Surgical device and method for performing combination revascularization and therapeutic substance delivery to tissue

Abstract

A surgical device is provided for both ablating a channel in a patient's tissue and also delivering a therapeutic agent. The device includes an elongated multi-lumen tube, an elongated tissue ablating assembly, and a therapeutic agent delivery assembly. The therapeutic agent is capable of being delivered into the channel and/or to the surrounding tissue. The device may further include a second multi-lumen tube also capable of delivering therapeutic agents. A method is also provided for using such a surgical device to ablate a channel in a patient's tissue and also deliver a therapeutic agent to the tissue, for example, for transmyocardial revascularization or other procedures.

1 . A method for ablating a channel and delivering a therapeutic agent into a desired region of tissue, comprising:
 (a) providing a surgical device having an elongated multi-lumen tube with a proximal end in connection with a control handle assembly and extending to a distal treatment end adapted for ablating and delivering the therapeutic agent to the tissue, said multi-lumen tube having a tissue ablating assembly extending through a first lumen of the multi-lumen tube and a therapeutic agent delivery assembly incorporating a second lumen of the multi-lumen tube, wherein the ablating assembly has a proximal end in connection with a source of ablating energy and extending distally to an ablating tip and the therapeutic agent delivery assembly has a therapeutic agent receiving port at a proximal end and extends distally to an injection tip and wherein the ablating tip and injection, tip are disposed such that the therapeutic agent can be delivered into tissue surrounding a channel formed by the ablating tip;   (b) positioning the treatment end adjacent to the desired region of tissue;   (c) energizing the source of ablating energy such that the ablating tip is capable of ablating the tissue;   (d) advancing the ablating tip to form a channel in the tissue; and   (e) dispensing the therapeutic agent from the injection tip into the tissue adjacent the channel.   
     
     
         2 . The method of  claim 1 , wherein the ablating energy is a laser and the ablating tip is a lasing tip. 
     
     
         3 . The method of  claim 1 , further comprising dispensing the therapeutic agent into the channel. 
     
     
         4 . The method of  claim 1 , wherein dispensing a therapeutic agent comprises dispensing the agent into multiple locations adjacent to the channel. 
     
     
         5 . The method of  claim 1 , wherein the injection tip in the form of a needle. 
     
     
         6 . The method of  claim 5 , wherein the device further comprises a second and third needle and the three needles are radially spaced so they enter the tissue surrounding and centered on the formed channel. 
     
     
         7 . The method of  claim 6 , wherein each of the needles comprises a plurality of holes arrayed along the length of the needle. 
     
     
         8 . The method of  claim 1 , wherein the region of tissue comprises myocardium. 
     
     
         9 . The method of  claim 1 , wherein the therapeutic agent comprises stem cells. 
     
     
         10 . A method for performing a combination myocardial revascularization procedure and delivering a therapeutic agent to a desired region of heart tissue, comprising the steps of:
 (a) providing a surgical device having an first elongated multi-lumen tube with a proximal end in connection with a control handle assembly and extending to a distal treatment end, said first multi-lumen tube having a tissue ablating assembly supported in a first lumen of the multi-lumen tube and a therapeutic agent delivery assembly supported in a second lumen of the multi-lumen tube, wherein the ablating assembly has a proximal end in connection with a source of ablating energy and extending distally to an ablating tip for creating a channel in the tissue and wherein the therapeutic agent delivery assembly has a proximal end that is connectable with a source of the therapeutic agent and extending distally to a delivery tip disposed proximally to the ablating tip such that the therapeutic agent can be delivered from the source and into the channel, said surgical device further comprising a second elongated multi-lumen tube connectable with a second therapeutic agent at a proximal end and extending to an injection tip and adapted for delivering the second therapeutic agent from the source to the injection tip for dispensing into the tissue;   (b) positioning the treatment end adjacent the desired region of tissue;   (c) energizing the source of ablating energy such that the ablating tip is capable of ablating the tissue;   (d) advancing the ablating tip into the tissue to form a channel in the tissue;   (e) advancing the injection tip into the desired region of tissue; and   (f) dispensing the therapeutic agent from the delivery tip into the channel.   
     
     
         11 . The method of  claim 10 , wherein the step of advancing the ablating tip comprises advancing the first multi-lumen lumen tube relative to the second multi-lumen lumen tube. 
     
     
         12 . The method of  claim 10 , wherein the step of advancing the ablating tip comprises advancing the ablating tip outwardly relative to the injection tip. 
     
     
         13 . The method of  claim 10 , further including the step of extending the first multi-lumen lumen tube relative to the second multi-lumen lumen tube. 
     
     
         14 . The method of  claim 10 , further comprising the step of dispensing a therapeutic agent from the agent injection tip into the desired region of tissue. 
     
     
         15 . The method of  claim 10 , wherein the ablating energy is a laser and the ablating tip is a lasing tip. 
     
     
         16 . The method of  claim 10 , wherein the step of dispensing the therapeutic agent comprises dispensing a first therapeutic agent through the first delivery tip and a second therapeutic agent through the injection tip. 
     
     
         17 . The method of  claim 10 , wherein the injection tip is advanced into the desired region of tissue prior to advancing the ablating tip into the tissue to form the channel. 
     
     
         18 . The method of  claim 10 , wherein the step of advancing the injection tip into the desired region of tissue and a step of injecting the second therapeutic agent into the desired region of tissue occur prior to the step of advancing the ablating tip into the tissue. 
     
     
         19 . The method of  claim 10 , further comprising the step of dispensing a first therapeutic agent from the delivery tip into the channel and dispensing a second therapeutic agent from the injection assembly into the desired region of tissue. 
     
     
         20 . The method of  claim 10 , wherein the step of dispensing a therapeutic agent further comprises dispensing the agent into the channel formed by the ablating tip and into tissue adjacent the channel. 
     
     
         21 . The method of  claim 10 , further including the step of retracting the ablating tip from the tissue. 
     
     
         22 . A method for performing a combination myocardial revascularization procedure and delivering a therapeutic agent to a desired region of heart tissue, comprising:
 positioning a surgical device having a proximal end with a control handle assembly and a distal end connected to a treatment assembly, such that the distal end of the treatment assembly is positioned adjacent to the desired region of heart tissue;   energizing a laser such that an ablating tip in the treatment assembly is capable of ablating the heart tissue;   advancing the ablating tip into the heart tissue and ablating tissue to form a channel in the heart tissue;   advancing a plurality of needles from the treatment assembly into the desired region of tissue; and   dispensing the therapeutic agent from a source in the surgical device through the plurality of needles directly into the heart tissue surrounding the channel.   
     
     
         23 . The method of  claim 22 , wherein the plurality of needles are radially spaced so that they are advanced into the tissue surrounding and centered on the channel. 
     
     
         24 . The method of  claim 22 , wherein each of the needles comprises a plurality of holes arrayed along the length of the needle. 
     
     
         25 . The method of  claim 24 , wherein the tip of each of the needles is capped with a point. 
     
     
         26 . The method of  claim 22 , wherein the plurality of needles is three needles. 
     
     
         27 . The method of  claim 22 , wherein the therapeutic agent comprises stem cells. 
     
     
         28 . The method of  claim 22 , wherein the advancement of the ablating tip and the needles into the heart tissue is a continuous operation accomplished by a single fully extended motion of an actuator located in the control handle assembly.