WO2021127718A1 - Intraoperative organ temperature regulation device - Google Patents

Intraoperative organ temperature regulation device Download PDF

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Publication number
WO2021127718A1
WO2021127718A1 PCT/AU2020/000140 AU2020000140W WO2021127718A1 WO 2021127718 A1 WO2021127718 A1 WO 2021127718A1 AU 2020000140 W AU2020000140 W AU 2020000140W WO 2021127718 A1 WO2021127718 A1 WO 2021127718A1
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WO
WIPO (PCT)
Prior art keywords
organ
layer
flexible enclosure
enclosure
patient
Prior art date
Application number
PCT/AU2020/000140
Other languages
French (fr)
Inventor
Shantanu BHATTACHARJYA
Original Assignee
Organ Recovery Systems Pty Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from AU2019904896A external-priority patent/AU2019904896A0/en
Application filed by Organ Recovery Systems Pty Ltd filed Critical Organ Recovery Systems Pty Ltd
Publication of WO2021127718A1 publication Critical patent/WO2021127718A1/en

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    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00—Preservation of bodies of humans or animals, or parts thereof
    • A01N1/02—Preservation of living parts
    • A01N1/0236—Mechanical aspects
    • A01N1/0263—Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving, e.g. cool boxes, blood bags or "straws" for cryopreservation
    • A—HUMAN NECESSITIES
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
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Definitions

  • the present invention relates generally to organ transplantation and more particularly to devices and methods for regulating the temperature of transplant organs during the perioperative period.
  • Organ transplantation has become an increasingly common treatment option for a variety of diseases and conditions.
  • rejection of the transplanted tissue continues to be a hurdle to successful transplantation.
  • Graft tissue quality is a major factor. The method of storing a donor organ once removed from the donor greatly impacts graft tissue quality.
  • hypothermic preservation is the most common method used for organ storage between procurement and implantation. Hypothermia retards anaerobic metabolism and prevents cell damage and death. It is widely accepted that the benefits of hypothermia are substantially lost once the temperature of an organ reaches greater than 15 degrees Celsius. Unfortunately, it is common for the temperature of an organ to exceed 15 degrees Celsius during the intraoperative period (i.e. the period during which a surgical operation is being carried out).
  • Intraoperative hypothermic preservation can be achieved by perfusion cooling which involves pumping a cold solution through the organ. Intraoperative hypothermic preservation can also be achieved by topical hypothermia which involves cooling the external surfaces of the organ with chilled solutions or devices.
  • topical hypothermia which involves cooling the external surfaces of the organ with chilled solutions or devices.
  • the complexity of the equipment complicates surgery.
  • There is a need for a system or device that can be used for hypothermic preservation of an organ during the intraoperative phase of surgery that is easy to use and/or portable and/or cost-effective and/or provides an alternative to existing systems or devices.
  • the present application arises from the inventor’s research on devices that retard heat transfer between a cold preserved organ and its surroundings during the process of implantation.
  • a device for regulating the temperature of a body organ during an intraoperative phase of surgery comprising: a flexible enclosure having a selectively closeable first opening that is large enough to permit the body organ to pass therethrough for positioning within the flexible enclosure, said flexible enclosure formed substantially from a multilayer composite insulating material that reduces heat transfer from outside the enclosure to an organ positioned in the enclosure as well as radiant heat loss from inside such that the organ can be maintained at or about a desired temperature during surgery.
  • the device needs to be sterilisable, relatively light weight and flexible, made with materials that are not toxic, can be safely removed without damaging the organ and prevents heat transfer by conduction, convection and radiation.
  • the multilayer composite insulating material of the device of the first aspect comprises a non-toxic waterproof outermost layer and a non-toxic waterproof innermost layer, a reflective layer between the outermost layer and the innermost layer, and an insulating layer between the outermost layer and the innermost layer.
  • the device may comprise a second opening configured to allow a vein, artery or duct from a body organ within the flexible enclosure to pass therethrough.
  • the insulating layer between the outermost layer and the innermost layer is an air layer.
  • the multilayer composite insulating material further comprises an air layer between the outermost layer and the innermost layer.
  • a method for regulating the temperature of a body organ during an intraoperative phase of surgery comprising: providing the device of the first aspect; positioning an organ that has been kept at a desired temperature in the flexible enclosure of the device; positioning the organ in the flexible enclosure of the device in an operable position in a patient; attaching a vein, artery or duct from the organ to a patient while the organ remains in the flexible enclosure of the device; and removing the organ from the flexible enclosure of the device after attaching the vein or duct to the patient.
  • Figure 1 is a schematic representation of an embodiment of a device for regulating the temperature of a body organ during an intraoperative phase of surgery with the organ inside the device;
  • Figure 2 is a part cross section view of a multilayer composite insulating material used in the device shown in Figure 1;
  • Figure 3 is an exploded view of a multilayer composite insulating material used in the device shown in Figure 1;
  • Figure 4 is a plot showing time vs temperature for a control chicken fillet at 4 degrees Celsius wrapped in ice and a chicken fillet at 4 degrees Celsius wrapped in the device as described herein;
  • Figure 5 is side view of an embodiment of a device for regulating the temperature of a body organ during an intraoperative phase of surgery with the device in the open state (left) and the closed state (right);
  • Figure 6 is top view of the embodiment shown in Figure 5 in an open state
  • Figure 7 is side view of the embodiment shown in Figure 5 in an closed state and with the pull cords retained away from the first opening;
  • Figure 8 is an exploded view of a multilayer composite insulating material used in the device shown in Figures 5 to 7;
  • Figure 9 is side view of an embodiment of a device for regulating the temperature of a body organ during an intraoperative phase of surgery with the device in the open state;
  • Figure 10 is a perspective view from below of the embodiment shown in Figure 9;
  • Figure 11 is a perspective view from above of the embodiment shown in Figure 9;
  • Figure 12 is an exploded view showing components of the embodiment shown in Figure 9;
  • Figure 13 is a perspective view of individual component layers of the embodiment shown in Figure 9 with a close up of a female luer lock attachment
  • Figure 14 is side views of the embodiment shown in Figure 9 with the device in the closed state and showing stowage of pull tabs.
  • a device 10 for regulating the temperature of a body organ during an intraoperative phase of surgery.
  • the device 10 comprises a flexible enclosure 12 having a selectively closeable first opening 14 that is large enough to permit the body organ 16 to pass therethrough for positioning within the flexible enclosure 12.
  • the flexible enclosure 12 also has a second opening 18 that is configured to allow a vein or duct 20 from the body organ 16 within the flexible enclosure 12 to pass therethrough.
  • a vein or duct 20 from the body organ 16 may extend through the first opening 14 when it is in a closed state.
  • the flexible enclosure 12 is formed substantially from a multilayer composite insulating material 22 that reduces heat transfer from outside the enclosure 12 to a body organ 16 positioned in the enclosure 12 as well as radiant heat loss from inside the enclosure 12 such that the organ 16 can be maintained at or about a desired temperature during surgery.
  • the device 10 is especially suitable for maintaining a body organ 16 to be transplanted into a patient at or below the desired temperature.
  • the organ 16 may be a kidney, liver, heart, lung or pancreas.
  • the benefits of hypothermia are substantially lost once the temperature of an organ reaches greater than 15 degrees Celsius and it is not uncommon for a transplant operation to take between 45 to 70 minutes.
  • the desired temperature is 15 degrees Celsius or less.
  • the present applicant has found that using the device 10 described herein it is possible to keep the temperature of an organ 16 that starts out at about 5 degrees Celsius at a temperature of less than about 15 degrees Celsius for a period of about 2 hours after removal of the organ 16 from a cooling source.
  • the device 10 takes the general shape of a pouch.
  • the pouch can be formed by peripherally fixing two pieces of the multilayer composite insulating material 22 together in a face to face manner to form a pouch structure.
  • the size, shape, configuration and/or form of the device 10 can be different depending on the type of body organ 16. Generally, the device 10 will be sized so that the body organ 16 fits relatively snugly within the flexible enclosure 12. In this way, the device 10 is as unobtrusive as possible during a surgical procedure.
  • the device 10 has the first opening 14 positioned generally at the top of the pouch.
  • a second opening 18 may or may not be present. If present, the second opening may be located anywhere on the pouch. In the embodiments illustrated in Figures 1, 9-12 and 14 the second opening 18 is positioned in a bottom seam of the pouch. In the embodiment illustrated in Figures 5-7 there is no second opening 18.
  • a pouch structure can be formed by stitching, heat sealing or ultrasound welding two or more pieces of insulating material 22 together in a face to face manner.
  • a single elongate piece of insulating material 22 can be folded in half and sewn, heat sealed or ultrasound welded together to form a pouch type structure.
  • the insulating material 22 is a multilayer composite material formed of a non-toxic waterproof outermost layer 24 and a non-toxic waterproof innermost layer 26.
  • a reflective layer 28 is positioned between the outermost layer 24 and the innermost layer 26.
  • An insulating layer 30 is positioned between the outermost layer 24 and the innermost layer 26.
  • An air layer 32 is positioned between the outermost layer 24 and the innermost layer 26.
  • the insulating material 22 is a multilayer composite material formed of a non-toxic waterproof outermost layer 24 and a non-toxic waterproof innermost layer 26.
  • a reflective layer 28 is positioned between the outermost layer 24 and the innermost layer 26.
  • the reflective layer also forms the insulating layer 30. This can be achieved, for example, by forming a reflective surface on the insulating layer material.
  • the insulating material 22 is a multilayer composite material formed of a non-toxic waterproof outermost layer 24 and a non-toxic waterproof innermost layer 26.
  • the insulating layer 30 is positioned between the outermost layer 24 and the innermost layer 26.
  • the reflective layer 28 is part of the innermost layer 26. This can be achieved, for example, by forming a reflective surface on the innermost layer material.
  • the outermost layer 24 and the innermost layer 26 can be formed from any material that is waterproof or able to be made waterproof, non-toxic and able to withstand sterilisation conditions.
  • Suitable materials include Nylon and polyester fabrics. The fabrics can be plain or twill weave. Nylon fabric has been found to be particularly suitable for this purpose.
  • One suitable nylon fabric is commercially available as Silicone / Urethane impregnated 30D ripstop Nylon fabric manufactured by Seattle Fabrics; 8702 Aurora Avenue North; Seattle WA 98103.
  • Another suitable material is appropriately heat sealed or low density polyethylene sheet.
  • Another suitable material is thermoplastic polyurethane (TPU), such as 0.1-0.2 mm medical grade TPU.
  • Still another suitable material is polypropylene (PP), such as 0.2-0.3 mm medical grade PP.
  • Still another suitable material is PET polyester, such as 0.2-0.3 mm medical grade PET.
  • the reflective layer 28 can be formed from metallized paper, metallized fabric and/or aluminium foil. Suitable commercially available materials that may be used for this purpose include metallized fabric such as the one commercially available as ThermoflectTM (manufactured by Encompass Group LLC, McDonough, GA 30253 USA), insulating polyester fibre based fabrics such as Insul-fleeceTM (manufactured by Pellon), and aluminium foil.
  • the reflective layer 28 can be formed on any of the other layers, such as the outermost layer 24, the innermost layer 26, the insulating layer 30 and/or the air layer 32, by impregnating the layer with a reflective material or by depositing a reflective material on the layer.
  • the reflective material may be aluminium, silver, tin or gold and the reflective material may be deposited using any suitable technique, such as by chemical vapour or vacuum deposition.
  • the insulating layer 30 is formed from a suitable insulating fabric or material. Suitable insulating fabrics or materials include polyester fleece and aerosolized silica gel. A particularly suitable polyester fleece is commercially available Pellon® 975 Insul-FleeceTM. This product is made from polyester fibres which are needle punched with an aluminized scrim binder (80% polyester/20% metallized polypropylene) that helps to reflect heat or cold back to its source. A particularly suitable aerosolized silica gel is an aerogel. Suitable insulating aerogel products are commercially available from Aspen Aerogels. The insulating layer may have a thickness of about 1mm. Alternatively, the insulating layer 30 may be a multilayered (e.g.
  • the insulating layer 30 may be a heat exchange layer in the form of a cold fluid layer, as best seen in Figure 12.
  • the cold fluid heat exchange layer 30 may be formed from a material that is configured to retain an endothermic fluid such as icy slush.
  • the cold fluid insulating layer 30 may be in the form of double layer pouch that is sealed around the edges.
  • the layers may be formed from any suitable water tight material. In the embodiment shown in Figures 12 and 13, the cold fluid heat exchange layer 30 is formed from two layers of aluminium foil that are heat sealed to form a water tight pouch.
  • the insulating layer 30 is also the reflective layer 28.
  • the cold fluid heat exchange layer 30 may contain a one way valve 46 that allows introduction of endothermic fluid into the insulating layer 30 but prevents egress of the fluid out of the layer 30.
  • the one way valve may contain a luer lock fitting and cap. In use, the one way valve 46 may extend through an aperture 50 in the outermost layer 24 and an aperture 52 in the air layer 32 so that it is accessible from the outside of the device 10 and cold fluid can be introduced before or at the time of surgery in order to maintain the temperature of the organ 16 contained in the device 10.
  • the air layer 32 can be formed by incorporating an air filled gap between any of the layers of the multilayer composite material 22.
  • the air layer 32 is formed by leaving a gap between the outermost layer 24 and the insulating layer 30.
  • the air layer 32 is formed by a layer of bubble film that contains pockets of air. Any suitable bubble film, such as 8 to 10 mm bubble film can be used. More than one layer of bubble film can be used.
  • the air layer 32 is constructed from two layers of polypropylene/thermoplastic urethane film that are heat sealed around their perimeter to form an air tight seal.
  • the bubble film layer may be provided in a deflated form for ease of transport and storage and it may be inflated before use or at the time of use by introducing air into a one way valve 44 that is in air tight connection with the internal air pockets in the film.
  • the one way valve 44 may extend through an aperture 54 in the outermost layer 24 so that it is accessible from the outside of the device 10.
  • the multilayer composite insulating material 22 can be formed by stitching the individual layers together. Alternatively, the multilayer composite insulating material 22 can be formed by affixing each of the respective layers together using a glue coating, such as a polyurethane glue coating. Alternatively, the multilayer composite insulating material 22 can be formed by heat sealing each of the respective layers together. Alternatively, the multilayer composite insulating material 22 can be formed by ultrasonically welding each of the respective layers together.
  • the device 10 further comprises a closure 34 for closing the first opening 14.
  • the closure 34 may be a zip, a series of press studs, a pull cord etc.
  • the closure 34 is in the form of one or more pull cords 36 that are contained within one or more channels 38 that surround the first opening 14.
  • the pull cord 36 can be made from any suitable medical grade string or rope material.
  • a pull cord 36 extends from each channel 38 so that a user can pull on the ends of the pull cord 36 to close the first opening 14, as best seen in Figure 5, 7 and 14.
  • the ends of the pull cord 36 may be connected to pull tabs 40 that enable a user to pull the pull cords 36 easily.
  • the pull tabs 40 may include apertures 42 that can be used to connect the pull tabs 40 (and hence the ends of the pull cords 36) to the air one way valve 44 and the cold fluid one way valve 46, as shown in Figure 14. In this way, the pull cords 36 can be retained out of the way when the device 10 is being used during an operation.
  • the device 10 is sterilisable.
  • the device 10 may also comprise a temperature indicator located on the main body.
  • the device 10 may also comprise one or more grasping point 48 located on the main body.
  • the grasping point 48 may allow the device 10 to be readily grasped by surgical instruments.
  • the grasping point 48 may be in the form of a loop incorporated on the outer surface of the device 10.
  • the device 10 is particularly suitable for use in regulating the temperature of a body organ 16 during an intraoperative phase of surgery.
  • a body organ 16 that has been kept at a desired temperature is positioned in the flexible enclosure 12 of the device 10.
  • the device 10 is then positioned in an operable position in a patient.
  • a vein, artery or duct 20 from the body organ 16 can then be attached to a patient while the organ 16 remains in the device 10.
  • the organ 16 can then be removed from the device 10 after attaching the vein or duct 20 to the patient.

Abstract

A device for regulating the temperature of a body organ during an intraoperative phase of surgery. The device comprises a flexible enclosure having a selectively closeable first opening that is large enough to permit the body organ to pass therethrough for positioning within the flexible enclosure. The flexible enclosure is formed substantially from a multilayer composite insulating material that reduces heat transfer from outside the enclosure to an organ positioned in the enclosure as well as radiant heat loss from inside such that the organ can be maintained at or about a desired temperature during surgery.

Description

INTRAOPERATIVE ORGAN TEMPERATURE REGULATION DEVICE
PRIORITY DOCUMENT
[0001] The present application claims priority from Australian Provisional Patent Application No. 2019904896 titled “INTRAOPERATIVE ORGAN TEMPERATURE REGULATION DEVICE” and filed on 23 December 2019, the content of which is hereby incorporated by reference in its entirety.
TECHNICAL FIELD
[0002] The present invention relates generally to organ transplantation and more particularly to devices and methods for regulating the temperature of transplant organs during the perioperative period.
BACKGROUND
[0003] Organ transplantation has become an increasingly common treatment option for a variety of diseases and conditions. However, rejection of the transplanted tissue continues to be a hurdle to successful transplantation. Graft tissue quality is a major factor. The method of storing a donor organ once removed from the donor greatly impacts graft tissue quality.
[0004] Hypothermic preservation is the most common method used for organ storage between procurement and implantation. Hypothermia retards anaerobic metabolism and prevents cell damage and death. It is widely accepted that the benefits of hypothermia are substantially lost once the temperature of an organ reaches greater than 15 degrees Celsius. Unfortunately, it is common for the temperature of an organ to exceed 15 degrees Celsius during the intraoperative period (i.e. the period during which a surgical operation is being carried out). Studies have shown the impact of anastomotic time that is a surrogate marker for organ rewarming on both short and longer term outcomes of an organ transplant (Irish, Ilsley, Schnitzler, Feng, & Brennan, 2010; Marzouk, Lawen, Alwayn, & Kiberd, 2013; Menon et al, 2014). During this time, the organ is removed from the chilled solution in which it was transported, and thus may warm, leading to greater tissue death and an increased number of cellular changes.
[0005] Intraoperative hypothermic preservation can be achieved by perfusion cooling which involves pumping a cold solution through the organ. Intraoperative hypothermic preservation can also be achieved by topical hypothermia which involves cooling the external surfaces of the organ with chilled solutions or devices. However, in each case, the complexity of the equipment complicates surgery. [0006] There is a need for a system or device that can be used for hypothermic preservation of an organ during the intraoperative phase of surgery that is easy to use and/or portable and/or cost-effective and/or provides an alternative to existing systems or devices.
SUMMARY
[0007] The present application arises from the inventor’s research on devices that retard heat transfer between a cold preserved organ and its surroundings during the process of implantation.
[0008] According to a first aspect of the present disclosure, there is provided a device for regulating the temperature of a body organ during an intraoperative phase of surgery, the device comprising: a flexible enclosure having a selectively closeable first opening that is large enough to permit the body organ to pass therethrough for positioning within the flexible enclosure, said flexible enclosure formed substantially from a multilayer composite insulating material that reduces heat transfer from outside the enclosure to an organ positioned in the enclosure as well as radiant heat loss from inside such that the organ can be maintained at or about a desired temperature during surgery.
[0009] To be clinically useful, the device needs to be sterilisable, relatively light weight and flexible, made with materials that are not toxic, can be safely removed without damaging the organ and prevents heat transfer by conduction, convection and radiation.
[0010] In certain embodiments, the multilayer composite insulating material of the device of the first aspect comprises a non-toxic waterproof outermost layer and a non-toxic waterproof innermost layer, a reflective layer between the outermost layer and the innermost layer, and an insulating layer between the outermost layer and the innermost layer.
[0011] Optionally, the device may comprise a second opening configured to allow a vein, artery or duct from a body organ within the flexible enclosure to pass therethrough.
[0012] In certain embodiments, the insulating layer between the outermost layer and the innermost layer is an air layer. Alternatively, or in addition, the multilayer composite insulating material further comprises an air layer between the outermost layer and the innermost layer.
[0013] According to a second aspect of the present disclosure, there is provided a method for regulating the temperature of a body organ during an intraoperative phase of surgery, the method comprising: providing the device of the first aspect; positioning an organ that has been kept at a desired temperature in the flexible enclosure of the device; positioning the organ in the flexible enclosure of the device in an operable position in a patient; attaching a vein, artery or duct from the organ to a patient while the organ remains in the flexible enclosure of the device; and removing the organ from the flexible enclosure of the device after attaching the vein or duct to the patient.
BRIEF DESCRIPTION OF DRAWINGS
[0014] Embodiments of the present disclosure will be discussed with reference to the accompanying drawings wherein:
[0015] Figure 1 is a schematic representation of an embodiment of a device for regulating the temperature of a body organ during an intraoperative phase of surgery with the organ inside the device;
[0016] Figure 2 is a part cross section view of a multilayer composite insulating material used in the device shown in Figure 1;
[0017] Figure 3 is an exploded view of a multilayer composite insulating material used in the device shown in Figure 1;
[0018] Figure 4 is a plot showing time vs temperature for a control chicken fillet at 4 degrees Celsius wrapped in ice and a chicken fillet at 4 degrees Celsius wrapped in the device as described herein;
[0019] Figure 5 is side view of an embodiment of a device for regulating the temperature of a body organ during an intraoperative phase of surgery with the device in the open state (left) and the closed state (right);
[0020] Figure 6 is top view of the embodiment shown in Figure 5 in an open state;
[0021] Figure 7 is side view of the embodiment shown in Figure 5 in an closed state and with the pull cords retained away from the first opening;
[0022] Figure 8 is an exploded view of a multilayer composite insulating material used in the device shown in Figures 5 to 7;
[0023] Figure 9 is side view of an embodiment of a device for regulating the temperature of a body organ during an intraoperative phase of surgery with the device in the open state; [0024] Figure 10 is a perspective view from below of the embodiment shown in Figure 9;
[0025] Figure 11 is a perspective view from above of the embodiment shown in Figure 9;
[0026] Figure 12 is an exploded view showing components of the embodiment shown in Figure 9;
[0027] Figure 13 is a perspective view of individual component layers of the embodiment shown in Figure 9 with a close up of a female luer lock attachment; and
[0028] Figure 14 is side views of the embodiment shown in Figure 9 with the device in the closed state and showing stowage of pull tabs.
DESCRIPTION OF EMBODIMENTS
[0029] The description that follows, and the embodiments described therein, are provided by way of illustration of an example, or examples, of particular embodiments of the principles of the present disclosure. These examples are provided for the purposes of explanation, and not of limitation, of those principles and of the disclosure. In the description, like parts are marked throughout the specification and the drawings with the same respective reference numerals. The drawings are not necessarily to scale and in some instances proportions may have been exaggerated in order more clearly to depict certain features.
[0030] As shown in Figures 1, 5-7, 9-12 and 14, disclosed herein is a device 10 for regulating the temperature of a body organ during an intraoperative phase of surgery. The device 10 comprises a flexible enclosure 12 having a selectively closeable first opening 14 that is large enough to permit the body organ 16 to pass therethrough for positioning within the flexible enclosure 12. Optionally, the flexible enclosure 12 also has a second opening 18 that is configured to allow a vein or duct 20 from the body organ 16 within the flexible enclosure 12 to pass therethrough. Alternatively, a vein or duct 20 from the body organ 16 may extend through the first opening 14 when it is in a closed state.
[0031] The flexible enclosure 12 is formed substantially from a multilayer composite insulating material 22 that reduces heat transfer from outside the enclosure 12 to a body organ 16 positioned in the enclosure 12 as well as radiant heat loss from inside the enclosure 12 such that the organ 16 can be maintained at or about a desired temperature during surgery.
[0032] The device 10 is especially suitable for maintaining a body organ 16 to be transplanted into a patient at or below the desired temperature. The organ 16 may be a kidney, liver, heart, lung or pancreas. As discussed earlier, for transplant organs the benefits of hypothermia are substantially lost once the temperature of an organ reaches greater than 15 degrees Celsius and it is not uncommon for a transplant operation to take between 45 to 70 minutes. Thus, the desired temperature is 15 degrees Celsius or less. Advantageously, the present applicant has found that using the device 10 described herein it is possible to keep the temperature of an organ 16 that starts out at about 5 degrees Celsius at a temperature of less than about 15 degrees Celsius for a period of about 2 hours after removal of the organ 16 from a cooling source.
[0033] In the illustrated embodiments, the device 10 takes the general shape of a pouch. The pouch can be formed by peripherally fixing two pieces of the multilayer composite insulating material 22 together in a face to face manner to form a pouch structure. The size, shape, configuration and/or form of the device 10 can be different depending on the type of body organ 16. Generally, the device 10 will be sized so that the body organ 16 fits relatively snugly within the flexible enclosure 12. In this way, the device 10 is as unobtrusive as possible during a surgical procedure.
[0034] The device 10 has the first opening 14 positioned generally at the top of the pouch. A second opening 18 may or may not be present. If present, the second opening may be located anywhere on the pouch. In the embodiments illustrated in Figures 1, 9-12 and 14 the second opening 18 is positioned in a bottom seam of the pouch. In the embodiment illustrated in Figures 5-7 there is no second opening 18.
[0035] A pouch structure can be formed by stitching, heat sealing or ultrasound welding two or more pieces of insulating material 22 together in a face to face manner. Alternatively, a single elongate piece of insulating material 22 can be folded in half and sewn, heat sealed or ultrasound welded together to form a pouch type structure.
[0036] In embodiments shown in Figures 2 and 3, the insulating material 22 is a multilayer composite material formed of a non-toxic waterproof outermost layer 24 and a non-toxic waterproof innermost layer 26. A reflective layer 28 is positioned between the outermost layer 24 and the innermost layer 26. An insulating layer 30 is positioned between the outermost layer 24 and the innermost layer 26. An air layer 32 is positioned between the outermost layer 24 and the innermost layer 26. Each of the non-toxic waterproof outermost layer 24, the non- toxic waterproof innermost layer 26, the reflective layer 28, and the insulating layer 30 are mutually overlapped.
[0037] In an embodiment shown in Figure 8, the insulating material 22 is a multilayer composite material formed of a non-toxic waterproof outermost layer 24 and a non-toxic waterproof innermost layer 26. A reflective layer 28 is positioned between the outermost layer 24 and the innermost layer 26. In this embodiment, the reflective layer also forms the insulating layer 30. This can be achieved, for example, by forming a reflective surface on the insulating layer material. [0038] In an embodiment shown in Figures 12 and 13, the insulating material 22 is a multilayer composite material formed of a non-toxic waterproof outermost layer 24 and a non-toxic waterproof innermost layer 26. The insulating layer 30 is positioned between the outermost layer 24 and the innermost layer 26. In this embodiment, the reflective layer 28 is part of the innermost layer 26. This can be achieved, for example, by forming a reflective surface on the innermost layer material.
[0039] The outermost layer 24 and the innermost layer 26 can be formed from any material that is waterproof or able to be made waterproof, non-toxic and able to withstand sterilisation conditions. Suitable materials include Nylon and polyester fabrics. The fabrics can be plain or twill weave. Nylon fabric has been found to be particularly suitable for this purpose. One suitable nylon fabric is commercially available as Silicone / Urethane impregnated 30D ripstop Nylon fabric manufactured by Seattle Fabrics; 8702 Aurora Avenue North; Seattle WA 98103. Another suitable material is appropriately heat sealed or low density polyethylene sheet. Another suitable material is thermoplastic polyurethane (TPU), such as 0.1-0.2 mm medical grade TPU. Still another suitable material is polypropylene (PP), such as 0.2-0.3 mm medical grade PP. Still another suitable material is PET polyester, such as 0.2-0.3 mm medical grade PET.
[0040] The reflective layer 28 can be formed from metallized paper, metallized fabric and/or aluminium foil. Suitable commercially available materials that may be used for this purpose include metallized fabric such as the one commercially available as Thermoflect™ (manufactured by Encompass Group LLC, McDonough, GA 30253 USA), insulating polyester fibre based fabrics such as Insul-fleece™ (manufactured by Pellon), and aluminium foil. The reflective layer 28 can be formed on any of the other layers, such as the outermost layer 24, the innermost layer 26, the insulating layer 30 and/or the air layer 32, by impregnating the layer with a reflective material or by depositing a reflective material on the layer. By way of example, the reflective material may be aluminium, silver, tin or gold and the reflective material may be deposited using any suitable technique, such as by chemical vapour or vacuum deposition.
[0041] The insulating layer 30 is formed from a suitable insulating fabric or material. Suitable insulating fabrics or materials include polyester fleece and aerosolized silica gel. A particularly suitable polyester fleece is commercially available Pellon® 975 Insul-Fleece™. This product is made from polyester fibres which are needle punched with an aluminized scrim binder (80% polyester/20% metallized polypropylene) that helps to reflect heat or cold back to its source. A particularly suitable aerosolized silica gel is an aerogel. Suitable insulating aerogel products are commercially available from Aspen Aerogels. The insulating layer may have a thickness of about 1mm. Alternatively, the insulating layer 30 may be a multilayered (e.g. 5 layers) heat sealed polyethylene (polythene) with air seals between the layers to a total thickness of 10 mm. [0042] Optionally, the insulating layer 30 may be a heat exchange layer in the form of a cold fluid layer, as best seen in Figure 12. The cold fluid heat exchange layer 30 may be formed from a material that is configured to retain an endothermic fluid such as icy slush. For example, the cold fluid insulating layer 30 may be in the form of double layer pouch that is sealed around the edges. The layers may be formed from any suitable water tight material. In the embodiment shown in Figures 12 and 13, the cold fluid heat exchange layer 30 is formed from two layers of aluminium foil that are heat sealed to form a water tight pouch. In this form, the insulating layer 30 is also the reflective layer 28. The cold fluid heat exchange layer 30 may contain a one way valve 46 that allows introduction of endothermic fluid into the insulating layer 30 but prevents egress of the fluid out of the layer 30. The one way valve may contain a luer lock fitting and cap. In use, the one way valve 46 may extend through an aperture 50 in the outermost layer 24 and an aperture 52 in the air layer 32 so that it is accessible from the outside of the device 10 and cold fluid can be introduced before or at the time of surgery in order to maintain the temperature of the organ 16 contained in the device 10.
[0043] The air layer 32 can be formed by incorporating an air filled gap between any of the layers of the multilayer composite material 22. In the embodiment shown in Figure 2, the air layer 32 is formed by leaving a gap between the outermost layer 24 and the insulating layer 30. In the embodiments shown in Figures 8 and 12, the air layer 32 is formed by a layer of bubble film that contains pockets of air. Any suitable bubble film, such as 8 to 10 mm bubble film can be used. More than one layer of bubble film can be used. In the embodiment shown in Figure 12, the air layer 32 is constructed from two layers of polypropylene/thermoplastic urethane film that are heat sealed around their perimeter to form an air tight seal. The bubble film layer may be provided in a deflated form for ease of transport and storage and it may be inflated before use or at the time of use by introducing air into a one way valve 44 that is in air tight connection with the internal air pockets in the film. In use, the one way valve 44 may extend through an aperture 54 in the outermost layer 24 so that it is accessible from the outside of the device 10.
[0044] The multilayer composite insulating material 22 can be formed by stitching the individual layers together. Alternatively, the multilayer composite insulating material 22 can be formed by affixing each of the respective layers together using a glue coating, such as a polyurethane glue coating. Alternatively, the multilayer composite insulating material 22 can be formed by heat sealing each of the respective layers together. Alternatively, the multilayer composite insulating material 22 can be formed by ultrasonically welding each of the respective layers together.
[0045] Optionally, the device 10 further comprises a closure 34 for closing the first opening 14. The closure 34 may be a zip, a series of press studs, a pull cord etc. In embodiments shown in Figures 5-7, 9- 12 and 14, the closure 34 is in the form of one or more pull cords 36 that are contained within one or more channels 38 that surround the first opening 14. The pull cord 36 can be made from any suitable medical grade string or rope material. A pull cord 36 extends from each channel 38 so that a user can pull on the ends of the pull cord 36 to close the first opening 14, as best seen in Figure 5, 7 and 14. In embodiments shown in Figures 9-12 and 14, the ends of the pull cord 36 may be connected to pull tabs 40 that enable a user to pull the pull cords 36 easily. Advantageously, the pull tabs 40 may include apertures 42 that can be used to connect the pull tabs 40 (and hence the ends of the pull cords 36) to the air one way valve 44 and the cold fluid one way valve 46, as shown in Figure 14. In this way, the pull cords 36 can be retained out of the way when the device 10 is being used during an operation.
[0046] The device 10 is sterilisable.
[0047] Optionally, the device 10 may also comprise a temperature indicator located on the main body.
[0048] Optionally, the device 10 may also comprise one or more grasping point 48 located on the main body. The grasping point 48 may allow the device 10 to be readily grasped by surgical instruments. The grasping point 48 may be in the form of a loop incorporated on the outer surface of the device 10.
[0049] The device 10 is particularly suitable for use in regulating the temperature of a body organ 16 during an intraoperative phase of surgery. A body organ 16 that has been kept at a desired temperature is positioned in the flexible enclosure 12 of the device 10. The device 10 is then positioned in an operable position in a patient. A vein, artery or duct 20 from the body organ 16 can then be attached to a patient while the organ 16 remains in the device 10. The organ 16 can then be removed from the device 10 after attaching the vein or duct 20 to the patient.
[0050] Trials of the device 10 using chicken breast fillets to replicate body organs were carried out. The results are shown in Figure 4 in which the data points show the temperature of a control fillet at 4 degrees Celsius packed with ice and the temperature of a fillet that started at 4 degrees Celsius and held within device 10. As can be seen, the temperature of the fillet was maintained at less than about 15 degrees Celsius for a period of about 2 hours without the use of an external cooling apparatus when it was kept in device 10. The same results were replicated in large animal models of kidney transplantation.
[0051] Throughout the specification and the claims that follow, unless the context requires otherwise, the words “comprise” and “include” and variations such as “comprising” and “including” will be understood to imply the inclusion of a stated integer or group of integers, but not the exclusion of any other integer or group of integers.
[0052] The reference to any prior art in this specification is not, and should not be taken as, an acknowledgement of any form of suggestion that such prior art forms part of the common general knowledge. [0053] It will be appreciated by those skilled in the art that the invention is not restricted in its use to the particular application described. Neither is the present invention restricted in its preferred embodiment with regard to the particular elements and/or features described or depicted herein. It will be appreciated that the invention is not limited to the embodiment or embodiments disclosed, but is capable of numerous rearrangements, modifications and substitutions without departing from the scope of the invention as set forth and defined by the following claims.
REFERENCES
[0054] Irish, W. D., Ilsley, J. N., Schnitzler, M. A., Feng, S., & Brennan, D. C. (2010). A risk prediction model for delayed graft function in the current era of deceased donor renal transplantation. Am J Transplant, 70(10), 2279-2286. doi : 10.1111 /j .1600-6143.2010.03179.x
[0055] Marzouk, K., Lawen, J., Alwayn, L, & Kiberd, B. A. (2013). The impact of vascular anastomosis time on early kidney transplant outcomes. Transplant Res, 2(1 ), 8. doi: 10.1186/2047-1440-2-8
[0056] Menon, M., Abaza, R., Sood, A., Ahlawat, R., Ghani, K. R., Jeong, W., . . . Bhandari, M. (2014). Robotic kidney transplantation with regional hypothermia: evolution of a novel procedure utilizing the IDEAL guidelines (IDEAL phase 0 and 1). Eur Urol, 65(5), 1001-1009. doi: 10.1016/j.eururo.2013.11.011

Claims

1. A device for regulating the temperature of a body organ during an intraoperative phase of surgery, the device comprising: a flexible enclosure having a selectively closeable first opening that is large enough to permit the body organ to pass therethrough for positioning within the flexible enclosure, said flexible enclosure formed substantially from a multilayer composite insulating material that reduces heat transfer from outside the enclosure to an organ positioned in the enclosure as well as radiant heat loss from inside such that the organ can be maintained at or about a desired temperature during surgery.
2. The device according to claim 1, wherein the multilayer composite insulating material comprises a non-toxic waterproof outermost layer and a non-toxic waterproof innermost layer, a reflective layer between the outermost layer and the innermost layer, and an insulating layer between the outermost layer and the innermost layer.
3. The device according to claim 2, wherein the multilayer composite insulating material further comprises an air layer between the outermost layer and the innermost layer.
4. The device according to any one of claims 1 to 3, further comprising a second opening configured to allow a vein or duct from a body organ within the flexible enclosure to pass therethrough.
5. The device according to any one of claims 1 to 4, wherein the body organ is an organ to be transplanted into a patient.
6. The device according to any one of claims 1 to 5, wherein the desired temperature is 15 degrees Celsius or less.
7. The device according to any one of claims 1 to 6, wherein the device is sterilisable.
8. The device according to any one of claims 1 to 7, wherein the outermost layer is formed from waterproof nylon fabric.
9. The device according to any one of claims 1 to 7, wherein the outermost layer is formed from thermoplastic polyurethane.
10. The device according to any one of claims 1 to 9, wherein the innermost layer is formed from waterproof nylon fabric.
11. The device according to any one of claims 1 to 9, wherein the innermost layer includes the reflective layer and is formed from aluminium foil.
12. The device according to any one of claims 1 to 11, wherein the reflective layer is formed from one or more of the group consisting of metallized paper, metallized fabric and aluminium foil.
13. The device according to any one of claims 1 to 12, wherein the insulating layer is formed from polyester fleece or multilayered polyethylene.
14. The device according to claim 13, wherein the insulating layer is about 10 mm in thickness.
15. The device according to any one of claims 1 to 12, wherein the insulating layer is a heat exchange layer.
16. The device according to any one of claims 1 to 15, further comprising a closure for closing the first opening of the flexible enclosure.
17. A method for regulating the temperature of a body organ during an intraoperative phase of surgery, the method comprising: providing the device of any one of claims 1 to 16; positioning an organ that has been kept at a desired temperature in the flexible enclosure of the device; positioning the organ in the flexible enclosure of the device in an operable position in a patient; attaching a vein, artery or duct from the organ to a patient while the organ remains in the flexible enclosure of the device; and removing the organ from the flexible enclosure of the device after attaching the vein or duct to the patient.
18. The method according to claim 17, wherein the body organ is an organ to be transplanted into a patient.
19. The method according to either claim 17 or claim 18, wherein the desired temperature is 15 degrees Celsius or less.
20. The method according to any one of claims 17 to 19, further comprising sterilising the device prior to positioning the organ that has been kept at a desired temperature in the flexible enclosure of the device.
PCT/AU2020/000140 2019-12-23 2020-12-18 Intraoperative organ temperature regulation device WO2021127718A1 (en)

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US4537313A (en) * 1984-02-27 1985-08-27 Eleanor Workman Flexible insulated container
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