WO2023111328A1

WO2023111328A1 - A forced air warming device

Info

Publication number: WO2023111328A1
Application number: PCT/EP2022/086490
Authority: WO
Inventors: Bram Bonsen; Marcel VAN DER POL; Berry TEUNISSEN
Original assignee: The Surgical Company International B.V.
Priority date: 2021-12-17
Filing date: 2022-12-16
Publication date: 2023-06-22

Abstract

The present invention relates to a forced air warming device and methods thereof. The device comprises an inflatable body for providing conditioned air to a patient and comprising an inlet; and an inflatable hose which is integrated with and at least partially detachable from the body. In use, the hose is at least partially detached from the inflatable body and the hose is used to conduct air into the inflatable body from an external air provider.

Description

A Forced Air Warming Device

Field of the invention

The present invention is in the field of forced air warming devices which are operated using temperature conditioned air received from an air provider, through a hose, and methods of manufacturing and using said devices.

Background of the invention

Perioperative hypothermia is a common complication that can occur to patients before, during and/or after medical procedures, such as during anaesthesia. If not managed carefully, a patient’s temperature can drop to less than 35°C within 30 to 40 minutes. Consequently, further complications may arise in the cardio-vascular system, the metabolic system, the central nervous system as well as the haematological and urogenital systems.

Several therapies have been developed to prevent inadvertent hypothermia. Temperatureregulation apparatuses are used to provide effective warming to patients. These apparatuses typically take the form of forced air warming devices, such as forced air warming blankets.

A forced air warming device usually includes an inflatable body, and an inlet port. The port is configured to receive a hose that is connected to an external air provider, also known as an air blower. The external air provider generates conditioned air, i.e. , heated air of a suitable range of temperatures (e.g., from 32 to 43 °C) that can be used to warm up a patient. A supply of conditioned air is provided through the hose into the inflatable body of the device, and the device is thereby inflated. Typically, the air warming device comprises an air permeable layer facing the patient, through which conditioned air passes to warm the patient by convection. The conditioned air is forced in use, by virtue of pressure within the forced air warming device, across the skin of, or around the desired parts of the body of the patient.

EP 2893910A1 describes a forced air warming blanket comprising a first blanket portion which comprises a generally U-shaped inflatable region and an inner blanket portion within the generally U-shaped region. The inflatable region comprises an inlet port for receiving temperature conditioned gas.

WO 2012/028603A1 describes a gown that has a thorax portion, a leg portion and a distributor attached to the inside of the leg portion. The distributor inflates when heated air is supplied and exhausts air into the gown.

WO 2014/092874A1 describes a warming device comprising a clinical garment having a surface and an inflatable convective warming apparatus on the surface, wherein the convective warming apparatus includes an inflatable central member attached to the surface, at least one inlet port to receive the end of an air hose, and at least one permeable peripheral diffuser that is separate from the clinical garment and coupled to the central member by a plated, non-kinking duct.

EP 3459508A1 describes a forced air warming blanket for regulating a temperature of a patient, the blanket having a patient drape detachably connected thereto, and an air inlet port which is configured to receive temperature conditioned air by way of a hose.

US 5392847 describes a pneumatic, disposable, temperature control blanket pressurized with heated or cooled air comprising an inflated envelope having a lower sheet having openings formed therein for impinging the air upon a patient. The air is introduced into the banket envelope at a single inlet port, and an interior flexible conduit or sub-tube located within the envelope communicates with the inlet for distributing freshly introduced air throughout the blanket length with little temperature loss.

US 2018/0000635A1 describes a combination comprising a garment, a configurable convective device and an attachment device configured to attach the configurable convective device to the garment. The configurable convective device comprises a pneumatic structure having a first portion, a second portion, and an inflatable channel connecting the first portion and the second portion and at least one opening into the pneumatic structure.

US 2019/0240067A1 describes a sectional warming blanket for patient warming having a structure comprising a first layer of material forming a bottom layer with openings to allow a profusion of air through the bottom layer, a second layer of material forming an upper layer, wherein the upper layer is coupled to the bottom layer via a plurality of seals to form a plurality of interconnected air passageways, and an inlet located on the upper or bottom layers.

US 2019/0060107A1 describes a convective blanket that includes an air permeable upper sheet having a periphery, a lower sheet bonded to the upper sheet with a peripheral seal proximate to the periphery of the upper sheet to form an interior space therein between the upper and lower sheets, and a wing portion partially surrounded by a portion of the peripheral seal and a body portion

US 2011/0022135A1 describes a pneumatic convective device including at least one inlet for being accessed through a clinical garment, a region in distribution with the inlet for distributing a stream of pressurized, thermally treated air, and a permeable member for emitting pressurized, thermally treated air from the distribution region.

US 2013/0245730A1 describes an inflatable convective pad for warming a person during surgery having two ends, two sides, and at least two openings, each located in an area of the pad between the two ends and between a respective side and the centre of the pad. The openings, which may be in the form of slits, allow the threading of a sheet or the person’s arms through the pad to restrain the arms during surgery.

ES 2356812T3 describes an inflatable blanket for use with patients.

It is therefore known to supply a forced air warming device using an external air provider that comprises a hose, through which conditioned air is introduced to an inlet port of the air warming device. The air warming device can be disposable whilst the external air provider is usually retained for future uses. Once the air provider is unpacked and used at least once, the cleanliness of its hose can be an issue. Unlike other parts of the provider, an open end of the hose can easily pick up pollutants such as particulates in the air, soils, stains, or other unwanted pieces such as human hairs. When in use, the unhygienic hose may contaminate the air and/or the air warming device which is clean and sterile. For example, pollutants may be blown into the air warming device. In some embodiments the hose is separable from the air provider. When in use, one end of the hose can be coupled to the air provider and the other end can be coupled to the air warming device. A separate hose is an additional item to clutter up storage space and an additional part to order and keep in stock. In addition, most of the hoses are made from plastic materials and shaped with concertinaed sides to allow a certain degree of expansion and contraction. The hose can thus become braided and/or twisted, subjected to further damage such as splits, bends, holes and/or worn areas. As such, storing the hose properly to maintain its effectiveness and capability can also be cumbersome. Some of the problems can be mitigated by providing single use covers to close the open end of the hose. It is also possible to provide several hoses as replacements to an air provider. However, such provisions have drawbacks that lead to clutter, consumption of plastics, and challenges to practitioners in efficiently finding covers and replacing hoses.

The invention seeks to provide an improved apparatus for forced air warming. Embodiments of the invention therefore seek to improve the hygiene of a hose, and/or to reduce the number of objects which must be stored or used during procedures.

Summary of the invention

In a first aspect of the invention, there is provided a forced air warming device comprising: (i) an inflatable body for providing conditioned air to a patient and comprising an inlet; and (ii) an inflatable hose that is integrated with the body and at least partially detachable from the body, a first end of the hose being connected or connectable to the inlet of the body and a second end of the hose being connectable to an external air provider to enable conditioned air to be introduced into the inflatable body through the hose. The inflatable body is typically at least partially air permeable. The inflatable hose is typically air impermeable with apertures at first and second ends of the hose. The inflatable body typically comprises a single inlet. The inflatable body typically comprises only one inlet. The inflatable body may comprise at least two inlets (e.g. two inlets). The first end of the hose is connected or connectable to the inlet. Typically, the conditioned air is introduced via the inlet into the other part of the inflatable body (i.e., inlet is typically configured to introduce conditioned air into the inflatable body). In this way, the inlet is different from an outlet which is typically configured to facilitate exit of the conditioned air from the inflatable body. In a second aspect of the invention, there is provided a method of manufacturing a device according to the first aspect of the invention, comprising the steps in sequence of: (i) providing a first layer and an opposed second layer, and (ii) attaching the opposed first and second layers with one or more seals to define the inflatable body and the inflatable hose. The inflatable hose is integrated with the inflatable body. It may be that the method comprises a step of perforating at least part of a region of the first layer that defines the inflatable body to make it air permeable. However, it may be that the first layer which is provided is (already) air permeable. It may be that the body is defined by said region of the first layer which is at least partially air permeable, and a region of the second layer which is air impermeable. The second layer may be air impermeable (as a whole). It may be that the hose is defined by other regions of the first and second layers that are both air impermeable. Attaching the layers with one or more seals may also define the inlet to the inflatable body.

In a third aspect of the invention, there is provided a method of using a forced air warming device comprising the steps of (i) providing a device according to the first aspect of the invention; (ii) connecting the hose to an air provider; and (iii) optionally inflating the body of the device with conditioned air through the hose, wherein the method further comprises a step of at least partially detaching the hose from the inflatable body. The at least partial detaching step can be either before, during or after step (iii), preferably before step (iii). It will be understood that the method described in this paragraph may be a method of operating the device or a method of preparing the device for use. Especially, the method steps described in this paragraph may relate to operating or preparing said forced air warming device.

The body and the hose are inflatable, and so they are capable of being filled with gas, such as air, wherein the volume of the body and the hose is typically expandable upon inflation. Typically, without inflation, the body and the hose have a substantially flat or planar configuration.

By a hose we refer to an elongated, flexible tube that includes a central opening for conveying conditioned air generated by an external air provider to the inflatable body. The tube has two opposed ends, a first end and a second end and extends therebetween. The hose according to the present invention is inflatable. It may be that the hose is made from the same material as the body.

The hose and inflatable body are integrated, taking the form of a single continuous apparatus. This contrasts with arrangements in which the hose is not integrated with the inflatable body and so is separate to the inflatable body and must be connected to the inflatable body in order to convey air during use. The hose is typically disposed outside the inflatable body. The hose is typically disposed not within the body. Typically, the hose is not part of the inflatable body although it is integrated with said body. The hose is typically air impermeable. Thus, the hose is typically configured to convey conditioned air into the inflatable body. Typically, the hose is not configured to provide conditioned air to a subject (e.g. a patient). This configuration contrasts with arrangements in which a part of the inflatable body is elongated and/or flexible and said part may be used to warm up the patient.

Accordingly, the integrated hose is part of the air warming device and can be stored in a packaging thereof until needed. The packaging can be suitably sterilised. The device itself can also be cleaned (e.g., sterilised) before or after packaging and/or before use. Any part of the device (Ze., the hose or the body) or the device perse is suitably disposable after use. There is typically no need to have other hoses (e.g., a hose comprised in an external air provider) to introduce conditioned air into the air warming device. During use, the integrated hose can be at least partially detached from the inflatable body, and one end (the second end) of the hose can be connected to an external air provider. Where it has been detached from the inflatable body the hose can extend away from the inflatable body to the air provider. The hose typically extends away from the inflatable body to the air provider in use.

These and other aspects, features and advantages will become apparent to those of ordinary skill in the art from a reading of the following detailed description, the description of the figures and the appended claims.

It may be that the inflatable body of the device is configured to cover at least part of a front or a back side of a patient. It may be that the inflatable body is configured to cover around at least part of a patient, e.g., a torso and/or a limb. The device may be an air warming blanket. Other possible formats include a gown, a face mask or shield, a limb or neck band.

When in use, a first end of the hose is connected to the inlet of the inflatable body, such that the interior of the hose is in gaseous communication with the interior of the inflatable body, and a second end of the hose is connected to an external air provider directly or indirectly. Conditioned air generated by the air provider is thus transferred from the second end to the first end of the hose and into the interior of the inflatable body from which it may egress through the air permeable portion and thereby regulate the temperature of a patient by forced convection during use.

It may be that the inflatable body has a length and a width. Typically, the length is greater than the width. The inflatable body may have a rectangular shape. It may be that the body has a round or obround or oval shape. It may be that the inflatable body is elongate along a longitudinal axis. Typically, the hose is disposed lengthwise relative to (e.g. adjacent to) the inflatable body. However, it is also possible for the hose to be disposed widthwise relative to (e.g. adjacent to) the inflatable body. It is further possible for the hose to be disposed both lengthwise and widthwise relative to (e.g. adjacent) the body. The hose typically extends lengthwise and/or widthwise adjacent the inflatable body. The hose is typically disposed adjacent to an edge of the inflatable body. The hose is typically disposed outside the body and not within the body. This is advantageous for ergonomic and flexible use of the hose, Ze., at least part of the hose can be detached during use without interfering with the body. In such dispositions, the hose typically extends alongside the edge of the inflatable body. The hose extending alongside the edge may have a straight or curved conformation, or a mixed conformation thereof.

The hose may contain one or more bends (at least while integrated with the inflatable body, before at least partial detachment). The hose may be arranged in a serpentine configuration. The hose may form at least part of an O-shaped conformation (e.g., the hose is at least partially coiled), at least part of a U-shaped conformation, at least part of a L-shaped conformation, or form any of the combined conformations thereof. The first end of the hose may be in alignment with one end of the edge, and the second end of the hose may be in alignment with a different preferably opposed end of the edge. It is also possible to have the second end of the hose in alignment with the same end of the edge e.g., when the hose is bent). It may be that the hose extends alongside the length of the inflatable body. Additionally or alternatively, it may be that the hose extends alongside the width of the inflatable body. It may be that the hose extends alongside the entire length of the body, and/or it may be that the hose extends alongside the entire width of the body. The flexible nature of the hose would generally allow the dispositions, extensions, and/or conformations as described above. Those arrangements permit ease of manufacturing, packaging and/or storage of the hose together with the inflatable body.

In use, the hose is at least partially detached from the inflatable body and may be straightened out.

The inflatable body comprises an inlet, typically configured to receive the first end of the hose. In use, the first end of the hose is connected to the inlet and the hose extends therefrom. Typically, the inlet is disposed in an edge region of the inflatable body (i.e., a region adjacent to an edge of the body).

It may be that the first end of the hose is connected to the inlet of the inflatable body such that the interiors of the hose and the inflatable body are in gaseous communication. The hose may be integral with the inflatable body. The hose may be coupled to the inflatable body. The walls of the inflatable body and the hose may be continuous with each other. The first end of the hose is typically merged with the inlet of the body and the hose extends from said inlet.

The hose, in this way, can be handled as part of the inflatable body before and during use, leading to benefits like decluttering and efficiency. The first end of the hose may be connected to an inlet disposed in an edge region of the inflatable body and the hose extends therefrom, the hose extends alongside said edge, outside the inflatable body. The inlet may be an outwardly protruding part of the body. In those embodiments, it is also possible for the hose to have a straight, or a curved, or a mixed conformation as described above, e.g. the hose may contain one or more bends. Optionally and additionally, the ends of the hose may be in alignment with one or more ends of said edge as described above.

However, in some embodiments the hose is not connected to the inlet of the inflatable body and the interior of the hose is not in gaseous communication with the inlet of the inflatable body. Thus, it may be that hose is connectable to the inlet of the inflatable body to bring the interiors of the hose and the inflatable body into gaseous communication. It may be that the hose is not connected to the inlet of the inflatable body and the interiors of the hose and the inflatable body are not in gaseous communication. The first end of the hose may be apart from the inlet of the inflatable body. The first end of the hose may be separate to the inlet of the inflatable body. It may be that the first end of the hose is not merged with the inlet.

Thus, in use the hose may be detached from the inflatable body and then the first end of the hose connected to the inlet of the inflatable body. As a result, the interior of the hose is brought into gaseous communication with the interior of the inflatable body. The hose may be coupled to the inlet of the inflatable body. Although there is a requirement for the step of connecting the first end of the hose to the inlet of the inflatable body which is not present in embodiments where the first end of the hose is already connected to (and optionally integral with) the inlet of the inflatable body, this arrangement still has the benefit that the hose is integrated with the body and the hose and body can be handled as a single item until the hose is at least partially (and perhaps fully) detached and then connected to the inlet of the inflatable body.

It may be that the first end of the hose comprises a connector for connecting the hose to the inflatable body. The connector may be a hose coupling. It may be that the inlet and the first end of the hose have complementary inter-engaging formations to permit engagement thereof. For example, the inlet may suitably comprise a port to receive a connecting feature of the hose (e.g., a connector comprised in the first end of the hose) so that the body and the hose can be connected to permit air flow during use. In this way, it is not necessary for the first end of the hose to be integral to the inflatable body. In certain preferred embodiments, an edge region of the inflatable body comprises an inlet port and the first end of the hose comprises a corresponding connector to be received in said port, and the hose extends alongside said edge and outside the inflatable body. The hose may further have the conformation and/or have its ends aligned as described above. Such arrangements increase the flexibility between the hose and the inflatable body, however, at a price of presenting more work for the practitioners to connect the first end of the hose to the inlet port.

It may be that the second end of the hose is directly connectable to an external air provider. Preferably, the second end of the hose comprises a connector, more preferably a hose coupling. Said connector is suitably configured to be connected directly to the air provider such that conditioned air is transferred directly from the provider to the second end of the hose and finally, to the first end of the hose before received by the inflatable body. It may be that the second end of the hose is indirectly connectable to an external air provider. The second end can be suitably connected to another hose (e.g., a short hose that is directly connectable to the external air provider). That is to say, the hose of the present invention can be an addition to a hose connected to the air provider. Both ‘direct’ and ‘indirect’ arrangements require the hose to be integrated with the inflatable body. Suitably, the hose can be stored in the original packaging of the air warming device until use and disposed afterwards, hence improvement of the hygiene of the hose perse an the ease of storage. The ‘indirect’ arrangement provides practitioners with more flexibility albeit demanding more resources and additional handling of a hose.

The air warming device of the present invention may suitably comprise at least two inflatable hoses (e.g. two inflatable hoses) that are integrated with the inflatable body of the device, wherein said hoses are at least partially detachable from said body, preferably fully detachable, and wherein the first ends of said hoses are connected or connectable to at least one inlet of said body and the second ends of said hoses are connectable to an external air provider to enable conditioned air to be introduced into said body through said hoses. In this way, at least one backup hose is provided in case one of the hoses is damaged or malfunctioned. Typically, this arrangement of at least two hoses is for embodiments wherein the hoses are not connected to the inlet of the inflatable body and the interior of the hoses is not in gaseous communication with the inlet of the body (i.e. the hoses are connectable to the inlet of the body). In these embodiments, multiple hoses can also help to maintain the cleanliness of the device if a practitioner wants to use said device multiple times. For example, a first hose may be used during a medical procedure and then suitably disposed. A second hose of the same device which is still clean can then be used during or after the procedure. The at least two hoses are suitably disposed outside the body and not within the body. At least one of the hoses may be disposed adjacent to an edge of the inflatable body. The hoses may be disposed adjacent to different edges of the body. For example, one of the at least two hoses (i.e. a first hose) may be disposed lengthwise relative to (e.g. adjacent) an edge of the body, and the other of the at least two hoses (i.e. a second hose) may be disposed widthwise relative to (e.g. adjacent) a different edge of the body. In other words, the first hose and the second hose may be orthogonal with respect to each other. It is also possible for the first hose to be disposed lengthwise relative to (e.g. adjacent) an edge of the body, and the second hose to be disposed lengthwise relative to (e.g. adjacent) an opposed edge of the body. In this way, the first hose and the second hose may be disposed in parallel. A further possible arrangement is for the first hose to be disposed widthwise relative to (e.g. adjacent) an edge of the body, and the second hose to be disposed widthwise relative to (e.g. adjacent to) an opposed edge of the body. The inflatable body may comprise at least one inlet suitable for connecting the at least two hoses to the body. The at least one inlet may be an inlet port (e.g. an inlet comprising a port). The inlet is typically disposed at an edge region (i.e., a region adjacent to an edge of the body) of the inflatable body. Preferably, the inlet is disposed at an edge region not adjacent to the at least two hoses. It may also be that the inflatable body comprises at least two inlets (e.g. at least two inlet ports). In this way, the at least two hoses can be used simultaneously to inflate the body.

The hose of the present invention is at least partially detachable from the inflatable body. In embodiments where the first end of the hose is connected to the inlet of the inflatable body, the hose is typically partially detachable from the inflatable body, such as to allow the first end of the hose to remain connected to the inlet of the inflatable body. In embodiments where the first end of the hose is separate from but connectable to the inlet of the inflatable body, the hose is typically partially or fully detachable from the inflatable body.

During use, the hose is at least partially detached to allow the flexibility, for example, to connect the second end of the hose to an external air provider. Before use, the hose is suitably connected along at least part of its length to the inflatable body. It may be that the hose is connected along its entire length to the inflatable body. In addition, the hose can be detached at least partially along its length from the body during use. It is also possible to put a detached hose back roughly into place, for example, during an intermittent medical procedure. Therefore, the hose can always be stored hygienically together with the inflatable body. It may be that the hose is disposed adjacent to an edge of but outside the inflatable body, and a side of the hose extending alongside and facing said edge is connected thereto and detachable therefrom, along at least part of the length of the hose. When the hose is connected along part of its length to the inflatable body, it is possible that one or more regions of the hose are also connected with one or more other regions of the hose. For example, if the hose forms a ‘U ’ shaped conformation, a side of one arm of the ‘U ’ may be connected to the inflatable body and opposed side of said arm may be connected to the other arm of the ‘ LT shape. The hose is hence kept integrated with the inflatable body, to provide benefits of hygiene, ease of storage and handling.

It may be that the hose is at least partially detachable from the inflatable body by way of a breakable mechanism disposed between the hose and the body. Preferably, the mechanism is disposed at the connection of the hose to the body as described above. The mechanism may comprise one or more tear lines that can be torn or cut to detach the hose partially or wholly. The tear lines may comprise one or more perforations, for example tear lines of perforations. It may be that one end of the mechanism (e.g., tear lines of perforations) extends to the periphery of the air warming device and the other end is within the periphery of the device, for example, when the first end of the hose is integral to the inflatable body. It may be that the other end extends to but does not reach the peripheries of the body and the hose. It may be that both ends of the mechanism (e.g, tear lines of perforations) extend to the periphery of the device. The breakable mechanism e.g., tear lines of perforations) may further be located between two or more sections of the hose. A suitable example is a U-shaped hose comprising a line of perforations between two arms of the U shape. Other breakable mechanisms may also be suitably used in the present invention, selected from but not limited to adhesive, tack, putty, clothes fastener such as snap fastener, zipper, and hook and loop fasteners. The breakable mechanism provides flexibility and ergonomics during use. The use of perforations simplifies manufacture.

The inflatable body typically comprises one or more walls which define an interior having an inlet (through which conditioned air is introduced in use), wherein at least part of the one or more walls is air permeable.

It may be that the inflatable body is defined by opposed first and second layers connected by one or more seals. The conditioned air is thus received in the interior of the body defined by the layers, in use. Typically, the first layer is at least partially air permeable. Typically, the opposed second layer is suitably air impermeable.

It may be that the first layer comprises a plurality of openings and/or perforations, thereby permitting the passage of air therethrough onto a patient. In use, the air impermeable second layer can be arranged facing away from a patient and the air permeable first layer facing the patient, hence impinging conditioned air onto the patient.

It may be that the inflatable hose is defined by the same first and second layers connected by one or more seals. The conditioned air is thus transferred through the interior of the hose defined by the layers. The regions of the layers that define the hose are suitably air impermeable, i.e. , the hose is suitably air impermeable. Typically, the hose is air impermeable (except at the first and second ends). In this way, the loss of conditioned air transferred from the hose to the inflatable body can be minimised during use.

It may be that the above-described first and second layers are provided by the same material (e.g. same sheet of material) folded over or rolled over. It may be that said same material is rolled over to form as a tube. It may be that the rolled material is then compressed. The same material (e.g. same sheet of material) may be connected (e.g. sealed) where necessary. The material (e.g. same sheet of material) may be connected (e.g. by one or more seals) to provide an interior of the inflatable body. The material (e.g. same sheet of material) may be connected (e.g. by one or more seals) to provide an interior of the inflatable hose. The material (e.g. same sheet of material) may be connected (e.g. by one or more seals) to define both the inflatable body (e.g. the periphery of the inflatable body) and the inflatable hose (e.g. the sides of the inflatable hose).

It may be that the above-described first layer is provided by a first sheet of material and the above-described second layer is provided by a second sheet of material. The material may be the same or different. It may be that the first and second sheets are connected (e.g. sealed) where necessary. The sheets may be connected (e.g. by one or more seals) to provide an interior of the inflatable body, and/or to provide an interior of the inflatable hose. The sheets may be connected (e.g. by one or more seals) to define both the body (e.g. the periphery of the body) and the hose (e.g. the sides of the hose).

The one or more seals may, for example, be heat seals or welds (for example ultrasonic welds). The method of manufacturing the device typically comprises forming one or more seals between the first and second layers.

Typically, one or more seals are disposed around the periphery of the inflatable body and along sides of the hose. In addition, there may be one or more seals disposed within the periphery of the inflatable body. Those seals may be disposed at spaced apart locations. The benefits of having intermediate seals include directing air flow (during initial inflation and/or subsequently) and/or maintaining the body configuration during use (to avoid the inflatable body ballooning excessively in operation).

Suitably, there may be no seals disposed within the periphery of the hose, i.e., interior of the hose typically extends between the first and second layers. As such, the first and second layers defining the hose are not tacked together between the hose periphery, thereby permitting maximum air flow from the hose to the body. Similarly, there may be no seals disposed within the periphery of the inlet of the inflatable body, i.e., interior of the inlet typically extends between the first and second layers. Suitably, there may be one or more seals disposed along sides of the hose. Suitably, there may be no seals disposed at the apertures of the first and second ends of the hose.

It may be that the one or more seals defining the body are continuous with the one or more seals defining the hose, for example, when the first end of the hose is integral to the body. It may be that there is one continuous seal defining the periphery of the body and the sides of the hose. It may be that the seal has a (typically single) gap forming the second end of the hose. It may be that the one continuous seal defines the periphery of the body and the hose and the hose has an aperture formed therein (for example in the first or second sheet) to form the second end. Around the first end of the hose, one or more seals defining the sides of the hose may be continuous with one or more seals defining the periphery of the body such that the continuous seal defines the inlet of the inflatable body. The method may comprise forming the hose with the first end of the hose connected to the inlet of the inflatable body and the interior of the hose in gaseous communication with the interior of the inflatable body through the inlet.

It may be that the one or more seals defining the body are separate to the one or more seals defining the hose. There may be one continuous seal defining the periphery of the body and a separate continuous seal defining the sides of the hose. It may be that two opposite seals are present to define the sides of the hose and the opposite seals are not connected at the first and second ends of the hose. The method may comprise forming a plurality of seals to form the inflatable body and, separately, the hose such that the interior of the hose is not connected to the inlet of the inflatable body such as to cause the interior of the hose to be in gaseous communication with the interior of the inflatable body through the inlet.

It may be that the breakable mechanism (e.g., tear lines of perforations) extends through the first and second layers. Suitably, the mechanism (e.g., tear lines of perforations) is disposed intermediate the one or more seals defining the body and the one or more seals defining the hose. In addition, the mechanism (e.g., tear lines of perforations) may be disposed intermediate the one or more seals defining the hose.

The method of manufacturing may comprise attaching opposed first and second layers by heat sealing. The method may comprise forming one continuous seal to define both the periphery of the inflatable body and the sides of the hose. The method may comprise forming one continuous seal defining the body and one or more seals to define the sides of the hose. The method may comprise forming one or more seals within the periphery of the inflatable body.

It may be that both the first and the second layers are initially air impermeable. It may be that the method of manufacturing comprises a step of perforating at least part of a region of the first layer that defines the inflatable body to make it air permeable, such that the inflatable body is defined by said region and a region of the second layer that is air impermeable. Typically, the hose is defined by other regions of the first and the second layers which both remain air impermeable. The perforating step can be performed either before, during or after the connection of the layers by seals.

The method of manufacture typically comprises forming said breakable mechanism. The method of manufacture may comprise forming one or more tear lines, for example rows of perforations. The method may comprise perforating through the first and second layers, for example between the one or more seals defining the hose and the body. The hose may therefore be at least partially detached using the perforations during use. The method may comprise perforating through said layers between two or more sections of the hose.

The integrated hose can be manufactured by using the same material as the inflatable body and detached at least partially during use. This provides flexibility and remains convenient for a practitioner to use the hose. Further, the process provides an economical and efficient way of manufacturing the air warming device.

It may be that the method comprises providing a material (e.g. a sheet of material). It may be that the method comprises folding said material to provide opposed first and second layers. It may be that the method comprises rolling said material (e.g. rolling said material to form a tube). It may be that the rolled material is then compressed to provide the first and second layers. The method may comprise connecting the material (e.g. by one or more seals) to define the inflatable body (e.g. the periphery of said body) and/or the inflatable hose (e.g. the sides of said hose).

It may be that the method comprises providing a first sheet of material and a second sheet of material. The material may be the same or different. The first sheet of material may provide the first layer and the second sheet of material may provide the second layer. The method may comprise connecting the two sheets (e.g. by one or more seals) to define the inflatable body (e.g. the periphery of said body) and/or the inflatable hose (e.g. the sides of said hose).

The method of manufacturing may extend to any effective means (including but not limited to the means as described above) to form the air warming device. For example, the inflatable body and/or the inflatable hose may be formed by bonding the same or different materials, or sewing said materials, or zippering said materials, or fastening said materials by any suitable means. The inflatable body and/or the inflatable hose may be formed by rolling, folding, and/or any suitable manipulations of the same or different materials. It will be understood that the various embodiments, versions, and examples are for the purpose of understanding. The skilled person will appreciate that these are exemplary only without limiting the scope of protection. The disclosure may be practiced in other ways without exhaustively stating each of the countless possible ways.

In the third aspect of the invention, there is provided a method of using an air warming device. A device according to the first aspect of the invention is provided. The device is suitably cleaned and contained in a sterilised packaging. When needed, the device is taken out of its packaging. The device can be suitably arranged above or under a patient. The second end of the hose is connected to an air provider. In embodiments where the hose is not already connected to the inlet of the inflatable body, the method comprises the step of connecting the first end of the hose to the inlet of the inflatable body. The inflatable body is typically inflated with conditioned air from the air provider through the hose.

Typically, the second end of the hose is directly connected to the air provider. It is also possible to connect the second end to another hose, which in turn is connected to the air provider. If the first end of the hose comprises a connector, the first end may be connected to a corresponding receiving part (e.g. an inlet port) of the body before inflation of the air. The method of use typically further comprises a step of at least partially detaching the hose from the inflatable body either before, during or after inflation, preferably before inflation. If the device comprises at least two inflatable hoses, one of the at least two hoses (i.e. a first hose) may be at least partially detached (e.g. preferably fully detached) from the body while the other hose (i.e. a second hose) remains integrated with the body during use. It may also be that the first hose and the second hose are both at least partially detached (e.g. preferably both fully detached) from the body. In this way, it may be that the first hose and the second hose are used simultaneously to inflate the body (i.e. when the device comprises at least two inlets). The air provider typically provides pressurised temperature conditioned air. The air from the air provider exits through the inflatable body to warm a patient by convection during use. The inflated device can be used to warm one or more desired parts of the patient, before, during or after a medical procedure. After use, the device can be suitably disposed of.

It will be understood that the method according to the third aspect may relate to operating or preparing the air warming device (i.e. preparing the air warming device for use), comprising (i) providing an air warming device according to the first aspect; (ii) connecting the inflatable hose to an air provider, and (iii) optionally inflating the body of the device with conditioned air through the inflatable hose, wherein said method further comprises a step of at least partially detaching the inflatable hose from the inflatable body. The step of at least partially detaching the inflatable hose can be before, during or after inflating the body of the device, preferably before. It may be that step (ii) comprises connecting the second end of the inflatable hose to a further hose and connecting the further hose to the air provider, thereby connecting the inflatable hose indirectly to the air provider. It may be that the method further comprises taking the air warming device out of its packaging (e.g. prior to step (ii)), and/or connecting the first end of the hose to the inlet of the inflatable body (e.g. prior to step (iii)). It may be that the air warming device comprises two inflatable hoses (i.e. a first inflatable hose and a second inflatable hose). The method may comprise connecting both inflatable hoses to one or more air providers (e.g. two air providers), inflating the body of the device with conditioned air through both inflatable hoses, wherein the method further comprises at least partially detaching or fully detaching both hoses before, during or after inflating the body. It may be that the method comprises at least partially detaching only one of the two hoses and inflating the body through said one hose, as described above. It may be that subsequent to these steps related to operating or preparing the air warming device, the inflated device is used to warm one or more desired parts of a patient.

It may be that the device is contained within a sterilised packaging to form a product. It may be that the device is suitably cleaned (e.g., sterilised) before or after being packed, and/or before use. It may be that the product further comprises instructions for use. The instructions may give detailed information for the steps of using the air warming device in accordance with the third aspect of the invention. The instructions may be supplied in the printed form of a label, a booklet, a brochure, or a leaflet.

Description of the figures Example embodiments of the present invention will now be illustrated with reference to the following non-limiting figures in which:

Figure 1 is a plan view of an air warming device of the present invention, wherein a hose (1) is disposed lengthwise alongside an inflatable body (2).

Figure 2 is a plan view of another air warming device of the present invention, wherein a hose (1) is disposed across the width of an inflatable body (2).

Figure 3 is a plan view of a further air warming device of the present invention, wherein a hose (1) is disposed across the width of an inflatable body (2) and the hose has a U-shaped conformation.

Figure 4 is a plan view of a still further air warming device of the present invention, wherein a hose (1) is disposed lengthwise alongside an inflatable body (2), and the hose comprises two connectors (11 , 18).

Figure 5 is a top, perspective view of an air warming device of the present invention, wherein the device is contained within a packaging (19).

Figure 6 is a plan view of an air warming device of the present invention, wherein a hose (1) is partially detached from an inflatable body (2).

Figure 7 is a plan view of an air warming device of the present invention, wherein a hose (1) is partially detached from an inflatable body (2) and the hose is attached to an external air provider (H) in use.

Figure 8 is a flow chart illustrating a method of manufacturing an air warming device.

Figure 9 is a flow chart illustrating a method of using an air warming device.

Figure 10 is a plan view of another air warming device of the present invention, wherein a hose (1) is disposed across the width of an inflatable body (2), and the hose comprises two connectors (11 , 18). Figure 11 is a plan view of still another air warming device of the present invention, wherein said device comprises a first hose (20) comprising two connectors (21 , 22), and a second hose

(1) comprising two connectors (11 , 18).

In the figures, like parts are denoted by like reference numerals.

In detail, figure 1 shows an air warming device in a form of an air warming blanket (A), comprising an inflatable body (2) and an inflatable hose (1), both defined by a first layer (3) and a second layer (4, not shown) connected by one continuous heat seal (5). The second layer (4) is air impermeable. The region of the first layer (3) which defines the hose (1) is air impermeable whilst another region of the first layer (3) defining the body (2) is at least partly air permeable. That is to say, the hose (1) is defined by a region of the first layer (3) and a region of a second layer (4) which are both air impermeable, and the body (2) is defined by other regions of the same layers, wherein the region of the first layer (3) is at least partially air permeable and the region of the second layer (4) is air impermeable The heat seal (5) is disposed around the periphery of the body (2) and along sides of the hose (1). The body (2) additionally comprises a plurality of spaced heat seals (6), disposed within the periphery thereof. When inflated, those internal seals (6) assist with inflation by directing the air flow and maintaining the body (2) configuration, e.g. preventing the body (2) from ballooning. The body

(2), the hose (1), and the blanket (A) per se are all of a rectangular shape. The hose (1) is disposed and extends lengthwise alongside the body (2). The hose (2) will also form a cylindrical shape when inflated (not shown).

The hose (1) is disposed outside the body (2), adjacent to an edge (7) thereof. A first end (8) of the hose (1) is merged with an inlet (9) disposed in the edge (7) region of the body (2), so that the interior of the hose (1) is in gaseous communication with the interior of the body (2) and the hose (1) extends therefrom alongside the edge (7) to a second end (10). Figure 1 shows that the inlet (9) is in a region adjacent to the edge (7) and said inlet (9) is an outwardly protruding part of the body (2). Figure 1 also shows that the first end (8) of the hose (1) is in alignment with one end of the edge (7) and the second end (10) is in alignment with the opposed end of the edge (7). The second end (10) further comprises a connector (11), such that the hose (1) can be connected to an external air provider (not shown) directly or indirectly, preferably directly.

In figure 1 , the first end (8) of the hose (1) is integral to the inflatable body. The hose (1) and the inlet (9) do not contain any seals within their peripheries in order to permit maximum air flow to the body (2). The hose (1) is connected to the body (2) lengthwise, along its entire length. There is a tear line of multiple perforations (12) disposed between the hose (1) and the body (2), along the length of the hose (1). The tear line (12) extends through the first and the second layers. One end of the tear line (12) extends to periphery of the air warming device (A) and an opposed end is within the periphery of the device, up to but not interfering with periphery of the inlet (9).

In detail, figure 2 shows an air warming blanket (B) which is similar to the blanket (A) shown in figure 1 , except that the hose (1) is disposed across the width of the inflatable body (2). The hose (1) is hence connected to the body (2) widthwise, still along the entire length of the hose (1)-

In detail, figure 3 shows a further air warming blanket (C) which is similar to the blanket (B) shown in figure 2. However, the hose (1) is disposed widthwise of a body (2) only along part of its length and forms a U-shaped conformation (13). The hose (1) is hence connected to the body (2) widthwise, only along part of its length. There is an additional tear line of perforations (14) disposed between two sections of the hose (1). One end of this tear line (14) extends to periphery of the air warming device (C) and an opposed end is within the periphery of the device, up to but not interfering with periphery of the hose (1).

In detail, figure 4 shows an air warming blanket (D) which is similar to the blanket (A). However, there is one continuous heat seal (16) defining the body (2) and a separate continuous heat seal (15) defining the hose (1). Both ends of a tear line of perforations (12) extend to periphery of the blanket (D). The inlet of the inflatable body (2) comprises a port (17) to receive a connector (18) comprised in a first end (8) of the hose (1). As such, the body (2) and the hose (1) can be connected to permit air flow during use. There is no outwardly protruding part of the body (2), and the hose (1) can be completely detached from the body (2) via the tear line of perforations (12). The hose also comprises a second connector (11) for connecting the hose to an external air provider (not shown), either directly or indirectly.

In detail, figure 5 shows an air warming blanket (E) that is the same as the blanket (A). The blanket (E) is contained within a sterilised packaging (19) to form a product. The packaging (19) is shown by dotted lines. The blanket (E) may be cleaned (e.g., sterilised) before or after being packed. Suitably, the clean blanket (E) remains in the packaging (19) until needed. The product may further comprise instructions for use (not shown). In detail, figure 6 shows an air warming blanket (F) that is the same as the blanket (A). However, the hose (1) is already partially detached from the body (2). The detachment is done by way of a tear line of perforations (12, not shown).

In detail, figure 7 shows an air warming blanket (G) that is the same as the blanket (F). A hose (1) is partially detached from a body (2) and is connected to an external air provider (H). A connector (11) comprised in a second end (10) of the hose (1) is directly connected to a receiving port (not shown) located at the back of the air provider (H). Both the end (10) and the connector (11) are shown by dotted lines.

In detail, figure 8 is a flow chart of a manufacturing process of an air warming device of the present invention. In step (801) and step (802), first and second layers are provided respectively, and both layers are initially air impermeable. The layers are put opposed to each other and connected by one or more heat seals to define a body and a hose (step 803). Preferably, the seals are disposed around periphery of the body and along sides of the hose. Preferably, there is one continuous seal defining the periphery of the body and the sides of the hose, wherein the seal has a single gap forming the second end of the hose. Although not shown in figure 8, the process therein may further have a step of disposing spaced heat seals within the periphery of the inflatable body. Those internal seals (6) can be seen in figure 1 as well as in figures 2-7. In step (804), at least part of a region of the first layer that defines the body is perforated such that the perforated part becomes air permeable. In this way, the inflatable body is defined by said region of the first layer and the second layer that is air impermeable and the hose is defined by other regions of the same layers that remain air impermeable. In step (805), the part of the first and second layers between the hose and the inflatable body is perforated through. Step (805) thus creates a tear line of perforations for detaching the hose from the body.

In detail, figure 9 is a flow chart of using an air warming device of the present invention. The device is contained within a sterilised packaging (step 901) and subsequently taken out (step 902). In step (903), the air inflatable hose is at least partially detached from the inflatable body. The device can be suitably arranged above or under a patient (step 904). Suitably, the second end of the hose comprises a connector. The second end of the hose is connected directly to an external air provider (step 905) via said connector. The temperature conditioned air generated by the air provider is introduced to inflate the body through the hose (step 906). In step 907, the inflated device is used to warm the desired parts of the patient. Preferably, the temperature conditioned air escapes through an air permeable first layer of the device to warm the patient. After use, the device can be suitably disposed of (step 908).

In detail, figure 10 shows an air warming blanket (I) which is similar to the blanket (D) shown in figure 4. However, the hose (1) is disposed across the width of the inflatable body (2). The hose (1) can be completely detached from the body (2) via the tear line of perforations (12). The inlet of the inflatable body (2) comprises a port (17) to receive a connector (18) comprised in a first end (8) of the hose (1). As such, the body (2) and the hose (1) can be connected to permit air flow during use. The hose also comprises a second connector (11) for connecting the hose to an external air provider (not shown), either directly or indirectly.

In detail, figure 11 shows an air warming blanket (J) which is similar to the blanket (I) shown in figure 10, except that the blanket (J) comprises two hoses (1 , 20). A first hose (20) is disposed lengthwise alongside the inflatable body (2). The first hose (20) comprises a connector (21) at one end of said hose and a further connector (22) at the opposed end. A second hose (1) is disposed across the width of the inflatable body (2). The second hose (1) also comprises a connector (18) at one end of said hose and a further connector (11) at the opposed end. The inlet of the inflatable body (2) comprises a port (17) to receive a connector (21) comprised in the first hose (20) or a connector (18) comprised in the second hose (1). The port (17) is disposed at an edge region (i.e., a region adjacent to an edge of the body) of the body (2) which is not adjacent to the hoses (1 , 20). Alternatively, it is also possible for the port (17) to be disposed at an edge region which is adjacent to at least one of the hoses (1 , 20) albeit not shown in figure 11. The first hose (20) can be completely detached from the body (2) via the tear line of perforations (23) and the second hose (1) can also be completely detached from the body (2) via a tear line of perforations (12).

Any feature of one aspect of the present invention may be utilised in any other aspect of the invention where appropriate. Any feature of a particular embodiment may be utilized in any other embodiment of the invention where appropriate. Any feature described as ‘preferred’ should be understood to be particularly preferred in combination with a further preferred feature or features. Unless otherwise stated, no features described should be considered incompatible with any other features, unless such a combination is clearly and inherently incompatible. It should be generally envisaged that each and every separate feature disclosed in the present invention is combinable in any appropriate way with any other feature, unless explicitly or clearly incompatible. The word ‘comprising’ is intended to mean ‘including’ but not necessarily ‘consisting of’ or ‘composed of’. In other words, the listed steps or options need not be exhaustive. Throughout the description and claims of this specification, the singular encompasses the plural unless the context otherwise requires, and vice versa. In particular, where the indefinite article is used, the specification is to be understood as contemplating plurality as well as singularity, unless the context requires otherwise. The examples and embodiments given in the description above are intended to clarify the invention but not to limit the invention.

Claims

24 Claims

1 . A forced air warming device comprising: (i) an inflatable body for providing conditioned air to a patient and comprising an inlet; and (ii) an inflatable hose that is integrated with the body and at least partially detachable from the body, a first end of the hose being connected or connectable to the inlet of the body and a second end of the hose being connectable to an external air provider to enable conditioned air to be introduced into the inflatable body through the hose.

2. A device according to claim 1 , wherein the hose is at least partially detachable from the inflatable body by way of a breakable mechanism disposed between the hose and the body.

3. A device according to claim 2, wherein the mechanism comprises one or more tear lines that can be torn or cut to detach the hose, preferably the one or more tear lines comprising one or more perforations.

4. A device according to any one of the preceding claims, wherein the hose is disposed adjacent to an edge of the inflatable body.

5. A device according to any one of the preceding claims, comprising opposed first and second layers wherein the layers are connected by one or more seals to define the inflatable body and the hose, such that a region of the first layer used to define the body is at least partially air permeable and a region of the second layer used to define the body is air impermeable, and other regions of the first and second layers used to define the hose are air impermeable.

6. A device according to claim 5, wherein the one or more seals are disposed around the periphery of the inflatable body and along sides of the hose.

7. A device according to claim 6, wherein the one or more seals defining the body are continuous with the one or more seals defining the hose.

8. A device according to claim 7, wherein one continuous seal defines the periphery around the inflatable body and sides of the hose and said seal has a single gap forming the second end of the hose.

9. A device according to any one of the preceding claims, wherein the first end of the hose is connected to the inlet of the inflatable body such that the interiors of the hose and the inflatable body are in gaseous communication.

10. A device according to any one of claims 1 to 8, wherein the first end of the hose is connectable to the inlet of the inflatable body but is not connected and the interiors of the hose and the inflatable body are not in gaseous communication.

11 . A device according to any one of the preceding claims, wherein the second end of the hose is suitable for being directly connectable to an external air provider in use.

12. A device according to any one of the preceding claims, wherein the inflatable hose is air impermeable with apertures at first and second ends of the hose and the inflatable hose is expandable upon inflation.

13. A device according to any one of the preceding claims, wherein the first end of the inflatable hose is in alignment with one end of the edge of the inflatable body, and the second end of the hose is in alignment with a different preferably opposed end of the edge, or the second end is in alignment with the same end of the edge.

14. A device according to any one of the preceding claims, wherein one or more seals are disposed along sides of the hose and no seals are disposed within the periphery of the hose.

15. A device according to any one of the preceding claims, wherein the inflatable body has only one inlet.

16. A device according to any one of the preceding claims, wherein the device comprises at least two inflatable hoses that are integrated with the inflatable body of the device, wherein the at least two hoses are at least partially detachable from the inflatable body, and wherein the first ends of the at least two hoses are connected or connectable to at least one inlet of the body and the second ends of the at least two hoses are connectable to an external air provider to enable conditioned air to be introduced into the inflatable body through the hoses.

17. A device according to any one of claims 10 -16, wherein the first end of the hose is apart from or separate to the inlet of the inflatable body.

18. A device according to any one of claims 10 -17, wherein the first end of the hose comprises a connector for connecting the hose to the inflatable body, and wherein optionally the inlet comprises a port to receive said connector.

19. A method of manufacturing a device according to any one of the preceding claims, comprising the steps in sequence of: (i) providing a first layer and an opposed second layer, and (ii) attaching the opposed first and second layers with one or more seals to define the inflatable body and the inflatable hose that is integrated with the inflatable body.

20. A method of manufacturing according to claim 19, comprising a step of perforating at least part of a region of the first layer that defines the inflatable body to make it air permeable, such that the body is defined by said region of the first layer and a region of the second layer that is air impermeable, and the hose is defined by other regions of the first and second layers that are air impermeable.

21. A method of using a forced air warming device comprising the steps of (i) providing a device according to any of claims 1 to 18; and (ii) connecting the hose to an air provider, wherein the method further comprises a step of at least partially detaching the hose from the inflatable body.

22. A product comprising an air warming device according to any of claims 1 to 18, wherein the device is contained within a sterilised packaging, and the product preferably comprises instructions for use.

23. A method according to claim 21 , comprising a step (iii) of inflating the body of the device with conditioned air through the hose.

24. A method according to claim 23, comprising a step (iv) of using the inflated forced air warming device to warm one or more parts of a patient.

25. A method of operating a forced air warming device or a method of preparing said device for use, comprising the steps of (i) providing a device according to any of claims 1 to 27 18; and (ii) connecting the inflatable hose to an air provider, wherein the method further comprises a step of at least partially detaching the inflatable hose from the inflatable body.

26. A method according to claim 25, comprising a step (iii) of inflating the inflatable body of the device with conditioned air through the inflatable hose.