KR102766983B1 - Apparatus and medhod for treating orthopedic diseases using bioactive and biodegradable material - Google Patents

Abstract

An orthopedic disease treatment device and method using a bioactive and biodegradable material are disclosed. The implant according to the present invention is characterized by including a case placed in an area of the spine where an intervertebral disc is provided; and a carrier provided in the internal space of the case and capable of absorbing a liquid bone morphogenetic protein and dissolving it into the treatment area.

Description

{APPARATUS AND MEDHOD FOR TREATING ORTHOPEDIC DISEASES USING BIOACTIVE AND BIODEGRADABLE MATERIAL}

The present invention relates to a device and method for treating spinal diseases and other related musculoskeletal and nervous system diseases, as well as preventing proliferation of spinal metastatic cancer cells by using new materials and biological activities.

As we transition to an aging society, the number of patients with spinal diseases such as spinal stenosis, herniated disc, and posterior facet hypertrophy is rapidly increasing, and research on treatment methods is also active. Spinal implants are used in fusion surgery, which has been used for a long time as a surgical treatment method for degenerative spinal diseases (including lumbar and cervical spine), and are also called spinal cages.

The intervertebral disc is a disc of cartilage between the vertebrae of the spine (backbone), and it absorbs the body's load and shock between each vertebra except for some of the cervical vertebrae, and performs a cushioning function that disperses the shock like a spring. At this time, the intervertebral disc holds the spine from being dislocated, separates the two vertebrae so that the spinal nerves are not compressed, maintains the range of the spinal joint space smoothly, and plays a role in facilitating the movement of each vertebra.

These intervertebral discs are usually made up of a structure of annulus fibrosus and nucleus pulposus. The annulus fibrosus controls the movement of the spinal segments, and the nucleus pulposus inside is made up of 70-80% water. It cushions or transmits vertical loads and shocks. In degenerative disc disease, the annulus fibrosus loses its ability to move or contain the nucleus pulposus, and its water content decreases.

Therefore, these complex results lead to diseases such as spinal stenosis, osteophyte formation, disc herniation, and nerve root compression. One method of treating diseases caused by the intervertebral disc is to remove the disc between the damaged vertebrae of the human body and replace it with an intervertebral disc implant in the space between two adjacent vertebrae (hereinafter referred to as 'disc space in between two vertebrae'). In other words, the goal is to create as natural a state as possible by transplanting it, and to restore the function of the spine by restoring the original distance between two adjacent vertebrae, which is the original height of the intervertebral disc.

These intervertebral disc implants generally have an appropriate thickness and an anatomical shape to restore the original height of the intervertebral disc, a hole is formed to facilitate bone growth after death, and a holding part is formed to firmly hold the end of the insertion device. Spinal interbody fusion is generally performed through the following process.

First, the intervertebral disc of the degenerated lumbar segment is removed, and a fusion body and cage are inserted in its place. The cage secures space for fusion while preventing contact between the vertebrae. After that, the fusion segment is fixed to the posterior bone using a pedicle screw and a connecting rod for fusion.

On the other hand, in patients with spinal tumors or metastatic cancer, it is difficult to restore spinal stability with only posterior instrumentation using pedicle screws and rods when the vertebral body collapses. In this case, the collapsed vertebral body must be removed and a vertebral body replacement implant must be inserted to restore anterior spinal column stability. However, in patients with spinal metastases, the lesion at the surgical site often grows again within a few days to a few weeks after the surgery, compressing the spinal cord and causing paralysis. Therefore, a new improvement measure is required to prevent this.

In addition, in patients with spinal tumors or spinal metastases that compress the spinal cord and cause paralysis, surgical approaches are performed to remove the tumor and decompress the spinal cord in order to maintain the patient's walking ability and urination-defecation function and relieve pain, thereby expecting recovery of paralyzed spinal cord function. However, due to the nature of tumors that continue to proliferate, there are many cases where the removed tumor or metastases proliferate again in the surgical site within a short period of time, causing paralysis to worsen again, and therefore, an improvement measure is required.

In addition, during spinal fusion surgery, bone morphogenetic protein-2 (BMP-2), an essential growth factor for bone formation, can induce differentiation into bone cells by itself, and due to this property, it is widely used in fields such as bone grafting or bone regeneration.

However, BMP-2 is a liquid-type substance that flows out into the surrounding area and causes an inflammatory reaction that stimulates unwanted soft tissues, which is problematic. In the case of anterior cervical fusion, this soft tissue inflammatory reaction has been reported to cause airway obstruction, resulting in fatal complications that lead to the death of the patient, so it must be used with extreme caution.

The above-described technical configuration is background technology to help understanding of the present invention, and does not mean a conventional technology widely known in the technical field to which the present invention belongs.

Korean Patent Publication No. 10-1950115 (Keimyung University Industry-Academic Cooperation Foundation) 2019. 02. 13. Korean Patent Publication No. 10-1845779 (Sewon Meditech Co., Ltd.) March 30, 2018

Therefore, the technical problem to be achieved by the present invention is to treat orthopedic diseases and defects using biodegradable composite materials and devices used in medical kits for treating spinal diseases and other related musculoskeletal and nervous system diseases.

According to one aspect of the present invention, an implant may be provided, comprising: a case disposed in an area of a spine provided with an intervertebral disc; and a biodegradable porous carrier provided in an internal space of the case and configured to absorb a liquid bone morphogenetic protein and to be released into a treatment site. The carrier may be provided with a mesh tissue to absorb the bone morphogenetic protein, thereby preventing the bone morphogenetic protein from leaking out of the case except for the treatment site. The carrier may include a cancellous bone allograft of the mesh tissue. The carrier may be provided with a porosity to absorb the bone morphogenetic protein, thereby preventing the bone morphogenetic protein from leaking out of the case except for the treatment site. The carrier may include porous hydroxyapatite. The carrier may include an absorbable collagen sponge (ACS). The case may be made of a material including PEEK (polyetheretherketone) or a cortical bone allograft. The bone morphogenetic protein may include BMP-2. The case and the carrier may be made integrally using 3D printing. The carrier may be made of a biodegradable porous polymer.

Embodiments of the present invention provide an orthopedic disease treatment kit used to treat spinal diseases and other related musculoskeletal and nervous system diseases, which satisfies biocompatibility and biodegradability without rejection reactions related to foreign substances in the human body, and can provide qualitatively improved treatment by using various biologically active substances suitable for disease treatment.

FIG. 1 is a schematic drawing of an implant equipped with a carrier that prevents leakage of bone morphogenetic protein according to one embodiment of the present invention.
Figure 2 is a schematic exploded perspective view of Figure 1.
FIG. 3 is a drawing showing a carrier applied to the present embodiment. FIG. 3 (a) illustrates a carrier made of a mesh tissue, FIG. 3 (b) illustrates a carrier made of porosity, and FIG. 3 (c) is a drawing showing a carrier made of an absorbable collagen sponge.
FIG. 4 is a schematic drawing of an implant used for the anterior lumbar spine, which is equipped with a carrier that prevents leakage of bone morphogenetic protein according to one embodiment of the present invention.
FIG. 5 is a schematic drawing of another implant used for the anterior lumbar spine, which is an implant equipped with a carrier that prevents leakage of bone morphogenetic protein according to one embodiment of the present invention.
FIG. 6 is a schematic drawing of an implant that prevents the proliferation of cancer cells according to one embodiment of the present invention.
Figure 7 is a schematic diagram illustrating an implant that prevents the proliferation of cancer cells as shown in Figure 6 is connected to a vertebral body.
FIG. 8 is a schematic drawing of an implant that prevents the proliferation of cancer cells according to one embodiment of the present invention.
FIG. 9 is a schematic diagram illustrating a tumor compressing the spinal cord, the compressed spinal cord, and the dura mater surrounding it according to one embodiment of the present invention.
FIG. 10 is a schematic diagram illustrating an anticancer substance-eluting filling unit for spinal decompression according to one embodiment of the present invention, which is provided in the space between the vertebral body and the dura mater or the epidural space.
FIG. 11 is a drawing schematically illustrating an anticancer substance dissolving filling unit for spinal decompression applied to one embodiment of the present invention.

Hereinafter, specific details for carrying out the present invention will be described based on examples with reference to the drawings. These examples are described in sufficient detail to enable those skilled in the art to carry out the present invention. It should be understood that the various embodiments of the present invention are different from each other, but are not necessarily mutually exclusive. For example, specific shapes, structures, and characteristics described herein may be implemented in other embodiments without departing from the spirit and scope of the present invention with respect to one embodiment. In addition, it should be understood that the positions or arrangements of individual components within each disclosed embodiment may be changed without departing from the spirit and scope of the present invention. Accordingly, the following detailed description is not intended to be limiting, and the scope of the present invention is defined only by the appended claims along with the full scope equivalent to what the claims claim, if properly described. In the drawings, similar reference numerals refer to the same or similar functions throughout. In order to fully understand the present invention, the operational advantages of the present invention, and the objects achieved by the practice of the present invention, reference should be made to the accompanying drawings illustrating preferred embodiments of the present invention and the contents described in the accompanying drawings.

Hereinafter, the present invention will be described in detail by describing preferred embodiments of the present invention with reference to the attached drawings. The same reference numerals presented in each drawing represent the same components.

FIG. 1 is a schematic drawing of an implant equipped with a carrier for preventing leakage of bone morphogenetic protein according to one embodiment of the present invention, FIG. 2 is a schematic exploded perspective view of FIG. 1, and FIG. 3 is a drawing of a carrier applied to the present embodiment, in which (a) of FIG. 3 is a drawing of a carrier formed of a mesh tissue, (b) of FIG. 3 is a drawing of a carrier formed of porosity, and (c) of FIG. 3 is a drawing of a carrier formed of an absorbable collagen sponge.

As shown in these drawings, an implant (1) equipped with a carrier that prevents leakage of bone morphogenetic protein according to the present embodiment comprises a case (10) placed in an area of the spine where an intervertebral disc is provided, and a carrier (20) provided in a receiving space (11) of the case (10) that absorbs liquid bone morphogenetic protein (30) and causes it to be dissolved in a treatment area.

The case (10) is placed in the space (intervertebral space) between two adjacent vertebrae to restore the original distance between two adjacent vertebrae, which is the original height of the intervertebral disc, thereby restoring the function of the spine.

In this embodiment, a receiving space (11) is provided in the case (10), as shown in FIG. 2, and a carrier (20) containing a liquid or powder type bone formation protein (30) can be provided in this receiving space (11).

In addition, in the present embodiment, a plurality of fixing protrusions (12) may be spaced apart from each other on the upper and lower surfaces of the case (10), as shown in Fig. 2. In the present embodiment, the plurality of fixing protrusions (12) may be engaged with two adjacent vertebrae, respectively, to fix the case (10) in position.

Furthermore, in the present embodiment, the case (10) may be made of a material including PEEK (polyetheretherketone) or a cortical bone allograft. In the present embodiment, if the case (10) is made of PEEK, it has a similar elastic coefficient to the cortical bone of the vertebral body, and thus has advantageous properties for load and stress distribution, and thus has a lower subsidence frequency than a titanium cage biomechanically, and thus has the advantage of maintaining spinal alignment and a high rate of intervertebral fusion due to stability.

The carrier (20), as shown in FIG. 1, is provided inside the case (10) and contains a liquid bone morphogenetic protein (30) so as to prevent the liquid bone morphogenetic protein (30) from leaking out to an area other than the treatment area.

That is, in the present embodiment, the carrier (20) is provided in a mesh-like or porous form so as to absorb and contain the liquid bone morphogenetic protein (30), thereby preventing the liquid bone morphogenetic protein (30) from leaking out to areas other than the treatment area.

In this embodiment, the carrier (20) may be prepared by making use of a biodegradable porous polymer and containing a liquid bone-forming protein, which is a bioactive substance.

In this embodiment, biodegradability generally means decomposing through hydrolysis and/or oxidative decomposition, or decomposing enzymatically or by the influence of microorganisms such as bacteria, yeast, fungi and algae within a reasonable period of time.

In this embodiment, "porous" refers to an arrangement of pores, channels, and cages, and the arrangement of the pores, channels, and cages may be irregular, regular, or periodic. In addition, the pores or channels may be separated or interconnected, and may be one-dimensional, two-dimensional, or three-dimensional. In this embodiment, the biodegradable porous polymer is not particularly limited in its specific type as long as it is a particle capable of forming a porous structure, but may include a natural polymer or a synthetic polymer.

In the present embodiment, the natural polymer may be collagen, hyaluronic acid, gelatin or chitosan, and the synthetic polymer may be poly(lactic-co-glycolic acid) (PLGA), poly(glycolic acid) (PGA), poly(lactic acid) (PLA) or polyethylene glycol (PEG), but is not limited thereto.

In this embodiment, the biodegradable porous polymer exhibits the porous morphology described above, so that liquid bone morphogenic protein can be effectively loaded into the pores, channels, and cages.

In this embodiment, the carrier (20) is formed as a mesh tissue as shown in (a) of FIG. 3 and absorbs the liquid bone morphogenetic protein (30), thereby preventing the bone morphogenetic protein (30) from leaking out of the case (10) except for the treatment area.

In the present embodiment, the carrier (20) may include a cancelous bone allograft of mesh-like tissue. In addition, as shown in (b) of FIG. 3, the carrier (20) in the present embodiment may be formed porous to absorb liquid bone morphogenetic protein (30), thereby preventing the bone morphogenetic protein (30) from leaking out of the case (10) except for the treatment area.

In the present embodiment, the carrier (20) may include porous hydroxyapatite. Furthermore, in the present embodiment, the carrier (20) may be formed of an absorbable collagen sponge (ACS), as shown in (c) of FIG. 3, to absorb the liquid bone morphogenetic protein (30), thereby preventing the bone morphogenetic protein (30) from leaking out of the case (10) except for the treatment area.

And in the present embodiment, the carrier (20) can be prepared integrally with the case (10) using 3D printing. In this case, the carrier (20) can be prepared by including calcium carbonate or calcium phosphate, which are bone formation-friendly materials.

Meanwhile, in the present embodiment, the internal structure of the carrier (20) can be provided differently. That is, the mesh tissue or porous structure placed in an area other than the treatment area can be provided more densely than the mesh tissue or porous structure placed in the treatment area.

For example, a mesh tissue or porous structure arranged in an edge region of the case (10) may be arranged to have a denser structure than a mesh tissue or porous structure in an area of a carrier (20) arranged in a central portion of the case (10).

In this case, it is possible to more effectively prevent the bone morphogenetic protein (30) from leaking out of the case (10) except for the treatment area. The bone morphogenetic protein (30) is prepared in a liquid form, and may be prepared in a manner in which the surgeon puts it into the carrier (20) described above during surgery, or may be prepared in a state in which it is contained in the carrier (20) and placed inside the case (10).

In the present embodiment, the bone morphogenic protein (30) may include bone morphogenic protein-2 (BMP-2). BMP-2 acts as a growth and differentiation factor in the body, and is known to act widely in all stages of bone formation from differentiation of mesenchymal stem cells to osteoblasts, and promote new bone formation, and is therefore most widely applied in clinical settings.

In the present embodiment, the bone morphogenetic protein (30) may be at least one selected from the group consisting of BMP-4, BMP-5, BMP-6, BMP-7, BMP-9, BMP-10, BMP-12, and BMP-13 in addition to BMP-2. In addition, in the present embodiment, the bone morphogenetic protein (30) may be contained in the carrier (20) in consideration of the treatment area of the patient or the size of the case (10).

FIG. 4 is a schematic drawing of an implant for use in the anterior lumbar spine, which is an implant equipped with a carrier for preventing leakage of a bone morphogenetic protein according to one embodiment of the present invention, and FIG. 5 is a schematic drawing of another implant for use in the anterior lumbar spine, which is an implant equipped with a carrier for preventing leakage of a bone morphogenetic protein according to one embodiment of the present invention.

This embodiment can also be applied to implants used for anterior lumbar surgery, as shown in FIGS. 4 and 5. For reference, the embodiment described above is an implant used for the cervical spine. In addition, the carrier (20) and bone morphogenetic protein (30) described above can be applied to this embodiment in the same manner. As described above, this embodiment can prevent bone morphogenetic protein from leaking out of the case except for the treatment area by having the carrier disposed inside the case absorb liquid bone morphogenetic protein and elute it into the treatment area.

As a result, the liquid bone morphogenetic protein can be prevented from flowing out around the case and stimulating unwanted soft tissues to cause inflammatory reactions. In the case of anterior cervical fusion, the risk of such soft tissue inflammatory reactions causing airway obstruction can be prevented in advance.

FIG. 6 is a schematic drawing of an implant that prevents the proliferation of cancer cells according to one embodiment of the present invention.

As illustrated in FIG. 6, an implant (1) for preventing proliferation of cancer cells according to the present embodiment comprises a case (10) inserted between adjacent vertebrae to replace a vertebrae, and an anticancer substance coating portion (20) coated so that an anticancer substance is released into the case (10) to inhibit proliferation of cancer cells at the surgical site.

The case (10) is inserted between adjacent vertebral bodies to replace the vertebral bodies, thereby restoring the function of the vertebral bodies by restoring the original distance between two adjacent vertebral bodies, which is the original height of the vertebral bodies.

In the present embodiment, the case (10) may have a cylindrical shape with an empty interior, as shown in Fig. 6. That is, in the present embodiment, a mesh cage having a hollow cylindrical mesh shape may be applied to the case (10).

In this embodiment, the case (10) can be made of titanium. Titanium is non-toxic and has excellent biostability and biocompatibility.

In this embodiment, the case (10) is provided with an internal space (11), and a bone morphogenic protein or a carrier containing the same can be provided in this internal space (11).

In addition, in the present embodiment, the case (10) may be made of a material including PEEK (polyetheretherketone) or a cortical bone allograft. In the case where the case (10) is made of PEEK in the present embodiment, it has a similar elastic coefficient to the cortical bone of the vertebral body, and thus has advantageous properties for load and stress distribution, and thus has a lower subsidence frequency than a titanium cage biomechanically, and thus has the advantage of maintaining the spinal alignment and a high intervertebral fusion rate due to stability.

And in the present embodiment, a plurality of fixing protrusions (12) may be spaced apart from each other on the upper and lower surfaces of the case (10), as shown in Fig. 6. In the present embodiment, a plurality of fixing protrusions (12) may be engaged with two adjacent vertebral bodies, respectively, to fix the case (10) in position.

The anticancer substance coating portion (20) is provided so that the anticancer substance is eluted into the case (10), thereby preventing cancer cells from proliferating at the surgical site and causing spinal cord compression within a short period of time after surgery, thereby preventing paralysis from worsening again.

In other words, in patients with spinal metastases, if the vertebral body collapses, it is difficult to restore spinal stability with only posterior instrumentation using pedicle screws and rods. In this case, the collapsed vertebral body must be removed and a vertebral body replacement implant must be inserted to restore anterior spinal stability. In patients with spinal metastases, there are frequent cases where the lesion at the surgical site grows again within a few days to a few weeks after such surgery, compressing the spinal cord and causing paralysis. However, if an anticancer substance-coated portion (20) is provided in the case (10) as in this embodiment, it is possible to prevent paralysis from worsening at the surgical site.

In this embodiment, the anticancer substance coating portion (20) may be provided in an area other than the internal space (11) of the case (10), as shown in Fig. 6. It is not limited thereto, and may optionally be provided in the internal space (11).

Additionally, in the present embodiment, the anticancer agent may include diethylstilbestrol (DES) or taxol. Diethylstilbestrol does not induce cancer cell proliferation, but may reduce the responsiveness of cancer cells to anticancer agents, thereby preventing cancer cells from becoming necrotic.

Furthermore, in the present embodiment, the anticancer substance coating portion (20) may be prepared by spraying the anticancer substance onto the case (10), or may be prepared by immersing the case (10) in a liquid anticancer substance so that the anticancer substance is applied to the case (10). In the present embodiment, the anticancer substance coating portion (20) may be prepared by forming the anticancer substance into a film and wrapping the outer surface of the case (10), and in addition to the above-described method, various methods may be applied to form the anticancer substance coating portion (20) on the case (10).

And in this embodiment, the degree of dissolution of the anticancer substance can be controlled by the thickness of the anticancer substance coating portion (20). In addition, in this embodiment, the degree of release of the anticancer substance can be controlled by the degree to which the anticancer substance is broken by bonding the anticancer substance to the surface of the case (10) through a chemical bond.

In this embodiment, a method for manufacturing an implant that prevents the proliferation of cancer cells includes a step of preparing a case (10) that is inserted between adjacent vertebral bodies to replace the vertebral bodies, and a step of providing an anticancer substance coating portion (20) that inhibits the proliferation of cancer cells at a surgical site by coating the case (10) so that an anticancer substance is eluted.

In the present embodiment, the step of preparing the anticancer substance coating portion (20) can be performed using the method described above, that is, spraying or immersing the anticancer substance into the case (10) or wrapping the outer surface of the case (10) with a film.

Meanwhile, in this embodiment, a biodegradable porous polymer is provided inside the case (10), and a carrier is provided by loading a stimulus-sensitive polymer and a bioactive substance including an anticancer agent and a cytostatic agent into the biodegradable porous polymer, thereby preventing the proliferation of cancer cells.

In this embodiment, the biodegradable porous polymer exhibits the porous morphology described above, so that bioactive substances such as anticancer agents and cytostatic drugs and stimuli-sensitive polymers can be effectively loaded into the pores, channels, and cages.

In the present embodiment, the anticancer agent and cytostatic drug may be at least one selected from the group consisting of Doxorubicin, Epirubicin, Gemcitabine, Cisplatin, Carboplatin, Procarbazine, Cyclophosphamide, Dactinomycin, Daunorubicin, Etoposide, Tamoxifen, Mitomycin 11, Bleomycin, Plicomycin, Transplatinum, Vinblastine, and Methotrexate, but is not limited thereto.

In the present embodiment, the stimuli-sensitive polymer refers to a polymer that can dissolve/decompose in response to various internal/external stimuli such as temperature, pH, etc., and may include, but is not limited to, gelatin, PCL (Polycaprolactone), chitosan, PNIPAAm (Poly(NˇIsopropylacrylamide)) and/or HEMA (2-hydroxyethyl(methacrylate)). In the present embodiment, the stimuli-sensitive polymer can dissolve/decompose in an internal temperature range of 36-40°C, and thus, anticancer agents and cytostatic drugs can be easily released from the biodegradable porous polymer.

FIG. 8 is a schematic drawing of an implant that prevents the proliferation of cancer cells according to another embodiment of the present invention.

The implant (1a) for preventing proliferation of cancer cells of the present embodiment includes a case (10) and the aforementioned anticancer substance coating portion (20) provided in the case, as shown in FIG. 8.

The case (10) is inserted between adjacent vertebral bodies to replace the vertebral bodies, and may have a cylindrical shape, as shown in FIG. 8.

In this embodiment, a plurality of fixing protrusions (12) may be spaced apart from each other on the upper and lower surfaces of the case (10), as shown in Fig. 8. In this embodiment, a plurality of fixing protrusions (12) may be engaged with two adjacent vertebrae, respectively, to fix the case (10) in position.

In addition, in the present embodiment, a fastening hole (13) is provided in the case (10), as shown in FIG. 8, and a plate (30) can be detachably screw-connected to the fastening hole (12).

Furthermore, in this embodiment, the case (10) is provided with a plurality of through holes (14) to induce bone formation. That is, the formation of new bone is promoted through the plurality of through holes (14) while allowing autograft or allograft to be accepted.

The anticancer substance coating portion (20) can be applied as is in the above-described embodiment.

As described above, the present embodiment provides an anticancer substance coating portion that allows an anticancer substance to be eluted in a case inserted between adjacent vertebral bodies to replace the vertebral bodies, thereby preventing cancer cells from proliferating at the surgical site and causing spinal cord compression to progress and worsen paralysis again within a short period of time after surgery.

FIG. 9 is a schematic drawing of a tumor compressing the spinal cord, the compressed spinal cord, and the dura mater surrounding it, and FIG. 10 is a schematic drawing of an anticancer substance-eluting filling unit for spinal decompression according to one embodiment of the present invention, which is provided in the space between the vertebral body and the dura mater or the epidural space.

The anticancer substance filling part (1) for spinal decompression according to the present embodiment can be provided in the space between the vertebral body (100) and the dura mater (300) or in the space outside the dura mater (300), as shown in FIG. 10, after removing the tumor (400) compressing the spinal cord (200) as shown in FIG. 9 and decompressing the spinal cord (200).

In the present embodiment, the anticancer substance filling portion (1) can be prepared using a biodegradable porous polymer, and can be prepared in a form in which an anticancer agent or a porous structure in the form of fine powder enters the mixture in the form of a gel and is distributed.

In this embodiment, the biodegradable porous polymer exhibits the porous morphology described above, so that bioactive substances such as anticancer agents and cytostatic drugs and stimuli-sensitive polymers can be effectively loaded into the pores, channels, and cages.

In the present embodiment, the anticancer agent and cytostatic drug may be at least one selected from the group consisting of Doxorubicin, Epirubicin, Gemcitabine, Cisplatin, Carboplatin, Procarbazine, Cyclophosphamide, Dactinomycin, Daunorubicin, Etoposide, Tamoxifen, Mitomycin, Bleomycin, Plicomycin, Transplatinum, Vinblastine, and Methotrexate, but is not limited thereto.

In the present embodiment, the stimuli-sensitive polymer refers to a polymer that can dissolve/decompose in response to various internal/external stimuli such as temperature, pH, etc., and may include, but is not limited to, gelatin, PCL (Polycaprolactone), chitosan, PNIPAAm (Poly(NˇIsopropylacrylamide)) and/or HEMA (2-hydroxyethyl(methacrylate)). In the present embodiment, the stimuli-sensitive polymer can dissolve/decompose in an internal temperature range of 36-40°C, and thus, anticancer agents and cytostatic drugs can be easily released from the biodegradable porous polymer.

In addition, in the present embodiment, the anticancer substance filling portion (1) for spinal decompression may be prepared as an absorbable gelatin sponge. In the present embodiment, the absorbable gelatin sponge may be prepared in a form that includes a gel form.

Meanwhile, the anticancer substance eluting charging unit (1) for spinal decompression according to the present embodiment comprises, as shown in FIG. 11, a base body (10) and an anticancer substance eluting unit (20) provided inside the base body (10) to elute the anticancer substance.

The base body (10) can be provided in the space between the vertebral body (100) and the dura mater (300) or in the space outside the dura mater (300).

In addition, in the present embodiment, the anticancer substance-dissolving charging unit (1) base body (10) is made of a soft material including silicone, so that the area in contact with the vertebral body (100) or the dura mater (300) or the extra-dural space (300) can be deformed to reduce the pressure applied to the vertebral body (100) or the dura mater (300) or the extra-dural space area. In the present embodiment, a plurality of holes may be provided in the base body (10) to discharge the anticancer substance.

Furthermore, in the present embodiment, the anticancer substance-eluting charging unit (1) base body (10) is provided in a mesh-like or porous form, and when the anticancer substance-eluting unit (20) is provided in a liquid form, the liquid anticancer substance can be absorbed and the anticancer substance can be discharged to the surgical site. In the present embodiment, the anticancer substance-eluting charging unit (1) base body (10) can be provided with a material including a mesh-like bone graft, porous hydroxyapatite, or an absorbable collagen sponge (ACS).

The anticancer substance eluting charging unit (1) is provided in the base body (10) as shown in FIG. 9, and eluting the anticancer substance into the surrounding area of the base body (10), can prevent cancer cells from proliferating again at the surgical site and worsening paralysis in a patient who has suffered paralysis due to spinal metastasis compressing the spinal cord (200) after surgically approaching and decompressing the spinal cord (200).

In the present embodiment, the anticancer substance eluting charging unit (1) and the anticancer substance eluting unit (20) may be provided in a paste form, such as Floseal, which is commonly used as a hemostatic agent, or in a gel-sol form, such as a surgical sealant and adhesive, or in a plastic clay form (putty form). In the present embodiment, the surgical sealant and adhesive may include duraseal.

In addition, in the present embodiment, the anticancer substance elution charging unit (1) anticancer substance elution unit (20) may be provided in a liquid state if the base body (10) is provided in a mesh-like or porous form that can contain liquid. In the present embodiment, if the base body (10) is provided in a mesh-like or porous form that can contain liquid, the internal structures of the anticancer substance elution charging unit (1) base body (10) may be provided differently. That is, the mesh-like or porous structure arranged in an area other than the treatment site may be provided more densely than the mesh-like or porous structure arranged in the treatment site, so as to control the degree of elution of the anticancer substance. For example, the mesh-like or porous structure of the area of the anticancer substance elution charging unit (1) base body (10) arranged in the edge area may be provided to have a less dense structure than the mesh-like or porous structure of the area of the anticancer substance elution charging unit (1) base body (10) arranged in the center. In this case, there is an advantage in that more anticancer substances can be supplied to the treatment site. In the present embodiment, the treatment site may be the upper and lower areas of the internal space (11) provided in the anticancer substance elution charging unit (1) base body (10), and the area facing the through hole provided in the wall of the anticancer substance elution charging unit (1) base body (10).

In addition, in this embodiment, a mesh tissue or porous structure is not provided in an area other than the area of the base body (10) of the anticancer substance elution charging portion (1) corresponding to the treatment area, thereby preventing the anticancer substance from being supplied to an area other than the treatment area.

In addition, in this embodiment, after a mesh tissue or porous structure is provided in the anticancer substance elution charging unit (1) base body (10), the anticancer substance elution charging unit (1) base body (10) is blocked with a harmless blocking film in an area other than the area corresponding to the treatment area during surgery, thereby preventing the anticancer substance from being supplied to an area other than the treatment area. In this embodiment, the blocking film includes a known film used in medical surgery.

In this embodiment, the anticancer substance provided in the anticancer substance elution charging unit (1) and the anticancer substance elution unit (20) may include paclitaxel or various cell proliferation inhibitory drugs.

The usage method of this embodiment is briefly described below.

First, the patient is put under general anesthesia, placed in a prone position, and the patient's lower back is exposed. A long incision is made along the center of the back of the lower back. The length of the incision is determined by the scope of the surgery.

Next, the posterior spine is resected, part of the posterior joint is resected, and the thickened ligamentum flavum is removed to perform nerve decompression surgery to prevent the spinal nerve (200) from being compressed.

Next, the ligament that is protruding and compressing the nerve is cut off, and a disc removal (100) is performed to remove the intervertebral disc in the relevant area. When a posterolateral fusion is performed, the disc (100) is not removed.

Afterwards, the disk (100) of the relevant area is removed, and the anticancer substance-eluting filling part for spinal decompression of the present embodiment is inserted into the empty space created.

Next, posterior fixation using metal connecting rods and screws is performed to supplement spinal instability, and bone grafting using autologous bone or artificial bone is performed to perform spinal fusion.

Finally, the incised skin is sutured.

As such, the present invention is not limited to the described embodiments, and it is obvious to those skilled in the art that various modifications and variations can be made without departing from the spirit and scope of the present invention. Accordingly, such modified or modified examples should fall within the scope of the claims of the present invention.

1: Bone morphogenetic protein carrier-integrated implant
10: Case
11: Interior space
12: Fixed protrusion
20: Carrier
30: Bone morphogenetic protein

Claims (3)

Cases where the disc is placed in the area of the spine where the intervertebral disc is located;
An anticancer substance coating portion in which the outer surface of the case is coated with an anticancer substance so that the anticancer substance is eluted; and
A biodegradable porous carrier provided in the internal space of the case and configured to absorb liquid bone morphogenetic protein and release it into the treatment area;
Here,
The above case is made of a material including PEEK (polyetheretherketone) or cortical bone allograft,
The above case has the shape of a hollow cylindrical mesh with an empty interior,
The above case has a plurality of fixing projections spaced apart on the upper and lower surfaces, and can be engaged with two adjacent vertebral bodies to fix the case in position.
The above anticancer substances include diethylstilbestrol (DES) or taxol.
The biodegradable porous carrier comprises at least one of a cancellous bone allograft, porous hydroxyapatite, and an absorbable collagen sponge.
Implants.
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