Injectable tissue repair devices and processes for preparation thereof
Disclosed are tissue repair devices, processes for preparing such devices, and methods of use of such devices. In an embodiment, a tissue repair device comprises porous, compressible pellets of a tissue repair material that may be provided and then hydrated in the barrel of a syringe. In an embodiment, the tissue repair material is configured in the barrel of the syringe such that an elongate channel is present, the channel being defined by the interior wall of the barrel and the tissue repair material.
1 . A method of forming a tissue repair device comprising the steps of:
a. providing a syringe comprising a barrel that is configured or configurable to be in fluid communication with a tip, the barrel comprising an interior wall, a tissue repair material, and an elongate channel extending over a length of the barrel, the elongate channel being defined by the interior wall and the tissue repair material and the elongate channel being configured such that the tissue repair material does not contact the interior wall within the elongate channel along the length, wherein the tissue repair material comprises porous, compressible pellets and the tissue repair material is porous and compressed; and
b. inserting a hydrating fluid into the elongate channel to form an extrudable tissue repair material.
2 . The method according to claim 1 , wherein the hydrating fluid is inserted into the barrel by attaching a second syringe containing the hydrating fluid to the tip in fluid communication with the barrel, and dispensing the hydrating fluid from the second syringe into the barrel via the tip.
3 . The method according to claim 1 , further comprising a second elongate channel positioned opposite the elongate channel, wherein the second elongate channel is defined by the interior wall of the barrel and the tissue repair material and the second elongate channel being configured such that the tissue repair material does not contact the interior wall within the second elongate channel along a length of the second elongate channel.
4 . The method according to claim 1 , wherein the tissue repair material comprises polymer fibers.
5 . The method according to claim 1 , wherein the tissue repair material comprises a lyophilized sponge comprising collagen fibers and mineral particles.
6 . The method according to claim 1 , wherein the mineral is present as particles having an average particle diameter of from 0.05 to 1 mm.
7 . The method according to claim 1 , wherein the tissue repair material comprises from 50 to 95 wt % of mineral and from 5 to 50 wt % of collagen, based on the total weight of the dry sponge or the solids of the slurry, respectively.
8 . The method according to claim 1 , wherein the tissue repair material comprises polymer fibers having an average length of from 1 mm to 5 mm.
9 . The method according to claim 1 , wherein the porous, compressible pellets comprise the shape of a triangular prism, a rectangular prism, other polygonal prism, or a cylinder.
10 . The method according to claim 1 , wherein the maximum dimension of the porous, compressible pellets is less than the inner diameter of the tip.
11 . The method according to claim 1 , wherein the porous, compressible pellets are compressed from 40% to 60% by volume.
12 . The method according to claim 1 , wherein the at least one elongate channel comprises from 1.5 to 4% of the total filled volume of the barrel.
13 . A flowable solution, gel, paste, or putty capable of extrusion formed according to the method of claim 1 .
14 . A tissue repair device comprising: a syringe comprising a barrel in fluid communication with a tip, the barrel comprising an interior wall and a porous, compressed tissue repair material comprising porous, compressible pellets present in the barrel,
wherein the tissue repair device comprises an elongate channel extending over a length of the barrel through the tissue repair material,
wherein the elongate channel is defined by the interior wall and the tissue repair material, the elongate channel being configured such that the tissue repair material does not contact the interior wall within the elongate channel along the length, and
wherein the tissue repair material comprises collagen fibers and mineral particles.
15 . The tissue repair device according to claim 14 , wherein the at least one elongate channel comprises from 1 to 10% of the total filled volume of the barrel.
16 . The tissue repair device according to claim 14 , wherein the density of the tissue repair material in the barrel is from 250 to 300 kg/m 3 .
17 . The tissue repair device according to claim 14 , wherein the syringe has a maximum volume of 1 to 15 cubic centimeters.
18 . The tissue repair device according to claim 14 , wherein the maximum dimension of the porous, compressible pellets is 6 mm or less.
19 . The tissue repair device according to claim 14 , wherein the mineral has an average particle diameter of from 0.05 to 2 mm.
20 . The tissue repair device according to claim 14 , wherein the tissue repair device comprises two elongate channels, wherein each elongate channel is defined by the interior wall and the tissue repair material, and each elongate channel is configured such that the tissue repair material does not contact the interior wall within each elongate channel along the length.
21 . The tissue repair device according to claim 20 , wherein each of the two elongate channels has a diameter of from 2 to 5 mm.
22 . The method of claim 1 , further comprising the steps of:
a. extruding the extrudable tissue repair material, thereby forming an extruded tissue repair material, and
b. inserting the extruded tissue repair material into a tissue defect in a human or animal body.
23 . A method for forming a tissue repair device comprising the steps of:
a. providing a syringe comprising a barrel that is configured or configurable to be in fluid communication with a tip, the barrel comprising an interior wall and at least one elongate obstruction extending over a length of the barrel, the at least one elongate obstruction being in contact with or proximate to the interior wall;
b. inserting into the barrel a plurality of porous, compressible pellets of a tissue repair material, the tissue repair material being extrudable via the tip upon hydration;
c. compressing at least some of the plurality of porous, compressible pellets; and
d. removing the at least one elongate obstruction.