Patent Application
20230263657
The present disclosure relates to the field of medical procedures and devices.
Each year, over 60 million surgical procedures are performed in the United States. Patient temperatures can drop precipitously during surgery due to the effects of general anesthesia, lack of insulating clothing, and/or exposure to cold operating room temperatures.
Described herein are systems, devices, and methods to facilitate patient normothermia maintenance in connection with certain medical procedures. In particular, systems, devices, and methods in accordance with one or more aspects of the present disclosure can facilitate the heating of patient core body temperature during a medical procedure through the use of certain wearable heating and/or compression systems, which may advantageously reduce the risk of contracting hypothermia and/or other complications associated with low core body temperature over certain periods of time.
In some implementations, the present disclosure relates to a temperature-management device comprising a wearable sleeve including a foot portion configured to cover at least a portion of a sole of a foot of a patient, a calf portion configured to cover at least a portion of a calf of the patient, the calf portion having one or more compression bladders associated therewith, and a popliteal fossa portion configured to cover at least a portion of a popliteal fossa of the patient. The temperature-management device further comprises a heater assembly configured to be removably secured to the wearable sleeve, the heater assembly including a foot heating pad, a popliteal fossa heating pad, and a physical connector extending between the foot heating pad and the popliteal fossa heating pad.
The foot portion can include a heel pad, such as an inflatable heel pad configured to be fluidly coupled to at least one of the one or more compression bladders. For example, such an inflatable heel pad can be fluidly coupled to a channel having a one-way valve associated therewith. In some embodiments, the popliteal fossa portion of the wearable sleeve has a knee cut-out, such that the wearable sleeve is open around a knee of the patient. The physical connector of the heater assembly may include electrical wiring contained within a connector portion of a fluid-tight pouch.
In some embodiments, the calf portion of the wearable sleeve is detachable from one or more of the foot portion or the popliteal fossa portion. The foot heating pad can have a visual indicator that corresponds with a corresponding indicator associated with the foot portion of the wearable sleeve. The wearable sleeve can include a closable cover configured to be covered over one or more portions of the heater assembly when the heater assembly is secured to the wearable sleeve. In some embodiments, the temperature-management device further comprises an extension component configured to connect to the calf portion over a shin of the patient. In some embodiments, the temperature-management device further comprises a fluid interface that is heat-sealed to the wearable sleeve and includes three fluidly-isolated conduits in fluid communication with three compression bladders of the one or more compression bladders, respectively.
In some embodiments, the heater assembly includes one or more color-coded indicators indicating a size of the heater assembly and the wearable sleeve includes one or more corresponding color-coded indicators on indicating a size of the wearable sleeve relative to the heater assembly. The wearable sleeve can include an adhesive strip configured to secure the heater assembly to the wearable sleeve. The wearable sleeve can include a heater assembly delineation pad on which the heater assembly is configured to be secured.
In some embodiments, the wearable sleeve and the heater assembly are configured such that, when the heater assembly is secured to the wearable sleeve, the foot heating pad and the popliteal fossa heating pad are disposed on an inside of the wearable sleeve and at least a portion of the physical connector is disposed on an outside of the wearable sleeve. For example, the at least a portion of the physical connector can be configured to run outside of the calf portion of the wearable sleeve when the heater assembly is secured to the wearable sleeve. In some embodiments, the heater assembly is configured such that the physical connector runs along a front or side of a leg of the patient between the foot and popliteal fossa when the heater assembly is secured to the wearable sleeve.
In some implementations, the present disclosure relates to a heater assembly comprising a first heating pad, a second heating pad, electrical wiring electrically coupling the first heating pad and the second heating pad to an electrical connector, and a pouch including a first heating pad portion covering at least a portion of the first heating pad, a second heating pad portion covering at least a portion of the second heating pad, and an elongate connector portion extending between the first heating pad portion and the second heating pad portion, the elongate connector portion covering at least a portion of the electrical wiring.
The electrical connector can project substantially perpendicularly from the connector portion. The heater assembly may further comprise a means for indicating a usage of the heater assembly. For example, the means for indicating can comprise a mechanical indicator. As another example, the means for indicating can comprise one or more light sources. The heater assembly may comprise control circuitry configured to determine a number of uses of the heater assembly and activate an indicator in response to said determination.
In some embodiments, the heater assembly further comprises one or more temperature sensors on a patient-facing side of one or more of the first heating pad and the second heating pad. The heater assembly may further comprise thermally-conductive gel disposed on at least a portion of a patient-facing side of one or more of the first heating pad and the second heating pad. In some embodiments, the first heating pad and the second heating pad comprise resistive heating devices.
The connector portion may follow a straight path between the first heating pad portion and the second heating pad portion. In some embodiments, the connector portion has one or more bends configured to allow for the connector portion to traverse a non-linear path.
In some implementations, the present disclosure relates to a method of treating a patient. The method comprises providing a wearable sleeve including one or more compression bladders, providing a heater assembly including a first heating pad, a second heating pad, and a connector portion that physically coupled between the first heating pad and the second heating pad, securing the heater assembly to the wearable sleeve, securing the wearable sleeve on a limb of a patient, compressing the limb of the patient using the one or more compression bladders, applying heat to a sole of a foot of the limb using the first heating pad, and applying heat to a popliteal fossa of the limb using the second heating pad. The method can further comprise inflating a heel pad of the wearable sleeve. In some implementations, compressing the limb, applying heat to the sole of the foot, and apply heat to the popliteal fossa are performed simultaneously
For purposes of summarizing the disclosure, certain aspects, advantages and novel features have been described. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, the disclosed embodiments may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.
Various embodiments are depicted in the accompanying drawings for illustrative purposes and should in no way be interpreted as limiting the scope of the inventions. In addition, various features of different disclosed embodiments can be combined to form additional embodiments, which are part of this disclosure. Throughout the drawings, reference numbers may be reused to indicate correspondence between reference elements.
The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention. Although certain preferred embodiments and examples are disclosed below, inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses and to modifications and equivalents thereof. Thus, the scope of the claims that may arise herefrom is not limited by any of the particular embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding certain embodiments; however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures, systems, and/or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, for example, various embodiments may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.
Although certain spatially relative terms, such as “outer.” “inner,” “upper.” “lower,” “below,” “above,” “vertical.” “horizontal,” “top.” “bottom,” and similar terms, are used herein to describe a spatial relationship of one device/element or anatomical structure to another device/element or anatomical structure, it is understood that these terms are used herein for ease of description to describe the positional relationship between element(s)/structures(s), as illustrated in the drawings. It should be understood that spatially relative terms are intended to encompass different orientations of the element(s)/structures(s), in use or operation, in addition to the orientations depicted in the drawings. For example, an element/structure described as “above” another element/structure may represent a position that is below or beside such other element/structure with respect to alternate orientations of the subject patient or element/structure, and vice-versa. It should be understood that spatially relative terms, including those listed above, may be understood relative to a respective illustrated orientation of a referenced figure.
Certain reference numbers are re-used across different figures of the figure set of the present disclosure as a matter of convenience for devices, components, systems, features, and/or modules having features that are similar in one or more respects. However, with respect to any of the embodiments disclosed herein, re-use of common reference numbers in the drawings does not necessarily indicate that such features, devices, components, or modules are identical or similar. Rather, one having ordinary skill in the art may be informed by context with respect to the degree to which usage of common reference numbers can imply similarity between referenced subject matter. Use of a particular reference number in the context of the description of a particular figure can be understood to relate to the identified device, component, aspect, feature, module, or system in that particular figure, and not necessarily to any devices, components, aspects, features, modules, or systems identified by the same reference number in another figure. Furthermore, aspects of separate figures identified with common reference numbers can be interpreted to share characteristics or to be entirely independent of one another.
The present disclosure relates to systems, devices, and methods for maintaining normothermia for a patient, such as during a medical procedure/surgery. Each year, over 60 million surgical procedures are performed in the United States. While great care may be taken to prevent surgical complications, one commonly overlooked and under-addressed problem is the risk of developing hypothermia before, during, or after surgery (referred to as “inadvertent perioperative hypothermia” or “IPH”). For example, patient temperatures can drop precipitously during surgery due to the effects of general anesthesia, lack of insulating clothing, and/or exposure to cold operating room temperatures. Even with modern standards of care, approximately 30-50% of surgical patients may develop hypothermia.
Hypothermia often causes much more than patient discomfort. Patients who suffer even mild IPH can face a significantly elevated risk of developing surgical site infections, cardiac morbidities, intraoperative bleeding, and other avoidable complications. Together, these complications can significantly increase recovery time and overall length of hospital stay, leading to increased costs for all parties. By some estimates, the unmanaged risk for IPH is a $15 billion problem in the United States alone, and yet it is largely overlooked.
Perioperative heat loss can occur predominantly via convective heat transfer, particularly through the palms of the hands, soles of the feet, and exposed surgical site surface area. During preoperative care, patients are often dressed solely in a gown and are often exposed to relatively cold waiting areas with little to no insulation. Although patients are generally only anesthetized at the start of surgery, patients often arrive at the surgical theater moderately hypothermic. This can put a patient at greater risk for developing severe hypothermia once anesthesia has been administered. Postoperative drops in core temperature can increase the likelihood of developing additional comorbidities, such as morbid cardiac outcomes, surgical site infections, and blood loss, any of which can prolong recovery and hospitalization.
Patients undergoing surgery can develop hypothermia during the surgical procedure itself, especially when the procedure involves the patient's core area, such as procedures involving the posterior or anterior sides of the thoracic, abdominal, and pelvic regions. Surgeries of the core involve the exposure of vital internal organs to the colder environment and thus carry a greater risk of hypothermia. Furthermore, core surgeries often necessitate uncovering of the trunk and chest, which render blankets and many other currently-available interventions inadequate. Once in the operating room, patients may be naked and exposed to a room temperature well below 36 degrees Celsius and to cold liquids used to wash the surgical site during sterilization preparation. At the onset of surgery, delivered anesthetics can immediately impair the normal autonomic thermoregulatory controls. Colder blood may be transferred from the peripheries of the body to the core through a phenomenon known as redistributive hypothermia. Vasodilatation and reduction in muscle tone can cause a significant drop in core temperature within the first half-hour of surgery.
Overall, compared to non-hypothermic patients, those who suffer from IPH experience greater rates of surgical site infections, bleeding, and cardiac complications. Such issues may require additional monitoring and/or increase the length of stay and/or subjective discomfort. The development of IPH is strongly correlated with a multitude of physiological organ system changes impacting the cardiovascular, respiratory, neurologic, immunologic, hematologic, drug-metabolic, and wound-healing mechanisms. The incidence of several post-surgical complications can be increased due to even mild hypothermia.
Intraoperatively, hypothermia can cause a decrease in cardiac output and heart rate, which can lead to ventricular dysrhythmias. Platelet functions can become impaired and there can be a decrease in coagulation factors, which can, in turn, lead to greater intraoperative bleeding and blood loss. Impaired immune functions can increase the rate of surgical site infections. Hypothermia is associated with a four-fold increase in surgical wound infection and twice as many morbid cardiac events. In select procedures such as colorectal, gynecologic, or spinal surgery, where infection rates are normally higher than other surgeries, hypothermia can be exceedingly dangerous to the intraoperative and postoperative recovery. These complications and others are supported in multiple studies and can result in both clinical and economic burdens.
Current methods of preventing hypothermia often are not completely effective. Even with the current interventions, up to 46% of patients are reported to be hypothermic at the start of surgery, and 33% are hypothermic upon arrival to the post-anesthesia care unit (PACU). Assuming the cost savings for maintaining normothermia in one patient is approximately $5.000 per patient, and approximately 30% of the 17 million high-risk surgical patients are hypothermic, a system-wide cost savings of $15 billion could be realized by keeping these patients normothermic. With rising healthcare costs and recent initiatives mandating the maintenance of perioperative normothermia, hospital administrators are in need of new, efficacious and cost-effective devices to address perioperative hypothermia, a product space that has seen little innovation since the introduction of the forced-air warming blanket nearly three decades ago.
Some solutions for perioperative warming may implement forced-air temperature management devices (e.g., warming blankets). Some temperature management solutions utilize high-heat transfer conduction heating blankets and intraoperative hand-warming devices. For example,
The patient-heating subsystem 122 may include a blanket-type structure or device 26, which may be draped and/or covered over at least a portion of the patient's body. For example, in connection with some procedures, the surgical operation(s) may require access to the chest or core of the patient. In such procedures, the blanket device 26 may be placed over at least a portion of the lower extremities and/or core of the patient 5. That is, the blanket device 26 may generally be placed over an area of the patient's body that is not presently being operated on to avoid interference with the surgical procedure/access. In some implementations, the blanket device 26 may have certain openings, apertures, slits, cutouts, or the like formed therein to provide access to the relevant parts of the patient anatomy, while still allowing for the blanket device 26 to be disposed generally about/near the access portion(s).
In some embodiments, the blanket device 26 may be configured to direct thermal energy to portions of the patient anatomy covered thereby. For example, in some implementations, the blanket device 26 may operate by having heated fluid, such as air, circulated and/or filled within one or more portions of the blanket device 26, such as through one or more channels thereof. For example, warm air may be circulated through the blanket device 26, wherein such air may be introduced into the blanket device 26 via one or more ports 25, wherein fluid may flow in a fluid circuit and/or exit the blanket device 26 via one or more ports, apertures, and/or other egress channels/pathways. The heated air/fluid can be provided by a fluid source unit 22, which may comprise one or more air compressors or the like and/or one or more heating elements for heating air provided thereby. The heated fluid (e.g., air) may be provided from the fluid source unit 22 to the port 25 via a hose 24 and/or hose interface 21.
Circulating fluid may be circulated through the blanket device 26 through one or more ports back to the fluid source unit 22 in some embodiments. Additionally or alternatively, heated air may exit the blanket device 26 via one or more patient-facing apertures or ports, which may serve to further heat the patient anatomy. In embodiments in which heated fluid exits the blanket device 26 towards the patient and/or into the surgical environment, such air may introduce certain contaminants into the surgical environment, which can result in infection or other medical issues. That is, it may be desirable for the surgical environment to be substantially sterile to prevent exposure of the patient anatomy, which may be of a particular concern with respect to internal patient anatomy that may be exposed to the surgical environment during the relevant procedure/operation. Forced-air, blanket-type heating systems may further present a relatively cumbersome physical structure that can get in the way, such as when the blanket is disposed in an area near the surgical site. Furthermore, in some situations, operating room staff may turn down the temperature on a forced-air device in consideration of their own comfort, as forced-air systems can heat the surrounding air/environment. Moreover, certain devices may not be used in preoperative warming for one or more of the following reasons, among others: (1) some devices may immobilize the upper limbs, impeding patient mobilization; (2) devices may be cumbersome (e.g., a device may float on the patient and get blown off or fall off during use and/or transport, and they require large, predominantly floor-based blowers that may not be mobile; (3) they may not attach to the patient and/or can become dislodged during transport and obstruct the bed and other monitors and devices; and (4) they can require a conscious administrative decision to implement.
Embodiments of the present disclosure advantageously provide certain improved devices, methods, and systems for maintaining a patient's core body temperature before, during, and/or after surgery. Furthermore, embodiments described herein provide methods and systems for core body temperature management in an unobtrusive, effective, and easy-to-use (e.g., easy to set-up) manner. Some embodiments of the present disclosure can be suitable for use before, during, and/or after a surgical procedure and can be acceptable to the patient while awake in the preoperative and/or postoperative settings.
In some embodiments, lower limbs of patients may be leveraged to provide therapy and/or enable mobility. For example, some devices described herein may provide flexibility and/or one or more spaces around a knee, ankle, and/or other portions of a patient's body to allow the patient to flex and/or extend the limbs. Such patient mobility may provide a variety of benefits, including allowing patients to stand up to use the restroom without removing and reapplying the device.
Some embodiments of temperature management devices disclosed herein may be configured to provide warming to one or more arteries and/or veins passing along the patient's lower limbs. Moreover, some embodiments may involve compression of one or more portions of the patient's body. For example, compression may be applied to the patient's calf. In some embodiments, compression may be performed in a sequential and/or gradient manner. Devices and systems disclosed herein advantageously combine separate sleeve structures/garments, which may include compression features, with heater assemblies that include one or more heating elements, wherein the heater assembly and the sleeve can be physically coupled to produce a combined wearable system. By utilizing separable and couplable heater assemblies and sleeve structures, such components of the temperature-management system can be used, combined, disposed of, powered, connected, and/or otherwise managed separately from one another, which can provide certain benefits with respect to patient matching, manufacturing, storage, organization, and/or other considerations.
The sleeve 30 may advantageously be open around the knee 8, as shown in
The temperature-management sleeve 30 may further include one or more fluid-fillable bladders/chambers 38, which may be used for implementing intermittent compression with respect to the leg 10 when the sleeve 30 is disposed on the leg 10 of the patient 5. For example, in some implementations, intermittent compression in the calf area 1 of the leg 10 may be implemented simultaneously with the application of thermal energy/heat to the sole 3 of the foot and the popliteal fossa 9 to facilitate heating of the venous and arterial blood of the patient 5, which may serve to increase the core temperature of the patient. Although fluid-filled bladders are described herein, it should be understood that references to fluid-filled bladders or the like may refer to any type of compression element, whether inflatable, fluid-containing, or any other type of compression element. For example, such compression elements may include certain elastic compression features. In some embodiments, compression elements associated with sleeve devices/structures of the present disclosure can include physical straps and/or smart material(s) configured to implement squeezing and/or relaxing around at least a portion of the calf. In some embodiments, circulation stimulation of the limb 10 may be implemented using electrical stimulation provided by one or more electrodes associated with the sleeve device 30, wherein such stimulation may be in the calf area 1 of the sleeve.
The patient-heating subsystem 120 can include a control unit, device, or system 20, which may be equipped with one or more fluid-compression devices, electrical power sources, and/or certain control circuitry configured to control the operation of the heating pads/devices 32, 34 and/or compression bladder(s) 38. In some embodiments, the sleeve device 30 includes one or more temperature sensors, which may be generally associated with and/or positioned near the heating pads/devices 32, 34, wherein signals generated by such sensors may be provided to the control unit 20 to provide feedback that may direct operation of the control unit with respect to the application of heating and/or compression to the leg 10. The control unit 20 may include one or more fluid and/or electrical tubes, cables, wires, and/or other connectors 62, which may be used to provide fluid (e.g., air) to the bladder(s) 38 and/or electrically drive the heaters 32, 34 to provide heat to the patient 5. In some embodiments, the control unit 20 is embodied at least in part in/on the sleeve assembly 30.
The sleeve 330 can include one or more compression bladders 338, which may be configured to receive fluid through one or more fluid interfaces/connectors 396 from a fluid source 322 of a control unit or system 320. In some embodiments, the sleeve 330 includes 2, 3, or more compression bladders, which may be individually inflatable and/or depletable to provide sequential compression of the limb of the patient. Although described as compression bladders for convenience, it should be understood that the feature(s) 338 may comprise any type of compression elements. In some embodiments, certain electrical wiring or other electrical connectivity component(s) may be coupled to each compression element 338 for providing electrical power to the respective compression element. For example, electrical current may be provided to the compression element(s) 338 to initiate mechanical tightening or relaxing of the element(s) in order to provide sequential compression of the limb of the patient.
In some embodiments, the sleeve 330 includes an inflatable heel pad 308, which may be fluidly coupled to one or more fluid channels associated with the compression bladder(s) 338. For example, the inflatable heel pad 308 may be configured to receive fluid/air through a one-way fluid valve from one or more of the compression bladder(s) 338 and/or fluid channels associated therewith. The inflatable heel pad 308 may advantageously reduce the risk and/or effects of pressure ulcers (e.g., bedsores) and/or other friction- or pressure-based physical injury that may occur to the heel of the limb on which the sleeve 330 is disposed due to, for example, prolonged positioning of the heel and/or repeated/agitated movement of the heel on the bed or other surface, which may occur during the course of a surgical operation. Although described in connection with certain embodiments as being an inflatable heel pad, it should be understood that any reference herein to a heel pad may be inflatable or non-inflatable. For example, the heel pad 308 can comprise foam or other cushioned material and/or form, which may be associated with a heel portion of the sleeve structure. The heel pad 308 may be a donut-/torus-shaped balloon or foam form.
The sleeve 330 may further have associated therewith a heater assembly 360, which may be removably attached or secured to the sleeve 330 using one or more aspects of the physical connector(s) 342 and/or other attachment means or mechanisms of the sleeve 330. The heater assembly 360 can include a plurality of heating pads/devices disposed within a pouch-type container 362. For example, the pouch 362 may comprise one or more layers of plastic that envelop at least a portion of the heating pads/devices 364, 365. In some embodiments, the heater assembly 360 is contained between fabric layers of the sleeve 330. For example, the heating assembly may be stitched or welded in place in/on the sleeve 330. In such embodiments, the heating assembly may not be contained in a pouch-type container 362 (e.g., polymer pouch), but rather the heating pads and connecting wires may be stitched/welded into/onto the sleeve 330.
The heating pads of the heater assembly 360 may include a foot heating pad 364 and a popliteal fossa heating pad 365. The term “heating pad” is used herein according to its broad and ordinary meaning, and may refer to a heating element that has a relatively broad surface configured to apply heat over a broad (e.g., relatively flat and/or contoured) area, such as an area of the sole of the foot and/or area of the popliteal fossa, or any other area corresponding to the form factor of the heating element/pad. Furthermore, the term “heating pad,” as used herein, may refer to the heating element itself, such as a resistive heating element implemented on an at least partially flat substrate or in an at least partially flat plane or form, and/or may be used to refer to a portion of a heater assembly including a heating element and one or more layers or components associated therewith and/or disposed adjacent thereto.
Although embodiments are described herein in the context of heating, it should be understood the various embodiments of temperature management systems and devices disclosed herein can be implemented to provide cooling to the limb of a patient. That is, any reference herein to heating, heating pads, heater assemblies, and/or other heating systems, processes, devices, or the like can be understood to refer to cooling, cooling pads, cooling assemblies, and/or other cooling systems, processes, devices, or the like. Furthermore, it should be understood that the various devices, systems, and processes disclosed herein can be used/implemented to perform or incorporate both heating and cooling functionality. In some embodiments, cooling using a cooling pad is implemented utilizing thermoelectric cooling element(s).
The structure of sleeves disclosed herein may include certain holes or other attachment features for attaching various components of a temperature-management system, including heater/cooler assemblies, physical connectors, tubes, pads, or other features. For example, certain straps (e.g., velcro) may be implemented to attach various components.
Certain electrical wiring and/or other type(s) of conductive tracing(s) 363 may generally be coupled to each of the foot heating pad 364 and the popliteal fossa heating pad 365 for providing electrical power to the respective heating elements/devices. For example, electrical current may be provided through the electrical wires 363 and through resistive conductor(s) of the respective heating pads to generate radiative heat. That is, the foot heating pad 364 and the popliteal fossa heating pad 365 may operate as resistive heaters that are configured to heat certain portions of the patient's anatomy through infrared/heat radiation. It should be understood that any references herein to electrical wiring can be understood to refer to any type of electrically-conductive tracing, or any other signal-transmission medium, means, or mechanism. For example, such signal-transmission means may comprise a pneumatic signal transmission system, which may include an air/gas-filled tube used for signal transmission in some implementations.
In some embodiments, the heating pads 364, 365 are associated with certain thermal insulation features 378, which may be disposed on a side of the heating pads that is generally away from the patient when the sleeve 330 is disposed on the patient's limb. Such insulation may reduce the risk of burn or damage from contact with the outside of the sleeve. Such insulation may further serve to direct heat in the direction of the patient rather than outwardly away from the patient when the heating pads are activated. In some embodiments, heat-transfer media 374 may be applied to one or more heating surfaces or areas of the respective heating pads 364, 365, wherein such transfer media may advantageously promote thermal conduction/transfer from the heating pads to the patient's skin. In some embodiments, heat transfer media can be applied to a patient-facing surface/area of the heating pad(s) 364, 365 and/or sleeve 330 to facilitate heat transfer between the sleeve and the patient's skin.
In some embodiments, the heater assembly 360 includes certain control circuitry 371, which may be implemented on one or more circuit boards or other electrical modules/devices electrically coupled to the wiring 363 in some manner. For example, in some embodiments, the control circuitry 371 may be implemented at least in part in one or more boards and/or chips disposed adjacent to and/or on one or more of the heating pads 364, 365. For example, the heating pads may comprise substrates on/in which resistive heating conductors are disposed, wherein the control circuitry is implemented in/on an area of the substrate that is not covered by the resistive heating conductors. The term “control circuitry” is used herein according to its broad and ordinary meaning, and may refer to any collection of processors, processing circuitry, processing modules/units, chips, dies (e.g., semiconductor dies including come or more active and/or passive devices and/or connectivity circuitry), microprocessors, micro-controllers, digital signal processors, microcomputers, central processing units, field programmable gate arrays, programmable logic devices, state machines (e.g., hardware state machines), logic circuitry, analog circuitry, digital circuitry, and/or any device that manipulates signals (analog and/or digital) based on hard coding of the circuitry and/or operational instructions. Control circuitry referenced herein may further comprise one or more, storage devices, which may be embodied in a single memory device, a plurality of memory devices, and/or embedded circuitry of a device. Such data storage may comprise read-only memory, random access memory, volatile memory, non-volatile memory, static memory, dynamic memory, flash memory, cache memory, data storage registers, and/or any device that stores digital information. It should be noted that in embodiments in which control circuitry comprises a hardware and/or software state machine, analog circuitry, digital circuitry, and/or logic circuitry, data storage device(s)/register(s) storing any associated operational instructions may be embedded within, or external to, the circuitry comprising the state machine, analog circuitry, digital circuitry, and/or logic circuitry.
The heater assembly 360 includes physical connector component(s) 339 that physically connect between the foot heating pad 364 and the popliteal fossa heating pad 365 to allow for the heater assembly 360 to span the distance between the popliteal fossa and the sole of the foot of the patient in a manner such that the heater assembly 360 provides a substantially unitary structure that can be placed and span the distance between the popliteal fossa and the sole of the foot. For example, the physical connector 339 may include one or more portions of the electrical wires 363 that connect between the heating pads, and/or between a respective heating pad and an electrical connector 369 of the heater assembly that is configured to be coupled to an electrical interface/connector 397 of the thermal-management sleeve 330. For example, the electrical connector 369 may be configured to be plugged into the electrical interface/connector 397 of the sleeve 330. In some embodiments, the electrical connector 369 is configured to plug directly into one or more cables 62 coupled to the control unit 320. For example, the connector 369 may be configured to be exposed externally from the sleeve 330 when the heater assembly is positioned in/on the sleeve 330.
The heater assembly 360 may further comprise one or more temperature sensors 368, such as one or more thermistors or the like. The temperature sensor(s) 368 may be configured to generate signals indicative of temperatures present and/or experienced at one or more portions of the heater assembly 360 and/or thermal management sleeve 330. For example, the temperature sensors 368 may provide signals indicating temperatures associated with the respective heating pads and/or areas of the sleeve and/or patient anatomy that are disposed/situated in proximity thereto. The temperature sensor(s) 368 may be configured to provide sensor signals to the electrical connector 369 and/or to the control unit 320 via the electrical connector 369 and/or electrical interface/connector 397. The temperature sensor(s) 368 may be disposed on a patient-facing side of the foot 364 and/or popliteal fossa 365 heating pads.
The connector assembly 335 of the thermal-management sleeve 330 may include one or more connectors for coupling to a fluid source 322 of/from the control unit 320, a power source 323 of/from the control unit 320, and/or the electrical connector 369 of the heater assembly. Although the connector assembly 335 is illustrated as including one or more separate fluid interface/connector 396 and electrical interface/connector 397 modules/components, it should be understood that such connectivity features may be implemented in a single connector structure in some embodiments. Furthermore, in some embodiments, either or both of the fluid interface/connector 396 and the electrical interface/connector 397 may be implemented in two or more separate connectors. For example, the electrical interface/connector 397 may comprise a first electrical connector for receiving electrical power from the control unit 320 as well as a second electrical connector for electrically coupling to the electrical connector 369 of the heater assembly 360 to provide power thereto and/or to receive certain electrical signals (e.g., temperature sensor signals) therefrom.
The temperature-management system shown in
The control unit 320 include certain control circuitry 325 configured to implement any of the various functional operations disclosed herein in connection with temperature management solutions of the present disclosure. For example, the control circuitry 225 may be configured to determine when and/or to what degree to activate the compression bladder(s) 338, foot heating pad 364, popliteal fossa heating pad 365, temperature sensor(s) 368, and/or user input/output functionality. The control unit 320 may further comprise certain user interface components, which may further allow for user engagement with the control unit 320 through provision of user input and/or notification/indication of certain information relating to the operation of the control unit 320. For example, the user interface component(s) 324 may include one or more user input buttons and/or one or more user output displays 327, lights 328, speakers or other audible notification means or mechanisms 329, or other input/output components for communication with a user. Example user interface representations are shown in block 324, which shows certain lights or other visual indicators 381 indicating a heating level of one or more heating pads of the heater assembly 360, and/or certain output indicators 383 indicating other conditions of the heater assembly. Additional indicators 382 may be provided to indicate which limb is presently subject to intermittent compression and/or the degree to which such compression is implemented.
In some embodiments, the sleeve 330 includes a pump attachment, such as a mini-pump, which may serve as a fluid source for intermittent compression and/or heated or cooled fluid circulation in the sleeve. The pump attachment may be secured to the calf portion of the sleeve in some implementations. The various components of the thermal management sleeve 330 can be configured to be battery powered. For example, the sleeve may be configured to include one or more battery packs or the like, which may be electrically coupled to the heater assembly 260 and/or one or more components thereof. The battery power source can be a component of the heater assembly in some embodiments. For example, the battery source can be contained within the pouch 362, which may advantageously provide protection from fluids and/or other contaminants for the batter(ies).
The sleeve 430 further includes a calf portion 402, which may be associated with one or more compression bladders 438, which may be implemented to provide sequential compression for the promotion of blood flow within the limb 10 and/or prevention/treatment of deep vein thrombosis. In some embodiments, sequential compression may be implemented in the calf portion 402 simultaneously with heating of the sole of the foot 3 and the popliteal fossa 9 using the heating pads 434 and 432, respectively. Such simultaneous implementation/execution of the heating and sequential compression as provided by the sleeve system 430 can advantageously provide improved heating and/or temperature maintenance for a patient during a surgical procedure, thereby reducing the risk of hypothermia development as described in detail herein.
In some embodiments, the calf portion 402 of the sleeve 430 is detachable from a foot portion 401 and/or a popliteal fossa portion 403 of the sleeve 430. For example, the sleeve 430 may include a detachable feature or region 491 configured to allow for detachment of the foot portion 401 from the calf portion 402. For example, such detachment/attachment means 491 may comprise a Velcro coupling, and/or other type of clip, strap, tie, snap, or other physical attachment means, mechanism or tearaway feature, wherein the structure of the foot portion 401 can be separated from and/or attached to the calf portion 402. The detachability of the foot portion 401 and/or popliteal fossa portion 403 from the calf portion 402 may allow for the calf portion 402 and associated sequential compression functionality to remain on the limb 10 and/or be implemented even after removal of the foot 401 and/or popliteal fossa 403 portions of the sleeve 430, which may be desirable for the purpose of an increasing patient comfort and/or allowing for patient mobility in certain situations.
The sleeve 430 includes certain physical connectors/couplings, such as one or more calf portion straps 442, foot portion straps 446, and/or popliteal fossa portion straps 444, which may serve to secure the sleeve 430 to the limb 10. The sleeve 430 may further include certain flexibility-enhancement features, such as a knee cut-out/opening 449 and/or ankle cut-out/opening 499. The ankle opening 499 can advantageously allow for rotation of the limb 10 at the ankle 4 with reduced discomfort and/or physical strain on the sleeve 430. The knee opening 449 may advantageously allow for bending of the limb 10 at the knee 8 with reduced obstruction and/or discomfort to the patient.
The sleeve 430 includes a connector assembly 435, which may comprise a physical connector for a fluid source, which may provide heated or non-heated fluid for inflation of the compression bladder(s) 438 and/or heel pad 408, and/or may allow for electrical coupling of the heater assembly 460 associated with the heating pads 432, 434 with an electrical power source, which may be provided from a control unit or the like (not shown in
The sleeve 530 further comprises certain straps or couplings 542, 543, 594, 595, which may be used to strap or secure the sleeve 530 to a limb of a patient. Certain visual indicator(s) 599 indicating a direction of the sleeve relative to the limb of the patient and/or orientation of the patient may further be included on one or more sides of the sleeve 530.
Sleeve 530 may further include a seating area or feature 585 on which a heater assembly 560 may be placed, disposed or otherwise secured to the sleeve 530. Features having characteristics that are similar to the feature 585 may be referred to herein as heater assembly delineation features, components, or portions. For example, such features may generally outline the footprint/profile of the heater assembly and provide support, protection, and/or visual direction/indication therefore. Although illustrated with heater assembly delineation features in some instances, it should be understood that the various embodiments of sleeves disclosed herein may or may not include such features.
In some embodiments, the delineation feature 585 may include certain visual indicators 536, 537 indicating positions of placement for a foot heating pad 564 and popliteal fossa heating pad 565, respectively, to assist a user in identifying the correct orientation of the heater assembly 560 relative to the sleeve 530. For example, a first indicator, marking, or other feature 536 may indicate that a foot heating pad is to be placed in the area associated therewith, wherein a corresponding indicator 568 may be associated with the heater assembly 560, wherein the markers/indicators 536, 568 indicate a match and relative placement of the heater pad 564 of the heater assembly 560 relative to the delineation area/feature 585 of the sleeve. Likewise, the popliteal was a heating pad 565 may have associated therewith a visual indicator 567 indicating the placement thereof in the area identified by the marking 537 on the sleeve 530. The respective markings 568, 567 and/or 536, 537 may include visual images indicating the parts of the patient anatomy associated therewith, namely the sole of the foot and the popliteal fossa, as shown in
The sleeve 530 may advantageously include certain gaps 598 for providing an opening around the patient's knee when the sleeve 530 is disposed on the leg of the patient to thereby allow for flexibility around the knee as well as to prevent the sleeve 530 from being placed with the heating pad 565 positioned over the knee as opposed to the popliteal fossa, which would represent a substantially less effective heating position for the heating pad 565 compared to the popliteal fossa area where the relevant blood vessels are closer to the skin. The illustrated side of the sleeve shown in
With further reference to
The popliteal fossa heating pad 665 and the foot heating pad 664 may include certain resistive electrical conductors configured to have electrical current passed therethrough, wherein such current produces radiant heat (e.g., in the form of infrared radiation), which may be used to provide heating to the patient. In some embodiments, with respect to the embodiment of
The heating pad 665 may have associated therewith one or more thermistors 669. For example, the thermistor(s) 669 may be disposed on or in proximity to a patient-facing side of the heating pad 665, which side is shown in the illustrations of
In some embodiments, the heater assembly 660 may include control circuitry 671, which may be configured to perform certain functionality or the heater assembly 660. For example, the control circuitry 671 may be configured to receive and/or provide electrical signals to/from the thermistor(s) 669/668. In some embodiments, the control circuitry 671 is primarily utilized for heater assembly usage-counting/tracking functionality, wherein additional control functionality is primarily handled by a control system/unit separate from the heater assembly 660. In some embodiments, the control circuitry 671 is configured to digitize thermistor readings. In some embodiments, the control circuitry 671 may be configured to activate the heating pad 665 and/or heating pad 664. That is, the control circuitry 671 may control the heating functionality of the pad(s). The control circuitry 671 may advantageously be electrically coupled to one or more of the electrical wires 663a. 663b. The control circuitry 671 may be embodied in one or more circuit boards, chips, application-specific integrated circuits (ASIC), and/or active and/or passive circuit devices (e.g., resistors, capacitors, inductors, diodes, etc.). In some embodiments, the control circuitry 671 is configured to condition certain electrical signals transferred to or from the control circuitry, such as certain filtering, amplification, multiplexing, switching, or the like. Although the control circuitry 671 is illustrated as being coupled to and/or associated with the popliteal fossa heating pad 665, it should be understood that the control circuitry 671 may be associated with the foot heating pad 664, or any region of the connector portion 672 of the heater assembly 660. The connector portion 672 may be considered to comprise the wires 663 and/or the connector portion of the pouch 662. For example, with respect to the embodiment of the
With reference to
The heater assembly 660 may include an electrical connector 661, which may be electrically coupled to one or more of the wires 663 that connect to the respective heating pads 665, 664. With respect to
With respect to pouch-contained embodiments, the pouch 762 can include multiple segments, such as a patient-facing sheet or segment 762a as well as a segment or sheet 760b disposed on an opposite side of the heater assembly 760, such that the first segment 762a and second segment 762b are bound together, such as through heat sealing or other method, to contain/sandwich the internal components of the heater assembly 760. The segments of the pouch 762 can include various portions/regions, including a foot heater portion 775, a popliteal fossa heater portion 773, and a connector portion 772 that spans between the foot heater portion 775 and popliteal fossa heater portion 773. The connector portion 772 may further include certain areas/portions, including one or more bends 701, 702, which may allow for the connector portion 772 to navigate a path between the heating pads over/under portions of a sleeve with which heater assembly 760 is configured to be coupled. Bends in the connector portion can allow for the connector 772 to traverse a non-linear path along one or more portions of a wearable sleeve.
The heater assembly 760 further comprises certain heat-transfer media 774, which may not be present with respect to certain embodiments of heater assemblies in accordance with the present disclosure. For example, the heat-transfer media 774 may comprise heat-transfer gel and/or other media configured to facilitate the transfer/conduction of thermal energy from a respective heating pad 764, 765 through the patient-facing side of the heater assembly 760. In some embodiments, the heat transfer media 774 is disposed on, over, and/or under one or more thermistors 768, 769, which may be used to determine temperature conditions at or near the respective heating pad portions of the heater assembly 760. The thermistors 768, 769 may be disposed in proximity to the patient-facing sides of the foot 764 and popliteal fossa 765 heating pads, respectively. The control circuitry 771 may be embodied at least in part in a flexible printed circuit board having a microcontroller or other circuitry associated therewith.
In some embodiments, the heater assembly 760 includes certain control circuitry 771, which may be associated with any of the illustrated components. For example, although the control circuitry 771 is shown as disposed on or proximate to the popliteal fossa heating pad 765, it should be understood that the control circuitry 771 may be disposed on or coupled to any of the illustrated components. Furthermore, although the control circuitry 771 is illustrated as a single block, it should be understood that control circuitry associated with the heater assembly 760 may be embodied in any number of components or devices, which may be combined in an integrated unit or device, or may be physically and/or electrically separate.
The heating pads 764, 765 may be any type of heating pads, such as resistive radiating heating pads. For example, the heating pads may comprise polyimide or other substrate material, which may be flexible or rigid in whole or in part. The heating pads 764, 765, thermistors 768, 769, and/or control circuitry 771 may be coupled to electrical wiring 763, which may be electrically coupled to an electrical connector 761. In some embodiments, the electrical connector 761 is a water-resistant electrical connector. The electrical connector 761 can be coupled to the wiring 763 via a portion of the wiring 708 that juts outward from the connector portion 772 and/or routing path of the wires 763, as shown.
In some embodiments, the heater assembly 760 further includes certain thermal insulation features 778, which may comprise heat-insulating foam and/or padding. Such thermal insulation features may improve patient and/or physician comfort and/or reduce the risk of injury or damage to equipment from thermal energy originating in the heating pad 764, 765. The insulation features 778 can further advantageously present pressure on the heating pads 764, 765 to push the heating pads towards the patient to thereby improve contact and heat transfer to the patient.
The heater assembly 860 includes a container pouch 862, which may be similar to heater assembly pouches described in connection with other embodiments herein. As described in detail herein, although shown with a pouch 862, it should be understood that the heater assembly 860 can be manufactured without a pouch. For pouch-contained embodiments, the pouch 862 may comprise a patient-facing 862a segment/portion and an away-facing 862b segment/portion. The heater pouch 862 may include a first heating pad portion 875 and a second heating pad portion 873 separated by a connector portion 872. Although some embodiments of heater assembly pouches disclosed herein include connector portions having one or more bends therein along the path between the heating pad portions, some embodiments, as illustrated in
Another apparent distinction between the various components of the heater assembly 860 compared to the heater assembly 760 illustrated in
The pouch 862 may include an electrical connector portion 879, which may jut out orthogonally from the path of the connector 872, as shown in
The respective heating portions of the sleeve 930 may be embodied at least in part in heater portions of a heater assembly as described in detail in connection with various embodiments disclosed herein. For example, such heater assemblies may include foot and popliteal fossa heating portions, wherein heating pads or other heating elements are disposed within a pouch, as shown in
In some embodiments, a thermistor 968, or a plurality of thermistors, is/are disposed on the patient-facing surface of the heating pad/element 960. Although shown directly in contact with the patient-facing surface of the heating element/pad 960, it should be understood that the thermistor(s) 968 may be disposed in any position between the heating pad/element 960 and the patient tissue 2, whether internal to the heater assembly pouch or between the heater assembly pouch and the fabric layer 927, or between the fabric layer 927 and the patient tissue 2. In some embodiments, a backside (i.e., facing away from the patient) of the heating element/pad 960 may be thermally buffered by a thermal insulation layer 978, which may be disposed/present between the heating pad/element 916 and the outward-facing pouch layer 962b. In some embodiments, a fabric layer 929 is disposed on outermost portion of the heater assembly. That is, a fabric cover 929 or the like may be placed over the heater assembly when the heater assembly is coupled as desired to the sleeve 930.
The heating pad 975 can comprise heat-transfer media 974, shown in
The heating element 960, which can be disposed between the thermal transfer layer 974 and a thermal insulating layer 978, may be any type of heater, such as a resistive radiating heater. For example, the heater 960 may comprise polyimide or other substrate material, which may be flexible or rigid in whole or in part. The thermal insulation layer/structure 978, which may comprise heat-insulating foam (e.g., relatively soft foam) and/or padding, may improve patient and/or physician comfort and/or reduce the risk of injury or damage to equipment from thermal energy originating in the heater 960. The insulation layer 978 can further advantageously present pressure on the heater 960 to push the heater 960 and thermal transfer layer 974 towards the patient to thereby improve contact and heat transfer to the patient.
The mechanical usage indicator 1005 may include one or more tabs, punch holes, or the like, wherein a user may mechanically punch a feature 1001 to thereby create an aperture/opening or other visual feature 1003 indicating a use count of the assembly 1060. That is, with each use, the user may punch one of the indicators 1001 to show a use count indicator 1003 in a used condition/state indicating that the use has occurred or will occur imminently. When the expiration indicator 1005 includes only used-condition counters 1003 (i.e., where each and every one of the use counts indicators old 1002 has been punch to a used condition/state 1003, the user may be notified or made aware that the heater assembly 1060 has reached the end of its useful life. In some embodiments, the mechanical usage indicator is associated with the sleeve member/article rather than the heater assembly. For example, with respect to embodiments including heater assemblies that are sewn into the sleeve without a pouch container around the heater assembly, it may be beneficial to incorporate the usage indicator (e.g., mechanical, or electrical as shown in
The connector portion 1281 may include one or more additional bends, such as the band 1207, which may allow for redirection of the connector portion 1281 in the direction of the foot heater portion 1282 of the heater assembly 1260. That is, the illustrated connector portion 1281 includes one or more straight, curved, and/or bend portions, which represent merely examples of different routing features/characteristics of a connector portion of a heater assembly in accordance with aspects of the present disclosure. Therefore, it should be understood, that embodiments of the present disclosure may include heater assemblies having any number and/or configuration of straight, curved, and/or bend portions configured/designed to accommodate a suitable path along a wearable sleeve (e.g. for a leg or other limb) that allows for placement and/or coupling with/to the sleeve. For example, the straight, curved, and/or bend portions of the connector 1281 may be configured to pass around a gap or opening 1292 on a back of the leg portion of the sleeve 1230 and/or an opening 1298 on the front of the leg portion of the sleeve 1230 to allow for desirable flexibility for the sleeve 1230. Furthermore, the connector portion 1281 may be configured to follow a path along an ankle connector portion 1291 of the sleeve 1230, wherein the ankle connector portion 1291 is routed around an ankle opening 1299 which may further provide flexibility and/or comfort for the patient.
Connector portions of heater assemblies in accordance with aspects of the present disclosure may be configured to pass along and/or under certain physical couplings, such as straps or the like. For example, in the illustrated embodiment of
The temperature-management system 1330 can include a plurality of compression bladders 1338 associated with the calf portion 1312 of the sleeve 1331. For example, the compression bladders 1338 may include a lower bladder 1338a, an intermediate bladder 1338b, and an upper bladder 1338c. Although three bladders are shown in vertical arrangement with respect to the vertical orientation of a leg on which the sleeve 1331 may be placed, it should be understood that compression bladder assemblies in accordance with aspects of the present disclosure may include any number of compression bladders and/or any relative position and/or orientation. The temperature-management system 1330 of
The heater assembly 1360 may pass along one or more portions of the sleeve 1331, such as along a heel connector portion/path 1391. In some embodiments, the heater assembly connector portion 1362 may pass at least partially over a portion of the bladder/compression assembly 1338, as shown. As with certain other embodiments disclosed herein, the connector portion 1362 of the heater assembly 1360 may include one or more straight 1303, 1372 and/or bend 1301, 1302 sections, which may allow for the connector portion 1362 to traverse the area between the foot heating pad 1364 and the popliteal fossa heating pad 1365 on the sleeve 1331.
In some embodiments, the attachment means 1402 is associated with a heater assembly delineation portion 148 of the sleeve 140. For example, the delineation portion 148 may comprise a form of fabric and/or other material on which the heater assembly 146 is disposed. For example, the delineation portion 148 may generally follow a similar path between the foot heat pad 141 and popliteal fossa heel pad 142 as the heater assembly, whether such path runs substantially on a straight path between the heating pads or on a more tortuous path/route as shown in
Prior to coupling of the heater assembly 166 to the sleeve structure 160, an adhesive covering 169 may be removed from over the adhesive surface 168, to thereby expose the adhesive surface 168 and allow for coupling therewith. For example, as shown in
In the illustrated embodiment of
In some embodiments, the covers 179, 177 comprise fabric or other material designed to provide comfort for the patient at the heating pad contact areas of the sleeve 170. Any attachment means disclosed or contemplated herein may be used to secure the covers 179, 177 in the closed configuration shown in
As with any of the embodiments of sleeves disclosed herein, the sleeve 180 may include a foot strap portion 181, which may be configured to be wrapped at least partially around a foot of the patient. The foot wrap portion 181 may have a width dimension D1 that may be between approximately 12″-16″. According to some embodiments, a large-sized sleeve may include a foot wrap dimension D1 of about 15″, whereas a medium-sized sleeve may include a foot wrap dimension D1 of about 15″, whereas a small-sized sleeve may include a foot wrap dimension D1 of about 13″.
Each of the remaining dimensions of the sleeve 180 of
Additional dimensions of the sleeve 180 include a width D2 of an ankle connector portion 183 (2″-5″, 3″, 4″, 4″), a width D3 of a calf portion 188 at a relatively narrow end or region thereof (16″-22″, 17″, 19″, 20″), a width D4 of the calf portion 188 at a relatively wide area/portion thereof (18″-28″, 19″, 21″, 26″), a width D5 of a popliteal fossa connector portion 184 (4″-6″, 4.5″, 5″, 5″), a width D6 of a popliteal fossa wrap portion 186 (20″-29″, 22″, 25″, 27″), an overall length D7 of the sleeve 180 (26″-37″, 28″, 32″, 35″), a length D8 of the foot and ankle portions 181, 183 together (11″-16″, 12″, 13.5″, 14.5″), a length D9 of the calf portion 188 (11″-16″, 12″, 13.5″, 14.5″), and a length D10 of the popliteal fossa wrap 186 and connector 184 portions together (3″-7″, 4″, 5″, 6″). In some embodiments, the foot and ankle portions 181, 183 may be detachable from the calf portion 188. Furthermore, the popliteal fossa 186 and connector 184 portions may be detachable from the calf portion 188 in some manner.
The heater assembly 206 may include certain color-based and/or other types of visual indicators that indicate that the heater assembly 206 is intended for use with a relatively large sleeve (i.e., the sleeve 2030). For example, as shown, certain portions of the pouch 2062 of the heater assembly 206 may include colored features 2002 and/or other visual markings/indicators indicating a size aspect/attribute of the heater assembly 206. The sleeve 2030 may further include certain corresponding color or other visual indicators/markings 2005 indicating the relative size of the sleeve 2030. For example, the color features 2005 may indicate that the sleeve 2030 is a relatively large-sized sleeve.
The heater assembly 206 may be configured to be physically secured or coupled to the sleeve 2030, as shown in
The temperature-management sleeve 2130 and associated heater assembly 216 of
The heater assembly 216 may include certain color-based and/or other types of visual indicators that indicate that the heater assembly 216 is intended for use with a medium-sized sleeve (i.e., the sleeve 2130). For example, as shown, certain portions of the pouch 2162 of the heater assembly 216 may include colored features 2102 and/or other visual markings/indicators indicating a size aspect/attribute of the heater assembly 216. The sleeve 2130 may further include certain corresponding color or other visual indicators/markings 2105 indicating the relative size of the sleeve 2130. For example, the color features 2105 may indicate that the sleeve 2130 is a medium-sized sleeve.
The heater assembly 216 may be configured to be physically secured or coupled to the sleeve 2130, as shown in
The temperature-management sleeve 2230 and associated heater assembly 226 of
The heater assembly 226 may include certain color-based and/or other types of visual indicators that indicate that the heater assembly 226 is intended for use with a relatively small sleeve (i.e., the sleeve 2230). For example, as shown, certain portions of the pouch 2262 of the heater assembly 226 may include colored features 2202 and/or other visual markings/indicators indicating a size aspect/attribute of the heater assembly 226. The sleeve 2230 may further include certain corresponding color or other visual indicators/markings 2205 indicating the relative size of the sleeve 2230. For example, the color features 2205 may indicate that the sleeve 2230 is a relatively small-sized sleeve.
The heater assembly 226 may be configured to be physically secured or coupled to the sleeve 2230, as shown in
At block 2204, the process 2200 involves securing/attaching the heater assembly to the sleeve. For example, attaching the heater assembly to the sleeve may involve engaging or attaching one or more straps, or other attachment means as described herein on or around one or more portions of the heater assembly. For example, one or more covers or other structures of the sleeve may be placed over one or more portions of the heater assembly and secured in a manner as to physically couple the heater assembly to the sleeve. In some embodiments, a portion of the heater assembly may be secured to the sleeve on a patient-facing side thereof, whereas one or more other portions of the heater assembly may be disposed outside of the heater assembly when the sleeve is attached to the limb of the patient.
In some implementations, the heater assembly may be stitched, welded, adhered, or otherwise attached/secured between fabric layers of the sleeve. For example, the heater assembly may be a pouch-less heater assembly (e.g., for a disposable embodiment of a temperature management sleeve).
At block 2205, the process 2200 involves physically attaching the sleeve to a limb of a patient. For example, the attaching the sleeve may involve fastening one or more straps or other physical attachment means/mechanism, as described in detail herein. Attaching may involve fastening attachment means associated with a foot portion, a calf portion, and a popliteal fossa portion of the sleeve.
At block 2206, the process 2200 involves coupling one or more electrical and/or pneumatic connectors to the sleeve assembly, wherein such connectors may be provided from one or more supply units, such as a control unit providing air compression and/or electrical resources for the sleeve assembly. The process 2200 may further involve inflating an inflatable heel pad associated with a heel portion of the sleeve, as shown as block 2207. For example, inflation of the heel pad may be implemented using air received over one or more of the connector(s) coupled in connection with block 2206.
In some embodiments, the sleeve assembly, with the heater assembly attached thereto and/or incorporated therewith, can include compression and heating functionality. That is, the sleeve structure may include one or more compression bladders, which may be implemented in accordance with a sequential compression process or mechanism as disclosed herein. Therefore, with the sleeve assembly disposed about the leg of the patient, the process 2200 may involve concurrently and/or over a common period of time, heating the popliteal fossa and sole of the foot using heating pad/devices of the heater assembly, as shown at block 2208, and applying compression to the calf area of the leg of the patient using one or more inflatable compression bladders of the sleeve structure, as shown at block 2210.
The various temperature-management sleeve assemblies disclosed herein may be adjustable in various manners to accommodate different sizes of patient limbs/legs.
Although certain embodiments are disclosed herein in which heater assemblies including connector portions that are routed in relatively tortuous paths along segments of the coupled sleeve, the embodiments shown in
In the embodiment of
The sleeve 230 may further include one or more cover portions 255, 256, 257, which may be configured to be placed at least partially over one or more portions of the heater assembly 260 when the heater assembly 260 is disposed in its intended position on the sleeve 230. For example, in some embodiments, the sleeve 230 may include a foot heater cover portion 255 configured to be placed over the foot heater 241 of the heater assembly 260, as shown in
Certain embodiments of heater assemblies disclosed herein and shown in the various figures accompanying the present disclosure include wires and/or connector portions between the respective heating pads of the heater assembly that run generally along a central path between the heating pads. That is, with respect to a center of mass of the heating pads of the heater assembly, the wires may be coupled to the respective heating pads in an area generally aligned with the centers of the heating pads and/or the connector may run along a path that is generally aligned with the centers of mass of the heating pads. Alternatively, as shown in
The wiring 281 of the heater assembly 280 may be disposed within a polymer pouch 289, or may be independent of any pouch. That is, the heater assembly 280 may be contained at least partially within a pouch 289 or may be a pouch-less embodiment of a heater assembly, as described in detail herein. The configuration of the wiring 281 may be facilitated through the use of one or more wire-management structures/clips 286, 287. For example, in some embodiments, such features 286, 287 may comprise injection-molded clips configured to physically hold/secure the wiring 281 in place during assembly and/or after assembly/manufacturing. In some embodiments, such wire-management clips may include certain channels or grooves into which the wiring 281 may be placed, wherein such channels/grooves orient and/or direct the wiring 281 in a desired orientation/direction. For example, the wire-management clips 286, 287 can be implemented in areas of the heater assembly 280 where the wiring 281 is bent and/or changes direction, such as at the 90° bends associated with the central clip 286, wherein the wiring 281 may be bent/channeled in opposite directions, which may present a 90° directional turn from the angle of the wiring 281 emanating from the connector 288, as shown. In addition, one or more elbow clips 287 may be implemented to bend the wiring 281 at a certain angle(s) towards a respective heating pad 282, as shown. In some embodiments, the heater assembly 280 may comprise two elbow clips 287, wherein each elbow clip 287 may be configured to bend the wiring 281 at a different angle to accommodate the particular layout/configuration of the wiring 281 of the heater assembly 280.
The electrical wiring 281 may further include certain wiring 297 for communicating power and/or other signals to/from a thermistor 283 or other temperature sensor device/element. The wiring 297 may be sealed and/or otherwise coupled to the heater pad 282 by the sealant/adhesive 284. The thermistor wiring 297 may be part of the wiring 281, but may be separate from wiring configured to power the heating pad 282.
The manufacturing process may further involve, as shown in
Depending on the embodiment, certain acts, events, or functions of any of the processes or algorithms described herein can be performed in a different sequence, may be added, merged, or left out altogether. Thus, in certain embodiments, not all described acts or events are necessary for the practice of the processes.
Conditional language used herein, such as, among others. “can.” “could.” “might.” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is intended in its ordinary sense and is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and/or steps. Thus, such conditional language is not generally intended to imply that features, elements and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and/or steps are included or are to be performed in any particular embodiment. The terms “comprising.” “including,” “having,” and the like are synonymous, are used in their ordinary sense, and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Conjunctive language such as the phrase “at least one of X, Y and Z,” unless specifically stated otherwise, is understood with the context as used in general to convey that an item, term, element, etc. may be either X, Y or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require at least one of X, at least one of Y and at least one of Z to each be present.
It should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, Figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than are expressly recited in that claim. Moreover, any components, features, or steps illustrated and/or described in a particular embodiment herein can be applied to or used with any other embodiment(s). Further, no component, feature, step, or group of components, features, or steps are necessary or indispensable for each embodiment. Thus, it is intended that the scope of the inventions herein disclosed and claimed below should not be limited by the particular embodiments described above, but should be determined only by a fair reading of the claims that follow.
It should be understood that certain ordinal terms (e.g., “first” or “second”) may be provided for ease of reference and do not necessarily imply physical characteristics or ordering. Therefore, as used herein, an ordinal term (e.g., “first,” “second,” “third,” etc.) used to modify an element, such as a structure, a component, an operation, etc., does not necessarily indicate priority or order of the element with respect to any other element, but rather may generally distinguish the element from another element having a similar or identical name (but for use of the ordinal term). In addition, as used herein, indefinite articles (“a” and “an”) may indicate “one or more” rather than “one.” Further, an operation performed “based on” a condition or event may also be performed based on one or more other conditions or events not explicitly recited.
Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which example embodiments belong. It be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and not be interpreted in an idealized or overly formal sense unless expressly so defined herein.
The spatially relative terms “outer,” “inner,” “upper” “lower.” “below,” “above,” “vertical.” “horizontal.” and similar terms, may be used herein for ease of description to describe the relations between one element or component and another element or component as illustrated in the drawings. It be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation, in addition to the orientation depicted in the drawings. For example, in the case where a device shown in the drawing is turned over, the device positioned “below” or “beneath” another device may be placed “above” another device. Accordingly, the illustrative term “below” may include both the lower and upper positions. The device may also be oriented in the other direction, and thus the spatially relative terms may be interpreted differently depending on the orientations.
Unless otherwise expressly stated, comparative and/or quantitative terms, such as “less.” “more,” “greater,” and the like, are intended to encompass the concepts of equality. For example, “less” can mean not only “less” in the strictest mathematical sense, but also, “less than or equal to.”
This application is a continuation of Int'l Application No. PCT/US21/54169, filed Oct. 8, 2021, entitled HEATER ASSEMBLIES FOR TEMPERATURE MANAGEMENT SLEEVES, which claims priority to the following applications: U.S. Provisional Application No. 63/089,884, filed Oct. 9, 2020, entitled TEMPERATURE MANAGEMENT SLEEVES; and U.S. Provisional Application No. 63/116,594, filed Nov. 20, 2020, entitled HEATER ASSEMBLIES FOR TEMPERATURE MANAGEMENT SLEEVES, the disclosures of which are hereby incorporated by reference in their entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63089884 | Oct 2020 | US | |
| 63116594 | Nov 2020 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US21/54169 | Oct 2021 | US |
| Child | 18131281 | US |
