Method and devices for creating a trap for confining therapeutic drugs and/or genes in the myocardium

Abstract

Devices and methods for effective administration of therapeutic drugs or gene therapy to the myocardium is achieved by creating a trap or pocket within the myocardium for confining the injected therapeutic. The pocket can be created using mechanical and light energy, or other means.

I claim:  
     
         1 . A device suitable for administering a predetermined amount of a therapeutic agent into a mammalian heart myocardium comprising: 
 a catheter terminating in a hollow open ended puncturing tip and in fluid flow communication therewith, said puncturing tip defining a fluid channel communicating with catheter,    an optical fiber within the catheter and having a distal end extending into the fluid channel, said optical fiber together with said catheter defining a confined flow passageway in communication with the fluid channel in the puncturing tip,    such that a therapeutic agent introduced via the confined flow passageway exits through the fluid channel of said tip.    
     
     
         2 . A device of    claim 1    wherein said tip is a hollow needle.  
     
     
         3 . A device of    claim 2    wherein said needle is beveled.  
     
     
         4 . A device of    claim 3    wherein said needle is crimped to grasp said optical fiber.  
     
     
         5 . A device of    claim 1    wherein said optical fiber is in a bundle of optical fibers.  
     
     
         6 . A device of    claim 1    wherein said fiber is covered by a buffer coat which defines channels within this coat that run substantially parallel with the length of the fiber, or spirally along the length of the fiber, and said channels maintain fluid communication through the length of the catheter.  
     
     
         7 . A device of    claim 2    wherein said needle contains protrusions within the bore of the needle which run substantially parallel with the length of the needle, or spirally along the length of the needle, and define channels which maintain fluid communication through the length of the needle when an optical fiber is fixed within the bore of said needle.  
     
     
         8 . A device of    claim 1    wherein said tip contains more than one fluid channel exiting said tip.  
     
     
         9 . A device of    claim 1    wherein said tip contains an optical lens.  
     
     
         10 . A device of    claim 1   , said tip and said catheter further having an external surface, and wherein said tip is attached to said catheter by means of a flanged fitting so as to leave a substantially smooth continuous surface between the external surface of the catheter and the external surface of the tip.  
     
     
         11 . A device of    claim 1    further comprising an outer catheter containing a lumen, wherein said catheter is inserted within said outer catheter and said device is suitable for insertion via a trocar into a patient.  
     
     
         12 . A surgical device for forming a pocket within tissue and allowing injection of a therapeutic agent into said pocket through said device comprising: 
 a flexible outer catheter having a distal end;    a flexible movable inner catheter defining a fluid flow channel and distal end, movably located within said outer catheter lumen;    a flexible optical fiber for transmission of light energy, having a distal end, located within said inner catheter so as to permit fluid flow along the length of said inner catheter;    a rigid hollow tip having at least one fluid channel exiting said tip, attached to the distal end of said inner catheter and fixed to a portion of said optical fiber located within said hollow tip wherein said inner catheter flow channel remains in fluid communication with said tip channel; and    an actuator operably connected to said inner catheter for selectively extending said inner catheter from said outer catheter such that said tip may mechanically penetrate tissue in opposition to the distal end of said outer catheter; and when said tip is further extended in conjunction with the transmission of light energy from said optical fiber, a cavity is formed within said tissue; and upon withdrawal of said tip a therapeutic agent may be injected via the inner catheter and tip into the cavity created by said light energy.    
     
     
         13 . A device of    claim 12    wherein said tip is a hollow needle.  
     
     
         14 . A device of    claim 13    wherein said needle is beveled.  
     
     
         15 . A device of    claim 14    wherein said needle is crimped to grasp said optical fiber.  
     
     
         16 . A device of    claim 15    wherein said optical fiber is in a bundle of optical fibers.  
     
     
         17 . A device of    claim 14    wherein said needle contains protrusions within the bore of the needle which run substantially parallel with the length of the needle, or spirally along the length of the needle, and define channels which maintain fluid communication through the length of the needle when an optical fiber is fixed within the bore of said needle.  
     
     
         18 . A device of    claim 12    wherein said tip contains more than one fluid channel exiting said tip.  
     
     
         19 . A device of    claim 12    wherein said tip contains an optical lens.  
     
     
         20 . A device of    claim 12   , said tip and said catheter further having an external surface, and wherein said tip is attached to said catheter by means of a flanged fitting so as to leave a substantially smooth continuous surface between the external surface of the catheter and the external surface of the tip.  
     
     
         21 . A device of    claim 12    suitable for insertion via a trocar into a patient.  
     
     
         22 . A method for treating heart muscle comprising penetrating the heart muscle with an optical fiber containing device, creating a cavity within the heart muscle using light energy, depositing a therapeutic agent, and withdrawing the optical fiber, such that the cavity retains therapeutic agent within the heart muscle after the device is removed.  
     
     
         23 . A method as in    claim 22    wherein said light energy is laser energy.  
     
     
         24 . A method as in    claim 22    wherein said optical fiber is penetrated into the heart muscle at least 10% of its total thickness at the point of penetration.  
     
     
         25 . A method as in    claim 24    wherein said optical fiber is penetrated into the heart muscle at least 20% of its total thickness at the point of penetration.  
     
     
         26 . A method as in    claim 25    wherein said optical fiber is penetrated into the heart muscle at least 30% of its total thickness at the point of penetration.  
     
     
         27 . A method as in    claim 26    wherein said optical fiber is penetrated into the heart muscle at least 40% of its total thickness at the point of penetration.  
     
     
         28 . A method as in    claim 22    wherein said light energy creates a cavity at least 10% of the thickness of the heart muscle at the point of treatment.  
     
     
         29 . A method as in    claim 28    wherein said light energy creates a cavity at least 20% of the thickness of the heart muscle at the point of treatment.  
     
     
         30 . A method as in    claim 29    wherein said light energy creates a cavity at least 30% of the thickness of the heart muscle at the point of treatment.  
     
     
         31 . A method as in    claim 30    wherein said light energy creates a cavity at least 40% of the thickness of the heart muscle at the point of treatment.  
     
     
         32 . A method as in    claim 22    wherein said optical fiber is withdrawn prior to administering a therapeutic agent.  
     
     
         33 . A method as in    claim 22    wherein said optical fiber containing device allows for administration of therapeutic agent via fluid communication channels.  
     
     
         34 . A method as in    claim 22    wherein said method is timed to coincide within a predetermined time period related to the heart's ECG.  
     
     
         35 . A method as in    claim 34    wherein said predetermined time period is related to the “r” wave of the heart's ECG.  
     
     
         36 . A method for treating a mammalian heart comprising using the device of    claim 1    to administer a therapeutic agent into the heart of a mammal needing treatment.  
     
     
         37 . A method for treating a mammalian heart comprising using the device of    claim 12    to administer a therapeutic agent into the heart of a mammal needing treatment.  
     
     
         38 . A device suitable for administering a predetermined amount of a therapeutic agent into a mammalian heart myocardium comprising: 
 a catheter terminating in a hollow open ended puncturing tip and in fluid flow communication therewith, said puncturing tip defining a fluid channel communicating with catheter,    a flexible drive cable within the catheter and having a distal end extending into the fluid channel and terminating in a rotatable burr, said cable together with said catheter defining a confined flow passageway in communication with the fluid channel in the puncturing tip, such that a therapeutic agent introduced via the confined flow passageway exits through the fluid channel of said tip.    
     
     
         39 . A device suitable for administering a predetermined amount of a therapeutic agent into a mammalian heart myocardium comprising: 
 a catheter terminating in a hollow open ended puncturing tip and in fluid flow communication therewith, said puncturing tip defining a fluid channel communicating with catheter,    an electrical lead within the catheter and having a distal end terminating in an electrode which allows transfer of electrical energy to a tissue in contact with said electrode,    said catheter defining a confined flow passageway in communication with the fluid channel in the puncturing tip, such that a therapeutic agent introduced via the confined flow passageway exits through the fluid channel of said tip.    
     
     
         40 . A method for treating heart muscle comprising penetrating the heart muscle with an electric lead containing device, creating a cavity within the heart muscle using electrical energy, depositing a therapeutic agent, and withdrawing the lead, such that the cavity retains therapeutic agent within the heart muscle after the device is removed.  
     
     
         41 . A method for treating heart muscle comprising penetrating the heart muscle with a rotating cable drive and linked mechanical burr containing device, creating a cavity within the heart muscle using a rotating burr, depositing a therapeutic agent, and withdrawing the device, such that the cavity retains therapeutic agent within the heart muscle after the device is removed.