PREPACKAGED SACROILIAC JOINT IMPLANT WITH PREPACKED BONE GROWTH FACTOR
An allograft implant for fusing a sacroiliac joint. The allograft implant has a body with a graft window disposed therein. A bone growth factor is prepacked into the graft window at the manufacturing stage, prior to packaging and shipping. The implant with the prepacked bone growth factor is hermetically sealed in a package. The allograft implant may be classified as “human cells, tissues, and cellular and tissue-based product (HCT/P),” while the bone growth factor may be classified as a non-HCT/P. The implant may comprise a dissolvable or bioabsorbable membrane for retaining the growth factor inside the graft window. The graft window may comprise a scaffold for retaining a putty-like or a sponge-like bone growth factor.
1 . A prepackaged implant for fusing a sacroiliac joint, comprising:
a body having a first face and a second face disposed in an opposing relationship to one another, the first face configured for abutting contact with a sacrum and the second face configured for abutting contact with an ilium when the body of the implant is inserted into the sacroiliac joint, wherein the body of the implant is composed of human cells, tissues, or cellular or tissue-based products (HCT/Ps);
a graft window disposed within the body of the implant and opening to the first and the second faces, whereby the graft window provides a passage between the first and the second faces through the body of the implant;
a non-HCT/P bone growth factor prepacked within the graft window; and
a package hermetically sealing the body of the implant and the non-HCT/P bone growth factor prepacked into the graft window thereof, wherein the non-HCT/P bone growth factor is prepacked into the graft window prior to sealing the implant within the package.
2 . The prepackaged implant of claim 1 , wherein the non-HCT/P bone growth factor comprises demineralized bone matrix (DBM) fibers and a carrier.
3 . The prepackaged implant of claim 2 , wherein the carrier is collagen.
4 . The prepackaged implant of claim 2 , wherein at least some of the DBM fibers traverse the graft window and are configured to connect the sacrum and the ilium when the implant is positioned within the sacroiliac joint.
5 . The prepackaged implant of claim 1 , wherein the non-HCT/P bone growth factor is freeze-dried.
6 . The prepackaged implant of claim 5 , wherein the DBM fibers are configured to expand when the body of the implant is placed into the sacroiliac joint.
7 . The prepackaged implant of claim 1 , wherein the body of the implant and the prepacked non-HCT/P bone growth factor collectively constitute a medical device under United States Food and Drug Administration (FDA) classification.
8 . The prepackaged implant of claim 7 , wherein the body of the implant is compliant with the FDA regulations governing the HCT/Ps.
9 . The prepackaged implant of claim 1 , further comprising a membrane affixed to the first or the second face of the body of the implant and configured to retain the non-HCT/P bone growth factor within the graft window.
10 . The prepackaged implant of claim 9 , wherein the membrane is configured to be dissolved or bioabsorbed when the implant is placed into the sacroiliac joint.
11 . The prepackaged implant of claim 1 , further comprising a retaining structure disposed within the graft window, wherein the retaining structure is configured to retain the non-HCT/P bone growth factor within the graft window.
12 . A method of performing a medical procedure for a sacroiliac joint fusion, comprising:
receiving a surgical instrument kit and a package containing an implant, wherein the implant has a body with a graft window disposed therein, wherein the body is composed of human cells, tissues, or cellular or tissue-based products (HCT/Ps), and wherein the graft window is prepacked with a non-HCT/P bone growth factor;
opening the package and removing therefrom, as a single unit, the body of the implant and the non-HCT/P bone growth factor prepacked into the graft window thereof; and
inserting, as the single unit, the body of the implant with the non-HCT/P bone growth factor prepacked into the graft window thereof into the sacroiliac joint, whereby the body of the implant and the non-HCT/P bone growth factor remain with the sacroiliac joint, thereby causing the sacroiliac joint fusion.
13 . The method of claim 12 , wherein the non-HCT/P bone growth factor comprises demineralized bone matrix (DBM) fibers and a carrier.
14 . The method of claim 13 , wherein the carrier is collagen.
15 . The method of claim 13 , wherein at least some of the DBM fibers traverse the graft window and are configured to connect the sacrum and the ilium when the body of the implant is positioned within the sacroiliac joint.
16 . The method of claim 12 , wherein the non-HCT/P bone growth factor comprises a synthetic substance.
17 . The method of claim 12 , further comprising a membrane affixed to the first or the second face of the body of the implant and configured to retain the non-HCT/P bone growth factor within the graft window.
18 . The method of claim 12 , further comprising a retaining structure disposed within the graft window, wherein the retaining structure is configured to retain the non-HCT/P bone growth factor within the graft window.
19 . The method of claim 12 , wherein the body of the implant and the prepacked non-HCT/P bone growth factor collectively constitute a medical device under United States Food and Drug Administration (FDA) classification.
20 . The method of claim 19 , wherein the body of the implant is compliant with the FDA regulations governing HCT/Ps.