CA2143622A1 - Hypothermia reducing body enclosure - Google Patents
Hypothermia reducing body enclosureInfo
- Publication number
- CA2143622A1 CA2143622A1 CA002143622A CA2143622A CA2143622A1 CA 2143622 A1 CA2143622 A1 CA 2143622A1 CA 002143622 A CA002143622 A CA 002143622A CA 2143622 A CA2143622 A CA 2143622A CA 2143622 A1 CA2143622 A1 CA 2143622A1
- Authority
- CA
- Canada
- Prior art keywords
- enclosure
- sheet
- air
- body enclosure
- sheets
- Prior art date
- Legal status (The legal status 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 status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
- A61F7/0053—Cabins, rooms, chairs or units for treatment with a hot or cold circulating fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
- A61F2007/0059—Heating or cooling appliances for medical or therapeutic treatment of the human body with an open fluid circuit
- A61F2007/006—Heating or cooling appliances for medical or therapeutic treatment of the human body with an open fluid circuit of gas
Abstract
A body enclosure (10) to prevent or treat hypothermia or hy-perthermia includes a first sheet having a first and second end. A
fastener (50, 53) releasably connects the first end to the second end to form an enclosure about the body. Air from outside of the enclo-sure (10) is admitted into the enclosure (10) to be in direct contact with the body. The air is then discharged from the enclosure. In an-other embodiment, the body enclosure (200) includes first, second and third sheets (226, 240, 260). The third sheet (260) has a longit-udinal seam (224) which is releasably connected by a fastener. The first sheet (226) includes an inlet (244) for inflating and deflating a mattress portion (248) that is enclosed between the first sheet (226) and the second sheet (240). The first sheet (226) also includes a sec-ond inlet (252) for admitting air into an enclosure disposed between the second sheet (240) and the third sheet (260).
fastener (50, 53) releasably connects the first end to the second end to form an enclosure about the body. Air from outside of the enclo-sure (10) is admitted into the enclosure (10) to be in direct contact with the body. The air is then discharged from the enclosure. In an-other embodiment, the body enclosure (200) includes first, second and third sheets (226, 240, 260). The third sheet (260) has a longit-udinal seam (224) which is releasably connected by a fastener. The first sheet (226) includes an inlet (244) for inflating and deflating a mattress portion (248) that is enclosed between the first sheet (226) and the second sheet (240). The first sheet (226) also includes a sec-ond inlet (252) for admitting air into an enclosure disposed between the second sheet (240) and the third sheet (260).
Description
~O 94/05238 ~ 1 q; 3 1~ 2 ~ PCI/US93/08133 HYPOTHERMIA REDUCING BODY ENCLOSURE
Field Of The Invention The present invention relates to the field of surgery and medicine and more particularly, to an improved enclosure for the body of a patient to reduce or 15 increase the loss of body heat during the course of or because of a surgical procedure, trauma, sepsis, prolonged cold exposure, hyperthermia, malignant hyperthermia, or neonatal hypothermia. The present invention also relates to an improved enclosure having a mattress portion to encourage flow of conditioned air around the entire body of the patient.
Background of the Invention Hypothermia, which may be defined as body temperature below 36C
occurs for a variety of reasons during surgery. The ability of a patient to conserve heat and vary heat production during surgery and post operatively is disturbed by 25 both anesthesia and exposure of the patient to the operating room environment.
This loss of body heat occurs by conduction, evaporation, convection and radiation.
Metabolic heat production by an anesthetized adult patient approximates 60-70K
calories per hour. Conduction to the operating table and surgical drapes accountfor less than 10% of heat loss. Evaporation loss occurs from exhaled air and from 30 exposed body cavities, and amounts to roughly 25K calories per hour. Variations in anesthesia circuitry including low flow systems, closed circuits, to and fromsystems and heat humidifiers can reduce evaporation losses to 10-1 5K calories per hour. Convection losses are naturally dependent upon ambient temperature. At 21 C, the patient loses approximately 80K calories per hour which in itself is W O 94/05Z38 PC~r/US93/08133 ~
greater than the amount of heat the patient can produce over a like period. In addition, radiant heat loss is approximately 100K calories per hour.
Additional causes of hypothermia include cold exposure, major trauma, massive blood transfusions, sepsis in elderly patients, prolonged periods of 5 unresponsiveness, maternal hypothermia and neonatal hypothermia in low birth weight infants.
Known methods used to reduce heat loss during and after a surgical procedure include heated and moisturized inhalation anesthetics, radiant heaters, warming blankets, reflecting blankets, warming of intravenous infusions and blood 10 transfusions and warm irrigation. It is also possible to increase arnbient temperature, but this may cause operating room personnel discomfort.
SummarY of the Invention The present invention is an enclosure for the body of a patient 15 undergoing a surgical procedure or one who develops hypothermia or hyperthermia for any reason. The present invention has non-medical uses, such as for use in the military, or to transport a patient, or for general outdoor use for those overexposed to the environment. This enclosure effectively reduces heat loss because of radiation and convection, the greatest sources of loss. It can also be used for heat 20 loss (cooling). This invention also includes a heating and cooling system for such an enclosure. As used hereinafter "heating system" encompasses both a system for cooling and/or heating air.
The enclosure is in the form of a suit that can be compartmentalized, transparent and adapted to enclose the arms, legs, thorax, abdomen, and in some 25 cases the head of a human body. Each of these compartments can be individually opened and closed by means of a seam joined by a pressure sensitive adhesive or hook and loop fastener (e.g., VELCR0~ - a trademark of Velcro USA, Inc., Manchester, NH). The seams facilitate the donning of the patient who often may be unable to assist. The seams can be partially opened and resealed for the 30 insertion of the patient or introduction of tubes, conduits or other equipment as 94/05238 2 1 ~ 3 ~ ~ ~ PCI/US93/08133 ~
needed. The seams preferably conform or mold to the shape and size of tubes and conduits and they may be further sealed, if needed, with pressure sensitive adhesive strips or tapes.
The enclosure can include a mattress portion to support the patient 5 within the enclosure. The inflated mattress portion will take on a shape similar to that of an inflated raft to allow the flow of conditioned air around the entire body of the patient.
One or more compartments or areas can be opened to permit a full range of surgical procedures. It is desirable to limit heat or cooling losses to such 10 open areas. This is accomplished by providing separate adhesive seals on the inner surfaces of each compartment boundary which directly contact the patient to demarcate and seal air flow to and from that compartment. Compartments on either side of the surgical field can be connected to an external heating or cooling system for circulating and controlling heated or cooled air. Known two piece 15 compression grommets can be attached to any location on the enclosure. Tubingfrom external air conditioning and circulating devices can be connected to one or more of the compartments. The portion of the enclosure encircled by the grommet can be cut away to access the compartments prior to connecting the tubing to thegrommet. The grommets can likewise be used as exhaust ports which can be 20 connected to one or more of the compartments. Other hose attachment fastenerscan be used instead of two piece grommets including an adhesive connecting hose device, a vacuum bag device connector or a slit next to the seal in the heater tube.
A moisture absorbent material or desiccant can be incorporated in the suit, hoses, connecting device or temperature control unit to retard the 25 accumulation of moisture and/or the heating or cooling air can be dehumidified.
The body enclosure can be completely transparent to allow vis~li7~tion of the entire body to permit continual inspection, monitoring and evaluation of the patient.
Grounding plates can be built into the enclosure, especially at the end of an extremity compartment to allow grounding of one of more electrocautery devices 30 or for any other reason. Sensors for monitoring the patient can be directly attached WO 94/05238 PCI/US93/08133 ~
to or incorporated into the enclosure. For example, a heat sensor may be used tomonitor the temperature of the enclosure or the temperature of the patient. These sensors can be used in a feedback loop to automatically control the heating or cooling system and the temperature of the enclosure or the patient.
In its broadest expression, tne present invention is an encasement for the body of a surgical patient for reducing or increasing heat loss and comprises a suit of a substantially gas impermeable flexible sheet material, sized to encompass the parts of a human body and having a longitudinally oriented separable seam substantially over the length of each part of the body.
Preferably the suit has an opening at one end allowing the head to extend therethrough and has arm elements. It may also have separate or integral leg elements. The leg elements need not have seams but if there are arm elementsit is preferred that they have longitudinal seams along the length thereof.
In a preferred embodiment, this invention is a body enclosure or suit having several compartments, each of which comprises a flexible sheet and has a re-openable seam for access to the compartment. The seams comprise pressure sensitive adhesive strips or hook and loop (VELCROn') fasteners along the lengthof the seam. While the seam can be overlapping and lie flat, alternatively the fastening material can be on the inner facing sides of the seam, such that when the two sides of the seams are joined, the seam is upstanding from the plane of the sheets. It is usually not necessary to have the seams absolutely airtight. The compartments of the enclosure can include head, arms, legs and abdominal/thoracic (torso) parts.
The body enclosure can have other pressure sensitive internal or external adhesive strips adjacent to compartment junctures adapted to seal the enclosure to the body to inhibit air flow to and from compartments. When an extremity compartment is removed, as for example, to operate on a thigh, or whena portion of a compartment is cut away for exposure of the surgical field, external pressured sensitive strips can be applied to seal the edges to maintain the circulation of heated or cooled air within the suit enclosure and to prevent the ~ 0 94/05238 2 ~ ~ ~ g ~ 2 PC~r/US93/08133 heated or cooled air from circulating over the sterile surgical field. Alternatively, the surgeon may tape the edges of the cut suit directly to the body of the patient, with a tape that is typically available in the operating room.
- The suit enclosure is preferably made of a substantially gas 5 impermeable plastic sheet such as of PVC, polyethylene, polypropylene or PTFE.Sheet rubbers such as a neoprene can be used, as well as, plastic coated paper or cloth. The surface of the plastic sheets can be embossed or treated by diamonding to prevent the skin from sticking to the sheets by allowing air under the skin. The plastic sheets can also be oriented to make the sheets flexible or soft.
When the seams are upstanding as above described, a particular advantage of the present invention is that the parts of the enclosure can be cutfrom flat stock. The adhesive strips, if required, for the seam are all on only one side and are applied before or after cutting of the sheets. Release strips are placed over the adhesive seams. The enclosure can then be folded and/or stacked flat for shipping and storage. Thus, only a minimal storage space is required for the stacked enclosures. Four sizes will usually be stocked: infant, small or young adult, regular adult and extra large adult, although additional sizes can be made as need be, alternatively an adjustable size can be used.
Brief Description of the Drawings In the drawings, like reference numerals designate like items throughout the several views, in which:
Figure 1 is a front elevational view, somewhat schematic, of a suit enclosure according to this invention;
Figure 2 is a fragmentary sectional view of the head element taken along the line 2-2 in Figure 1;
Figure 3 is a fragmentary sectional view of a portion of a foot element taken along the line 3-3 in Figure 1;
Figure 4 is a fragmentary sectional view of a longitudinal oriented separable seam within one compartment taken along the line 4-4 in Figure 1;
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Figure 5 is a transverse oriented seam joining one compartment to another taken along the line 5-5 in Figure 1;
Figures 6A and 6B are functional block diagram of two types of air heating units shown attached to an arm and leg compartrnent of the suit enclosure 5 of Figure 1;
Figures 7A and 7B are side and perspective views of an adhesive connecting hose device adapted to connect to the elements of the suit enclosure of Figure 1;
Figure 8 is a front elevation view of the suit enclosure including air 10 inlet portals according to the invention;
Figure 9 is front elevation view of the suit enclosure set-up for performing an abdominal operation according to the invention;
Figure 10 is a front elevation view of the suit enclosure set up for performing a groin operation according to the invention;
Figure 11 is a front elevation view of the suit enclosure, including air exhaust portals according to the invention;
Figure 12 is a perspective view of a suit enclosure according to a second embodiment of the present invention;
Figure 13 is a schematic front elevation view of a first sheet of the second embodiment of a suit enclosure according to the present invention;
Figure 14 is a schematic front elevation view of a second sheet of the suit of Fig. 12 enclosure according to the present invention;
Figure 15 is a schematic front elevation view of a third sheet of the suit enclosure of Fig. 12 according to the present invention;
Figure 16 is a partial cross sectional view of a mattress portion of the suit enclosure taken along line 16-16 of Fig. 12 according to the present invention;
and Figure 17 is an exploded perspective view showing the longitudinal seam of the suit enclosure taken along line 17-17 of Fig. 12 according to the 30 present invention.
~14~2~
0 94/05238 PC~r/US93/08133 Detailed Descri~.lion of tlle P~efer,ed Embodiment of the Invention In accordance with the present invention an enclosure or suit 10, is formed of a flexible plastic sheet such as a PVC, polyethylene or polypropylene sheet. Thickness of 0.01 to 1.0 mm are generally suitable although other 5 thicknesses can be used. Where maximum transparency is not required, some or all of the components can be made from fibrous materials or a metalized plastic.The body enclosure includes a head element 1 1, left and right arm elements 12 and 13, respectively, thoracic/abdominal elements 14 and 15, respectively, and left and right leg elements 16 and 17, respectively.
Each element includes a longitudinal separable seam which enables the element to be placed about a part of the body of a patient and then resealed to encase that body part. For example, leg element 16 has longitudinal seam 38 and thoracic/abdominal elements 14 and 15, respectively, have longitudinal seams 33 and 37, respectively. These seams correspond to the seam 31 illustrated in Figure 15 4. Each portion of the element 1 3A and 1 3B also can include an edge area having separable means 24, 23 respectively, for connecting with a corresponding area onan adjacent portion of an element whereby each element can be fully assembled.
Similarly each element includes a transverse separable seam which enables adjacent elements to join together. For example, leg element 16 connects with abdominal 20 element 15 at transverse seam 36 and arm element 13 connects to element 14 atlongitudinal seam 32. All the transverse seams 26, 35, and 36 are constructed inthe same manner as the longitudinal seams 29, 31, 32, 33, 37 and 38. For example, the construction of transverse seam 36 of Figure 5 corresponds to the construction of seam 31 of Figure 4 except for the sealing strips discussed below.
25 Referring now to Figure 5, each element can additionally be provided adjacent its connecting edge area at transverse seams such as 35 and 36 with pressure sensitive adhesive strips 50, 53 for sealing to the body at that point. Such pressure sensitive strips 50, 53 are indicated next to the transverse seams 26, 35 and 36 by dotted areas in Fig. 9. Alternatively, the suit 10 may not be provided30 with strips 50, 53, and the surgeon, or other personnel may tape the exposed 2~3~ PCr/US93/08133 ~
edges of the suit directly to the body with tape that is typically available in the preparation or operating room.
The pressure sensitive adhesive strips 50, 53 are protected by a release paper or the like 54, 55, (See Fig. 5) respectively, in a known manner prior 5 to use. It is preferable to have the pressure sensitive adhesive strip on both sides of a seam although it can be used on only one side or may not be used at all.
Although contact adhesive strips can be used for the seams, it is preferable to use VELCROrM closures for the seams, particularly the major ones such as seams 20, 33 and 37. Rather than have each of the elements 1 1, 12, 13, 14, 15, 16 and 17 10 supplied separately and then assembled on the patient, it is preferred to have the enclosure 10 supplied as a single, complete enclosure. To this end, all of the elements can be cut from flat strips as a single enclosure, or the elements such as 12 and 16 may be separately cut from a flat stock and then have the pressure sensitive and VELCR0~ strips attached thereafter, or they can be permanently 1 5 attached to the thora. cic/abdominal unit 14 and 15 on the underside of the enclosure 10 as by a simple overlapping seam (not shown); this seam can be adhesively or heat welded in a known manner.
Depending on the particular design and considering the cost of waste material in some instances a more complete enclosure can be die cut from the 20 plastic film. For example, head element 11 can be integrated and cut with the main body element 14 and 15, leaving just the arm and leg units to be attached. In addition, the head, arm and leg units can alternately be made as a unitary one piece enclosure.
Referring to Figure 2, the seam of head element 11 is shown in 25 traverse view as 20, and this seam 20 is also constructed; in the same manner as seam 31 illustrated in Figure 4. The seam 31 consists of the two edgcs of the plastic sheets 1 3A and 1 3B each of which have in this case contact adhesive strips 23 and 24. These are turned upright as shown and brought into contact to make the seal.
2~4~2~
~0 94/05238 PCr/US93/08133 Turning to Figure 5, the element joining seams 36, having adhesive strips 23 and 24 attached to plastic sheets 18 and 19 and may be closed in a similar manner. These seams, in addition, have body contacting adhesive strips 50 and 53 on the underside as previously discussed.
Elements 16 and 17 are symmetrical as are elements 12 and 13 so that only one die is needed for each pair.
When the patient has been positioned on the open body enclosure 10, the seams are joined by bringing the edges of the element up and around the patient and gently pressing them together. Of course, when pressure sensitive adhesive strips are used, the elements are joined one to another by bringing their edges together only after exposing the adhesive layer thereunder by removing itsrelease paper. Also, if the underlying body contacting strip is to be sealed to the patient, its release paper is removed prior to closing the seam.
When it is desired to supply heated or cooled gas or air to the body enclosure 10, this is accomplished simply by closing a seam around an inlet tube(not shown) or as described in more detail infra. Such tube can also be used as an outlet tube. The tube could also be placed in one of the arm elements, leg elements, or other compartments as shown in Figure 8. The gas is allowed to exhaust at any point therein by simply incorporating exit tubes at such point asshown in Figure 11, or leaving the seam closed or partially open. Examples of the location of portals formed merely by closing a seam around an inlet/outlet tube are portals S1 and S2 and are shown in Figures 8-11. In addition, the VELCR0 closures permit air to escape. A more secure air inlet/exit arrangement comparedto simply closing the seam around an inlet tube is constructed of grommets (not shown) or utilize hose attachment devices as shown in Figs. 6A and 6B (and described in more detail infra) which can be attached to any area of the enclosure.
Following the closure of a two piece grommet, the enclosure spanning the eyelet opening is cut away to open the portal thus allowing the air or gas supplied by inlet line to pass into the enclosure 10. Similarly, exhaust ports can be attached at any - 30 point as shown in Figure 10. It may be desirable to have one or multiple 2~
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connections to an air/heating or cooling unit 100 as shown in Figs. 6A and 6B and described in detail infra, for the purposes of heating or cooling and dehumidifying, especially when suit compartments are isolated from one another by an intervening surgical field. Parameter sensors, such as, temperature and dehumidifying sensitive 5 recording materials or sensors can be constructed within or on the outside of the suit enclosure as shown in Figs. 6A and 6B and described in more detail infra. The suit enclosure 10 can be constructed of a single layer of material or multiple layers with intervening air pockets for insulation and padding; e.g., the familiar air bubble type of insulation. While it is preferred that an element or compartment may be left 10 off in order to expose the surgical field as shown in Figures 9 and 10 and described in detail infra, the plastic sheeting can also be cut away to expose the surgical field and the cut edges sealed to the body with an externally applied adhesive strip or tape, if a pre-existing seam is not available. Thoraciclabdominal unit 14, and 15 can have a body contact adhesive strip 50 (see Figure 5) which can be used to seal 15 against the patient if, for example, the thoracic or the abdominal area has to be exposed. These seams or external adhesives serve the purpose of sealing against the passage of air from each individual element or compartment not involved in the surgical procedure. Thus, the convection between areas enclosed by the individual elements is effectively prevented and heat or cooling losses will be confined to20 those areas which cannot otherwise be effectively sealed.
Two different types of air heating or cooling units can be utilized. The first is an air heating or cooling device that is used for compressed air lines that are available in operating rooms. In operating rooms without compressed air availability or in other areas of the hospital without compressed air availability (e.g. recovery 25 rooms, intensive care units, emergency rooms), a free standing heating or cooling unit is used.
A heating or cooling unit for compressed air, generally designated by numeral 100, is illustrated in Figure 6A. The unit 100 comprises an electricallyoperated heater or cooler unit 101 with multi-ported heated or cooled air outlets 30 103 and parameter sensing means, or remote temperature sensing means, or ~1~3~
0 94/05238 PC~r/US93/08133 sensors 105, on or within the suit 10 and/or on the patient (not shown) are used.
The heating or cooling unit 101 contains a conventional regulator and valve system 107 that is attached in-line to a compressed air source 109. This system 107 provides for the control of air flow through the heater or cooler unit 101. The 5 heater or cooler unit 101 has a conventional temperature control section or means 108 and conventional air flow control means 112 comprising individual, flow controls 111 for final output control of air flowing into multiple input portals (up to about nine) disposed on the suit 10 connected through tubing conduits 1 15 to the suit 10. The temperature control section 108 can include a plurality of separate10 temperature control units connected to the plurality of flow controls 1 1 1, so that the temperature of the air flowing through each of these units can be individually controlled, if desired. The final range of heat or cooling output (temperature and air flow) is modified depending on the volume of the particular compartment(s) being heated or cooled. An additional parameter sensing means or safety sensor(s) 15 or temperature sensing means 1 17 is placed in the tubing conduits just downstream of the heating or cooling device 101. This safety sensor(s) 1 17 provides a signal to automatically regulate or cut off the heat or cool air generated to prevent overheating or overcooling of the patient.
The heating or cooling unit 101 can include two methods of controlling 20 air flow and temperature. The first can be controlled automatically and utilizes a feedback loop 1 19 coupled to a conventional control system 121 which is coupledto the heating or cooling device 101 from remote sensor(s) 105. These remote sensor(s) 105 may be within the patient (e.g., internal rectal or esophageal thermosensors for determining core temperature), on the skin of the patient, and/or 25 on or within the suit 10 as shown. The control system 121 is also used to automatically control the heating or cooling device 101 to prevent hypothermia or hyperthermia, respectively. The second method utilizes a manual control system 131 regulated by operating room personnel (anesthesiologists, nurses, surgeons).Both the manual and automatic systems include the downstream safety sensor(s) 30 1 17 which provides regulatory or cut off capabilities described supra.
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Referring now to Figure 6B, the heating or cooling unit 101 can have multiple air outlet port capability so that from one to about nine tube conduits can be connected to heat or cool one or more compartments of internal heating tubes 246 of Figure 13 of the unit 10 at any given time. A conventional output port control system is incorporated in the heating or cooling device 101 to regulate the number of output ports that are functional at any given time. This port control may be as simple as individual on-off valves at each output connector, or as complexas independent regulatory devices to adjust the rate and volume of heated or cooled air flow delivered to an individual compartment of the suit 10 based on the individual volume and location of that compartment on the patient (i.e., heating or cooling the thorax or abdomen may have different requirements, than heating or cooling an arm or leg, based on body surface area to mass ratios).
The second type of air heating or cooling unit is a free standing heating or cooling unit that utilizes ambient air. All of the features describedpreviously, except that the source of air will be ambient through an electrically operated air blower that has controls to adjust cubic feet per minute of air flow volume. As described previously the air flow can be controlled automatically through feedback from sensing devices, by manual controls or even utilize both methods.
An alternative to the grommet system used as a hose attachment described previously is an adhesive connecting hose device 141 (Figs. 7A & 7B).
The flat lower surface 143 of the washer portion 145 of the connecting device 141 has an adhesive 147 affixed to surface 143 that is protected by a release paper 149. These adhesive connecting devices 141 are attached to different areas of the suit 10 depending on the type of operation performed. The central area of the suit surrounded by the washer portion 145 of the connecting device 141 are cut away or punched out after they are adhesively affixed to the upper surface of the suit 10, to allow airflow into the suit 10. The suit 10 also has partially perforated portals A through I on predetermined areas of the suit to facilitate attachment of the adhesive connecting devices 141, and "punching out" a hole therethrough for the 94/05238 2 1 ~ ~ 5 ~ 2 PC~r/US93/08133 ~0 entry of air. Such portals are shown in Figure 8 and described in detail infra.
Another alternative hose attachment means include a device that would punch the resulting hole(s) in the suit 10 at the same time (a "jack" type attachment). Each of these aforementioned hose attachment devices have a pressure sensitive fitting 5 that inserts into one end of the hose, that is attached to the air heating units previously described.
Referring now to Figure 8, the particular location of partially perforated air inlet portals A-l for hose connecting devices, used with such type of air inlet portals, are determined by the use of the suit 10 for standard or commonly 10 performed operating (i.e., universal applications of the suit). However, in the case of an unusual application of the suit 10, hose attachments can be made to any area of the suit 10 that is required. These latter areas will now have the partially perforated portals described previously.
Referring again to Figure 8, nine partially perforated inlet portals A-l 15 are provided in the suit for conventional hose attachments. Portal A is located on the head compartment 11, portals B and C on the shoulder areas of the thoracic compartment 14, portals D and E on the anterolateral sides of the abdominal compartment 15, portals F and G on each of the arm compartments 12, 13, respectively, and portals H and I on each of the leg compartments 16, 17, 20 respectively.
If for example, an abdominal operation is to be performed, there would be three areas of the suit 10 attached to three hoses from the heating or cooling unit (Figure 9). Each leg compartment 16, 17 sealed to the patient at transverseseam 36, is independently attached to the heating unit at portals H and 1, 25 respectively. The upper portion of the suit 10, sealed to the patient at seam 35, may be attached to a single heater hose at portal B. This upper portion of the suit comprising the head, thoracic and arm compartments 1 1, 14, 12 and 13, respectively, may be heated as a single unit. Additional heater or cooler hoses can be attached to arm or head portals 12, 13, 11 respectively, to increase the heated 30 or cooled air flow to this upper unit as needed.
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If for example a groin operation is to be performed, one leg 17, and one-half of the abdominal portions 15B of the suit 10 would be removed (Figure 10). The patient is then sealed to the suit 10 at seams 35 and 37. The remainderof the suit would be heated through portals F, G and H for operations resulting in 5 mild degrees of hypothermia. Additional portals could be used for longer operations or situations predisposing to more severe hypothermia. The number of heating portals used would be an additional factor in regulating the amount of heat delivered to the patient.
In a situation predisposed to severe hypothermia, with the additional 10 problem of the need for a large surface area of the patient to be exposed to the operating field (e.g., an abdominal and lower extremity bypass requiring the abdomen and both legs to be in the operative filed), only the head, arm and thoracic compartments 1 1, 12, 13, 14, respectively, would be available to deliver heated air to the patient. In this situation all five available ports A, B, C, F, and G, 15 would be utilized simultaneously. Since drapes used to cover the patient havesubstantial weight, the use of all such five portals may be necessary to increase the surface contact of heated air with the patient.
One possible anticipated finding may be that the suit 10 functions better by using all the portals available in every compartment, with or without 20 separating the co, "~a, Il, ,ents by the adhesive strips 50, 53 attached to the patient.
Exhaust of air from the exhaust portals J-Q of the suit 10, as briefly described previously, can be simply accomplished by merely incorporating exit tubes or just leaving the VELCRO~ separating means 23, 24 partially open, or leaving the seam closed and allowing air to exit through the closed VELCROm seal.
25 If adhesive is used to seal the longitudinal seams, then exhaust ports for the escape of air will be necessary. These exhaust ports, J-Q, like the input portals A-l, can be partially perforated portals located in areas of each compartment as shown inFigure 11, such that they maximize airflow in contact with the patient's body surface .
2143~2 0 94/05238 PC~r/US93/08133 The inlet portals A-l are preferably disposed on the suit 10, so as to use the shortest lengths of hoses, to increase conduction heating and cooling ofthe suit 10 thereby maximizing heating and cooling. The location of the portal also improves the efficiency and convenience of hose placement for operating room 5 personnel.
Drying or desiccating agents such as calcium chloride can be incorporated within areas on the inner surface of the suit 10, within the tubingconnecting the air heating or cooling unit to the inlet portals, on the air inlets to the air heating or cooling unit, or within the hose attachment devices. The hose 10 attachment devices can likewise be attached at an exhaust portal to increase the drying capabilities of the suit. Drying or desiccating agents associated with the suit or hose attachment devices would also be discarded with the suit. Drying or desiccating agents associated with the heater can be compartmentalized to permitchanging and refilling of these compartments with drying agents.
Normally, the head compartment will be left open and sealed to the neck with adhesive strips. Once the patient is anesthetized and with the anesthesia and monitoring equipment leads and tubes in place, the head compartment can then be closed about the surface of the communicating tubes.
The suit enclosure 10 can, of course, be manufactured and sold without the head 20 element, leaving the user to insulate or heat the head by other means.
During the course of a surgical procedure, convection loss will occur only from the compartments which are open for access to the surgical field.
Radiation loss will be reduced depending upon the heat reflecting capability of the material from which the suit enclosure 10 is formed. In the case of metalized sheet 25 material, the reduction of radiant heat loss may be greater than with clear plastic material. The plastic material can be lightly reflectively coated on the inner or outer surfaces so as not to unduly reduce transparency.
As previously noted, the device can be manufactured in a relatively small number of sizes; e.g. four, as close fitting is not required. It can be made and 30 shipped flat with the adhesive strips thereon being only on one side and overlaid WO 94/05238 ~ PCr/US93/08133 ~
with a removable release sheet. The patient can be placed in the suit enclosure or removed from the enclosure by opening some or all of the seams. Normally, the suit enclosure will not be reused as its low cost does not justify attempting to clean and reuse the suit enclosure.
Reference is now made to Figs. 12-17 where a second illustrative embodirnent of the body enclosure or suit 200 is shown. The body enclosure 200 includes a head element 21 1, left and right arm elements 212 and 213, respectively, thoracic/abdominal elements 214 and 21 5, respectively, and left and right leg elements 216 and 217, respectively. In the preferred embodiment, the enclosure 200 is assembled as a unitary or integral assembly that is manufactured by sealing together three planer sheets of plastic material 226, 240 and 260 (Fig.
13-15). The three sheets 226, 240 and 260 are made from a material that is substantially impermeable to gas or air. Likewise, the seals between each sheet are also substantially impermeable to air. The body enclosures 10, 200 are each symmetrical about a vertical axis.
A heater/blower assembly 220 provides a flow of heated or cooled air or gas through a pair of connecting hoses 222 to the interior of the enclosure thereby controlling the temperature of the patient. As used herein "conditioned air"
encompasses a heated or cooled air or gas. The heater/blower assembly 220 controls the temperature of the gas exiting from the assembly 220 within a predetermined range. Accordingly, the temperature of the air exiting the assembly 220 is monitored by a conventional feed-back control system (not shown) to regulate the temperature of the air exiting the heater/blower assembly 220. The conditioned air enters the enclosure, in a manner to be described below, and passes over that much of the body portion of the patient that is enclosed by enclosure 200. The conditioned air then exits from the enclosure through a passage in the longitudinal seam 224.
The body enclosure 200 is made from three sheets of substantially planer plastic or other flexible material. The first or bottommost sheet 226, which is shown in Fig. 13, has an outer perimeter edge 228 defining leg, ~ O 94/05238 2 1 ~ ~ 6 ~i ~ PC~r/US93/08133 thoracic/abdominal, arm and head portions of the body enclosure 200. A pair of strips 232 of plastic material are sealed to the first sheet 226 such that the plastic strips 232 are below the first sheet 226. The strips of plastic 232 each include a through hole 234 at each end to allow the strips of plastic to be used as handles for carrying the body enclosure. The first sheet 226 is designed to be the same length as the second and third sheets 240, 260, such that an extension 270, 272 of all three sheets extend beyond the head portion and the foot portion. The extension 270 includes a hole 274, and the extension 272 includes a pair of holes 276, to allow the extensions 270, 272 to be used as handles for carrying the body enclosure.
The seals between the sheets of plastic material are preferably made by radio frequency (RF) sealing, although other types of sealing such as heat sealing or laser sealing may be used, if desired. However, whichever sealing method is employed, the resulting seal must be substantially impermeable to gas or air and have sufficient strength to maintain the seal's i"Legril~ during normal use.
The first sheet 226 is sealed to the second sheet 240 (see also Fig.
14) along the entire outer perimeter of the first and second sheets 226, 240 as indicated by seal areas 230. The first sheet 226 is additionally sealed to the second sheet 240 along a plurality of discreet interior seal lines 238 that are located within their respective outer perimeters. The plurality of discreet seal lines 238 form a plurality of spaced passageways between the first and second sheets 226, 240. The first sheet 226 also includes a pair of openings 242, forming heater hose ports, to allow conditioned air to enter into the enclosure from the hoses 222 of the heater/blower assembly. The hoses 222 are connected to the first sheet onthe lower surface, that is, the surface opposite to the second sheet 240. The hoses 222 are sealed to the first sheet 226 by a manner known in the art. For example, a "vacuum cleaner" type connection between the hose 222 and the heater hose port 242 can be used. Alternatively, a slit may be cut in the heatertube 246 and the hose 222 may be inserted into the slit. If this type of connection - 30 is used, a connecter placed within the heater tube 246 will facilitate securing hose W O 94/05238 ~3~ PC~r/US93/08133 ~
222 to the heater tube 246. A third set of openings 244, forming a mattress inflation/deflation port, are located in the head, arm and leg portion of the first sheet 226. The port 244 is used to inflate/deflate a mattress portion that is disposed between the first and second sheet. The mattress portion is preferably 5 inflated with gas or air (e.g., by a C02 cartridge), which is typically at room temperature or lower. The heater/blower assembly may be run prior to insertion of a patient to allow the temperature of the gas or air within the mattress portion to be within the same range as the air entering the enclosure.
Fig. 14 shows the second or middle sheet 240 and the common seal 10 lines with respect to the first sheet 226. The space between the first and second sheet 226, 240 includes a mattress portion 248, a heater tube portion 246, and a spinal access panel 250. The mattress portion 248, the heater tube portion 246, and the spinal access panel 250 are separately disposed between the first and second sheets and do not communicate with one another. Accordingly, the 15 mattress portion 248 is inflated and deflated via the port 244. Each heater tube portion 248 receives conditioned air from inlets 242.
The second sheet 240 includes plurality of heater outlet ports 252 located within the heater tube portion 246. The conditioned air entering the heater hose portion 246 from inlet 242 is distributed to the patient by the plurality of 20 heater outlet ports 252. The heater tube is shaped such that the flow of conditioned air is substantially uniform throughout the enclosure. To this extent, each heater tube has two branches 246a and 246b near the arm portion to evenly distribute the conditioned air to the arms and to the head and neck portion of the patient. In this regard, a sealed line 254 splits the heater tube into two and is 25 designed to direct the conditioned air evenly between the arm portions and the head and neck portions of the enclosure.
The first and second sheets 226, 240 are also provided with a spinal access panel 250. The spinal access panel 250 allows access to the spinal area of the patient. To access the spinal area, the surgeon can cut out the desired area 30 in the spinal access panel 250 of the first and second sheets 226, 240. If desired, ~O 94/05238 2 ~ ~ 3 ~ ~ ~ PCI/US93/08133 the cut edges of these sheets can be taped directly to the body. The surgeon canthus treat the spinal area by, for example, administering an epidural to the patient.
Hence, the spinal area can be accessed without compromising the integrity of theinflated area of the mattress portion 248.
The first sheet 226 is sealed to the second and third sheet 260 (see also Fig. 15) along the entire outer perimeter of the sheets 226, 260 as indicated by seal lines 2Z8 and 236. As shown, the seal line 230 between the first sheet 226 and the second sheet 240 is adjacent to and within the outer perimeter seal line 236. The third sheet 260 has a longitudinal seam 224, similar to seam 24 described above, that is preferably made from a hook and loop type fastener (i.e., a VELCRO~ fastener).
Referring now to Fig. 17, the longitudinal seam 224 is shown in sectional detail. The seam 224 includes a pair of L-shaped brackets 262 that aresealed to a first end 265 and a second end 267 of the third sheet 260. The hook and loop type fastener 264 is attached to the upstanding portions 263 of the L-shaped brackets 262. The L-shaped brackets 262 are preferably made of a more rigid plastic material than the plastic material of the third sheet 260. Thus, the user can easily grab the upstanding portion 263 of the brackets 262 to effectively open or close the longitudinal seam 224. Preferably, a hook and loop type fastener system is used to allow the conditioned air in the enclosure to exit therefrom along the entire seam length. However, any type of fastener system may be used as longas a passage exists between the first and second ends 265, 267 of the third sheet 260 to allow conditioned air to exit from the enclosure regardless of whether the seam is in the open or closed position. Additionally, exhaust portals within thethird sheet may be used as in the suit enclosure shown in Figs. 1-11.
Referring now to Fig. 16, the mattress portion 248 is shown in sectional detail. Once the mattress portion is inflated through the inflation port 244, the mattress portion takes on a shape similar to that of an inflatable raft. The patient will be supported on a plurality of spaced projections 266 on the secondsheet 240. Thus, there will be a gap 249 between each projection 266 of the -W094/05238 ~ PCr/US93/08133 ~
second sheet and underneath the body of the patient to form a through passageway between the second sheet 240 and the body for the conditioned air.
Furthermore, the conditioned air entering the portion of the suit housing the patient, located between the second and third sheets 240, 260, will flow totally around the 5 patient to transfer heat either to or away from the patient, as desired. The heater outlet ports 252 are designed in association with the discreet seams 238, which form the mattress portion 248, to encourage the flow of conditioned air around the entire body of the patient. Of course, the discreet seams 238 could be designed differently then as exemplified as transverse seams in the drawings. For example, 10 the seams 238 in the head or other portions could be oriented longitudinally. The seams 238 could extend to seal line 230. Additionally, the seams 238 could be curvalinear or circular.
The mattress portion 248 effectively holds the patient away from the operating table and thus significantly reduces, if not eliminates, conduction heat 15 losses due to direct contact with the operating table. In addition, the mattress portion 248 reduces the risk of injury (e.g., pressure sores) to pressure sensitive areas, such as the ankles, heel and sacrum, by providing a cushioned surface between the tissue and the operating table.
The body suit is thus assembled from three sheets of substantially 20 planer gas impermeable material. During use, it is preferred to first inflate the mattress portion 248, via inflation ports 244, prior to placing a patient within the enclosure. Once the mattress portion is filled, preferably with conditioned gas (CO2) or air, the inflation ports 244 is closed. At this point, the patient is placed within the enclosure, i.e., on top of the second sheet 240 and below the third 25 sheet 260. The heater/blower assembly then starts blowing conditioned air into the enclosure via tubes 222. The conditioned air enters the heater tube portion located between the first and second sheets 226, 240 and is then distributed to the enclosure between the second and third sheet 240, 260, via the heater outlet ports 252. The air flows completely around the different portions of the body through 30 the plurality of passageways (249) underneath the body, i.e., between the body 094/05238 ~ 1 4 ~ ~ ~ 2 PCT/US93/08133 and adjacent projections 266 of the mattress portion 248. The conditioned air will eventually flow out of the enclosure through the longitudinal seam 224 regardless of whether the seam is in the open or the closed position.
The transverse seams 238 which, in part, forms the mattress portion help create the conditioned air flow below the body. The mattress portion 248 also includes a plurality of longitudinal passageways 251 and longitudinal seams238 (e.g., the seam separating the leg portions) adjacent to the ends of the transverse seams 238. The longitudinal passageways 251 and seams help prevent curling and/or shortening of the suit. Without these longitudinal passageways 251 and seams, the suit would have a tendency to curl and shorten in length. The longitudinal passageways 251 also aid in inflating/deflating the mattress portion 248 by allowing the gas to readily access the entire mattress portion.
Once the patient is placed within the suit enclosure and the conditioned air from the heater/blower assembly 220 is running at a steady state, the patient can be anesthetized. At this time, it is preferred that all of the longitudinal seams 224 be closed except those in the head portion of the suit.
Once the patient is fully anesthetized, the suit can be totally closed by closing the seal 224 about the anesthesia tube or tubes.
The surgeon can now access whatever area of the body enclosure that is necessary to perform the operation. The surgeon will simply cut out the desired area from the third sheet 260 (see Fig. 12) even cutting through the longitudinal seam 224, if necessary. The cut edges of the third sheet 260 can be taped directly to the body to effectively prevent the conditioned air within the enclosure fromexiting in the area of the cut. The surgeon will then typically place towels around the area of the third sheet 260 that has been cut and taped. An iodine impregnated surgical drape, such as a commercially available STERI DRAPE~, can then be placed over the entire cut opening. The operation can thus proceed in a manner known in the art.
If at any time it is necessary to deflate the mattress portion 248 - 30 quickly, the inflation/deflation port 244 simply needs to be opened. The port 244 W O 94/0523~ ~ 4~6~ PC~r/US93/08133 ~
is sized to allow the mattress portion 248 to deflate quickly in the case of an emergency, e.g., in the case that CPR needs to be performed on the patient.
Air inflatable compression segments for intermittently compressing the calves of the patient may be incorporated into the leg compartrnents of the 5 enclosure. These intermittent compressions will prevent clots from forming inside the deep veins of the legs.
Sensors for monitoring the patient can be directly attached to or incorporated into the enclosure. The sensors can be heat sensors to monitor the temperature of the enclosure or the temperature of the patient. These sensors can 10 be used in the feedback control system to automatically control the enclosure of the patient.
From the foregoing description, it will be appreciated that the present invention makes available a body suit that is easy to manufacture at a cost effective price. An embodiment of the body suit has flow channels beneath the 15 body to improve the convection surface area of the body.
Having described the presently preferred embodiment of a new and improved body enclosure in accordance with the present invention, it is believedthat other modifications, variations, and changes will be suggested to those skilled in the art in view of the teachings set forth herein. It is therefore to be understood 20 that all such variations, modifications, and changes are believed to fall within the scope of the present invention as defined by the appended claims.
Field Of The Invention The present invention relates to the field of surgery and medicine and more particularly, to an improved enclosure for the body of a patient to reduce or 15 increase the loss of body heat during the course of or because of a surgical procedure, trauma, sepsis, prolonged cold exposure, hyperthermia, malignant hyperthermia, or neonatal hypothermia. The present invention also relates to an improved enclosure having a mattress portion to encourage flow of conditioned air around the entire body of the patient.
Background of the Invention Hypothermia, which may be defined as body temperature below 36C
occurs for a variety of reasons during surgery. The ability of a patient to conserve heat and vary heat production during surgery and post operatively is disturbed by 25 both anesthesia and exposure of the patient to the operating room environment.
This loss of body heat occurs by conduction, evaporation, convection and radiation.
Metabolic heat production by an anesthetized adult patient approximates 60-70K
calories per hour. Conduction to the operating table and surgical drapes accountfor less than 10% of heat loss. Evaporation loss occurs from exhaled air and from 30 exposed body cavities, and amounts to roughly 25K calories per hour. Variations in anesthesia circuitry including low flow systems, closed circuits, to and fromsystems and heat humidifiers can reduce evaporation losses to 10-1 5K calories per hour. Convection losses are naturally dependent upon ambient temperature. At 21 C, the patient loses approximately 80K calories per hour which in itself is W O 94/05Z38 PC~r/US93/08133 ~
greater than the amount of heat the patient can produce over a like period. In addition, radiant heat loss is approximately 100K calories per hour.
Additional causes of hypothermia include cold exposure, major trauma, massive blood transfusions, sepsis in elderly patients, prolonged periods of 5 unresponsiveness, maternal hypothermia and neonatal hypothermia in low birth weight infants.
Known methods used to reduce heat loss during and after a surgical procedure include heated and moisturized inhalation anesthetics, radiant heaters, warming blankets, reflecting blankets, warming of intravenous infusions and blood 10 transfusions and warm irrigation. It is also possible to increase arnbient temperature, but this may cause operating room personnel discomfort.
SummarY of the Invention The present invention is an enclosure for the body of a patient 15 undergoing a surgical procedure or one who develops hypothermia or hyperthermia for any reason. The present invention has non-medical uses, such as for use in the military, or to transport a patient, or for general outdoor use for those overexposed to the environment. This enclosure effectively reduces heat loss because of radiation and convection, the greatest sources of loss. It can also be used for heat 20 loss (cooling). This invention also includes a heating and cooling system for such an enclosure. As used hereinafter "heating system" encompasses both a system for cooling and/or heating air.
The enclosure is in the form of a suit that can be compartmentalized, transparent and adapted to enclose the arms, legs, thorax, abdomen, and in some 25 cases the head of a human body. Each of these compartments can be individually opened and closed by means of a seam joined by a pressure sensitive adhesive or hook and loop fastener (e.g., VELCR0~ - a trademark of Velcro USA, Inc., Manchester, NH). The seams facilitate the donning of the patient who often may be unable to assist. The seams can be partially opened and resealed for the 30 insertion of the patient or introduction of tubes, conduits or other equipment as 94/05238 2 1 ~ 3 ~ ~ ~ PCI/US93/08133 ~
needed. The seams preferably conform or mold to the shape and size of tubes and conduits and they may be further sealed, if needed, with pressure sensitive adhesive strips or tapes.
The enclosure can include a mattress portion to support the patient 5 within the enclosure. The inflated mattress portion will take on a shape similar to that of an inflated raft to allow the flow of conditioned air around the entire body of the patient.
One or more compartments or areas can be opened to permit a full range of surgical procedures. It is desirable to limit heat or cooling losses to such 10 open areas. This is accomplished by providing separate adhesive seals on the inner surfaces of each compartment boundary which directly contact the patient to demarcate and seal air flow to and from that compartment. Compartments on either side of the surgical field can be connected to an external heating or cooling system for circulating and controlling heated or cooled air. Known two piece 15 compression grommets can be attached to any location on the enclosure. Tubingfrom external air conditioning and circulating devices can be connected to one or more of the compartments. The portion of the enclosure encircled by the grommet can be cut away to access the compartments prior to connecting the tubing to thegrommet. The grommets can likewise be used as exhaust ports which can be 20 connected to one or more of the compartments. Other hose attachment fastenerscan be used instead of two piece grommets including an adhesive connecting hose device, a vacuum bag device connector or a slit next to the seal in the heater tube.
A moisture absorbent material or desiccant can be incorporated in the suit, hoses, connecting device or temperature control unit to retard the 25 accumulation of moisture and/or the heating or cooling air can be dehumidified.
The body enclosure can be completely transparent to allow vis~li7~tion of the entire body to permit continual inspection, monitoring and evaluation of the patient.
Grounding plates can be built into the enclosure, especially at the end of an extremity compartment to allow grounding of one of more electrocautery devices 30 or for any other reason. Sensors for monitoring the patient can be directly attached WO 94/05238 PCI/US93/08133 ~
to or incorporated into the enclosure. For example, a heat sensor may be used tomonitor the temperature of the enclosure or the temperature of the patient. These sensors can be used in a feedback loop to automatically control the heating or cooling system and the temperature of the enclosure or the patient.
In its broadest expression, tne present invention is an encasement for the body of a surgical patient for reducing or increasing heat loss and comprises a suit of a substantially gas impermeable flexible sheet material, sized to encompass the parts of a human body and having a longitudinally oriented separable seam substantially over the length of each part of the body.
Preferably the suit has an opening at one end allowing the head to extend therethrough and has arm elements. It may also have separate or integral leg elements. The leg elements need not have seams but if there are arm elementsit is preferred that they have longitudinal seams along the length thereof.
In a preferred embodiment, this invention is a body enclosure or suit having several compartments, each of which comprises a flexible sheet and has a re-openable seam for access to the compartment. The seams comprise pressure sensitive adhesive strips or hook and loop (VELCROn') fasteners along the lengthof the seam. While the seam can be overlapping and lie flat, alternatively the fastening material can be on the inner facing sides of the seam, such that when the two sides of the seams are joined, the seam is upstanding from the plane of the sheets. It is usually not necessary to have the seams absolutely airtight. The compartments of the enclosure can include head, arms, legs and abdominal/thoracic (torso) parts.
The body enclosure can have other pressure sensitive internal or external adhesive strips adjacent to compartment junctures adapted to seal the enclosure to the body to inhibit air flow to and from compartments. When an extremity compartment is removed, as for example, to operate on a thigh, or whena portion of a compartment is cut away for exposure of the surgical field, external pressured sensitive strips can be applied to seal the edges to maintain the circulation of heated or cooled air within the suit enclosure and to prevent the ~ 0 94/05238 2 ~ ~ ~ g ~ 2 PC~r/US93/08133 heated or cooled air from circulating over the sterile surgical field. Alternatively, the surgeon may tape the edges of the cut suit directly to the body of the patient, with a tape that is typically available in the operating room.
- The suit enclosure is preferably made of a substantially gas 5 impermeable plastic sheet such as of PVC, polyethylene, polypropylene or PTFE.Sheet rubbers such as a neoprene can be used, as well as, plastic coated paper or cloth. The surface of the plastic sheets can be embossed or treated by diamonding to prevent the skin from sticking to the sheets by allowing air under the skin. The plastic sheets can also be oriented to make the sheets flexible or soft.
When the seams are upstanding as above described, a particular advantage of the present invention is that the parts of the enclosure can be cutfrom flat stock. The adhesive strips, if required, for the seam are all on only one side and are applied before or after cutting of the sheets. Release strips are placed over the adhesive seams. The enclosure can then be folded and/or stacked flat for shipping and storage. Thus, only a minimal storage space is required for the stacked enclosures. Four sizes will usually be stocked: infant, small or young adult, regular adult and extra large adult, although additional sizes can be made as need be, alternatively an adjustable size can be used.
Brief Description of the Drawings In the drawings, like reference numerals designate like items throughout the several views, in which:
Figure 1 is a front elevational view, somewhat schematic, of a suit enclosure according to this invention;
Figure 2 is a fragmentary sectional view of the head element taken along the line 2-2 in Figure 1;
Figure 3 is a fragmentary sectional view of a portion of a foot element taken along the line 3-3 in Figure 1;
Figure 4 is a fragmentary sectional view of a longitudinal oriented separable seam within one compartment taken along the line 4-4 in Figure 1;
6~2 W O 94/05238 PC~r/US93/08133 ~
Figure 5 is a transverse oriented seam joining one compartment to another taken along the line 5-5 in Figure 1;
Figures 6A and 6B are functional block diagram of two types of air heating units shown attached to an arm and leg compartrnent of the suit enclosure 5 of Figure 1;
Figures 7A and 7B are side and perspective views of an adhesive connecting hose device adapted to connect to the elements of the suit enclosure of Figure 1;
Figure 8 is a front elevation view of the suit enclosure including air 10 inlet portals according to the invention;
Figure 9 is front elevation view of the suit enclosure set-up for performing an abdominal operation according to the invention;
Figure 10 is a front elevation view of the suit enclosure set up for performing a groin operation according to the invention;
Figure 11 is a front elevation view of the suit enclosure, including air exhaust portals according to the invention;
Figure 12 is a perspective view of a suit enclosure according to a second embodiment of the present invention;
Figure 13 is a schematic front elevation view of a first sheet of the second embodiment of a suit enclosure according to the present invention;
Figure 14 is a schematic front elevation view of a second sheet of the suit of Fig. 12 enclosure according to the present invention;
Figure 15 is a schematic front elevation view of a third sheet of the suit enclosure of Fig. 12 according to the present invention;
Figure 16 is a partial cross sectional view of a mattress portion of the suit enclosure taken along line 16-16 of Fig. 12 according to the present invention;
and Figure 17 is an exploded perspective view showing the longitudinal seam of the suit enclosure taken along line 17-17 of Fig. 12 according to the 30 present invention.
~14~2~
0 94/05238 PC~r/US93/08133 Detailed Descri~.lion of tlle P~efer,ed Embodiment of the Invention In accordance with the present invention an enclosure or suit 10, is formed of a flexible plastic sheet such as a PVC, polyethylene or polypropylene sheet. Thickness of 0.01 to 1.0 mm are generally suitable although other 5 thicknesses can be used. Where maximum transparency is not required, some or all of the components can be made from fibrous materials or a metalized plastic.The body enclosure includes a head element 1 1, left and right arm elements 12 and 13, respectively, thoracic/abdominal elements 14 and 15, respectively, and left and right leg elements 16 and 17, respectively.
Each element includes a longitudinal separable seam which enables the element to be placed about a part of the body of a patient and then resealed to encase that body part. For example, leg element 16 has longitudinal seam 38 and thoracic/abdominal elements 14 and 15, respectively, have longitudinal seams 33 and 37, respectively. These seams correspond to the seam 31 illustrated in Figure 15 4. Each portion of the element 1 3A and 1 3B also can include an edge area having separable means 24, 23 respectively, for connecting with a corresponding area onan adjacent portion of an element whereby each element can be fully assembled.
Similarly each element includes a transverse separable seam which enables adjacent elements to join together. For example, leg element 16 connects with abdominal 20 element 15 at transverse seam 36 and arm element 13 connects to element 14 atlongitudinal seam 32. All the transverse seams 26, 35, and 36 are constructed inthe same manner as the longitudinal seams 29, 31, 32, 33, 37 and 38. For example, the construction of transverse seam 36 of Figure 5 corresponds to the construction of seam 31 of Figure 4 except for the sealing strips discussed below.
25 Referring now to Figure 5, each element can additionally be provided adjacent its connecting edge area at transverse seams such as 35 and 36 with pressure sensitive adhesive strips 50, 53 for sealing to the body at that point. Such pressure sensitive strips 50, 53 are indicated next to the transverse seams 26, 35 and 36 by dotted areas in Fig. 9. Alternatively, the suit 10 may not be provided30 with strips 50, 53, and the surgeon, or other personnel may tape the exposed 2~3~ PCr/US93/08133 ~
edges of the suit directly to the body with tape that is typically available in the preparation or operating room.
The pressure sensitive adhesive strips 50, 53 are protected by a release paper or the like 54, 55, (See Fig. 5) respectively, in a known manner prior 5 to use. It is preferable to have the pressure sensitive adhesive strip on both sides of a seam although it can be used on only one side or may not be used at all.
Although contact adhesive strips can be used for the seams, it is preferable to use VELCROrM closures for the seams, particularly the major ones such as seams 20, 33 and 37. Rather than have each of the elements 1 1, 12, 13, 14, 15, 16 and 17 10 supplied separately and then assembled on the patient, it is preferred to have the enclosure 10 supplied as a single, complete enclosure. To this end, all of the elements can be cut from flat strips as a single enclosure, or the elements such as 12 and 16 may be separately cut from a flat stock and then have the pressure sensitive and VELCR0~ strips attached thereafter, or they can be permanently 1 5 attached to the thora. cic/abdominal unit 14 and 15 on the underside of the enclosure 10 as by a simple overlapping seam (not shown); this seam can be adhesively or heat welded in a known manner.
Depending on the particular design and considering the cost of waste material in some instances a more complete enclosure can be die cut from the 20 plastic film. For example, head element 11 can be integrated and cut with the main body element 14 and 15, leaving just the arm and leg units to be attached. In addition, the head, arm and leg units can alternately be made as a unitary one piece enclosure.
Referring to Figure 2, the seam of head element 11 is shown in 25 traverse view as 20, and this seam 20 is also constructed; in the same manner as seam 31 illustrated in Figure 4. The seam 31 consists of the two edgcs of the plastic sheets 1 3A and 1 3B each of which have in this case contact adhesive strips 23 and 24. These are turned upright as shown and brought into contact to make the seal.
2~4~2~
~0 94/05238 PCr/US93/08133 Turning to Figure 5, the element joining seams 36, having adhesive strips 23 and 24 attached to plastic sheets 18 and 19 and may be closed in a similar manner. These seams, in addition, have body contacting adhesive strips 50 and 53 on the underside as previously discussed.
Elements 16 and 17 are symmetrical as are elements 12 and 13 so that only one die is needed for each pair.
When the patient has been positioned on the open body enclosure 10, the seams are joined by bringing the edges of the element up and around the patient and gently pressing them together. Of course, when pressure sensitive adhesive strips are used, the elements are joined one to another by bringing their edges together only after exposing the adhesive layer thereunder by removing itsrelease paper. Also, if the underlying body contacting strip is to be sealed to the patient, its release paper is removed prior to closing the seam.
When it is desired to supply heated or cooled gas or air to the body enclosure 10, this is accomplished simply by closing a seam around an inlet tube(not shown) or as described in more detail infra. Such tube can also be used as an outlet tube. The tube could also be placed in one of the arm elements, leg elements, or other compartments as shown in Figure 8. The gas is allowed to exhaust at any point therein by simply incorporating exit tubes at such point asshown in Figure 11, or leaving the seam closed or partially open. Examples of the location of portals formed merely by closing a seam around an inlet/outlet tube are portals S1 and S2 and are shown in Figures 8-11. In addition, the VELCR0 closures permit air to escape. A more secure air inlet/exit arrangement comparedto simply closing the seam around an inlet tube is constructed of grommets (not shown) or utilize hose attachment devices as shown in Figs. 6A and 6B (and described in more detail infra) which can be attached to any area of the enclosure.
Following the closure of a two piece grommet, the enclosure spanning the eyelet opening is cut away to open the portal thus allowing the air or gas supplied by inlet line to pass into the enclosure 10. Similarly, exhaust ports can be attached at any - 30 point as shown in Figure 10. It may be desirable to have one or multiple 2~
WO 94/05238 PCr/US93/08133 ~
connections to an air/heating or cooling unit 100 as shown in Figs. 6A and 6B and described in detail infra, for the purposes of heating or cooling and dehumidifying, especially when suit compartments are isolated from one another by an intervening surgical field. Parameter sensors, such as, temperature and dehumidifying sensitive 5 recording materials or sensors can be constructed within or on the outside of the suit enclosure as shown in Figs. 6A and 6B and described in more detail infra. The suit enclosure 10 can be constructed of a single layer of material or multiple layers with intervening air pockets for insulation and padding; e.g., the familiar air bubble type of insulation. While it is preferred that an element or compartment may be left 10 off in order to expose the surgical field as shown in Figures 9 and 10 and described in detail infra, the plastic sheeting can also be cut away to expose the surgical field and the cut edges sealed to the body with an externally applied adhesive strip or tape, if a pre-existing seam is not available. Thoraciclabdominal unit 14, and 15 can have a body contact adhesive strip 50 (see Figure 5) which can be used to seal 15 against the patient if, for example, the thoracic or the abdominal area has to be exposed. These seams or external adhesives serve the purpose of sealing against the passage of air from each individual element or compartment not involved in the surgical procedure. Thus, the convection between areas enclosed by the individual elements is effectively prevented and heat or cooling losses will be confined to20 those areas which cannot otherwise be effectively sealed.
Two different types of air heating or cooling units can be utilized. The first is an air heating or cooling device that is used for compressed air lines that are available in operating rooms. In operating rooms without compressed air availability or in other areas of the hospital without compressed air availability (e.g. recovery 25 rooms, intensive care units, emergency rooms), a free standing heating or cooling unit is used.
A heating or cooling unit for compressed air, generally designated by numeral 100, is illustrated in Figure 6A. The unit 100 comprises an electricallyoperated heater or cooler unit 101 with multi-ported heated or cooled air outlets 30 103 and parameter sensing means, or remote temperature sensing means, or ~1~3~
0 94/05238 PC~r/US93/08133 sensors 105, on or within the suit 10 and/or on the patient (not shown) are used.
The heating or cooling unit 101 contains a conventional regulator and valve system 107 that is attached in-line to a compressed air source 109. This system 107 provides for the control of air flow through the heater or cooler unit 101. The 5 heater or cooler unit 101 has a conventional temperature control section or means 108 and conventional air flow control means 112 comprising individual, flow controls 111 for final output control of air flowing into multiple input portals (up to about nine) disposed on the suit 10 connected through tubing conduits 1 15 to the suit 10. The temperature control section 108 can include a plurality of separate10 temperature control units connected to the plurality of flow controls 1 1 1, so that the temperature of the air flowing through each of these units can be individually controlled, if desired. The final range of heat or cooling output (temperature and air flow) is modified depending on the volume of the particular compartment(s) being heated or cooled. An additional parameter sensing means or safety sensor(s) 15 or temperature sensing means 1 17 is placed in the tubing conduits just downstream of the heating or cooling device 101. This safety sensor(s) 1 17 provides a signal to automatically regulate or cut off the heat or cool air generated to prevent overheating or overcooling of the patient.
The heating or cooling unit 101 can include two methods of controlling 20 air flow and temperature. The first can be controlled automatically and utilizes a feedback loop 1 19 coupled to a conventional control system 121 which is coupledto the heating or cooling device 101 from remote sensor(s) 105. These remote sensor(s) 105 may be within the patient (e.g., internal rectal or esophageal thermosensors for determining core temperature), on the skin of the patient, and/or 25 on or within the suit 10 as shown. The control system 121 is also used to automatically control the heating or cooling device 101 to prevent hypothermia or hyperthermia, respectively. The second method utilizes a manual control system 131 regulated by operating room personnel (anesthesiologists, nurses, surgeons).Both the manual and automatic systems include the downstream safety sensor(s) 30 1 17 which provides regulatory or cut off capabilities described supra.
WO 94/05238 ~3~ PCI/US93/08133 ~
Referring now to Figure 6B, the heating or cooling unit 101 can have multiple air outlet port capability so that from one to about nine tube conduits can be connected to heat or cool one or more compartments of internal heating tubes 246 of Figure 13 of the unit 10 at any given time. A conventional output port control system is incorporated in the heating or cooling device 101 to regulate the number of output ports that are functional at any given time. This port control may be as simple as individual on-off valves at each output connector, or as complexas independent regulatory devices to adjust the rate and volume of heated or cooled air flow delivered to an individual compartment of the suit 10 based on the individual volume and location of that compartment on the patient (i.e., heating or cooling the thorax or abdomen may have different requirements, than heating or cooling an arm or leg, based on body surface area to mass ratios).
The second type of air heating or cooling unit is a free standing heating or cooling unit that utilizes ambient air. All of the features describedpreviously, except that the source of air will be ambient through an electrically operated air blower that has controls to adjust cubic feet per minute of air flow volume. As described previously the air flow can be controlled automatically through feedback from sensing devices, by manual controls or even utilize both methods.
An alternative to the grommet system used as a hose attachment described previously is an adhesive connecting hose device 141 (Figs. 7A & 7B).
The flat lower surface 143 of the washer portion 145 of the connecting device 141 has an adhesive 147 affixed to surface 143 that is protected by a release paper 149. These adhesive connecting devices 141 are attached to different areas of the suit 10 depending on the type of operation performed. The central area of the suit surrounded by the washer portion 145 of the connecting device 141 are cut away or punched out after they are adhesively affixed to the upper surface of the suit 10, to allow airflow into the suit 10. The suit 10 also has partially perforated portals A through I on predetermined areas of the suit to facilitate attachment of the adhesive connecting devices 141, and "punching out" a hole therethrough for the 94/05238 2 1 ~ ~ 5 ~ 2 PC~r/US93/08133 ~0 entry of air. Such portals are shown in Figure 8 and described in detail infra.
Another alternative hose attachment means include a device that would punch the resulting hole(s) in the suit 10 at the same time (a "jack" type attachment). Each of these aforementioned hose attachment devices have a pressure sensitive fitting 5 that inserts into one end of the hose, that is attached to the air heating units previously described.
Referring now to Figure 8, the particular location of partially perforated air inlet portals A-l for hose connecting devices, used with such type of air inlet portals, are determined by the use of the suit 10 for standard or commonly 10 performed operating (i.e., universal applications of the suit). However, in the case of an unusual application of the suit 10, hose attachments can be made to any area of the suit 10 that is required. These latter areas will now have the partially perforated portals described previously.
Referring again to Figure 8, nine partially perforated inlet portals A-l 15 are provided in the suit for conventional hose attachments. Portal A is located on the head compartment 11, portals B and C on the shoulder areas of the thoracic compartment 14, portals D and E on the anterolateral sides of the abdominal compartment 15, portals F and G on each of the arm compartments 12, 13, respectively, and portals H and I on each of the leg compartments 16, 17, 20 respectively.
If for example, an abdominal operation is to be performed, there would be three areas of the suit 10 attached to three hoses from the heating or cooling unit (Figure 9). Each leg compartment 16, 17 sealed to the patient at transverseseam 36, is independently attached to the heating unit at portals H and 1, 25 respectively. The upper portion of the suit 10, sealed to the patient at seam 35, may be attached to a single heater hose at portal B. This upper portion of the suit comprising the head, thoracic and arm compartments 1 1, 14, 12 and 13, respectively, may be heated as a single unit. Additional heater or cooler hoses can be attached to arm or head portals 12, 13, 11 respectively, to increase the heated 30 or cooled air flow to this upper unit as needed.
W O 94/05238 PC~r/US93/08133 ~
If for example a groin operation is to be performed, one leg 17, and one-half of the abdominal portions 15B of the suit 10 would be removed (Figure 10). The patient is then sealed to the suit 10 at seams 35 and 37. The remainderof the suit would be heated through portals F, G and H for operations resulting in 5 mild degrees of hypothermia. Additional portals could be used for longer operations or situations predisposing to more severe hypothermia. The number of heating portals used would be an additional factor in regulating the amount of heat delivered to the patient.
In a situation predisposed to severe hypothermia, with the additional 10 problem of the need for a large surface area of the patient to be exposed to the operating field (e.g., an abdominal and lower extremity bypass requiring the abdomen and both legs to be in the operative filed), only the head, arm and thoracic compartments 1 1, 12, 13, 14, respectively, would be available to deliver heated air to the patient. In this situation all five available ports A, B, C, F, and G, 15 would be utilized simultaneously. Since drapes used to cover the patient havesubstantial weight, the use of all such five portals may be necessary to increase the surface contact of heated air with the patient.
One possible anticipated finding may be that the suit 10 functions better by using all the portals available in every compartment, with or without 20 separating the co, "~a, Il, ,ents by the adhesive strips 50, 53 attached to the patient.
Exhaust of air from the exhaust portals J-Q of the suit 10, as briefly described previously, can be simply accomplished by merely incorporating exit tubes or just leaving the VELCRO~ separating means 23, 24 partially open, or leaving the seam closed and allowing air to exit through the closed VELCROm seal.
25 If adhesive is used to seal the longitudinal seams, then exhaust ports for the escape of air will be necessary. These exhaust ports, J-Q, like the input portals A-l, can be partially perforated portals located in areas of each compartment as shown inFigure 11, such that they maximize airflow in contact with the patient's body surface .
2143~2 0 94/05238 PC~r/US93/08133 The inlet portals A-l are preferably disposed on the suit 10, so as to use the shortest lengths of hoses, to increase conduction heating and cooling ofthe suit 10 thereby maximizing heating and cooling. The location of the portal also improves the efficiency and convenience of hose placement for operating room 5 personnel.
Drying or desiccating agents such as calcium chloride can be incorporated within areas on the inner surface of the suit 10, within the tubingconnecting the air heating or cooling unit to the inlet portals, on the air inlets to the air heating or cooling unit, or within the hose attachment devices. The hose 10 attachment devices can likewise be attached at an exhaust portal to increase the drying capabilities of the suit. Drying or desiccating agents associated with the suit or hose attachment devices would also be discarded with the suit. Drying or desiccating agents associated with the heater can be compartmentalized to permitchanging and refilling of these compartments with drying agents.
Normally, the head compartment will be left open and sealed to the neck with adhesive strips. Once the patient is anesthetized and with the anesthesia and monitoring equipment leads and tubes in place, the head compartment can then be closed about the surface of the communicating tubes.
The suit enclosure 10 can, of course, be manufactured and sold without the head 20 element, leaving the user to insulate or heat the head by other means.
During the course of a surgical procedure, convection loss will occur only from the compartments which are open for access to the surgical field.
Radiation loss will be reduced depending upon the heat reflecting capability of the material from which the suit enclosure 10 is formed. In the case of metalized sheet 25 material, the reduction of radiant heat loss may be greater than with clear plastic material. The plastic material can be lightly reflectively coated on the inner or outer surfaces so as not to unduly reduce transparency.
As previously noted, the device can be manufactured in a relatively small number of sizes; e.g. four, as close fitting is not required. It can be made and 30 shipped flat with the adhesive strips thereon being only on one side and overlaid WO 94/05238 ~ PCr/US93/08133 ~
with a removable release sheet. The patient can be placed in the suit enclosure or removed from the enclosure by opening some or all of the seams. Normally, the suit enclosure will not be reused as its low cost does not justify attempting to clean and reuse the suit enclosure.
Reference is now made to Figs. 12-17 where a second illustrative embodirnent of the body enclosure or suit 200 is shown. The body enclosure 200 includes a head element 21 1, left and right arm elements 212 and 213, respectively, thoracic/abdominal elements 214 and 21 5, respectively, and left and right leg elements 216 and 217, respectively. In the preferred embodiment, the enclosure 200 is assembled as a unitary or integral assembly that is manufactured by sealing together three planer sheets of plastic material 226, 240 and 260 (Fig.
13-15). The three sheets 226, 240 and 260 are made from a material that is substantially impermeable to gas or air. Likewise, the seals between each sheet are also substantially impermeable to air. The body enclosures 10, 200 are each symmetrical about a vertical axis.
A heater/blower assembly 220 provides a flow of heated or cooled air or gas through a pair of connecting hoses 222 to the interior of the enclosure thereby controlling the temperature of the patient. As used herein "conditioned air"
encompasses a heated or cooled air or gas. The heater/blower assembly 220 controls the temperature of the gas exiting from the assembly 220 within a predetermined range. Accordingly, the temperature of the air exiting the assembly 220 is monitored by a conventional feed-back control system (not shown) to regulate the temperature of the air exiting the heater/blower assembly 220. The conditioned air enters the enclosure, in a manner to be described below, and passes over that much of the body portion of the patient that is enclosed by enclosure 200. The conditioned air then exits from the enclosure through a passage in the longitudinal seam 224.
The body enclosure 200 is made from three sheets of substantially planer plastic or other flexible material. The first or bottommost sheet 226, which is shown in Fig. 13, has an outer perimeter edge 228 defining leg, ~ O 94/05238 2 1 ~ ~ 6 ~i ~ PC~r/US93/08133 thoracic/abdominal, arm and head portions of the body enclosure 200. A pair of strips 232 of plastic material are sealed to the first sheet 226 such that the plastic strips 232 are below the first sheet 226. The strips of plastic 232 each include a through hole 234 at each end to allow the strips of plastic to be used as handles for carrying the body enclosure. The first sheet 226 is designed to be the same length as the second and third sheets 240, 260, such that an extension 270, 272 of all three sheets extend beyond the head portion and the foot portion. The extension 270 includes a hole 274, and the extension 272 includes a pair of holes 276, to allow the extensions 270, 272 to be used as handles for carrying the body enclosure.
The seals between the sheets of plastic material are preferably made by radio frequency (RF) sealing, although other types of sealing such as heat sealing or laser sealing may be used, if desired. However, whichever sealing method is employed, the resulting seal must be substantially impermeable to gas or air and have sufficient strength to maintain the seal's i"Legril~ during normal use.
The first sheet 226 is sealed to the second sheet 240 (see also Fig.
14) along the entire outer perimeter of the first and second sheets 226, 240 as indicated by seal areas 230. The first sheet 226 is additionally sealed to the second sheet 240 along a plurality of discreet interior seal lines 238 that are located within their respective outer perimeters. The plurality of discreet seal lines 238 form a plurality of spaced passageways between the first and second sheets 226, 240. The first sheet 226 also includes a pair of openings 242, forming heater hose ports, to allow conditioned air to enter into the enclosure from the hoses 222 of the heater/blower assembly. The hoses 222 are connected to the first sheet onthe lower surface, that is, the surface opposite to the second sheet 240. The hoses 222 are sealed to the first sheet 226 by a manner known in the art. For example, a "vacuum cleaner" type connection between the hose 222 and the heater hose port 242 can be used. Alternatively, a slit may be cut in the heatertube 246 and the hose 222 may be inserted into the slit. If this type of connection - 30 is used, a connecter placed within the heater tube 246 will facilitate securing hose W O 94/05238 ~3~ PC~r/US93/08133 ~
222 to the heater tube 246. A third set of openings 244, forming a mattress inflation/deflation port, are located in the head, arm and leg portion of the first sheet 226. The port 244 is used to inflate/deflate a mattress portion that is disposed between the first and second sheet. The mattress portion is preferably 5 inflated with gas or air (e.g., by a C02 cartridge), which is typically at room temperature or lower. The heater/blower assembly may be run prior to insertion of a patient to allow the temperature of the gas or air within the mattress portion to be within the same range as the air entering the enclosure.
Fig. 14 shows the second or middle sheet 240 and the common seal 10 lines with respect to the first sheet 226. The space between the first and second sheet 226, 240 includes a mattress portion 248, a heater tube portion 246, and a spinal access panel 250. The mattress portion 248, the heater tube portion 246, and the spinal access panel 250 are separately disposed between the first and second sheets and do not communicate with one another. Accordingly, the 15 mattress portion 248 is inflated and deflated via the port 244. Each heater tube portion 248 receives conditioned air from inlets 242.
The second sheet 240 includes plurality of heater outlet ports 252 located within the heater tube portion 246. The conditioned air entering the heater hose portion 246 from inlet 242 is distributed to the patient by the plurality of 20 heater outlet ports 252. The heater tube is shaped such that the flow of conditioned air is substantially uniform throughout the enclosure. To this extent, each heater tube has two branches 246a and 246b near the arm portion to evenly distribute the conditioned air to the arms and to the head and neck portion of the patient. In this regard, a sealed line 254 splits the heater tube into two and is 25 designed to direct the conditioned air evenly between the arm portions and the head and neck portions of the enclosure.
The first and second sheets 226, 240 are also provided with a spinal access panel 250. The spinal access panel 250 allows access to the spinal area of the patient. To access the spinal area, the surgeon can cut out the desired area 30 in the spinal access panel 250 of the first and second sheets 226, 240. If desired, ~O 94/05238 2 ~ ~ 3 ~ ~ ~ PCI/US93/08133 the cut edges of these sheets can be taped directly to the body. The surgeon canthus treat the spinal area by, for example, administering an epidural to the patient.
Hence, the spinal area can be accessed without compromising the integrity of theinflated area of the mattress portion 248.
The first sheet 226 is sealed to the second and third sheet 260 (see also Fig. 15) along the entire outer perimeter of the sheets 226, 260 as indicated by seal lines 2Z8 and 236. As shown, the seal line 230 between the first sheet 226 and the second sheet 240 is adjacent to and within the outer perimeter seal line 236. The third sheet 260 has a longitudinal seam 224, similar to seam 24 described above, that is preferably made from a hook and loop type fastener (i.e., a VELCRO~ fastener).
Referring now to Fig. 17, the longitudinal seam 224 is shown in sectional detail. The seam 224 includes a pair of L-shaped brackets 262 that aresealed to a first end 265 and a second end 267 of the third sheet 260. The hook and loop type fastener 264 is attached to the upstanding portions 263 of the L-shaped brackets 262. The L-shaped brackets 262 are preferably made of a more rigid plastic material than the plastic material of the third sheet 260. Thus, the user can easily grab the upstanding portion 263 of the brackets 262 to effectively open or close the longitudinal seam 224. Preferably, a hook and loop type fastener system is used to allow the conditioned air in the enclosure to exit therefrom along the entire seam length. However, any type of fastener system may be used as longas a passage exists between the first and second ends 265, 267 of the third sheet 260 to allow conditioned air to exit from the enclosure regardless of whether the seam is in the open or closed position. Additionally, exhaust portals within thethird sheet may be used as in the suit enclosure shown in Figs. 1-11.
Referring now to Fig. 16, the mattress portion 248 is shown in sectional detail. Once the mattress portion is inflated through the inflation port 244, the mattress portion takes on a shape similar to that of an inflatable raft. The patient will be supported on a plurality of spaced projections 266 on the secondsheet 240. Thus, there will be a gap 249 between each projection 266 of the -W094/05238 ~ PCr/US93/08133 ~
second sheet and underneath the body of the patient to form a through passageway between the second sheet 240 and the body for the conditioned air.
Furthermore, the conditioned air entering the portion of the suit housing the patient, located between the second and third sheets 240, 260, will flow totally around the 5 patient to transfer heat either to or away from the patient, as desired. The heater outlet ports 252 are designed in association with the discreet seams 238, which form the mattress portion 248, to encourage the flow of conditioned air around the entire body of the patient. Of course, the discreet seams 238 could be designed differently then as exemplified as transverse seams in the drawings. For example, 10 the seams 238 in the head or other portions could be oriented longitudinally. The seams 238 could extend to seal line 230. Additionally, the seams 238 could be curvalinear or circular.
The mattress portion 248 effectively holds the patient away from the operating table and thus significantly reduces, if not eliminates, conduction heat 15 losses due to direct contact with the operating table. In addition, the mattress portion 248 reduces the risk of injury (e.g., pressure sores) to pressure sensitive areas, such as the ankles, heel and sacrum, by providing a cushioned surface between the tissue and the operating table.
The body suit is thus assembled from three sheets of substantially 20 planer gas impermeable material. During use, it is preferred to first inflate the mattress portion 248, via inflation ports 244, prior to placing a patient within the enclosure. Once the mattress portion is filled, preferably with conditioned gas (CO2) or air, the inflation ports 244 is closed. At this point, the patient is placed within the enclosure, i.e., on top of the second sheet 240 and below the third 25 sheet 260. The heater/blower assembly then starts blowing conditioned air into the enclosure via tubes 222. The conditioned air enters the heater tube portion located between the first and second sheets 226, 240 and is then distributed to the enclosure between the second and third sheet 240, 260, via the heater outlet ports 252. The air flows completely around the different portions of the body through 30 the plurality of passageways (249) underneath the body, i.e., between the body 094/05238 ~ 1 4 ~ ~ ~ 2 PCT/US93/08133 and adjacent projections 266 of the mattress portion 248. The conditioned air will eventually flow out of the enclosure through the longitudinal seam 224 regardless of whether the seam is in the open or the closed position.
The transverse seams 238 which, in part, forms the mattress portion help create the conditioned air flow below the body. The mattress portion 248 also includes a plurality of longitudinal passageways 251 and longitudinal seams238 (e.g., the seam separating the leg portions) adjacent to the ends of the transverse seams 238. The longitudinal passageways 251 and seams help prevent curling and/or shortening of the suit. Without these longitudinal passageways 251 and seams, the suit would have a tendency to curl and shorten in length. The longitudinal passageways 251 also aid in inflating/deflating the mattress portion 248 by allowing the gas to readily access the entire mattress portion.
Once the patient is placed within the suit enclosure and the conditioned air from the heater/blower assembly 220 is running at a steady state, the patient can be anesthetized. At this time, it is preferred that all of the longitudinal seams 224 be closed except those in the head portion of the suit.
Once the patient is fully anesthetized, the suit can be totally closed by closing the seal 224 about the anesthesia tube or tubes.
The surgeon can now access whatever area of the body enclosure that is necessary to perform the operation. The surgeon will simply cut out the desired area from the third sheet 260 (see Fig. 12) even cutting through the longitudinal seam 224, if necessary. The cut edges of the third sheet 260 can be taped directly to the body to effectively prevent the conditioned air within the enclosure fromexiting in the area of the cut. The surgeon will then typically place towels around the area of the third sheet 260 that has been cut and taped. An iodine impregnated surgical drape, such as a commercially available STERI DRAPE~, can then be placed over the entire cut opening. The operation can thus proceed in a manner known in the art.
If at any time it is necessary to deflate the mattress portion 248 - 30 quickly, the inflation/deflation port 244 simply needs to be opened. The port 244 W O 94/0523~ ~ 4~6~ PC~r/US93/08133 ~
is sized to allow the mattress portion 248 to deflate quickly in the case of an emergency, e.g., in the case that CPR needs to be performed on the patient.
Air inflatable compression segments for intermittently compressing the calves of the patient may be incorporated into the leg compartrnents of the 5 enclosure. These intermittent compressions will prevent clots from forming inside the deep veins of the legs.
Sensors for monitoring the patient can be directly attached to or incorporated into the enclosure. The sensors can be heat sensors to monitor the temperature of the enclosure or the temperature of the patient. These sensors can 10 be used in the feedback control system to automatically control the enclosure of the patient.
From the foregoing description, it will be appreciated that the present invention makes available a body suit that is easy to manufacture at a cost effective price. An embodiment of the body suit has flow channels beneath the 15 body to improve the convection surface area of the body.
Having described the presently preferred embodiment of a new and improved body enclosure in accordance with the present invention, it is believedthat other modifications, variations, and changes will be suggested to those skilled in the art in view of the teachings set forth herein. It is therefore to be understood 20 that all such variations, modifications, and changes are believed to fall within the scope of the present invention as defined by the appended claims.
Claims (65)
1. A body enclosure comprising:
(a) a first sheet having a first end and a second end, said first sheet being made of a substantially gas impermeable flexible material;
(b) means for releasably connecting said first end to said second end to form said enclosure about a body;
(c) inlet means for admitting air from outside of said enclosure into said enclosure and in contact with said body, said air being controlled to be within a predetermined temperature range; and (d) exhaust means for discharging air from within said enclosure.
(a) a first sheet having a first end and a second end, said first sheet being made of a substantially gas impermeable flexible material;
(b) means for releasably connecting said first end to said second end to form said enclosure about a body;
(c) inlet means for admitting air from outside of said enclosure into said enclosure and in contact with said body, said air being controlled to be within a predetermined temperature range; and (d) exhaust means for discharging air from within said enclosure.
2. The body enclosure as claimed in claim 1 wherein said inlet means admits heated air into said enclosure.
3. The body enclosure as claimed in claim 1 wherein said inlet means admits cooled air into said enclosure.
4. The body enclosure as claimed in claim 2 wherein said connecting means form a longitudinally oriented seam with respect to said body.
5. The body enclosure as claimed in claim 4 wherein said connecting means includes a hook and loop fastener.
6. The body enclosure as claimed in claim 5 wherein said hook and loop fasteners are disposed on the same side of said first sheet such that when joined said longitudinal seam is upstanding with respect to said body and said hook portion and said loop portion of said fastener face each other.
7. The body enclosure as claimed in claim 5 wherein said exhaust means includes a plurality of exhaust ports.
8. The body enclosure as claimed in claim 5 wherein said passage is located through said hook and loop fasteners of said longitudinal seam.
9. The body enclosure as claimed in claim 8 wherein said longitudinal seam substantially encompasses a torso portion of said enclosure.
10. The body enclosure as claimed in claim 9 wherein said longitudinal seam substantially encompasses a head portion of said enclosure.
11. The body enclosure as claimed in claim 10 wherein said longitudinal seam substantially encompasses at least one arm portion of said enclosure.
12. The body enclosure as claimed in claim 11 wherein said longitudinal seam substantially encompasses at least one leg portion of said enclosure.
13. The body enclosure as claimed in claim 5 wherein said first sheet is made of a plastic material selected from the group consisting of polyvinylchloride, polyethylene, polypropylene and polytetrafluoroethylene.
14. The body enclosure as claimed in claim 1 wherein said exhaust means is disposed through a passage located between said first end and said second end.
15. A method of preventing and treating hypothermia or hyperthermia in a patient comprising the steps of:
(a) enclosing the patient within a sheet of gas impermeable flexible material having a first end and a second end;
(b) connecting said first end to said second end to at least partially close a seam created by the juncture of said first and second ends andform an enclosure about said patient;
(c) supplying air from outside of said enclosure into said enclosure and in contact with said patient;
(d) controlling a temperature of said air to be within a predetermined temperature range; and (e) exhausting air from within said enclosure.
(a) enclosing the patient within a sheet of gas impermeable flexible material having a first end and a second end;
(b) connecting said first end to said second end to at least partially close a seam created by the juncture of said first and second ends andform an enclosure about said patient;
(c) supplying air from outside of said enclosure into said enclosure and in contact with said patient;
(d) controlling a temperature of said air to be within a predetermined temperature range; and (e) exhausting air from within said enclosure.
16. The method as claimed in claim 15 wherein said air supplied into said enclosure is a heated air.
17. The method as claimed in claim 15 wherein said air supplied into said enclosure is a cooled air.
18. The method as claimed in claim 15 further including the step of inserting at least one equipment tube for providing fluid communication from outside of said enclosure to within said enclosure, said equipment tube penetrating said enclosure at said seam.
19. The method as claimed in claim 18 wherein said first end and said second end are closed about said equipment tube.
20. The method as claimed in claim 15 wherein said temperature of said air is further monitored so that when said monitored temperature exceeds a predetermined temperature an alarm is actuated.
21. The method as claimed in claim 16, wherein when said alarm is actuated said temperature is controlled in response thereto.
22. The method as claimed in claim 15 further including the step of controlling the flow of air being supplied to said enclosure.
23. The method as claimed in claim 15 wherein said exhausting air passes through a passage located between said first end and said second end.
24. A body enclosure comprising:
(a) a substantially planer first sheet having a perimeter;
(b) a substantially planer second sheet having a perimeter being approximately of equal size to said perimeter of said first sheet, said sheets being sealed to one another substantially about said perimeter, said first sheet being further sealed to said second sheet along a plurality of discreet lines within the interior of said outer perimeters of said first and second sheets to form a mattress portion disposed between said first and said second sheet;
(c) a substantially planer third sheet having a perimeter being approximately of equal size to said perimeters of said first and second sheets, said third sheet being sealed to said first and second sheets substantially about said perimeter, said third sheet further including at least one seam;
(d) means for releasably connecting said at least one seam;
(e) a first inlet means for inflating and deflating said first mattress portion enclosed between said first sheet and said second sheets; and (f) a second inlet means for admitting air into said enclosure, said enclosure being disposed between said second sheet and said third sheet.
(a) a substantially planer first sheet having a perimeter;
(b) a substantially planer second sheet having a perimeter being approximately of equal size to said perimeter of said first sheet, said sheets being sealed to one another substantially about said perimeter, said first sheet being further sealed to said second sheet along a plurality of discreet lines within the interior of said outer perimeters of said first and second sheets to form a mattress portion disposed between said first and said second sheet;
(c) a substantially planer third sheet having a perimeter being approximately of equal size to said perimeters of said first and second sheets, said third sheet being sealed to said first and second sheets substantially about said perimeter, said third sheet further including at least one seam;
(d) means for releasably connecting said at least one seam;
(e) a first inlet means for inflating and deflating said first mattress portion enclosed between said first sheet and said second sheets; and (f) a second inlet means for admitting air into said enclosure, said enclosure being disposed between said second sheet and said third sheet.
25. The body enclosure as claimed in claim 24 wherein said mattress portion includes a plurality of spaced apart passageways between said first and second sheets being formed by said plurality of discreet lines, said plurality of passageways forming fluid communication below said body and between a surface of said second sheet that is opposite said passageways to allow convection heat transfer to occur between said air admitted by said second inlet means and said body.
26. The body enclosure as claimed in claim 25 wherein said mattress portion encompasses at least one torso portion of said enclosure.
27. The body enclosure as claimed in claim 26 wherein said mattress portion encompasses at least one arm portion of said enclosure.
28. The body enclosure as claimed in claim 27 wherein said mattress portion encompasses at least one leg portion of said enclosure.
29. The body enclosure as claimed in claim 28 wherein said mattress portion encompasses a head portion of said enclosure.
30. The body enclosure as claimed in claim 25 wherein said first and second sheets include a spinal access panel that is devoid of said mattress portion.
31. The body enclosure as claimed in claim 24 further including at least one handle strip sealed to said first sheet, said at least one strip beingdisposed on a side opposite of said second sheet.
32. The body enclosure as claimed in claim 31 wherein said at least one strip includes a first end and a second end, each of said first end and saidsecond end projecting beyond said outer perimeter of said first and second sheets, each of said first end and said second end including a through hole.
33. The body enclosure as claimed in claim 24 wherein said three sheets includes a pair of extensions of material, projecting beyond said outer perimeter of said first and second sheets, and being disposed at a head portion and a leg portion of said enclosure.
34. The body enclosure as claimed in claim 33 wherein said pair of extensions of material each include at least one through hole.
35. The body enclosure as claimed in claim 24 wherein said second inlet means is disposed in said first sheet at a foot portion of said enclosure.
36. The body enclosure as claimed in claim 24 wherein said second inlet means is disposed in said first sheet at a head portion of said enclosure.
37. The body enclosure as claimed in claim 24 wherein said second inlet means is disposed in said first sheet at a arm portion of said enclosure.
38. The body enclosure as claimed in claim 35 wherein said second inlet means is in fluid communication with a heater tube disposed between said first sheet and said second sheet.
39. The body enclosure as claimed in claim 38 wherein said heater tube includes a plurality of heater outlets in fluid communication with said enclosure disposed between said second sheet and said third sheet.
40. The body enclosure as claimed in claim 39 wherein said heater tube divides into at least two paths, a first path being directed toward said arm portion and a second path being directed toward said head portion.
41. The body enclosure as claimed in claim 40 wherein said heater tube includes a dividing line, formed by one of said discreet lines, to facilitate air flow to said arm portion and said head portion.
42. The body enclosure as claimed in claim 41 wherein said dividing line projects into said heater tube.
43. The body enclosure as claimed in claim 24 wherein said second inlet means includes a collar type connection.
44. The body enclosure as claimed in claim 24 wherein said first inlet means is of sufficient size to allow for rapid deflation of said mattress portion.
45. The body enclosure as claimed in claim 24 wherein said second inlet means admits heated air into said enclosure.
46. The body enclosure as claimed in claim 24 wherein said second inlet means admits cooled air into said enclosure.
47. The body enclosure as claimed in claim 45 wherein said connecting means form a longitudinally oriented seam with respect to said body.
48. The body enclosure as claimed in claim 47 wherein said connecting means includes a hook and loop fastener.
49. The body enclosure as claimed in claim 47 wherein said connecting means includes a pressure sensitive adhesive.
50. The body enclosure as claimed in claim 48 wherein said hook and loop fasteners are disposed on the same side of said third sheet such that when joined said longitudinal seam is upstanding with respect to said body and said hook portion and said loop portion of said fastener face each other.
51. The body enclosure as claimed in claim 48 further including a pair of L-shaped brackets attached to said third sheet, each of said L-shaped brackets having an upstanding portion with respect to said body, said hook and loop fasteners being attached to said upstanding portions such that said hook portion of said fastener faces said loop portion of said fastener.
52. The body enclosure as claimed in claim 45 further including an exhaust means for discharging air from said enclosure.
53. The body enclosure as claimed in claim 48 further including an exhaust means for discharging air from said enclosure.
54. The body enclosure as claimed in claim 53 wherein said exhaust means includes a plurality of exhaust ports.
55. The body enclosure as claimed in claim 53 wherein said exhaust means includes said air exiting through said hook and loop fasteners of said longitudinal seam.
56. The body enclosure as claimed in claim 55 wherein said longitudinal seam substantially encompasses a torso portion of said enclosure.
57. The body enclosure as claimed in claim 56 wherein said longitudinal seam substantially encompasses a head portion of said enclosure.
58. The body enclosure as claimed in claim 57 wherein said longitudinal seam substantially encompasses at least one arm portion of said enclosure.
59. The body enclosure as claimed in claim 58 wherein said longitudinal seam substantially encompasses at least one leg portion of said enclosure.
60. The body enclosure as claimed in claim 52 wherein said first, second and third sheets are made of a plastic material selected from the group consisting of polyvinylchloride, polyethylene, polypropylene and polytetrafluoroethylene.
61. A method of manufacturing a body enclosure comprising the steps of:
(a) laying out a substantially planer first sheet of gas impermeable flexible material, said first sheet having a perimeter;
(b) laying out a substantially planer second sheet of gas impermeable flexible material on top of said first sheet, said second sheet having a perimeter of approximately equal size of said outer perimeter of said first sheet;
(c) sealing said first sheet to said second sheet about said perimeter and along a plurality of discreet lines within said perimeter;
(d) laying out a substantially planer third sheet of gas impermeable flexible material on top of said first and second sheets, said thirdsheet having a perimeter of approximately equal size of said perimeters of said first and second sheets; and (e) sealing said third sheet to said first and second sheets about said perimeter.
(a) laying out a substantially planer first sheet of gas impermeable flexible material, said first sheet having a perimeter;
(b) laying out a substantially planer second sheet of gas impermeable flexible material on top of said first sheet, said second sheet having a perimeter of approximately equal size of said outer perimeter of said first sheet;
(c) sealing said first sheet to said second sheet about said perimeter and along a plurality of discreet lines within said perimeter;
(d) laying out a substantially planer third sheet of gas impermeable flexible material on top of said first and second sheets, said thirdsheet having a perimeter of approximately equal size of said perimeters of said first and second sheets; and (e) sealing said third sheet to said first and second sheets about said perimeter.
62. The method as claimed in claim 61 wherein said sealing of said third sheet to said first and second sheets is adjacent to said sealing of said first sheet to said second sheet.
63. The method as claimed in claim 61 wherein said sealing is achieved by radio frequency sealing.
64. The method as claimed in claim 61 wherein said sealing is achieved by heat sealing.
65. The method as claimed in claim 61 wherein said sealing is achieved by laser sealing.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US938,828 | 1986-12-08 | ||
| US07/938,828 US5383918A (en) | 1992-08-31 | 1992-08-31 | Hypothermia reducing body exclosure |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2143622A1 true CA2143622A1 (en) | 1994-03-17 |
Family
ID=25472036
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002143622A Abandoned CA2143622A1 (en) | 1992-08-31 | 1993-08-30 | Hypothermia reducing body enclosure |
Country Status (5)
| Country | Link |
|---|---|
| US (1) | US5383918A (en) |
| AU (1) | AU5096193A (en) |
| CA (1) | CA2143622A1 (en) |
| GB (1) | GB2284555A (en) |
| WO (1) | WO1994005238A1 (en) |
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- 1993-08-30 AU AU50961/93A patent/AU5096193A/en not_active Abandoned
- 1993-08-30 WO PCT/US1993/008133 patent/WO1994005238A1/en active Application Filing
- 1993-08-30 CA CA002143622A patent/CA2143622A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| GB9503957D0 (en) | 1995-04-19 |
| GB2284555A (en) | 1995-06-14 |
| US5383918A (en) | 1995-01-24 |
| WO1994005238A1 (en) | 1994-03-17 |
| AU5096193A (en) | 1994-03-29 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued | ||
| FZDE | Discontinued |
Effective date: 19980831 |