Abstract:
A method and apparatus for thermally affecting graft organs during harvesting and transplantation operations. An insulation jacket may be configured to conform to the shape of the graft organ. The insulation jacket may include a body portion constructed from a flexible surgical grade plastic, insulation foam, or thermo mass. The body portion may include a plurality of non-communicating pillows capable of retaining a malleable condition when cooled. The selection of material for the body portion and the sterile nature of the cooling material allow the insulation jacket to be placed inside a patient&#39;s body during surgery. When secured about a graft organ, the insulation jacket provides openings for access to graft organ vessels, thereby allowing the implantation surgery to proceed while at least a portion of the graft organ remains enclosed in the insulation jacket. The insulation jacket may also include at least one layer of insulation.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
       [0001]     This application is a continuation-in-part of U.S. patent application Ser. No. 10/972,758, filed on Oct. 25, 2004. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     The present invention pertains to a method and apparatus for thermally affecting graft organs during harvesting and transplantation procedures. More particularly, the present invention pertains to an insulation jacket that may cool a graft organ and/or insulate a graft organ from external heat sources during harvesting and transplantation procedures.  
         [0003]     Transplantation surgery is one of the leading and fastest growing surgical technologies of our time. The rapid development of this field is due to current organ donation policies, changes in public awareness and viewpoints pertaining to the necessity for donors, and recent technical innovations that are making transplantations easier and safer to perform. While technological improvements have reduced some of the complications associated with transplantation surgery, other severe complications continue to exist.  
         [0004]     One of the most frequent causes leading to complications in transplantation surgeries is ischemia. Ischemia is the reduction or stoppage of flow of oxygen and nutrients to living cells. Ischemia may have drastic consequences, including apoptosis and senescence, which entails the death of the oxygen and nutrient deprived cells. Unfortunately, because the supply of blood and nutrients ceases when a graft organ is removed from a donor&#39;s body, ischemia is always present in transplantation procedures.  
         [0005]     Ischemia has been the central focus of numerous research projects and studies. As a result of these studies, many theories have been developed to better explain the detection and consequences of ischemia and to suggest how to slow down its damaging effects. Previous attempts to limit the consequences of ischemia, and thereby improve graft organ preservation, include training centers for surgeons devoted to reducing operation time and improving implantation techniques, the development of drugs designed to protect cells from entering into apoptosis, and the cooling of donated graft organs prior to implantation.  
         [0006]     From these studies and projects, two types of ischemia have been defined, namely warm ischemia and cold ischemia. Warm ischemia typically begins when the blood supply to the organ is stopped and the graft organ is removed from the donor&#39;s body. The onset of apoptosis during warm ischemia typically occurs extremely fast and leads to irreversible damages. Injury due to warm ischemia has had a severe influence on the viability and post-transplantation outcome of organ grafts. However, after many years of research, it was discovered that the apoptosis process could be slowed down by reducing the temperature of the graft organ, which is known as cold ischemia.  
         [0007]     Cold ischemia reduces the temperature of the removed graft organ so that enzymatic activity is delayed or stops altogether. The slowing of the apoptosis process through the use of cold ischemia significantly reduces the presence of irreversible complications. For example, while exposure of the graft organ to warm ischemia is measured in minutes, cold ischemia is measured in hours. Thus, the discovery of the benefits of cold ischemia over warm ischemia was a big step towards improving the success of transplantation procedures.  
         [0008]     Yet, injuries due to cold and warm ischemia remain an important source of morbidity and mortality in some transplantation procedures. For instance, while cold ischemia may slow the apoptosis process, the graft organ may be irreparably damaged if cooled below 4° Celsius. Further, similar to warm ischemia, there is a time limit on how long a graft organ may withstand cold ischemia.  
         [0009]     However, because of the benefits offered by cold ischemia, graft organs are prepared for transplantation in a cold environment. A graft organ is typically reduced to a temperature of approximately 4° Celsius. However, during the implantation operation, the temperature of the graft organ gradually increases and results in the onset of undesirable warm ischemia. This increase in temperature may be facilitated by the exposure of the graft organ to a number of different heat sources, including warmth from the recipient&#39;s body, the surgeon&#39;s hands, operating lights, general room illumination, room temperature, and operating instruments.  
         [0010]     Many existing cooling packs are designed to cool a variety of items, including food, beverages, and biological materials, such as organs. Such cooling packs may be similar to ice packs in which a sealed pouch is filled with a thermal cooling agent that is converted to a frozen solid state when cooled, whereupon the cooling agent may no longer be malleable. Other prior art devices include a thermal cooling agent that does not transform into a solid state when cooled. However, these thermal cooling agents are often contained within a single bladder-like enclosure or a series of individual chambers that are in communication with adjacent chambers. The problem with such configurations is that if one section of the bladder or a single chamber is accidentally or purposefully breached, a significant portion, if not all, of the cooling agent may flow out of the cooling pack, and thus hinder or ruin the ability of the cooling pack to function.  
         [0011]     Further, prior art cooling packs may have a general, non-organ specific shape or configuration. Unfortunately, in organ transplantation and harvesting operations, the general shape of a cooling pack may result in unnecessary interference with the field of operation. Additionally, by not providing a cooling pack that is configured for use with a specific type of graft organ, the prior art devices may not, when at least partially secured about a graft organ, provide openings through which graft organ vessels or veins may pass away from the graft organ and cooling pack. The lack of openings may prevent the surgeon from having access to necessary vessels and veins during a harvesting or transplantation procedure.  
         [0012]     Therefore, it is an object of the present invention to prevent or delay the warming of a graft organ during an implantation process.  
         [0013]     It is another object of the present invention to provide an apparatus and method for insulating a graft organ placed inside a recipient&#39;s body during a transplantation operation and thereby prevent the onset of warm ischemia.  
         [0014]     It is a further object of the present invention to provide a thin organ insulation jacket that is configured to have the general shape of the particular graft organ that is being harvested or transplanted.  
         [0015]     It is another object of the present invention to provide an organ insulation jacket that provides a surgeon with access to required vessels of the graft organ during transplantation surgery while the insulation jacket continues to enclose at least a portion of the graft organ.  
         [0016]     It is a further object of the present invention to provide an insulation jacket that may be sterilized so that the insulation jacket may enclose the graft organ while inside a patient&#39;s body during a transplantation procedure.  
         [0017]     It is also an object of the present invention to provide a insulation jacket that may include a non-toxic and sterile cooling material that may reduce the temperature of the graft organ, the cooling material being able to retain a malleable nature when cooled to desired implantation temperatures.  
         [0018]     At least one of the preceding objects is met, in whole or in part, by the present invention, which will become apparent in view of the present specification, including the claims and drawings.  
       BRIEF SUMMARY OF THE INVENTION  
       [0019]     The present invention pertains to a method and apparatus for insulating graft organs during harvesting and transplantation procedures. More particularly, the present invention pertains to an insulation jacket that may enclose at least a portion of a graft organ and which may be sterilized so as to be capable of being placed within the body of a patient during a harvesting and transplantation operation. The insulation jacket includes a body portion that may be constructed from a flexible surgical grade plastic, insulation foam, or a thermo mass, for example a dense gel. The body portion may also be operably connected to connectors that allow the body portion to be secured in a closed position when manipulated about at least a portion of a graft organ. In one embodiment of the present invention, the body portion may be configured to form a plurality of pillows, the pillows being configured to contain a non-toxic sterile cooling material. In such an embodiment, the cooling material may assist in reducing the temperature of the graft organ to desired transplantation temperatures. Further, some embodiments of the present invention may also include at least one layer of insulation that may assist in insulating the graft organ and/or cooling materials from outside heat sources. The selection of materials for the body portion and, when used, the sterile nature of the cooling material allows the insulation jacket to be placed inside a patient&#39;s body during harvesting and transplantation surgery.  
         [0020]     The body portion includes inner and outer walls and may be specifically shaped for a particular type of organ and its attached veins and vessels, such as, but not limited to, a heart, liver, lung, pancreas, and kidney. The body portion may be comprised of at least one panel. The panel may be operably connected to an adjacent panel through the use of an adhesive. The body portion may also be configured so that, when enclosed about at least a portion of the graft organ, the insulation jacket includes openings which may be positioned around vessels and arteries of the graft organ so that the vessels may pass through or extend away from the insulation jacket. These openings in the insulation jacket provide the surgeon with access to organ vessels, which allows the surgeon to conduct the transplantation surgery while at least a portion of the graft organ remains enclosed in the insulation jacket.  
         [0021]     The non-toxic sterile cooling material may include, but is not limited to, a sterile liquid or gel. The selected cooling material may be capable of retaining a malleable condition when cooled to a temperature of approximately 4° Celsius. Each of the plurality of pillows may not be in communication with adjacent pillows, and thus the puncture or rupture of one pillow may not result in the loss of cooling material from adjacent pillows. Therefore, in the event that a pillow is punctured, torn, or ruptures, adjacent pillows may still retain the chilled or unchilled cooling material.  
         [0022]     Further, the selection of materials for the body portion may also allow the body portion to have an elastic nature. For example, the flexible nature of some surgical grade plastics may allow at least some areas of the body portion between the non-communicating pillows to function as elastic bands. Besides connecting adjacent pillows, the flexible nature of any such elastic bands could assist in the ability of the insulation jacket to be manipulated about the specific graft organ that the insulation jacket was designed to at least partially enclose.  
         [0023]     In some embodiments of the present invention, the body portion may be operably connected to at least one layer of insulation. The insulation may be operably affixed along at least a portion of the inner wall and/or outer wall of the body portion of the insulation jacket. Also, the layer of insulation may be constructed from a number of different materials, including, but not limited to, a closed cell insulating foam, including a polyethylene closed cell foam. Further, the layer of insulation may be thin and malleable in nature so as to not interfere with the flexibility of the body portion. The layer of insulation may also serve as a wall of the body portion.  
         [0024]     When used, the insulation jacket may be placed around the organ before transplantation into the recipient, including prior to harvesting the graft organ from the donor&#39;s body. For example, when possible, to further attempt to minimize the onset of warm ischemia, it may be preferable to not cut the vessels supplying blood and oxygen to the harvested organ until the insulation jacket has been placed around the graft organ. Once secured around the graft organ, the graft organ may be removed from the donor&#39;s body. The graft organ may then be prepared for implantation into the body of the recipient.  
         [0025]     While being prepared for transplantation, the organ is preferably maintained at approximately 4° Celsius. During the transplantation operation, the graft organ may remain enclosed at least in part by the insulation jacket so as to prevent damage to the cells that is associated with warm ischemia. For embodiments of the present invention that include a plurality of pillows, because the pillows may not be in communication with adjacent pillows, the loss of cooling material in pillows that are damaged (i.e. pillows that may be ruptured, punctured, torn, severed, or pierced) may not cause undamaged adjacent pillows to lose any of their cooling material. Therefore, the surgeon may accidentally or purposely remove cooling material from some pillows without completely destroying the ability of the insulation jacket to continue to cool the graft organ.  
     
    
     BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS  
       [0026]      FIG. 1  illustrates an inside elevation view of an insulation jacket in accordance with one embodiment of the present invention.  
         [0027]      FIG. 2  illustrates an outside elevation view of an insulation jacket configured to enclose at least a portion of a graft organ in accordance with one embodiment of the present invention.  
         [0028]      FIG. 3  illustrates a cross sectional view of the pillows of an insulation jacket in accordance with one embodiment of the present invention.  
         [0029]      FIG. 4  illustrates an outside elevation view of an insulation jacket having a plurality of panels and connectors in which the insulation jacket is secured about at least a portion of a graft organ in accordance with one embodiment of the present invention.  
         [0030]      FIG. 5  illustrates a partial, cross-sectional end view of an insulation jacket in accordance with one embodiment of the present invention.  
         [0031]      FIG. 6 , illustrates an outside elevation view of an insulation jacket having an insulated outer wall in accordance with one embodiment of the present invention.  
         [0032]      FIG. 7  illustrates a cross sectional view of an insulation jacket having an insulated outer wall in accordance with one embodiment of the present invention.  
         [0033]      FIG. 8  illustrates of an outside elevation view of an insulation jacket having an insulated outer wall, in which the insulation jacket is secured about at least a portion of a graft organ in accordance with one embodiment of the present invention.  
         [0034]      FIG. 9  illustrates a partial, cross-sectional end view of an insulation jacket having insulation on the outer wall in accordance with one embodiment of the present invention.  
         [0035]      FIG. 10  illustrates an inside elevation view of an insulation jacket having an insulated outer wall and an inner wall that is not insulated in accordance with one embodiment of the present invention.  
         [0036]      FIG. 11  illustrates an outside elevation view of an insulation jacket having an insulated outer wall and an insulated inner wall in accordance with one embodiment of the present invention.  
         [0037]      FIG. 12  illustrates a cross sectional view of the insulation jacket that is insulated on both the inner wall and outer wall in accordance with one embodiment of the present invention.  
         [0038]      FIG. 13  illustrates of an outside elevation view of an insulation having an outer wall and an insulated inner wall in which the insulation jacket is secured about at least a portion of a graft organ in accordance with one embodiment of the present invention.  
         [0039]      FIG. 14  illustrates a partial, cross-sectional end view of an insulation jacket having insulation on both the inner wall and outer wall in accordance with one embodiment of the present invention.  
         [0040]      FIG. 15  illustrates an inside elevation view of insulation jacket having an insulated inner and outer wall in accordance with one embodiment of the present invention.  
         [0041]      FIG. 16  illustrates an inside elevation view of an insulation jacket in accordance with one embodiment of the present invention in which the body portion is comprised of an insulation foam.  
         [0042]      FIG. 17  illustrates an outside elevation view of an insulation jacket configured to enclose at least a portion of a graft organ in accordance with one embodiment of the present invention in which the body portion is comprised of an insulation foam.  
         [0043]      FIG. 18  illustrates a cross sectional view of the closed cells of an insulation jacket in accordance with one embodiment of the present invention in which the body portion is comprised of an insulation foam.  
         [0044]      FIG. 19  illustrates of an outside elevation view of an insulation jacket having a plurality of panels and connectors in which the insulation jacket is secured about at least a portion of a graft organ in accordance with one embodiment of the present invention in which the body portion is comprised of an insulation foam.  
         [0045]      FIG. 20  illustrates an inside elevation view of an insulation jacket in accordance with one embodiment of the present invention in which the body portion is comprised of a thermo mass.  
         [0046]      FIG. 21  illustrates an outside elevation view of an insulation jacket configured to enclose at least a portion of a graft organ in accordance with one embodiment of the present invention in which the body portion is comprised of a thermo mass.  
         [0047]      FIG. 22  illustrates of an outside elevation view of an insulation jacket having a plurality of panels and connectors in which the insulation jacket is secured about at least a portion of a graft organ in accordance with one embodiment of the present invention in which the body portion is comprised of a thermo mass.  
         [0048]      FIG. 23  illustrates a cross sectional view of a cooling jacket in accordance with one embodiment of the present invention.  
         [0049]      FIG. 24  illustrates an inside elevation view of a cooling jacket having a segmented thermal absorbent body in accordance with one embodiment of the present invention.  
         [0050]      FIG. 25  illustrates a cross sectional view of a cooling jacket having a segmented thermal absorbent body in accordance with one embodiment of the present invention.  
         [0051]      FIG. 26  illustrates a cross sectional view of a cooling jacket having an inner film in accordance with one embodiment of the present invention.  
         [0052]      FIG. 27  illustrates an outside view of the outer shell of an opened cooling jacket having an envelope configuration in accordance with one embodiment of the present invention.  
         [0053]      FIG. 28   a  illustrates a bottom view of the outer shell of a cooling jacket having an envelope configuration in accordance with one embodiment of the present invention.  
         [0054]      FIG. 28   b  illustrates a cross sectional view of the outer shell of a cooling jacket having an envelope configuration in accordance with one embodiment of the present invention.  
         [0055]      FIG. 29  illustrates an end side view of the outer shell of a cooling jacket having an envelope configuration in accordance with one embodiment of the present invention.  
         [0056]      FIG. 30  illustrates a top view of the outer shell of a cooling jacket having an envelope configuration in accordance with one embodiment of the present invention.  
         [0057]      FIG. 31  illustrates a side elevation view of a cooling jacket having an envelope configuration enclosing at least part of a kidney graft organ in accordance with one embodiment of the present invention.  
         [0058]      FIG. 32  illustrates a side elevation view of a cooling jacket having an envelope configuration shaped to enclose at least a portion of a liver graft organ in accordance with one embodiment of the present invention.  
         [0059]      FIG. 33  illustrates a side elevation view of a cooling jacket having an envelope configuration shaped to enclose at least a portion of a kidney graft organ in accordance with one embodiment of the present invention.  
         [0060]      FIG. 34   a  illustrates a liver graft organ.  
         [0061]      FIG. 34   b  illustrates a panel of a cooling jacket positioned about at least a portion of a liver graft organ in accordance with one embodiment of the present invention.  
         [0062]      FIG. 34   c  illustrates multiple panels of a cooling jacket assembled and secured about at least a portion of a liver graft organ in accordance with one embodiment of the present invention. 
     
    
       [0063]     The foregoing summary, as well as the following detailed description of certain embodiments of the present invention, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there is shown in the drawings, certain embodiments. It should be understood, however, that the present invention is not limited to the arrangements and instrumentalities shown in the attached drawings.  
       DETAILED DESCRIPTION OF THE INVENTION  
       [0064]      FIG. 1  illustrates an inside elevation view of an insulation jacket  10  that is configured to enclose at least a portion of a graft organ  15  in accordance with one embodiment of the present invention. The insulation jacket  10  may include a body portion  11  and a plurality of connectors. As shown in  FIGS. 1 and 2 , the body portion  11  has an inner wall  12  and an outer wall  14  and may be constructed from relatively thin and flexible surgical grade plastics. Further, the inner wall  12  and outer wall  14  may be separate pieces of flexible surgical grade plastics that are operably connected, such as through the use of adhesive materials, to form the body portion  11 . The size and shape of the body portion  11  may be determined by the specific type of graft organ  15 . More specifically, the insulation jacket  10  may be contoured and sized to enclose at least a portion of a specific organ, for example a heart, liver, lung, or kidney, while still providing access to the vessels  17  of the graft organ  15 .  
         [0065]     For example, as is known, different types of graft organs have different shapes and sizes. More specifically, although the actual size of a graft organ may vary from person to person, generally, a normal adult liver may be 28 cm long, 8 cm in height, and 18 cm in antero-posterior thickness. Further, an average kidney in a living adult may weigh from 2000 to 2500 grams, while the liver in a cadaver may weigh 1400 to 1500 grams. Although the actual dimensions of the kidney of an adult may vary depending on a variety of factors, including sex, age, and pathology, a normal adult kidney may be 10 to 12 cm long vertically, 5 to 6 cm wide, have a 3 cm antero-posterior thickness, and weigh 115 to 150 grams. Additionally, while a variety of factors may also affect the size of a lung, a lung removed from an adult of intermediary respiratory status may have a vertical length of 25 cm, a width at the base of 15 cm, a transversal base measurement of 10 cm, and a weight of 700 grams. Therefore, by designing the shape of the body portion  11  to cover at least a portion of specific type of graft organ  15 , the organ specific body portion  11  may occupy a minimal amount of space in the operation field and thus may minimize the potential risk that the insulation jacket  10  may interfere with the vision or maneuverability of the surgeon during an implantation operation.  
         [0066]     While the body portion  11  may be a single panel  20  that is designed to encompass at least a portion of a graft organ  15 , in the illustrated embodiment, the body portion  11  may be comprised of a plurality of panels  20   b ,  20   c  that are operably connected to an adjacent panel. In such an embodiment, the panels  20   a ,  20   b ,  20   c  may be operably connected to an adjacent panel through the use of an adhesive. The location of the attachment of panels  20   a ,  20   b ,  20   c  may result in the formation of creases  19   a ,  19   b  between adjacent panels  20   a ,  20   b ,  20   c . Because the insulation jacket  10  may be designed for use with a specific type of graft organ  15 , the creases  19   a ,  19   b  may be positioned in locations in which the body portion  11  is folded about at least a portion of the graft organ, thereby assisting in preventing the formation of undesirable protruding points and corners that may harm adjacent tissue or take up additional space in the operating field.  
         [0067]      FIG. 3  illustrates a cross sectional view of the pillows of an insulation jacket  10  in accordance with one embodiment of the present invention. As illustrated in  FIG. 3 , the inner wall  12  and outer wall  14  of the body portion  11  may be configured to allow for the formation of a plurality of pillows  22 . The pillows  22  may include an inner section  25  that is configured to contain a cooling material. The cooling material may be a sterile liquid or gel that will not freeze solid when cooled to temperatures of at least approximately 4° Celsius and which will remain malleable at low temperatures. Suitable cooling material include, but are not limited to, Aquasonic™ Clear ultrasound gel from Parker Laboratories Inc. of Fairfield, N.J., lubricants such as K-Y™ lubricants offered by a division of McNeil-P.P.C., Inc. of Skillman, N.J., a Johnson and Johnson company, and saline solutions.  
         [0068]     In the illustrated embodiment, the pillows  22  may not be in communication with other adjacent pillows  22 , but instead may be separated so that the tearing or puncturing of one pillow  22  will not result in the loss of cooling material from an adjacent undamaged pillow  22 . In the illustrated embodiment, the connection of the inner wall  12  and outer wall  14  across the interconnecting region between adjacent non-communicating pillows  22  allows for the formation of bands  23 . Because of the flexible nature of the material used for the body portion  11 , the bands  23  may be elastic in nature and thus may assist in providing flexibility and/or plasticity to the body portion  11 .  
         [0069]      FIG. 2  illustrates an outside elevation view of an insulation jacket  10  configured in accordance with one embodiment of the present invention. Connectors may be used to secure the body portion  11  around at least a portion of the graft organ  15 . The connectors may include, but are not limited to, mating strips of hook and loop material, staples, tape, and adhesives.  
         [0070]      FIG. 4  illustrates an outside elevation view of an insulation jacket  10  having a plurality of panels  20   a ,  20   b ,  20   c  and connectors in which the insulation jacket is secured about at least a portion of a graft organ in accordance with one embodiment of the present invention. As shown, the connectors may include mating strips of hook and loop material in which a first strip  26  is positioned to attach to a mating second strip  28  when the body portion  11  is partially secured around a graft organ  15 . Further, in the embodiment of the present invention illustrated in  FIGS. 1, 2 , and  4 , the connectors may be operably attached to the outer wall  14  of the body portion  11 , including through the use of an adhesive material.  
         [0071]     As also illustrated in  FIG. 4 , the contours and shape of the body portion  11  allow the insulation jacket  10  to enclose at least a portion of the graft organ  15  while still providing openings  18  for the vessels  17  and/or arteries of the graft organ  15  to pass out of the insulation jacket  10 . By providing these openings  18 , a surgeon may have access to the main vessels  17  and/or veins while the insulation jacket  10  is placed around at least a portion of the graft organ  15  during the removal and/or subsequent transplantation of the graft organ  15 .  
         [0072]      FIG. 5  illustrates a partial, cross-sectional end view of an insulation jacket  10  of  FIG. 4 . The crease  196  is shown along with a cross section of the panels  20   b  and  20   c . When wrapped about at least a portion of a graft organ (not shown), the surface of the pillows  22  along the inner wall  12  may come into direct contact with at least a portion of the enclosed graft organ. In such an embodiment, because of the potential direct physical contact between the surface of the pillows  22  along the inner wall  12  and the graft organ, the temperature of the cooling material contained within the pillows  22  should not be reduced to temperatures that may cause damage to the graft organ. More particularly, the temperature of the pillows  22  and cooling material contained therein preferably should not be cooled to be below 4° Celsius so as to ensure that the tissue and cells of the graft organ that come into contact with the pillows  22  are not unnecessarily damaged.  
         [0073]      FIGS. 6, 7 ,  9 , and  10  illustrate an outside elevation view, a cross sectional view, a partial cross-sectional end view, and an inside elevation view, respectively, of an insulation jacket  10  having an insulated outer wall  14  in accordance with one embodiment of the present invention.  FIG. 8  illustrates an outside elevation view of an insulation jacket  10  having an insulated outer wall  14 , in which the insulation jacket  10  is secured about at least a portion of a graft organ  15 . As shown in  FIGS. 6, 7 ,  8 ,  9 , and  10 , the insulation jacket  10  shown in  FIGS. 1-5  may be adapted to include an outer layer of insulation  30  along at least a portion of the outer wall  14 .  
         [0074]     The outer layer of insulation  30  may be operably attached to the body portion  11 , including through the use of an adhesive. For example, the outer layer of insulation  30  may be adhered to the outer wall  14 . Further, as shown, the outer layer of insulation  30  may also be operably connected to the first and second strips  26 ,  28  of the connectors, such as through the use of an adhesive material. Additionally, the outer layer of insulation  30  may be comprised of an insulation foam, including, but not limited to, a closed cell insulating foam, for example a polyethylene foam. Alternatively, the outer layer of insulation  30  may be comprised of multiple layers of sterile drapes that are encapsulated in a surgical grade material. By placing the outer layer of insulation  30  along the outer wall  14 , the outer layer of insulation  30  may insulate the insulation jacket  10  from outside heat sources, including, but not limited to, heat from the body of the patient, surgical lights, and surgical equipment, and thereby assist in retaining the cool temperature of the cooling material and/or graft organ  15  for longer periods of time. Similarly, the layer of insulation may be positioned along a portion of the inner wall  12  of the insulation jacket  10  rather than being along the outer wall  14 , as would be understood by one of ordinary skill in the art.  
         [0075]      FIGS. 11, 12 ,  14 , and  15  illustrate an outside elevation view, a cross sectional view, a partial cross-sectional end view, and an inside elevation view of an insulation jacket  10  having an insulated outer wall  14  and an insulated inner wall  12  in accordance with one embodiment of the present invention.  FIG. 13  illustrates an outside elevation view of an insulation jacket  10  having an insulated outer wall  14  and an insulated inner wall  12 , in which the insulation jacket  10  is secured about at least a portion of a graft organ  15  in accordance with one embodiment of the present invention. The embodiment shown in  FIGS. 11, 12 ,  3 ,  14 , and  15  illustrate a cooling jacket  10  similar to that shown in  FIGS. 1-5  in which both the inner and outer walls  12 ,  14  are insulated.  
         [0076]     As previously discussed, at least a portion of the outer wall  14  may be operably connected to an outer layer of insulation  30  and may also be operably connected to the connectors. Similarly, at least a portion of the inner wall  12  may be operably connected to an inner layer of insulation  32 , including through the use of an adhesive. As with the outer layer of insulation  30 , the inner layer of insulation  32  may be comprised of an insulation foam, for example a closed cell foam, or alternatively, may be comprised of multiple layers of sterile drapes that are encapsulated in a surgical grade material.  
         [0077]     By insulating both the inner and outer walls  12 ,  14 , the cooling medium may be able to maintain desirable temperatures during organ harvesting and/or transplantation procedures for longer periods of time so as to prevent or delay the harmful affects of warm ischemia. For example, the inner layer of insulation  32  may prevent the warming of the cooling material contained within the plurality of pillows  22  from exposure to the body heat of a patient. Additionally, the presence of the inner layer of insulation  32  may allow for the temperature of the cooling material to be lower than what may typically be achieved in embodiments that do not include an inner layer of insulation  32 , such as temperatures below approximately 4° Celsius. In such circumstances, because the inner layer of insulation  32  does not function as a cooling source, but instead is an insulator, the inner layer of insulation  32  is able to insulate the cooling material from outside heat sources and ambient temperatures while also acting as a buffer against the direct exposure of the graft organ  15  to the pillows  22  and the cooled cooling material contained therein. By acting as a buffer, the inner layer of insulation  32  may prevent damage to the graft organ  15  and its tissue that may otherwise occur from direct contact with the chilled pillows  22 . In such embodiments, the inner layer of insulation  32  may reach a thickness of approximately one-quarter inch (¼″). Preferably, the inner layer of insulation  32  is a layer of closed cell foam having a thickness of one-eighth (⅛″) to one-quarter (¼″).  
         [0078]     The method for using the insulation jacket  10  of the present invention includes chilling the cooling material contained within the insulation jacket  10 . One factor considered in determining the appropriate chilling temperature for the cooling material is what temperatures the graft organ may be exposed to without causing cell and tissue damage. As previously discussed, the cooling material may be chilled so that when the insulation jacket  10  encloses at least a portion of the graft organ  15 , the temperature of the portion of the insulation jacket  10  that comes into direct contact with the graft organ  15  should not be below approximately 4° Celsius. However, if the insulation jacket  10  includes an inner layer of insulation  32 , the cooling material may be exposed to lower chilling or even freezing temperatures than what may be acceptable for embodiments of the present invention that do not include an inner layer of insulation  32 .  
         [0079]     The method of the present invention may also include cutting the panels  20   a ,  20   b ,  20   c  to better accommodate the graft organ  15 . Selective pillows  22  may also be punctured to provide a better fit for the graft organ  15 .  
         [0080]     As illustrated in  FIGS. 4, 8 , and  13 , the insulation jacket  10  may include openings  18  that allow the insulation jacket  10  to be placed around at least a portion of the graft organ  15  before the graft organ  15  is severed from the body of the donor. Further, when harvesting a graft organ  15 , because the pillows  22  may not be in communication with adjacent pillows  22 , the surgeon may elect to puncture some pillows  22  in order to improve the positioning and/or enclosure of the insulation jacket  10  about at least a portion of the graft organ  15  or to improve the field of operation without destroying the cooling capabilities of insulation jacket  10 .  
         [0081]     After preparing the graft organ  15  for transplantation, at least a portion of the graft organ  15  is enclosed by the insulation jacket  10  prior to the insertion of the graft organ  15  into the body of the recipient. During this aspect of the procedure, the openings  18  provide the surgeon with access to the vessels  17  of the graft organ  15  needed for reattaching the graft organ  15  in the body of the recipient. This access permits the insulation jacket  10  to continue enclosing at least a portion of the graft organ  15  during the transplantation surgery, and thus may prevent or delay the onset of warm ischemia. As with the harvesting process, during the transplantation procedure, because of the sterile non-toxic nature of the cooling material, the surgeon also may elect to puncture some of the pillows  22  without destroying the cooling capabilities of the insulation jacket  10  or harming the graft organ  15  or patient. Upon completion of the transplantation procedure, the insulation jacket  10  may be removed from the body of the patient. Given the nature of use, the insulation jacket may typically be used for only one transplantation operation.  
         [0082]      FIGS. 16 and 17  illustrate inside and outside elevation views of an insulation jacket  50  in accordance with alternative embodiment of the present invention in which insulation jacket  50  includes a body portion  40  that is comprised of an insulation foam, for example a polyethylene closed cell foam. The body portion  40  may have an inner wall  44  and an outer wall  46 , as further shown in  FIG. 18 . The body portion  40  may also be comprised of a single panel or a plurality of panels  42   a ,  42   b ,  42   c , in which case the plurality of panels  42   a ,  42   b ,  42   c  may be operably connected to the adjacent panel, including being connected through the use of adhesives.  
         [0083]      FIG. 19  illustrates an outside elevation view of an insulation jacket  50  having a plurality of panels  42   a ,  42   b ,  42   c  and connectors  48  in which the insulation jacket is secured about at least a portion of a graft organ in accordance with one embodiment of the present invention in which the body portion is comprised of an insulation foam. As shown, the insulation jacket  50  may be operably secured around at least a portion of the graft organ  15  through the use of connectors  48 , including mating strips of hook and loop material, staples, tape, and adhesives. Additionally, the connectors  48  may be operably secured to the body portion  50 , for example through the use of an adhesive material. Further, the body portion  40  may also be configured to generally conform to the shape of a specific type of a graft organ  15 . By configuring the shape of the body portion  40  to generally conform to the shape of the graft organ  15 , the insulation jacket  50  may have improved insulation characteristics while also minimizing the space in the operation field that is occupied by said insulation jacket  50  when the insulation jacket  50  is enclosed about at least a portion of the graft organ  15   
         [0084]     In an alternative embodiment of the insulation jacket  50  illustrated in  FIG. 19 , either the inner wall or the outer wall  46  of the body portion  40  may be operably connected to a liner. For example, the liner, which may be constructed from a flexible surgical grade plastic, may be connected to at least a portion of the inner wall  44  or outer wall  46  through the use of an adhesive material. When connected to the inner wall  44  or the outer wall  46  of the body portion  40 , the liner may be configured to form a plurality of non-communicating pillows between said liner and the inner wall  44  or outer wall  46 . The pillows may contain a cooling material that may assist in cooling or retaining the chilled temperature of a graft organ. In such an embodiment, the selection of material for the body portion  40 , for example the use of a closed cell foam, may prohibit cooling material contained within the pillows from leaking or seeping through the inner or outer walls  44 ,  46  of the body portion  40  respectively.  
         [0085]      FIGS. 20 and 21  illustrate inside and outside elevation views of an insulation jacket  60  in accordance with another alternative embodiment of the present invention in which insulation jacket  60  includes a body portion  61 . The thermo mass  62  may include an inner wall  64  and an outer wall  64  and may be comprised of, but is not limited to, a dense rubber thermo conductor gel, for example commercially available Akton™ Polymer from Action Products of Hagerstown, Md. In the illustrated embodiment, the thermo mass may be ¼ inch thick. In such an embodiment, the thermo mass  62  may have a sufficient density so that the thermo mass  62  may not have to be contained within a separate bladder, while still being sufficiently plyable so as to allow the body portion  61  to be manipulated about at least a portion of the graft organ  15 .  
         [0086]      FIG. 22  illustrates an outside elevation view of the insulation jacket  60  in which the insulation jacket  60  is secured about at least a portion of a graft organ  15 . As with the previous embodiments, the thermo mass  62  may be shaped to conform to the shape of the graft organ  15  while still providing openings for the passage and/or access to the vessels  17  of the graft organ  15 . Further, the body portion  61  may be operably connected to at least one connector  68 , the connector  68  being configured to assist in securing the insulation jacket  60  about at least a portion of the graft organ  60 . Additionally, the inner wall  64  and/or outer wall  66  of the body portion  61  may be operably connected to at least one layer of insulation, the at least one layer of insulation being configured to insulate the graft organ  15  from outside heat sources and assist in retaining the cool temperature of the chilled graft organ  15 .  
         [0087]     In another embodiment of the present invention, the cooling jacket may include an insulating outer shell that is operably connected to a thermal absorbent body, in which the thermal absorbent body may be configured to retain and/or absorb a liquid coolant.  FIG. 23  illustrates a cross sectional view of a cooling jacket  100  in accordance with such embodiment of the present invention. As shown in  FIG. 23 , the cooling jacket  100  may include an outer shell  102 , a thermal absorbent body  104 , and at least one connector  106  that may be configured to secure at least a portion of the cooling jacket  100  about a graft organ  15  (shown for example in  FIG. 4 ). Connectors  106  may be attached to the outer shell  102  or the thermal absorbent body  104 . Examples of connectors  106  include, but are not limited to, mating strips of hook and loop material, staples, sutures, tape, and adhesives.  
         [0088]     The outer shell  102  of the cooling jacket  100  may be constructed from an insulation foam, including a polyethylene closed cell foam, that may be at least semi-impervious to liquids. The outer shell  102  may insulate the graft organ  15  from body heat and other external heat sources, and may assist in maintaining the cool temperature of the thermal absorbent body  104  and any absorbed or retained liquid coolant that may be associated with the thermal absorbent body  104 . Further, the semi-impervious nature of the outer shell  102  may assist in preventing liquid coolant from seeping through the outer shell  102  and away from the thermal absorbent body  104 .  
         [0089]     The thermal absorbent body  104  may include an open cell foam that may absorb (similar to a sponge), retain, or be coated with a sterile liquid coolant. The thermal absorbent body  104  may be exposed to the liquid coolant prior to, or after, the liquid coolant has been chilled to temperatures that may minimize the onset of warm ischemia in the graft organ  15 , such as approximately 4° Celsius. Alternatively, the thermal absorbent body  104  may be replaced by a non-absorbent soft high density polymer, such as silicone, that is capable of being chilled and/or retaining cold temperatures for long periods of time, including desired harvesting temperatures of approximately 4° Celsius.  
         [0090]     The thermal absorbent body  104  may or may not be operably connected to the outer shell  102 . In some embodiments, the thermal absorbent body  104  may be operably connected to the outer shell  102  through the use of adhesives, staples, tape, hook and loop material, and sutures, among others. In other embodiments, the outer shell  102  may be assembled or wrapped about at least a portion of the thermal absorbent body  104  after the thermal absorbent body  104  has been placed about at least a portion of the graft organ. In such embodiments, the thermal absorbent body may have a blanket configuration that is shaped to conform at least in part to the shape and vessels of the graft organ when the thermal absorbent body is wrapped about at least a portion of said graft organ, in which case the outer shell may be subsequently positioned and/or secured about at least a portion of the thermal absorbent body. Alternatively, the thermal absorbent body may be constructed from a plurality of individual panels that are positioned about the graft organ and may be attached or secured to adjacent panels of the thermal absorbent body before the addition of the outer shell about at least a portion of the thermal absorbent body.  
         [0091]      FIG. 24  illustrates an inside elevation view of a cooling jacket  100  having a segmented thermal absorbent body  104  in accordance with one embodiment of the present invention. Segmentation of the thermal absorbent body  104  may assist in inhibiting or delaying liquid coolant that has been absorbed or retained by the thermal absorbent body  104  from migrating to an adjacent portion of the thermal absorbent body  104 , or in a generally downward direction via the force of gravity. By inhibiting the migration of liquid coolant, segmentation may assist in preventing the lose of liquid coolant in some areas of the thermal absorbent body  104 , and thus may prevent those areas of the thermal absorbent body  104  from prematurely having a reduction in cooling capabilities.  
         [0092]      FIG. 25  illustrates a cross sectional view of a cooling jacket  100  having a segmented thermal absorbent body  104  in accordance with one embodiment of the present invention. Segmentation may involve spacing portions or different sections of the thermal absorbent body  104  away from other portions of the thermal absorbent body  104 . For instance, segments of thermal absorbent body  104  may be positioned so that gaps of space may be present between adjacent segments of the thermal absorbent body  104 . Alternatively segmentation may include the use of a barrier, such as a liner or stitching, between portions of the thermal absorbent body  104  that may resist the migration of the liquid coolant in the thermal absorbent body  104 .  
         [0093]     Factors considered in selecting a liquid coolant that may be used with the thermal absorbent body  104  may include the sterility and freezing point of the liquid coolant. The ability of the liquid coolant to remain in a liquid state when cooled to desired harvesting temperatures may allow the thermal absorbent body  104  to retain at least a partial flexible or pliable nature so that the thermal absorbent body  104  may be manipulated about the graft organ  15 . Suitable liquid coolants may include, but are not limited to, saline and sterile water.  
         [0094]      FIG. 26  illustrates a cross sectional view of a cooling jacket  100  having an inner film  116  in accordance with one embodiment of the present invention. The inner film  116  may be operably attached to at least a portion of the thermal absorbent body  104 , such as through an adhesive, tape, staple, suture, or hook and loop material. The inner film  116  may also be at least semi-impervious to liquids and may be comprised of surgical grade plastics, multiple layers of sterile drapes that are encapsulated in a surgical grade material, or an insulation foam, including, but not limited to, a closed cell insulating foam, such as a polyethylene foam. In such an embodiment, the semi-impervious nature of the inner film  116  may assist in retaining liquid coolant in or around at least a portion of the thermal absorbent body  104 .  
         [0095]     In another embodiment of the present invention, the inner film  116  may be attached to the outer shell  102  rather than to the thermal absorbent body  104 . When attached to the outer shell  102 , the inner film  116  may be configured to create an area between the outer shell  102  and inner film  116  in which the thermal absorbent body  104  may be removably or permanently inserted. Additionally, the attachment of the inner film  116  to the outer shell  102  may be configured to allow for the formation of a plurality of pillows between the inner film  116  and the outer shell  102 . At least a portion of the pillows may contain a thermal absorbent body  104 . In such embodiments, the connection between the inner film  116  and outer shell  102  may be configured to permit the passage of liquid coolant to, or around, at least a portion of the thermal absorbent body  104  that may be positioned between the inner film  116  and outer shell  102 .  
         [0096]      FIG. 27  illustrates an outside view of the outer shell  102  of an opened cooling jacket  100  having an envelope configuration in accordance with one embodiment of the present invention. The outer shell  102  may include one or more panels  110   a ,  110   b  that may be molded or formed together to create a uni-body construction. In another embodiment, the outer shell  102  may be formed by a series of individual panels. In such an embodiment, each individual panel may be operably connected to an adjacent panel, such as through the use of adhesives, staples, tape, hook and loop material, and sutures. In another embodiment, an outer shell  102  having an envelope configuration may be formed or molded to have a shape similar to an opened sleeve or pouch, wherein the graft organ may be slid or inserted into an opening along at least a portion of the outer shell  102 , as discussed in more detail hereinafter.  
         [0097]      FIGS. 28   a  and  28   b  illustrate a bottom and cross sectional view of the outer shell  102  of a cooling jacket  100  having an envelope configuration in accordance with one embodiment of the present invention. The thermal absorbent body  104  may be constructed to conform to the size and shape of the outer shell  102 . Thus, a cooling jacket  100  having a single panel uni-body outer shell  102  may also include a single or multi-panel thermal absorbent body  104  that generally conforms to the shape or boundaries of the outer shell  102 . Similarly, for those embodiments of the present invention in which the outer shell  102  may be constructed from a plurality of individual panels, each individual panel of the outer shell  102  may be attached to a portion of a single panel thermal absorbent body  104 , or, alternatively, may be connected to individual panels of the thermal absorbent body  104 .  
         [0098]      FIG. 29  illustrates an end side view of the outer shell  102  of a cooling jacket  100  having an envelope configuration in accordance with one embodiment of the present invention. As shown, the outer shell  102  may include closure ears  114   a  that may assist in securing the cooling jacket  100  around the graft organ  15 . Closure ears  114   a  may be operably connected to mating closure ears  114   b  through the use of connectors  106   a ,  106   b . More specifically, connectors  106   a  may be positioned on the inner or outer surface of the outer shell  102  and aligned so as to mate with connectors  106   b  on opposing closure ears  114   b , or other portions of the outer shell  102 , so that the cooling jacket  100  may be secured to at least a portion of the graft organ  15 .  
         [0099]      FIG. 30  illustrates a top view of the outer shell  102  of a cooling jacket  100  having an envelope configuration in accordance with one embodiment of the present invention. As shown, at least one opening  123  may be present about at least a portion of an outer shell  102  that has an envelope configuration. The opening  123  may be created through the manipulation, shaping, and/or at least partial closure of the outer shell  102 . For example, in instances in which the opening  123  is formed into, or by the manipulation of, the outer shell  102  before the outer shell  102  comes into contact with the graft organ, the outer shell  102  may be similar to a pouch or sleeve, which may permit the graft organ to be placed or slid into the outer shell  102 . Alternatively, the envelope configuration of the outer shell  102  may be created by the wrapping of the cooling jacket  100  about at least a portion of the graft organ.  
         [0100]      FIG. 31  illustrates a side elevation view of a cooling jacket  100  having an envelope configuration enclosing at least a portion of a kidney graft  15  organ in accordance with one embodiment of the present invention. As shown, the connection or attachment between the mating closure ears  114   a ,  114   b  may assist in securing the organ jacket  100  about the graft organ  15 . In the illustrated embodiment, the closure ears  114   a ,  114   b  may be positioned and shaped so that, when the mating closure ears  114   a ,  114   b  are connected, a passageway or opening may be formed through which vessels  17  of the graft organ  15  may pass.  
         [0101]      FIGS. 32 and 33  illustrate side elevation views of cooling jackets  100  having envelope configurations that are shaped to enclose at least a portion of a liver and kidney graft organ  15 , respectively, in accordance with an embodiment of the present invention. As shown, the size and shape of the cooling jacket  100 , including the outer shell  102 , thermal absorbent body  104 , and any closure ears  114   a , may be tailored to fit a specific type of graft organ  15 . Further, the cooling jacket  100  may be configured to provide openings for some of the vessels of the graft organ. The number and location of closure ears  114   a ,  114   b  may also be varied for different cooling jackets  100  so as to accommodate the shape of the particular graft organ  15 .  
         [0102]      FIGS. 34   a ,  34   b ,  34   c  illustrate another embodiment of the present invention in which multiple panels  110   a ,  110   b  are used to assemble and secure a cooling jacket  100  about at least a portion of a liver graft organ  15  in accordance with one embodiment of the present invention. In one embodiment, each panel  110   a ,  110   b  may include a thermal absorbent body portion and an outer shell portion. Alternatively, each panel  110   a ,  100   b  may be a section of the thermal absorbent body, in which case, after the panels  110   a ,  110   b  have been positioned, secured, or assembled to form the thermal absorbent body, the outer shell may be wrapped or assembled about the panels  110   a ,  110   b.    
         [0103]     As shown in  FIG. 34   b , a first panel  110   a  may be positioned about at least a portion of the liver graft organ  15 . A second panel  110   b , as shown in  FIG. 34   c , may then be subsequently positioned about a portion of the liver graft organ  15 , and may be connected to the first panel  110   a  through the use of a connector  106 . In such an embodiment, the flexibility to select and position appropriate sized individual panels  110   a ,  110   b  may allow a technician or surgeon to further refine or customize the size, shape, and opening locations of the cooling jacket  100  to accommodate the particular graft organ  15 . Further, because the individual panels  110   a ,  110   b  may be assembled and arranged at the surgical site to create the cooling jacket  100 , each individual panel  110   a ,  110   b  may not necessarily be designed for a specific organ. Instead, a variety of different shaped panels  110   a ,  110   b  may be assembled and secured to an adjacent panel so as to allow the surgeon to fashion an appropriately shaped cooling jacket  100  for the particular graft organ  15  and associated vessels  17 . Additionally, the surgeon may elect to cut portions of the cooling jacket  100  so as to further accommodate the size and openings of the graft organ  15  without destroying the cooling ability of the thermal absorbent body  104 . Although the embodiment illustrated in  FIGS. 24   a ,  34   b , and  34   c  have, by way of example, described the assembly of a plurality of panels  
         [0104]     While the invention has been described with reference to certain embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from its scope. Therefore, it is intended that the invention not be limited to the particular embodiment disclosed, but that the invention will include all embodiments falling within the scope of the appended claims.