Implant placement and removal systems

Abstract

Devices, methods, and systems are provided for placing an implant into a patient and removing it therefrom.

1 . A system for placing an implant, comprising:
 a placement tool comprising
 a handle portion, and 
 a placement cannula having a length, a proximal end arranged near the handle portion and a distal end opposite the proximal end, the placement cannula configured to deliver the implant within a tissue of a patient via an incision in the skin of the patient at an implantation site; and 
   a placement guide comprising
 a first surface having a contact face and an opposite non-contact face, the first surface contact face configured to be disposed in contact with a surface of the skin of the patient at the implantation site, and 
 a pilot-tube projecting from the contact face of the first surface and comprising a proximal end configured to receive the distal end of the placement cannula, a distal end spaced apart from the proximal end at a first distance, and a length defined by the first distance, wherein the length of the pilot-tube is disposed in contact with the surface of the skin of the patient at the implantation site; 
   wherein the placement guide is configured to guide the placement cannula within the tissue of the patient at the implantation site to effect implantation of the implant at a predetermined placement depth beneath the outer surface of the skin of the patient at the implantation site beneath the first surface contact face; and   wherein the placement cannula is movable either within or adjacent to the pilot-tube.   
     
     
         2 . The system of  claim 1 , wherein the pilot-tube further comprises a longitudinal central axis arranged relative to the first surface at either of the first surface at either or both of a second distance and an angle, and wherein at least one of the first distance, the second distance, and the angle of the longitudinal central axis of the pilot-tube are configured to orient the longitudinal central axis in order to guide the placement cannula for the delivery of the implant at the predetermined placement depth. 
     
     
         3 . The system of  claim 1 , wherein the predetermined placement depth is 0.5 mm to 4.5 mm beneath the surface of the skin of the patient. 
     
     
         4 . The system of  claim 1 , wherein the placement guide further comprises a visualization window or opening, wherein the visualization window or opening extends along a length and a width of the placement guide and is configured to allow visual observation and/or palpation of an area of the surface of the skin of the patient around the implantation site. 
     
     
         5 . (canceled) 
     
     
         6 . The system of  claim 1 , wherein the implant is an osmotic pump. 
     
     
         7 . The system of  claim 1 , configured to permit clockwise and counterclockwise rotation of the placement cannula within the pilot-tube. 
     
     
         8 . A method for placing an implant, comprising:
 providing a placement system according to  claim 1 .   
     
     
         9 . The method of  claim 8 , further comprising at least one of:
 loading the implant into the distal end of the placement cannula;   creating an incision in the skin at the implantation site;   arranging the placement guide at the implantation site, such that the distal end of the pilot-tube is aligned with the incision;   inserting the distal end of the loaded placement cannula in the proximal end of the pilot-tube;   moving the placement cannula relative to the pilot-tube until at least a part of the handle portion is proximate the proximal end of the pilot-tube such that the distal end of the placement cannula is guided farther into the incision and into the tissue beneath and/or adjacent the incision;   releasing the implant from the placement cannula;   removing the placement cannula from the skin of the patient; and   removing of the placement guide from the skin of the patient.   
     
     
         10 . The method of  claim 9 , wherein the placement cannula is guided into the incision and into the tissue with rotation of the handle portion, thereby resulting in rotation of the placement cannula within the pilot-tube. 
     
     
         11 . The method of  claim 9 , wherein prior to creating the incision, the method further comprises one or more of:
 cleaning the skin at the implantation site;   marking the skin for making the incision; and   injecting a local anesthetic in a vicinity of the marked skin.   
     
     
         12 . The method of  claim 9 , wherein after release and/or removal of the placement cannula, and/or removal of the placement guide, the method further comprises at least one of:
 cleaning the incision;   applying pressure to the incision;   applying an adhesive to at least one side of the incision; and   closing the incision.   
     
     
         13 - 16 . (canceled) 
     
     
         17 . A placement guide for use with a placement tool, the placement guide comprising:
 a first surface having a contact face and an opposite non-contact face, the first surface contact face configured to be disposed in contact with a surface of the skin of the patient at the implantation site; and   a pilot-tube projecting from the contact face of the first surface and comprising a proximal end configured to receive the distal end of a placement cannula of the placement tool for delivering an implant to tissue; a distal end spaced apart from the proximal end at a first distance, and a length defined by the first distance, wherein the length of the pilot-tube is disposed in contact with the surface of the skin of the patient at the implantation site;   wherein the placement guide is configured to guide the placement cannula of the placement tool within the tissue to effect implantation of the implant at a predetermined placement depth beneath the surface of the skin of the patient at the implantation site.   
     
     
         18 . The placement guide of  claim 17 , wherein the pilot-tube is configured to permit rotation of the placement cannula of the placement tool within the pilot-tube. 
     
     
         19 . The placement guide of  claim 17 , further comprising a visualization window or opening that extends along a length and a width of the first surface and configured to enable visual observation and/or palpation of an area of the surface of skin of the patient around the implantation site. 
     
     
         20 . The placement guide of  claim 19 , wherein the visualization window or opening has a length that extends beyond a tip of the cannula when the cannula is inserted into, and fully extended through, the pilot-tube. 
     
     
         21 . The placement guide of  claim 17 , wherein the predetermined placement depth is from 0.5 mm to 4.5 mm beneath the surface of the skin of the patient. 
     
     
         22 . The placement guide of  claim 17 , wherein the pilot-tube is configured to receive and guide the placement cannula into tissue. 
     
     
         23 . The placement guide of  claim 17 , wherein the placement guide is made from a material that is translucent or clear. 
     
     
         24 . The placement guide of  claim 17 , wherein the pilot-tube is configured at an incline relative to a level underside of the placement guide. 
     
     
         25 . The placement guide of  claim 17 , wherein the placement guide cannot readily be flexed or bent, length-wise or width-wise, by a user. 
     
     
         26 - 44 . (canceled)