Enclosure device for an implantable repair device
An enclosure device is disclosed for delivering an implantable sheet-like support or repair device, such as ligament, tendon or other soft tissue support or repair device, to a surgical site. The enclosure device protects the support or repair device from unwanted adhesion and deformation during delivery and facilitates its optimal positioning at the injury or repair site where the support or repair device will be implanted. The enclosure device has a planar body foldable along one or more fold lines into at least two panels configured to contain the repair device between the panels; an optional cutout in one or more panels of the planar body at the panel edge opposite the fold line configured to expose a portion of the repair device; an optional positioning tab extending out from the fold line; and an optional securing mechanism to secure the enclosure device in a folded position. Methods of using the enclosure device are described.
1. An enclosure device for delivering an implantable sheet-like repair device to a surgical site comprising:
a planar body foldable along one or more fold lines into at least two panels to contain the implantable sheet-like repair device comprising two planar sides;
a cutout in one or more panels of the planar body at an open edge of the panel opposite one of the fold lines to expose both planar sides of a portion of the implantable sheet-like repair device;
a positioning mechanism proximate to a fold line of the enclosure device; and
a securing mechanism to secure the enclosure device in a folded position.
2. An enclosure device of claim 1 , wherein the shape of the enclosure device is substantially rectilinear, such as a rectangle or square.
3. An enclosure device of claim 1 , wherein the implantable sheet-like repair device supports the healing or repair of a soft tissue.
4. An enclosure device of claim 3 , wherein the sheet-like, soft tissue repair device comprises substantially pure collagen or a mixture of collagen and a biocompatible polymer.
5. An enclosure device of claim 4 , wherein the biocompatible polymer is selected from the group consisting of polylactic acid (PLA), poly(D-lactic acid)(PDLA), poly(D,L-lactic acid) (PDLLA), poly(lactic-co-glycolic acid) (PLGA), poly(glycolic acid) (PGA) and mixtures thereof.
6. An enclosure device of claim 1 , wherein the enclosure device comprises a material selected from the group consisting of Acetal, Polyurethane (PUR), Ultra-high-molecular-weight Polyethylene (UHMW-PE), Low-density Polyethylene (LDPE), High-density Polyethylene (HDPE), polylactic acid (PLA), Polyether ether ketone (PEEK), Polyethylene terephthalate (PET), Polytetrafluoroethylene (PTFE or “Teflon”), and Polyvinylidene fluoride (PVDF).
7. An enclosure device of claim 1 , wherein the securing mechanism comprises a mated tab and slit.
8. An enclosure device of claim 1 , wherein the positioning mechanism comprises a positioning tab extending out from one of the fold lines of the enclosure device.
9. An enclosure device of claim 2 , wherein the enclosure device comprises a rounded corner when in the folded position.
10. An enclosure device of claim 8 , wherein the positioning tab comprises a rounded edge.
11. An enclosure device of claim 1 , wherein the positioning mechanism comprises an attachment site to pass a filament through the enclosure device such that manipulating the filament positions the enclosure device.
12. An enclosure device of claim 11 , wherein the attachment site is a hole that passes through the enclosure device when in the folded position.
13. An enclosure device of claim of claim 8 , wherein the positioning tab comprises an attachment site to pass a filament through the positioning tab such that manipulating the filament positions the enclosure device.
14. An enclosure device of claim 1 , wherein the securing mechanism is selected from a group consisting of slits and tabs, clasps, crimps, welds, ties, fasteners, snaps, hooks, adhesives, tapes, and bands.
15. A method of delivering an implantable sheet-like repair device to a surgical site using an enclosure device with a planar body foldable along one or more fold lines into at least two panels to contain the implantable sheet-like repair device comprising two planar sides, a cutout in one or more panels of the planar body at an open edge of the panel opposite one of the fold lines to expose both planar sides of a portion of the implantable sheet-like repair device, and a securing mechanism to secure the enclosure device in a folded position, the method comprising steps of:
positioning, using a positioning mechanism proximate to one of the fold lines of the enclosure device, within the surgical site;
separating the enclosure device from the repair device; and
implanting the repair device at the surgical site.
16. A method of claim 15 , wherein the positioning step comprises the steps of:
placing the enclosure device at the surgical site, and
holding the portion of the repair device exposed through the cutout in the panels to place the repair device within the surgical site.
17. A method of claim 15 , wherein the separating step comprises the step of
pulling the positioning mechanism to remove the enclosure device, thereby leaving the implantable sheet-like repair device positioned at the surgical site.
18. A method of claim 15 , wherein the implantable sheet-like repair device is a sheet-like, soft tissue repair device.
19. A method of claim 18 , wherein the sheet-like, soft tissue repair device comprises collagen or a mixture of collagen and a biocompatible polymer.
20. A method of claim 18 , wherein the biocompatible polymer is selected from the group consisting of polylactic acid (PLA), poly(D-lactic acid)(PDLA), poly(D,L-lactic acid) (PDLLA), poly(lactic-co-glycolic acid) (PLGA), poly(glycolic acid) (PGA) and mixtures thereof.
21. A method of claim 15 , wherein the enclosure device comprises a material selected from the group consisting of Acetal, Polyurethane (PUR), Ultra-high-molecular-weight Polyethylene (UHMW-PE), Low-density Polyethylene (LDPE), High-density Polyethylene (HDPE), polylactic acid (PLA), Polyether ether ketone (PEEK), Polyethylene terephthalate (PET), Polytetrafluoroethylene (PTFE or “Teflon”), and Polyvinylidene fluoride (PVDF).
22. A method of claim 15 , wherein the securing mechanism comprises a mated tab and slit.
23. A method of claim 15 , wherein the positioning mechanism comprises a positioning tab extending out from one of the fold lines of the enclosure device.