Delivery system for bone growth promoting material

• US 7,534,264 B2
• Filed: 01/28/2004
• Issued: 05/19/2009
• Est. Priority Date: 01/28/2004
• Status: Expired due to Fees

• Current Assignee: Ultradent Products Incorporated
• Original Assignee: Ultradent Products Incorporated
• Inventors: Fischer, Dan E.
• Primary Examiner(s): Saucier; Sandra
• Assistant Examiner(s): Singh; Satyendra K
• Application Number:
  US10/766,503
• Publication Number:
  US 20050163820A1
• Time in Patent Office: 1,938 Days
• Field of Search: None
• US Class Current: 623/16.11
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 2017/564 Methods for bone or joint treatment
• CPC Class Codes: A61C 5/62 Applicators, e.g. syringes or guns
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2310/00359 Bone or bony tissue
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/32 Phosphorus-containing materials, e.g. apatite
• CPC Class Codes: A61L 27/3608 Bone, e.g. demineralised bone matrix [DBM], bone powder
• CPC Class Codes: A61L 27/365 Bones
• CPC Class Codes: A61L 27/46 with phosphorus-containing inorganic fillers

Abstract

A delivery system that includes a bone growth promoting material encapsulated within a water absorptive gelatinizable covering is used to promote bone growth in order to repair a bone defect and/or strengthen a weakened bone region. The delivery system may be shaped and sized in order to fit within a bleeding wound (e.g. one that is formed in the gingiva when a tooth is extracted). The covering may be formed of a gelatinizable gauze that forms a gel-like material when moistened with water. The delivery system is contained within a moisture resistant package prior to use. Alternatively, the delivery system comprises a bone growth promoting material and thickening agent contained within a syringe that, upon adding water, form a viscous gel or stiff putty.

Claims

1. A moisture activated implant device for placement into a tooth extraction site or other bone defect and promoting bone growth in the bone defect, comprising:

a dry covering comprised of a water absorbing gelatinizable material that defines an enclosed space, wherein the dry covering consists essentially of oxidized cellulose; and

a bone growth promoting material, disposed within the enclosed space defined by the dry covering, selected from the group consisting of hydroxyapatite, beta-tricalcium phosphate, purified coral shell, freeze dried natural bone powder, freeze dried natural bone particles, demineralized natural bone powder, demineralized natural bone particles, demineralized natural bone shards, demineralized natural bone fragments, and combinations thereof,

wherein the dry covering encapsulates and retains the bone growth promoting material within the enclosed space prior to use and becomes gelatinous and adhesive upon contact with water so as to retain the bone growth promoting material within a tooth extraction site or other bone defect during use.

2. The implant device as recited in claim 1, wherein the implant device consists essentially of oxidized cellulose and the bone growth promoting material.

3. The implant device as recited in claim 1, wherein the water absorbing gelatinizable material is resorbable.

4. The implant device as recited in claim 1, wherein the implant device has an elongate sausage-like configuration.

5. The implant device as recited in claim 1, wherein the implant device has a pillow like configuration.

6. The implant device as recited in claim 1, further comprising moisture-resistant packaging within which the implant device is stored prior to use.

7. The implant device as recited in claim 1, wherein the implant device further comprises an adhesive dispersed with the bone growth promoting material for adhering the bone growth material together.

8. The implant device as recited in claim 7, wherein the adhesive comprises at least one of fibrin powder or chopped adhesive gauze.

9. A method of manufacturing the implant device for promoting bone growth according to claim 1, comprising:

forming the water absorbing gelatinizable material into a hollow tube or pouch;

inserting the bone growth promoting material into at least a portion of the tube or pouch; and

closing the open ends of the tube or pouch filled with the bone growth promoting material to form the implant device for promoting bone growth.

10. The method of manufacturing as recited in claim 9, wherein the act of closing the open ends of the tube or pouch comprises wet sealing and then drying the ends.

11. The method of manufacturing as recited in claim 9, wherein the tube or pouch is divided into a plurality of individual sections that are separated and individually sealed so as to form a plurality of implant devices from a single tube or pouch filled with the bone growth promoting material.

12. A method of promoting bone growth within a tooth extraction site or other bone defect, comprising:

providing the implant device recited in claim 1, the covering of the implant device being dry and initially non-adhesive; and

placing the implant device within a tooth extraction site or other bone defect;

wherein the covering of the implant device becomes gelatinous and adhesive upon contact with water and retains the bone growth material within the tooth extraction site or other bone defect.

13. The method as defined in claim 12, wherein the implant device is placed into a bone defect resulting from the removal of a tooth.

14. A moisture activated implant device for placement into a tooth extraction site or other bone defect and promoting bone growth in the bone defect, comprising:

a dry covering comprised of a water absorbing gelatinizable material that defines an enclosed space, wherein the dry covering consists essentially of oxidized cellulose;

a bone growth promoting material in granule or powder form disposed within the enclosed space defined by the dry covering, wherein the bone growth promoting material comprises hydroxyapatite, beta-tricalcium phosphate, purified coral shell, natural bone, demineralized natural bone, or a combination thereof; and

a thickener dispersed among the bone growth promoting material, the thickener comprising a material that forms a viscous gel or firm putty upon contact with water, wherein the dry covering encapsulates and retains the bone growth promoting material within the enclosed space prior to use and becomes gelatinous and adhesive upon contact with water so as to retain the bone growth promoting material within a tooth extraction site or other bone defect during use.

15. The implant device as recited in claim 14, wherein the implant device consists essentially of oxidized cellulose, the bone growth promoting material, and the thickener.

16. The implant device as recited in claim 14, wherein the thickener comprises at least one of gelatinizable gauze, oxidized cellulose, oxidized regenerated cellulose, ground catgut, or powdered catgut.

17. The implant device as recited in claim 14, wherein the thickener comprises a biocompatible gelatinous collagen material.

18. The implant device as in recited in claim 14, wherein the dry covering is woven, knitted, or braided.