US2004039430A1PendingUtilityA1

System and method using the rectal mucosal membrane for inducing hypothermia and warming

Assignee: XANODYNE PHARMACAL INCPriority: Aug 20, 2002Filed: Aug 20, 2002Published: Feb 26, 2004
Est. expiryAug 20, 2022(expired)· nominal 20-yr term from priority
A61F 2007/0028A61F 7/123A61F 2007/0054
46
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Claims

Abstract

A system and method for cooling and warming the central nervous system of a patient comprises a delivery tube with one of the ends couplable to a supply of fluid. A head structure is coupled to the other end of the delivery tube and cooling or warming fluid is directed through the tube to the head structure. The head structure is configured to be placed within the rectal cavity of a patient such that either a contact surface on the head structure or the fluid itself directly contacts a portion of the rectal mucosal membrane. A means for reversing the vertebral venous flow of blood through Batson's plexus supplies cooled or warmed blood directly to the vertebral structures. Unique methods of utilizing the system to selectively cool and warm the central nervous system structures of a patient are set forth herein.

Claims

exact text as granted — not AI-modified
What is claimed is:  
     
         1 . A device for cooling or warming a portion of a body of a patient, comprising: 
 a supply of fluid;    a head structure configured to receive the fluid and operable to transfer caloric energy between the fluid and a contact surface of the head structure;    a delivery tube coupled between the supply and head structure for delivering fluid to the head structure to affect the temperature of the head structure;    the head structure configured to be positioned within the rectal cavity of a patient with the contact surface contacting rectal tissue in the cavity, the contact surface operable for transferring caloric energy between the rectal tissue and the fluid.    
     
     
         2 . The device of  claim 1  further comprising means for reversing the vertebral venous flow of blood through Batson's plexus to supply blood, affected by the temperature of the head structure, to the vertebral structures.  
     
     
         3 . The device of  claim 1 , the delivery tube further comprising an inflow lumen and an outflow lumen, the inflow lumen operable to deliver the fluid to the head structure, the outflow lumen operable to remove the fluid from the head structure.  
     
     
         4 . The device of  claim 1 , wherein the contact surface of the head structure is extensive for contacting a significant amount of the rectal tissue.  
     
     
         5 . The device of  claim 2 , wherein the means for reversing vertebral venous blood flow through Batson's plexus is selected from the group consisting of a lumbar support, an abdominal restraint, and an abdominal binder.  
     
     
         6 . The device of  claim 1 , wherein the shape of the head structure is selected from the group consisting of a bulb, an expandable bag, and a helix tip.  
     
     
         7 . The device of  claim 1 , wherein the head structure is made of a pliable material.  
     
     
         8 . The device of  claim 1 , wherein the head structure is compressible for insertion within the rectal cavity.  
     
     
         9 . The device of  claim 1 , wherein the head structure is operable to expand and conform generally to the shape of the rectal cavity after insertion within the rectal cavity.  
     
     
         10 . The device of  claim 1  further comprising a pump device coupled to the supply of fluid to pump fluid to the head structure.  
     
     
         11 . The device of  claim 10 , wherein the head structure is operable expand in direct relation to an inflow rate of the fluid pumped thereto.  
     
     
         12 . The device of  claim 1  wherein the head structure is configured for dispensing a substance proximate to the rectal tissue contacted by the head structure.  
     
     
         13 . The device of  claim 12  wherein the head structure is configured for dispensing a vasodilator proximate the rectal tissue.  
     
     
         14 . The device of  claim 1 , wherein the head structure comprises a proximal bulb and a distal bulb configured for being simultaneously positioned in the rectal cavity, the bulbs configured for receiving fluid for transferring caloric energy between the rectal tissue and the fluid.  
     
     
         15 . The device of  claim 14 , wherein the proximal bulb is configured for being positioned within the portion of the rectum generally drained by at least one of the middle and inferior rectal veins.  
     
     
         16 . The device of  claim 14 , wherein the distal bulb is configured for being positioned at least partially within a portion of the rectal cavity generally drained by the superior rectal vein.  
     
     
         17 . The device of  claim 14 , further comprising a supply of cooling fluid coupled to the proximal bulb to cool the proximal bulb.  
     
     
         18 . The device of  claim 14 , further comprising a supply of cooling fluid coupled to the distal bulb to cool the distal bulb.  
     
     
         19 . The device of  claim 14 , further comprising a supply of warming fluid coupled to the proximal bulb to warm the proximal bulb.  
     
     
         20 . The device of  claim 14 , further comprising a supply of warming fluid coupled to the distal bulb to warm the distal bulb.  
     
     
         21 . The device of  claim 1  wherein at least one of the bulbs is configured for dispensing a substance proximate to the rectal tissue contacted by the bulb.  
     
     
         22 . A device for cooling or warming a portion of a body of a patient, comprising: 
 a supply of fluid;    a head structure configured to receive the fluid;    a delivery tube coupled between the supply and head structure for delivering fluid to the head structure;    the head structure configured to be positioned within the rectal cavity of a patient and operable to disperse the fluid to contact the rectal tissue in the cavity for transferring caloric energy between the rectal tissue and the fluid.    
     
     
         23 . The device of  claim 22 , wherein the head structure includes a plurality of inflow apertures formed therein and operable for capturing dispersed fluid after it has contacted the rectal tissue.  
     
     
         24 . The device of  claim 22 , wherein the fluid is generally not absorbable into the bloodstream of a patient through the rectal tissue.  
     
     
         25 . The device of  claim 22 , wherein the fluid is at least partially absorbable into the bloodstream of a patient through the rectal tissue.  
     
     
         26 . The device of  claim 25 , wherein the fluid further comprises an absorbable vasodilator composition.  
     
     
         27 . The device of  claim 22  wherein the head structure further comprises a plurality of outflow apertures for dispersing the fluid.  
     
     
         28 . The device of  claim 22  wherein the head structure further comprises a proximal bulb and a distal bulb, the proximal bulb having a plurality of outflow apertures operable for dispersing fluid to contact the rectal tissue.  
     
     
         29 . The device of  claim 28 , further comprising a supply of cooling fluid coupled to the proximal bulb to be dispersed by the proximal bulb.  
     
     
         30 . The device of  claim 28 , further comprising a supply of warming fluid coupled to the proximal bulb to be dispersed by the proximal bulb.  
     
     
         31 . The device of  claim 28  wherein at least one of the bulbs is configured for dispensing a substance proximate to the rectal tissue contacted by the bulb.  
     
     
         32 . The device of  claim 28  wherein the distal bulb comprises a plurality of inflow apertures for capturing dispersed fluid after it has contacted the rectal tissue.  
     
     
         33 . The device of  claim 22  further comprising means for reversing the vertebral venous flow of blood through Batson's plexus to supply blood, affected by the temperature of the fluid, to the vertebral structures.  
     
     
         34 . The device of  claim 22 , the delivery tube further comprising an inflow lumen and an outflow lumen, the inflow lumen operable to deliver the fluid to the head structure, the outflow lumen operable to remove the fluid from the head structure.  
     
     
         35 . The device of  claim 33 , wherein the means for reversing vertebral venous blood flow through Batson's plexus is selected from the group consisting of a lumbar support, an abdominal restraint, and an abdominal binder.  
     
     
         36 . The device of  claim 28 , wherein the proximal bulb is configured for being positioned within the portion of the rectum generally drained by at least one of the middle and inferior rectal veins.  
     
     
         37 . The device of  claim 28 , wherein the distal bulb is configured for being positioned at least partially within a portion of the rectal cavity generally drained by the superior rectal vein.  
     
     
         38 . A method of cooling or warming a portion of a body of a patient comprising: 
 positioning a head structure within the rectal cavity of a patient proximate to rectal tissue;    delivering fluid to the head structure which is operable to exchange caloric energy with the head structure;    transferring caloric energy between the head structure and tissue to affect the temperature of the rectal tissue;    reversing the vertebral venous flow of blood through Batson's plexus to direct blood from the rectal tissue to the vertebral structures.    
     
     
         39 . The method of  claim 38  further comprising reversing the vertebral venous flow by applying abdominal pressure to the patient body.  
     
     
         40 . The method of  claim 38 , further comprising positioning the head structure at least partially within the outermost two-thirds of the rectal cavity and affect a portion of the rectal tissue generally drained by at least one of the middle and inferior rectal veins.  
     
     
         41 . The method of  claim 38  further comprising dispensing a vasodilator composition proximate the head structure and onto the rectal tissue.  
     
     
         42 . The method of  claim 38  further comprising delivering cooled fluid to the head structure and absorbing caloric energy from the tissue with the head structure to lower the temperature of the rectal tissue.  
     
     
         43 . The method of  claim 38  further comprising delivering warmed fluid to the head structure and delivering caloric energy to the tissue with the head structure to raise the temperature of the rectal tissue.  
     
     
         44 . The method of  claim 38  wherein the head structure includes a proximal structure and a distal structure, the method further comprising delivering fluid to proximal and distal structures; 
 transferring caloric energy between the proximal and distal structures and tissue to affect the temperature of the rectal tissue.  
 
     
     
         45 . The method of  claim 44  further comprising delivering a cooled fluid to the proximal structure and absorbing caloric energy from the tissue with the proximal structure to lower the temperature of the rectal tissue.  
     
     
         46 . The method of  claim 44  further comprising delivering a cooled fluid to the distal structure and absorbing caloric energy from the tissue with the distal structure to lower the temperature of the rectal tissue.  
     
     
         47 . The method of  claim 44  further comprising delivering a warmed fluid to the proximal structure and delivering caloric energy to the tissue with the proximal structure to raise the temperature of the rectal tissue.  
     
     
         48 . The method of  claim 44  further comprising delivering a warmed fluid to the distal structure and delivering caloric energy to the tissue with the distal structure to raise the temperature of the rectal tissue.  
     
     
         49 . The method of  claim 39  further comprising positioning the proximal structure at least partially within the portion of the rectal cavity drained by the inferior rectal vein.  
     
     
         50 . A method of cooling or warming a portion of a body of a patient comprising: 
 positioning a head structure within the rectal cavity of a patient proximate to rectal tissue;    delivering fluid to the head structure and dispersing the fluid proximate the rectal tissue for transferring caloric energy between the fluid and tissue to affect the temperature of the rectal tissue;    reversing the vertebral venous flow of blood through Batson's plexus to direct blood from the rectal tissue to the vertebral structures.    
     
     
         51 . The method of  claim 50  further comprising reversing the vertebral venous flow by applying abdominal pressure to the patient body.  
     
     
         52 . The method of  claim 50 , further comprising positioning the head structure at least partially within the outermost two-thirds of the rectal cavity to transfer caloric energy with a portion of the rectal tissue generally drained by at least one of the middle and inferior rectal veins.  
     
     
         53 . The method of  claim 50  further comprising dispensing a vasodilator composition proximate the head structure and onto the rectal tissue.  
     
     
         54 . The method of  claim 50  further comprising delivering cooled fluid to the head structure and absorbing caloric energy from the tissue to lower the temperature of the rectal tissue.  
     
     
         55 . The method of  claim 50  further comprising delivering warmed fluid to the head structure and delivering caloric energy to the tissue to raise the temperature of the rectal tissue.  
     
     
         56 . The method of  claim 50  wherein the head structure includes a proximal structure and a distal structure, the method further comprising delivering fluid to the proximal and distal structures and dispersing fluid with the proximal structure for transferring caloric energy between the fluid and tissue.  
     
     
         57 . The method of  claim 56  further comprising delivering a cooled fluid to the proximal structure and absorbing caloric energy from the tissue to lower the temperature of the rectal tissue.  
     
     
         58 . The method of  claim 57  further comprising delivering a warmed fluid to the proximal structure and delivering caloric energy to the tissue to raise the temperature of the rectal tissue.  
     
     
         59 . The method of  claim 56  further comprising collecting dispersed fluid with the distal structure.  
     
     
         60 . The method of  claim 56  further comprising positioning the proximal structure at least partially within the portion of the rectal cavity drained by the inferior rectal vein.  
     
     
         61 . The method of  claim 50  further comprising collecting the fluid back into the head structure after it contacts the rectal tissue.  
     
     
         62 . A method for cooling or warming the central nervous system in a patient comprising: 
 cooling or warming rectal mucosal membranes of the rectal cavity; and    reversing the direction of blood flow in the vertebral venous plexus so as to selectively direct cooled or warmed venous blood to cool the central nervous system.

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