KR19990022691A - Improved dilation device for surgical protocols involving the treatment of fractured or diseased bone - Google Patents

Abstract

The present invention is an apparatus 12 used to compress the bones and bone marrow (also called medulla or columnar bone) of reticulated tissue against the internal cortex, with or without bone fractures. The instrument consists of an expandable non-expandable instrument that can be inserted into such bones. The body forms a cavity in the reticular bone and has a shape and size that can press at least a portion of the reticular bone to restore the original location of the outer medulla when the bone is broken or dislocated. This mechanism prevents excessive pressure on the external medulla bone. The wall of the instrument is properly inflated to allow for optimal pressure on all bone marrow. The instrument is foldable and can be quickly inserted into the bone. This device may be manufactured to include a suction catheter 16. This therapeutic material may be coated. The main purpose of the instrument is to form or enlarge a cavity or passageway in the bone, which can be used especially for the vertebrae, but not limited thereto. Another important purpose is to administer therapeutic substances to bone in an improved way.

Description

Improved expansion device for surgical protocols involving the treatment of fractured or diseased bone

U.S. Patent Nos. 4,969,888 and 5,108,404 disclose devices and methods for the fixation of osteoporotic or non-osteoporotic fractures or other conditions of the human and other animal bone systems. The device and method may be best suited for the treatment of spinal compression fractures, colis fractures and proximal humerus, but are not limited thereto.

The methods described in these two patents involve surgeons or health care providers in treating fractures or bone diseases (osteoporotic bone, osteoporotic fractures, metaphyseal and epiphyseal bones, osteoporotic vertebrae, osteoporotic vertebral fractures, tumors, in particular circular cell tumors). To vertebral fractures, circulative necrosis of the iliac crest, especially the proximal femur, the femoral necrosis of the distal femur and proximal humerus, and diseases resulting from endocrine conditions) A method is disclosed that includes a series of steps that can be performed.

This method involves incising the skin after inserting a guide pin that moves through the cartilage (usually a second incision may be necessary if a single incision or suction device is used).

The method also includes a bone healing tool that creates cavities and passages in the bone and inserts a balloon-shaped expansion device into the cavity or passage. Inflating the device compresses the reticulated bone and bone marrow to the inner surface of the cortical wall of the bone, further expanding the cavity or passageway. When the work is complete, the inflation device is retracted and completely removed from the bone. Smaller expansion devices (starting mechanisms) can be used initially if needed to undertake bone marrow compression and to form cavity and passageways of reticular bone and bone marrow. After this is done, a larger inflation device can be inserted into the cavity or passageway to compress the bone marrow in all directions.

The bone structure is then supported by flowing a non-rejectable, fluid-filled material, such as methyl methacrylate adhesive or synthetic bone substitute, into the cavity or passageway to fix it in a rigid state. When this later step is completed, the insertion tool is removed from the body and the incision site of the skin is covered with a bandage.

Although the devices and methods of this patent provide a suitable protocol for bone treatment, compressing the bone marrow and / or vertebrae and / or reticulum bones to the inner surface of the cortical wall of the bone to be treated is an expansion with new engineering features. It has been found that it can be significantly improved when using the device and this function has not been described so far and is not adequately controlled by the spherical expansion device included in the patent. It has also been found that therapeutic substances can be administered in unexpected ways using the devices and methods included in the patent. It has further been found that the devices and methods of this patent can be applied in ways not described so far to enhance the incision surgery for treating, synthesizing or removing bone as well as administering the therapeutic material during surgery. Thus, there is a need to improve the shape, structure and size of the expansion device so that the previously used devices and methods can be used in new methods.

Conventional Inpatient Device Manufacturing Method

A review of the prior art associated with instrument construction reveals a significant amount of basic information about the formation of intraocular catheters that enter the patient's cardiovascular system through the arm and femoral arteries. However, there are few explanations related to the expansion device used in bone, and there is no explanation about the compression of bone marrow in the spine and long bone.

In an expansion catheter, the catheter continues into the patient's body until the instrument is properly positioned at the site of the disorder to be treated. The instrument is inflated by an impermeable liquid at pressures above 4 atmospheres and squeezes the arterial vessels by squeezing the plane of the disorder site. The instrument is then contracted to remove from the artery and allow blood to flow back into the expanded artery.

A description of catheter use techniques is clearly described in US Pat. No. 5,163,989. For more details about angioplasty procedures and the instruments used in those procedures, see US Pat. Nos. 4,323,071, 4,332,254, 4,439,185, 4,168,224, 4,516,672, 4,538,622, 4,554,929. And 4,616,652.

Mold injection was also used to create prismatic shaped instruments that required highly accurate machining of the inner surface to produce a quality angiogenic catheter. However, this injection technique has limitations in that it creates a dividing line in the instrument product, which diminishes the walls of the instrument itself.

Patent 5,163, 989 discloses a technique for making an expanded catheter mold without dividing lines in the mold and catheter device. The technique is to expand the tubular plastic member to press the heated inner mold surface. The expansion device is made into the desired size and shape using a mold and then taken out of the mold after cooling and shrinking. As described herein, the instruments of the present invention are particularly suitable for forming prismatic shaped instruments and can be used to form instruments of various other sizes and shapes.

A particularly improved catheter technique in connection with this patent, ie US Pat. No. 4,706,670, is the use of a coaxial catheter with inner and outer tubes formed and reinforced by continuous spiral filaments. These filaments can cross each other and shorten the length of the instrument while extending the length of the body moving part. With proper balance between the length and angle of the instrument woven fabric and the moving part of the filament, the length can be altered to offset the difference. Thus, the position of the inner and outer tubes can be adjusted as necessary to maintain the instrument in the desired position in the vessel.

Other patents related to the insertion of inflation equipment to treat a patient's skeleton include:

U.S. Patent No. 4,313,434 relates to the treatment of the long bones by inserting the contracted flexible air pockets into the cavity of the bone marrow, inflating the air pockets of the instrument, suturing the interior of the long bones until healed, then removing the air pockets and air from the long bones. Fill the incision with the pouch removed.

U. S. Patent No. 5,102, 413 discloses a method of securing metal rods for the treatment of fractured long bones using an inflated air bag.

Other references that describe how to use instruments and adhesives to secure prostheses include US Pat. Nos. 5,147,336, 4,892,550, 4,697,584, 4,562,598 and 4,399,814.

Dutch patent 901858 describes a method of fracture treatment in which a bag of adhesive is expanded into a preformed cavity to coagulate.

Examining the prior art as described above, it can be concluded that there is not much information about the expansion device used to make the cavity in the bone. Prior art has not been mentioned for a device that creates a cavity that can best support bone when properly filled. It also has not been mentioned how to prevent the ball from becoming inflated when it is inflated. Current medical instruments can compress the bones, but they are too small and usually have a wrong configuration and are not powerful enough to form the proper cavity in the spine or long bone.

U.S. Patent Nos. 4,969,888 and 5,108,404 describe a checkerboard-type instrument used for compressing reticulated bone, but does not mention how to maintain its shape when it is inflated. It also does not mention how to improve the supply of therapeutics.

U.S. Patent No. 4,892,550 describes a stretchable mechanism for securing a metal prosthesis inside a bone. U. S. Patent No. 4,313, 434 describes a shrinkable air pocket to replace a metal rod used inside the inner bone marrow to bind together while the fractured long bone (femur, leg and arm) heals.

Accordingly, there is a need to continue to improve the expansion devices and methods to be used for fractures and / or diseased bone.

This application is a U.S. patent application filed on Jun. 7, 1995, which is part of US patent application Ser. No. 08 / 188,224, an improved expansion device for surgical protocols involving bone fixation, filed Jan. 26, 1994. Partial application of No. 08 / 485,394.

This invention relates to an improvement in surgical treatment of bone system conditions in humans and other animals, in particular to inflatable instrument devices for use in treating such bone conditions.

Osteoporosis, bloody necrosis and bone marrow cancer are diseases that cause bone fractures or dislocations. In the United States, 2 million fractures occur each year, of which 1.3 million fractures are due to osteoporosis and few are caused by acute necrosis and bone marrow cancer. This condition is neglected, causing bone problems and resulting in malformations and chronic complications.

The effectiveness of many other orthopedic surgeries for bone treatment, such as incision surgery for fractures due to infection, incomplete treatment or severe trauma, may also be improved. Now, the standard tool, usually made of metal, is used to remove diseased or damaged bones before the bone graft or bone replacement material is ready for administration. A gap between the patient's remaining bone and the insert will delay or hinder treatment.

Therapeutic agents, such as antibiotics and bone growth factors, have not been administered in a manner that maintains optimal contact with the required site of bone. Antibiotics, bone growth factors and other drugs prevent complications and promote treatment. These materials are currently applied around the bone treatment site in the form of dry powder or liquid or formulated into gel or degradable plastic polymer and inserted into the defect site (cavity of the bone). Substances administered in this way are immediately washed away by blood or other secretions as the container disintegrates. In addition, the amount of therapeutic substance administered in the form of a gel or polymer is limited by the size of the defect site space.

1 is a side view of a first aspect of the appliance of the present invention in the form of a doughnut stack.

FIG. 2 is a vertical cross sectional view of the instrument of FIG. 1 showing how the donut portion of the instrument of FIG.

Fig. 3 is a schematic diagram of another form of the apparatus of the present invention, showing the apparatus stacked in three layers and a string-shaped suppressing apparatus for suppressing the expansion of the apparatus.

4 is a plan view of a spherical instrument with a cylindrical ring around the instrument.

FIG. 5 is a vertical sectional view of the spherical instrument and ring of FIG.

Fig. 6 shows an elongated elliptical instrument in which the catheter extends to the central portion of the instrument.

FIG. 6A is a side view illustrating a method of arranging the catheter in relation to the inner tube for balloon expansion of FIG.

7 is a suction and control injection tube that performs instrument expansion and removes debris resulting from the expansion of the instrument itself.

8 is a vertical cross-sectional view of the instrument inserted into the vertebral body of the human body after being contracted.

9 and 9A are side views illustrating how the protective sleeve or protective member expands when it exits the cannula.

Fig. 9B is a vertical cross sectional view of the vertebra with the access holes drilled.

Figure 10 is a side view showing another form of the apparatus of the present invention formed into a kidney bean shape.

FIG. 11 is a side view of the vertebra showing the kidney bean shaped instrument of FIG. 10 being inserted into the bone and inflated. FIG.

Fig. 12 is a plan view of a kidney bean-shaped device in which several partitions are formed by a heating element or a synthesis tool.

FIG. 13 is a cross-sectional view taken along line 13-13 of FIG. 12 in which two kidney bean-shaped apparatus are stacked.

Fig. 14 is similar to Fig. 11 but shows a state in which the kidney bean-shaped apparatus of Fig. 13 is stacked on the vertebrae.

Fig. 15 is a plan view of a kidney bean-shaped device, showing an external file for fixing an internal file connecting the upper and lower portions of the device wall in place.

FIG. 16 is a cross-sectional view of FIG. 15 taken along line 16-16.

Fig. 17A is a view of the dorsal banana-shaped instrument inserted into the right distal radius from the back, and Fig. 17B is a cross-sectional view taken along the line 17B-17B of Fig. 17A.

Fig. 18 is a spherical instrument with a base inserted into the proximal humerus seen from the front (frontal) of the left proximal humerus.

18A is a cylindrical instrument seen from the front side (potential) of the left proximal humerus.

Fig. 19A is a front view of the proximal tibia with an elliptical cylinder mechanism inserted below the central tibia plateau;

Figure 19B is a perspective view of the instrument of Figure 19A.

Figure 19C is a side view of Figure 19A.

19D is a top view of the instrument of FIG. 19A.

Figure 20 shows a spherical instrument used to treat the acupoint necrosis of the femoral (or humerus) head from the front (potential) of the left hip.

FIG. 20A is a side view of a hemispherical instrument used to treat pleural necrosis of the femur (or humerus) head.

Fig. 21 is a view of the mechanism for preventing hip fracture from the front (potential) of the left hip;

22A-22C are schematic illustrations of representative methods and systems for administering a therapeutic agent to bone in accordance with the present invention.

The present invention focuses on the device-like expansion or mechanism used to implement the devices and methods of the above mentioned patents 4,969,888 and 5,108,404, new methods of using such devices, and new uses of these methods and devices. have. Such inflation devices, sometimes referred to herein as instruments, have a form for pressing the reticulated bone and bone marrow (also called medulla or columnar bone) against the internal cortex of the bone, with or without bone fracture.

In particular, the present invention focuses on the apparatus for treating bones that are susceptible to fractures and dislocations. The instrument consists of an expandable non-enlarging mechanism that can be inserted into these bones. This mechanism is predetermined in shape and size. The mechanism is predetermined in shape and size sufficient to compress at least a portion of the internal reticular bone to create a cavity in the reticular bone when fully inflated and to restore the original location of the fractured or distal external medulla bone. The instrument is restrained to produce a predetermined shape and size to prevent the fully expanded instrument from applying significant pressure on the inner surface of the bone when the external cortical bone is fractured or dislocated. Significant pressure here refers to a pressure that can alter the normal composition of cortical bone.

In addition to the shape of the inflation device itself, another important aspect is the structure of the instrument wall, which properly inflates the body so as to apply optimal pressure to all bone marrow. The material of the instrument should also be carefully selected to withstand the high pressures that can be folded and folded to quickly and easily insert the instrument into the bone using guide pins and cannula. The instrument optionally includes a raised or curved device that will be left in the cavity after the instrument is removed to improve the stability of the filler. In addition, the inflation device may be designed to optionally incorporate a suction catheter. It is used to remove fat or secretions from the bone while the instrument is inflating. The instrument can be protected from puncture by cortical bone or cannula by covering it with an optional protective sleeve made of a suitable material such as Kevlar, PET or other polymers or materials that can protect the instrument while in the cannula. The main purpose of the expansion device is therefore to form and enlarge a cavity or passageway in a bone, especially the spine, but is not limited thereto.

In some aspects, the invention provides an improved instrument-shaped inflation device that can be used to implement surgical protocols that cavity the bone to improve the effectiveness of the protocol, minimize the time before the procedure for which the protocol is designed, and improve the therapeutic effect. do. These instruments are made to resemble the internal shape of the bone to be inserted in order to squeeze the reticulum bones to the maximum. This may add design elements to achieve specific therapeutic goals. The instrument is made of non-stretchable material, the use of non-stretchable material on the instrument body, the seam of the instrument body made by bonding or melting several pieces of separated material, dissolving or adhering together the opposite side of the instrument body, the outside or Various restraining devices, including, but not limited to, fabrics bonded therein, strings or bands attached to selected points of the appliance, and similar or different sized or shaped instruments stacked up using adhesive or heat melting. It is desirable to maintain the defined configuration when inflated using. The raised or curved device, which is provided as an option in the above-mentioned structure or which is bonded with additional materials, increases the stability of the filler. The optional suction device allows the cavity to be cleaned before filling and should be positioned so that at least one hole is at the lowest point of the cavity to be formed.

In another aspect, the invention provides these devices with new uses and uses. The therapeutic material may be coated and used to administer the therapeutic material prior to inserting the device into the bone. When the coated device expands in the bone, the therapeutic material is buried in the bone while the reticulated bone is pressed by the device. This allows direct administration of the required amount of therapeutic material to the treatment site in such a way that it can be maintained for a long time. The instrument can be used during less invasive incisions to provide more space for orthopedic implants, bone grafts, bone replacements, acrylic adhesives, bone fillers, bone growth factors, chemotherapy agents, antibiotics or other medicines. . Drugs in the bone can be used to treat the bone itself or as a preliminary drug for nearby structures such as osteosarcoma.

In another aspect of this invention, the device is used to provide temporary structural support for fractured or dislocated bone. In this case, the fracture or dislocated bone can be treated by inflating the device at the treatment site and leaving it there until the surrounding cortical bone has healed. In other words, the device can replace the non-reactive filling material used in conventional methods to support fractured or dislocated bone. The invention includes a mechanical device for sealing the expanded device outside the bone cavity and inside the patient. As in the past, the closure has a metal or plastic clip, a check valve actuated by unscrewing the expansion tube, and a stopper used to block the internal passages of the instrument. Squeezed and inflated to create a cavity. The inflated device is then blocked by, for example, plugging it through an inflation hole. The dilatation tube is removed from the patient and the incision of the skin is closed. Fluid pressure inside the instrument provides sufficient support for the bone to heal. The instrument can be left inflated in the bone cavity for the time required for the outer cortical bone to be fully or at least partially healed, which is usually from one to three months and is suitable for six to eight weeks. In this aspect of the invention, the instrument provides at least four functions: (1) bone repositioning (2) removal or at least a reduction in diseased internal reticular bone (3) external cortical bone by receiving additional calcium from the internal reticular bone that heals and merges with the external cortical bone (4) The role of the inner cast while the cortical bone is healing. Once the cortical bone has healed, the surgeon can access the instrument through the same or different skin incisions and remove the clip, plug, or, in the case of a check valve, by turning the expansion tube screw into the instrument to constrict the instrument. In most cases, the cortical bone receives additional calcium from the compressed reticular tissue, making it strong enough through the healing process. In this case, the instrument is removed from the bone cavity. The instrument can be coated with an external surface such as gelfoam or antibiotics to stop bleeding, to prevent infection, to minimize bone growth towards the instrument, and to be easily detached from the bone when the instrument is retracted. However, if the doctor determines that the cortical bone is still too weak (for example, by bone density scan or other measurement method), before removing the instrument, use a suitable support material such as acrylic adhesive, bone substitute, bone filler or bone growth factor. It can be inserted into the bone cavity.

The method of the patent mentioned above and the following improvements can be used in any fracture where there are reticular and / or columnar structures and / or bone marrow bones.

Various aspects of the present invention include the following.

1. An appliance in the form of a donut (or calyx) with an optional built-in suction catheter to remove secreted fat and other secretions while the appliance is expanded.

2. A spherical external shape surrounded by an annular mechanism for the formation of a human cavity.

3. Apparatus in the form of kidney beans, which may be in the form of a single layer or several layers stacked up. This type of instrument may be square or rectangular instead of kidney beans.

4. Spherical instruments similar in size to the head of the femur (ie proximal femur), which may be hemispherical.

5. Bent bananas or metabolic pyramidal instruments, similar in shape to the distal end of the radius (ie distal radial end and interphasic end).

6. Cylindrical elliptical instrument similar in configuration to the central half or side half of the proximal tibia, which may be similar to the configuration of both halves of the proximal tibia.

7. A spherical instrument with a stopper for pressing and suturing reticular bone against the intervertebral bone, placed on a support similar to the shape of the lumbar proximal humerus and metaphyseal, such an instrument may be cylindrical.

8. A boomerang-type instrument similar to the femoral head and inside the trochanter, allowing for hip fracture prevention procedures.

9. A cylinder shaped instrument similar in size and shape to the proximal humerus or distal radius.

10. Apparatus with an optional suction device.

11. Protective cover option that acts as a puncture protection member to cover each instrument inside the catheter.

The present invention therefore provides an improved expansion device for creating and enlarging a cavity or passageway for inserting the device into bone. The configuration of each device is defined by the surrounding cortical bones and adjacent internal structures and is designed to occupy 70 to 90% of the bone's internal volume, but small instruments that occupy about 40% or large instruments that occupy about 99% Can be used. In some cases, it is usually a case of circulating necrosis, but due to the local condition of fractures and dislocations, the size of the instrument may be as small as 10% of the volume of the reticular bone at the treatment site. The fully enlarged size and shape of the instrument is limited by the extra material of the selected portion of the instrument body forming the restraint device and the internal or external restraint device formed on the device because of the particular thickness, which may be partly due to meshing, the instrument body. This includes, but is not limited to, windings of laminated materials, internal adhesives, or externally bonded strings and two mechanisms fixed in specific locations by connection to the outside, or by bonding the opposite sides of the apparatus with adhesive or heat. It doesn't work. The spherical portion of the instrument may be inhibited by the use of non-stretchable materials in the fabrication of the instrument and may be subject to the additional suppression device just described. The material of the device is preferably a non-stretchable material such as polyethylene tetraphthalate (PET), Kevlar or other patented medical device material. The instrument may also be made of semi-elastic material such as silicone or elastic material such as latex, with the appropriate suppression device incorporated. Inhibitor devices can be made of, but not limited to, high tensile strength materials such as those described in US Pat. No. 4,706,670, which is flexible and non-stretchable. The wall of the instrument is usually between 2/1000 and 25/1000 inches or thick enough to withstand a pressure of 250 to 400 psi.

An important object of the vertebral body augmentation through the skin of the present invention is to provide a device capable of making a cavity inside the vertebral agent with an optimal configuration for bone support. Another important purpose is to maintain the height by returning the top of the vertebral body in place if possible, but both aim to alter the outer diameter of the vertebral body by fracture of the cortical wall of the vertebral body or by moving the fractured bone. Must be achieved without This feature allows the vertebrae to be pushed towards the spinal cord, which is not desirable.

The present invention fulfills this object through the design of an expansion device, which will be described below. Inflating this device forces the calcium-containing reticulated cartilage into a thin crust covering the inside of the cortical tibia, which creates a large cavity.

At the same time, biological components (red blood cells, bone progenitor cells) inside the cartilage are stretched out and removed by washing during this process. This mechanism reproduces the internal shape of the unfractured vertebral body but is most appropriate to stop at about 70-90% of the internal volume. Since the instrument of the present invention is non-stretchable, only a predetermined shape and size are reproduced even when it is inflated to the maximum. However, conventional instruments become spherical when inflated. The spheres contact only a single point on each surface of the vertebral body (the equivalent of a circle in a rectangle, or a sphere in a cylinder), so that the solidified bone adhesive cannot properly support the spine. The instrument of the present invention includes limitations to maintain the shape as desired so that the flat surface of the vertebral body can be reproduced. This can strengthen the spine because it maximizes the contact between the vertebral surface and bone cement. In addition, the spine can be strengthened because it maximizes contact between the vertebral body surface and bone cement. In addition, the volume of bone cement filling this cavity forms a thick cement film (4 mm or more) that is essential to maintain adequate pressure. Another useful function, though not essential, is the elevation of the instrument that leaves marks on the endothelium of the compressed reticular bone. As a result, a finger of the bone adhesive is formed to improve the stability.

The instrument that most appropriately presses the reticulum bone of the vertebral body is the instrument indicated by types 1,2 and 3 in the list above. This instrument is constructed similarly to the shape of the vertebral body. Since the instrument is chosen to occupy 70% to 90% of the interior, it does not exert excessive pressure on both sides of the vertebral body so that the vertebral body does not extend beyond its normal size (with or without fracture), but the instrument is not fractured. Because of its height, the dislocated top can be restored to its original position. You can stack any number of instruments, and you can mix and match the shapes and sizes of instrument types 1, 2, and 3 to provide increased flexibility and / or control.

The main purpose of proximal humerus expansion through the skin is to form a cavity within the proximal humerus that best supports it. Another important purpose is to realign the humeral head to the humeral shaft separated by a fracture. These two objectives should be achieved primarily by applying pressure to the reticular bones, not the cortical bones. Excessive pressure on the cortical bones can fracture the cortical bones and worsen shoulder fractures.

The present invention fulfills this object through the design of the expansion device, which will be described later. Inflating such a device compresses the reticulated bones against the cortical walls of the proximal humeral epiphyseal and interphyseal terminals to form a cavity. In some cases, depending on the location of the fracture, an instrument or inflation device is used to extend the cavity to the proximal region of the humerus bone.

Due to the design of the spherical instrument (described above in Section 7) on the base, the cavity created by this instrument resembles or resembles the shape inside the cortical wall of the proximal humerus. The volume of the cavity created by the spherical instrument resting on the base occupies about 70% to 90% of the proximal humeral epiphyseal and metaphyseal, which are mainly but not necessarily monolithic. Its form is similar to that of humeral head. The base is designed to compress the columnar structural bone against the bone cap of the distal interproximal or proximal bone. This plug of bone prevents the infusion material from flowing into the axis of the humerus to improve the therapeutic effect. Spheres can be used without a base. Alternatively, the instrument may be bulging cylindrical, with one end on top of the humerus head attached to the catheter and the other end acting as a stopper. The cylinder may be formed such that the diameter of the humerus tip is larger than the diameter of the tip which acts as a stopper.

The main purpose of distal radial enlargement through the skin is to form a cavity that is most suitable for supporting the distal radius within the radius. Another important purpose is to fine tune the fracture after it has been partially refitted by a finger trap. These two objectives are mainly achieved by applying pressure to the reticulated bones, not the cortical bones. Excessive pressure on cortical bones can cause fractures and worsen the condition.

The present invention fulfills these objects through the expansion device design described above or later.

The curved banana-shaped design or the modified pyramidal design (described in point 5 above) is similar to the shape of the distal radius, so the cavity created by this instrument is also similar to the shape of the distal radius. The volume of the cavities produced by the curved banana-shaped instrument occupies about 70% to 90% of the distal radial epiphyseal and metaphyseal, although not necessarily monopoly. Inflating such a device compresses the reticular tissue bones into the interosseous and distal cortical walls of the distal radius to form a cavity. In some cases, depending on the location of the fracture, a boned device or expansion device is used to extend the cavity to the distal portion of the radial bone.

The main purpose of expanding the femoral head (or humeral head) through the skin is to form a cavity having a configuration most suitable for supporting the femur head inside the femur head (or humeral head). Another important purpose is to help squeeze the bleeding (or sterile) necrosis bone or support the spheroid necrosis bone of the femur head. These objectives include having the spherical bones previously realigned in place in order to improve the spherical head's spherical shape. These two aims are mainly achieved by applying pressure to the reticulated bones inside the femoral head.

The present invention fulfills these objects through the expansion device design described above or later.

A spherical boned instrument (described above in section 4) is similar in shape to the femur head and thus also forms a cavity similar to the shape of the femur head. (Note that the spherical shape of this dilation device is similar to the shape of the humerus head, and is also suitable for the formation of a cavity at the location of this bone.) Inflating this device causes compression of the femoral head by pressing against the internal cortical wall of the reticular bone of the femur head. Will form. In some cases, depending on the degree of spheroid necrosis, small or large cavities are formed inside the femoral head. If the site of small blood necrosis is small, a small device capable of forming a cavity corresponding to 10% to 15% of the total volume of the femoral head is used. If the wider femoral head is associated with cerebral necrosis, a large instrument is available that can form a cavity equivalent to 80% to 90% of the femoral head volume.

The hemispherical instrument is similar in shape to the upper half of the femur (or humerus) head and provides a means of compressing the reticular tissue bone at the site of acupoint necrosis or small fracture without touching the rest of the head. This makes it easy if you need to replace the entire joint in the future.

Buttock enlargement through the skin is designed to prevent hip fractures by squeezing the weak reticulum bones of the femur where the hip fracture has occurred and replacing it with a suitable support material. The main purpose of hip enlargement through the skin is to prevent hip fractures by forming cavities that can compress and replace diseased reticulated bones inside the femur head, femoral neck, and small trochanter with suitable supporting materials. The cavity formed by this process usually extends past the small electrons from the femoral head by a limited amount, but generally no more. The cavity should not expand into the hip when the hip fracture does not affect the patient because this prevents the hip fracture from expanding into small electrons that will affect the patient. The instrument should compress the reticular bone as completely as possible without pushing the internal cortical bone, which may cause (instead of preventing) fracture.

The present invention fulfills this object by providing an expansion device with a special function, which will be described later, which is installed on the catheter to properly orient the appliance.

The main purpose of proximal tibial dilatation through the skin is to form a cavity in the proximal tibia with a configuration most suitable for supporting a central or lateral tibial plateau. Another important purpose is to realign the fragments of the tibial plato fracture, in particular to lower the fragments below the normal position (or lower). These two objectives are mainly achieved by applying pressure to the reticulated bones, not the cortical bones. Applying pressure to cortical bones can worsen tibial plateau fractures.

The present invention fulfills these objects through the expansion device design described below. Inflating such a device compresses the reticulated bone to the cortical wall of the central or lateral tibial plateau, thereby forming a cavity.

Due to the design of the elliptical cylinder instrument (described in Instrument Type No. 6 above), the cavity created by the instrument resembles or resembles the shape of the cortical wall of the oral plateau on the central or lateral surface. The volume of the cavity created by a suitable elliptical cylinder mechanism occupies about 50% to 90% of the proximal epiphyseal bone of the middle or lateral half of the tibia.

Depending on the nature of the injury, disease or other treatment, it may be better to treat the bone using the device of this invention during incision surgery. In addition to this, the purpose of the canal surgery through the skin may be to replace diseased or injured bone with a non-flowable ash (bone filler or some medicine).

The present invention fulfills these objects through the systems and methods of the present invention described below.

Other objects of the present invention will become apparent upon reading the following description and referring to the accompanying drawings which illustrate embodiments of the present invention.

Spinal instruments

The first form of the device of the present invention (FIG. 1) is broadly indicated by the number 10 and represents a device containing hollow non-expansible expansion parts 12, 14 made of a flexible material such as PET or Kevlar. It is included. These parts 12, 14 have suction tubes between them which suck up fat or other debris and send it to a remote disposal location. The catheter 16 has one or more suction holes to allow suction sources (not shown) to be drawn to the open end of the tube 16.

Parts 12 and 14 are connected to each other using a suitable kind of adhesive. Parts 12 and 14 are tubes 18, as shown in Fig. 1, which are donut shaped and connected to an expanding liquid source (not shown) which is in communication with the parts 12 and 14, respectively, and which is expanded and pressurized; (20) is attached. This liquid may be a sterilized solution without rejection. The liquid expands the instrument 10, in particular the parts 12 and 14, after being inserted into the bone to be treated, such as the vertebrae 22 of FIG. 2, in a contracted state (FIG. 8). The aforementioned patents 4,969,888 and 5,108,404 describe the use of guide pins and cannulas for inserting a contracted instrument into the bone to be treated. The instrument is inserted into the tube and then sent by the catheter to the cortical bone where the instrument is expanded.

8 shows the retracted instrument 10 inserted into the bone through the cannula 26. The instrument of the cannula 26 is pushed into the cannula by applying a hand force to the catheter 21, which is retracted and penetrates into the passage 28 extending into the bone. The catheter is somewhat flexible but hard enough to allow the instrument to enter the interior of the bone, and the fluid expands in the bone when the outlet is directed to a tube 88 whose outlet is connected to the components 12 and 14, respectively.

In use, the instrument 10 is first in a retracted state, and the bone that is to be filled with the instrument is ready to receive the instrument through a cold cavity, and the retracted instrument enters through the cannula 26 in a collapsed state. Such bones can be seen in FIG. The instrument is placed in the preferred direction in the bone so that if there is no fracture or dislocation in the bone, only minimal pressure is applied to the bone marrow and / or reticulum bone. This pressure forces the bone marrow and / or reticulum bones against the inner wall of the cortical bone to squeeze the bone marrow of the bone to be treated and further enlarge the cavity where the bone marrow will be replaced with a fluid bone material that is not rejected.

The instrument is then inflated to compress the bone marrow and / or reticulum bone of the cavity, and after the bone marrow and / or reticulum bone is compressed, the instrument is contracted and removed from the cavity. During the expansion and compression of the instrument, fat and other debris are drawn into the catheter tube 16 by suction force from the space between and around the parts 12 and 14. After this operation and bone marrow compression, the instrument is retracted to force the catheter canal 21 out of the cavity.

The second form of the inflation device of the present invention is broadly indicated by numeral 60 and is shown in FIGS. 4 and 5. The instrument 60 includes a central spherical component 62 that is hollow and receives expansion liquid that is pressurized through the tube 64. This spherical part is provided with a spherical outer surface 66 and the outer periphery is surrounded by an annular part 68 having a tubular part 70 used for the expansion of the large part part 68. The pair of passages 69 interconnect the components 62 and 68. The suction tube portion 72 draws liquid and debris from the bone cavity formed by the instrument 60.

Instrument sleeves for use with the instrument 60 and all instruments described herein may be supplied. Instrument sleeve 71 (FIG. 9) is removably attached to outer tube 71a and can be used to insert retracted instrument 60 into cortical bone. The sleeve 71 has a resilient finger 71b supporting the inside of the entry opening 71c of the vertebrae 22 (Fig. 9A) to prevent the instrument from tearing. When the instrument sleeve is removed, the liquid under pressure flows into the tube 64, causing the parts 62 and 68 to expand, compressing the bone marrow inside the cortical bone. The instrument 60 then contracts and is removed from the bone cavity.

6 and 6A show several shapes of a modified donut shaped instrument 80 of the same kind as shown in FIGS. 1 and 2 except that the donut shapes of the instrument 80 are not sewn together. In FIG. 6, the instrument 80 has a pear-shaped convex outer surface 82 consisting of a first hollow part 84 and a second hollow part 85. The tube 88 is for flowing liquid into the two parts along the branch tubes 90 and 92 to expand the part after it is inserted into the spinal cord cavity of the bone. The catheter tube 16 is inserted into the space 96 between the two parts of the instrument 80. Adhesive is used to join the two parts 84 and 85 together at the contact surface.

6A shows how to insert the catheter tube 16 into the space or opening 96 between two parts of the instrument 80.

FIG. 7 shows a tube 88 capable of X-ray imaging of the instrument inflated by the inflation material to inject the control material into the instrument 80 after the inflation fluid flows into the instrument 80 to determine whether the instrument is in the proper position. ) The tube 16 can also be seen in Figure 6, which is attached to the outer side surface of the tube 88 in a suitable manner.

Another form of the invention can be seen in FIG. 3, which is not circularly doughnut-shaped but has three expandable and string-like suppressors 117 which limit the expansion of the instrument in the direction of the longitudinal axis of the instrument. Similar to FIG. 1 except that it includes an expansion device 109 having mechanisms 110, 112. This suppression device uses some of the same or similar material as the instrument, but with some elasticity but little magnification.

The tubing system 115 allows the pressurized liquid to be used to inflate the instrument, which flows the instruments 110, 112, and 114 when it is placed inside the bone in a retracted state. After the device is properly inflated and the bone marrow is compressed, it is contracted and pulled out of the bone being treated. The suppression device keeps opposing sides 77 and 79 almost flat and horizontal to each other.

Another expansion mechanism form can be seen in FIG. The device is a kidney bean shape having a pair of opposing kidney bean sidewalls 132 that can contract and cooperate with a continuous end wall 134 to push the instrument 130 into the bone 136 of FIG. Mechanical body 130. The tube 138 is used to inflate the instrument and to flow the inflation fluid to have the same dimensions and location as the spinal agent 136 of FIG. The device 130 compresses the fractured bone if there is no fracture or dislocation in the reticular bone. The limitation of this activity is due to the side walls and end walls of the appliance.

Figure 12 also shows an instrument 140 that is also shaped like a kidney bean and has a tube 142 for flowing expansion liquid into the tube to inflate the instrument. The instrument may initially be synthesized along a curve or strip 141 to form an accessory line 144 that appears in the form of a partition 146 arranged side by side in a kidney bean shape as shown in FIG. 13. . For a square or rectangular instrument, a similar strip (140) is used but a straight strip is used. When synthesized, the material is a standard medical device material that is similar to plastic and can be formed by heat, so the two sides of the air bag are welded.

FIG. 14 is a side view of the vertebral body 147 including the instrument of FIG. 12 showing a double stacked instrument 140 when inserted into the vertebrae 147.

Figure 15 shows a shape similar to that of Figure 10, but the tufts 155, which is a string-like suppressor, extend between the side walls 152 of the expansion device 150 to connect both walls and limit the expansion of the side walls with respect to each other. Are usually horizontal to each other. The tube 88 is used to fill the expansion liquid into the kidney bean shaped instrument in the manner described above.

Spinal instrument specifications vary by range. The height of the vertebral instrument (H in FIG. 11) for both lumbar and thoracic vertebral bodies usually ranges from 0.5 cm to 3.5 cm. It is usually in the range 0.5 cm to 3.5 cm of the specification of the vertebral instrument from dislocation to posterior to the lumbar and thoracic vertebral bodies (A in FIG. 11). The vertebral body specification between both side ends (L in FIG. 11) for the thoracic vertebral body ranges from 0.5 cm to 3.5 cm. The vertebral body specification between both sides for the lumbar vertebral body ranges from 0.5 cm to 5.0 cm. The optimal vertebral instrument is stacked with two or more members of different heights, each of which can be inflated separately through an independent tubular system. The entire stacked height when fully inflated shall be within the height range specified above. This design gradually returns the fractured vertebral body to its original height, which is easier for the surrounding tissues. This design also allows the same instrument to be used for a wide range of vertebral body sizes.

Selecting the right instrument for a certain vertebral body is based on several factors. The instrument size of the displaced posterior (A-P) for a certain vertebral body can be selected by viewing the vertebral body by CT scan or plain film X-rays. The A-P specification measures the inner cortical wall of the transverse cortex of the vertebral body to the inner cortical wall of the posterior cortex. Normally, a suitable A-P instrument specification is 5 to 7 millimeters less than this measurement.

Appropriate lateral instrument dimensions for certain vertebral bodies can be selected by CT scan or plain film X-ray of the vertebral body to be treated. Lateral distance can be measured from the inner cortical wall of the vertebral body side. Normally, suitable side instrument dimensions are 5 to 7 millimeters less than this measurement. The A-P specification of the lumbar vertebral body tends to be much wider than the lateral specification. In the thoracic vertebral body, lateral and A-P specifications are almost identical.

The appropriate height of the vertebral body for a given vertebral body can be selected by CT scan or film X-ray of the vertebral body above and below the vertebral body to be treated. The heights of the vertebral bodies above and below the vertebral body to be treated are measured and averaged. This average is used to determine the appropriate height of the selected vertebral instrument.

Iliac instruments

The iliac bone that can be treated using the instrument of the present invention includes distal radius (large arm bone in wrist), proximal tibia plateau (leg bone just below knee), proximal humerus (upper end of arm in shoulder) and proximal femur head (Long bone at the buttocks) is included.

Distal radius instrument

For the distal radius, the instrument 160 is shown with respect to the distal radius 152, which is similar to a pyramid, but in more detail, the reticulated bone 154 is lightly pressed against the inner surface 156 of the cortical bone 158. It can be considered that the back is in the form of a curved banana in substantially filling the interior of the distal radius space for pushing. Note that the spherical radial instrument discussed above is of a suitable size for the distal radius 152 as well.

The instrument 160 has a lower conical portion 159 that extends into an empty space below the distal radius 152, which increases in cross section as it approaches the central distal portion 161. The cross section of the instrument 160 can be seen in the central position (FIG. 17B), which is close to the widest position of the instrument. The top of the instrument, indicated by the number 162, converges with the catheter 88, which is intended to inflate the instrument and flow liquid into the instrument to squeeze the reticulated bone to the inner surface of the cortical bone. The shape of the instrument 160 is determined and suppressed by the liquor formed by the row suppressor 165. This suppression device is optional and further strengthens the mechanism 160 but is not necessary to achieve the desired configuration. This instrument is inserted into and removed from the distal radius in the same manner as described above for the vertebrae.

The specifications of the distal radius instrument vary as follows:

The proximal end of the instrument (ie the part closest to the elbow) is cylindrical and varies from 0.5 x 0.5 cm to 1.8 x 1.8 cm.

The length of the distal radius instrument varies from 1.0 cm to 12.0 cm.

The widest specification from the center to the side of the distal radius instrument is the position close to the distal radial-vertebral joint, measured from 1.0 cm to 2.5 cm.

The distal dislocation- posterior specification of the distal radius instrument varies from 0.5 cm to 3.0 cm.

Proximal Humerus Fracture Apparatus

Choosing the appropriate size of the instrument for treating certain fractures of the distal radius depends on the size of the radiation and the location of the fracture of the distal radius.

In the case of distal humerus 169, the instrument 166 seen in FIG. 18 is spherical and the base is designed. This instrument compresses the reticulated bones of the proximal humerus. An embedded or laminated and / or wound mesh 170 may be used to form the neck 172 of the instrument 166 and the second mesh 170a may be used to form the bottom of the base 172a where the interbody begins. It can be used to match the shape of the cortical walls. Such a restraining device makes the mechanism stronger, but the configuration can be achieved through the mold of the mechanism. This allows the reticulated bone to be visible in the compressed area surrounding the instrument 166 of FIG. Cortical bone 173 is relatively wide at base 174 and thinner at wall 175. The instrument 166 has a supply tube 177 through which the liquid under pressure is injected into the instrument to swell it and to lightly squeeze the reticulated bone of the proximal humerus. This instrument is inserted into and removed from the proximal radius in the same manner as described above for the vertebrae.

The specifications of the proximal radial fracture instrument vary as follows.

The spherical end of the instrument varies from 1.0 x 1.0 cm to 3.0 x 3.0 cm.

The neck of the proximal radial fracture instrument varies from 0.8 x 0.8 cm to 3.0 x 3.0 cm.

The width of the proximal or distal portion of the proximal radial fracture instrument varies from 0.5 x 0.5 cm to 2.5 x 2.5 cm.

The length of the instrument varies from 4.0 cm to 14.0 cm.

Selecting a suitable device for treating a constant proximal radial fracture depends on the size of the proximal radial radiation and the location of the fracture.

Another instrument suitable for use in the proximal radius 169 is the cylindrical instrument 225 seen in Figure 18A. As with the supply pipe 177 of Fig. 18, the cylindrical mechanism 225 also has an expansion pipe 226 for liquid insertion. (227) shows a typical shoulder fracture site. The cylinder may have a uniform circumference or one end may be wider than the other. A wide end is attached to the dilation tube 226 to compress the reticular bone 168 of the humeral head 168a. Inhibitors suitable for maintaining shape include a plurality of inelastic bands (228 of which are God) placed around the circumference at regular intervals. In cylinders with uniform widths, the bands that act as suppressors usually have the same diameter. In cylinders where one end is wider than the other, each band has an increasingly wider band in succession.

The length of the instrument is usually the same length of the base spheres, preferably in the range of 4-14 cm, the width usually being between 0.5 cm and 2.5 cm. The surgeon uses a flat film X-ray of the humerus to be treated. The required length is clarified by measuring the distance from the inner humeral head of the insertion site to about 3 cm below the fracture site. The diameter should be at least 0.5 cm smaller than the internal diameter of the humeral cortex (at the narrowest point along the length of the instrument).

Proximal Tibia Plateau Fracture Apparatus

Tibial fractures can be seen in FIG. 19A where instrument 180 is placed on one side 182 of tibia 183. When the instrument is inflated it compresses the reticulated tissue bones of the layer 184 surrounding the instrument 180. One cross section of a mechanism having a pair of opposite sides 185 and 187 interconnected by a suppression device 188 that may take the form of a string or a flexible member of suitable configuration is shown in FIG. 19C. The main purpose of the suppression device is to make the sides 185 and 187 almost horizontal and non-spherical with respect to each other. The plate 190 is connected with the instrument 190 to flow liquid into and out of the tube. The end of the suppression device can be seen in Figures 19B and 19D and is indicated by numeral 191. This instrument is inserted into and removed from the tibia in the same manner as described above for the vertebrae. 19B shows an almost circular instrument configuration. 19D, on the other hand, shows a nearly elliptical instrument version.

The specifications of the proximal tibial plateau fracture apparatus vary as follows.

The thickness or height of the instrument varies from 0.5 cm to 5.0 cm.

The specification from the front / back (front to back) varies from 1.0 cm to 6.0 cm.

Side (center to side) specifications vary from 1.0 cm to 6.0 cm.

Choosing a suitable instrument for treating a constant tibial plateau fracture depends on the size of the proximal tibia's radiation and the location of the fracture.

Femur Head Instrument

For the femoral head, the instrument 200 is inserted into the cortical bone 202 of the femur head, which is thin at the outer end 204 and increases in thickness at the lower end 206 of the femur. Cortical bone surrounds the reticulated bone 207 which is compressed by the instrument 200 being inflated. The tube through which liquid flows to inflate the instrument is indicated by numeral 209. The tube extends along the femur neck and enters the femoral head, which is usually composed of a thigh. 20A shows that the instrument 200a may be spherical or hemispherical as in FIG. 20. The instrument 200 is inserted into and removed from the femur head in the same manner as described above for the vertebrae. The hemispherical shape in this example joins the overlapped portions of the bottom to form a pleat 200b as shown in FIG. 20A.

The specification of the femoral head mechanism varies as follows.

The diameter of the femoral head apparatus varies from 1.0 cm to 4.5 cm. Choosing the appropriate size of the femoral head apparatus depends on the size of the radiographic or CT scan of the femur head and the location and size of the spheroid necrosis bone. The specifications of the hemispherical instrument are the same as those of the spherical instrument, except that about half are provided.

Prevention of hip fractures

21 shows a boomerang mechanism 210 suitable for hip fracture prevention. The boomerang mechanism is cylindrical when first inflated, but the middle part is curved like a boomerang, extending about 0.5 cm from the tip of the femoral head 211 to the femoral neck 212 and then proximal the small electron 214 about 5-7 cm. Come down to the femoral bones (213). The instrument 210 is looped from an inelastic material attached to one side of the non-elastic strip 216, which is as long as the side length of the instrument on one side and close together and more widely attached to the long non-elastic strip 217 bonded to the opposite side. It is good to keep the form by (215) God.

The instrument 210 is folded in the expansion tube 219 before and after expansion (indicated by the dashed line at 218). The instrument 210 remains rolled up in an expansion tube with a loose attachment that falls off when the instrument expands before inflating. To insert the instrument from the dilation tube into the instrument, the surgeon uses an electric cold air guided by the radiograph to begin with a common 4-6 mm wide cavity starting in the lateral femoral cortex 221 and traveling to the femoral head 211. 220). It is not advisable to expand the instrument 210 into the trochanter zone 222 instead of the femoral interosseous 213 side and is prevented by the shape of the instrument and by placement and correct orientation (the contracted instrument is directed towards the small electrons). do. After the instrument 210 expands inside the cavity 220 (see dashed line in FIG. 21), the predetermined size and shape of the instrument causes the proximal portion of the instrument to bend toward the small electrons. Optionally, a second cavity starting at the same entry point or on the other side can be fro the bones.

Patients with hip bone density below the threshold increase the risk of hip fracture, and the lower the density, the greater the risk. Patient selection is completed through a bone density scan. The length of the instrument is selected by the surgeon to extend from about 0.5 cm at the end of the femoral head, through the femoral neck, and to the proximal femoral bone shaft, usually about 4-8 cm below the small trochanter. The diameter of the instrument is determined by measuring the inner cortical diameter (the narrowest part) of the femoral neck and subtracting 0.5 cm from it. Preferred diameters for boomerang instruments are 10-20 cm in total length and about 1.0-2.5 cm in diameter. (Banned banana instruments with adequate length may also be used to prevent hip fractures as long as the width of the bent back does not exceed the permissible femoral neck rule. Can be used).

Patients with the lowest bone density in the femoral head may need more compression of the femur head, for example, following the boomerang, the femoral head instrument (inserted at the same point and expanded before inserting the support material). Can be provided by using two instruments in sequence. Alternatively, the boomerang instrument may be modified to have a distal portion similar to the form of the femoral head instrument.

Other uses, methods and instruments

The cavity formed by the instrument can be filled with a medically suitable drug or growth factor. As an example of drug administration, the dose of gentamicin, a common antibiotic for treating local osteomyelitis (bone infection), is 1 gram (the range of treatment for gentamicin is 1 nanogram depending on the condition of the affected area and the size of the treated area). Much larger up to 100 grams.) A medically suitable gel formulated with a suitable gel material, such as polyethylene glycol, contains 1 gram of gentaminic acid in a volume of gel such as 10 cc. This volume of instruments of suitable shape and size (ie, unable to move and break cortical bone when inflated at the selected site) can be used to compress infected reticulated bone. This creates a space to fill with antibiotic gels by development or minimally invasive procedure. This will give you the amount of medication you need to treat it and prevent it from being washed off by blood or other secretions. In addition to optimizing the dosage, additional medications can be taken without the need for future incisions, thereby increasing the effectiveness of the treatment. If the cavity needed for optimal drug administration weakens the bone, the bone can be protected from future fracture by a cast or current or internal metal or plastic fixation device. Therapeutic agents administered to bones may also be effective outside the bones. Formulations containing chemotherapeutic agents can be used to treat local malignancies, localized multiple myeloma, or adjacent osteosarcomas or other tumors near the bone.

Another method for administering a therapeutic substance is a pharmaceutical preparation (often drying) containing the necessary amount of antibiotic, bone growth factor or other therapeutic agent that is therapeutically effective to apply the above-mentioned substance before inserting the device into the bone to be treated. Powder, liquid or gel). Optionally, the device may be inflated in whole or in part by introducing air or liquid before applying the material. As an alternative, the instrument may be dried by air or other means when the instrument is applied with a wet preparation such as liquid or gel. The instrument can be folded back as needed and immediately used or stored when appropriate or necessary. The therapeutic material coated on the instrument can be administered while the reticulum bone is pressed, or once the cavity has been created, using another instrument.

The method described above may also be used to coat gel foam or other therapeutic agents prior to using the instrument. Inflation of the gel-coated instrument within the bone allows for additional filling of fractured fractures that have not already been filled by the compressed reticular bone.

22A-22C schematically illustrate one system and method for administering a therapeutic agent to bone by the present invention. As shown in FIG. 22A, the expanded mechanism 229 attached to the expansion tube 230 is stabilized with a clip 231 connecting the tube 230 and the wire 232. As shown in FIG. 22B, the measured amount of gel preparation containing the desired amount of material 233 is uniformly painted on the outer surface of the instrument 236 in thin lines such as containers 234 and 235. As shown in Figure 22C, the coated instrument 237 is deflated and dried until the gel is mounted. This instrument 237 is packaged for use by a surgeon. Of course, the coating can be done without previously inflating the device. In addition to this, the coating material may be a natural desired mixture (solid, liquid or gas) or may be a suitable preparation such as a dry powder, aerosol or solution. Of course, the drying time option depends on the condition of the mixture and its preparation.

Administering the therapeutic material outside the instrument used to compress the bone or by a second (slightly larger) instrument after the bone is pressed is qualitatively different from administering the pharmaceutical product directly to the cavity. The substance administered while compressing the bone becomes part of the compressed bone. This is like an immediate preparation of a drug that slowly releases the therapeutic substance. This at the same time allows the surgeon to fill the cavity with a suitable support material, such as acrylic bone cement or non-base reaction bone substitutes, thus eliminating the need for casts or metal fixtures. This combination allows the surgeon to treat osteoporosis fractures through the skin, for example, while administering a therapeutic material (antibiotic, bone growth factor or osteoporosis drug) to the site. Thus, casts or metal fixings are generally not required at all.

The amount of therapeutic substance that has a therapeutic effect is determined by the manufacturer or sponsor, which in some cases is somewhat different but usually requires between 10 nanograms and 50 milligrams per site. Common antibiotics include gentamicin and tobramycin. Common bone growth factors include bone morphogenetic factor, bone morphogenetic protein, connective tissue forming cell growth factor, insulinogenic growth factor and transforming growth factor alpha and beta family products. Chemotherapy and related therapeutic agents include cisplatin, doxorubicin, daunorubicin, methotrexate, taxol and tamoxifen. Osteoporosis drugs include estrogen, calcitonin, diphosphonate and parathyroid hormone antagonists.

The instruments described in this invention can also be used in the open surgical procedures of the sites discussed above to expand the space to insert orthopedic implants, bone grafts, bone replacements, bone fillers or therapeutic materials. The choice of size and shape of the instrument is determined by the size, shape or amount of material that the treatment site and the surgeon desire to insert into the remaining bone. Square and rectangular instruments can be used at any site to introduce bone substitutes such as hydroxyapatite supplied in such form. The instrument is made to fit this predetermined size and the surgeon selects the instrument that is appropriate for the size of the material selected.

To insert a material that does not flow into the cavity created by the instrument, such as hydroxyapatite granules or bone mineral matrix, the surgeon uses a less invasive procedure to insert it into the tube using a long pin slightly narrower than the inner diameter of the cannula. Pushed in. During the incision, the surgeon can access the bone to be treated, as is the procedure through the skin, except that there is no skin or tissue between the doctor and the bone to be treated. This minimizes damage to cortical bones. If the material to be inserted is not fluid and should not be pushed through the cannula (for damaging hydroxyapatite blocks), the surgeon will create a cavity using a method that minimizes invasiveness and standard tools (punch, tablet or string). ), Drill a hole in one side of the cortical bone and insert the block. This same method can also be used to implant metal prostheses, such as the metal tibia component of the entire knee replacement system.

Instruments of different sizes and / or shapes may also be used in areas not described above, such as the jawbone, intermediate bones of the arm and leg bones, cervical vertebral bodies, feet and ankles, ribs, and the like. The key to selecting the shape and size of a device in treating or preventing bone fractures is that if the bone disease causing the fracture causes mass loss of the reticular bone (like osteoporosis), about 70-90% of the condition is optimal. The lesson of this application is that the reticulated bone needs to be compressed. Compressing the reticulated bone below the optimal 70-90% (or 40-99% working range) at the treatment site leaves too much diseased reticulated bone at the treated area. Diseased reticulum bones remain weak and later collapse and cause fractures despite treatment. According to this principle, the shape and minimum size for the selected bone will be explained and determined.

There are certain exceptions to the 70-90% rule as described in this specification. One is when bone disease being treated is localized, such as in bloody necrosis, killing bone in areas where local loss of blood supply is limited. In this case, the instrument may be smaller because the disease site to be treated is small. The second exception is the use of devices to facilitate the insertion of rigid materials with a determined form, such as hydroxyapatite and whole joint replacement parts. In this case, the shape and size of the instrument is determined by the shape and size of the material to be inserted. Another exception is the administration of therapeutic substances. In this case, the reticulated bones may or may not be affected. If not affected, pressing to improve the administration of drugs or growth factors with important therapeutic purposes is at the expense of this bone. In this case, the bone into which the drug is administered is supported during the action of the drug and then healed through a cast or current fixation device.

Another key to selecting the shape and size of the instrument is the lesson of this invention that non-elastic instrument suppression devices are generally needed and non-stretch instrument materials are better. These materials safely and easily prevent the instruments from expanding beyond the predetermined shape and size defined by the normal specification limits of the outer edge of the reticular bone (inside the cortical bone). For example, too large instruments pose a threat to fracture immediately, which determines the maximum limit of instrument size at each site. When using many typical angioplasty instruments, the surgeon usually relies on monitoring pressure (instead of the instrument design features of this invention) to prevent the instrument from expanding too much. This requires more surgical techniques than the lessons of this application, which take an x-ray of the area to be treated and measure the critical specifications described here. In addition, relying on pressure in bone treatment can lead to inferior therapeutic effects. Since pressure depends on the thickness of the reticulum bone and the degree of density lost due to the disease, the surgeon usually does not know in advance how much pressure is required. Surgeons tend to inflate the instrument less to avoid fatal consequences of overexpansion and immediate fractures. This results in too many reticulated bones, leading to future fractures.

Another lesson in this application is that optimal pressure must be applied evenly in all directions to compress the reticulated bones. This is an essential characteristic of this application and all others described in the instruments and specifications shown in the figures. If the instrument does not allow this, it is not pressing the reticulated bones. Reticulum to be compressed The types of bones and local tissues that can be damaged when bones are improperly moved are well known to medical professionals who use human skeletal anatomy textbooks and have knowledge of bone sites, diseases or injuries. . The range of forms and specifications is determined by the area to be treated. The exact specification for a given patient is determined by the X-ray of the site to be treated, the therapeutic purpose and the safety suppression device. For diseased bones, it is desirable to replace most reticulated bones, so a device with a shape and size that can compress about 70-90% of the reticulated bone volume in the treatment area is selected. However, smaller or larger instruments may be conjugated if the main purpose is the administration of a therapeutic substance. In this case, the size of the device may be selected by the amount of therapeutic material required, but it should be borne in mind that the device should not alter cortical bone beyond normal specifications.

Claims (48)

In the method of administering a therapeutic substance to the treatment site of bone, Providing a mechanism that is hollow and capable of contraction and expansion; Applying a therapeutic material to the outer surface of the instrument, Inserting the instrument into the space within the bone, Inflating the instrument to deliver the therapeutic material to the bone. The method of claim 1, further comprising the steps of: expanding the instrument to have sufficient fluid pressure to compress at least a portion of the internal reticular bone; Delivering the therapeutic material to the compressed internal reticular bone to incorporate the therapeutic material directly into the bone. The method of claim 1, further comprising expanding the exterior of the patient's body to apply the therapeutic material to the exterior surface of the expanded instrument. 4. The method of claim 3, further comprising contracting the instrument to introduce the instrument and therapeutic material through the skin into the space in the bone. The method of claim 1, wherein the application step is carried out by delivering the gel preparation to the exterior surface of the instrument. The method of claim 1 wherein the applying step is performed by coating the apparatus with powder. The method of claim 2, wherein the instrument forms a cavity in the bone, and the method also includes inserting bone support material into the cavity while the instrument is inflated. The method of claim 1, wherein the therapeutic material comprises a filling material, the method also comprising filling the crack of the fractured bone by inflating the device and administering the filling material to the crack. The method of claim 1, wherein the therapeutic material comprises a bone growth factor. The method of claim 1, wherein the therapeutic substance comprises an antibiotic. The method of claim 1, further comprising inflating the instrument to have sufficient fluid pressure to compress at least 70% of the reticulum bone of the treatment site without applying excessive pressure on the bone. The method of claim 1, further comprising inflating the instrument to have sufficient fluid pressure to compress about 90% of the reticulum bone at the treatment site without applying excessive pressure on the bone. In a system for delivering a therapeutic substance to a treatment site inside a bone, A flexible non-stretch material that is expandable from the contractile configuration to the expanded configuration and has a predetermined size of the expanded configuration for compressing at least a portion of the internal reticular bone, wherein the non-stretchable material exceeds the predetermined size A hollow mechanism body for preventing enlargement and forming an inner passageway for passing the outer surface and the expansion liquid to the mechanism body, And an applicator for applying the therapeutic material to the outer surface of the device. 14. The system of claim 13, wherein the applicator comprises a container having an inner chamber for storing the therapeutic material and a nozzle for spraying a gel preparation on an outer surface of the device. The system of claim 13, wherein the applicator comprises a dry powder dispenser. 14. The system of claim 13, wherein the applicator includes a sparging device that sprays powdered medicine onto an exterior surface of the device. The system of claim 13, wherein the predetermined size of the instrument is selected in an enlarged configuration to compress almost the majority of the internal reticular bone and direct the therapeutic material into the compressed reticular bone. 18. The system of claim 17, further comprising means for inserting the instrument into the space within the bone and means for inflating the instrument within the space to deliver the therapeutic material to the instrument. The system of claim 13, wherein the therapeutic material includes a filler material that expands the device and delivers the filler material to the crack to fill the fracture of the fractured bone. The system of claim 13, wherein the therapeutic material comprises a bone growth factor. The system of claim 13, wherein the therapeutic substance comprises an antibiotic. The system of claim 13, wherein the enlarged construct has a size and shape capable of compressing at least 70% of the reticulated bone at the treatment site without significant pressure on the bone. The system of claim 13, wherein the enlarged construct has a size and shape capable of compressing about 70% of the reticulated bone at the treatment site without significant pressure on the bone. 14. The instrument of claim 13 wherein the instrument body has approximately the same shape in an enlarged or retracted state. In the device for treating hips of a patient, A hollow elongated instrument body provided with an inflexible material expandable from a constricted configuration to an enlarged configuration and forming an internal passage through which the expansion liquid passes into the instrument body, The apparatus has a predetermined size of enlargement configuration extending from the femoral head of the patient to the proximal femoral bone between the femoral neck and the non-stretch material prevents the instrument from expanding beyond the predetermined size of the instrument. Features of the appliance. 26. The long distal portion of claim 25, wherein the long distal portion extends through the femoral neck of the enlarged configuration to a portion of the femoral head, and the long proximal portion that extends across the proximal portion and extends to a portion of the femur bone in the enlarged configuration. And a bow portion connecting the proximal portion to each other. 27. The device of claim 26, further comprising means for inclining the proximal portion of the appliance from an insertion configuration where the proximal and distal portions are substantially horizontal relative to each other from an operating configuration in which the proximal portion extends into the proximal femur bone. Instrument. The apparatus of claim 27, further comprising at least one suppressor member for retaining the proximal portion of the instrument in the insertion configuration when the instrument body is in a retracted configuration, wherein the suppression member is inflated in the enlarged configuration. Apparatus characterized in that it is suitable for releasing the proximal portion. 27. The instrument of claim 25 comprising at least one support member for holding the instrument body in a predetermined size and shape in an enlarged configuration. 30. The instrument of claim 29, wherein the support member comprises at least one non-stretchable ring member surrounding the elongated mechanism body and at least one non-stretchable shaft strip connected to the ring member. 27. The instrument of claim 25, wherein the instrument in enlarged configuration extends the small proximal femur between about 5 and 7 cm from about 0.3 cm to 0.7 cm from the tip of the femoral head. 27. The instrument of claim 25 wherein the instrument body in the enlarged configuration is between about 10 cm and 20 cm in length and between about 1.0 cm and 2.5 cm in diameter. In the method of treating hips of a patient, Forming a passageway extending through the femur neck to at least a portion of the femur head, Expanding the elongated instrument to have a sufficient fluid pressure to squeeze at least a portion of the internal reticular bone; Forming a cavity in the instrument as a function of the dilation step extending from the femur head to the proximal femur bone. 34. The method of claim 33, wherein the forming step comprises puncturing a substantially linear passage from the lateral femoral cortex through the femur neck to the femoral head. 35. The method of claim 34, comprising the step of delivering an elongate instrument into said linear passage through skin penetration. 35. The proximal portion of the apparatus of claim 34, wherein the proximal portion compresses the internal reticular bone within the proximal femoral bone and moves to the proximal femoral bone in a direction transverse to the distal portion of the instrument. And tilting toward the femoral bones. 34. The method of claim 33, further comprising inhibiting the elongated instrument body from expanding beyond a predetermined size and shape to prevent the instrument from exerting excessive pressure on the cortical bone. In a system that temporarily supports and strengthens damaged bones, A body having a predetermined size in the enlarged configuration selected to include at least a portion of the internal reticular bone to the outer cortical bone to include a flexible non-stretchable material that is expandable from the contractile configuration to the enlarged configuration and to strengthen the outer cortical bone The non-stretchable material may be a hollow mechanism body that is capable of temporarily supporting the outer cortical bone when the instrument body is in the inflation configuration and forms an internal passageway through which the expansion liquid passes into the body body; And means for sealing the internal passages of the instrument when the instrument is in an expanded configuration to provide a temporary support structure for the outer cortical bone. 39. The system of claim 38, wherein the closure means comprises a closure sized to fit snugly within the interior passageway. 39. The system of claim 38, wherein the closure means includes a clip to seal the interior passageway and to isolate the interior chamber of the instrument from the fluid. 39. The system of claim 38, wherein the instrument forms a cavity by forcing the inner reticulated bone against the outer cortical bone, and the closure means is disposed outside of the cavity and inside the patient. 39. The system of claim 38, wherein the damaged bone is a fractured cortical bone and the apparatus is adapted to support the fractured cortical bone until the cortical bone has healed. In the method for temporarily supporting and strengthening fractured or dislocated bone, Inserting a hollow instrument into the internal reticulum bone of the patient, Expanding the instrument to have sufficient fluid pressure to compress at least a portion of the internal reticular bone to form a cavity therein; Suturing the instrument within the patient to provide temporary structural support for the outer cortical bone. 44. The method of claim 43, further comprising pressing a sufficient portion of the internal reticular bone to the external cortical bone to strengthen the bone after the external cortical bone has healed. 44. The method of claim 43, wherein the expansion step is performed by delivering the expansion liquid through the inner passage to the inner chamber in the instrument, the sealing step comprising using a clip in the inner passage to isolate the inner chamber from the fluid. How to. 44. The method of claim 43, wherein the closing comprises closing the inner passage of the instrument with a stopper. 44. The method of claim 43, further comprising, after the suturing step, the instrument remains inside the cavity to serve as an inner cast while the cortical bone is healing. 48. The method of claim 47, further comprising contracting the instrument to remove it from the cavity.