Heart band with fillable chambers to modify heart valve function

Abstract

The present invention relates to an external heart device, having a layered band dimensioned to be received around a patient's heart, which also includes at least one fillable chamber between the layers in the band that functions to apply localized pressure to the outside of the heart when filled. More particularly, the fillable chambers are positioned such that they exert an inward radial force on a heart valve. Areas between the fillable chambers may also be sized and positioned to form a bridge of little to no pressure over the vascular structures of the heart.

What is claimed is: 
     
       1. An external heart device, comprising:
 (a) a band dimensioned to be received around a patient's heart, the band comprising an inner layer and an outer layer, wherein some but not all areas of the inner layer and outer layer are bound to one another; and 
 (b) at least two three fillable chambers in the band, the at least two three fillable chambers being spaced apart from one another and located in areas where the inner layer and the outer layer are not bound to one another, the at least two of the at least three fillable chambers being separated by a gap, wherein the gap and each of the at least two three fillable chambers have a circumferential length, and wherein the circumferential length of the gap is greater than the circumferential length of each of the at least two three fillable chambers; and 
 (c) a filling tube associated with each of said fillable chambers, wherein each of said fillable chambers is configured and arranged to be selectively individually filled, via an associated one of said filling tubes, whereby three different ones of said fillable chambers can be selectively filled to three different levels, respectively, 
 wherein the at least two three fillable chambers are positioned on the heart spaced apart from one another with the gap being placed over heart vasculature so as to form a pressure-reducing bridge over the heart vasculature contacting and applying constant localized pressure to the heart in a predetermined location to modify a heart valve shape when the at least two three fillable chambers are filled. 
 
     
     
       2. The external heart device of  claim 1 , wherein the at least two three fillable chambers are formed into the areas where the inner layer and the outer layer are not bound to one another. 
     
     
       3. The external heart device of  claim 1 , wherein the at least two three fillable chambers are inserted into the areas where the inner layer and the outer layer are not bound to one another. 
     
     
       4. The external heart device of  claim 1 , wherein the band is transparent. 
     
     
       5. The external heart device of  claim 1 , wherein the band is made of silicone rubber. 
     
     
       6. The external heart device of  claim 1 , wherein the inner layer and outer layer are bound to one another by adhesives. 
     
     
       7. The external heart device of  claim 1 , wherein the inner layer and outer layer are bound to one another by crosslinking. 
     
     
       8. The external heart device of  claim 1 , wherein the inner layer and outer layer are bound to one another by stitching. 
     
     
       9. The external heart device of  claim 1 , wherein an interior surface of the inner layer is textured. 
     
     
       10. The external heart device of  claim 1 , wherein the at least two three fillable chambers are a plurality of fillable chambers. 
     
     
       11. The external heart device of  claim 10 , wherein two of the plurality of fillable chambers are positioned spaced apart from one another, and wherein the band forms a bridge therebetween. 
     
     
       12. The external heart device of  claim 11 , wherein the bridge in the band is dimensioned to be positioned over vasculature on the exterior of the heart when at least one of the plurality of fillable chambers is filled. 
     
     
       13. The external heart device of  claim 10 , wherein the plurality of fillable chambers is five fillable chambers. 
     
     
       14. The external heart device of  claim 1 , further comprising a filling tube in fluid communication with the at least two three fillable chambers. 
     
     
       15. The external heart device of  claim 14 , wherein the filling tube is fillable through a blunt needle port. 
     
     
       16. The external heart device of  claim 14 , wherein the filling tube is fillable through a sharp needle port. 
     
     
       17. The external heart device of  claim 14 , wherein the filling tube is fillable through a subcutaneous port. 
     
     
       18. The external heart device of  claim 14 , wherein the filling tube is made of silicone. 
     
     
       19. The external heart device of  claim 14 , wherein the filling tube comprises identifying indicia. 
     
     
       20. The external heart device of  claim 17 , An external heart device, comprising:
 (a) a band dimensioned to be received around a patient's heart, the band comprising an inner layer and an outer layer, wherein some but not all areas of the inner layer and outer layer are bound to one another; 
 (b) at least two fillable chambers in the band, the at least two fillable chambers being spaced apart from one another and located in areas where the inner layer and the outer layer are not bound to one another, the at least two fillable chambers being separated by a gap, wherein the gap and each of the at least two fillable chambers have a circumferential length, and wherein the circumferential length of the gap is greater than the circumferential length of each of the at least two fillable chambers; and 
 (c) a filling tube associated with each of said fillable chambers, wherein each of said fillable chambers is configured and arranged to be selectively individually filled, via an associated one of said filling tubes, whereby different ones of said fillable chambers can be filled to different levels, 
 wherein the at least two fillable chambers comprises a plurality of fillable chambers and wherein a one of the filling tube tubes is in fluid communication with each fillable chamber, and wherein each filling tube is fillable through a subcutaneous port, and wherein the plurality of subcutaneous ports are disposed on a sheet, and 
 wherein the at least two fillable chambers are positioned on the heart spaced apart from one another with the gap being placed over heart vasculature so as to form a pressure-reducing bridge over the heart vasculature contacting and applying constant localized pressure to the heart in a predetermined location to modify a heart valve shape when the at least two fillable chambers are filled. 
 
     
     
       21. The external heart device of  claim 20 , wherein the sheet is made of silicone or polyester. 
     
     
       22. The external heart device of  claim 1 , wherein the at least two three fillable chambers are filled by saline. 
     
     
       23. The external heart device of  claim 1 , wherein the at least two three fillable chambers are filled by a hardening polymer. 
     
     
       24. The external heart device of  claim 1 , wherein the at least two three fillable chambers are filled by a gas. 
     
     
       25. The external heart device of  claim 1 , wherein the at least two three fillable chambers are filled by a gel. 
     
     
       26. The external heart device of  claim 1 , further comprising at least one sleeve positioned around an exterior surface of the outer layer. 
     
     
       27. The external heart device of  claim 26 , wherein the at least one sleeve is made of polyester. 
     
     
       28. A method of modifying heart valve function, comprising:
 placing a band around a patient's heart, the band comprising an inner layer and an outer layer, wherein areas of the inner layer and outer layer are bound to one another, and wherein at least two fillable chambers in the band are spaced apart from each other and are located in areas where the inner layer and the outer layer are not bound to one another, the at least two fillable chambers being separated by a gap, wherein the gap and each of the at least two fillable chambers have a circumferential length, the circumferential length of the gap being greater than the circumferential length of each of the at least two fillable chambers, the at least two fillable chambers positioned on the heart spaced apart from one another with the gap placed over heart vasculature to form a pressure-reducing bridge over the heart vasculature; and 
 filling the at least two fillable chambers with a fluid to cause the at least two fillable chambers to contact and apply constant localized pressure to the heart in a predetermined location to modify the shape of a single heart valve shape; 
 wherein said step of filling the at least two fillable chambers comprises filling a first one of said fillable chambers to a first level and filling a second one of said fillable chambers to a second level, wherein said first level is different from said second level. 
 
     
     
       29. An external heart device, comprising:
 (a) a band dimensioned to be received around a patient's heart, the band comprising an inner layer and an outer layer, wherein some but not all areas of the inner layer and outer layer are bound to one another;   (b) at least two fillable chambers in the band, the at least two fillable chambers being spaced apart from one another and located in areas where the inner layer and the outer layer are not bound to one another, the at least two fillable chambers being separated by a gap, wherein the gap and each of the at least two fillable chambers have a circumferential length, and wherein the circumferential length of the gap is greater than the circumferential length of each of the at least two fillable chambers;   (c) a filling tube associated with each of said fillable chambers, wherein each of said fillable chambers is configured and arranged to be selectively individually filled, via an associated one of said filling tubes, whereby different ones of said fillable chambers can be filled to different levels; and   (d) an additional outer layer positioned outwardly of the filling tubes, wherein said additional outer layer is bound to the outer layer of the band, thereby resulting in the band including the inner layer located inwardly of the filling tubes and both the outer layer and the additional outer layer being located outwardly of the filling tubes,   wherein the at least two fillable chambers are positioned on the heart spaced apart from one another with the gap being placed over heart vasculature so as to form a pressure-reducing bridge over the heart vasculature contacting and applying constant localized pressure to the heart in a predetermined location to modify a heart valve shape when the at least two fillable chambers are filled.   
     
     
       30. The external heart device of claim 29, further comprising a tube bonding tab associated with each of the filling tubes, whereby the tube bonding tabs are bonded to an outer surface the inner layer of the band. 
     
     
       31. The external heart device of claim 29, wherein the additional outer layer includes sections removed therefrom, wherein each of the removed sections corresponds to one of the fillable chambers. 
     
     
       32. The external heart device of claim 29, wherein the additional outer layer includes sections removed therefrom, wherein each of the removed sections defines a pocket between the inner layer and the outer layer, and further wherein the pockets each form one of the fillable chambers. 
     
     
       33. The method of claim 28, wherein the band further comprises a filling tube associated with each of said fillable chambers; and an additional outer layer positioned outwardly of the filling tubes, wherein said additional outer layer is bound to the outer layer of the band, thereby resulting in the band including the inner layer located inwardly of the filling tubes and both the outer layer and the additional outer layer being located outwardly of the filling tubes, and further wherein said step of filling the at least two fillable chambers comprises passing the fluid through at least two of the filling tubes and into the at least two associated fillable chambers. 
     
     
       34. The external heart device of claim 1, wherein each of said filling tubes is fillable through a subcutaneous port. 
     
     
       35. The external heart device of claim 34, wherein a plurality of said subcutaneous ports are disposed on a sheet. 
     
     
       36. The method of claim 28, wherein the band includes at least three fillable chambers, and further wherein said step of filling the fillable chambers comprises filling a first one of said fillable chambers and a second one of said fillable chambers, without filling a third one of said fillable chambers. 
     
     
       37. An external heart device, comprising:
 (a) a band dimensioned to be received around a patient's heart, the band comprising an inner layer and an outer layer, wherein some but not all areas of the inner layer and outer layer are bound to one another;   (b) at least two fillable chambers in the band, the at least two fillable chambers being spaced apart from one another and located in areas where the inner layer and the outer layer are not bound to one another, the at least two fillable chambers being separated by a gap, wherein the gap and each of the at least two fillable chambers have a circumferential length, and wherein the circumferential length of the gap is greater than the circumferential length of each of the at least two fillable chambers;   (c) a filling tube associated with each of said fillable chambers, wherein each of said fillable chambers is configured and arranged to be selectively individually filled, via an associated one of said filling tubes, whereby different ones of said fillable chambers can be filled to different levels; and   (d) a port in fluid communication with each of said filling tubes that is configured and arranged to enable filling and deflating an associated one of said fillable chambers,   wherein at least one of said ports is of a different type than the remainder of said ports, and   wherein the at least two fillable chambers are positioned on the heart spaced apart from one another with the gap being placed over heart vasculature so as to form a pressure-reducing bridge over the heart vasculature contacting and applying constant localized pressure to the heart in a predetermined location to modify a heart valve shape when the at least two fillable chambers are filled.   
     
     
       38. The external heart device of claim 37, wherein the type of each of said ports is selected from the group consisting of a blunt needle port, a sharp needle port, a subcutaneous port, and a Luer port. 
     
     
       39. An external heart device, comprising:
 (a) a band dimensioned to be received around a patient's heart, the band comprising an inner layer and an outer layer, wherein some but not all areas of the inner layer and outer layer are bound to one another;   (b) at least two fillable chambers in the band, the at least two fillable chambers being spaced apart from one another and located in areas where the inner layer and the outer layer are not bound to one another, the at least two fillable chambers being separated by a gap, wherein the gap and each of the at least two fillable chambers have a circumferential length, and wherein the circumferential length of the gap is greater than the circumferential length of each of the at least two fillable chambers;   (c) a filling tube associated with each of said fillable chambers, wherein each of said fillable chambers is configured and arranged to be selectively individually filled, via an associated one of said filling tubes, whereby different ones of said fillable chambers can be filled to different levels; and   (d) a port in fluid communication with each of said filling tubes that is configured and arranged to enable filling and deflating an associated one of said fillable chambers,   wherein all but one of said ports comprise subcutaneous ports, and   wherein the at least two fillable chambers are positioned on the heart spaced apart from one another with the gap being placed over heart vasculature so as to form a pressure-reducing bridge over the heart vasculature contacting and applying constant localized pressure to the heart in a predetermined location to modify a heart valve shape when the at least two fillable chambers are filled.   
     
     
       40. The external heart device of claim 39, wherein said port that is not a subcutaneous port comprises a blunt needle port. 
     
     
       41. A method of modifying heart valve function, comprising:
 placing a band around a patient's heart, the band comprising an inner layer and an outer layer, wherein areas of the inner layer and outer layer are bound to one another, and wherein at least two fillable chambers in the band are spaced apart from each other and are located in areas where the inner layer and the outer layer are not bound to one another, the at least two fillable chambers being separated by a gap, wherein the gap and each of the at least two fillable chambers have a circumferential length, the circumferential length of the gap being greater than the circumferential length of each of the at least two fillable chambers, the at least two fillable chambers positioned on the heart spaced apart from one another with the gap placed over heart vasculature to form a pressure-reducing bridge over the heart vasculature; and   filling the at least two fillable chambers with a fluid to cause the at least two fillable chambers to contact and apply constant localized pressure to the heart in a predetermined location to modify heart valve shape,   wherein said step of filling the at least two fillable chambers comprises filling a first one of said fillable chambers to a first level and filling a second one of said fillable chambers to a second level, wherein said first level is different from said second level,   wherein said step of filling the at least two fillable chambers comprises filling the first one of said fillable chambers to the first level via a first type of port and filling the second one of said fillable chambers to the second level via a second type of port, and wherein said first type of port is different from said second type of port.   
     
     
       42. The method of claim 41, wherein said second type of port is configured and arranged to allow for post-operative changes to the fluid level of the associated fillable chamber, while said first type of port is not configured and arranged to allow for post-operative changes to the fluid level of the associated fillable chamber. 
     
     
       43. The method of claim 42, wherein said first type of port comprises a blunt needle port. 
     
     
       44. The method of claim 42, wherein said second type of port comprises a subcutaneous port. 
     
     
       45. An external heart device, comprising:
 (a) a band dimensioned to be received around a patient's heart, the band comprising an inner layer and an outer layer, wherein some but not all areas of the inner layer and outer layer are bound to one another;   (b) at least two fillable chambers in the band, the at least two fillable chambers being spaced apart from one another and located in areas where the inner layer and the outer layer are not bound to one another, the at least two fillable chambers being separated by a gap, wherein the gap and each of the at least two fillable chambers have a circumferential length, and wherein the circumferential length of the gap is greater than the circumferential length of each of the at least two fillable chambers;   (c) a filling tube associated with each of said fillable chambers, wherein each of said fillable chambers is configured and arranged to be selectively individually filled, via an associated one of said fillable tubes, whereby different ones of said fillable chambers can be filled to different fluid levels;   (d) an additional outer layer positioned outwardly of the filling tubes, wherein said additional outer layer is bound to the outer layer of the band, thereby resulting in the band including the inner layer located inwardly of the filling tubes and both the outer layer and the additional outer layer being located outwardly of the filling tubes; and   (e) a port in fluid communication with each of said filling tubes that is configured and arranged to enable filling and deflating an associated one of said fillable chambers, wherein at least one of said ports is of a different type than the remainder of said ports;   wherein the at least two fillable chambers are positioned on the heart spaced apart from one another with the gap being placed over heart vasculature so as to form a pressure-reducing bridge over the heart vasculature contacting and applying constant localized pressure to the heart in a predetermined location to modify a heart valve shape when the at least two fillable chambers are filled.   
     
     
       46. The external heart device of claim 45, wherein all but one of said ports is of a first type and the single remaining port is of a second type, wherein said first type is different from said second type. 
     
     
       47. The external heart device of claim 45, wherein:
 at least one of said ports is of a first type and the remainder of said ports are of a second type;   said first type is different from said second type; and   said second type of port is configured and arranged to allow for post-operative changes to the fluid level of the associated fillable chamber, while said first type of port is not configured and arranged to allow for post-operative changes to the fluid level of the associated fillable chamber.   
     
     
       48. The external heart device of claim 45, wherein:
 said first type of port is a blunt needle port; and   said second type of port is selected from the group consisting of a sharp needle port, a subcutaneous port, and a Luer port.