Pliable medical device and method of use

Abstract

A firm but pliable medical device for use as a bone graft substitute or bone graft extender retains its shape without the requirement of a containment device, such as a syringe. Because the device is solid, it is easy to locate or position in-vivo and, in the moist environment of the body, it will hold its shape well, for an extended time. Because the lyophilized pliable medical device is porous, it adsorbs blood and other beneficial cells containing body fluids, such as bone marrow, contributing to its superior bone repair efficacy in comparison to an analogous putty that has not been lyophilized. In addition these lyophilized pliable medical devices are easier to terminally steam sterilize than the analogous putty because there is no moisture present to boil and ‘blow-out’ of the containment device (syringe). The glycerin that is present in the formulation lends pliability but has a low vapor pressure.

1 - 61 . (canceled) 
     
     
         62 . A method for preparing a pliable implantable composition useful for repairing bone damage and promoting bone formation in mammals, the method comprising the steps of:
 (a) preparing a hydrogel material by mixing (i) a polymer with (ii) a dispersing agent, and (iii) water;   (b) mixing the hydrogel material with an osteoconductive component comprising anorganic bone mineral particles having diameters between 50 microns to 2000 microns to form a putty; and   (c) lyophilizing the putty,   wherein step (c) results in formation of an implantable composition having a porosity of 5% to 30% without an occlusive skin being formed around the anorganic bone mineral particles.   
     
     
         63 . The method of  claim 62 , wherein the polymer is selected from sodium carboxymethylcellulose, hydroxyethyl cellulose, hydroxypropyl methylcellulose, methylcellulose, and ethylcellulose. 
     
     
         64 . The method of  claim 62 , wherein the dispersing agent is selected from elected from glycerin, polyethylene glycol, N-methyl pyrrolidone, and triacetin. 
     
     
         65 . The method of  claim 62 , wherein the polymer is sodium carboxymethylcellulose and the dispersing agent is glycerin. 
     
     
         66 . The method of  claim 62 , wherein the anorganic bone mineral particles have diameters between 250 microns to 425 microns. 
     
     
         67 . The method of  claim 62 , wherein the pliable implantable composition has the shape of a cylinder, a cube, a sheet, a star, a toroid, a pyramid, a sphere, or an irregular shape. 
     
     
         68 . The method of  claim 67 , wherein the shape is a cylinder. 
     
     
         69 . The method of  claim 67 , wherein the shape is a cube. 
     
     
         70 . The method of  claim 67 , wherein the shape is a sheet. 
     
     
         71 . The method of  claim 62 , wherein the pliable implantable composition comprises:
 (i) from 5% to 20% (w/w) of a dispersing agent selected from glycerin and polyethylene glycol;   (ii) from 1.0% to 6.0% (w/w) of a polymer selected from sodium carboxymethylcellulose, hydroxyethyl cellulose, hydroxypropyl methylcellulose, and methylcellulose;   (iii) from 65% to 90% (w/w) of an osteoconductive component comprising anorganic bone mineral particles having diameters between 250 microns to 425 microns; and   (iv) from 1% to 5% (w/w) water.   
     
     
         72 . The method of  claim 71 , wherein the dispersing agent is glycerin. 
     
     
         73 . The method of  claim 71 , wherein the polymer is sodium carboxymethylcellulose. 
     
     
         74 . The method of  claim 71 , wherein the polymer is sodium carboxymethylcellulose and the dispersing agent is glycerin. 
     
     
         75 . The method of  claim 71 , wherein the osteoconductive component further comprises the biologically active peptide P-15. 
     
     
         76 . The method of  claim 71 , wherein the wherein the pliable implantable composition is in the shape of a cylinder. 
     
     
         77 . The method of  claim 71 , wherein the pliable implantable composition is in the shape of a cube. 
     
     
         78 . The method of  claim 71 , wherein the pliable implantable composition is in the shape of a sheet. 
     
     
         79 . The method of  claim 71 , wherein the pliable implantable composition has a porosity of 10% to 25%. 
     
     
         80 . The method of  claim 71 , wherein the pliable implantable composition comprises:
 (i) from 8% to 15% (w/w) glycerin;   (ii) from 1.5% to 3.0% (w/w) sodium carboxymethylcellulose;   (iii) from 82% to 90% (w/w) anorganic bone mineral; and   (iv) from 2.5% to 5% (w/w) water.