Delivery system for bone growth promoting material

• US 8,277,828 B2
• Filed: 10/13/2006
• Issued: 10/02/2012
• Est. Priority Date: 01/28/2004
• Status: Active Grant

• Current Assignee: Ultradent Products Incorporated
• Original Assignee: Ultradent Products Incorporated
• Inventors: Fischer, Dan E.
• Primary Examiner(s): Weber, Jon P
• Assistant Examiner(s): SINGH, SATYENDRA K
• Application Number:
  US11/549,540
• Publication Number:
  US 20070071791A1
• Time in Patent Office: 2,181 Days
• Field of Search: None
• US Class Current: 424/422
• 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. A polymerizable resin may be placed over the bone growth composition after placement on a bone to form a protective barrier layer.

Claims

1. A method for promoting bone growth in a bone defect, comprising:

providing a bone growth promoting composition, the bone growth promoting composition comprising;

a bone growth promoting material in granule or powder form, wherein the bone growth promoting material is a mineral-containing material selected from the group consisting of calcium hydroxyapatite, tricalcium phosphate, purified coral shell, freeze dried natural bone powder, freeze dried natural bone granules, and mixtures thereof;

water or blood; and

a water-gelatinizable thickener dispersed among the bone growth promoting material that, in combination with the water and bone growth promoting material, causes the bone growth promoting composition to have the consistency of a viscous gel or firm putty, the water-gelatinizable thickener being free of collagen; and

thereafter introducing the bone growth promoting composition in the form of the viscous gel or firm putty into a bone defect.

2. A method as defined in claim 1, wherein the water-gelatinizable thickener comprises at least one of water-gelatinizable gauze, water-gelatinizable oxidized cellulose, or water-gelatinizable oxidized regenerated cellulose ground up or in powder form so as to be gelatinizable.

3. A method as defined in claim 1, further comprising adding a preservative in the bone growth composition.

4. A method as defined in claim 1, wherein an initial composition comprising bone growth promoting material and thickener is initially pre-loaded in dry form within a syringe, the method further comprising adding water to the syringe to form the bone growth composition in the form of the viscous gel or firm putty.

5. A method as defined in claim 4, wherein the bone growth composition is mixed with blood prior to being introduced into the bone defect.

6. A method as defined in claim 1, wherein the bone growth composition is introduced into the bone defect using a syringe.

7. A method of promoting bone growth in a bone void formed by removing a tooth, comprising:

providing a bone void formed by removing a tooth;

providing a bone growth composition initially in dry form, the bone growth composition being comprised of;

a bone growth promoting material in granule or powder form; and

a water-gelatinizable thickener dispersed among the bone growth promoting material that, upon addition of water, causes the composition to form a viscous gel or firm putty, the water-gelatinizable thickener being free of collagen;

adding water or blood to the bone growth composition so as to form a viscous gel or firm putty; and

thereafter placing the viscous gel or firm putty within the bone void formed by removing a tooth.

8. A method as defined in claim 7, further comprising dispensing the viscous gel or firm putty adjacent to the bone tissue by means of a syringe.

9. A method as defined in claim 7, further comprising placing and curing a polymerizable resin over the bone growth composition so as to form a barrier layer.

10. A method as recited in claim 9, wherein the polymerizable resin is light cured.

11. A method as recited in claim 9, wherein the polymerizable resin is chemically cured.

12. A method as defined in claim 7, wherein the thickener is comprised of at least one of gelatinizable gauze, gelatinizable oxidized cellulose, or gelatinizable oxidized regenerated cellulose, or cat gut ground up or in powder form so as to be gelatinizable.

13. A method as defined in claim 7, further comprising adding a preservative to the bone growth composition.

14. A method for promoting bone growth in a bone defect, comprising:

providing a bone growth promoting composition, the bone growth promoting composition comprising;

a bone growth promoting material in granule or powder form, wherein the bone growth promoting material is a mineral-containing material selected from the group consisting of calcium hydroxyapatite, tricalcium phosphate, purified coral shell, freeze dried natural bone powder, freeze dried natural bone granules, and mixtures thereof;

water or blood; and

a water-gelatinizable thickener dispersed among the bone growth promoting material that, in combination with the water and bone growth promoting material, causes the bone growth promoting composition to have the consistency of a paste, gel or putty, wherein the water-gelatinizable thickener comprises at least one of gelatinizable gauze, gelatinizable oxidized cellulose, or gelatinizable oxidized regenerated cellulose; and

thereafter introducing the bone growth promoting composition into a bone defect.

15. A method of promoting bone growth on a bone or in a bone defect, comprising:

providing a syringe containing therein a bone growth composition in dry form, the bone growth composition being comprised of;

a bone growth promoting material in granule or powder form; and

a water-gelatinizable thickener dispersed among the bone growth promoting material that, upon addition of water, causes the composition to form a viscous gel or firm putty, the water-gelatinizable thickener being free of collagen;

introducing water into the syringe in order to convert the bone growth composition into a paste or gel that can be expressed onto a bone or into a bone defect by means of the syringe; and

expressing the paste or gel onto a bone or into a bone defect by means of the syringe.

16. A method as defined in claim 15, wherein introducing water into the syringe includes introducing blood into the syringe.