Abstract: A tendon repair implant for treatment of a partial thickness tear in the supraspinatus tendon of the shoulder is provided. The implant may incorporate features of rapid deployment and fixation by arthroscopic means that compliment current procedures; tensile properties that result in desired sharing of anatomical load between the implant and native tendon during rehabilitation; selected porosity and longitudinal pathways for tissue in-growth; sufficient cyclic straining of the implant in the longitudinal direction to promote remodeling of new tissue to tendon-like tissue; and, may include a bioresorbable construction to provide transfer of additional load to new tendon-like tissue and native tendon over time.

Abstract: A tendon repair implant for treatment of a partial thickness tear in the supraspinatus tendon of the shoulder is provided. The implant may incorporate features of rapid deployment and fixation by arthroscopic means that compliment current procedures; tensile properties that result in desired sharing of anatomical load between the implant and native tendon during rehabilitation; selected porosity and longitudinal pathways for tissue in-growth; sufficient cyclic straining of the implant in the longitudinal direction to promote remodeling of new tissue to tendon-like tissue; and, may include a bioresorbable construction to provide transfer of additional load to new tendon-like tissue and native tendon over time.

Abstract: A fastener for attaching a sheet-like implant to tissue or bone may be provided with a first arm having a proximal end and a distal end, a second arm having a proximal end and a distal end, and a bridge extending therebetween. Each of the first and second arms include a trunk portion defining at least a portion thereof, the trunk portion having a lateral extent larger than a lateral extent of the bridge or non-trunk portion of the arm adjacent thereto and can be mounted eccentrically to the bridge or non-trunk portion of the arm adjacent thereto such that the staple includes a first change in lateral stiffness disposed proximate the bridge or non-trunk portion of the arm abutment with the trunk. Fastener delivery devices and methods are also disclosed.

Abstract: A method of deploying an ocular implant into Schlemm's canal of a human eye including the following steps: inserting a distal tip of a delivery tool within an anterior chamber of the eye through trabecular meshwork of the eye into Schlemm's canal of the eye; and advancing an ocular implant through a curved portion and a distal opening of the delivery tool to place a body portion of the ocular implant in Schlemm's canal and an inlet portion of the ocular implant in the anterior chamber.

Abstract: A fastener for attaching a sheet-like implant to tissue or bone may be provided with a first arm having a proximal portion and a distal portion, a second arm having a proximal portion and a distal portion, and a bridge formed at least in part by the proximal portion of the first arm overlapping the proximal portion of the second arm. Each of the first and second arms can include at least a partial loop member having a lumen therethrough slidably receiving the other arm, each arm further including a tissue retention member on a distal portion having a projection extending therefrom for engagement of bone or tissue when inserted therein. The staple can also include a one-way position retention assembly for allowing distal movement of each at least partial loop member relative to the other arm therethrough to tension the fastener and maintain a desired configuration.

Abstract: A staple for attaching a sheet-like implant to tissue or bone may include first and second arms, and first and second flukes. In some embodiments, the first arm has a proximal end and a distal end, and the second arm has a proximal end and a distal end. A bridge extends from the proximal end of the first arm to the proximal end of the second arm. The first fluke has a proximal end abutting the distal end of the first arm, and the first fluke extends distally from the first arm. The first fluke has a lateral extent larger than a lateral extent of the first arm and is mounted eccentrically thereto. The first fluke includes a proximal surface projecting at an outward angle in a proximal direction away from the distal end of the first arm to engage the tissue or bone when inserted therein. The second fluke has similar features. This arrangement causes the first and second flukes to rotate in response to a pullout force on the bridge.

Abstract: A tissue marker assembly which can be useful with an implant delivery system for delivering a sheet-like implant is disclosed. The tissue marker assembly can include a delivery sleeve with a tissue marker slidably disposed within a lumen therethrough. A proximal handle can be coupled to the tissue marker and delivery sleeve, having a first part and a second part. The second part of the proximal handle can be releasably attached to the tissue marker proximal end so that the second part can be removed to allow the delivery sleeve to be removed proximally over the tissue marker after it is affixed to tissue. The distal portion of the marker can include a plurality of longitudinally extending arms when unconstrained project outward from the shaft to retain the marker's position in tissue.

Abstract: An implant delivery system for delivering a sheet-like implant is disclosed. The implant delivery system includes a distal guidewire port for receiving the proximal end of guidewire after the guidewire distal end has been affixed to a first point on bone or other tissue. The implant delivery system is tracked over the guidewire to a selected position defined by the guidewire attachment. The device includes an implant spreader assembly disposed proximate the distal end of a delivery shaft. The implant spreader assembly includes a first arm and a second arm. The arms are coupled to the delivery shaft such that the first arm and second arm are moveable between a closed position and an open position. When pivoting to the open position the distal end of each arm travels in a generally transverse direction to spread a sheet-like implant.

Abstract: Apparatus and methods for forming pilot holes in bone and deploying a staple therein for fixing a sheet-like implant to the bone. A pilot hole forming trocar assembly including a trocar and a position retention sleeve can be included. The trocar can be releasably coupled to the position retention sleeve and slide in keyed arrangement within the sleeve when uncoupled. The trocar can include a distal portion having a retractable blade and a pair of pilot hole forming spikes extending distally from the trocar shaft. Once the pilot holes are formed, the position retention sleeve maintains the position relative to the pilot holes while the trocar is removed and a staple delivery device can be inserted in the lumen of the position retention sleeve to deploy a staple in the pilot holes.

Abstract: An implant delivery system for delivering a sheet-like implant is disclosed. The implant delivery system includes a distal guidewire port for receiving the proximal end of guidewire after the guidewire distal end has been affixed to a first point on bone or other tissue. The implant delivery system is tracked over the guidewire to a selected position defined by the guidewire attachment. The device includes an implant spreader assembly disposed proximate the distal end of a delivery shaft. The implant spreader assembly includes a first arm and a second arm. The arms are coupled to the delivery shaft such that the first arm and second arm are moveable between a closed position and an open position. When pivoting to the open position the distal end of each arm travels in a generally transverse direction to spread a sheet-like implant.

Abstract: A fastener for attaching a sheet-like implant to tissue or bone may be provided with a first arm having a proximal portion and a distal portion, a second arm having a proximal portion and a distal portion, and a bridge formed at least in part by the proximal portion of the first arm overlapping the proximal portion of the second arm. Each of the first and second arms can include at least a partial loop member having a lumen therethrough slidably receiving the other arm, each arm further including a tissue retention member on a distal portion having a projection extending therefrom for engagement of bone or tissue when inserted therein. The staple can also include a one-way position retention assembly for allowing distal movement of each at least partial loop member relative to the other arm therethrough to tension the fastener and maintain a desired configuration.

Abstract: A tissue marker assembly which can be useful with an implant delivery system for delivering a sheet-like implant is disclosed. The tissue marker assembly can include a delivery sleeve with a tissue marker slidably disposed within a lumen therethrough. A proximal handle can be coupled to the tissue marker and delivery sleeve, having a first part and a second part. The second part of the proximal handle can be releasably attached to the tissue marker proximal end so that the second part can be removed to allow the delivery sleeve to be removed proximally over the tissue marker after it is affixed to tissue. The distal portion of the marker can include a plurality of longitudinally extending arms when unconstrained project outward from the shaft to retain the marker's position in tissue.

Abstract: A staple for attaching a sheet-like implant to tissue or bone may include first and second arms, and first and second flukes. In some embodiments, the first arm has a proximal end and a distal end, and the second arm has a proximal end and a distal end. A bridge extends from the proximal end of the first arm to the proximal end of the second arm. The first fluke has a proximal end abutting the distal end of the first arm, and the first fluke extends distally from the first arm. The first fluke has a lateral extent larger than a lateral extent of the first arm and is mounted eccentrically thereto. The first fluke includes a proximal surface projecting at an outward angle in a proximal direction away from the distal end of the first arm to engage the tissue or bone when inserted therein. The second fluke has similar features. This arrangement causes the first and second flukes to rotate in response to a pullout force on the bridge.

Abstract: A tendon repair implant delivery system and methods incorporating a guide member having a temporary fixation member on or adjacent to the distal end. The point of fixation defines a target site for placement of the tendon repair implant which is subsequently affixed to the tendon.

Abstract: Implant delivery systems for delivering sheet-like implants include a delivery shaft, an implant expander, a sheath, and a sheet-like implant. In some embodiments, the delivery shaft has a proximal end and a distal end. The implant expander is mounted to the distal end of the delivery shaft. The implant expander includes a central portion and a plurality of leg portions radiating from the central portion. The implant expander is evertable between an unstressed configuration in which a distal surface of the implant expander defines a concave surface, and a first compact configuration in which the distal surface of the implant expander defines a convex surface. The implant expander has a first lateral extent when the implant expander is free to assume the unstressed configuration. The sheath defines a lumen having a lumen diameter. At least a portion of the delivery shaft is slidably disposed in the lumen.

Abstract: Apparatus and methods for forming pilot holes in bone and deploying a staple therein for fixing a sheet-like implant to the bone. A pilot hole forming trocar assembly including a trocar and a position retention sleeve can be included. The trocar can be releasably coupled to the position retention sleeve and slide in keyed arrangement within the sleeve when uncoupled. The trocar can include a distal portion having a retractable blade and a pair of pilot hole forming spikes extending distally from the trocar shaft. Once the pilot holes are formed, the position retention sleeve maintains the position relative to the pilot holes while the trocar is removed and a staple delivery device can be inserted in the lumen of the position retention sleeve to deploy a staple in the pilot holes.

Abstract: A method of deploying an ocular implant into Schlemm's canal of a human eye including the following steps: inserting a distal tip of a delivery tool within an anterior chamber of the eye through trabecular meshwork of the eye into Schlemm's canal of the eye; and advancing an ocular implant through a curved portion and a distal opening of the delivery tool to place a body portion of the ocular implant in Schlemm's canal and an inlet portion of the ocular implant in the anterior chamber.

Abstract: A tissue marker assembly which can be useful with an implant delivery system for delivering a sheet-like implant is disclosed. The tissue marker assembly can include a delivery sleeve with a tissue marker slidably disposed within a lumen therethrough. A proximal handle can be coupled to the tissue marker and delivery sleeve, having a first part and a second part. The second part of the proximal handle can be releasably attached to the tissue marker proximal end so that the second part can be removed to allow the delivery sleeve to be removed proximally over the tissue marker after it is affixed to tissue. The distal portion of the marker can include a plurality of longitudinally extending arms when unconstrained project outward from the shaft to retain the marker's position in tissue.

Abstract: An implant delivery system for delivering a sheet-like implant is disclosed. The implant delivery system includes a distal guidewire port for receiving the proximal end of guidewire after the guidewire distal end has been affixed to a first point on bone or other tissue. The implant delivery system is tracked over the guidewire to a selected position defined by the guidewire attachment. The device includes an implant spreader assembly disposed proximate the distal end of a delivery shaft. The implant spreader assembly includes a first arm and a second arm. The arms are coupled to the delivery shaft such that the first arm and second arm are moveable between a closed position and an open position. When pivoting to the open position the distal end of each arm travels in a generally transverse direction to spread a sheet-like implant.

Abstract: A tendon repair implant for treatment of a partial thickness tear in the supraspinatus tendon of the shoulder is provided. The implant may incorporate features of rapid deployment and fixation by arthroscopic means that compliment current procedures; tensile properties that result in desired sharing of anatomical load between the implant and native tendon during rehabilitation; selected porosity and longitudinal pathways for tissue in-growth; sufficient cyclic straining of the implant in the longitudinal direction to promote remodeling of new tissue to tendon-like tissue; and, may include a bioresorbable construction to provide transfer of additional load to new tendon-like tissue and native tendon over time.