Patient warming system and corresponding method

Abstract

A clinical garment for warming a patient includes: a front body panel including a first edge and opposing second edges; an insulating sheet including an insulating layer positioned between an outer layer and a membrane layer; a permeable layer adjacent to the membrane layer of the insulating sheet; a blanket section defined by a lower portion of the insulating sheet sealed to a lower portion of the permeable layer along a top edge, a bottom edge, and opposing first and second side edges of the blanket section; and at least one inlet port extending into the blanket section. The garment also includes a first back panel secured to at least a portion of the first edge of the front body panel; and a second back panel secured to at least a portion of the second edge of the front body panel.

Description

Technical Field

[0001] The present invention relates generally to patient warming devices, and more specifically to heated clothing and blankets for patient temperature management. Background Technology

[0002] Pneumatic devices for transferring heat between conditioned air and the body are known. For example, there are expandable pneumatic devices that receive a pressurized flow of hot air, expand in response to the pressurized air, distribute the hot air within the pneumatic structure, and dissipate the hot air onto the body to achieve purposes such as increasing patient comfort, reducing shivering, and treating or preventing hypothermia. These expandable devices are typically characterized as “heated blankets” or “heated covers.” For example, such expandable devices are commercially available under the trade name “Bair Hugger” from the 3M Company of St. Paul, MN.

[0003] Inflatable pneumatic warming blankets or coverings are particularly well-suited for use with supine individuals and are typically deployed by placing them directly on a person lying on a bed, wheelchair, or operating table to drape or cover a portion of the person. Because these devices are designed to cover and hang around or above a supine person, they are not easily or conveniently deployed on standing, sitting, reclining, or moving individuals. Specifically, inflatable blankets are generally unsuitable for clinical settings where patient warming is desired and the patient must be able to move between various positions. Furthermore, various clinical settings exist where patient warming is desired, each requiring its own unique access to the patient's anatomy that may not be achievable with the use of an inflatable blanket. For example, examination or treatment of a patient in a post-anesthesia recovery unit (PACU) may require access to patient tubing in the chest area, placement of an IV in the arm, application of a stethoscope to the back and / or sides, or application of a blood pressure cuff, making the use of an inflatable blanket potentially inconvenient. Additionally, patient mobility may be adversely affected if an attempt is made to maintain coverage with an inflatable blanket while moving around in a clinic, nursing home, or hospital. For example, transporting a patient in a wheelchair to an X-ray or MRI location may be more difficult when trying to keep the patient covered with an expandable blanket.

[0004] Therefore, smocks incorporating pneumatic convection devices have been developed for patients to wear, minimizing some of the inconveniences compared to expandable warming blankets. Such smocks can provide warmth to patients in a variety of environments. For example, convection smocks can be used for comfort warming in preoperative environments, such as before surgery and / or while waiting in a room different from the operating room. While many of these smocks are effective in providing the desired patient warmth, there is a need for alternative smock constructions to address varying patient needs, which can also be efficiently manufactured and assembled. Using such manufacturing and assembly techniques in the production of expandable warming blankets is also advantageous. Summary of the Invention

[0005] The clinical garment described herein consists of a front panel and two back panels. The front panel can be manufactured on an automated blanket production line from two input materials, each of which may include one or more layers. The two back panels have optional, one-piece sleeves that can be manually sewn together. The front panel includes an insulating sheet, a permeable sheet, an expandable blanket section, and optional pocket sections for accommodating a forced-air heating blanket. When included, the forced-air heating blanket can be manually placed into the pocket and removed for use as needed.

[0006] In one embodiment, a clinical garment for patient warming is provided, the garment comprising: a front body panel including a first edge and opposing second edges; an insulating sheet including an insulating layer positioned between an outer layer and a membrane layer; a permeable sheet adjacent to the membrane layer of the insulating sheet; a blanket section defined by a lower portion of the insulating sheet sealed to a lower portion of the permeable sheet along a top edge, a bottom edge, and opposing first and second side edges of the blanket section; and at least one inlet port extending into the blanket section. The garment also includes a first back panel secured to at least a portion of the first edge of the front body panel; and a second back panel secured to at least a portion of the second edge of the front body panel. Patient warming using this garment can be provided by convection through the permeable sheet, wherein the permeable sheet may be an impermeable material through which multiple perforations extend.

[0007] The forebody panel of the clinical garment may further include an upper pocket section defined by the top edge of the blanket section and a portion of the insulating sheet, the portion of the insulating sheet being attached to a portion of the permeable sheet along the top edge of the upper pocket section, wherein the upper pocket section may include at least one pocket opening between the insulating sheet and the permeable sheet. The pocket opening may include at least one side opening adjacent to at least one of a first edge and a second edge of the forebody panel, and / or may include at least one top opening adjacent to the top edge of the upper pocket section, and / or may include at least one bottom opening adjacent to the top edge of the blanket section. In one embodiment, the upper pocket section is defined by the top edge of the blanket section and a portion of the insulating sheet, the portion of the insulating sheet being attached to a portion of the permeable sheet along the top edge of the upper pocket section, the upper pocket section including at least one pocket opening defined by an opening formed between the insulating sheet and the permeable sheet above the top edge of the blanket section. The forced air heating blanket can be removably positioned within the upper pocket section. The forced air heating blanket can be an upper body blanket, lower body blanket, underbody blanket, full body blanket, torso blanket, surgical inlet blanket, etc.

[0008] The clinical garment may further include a peripheral seal that seals the outer layer, the insulating layer, and the membrane of the insulating sheet to the permeable sheet along at least a portion of the top edge of the upper pocket section and at least a portion of the bottom edge of the front panel, and seals the insulating layer to the outer layer and the membrane along at least a portion of the first and second edges of the front panel, along at least a portion of the top edge of the upper pocket section, and along at least a portion of the bottom edge of the front panel. In one embodiment, at least one of the first and second side edges of the permeable sheet may be at least slightly inwardly spaced from at least one of the first and second side edges of the insulating sheet, respectively. In one embodiment, the insulating sheet has a width defined by the distance between the first and second edges of the front panel, wherein the permeable sheet has a width smaller than the width of the insulating sheet.

[0009] In one embodiment, a clinical garment for use with a patient heating system is provided, the garment comprising an inner surface; an outer surface; an upper pocket section defined by an insulating sheet sealed to a permeable sheet at least along the edges of a top pocket and a bottom pocket; and a lower heating section adjacent to the upper pocket section. The lower heating section is defined by the insulating sheet, which is sealed to the permeable sheet to provide an interior region accessible via at least one port extending into the lower heating section. The insulating sheet includes an insulating layer positioned between an outer layer and a membrane layer.

[0010] In one embodiment, a method of manufacturing a forebody piece for clinical garments is provided, the method comprising the steps of: providing an insulating sheet including an insulating layer positioned between an outer layer and a membrane layer; providing a permeable sheet; positioning the membrane layer of the insulating sheet adjacent to an inner surface of the permeable sheet; cutting an outer peripheral shape of the forebody piece from the combination of the insulating sheet and the permeable sheet; forming a lower blanket section of the clinical garment by sealing the permeable sheet to the insulating sheet along a sealing pattern, wherein the lower blanket section includes an expandable air space between the permeable sheet and the insulating sheet and within the sealing pattern; and sealing the outer peripheral shape of the forebody piece.

[0011] In this method, the step of forming the lower blanket section can be performed simultaneously with the step of sealing the outer peripheral shape of the pre-body piece. In one embodiment, the step of cutting the outer peripheral shape of the pre-body piece can occur after at least one of the steps of forming the lower blanket section and sealing the outer peripheral shape of the pre-body piece. The insulating sheet can be wider than the permeable sheet, and the insulating sheet can have a width substantially the same as the width of the permeable sheet, or the permeable sheet can be wider than the insulating sheet. Furthermore, the step of sealing the outer peripheral shape of the pre-body piece can include sealing the insulating sheet to the permeable sheet at the top and bottom edges of the pre-body piece, and sealing the insulating layer, the outer layer, and the membrane layer of the insulating sheet together at the first and second side edges of the insulating sheet. The upper pocket section can be formed above the lower blanket section.

[0012] In one embodiment, a clinical blanket for patient warming is provided, the clinical blanket comprising: an insulating sheet having an insulating layer positioned between an outer layer and a membrane layer; and a permeable sheet adjacent to the membrane layer of the insulating sheet. The insulating sheet is sealed to the permeable sheet along a sealing pattern to define an expandable air space between portions of the insulating sheet and the permeable sheet. The blanket includes at least one inlet port extending into the expandable air space.

[0013] In one embodiment, a clinical garment for warming a patient is provided, the garment comprising: a front body panel including a first edge and an opposing second edge; an insulating sheet including an insulating layer positioned between an outer layer and a membrane layer; a permeable sheet adjacent to the membrane layer of the insulating sheet; a blanket section defined by at least a portion of the insulating sheet sealed along a periphery to a portion of the permeable sheet; and at least one inlet port extending into the blanket section. The garment also includes a first back panel secured to at least a portion of the first edge of the front body panel; and a second back panel secured to at least a portion of the second edge of the front body panel. In this embodiment, the blanket section may comprise the entire front body panel or a sub-segment of the front body panel. The garment may also include a pocket section adjacent to the blanket section, wherein the blanket section may be, for example, below and / or above the pocket section. Attached Figure Description

[0014] The invention will be further explained with reference to the accompanying drawings, wherein:

[0015] Figure 1 This is a perspective view of one implementation of a clinical garment, showing a portion of the garment's interior as viewed from the rear.

[0016] Figure 2 yes Figure 1 A top view of one embodiment of the forebody piece of the clinical garment of the type shown;

[0017] Figure 3a is Figure 1 and Figure 2 A sectional view of a portion of the front body panel of the clinical garment of the type shown;

[0018] Figure 3b is Figure 1 and Figure 2 A sectional view of a portion of another embodiment of the forebody piece of the clinical garment of the type shown;

[0019] Figure 4 This is an enlarged top view of part of the top pocket area of ​​the clinical garment;

[0020] Figure 5 yes Figure 4 Another enlarged top view of a portion of the top pocket area of ​​the clinical garment shown, where the pocket is held in a partially open configuration;

[0021] Figure 6 It is a top view of the upper pocket section of the clinical garment from which the upper body blanket extends partially;

[0022] Figure 7This is a top front view of one embodiment of a clinical garment assembled with a front panel and two back panels;

[0023] Figure 8 yes Figure 7 Top rear view of the clinical garment, with the back panel in the closed position;

[0024] Figure 9 This is an enlarged view of one sleeve area in one embodiment of a clinical garment;

[0025] Figure 10 This is an enlarged view of the attachment area between the front and back panels of the clinical garment.

[0026] Figure 11 This is an enlarged view of one embodiment of a pocket opening in a clinical garment, showing the adhesion between a front panel layer and a back panel layer;

[0027] Figure 12 This is a top view of one implementation of the pre-body pattern for clinical garments; and

[0028] Figure 13 This is a top view of a hose clip with a hose access port through which air can enter the clinical garment. Detailed Implementation

[0029] Now refer to the attached diagram, and first refer to... Figure 1 The illustration shows one embodiment of a clinical garment 10, which typically includes a front body panel 12, a first back panel 14, and a second back panel 16. Although the seams are not visible, the first back panel 14 is attached to one side edge of the front body panel 12, and the second back panel 16 is attached to the opposite side edge of the front body panel 12. In one embodiment, the front body panel 12 is manufactured using an automated material assembly process that attaches two layers of material to each other in a defined pattern. These materials may be provided in rolls and / or as pre-cut or pre-formed sheets of material. The first back panel 14 and the second back panel 16 (which may include integrated sleeve portions) are then sewn onto the front body panel 12 using a manual, automated, or semi-automatic process. The garment 10 may also include features for holding the garment securely to the patient, such as the illustrated ties 18, or other fastening features such as adhesives, microstructure mating surfaces, etc.

[0030] See also: Figure 2The image shows a top view of the forebody panel 12. Panel 12 typically includes an expandable lower blanket section 20 and an upper pocket section 22, the upper pocket section being configured to accommodate at least one removable forced-air heated blanket, such as an upper body blanket, lower body blanket, underbody blanket, full-body blanket, torso blanket, and surgical entry blanket. The dimensions of the lower blanket section 20 may vary relative to the overall dimensions of the forebody panel 12, but embodiments will include a lower blanket section with a surface area of ​​at least 40% of the area of ​​the forebody panel 12, but may be at least 50%, at least 60%, or even a greater percentage of the surface area of ​​the forebody panel. It is also contemplated that alternative embodiments will not include the pocket section, but will instead include a heated area over all, some, or most of the surface area of ​​the forebody panel.

[0031] The front body panel 12 is a generally flat panel with an outer peripheral shape, comprising a first edge 24 spaced apart from an opposing second edge 26 across the width of the panel 12, a top edge 28 extending between the first edge 24 and the second edge 26, and a bottom edge 30 spaced apart from the top edge 28 and extending between the first edge 24 and the second edge 26. The top edge 28 may optionally include a recessed or cut-out neck portion 32, which may optionally be U-shaped, as shown. The distance between the edges of the front panel 12 may vary depending on the desired size of the clinical garment 10, wherein garments sized for larger body types will have a greater distance between the edges and a correspondingly larger surface area than garments sized for smaller body types.

[0032] The front panel 12 consists of two main layers or sheets, which together generally... Figure 2 The details are shown in Figure 3a and also in a cross-sectional side view. According to this exemplary embodiment, the forebody panel includes a first sheet or layer 40 and a second sheet or layer 50. The first sheet or layer 40, also referred to herein as a "permeable sheet," is designed as the inner surface of the assembled clinical garment 10, while the second sheet or layer 50, also referred to herein as a "thermal insulating sheet," is designed as the outer surface of the assembled clinical garment 12.

[0033] The permeable sheet 40 is a material that can be coated on one or both sides, making it impermeable except for areas where perforations, holes, or openings 42 extend through its thickness, to provide the desired permeability to air, particularly pressurized air. Alternatively, the sheet 40 may be a breathable membrane material or a membrane-type membrane without the need for discrete perforations, holes, or openings extending through it. When constructing the pre-cut sheet 12, the sheets 40 and 50 form an aerodynamic structure between them to receive and distribute pressurized air. At least one component of the device (e.g., the permeable sheet 40) cooperates with the aerodynamic structure to dissipate pressurized air from the device. In this regard, one end of an air hose may be received through an inlet port, and the pressurized, thermoconditioned airflow introduced through the air hose will fill and distribute throughout the space between the sheets 40 and 50. The pressurized air will dissipate from the aerodynamic structure through the permeable sheet 40, and the movement of the dissipated air supports heat transfer with the body of the facing layer 40 adjacent, close, or near the aerodynamic structure. For example, the material selected for the permeable sheet 40 can be chosen to be compatible with the patient's skin for comfort, but not breathable, such as a 50gsm coating material.

[0034] When the permeable sheet 40 includes perforations (e.g., perforation 42), they may be the same or different from each other across the entire surface of the layer. Generally, the perforations may have certain dimensions, such as the diameter in an example with circular openings, and the spacing between the centers of the openings. In some examples, the openings are circular in shape at the outer surface of the permeable sheet 40. In other examples, the perforations may have non-circular shapes, such as elliptical shapes, oval shapes, shapes with at least one straight edge, irregular shapes, etc. For any of the perforations, the shape may be symmetrical or asymmetrical about an axis that extends approximately through the center of the perforation. In some examples, each perforation may have a diameter of approximately 0.48 mm. 2 The area, and in some examples, can be approximately 0.20 mm. 2 Up to 0.80mm 2 The area within the range. In some examples, the spacing and number of openings provided on layer 40 are approximately 23.12 cm. 2 The total perforation area, and in some examples, within a closure of approximately 5000 cm². 2 Up to 10000cm 2 The expansion region of layer 40 within the range has approximately 10 cm 2 Up to 40cm 2 The total perforated area within these ranges. The perforation density can be higher or lower than these ranges.

[0035] The insulating sheet 50 is a composite material consisting of a central insulating layer 54 positioned between the outer layer 52 and the membrane layer 56, and the insulating sheet may be impermeable. Exemplary constructions and materials of these sublayers 52, 54, and 56 for layer 50 are provided in the following paragraphs.

[0036] The outer layer 52 may be a nonwoven material, which may include any or more of polyester, cotton, rayon, polypropylene, and wood pulp. Layer 52 may be in the range of about 5 gsm to 60 gsm.

[0037] The insulation layer 54 may be an insulating nonwoven material layer and may be formed of a number of suitable materials or combinations thereof, including but not limited to foams, nonwoven materials, and woven materials made of polymers such as polyester, polypropylene, polyethylene, polyethylene terephthalate, polyamide, polyvinyl chloride, acrylic acid, acrylic copolymers, polystyrene, rayon, acetate, and polysulfone. In a preferred embodiment, the insulation layer 54 comprises a microfiber-based web made of polypropylene and polyester, as described in U.S. Patent 4,118,531 (Hauser), and is commercially available under the trade name “Thinsulate” from the 3M Company of St. Paul, Minnesota. Some examples of suitable materials used as insulation layer 54 are 20 g / m². 2 Up to 70g / m 2 Thinsulate (Type C), 60g / m 2 Up to 80g / m 2 Thinsulate (G type), 65 gg / m 2 Woven nylon or 182g / m 2 The insulation layer 54 may comprise one or more loosely woven fabrics to contain a nonwoven material. In one example, the insulation layer 54 may have a thickness of no more than 4 cm, no more than 3 cm, no more than 2 cm, or no more than 1 cm as measured using ASTM D 5736 at 0.002 psi. In at least one embodiment, the insulation layer 54 may have a thickness between 20 g / m². 2 Up to 200g / m 2 Between, and more preferably between 40 g / m 2 Up to 100g / m 2 The base weight is adjusted to balance patient thermal comfort and preheating effectiveness.

[0038] Layer 56 may be a blown film made of a suitable flexible polymer material, such as polyethylene, polyester, polypropylene (PP), high-density polyethylene (HDPE), polyethylene terephthalate (PET), polyamide (PA), etc. Blown films are typically made of homogeneous materials. In some cases, layer 56 may be formed of a flexible, fibrous, preferably nonwoven structure, which is composed of a polymer material capable of being bonded to an upper sheet of a heat-sealable polymer material. For example, layer 56 may be a nonwoven, water-entangled polyester material or polyolefin, such as a polypropylene film extruded, heat-laminated, or adhesively laminated onto a polyester layer. Alternatively, layer 56 may be a nonwoven paper-based material, including another layer of polyethylene, polyester, or polypropylene film that has been adhesively laminated to the nonwoven paper-based material. In one embodiment, layer 56 may be made of a layer of absorbent paper pre-laminated using a heat-sealable plastic layer.

[0039] As shown in the figure, membrane layer 56 is adjacent to the inner surface of permeable sheet 40, with a slight air space 44 between them. This air space 44 is for illustrative purposes to show that these layers do not adhere to each other in the area where expansion occurs, because layers 40 and 56 would normally be in contact with each other except when the lower blanket section 20 expands.

[0040] An alternative construction of the precursor body piece 12 is shown in Figure 3b as a three-layer structure. This embodiment includes a permeable sheet 40a, an insulating layer 54a, and an outer layer 52a, which may be a perforated or membrane material layer. In such embodiments, the outer layer 52a may be coated to make it impermeable. Other features of the multi-layer body piece construction described herein also apply to this construction of the precursor body piece shown in Figure 3b.

[0041] In the production of the double-layered front body panel 12, the material constituting the permeable sheet 40 can be produced and supplied to the production line, and the three materials or sub-layers constituting the insulating sheet 50 can be made into a single roll of material also supplied to the same production line. The materials from these two rolls can be secured to each other along the top edge 28 and bottom edge 30 of the body panel 12, and the multiple sub-layers of the insulating sheet 50 are sealed to each other along the first side edge 24 and the second side edge 26. This sealing along the periphery of the body panel 12 can use the same or different sealing techniques as those used for the sealing pattern 60 (discussed below), which defines the lower blanket section 20 to seal the sheets 40 and 50 to each other within the outer periphery of the body panel 12. The outer peripheral shape of the front body panel 12 can then be cut. These steps can be performed in a variety of sequences, or at least two of these steps can be performed simultaneously.

[0042] Although the above description describes a manufacturing and assembly technique involving the supply of multiple layers from rolls, which are secured to each other as the material is unrolled from their respective supply rolls and then cut into the desired shape, it is conceivable that multiple pieces of the precursor body panel could instead be supplied as pre-cut pieces. These pieces could then be positioned adjacent to each other and sealed relative to the precursor body panel made directly from the rolls, as described.

[0043] like Figure 2 As shown, the lower blanket section 20 of the pre-body panel 12 is defined by sealing the permeable sheet 40 to the insulating sheet 50 along a sealing pattern 60 located within a peripheral seal of the pre-body panel 12. For example, the sealing can be accomplished by a heating process and / or an ultrasonic process. The illustrated sealing pattern 60 includes an outer continuous peripheral seal, which is generally rectangular and has a series of flanges 62 spaced apart from each other and extending toward the center of the lower blanket section 20. The sealing pattern 60 also includes a plurality of sealing points 64 spaced apart from each other and arranged in multiple rows offset from each other. The sealing pattern 60 is merely exemplary, as the construction used to seal the layers together may vary slightly or significantly from the pattern shown. For example, the sealing pattern may not include flanges, may include more, fewer, or differently positioned flanges, may not include sealing points, and / or may include more, fewer, or differently positioned sealing points. The flanges 62 may also be at different angles to each other, may differ from those shown, and may be longer or shorter than those shown. In any of the arrangements, the sealing pattern 60 is selected to provide a series of interconnected channels that allow for the uniform distribution of air within the lower blanket section 20, enabling air to move evenly from the permeable sheet 40 to warm the patient.

[0044] The outer periphery of the sealing pattern 60 seals the permeable sheet 40 to the insulating sheet 50, providing a cavity or closure boundary that allows air to be supplied to the lower blanket section 20. Upon expansion, the space 44 between the inner surface of the permeable sheet 40 and the inner surface of the layer 56 within the periphery of the sealing portion can be filled with air. The air can then exit through the perforations 42 of the permeable sheet 40 for warming the patient wearing the clinical garment 10.

[0045] The term "air" is used throughout the specification for embodiments supplied to clinical gowns, blankets, etc., where the supplied air can be conditioned air, including warmed air. When the air is warmed, it can be supplied at a variable temperature that will provide sufficient comfort and warmth to the patient without causing discomfort. In other embodiments, for example, it is conceivable to supply cooled air or air at ambient temperature.

[0046] See also Figure 2The permeable sheet 40 includes opposing first edges 46 and second edges 48 spaced apart across its width. In one embodiment, the width of the permeable sheet 40 is at least slightly smaller than the width of the insulation sheet 50. In this way, when sealing the periphery of the body panel 12 around its outer periphery, the permeable sheet 40 will only be sealed to the insulation sheet 50 along the width of the permeable sheet 40 at the top edge 28 and bottom edge 30 of the body panel 12. Because the permeable sheet 40 does not extend to the first edge 24 and second edge 26 of the body panel 12, the sealing process along those edges is only provided to seal layers 52, 54, and 56 of the insulation sheet 50 to each other. However, it is conceivable that the width of the permeable sheet 40 is the same as the width of the insulation sheet 50, or that the permeable sheet 40 is at least slightly larger than the width of the insulation sheet 50.

[0047] The peripheral seal of the pre-body piece 12 can have various configurations. One exemplary seal includes a series of discrete seals that provide a relatively flexible sealing arrangement that is more comfortable when the patient's skin comes into contact with the seal. In one example, the discrete seals are 3 / 16-inch high diamond-shaped seals. However, it should be understood that the seal may alternatively have different patterns of discrete shapes spaced apart from each other, and may include a continuous seal without space, and / or any other sealing configuration that provides the desired attachment of layers to each other.

[0048] Because the first edge 46 and the second edge 48 of the permeable sheet 40 are not sealed to the insulation sheet 50 at the first edge 24 and the second edge 26, these edges provide openings into the upper pocket section 22. Therefore, the periphery of the upper pocket section 22 is defined by the sealed top edge 28, the first edge 46 and the second edge 48 of the permeable sheet 40 above the lower blanket section 20, and the top edge of the lower blanket section 20. Figures 4 to 6 The image shows an enlarged view of pocket section 22, in which... Figure 4 Pocket 22 in a closed configuration is shown, and Figure 5 A pocket 22 is shown opened by pulling the permeable sheet 40 away from the insulating sheet 50 in the area of ​​the second edge 26 of the front body panel 12 and the second edge 48 of the permeable sheet 40. In an alternative embodiment, the upper pocket section includes an opening at or near the top edge 28, rather than on one or both sides of the upper pocket section, or in any other way. In yet another alternative embodiment, the upper pocket section includes an opening at or near the top edge of the lower blanket section, rather than on one or both sides of the upper pocket section, or in any other way.

[0049] Figure 6An upper body blanket 70 extending partially from one side of the upper pocket section 22 is shown. The upper body blanket 70 may be an aerodynamic convection device, such as an upper body blanket commercially available from the 3M Company of St. Paul, MN, which may be a Bair Hugger model 622. Such an upper body blanket may optionally be folded before being inserted into the upper pocket section 22 and may also optionally be in a sealed package. As previously discussed, the pocket may include any kind of forced-air heated blanket, other than an upper body blanket, such as a lower body blanket, underbody blanket, full-body blanket, torso blanket, and surgical entry blanket.

[0050] Shedding can be reduced by sealing the edges of the insulation sheet 50 as described above. As used herein, the term "shedding" refers to the release of particles from a layer that has never been sealed to prevent such release. Shedding can be measured using the Gelbo-flex shedding test to measure the number of airborne particles per cubic foot of air sloshing from the fabric. The standard protocol for shedding testing is ASTM 160.1. The particle size is typically 0.5 micrometers or larger. As defined herein, non-shedding can generally refer to a heating device having a treated or sealed insulation edge portion with a Gelboflex particle count of less than 20,000, less than 10,000, less than 5,000, less than 2,500, less than 1,000, or less than 500. In at least one embodiment, the test standard may be ISO 9073-10 (2003). According to this testing standard, "non-shedding" can also refer to a shedding coefficient of no more than 4.5, or no more than 4.4, 4.3, 4.2, 4.1, 4, 3.9, 3.8, 3.7, 3.6, or 3.5. Regarding... Figure 2 In some implementations, various techniques may be used to seal or encapsulate the peripheral edges of the front body piece 12 to prevent edge shedding. For example, outer peripheral edges 24, 26, 28, and 30 may include the aforementioned peripheral sealing patterns and / or may be flame-laminated, coated, heated, sintered, sewn, glued, or combinations thereof.

[0051] Figure 7 and Figure 8Clinical garment 10 is shown, wherein a first back panel 14 is attached to one edge of a front panel 12 and a second back panel 16 is attached to the opposite edge of the front panel 12. The first back panel 14 includes an integrated arm portion 15, and the second back panel 16 includes an integrated arm portion 17. The back panels 14 and 16 can be attached to the front panel 12 by side stitching along the lower heated section, although they can also be attached using double-sided adhesive, hook and loop materials (including microstructured interlocking materials), snaps, heat, ultrasonic devices, rivets, combinations thereof, and / or the like. Attachment of the back panels 14 and 16 in the area of ​​the upper pocket section 22 can be done using adhesive, particularly where the attachment area is difficult to access with a sewing machine, or it can also be done by hand stitching. Any combination of these or other attachment techniques can be used in various areas of the clinical garment 10.

[0052] like Figure 7 As shown, the front body panel 12 includes a port 72 through which air can be supplied to the inflatable lower blanket section 20. Specifically, port 72 extends through layers 52, 54, and 56 of the insulation sheet 50 and into the space 44 between the permeable sheet 40 and the insulation sheet 50. In operation, the patient inserts their arms into arm portions 15 and 17 of the clinical garment 12, with the front body panel 12 positioned over the front of the patient's body. A first rear panel 14 and a second rear panel 16 wrap around the patient's back and are fastened or otherwise secured to the patient. One end of an air hose can then be connected to port 72, while the other end of the air hose is connected to a heating unit. The heating unit provides a pressurized, heat-treated airflow that is directed into the space 44 to at least partially inflate the lower blanket section 20. Heating units that can be used in this application include those types that can be commercially available from the 3M Company of St. Paul, MN, including the Bair Hugger Model 675, Bair Hugger Model 775, or Bair Hugger Model 875.

[0053] The temperature of the air before entering the lower blanket section 20 can range from ambient temperature up to approximately 46°C. The average air temperature delivered to the patient can be lower than this, depending on the garment design. The airflow before entering the lower blanket section 20 can be in the range of approximately 5 CFM to 70 CFM. In at least one embodiment, the airflow can be at least 20 CFM, at least 30 CFM, or at least 40 CFM. For example, the pressure within the lower blanket section 20 can be in the range of approximately 0.05 in to 1.2 in H2O. The warming unit can be mounted on an IV stand, particularly where movement is required while the patient is wearing clinical garment 10.

[0054] When pressurized, heat-treated air is supplied to the lower blanket section 20, the lower blanket section 20 expands at least partially, causing the air to dissipate under pressure through perforations in the permeable sheet 40, thereby providing the patient with heat-controlled air at the desired temperature and flow rate. In one embodiment, the clinical garment 10 is worn such that the perforations 42 of the permeable sheet 40 face the patient primarily in the area between the neck and thighs. Thus, when pressurized, heat-treated air is supplied to the lower blanket section 20, which is distributed and then dissipated through the perforations 42 in the patient's central core or torso area. Convection then results in heat transfer between the dissipated heat-treated air and the body core, or reduces heat loss from the body to the environment.

[0055] See also Figure 7 and Figure 8 See also Figures 9 to 11 The integrated arm portions 15 and 17 of the first back piece 14 and the second back piece 16 are respectively (the arm portion 17 of the second back piece is in Figures 9 to 11 (As shown in the enlarged image) through a method such as double-sided adhesive (which in...) Figure 11 The attachment method (best shown in the diagram) is used to attach the garment to the front panel 12. Through this process, the sleeves do not need to be sewn using a separate process. As described above, although the main portions of the first back panel 14 and the second back panel 16 are sewn and / or otherwise attached to the side edges of the front body panel 12, the production rate of assembling these clinical garments 10 is increased by eliminating the need to also sew separate sleeves to the garment.

[0056] While the above discussion describes implementation schemes and variations of the front body piece, a variety of other constructions for the front body piece are conceivable, which may include different patterns for sealing the lower blanket section, different shapes for the entire perimeter of the front body piece, and other variations. Figure 12 An alternative embodiment of such an alternative implementation of the forebody panel 112 is shown. As shown, the forebody panel 112 typically includes an expandable lower blanket section 120 and an upper pocket section 122 configured to accommodate a removable forced-air heated blanket. The dimensions of the lower blanket section 120 may vary relative to the overall dimensions of the forebody panel 112, but the embodiment will include a lower blanket section with a surface area of ​​at least 40% of the area of ​​the forebody panel 112, but may be at least 50%, at least 60%, or even a greater percentage of the surface area of ​​the forebody panel. It is also contemplated that the alternative embodiment will not include the pocket section, but will instead include a heated area over all or most of the surface area of ​​the forebody panel.

[0057] The front body panel 112 is a generally flat panel with an outer peripheral shape, comprising a first edge 124 spaced apart from an opposing second edge 126 across the width of the panel 112, a top edge 128 extending between the first edge 124 and the second edge 126, and a bottom edge 130 also extending between the first edge 124 and the second edge 126. The top edge 128 may optionally include a U-shaped neck 132, as shown. The distance between the edges of the front panel 112 can vary depending on the desired size of the clinical garment to which the front panel will be used.

[0058] The front panel 112 consists of two main layers, which together generally... Figure 12 As shown in and similar to in Figure 2 The examples shown in Figure 3a are those in the cross-sectional side view. According to this exemplary embodiment, the forebody panel includes a permeable sheet 140 and an insulating sheet 150. The permeable sheet 140 is also referred to herein as the “inner layer” because it is designed as the inner surface of the assembled clinical garment, while the insulating sheet 150 is also referred to herein as the “outer layer” because it is designed as the outer surface of the assembled clinical garment.

[0059] The inner layer 140 is a material that can be coated on one or both sides, making it impermeable except in areas where perforations, holes, or openings extend through its thickness. Alternatively, layer 140 can be a breathable membrane material or a membrane-type membrane without the need for specific perforations extending through it. When constructing the front panel 112, layers 140 and 150 form an aerodynamic structure between them to receive and distribute pressurized air. At least one component of the device (e.g., sheet 140) engages with the aerodynamic structure to dissipate pressurized air from the device. In this regard, one end of an air hose may be received through an inlet port, and the pressurized, thermoconditioned airflow introduced through the air hose will fill and distribute throughout the space between layers 140 and 150. Pressurized air is dissipated from the aerodynamic structure through layer 140, and the movement of the dissipated air supports heat transfer with adjacent, adjacent, or close to the body facing layer 140 of the aerodynamic structure. For example, the material selected for layer 140 can be chosen to be compatible with the patient's skin for comfort, but not breathable, such as a 50gsm coating material. Layer 150 is a composite material consisting of a central insulating layer positioned between the outer layer and the membrane layer, which can be impermeable.

[0060] Such as about Figure 2 As shown in Figure 3, the film layer of layer 150 is adjacent to the inner surface of layer 140. Except when the lower blanket section 120 expands, these layers will generally be in contact with each other.

[0061] In the production of the double-layered front body piece 112, the material constituting layer 140 can be produced and supplied to the production line, and multiple materials or sublayers constituting layer 150 can be made into a single roll of material also supplied to the same production line. Materials from these two rolls can be secured to each other along the top edge 128 and the bottom edge 130, and multiple sublayers of layer 150 are sealed to each other along the first side edge 124 and the second side edge 126. This sealing along the periphery of the body piece 112 can use the same or different sealing techniques as those used for the sealing pattern 160 (discussed below), which defines the lower blanket section 120 to seal layers 140 and 150 to each other within the outer periphery of the body piece 112. The outer peripheral shape of the front body piece 112 can then be cut. These steps can be performed in a variety of sequences, or at least two of these steps can be performed simultaneously.

[0062] Although the above description describes a manufacturing and assembly technique involving the supply of multiple layers from rolls that are secured to each other as material is unrolled from their respective supply rolls and then cut into desired shapes, it is conceivable that multiple pieces of the precursor body panel could instead be supplied as pre-cut pieces. These pieces could then be positioned adjacent to each other and sealed relative to the precursor body panel made directly from the rolls, as described.

[0063] like Figure 12 As shown, the lower blanket section 120 is defined by sealing layer 140 to layer 150 along a sealing pattern 160. For example, the sealing can be accomplished by a heating process or an ultrasonic process. The illustrated sealing pattern 160 includes an outer continuous peripheral seal and a plurality of sealing bands 164 spaced apart from each other and arranged in multiple offset rows. The sealing pattern 160 is merely exemplary, as the construction used to seal the layers to each other may vary slightly or significantly from the illustrated pattern. In any of the arrangements, the sealing pattern 160 is designed to allow for a uniform distribution of air within the lower blanket section 120, allowing air to move uniformly from layer 140 to warm the patient. In any of the arrangements, the sealing pattern 160 is chosen to provide a series of interconnected channels that allow for a uniform distribution of air within the lower blanket section 120, allowing air to move uniformly from layer 140 to warm the patient.

[0064] The outer peripheral portion of the sealing pattern 160 seals layer 140 to layer 150 to provide the boundary of a cavity or closure that allows air to be supplied to the lower blanket section 120. Upon expansion, the space between the inner surfaces of layer 140 and layer 50 within the periphery of the sealing portion can be filled with air. The supplied air can then exit through perforations in layer 140 for warming a patient wearing clinical clothing.

[0065] See also Figure 12Layer 140 includes opposing first edges 146 and second edges 418 spaced apart across its width. The width of layer 140 is at least slightly smaller than the width of layer 150. In this way, when sealing the periphery of the body piece 112 around the outer periphery of the front body piece 112, layer 140 will only be sealed to layer 150 along the width of layer 140 at the top edge 128 and bottom edge 130 of the front body piece 112. Because layer 140 does not extend to the first edge 124 and second edge 126 of the front body piece 112, the sealing process along those edges is only provided to seal the multiple sublayers of layer 150 to each other. However, it is conceivable that the width of layer 140 is the same as the width of layer 150, or that layer 140 is at least slightly larger than the width of layer 150.

[0066] Because the first edge 146 and the second edge 148 of layer 140 are not sealed to layer 150 at the first edge 124 and the second edge 126 of layer 150, these edges provide openings into the upper pocket section 122. Therefore, the periphery of the upper pocket section 122 is defined by the sealed top edge 128, the first edge 146 and the second edge 148 of layer 140 above the lower blanket section 120, and the top edge of the lower blanket section 120.

[0067] The front panel described herein can be incorporated into a variety of clinical garments, both the same as and different from those discussed, including standard smocks, modified smocks, or special-purpose smocks. Smocks may have a back opening, a front opening, or other suitable openings, such as a head opening in a cape-type smock.

[0068] In the above embodiments, the multiple layers of the front body piece are described as having different widths, which allow for the creation of pocket sections in the unsealed edge area above the lower blanket section. However, it is also conceivable that these layers have the same width, where they will be attached to each other around the entire perimeter of the front body piece. In this case, an opening to the upper pocket section is created by cutting or otherwise separating the first and second layers at one or both edges of the front body piece.

[0069] The layers discussed herein, relating to the anterior body piece, can also be configured as a patient warming blanket. In such a configuration, the first blanket layer comprises a perforated material, and the second layer comprises an insulating layer positioned between the outer layer and the membrane layer, as described above regarding the layers of the anterior body piece. The air space between the layers allows the blanket to expand and allows air to flow through the perforated material to warm the patient.

[0070] Figure 13This is a top view of the hose inlet port 80 of the hose clip 82, through which air can be supplied to clinical garments, such as, for example, the clinical garment 10 described herein. The flat portion 84 of the hose clip 82 can be adhesively or otherwise attached to the surface of the front body piece of the clinical garment or blanket, to which conditioned air will be supplied. The layer through which the inlet port 80 extends can be flattened in the area of ​​the hose clip 82 to compress it, which can reduce fiber migration when insulation and / or materials with loose fibers are used in the garment or blanket. Heat and / or pressure can be used during this flattening process if desired. Alternatively or in addition, tape or another material can be attached to the outer surface of the layer to which the hose clip is attached to reduce fiber migration. In any of these configurations, one or more cuts can be made within the port 80 through the flat portion 84 of the hose clip 82 to the layer of the garment to which it is attached, such as... Figure 13 The X-shaped cut 86 shown.

[0071] The invention has now been described with reference to several embodiments thereof. The entire disclosure of any patent or patent application mentioned herein is incorporated herein by reference. The foregoing detailed descriptions and examples are provided only for a clear understanding of the invention. However, they should not be construed as unnecessary limitations. It will be apparent to those skilled in the art that various modifications can be made to the described embodiments without departing from the scope of the invention. Therefore, the scope of the invention should not be limited to the structures described herein, but only to the structures described in the text of the claims and their equivalents.

Claims

1. A clinical garment for warming patients, comprising: A separate, multi-layered front body panel, the front body panel having a first edge and opposing second edges, and comprising: A thermal insulation sheet comprising an outer layer, a film layer, and a thermal insulation layer positioned between the outer layer and the film layer, wherein the outer layer, the thermal insulation layer, and the film layer are sealed to each other along a first edge and a second edge; and A permeable sheet, the permeable sheet being adjacent to the membrane layer of the insulating sheet to define a cavity therebetween; The insulating sheet and the permeable sheet are selectively sealed together to define: A pocket section, the pocket section defining at least one pocket opening for receiving accessories; and A blanket section defined by the lower portion of the insulation sheet, the lower portion of the insulation sheet being sealed to the lower portion of the permeable sheet along the top edge, bottom edge, and opposite first and second side edges of the blanket section; The blanket section provides at least one inlet port that is in fluid communication with the cavity for supplying hot air into the cavity to provide warmth to the patient; A first rear piece, formed separately from the front body piece, and attached to at least a portion of a first edge of the front body piece; and The second rear piece is formed separately from the front body piece and is attached to at least a portion of the second edge of the front body piece; The pocket section is an upper pocket section defined by the top edge of the blanket section and a portion of the insulation sheet, the portion of the insulation sheet being attached to a portion of the permeable sheet along the top edge of the upper pocket section, the upper pocket section including at least one pocket opening between the insulation sheet and the permeable sheet.

2. The clinical garment of claim 1, wherein the at least one pocket opening comprises at least one side opening adjacent to at least one of the first edge and the second edge of the front body panel.

3. The clinical garment of claim 1, wherein the at least one pocket opening comprises at least one top opening adjacent to the top edge of the upper pocket section.

4. The clinical garment of claim 1, wherein the at least one pocket opening includes at least one bottom opening adjacent to the top edge of the blanket section.

5. The clinical garment of claim 1 further includes a forced-air heating blanket removably positioned within the upper pocket section.

6. The clinical garment of claim 5, wherein the forced air heating blanket comprises at least one of an upper body blanket, a lower body blanket, a sub-body blanket, a full body blanket, a trunk blanket, and a surgical entrance blanket.

7. The clinical garment of claim 1, further comprising a peripheral seal that seals the outer layer, the insulation layer, and the membrane of the insulation sheet to the permeable sheet along at least a portion of the top edge of the upper pocket section and at least a portion of the bottom edge of the front panel, and seals the insulation layer to the outer layer and the membrane along a first and second edge of the front panel, along at least a portion of the top edge of the upper pocket section, and along at least a portion of the bottom edge of the front panel.

8. The clinical garment of claim 1, wherein at least one of the first and second side edges of the permeable sheet is at least slightly inwardly spaced from at least one of the first and second side edges of the insulating sheet.

9. The clinical garment of claim 1, wherein the insulating sheet has a width defined by the distance between a first edge and a second edge of the front body panel, and wherein the permeable sheet has a width smaller than the width of the insulating sheet.

10. The clinical garment of claim 1, wherein the upper pocket section includes at least one pocket opening defined by an opening formed between the insulating sheet and the permeable sheet above the top edge of the blanket section.

11. The clinical garment of claim 1, wherein patient warming is provided by convection through the permeable sheet.

12. The clinical garment of claim 1, wherein the permeable sheet comprises an impermeable material, and a plurality of perforations extend through the impermeable material.

13. A method for manufacturing a pre-body piece for clinical garments, comprising the following steps: A heat insulation sheet is provided, the heat insulation sheet comprising an outer layer, a film layer, and a heat insulation layer positioned between the outer layer and the film layer, and the outer layer, the heat insulation layer, and the film layer are sealed to each other along a first edge and an opposite second edge of the heat insulation sheet; Provide permeable sheets; The membrane layer of the thermal insulation sheet is positioned adjacent to the inner surface of the permeable sheet; The outer periphery shape of the front body piece is cut from the combination of the thermal insulation sheet and the permeable sheet; The permeable sheet is sealed to the insulating sheet along the sealing pattern to define: A pocket section, the pocket section defining at least one pocket opening; and The lower blanket section includes an expandable air space between the permeable sheet and the insulating sheet for receiving hot air to warm the patient. The pocket section is an upper pocket section defined by the top edge of the blanket section and a portion of the insulation sheet, the portion of the insulation sheet being attached to a portion of the permeable sheet along the top edge of the upper pocket section, the upper pocket section including at least one pocket opening between the insulation sheet and the permeable sheet.

14. The method of claim 13, wherein the step of forming the lower blanket section simultaneously seals the outer peripheral shape of the front body piece.

15. The method of claim 13, wherein the step of cutting the outer peripheral shape of the front body piece occurs after the step of forming the lower blanket section.

16. The method of claim 13, wherein the insulating sheet is wider than the permeable sheet.

17. The method of claim 13, wherein the width of the insulating sheet is generally the same as the width of the permeable sheet.

18. The method of claim 13, wherein the permeable sheet is wider than the insulating sheet.

19. The method of claim 14, wherein sealing the outer peripheral shape of the front body piece comprises: The insulating sheet is sealed to the permeable sheet at the top and bottom edges of the front body piece.

20. The method of claim 13, wherein the pocket section is an upper pocket section formed above the lower blanket section.

21. A front body piece for a clinical garment used for patient warming, said front body piece having: A first edge, the first edge being able to be attached to a first part of the clinical garment; and The opposite second edge, which can be attached to the second part of the clinical garment; Furthermore, the preceding body panel has a multi-layered structure, comprising: A thermal insulation sheet comprising an outer layer, a film layer, and a thermal insulation layer positioned between the outer layer and the film layer, wherein the outer layer, the thermal insulation layer, and the film layer are sealed to each other along a first edge and a second edge; and A permeable sheet, the permeable sheet being adjacent to the membrane layer of the insulating sheet to define a cavity therebetween; The insulating sheet and the permeable sheet are selectively sealed together to define: A pocket section, the pocket section defining at least one pocket opening for receiving accessories; and A blanket section, the blanket section being defined by at least a portion of the insulating sheet that is sealed along the periphery of the blanket to a portion of the permeable sheet; The blanket section provides at least one inlet port that is in fluid communication with the cavity for supplying hot air into the cavity to provide warmth to the patient; The pocket section is an upper pocket section defined by the top edge of the blanket section and a portion of the insulation sheet, the portion of the insulation sheet being attached to a portion of the permeable sheet along the top edge of the upper pocket section, the upper pocket section including at least one pocket opening between the insulation sheet and the permeable sheet.

22. The forebody piece of claim 21, wherein the blanket section comprises the entire forebody piece.

23. The pre-body piece according to claim 21, wherein the blanket segment includes a sub-segment of the pre-body piece.

24. The forebody piece according to claim 23, wherein the pocket section is adjacent to the blanket section.

25. The forebody piece of claim 24, wherein the blanket section is located below the pocket section.

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