Bone regeneration

• US 5,824,087 A
• Filed: 01/21/1997
• Issued: 10/20/1998
• Est. Priority Date: 04/11/1994
• Status: Expired due to Fees

• Current Assignee: Aberdeen University, Plasma Biotal Limited
• Original Assignee: Aberdeen University and Plasma Biotal Limited
• Inventors: Aspden, Richard Malcom, Porter, Richard William, Murali, Srimathi Rajagopalan
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US08/727,396
• Time in Patent Office: 637 Days
• Field of Search: 606/92, 606/93, 606/94, 606/99, 606/100, 623/16, 604/264, 604/274
• US Class Current: 606/94
• CPC Class Codes: A61B 17/8811 characterised by the introducer tip, i.e. the part inserted into or onto the bone
• CPC Class Codes: A61B 17/8819 characterised by the introducer proximal part, e.g. cannula handle, or by parts which are inserted inside each other, e.g. stylet and cannula A61B17/8825 takes precedence
• 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 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30289 helically-coiled
• CPC Class Codes: A61F 2002/30879 Ribs
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61K 38/27 Growth hormone [GH], i.e. somatotropin
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 24/0015 Medicaments; Biocides
• CPC Class Codes: A61L 24/0063 Phosphorus containing materials, e.g. apatite
• CPC Class Codes: A61L 24/106 Fibrin; Fibrinogen
• CPC Class Codes: A61L 27/227 Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
• CPC Class Codes: A61L 27/425 of phosphorus containing material, e.g. apatite
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence

Abstract

An intraosseous device having an elongated shaft and handle with a syringe attached to the shaft is disclosed. The syringe can be filled with an intraosseous liquid suspension which is made of a hydroxyapatite, a carbonated apatite, a calcium ion source, and a hormone mixture. The shaft includes a frusto-conical connector for releasable interconnection with cortical bone, and the handle facilitates turning the shaft to interconnect it to the bone.

Claims

1. An intraosseous injection device comprising:

(a) an elongated shaft having a proximal and distal end and a through bore beginning at the proximal end and terminating at the distal end in a frusto-conical connector portion for releasable interconnection with cortical bone;

(b) a handle means associated with said elongated shaft at the proximal end for turning said shaft so that said shaft is releasably interconnected with the cortical bone; and

(c) a syringe for the injection of an intraosseous liquid suspension into the through bore in said elongated shaft wherein said syringe is connected to said shaft.

2. The intraosseous injection device of claim 1 wherein the proximal end of said elongated shaft terminates in a hub, said hub comprising a recessed portion for the releasable engagement of manipulatable parts.

3. The intraosseous injection device of claim 2 further comprising manipulatable parts in the recessed portion of said hub.

4. The intraosseous injection device of claim 1 further comprising a means to withdraw said syringe during an injection sequence so that intraosseous liquid is applied under pressure over a selected portion of cortical bone.

5. The intraosseous injection device of claim 1 further comprising an intraosseous liquid suspension composition in said syringe wherein said intraosseous injectable composition comprises hydroxyapatite, carbonated apatite, or a mixture of hydroxyapatite and carbonated apatite, a biocompatable source of calcium ions, and a hormone selected from the group consisting of human growth hormone, insulin-like growth factor-1 and insulin-like growth factor-2 and wherein the composition is in the form of a settable injectable liquid.

6. The intraosseous injection device of claim 5 wherein said carbonated apatite or hydroxyapatite of said intraosseous injectable composition has a particle size of 30-300 μ

m, to obtain a spacing of about 200-250 μ

m between said particles in use.

7. The intraosseous injection device of claim 5 wherein said composition comprises 70 to 30% carbonated apatite or 70 to 30% hydroxyapatite, 30 to 70% calcium salt and up to 4 units of the protein, with distilled water or saline being then added to the solid admixed components in the amount of 50 to 70% by weight.

8. The intraosseous injection device of claim 5, wherein the calcium ions are derived from calcium sulphate, tricalcium phosphate, monocalcium phosphate monohydrate or calcium carbonate.

9. An intraosseous injection device comprising:

(a) an elongated shaft having a proximal and distal end and a through bore beginning at the proximal end and terminating at the distal end in a frusto-conical connector portion for releasable interconnection with cortical bone, wherein the proximal end of said elongated shaft terminates in a hub having a recessed portion for the releasable engagement of manipulatable parts comprising a needle carrying hub having a vented double hollow needle and a proximal chamber for operative interengagement with a syringe;

(b) a handle means associated with said elongated shaft at the proximal end for turning said shaft so that said shaft is releasably interconnected with cortical bone; and

(c) a syringe operatively interengaged with the hub of said elongated shaft for the injection of an intraosseous liquid suspension into the through bore in said elongated shaft.