unless otherwise indicated, and are intended for limiting purposes. Therefore, the scope of claims is not limited thereto. Further, those skilled in the art will appreciate that certain steps of the methods discussed herein can be arranged in a different order, or the steps can be combined. Accordingly, the appended claims are not to be limited to the specific embodiments disclosed herein. Finally, it should be noted that the subheadings used herein are for the convenience of the reader and should not be construed as limiting.

Claims (38)

Removing at least a portion of the tumor from an animal or human spinal site;
Implanting a polymeric biocompatible product that is biodegradable or bioabsorbable in vivo into the animal or human spinal column, a method of medical treatment of an animal or human subject in need thereof.   The method of claim 1, wherein the polymeric biocompatible product is electrically conductive.   The implanting step comprises polymerizing the animal or human spine adjacent to the site of the spinal column so that a polymeric biocompatible product at least partially surrounds the tumor site after surgical excision of the tumor. The method of claim 1, comprising implanting a biocompatible product.   The method of claim 1, wherein the polymeric biocompatible product is substantially tubular.   The method of claim 1, wherein the polymeric biocompatible product is a hollow tube.   The method of claim 1, wherein the polymeric biocompatible product forms a tube having a diameter of about 0.1 microns to about 10 millimeters.   The method of claim 6, wherein the diameter is from about 50 microns to about 175 microns.   The method of claim 1, wherein the polymeric biocompatible product is longer than the spinal cord tumor tissue.   The method of claim 1, wherein the polymeric biocompatible product is at least about 1.5 times longer than the site.   The method of claim 1, wherein the polymeric biocompatible product is completely and gradually resorbed after implantation.   12. The method of claim 10, wherein the polymeric biocompatible product has a degradation rate of about 30 days to about 60 days in vivo.   The polymeric biocompatible product comprises one or more polymers selected from the group consisting of polypyrrole polymers, polyaniline, polyacetylin, poly-p-phenylene, poly-p-phenylene-vinylene, polythiophene, hemosin, and combinations thereof. The method of claim 1.   The method of claim 12, wherein the one or more polymers comprises polypyrrole.   13. The one or more polymers comprise one or more repeating monomers selected from the group consisting of glycolide, lactide, dioxanone, caprolactone, trimethylene carbonate, ethylene glycol, lysine and combinations thereof. the method of.   13. The method of claim 12, wherein the one or more polymers comprise a biodegradable or bioabsorbable linear aliphatic polyester.   The method of claim 15, wherein the linear aliphatic polyester comprises polyglycolide or poly (glycolide-co-lactide).   The method of claim 1, wherein the polymeric biocompatible product consists essentially of a single scaffold of moldable biocompatible material comprising poly (lactic acid-co-glycolic acid).   18. The method of claim 17, wherein the poly (lactic acid-co-glycolic acid) is 75% poly (lactic acid-co-glycolic acid) and the average molecular weight (Mn) is from about 20,000 to about 50,000. .   2. The polymeric biocompatible product consists essentially of an approximately 50:50 blend of poly (lactic acid-co-glycolic acid) and poly (lactic acid-co-glycolic acid) -polylysine block copolymers. the method of.   The poly (lactic acid-co-glycolic acid) -polylysine block copolymer is about 25% poly (lactic acid-co-glycolic acid) -polylysine copolymer, and the poly (lactic acid-co-glycolic acid) block is about 20,000- The method of claim 19, wherein the method has an average molecular weight (Mn) of about 50,000 and the polylysine block has an average molecular weight (Mn) of about 1,000 to about 3,000.   The method of claim 1, wherein the polymeric biocompatible product is a moldable biocompatible polymeric material comprising a conductive polymer.   The method of claim 21, wherein the conductive polymer is selected from the group consisting of polypyrrole polymers, polyaniline, polyacetylin, poly-p-phenylene, poly-p-phenylene-vinylene, polythiophene, hemosin and combinations thereof.   2. The method of claim 1, wherein the polymeric biocompatible product comprises one or more agents that are compatible with spinal nerve regeneration or healing.   24. The method of claim 23, wherein the one or more agents that stimulate spinal column regeneration or healing assist in restoring motor or sensory function in an animal or human after spinal tumor surgery.   25. The method of claim 24, wherein the one or more agents that stimulate spinal column regeneration or healing include one or more therapeutic agents.   The one or more therapeutic agents are selected from the group consisting of an anti-inflammatory compound, an anti-cancer agent, an antioxidant free radical scavenger, a wound healing promoter, a pain control agent, a neuroplasticity enhancer, and an anti-degenerative compound; 26. The method of claim 25.   27. The method of claim 26, wherein the one or more agents that stimulate spinal nerve regeneration or healing are present on the surface of a polymeric conductive product.   The method of claim 1, wherein the polymeric biocompatible product is a tube and the one or more agents are contained on the inner surface of the tube.   30. The method of claim 28, wherein the one or more agents that stimulate spinal column regeneration or healing comprise one or more donor neurons.   30. The method of claim 29, wherein the one or more donor neural cells comprise one or more human neural stem cells.   32. The method of claim 30, wherein the one or more agents that stimulate spinal column regeneration or healing comprise one or more mesenchymal stem cells. Removing at least a portion of a tumor from an animal or human spine site;
Molding a polymeric biocompatible material consisting essentially of a single scaffold product comprising poly (lactic acid-co-glycolic acid);
Implanting the polymeric biocompatible product in the animal or human spinal column adjacent to the site of the spinal column such that the polymeric biocompatible product at least partially surrounds the tumor site after surgical resection of the tumor A method of medical treatment of an animal or human subject in need thereof.   35. The method of claim 32, further comprising stem cells associated with the polymeric biocompatible material.   In one or more containers, include one or more polymeric biocompatible products and instructions for their use in a surgical procedure to remove at least a portion of a tumor from an animal or human spinal column A kit for use in medical treatment of an animal or human subject in need thereof.   35. The kit of claim 34, further comprising one or more pieces of artificial dura mater.   36. The kit of claim 35, further comprising one or more trimming tools. Surgically exposing the surgical site to allow surgical access to the spinal column containing the tumor;
Providing an implantation site for the polymeric biocompatible product by excising at least a portion of the tumor;
Implanting a polymeric biocompatible product into the implantation site; and
Surgically closing the surgical site, and a method of medical treatment of an animal or human subject in need thereof. An animal or human in need thereof comprising instructing a healthcare professional to implant a polymeric biocompatible product into the spine of an animal or human subject after surgically removing at least a portion of the tumor from the spinal column The medical treatment method of the subject.