Systems and methods for delivering agents into targeted tissue of a living being

Abstract

The systems basically comprise a delivery system for accessing the targeted tissue within the living being and introduction of at least one agent at select locations in the into the myocardium and other select tissues. The delivery systems are arranged to access the tissues of the heart. One or more of the systems can be utilized during transluminal, transthoracic and direct surgical access procedures. Where appropriate, for example in the case of intraventricular access, portions of the system are steerable to properly orient the device. The instruments may pierce the heart tissue and create channels extending from the endocardium, the epicardium, or the cardiac vessels. When tissue penetration is utilized, the device may include a feature to control the depth of penetration. To minimize bleeding through the channels the device can dilate small initial punctures that later contract down after device removal. When the formation of channels is required, this can be achieved, by way of example, with a rotary-tipped device, pressurized fluid jet devices, vibratory instruments and piercing needle-like tip devices. The system may utilize some form of mechanical action or application of energy (e.g. electrical, sonic, thermal, optical, pressurized fluid, radio frequency (RF), nuclear) in the process. The mechanical action or energy application may affect the surroundings tissues at a distance from the device. The agent delivered to the tissue may include one or more of pharmaceuticals, biologically active agents, radiopaque materials, etc.

1 . A catheter system for delivering a fluid to heart tissue, comprising:
 a pressurized fluid source containing a fluid therein, the pressurized fluid source generating a high transient pressure sufficient to pierce bodily tissue; and   an injection catheter including an elongate shaft having a proximal end, a distal end and an infusion lumen extending therein, the proximal end of the shaft connected to the pressurized fluid source, the infusion lumen in fluid communication with the fluid contained in the pressurized fluid source, the distal end of the shaft including a nozzle having an injection port in fluid communication with the infusion lumen such that fluid from the pressurized fluid source may be delivered to the heart tissue via the infusion lumen of the shaft and the injection port at a sufficient exit velocity to at least partially penetrate the heart tissue.   
   
   
       2 . The catheter system of  claim 1 , wherein the injection port has a diameter selected from the group consisting of 0.05 inches or less, 0.010 inches or less and 0.005 inches or less. 
   
   
       3 . The catheter system of  claim 1 , wherein the nozzle defines a nozzle lumen having a diameter, and wherein the injection port has a diameter substantially the same as the diameter of the nozzle lumen. 
   
   
       4 . The catheter system of  claim 1 , wherein the nozzle defines a nozzle lumen having a diameter, and wherein the injection port has a diameter smaller than the diameter of the nozzle lumen. 
   
   
       5 . The catheter system of  claim 1 , wherein the nozzle includes a sharpened distal end to at least partially penetrate the heart tissue. 
   
   
       6 . The catheter system of  claim 1 , wherein the injection port is one of directed distally or directed laterally. 
   
   
       7 . The catheter system of  claim 1 , further comprising:
 a vacuum source; and   a sheath disposed about the injection catheter, the sheath having a proximal end, a distal end and a suction lumen disposed therein, the proximal end of the sheath connected to the vacuum source with the suction lumen of the sheath in fluid communication with the vacuum source, wherein the distal end of the sheath is disposed adjacent the heart tissue such that the distal end of the sheath is stabilized against the heart tissue when a vacuum is applied to the suction lumen using the vacuum source.   
   
   
       8 . The catheter system of  claim 1  wherein said heart tissue comprises the myocardium. 
   
   
       9 . The catheter system of  claim 1 , additionally comprising releasable securement means, wherein said securement means stabilizes said delivery system against tissue during its operation. 
   
   
       10 . The catheter system of  claim 9 , wherein said securement means comprises a suction hood. 
   
   
       11 . The system of  claim 1 , wherein said fluid additionally comprises a carrier for a first flowable agent. 
   
   
       12 . The system of  claim 11 , wherein said first flowable agent comprises at least one of saline, pharmaceuticals, growth factors, biomaterials, small particles, genetic based material or cellular based material. 
   
   
       13 . The system of  claim 12 , wherein said small particles comprise microspheres comprising at least one of resorbable materials, non-resorbable materials or partially resorbable materials. 
   
   
       14 . The system of  claim 13 , wherein said microspheres are arranged for time-phased delivery of said beneficial treatment. 
   
   
       15 . The catheter system of  claim 11 , wherein said catheter system additionally comprises a second flowable agent. 
   
   
       16 . The catheter system of  claim 1 , arranged to be operated as an adjunctive therapy to a primary therapy. 
   
   
       17 . The catheter system of  claim 16 , wherein said primary therapy comprises percutaneous transluminal angioplasty, stenting, or coronary artery by-pass surgery. 
   
   
       18 . The catheter system of  claim 1 , wherein the distal end defines said injection port having a diameter, and wherein the outlet port has a diameter substantially the same as the diameter of said infusion lumen. 
   
   
       19 . The catheter system of  claim 1 , wherein the distal end defines said injection port having a diameter, and wherein the injection port has a diameter smaller than the diameter of the infusion lumen to increase the exit velocity of the fluid. 
   
   
       20 . The catheter system as in  claim 1 , wherein the distal end includes a sharpened portion to partially penetrate the heart tissue. 
   
   
       21 . The catheter system of  claim 1  wherein the injection port is directed distally. 
   
   
       22 . The catheter system of  claim 1 , wherein said injection port is arranged radially from said infusion lumen. 
   
   
       23 . A method of delivering a flowable agent to a target tissue site in target tissue of a patient, comprising the steps of:
 providing a reservoir containing a flowable agent therein, and a delivery injector, said reservoir arranged to generate a high transient pressure sufficient to cause said flowable agent to enter target tissue;   providing a delivery instrument comprising a suction head having a proximal end, a distal end and a flow path extending therein, the distal end of the delivery instrument including an outlet port;   inserting the delivery instrument into the patient;   navigating the delivery instrument until the distal end of the delivery instrument is positioned adjacent the target tissue site; and   actuating the fluid source to inject flowable agent into the target tissue via the flow path of the suction head and the outlet port at a sufficient exit velocity to partially penetrate the target tissue.   
   
   
       24 . The method of  claim 23 , wherein said delivery instrument further supplies additional energy to said body. 
   
   
       25 . The method of  claim 24 , wherein said additional energy is selected from the group consisting of thermal, mechanical, electrical, and electromagnetic. 
   
   
       26 . The method of  claim 25 , wherein said mechanical energy is selected from the group consisting of hydraulic energy and vibrational energy. 
   
   
       27 . The method of  claim 24 , wherein said additional energy disables or denervates local nerves in said target tissue. 
   
   
       28 . The method of  claim 23 , wherein said high pressure is about several thousand psi.