# Patent

## Title
Implants and methods for treating bone

## Abstract

An orthopedic implant comprising a deformable, expandable implant body configured for treating abnormalities in bones, such as compression fractures of vertebra, necrosis of femurs and the like. An exemplary implant body comprises a small cross-section threaded element that is introduced into a bone region and thereafter is expanded into a larger cross-section, monolithic assembly to provide a bone support. In one embodiment, the implant body is at least partly fabricated of a magnesium alloy that is biodegradable to allow for later tissue ingrowth.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
Priority Claim
This application is a continuation of U.S. application Ser. No. 11/146,893, filed Jun. 7, 2005, which claims benefit of Provisional U.S. Application No. 60/577,559, filed Jun. 7, 2004, the contents of which are incorporated herein by reference in its entirety.


BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to medical implants and more particularly to expandable open cell reticulated implants configured as bone support implants for treating abnormalities in bones such as compression fractures of vertebra, necrosis of femurs and the like. An exemplary implant body comprises a small cross-section threaded element that is introduced into a bone region and thereafter is expanded into a larger cross-section, open cell reticulated monolith to provide a bone support.
2. Description of the Related Art
Osteoporotic fractures are prevalent in the elderly, with an annual estimate of 1.5 million fractures in the United States alone. These include 750,000 vertebral compression fractures (VCFs) and 250,000 hip fractures. The annual cost of osteoporotic fractures in the United States has been estimated at $13.8 billion. The prevalence of VCFs in women age 50 and older has been estimated at 26%. The prevalence increases with age, reaching 40% among 80-year-old women. Medical advances aimed at slowing or arresting bone loss from aging have not provided solutions to this problem. Further, the affected population will grow steadily as life expectancy increases. Osteoporosis affects the entire skeleton but most commonly causes fractures in the spine and hip. Spinal or vertebral fractures also have serious consequences, with patients suffering from loss of height, deformity and persistent pain which can significantly impair mobility and quality of life. Fracture pain usually lasts 4 to 6 weeks, with intense pain at the fracture site. Chronic pain often occurs when one level is greatly collapsed or multiple levels are collapsed.
Postmenopausal women are predisposed to fractures, such as in the vertebrae, due to a decrease in bone mineral density that accompanies postmenopausal osteoporosis. Osteoporosis is a pathologic state that literally means “porous bones”. Skeletal bones are made up of a thick cortical shell and a strong inner meshwork, or cancellous bone, of collagen, calcium salts and other minerals. Cancellous bone is similar to a honeycomb, with blood vessels and bone marrow in the spaces. Osteoporosis describes a condition of decreased bone mass that leads to fragile bones which are at an increased risk for fractures. In an osteoporosic bone, the sponge-like cancellous bone has pores or voids that increase in dimension, making the bone very fragile. In young, healthy bone tissue, bone breakdown occurs continually as the result of osteoclast activity, but the breakdown is balanced by new bone formation by osteoblasts. In an elderly patient, bone resorption can surpass bone formation thus resulting in deterioration of bone density. Osteoporosis occurs largely without symptoms until a fracture occurs.
Vertebroplasty and kyphoplasty are recently developed techniques for treating vertebral compression fractures. Percutaneous vertebroplasty was first reported by a French group in 1987 for the treatment of painful hemangiomas. In the 1990's, percutaneous vertebroplasty was extended to indications including osteoporotic vertebral compression fractures, traumatic compression fractures, and painful vertebral metastasis. In one percutaneous vertebroplasty technique, bone cement such as PMMA (polymethylmethacrylate) is percutaneously injected into a fractured vertebral body via a trocar and cannula system. The targeted vertebrae are identified under fluoroscopy. A needle is introduced into the vertebral body under fluoroscopic control to allow direct visualization. A transpedicular (through the pedicle of the vertebrae) approach is typically bilateral but can be done unilaterally. The bilateral transpedicular approach is typically used because inadequate PMMA infill is achieved with a unilateral approach.
In a bilateral approach, approximately 1 to 4 ml of PMMA are injected on each side of the vertebra. Since the PMMA needs to be forced into cancellous bone, the technique requires high pressures and fairly low viscosity cement. Since the cortical bone of the targeted vertebra may have a recent fracture, there is the potential of PMMA leakage. The PMMA cement contains radiopaque materials so that when injected under live fluoroscopy, cement localization and leakage can be observed. The visualization of PMMA injection and extravasion are critical to the technique—and the physician terminates PMMA injection when leakage is evident. The cement is injected using small syringe-like injectors to allow the physician to manually control the injection pressures.
Kyphoplasty is a modification of percutaneous vertebroplasty. Kyphoplasty involves a preliminary step that comprises the percutaneous placement of an inflatable balloon tamp in the vertebral body. Inflation of the balloon creates a cavity in the bone prior to cement injection. Further, the proponents of percutaneous kyphoplasty have suggested that high pressure balloon-tamp inflation can at least partially restore vertebral body height. In kyphoplasty, it has been proposed that PMMA can be injected at lower pressures into the collapsed vertebra since a cavity exists to receive the cement—which is not the case in conventional vertebroplasty.
The principal indications for any form of vertebroplasty are osteoporotic vertebral collapse with debilitating pain. Radiography and computed tomography must be performed in the days preceding treatment to determine the extent of vertebral collapse, the presence of epidural or foraminal stenosis caused by bone fragment retropulsion, the presence of cortical destruction or fracture and the visibility and degree of involvement of the pedicles. Leakage of PMMA during vertebroplasty can result in very serious complications including compression of adjacent structures that necessitate emergency decompressive surgery.
Leakage or extravasion of PMMA is a critical issue and can be divided into paravertebral leakage, venous infiltration, epidural leakage and intradiscal leakage. The exothermic reaction of PMMA carries potential catastrophic consequences if thermal damage were to extend to the dural sac, cord, and nerve roots. Surgical evacuation of leaked cement in the spinal canal has been reported. It has been found that leakage of PMMA is related to various clinical factors such as the vertebral compression pattern, and the extent of the cortical fracture, bone mineral density, the interval from injury to operation, the amount of PMMA injected and the location of the injector tip. In one recent study, close to 50% of vertebroplasty cases resulted in leakage of PMMA from the vertebral bodies. See Hyun-Woo Do et al, “The Analysis of Polymethylmethacrylate Leakage after Vertebroplasty for Vertebral Body Compression Fractures”, Jour. of Korean Neurosurg. Soc. Vol. 35, No. 5 (May 2004) pp. 478-82, (http://www.jkns.or.kr/htm/abstract.asp?no=0042004086).
Another recent study was directed to the incidence of new VCFs adjacent to the vertebral bodies that were initially treated. Vertebroplasty patients often return with new pain caused by a new vertebral body fracture. Leakage of cement into an adjacent disc space during vertebroplasty increases the risk of a new fracture of adjacent vertebral bodies. See Am. J. Neuroradiol. 2004 February; 25(2):175-80. The study found that 58% of vertebral bodies adjacent to a disc with cement leakage fractured during the follow-up period compared with 12% of vertebral bodies adjacent to a disc without cement leakage.
Another life-threatening complication of vertebroplasty is pulmonary embolism. See Bernhard, J. et al., “Asymptomatic diffuse pulmonary embolism caused by acrylic cement: an unusual complication of percutaneous vertebroplasty”, Ann. Rheum. Dis. 2003; 62:85-86. The vapors from PMMA preparation and injection are also cause for concern. See Kirby, B., et al., “Acute bronchospasm due to exposure to polymethylmethacrylate vapors during percutaneous vertebroplasty”, Am. J. Roentgenol. 2003; 180:543-544.
Another disadvantage of PMMA is its inability to undergo remodeling—and the inability to use the PMMA to deliver osteoinductive agents, growth factors, chemotherapeutic agents and the like. Yet another disadvantage of PMMA is the need to add radiopaque agents which lower its viscosity with unclear consequences on its long-term endurance.
In both higher pressure cement injection (vertebroplasty) and balloon-tamped cementing procedures (kyphoplasty), the methods do not provide for well controlled augmentation of vertebral body height. The direct injection of bone cement simply follows the path of least resistance within the fractured bone. The expansion of a balloon also applies compacting forces along lines of least resistance in the collapsed cancellous bone. Thus, the reduction of a vertebral compression fracture is not optimized or controlled in high pressure balloons as forces of balloon expansion occur in multiple directions.
In a kyphoplasty procedure, the physician often uses very high pressures (e.g., up to 200 or 300 psi) to inflate the balloon which first crushes and compacts cancellous bone. Expansion of the balloon under high pressures close to cortical bone can fracture the cortical bone, or cause regional damage to the cortical bone that can result in cortical bone necrosis. Such cortical bone damage is highly undesirable and results in weakened cortical endplates.
Kyphoplasty also does not provide a distraction mechanism capable of 100% vertebral height restoration. Further, the kyphoplasty balloons under very high pressure typically apply forces to vertebral endplates within a central region of the cortical bone that may be weak, rather than distributing forces over the endplate.
There is a general need to provide systems and methods for use in treatment of vertebral compression fractures that provide a greater degree of control over introduction of bone support material, and that provide better outcomes. Embodiments of the present invention meet one or more of the above needs, or other needs, and provide several other advantages in a novel and non-obvious manner.
SUMMARY OF THE INVENTION
The invention provides a method of correcting numerous bone abnormalities including vertebral compression fractures, bone tumors and cysts, avascular necrosis of the femoral head and the like. The abnormality may be corrected by first accessing and boring into the damaged tissue or bone (FIG. 1). Thereafter, the implant body is advanced into the bore, wherein successive axial segments of the implant engage one another to provide radial expansion of the implant. The implant system eliminates the need to ream, compact, tamp or otherwise treat the bone region before the insertion of the implant assembly.



BRIEF DESCRIPTION OF THE DRAWINGS
In the following detailed description, similar reference numerals are used to depict like elements in the various figures.
FIG. 1 is a side view of a segment of a spine with a vertebral compression fracture that can be treated with the present invention, showing an introducer in posterior access path to the targeted treatment site.
FIG. 2A is a greatly enlarged view of the reticulated material of the expandable implants corresponding to the invention.
FIG. 2B is a side view of a segmented reticulated implant body corresponding to the invention.
FIG. 3A is a sectional perspective view of one of the reticulated implant segments of FIG. 2B taken along line 3-3 of FIG. 2B.
FIG. 3B is a view of a helical element that is a component of the reticulated implant segment as in FIG. 3A.
FIGS. 4A-4C are schematic views of a method of the invention in treating a fracture as depicted in FIG. 1.
FIG. 5A is a cross-sectional view of the vertebra and fracture of FIG. 1 with multiple implants deployed in a targeted region from a single access.
FIG. 5B is a cross-sectional view of the vertebra and fracture of FIG. 1 with multiple implants deployed from two access paths.
FIG. 6 is a schematic view of the damaged vertebra of FIG. 1 with the reticulated implant monolith I in place after expanding the height of the damaged vertebrae and providing a reticulated scaffold therein.



DETAILED DESCRIPTION OF THE INVENTION
The present invention comprises a bone implant of a reticulated material that can be radially expanded in cross-section to support a bone, and more particularly to move apart cortical endplates to at least partly restore vertebral height. In one embodiment, the implants elements comprise reticulated scaffold structures that can allow for later bone ingrowth. FIG. 2A illustrates a greatly enlarged view of an exemplary open cell reticulated material 10 corresponding to the invention that is useful for defining terms used herein to describe the implants. In general, the term reticulated means having the appearance of, or functioning as wire network or substantially rigid net structure. The related term reticulate mean resembling or forming a network. The terms reticulated, reticulate and trabecular are used interchangeably herein to describe structures having ligaments 15 that bound an open cells 18 or closed cell in the interior structure.
Such reticulated structures 10 as in FIG. 2A are further defined by density which—describes the ligament volume as a percentage of a solid. In other words, the density defines the volume of material relative to the volume of open cells in a monolith of the base material. As density of the ligaments increase with larger cross-sections and smaller cell dimensions, the elastic modulus of the material will increase.
The cells of reticulated structure 10 (FIG. 2A) also define a mean cross section which can be expressed in microns. In preferred embodiments, the cells are bounded by polyhedral faces, typically pentagonal or hexagonal, that are formed with five or six ligaments 15. Cell dimension is selected for enhancing tissue ingrowth, and mean cell cross-sections can range between 10 micron and 300 microns; and more preferably ranges between 20 microns and 200 microns.
In general, the system and method of invention relates to minimally invasive percutaneous interventions for providing bone support with an implant scaffold that is expanded in situ into a rigid, reticulated monolithic body. FIG. 1 illustrates a spine segment 100 with vertebrae 102a and 102b and disc 104. The vertebra 102a and cancellous bone 106 therein is depicted as having suffered a compression fracture 108 that can be repaired with the present invention. The targeted treatment region 110 (FIG. 1) can be accessed in either posterior or anterior approach A with a minimally invasive access pathway, for example with an introducer 115 having a 5 mm. or smaller diameter. In other embodiments, the introducer and implants are preferably less than about 3 mm. in cross-section.
Now referring to FIG. 2B, an exemplary radially expandable implant body 120 is illustrated in a first pre-deployed configuration. In this configuration, it can be seen that the elongate body 120 comprises a plurality of axial-extending segments 122a-122d that extend along axis 125. In a preferred embodiment, the segments 122a-122d are linked by break-away joints. Alternatively, the segments are cannulated and carried about a shaft indicated at 128. As another alternative, the segments 122a-122d are independent bodies that are introduced sequentially through introducer sleeve 130. The segments 122a-122d are configured for axial segment-to-segment insertion to thereby radially expand the assembled implant body. The expandable implant can includes from 2 to 20 body segments.
As illustrated in FIG. 2B, the radially expandable implant body 120 is housed in an introducer 130 that comprises a sleeve extending from a handle (not shown). The introducer and handle carry a rotational/helical advancement mechanism for engaging the proximal end 132 of the implant, and preferably includes a motor-driven mechanism.
FIGS. 3A and 3B are views of a segment 122a of the radially expandable implant body 120. In FIG. 3A, it can be seen that each segment consists of a plurality of segment subcomponents or elements 140 (collectively) that are configured to helically intertwine.
FIG. 3B illustrates a single segment element 140 de-mated from the cooperating elements. The element is of a metal or polymer that is somewhat deformable. The elements can further be configured with weakened planes, relaxing cuts, hinge or flex portions 144 or the like to allow bending of the elements to permit controlled deformation and expansion of the body. In preferred embodiments, the expandable implant 120 has segments with a surface spiral thread. In another preferred embodiment, the hinge or flex portions 144 comprise flexible reticulated (open cell) polymer that couples together the rigid reticulated metal portions. Thus, the scope of the invention includes for the first time inventive means for fabricating a deformable but non-collapsible reticulated implant body.
The elements 140 are fabricated of a reticulated material 100 (FIG. 3A) that has a ligament density ranging between 20 percent and 90 percent. More preferably, the reticulated material has a ligament density ranging between 20 percent and 50 percent. In one embodiment, the reticulated material includes titanium, tantalum, stainless steel or a magnesium alloy that is biodegradable. In another embodiment, the reticulated material is at least partly a polymer, which can be at least one of bioerodible, bioabsorbable or bioexcretable.
FIGS. 4A-4C illustrate an exemplary sequence of utilizing a 3 or 4 segment implant to create a radially expanded reticulated monolith 120′. For example, a pre-deployed implant as in FIG. 2B can have a diameter of about 4 mm.—and can be expanded to a selected oval or roughly spherical shape having a diameter of 12 to 16 mm. The expandable, reticulated segments can have common right-hand or left-hand surface spiral thread configurations. Alternatively, the segments can have different right-hand and left-hand surface spiral thread configurations.
It can be easily understood that an expandable implant can have variable open cell cross sections, or a radial gradient in open cell cross sections by providing different segment with different densities and cell dimension.
An expandable implant also can have reticulated material provided with open cells filled with an infill polymer. Such an infill polymer is at least one of bioerodible, bioabsorbable or bioexcretable.
The method of the invention include treating, or prophylactically preventing, a fracture in a bone structure and comprised the steps of introducing a reticulated body of a deformable reticulated elements in a first cross-sectional dimension into the bone structure. Thereafter, the implant body is expanding into a reticulated monolith to a second increased cross-sectional dimension as depicted in FIG. 6. The method includes expanding the implant to replace or displace trabecular bone with the reticulated body. The method includes expanding the implant to support cortical bone adjacent the reticulated body, and to jack apart the cortical vertebral endplates.
Of particular interest, the expandable implant may be used in a prophylactic manner with small introducers, for example, to provide bone support in vertebrae of patients in advance of compression fracture. FIGS. 5A and 5B indicate that the treatment site 110 can be a single region accessed from a single access pathway or multiple spaced apart regions, for example accessed by two minimally invasive access pathways.
The expandable implant of the invention also can be used as a fusion implant to controllably expand in an intervertebral space to controllably engage first and second vertebral bodies. The system allows for less invasive access to a targeted site for such a fusion implant.
Reticulated metals are available from ERG Materials and Aerospace Corp., 900 Stanford Avenue, Oakland Calif. 94608 or Porvair Advanced Materials, Inc., 700 Shepherd Street, Hendersonville N.C. 28792.
In any embodiment, the implant segments 122a-112d further can carry a radiopaque composition if the material of the implant itself is not radiovisible.
In any embodiment, the segments further can carry any pharmacological agent or any of the following: antibiotics, cortical bone material, synthetic cortical replacement material, demineralized bone material, autograft and allograft materials. The implant body also can include drugs and agents for inducing bone growth, such as bone morphogenic protein (BMP). The implants can carry the pharmacological agents for immediate or timed release.
The above description of the invention intended to be illustrative and not exhaustive. A number of variations and alternatives will be apparent to one having ordinary skills in the art. Such alternatives and variations are intended to be included within the scope of the claims. Particular features that are presented in dependent claims can be combined and fall within the scope of the invention. The invention also encompasses embodiments as if dependent claims were alternatively written in a multiple dependent claim format with reference to other independent claims.

## Claims

1. A method of treating or prophylactically preventing a fracture of a bone comprising:
introducing into a bone a first implant body segment comprising a reticulated, radially-expandable segment extending about an axis of the first implant body segment, at least a portion of the reticulated, radially-expanding body segment contacting the bone; and
introducing at least two additional implant body segments into the interior of the first body segment to thereby radially expand the reticulated segment of the first implant body segment outward from the axis in a direction perpendicular to the axis to support the bone.

2. The method of claim 1, wherein introducing the implant body segments displaces cancellous bone.

3. The method of claim 1, wherein introducing the implant body segments moves cortical bone.

4. The method of claim 3, wherein introducing the implant body segments at least partially restores vertebral height.

5. The method of claim 1, wherein the bone is a vertebra.

6. The method of claim 1, wherein introducing the at least two additional implant body segments into the first body segment comprises breaking a break-away joint between the additional implant body segments and the first body segment.

7. The method of claim 1, wherein introducing the at least two additional implant body segments into the first body segment comprises sequentially introducing independent body segments through an introducer sleeve.