AU6881401A - Surgical implant containing a resorbable radiopaque marker - Google Patents

Description

P/00/01i1 Regulation 3.2

AUSTRALIA

Patents Act 1990

ORIGINAL

COMPLETE SPECIFICATION STANDARD PATENT Invention Title: Surgical implant containing a resorbable radiopaque marker The following statement is a full description of this invention, including the best method of performing it known to us: r-reenIIjs L~arter ~mitn ~eaoie MeIoourne\uu.j~yf1~b Printed 7 September 2001 (15:16) page 2 Freenills Carter Smith Beadle Melbourne\003897186 Printed 7 September 2001 (15:16) page 2 2 SURGICAL IMPLANT CONTAINING A RESORBABLE RADIOPAQUE MARKER BACKGROUND OF THE INVENTION This invention is directed to a surgical implant, more particularly one containing a radiopaque marker which enables the position and/or orientation of the implant to be readily determined by x-ray or other radiographic technique following its surgical implantation in the body.

Osteoprosthetic implants are useful for repairing a variety of skeletal defects and irregularities. It may be necessary to confirm the location of an implant following its placement in the body. However, many osteoprosthetic implants are fabricated from materials, synthetic resins, that are transparent to radiographic imaging such as x-ray. Osteoprosthetic implants of this type have been provided with a radiopaque marker facilitating the determination of the position of the installed implant employing x-ray or other radiographic technique. See, U.S.

Pat. Nos. 3,829,904, 3,891,997, 3,922,726, 4,123,806, 4,224,698, 4,450,592, 5,405,402, 5,425,762, and 5,476,880. The radiopaque markers in the implants described in these patents takes the form of a metal wire formed from a biologically compatible metal such as stainless steel.

20 SUMMARY OF THE INVENTION One aspect of the invention provides a surgical implant for surgical implantation in the body, the implant being fabricated from radiolucent material and possessing a resorbable radiopaque marker, wherein the radiolucent material is Sresorbable demineralized bone or collagen.

Another aspect of the invention provides a surgical implant for surgical implantation in the body, the implant being fabricated from radiolucent material and possessing a resorbable radiopaque marker, wherein the resorbable radiopaque marker is a calcium-based mineral selected from the group consisting of hydroxyapatite, tricalcium phosphate, fluorapatite and their mixtures, the resorbable radiopaque marker being arranged within the implant in accordance with a Melboume\003897155 Printed 7 September 2001 (14:54) 3 predetermined pattern.

A further aspect of the invention provides a surgical implant for surgical implantation in the body, the implant being fabricated from radiolucent material and possessing a resorbable particulate radiopaque marker arranged within the radiolucent material in a predetermined geometric pattern.

In accordance with the present invention, an implant for repairing skeletal defects and irregularities is provided which comprises an implant fabricated from a radiolucent material and possessing a resorbable radiopaque marker, e.g., nondemineralized or partially demineralized bone particles. Unlike the metal wire radiopaque marker in the synthetic prostheses of the patents identified above, the implant of this invention has a radiopaque marker component which is resorbable in its entirety and may contribute to the healing of bone through natural processes.

DESCRIPTION OF THE PREFERRED EMBODIMENTS The implant can be manufactured from any of several radiolucent resorbable or non-resorbable materials including demineralized bone sheet, particles, etc., collagen and collagen derivatives, plastic such as polyethylene cetabular cups.

In one embodiment of the present invention, the resorbable implant is manufactured from elongate demineralized bone particles as disclosed in U.S. Pat.

No. 5,507,813, the contents of which are incorporated herein by reference.

According to the method described in U.S. Pat. No. 5,507,813, elongate bone particles are obtained by milling from a section of whole bone, the particles are demineralized with acid in accordance with known and conventional procedures to provide substantially completely demineralized bone particles which are characteristically radiolucent and the bone particles are then formed into a shaped material possessing a definite geometrical configuration, a sheet possessing a square or rectangular shape. The sheet is formed by a wet-laying process the steps of which are as follows: slurrying a quantity of the demineralized elongate bone particles in a suitable liquid, water, organic protic solvent, aqueous solution such as physiological saline, etc., and optionally containing one or more biocompatible ingredients such as adhesives, fillers, plasticizers, flexibilizing Melboure\003897155 Printed 7 September 2001 (14:54) agents, biostatic/biocidal agents, surface active agents, medically/surgically useful substances, etc., applying the slurry to a porous support, a flat perforate sheet, mesh screen or three-dimensional mold, through which excess slurry liquid drains thereby providing a coherent, shaped wetted mass of demineralized bone particles and, optionally, drying the wetted mass. The sheet material thus formed is relatively rigid when dry and, upon contact with a biocompatible liquid, water, saline solution, etc., becomes pliable and flexible thus making it readily conformable to a desired bone repair site.

The radiopaque marker which is to be incorporated into the resorbable implant of this invention is advantageously provided as native bone obtained from either human or animal bone, by cutting, milling, grinding or other suitable technique. The radiopaque marker can also be partially demineralized bone, the extent of demineralization being not so great as to substantially impair its radiopaque character. For example, partially demineralized bone containing not less than about 50 weight percent of its original mineral content can be utilized as the radiopaque component of the implant of this invention. The radiopaque marker can also be a resorbable calcium-based mineral, hydroxyapatite, tricalcium phosphate, etc., or other resorbable inorganic material. The radiopaque marker is preferably provided in particulate form with an average particle size of from about 0.1 mm to about 10 mm and preferably from about 1 mm to about 5 mm. The radiopaque marker can be shaped in the form of spherical, quasi-spherical, cuboid, rectangular or any other shape which may be useful.

The radiopaque marker can be incorporated into the resorbable implant at any stage in the manufacture of the latter, in the case of a bone sheet manufactured in accordance with aforementioned U.S. Pat. No. 5,507,813, by introduction into the slurry from which the bone sheet is made. The radiopaque marker can also be incorporated into the milled bone particles prior to their demineralization and formation into the bone sheet. However, as will be recognized, the radiopaque marker in this embodiment must be able to survive or be resistant to the demineralization process. In the case of a radiopaque marker made up of bone Melbourne\003897155 Printed 7 September 2001 (14;54) particles, by making such particles larger and/or thicker than the elongate bone particles intended for demineralization, it is possible to limit the extent of their demineralization so that they still contain sufficient inorganic matter to render them radiopaque while the elongate bone particles undergo complete, or nearly complete, demineralization. Another method of imparting resistance to demineralization to bone particles intended to function as the radiopaque marker is to coat the particles with a substance that is less susceptible to acid attack.

When incorporating the radiopaque marker into the resorbable implant, the marker can be arranged within the implant in a predetermined pattern, a geometric pattern such as a grid. This can be readily accomplished by use of a template placed over the implant during a processing step so that marker material that is poured or cast over the implant is only imbedded in desired areas. The usefulness of a predetermined pattern for the markers is to render the implant easily distinguishable from other surrounding structures in situ.

In the case of a resorbable implant which is fabricated from demineralized bone, application of the implant to the site of a bone defect, one resulting from injury, infection, malignancy or developmental malformation, leads to new bone ingrowth by one or more biological mechanisms such as osteogenesis, osteoconduction and/or osteoinduction or by one or more physical mechanisms such as providing a physical barrier to soft tissue ingrowth, presenting a support or scaffolding for new bone growth, etc.

S- Upon implantation of the implant into the body at a defect site, the implant can be viewed by using any of several known and conventional radiographic techniques such as x-ray imaging. In the case of x-ray imaging, the radiopaque marker is displayed on the exposed and developed x-ray film as white spots allowing the location and/or the orientation of the implant to be accurately determined.

The implant of this invention can be utilized in a wide variety of orthopaedic, neurosurgical and oral and maxillofacial surgical procedures such as the repair of simple and compound fractures and non-unions, external and internal fixations, Melboume\003897155 Printed 7 September 2001 (14:54) joint reconstructions such as arthrodesis, general arthroplasty, cup arthroplasty of the hip, femoral and humeral head replacement, femoral head surface replacement and total joint replacement, repairs of the vertebral column including spinal fusion and internal fixation, tumor surgery, e.g. deficit filling, discectomy, laminectomy, excision of spinal cord tumors, anterior cervical and thoracic operations, repair of spinal injuries, scoliosis, lordosis and kyphosis treatments, intermaxillary fixation of fractures, mentoplasty, temporomandibular joint replacement, alveolar ridge augmentation and reconstruction, inlay bone grafts, implant placement and revision, sinus lifts, etc. These materials can be sutured or stapled in place for anchoring purposes and serve in guided tissue regeneration or as barrier materials.

The following examples are illustrative of the resorbable implant of this invention.

EXAMPLE 1 A sheet fabricated from demineralized elongate bone particles is manufactured according to the method described in U.S. Pat. No. 5,507,813. While l the sheet is being wet-laid nondemineralized bone particles that have been classified to a predetermined range are added thereto. The mineralized particles are uniformly distributed within the wet sheet which is then subjected to the remaining manufacturing operations described in the aforesaid patent. The resultant flexible sheets are then cut into implant-sized pieces.

EXAMPLE 2 A small sheet from Example 1 is rehydrated and implanted into an animal at a calvarial defect site. The site is then sutured closed and the skull is x-rayed. The mineralized particles are displayed on the resultant x-ray film as white spots allowing the location of the implant to be precisely determined.

EXAMPLE 3 The nondemineralized bone particles in Example 1 can be incorporated into Melbourne\003897155 Printed 7 September 2001 (14:54) the wet-laid sheet in a regular pattern such as a grid with 5 mm spaces between particles. When the sheet processing is completed and a small sheet segment is rehydrated and implanted as in Example 2, the position/orientation of the sheet segment is more easily determined via x-ray imaging due to the regular pattern of the radiopaque nondemineralized particles.

EXAMPLE 4 The nondemineralized particles of Example 1 can be distributed in a flowable osteogenic composition which is comprised of demineralized bone particles and an inert carrier such as glycerol.

*o *oo Melboume\003897155 Printed 7 September 2001 (14:54)

Claims (22)

1. A surgical implant for surgical implantation in the body, the implant being fabricated from radiolucent material and possessing a resorbable radiopaque marker, wherein the radiolucent material is resorbable demineralized bone or collagen.

2. A surgical implant according to claim 1, wherein the resorbable material is a flexible sheet of demineralized bone.

3. A surgical implant according to claim 1, wherein the resorbable .radiopaque marker comprises nondemineralized or partially demineralized bone particles.

4. A surgical implant according to claim 3, wherein the nondemineralized or partially demineralized bone particles are selected from the group consisting of human and animal bone. *o

5. A surgical implant according to claim 3, wherein the nondemineralized or partially demineralized bone particles are of a predetermined shape selected from the group consisting of spherical, quasi-spherical, cuboid, tube, fiber, spiral and rectangular.

6. A surgical implant according to claim 3, wherein the partially demineralized bone particles contain not less than about 20 weight percent residual inorganic matter.

7. A surgical implant for surgical implantation in the body, the implant being fabricated from radiolucent material and possessing a resorbable radiopaque marker, wherein the resorbable radiopaque marker is a calcium-based mineral selected from the group consisting of hydroxyapatite, tricalcium phosphate, Melboume\003897155 Printed 7 September 2001 (14:54) fluorapatite and their mixtures, the resorbable radiopaque marker being arranged within the implant in accordance with a predetermined pattern.

8. A surgical implant according to either one of claims 1 or 7, which possess a definite geometrical configuration.

9. A surgical implant according to claim 7, wherein the predetermined pattern is a grid.

10. A surgical implant for surgical implantation in the body, the implant being fabricated from radiolucent material and possessing a resorbable particulate radiopaque marker arranged within the radiolucent material in a predetermined geometric pattern.

11. A surgical implant according to claim 10, wherein the radiolucent material is resorbable.

12. A surgical implant according to claim 11, wherein the resorbable material is demineralized bone or collagen.

13. A surgical implant according to claim 11, wherein the resorbable material is a flexible sheet of demineralized bone.

14. A surgical implant according to claim 10 which possesses a definite geometrical configuration.

15. A surgical implant according to claim 11, wherein the resorbable radiopaque marker comprises a nondemineralized or partially demineralized bone particles.

16. A surgical implant according to claim 15, wherein the nondemineralized or Melboure\003897155 Printed 7 September 2001 (14:54) partially demineralized bone particles are selected from the group consisting of human and animal bone.

17. A surgical implant according to claim 15 wherein the nondemineralized or partially demineralized bone particles are of a predetermined shape selected from the group consisting of spherical, quasi-spherical, cuboid, tube, fiber, spiral and rectangular.

18. A surgical implant according to claim 15, wherein the partially demineralized bone particles contain not less than about 20 weight percent residual inorganic matter.

19. A surgical implant according to claim 11 wherein the resorbable radiopaque marker is a calcium-based mineral selected from the group consisting of hydroxyapatite, tricalcium phosphate, fluorapatite and their mixtures.

20. A surgical implant according to claim 11, wherein the resorbable radiopaque marker is arranged within the implant in accordance with a predetermined pattern.

21. A surgical implant according to claim 20 wherein the predetermined pattern is a grid.

22. A surgical implant substantially as hereinbefore described with reference to the accompanying drawings. Dated: 7 September, 2001 FREEHILLS CARTER SMITH BEADLE Patent Attorneys for the Applicant OSTEOTECH, INC Melboure\003897155 Printed 7 September 2001 (14:54)