Method for rinsing and delivering bone graft

Patent metadata

Field	Value
Publication number	US-9427335-B2
Application number	US-201414218013-A
Country	US
Kind code	B2
Filing date	Mar 18, 2014
Priority date	Mar 18, 2014
Publication date	Aug 30, 2016
Grant date	Aug 30, 2016

Abstract

A method for rinsing and delivering a bone graft. The method includes selecting a delivery syringe containing bone graft material wherein the syringe is coupled to a filter assembly, determining a bone graft:fluid ratio, washing the bone graft material, reconstituting the bone graft material to generate the bone graft with the predetermined bone graft:fluid ratio, and delivering the bone graft to a surgical site.

First claim

What is claimed is:

1. A method for rinsing and delivering a bone graft comprising:
a. selecting a delivery syringe comprising a proximal plunger, a distal open bore, and a filter assembly comprising a filter and a nozzle, the filter being removably coupled to the syringe adjacent to the distal open bore, and the syringe having a bone graft material and a cryopreservative solution therein;
b. determining a bone graft material:fluid ratio;
c. depressing the plunger to expel the cryopreservative solution from the delivery syringe, through the filter and out the nozzle, wherein the bone graft material is maintained within the syringe;
d. inserting a distal end of the syringe into a receptacle containing a wash solution and drawing the plunger to aspirate a wash solution into the syringe;
e. inverting the syringe to mix the wash solution with the bone graft material;
f. depressing the plunger to expel the wash solution;
g. d. through f. to wash the bone graft material;
h. reconstituting the bone graft material, including inserting the distal end of the syringe into a second receptacle containing a reconstitution fluid and drawing the plunger to aspirate the reconstitution fluid to generate the bone graft with the predetermined bone graft material:fluid ratio; and
i. removing the filter assembly from the syringe and delivering the bone graft material through the open bore to a surgical site by depressing the plunger.

2. The method according to claim 1 , wherein d. through f. are repeated one or more times.

3. The method according to claim 1 , wherein the wash solution comprises saline or phosphate buffered saline.

4. The method according to claim 1 , wherein the reconstitution fluid is selected from saline, phosphate buffered saline, whole blood, a blood fraction, bone marrow aspirate, concentrated bone marrow aspirate, and a combination thereof.

5. The method according to claim 1 , wherein the reconstitution fluid comprises monocytes, lymphocytes, neutrophils, eosinophils, basophils, platelets, platelet rich plasma, platelet poor plasma, or a combination thereof.

6. The method according to claim 1 , wherein the reconstitution fluid comprises stromal cells, mesenchymal stem cells, or both.

7. The method according to claim 1 , wherein reconstituting includes inverting the syringe to mix the bone graft material and the reconstitution fluid.

8. The method according to claim 1 , wherein the reconstitution fluid comprises a supplemental component that is autologous to the subject.

9. The method according to claim 1 , wherein the reconstitution fluid comprises a component selected from interleukin-1 receptor antagonist (IL-1ra), soluble tumor necrosis factor-receptor I (sTNF-RI), soluble tumor necrosis factor-receptor II (sTNF-RII), soluble interleukin-1 receptor II (sIl-1 RII), platelet-derived growth factor-AB (PDGF-AB), platelet-derived growth factor-BB (PDGF-BB), insulin-like growth factor-I (IGF-I), transforming growth factor-β1 (TGF-β1), hepatocyte growth factor (HGF), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), and a combination thereof.

10. The method according to claim 1 , wherein the bone graft material:fluid ratio is from about 10:1 to about 1:1.

11. The method according to claim 1 , wherein reconstituting includes aspirating an excess amount of the reconstitution fluid into the syringe and depressing the plunger to expel a portion of the reconstitution fluid out through the filter until the predetermined bone graft material:fluid ratio is obtained.

12. A method comprising:
obtaining a syringe comprising a filter removably coupled to the syringe, wherein the syringe has bone graft particles and a cryopreservative solution contained therein, and wherein the filter has a pore size such that only a negligible amount of the bone graft particles can pass through;
depressing a plunger of the syringe to expel the cryopreservative solution through the filter, wherein the bone graft particles are maintained within the syringe;
washing the bone graft particles, including drawing the plunger to aspirate a wash solution into the syringe, inverting the syringe to mix the wash solution and bone graft particles, and depressing the plunger to expel the wash solution;
reconstituting the bone graft particles in a reconstitution fluid;
removing the filter from the syringe; and
depressing the plunger to deliver the bone graft particles through an open bore of the syringe.

13. The method according to claim 12 , wherein the wash solution is different from the reconstitution fluid.

14. The method according to claim 12 , wherein the wash solution comprises saline or phosphate buffered saline.

15. The method according to claim 12 , wherein reconstituting the graft material comprises:
drawing the plunger to aspirate an excess amount of the reconstitution fluid;
inverting the syringe to mix the reconstitution fluid with the bone graft particles; and
depressing the plunger to expel a portion of the reconstitution fluid until a desired bone graft particle:fluid ratio is obtained.

16. The method according to claim 12 , wherein the reconstitution fluid comprises saline, phosphate buffered saline, an antimicrobial agent, whole blood, a blood fraction, bone marrow aspirate, concentrated bone marrow aspirate, or a combination thereof.

17. The method according to claim 12 , wherein the reconstitution fluid comprises stromal cells or mesenchymal stem cells.

18. The method according to claim 12 , wherein the filter has a pore size between about 150 μm and about 200 μm.

19. The method according to claim 12 , wherein the bone graft particles have diameters ranging from about 125 μm to about 5000 μm.

20. A method for rinsing and delivering a bone graft comprising:
a. selecting a syringe containing bone graft material and a cryopreservative solution, the syringe comprising a proximal plunger, a distal open bore, and a filter removably coupled to the syringe adjacent to the distal open bore, wherein the bone graft material comprises bone particles with diameters of from about 50 μm to about 5 mm and wherein the filter has a pore size of from about 150 μm to about 200 μm;
b. determining a bone graft material:fluid ratio of from about 10:1 to about 1:1;
c. depressing the plunger to expel the cryopreservative solution from the syringe and through the filter, wherein the bone graft material is maintained within the syringe;
d. inserting a distal end of the syringe into a receptacle containing a wash fluid and drawing the plunger to aspirate the wash solution into the syringe, wherein the wash fluid is saline or phosphate buffered saline;
e. inverting the syringe to mix the wash solution with the bone graft material;
f. depressing the plunger to expel the wash solution;
g. repeating d. through f. one or more times to wash the bone graft material;
h. reconstituting the bone graft material by inserting the distal end of the syringe into a second receptacle containing a reconstitution fluid and drawing the plunger to aspirate the reconstitution fluid to obtain the bone graft material with the predetermined bone graft material:fluid ratio, wherein the reconstitution fluid comprises saline, phosphate buffered saline, whole blood, white blood cells, platelets, platelet rich plasma, platelet poor plasma, bone marrow aspirate, concentrated bone marrow aspirate, or a combination thereof; and
i. removing the filter from the syringe and delivering the reconstituted bone graft material through the open bore to a surgic

Assignees

• Biomet Biologics Llc
• Biomet Biologics Llc

Inventors

• Ponticiello Michael
• Mathur Surinder Saran

Classifications

• A61F2002/2835

  Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material · CPC title

• A61F2/4601

  for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity · CPC title

• A61F2/28

  Bones · CPC title

• A61F2/4644 Primary

  Preparation of bone graft, bone plugs or bone dowels, e.g. grinding or milling bone material (bone material A61F2/28; disintegrating or milling devices B02C) · CPC title

• A61B17/8825

  characterised by syringe details (A61B17/8822, A61B17/8827 take precedence) · CPC title