Methods of manufacturing a delivery system for promoting bone growth

• US 8,323,339 B2
• Filed: 09/02/2008
• Issued: 12/04/2012
• 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): Marx, Irene
• Assistant Examiner(s): SINGH, SATYENDRA K
• Application Number:
  US12/202,886
• Publication Number:
  US 20080317817A1
• Time in Patent Office: 1,554 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 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 that becomes gelatinous and self-adhesive when moistened with water into a hollow tube or pouch having an initially open end;

inserting a bone growth promoting material into the hollow tube or pouch through the initially open end;

closing the initially open end of the tube or pouch;

moistening the closed end with water so that it temporarily becomes gelatinous and self-adhesive; and

drying the closed, moistened, and self-adhesive end to form a sealed end of the tube or pouch and thereby 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,

wherein the outer covering becomes sticky and adhesive to tissue in a bone void when moistened with water.

2. A method as recited in claim 1, the hollow tube or pouch including a plurality of initially open ends that are closed, moistened with water, and dried to form a plurality of sealed ends.

3. A method as recited in claim 1, wherein drying causes the gelatinous and self-adhesive material to harden so as to form a dried seal.

4. A method as recited in claim 1, further comprising:

dividing the tube or pouch into individual sections,

individually wet 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, and

separating the delivery systems prior to use.

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

6. A method as recited in claim 5, wherein the covering material is oxidized in the intermediate process prior to inserting the bone growth promoting material into at least a portion of the tube or pouch.

7. A method as recited in claim 5, wherein the covering material is oxidized in the intermediate process after inserting the bone growth promoting material into at least a portion of the tube or pouch.

8. 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.

9. 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.

10. A method as recited in claim 1, wherein the delivery system has an elongate sausage-like configuration comprising at least one wet sealed end.

11. A method as recited in claim 1, wherein the delivery system has a pillow-like configuration comprising at least one wet sealed end.

12. 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 prior to placement into the bone void.

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

14. A method as recited in claim 13, wherein the adhesive comprises at least one of fibrin powder or chopped adhesive gauze.

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

forming a non water-gelatinizable cellulose fabric into a hollow tube or pouch;

inserting a bone growth promoting material into the tube or pouch;

after inserting the bone growth promoting material into the tube or pouch, oxidizing the cellulose fabric in order to convert it into a water-absorbing, water-gelatinizable material that becomes sticky and adhesive to tissue in a bone void when moistened 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,

wherein the outer covering becomes sticky and adhesive to tissue in a bone socket when moistened with water.

16. A method as recited in claim 15, wherein closing one or more initially open ends of the tube or pouch comprises wet sealing and drying the ends.

17. A method as recited in claim 15, further comprising:

dividing the tube or pouch into individual sections, and

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.

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

forming an oxidized cellulose gauze into a hollow tube or pouch having an initially open end, the oxidized cellulose gauze becoming gelatinous and self-adhesive when moistened with water;

inserting a bone growth promoting material the hollow tube or pouch through the initially open end;

closing and applying moisture to the initially closed end so that it temporarily becomes gelatinous and self-adhesive; and

drying the closed and moistened end to form a sealed end of the tube or pouch and thereby 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,

wherein the outer covering becomes sticky and adhesive to tissue in a bone socket when moistened with water.

19. A method as recited in claim 18, 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,

wherein the plurality of delivery systems can be separated into individual delivery systems prior to use.

20. A method as recited in claim 18, 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.