Method of making a biodegradable interbody spinal fusion...

Details Method of making a biodegradable interbody spinal fusion... Method of making a biodegradable interbody spinal fusion...

2001-07-13

2003-04-15

Silbaugh, Jan H. (Department: 1732)

Plastic and nonmetallic article shaping or treating: processes

Prestressing solid body and uniting in stressed condition

C264S261000, C264S275000, C264S277000

Reexamination Certificate

active

06548002

ABSTRACT:

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
Not applicable
BACKGROUND OF THE INVENTION
The present invention relates to the field of interbody spinal fusion devices.
In the structure of the spine of vertebrates including humans, the space between adjacent vertebrae is referred to as the interbody space. In normal spines, this space is occupied by the structure commonly referred to as a disc. This intervertebral structure separates and cushions the vertebrae.
Various pathologic and traumatic conditions require excision of a spinal disc and stabilization of the superior and inferior vertebrae while bony fusion develops. In 1995, approximately 225,000 new spinal fusions were performed in the United States alone, and of these about one half were performed in the, thoracic and cervical spine, with the remaining spinal fusions focused on the lumbar spine. To stabilize the spine where the surgery has occurred, an internal fixation device is frequently used. Such implants provide the ability to improve spinal alignment and maintain the developing alignment while fusion develops. Fixation of the spine can further correct deformity and provide immediate stability, thereby facilitating spinal fusion, early mobilization, and, when necessary, entry into rehabilitative programs.
The use of fixation devices is beneficial in several ways. First, the avoidance of long-term bed rest, thought by many to decrease non-neurological morbidity, is achieved. Additionally, fixation devices are thought to promote fracture healing and therefore reduce the need for rigid and cumbersome post-operative bracing.
While a number of commercially available implants for spinal stabilization are known, these devices are not resorbable and therefore, remain permanently at the implant site. Meticulous bone preparation and grafting is essential for successful long-term stability using current devices. Metallic and graphite implants have been known to fatigue and will eventually fail if the desired solid bony fusion is not achieved. Thus, it would be advantageous to obtain successful bony fusion and spinal development while avoiding the use of devices having the aforementioned drawbacks.
SUMMARY OF THE INVENTION
The present invention is directed to resorbable interbody fusion devices for use as spacers in spinal fixation, wherein the device is composed of 25-100% bioresorbable or resorbable material. The devices can be in any convenient form, such as a wedge, screw or cage. In one embodiment, the interbody fusion device of the invention further desirably incorporates' structural features such as serrations to better anchor the device in the adjoining vertebrae. In another embodiment, the device comprises a plurality of peripheral voids and more desirably a central void space therein, which may desirably be filled with a grafting material for facilitating bony development and/or spinal fusion, such as an autologous grafting material. In addition, void spaces increase the surface area of the device, thereby providing multiple sites for resorption to occur.
In yet another embodiment, the interbody fusion device of the invention further includes reinforcing fibers to enhance the structural properties thereof. These fibers may be made of the same polymeric material as the resorbable material from which the interbody fusion device is made, from a neutralization compound or, alternatively, from another biocompatible polymer, which may be crosslinked with a suitable crosslinking agent to yield an interpenetrating network for increased strength and stability. In another alternative embodiment, the reinforcing fibers are incorporated into the device, e.g., during the molding process, being placed in the mold under tension and released after the process of molding is complete.
Bioerodible polymers that are useful in the invention include polydioxanone, poly(&egr;-caprolactone); polyanhydride; poly(ortho ester); copoly(ether-ester); polyamide; polylactone; poly(propylene fumarate) (H[—OCH (CH
3
)—CH
2
—O—CO—CH═CH—CO—]
n
OH); and combinations thereof. In a preferred embodiment, the polymer poly(lactide-coglycolide) (PLGA: H[—OCHR—CO—]
n
OH, R═H, CH
3
), with a lactide to glycolide ratio in the range of 0:100% to 100:0% inclusive, is used.
As many of the preferred bioerodible polymers from which the resorbable interbody fusion device is manufactured are polymers that can produce acidic products upon hydrolytic degradation, the device preferably further includes a neutralization compound, or buffer. The neutralization compound is included in sufficiently high concentration to decrease the rate of pH change as the device degrades, in order to prevent sterile abscess formation caused by the accumulation of unbuffered acidic products in the area of the implant. Most preferably, the buffering or neutralizing agent is selected from a group of compounds wherein the pKa of the conjugate acids of the buffering or neutralization compound is greater than the pKa of the acids produced by hydrolysis of the polymers from which the device is prepared.
The neutralization compound, or buffer, included in the bioerodible material of the invention may be any base, base-containing material or base-generating material that is capable of reacting with the acidic products generated upon hydrolysis of the bioerodible polymer. Polymeric buffers which preferably include basic groups which neutralize the acidic degradation products may also be used as buffering compounds. Another class of useful buffering compounds are those which, on exposure to water, hydrolyze to form a base as one reaction product.
In another alternative embodiment, the resorbable interbody fusion device of the invention preferably includes a biological growth factor, e.g., bone morphogenic protein, to enhance bone cell growth. To protect the growth factor and to provide for controlled delivery, the biological growth factor may itself be compounded with a resorbable polymer in some of the many techniques available and prepared as a growth factor/polymer composite in pellet form, in small particle form or within the interstices or pores of a polymeric foam or low-density polymer and this polymer/growth factor composite is deposited into void spaces of the resorbable spinal fusion device. Alternatively, the growth factor, or protected growth factor, may simply be directly incorporated into the component formulation of the resorbable spinal fusion device.
Active periosteum cells may also be incorporated into a foam, e.g., deposited into void spaces of the resorbable spinal fusion device, in order to facilitate bone cell fusion. Further, the resorbable spinal fusion device of the invention may be prepared in such a manner as to exhibit a piezoelectric effect, to enhance bone wound healing.
As used herein, the terms “resorbable” and “bioresorbable” are defined as the biologic elimination of the products of degradation by metabolism and/or excretion and the term “bioerodible” is defined as the susceptibility of a biomaterial to degradation over time, usually months. The terms “neutralization compound” or “buffer” are defined as any material that limits or moderates the rate of change of the pH in the implant and its near environment upon exposure to acid or base. The term “acidic products” is defined herein as any product that generates an aqueous solution with a pH less than
7
.


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