Catheter systems and methods useful for cell therapy

Abstract

Described in one aspect is a multi-pressure monitoring system for cell or other therapy includes a first catheter having a first lumen for accepting a treatment device, a second lumen for inflating a balloon, a pressure sensor for monitoring fluid pressure within the first lumen, and a flow restrictor such as a hemostasis valve for limiting the exchange of fluids into and out of the first lumen while treatment devices are present or exchanged in the first lumen. Also disclosed is a method of using the first catheter with a first pressure monitor coupled to the first pressure sensor along with a second catheter attached to a second pressure sensor coupled to a second pressure monitor. The second catheter is positioned within the first lumen of the first catheter during treatment operations and the first and second pressure monitors are used to verify proper pressures throughout the procedure. Described also are novel methods, systems, and catheters for delivering flowable therapeutic substances, such as viable cellular preparations, to patients.

What is claimed is: 
     
         1 . A method of delivering a liquid medium to a patient, comprising:
 advancing the liquid medium under pressure through a first catheter lumen and into a patient bodily lumen so as to generate a first fluid pressure in the catheter lumen and a second fluid pressure in the bodily lumen;   during said advancing, measuring the first fluid pressure with a first fluid pressure sensor operably coupled to the first catheter lumen; and   during said advancing, measuring the second fluid pressure with a second fluid pressure sensor operably coupled to a second catheter lumen in fluid communication with the bodily lumen.   
     
     
         2 . The method of  claim 1 , wherein the liquid medium contains viable cells. 
     
     
         3 . A method of delivering viable cells to a target bodily passage site of a patient, comprising:
 (a) occluding a first bodily passage site of the patient that is proximal to the target bodily passage site, the occluding including:
 (i) first advancing an inflatable balloon of a first catheter to the first bodily passage site, the first catheter having a first catheter shaft defining a first lumen, the first lumen communicating with a first lumen proximal port and a first lumen distal port, the first catheter having the inflatable balloon mounted on the first catheter shaft proximal to the first lumen distal port, the first catheter shaft also defining a second lumen extending from a proximal port to a distal port in fluid communication with an inner void of the inflatable balloon; and 
 (ii) introducing a fluid into the inner void of the balloon through the second lumen to inflate the balloon and occlude the first bodily passage site; and 
   (b) second advancing a distal port of a second catheter to the target bodily passage site, wherein during said second advancing a catheter shaft of the second catheter is received coaxially and rotatably within the first lumen of the first catheter shaft, the catheter shaft of the second catheter defining a lumen fluidly communicating with the distal port of the second catheter; and   (c) passing a liquid medium including the viable cells through the lumen of the second catheter, out the distal port of the second catheter, and into the target bodily passage site.   
     
     
         4 . The method of  claim 3 , wherein the second catheter includes a distal tip region having a set curved condition offset at an angle of about 3 to about 90 degrees from a longitudinal axis of the second catheter shaft. 
     
     
         5 . The method of  claim 3 , also comprising:
 during said passing, measuring a first fluid pressure in the lumen of the second catheter, measuring a second fluid pressure in the target bodily passage site, or measuring both said first fluid pressure and said second fluid pressure.   
     
     
         6 . The method of  claim 3 , wherein the first bodily passage site is in the coronary sinus and/or anterior descending coronary vein of the patient. 
     
     
         7 . The method of  claim 3 , wherein the target bodily passage is within a heart wall of the patient. 
     
     
         8 . The method of  claim 3 , wherein a normal blood flow of the patient travels in a direction from said target bodily passage site downstream to said first bodily passage site, and wherein said passing forces the liquid medium retrograde to said normal blood flow. 
     
     
         9 . The method of  claim 8 , also comprising occluding blood flow of the patient at a second bodily passage site upstream of said target bodily passage site 
     
     
         10 . The method of  claim 9 , wherein said passing is conducted while performing both said occluding the first bodily passage site and said occluding the second bodily passage site. 
     
     
         11 . The method of  claim 9 , wherein said occluding the second bodily passage site is conducted with an inflatable balloon mounted on the catheter shaft of the second catheter distally of the distal port of the second catheter. 
     
     
         12 . The method of  claim 9 , wherein said occluding the second bodily passage site is conducted with an inflatable balloon mounted on a third catheter. 
     
     
         13 . The method of  claim 3 , also comprising insonating the target bodily passage site to impart stress to walls of the bodily passage site. 
     
     
         14 . A microcatheter for delivery of a flowable therapeutic substance to a bodily passage, comprising:
 a catheter shaft having an outer diameter of about 1 mm or less;   an inflatable balloon mounted on a distal portion of the catheter shaft, wherein the catheter shaft and inflatable balloon are receivable through a lumen of an outer catheter;   an inflation lumen extending through the catheter shaft, for inflating the inflatable balloon;   a fluid delivery lumen extending through the catheter shaft to at least one port in a distal region of the catheter shaft occurring distally of the inflatable balloon; and   at least one of:
 (a) an ultrasound emitting element mounted on the distal region of the catheter shaft; 
 (b) a set curve in the distal region of the catheter shaft; and 
 (c) said at least one port including a plurality of sidewall ports in fluid communication with the fluid delivery lumen. 
   
     
     
         15 . The microcatheter of  claim 14 , including both (a) an ultrasound emitting element mounted on the distal region of the catheter shaft, and (b) a set curve in the distal region of the catheter shaft. 
     
     
         16 . The microcatheter of  claim 14 , including both (a) an ultrasound emitting element mounted on the distal region of the catheter shaft, and (c) said at least one port including a plurality of sidewall ports in fluid communication with the fluid delivery lumen. 
     
     
         17 . The microcatheter of  claim 14 , including both (b) a set curve in the distal region of the catheter shaft, and (c) said at least one port including a plurality of sidewall ports in fluid communication with the fluid delivery lumen. 
     
     
         18 . The microcatheter of  claim 14 , in combination with a second catheter having a lumen through which the microcatheter is rotatably receivable. 
     
     
         19 . The microcatheter of  claim 18 , wherein the second catheter is a balloon catheter. 
     
     
         20 . The microcatheter of  claim 14 , in combination with a pressure sensor operable to measure pressure of fluid forced into the fluid delivery lumen.