Lock and release implant delivery system

Abstract

Injection-molded devices and systems for graft or other tissue delivery, methods for their single-use in delivery of an implant, and kits for their sterile delivery to a practitioner are disclosed herein. Systems for implant delivery comprise an injection moldable implant body and an insertion device comprising: an inner and outer shaft that form a locking mechanism that secures an implant body in place and releases it upon placement within a patient. Systems are configured to be manufactured by injection molding, such that they can be cost-effectively manufactured and discarded after a single use to avoid costs and risks associated with re-sterilization and cleaning, but can in some cases optionally also be manufactured by machining to be re-sterilized and reused.

What is claimed is: 
     
         1 . An implant delivery system comprising:
 a) an implant body comprising: an outer surface; a main slot indented into the outer surface; a chamber indented from the main slot, the chamber being deeper than the main slot; two side slots at the outer surface proximal to the main slot; and an empty internal space passing through the bottom to the top of the implant body;   wherein the implant body is substantially toroidal, the internal space is not covered at a top cross section and a bottom cross section thereof by the support structure, and the internal space is configured to receive at least one graft material therewithin; and   b) an implant insertion device comprising: i) an inner shaft comprising: an inner shaft body; a knob at a base of the inner shaft body, the knob comprising a cam feature; an inner shaft tip at an insertion end of the inner shaft body, wherein the inner shaft tip is not substantially cylindrically circular and the inner shaft tip is wider than the inner shaft body immediately adjacent thereto in at least one dimension perpendicular to a plane of rotation of the inner shaft tip; ii) an outer shaft configured to hold the inner shaft body therein, the outer shaft comprising: a hollow outer shaft body, wherein the outer shaft body is configured to accommodate the inner shaft body therewithin; an outer face; an outer shaft opening at the outer face of the outer shaft, the outer shaft opening being configured to allow passage of the inner shaft tip; two outer shaft tips at the outer face to fit the two side slots of the implant body; a first surface at a base of the outer shaft configured to receive the cam feature of the knob at a first position; a second surface at the base of the outer shaft configured to receive the cam feature of the knob at a second position; a stopper at the base of the outer shaft configured to stop the cam feature at the first or the second position; a ramp at the base of the outer shaft, wherein the ramp connects the first surface to the second surface,   wherein the inner shaft is configured to rotate within the outer shaft such that the cam feature moves to the first position or the second position at the base of the outer shaft,   wherein the rotation of the inner shaft is configured to transform into a linear movement of the inner shaft along a direction perpendicular to a plane of the rotation of the inner shaft tip,   wherein the inner shaft tip is configured to fit through the main slot of the implant body and rotate in the chamber of the implant body so as to lock or unlock the implant body to the inner shaft, and the two side slots of the implant body are configured to fit the two outer shaft tips at the outer face of the outer shaft so as to attach the implant body to the outer shaft, and   wherein the inner shaft is unlocked from the outer shaft at the first position and the inner shaft is locked to the outer shaft at the second position.   
     
     
         2 . An implant delivery system comprising:
 an implant insertion device comprising:
 i) an inner shaft comprising: an inner shaft body; a knob at a base of the inner shaft body, the knob comprising a first interface; an inner shaft tip at an insertion end of the inner shaft body, wherein the inner shaft tip is not substantially cylindrically circular; and 
 ii) an outer shaft configured to hold the inner shaft body therein, the outer shaft comprising: a hollow outer shaft body, wherein the outer shaft body is configured to accommodate the inner shaft body therewithin; an outer face; an outer shaft opening at the outer face of the outer shaft; a first complementary interface at a base of the outer shaft configured to receive the first interface of the inner shaft; a second complementary interface at the outer face to receive a second interface of the implant body; 
   wherein a rotation of the inner shaft is configured to associate the first complementary interface to the first interface at a first position or at a second position,   wherein the inner shaft tip is configured to fit through a main slot of an implant body and rotate in a chamber of the implant body so as to lock the implant body to the inner shaft.   
     
     
         3 . The device of  claim 2 , wherein the implant delivery system comprises an implant body comprising a support structure comprising: an outer surface; a main slot indented into the outer surface; a chamber indented from the main slot, the chamber being deeper than the main slot; and a second interface at the outer surface proximal to the main slot;
 wherein the implant body is substantially toroidal, and the internal space is not covered at a top cross section, a bottom cross section, or the top and bottom cross sections thereof by the support structure, and the internal space is configured to receive at least one graft material; and   an internal space configured to contain at least a graft material.   
     
     
         4 . The device of  claim 2 , wherein the second interface of the implant body is configured to fit the second complementary interface at the outer face of the outer shaft so as to attach the implant body to the outer shaft. 
     
     
         5 . The device of  claim 2 , wherein the implant insertion device is injection molded. 
     
     
         6 . The device of  claim 2 , wherein the implant delivery system is for one-time use only. 
     
     
         7 . The device of  claim 2 , wherein the internal space of the implant body is filled at least partly by at least one graft material. 
     
     
         8 . The device of  claim 2 , wherein the inner shaft comprises at least one material selected from carbon fiber-reinforced polymer, carbon fiber-reinforced plastic, carbon fiber-reinforced thermoplastic, glass fiber-reinforced polymer, glass fiber-reinforced plastic, and polyarylamide. 
     
     
         9 . The device of  claim 2 , wherein the inner shaft body is flexible so as to fit in a curved outer shaft body. 
     
     
         10 . The device of  claim 2 , wherein the inner shaft tip is substantially rectangular cuboid or cylindrically elliptical. 
     
     
         11 . The device of  claim 2 , wherein the first interface comprises a cam feature. 
     
     
         12 . The device of  claim 2 , wherein the inner shaft tip is configured to fit and rotate in the chamber of the implant body. 
     
     
         13 . The device of  claim 2 , wherein the inner shaft tip is configured to pass through the outer shaft opening. 
     
     
         14 . The device of  claim 2 , wherein the first or the second interface comprises a first surface and a second surface, wherein the first surface and the second surface are connected by a ramp. 
     
     
         15 . The device of  claim 14 , wherein the first and the second surface are displaced by a distance that the inner shaft tip is capable of moving with respect to the outer shaft. 
     
     
         16 . The device of  claim 2 , wherein the outer shaft body is curved. 
     
     
         17 . The device of  claim 2 , wherein the outer shaft comprises at least one material selected from the list consisting of carbon fiber-reinforced polymer, carbon fiber-reinforced plastic, carbon fiber-reinforced thermoplastic, glass fiber-reinforced polymer, glass fiber-reinforced plastic, and polyarylamide. 
     
     
         18 . The device of  claim 2 , wherein the outer shaft is injection moldable. 
     
     
         19 . The device of  claim 2 , wherein the outer shaft opening is configured to allow passage of the inner shaft tip. 
     
     
         20 . The device of  claim 2 , wherein the linear movement of the inner shaft body is determined by a height of the interface or the complimentary interface and a rotation angle that the cam feature rotates through from a predetermined location along a circumference of the knob. 
     
     
         21 . A method for delivering an implant body using an implant insertion device comprising:
 a) locking the implant body to the implant insertion device by rotating a knob of an inner shaft of the implant insertion device in a manner such that the rotation of the knob
 i) rotates an inner shaft tip within a chamber of the implant body such that a major axis of a main slot and a major axis of the inner shaft tip are not substantially parallel, 
 ii) linearly moves the implant body towards an insertion end of an outer shaft of the implant insertion device so as to secure the implant body against the insertion end of the outer shaft, 
   b) delivering the implant body into a subject using the implanting insertion device; and   c) reversely rotating the knob of the inner shaft of the implant insertion device in a manner such that the reverse rotation of the knob
 i) rotates the inner shaft tip within the main slot in the implant body such that the major axis of the main slot and the major axis of the inner shaft tip are substantially parallel, 
 ii) associates the first interface of the knob to the first complimentary interface at the outer shaft at a second position. 
   
     
     
         22 . The method of  claim 21  comprising removing the insertion device from a sterile package prior to use. 
     
     
         23 . The method of  claim 21  comprising fitting at least one side slot of the implant body to at least one outer shaft tip at the insertion end of the outer shaft such that the implant body is substantially locked to the insertion device. 
     
     
         24 . The method of  claim 21  comprising disposing the implant insertion device after a single use. 
     
     
         25 . The method of  claim 21 , wherein the first and the second surfaces are displaced by a distance that the inner shaft tip is capable of moving with respect to the outer shaft. 
     
     
         26 . The method of  claim 21 , wherein the first and the second surfaces are displace by a distance determined by a length and a rising angle of the ramp. 
     
     
         27 . The method of  claim 21  comprises rotating the knob of an inner shaft of the implant insertion device in a manner such that the rotation of the knob linearly displaces the implant body from the insertion end of the outer shaft of the implant insertion device. 
     
     
         28 . A sterile kit containing a single-use implant body insertion device and a single use implant, the sterile kit comprising:
 a) a sterile kit cover sealed to enclose at least one device tray, at least one implant body, and at least one implant insertion device therewithin, wherein the at least one implant body and the at least one implant insertion device are configured for a single usage;   b) the at least one device tray configured to secure the at least one implant insertion device; and the at least one implant body;   c) the at least one implant insertion device comprising: a shaft; a tip; a first interface for locking the at least one implant body; a second interface for locking the at least one implant body; a first position; a second position; and   d) the at least one implant body comprising: an internal space, a slot for locking the at least one implant body against the at least one implant insertion device at the first position; a first complimentary interface for receiving the interface of the at least one implant insertion device at the first position or the second position; a second complimentary interface for receiving the second interface of the at least one implant insertion device at the first position.   
     
     
         29 . The kit of  claim 28  comprising a second sterile kit cover sealed to enclose the sterile kit cover. 
     
     
         30 . The kit of  claim 28 , wherein the device tray comprises a compartment to secure at least one implant body to facilitate loading at least one graft material to the internal space of the implant body.