KR20080085089A - Device for compacting cancellous bone - Google Patents

Abstract

Expandable fabric bags (22) and methods of use for reduction, fixation, support and treatment of bone abnormalities such as tibial plateau fractures, femoral head necrosis, compression fractures of the spine and other bone abnormalities.

Description

Spongy bone consolidation device {DEVICE FOR COMPACTING CANCELLOUS BONE}

Reference of related application

This application claims priority to US Provisional Application No. 60 / 219,853, filed July 21, 2000, which is hereby incorporated by reference in its entirety.

The present invention relates to an apparatus and method for correcting bone abnormalities and involves the use of a cavity mesh bag inserted into a bone. The bag is inflated using bone replacement material to inflate and fill the cavity.

U.S. Pat.Nos. 5,549,679 and 5,571,189 to Kuslich disclose devices and methods for stabilizing spinal segments, which devices are reamed, filled with materials that facilitate bone fusion. ) Has an expandable porous fabric implant for insertion into the interior of the disc. In the present invention, similar bags are used to correct bone abnormalities including but not limited to bone tumors and water bumps, tibual plateau fractures, avascular necrosis of the femoral head and compression fractures of the spine.

U.S. Pat.Nos. 5,108,404 and 4,969,888 to Scholten et al. Describe osteoporotic bone using an inflatable balloon that consolidates bone to form a cavity into which bone cement is injected after the balloon is decayed. Disclosed is a device for restoring. The invention requires the use of fluoroscopy to monitor the infusion and prevent leakage of the binder through gaps in the bone. Unfortunately, it is known that such leakage can occur despite precautions. These leaks can cause fatal injuries, including paralysis, so improved devices and methods are needed.

U. S. Patent No. 5,972, 015 to Scribner et al. Places a catheter tube in the interior of the spine and expands a specially constructed nonporous balloon therein to consolidate the spongy bone to form a cavity. Disclosed is a device for letting. Scribner's method of 5,972,015 uses a nonporous balloon that expands in bone to consolidate. Thus, the cavity can then be filled with bone binder. Unfortunately, the bag used by the scrubber can rupture during inflation to consolidate the spongy bone by sharp protrusions found within the cavity being inflated. Filling the resulting cavities enables the leakage of bone binder from the bone to blood vessels or nerves, which can cause undesirable problems.

The present invention avoids problems that may arise with the apparatus of US Pat. No. 5,972,015 and includes all of the above described improvements.

All US patents, applications, and all other published documents mentioned in this application are hereby incorporated by reference in their entirety.

Unless specifically noted, any patent, disclosure, or other information referred to herein in this section is not intended to constitute an acknowledgment of "prior art" for the present invention. In addition, this section may have been investigated or 37 C.F.R. It should not be considered to mean that no other relevant information as defined in §1.56 (a) exists.

It is an object of the present invention to prevent leakage of the binder and to prevent the possibility that the balloon can be ruptured during inflation to consolidate the spongy bone by sharp protrusions found in the cavity in which it is inflated.

The present invention provides a method for correcting numerous bone abnormalities, including bone tumors and water nodules, avascular necrosis of the femoral head, shin plateau fractures, and compression fractures of the spine. This abnormality can be corrected by first approaching and drilling into the damaged tissue or bone and widening the damaged and / or diseased area using any currently accepted treatment, or the damaged area may be damaged to consolidate the spongy bone. It can be prepared by inflating the bag in the bone. After removal and / or filling of damaged tissue, the bone should stabilize.

In the case of bone compaction, the apparatus and method of the present invention use a catheter tube attached to an expandable porous fabric bag, as disclosed in U.S. Pat.Nos. 5,549,679 and 5,571,189 to Kusrish, which patent discloses Incorporated by reference in the specification. Such a bag can be inflated so that there is less risk of being punctured than a thin-walled rubber balloon and less risk of leakage of the expansion medium. Such a bag may also be used on the balloon of the scrubber to prevent the balloon from breaking and resulting leakage.

The devices of U.S. Pat.Nos. 5,549,679 and 5,571,189 to Kuthrish are inflated through the introduction of filler material such as bone repair media to compensate for bone damage and defects and to stabilize bones in one processing step. Provides the surgeon with the benefit of safely omitting the initial balloon inflation step of Ribner and Scolton.

As mentioned above, the damaged bone can be removed by any conventional reamer. Examples of reamers are described in US Pat. No. 5,015,255; US Patent Application No. 09 / 782,176 to Kusrisch et al., Entitled "Inflatable Reamer," filed February 13, 2001; The invention, filed April 5, 2001, is disclosed in US Patent Application No. 09 / 827,202 to Peterson et al., "Outer Cutting Reaming Tool." Other examples of reamers are also known and can be used. After the damaged bone or tissue is removed, the bone repair medium can be inserted through the expandable fabric bags and catheter disclosed in US Pat. Nos. 5,549,679 and 5,571,189 into the cavity to be formed.

Alternatively, smaller cavities than the desired cavities may be formed into bones that are enlarged by consolidation or may be formed only by consolidation through the introduction of filler into the bag. In each case, the bag may be placed over an inflation balloon that expands within the bone location to provide the required degree of compaction. The bag may then be filled with a filler, such as bone repair medium, while the balloon is in place in the bag. Alternatively, the balloon may be removed from the bag before filling it.

The configuration of the present invention has the effect of preventing the leakage of the binder and preventing the possibility of tearing during expansion for consolidating the spongy bone by sharp projections found in the cavity in which the balloon is inflated.

In the detailed description below, like reference numerals are used to indicate like elements in the various figures.

Figure 1 shows a typical vertebra 10 with a fracture 12, a higher end plate 8 and a lower end plate 9 that need to be repaired. As described above, the damaged area of the vertebrae 10 may be reamed to fill or repair. For example, FIG. 2 shows the reamer 14 entering the vertebrae 10 prior to forming the opening 15 or cavity 16. In addition, a plurality of cavities 16 may be formed as shown in FIG.

As described above, the damaged area of vertebrae 10 may be filled after being reamed or filled instead of reaming. In FIG. 4, the transfer tube or catheter 20 illustrates the process of transferring the inflatable fabric bag 22 into the vertebrae 10 or a cavity present within the vertebrae 10. As shown, the cavity 16 can be created through reaming and filled by the bag 22, other devices, or other means. Once the bag 22 is positioned within the vertebrae 10, the filling material 19 can be inserted or injected into the bag 22 to allow the bag 22 to expand or expand to the extent of the cavity.

FIG. 5 shows an expanded fabric bag 22 filled with a second inflatable bag located therein that is inserted into the cavity 16 and inflated.

6-9 sequentially illustrate the process by which the opening 15 and the cavity 16 are created. Regardless of the direction through the vertebrae 10 where the surgery is to be performed in all forms, the formed cavity 16 is filled with an acceptable bone replacement material.

The bone replacement material 19 may be one or more of the following materials or any other material that is well associated with biological tissue that is determined to have a good physiological response.

A) Cortical reticular tissues including demineralized bone material, granular bone grafts, cortex, reticular or autologous, taga and xenografts

B) any bone graft substitute or combination of bone graft substitutes, a combination of bone graft and bone graft substitutes, or tertiary calcium phosphate, tertiary calcium sulphate, tertiary calcium carbonate, hydroxyapatite, bone structure generating protein, calcification and / or Or bones including materials including but not limited to demineralized bone derivatives

C) ceramic and polymethylmethacrylate bone binders

The bone replacement material is inserted into the bag 22 through a needle, catheter 20 or other form of filling tool. The bone substitute material inflates the bag to the extent of the cavity 16.

The original bag 22 may be a small fabric bag about 1-4 cm in diameter, and may be elliptical and other geometrical shapes, but in the form of a sphere. The bag is flexible and malleable before the interior space 21 is filled with the contents to be described. The material of the bag 22 can be configured to follow the shape of the cavity in which the bag is located. When in this initial shape, the bag may not be inflated by being pushed through a relatively small tube or inlet, about 3 mm to 1 cm in diameter.

Bag 22 as best shown in FIG. 9 is constructed in a special and novel manner. Bag 22 may be composed of fabric 23. The fabric 23 is a bone conducting organism known to promote the formation of bone grafts, hydroxyapatite or bone, although the fibrous pores allow fluid and solution to enter and exit the blood vessels, fibrous tissue, and bone graft tissue It may be a knitted or knitted fabric, knitted or molded, at a density tight enough to retain small particles of surrounding material, such as bone graft substitutes, such as other materials that are well associated with tissue. Fabric 23 defines a plurality of pores 25. In general, the pores 25 of the fabric 23 have a diameter of about 0.25 mm, or have a diameter of about 5.0 mm or less. This size contains the material packed in the bag but is selected to allow internal growth of the tissue. If a bone binder or other material is used that does not cause internal growth of the bone, the pores 25 may be more airtight to prevent the medium from leaking from the bag 22 into the cavity 16. This prevents leaks that can affect nerves, blood vessels, etc. when they come out of bone.

One or more pores 25 may be used as the filling opening 27 and the fabric 23 may be adjusted to extend the pores to a diameter greater than 5 mm but less than about 1 cm. Preferably, the filling opening 27 is about 5 mm or less in diameter. Such pore / fill openings 27 insert or inject filling material into the interior 21 of the bag 22 through the fabric 23 without compromising the integrity of the catheter, needle, filling tube or bag 22. It is large enough to allow other devices to do it.

When the bag 22 is fully filled with the filling material, the bag generally forms a self-retaining shape that fills the cavity 16. When fully filled, the filling mechanism for placing the filling material into the bag interior 21 is removed from the opening 27. When the opening 27 is not a pore 25 but a separate, separate opening in the bag 22, the opening 27 is, for example, bundled, fastened, welded, glued or opened 27 after the bag is filled. It may be a set diameter requiring sealing by other means of closing. If the opening 27 is a pore 25, upon removal of the catheter or filling mechanism from the opening 27, the fabric 23 changes the diameter of the opening 27 such that it is approximately similar to the diameter of the other pores 25. Shrink to reduce.

The size and density of the pores determines the ease with which the materials pass through the mesh. For example, very small pores (less than 0.5 mm) prevent the passage of everything except the smallest particles and liquids. The pore size and density can be controlled in the manufacturing process so that the finished product can be matched to the surgeon's needs. For example, when methyl methacrylate bone binder is used, the pore size needs to be very small, such as about 0.5 mm to less than about 1.0 mm, while ceramic fines that are well occupied with bone grafts or biological tissues are used. In this case, pore sizes with a range of about 1.0 mm to about 5.0 mm or more may be acceptable. The fact that the fabric 16 is suitably porous allows the fabric to limit the potential dangerous flow of fill material outside the area of the bag.

Fabrics are light, biocompatible, flexible, easy to handle and have very good tensile strength, so they do not tear well during insertion and expansion. When the device is inflated, the device is inflated to fill the previously excavated cavity.

Since the use of the term "fabric" herein includes any material that has a common definition of the term and functions as a fabric, the "fabric" of the present invention is allowed under the terms where the material and fluid flows are described. A plurality of pores 25 must be provided, and the "fabric" must be flexible enough to be buckled and inserted into an opening smaller than the expanded bag size.

Bag 22 need not be woven and can be molded or otherwise formed as is known in the art. Good materials can impart tailored organic adsorbate rate performance. Any suture material used medically may be used to form the bag 22. The bag can also be made of plastic or metal. In at least one embodiment, the bag 22 is formed by combining a resorbable or non-resorbable fiber. Bag 22 may include a filling opening 27 which may be a bushing that is organic, non-adsorbable plastic, ceramic, or metal. The opening 27 may be hydroxyapatite, or may be plastic or metal. The opening 27 can be characterized as a pore 25, wherein the pore 25 of the fabric 23 is inflated to allow catheter 20 or other filling mechanism to penetrate into the interior of the bag 22. Bag 22 may be made from a solid material with added permeability. Bag 22 may be a partially or wholly absorbable metal, plastic, fabric, solid, film or protruding balloon.

In an embodiment of the present invention, the damaged tissue of the body, such as the vertebrae 10, can be treated according to the following procedure as shown in Figures 1-9.

First, vertebrae 10 that require repair form at least one cavity 16 and are surgically exposed. The cavity or cavities 16 may be formed by various other means such as reaming. Reaming can be accomplished by a variety of means including, for example, a reamer 14, such as the Kuslich Expanable Reamer, disclosed in US Pat. No. 5,015,255, which is incorporated herein by reference in its entirety. . Next, an uninflated mesh bag or inflatable fabric bag device (EFBD) 22 is inserted into the cavity or cavities through the catheter 20 or other means. At some point, fill material 19 is prepared for insertion or injection into FEBD 22. The preparation of the filling material 19 below is such that the material is injected or inserted into the bag 22 using sufficient pressure to allow the bag 22 to be filled and inflated to reach the degree of correction required by the fracture. Create stiffness and tension in the cavities 16. Finally, the filling opening 27 is closed to prevent the outflow of the inflation material 19.

10-15 illustrate aspects of the present invention in which balloon 30 and catheter tube 32 are employed. The balloon 30 is surrounded by the expandable fabric bag 22 to protect the balloon from bursting during the expansion phase and to hold it in place to prevent undesired escape of the injected material into the cavity formed in the bone. Balloon 30 may be any medical grade elastomer balloon. The balloon 30 may be made of latex, urethane, thermoplastic elastomer, or other material suitable for use as the expandable member. Examples of suitable balloons include US patents issued to balloons, Scribner, et al., Using the Fogarty occlusion catheter manufactured by Baxter Healthcare Corporation of Santa Anna, CA. Balloons of the type disclosed in US Pat. No. 5,972,015, but are not limited thereto. The method includes the step of placing the inflatable fabric bag 22 of the present invention with respect to the balloon 30 granted to Scribner et al. The inflatable bag 22 is held in place before the cavity 16 is filled with a bone substitute or bone binder. The inflatable fabric bag 22 prevents breakage of the balloon 30 and greatly limits the ability of the filling material from leaking out of the cavity through bone gaps that can cause damage.

As best shown in FIGS. 11, 13 and 15, the bag 22 may include a neck portion 29 extending outwardly from the bag 22 to completely overlap the shape of the balloon 30. . Bag 22 and / or balloon 30 may each have a variety of shapes and sizes.

If necessary, when the fabric porosity is airtight and the expansion medium has a significant viscosity, the balloon 30, such as a scrubber, is removed so that the inflatable fabric bag 22 can be used as the sole expansion device.

While many prior embodiments have described the use of the bag 22 for repair of tissue such as the spinal body, FIGS. 16-18 illustrate how the bag 22 can be used to treat avascular necrosis of the femoral head. do. In Fig. 16, the femoral head 40 is shown in a state requiring repair. Figure 17 shows the femoral head reamed by the reamer 14, as described above. The reamer 14 forms a cavity 16. In FIG. 18, the bag 22 is shown in a cavity 16 formed inside the femoral head 40. The opening 27 of the bag 22 is occluded after it has been filled and expanded by the bone substitute material.

In an alternative embodiment, a balloon, such as a scrubber, as described above, may also be used as the restorative bag 22 of the femoral head 40.

Referring to the embodiment of the present invention shown in Figures 19-21, a shin plateau 48 having a fracture section 50 is shown. Fracture 50 is repaired by forming a cavity 16 with reamer 14 as shown in FIG. As shown in Figure 21, once the cavity 16 has been properly reamed, the bag 22 is inserted into it and filled with bone repair medium 19.

In addition, other tissue and bone abnormalities can be treated with the methods and bags 22 described above. The invention is not limited to the treatment of the vertebral body, femoral head and shin plateau. The bags 22 and methods of treatment described herein can be used to treat many types of bone and tissue abnormalities, including those described herein, as well as others throughout the mammalian body.

In addition to what is indicated by the specific combinations of features claimed below, the invention also discloses embodiments having other combinations of the dependent features claimed below and other combinations of the foregoing features.

The above disclosure is for illustration only and is not intended to be exhaustive. This description will suggest many variations and alternatives to one of ordinary skill in the art. All such alternatives and modifications are intended to be included within the scope of the claims where the term "comprising" is used to mean "including but not limited to." Those skilled in the art will recognize other equivalents to the specific embodiments described herein where equivalents are also covered by the claims.

In addition, certain features described in the dependent claims can be combined with one another in different ways within the scope of the invention so that the invention is also specifically indicated as alternative embodiments having possible other combinations of the features of the dependent claims. For example, for the purposes of claim disclosure, if any of the subordinate claims below, such a subordinate claim form is a legally acceptable form, a multiple subordinate claim that cites all previous claims, including all preceding claims referred to in this subclaim. Should be taken as described and replaced in form (ie, each claim directly reciting claim 1 should be replaced by quoting all preceding claims). In legislation where multiple subordinate claim forms are restricted, subsequent subordinate terms are described as being replaced by a single subordinate subtype, each of which generates a citation relationship from a term that includes a preceding preceding term rather than a specific term described in the subordinate claims below. (Ie, claim 3 may be replaced by quoting paragraph 2, paragraph 5 may be replaced by quoting paragraph 3, and paragraph 6 may be replaced by quoting paragraph 3). And paragraph 7 may be replaced by quoting any one of paragraphs 3, 5 and 6. etc.).

1 is a side elevational view of a vertebrae in need of fracture and repair;

FIG. 2 is a side view of the vertebra of FIG. 1, reamed using the reaming tool of the forward approach. FIG.

3 is a plan view of the vertebra of FIG. 1 showing a reamer forming a pair of cavities in the vertebrae by anterior approach;

Figure 4 is a side elevational view of the vertebrae of Figure 2, showing the location of the inflatable fabric bag of the present invention.

FIG. 5 is a top front view of the vertebrae of FIG. 3, showing the location of the second two expandable fabric bags of the present invention; FIG.

Figure 6 is a side view of the vertebrae reamed by a posterior approach.

FIG. 7 is a top view of the vertebra of FIG. 6 with a second cavity reamed with the bag in place; FIG.

Figure 8 is a side elevational view of the vertebrae of Figure 6, with the inflatable fabric bag of the present invention in place.

9 is a plan view of the vertebra of FIG. 7 with one bag inflated and a second bag deployed therein;

Fig. 10 is a side elevational view showing the vertebral cavity expanded by the inflatable fabric bag around the expansion device in cross section;

FIG. 11 illustrates the bag system of FIG. 10 with a virtual vertebrae to illustrate the bag system.

FIG. 12 is a view similar to FIG. 10 showing another access to the interior of the vertebrae;

FIG. 13 is a view similar to FIG. 11, showing the approach of FIG.

14 illustrates the bag of FIG. 12 in a closed, filled, inflated position;

FIG. 15 is a top view of the bag system of FIG. 12 expanded through a catheter tube. FIG.

Figure 16 shows the femoral head with avascular necrosis.

Figure 17 shows the femoral head of Figure 16 being reamed.

Figure 18 illustrates positioning the bag system of the present invention in the cavity of the femoral head.

19 is a side elevational view of the shin plateau fracture.

20 is a side view of the fracture of FIG. 19 with a cavity formed into a reamer;

FIG. 21 illustrates a shin plateau fracture repaired with the inflated inflatable fabric bag in place.

Claims (4)

Is a device for consolidating sponges, Including an inner layer and an outer layer, The outer layer is formed of a flexible material surrounding the inner layer, The inner layer is formed of an elastomer body, The outer layer comprises a plurality of pores extending therethrough, An expandable body is formed by a combination of an inner layer and an outer layer, which takes a constricted shape to be deployed to the bone side and has an expanded shape that will consolidate the spongy bone to form a cavity, The inner layer forms a hollow chamber, The inner and outer layers form at least one opening, The expandable body expands from the retracted shape to the expanded shape when a predetermined amount of filler material is placed in the hollow chamber through the at least one opening, The outer layer surrounds the inner layer to prevent the inner layer from penetrating against the canceling bone while the expandable body expands.  2. The spongy bone consolidation device of claim 1, wherein the inner layer is a medical balloon.  3. The spongy bone consolidation device of claim 2, wherein the medical balloon comprises at least one member from the group consisting of latex, thermoplastic elastomer, urethane, and combinations thereof.  The apparatus of claim 1, wherein the outer layer is an expandable mesh Caucasian sponge.

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