Use of a collagen membrane in surgical articles for protecting spinal area

Abstract: There is described the use of a sheet of collagen membrane material for the protection of the spinal cord during or after surgery and a method for using such a membrane in the protection of the spinal area of a patient during and/or after surgery.

Description: The present invention relates to the field of spinal surgery, including the manufacture of surgical articles for protecting a spinal area of a patient during or after surgery. There are numerous spinal surgeries performed each year to treat disc injuries, to repair, remove or fuse vertebrae, or combinations thereof. During such surgeries, it is desirable to protect the spinal cord and the dura sheath surrounding the spinal cord from injury. Spinal surgeries often also involve insert of bone graft material to repair or replace damaged vertebrae. During the subsequent healing process, it is desirable to protect the spinal area from ingrowth of connective tissue and undesired cells which might interfere with proper healing. Use of a polyvinyl alcohol membrane as an anti-adhesive interposition after spinal surgery is described in SPINE Vol. 20, No. 21, pages 2272-2277 (1995). Such membranes must be surgically removed after healing. There remains a need in the art for new methods and materials to assist in spinal surgery or for protecting spinal areas of a patient during and after surgery. The present invention is concerned with protecting a spinal area of a patient by positioning a sheet of collagen membrane material so as to surround at least a portion of a patient's spinal cord and to the use of a collagen membrane material as a surgical article in spinal surgery. This may be to assist in vertebral fusion and/or for protecting the spinal cord during and/or after surgery. Thus according to the one aspect, the present invention provides the use of a sheet of collagen membrane material comprised of at least one barrier layer having at least one smooth face so as to inhibit cell adhesion thereon and act as a barrier to prevent passage of cells therethrough in the preparation of a surgical article for use in or after spinal surgery by positioning around at least a portion of a vertebra and/or spinal cord. In the accompanying drawings: Fig. 1 is a sectional schematic view showing a spinal cord surrounded by a sheet of collagen membrane material in accordance with one embodiment of the present invention. Fig. 2 is a schematic plan view in partial cross-section showing a second embodiment of the present invention wherein a first sheet of collagen membrane material is immediately adjacent a patient's spinal cord, and a second sheet of collagen membrane material is positioned outside a patient's vertebra, spinal disc and inserted vertebra implant material. Fig. 3 is a side elevation schematic view showing a single-layered membrane for use in accordance with the present invention. Fig. 4 is a side elevation schematic view showing a double-layer membrane for use in accordance with the present invention. Fig. 5 is a side elevation schematic view showing a triple-layer membrane for use in accordance with the present invention. In accordance with one embodiment of the invention, a sheet of collagen membrane material comprised of at least one barrier layer having at least one smooth face 16 so as to inhibit cell adhesion thereon and act as a barrier to prevent passage of cells therethrough is used in the preparation of a surgical article for use in or after spinal surgery by positioning around at least a portion of a vertebra and/or spinal cord. See Fig. 3. In accordance with this embodiment, the barrier layer further has a fibrous face 18 opposite the smooth face 16, the fibrous face allowing cell growth thereon. In preferred embodiments, the barrier layer is predominantly collagen I, collagen III or a mixture thereof. One suitable material is Biogide®, from Ed. Geistlich Söhne AG für Chemische Industrie, the present applicant. The Biogide® material is described in U.S. Patent No. 5,837,278. Fig. 4 shows a second type of membrane which may be used in accordance with the present invention. This membrane includes a barrier layer 15 as shown in Fig. 3, and further includes a matrix layer 20 predominantly of collagen II having an open sponge-like texture. A collagen membrane as shown in Fig. 4 is described in International Patent Application No. WO99/19005. In one preferred embodiment, a collagen membrane material as shown in Fig. 4 is utilized, wherein the barrier layer 15, the matrix layer 20, or both are impregnated with a glycosaminoglycan. Examples of suitable glycosaminoglycans include hyaluronic acid, chondroitin 6-sulphate, keratin sulphate or dermatan sulphate. Fig. 5 shows still another type of membrane suitable for use in accordance with the present invention. The membrane of Fig. 5 includes two barrier layers 15, between which is sandwiched a resorbable polymer layer. In preferred embodiments, the polymer is a polylactic acid polymer. Referring back to Fig. 2, a sheet 10' of collagen membrane material is positioned so as to surround at least a portion of a vertebra 22 surrounding the spinal cord 14. In certain surgeries, a vertebra implant material 24 such as resorbable bone mineral may be positioned between two vertebrae 22a and 22b so as to facilitate fusion of vertebrae 22a and 22b. One suitable vertebra implant material is Bio-Oss® from Ed. Geistlich Söhne AG Für Chemische Industrie. Bio-Oss® is described in U.S. Patent Nos. 5,167,961 and 5,417,975. Another suitable vertebra implant material is Bio-Oss Collagen® from Ed. Geistlich Söhne AG Für Chemische Industrie, which is resorbable bone mineral in a collagen matrix. Bio-Oss Collagen® is described in U.S. Patent No. 5,573,771. The present invention is also applicable to other bone graft methods, such as the "cage technique", in which a net of titanium enclosing bone graft material is inserted between vertebrae. In accordance with a further embodiment during spinal surgery in which the dura sheath surrounding the spinal cord is exposed, a sheet of collagen membrane material 10 is positioned adjacent the dura sheath 12 surrounding a patient's spinal cord 14 so as to protect the dura sheath 12. See Figs. 1 and 2. In accordance with these and other embodiments, a sheet of collagen membrane material can protect against ingrowth of any connective tissue and other cells from outside adjacent bone material, which might interfere with osteocytes and other bone-regenerating cells from fully incorporating the spinal implant material into the spinal column for maximum strength and healing. The use of the present invention also encompasses preparing a sheet of collagen membrane material 10' adapted for positioning so as to surround at least a portion of a spinal disc 26 surrounding spinal cord 14 as shown in Fig. 2. In the embodiment shown in Fig. 2, the dura 12 has been surrounded by a collagen membrane 10 in accordance with the present invention, and in addition thereto, a second collagen membrane 10' has been wrapped around vertebrae 22a and 22b, as well as disc 26 and vertebra implant material 24 for protection thereof. The present invention is thus capable of protecting the spinal cord dura from physical injury during surgery, and the barrier layer of membrane 10' protects the surgical site from ingrowth of unwanted cells during the healing process when membrane 10' is wrapped around the spinal column as shown in Fig. 2. The collagen membrane material 10, 10' is gradually resorbed into the patient's body, avoiding any necessity of having to surgically remove the membranes after healing.

Claims: The use of a sheet of collagen membrane material comprised of at least one barrier layer having at least one smooth face so as to inhibit cell adhesion thereon and act as a barrier to prevent passage of cells therethrough in the preparation of a surgical article for use in or after spinal surgery by positioning around at least a portion of a vertebra and/or spinal cord. The use of claim 1 wherein said barrier layer further has a fibrous face opposite said smooth face, said fibrous face allowing cell growth thereon. The use of claim 1 or claim 2 wherein said barrier layer is predominantly collagen I, collagen III or a mixture thereof. The use of claim 3 wherein said collagen membrane further comprises a matrix layer predominantly of collagen II having an open sponge-like texture. The use of any of claims 1 to 4 wherein said barrier layer, said matrix layer or both, are impregnated with glycosaminoglycan. The use of claim 5 wherein the glycosaminoglycan is hyaluronic acid, chondroitin 6-sulphate, keratin sulphate or dermatan sulphate. The use of any of claims 1 to 6 wherein said membrane material further comprises a second barrier layer, with a resorbable polymer layer sandwiched between the barrier layers. The use of claim 7 wherein said polymer is a polylactic acid polymer. The use as claimed in any of claims 1 to 8 wherein the spinal surgery includes vertebral fusion and/or insertion of a vertebra implant material. The use of any of claims 1 to 9 wherein said sheet is adapted to be positioned during protection of the spinal cord adjacent a dura sheath of said spinal cord so as to protect said dura sheath. The use of any of claims 1 to 10 wherein said sheet is adapted to be positioned so as to surround at least a portion of a spinal disc surrounding said spinal cord.

Inventors: BOYNE PHILIP J, GEISTLICH PETER, SCHLOESSER LOTHAR, BOYNE, PHILIP J., GEISTLICH, PETER, SCHLOESSER, LOTHAR, Schlösser, Lothar 
Applicants: GEISTLICH SOEHNE AG, ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE
Application year: 2000
Main classification: A61L31
IPC codes: A61F2, A61L27, A61L31