METHODS OF MANUFACTURING A DELIVERY SYSTEM FOR PROMOTING BONE GROWTH

• US 20080317817A1
• Filed: 09/02/2008
• Published: 12/25/2008
• Est. Priority Date: 01/28/2004
• Status: Active Grant

• Current Assignee: Ultradent Products Incorporated
• Original Assignee: Ultradent Products Incorporated
• Inventors: Fischer, Dan E.
• Granted Patent: US 8,323,339 B2
• Time in Patent Office: Days
• US Class Current: 424/426
• 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 method for manufacturing a delivery system that includes a bone growth promoting material encapsulated within a water-absorbing, water-gelatinizable covering 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 (e.g., oxidized cellulose) that forms a gel-like material when moistened with water. The delivery system may be stored in a moisture resistant package prior to use.

Claims

1. A method of manufacturing a delivery system for promoting bone growth comprising:

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

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

closing one or more initially open ends of the tube or pouch to form a delivery system for promoting bone growth comprised of an outer covering formed from the water-absorbing, water-gelatinizable material that defines an interior space and the bone growth promoting material encapsulated within the interior space by the outer covering.

2. A method as recited in claim 1, wherein closing one or more initially open ends of the tube or pouch comprises wet sealing and then drying the ends.

3. A method as recited in claim 2, wherein wet sealing causes the water-absorbing, water-gelatinizable material at or near the one or more initially open ends of the tube or pouch to become a gelatinous and self-adhesive material.

4. A method as recited in claim 3, wherein drying causes the gelatinous and self-adhesive material to harden so as to form a dried seal.

5. A method as recited in claim 1, further comprising dividing the tube or pouch into individual sections and then individually sealing ends of each individual section so as to form a plurality of delivery systems from a single tube or pouch filled with the bone growth promoting material.

6. A method as recited in claim 1, wherein the water-absorbing, water-gelatinizable material is formed by oxidizing an intermediate covering material that is initially non-water-absorbing and non-water-gelatinizable prior to being oxidized.

7. A method as recited in claim 6, wherein the covering material is oxidized prior to inserting the bone growth promoting material into at least a portion of the tube or pouch.

8. A method as recited in claim 6, wherein the covering material is oxidized after inserting the bone growth promoting material into at least a portion of the tube or pouch.

9. A method as recited in claim 1, wherein the water-absorbing, water-gelatinizable material comprises oxidized cellulose, gelatinizable gauze, oxidized regenerated cellulose, or gelatinizable cat gut.

10. A method as recited in claim 1, wherein the bone growth promoting material comprises at least one of calcium hydroxyapatite, beta-tricalcium phosphate, purified coral shell, freeze dried natural bone powder, freeze dried natural bone particles, demineralized natural bone powder, or demineralized natural bone particles, shards or fragments.

11. A method as recited in claim 1, wherein the delivery system has an elongate sausage-like configuration.

12. A method as recited in claim 1, wherein the delivery system has a pillow-like configuration.

13. A method as recited in claim 1, further comprising placing the delivery system into a moisture-resistant package in order to maintain the outer covering in a dry condition prior to use and prevent premature gelatinization.

14. A method as recited in claim 1, further comprising dispersing an adhesive within the bone growth promoting material.

15. A method as recited in claim 15, wherein the adhesive comprises at least one of fibrin powder or chopped adhesive gauze.

16. A method of manufacturing a delivery system for promoting bone growth comprising:

forming a cellulose fabric into a hollow tube or pouch;

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

oxidizing the cellulose fabric in order to convert it into a water-absorbing, water-gelatinizable material that becomes gelatinous when contacted with water; and

closing one or more initially open ends of the tube or pouch to form a delivery system for promoting bone growth comprised of an outer covering formed from the water-absorbing, water-gelatinizable material that defines an interior space and the bone growth promoting material encapsulated within the interior space by the outer covering.

17. A method as recited in claim 16, wherein closing one or more initially open ends of the tube or pouch comprises wet sealing and drying the ends.

18. A method as recited in claim 16, further comprising dividing the tube or pouch into individual sections and then individually wet sealing and drying ends of each individual section so as to form a plurality of delivery systems from a single tube or pouch filled with the bone growth promoting material.

19. A method of manufacturing a delivery system for promoting bone growth comprising:

forming an oxidized cellulose gauze into a hollow tube or pouch;

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

wet sealing and drying one or more initially open ends of the tube or pouch to form a delivery system for promoting bone growth comprised of an outer covering formed from the water-absorbing, water-gelatinizable material that defines an interior space and the bone growth promoting material encapsulated within the interior space by the outer covering.

20. A method as recited in claim 19, further comprising dividing the tube or pouch into individual sections and then individually wet sealing and drying ends of each individual section so as to form a plurality of delivery systems from a single tube or pouch filled with the bone growth promoting material.