Methods, systems, and kits for implanting articles

Abstract

Methods, systems, and kits for subcutaneously implanting articles, such as drug inserts and reservoirs. The methods rely on percutaneously forming a tissue tract and radially dilating the tract to a diameter which permits introduction of the article. By fully expanding the lumenal diameter of the tissue tract prior to introduction of the article, damage to the article resulting from passage through a partially expanded tissue tract can be avoided. In the exemplary embodiment, a radially expandable sleeve is first percutaneously introduced to the subcutaneous target site. An assembly of a cannula and dilator is then passed through the sleeve, effecting radial expansion. The dilator is removed and the article is then introduced through a lumen of the cannula.

1 . A system for implanting an article into solid tissue comprising:
 a needle;   a radially expandable sleeve including a lumen extending therethrough configured and dimensioned to receive the needle;   a tubular cannula configured and dimensioned for insertion through the lumen of the sleeve, the cannula including a non-collapsible lumen extending therethrough;   a dilator configured and dimensioned for insertion through the lumen of the cannula; and   at least one pharmaceutical implant having peripheral dimensions permitting the at least one pharmaceutical implant to be delivered into the tissue through the lumen of the cannula.   
     
     
         2 . The system of  claim 1 , wherein the sleeve is configured and dimensioned such that the lumen extending therethrough is collapsible. 
     
     
         3 . The system of  claim 2 , wherein the sleeve includes a tubular braid formed from a mesh of non-elastic filaments which cause the sleeve to axially shorten as the sleeve is expanded radially. 
     
     
         4 . The system of  claim 1 , wherein the cannula and the sleeve are configured and dimensioned such that a distal-most end of the cannula extends beyond a distal-most end of the sleeve upon complete insertion of the cannula into the lumen of the sleeve. 
     
     
         5 . The system of  claim 4 , wherein the dilator and the cannula are configured and dimensioned such that a distal-most end of the dilator extends beyond a distal-most end of the cannula upon complete insertion of the dilator into the lumen of the cannula. 
     
     
         6 . The system of  claim 1 , wherein the cannula is configured and dimensioned such that the lumen extending therethrough remains fully open absent the dilator and the at least one pharmaceutical implant. 
     
     
         7 . The system of  claim 1 , wherein the sleeve includes a removable sheath. 
     
     
         8 . The system of  claim 1 , further including a container configured and dimensioned to retain at least one of the needle, the radially expandable sleeve, the tubular cannula, the dilator, and the at least one pharmaceutical implant therein. 
     
     
         9 . The system of  claim 1 , wherein the dilator includes a tapered distal end portion. 
     
     
         10 . The system of  claim 1 , wherein the lumen of the cannula has a diameter substantially in the range of approximately 2 mm to approximately 20 mm. 
     
     
         11 . The system of  claim 1 , wherein the at least one pharmaceutical implant includes a medicament controllably releasing a drug selected from the group consisting of estrogen, progesterone, and testosterone. 
     
     
         12 . The system of  claim 1 , wherein the needle includes a lumen extending therethrough. 
     
     
         13 . The system of  claim 1 , wherein the system further includes a guidewire configured and dimensioned for insertion through the lumen extending through the needle. 
     
     
         14 . The system of  claim 1 , wherein the needle is a solid core rod. 
     
     
         15 . The system of  claim 1 , wherein the needle includes an incisive distal tip, the needle being configured and dimensioned such that the incisive distal tip extends beyond a distal-most end of the sleeve. 
     
     
         16 . The system of  claim 1 , wherein the sleeve includes a handle at a proximal end thereof with an aperture extending therethrough, the aperture being in alignment with the lumen extending through the sleeve. 
     
     
         17 . A method for implanting an article within solid tissue, the method comprising the steps of:
 inserting an assembly of a needle and a radially expandable sleeve into the tissue;   then withdrawing the needle from the sleeve;   then inserting an assembly of a cannula and a dilator into the sleeve such that a distal-most end of the cannula reaches a target site in the tissue and extends beyond a distal-most end of the sleeve, and a distal-most end of the dilator extends beyond a distal-most end of the cannula;   then withdrawing the dilator from the cannula to reveal an opening in the tissue positioned adjacent the distal-most end of the cannula;   then advancing the article through the lumen of the cannula; and   then depositing the article within the opening in the tissue.   
     
     
         18 . The method of  claim 17 , wherein the step of inserting the assembly of the needle and the sleeve includes advancing the sleeve into intramuscular tissue. 
     
     
         19 . The method of  claim 18 , wherein the step of inserting the assembly of the cannula and the dilator includes penetrating the intramuscular tissue with a distal tapered portion of the dilator. 
     
     
         20 . The method of  claim 17 , further including the step of inserting a guidewire into a lumen extending through the needle, and advancing the assembly of the needle and the sleeve distally over the guidewire.