MEDICAL TOOLS FOR CORNEAL TISSUE DELIVERY
Devices, kits and tools that facilitate pre-loading, storage, transportation and small incision, partial thickness corneal replacement procedures, including deep lamellar endothelial keratoplasty (DLEK), Descemet's stripping endothelial keratoplasty (DSEK) and Descemet's stripping automated endothelial keratoplasty (DSAEK), using donor eye tissue are provided.
1 . A donor corneal tissue storage and delivery device, comprising:
a storage fluid;
a cannula having a proximal end and a distal end;
at least one fluid channel with a proximal end and a distal end, the distal end disposed within the proximal end of the cannula;
a flexible support configured to receive a donor corneal tissue and retract into the cannula;
a retractor assembly coupled to the flexible support and operable to retract the coupled flexible support thereby retracting the donor corneal tissue into the cannula;
a deployment assembly coupled to the cannula and configured to retract the cannula and deliver the donor corneal tissue to an implantation site from the flexible support retracted into the cannula; and
a removable reservoir removably coupled to the deployment assembly and in fluid communication with the at least one fluid channel, wherein the removable reservoir is configured to receive the storage fluid for hydrating the donor corneal tissue received by the flexible support while the flexible support is retracted into the cannula,
wherein the at least one fluid channel, the cannula, and the removable reservoir are all filled with the storage fluid.
2 . The donor corneal tissue storage and delivery device according to claim 1 , further comprising a housing having a proximal end and a distal end, wherein the cannula is disposed at and tapers towards the distal end of the housing.
3 . The donor corneal tissue storage and delivery device according to claim 2 , wherein the cannula is slidably retractable relative to the housing, and wherein the deployment assembly is configured to inhibit axial retraction of the cannula.
4 . The donor corneal tissue storage and delivery device according to claim 3 , further comprising a locking guard member in communication with the deployment assembly and configured to inhibit axial retraction of the cannula.
5 . The donor corneal tissue storage and delivery device according to claim 4 , wherein the locking guard member is removable from the housing to allow the deployment assembly to retract the cannula into the housing, and wherein the at least one fluid channel remains stationary within the retracting cannula and acts to push the donor corneal tissue out of the cannula.
6 . The donor corneal tissue storage and delivery device according to claim 1 , wherein the retractor assembly comprises a retractor shaft coupled to the flexible support and one or more loading members coupled to the retractor shaft and operable to retract the retractor shaft and coupled flexible support thereby retracting the flexible support and donor corneal tissue into the cannula.
7 . The donor corneal tissue storage and delivery device according to claim 6 , further comprising a housing having a proximal end and a distal end, wherein the cannula is disposed at the distal end of the housing, and wherein the one or more loading members of the retractor assembly are held by the housing.
8 . The donor corneal tissue storage and delivery device according to claim 1 , wherein the deployment assembly comprises a deployment shaft coupled to the cannula and one or more deployment members coupled to the deployment shaft and operable to cause the deployment shaft to retract the cannula and to deliver the donor corneal tissue to an implantation site from the flexible support retracted into the cannula.
9 . The donor corneal tissue storage and delivery device according to claim 8 , further comprising a housing having a proximal end and a distal end, wherein the cannula is disposed at the distal end of the housing, and wherein the deployment shaft of the deployment assembly is configured to retract into the distal end of the housing.
10 . The donor corneal tissue storage and delivery device according to claim 1 , wherein the at least one fluid channel is configured to receive irrigation fluid and direct the irrigation fluid to the cannula to provide irrigation to the donor corneal tissue and the implantation site and configured to help flowably deliver the donor corneal tissue when the deployment assembly is operated.
11 . The donor corneal tissue storage and delivery device according to claim 1 , further comprising a fluid channel connector coupled to the proximal end of the at least one fluid channel and a fluid pressure source configured to releasably engage the fluid channel connector to help deliver the donor corneal tissue into a small incision scleral access site.
12 . The donor corneal tissue storage and delivery device according to claim 1 , wherein the removable reservoir contains the storage fluid, wherein the storage fluid comprises a biocompatible fluid.
13 . The donor corneal tissue storage and delivery device according to claim 12 , wherein the biocompatible fluid is a cornea storage solution.
14 . The donor corneal tissue storage and delivery device according to claim 1 , wherein the removable reservoir comprises a reservoir base configured to removably couple the removable reservoir to a distal end of the deployment assembly, a reservoir body extending distally from the reservoir base, and a reservoir cap distal the reservoir base, the reservoir cap removably coupled to the reservoir body.
15 . The donor corneal tissue storage and delivery device according to claim 1 , wherein the flexible support and donor corneal tissue adopt a rolled shape when retracted into the cannula.
16 . The donor corneal tissue storage and delivery device according to claim 1 , wherein the removable reservoir encloses the flexible support and cannula when the removable reservoir is removably coupled to the deployment assembly.
17 . The donor corneal tissue storage and delivery device according to claim 1 , wherein the removable reservoir further comprises a fluid flow restrictor disposed therein.
18 . The donor corneal tissue storage and delivery device according to claim 1 , wherein at least a portion of the cannula is visually transmissive.
19 . The donor corneal tissue storage and delivery device according to claim 1 , wherein a proximal portion of the deployment assembly is slidably engaged to the retractor assembly at a junction, the junction including a one-way valve or gasket that inhibits leakage of the storage fluid.
20 . The donor corneal tissue storage and delivery device according to claim 19 , wherein the retractor assembly comprises a retractor shaft coupled to the flexible support, and wherein the proximal portion of the deployment assembly is slidably engaged to the retractor shaft at the junction.