Surgery – Instruments – Cutting – puncturing or piercing
Reexamination Certificate
1999-03-17
2002-04-23
Shoap, Allan N. (Department: 3727)
Surgery
Instruments
Cutting, puncturing or piercing
C623S016110
Reexamination Certificate
active
06375663
ABSTRACT:
BACKGROUND OF THE INVENTION
TECHNICAL FIELD
The present invention relates to the field of medicine, and more particularly, to the field of bone grafting. The invention has particular utility in connection with the removal and collection of bone from the surface of one or more donor sites, and the preparation and placement of the autogenous bone material at a second location in the same patient., e.g. for use in grafting bone to osseous deficiencies, such as periodontal and dentoalveolar defects, bone deficiencies around dental implants, and numerous orthopedic applications that require bone grafting, and will be described in connection with such utility, although other utilities are contemplated.
Many reconstructive procedures used in medicine and dentistry involve the manipulation and healing of bones. Such procedures may involve changes in the position, orientation, shape and size of skeletal structures. A problem that is commonly encountered during such procedures is a lack of bone graft material. Bone graft material may be used in many applications, such as to fill between sections of bone that have been repositioned, to change surface geometry, or to add bone to an area that is deficient, such as in conjunction with joint fusion, bone cyst site repair, periodontal surgery or dental implants in a patient's jaw.
Harvesting of small bone grafts from intraoral sites has been a common practice in periodontal surgery to restore bone defects around teeth. In the case of dental implant surgery, bone grafts may be needed to augment atrophic alveolar ridges of the maxilla and/or mandible and the sinus floor to increase the dimension of these bone sites to accommodate and totally cover the endosseous portion of implant fixtures. Bone grafts also are used in conjunction with guided tissue regeneration, a technique that uses a membrane to isolate hard tissue from soft tissue sites and potentiate hard tissue healing.
It is often difficult to harvest adequate amounts of autogenous bone from intraoral sites. Therefore, clinicians often rely on non-autogenous sources of graft material, such as bone from cadaver sources (homologous or allogeneic grafts), animal sources (heterogenous or xenogeneic grafts), or synthetic (alloplastic) bone substitutes. However, healing of non-autogenous material grafts is not as extensive or predictable as healing of autogenous bone obtained directly from the patient; plus the additional cost of such non-autogenous graft materials which can be significant. Autogenous bone is widely known and accepted as the “gold standard.”
Clinicians use several techniques to remove bone for grafting for intraoral procedures. In one such technique a rotary instrument, such as a side cutting burr or trephine, is used to remove a piece or section of cortical bone from a local intraoral site in the maxilla or mandible. The cortical bone is often morsalized into a particulate form, either manually with a rongeur like instrument or in a bone mill. The resulting particulate bone is then positioned and packed into the osseous defect around the teeth or implant.
Another technique is to collect bone dust generated by twist drills or taps used to prepare sites for implant placement. Suction devices with filters have been fabricated and manufactured to collect the bone dust from rotary instruments. This bone is then combined with blood to form an osseous coagulum. However, twist drills tend to generate significant heat which causes some necrosis and denatures proteins. While the site may be irrigated to cool the drill bit, much of the bone material may be lost in the irrigating fluid. Saws, burrs and bone mills also may be used for harvesting and/or preparing bone material for grafting; however, the resulting bone material is either quite powdery or block-like particles with pointed or sharp edges with low aspect ratio. Such materials tend to consolidate with minimal porosity. Robinson, R. E. “Osseous Coagulum for Bone Induction”, J. Periodontology 40:503(1969). See Hutchinson, R A “Utilization of an Osseous Coagulum Collection Filter”, J. Periodontology 44:668(1973). See also Goldman, et al, “Periodontal Therapy”, pp 994-1005, C. V. Mosby Co., (1980); and Haggarty, et al., “Autogeneous Bone Grafts: A Revolution in the Treatment of Vertical Bone Defects”, J. Periodontology 42:626(1971). While such techniques are widely used by clinicians, such techniques have limitations, since sites for harvesting sections of intraoral bone are limited in number and extent because of limited intraoral access, proximity to tooth roots, nerve structures and sinus cavities, and thin plates of bone.
Surgeons also employ various hand-driven devices such as rasps, reamers, files, rongers, gouges, chisels and osteotomes to cut and harvest bone. However, such hand-held devices are inefficient for harvesting bone for grafting applications, and normally produce powder-like particles. Additionally, harvesting bone using chisels or the like may be hazardous.
When larger amounts of bone are needed for major reconstructive procedures, sites such as the hip (anterior or posterior ilium), tibia, ribs, or the calvarium often are used. However, using such sources necessitates a second surgical site, which may involve more morbidity and require postoperative hospitalization, and thus is less amenable, e.g. in the case of an out-patient dental procedure.
Various surgical devices have been proposed and/or are in use to harvest bone marrow samples for biopsy, or devices such as rongeurs or bone cutters or punches to remove sections or convex edges of bone. Surgical devices also are in use in arthroscopy and endoscopy for cutting or drilling bone or tissue and removing the tissue fragments. Ultrasonic devices also are in use to cut bone; however, such devices require the removal of the irrigant and debris liberated by the apparatus. Each of these methods and/or devices, however, suffers from one or more deficiencies as applied to the collection of bone for grafting.
U.S. Pat. Nos. 5,403,317 and 5,269,785 to Bonutti show a method and apparatus for the percutaneous cutting and removal of tissue fragments from human. The Bonutti device removes the tissue fragments by suction, where it can be collected and then placed elsewhere in the patient from where originally obtained. Bonutti employs a flexible drill, and suction to remove the debris to an externally placed collection reservoir, where it is compressed before being replaced into the patient.
U.S. Pat. No. 2,526,662 to Hipps discloses a bone meal extractor apparatus for mechanically removing bone meal from a donor bone site through a small percutaneous site using a drill. The drill shavings, which comprise primarily sub-surface bone, are then evacuated into an open cut that the drill passes through, for collection.
U.S. Pat. No. 4,798,213 to Doppelt teaches a device for obtaining a bone biopsy for diagnosis of various bone diseases. The Doppelt device is intended to remove a core of bone using a tubular drill, while maintaining the architecture of the tissue. The sample is obtained from the marrow space and not intended for re-implantation.
U.S. Pat. No. 5,133,359 to Kedem shows a hard tissue biopsy instrument in which samples are taken using a rotatably driven hollow needle.
U.S. Pat. No. 4,366,822 to Altshuler discloses a method and apparatus for bone marrow cell separation and analysis. The Altshuler apparatus collects bone marrow cells in a filtration chamber on a filter interposed between a needle directed into the bone marrow site and an aspirator or vacuum source, i.e. using negative pressure to withdrawal marrow cells through a needle.
U.S. Pat. No. 5,052,411 to Schoolman teaches, a vacuum barrier attachment for shielding the operator of a medical tool from harmful aerosols and blood, etc. created by drilling, sawing types of actions, etc. The Schoolman device requires vacuum and is not intended for harvesting tissue for re-implantation.
U.S. Pat. No. 4,722,338 to Wright et al discloses a device instrument for removing bone which uses a shearing action similar
Altobelli David E.
Ebner Peter R.
Hayes Soloway
Maxilon Laboratories, Inc.
Ngo Lien
Shoap Allan N.
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