Patient enteral hydration with cooled fluids

Abstract

A device and method for enterally hydrating a patient with cooled fluids. The patient may be a paralyzed or limited upper body mobility patient with a functional gastrointestinal system who is nonetheless incapable or not fully capable of drinking unassisted. Here fluids are provided by a suspended container which also has a pouch to admit cooling material such as ice, but to keep the cooling material separate from the fluid. The container may also have optional graduation markings to allow for convenient estimation of fluid use, and an upper open and closeable cap to allow the container to be refilled. The container has a lower fluid conducting tube that terminates in a mouthpiece. The mouthpiece contains a fluid valve formed from at least one slit in an elastic material. Patient mouth force on the valve causes the slit to enlarge, thus enabling cooled fluid to flow into the patient.

1 . A method of enterally hydrating a patient with a cooled fluid, said method comprising:
 providing a substantially transparent fluid container comprising a plurality of sides, at least some of said sides being substantially deformable, wherein at least one of said sides further comprises at least a portion of a side of a pouch;   said pouch configured to both receive and then hold a cooling material against at least one side of said fluid container without said cooling material being in direct contact with fluid in said fluid container;   at least one side of said fluid container comprising a support with a fenestrated opening configured to enable said fluid container to be suspended from an IV pole or other support structure;   said fluid container further comprising a lower opening with either a tube adapter connected to the distal opening of a hollow tube, or a directly connected hollow tube;   wherein, when said fluid container is suspended near said patient, said hollow tube having sufficient length to deliver fluid from said fluid container to a mouthpiece attached to the proximal opening of said hollow tube, said mouthpiece configured to be placed in the mouth of said patient;   said sufficient length being a length between two and 20 feet;   said mouthpiece configured with a valve comprising at least one narrow slit in an elastic and deformable material;   wherein in the absence of patient mouth generated force, said deformable material holds said slit shut, thus preventing fluid flow;   wherein in the presence of patient mouth generated force, said deformable material deforms thus causing said slit to enlarge and permitting fluid flow;   placing a cooling material into said pouch;   either before or after said cooling material is placed in said pouch, filling said fluid container with fluid for said patient;   wherein said fluid is subsequently cooled by thermal transfer of fluid heat to said cooling material;   mounting said container on a support structure using said fenestrated opening; and   providing said tube and mouthpiece to said patient.   
     
     
         2 . The method of  claim 1 , wherein at least one of said container sides contains a fill line and a series of graduated markings and numbers set at various fluid levels so that the quantity of fluid used by said patient may be accurately determined; and
 wherein the top side of said fluid container further comprises a substantially non-deformable portion with a one-piece rigid or semi-rigid press-clamp cap configured to either open to admit fluids, or snap shut.   
     
     
         3 . The method of  claim 1 , wherein said container is filled with a fluid, sealed, and then sterilized before use, thus delivering either sterile or microbial load reduced fluid to said patient. 
     
     
         4 . The method of  claim 1 , wherein said pouch further comprises:
 first and second pouch sides laminated together to form a pouch structure with an open pouch top, laminated pouch sides, and a laminated bottom;   at least a portion of the first side of said pouch sides also forming a side of said fluid container; and   the second pouch side comprising a deformable side that has a surface area sufficiently larger than said first pouch side so as to accommodate said cooling material when said cooling material is inserted into said pouch through said open pouch top.   
     
     
         5 . The method of  claim 4 , wherein at least a portion of both pouch sides further comprise two sides of a flap;
 wherein said fluid container further comprises a clamping mechanism disposed to allow said flap to be sealed at least after said cooling material has been inserted into said pouch through said open top.   
     
     
         6 . The method of  claim 1 , wherein said valve is configured to open in response to the patient mouth generated force of biting; or
 wherein said valve is configured to open in response to the patient mouth generated force of suction.   
     
     
         7 . The method of  claim 1 , wherein said hollow tube further comprises a thumb controlled tubing clamp configured to provide an independent method of stopping fluid flow along said hollow tube. 
     
     
         8 . The method of  claim 1 , wherein said hollow tube proximate said mouthpiece, or said mouthpiece, further comprises a clip configured to fix said mouthpiece to a location near the mouth of said patient. 
     
     
         9 . The method of  claim 1 , wherein said container and hollow tube are formed from a polymer selected from the group of transparent polymers generally recognized as suitable for fluid storage and transport in a medical setting. 
     
     
         10 . A device for enterally hydrating a patient with a cooled fluid, said device comprising:
 a substantially transparent fluid container comprising a plurality of sides, at least some of said sides being substantially deformable, wherein at least one of said sides further comprise at least a portion of a side of a pouch;   said pouch configured to both receive and then hold a cooling material against at least one side of said fluid container without said cooling material being in direct contact with fluid in said fluid container;   at least one side of said fluid container comprising a support with a fenestrated opening, said fenestrated opening configured to enable said fluid container to be suspended from an IV pole or other support structure;   said fluid container further comprising a lower opening with either a tube adapter connected to the distal opening of a hollow tube, or a directly connected hollow tube.   
     
     
         11 . The device of  claim 10 , wherein said pouch further comprises:
 first and second pouch sides laminated or sealed together at the edges to form a pouch structure with an open pouch top, laminated pouch sides, and a laminated bottom;   at least a portion of the first side of said pouch also forming a side of said fluid container; and   the second pouch side comprising a deformable side that has a surface area sufficiently larger than said first pouch side so as to accommodate said cooling material when said cooling material is inserted into said pouch through said open pouch top.   
     
     
         12 . The device of  claim 11 , wherein at least a portion of both pouch sides further comprises a two sides of a flap;
 wherein said fluid container further comprises a clamping mechanism disposed to allow said flap to be sealed at least after said cooling material has been inserted into said pouch through said open top.   
     
     
         13 . The device of  claim 10 , wherein at least one of said container sides contains a fill line and a series of graduated markings and numbers set at various fluid levels so that the quantity of fluid used by said patient may be accurately determined; and
 wherein the top side of said fluid container further comprises a substantially non-deformable portion with a one-piece rigid or semi-rigid press-clamp cap configured to either open to admit fluids, or snap shut.   
     
     
         14 . The device of  claim 10 , wherein said device is non-refillable device, and wherein said device contains either sterile or microbial load reduced fluid. 
     
     
         15 . The device of  claim 10 , wherein said hollow tube has a length between two and 20 feet, and is configured to deliver fluid from said fluid container to a hollow tube connected mouthpiece attached to the proximal opening of said hollow tube;
 said mouthpiece further comprising a valve comprising at least one narrow slit in an elastic and deformable valve material;   wherein in the absence of patient mouth generated force, said deformable valve material holds said slit shut, thus preventing fluid flow to the mouth of said patient; and   wherein in the presence of patient mouth generated force, said deformable valve material deforms thus causing said slit to enlarge and permitting fluid flow to the mouth of said patent.   
     
     
         16 . The device of  claim 15 , wherein said valve is configured to open in response to the patient mouth generated force of biting; or
 wherein said valve is configured to open in response to the patient mouth generated force of suction.   
     
     
         17 . The device of  claim 15 , wherein said hollow tube further comprises a thumb controlled tubing clamp configured to provide an independent shut-off for stopping fluid flow along said hollow tube; or
 wherein said hollow tube proximate said mouthpiece, or said mouthpiece, further comprises a clip configured to fix said mouthpiece to a location near the mouth of said patient.   
     
     
         18 . A device for enterally hydrating a patient with a cooled fluid, said device comprising:
 a substantially transparent fluid container comprising a plurality sides, at least some of said sides being substantially deformable, wherein at least one of said sides further comprises at least a portion of a side of a pouch;   said pouch configured to both receive and then hold a cooling material against at least one side of said fluid container without said cooling material being in direct contact with fluid in said fluid container;   wherein said pouch further comprises:   first and second pouch sides laminated or sealed together at the edges to form a pouch structure with an open pouch top, laminated pouch sides, and a laminated bottom;   at least portion of the first side of said deformable pouch sides also forming a side of said fluid container; and   the second pouch side comprising a deformable side that has a surface area sufficiently larger than said first pouch side so as to accommodate said cooling material when said cooling material is inserted into said pouch through said open pouch top;   at least one side of said fluid container comprising a support with a fenestrated opening, said fenestrated opening configured to enable said fluid container to be suspended from an IV pole or other support structure;   said fluid container further comprising a lower opening with either a tube adapter connected to the distal opening of a hollow tube, or a directly connected hollow tube;   wherein said hollow tube has a length between two and 20 feet, and is configured to deliver fluid from said fluid container to a mouthpiece attached to the proximal opening of said hollow tube,   wherein said mouthpiece further comprises a valve comprising at least one narrow slit in an elastic and deformable valve material;   wherein in the absence of patient mouth generated force, said deformable valve material holds said slit shut, thus preventing fluid flow to the mouth of said patient; and   wherein in the presence of patient mouth generated force, said deformable valve material deforms thus causing said slit to enlarge and permitting fluid flow to the mouth of said patent.   
     
     
         19 . The device of  claim 18 , wherein at least a portion of both pouch sides further comprise two sides of a flap;
 wherein either   A: said fluid container further comprises a clamping mechanism disposed to allow said flap to be sealed at least after said cooling material has been inserted into said pouch through said open top; or   B: at least one of said container sides contains a fill line and a series of graduated markings and numbers set at various fluid levels so that the quantity of fluid used by said patient may be accurately determined; and   wherein the top side of said fluid container further comprises a substantially non-deformable portion with a one-piece rigid or semi-rigid press-clamp cap configured to either open to admit fluids, or snap shut.   
     
     
         20 . The device of  claim 18 , wherein said device is a non-refillable device, and wherein said device contains either sterile or microbial load reduced fluid.