Improved inflatable device for use in surgical protocol relating to fixation of bone

Description: TECHNICAL FIELD [Detailed description of the invention]

The present invention is an improvement on the method of surgically treating the bone condition of human and other animal bone systems, more specifically, the expandable balloon shape used when treating such bone condition. Regarding the device. Osteoporosis, avascular necrosis, and bone cancer are bone diseases that predispose to fractures or bone collapse. In the United States, there are more than 2 million fractures per year, of which 1.3 million are due to osteoporosis. Avascular necrosis and bone cancer, which are more rare, can now result in bone damage that cannot be adequately addressed. Background of the invention U.S. Pat. Nos. 4,969,888 and 5,108,404 disclose devices and methods for treating fractures or other conditions of the bone system of humans and other animals, both osteoporosis and non-osteoporosis. The device and method are particularly suitable for, but not limited to, treating fractures due to compression of the vertebral body, Coles fractures, and fractures of the humerus proximal phalanx. The methods disclosed in these two patents include a series of steps that can be performed by a surgeon or a health care person, who steps in the diseased bone (osteoporotic bone, osteoporotic bone stem end). And bone tips, osteoporotic vertebral body fractures, osteoporotic vertebral body fractures, tumors, especially vertebral body fractures due to circular cell tumors, avascular necrosis of the long bone ends, especially the femoral basal bone, femur Includes the formation of cavities in (including, but not limited to, avascular necrosis of the terminal and femoral basal bones, disorders resulting from endocrine conditions). This method further involves making an incision in the skin (usually a single incision, but a second slight incision may be required for suction introduction and derivation), followed by a guide. Place the pin and advance the guide pin through the flexible tissue to the bone and into the bone. This method further comprises perforating the bone to be treated in order to form a cavity or passage in the bone, after which an expandable balloon-like device is inserted and expanded into the cavity or passage. With the expansion of this expandable device, cancellous bone and bone marrow are pressed against the inner surface of the cortical wall of the bone to further expand the cavity or passage. The expandable device is then contracted and then completely removed from the bone. If necessary, first use a smaller diameter expandable device (starting balloon) to initiate compression of the bone marrow and also to create cavities or passages in the cancellous bone and bone marrow. .. After this, a larger diameter expandable device is inserted into the cavity or passage to further compress the bone marrow in all directions. A fluid and biocompatible filling material, such as methyl methacrylate cement, or a synthetic bone substitute is then introduced into the cavity or passageway to cure to a hardened state and structurally to the bone. Allow support to be provided. After this latter step, the insertion instrument is removed from the body and the incision in the skin is covered with a bandage. The patented devices and methods provide sufficient therapeutic methods for treating bone, but for the inner surface of the cortical wall of bone to be treated with bone marrow and / or cancellous bone and / or cancellous bone. It has been found that compression can be significantly improved by using expandable devices that embody additional technical features, but such features are not described in the above patents and are also not described. , The prior art expandable device in such patents cannot be adequately controlled. Therefore, there is a need to improve the shape, structure and dimensions of the expandable device used with the above devices and methods, and the present invention satisfies this need. Conventional technology for manufacturing balloons used in the patient's body Examination of prior art in the manufacture of balloons reveals that there is a significant amount of background information regarding the guidance of catheters that are introduced into the patient's cardiovascular system through the arm or femoral artery. However, there is little information about the expandable devices used within the bone, and no information about compressing the bone marrow of the vertebral body and long bones. In a dilated catheter, the catheter is advanced into the patient's body until the balloon is properly placed across the treatment site. The balloon is inflated with a radiation-impermeable liquid at atmospheric pressures above 4 atmospheres, compressing the plaque at that site, thereby dilating the lumen of the artery. The balloon is then contracted and then removed from the artery so that blood flow can be restored through the dilated artery. Techniques for using such catheters are disclosed and clearly described in US Pat. No. 5,163,989. Other details of the angioplasty catheterization method, as well as the details of the balloons used in such methods, are described in US Pat. Nos. 4,323,071, 4,332,254, 4,439,185, 4,168,224, 4,516,672, 4,538,622. It can also be found in No. 4,554,929 and No. 4,616,652. We also manufacture extruded products to form prismatic balloons using a mold, which molds extremely precisely on the inner surface to form an acceptable balloon for angioplasty catheters. Needs to be machined. However, this extrusion technique is problematic in that it forms a separation line in the balloon product, which provides a weak wall against the balloon itself. U.S. Pat. No. 5,163,989 discloses a mold for forming an expansion catheter and its technique, in which case the balloon of the catheter has no separation line. The technique involves expanding a tubular shaped plastic member and pressing the member against a heated molding inner surface. The expandable device is molded to the desired size and shape and then cooled and shrunk to remove the device from the mold. According to the description of this patent, the balloon of the present invention is particularly suitable for forming a prismatic balloon, but this method is also suitable for forming balloons of various sizes and shapes. A special improvement in catheter technology with respect to this patent, US Pat. No. 4,706,670, is the use of coaxial catheters with inner and outer tubes formed and reinforced with continuous spiral filaments. Such filaments intersect each other to reduce the length of the balloon shaft, while increasing the length of the movable portion of the shaft portion. By appropriately balancing the lengths or weaving angles of the movable parts of the balloon and the filament, the difference in length can be eliminated from each other. In this way, the positions of the inner and outer tubes can be adjusted as needed to keep the balloon in the desired position within the blood vessel. Other disclosures relating to the insertion of expandable devices that treat the patient's skeleton include: US Pat. No. 4,313,434 inserts a contracted flexible pouch into the cavity of the pulp, inflates the balloon pouch, seals the inside of the long bone until healed, and then the pouch. It relates to treating the long bone by removing the sac and filling the opening where the sac-like body exits the long bone. U.S. Pat. No. 5,102,413 discloses a method of using an expandable pouch to anchor a metal rod for the treatment of a fractured long bone. Other literature that uses balloons and discloses binders that anchor the prosthesis includes US Pat. Nos. 5,147,366, 4,892,550, 4,694,584, 4,562,598, 4,399,814. .. Dutch Patent No. NL901858 discloses a means of treating a fracture with a bag impregnated with a binder that is allowed to expand and cure in a preformed cavity. From the above studies of the prior art, it can be concluded that there is little or virtually no information about the expandable device used to form the cavity in the bone. Nothing teaches the shape of a balloon that forms a cavity that best supports the bone when properly filled. Also, there is no teaching of how to prevent the balloon from becoming spherical when expanded, i.e. when needed. Current medical balloons can compress bone, but are too small and, as a whole, are not well-shaped to form sufficient cavities in either the vertebral body or long bones of the body. Also, it is not robust enough. U.S. Pat. Nos. 4,969,888 and 5,108,404 disclose a checkered balloon that presses against the cancellous bone, but does not provide information on how the balloon retains its shape when expanded. Absent. As described above, an expandable device for improvement and a treatment method thereof used for diseased bone are still a problem. Outline of the invention The present invention relates to a balloon-shaped expandable device or balloon used to embody the devices and methods of Japanese Patent Nos. 4,969,888 and 5,108,404 described above. Such an expandable device, hereinafter referred to as a balloon, compresses cancellous bone and bone marrow (also known as medulla oblongata or trabecular bone) against the medial cortex of bone, whether or not the bone is fractured. It has a shape. In particular, the present invention relates to balloons used when treating bone that may be fractured or crushed. The balloon consists of an expandable, non-inflatable balloon body for insertion into the bone described above. The body forms a cavity in the cancellous bone and is approximately sufficient to compress at least part of the medial cancellous bone to regain its original position in the lateral cortical bone when fractured or crushed. When expanded, it has a predetermined shape and dimensions. The balloon body is constrained to be able to form the predetermined shape and dimensions described above, so that the fully expanded balloon body is placed on the inner surface of the outer cortical bone when the bone fractures or does not collapse. Significant pressure is prevented. In addition to the shape of the expandable device itself, another important feature is the structure of the balloon wall so that the balloon body can be properly expanded for optimal compression of all bone marrow. .. The material of the balloon is also selected as desired, so that the balloon can be folded and quickly and easily inserted into the bone using guide pins and cannulas, but when expanded, the balloon becomes high pressure. Make it bearable. The balloon can include optional ridges or recesses that remain in the cavity after the balloon is removed. The expandable device can also be optionally formed to incorporate a suction catheter. This catheter is used to remove oil or fluid extruded from the bone while the bone expands within the bone. Also, the balloon body, when in the cannula, is covered with a Kerber capable of protecting the balloon, or an optional protective sleeve made of a suitable material such as PET or other polymer or material. Protects against tearing by cortical bone or cannula. For this reason, the main purpose of this expandable device is to form or extend a cavity or passage in bone, especially in the vertebral body, but is not limited to this vertebral body. .. A main object of the present invention is to improve the efficiency of a surgical method, to minimize the time before performing the surgical operation of interest to the surgical method, and to improve the clinical effect. It is to provide a balloon-shaped expandable device. These balloons should approximate the internal shape of the bone in which the balloon is located so that the cancellous bone can be compressed to the maximum extent possible. These balloons have additional design elements to achieve specific clinical effects. These balloons are made of an inelastic material, and it is preferable that the balloon can maintain its predetermined shape when expanded by various restraining means, and the restraining means is inelastic to the balloon body. Forming seams on the balloon body by using materials, by adhering or fusing different pieces of material to each other, or by fusing or adhering both sides of the balloon body together, weaving Balloons of similar or different size or shape due to gluing material to the inside or outside of the balloon body, placing a string or band in place within the balloon body, gluing or heat fusion Includes (but is not limited to) stacking each other. The stability of the filler is increased if optional ridges or recesses are formed by the above structures or added by adhering additional materials. If there is at least one hole in the lowermost portion of the cavity to be formed, it is preferable to place an optional suction device so that the cavity can be cleaned prior to filling. Various embodiments of the present invention include: 1. A donut-shaped (or annular) balloon with an optional built-in suction catheter to remove oils and other products extruded during balloon expansion. 2. A balloon with a spherical outer shape surrounded by a ring-shaped balloon part to form the hollow part of the main body. 3. A balloon in the shape of broad beans. Such balloons can be formed in a single layer or in several layers stacked on top of each other. 4. A spherical balloon that approximates the dimensions of the femoral head (ie, the base end of the femur). The balloon may also be hemispherical. 5. A curved banana that approximates the end of the radius (ie, the epiphysis and metaphysis of the terminal radius), or a modified prismatic shaped balloon. 6. A balloon with a cylindrical shape that approximates the shape of either the middle or lateral hemisphere of the epiphyseal tibia at the base. Further, the balloon may have a structure that approximates the shape of both halves of the epiphyseal bone of the proximal tibia. 7. A spherical balloon at the base that approximates the shape of the base femoral end and the metaphysis, with a plug for compressing the cancellous bone into the diaphysis. 8. Balloon device with optional suction balloon. 9. A protective sheath that acts as a tear-prevention member that selectively covers each balloon inside the catheter. As described above, the present invention provides an expandable device according to an improvement, which forms a cavity or a passage in a bone or expands the cavity or a passage, and is inserted into the bone. .. The shape of each device is defined by the surrounding cortical bone and adjacent internal structures and is designed to occupy about 70-90% of the internal volume of the bone, but is about 40% smaller and about 99%. Even a moderately large balloon can act on fractures. In certain cases, usually in the case of avascular necrosis, the size of the balloon can be reduced to as much as 10% of the cancellous bone volume of the area of bone to be treated, which is local to fractures or collapses. It is due to the nature of the bone. The fully expanded size and shape of the balloon is controlled by adding additional material to a predetermined portion of the balloon body, the additional thickness of which forms a restraining means. Also, the extended dimensions and shape of the balloon are limited by internal or external restraining means formed on the device. The restraining means include, but are not limited to: That is, a continuous or discontinuous string-like body is defined by laminating a mesh part, a winding or a spool-like material on the part of the balloon body, by using an internal adhesive, or by penetrating it to the outside. A seam is formed in the balloon body by holding it inside at a position, or by adhering two pieces of the body together, or by adhering both sides of the body through an adhesive or heat. The spherical portion of the balloon can be constrained by using an inelastic material to form the balloon body, or can be further constrained as described above. The material of the balloon is preferably an inelastic material such as polyethylene terephthalate (PET), Kerber or other patented medical balloon material. The balloon can also be made of a semi-elastic material such as silicon or an elastic material such as latex, provided that suitable restraining means are incorporated. The binding means is US Pat. No. 4,706, It can be formed of a flexible, inelastic, high-strength material that includes, but is not limited to, the materials described in No. 670. Balloon wall thicknesses typically range from 0.0508 mm (0.002 inches) to 0.635 mm (0.025 inches), but other wall thicknesses that can withstand pressures of 250 to 400 psi are possible. A primary object of percutaneously strengthening the vertebral body according to the present invention is to provide a balloon capable of forming a cavity in the vertebral body that is optimally shaped to support the bone. Another important goal is, if possible, to return the parietal bone of the vertebral body to a position that holds the body, in which case the above two goals are achieved without breaking the cortical wall of the vertebral body. Must be done. This feature can push the vertebrae towards the spinal cord, which is an undesirable condition. The present invention achieves these objects through the design of expandable devices described below. When such a device is expanded, calcium-containing cancellous bone is compressed into a thin exodermis that lines the inside of the hard cancellous bone that forms a large cavity. At the same time, during the process, biological components (erythrocytes, bone progenitors) in the cartilage are squeezed out and removed by washing with water. This body restores the internal shape of the unbroken vertebral body, but the restoration is optimally stopped at about 70-90% of the internal volume. The balloon of the present invention is inelastic and therefore can be restored to a predetermined shape and size by maximally expanding the balloon. However, conventional balloons become spherical when expanded. The spherical shape does not allow the hardened bone binder to adequately support the spinal column, because the spherical shape makes a single point contact with the surface of each spinal bone body (square). Corresponds to the inner circle of the cylinder, or the inner circle of the cylinder). The balloon of the present invention is to restore the flat surface of the vertebral body by including a restraining means that keeps the balloon in the desired shape. This maximizes contact between the surface of the vertebral body and the bone binder, which strengthens the spinal column. In addition, the volume of bone binder that fills these cavities forms a thin film of binder (4 mm or more) required for the appropriate compression strength. Another useful feature, though not required, is the formation of a balloon on the ridge that leaves its footprint on the backing of the compressed cancellous bone. The "finger" of the bone binder formed improves stability. The balloons that optimally press the cancellous bone of the vertebrae are the balloons listed as balloon types 1, 2, and 3. These balloons have a shape that resembles the shape of the vertebrae. Since the balloon is selected to occupy 70-90% of its internal volume, it does not exert excessive pressure on the sides of the spinal body, so that the spinal body has its normal dimensions (fractures). It does not extend beyond the condition (or condition without fracture). However, since the height of the balloon is equal to the height of the unbroken vertebral body, the balloon can return the crushed parietal bone to its original position. The main purpose of percutaneously strengthening the proximal humerus is to form a cavity within the proximal humerus that is optimally shaped to support the proximal humerus. Another important purpose is to facilitate realignment of the humeral apex and humerus diaphysis when separated by a fracture. These two objectives must be achieved primarily by applying pressure to the cancellous bone, not the cortical bone. Excessive pressure on the cortical bone can result in a fracture of the cortical bone, which can lead to an exacerbated condition of bone fracture. The present invention achieves these objects through the design of expandable devices described below. When such a device is expanded, the cancellous bone is pressed against the cortical walls of the epiphysis and metaphysis of the proximal humerus, thereby forming a cavity. In some cases, depending on the location of the fracture, a balloon or expandable device can be used to extend the cavity to the proximal portion of the diaphysis of the humerus. Due to the design of the "stand top sphere" balloon (indicated by reference numeral 7 above), the cavity formed by this balloon restored or approximated the shape of the cortical wall inside the humerus at the proximal end. Make it a thing. The approximate volume of the cavity formed by the "sphere on the stand balloon" is mainly, but not essential, at 70-90% of the epiphysis and metaphyseal volume of the diaphysis, excluding the diaphysis. is there. This shape approximates the shape of the humeral apical bone. The "base" is designed to compress the columnar bone into the "plug" of the bone at the end of the epiphysis or within the diaphysis. This bone plug prevents parkable material from flowing into the diaphysis of the humerus, improving clinical efficacy. It is also possible to use this sphere without using the base. The main purpose of percutaneously strengthening the terminal radius is to form a cavity within the terminal radius that is optimally shaped to support the terminal radius. Another important purpose is to facilitate fine-tuning of the realignment state of the fractured part after the fractured part has been partially realigned with a finger trap. These two objectives must be achieved primarily by applying pressure to the cancellous bone, not the cortical bone. Excessive pressure on the cortical bone may cause the cortical bone to fracture, which may exacerbate the situation. The present invention achieves these objects through the design of expandable devices already described above or below. The design of the "curved banana" or modified prismatic design (shown with reference numeral 5 above) approximates the shape of the terminal radius, so that the cavity formed by this balloon is similarly of the terminal radius. Approximate to the shape. The approximate volume of the cavity formed by this curved banana-shaped balloon is mainly, but not essential, at 70-90% of the epiphysis and metaphysis volume of the terminal radius, except for the diaphysis of the terminal radius. is there. When such a device is expanded, the cancellous bone is pressed against the cortical wall at the epiphysis and metaphysis of the terminal radius to form a cavity. In some cases, a bone-like balloon or expandable device can be used to extend the cavity into the distal portion of the radial diaphysis, depending on the location of the fracture. The main purpose of percutaneously strengthening the femoral head (or humerus) is to form a cavity in the femoral head (or humerus) that is optimally shaped to support the femoral head. Another important purpose is to compress the avascular necrosis (or aseptic) bone or to facilitate the support of the avascular necrosis within the femoral head. This object can include realigning the avascular necrosis to a position previously within the femoral head, facilitating improvement of the spherical shape of the femoral head. These objectives must be achieved primarily by applying pressure to the cancellous bone within the femoral head. The present invention achieves these objects through the design of expandable devices already described above or described below. The design of a spherical balloon that resembles a bone (described as Balloon Type 4 above) mimics the shape of the femoral head, thus forming a cavity that also mimics the shape of the femoral head (and this). It should be understood that the spherical shape of the expandable device mimics the shape of the humerus skull and is, in fact, similarly suitable for forming cavities in positions similar to this bone. is there). When such a device is expanded, the cancellous bone of the femoral head is pressed against the inner wall of its cortex to form a cavity. In some cases, the cavities that form in the femoral head are made smaller or larger, depending on the degree of avascular necrosis. In some cases, if the area of avascular necrosis is small, a small balloon is utilized, in which case a cavity equal to only 10-15% of the total volume of the femoral head is formed. If the area of the femoral head associated with avascular necrosis is larger, a larger balloon is utilized, in which case a much larger cavity equal to about 80% to% 90% of the volume of the femoral head is formed. .. The hemispherical balloon resembles the shape of the upper body of the femur (and humerus) skull and compresses the cancellous bone into avascular necrosis or small fractures without interfering with the rest of the skull. Provide means. This makes it easier to replace the joints throughout the fracture, if necessary. The primary purpose of percutaneously strengthening the proximal tibia is to form a cavity in the proximal tibia that is optimally shaped to support either the intermediate or lateral tibial plateau. Another important objective is to facilitate realignment of the fractured portion of the tibial plateau, especially its features, with the indentation below (or below) its normal position. These two objectives must be achieved primarily by applying pressure to the cancellous bone, not the cortical bone. When pressure is applied to the cortical bone, it is thought that the tibial plateau is fractured, resulting in an exacerbated condition. The present invention achieves these objects through the design of expandable devices described below. When such a device is expanded, the cancellous bone is compressed against the cortical wall of the mid- or lateral tibial plateau to form a cavity. Due to the balloon design of the "elliptical cylinder" (described as Balloon Type 6 above), the cavity formed by this balloon restores the shape of the cortical wall, either in the middle or lateral tibial plateau, or is this. Make it similar to the shape. The approximate volume of the cavity formed by the substantially elliptical cylindrical balloon is 50-90% of the volume in the epiphyseal bone at the base of either the middle or lateral half of the tibia. Other objects of the invention will become apparent from the following description herein with reference to the accompanying drawings illustrating the invention. A brief description of the drawing FIG. 1 is a perspective view of the first embodiment of the balloon of the present invention in the shape of a stacked donut-shaped assembly. FIG. 2 is a longitudinal cross-sectional view of the balloon of FIG. 1, showing how the donut portion of the balloon of FIG. 1 is fitted into the cavity of the vertebral body. FIG. 3 is a schematic diagram showing another embodiment of the balloon of the present invention, showing three stacked balloons and string restraining means that limit the balloon from expanding in the expanding direction. FIG. 4 is a plan view of a spherical balloon with a cylindrical ring surrounding the balloon. FIG. 5 is a vertical cross-sectional view of the spherical balloon and ring of FIG. FIG. 6 shows an elliptical shaped balloon with a catheter extending within the central portion of the balloon, FIG. 6A is a perspective view showing how a catheter is placed with respect to the inner tube to inflate the balloon of FIG. FIG. 7 is a diagram of a suction tube and a control solution infusion tube that expands the balloon and removes tissue fragments due to the expansion of the balloon itself. FIG. 8 is a longitudinal section of the balloon as it is contracted and inserted into the human vertebral body. 9 and 9A are side views of the cannula, showing a state in which the protective sleeve or member expands when pulled out of the cannula. FIG. 9B is a longitudinal section of the vertebra with perforated access holes. FIG. 10 is a perspective view of another embodiment of the balloon of the present invention formed in the shape of broad beans. FIG. 11 is a perspective view of the vertebrae showing a broad bean-shaped balloon of FIG. 10 when inserted and expanded into the bone. FIG. 12 is a plan view of a broad bean-shaped balloon formed in several compartments by a heating element or a baking iron tool. FIG. 13 is a cross-sectional view taken along line 13-13 of FIG. 12 when two broad bean-shaped balloons are stacked. FIG. 14 shows a state in which the broad bean-shaped balloons of FIG. 13 are stacked in the vertebra, similar to FIG. FIG. 15 is a plan view of a broad bean balloon, showing an outer tufted portion that holds the inner cord in place and interconnects the top and bottom walls of the balloon. FIG. 16 is a cross-sectional view taken along line 16-16 of FIG. FIG. 17A is a rear view of a curved banana-shaped balloon in the right terminal radius, FIG. 17B is a cross-sectional view of FIG. 17A along line 17B-17B of FIG. 17A. FIG. 18 is a view of a spherical balloon when the base of the proximal humerus is viewed from the front (anterior) of the left proximal humerus. FIG. 19A is an anterior (anterior) view of the proximal tibia when an elliptical cylindrical balloon is inserted below the mid-tibial plateau. FIG. 19B is a semi-lateral view of the balloon of FIG. 19A. FIG. 19C is a side view of the balloon of FIG. 19A. FIG. 19D is a plan view of the balloon of FIG. 19A. FIG. 20 is a view of a spherical balloon for treating avascular necrosis of the skull of the femur (or humerus) when viewed from the front (anterior) of the left buttock. FIG. 20A is a lateral head view of a spherically shaped balloon for treating avascular necrosis of the femur (or humerus) skull. Detailed description of preferred embodiments Balloon for the body of the vertebra The first form of the balloon of the present invention (FIG. 1) is illustrated by reference numeral 10 as a whole, the balloon being hollow, expandable and non-expandable made of a flexible material such as PET or Kerber. It comprises a balloon body 11 having a pair of inflatable portions 12, 14. These portions 12 and 14 include a suction tube 16 that draws into the tube 16 and extends through it to suck oil and other tissue debris for delivery to a distant disposal site. The catheter 16 has one or more suction holes, so that a suction force can be applied to the open end of the tube 16 from a suction source (not shown). The parts 12 and 14 are connected to each other by an adhesive which can be of any suitable type. The portions 12 and 14 have a donut-shaped shape as shown in FIG. 1, and these portions communicate with the portions 12 and 14 and extend from these portions 12 and 14, respectively, to expand the pressure liquid. It has tubes 18 and 20 that reach the source (not shown). This liquid can be any sterile biocompatible solution. This fluid expands the balloon 10, especially parts 12 and 14, after inserting the balloon in a contracted state (FIG. 8) into the bone to be treated, such as the vertebra 22 in FIG. U.S. Pat. Nos. 4,969,888 and 5,108,404 described above disclose the use of guide pins and cannulas that insert the balloon into the bone to be treated when the balloon is contracted, and the balloon is placed in the tube. It is inserted and pushed into the cortical bone by a catheter, where the balloon is dilated. FIG. 8 shows a contracted balloon 10 inserted into the bone through the cannula 26. The balloon in the cannula 26 contracts and is pushed through the cannula by manually exerting a force on the catheter 21 extending into the passage 28 extending into the bone. The catheter is slightly flexible, but rigid enough to allow the balloon to be pushed into the bone, and then inside the bone, by introducing fluid into the tube 88, the balloon. Is expanded and the outlet end of the tube is coupled to parts 12 and 14, respectively. In use, the balloon 10 is first contracted, and when the bone to be filled with the balloon is ready to receive the balloon by perforation, the contracted balloon is pushed into the bone in a contracted state through the cannula 26. This bone is illustrated in Figure 2. The direction of the balloon in the bone is preferably as follows. That is, if the balloon is not fractured or crushed, the direction should be such that the pressure applied to the bone marrow and / or cancellous bone is minimal. Such pressure compresses the bone marrow and / or cancellous bone against the inner surface of the cortical bone, thereby compressing the bone marrow of the bone to be treated, within which the bone marrow is biocompatible and fluid. Further expand the cavity to be replaced with material. The balloon is then expanded to compress the bone marrow and / or cancellous bone in the cavity, compressing the bone marrow and / or cancellous bone, and then contracting the balloon to remove it from the cavity. By applying suction to the catheter tube 16 during the expansion and compression of the balloon, oil and other tissue debris are aspirated from between parts 12 and 14 and from the space around these parts 12 and 14. .. Then, again, after compression of the bone marrow, a manual pulling force is applied to the catheter tube 21 to contract the balloon and pull it out of the cavity. A second embodiment of the expandable device of the present invention is illustrated by reference numeral 60 as a whole, and this embodiment is shown in FIGS. 4 and 5. The balloon 60 comprises a hollow central spherical portion 62 that receives the pressure expanding liquid through the tube 64. The spherical portion is provided with a spherical outer surface 66, which has an outer circumference substantially surrounded by a ring-shaped portion 68 having a tube portion 70 that expands the portion 68. A pair of passages 69 connect portions 62, 68 to each other. The suction tube portion 72 sucks fluid and tissue debris from the bone cavity formed by the balloon 60. A balloon sleeve 71 can be provided for the balloon 60 and all balloons disclosed herein. The balloon sleeve 71 (FIG. 9) is slidably attached to the lateral tube 71a and can be used to insert into the balloon 60 cortical bone when contracted. The sleeve 71 comprises an elastic finger-like body 71b that abuts inside the entrance opening 71c of the vertebra 22 (FIG. 9A) to prevent tearing of the balloon. When the balloon sleeve is removed, the pressure fluid is introduced into the tube 64, which dilates parts 62, 68 and compresses the bone marrow within the cortical bone. The balloon 60 is then contracted and removed from the bone cavity. 6 and 6A show some drawings of the modified donut-shaped balloon 80 of the form shown in FIGS. 1 and 2, but the donut-shaped shapes of the balloon 80 are not joined to each other. In FIG. 6, the balloon 80 has a pear-shaped convex outer surface 82 composed of a first hollow portion 84 and a second hollow portion 85. A tube 88 for introducing liquid is provided in two parts along the branch tubes 90 and 92, and after inserting the above part into the medulla oblongata cavity of the bone, the part is expanded. The catheter tube 16 is inserted into the space 96 between the two parts of the balloon 80. The adhesive glues the two parts 84, 85 together at their interconnect surfaces. FIG. 6A shows how to insert the catheter tube 16 into the space or opening 96 between the two parts of the balloon 80. FIG. 7 shows a tube 88 injecting a control material into the balloon 80 after introducing the expanding liquid into the balloon 80, which allows the balloon to be X-rayed with the expanding material inside it and the balloon. Can be determined if is placed correctly. The tube 16 is also shown in FIG. 6, which is attached to the outer surface of the tube 88 in a suitable manner. Another embodiment of the present invention is shown in FIG. 3, which is similar to FIG. The difference is that this embodiment is circular rather than donut-shaped and includes an expandable device 109 with three balloon units 110, 112, 114, which are expandable. And with string-like restraint means 117, these restraint means limit the extent to which the balloon unit expands in the transverse direction with respect to the longitudinal axis of the balloon unit. These restraining means are made of the same or similar material as the material of the balloon, so that these restraining means have some elasticity but are not substantially inflatable. A tubing system 115 is provided to use the liquid to expand the balloon when the pressure liquid is introduced into the balloon units 110, 112, 114 and placed in the bone in a contracted state. After proper dilation and compression of the bone marrow, the balloon can be removed by contracting and pulling out of the bone being treated. Restraint means keep both sides 77, 79 substantially flat and parallel to each other. FIG. 10 illustrates another embodiment of the expandable balloon. The device has a pair of opposing broad bean-shaped side walls 132 that allow the balloon 130 to be pushed into the bone 136 illustrated in FIG. 11 in cooperation with a contracting and continuous end wall 134. It is a broad bean-shaped balloon body 130. A tube 138 is used to introduce the dilating fluid into the balloon so that the balloon is dilated and the balloon takes the dimensions and position of the vertebral body 136 shown in FIG. Device 130 compresses the cancellous bone if it is not fractured or crushed. The restraining means of this movement is due to the action of the side and wall of the balloon. FIG. 12 shows a balloon 140 similarly shaped like a broad bean, which comprises a tube 142 that introduces an expandable liquid into the tube to expand the balloon. The balloon is initially a single-chamber sac, which is branded along a curved line or strip 141 and juxtaposed in a broad bean shape, as shown in FIG. A mounting wire 144 having the shape of the portion 146 is formed. Since the material is similar to plastic and is a standard medical balloon material that can be formed by heat, this branding irons both sides of the bag. FIG. 14 is a perspective view of the vertebral body 147 containing the balloon of FIG. 12, showing the doubly stacked balloons 140 when inserted into the vertebral bone 147. FIG. 15 is similar to FIG. 10, except that the string restraint means tuft 155 extends between and is connected to the side wall 152 of the expandable device 150. It controls the sidewalls to expand with respect to each other, thereby making the sidewalls substantially parallel to each other. Tube 88 is used to fill the broad bean balloon with the expanding liquid as described above. The size of the balloon in the body of the vertebra can be changed over a wide range. The height of the vertebral balloon body (H in FIG. 11) for both the lumbar and thoracic vertebral bodies is generally in the range of 0.5 cm to 3.5 cm. Balloon dimensions for the vertebral body from both anterior to posterior to both the lumbar and thoracic vertebral bodies (A in FIG. 11) range from 0.5 cm to 3.5 cm. The dimensions of the thoracic spine body from side to side (L in FIG. 11) range from 0.5 cm to 3.5 cm. The dimensions of the lumbar vertebral body from side to side range from 0.5 cm to 5 cm. For example, the final selection of a suitable balloon for a given vertebral body is based on several factors. The anterior-posterior (AP) balloon dimensions for a given vertebral body are selected based on a CT scan of the vertebral body or a simple x-ray film image. AP dimensions are measured from the medial cortical wall of the anterior cortex to the medial cortical wall of the posterior cortex of the vertebral body. In general, a suitable balloon size for an AP is 5-7 mm smaller than this measurement. Appropriate side-to-side balloon dimensions for a given vertebral body are selected based on a CT scan of the vertebral body to be treated or a simple x-ray film image. This side-to-side distance was measured from the medial cortical wall on the side of the vertebra. In general, the appropriate side-to-side dimension of the balloon is 5-7 mm smaller than this dimension, and with the addition of the lumbar vertebral body, it is much larger than its AP dimension, side-to-side. It tends to be closer. In the thoracic vertebra body, the side-to-side dimensions and their AP dimensions are approximately equal. The proper height dimension of the vertebral body balloon for a given vertebral body is selected based on CT scans or x-ray images of the vertebral body above and below the vertebral body to be treated. Measure and average the height of the vertebral body above and below the body to be treated. This mean is used to set the proper height dimension for the selected vertebral body balloon. Long bone balloon The long bones that can be treated using the balloons of the present invention are the distal radius (long arm bone in the lumbar region), the tibial plateau at the proximal end (leg bone just below the knee), and the humerus bone at the proximal end (shoulder arm). Includes the upper end bone) and the base femoral head bone (the leg bone in the buttocks). Balloon for the terminal radius In the case of the distal radius, the balloon 160 is shown to be within the distal radius 152, which resembles a prism but more accurately has a shape that can be considered as a curved banana shape. In this case, the inside of the space of the terminal radius is roughly filled, and the cancellous bone 154 is lightly pressed against the inner surface 156 of the cortical bone 158. Balloon 160 comprises a lower conical portion 159 extending downward into the hollow space of the terminal radius 152, which conical portion 159 increases in cross section as it approaches the central terminal portion 161. To do. The cross section of the balloon 160 is shown in the central position (FIG. 17B), which is close to the widest position of the balloon. The upper end of the balloon, indicated by reference numeral 162, converges on the catheter 88, introduces fluid into the balloon, dilates the balloon, and presses the cancellous bone against the inner surface of the cortical bone. The shape of the balloon 160 is set and constrained by the tuft formed by the string-like restraining means 165. These restraining means are optional and provide additional strength to the balloon body 160, but are not required to achieve the desired form. The balloon is placed in and removed from the terminal radius in the same manner as described above for the vertebra. The dimensions of the terminal radial balloon can be changed as follows. The base end of the balloon (the part closest to the elbow) has a cylindrical shape and can be changed in the range of 0.5 x 0.5 cm to 1.8 x 1.8 cm. The length of the terminal radial balloon can be varied from 1.0 cm to 12.0 cm. The widest mid-to-lateral dimension of the terminal radial balloon near the distal radial ulnar joint ranges from 1.0 cm to 2.5 cm. The anterior-posterior dimension of the end of the terminal radial balloon can be varied from 0.5 to 3.0 cm. Balloon for fracture of the proximal humerus Choosing a suitable balloon size to treat a given fracture of the terminal radius depends on the radiological size of the terminal radius and the location of the fracture. In the case of the proximal humerus 169, the balloon 166 shown in FIG. 18 is spherical and has a base design. The balloon compresses the cancellous bone 168 within the proximal humerus 169. An embedded or laminated mesh 170 and / or winding can be used to form a neck 172 on the balloon 166, and a second mesh 170a can be used to diaphysis the bottom of the base 172a. It can correspond to the shape of the inner wall of the cortex at the beginning of the. By such restraint, the balloon body can be increased in strength, but this form can be realized through the molding of the balloon body. As shown in FIG. 18, the cancellous bone is in the state shown in the compression region surrounding the balloon 166. Cortical bone 173 is relatively wide at the base 174 and thin at the top 175. The balloon 166 comprises a supply tube 177 that introduces a pressure fluid into the supply tube to dilate the balloon and lightly compress the cancellous bone of the proximal humerus. The balloon is inserted into and removed from the proximal humerus in the same manner as described above for the lumbar spine. The dimensions of the humerus fracture balloon at the proximal end can be changed as follows. The spherical end of the balloon can be changed in the range of 1.0 × 1.0 cm to 3.0 × 3.0 cm. The neck of the proximal humerus fracture balloon can be varied from 0.8 x 0.8 cm to 0.3 x 3.0 cm. The width of the base or end of the substrate humerus fracture balloon can be varied in the range of 0.5 x 0.5 cm to 2.5 x 2.5 cm. The length of the balloon can be changed in the range of 4.0 cm to 14.0 cm. The choice of balloon suitable for treating a given proximal humerus fracture depends on the radiological dimensions of the proximal humerus and the location of the fracture. Balloon for fracture of the base tibial plateau The fractured state of the tibia is shown in FIG. 19A, in which the balloon 180 is located at 182 on one side of the tibia 183. When expanded, the balloon compresses the cancellous bone within layer 184 surrounding the balloon 180. A cross section of the balloon is shown in FIG. 19C, in which case the balloon comprises a pair of side walls 185, 187 interconnected by a restraint 188, the restraint being a cord or string. It can be in the form of a flexible member of any suitable structure. The main purpose of the restraint is to make the side portions 185 and 187 substantially parallel to each other so as to have a non-spherical shape. A tube 190 is coupled to the balloon 180 to supply the liquid to and drain the liquid from the balloon. The ends of the restraint are shown in FIGS. 19B and 19D and are also illustrated by reference numeral 191. The balloon is inserted into the tibia and removed from the tibia in the same manner as described above for the lumbar spine. FIG. 19B shows the substantially circular shape of the balloon, while FIG. 19D shows the substantially elliptical shape of the balloon. The dimensions of the base tibial plateau fracture balloon can be changed as follows. The thickness or height of the balloon can be varied from 0.5 cm to 5.0 cm. The anterior / posterior (front to rear) dimensions can be varied from 1.0 cm to 6.0 cm. The side-to-side (middle to side) dimensions can be changed in the range of 1.0 cm to 6.0 cm. The size of the balloon suitable for treating a given tibial plateau fracture depends on the radiological dimensions of the proximal tibia and the location of the fracture. Balloon for femoral head In the case of the femoral head, a balloon 200 inserted into the cortical bone 202 of the femur can be shown to be thinner at the outer end 204 of the femur and thicker at the lower end 206 of the femur. is there. The cortical bone surrounds the cancellous bone 207, which is compressed by the dilation of the balloon 200. The tube that introduces the liquid into the balloon for expansion purposes is indicated by reference numeral 209. The canal extends along the neck of the femur and is introduced into the femoral head, which has an overall spherical shape. FIG. 20A shows that the balloon indicated by reference numeral 200a can be hemispherical and spherical, as shown in FIG. The balloon 200 is inserted into and removed from the femoral head in the same manner as described for the lumbar spine. The hemispherical shape is maintained in this embodiment by joining the overlapping portions of the bottom to form the folds 200b as shown in FIG. 20A. The dimensions of the femoral head balloon can be changed as follows. The size of the femoral head balloon can be changed in the range of 1.0 cm to 4.5 cm. The proper size of the femoral head balloon to be selected depends on the radiological size of the femoral head or the CT scan size, the location of the ischemic necrotic bone and its size. The size of the hemispherical balloon is equal to the size of the spherical balloon, except that a substantially hemibody is provided.