Method and container for delivering bone graft material
A method for delivering bone graft material includes removing a container housing a bone graft material from a cryopreservation environment, wherein the bone graft material includes cellular matrix. The container includes an elongate tubular body having a first opening on a first end and a second opening on the second end. The container includes a first cap covering the first opening and a second cap covering the second opening. The method includes placing the container within a bath, removing the container from the bath, removing the first cap and the second cap from the elongate tubular body, coupling the elongate tubular body to a body of a bone graft delivery device while the bone graft material is positioned within the elongate tubular body, and delivering bone graft material through the elongate tubular body to a surgical location using the bone graft delivery device.
1 . A method for delivering bone graft material to a surgical location comprising:
placing a container within a 23° C. bath, the container housing a bone graft material in a frozen state, wherein the bone graft material comprises cellular matrix, wherein the container comprises an elongate tubular body having a first opening on a first end and a second opening on a second end, the elongate tubular body having an outer diameter of 9 mm, an inner diameter of 6 mm, a wall thickness of 1.5 mm; and either a first length of 196 mm, a first effective outer surface area of 5598.3 mm 2 and a first effective inner surface area of 3751.1 mm 2 , or a second length of 285 mm, a second effective outer surface area of 8114.7 mm 2 , and a second effective inner surface area of 5428.7 mm 2 ; wherein the first effective outer surface area or the second effective outer surface area of the container is an outer surface area of only sections of the container housing the bone graft material or an outer surface of only sections of container in which the bone graft material contacts an opposing inside surface of the container, wherein the first effective inner surface area or the second effective inner surface area of the container is an inner surface area of only sections of the container housing the bone graft material or an inner surface area of only sections of the container in which the bone graft material contacts an inner surface of the container, wherein placing the container within the bath thaws the bone graft material within 2 minutes;
removing the container from the bath;
coupling the elongate tubular body to a body of a bone graft delivery device while the bone graft material is positioned within the elongate tubular body; and
delivering bone graft material through the elongate tubular body to a surgical location using the bone graft delivery device.
2 . The method of claim 1 , wherein removing the container from the bath comprises removing the container from the bath after a temperature of the bone graft material within the container is above 20° C.
3 . The method of claim 1 , wherein removing the container from the bath comprises removing the container from the bath after a temperature of the bone graft material within the container is between 1° C. and 42° C.
4 . The method of claim 1 , wherein the container comprises a first plug, cap, or seal covering the first opening and a second plug, cap, or seal covering the second opening.
5 . The method of claim 4 , further comprising removing the first plug, cap, or seal from the elongate tubular body prior to coupling the elongate tubular body to the bone graft delivery device.
6 . The method of claim 1 , wherein the bone graft delivery device comprises a plunger, wherein delivering bone graft material comprises advancing the plunger through the elongate tubular body.
7 . The method of claim 6 , wherein the bone graft delivery device comprises a handle configured to removably couple to the elongate tubular body, wherein the handle comprises a channel configured to align with the first opening of the elongate tubular body and receive the plunger therethrough.
8 . The method of claim 1 , wherein delivering the bone graft material is performed without rinsing the bone graft material after the bone graft material is thawed.
9 . A container for storing and delivering bone graft material, the container comprising:
an elongate tubular body comprising:
a first opening on a first end;
a second opening on a second end;
an outer diameter of 9 mm;
an inner diameter of 6 mm;
a wall thickness of 1.5 mm; and
either a first length of 196 mm, a first effective outer surface area of 5598.3 mm 2 , and a first effective inner surface area of 3751.1 mm 2 , or a second length of 285 mm, a second effective outer surface area of 8114.7 mm 2 , and a second effective inner surface area of 5428.7 mm 2 ,
a first cap, plug, or seal covering the first opening;
a second cap, plug, or seal covering the second opening; and
a bone graft material comprising cellular matrix within the elongate tubular body;
wherein:
the elongate tubular body is configured to allow the cellular matrix to thaw from a frozen state within 2 minutes when the elongate tubular body is placed in a 23° C. bath;
the first effective outer surface area or the second effective outer surface area of the container is an outer surface area of only sections of the container housing the bone graft material or an outer surface of only sections of container in which the bone graft material contacts an opposing inside surface of the container; and
the first effective inner surface area or the second effective inner surface area of the container is an inner surface area of only sections of the container housing the bone graft material or an inner surface area of only sections of the container in which the bone graft material contacts an inner surface of the container.
10 . The container of claim 9 , wherein the elongate tubular body is configured to allow the cellular matrix to thaw from a frozen state to a temperature above 20° C. within 2 minutes when the elongate tubular body is placed in a 23° C. bath.
11 . The container of claim 9 , wherein the elongate tubular body is configured to withstand at least 30 lbf in a burst test.
12 . The container of claim 9 , wherein the elongate tubular body is configured to withstand bending to 45° in a forward direction, a rearward direction, a leftward direction, and a rightward direction in a bend test.
13 . The container of claim 9 , wherein the elongate tubular body is configured to allow the cellular matrix to thaw from a frozen state to a temperature suitable for delivery and introduction into the body when the elongate tubular body is placed in a 23° C. bath.
14 . A bone graft delivery system comprising:
the container of claim 9 ; and
a plunger configured to be advanced through the first opening of the elongate tubular body to advance the bone graft material out of the second opening of the elongate tubular body.
15 . The bone graft delivery system of claim 14 , further comprising a handle configured to be removably coupled to the elongate tubular body, wherein the handle comprises a channel configured to align with the first opening of the elongate tubular body and receive the plunger therethrough.
16 . A method for thawing a bone graft material, comprising:
receiving a container comprising an elongate tubular body and housing a bone graft material in a frozen state, wherein the elongate tubular body comprises an outer diameter of 9 mm, an inner diameter of 6 mm, a wall thickness of 1.5 mm, and either a first length of 196 mm, a first effective outer surface area of 5598.3 mm 2 , and a first effective inner surface area of 3751.1 mm 2 , or a second length of 285 mm, a second effective outer surface area of 8114.7 mm 2 , and a second effective inner surface area of 5428.7 mm 2 , and
placing the container within a bath at a temperature of 23° C. to thaw the bone graft material within 2 minutes;
wherein:
the first effective outer surface area or the second effective outer surface area of the container is an outer surface area of only sections of the container housing the bone graft material or an outer surface of only sections of container in which the bone graft material contacts an opposing inside surface of the container; and
the first effective inner surface area or the second effective inner surface area of the container is an inner surface area of only sections of the container housing the bone graft material or an inner surface area of only sections of the container in which the bone graft material contacts an inner surface of the container.
17 . The method of claim 16 , further comprising removing the container from the bath after a temperature of the bone graft material within the container is above 20° C.