WO2014189747A1

WO2014189747A1 - Multi-sectional temperature regulating surgical barrier device

Info

Publication number: WO2014189747A1
Application number: PCT/US2014/038071
Authority: WO
Inventors: John P. Rock; Nicholas R. Powley; Andrew J. Mcgregor; Christopher M. KONCAR
Original assignee: 3M Innovative Properties Co
Current assignee: 3M Innovative Properties Co
Priority date: 2013-05-22
Filing date: 2014-05-15
Publication date: 2014-11-27
Anticipated expiration: 2015-11-22

Abstract

At least some aspects of the present disclosure feature a temperature regulating surgical barrier device comprising a surgical drape and an attachment device. The surgical drape includes a plurality of drape sections. At least one of the drape sections includes an air impermeable drape sheet and an air permeable base sheet attached to the drape sheet to form an inflatable portion. The attachment device is configured to attach at least a portion of the surgical drape to a patient.

Description

MULTI-SECTIONAL TEMPERATURE REGULATING SURGICAL BARRIER DEVICE

Technical Field

[0001] This disclosure relates generally to medical devices used during surgery to provide warming to patients and barrier functions to protect sterile field.

Summary

[0002] At least some aspects of the present disclosure feature a combination for use during surgery on a patient. The combination includes a surgical drape, an inflatable thermal blanket, a first attachment device, and a second attachment device. The surgical drape includes a plurality of drape sections, each drape section comprising a drape sheet of flexible material. The inflatable thermal blanket includes a base sheet, a material sheet attached to a first surface of the base sheet by a plurality of seals to form an inflatable portion, and a plurality of apertures through the base sheet within the inflatable portion. The first attachment device configured to attach the inflatable thermal blanket to the patient. The second attachment device configured to attach at least a portion of the surgical drape to the patient. At least one of the plurality of drape sections is integrated with or attached to the inflatable thermal blanket.

[0003] At least some aspects of the present disclosure feature a temperature regulating surgical barrier device comprising a surgical drape and an attachment device. The surgical drape includes a plurality of drape sections. At least one of the drape sections includes an air impermeable drape sheet and an air permeable base sheet attached to a first surface of the drape sheet via a plurality of seals to form an inflatable portion. The attachment device is configured to attach at least a portion of the surgical drape to a patient.

Brief Description of Drawings

[0004] The accompanying drawings are incorporated in and constitute a part of this specification and, together with the description, explain the advantages and principles of the invention. In the drawings,

[0005] Figure 1 A is a side elevation view of an inflatable thermal blanket, with the blanket in use, and associated thermal apparatus indicated schematically; Figure IB is an enlarged top plan view of the inflatable thermal blanket of Figure 1 , opened flat;

[0006] Figure 2A is a perspective view of another embodiment of an inflatable thermal blanket;

[0007] Figure 2B is a bottom view of the embodiment illustrated in Figure 2A;

[0008] Figure 2C shows a cross sectional view of the embodiment of the inflatable thermal blanket illustrated in Figures 2 A and 2B; [0009] Figures 2D is an enlarged view of a portion of the inflatable thermal blanket illustrated in Figure 2C;

[0010] Figure 3 is an enlarged sectional view taken along line 3-3 of Figure IB;

[0011] Figure 4 is a further enlarged sectional view taken along line 4-4 of Figure 3;

[0012] Figure 5 is a partial underside view of the inflatable thermal blanket of Figure 1A;

[0013] Figure 6 illustrates a plan view of an embodiment of a multi-sectional temperature regulating surgical barrier device;

[0014] Figures 7A and 7B illustrate two configuration of an adhesive area of an adhesive strip;

[0015] Figures 8A and 8B are cross-sectional views of two embodiments of a surgical barrier device;

[0016] Figures 9A and 9B illustrate diagrammatic cross-sectional views of embodiments of a surgical barrier device when the inflatable thermal blanket is inflated;

[0017] Figures 9C and 9D illustrate various sizes and shapes of drape sections;

[0018] Figure 10A is a diagrammatic plan view of an embodiment of a multi-sectional temperature regulating surgical barrier device;

[0019] Figure 10B is a perspective view of the surgical barrier device of Figure 10A;

[0020] Figure 1 1 A is a diagrammatic plan view of another embodiment of a multi-sectional temperature regulating surgical barrier device;

[0021] Figure 1 IB is a perspective view of the surgical barrier device of Figure 1 1A;

[0022] Figure 12A is a diagrammatic cross sectional view of an embodiment of a surgical barrier device;

[0023] Figure 12B is an enlargement of a portion of the surgical barrier device of Figure 12A;

[0024] Figure 13 A is a diagrammatic cross sectional view of another embodiment of a surgical barrier device;

[0025] Figure 13B is an enlargement of a portion of the surgical barrier device of Figure 13A;

[0026] Figure 14A is a diagrammatic cross sectional view of one other embodiment of a surgical barrier device; and

[0027] Figure 14B is an enlargement of a portion of the surgical barrier device of Figure 14A.

Detailed Description

[0028] An inflatable thermal blanket is typically placed over a patient and inflated by a thermally controlled inflating medium, such as warmed air. The pressure of the inflating medium causes the blanket to expel the warmed air through holes in the underside of the blanket, thereby creating an ambient environment about the patient, the thermal characteristics of which are determined by the temperature of the inflating medium. Such an inflatable thermal blanket is intended, among other things, for the treatment or prevention of hypothermia, as might occur intraoperatively, or postoperatively. They also are used preoperatively to warm the patient to help prevent intraoperative hypothermia. [0029] A surgical drape is the usual means employed for provision of a barrier between a surgical site and other fields, during surgery. Typically, a surgical drape is employed for such purposes as keeping fluids confined to the surgical site, maintaining sterility of the surgical site, and screening the anesthesia work area.

[0030] Embodiments of the present disclosure direct to a multi-sectional temperature regulating surgical barrier device that can be configured to use with various surgical procedure types and patient sizes. In some embodiments, the multi-sectional temperature regulating surgical barrier device includes a surgical drape having multiple drape sections, at least one drape section integrated with or attached to an inflatable thermal blanket, a first attachment device configured to attach the inflatable thermal blanket to the patient, and a second attachment device configured to attach at least a portion of the surgical drape to the patient. The drape sections can be disposed to form a surgical access with various configurations suitable to the surgical site. For example, the surgical access can have different shapes and disposed at different sites.

[0031] Inflatable Thermal Blankets:

[0032] Inflatable thermal blanket refers to an inflatable structure for delivering a thermally controlled inflating medium to space occupied by at least a portion of a patient's body when the inflatable thermal blanket is inflated. The purpose of the inflatable thermal blanket is to efficiently administer a uniformly thermally-controlled bath of the inflating medium to a patient within space beneath the blanket. As used herein the term "inflatable" refers to a structure which increases in volume when air or other gas is supplied a pressure greater than atmospheric pressure to the interior of the structure. Typically these structures inflate at relatively low pressures such as pressures less than lOOmmHg, preferably at pressures less than 50mmHg, more preferably at pressures less than 25mmHg. Typically the volume will increase by greater than 100% volume.

[0033] An embodiment of inflatable thermal blanket is illustrated in Figure 1 A. In Figure 1 A, an inflatable thermal blanket 10 has a head end 12, a foot end 14 and two lateral edges, one such lateral edge indicated by 15. In the embodiment as illustrated, the blanket 10 is inflated via an inflation inlet cuff 16 that is connected to a heater/blower assembly 18. In some cases, the heater/blower assembly 18 has a compressor 18a, a heater 18b and a control unit 18c which may include user-selectable fan speeds, controllable heat amounts and temperature control. The heater/blower assembly 18 provides a stream of heated air through a connecting hose 20. When the heater/blower assembly 18 is operated, the stream of heated airflows through the inflation cuff 16. Figure IB is a plan view of the inflatable thermal blanket 10 opened flat to show details of its structure. Figure IB illustrates the upper surface of the inflatable thermal blanket, that is, the side that is visible in Figure 1A. As seen, the upper surface consists of a parallel array of elongated channels of which 30 and 32 are the lateral most channels, 34 is the center channel, and the channels 38 are arrayed between one of the lateral most channels and the center channel. Each channel is separated from an adjacent channel by a seam, which can be continuous or discontinuous, one of which is indicated by 40. The seam 40 separates the channel 32 and its nearest adjacent neighbor 38. The discontinuous seam 40 is interrupted by passageways 42 communicating between the channels. An interrupted seam separates every channel from one adjacent neighboring channel. The seams permit the inflatable thermal blanket, when inflated, to assume a tubular structure on the upper surface, while the ports 42 permit full circulation of the inflating medium throughout the array of channels. The foot-end seam 45 is continuous. The channels are inflated through the center channel 34 which transitions to a port 36, through which the inflation cuff 16 is inserted. A seal can be made between the inflation port 36 and the inflation cuff 16 by any conventional means, for example, an o-ring, or even tape. When the inflating medium is introduced into the center channel 34, it flows laterally from the center channel into all of the other channels through the ports 42.

[0034] Construction details of embodiments of the inflatable thermal blanket 10 are illustrated in Figures 3 and 4. In some embodiments, the inflatable thermal blanket 10 is assembled from a base sheet and a top sheet. The base sheet consists of an underside layer 50 formed from a flexible, fibrous, preferably non- woven structure composed of synthetic or natural materials capable of bonding to an upper side layer 52 of a heat-sealable synthetic material such as plastic. For example, the underside layer 50 may be a non- woven, hydroentangled polyester material and the upper side layer 52 may include a polyolefin such as a polypropylene film which is extrusion-coated, thermally laminated, or adhesively laminated onto the polyester layer 50. Alternatively, the underside layer 50 may comprise a non-woven, paper-based material to which the upper side layer 52, including either a polyethylene or polypropylene film, has been glue laminated. In one embodiment, the layers 50 and 52 are made with a stratum of absorbent tissue paper pre laminated with a layer of heat-sealable plastic has been used.

[0035] The top sheet 53 of the inflatable thermal blanket preferably comprises the same material as the upper side layer 52 of the base sheet. The top sheet 53 thus may consist of a sheet of plastic bonded to the plastic upper side 52 of the base sheet. It is preferably attached by a continuously-running web process including stations that provide an interruptible heat-sealing process. This interruptible heat sealing process can be controlled to form elongate heat seals that define the inflatable channels therebetween. The seals can be formed as continuous air impervious seals or discontinuous air permeable seals. The interruptible heat sealing process is used to form the continuous seams, one of which is the seam 40 in Figure IB, the interrupted seams, one of which is indicated by 54, and the inflatable channels, one of which is indicated by 55. As can be seen in Figure 3, the interruption of the seam 54 forms a passageway 56 between adjacent channels 55 and 57. In some cases, absorbent material can be applied to the thermal blanket, for example, applied as a single material layer 60. The absorbent material can be bonded to the upper plastic layer by heat processing or by gluing.

[0036] The inflatable thermal blanket is enabled to bathe a patient in the thermally controlled inflating medium introduced into the inflatable thermal blanket, when inflated, by means of a plurality of apertures 62 shown in Figures 4 and 5. The apertures extend through the underside of the blanket, which includes the layers 50 and 52. In some implementations, the apertures 62 are made in the footprints of the channels of the blanket upper side according to a pattern which has been determined to deliver a very uniform thermal bath. In this regard, no apertures are provided through the underside into the lateral most channels 30 and 32, or into the center channel 34. In addition, the apertures 62 are provided through the underside to the channels in a density which varies inversely with the proximity of the channel to the center channel 34. Thus, the density of apertures increases from the channel 38a through the channel 38d. The varying density of the apertures 62 tends to reduce this gradient further by forcing hotter air to the edges of the blanket. Thus, the thermal bath delivered to the patient is of a generally uniform temperature. The aperture density variation also equalizes the flow of inflating medium out of the apertures. As will be evident, the inflating pressure will be greatest at the center channel 34 and will tend to diminish toward the lateral edges of the inflatable thermal blanket. Therefore, fewer apertures are required for the channels near the center channel 34 to deliver the same amount of air as the relatively greater number of apertures in the channels at a greater distance from the center channel 34. The apertures comprise openings which can be of any appropriate shape.

[0037] Figures 2A and 2B illustrate another embodiment of an inflatable thermal blanket 210. Figure 2A is a perspective view of the embodiment of the inflatable thermal blanket 210 and Figure 2B is a bottom view of the embodiment illustrated in Figure 2A. The inflatable thermal blanket 210 includes a material layer 212 and a base layer 213 brought together at a periphery 214. The top layer 212 is attached to the bottom layer 213 at least one location within the periphery 214. In some embodiments, the top layer 212 is attached to the bottom layer 213 at a plurality of locations 216. The top layer 212 and/or the bottom layer 213 are air permeable using various materials or mechanical structures, for example, air-permeable materials, apertures, interstices, slits, or the like. In order to provide an input of pressurized and thermally regulated air to inflate the blanket 210, one or more openings are provided in the blanket 210. For example, the openings can include one or more inlet ports (218 illustrated in Figure 2A), cuffs (e.g. 16 illustrated in Figure 1 A), sleeve openings at the edge of the top and bottom layers, or the like. A relatively stiff collar 219 of material is provided for receiving the end of an air hose A. Another end (not shown) of the air hose A may be connected to a source of pressurized, warmed air, such as the heater/blower that is illustrated in Figure 1 A. The air is conducted through the air hose A through the inlet port 218 whence it flows throughout the interior of the blanket 210 between the top and bottom layers of the blanket 210 and causes the blanket 210 to inflate. More than one inflation port may be provided. For example, the port 220 with inflation collar 221 is shown in Figure 2A. The unused inflation port or ports would, of course, be sealed in order to prevent the exit of the pressurized gas during operation of the blanket 210.

[0038] Figure 2C shows a cross sectional view of the embodiment of the inflatable thermal blanket illustrated in Figures 2A and 2B. Figures 2D is an enlarged view of a portion of the inflatable thermal blanket illustrated in Figure 2C. In some embodiments, the top layer 212 and/or bottom layer 213 are made from a polyester non-woven extrusion 212p and 213p, each with a coating of polypropylene 212c and 213c on one side. One of the top layer 212 and bottom layer 213 may have holes 229 formed by punching, slitting, or cutting to permit the flow of pressurized air from the pad through the layer. In some cases, the holes 229 can be opened through both layers 212 and 213. When the pad is assembled, the polypropylene-coated side 212c of the top layer 212 is sealed to the polypropylene-coated side 213c of the bottom layer 213 at the periphery 214, and the one or more locations 216 to form the pad. The sealing process can use various techniques, for example, ultrasonic welding, radio frequency welding, heat sealing, or the like. Alternatively, the top layer 212 and bottom layer 213 may each include a laminate of polypropylene and polyolefin web with holes formed in at least one of the layers to support passage of pressurized air. In yet another embodiment, at least one of the layers 212 and 213 can use air permeable material, for example, spunbond-meltblown-spunbond (SMS) nonwoven material, or the like.

[0039] Multi-sectional temperature regulating surgical barrier device

[0040] Figure 6 illustrates a plan view of an embodiment of a multi-sectional temperature regulating surgical barrier device 600. The surgical barrier device 600 includes a surgical drape 610 and an inflatable thermal blanket 630. The surgical drape 610 includes a plurality of drape sections, 601, 602, 603, and 604 as illustrated in Figure 6. Each drape section includes a drape sheet of flexible material 605 that is configured to provide barrier for a surgical site on a patient's body to protect the sterile field. The inflatable thermal blanket 630 is configured to cover a portion of the patient's body and can be any of the embodiments as described above. The surgical barrier device 600 can optionally include a first attachment device 640 disposed on one or both surfaces of the inflatable thermal blanket 630 and configured to attach the inflatable thermal blanket 630 to the patient and/or the surgical drape 610. The first attachment device 640 may be disposed on either the patient side of the thermal blanket 630 or on the drape side of the thermal blanket or both. In some cases, the first attachment device 640 can be applied to the thermal blanket 630. In some other cases, the first attachment device 640 can be provided separately from the thermal blanket 630. Additionally, the attachment device 640 may include one or more adhesive and/or mechanical attachment means. In some configurations, the attachment device 640 can include a plurality of attachment segments on one or both sides of the thermal warming blanket allowing a health care provider to reposition the thermal blanket relative to the surgical drape 610 during the operation. When used to secure the thermal blanket 630 to the patient, the attachment device 640 may include one or more individual sections of skin compatible adhesive, each section with an individual release liner.

When used to secure the thermal blanket 630 to the surgical drape 610, the attachment device 640 may include one or more individual sections of repositionable pressure sensitive adhesive, each section with an individual release liner, or mechanical fasteners such as those described below related to the attachment device 809 in Figures 8A and 8B.

[0041] In some embodiments, the surgical barrier device 600 can optionally include a second attachment device 620 disposed on a surface of the surgical drape 610 and configured to attach at least a portion of the surgical drape 610 to the patient. In some cases, the second attachment device 620 can be provided separately from the surgical drape 610. In the embodiment illustrated in Figure 6, the second attachment device 620 can include a plurality of adhesive strips, where each strip is configured to attach a portion of a drape section to the patient. In some cases, at least one of the drape sections includes a mark to identify a portion of the drape section, the location and/or perimeter of the inflatable warming blanket, for example, such as 650 and 660 illustrated in Figure 6. For example, mark 650 can be used to show the center of the inflatable thermal blanket 630. As another example, mark 660 can be used to show the vertical middle line of the drape section 602. Additionally, the surgical drape 610 can be shaded, colored, marked, or labeled with an adhesive label in an area, areas, or pattern that represents the location of the underlying inflatable thermal blanket 630. As illustrated in Figure 6, the drape sections are generally rectangular. In some alternative embodiments, the surgical drape 610 can have drape sections with various sizes and shapes.

[0042] The first attachment device 640 and /or second attachment device 620 can include skin compatible adhesive that provides an adequate seal between the surgical site and the rest of the patient, portions of which may be warmed by the inflatable thermal blanket. As illustrated in Figure 7A, the adhesive of an adhesive strip can be continuous. Alternatively, as illustrated in Figure IB, an adhesive strip can have patterned adhesive areas, where one or more adhesive areas may include adhesives of various properties and compositions to enable optimal adhesion to either skin, drape materials, or other surfaces. In addition, such patterned adhesive areas can have better insulation capability to prevent inflating medium from leaking through the adhesive strip. Preferred adhesives are relatively unaffected by the warm air and do not build adhesion excessively with exposed to this heat for two hours or more. Preferred adhesives include acrylates and silicone pressure sensitive adhesives.

[0043] Figures 8A and 8B are cross-sectional views of two embodiments of a surgical barrier device 800 with a surgical drape attached to or integrated with an inflatable thermal blanket. As illustrated in Figure 8A, the surgical barrier device 800 includes a drape sheet 810, a material sheet 803, a base sheet 804, and an attachment device 809. The drape sheet 810 includes a barrier sheet 802 and an optional top sheet 801. The barrier sheet 802 is impermeable to liquid penetration. Preferred barrier sheets are free of pin holes. The top sheet 801 is typically a nonwoven fabric, such as a spunbond, hydroentangled or carded web. The top sheet 801 may be hydrophilic or hydrophobic and may have treatment in or on the fibers to impart this property. In some cases, the base sheet 804 is air permeable and the material sheet 803 is not air permeable. The material sheet 803 is attached to a surface of the base sheet 804 to form an inflatable portion. The attachment device 809 can use any permanent or releasable attachment means, for example, two-sided adhesive, perforated tear-away tabs, hook and loop, sewing, snaps, heat, ultrasonic, rivets, repositionable adhesives, mechanical reclosable fasteners, or the like. In some cases, the drape sheet 810 has a first drape surface 810a and a second drape surface 810b, where the first drape surface has greater friction coefficient than the second drape surface. In some embodiments, the coefficient of friction of either surface 810a or 810b can be selectively varied to create areas that can retain or be adapted to retain surgical related instruments, cables, or hoses. [0044] Alternatively, as illustrated in Figure 8B, the surgical barrier device 800 includes a drape sheet 810, a base sheet 804, and an attachment device 809. In such embodiment, the drape sheet 810 is not air permeable. The drape sheet 810 is attached to a surface of the base sheet 804 to form an inflatable portion by the attachment device 809.

[0045] Figure 9A illustrates a diagrammatic cross-sectional view of an embodiment of a surgical barrier device 900 when the inflatable thermal blanket is inflated. The surgical barrier device 900 includes a surgical drape 910, an inflatable thermal blanket 920, an attachment device 906 configured to attach the drape 910 to a patient 902. The surgical drape includes a drape sheet 905. The inflatable thermal blanket 920 includes a base sheet 908 and a material sheet 907. The inflatable portion 921 formed by a base sheet 908 and a material sheet 907 is configured to have a recess 926 close to the location where the surgical drape 910 is attached to the patient 902 via the attachment device 906. In some cases, this recess may be formed by joining or sealing portions of base sheet 908 and material sheet 907 at one or more locations in order to limit the inflatable loft of the thermal blanket 920 at discrete locations. In some cases, the blanket 920 can be attached to the patient 902 via an attachment device 924.

[0046] In some cases, the inflatable portion may have sections with various volumes when inflated. As an example, the inflatable portion may have a section 931 with lower volume than the volume of the other sections 932 and 933, as illustrated in Figure 9B. In some configurations, the section 931 is in the middle of the warming blanket. Such configurations can provide uniform warming across the blanket. In some other configurations, the volume of the section 932 can be different from the volume of the section 933.

[0047] In some cases, a surgical barrier device can include more than one inflatable thermal blanket and various numbers and shapes of drape sections, as illustrated in Figures 9C and 9D. Referring to Figure 9C, a surgical barrier device 940 can include two drape sections 951b and 952b and two inflatable thermal blankets 960a and 960b. The inflatable thermal blankets 960a and 960b can be attached to or integrated with the drape sections as any of the embodiments described above. In some cases, the inflatable thermal blankets 960a or 960b may extend beyond the perimeter of the drape sections 951b or 951b, to cover the patient. The drape sections 951b and 952b are generally L-shape. Referring to Figure 9D, a surgical barrier device 940 can include two drape sections 951c and 952c and an inflatable thermal blanket 960c. The drape section 951c is generally rectangular and the drape section 952c is generally U- shape.

[0048] Figures 1 OA and 10B show one embodiment of the multi-sectional temperature regulating surgical barrier device, in which the inflatable thermal blanket is deployed over the pelvic area and lower extremities of the patient. In Figure 10A, a patient 300 reclines on an examination table 302. The patient's head 304 lies prone on the table 302, as do the patient's torso 306, arms 308, legs 310, and feet 312. The patient's arms 308 lie at the patient's side and the patient's feet 312 are slightly apart. A surgical barrier device 319 includes an inflatable thermal blanket 320, constructed to warm convectively by exhausting warm air onto the patient 300, and a surgical drape 321 constructed to provide a fluid barrier between a surgical site on a patient's body and the remainder of the patient's body. The surgical drape 321 includes two drape sections 321a and 321b. As illustrated, the sides 326a and 327a of the drape section 321a can overlap with the sides 326b and 327b of the drape section 321b. The inflatable thermal blanket 320 is configured to cover the patient's pelvic area and lower extremities, while the drape 321 provides barrier functions, in addition to covering additional portions of the patient and providing access to a surgical site. The surgical barrier device 319 includes two ends 322 and 324 and an inflation inlet port 328 that opens into the inflatable thermal blanket 320. The inlet port 328 may be connected through a flexible heater hose, such as the hose 20 shown in Figure 1 , to a heater/blower assembly such as the assembly 18 shown in Figure 1A. In Figures 10A and 10B, the inlet port 328 is shown mounted on the underside of the inflatable thermal blanket 320, but it could also be mounted on the upper side or the edge of the blanket.

[0049] The inflatable thermal blanket 320 is formed as an inflatable covering that includes a flexible upper sheet 340 and a flexible base sheet 342, as shown in Figures 12A and 12B. These sheets are secured to each other along a peripheral seam 344 that extends around the periphery of the inflatable thermal blanket. The peripheral seam 344 can be formed by a heat sealing process, as described above. It is preferably continuous, but may also be formed with interruptions at selected locations thereof to facilitate egress of the inflating medium, e.g., heated air, for the purposes described above. The upper sheet 340 and the base sheet 342 are constructed using the materials and techniques described above, forming a parallel array of elongated channels using seams formed by elongated heat seals as shown in Figures 1 A and IB, an array of quasi-discrete inflatable spaces 348 formed using point seals 350, as shown in Figures 10A and 10B, or other equivalent embodiments. As Figures 12A and 12B show, a plurality of apertures 352 (identical to the apertures 62 shown in Figure 5) open through the base sheet 342 into the inflatable thermal blanket 320. The apertures allow convective delivery of the inflating medium into the space surrounding the patient, which is enclosed by the surgical barrier device 319. The base sheet 342 of the inflatable thermal blanket 320 can be constructed like the base sheet of Figure 3, which comprises an underside layer 50 made from a flexible, fibrous material, and an upper side layer 52 made from a heat- sealable synthetic material. The apertures may be formed as holes extending through both of the layers 50 and 52 of this base sheet. Alternatively, the apertures may be formed as holes extending through the upper layer 52 of the base sheet, and as spaces which naturally occur between the fibers of the fibrous material used to form the underside layer 50.

[0050] Returning to Figures 10A and 10B, the inflatable thermal blanket 320 is attached to, or integrally formed with, one or more drape sections of the surgical drape 321. The drape 321 including drape sections 321a and 321b, extends from the periphery of the inflatable thermal blanket 320, extends outwardly to define the ends 322 and 324 and the sides 326 and 327 of the surgical barrier device 319. As shown in Figure 10A, the drape sections 321a and 321b are generally L-shape. The surgical drape 321 is preferably sized so that it extends over the entire upper surface of the table 302, so as to completely cover the patient 300. As such, the end 322 extends at least to cover the patient's head, the end 324 extends at least to cover the patient's feet, and the sides 326 and 327 extend at least to cover the patient's sides, arms and legs. More preferably, the drape 321, at the foot end 324 and sides 326 and 327, hangs well below the edge of the table 302.

[0051] In order to provide access to the patient 300 for performing surgery at a surgical site 362, the drape sections of the surgical drape 321 can form a surgical access window 364. With a surgical drape 321 having multiple drape sections, a health care provider can lay down each drape section to form a surgical access window 364 at a desired location and with a suitable size and shape. Additionally, one or more drape sections can have a warming blanket integrated with or attached to the drape sheet such that the health care provider can control the warming configuration. Optionally, the surgical barrier device 319 can include a surgical incise drape 365 (i.e., an adhesive coated flexible plastic barrier drape adhered to the patient through which a surgeon makes an incision) that can be attached to the patient covering the surgical site 362. The surgical incise drape 365 is configured to cover at least a portion of the surgical access 364. An attachment device 366, such as one or more pressure sensitive adhesive strips, may be provided around the edges of the surgical access 364 in order to secure the drape 321 to the patient and to provide a seal that isolates the surgical site and keeps the inflating medium away from it. Because the drape 321 is not inflatable, it may be pressed flush against the patient 300 around the periphery of the surgical access 364, and optionally secured, so that unobstructed access to the patient is ensured.

Optionally, another attachment device 352, such as one or more surgical adhesive strips, may be provided at the edge of the inflatable thermal blanket 320 proximate to the surgical access window 364 that can keep the inflating medium away from the surgical site. In the implementation as illustrated, the inflatable thermal blanket 320 is attached to the patient at a location that is covered by the surgical drape 321. Optionally, a third attachment device (not shown), which may be applied on one or more drape sections or provided separately, can be used to releasably attach at least two of the drape sections to one another. The third attachment device can use pressure sensitive adhesive materials, nontacky adhesive materials, perforated connections, static clings, and a combination thereof.

[0052] The drape 321 is employed for the same purposes as surgical drapes that are known in the art. The drape 321 also helps retain the inflating medium proximate to the patient body, after it has been exhausted from the blanket 320 through apertures in the base sheet thereof. Air that is exhausted from the inflatable thermal blanket 320 flows beyond the edge thereof and beneath the drape 321, where it is maintained in proximity to the patient 300. At the head end 322, it is necessary to keep the drape 321 away from the patient's nose and mouth, so that respiration is not impaired. For that purpose, a frame structure, which may be formed by a pair of vertical posts 368 mounted on the table 302, is provided. The head end 322 of the surgical barrier structure 319 may be wrapped around the posts 368 and secured using tape 370 or any other appropriate fastening device, such as clips, etc. [0053] A drape section can be formed in a variety of ways. As shown in Figures 12A and 12B, a drape section 321x of the drape 321 can be formed as an extension of the material forming the upper sheet 340 of the inflatable thermal blanket 320. Alternatively, as shown in Figures 13A and 13B, the drape section 321x can be formed as an extension of the material forming the base sheet 342 of the inflatable thermal blanket 320. A drape section can also be formed as an extension of both of the aforementioned sheets 340 and 342. This is shown by the dotted line 340a, which represents extension of the upper sheet 340, if desired. In these embodiments, the drape section 321x is formed integrally with the inflatable thermal blanket 320.

[0054] Alternatively, as shown in Figures 14A and 14B, the drape section 321x can be formed as one or more separate sheets of material 372 that are attached by heat sealing, gluing, welding or the like, around the periphery of the upper sheet 340 (or the base sheet 342) at the location of the edge seam 344. Each sheet 372 may be configured as fringe sheet that is attached at an edge portion thereof to the upper sheet 340 (or the base sheet 342). More preferably, however, one or more single large sheets may be placed over and attached to the top of the upper sheet 340.

[0055] Figure 1 1 A illustrates a plan view of one embodiment of a surgical barrier device 419 used on a patient. Figure 1 IB is a perspective view of the embodiment depicted in Figure 1 1A. As illustrated in Figures 1 1A and 1 IB, the surgical barrier device 419 is used in abdominal surgery, in which an inflatable thermal blanket 420 is deployed for thermally bathing the chest and upper extremities of a patient, and a surgical drape 421 is deployed for covering portions of the patient's body, while performing barrier functions and providing access to a surgical site in the patient's abdomen and lower chest area.

[0056] In Figure 1 1A, a patient 400 is laid on an examination table 402. The patient's head 404 lies prone on the table 402, as do the patient's torso 406, arms 408, legs 410 and feet 412. The patient's feet 412 are slightly apart. The patient's arms 408 are spread apart laterally at approximate right angles to the patient 400 and are supported on lateral arm rests 414 that are attached to the table 402. The surgical barrier device 419 (that includes the inflatable thermal blanket 420 and the surgical drape 421) is deployed over the patient. In some implementations, the drape 421 and blanket 420 are deployed together. In some cases, the combination is folded for easy deployment over the patient. For example, in one embodiment, the combination is placed at the incision site and may or may not be secured to the patient. The drape/blanket combination then is deployed by pulling the upper section up and over the patient and anesthesia screen and the lower section down over the lower part of the patient. In some cases, the drape/blanket combination is folded to provide simple and smooth unfolding in this manner.

[0057] The thermal blanket 420 is constructed to convectively warm by exhausting warm air onto the patient 400. The inflatable thermal blanket 420 is similar in most respects to the inflatable thermal blankets shown in the preceding embodiments, except that it is configured to have an inflatable portion that extends over the patient's chest and upper extremities, while the surgical drape 421 covers additional portions of the patient. In some embodiments, the drape and/or blanket comprises means to prevent exhausting air flow from contaminating the surgical wound. For example, pressure sensitive adhesive strips may be used to seal off the heated air section from the incision site. The surgical drape 421 includes ends 422 and 424. In one embodiment as illustrated in Figure 1 1A, the surgical drape 421 has four drape sections 421a, 421b, 421c, and 421d. Each drape sections cover a portion of the patient 400 respectively. As illustrated in Figures 1 1A and 1 IB, the drape section 421a covers the upper portion, the drape section 421b covers the lower portion, and the drape sections 421c and 421d cover two sides. The surgical barrier device 421 has an inflation inlet cuff 428 that opens into the inflatable thermal blanket 420. The inlet cuff 428 may be connected through a flexible heater hose, such as the heater hose 20, to the heater/blower assembly 18, the construction of which is described above in connection with Figure 1 A. In Figures 1 1A and 1 IB, the inlet cuff 428 is shown mounted to the underside of the blanket 420, but it could also be mounted to the upper side of the blanket.

[0058] The inflatable thermal blanket 420 is elongated at 430 and 432 so as to traverse substantially all of the patient's arms 408 as they lie on the arm rests 414 of the table 402. In some embodiments, the inflatable thermal blanket 420 is formed as an inflatable covering that includes a flexible upper sheet and a flexible base sheet that are identical to the upper and base sheets 340 and 342 shown in Figures 12A and 12B. These sheets are secured to each other along a peripheral seam 444 that extends around the periphery of the inflatable portion. The peripheral seam 444 can be formed by a heat sealing process as described above. It is preferably continuous, but may also be formed with interruptions at selected locations thereof to facilitate egress of the inflating medium, e.g., heated air, as described above. The upper and base sheets of the inflatable thermal blanket 420 can be constructed, for example, using the materials and techniques described above in connection with Figures 2-4, forming a parallel array of elongated channels using seams formed by elongated heat seals as shown in Figures 1A and IB, or an array of quasi-discrete inflatable chambers 448 formed using point seals 450, as shown in Figures 10A and 10B, or other equivalent embodiments. A plurality of apertures identical to the apertures 352 shown in Figures 12A and 12B open through the base sheet into the inflatable thermal blanket 420. The apertures convectively deliver the inflating medium into space surrounding the patient, which is enclosed by the surgical barrier device 419. The base sheet of the inflatable thermal blanket 420 is preferably constructed like the base sheet of Figure 3, which comprises an underside layer 50 made from a flexible, fibrous material, and an upper side layer 52 made from a heat-sealable synthetic material. The apertures may be formed as holes extending through both of the layers 50 and 52 of this base sheet. Alternatively, the apertures may be formed as holes extending through the upper layer 52, and as spaces which naturally occur between the fibers of the fibrous material used to form the underside layer 50.

[0059] The inflatable thermal blanket 420 is attached to, or formed integrally with, one or more drape sections of the surgical drape 421. The drape section 421a extends from the periphery of the inflatable thermal blanket 420 outwardly to define the head end 422, the foot end 424a, the sides 426a and 427a of the drape section 421a. As shown in Figure 1 IB, the surgical drape 421 is preferably sized so that it extends over the entire upper surface of the table 402 so as to completely cover the patient 400. As such, the end 422 will extend at least to cover the patient's-head, the foot end 424 of the surgical drape 421 will extend at least to cover the patient's feet, the sides 426a and 427a of the drape section 421a can extend at least to cover the patient's torso and legs, and the sides 426b and 427b of the drape section 421b can extend at least to cover the patient's extended arms. More preferably, the drape section 421b, at the foot end 424, hangs well below the edge of the table 402.

[0060] In order to provide access to the patient 400 for performing surgery at a surgical site 462, the drape sections 421a, 421b, 421c, and 421d of the surgical drape 421 can form a surgical access 464 by the edges of the drape sections. An attachment device 466, such as one or more adhesive strips, may be provided close to the edges of the surgical access 464 in order to secure the drape 421 to the patient, and provide a seal that isolates the surgical site and keeps the inflating medium away from it. Because the drape 421 is not inflatable, it may be pressed flush against the patient 400 around the periphery of the surgical access 464, and optionally secured, so that unobstructed access to the patient is ensured.

[0061] The drape 421 is employed for the same purposes as surgical drapes that are known in the art. The drape 421 also helps retain the inflating medium proximate to the patient body. Air that is exhausted from the inflatable thermal blanket 420 flows beyond the edge thereof and beneath the drape 421, where it is maintained in proximity to the patient 400. At the head end 422, it is necessary to keep the drape 421 away from the patient's nose and mouth, so that respiration is not affected. For that purpose, a frame structure, which may be formed by a pair of vertical posts 468 mounted on the table 402, is provided. The head end 422 of the surgical barrier device 419 may be wrapped around the posts 468 and secured using tape 470 or any other appropriate fastening device, such as clips, etc.

[0062] In one embodiment, an inflatable thermal blanket is folded within one of the drape sections of the surgical drapes but it is not attached to any of the drape sections. With such embodiment, the inflatable thermal blanket and the surgical drape can be disposed on a patient at the same time.

Exemplary Embodiments

[0063] Embodiment 1. A combination for use during surgery on a patient, comprising:

a surgical drape comprising a plurality of drape sections, each drape section comprising a drape sheet of flexible material;

an inflatable thermal blanket comprising:

a flexible base sheet;

a material sheet attached to a first surface of the base sheet by a plurality of seals to form an inflatable portion; and

a plurality of apertures through the base sheet within the inflatable portion; a first attachment device configured to attach the inflatable thermal blanket to the patient; and a second attachment device configured to attach at least a portion of the surgical drape to the patient,

wherein at least one of the plurality of drape sections is integrated with or attached to the inflatable thermal blanket.

[0064] Embodiment 2. The combination of Embodiment 1, wherein the first attachment device comprises one or more adhesive strips.

[0065] Embodiment 3. The combination of Embodiment 1 or Embodiment 2, wherein the second attachment device comprises one or more adhesive strips.

[0066] Embodiment 4. The combination of any one of the Embodiment 1 to Embodiment 3, wherein the plurality of drape sections comprise a large sized drape section, a medium sized drape section, and two small sized drape sections.

[0067] Embodiment 5. The combination of any one of the Embodiment 1 to Embodiment 4, wherein the drape sheet of at least one of the plurality of drape sections comprises a first drape surface and a second drape surface, the first drape surface having greater friction coefficient than the second drape surface.

[0068] Embodiment 6. The combination of any one of the Embodiment 1 to Embodiment 5, wherein at least one of the drape sections comprises a mark.

[0069] Embodiment 7. The combination of any one of the Embodiment 1 to Embodiment 6, wherein the plurality of drape sections are configured to provide a surgical access among two or more edges of the drape sections for accessing a surgical site on the patient.

[0070] Embodiment 8. The combination of any one of the Embodiment 1 to Embodiment 7, wherein the first attachment device is configured to be applied to the inflatable thermal blanket at a location, wherein the location is covered by the surgical drape.

[0071] Embodiment 9. The combination of Embodiment 8, wherein the inflatable portion is configured to have a recess proximate to the location when it is inflated.

[0072] Embodiment 10. The combination of any one of the Embodiment 1 to Embodiment 9, further comprising: a surgical incise drape configured to cover at least a portion of the surgical access.

[0073] Embodiment 1 1. The combination of any one of the Embodiment 1 to Embodiment 10, further comprising: a third attachment device configured to releasably attach at least two of the drape sections to one another.

[0074] Embodiment 12. The combination of Embodiment 1 1, wherein the third attachment device comprises at least one of adhesive material, perforated connections, and static cling.

[0075] Embodiment 13. The combination of Embodiment 4, wherein the large sized drape section and the medium sized drape section are configured to cover a head end and a foot end of the patient, and wherein the two small sized drape section are configured to cover two sides of the patient.

[0076] Embodiment 14. A temperature regulating surgical barrier device, comprising: a surgical drape comprising a plurality of drape sections, at least one of the drape sections comprising an air impermeable drape sheet, the at least one of the drape sections further comprising: an air permeable base sheet attached to a first surface of the drape sheet via a plurality of seals to form an inflatable portion;

a first attachment device configured to attach at least a portion of the surgical drape to a patient.

[0077] Embodiment 15. The temperature regulating surgical barrier device of Embodiment 14, wherein the first attachment device comprises one or more adhesive strips.

[0078] Embodiment 16. The temperature regulating surgical barrier device of Embodiment 14 or Embodiment 15, wherein the plurality of drape sections comprise a large sized drape section, a medium sized drape section, and two small sized drape sections.

[0079] Embodiment 17. The temperature regulating surgical barrier device of any one of the

Embodiment 14 to Embodiment 16, wherein the drape sheet comprises a first drape surface and a second drape surface, the first drape surface having greater friction coefficient than the second drape surface.

[0080] Embodiment 18. The temperature regulating surgical barrier device of any one of the

Embodiment 14 to Embodiment 17, wherein at least one of the drape sections comprises a mark.

[0081] Embodiment 19. The temperature regulating surgical barrier device of any one of the

Embodiment 14 to Embodiment 18, wherein the plurality of drape sections are configured to provide a surgical access among two or more edges of the drape sections for accessing a surgical site on the patient.

[0082] Embodiment 20. The temperature regulating surgical barrier device of any one of the

Embodiment 14 to Embodiment 19, wherein the inflatable portion is configured to have a recess when it is inflated, wherein the recess is proximate to a location where the first attachment device is applied.

[0083] Embodiment 21. The temperature regulating surgical barrier device of any one of the

Embodiment 14 to Embodiment 20, further comprising: a surgical incise drape configured to cover at least a portion of the surgical access.

[0084] Embodiment 22. The temperature regulating surgical barrier device of any one of the

Embodiment 14 to Embodiment 21 , further comprising: a second attachment device configured to releasably attach at least two of the drape sections to one another.

[0085] Embodiment 23. The temperature regulating surgical barrier device of Embodiment 22, wherein the second attachment device comprises at least one of adhesive material, perforated connections, and static cling.

[0086] Embodiment 24. The temperature regulating surgical barrier device of Embodiment 16, wherein the large sized drape section and the medium sized drape section are configured to cover a head end and a foot end of the patient, and wherein the two small sized drape section are configured to cover two sides of the patient. [0087] Embodiment 25. The temperature regulating surgical barrier device of any one of the

Embodiment 14 to Embodiment 23, wherein the plurality of drape sections comprise an L-shape drape section.

[0088] Embodiment 26. The temperature regulating surgical barrier device of any one of the

Embodiment 14 to Embodiment 25, wherein the plurality of drape sections comprise a U-shape drape section.

[0089] The present invention should not be considered limited to the particular examples and embodiments described above, as such embodiments are described in detail to facilitate explanation of various aspects of the invention. Rather the present invention should be understood to cover all aspects of the invention, including various modifications, equivalent processes, and alternative devices falling within the spirit and scope of the invention as defined by the appended claims.

Claims

What is claimed is:

1. A combination for use during surgery on a patient, comprising:

an inflatable thermal blanket comprising:

a flexible base sheet;

2. The combination of claim 1, wherein the first attachment device comprises one or more adhesive strips.

3. The combination of claim 1, wherein the second attachment device comprises one or more adhesive strips.

4. The combination of claim 1, wherein the drape sheet of at least one of the plurality of drape sections comprises a first drape surface and a second drape surface, the first drape surface having greater friction coefficient than the second drape surface.

5. The combination of claim 1, wherein the first attachment device is configured to be applied to the inflatable thermal blanket at a location, wherein the location is covered by the surgical drape.

6. The combination of claim 5, wherein the inflatable portion is configured to have a recess proximate to the location when it is inflated.

7. The combination of claim 1, further comprising:

a surgical incise drape configured to cover at least a portion of the surgical access.

8. A temperature regulating surgical barrier device, comprising: a surgical drape comprising a plurality of drape sections, at least one of the drape sections comprising an air impermeable drape sheet, the at least one of the drape sections further comprising:

an air permeable base sheet attached to a first surface of the drape sheet via a plurality of seals to form an inflatable portion;

9. The temperature regulating surgical barrier device of claim 8, wherein the first attachment device comprises one or more adhesive strips.

10. The temperature regulating surgical barrier device of claim 8, wherein at least one of the drape sections comprises a mark.

1 1. The temperature regulating surgical barrier device of claim 8, wherein the inflatable portion is configured to have a recess when it is inflated, wherein the recess is proximate to a location where the first attachment device is applied.

12. The temperature regulating surgical barrier device of claim 8, further comprising:

a second attachment device configured to releasably attach at least two of the drape sections to one another.

13. The temperature regulating surgical barrier device of claim 12, wherein the second attachment device comprises at least one of adhesive material, perforated connections, and static cling.

14. The temperature regulating surgical barrier device of claim 8, wherein the plurality of drape sections comprise an L-shape drape section.

15. The temperature regulating surgical barrier device of claim 8, wherein the plurality of drape sections comprise a U-shape drape section.