CN215688931U - Heater assembly and temperature management device - Google Patents
Heater assembly and temperature management device Download PDFInfo
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- CN215688931U CN215688931U CN202022555920.3U CN202022555920U CN215688931U CN 215688931 U CN215688931 U CN 215688931U CN 202022555920 U CN202022555920 U CN 202022555920U CN 215688931 U CN215688931 U CN 215688931U
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Abstract
The invention relates to a heater assembly and a temperature management device. The temperature management device includes a wearable sleeve including a foot portion configured to cover at least a portion of a sole of a foot of a patient, a lower leg portion configured to cover at least a portion of a lower leg of the patient, the lower leg portion having one or more compression bladders associated therewith, and a popliteal portion configured to cover at least a portion of a popliteal fossa of the patient. The temperature management device also includes a heater assembly configured to be removably secured to the wearable sleeve, the heater assembly including a foot heating pad, a popliteal heating pad, and a physical connector extending between the foot heating pad and the popliteal heating pad.
Description
Technical Field
The present disclosure relates to the field of medical procedures and devices.
Background
There are over 6000 million surgical procedures in the united states each year. The patient's body temperature drops dramatically during surgery due to general anesthesia, lack of thermal insulation and/or exposure to cold operating room temperatures.
Disclosure of Invention
Systems, devices, and methods are described herein that facilitate maintaining normothermia in a patient in conjunction with certain medical procedures. In particular, systems, devices, and methods according to one or more aspects of the present disclosure may facilitate heating of a patient's core body temperature during a medical procedure by using certain wearable heating and/or compression systems, which may advantageously reduce the risk of developing hypothermia and/or other complications associated with hypothermia over a period of time.
In some embodiments, the present disclosure is directed to a temperature management device comprising a wearable sleeve including a foot portion configured to cover at least a portion of a patient's sole, a lower leg portion configured to cover at least a portion of a patient's lower leg, and a popliteal portion configured to cover at least a portion of a patient's popliteal fossa, the lower leg portion having one or more compression bladders associated therewith. The temperature management device also includes a heater assembly configured to be removably secured to the wearable sleeve, the heater assembly including a foot heating pad, a popliteal heating pad, and a physical connector extending between the foot heating pad and the popliteal heating pad.
The foot portion may 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 may be fluidly coupled to a channel having a one-way valve associated therewith. In some embodiments, the popliteal portion of the wearable sleeve has a knee cut, such that the wearable sleeve opens around the knee of the patient. The physical connector of the heater assembly may include a wire contained within a connector portion of the fluid-tight bag.
In some embodiments, the lower leg portion of the wearable sleeve is detachable from one or more of the foot portion or the popliteal fossa portion. The foot heating pad may have visual indicators corresponding to respective indicators associated with the foot portion of the wearable sleeve. The wearable sleeve may include a closable cover configured to cover 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 be coupled to a portion of the lower leg above the patient's tibia. In some embodiments, the temperature management device further comprises a fluid interface thermally sealed to the wearable sleeve and comprising three fluid isolation conduits in fluid communication with three of the one or more compression bladders, respectively.
In some embodiments, the heater assembly includes one or more color-coded indicators indicative of the size of the heater assembly, and the wearable sleeve includes one or more corresponding color-coded indicators indicative of the size of the wearable sleeve relative to the heater assembly. The wearable sleeve may include an adhesive tape configured to secure the heater assembly to the wearable sleeve. The wearable sleeve may include a heater assembly tick 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 heating pad are disposed inside the wearable sleeve, and at least a portion of the physical connector is disposed outside the wearable sleeve. For example, at least a portion of the physical connector can be configured to extend beyond a lower leg 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 when the heater assembly is secured to the wearable sleeve, the physical connector extends along an anterior or lateral portion of the patient's leg between the foot and the popliteal fossa.
In some embodiments, the present disclosure relates to a heater assembly including a first heating pad, a second heating pad, wires electrically coupling the first heating pad and the second heating pad to an electrical connector, and a bladder 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 elongated connector portion extending between the first heating pad portion and the second heating pad portion, the elongated connector portion covering at least a portion of the wires.
The electrical connector may protrude substantially perpendicularly from the connector portion. The heater assembly may also include means for indicating use of the heater assembly. For example, the means for indicating may comprise a mechanical indicator. As another example, the means for indicating may include one or more light sources. The heater assembly may include a control circuit configured to determine a number of uses of the heater assembly and activate the indicator in response to the determination.
In some embodiments, the heater assembly further comprises one or more temperature sensors located on a patient facing side of one or more of the first and second heating pads. The heater assembly may also include a thermally conductive gel disposed on at least a portion of the patient facing side of one or more of the first and second heating pads. In some embodiments, the first heating pad and the second heating pad comprise a resistive heating device.
The connector portion may follow a straight path between the first and second heating pad portions. In some embodiments, the connector portion has one or more bends configured to allow the connector portion to traverse a non-linear path.
In some embodiments, the present disclosure relates to a method of treating a patient. The method includes providing a wearable sleeve containing one or more compression bladders, providing a heater assembly including a first heating pad, a second heating pad, and a connector portion physically coupled between the first heating pad and the second heating pad, securing the heater assembly to the wearable sleeve, securing the wearable sleeve to a limb of a patient, compressing the limb of the patient using the one or more compression bladders, applying heat to a sole 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 may further include inflating a heel pad of the wearable sleeve. In some embodiments, compressing the limb, applying heat to the sole of the foot, and applying 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 implemented 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.
Drawings
Various embodiments are depicted in the drawings for purposes of illustration, and should not be construed to limit the scope of the invention. Moreover, various features of different disclosed embodiments can be combined to form additional embodiments that are part of this disclosure. Throughout the drawings, reference numerals may be reused to indicate correspondence between reference elements.
Fig. 1 illustrates an embodiment of a surgical system including a patient heating subsystem in accordance with one or more embodiments.
Fig. 2 illustrates an embodiment of a surgical system including a patient heating subsystem in accordance with one or more embodiments.
FIG. 3 is a block diagram of components comprising a temperature management system in accordance with one or more embodiments.
Fig. 4 illustrates a side view of a temperature management sleeve system secured to a patient in accordance with one or more embodiments.
FIG. 5 illustrates components of a temperature management system in accordance with one or more embodiments.
FIG. 6 illustrates a heater assembly in accordance with one or more embodiments.
FIG. 7 is an exploded view of an example heater assembly in accordance with one or more embodiments.
FIG. 8 is an exploded view of an example heater assembly in accordance with one or more embodiments.
FIG. 9 illustrates a detailed cross-sectional view of a temperature management sleeve including one or more heater sections in accordance with one or more embodiments.
FIG. 10 illustrates a heater assembly including a mechanical use indicator in accordance with one or more embodiments.
FIG. 11 illustrates a heater assembly including an electrical usage indicator in accordance with one or more embodiments.
FIG. 12 illustrates a side view of a temperature management system having a heater assembly secured thereto in accordance with one or more embodiments.
FIG. 13A illustrates a temperature management system with a heater assembly placed thereon according to one or more embodiments.
Fig. 13B-13D illustrate views of a fluid coupling of the temperature management system of fig. 13A in accordance with one or more embodiments.
FIG. 14 illustrates a temperature management sleeve with a heater assembly cover in accordance with one or more embodiments.
Fig. 15 illustrates the temperature management sleeve of fig. 14 with the heater assembly cover in a closed configuration in accordance with one or more embodiments.
Fig. 16A illustrates a temperature management sleeve having an adhesive coupling feature and a heater assembly in accordance with one or more embodiments.
Fig. 16B illustrates the temperature management sleeve of fig. 16A with a heater assembly secured to the adhesive coupling feature in accordance with one or more embodiments.
Fig. 17A and 17B illustrate a temperature management sleeve having a heater assembly associated therewith, with a heater cover in open and closed configurations, respectively, according to one or more embodiments.
FIG. 18 illustrates a temperature management sleeve having particular dimensions in accordance with one or more embodiments.
19-21 illustrate a color coordinated temperature management sleeve and associated heater assembly in accordance with one or more embodiments.
Fig. 22 is a flow diagram illustrating a process for managing a patient's body temperature in accordance with one or more embodiments.
Fig. 23A illustrates a temperature management sleeve extension component in accordance with one or more embodiments.
23B and 23C illustrate a temperature management sleeve disposed on a lower limb of a patient according to one or more embodiments, with the sleeve extension component of FIG. 23A in a detached and attached configuration, respectively.
Fig. 24A-24C illustrate a wearable sleeve and heater assembly in various configurations and/or coupled states in accordance with one or more embodiments.
Fig. 25 illustrates a temperature management sleeve disposed on a limb of a patient in accordance with one or more embodiments.
Detailed Description
Headings are provided herein 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, the inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses and modifications and equivalents thereof. Thus, the scope of the claims appended hereto are not limited by any of the specific embodiments described below. For example, in any method or process disclosed herein, the acts or operations of that method or process may be performed in any suitable order and are not necessarily limited to any particular disclosed order. Various operations may be described as multiple discrete operations in turn, in a manner that is helpful in understanding certain embodiments; however, the order of description should not be construed as to imply that these operations are order dependent. Further, the structures, systems, and/or devices described herein may be embodied as integrated components or as stand-alone components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not all of these aspects or advantages may be 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 be taught or suggested herein.
Although certain spatially relative terms, such as "exterior", "interior", "upper", "lower", "below", "above", "vertical", "horizontal", "top", "bottom", and the like, may be used herein to describe a spatial relationship of one device/element or anatomical structure to another device/element or anatomical structure, it should be understood that such terms are used herein to describe a positional relationship between the elements/structures, as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the elements/structures in use or operation in addition to the orientation depicted in the figures. For example, an element/structure described as "above" another element/structure may refer to a position below or beside such other element/structure with respect to an alternate orientation of the subject patient or element/structure, and vice versa. It will be appreciated that spatially relative terms, including those listed above, may be understood with respect to the respective illustrated orientations with reference to the figures.
For convenience, certain reference numbers are repeated in different figures of a set of figures of the present disclosure for devices, components, systems, features, and/or modules having similar features in one or more respects. However, the repeated use of common reference symbols in the drawings does not necessarily indicate that such features, devices, components, or modules are the same or similar with respect to any of the embodiments disclosed herein. Rather, one of ordinary skill in the art will appreciate from the context that the use of common reference numerals may imply a degree of similarity between the referenced subject matter. Use of a particular reference number in the context of description of a particular figure may be understood to refer to the device, component, aspect, feature, module or system identified in that particular figure, but not necessarily to any device, component, aspect, feature, module or system identified by the same reference number in another figure. In addition, aspects of the individual figures identified with common reference numerals may be interpreted as having common features or being entirely independent of each other.
Overview
The present disclosure relates to systems, devices, and methods for maintaining a normothermic patient, e.g., during a medical procedure/procedure. There are over 6000 million surgical procedures in the united states each year. While great care may be taken to prevent surgical complications, one problem that is often overlooked and not adequately addressed is the risk of hypothermia (known as "peri-accident hypothermia" or "IPH") occurring before, during, or after surgery. The patient's body temperature drops dramatically during surgery due to general anesthesia, lack of thermal insulation and exposure to cold operating room temperatures. Even with today's standard of care, hypothermia may occur in 30% to 50% of surgical patients.
Hypothermia often causes more than just patient discomfort. Even patients with mild IPH disease may be at significantly elevated risk for surgical site infections, heart disease, intraoperative hemorrhage and other avoidable complications. In sum, these complications can significantly increase recovery time and total hospital stays, leading to increased costs for each party. It is estimated that the unmanaged risk of IPH is as high as $ 150 billion in the united states alone, but this problem is largely ignored.
Perioperative heat loss occurs primarily through convective heat transfer, particularly through the palms, soles and exposed surgical site surface areas. During pre-operative care, patients typically wear a gown only, and are often exposed to relatively cold waiting areas with little or no isolation. Although patients are usually anesthetized only at the beginning of the surgery, they usually arrive at the operating room at moderately low temperatures. This may expose the patient to a greater risk of severe hypothermia once anesthesia is administered. A decrease in core temperature after surgery increases the likelihood of other complications, such as pathologic cardiac outcome, surgical site infection, and blood loss, any of which can prolong recovery and hospital stays.
Hypothermia occurs during surgery in patients undergoing surgery, particularly when the surgery involves the core areas of the patient, such as posterior or anterior surgery involving the thoracic, abdominal and pelvic regions. Core surgery involves exposing vital internal organs to colder conditions and therefore greater risk of hypothermia. In addition, core surgery often requires exposure of the torso and chest, which makes blankets and many other currently available interventions inadequate. Once in the operating room, the patient may be nude, exposed to room temperature well below 36 degrees celsius, and exposed to cold fluids used to clean the surgical site during the disinfection preparation. At the start of the surgery, the delivered anesthetic immediately compromises normal autonomic thermoregulatory control. Cooler blood may be transferred from the periphery to the core of the body by a phenomenon known as redistributive hypothermia. Vasodilatation and a reduction in muscle tone can result in a significant decrease in core temperature half an hour prior to surgery.
Overall, IPH patients have a higher incidence of surgical site infections, bleeding and cardiac complications than non-hypothermic patients. Such problems may require additional monitoring and/or increased hospital stay and/or subjective discomfort. The development of IPH is closely related to many physiological organ system changes that affect cardiovascular, respiratory, neural, immune, blood, drug metabolism and wound healing mechanisms. The incidence of several postoperative complications may be increased by even mild hypothermia.
Intraoperative hypothermia can lead to a decrease in cardiac output and heart rate, resulting in ventricular dysrhythmia. Platelet function may be impaired and clotting factors may be reduced, leading to increased intraoperative bleeding and blood loss. Impaired immune function can increase the infection rate at the surgical site. Hypothermia is associated with pathological cardiac events that increase surgical wound infection by four and two times. In certain operations such as colorectal, gynecological or spinal surgery, the infection rate is often higher than in other operations, and low temperatures are very dangerous for intraoperative and postoperative recovery. These and other complications are supported by multiple studies and may lead to clinical and economic burdens.
Current methods of preventing hypothermia may not be entirely effective. Even with current interventions, it has been reported that up to 46% of patients are hypothermic at the beginning of surgery and 33% of patients are hypothermic when they arrive at a post-anesthesia care unit (PACU). Assuming that the cost savings of maintaining normothermia for one patient is approximately $ 5000 per patient, and approximately 30% hypothermia in 1700 ten thousand high risk surgical patients, maintaining normothermia for these patients can result in a cost savings of $ 150 billion for the entire system. With rising medical costs and recent initiatives to require maintenance of perioperative normothermia, hospital administrators throughout the country need new, effective, and cost-effective equipment to address the problem of perioperative hypothermia, and since forced-air warming blankets were introduced nearly 30 years ago, there was little innovation in this product area.
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, fig. 1 shows an embodiment of a surgical system 101 that includes a forced air carpet patient heating subsystem 122 in accordance with one or more embodiments. The system 101 may be implemented in a surgical environment, such as an operating room or other patient treatment environment or facility. The patient heating subsystem 122 may be implemented as a device that prevents the core body temperature of the patient 5 from dropping below a particular level and/or below a desired level over a period of time, which may result in hypothermia and/or other medical complications or adverse health effects on the patient 5. The surgical environment may include a table 16 supported by a base 14, and one or more monitoring systems 51, which may include one or more displays 56, towers 52, and/or moving features 54.
The patient heating subsystem 122 may include a blanket structure or device 26 that may cover and/or overlay at least a portion of the patient's body. For example, in some surgical procedures, the surgical procedure 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 limbs and/or core of the patient 5. That is, the blanket device 26 may be generally placed over an area of the patient's body that is not currently undergoing surgery to avoid interfering with the surgery/access. In some embodiments, the blanket device 26 may have specific openings, holes, slits, cutouts, etc. formed therein to provide access to relevant portions of the patient's anatomy while still allowing the blanket device 26 to be disposed generally around/near the access portion.
In some embodiments, the blanket device 26 may be configured to direct thermal energy to the portion of the patient's anatomy that it covers. For example, in some embodiments, the blanket device 26 may operate by circulating and/or inflating a heated fluid (e.g., air) within one or more portions of the blanket device 26, such as through one or more channels thereof. For example, hot air can be circulated through the blanket device 26, wherein such air can be introduced into the blanket device 26 via the one or more ports 25, wherein the fluid can flow in a fluid circuit and/or exit the blanket device 26 via the one or more ports, apertures, and/or other outlet channels/paths. The heated air/fluid may be provided by a fluid source unit 22, which fluid source unit 22 may comprise one or more air compressors or the like and/or one or more heating elements for heating the air provided thereby. Heated fluid (e.g., air) may be provided from the fluid source unit 22 to the port 25 through the hose 24 and/or the hose interface 21.
In some embodiments, the circulating fluid may be pushed or pulled from the blanket device 26 through one or more ports to the fluid source unit 22. Additionally or alternatively, the heated air may exit the blanket device 26 via one or more patient-facing apertures or ports, which may be used to further heat the patient anatomy. In embodiments where the heated fluid exits the blanket device 26 to the patient and/or enters the surgical environment, such air may introduce certain contaminants into the surgical environment, which may lead to infection or other medical problems. That is, it may be desirable for the surgical environment to be substantially sterile to prevent exposure of the patient's anatomy, which may be of particular concern for the patient's internal anatomy that may be exposed to the surgical environment during the relevant procedure/procedure. Forced air, carpet heating systems may further present a relatively bulky physical structure that may be obstructive, for example, when placing a carpet in an area near a surgical site. Furthermore, in some cases, operating room personnel may turn down the temperature of the forced air device for their own comfort, as the forced air system heats the surrounding air/environment. Furthermore, some devices cannot be used for preoperative warming for one or more of the following reasons: (1) some devices may immobilize the upper limbs, impeding patient movement; (2) the device may be cumbersome (e.g., the device may float on the patient, be blown off or dropped during use and/or transport, and it requires a large, primarily floor-mounted blower, which may not be removable), (3) it may not adhere to the patient and/or may fall off during transport and interfere with beds and other monitors and equipment, and (4) it may require conscious administrative decisions to implement.
Embodiments of the present disclosure advantageously provide certain improved devices, methods, and systems for maintaining a core body temperature of a patient before, during, and/or after surgery. Furthermore, the embodiments described herein provide methods and systems for core body temperature management in an unobtrusive, efficient, and easy to use manner (e.g., easy to set). Some embodiments of the present disclosure may be applicable before, during, and/or after surgery, and may be acceptable when the patient is awake before and/or after surgery.
In some embodiments, the lower limb of the patient may be utilized to provide therapy and/or to achieve mobility. For example, some devices described herein may provide flexibility and/or one or more spaces around the knee, ankle, and/or other portions of the patient's body to allow the patient to bend and/or extend the limb. Such patient mobility may provide a number of benefits, including allowing a patient to stand up to use a restroom without the need to remove and reapply the device.
Some embodiments of the temperature management devices disclosed herein may be configured to provide warming to one or more arteries and/or veins along the lower limb of a patient. Further, some embodiments may include compressing one or more portions of the patient's body. For example, a compressive force may be applied to the lower leg of the patient. In some embodiments, the compression may be performed in a sequential and/or gradient manner. The devices and systems disclosed herein advantageously combine a separate sleeve structure/garment, which may include compression features, with a heater assembly including one or more heating elements, where the heater assembly and sleeve may be physically coupled to create a combined wearable system. By utilizing separable and couplable heater assemblies and sleeve structures, these 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.
Temperature management sleeve and system
Fig. 2 illustrates an embodiment of a surgical system 100 including a patient heating subsystem 120 in accordance with one or more embodiments. System 100 includes a sleeve patient heating subsystem 120, which may represent an alternative to the blanket heating system described above with reference to fig. 1. The telescopic heating subsystem 120 may include one or more temperature management sleeves 30 disposed over and/or over a portion(s) of one or more lower limbs 10 (e.g., legs) of the patient 5. The sleeve 30 may include one or more heating elements/devices (referred to herein as "heaters," "heater pads," "heating pads," etc.), wherein, when the sleeve 30 is disposed on the lower limb 10, at least one such heating element or device 34 is positioned above or over the sole 3 of the foot 6 of the patient 5, while another heating element/device 32 is positioned above or over the popliteal fossa 9 of the lower limb 10, on the side of the limb 10 opposite the knee 8.
As shown in fig. 2, the sleeve 30 may advantageously be opened around the knee 8, thereby providing flexibility, comfort and/or accessibility of the knee 8 when the sleeve 30 is disposed on the leg 10 of a patient. Generally, sleeve 30 is implemented such that the knee covering portion may be open and/or uncovered, as the heating in this region of leg 10 is concentrated and/or confined to the popliteal fossa region 9, which is generally behind the knee on the posterior side of leg 10. That is, the sleeve 30 may advantageously not heat the front of the leg in the region of the knee 8, which is desirable to avoid overheating of the leg and/or its knee covering portions, which may result in injury and/or other complications to the patient 5. Concentrating and/or limiting the heating of the upper portion of sleeve 30 to the popliteal region/area 9 may be effective because certain blood vessels in the popliteal region are close to the skin relative to other areas of the leg (e.g., the front of the leg and/or knee 8) where the blood vessels may be less close to the skin, and thus heating in these areas may be less effective to increase and/or maintain the core temperature of patient 5.
The temperature management sleeve 30 may also include one or more fluid-fillable bladders/chambers 38, the bladders/chambers 38 being operable to achieve intermittent compression relative to the leg 10 when the sleeve 30 is disposed on the leg 10 of the patient 5. For example, in some embodiments, intermittent compression in the lower leg region 1 of the leg 10 may be performed simultaneously with the application of thermal energy/heat to the sole 3 and popliteal fossa 9 in order to heat venous and arterial blood of the patient 5, which may be used 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, etc., may refer to any type of compression element, whether inflatable, fluid-containing, or any other type of compression element. For example, such a compression element may include certain resilient compression features. In some embodiments, the compression elements associated with the sleeve devices/structures of the present disclosure may include physical straps and/or smart materials configured to effect compression and/or relaxation around at least a portion of the lower leg.
The patient heating subsystem 120 may include a control unit, device or system 20, which may be equipped with one or more fluid compression devices, a power source, and/or some control circuitry configured to control the operation of the heating pads/ devices 32, 34 and/or the compression bladders 38. In some embodiments, the sleeve device 30 includes one or more temperature sensors, which may be generally associated with the heating pads/ devices 32, 34 and/or located proximate to 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 the control unit as to the operation of applying heat and/or compression to the leg 10. The control unit 20 may include one or more fluid and/or tubing, cables, wires, and/or other connectors 62 that may be used to provide fluid (e.g., air) to the bladder 38 and/or electrically drive the heaters 32, 34 to provide heat to the patient 5. In some embodiments, control unit 20 is at least partially embodied in/on sleeve assembly 30.
Fig. 3 is a block diagram of example components including a temperature management system according to one or more embodiments of the present disclosure. The system includes a temperature management sleeve 330, which temperature management sleeve 330 may include a body-wearable structure/garment configured to be disposed around at least a portion of a limb of the patient 5, such as a lower limb/leg. The term "sleeve" is used herein in accordance with its broad and ordinary meaning and may refer to any type of sleeve, garment, cuff, sock, boot, wrap, etc., that is configured to be placed and/or secured on or around a limb or other body part of a person. The thermal management sleeve 330 may include one or more physical connectors 342, which may include one or more straps, clips, clasps, folds, elastically deformable materials or components, wraps, or other physical components of the sleeve, which may be used to secure the sleeve to a limb of a patient.
The sleeve 330 may include one or more compression bladders 338, which may be configured to receive fluid from the fluid source 322 of the control unit or system 320 via one or more fluid interfaces/connectors 396. In some embodiments, sleeve 330 includes 2, 3, or more compression bladders that may be individually inflated and/or deflated to provide sequential compression of the patient's limb. Although described as a compression bladder for convenience, it should be understood that the features 338 may include any type of compression element. In some embodiments, certain wires or other electrical connection components may be coupled to each compression element 338 for providing power to the respective compression element. For example, an electrical current may be provided to the compression element 338 to initiate mechanical tightening or loosening of the elements to provide sequential compression of the patient's limb.
In some embodiments, the sleeve 330 includes an inflatable heel pad 308, which may be fluidly coupled to one or more fluid passages associated with the compression bladder 338. For example, inflatable heel pad 308 may be configured to receive fluid/air from one or more compression bladders 338 and/or fluid channels associated therewith through one-way fluid valves. Inflatable heel pad 308 may advantageously reduce the risk and/or impact of pressure sores (e.g., pressure sores) and/or other friction or pressure based physical injuries that may occur on the heel of the limb on which sleeve 330 is disposed due to, for example, prolonged positioning of the heel on a bed or other surface and/or repeated/agitated movement of the heel that may occur during a surgical procedure. Although described in connection with certain embodiments as an inflatable heel pad, it should be understood that references herein to a heel pad may or may not be inflatable. For example, heel pad 308 may include foam or other cushioning material and/or forms, which may be associated with the heel portion of the sleeve structure.
The sleeve 330 may also have a heater assembly 360 associated therewith, and the heater assembly 360 may be removably attached or secured to the sleeve 330 using one or more aspects of the physical connector 342 and/or other attachment devices or mechanisms of the sleeve 330. The heater assembly 360 may include a plurality of heating pads/devices disposed within a pouch-type receptacle 362. For example, the pouch 362 may include one or more layers of plastic that encases at least a portion of the heating pads/ devices 364, 365. The heating pads of heater assembly 360 may include a foot heating pad 364 and a popliteal heating pad 365. The term "heating pad" is used herein in its broadest and ordinary sense and may refer to a heating element having a relatively wide surface configured to apply heat over a wide area, such as the plantar and/or popliteal regions, or any other region corresponding to the form factor of the heating element/pad. Further, the term "heating mat" as used herein may refer to the heating element itself, such as a resistive heating element implemented on an at least partially planar substrate or in an at least partially planar plane or shape, and/or may be used to refer to a portion of a heater assembly that includes the 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 that various embodiments of the temperature management systems and devices disclosed herein may be implemented to provide cooling to a limb of a patient. That is, any reference herein to heating, heating pads, heater assemblies, and/or other heating systems, processes, devices, etc., may be understood to refer to cooling, cooling pads, cooling assemblies, and/or other cooling systems, processes, devices, etc. Further, it is to be understood that the various devices, systems, and processes disclosed herein can be used/implemented to perform or combine both heating and cooling functions.
The sleeve structures disclosed herein may include specific holes or other connection features for connecting various components of the temperature management system, including heater/cooler assemblies, physical connectors, tubes, mats, or other features.
Certain wires and/or other types of conductive traces 363 may generally be coupled to each of the foot heating pad 364 and the popliteal heating pad 365 for providing electrical energy to the respective heating elements/devices. For example, electrical current may be provided through the wires 363 and resistive conductors of the respective heating pads to generate radiant heat. That is, the foot heating pad 364 and the popliteal heating pad 365 may operate as radiant heaters configured to heat a particular portion of the patient's anatomy via infrared/thermal radiation. It should be understood that any reference herein to a wire may be understood to refer to any type of conductive trace or any other signal transmission medium, device or mechanism. For example, such signal transmission means may comprise a pneumatic signal transmission system, which in some embodiments may comprise an air/gas fill tube for signal transmission.
In some embodiments, the heating pads 364, 365 are associated with certain insulating features 378, which may be disposed on a side of the heating pad generally away from the patient when the sleeve 330 is disposed on the limb of the patient. This isolation may reduce the risk of burning or damage from contact with the exterior of the sleeve. This isolation may also be used to direct heat toward the patient when the heating pad is activated, rather than outward away from the patient. In some embodiments, a heat transfer medium 374 can be applied to one or more heating surfaces or areas of the respective heating pad 364, 365, wherein such heat transfer medium can advantageously facilitate heat conduction/transfer from the heating pad to the patient's skin. In some embodiments, a heat transfer medium may be applied to the patient-facing surface/area of sleeve 330 to promote 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 that are electrically coupled in some manner to the electrical wires 363. For example, in some embodiments, the control circuit 371 may be implemented at least partially adjacent to one or more of the heating pads 364, 365 and/or in one or more boards and/or chips disposed on one or more of the heating pads 364, 365. For example, the heating mat may comprise a substrate on which the resistive heating conductor is arranged, wherein the control circuit is implemented in/on an area of the substrate not covered by the resistive heating conductor. The term "control circuit" is used herein in its broadest and ordinary sense and can refer to any collection of processors, processing circuits, processing modules/units, chips, dies (e.g., semiconductor dies, including one or more active and/or passive devices and/or connecting circuits), microprocessors, microcontrollers, digital signal processors, microcomputers, central processing units, field programmable gate arrays, programmable logic devices, state machines (e.g., hardware state machines), logic circuits, analog circuits, digital circuits, and/or any devices that manipulate signals (analog and/or digital) based on hard coding of the circuits and/or operational instructions. The control circuitry referenced herein may also include one or more memory devices, which may be embodied in a single memory device, multiple memory devices, and/or embedded circuitry of a device. Such data stores may include 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 where the control circuitry comprises a hardware and/or software state machine, analog circuitry, digital circuitry, and/or logic circuitry, the data storage device/register 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 may also include one or more temperature sensors 368, such as one or more thermistors or the like. The temperature sensor 368 may be configured to generate a signal indicative of a temperature present and/or experienced at one or more portions of the heater assembly 360 and/or the thermal management sleeve 330. For example, the temperature sensor 368 may provide a signal indicative of a temperature associated with a region of the respective heating pad and/or sleeve and/or patient anatomy disposed/located proximate thereto. The temperature sensor 368 may be configured to provide a sensor signal to the electrical connector 369 and/or the control unit 320 via the electrical connector 369 and/or the electrical interface/connector 397.
The connector assembly 335 of the thermal management sleeve 330 may include one or more connectors for coupling to the fluid source 322 of the control unit 320/from the control unit 320, the power source 323 of the control unit 320/from the control unit 320, and/or the electrical connector 369 of the heater assembly. Although connector assembly 335 is illustrated as including one or more separate fluidic interface/connector 396 and electrical interface/connector 397 modules/components, it should be understood that in some embodiments, such connection features may be implemented in a single connector structure. Further, in some embodiments, either or both of fluid interface/connector 396 and electrical interface/connector 397 may be implemented in two or more separate connectors. For example, the electrical interface/connector 397 may include a first electrical connector for receiving power from the control unit 320 and a second electrical connector for electrically coupling to the electrical connector 369 of the heater assembly 360 to provide power thereto and/or receive certain electrical signals (e.g., temperature sensor signals).
The temperature management system shown in fig. 3 further comprises a control unit 320. It should be appreciated that although the control unit 320 is shown using a single block, the functions and/or components associated therewith may be implemented in separate devices, systems, modules, and/or components. The control unit 320 may include a power supply 323, the power supply 323 configured to provide power to the thermal management sleeve for providing power to, for example, the heating element, the control circuit 371, and/or the temperature sensor 368 of the heater assembly 360. The control unit 320 may also include a fluid source 322, which may include one or more air compressors or the like. The fluid source 322 may be used to provide fluid/air to the compression balloon 338 to effect sequential compression in the conduit region of the sleeve 330.
The control unit 320 includes certain control circuitry 325, the control circuitry 325 being configured to implement any of the various functional operations disclosed herein in connection with the temperature management solution of the present disclosure. For example, the control circuitry 225 may be configured to determine when and/or to what extent to activate the compression balloon 338, the foot heating pad 364, the popliteal heating pad 365, the temperature sensor 368, and/or user input/output functions. The control unit 320 may also include certain user interface components that may further allow a user to interact with the control unit 320 by providing user input and/or notifications/indications of certain information related to the operation of the control unit 320. For example, the user interface components 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 devices or mechanisms 329, or other input/output components for communicating with a user. An example user interface representation is shown in block 324, which shows specific lights or other visual indicators 381 that indicate the level of heating of one or more heating pads of the heater assembly 360, and/or specific output indicators 383 that indicate other conditions of the heater assembly. Additional indicators 382 may be provided to indicate which limb is currently being intermittently compressed and/or the degree to which such compression is being effected.
In some embodiments, the sleeve 330 includes a pump attachment, such as a micropump, which may be used as a fluid source for intermittently compressing and/or heating or cooling the fluid circulation in the sleeve. In some embodiments, the pump attachment can be secured to the lower leg portion of the sleeve. The various components of the thermal management sleeve 330 may be configured to be battery powered. For example, the cartridge 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. In some embodiments, the battery power source may be a component of the heater assembly. For example, a battery source may be contained within the pocket 362, which may advantageously provide protection for the battery from fluids and/or other contaminants.
Fig. 4 illustrates a side view of a temperature management sleeve system 430 secured to a patient's limb 10 according to one or more embodiments of the present disclosure. The temperature management sleeve 430 includes a plurality of heating pads, including a first heating pad 434 disposed in an area of the sleeve 430, the first heating pad 434 configured to be placed on and/or adjacent the sole 3 of a patient's foot 6. Sleeve 430 also includes a second heating pad/device 432 configured to be positioned/disposed on or near a popliteal region 9 of a limb 10 of a patient, which popliteal region 9 may be generally on the back of limb 10 opposite knee 8. The heating pads 432, 434 may be part of a heater assembly 460, the heater assembly 460 being attachable and/or configured to be coupled to the sleeve 430.
The sleeve 430 also includes a lower leg portion 402 that may be associated with one or more compression bladders 438, the compression bladders 438 being implemented to provide sequential compression to promote blood flow within the limb 10 and/or to prevent/treat deep vein thrombosis. In some embodiments, sequential compression may be implemented in the lower leg portion 402 while heating the sole 3 and popliteal fossa 9 using heating pads 434 and 432, respectively. Such simultaneous implementation/performance of heating and sequential compression provided by sleeve system 430 may advantageously provide improved heating and/or temperature maintenance to the patient during surgery, thereby reducing the risk of developing hypothermia as described in detail herein.
In some embodiments, lower leg portion 402 of sleeve 430 is detachable from foot portion 401 and/or popliteal portion 403 of sleeve 430. For example, sleeve 430 may include a removable feature or area 491 configured to allow foot portion 401 to be removed from calf portion 402. For example, such a detachment/attachment device 491 may include a Velcro coupling and/or other type of clip, strap, tie, snap, or other physical attachment device, mechanism, or tear-away feature, wherein the structure of the foot portion 401 may be detached from and/or attached to the calf portion 402. The ability to detach the foot portion 401 and/or the popliteal portion 403 from the lower leg portion 402 may allow the lower leg portion 402 and associated sequential compression functions to remain on the limb 10 and/or even be accomplished after removal of the foot portion 401 and/or the popliteal portion 403 of the sleeve 430, which may be desirable for the purpose of increasing patient comfort and/or allowing the patient the ability to move in certain situations.
The sleeve 430 includes a connector assembly 435, and the connector assembly 435 may include a physical connector for a fluid source that may provide heated or non-heated fluid for expansion of the compression bladder 438 and/or the heel pad 408, and/or may allow electrical coupling of a heater assembly 460 associated with the heating pads 432, 434 to a power source, which may be provided by a control unit or the like (not shown in fig. 4; see fig. 2, 3). In some embodiments, the sleeve 430 includes certain color-tuning features 441, 443 that can be used to associate the sleeve 430 with a suitable heater assembly configured and/or designed to mate with and/or attach to the sleeve 430. For example, the heater assembly may have a corresponding color indicator indicating a match/association between the heater assembly and the sleeve 430. The color-toning features 441, 443 can be associated with an exterior trim, band, or similar structural feature of the sleeve 430.
Heater assembly and temperature management sleeve
Fig. 5 illustrates components of a temperature management system 500 including a sleeve 530 and a heater assembly 560 according to one or more embodiments of the present disclosure. Sleeve 530 includes a foot portion 501, a lower leg portion 502, and a popliteal portion 503. In some embodiments, the various portions of the sleeve 503 may be separate from one another. Specifically, as shown, the apparatus 530 may include certain attachment/detachment features 591 configured to allow detachment and/or attachment of the foot portion 501 with the lower leg portion 502. Such attachment/detachment features may include any of the attachment or detachment devices disclosed herein in connection with any of the disclosed embodiments. Additionally or alternatively, the sleeve 530 may include certain attachment/detachment features 593 configured to allow the popliteal portion 503 to detach and/or attach from the calf portion 502, as shown. Such attachment/detachment features 593 may include any attachment or detachment apparatus disclosed herein.
The sleeve 530 also includes certain straps or couplers 542, 543, 594, 595 that may be used to tie or secure the sleeve 530 to the limb of the patient. Specific visual indicators 599 indicating the orientation and/or patient orientation of the sleeve relative to the patient's limb may also be included on one or more sides of the sleeve 530.
The sleeve 530 may also include a seating region or feature 585, and the heater assembly 560 may be placed, disposed, or otherwise secured to the sleeve 530. Features having similar characteristics to features 585 may be referred to herein as heater assembly delineation features, components or portions. For example, these features may generally outline the footprint/profile of the heater assembly and thus provide support, protection, and/or visual guidance/indication. While described with heater assembly delineation features in certain instances, it is to be understood that various embodiments of the sleeves disclosed herein may or may not include such features.
In some embodiments, the delineation feature 585 may include certain visual indicators 536, 537 that indicate the placement of the foot heating pad 564 and the popliteal heating pad 565, respectively, to help the user identify the proper 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 markings/ indicators 536, 568 indicate the matching and relative placement of the heater pad 564 of the heater assembly 560 relative to the delineated region/feature 585 of the sleeve. Likewise, the popliteal fossa is a heating pad 565, which heating pad 565 may have a visual indicator 567 associated therewith that indicates its position in the area identified by the indicia 537 on the sleeve 530. The respective markers 568, 567 and/or 536, 537 may include visual images indicative of the portions of the patient's anatomy associated therewith, i.e., the plantar and popliteal fossa, as shown in fig. 5. The sleeve 530 may also include a connector 535 configured to receive a fluid source connector for receiving air from a compression chamber or the like, and an electrical connector 597 for inserting a corresponding electrical connector 561 of the heater assembly 560 into the sleeve 530. The sleeve 530 may in turn receive electrical power from an electrical connection/cable provided by a control unit or other power source.
FIG. 6 illustrates a heater assembly 660 according to one or more embodiments of the present disclosure. The heater assembly 660 may be fixed or otherwise placed/disposed on or fixed or attached to a wearable sleeve structure, such as the compressible sleeve devices described herein. Heater assembly 660 may advantageously span a distance D, which represents the distance between the patient's foot bottom and the patient's popliteal region, such that heater assembly 660 may be positioned with its first heating pad 665 positioned at or near the foot bottom and, when heater assembly 660 is coupled to a wearable sleeve, the second heating pad 664 positioned at or near the patient's popliteal fossa. In some embodiments, at least some of the components of the heater assembly 660 are contained within a bag, pouch, bag, or other similar type of container or structure 662. The term "pouch" is used herein in a broad and ordinary sense and may refer to any liner, cover, pouch, container, compartment, pocket, enclosure, or the like, whether sealed or at least partially open and/or whether wholly or partially flexible or rigid. With respect to the heater assembly 660, the bag 662 may advantageously provide a fluid seal to prevent contamination and/or damage to the various electronics and/or other components disposed therein.
The heater assembly 660 includes a connector portion 672 that spans a distance D between the first heater pad 665 and the second heater pad 664. In some embodiments, wires configured to provide electrical power to the respective heating pads and/or receive temperature sensor signals and/or other data signals from the thermistors 669, 668 and/or the control circuitry 671 are coupled to the respective heating pads and routed/contained within the connector portion 672 to an outlet portion 679 of the pouch 662, which outlet portion 679 may be positioned/located along the heater assembly 660 and/or the connector portion 672 of the pouch 662. In some embodiments, connector portion 672 may comprise an elongate sealing portion of bag 662.
The popliteal heating pad 665 and the foot heating pad 664 may include certain resistive electrical conductors configured to have an electrical current passed therethrough, wherein such electrical current generates radiant heat (e.g., in the form of infrared radiation) that may be used to provide heating to a patient. In some embodiments, pouch 662 includes a popliteal heating portion 673 configured to enclose a popliteal heating pad 665. In some embodiments, the pocket portion 673 may have one or more visual indicators or markings 667 associated therewith indicating the association of the pocket portion 673 and the heating pad 665 with the popliteal fossa and/or portion/region of the popliteal fossa to which the heater assembly 660 is configured to be coupled of the sleeve. Such indicia/indicators 667 can include images of the relevant physiological anatomy, one or more shapes or icons indicative of the anatomy, and/or certain color coordination features indicative of location (e.g., color indicators/indicia corresponding to similar color indicators/indicia on the relevant portion of the sleeve to which the heater assembly 660 is to be coupled). The position indicator/marker 667 can be disposed on the pocket portion 673 or, alternatively, can be disposed on a location coupled with the heating pad 665.
The heating pad 665 may have one or more thermistors 669 associated therewith. For example, thermistor 669 can be disposed on or near the patient-facing side of heating pad 665, which is shown in the illustration of fig. 6. In some embodiments, a marker/ indicator 667, 666 is associated with the side of the heater assembly 660 that faces away from the patient when secured to the sleeve (i.e., the side of the heater assembly is not visible in the image of fig. 6). Thermistor 669 can be used to provide a sensor signal indicative of the temperature of heating pad 665 and/or adjacent area, which can include the temperature of the skin/tissue of the patient's popliteal region and/or the sleeve adjacent to heating pad 665.
In some embodiments, heater assembly 660 may include a control circuit 671, which may be configured to perform certain functions of heater assembly 660. For example, the control circuit 671 may be configured to receive an electrical signal from the thermistor 669/668 and/or provide an electrical signal to the thermistor 669/668. In some embodiments, the control circuit 671 is primarily for heater assembly usage counting/tracking functions, with additional control functions primarily handled by a control system/unit separate from the heater assembly 660. In some embodiments, the control circuit 671 may be configured to digitize thermistor readings. In some embodiments, the control circuit 671 may be configured to activate the heating pad 665 and/or the heating pad 664. That is, the control circuit 671 may control the heating function of the pad. The control circuit 671 may advantageously be electrically coupled to one or more of the electrical lines 663a, 663 b. The control circuit 671 can be embodied in one or more circuit boards, chips, Application Specific Integrated Circuits (ASICs), 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 transmitted to or from the control circuitry, e.g., certain filtering, amplification, multiplexing, switching, etc. Although the control circuit 671 is illustrated as being coupled to the popliteal heating pad 665 and/or associated with the popliteal heating pad 665, it should be understood that the control circuit 671 may be associated with any region of the foot heating pad 664 or the connector portion 672 of the heater assembly 660.
The pocket 662 may also include a foot pocket portion 675 configured to enclose/house the foot heating pad 664. For example, as with the popliteal pocket portion 673, the foot heater pocket portion 675 may represent an expanded portion of the pocket relative to the connector portion 672, having width and length dimensions sufficient to cover the heating pad 664. The bag portion 675 and/or the heating pad 664 can include a marker/indicator 666 configured to indicate the position of the heating pad 664 and the bag portion 675 relative to the sleeve or the patient. For example, such indicators/markings 666 may visually indicate the anatomy of the foot and/or sole of the foot, or may include certain labels, color features, shapes, and/or the like that indicate anatomical location and/or relevance to the sleeve portion to which the heater assembly 660 is to be coupled. As with the popliteal heating pad 655, the foot heating pad 664 may have one or more thermistors 668 associated therewith, and the thermistors 668 may be disposed on and/or associated with a patient-facing side of the heating pad 664, the side shown in fig. 6.
The heater assembly 660 can include an electrical connector 661 that can be electrically coupled to one or more electrical wires 663 connected to the respective heating mat 665, 664. The electrical connector 661 may be associated with an exit portion 679 of the bag 662, which exit portion 679 may have an access opening/hole through which electrical conductors may enter and exit the bag 662. In some embodiments, a fluid seal (e.g., a hermetic seal) is formed between the bag outlet portion 679 and the electrical connector 661 and/or the electrical wire 663 such that the interior of the bag 662 remains isolated from the external environment. For example, such a seal may provide a sanitary barrier between the internal components of the bag 662 and the external environment, which may advantageously prevent the external surgical field from contaminating the components contained within the bag 662.
FIG. 7 is an exploded view of an example heater assembly 760 in accordance with one or more embodiments. The heater assembly 760 includes a bag 762, which bag 762 may comprise plastic, fabric, or other material, and may be configured to contain the internal components of the heater assembly 760. The bag 762 may include multiple sections, such as a patient facing section or portion 762a, and a portion or sheet 760b disposed on opposite sides of the heater assembly 760, such that the first and second sections 762a, 762b are shielded together, such as by heat sealing or other methods, to receive/clamp the internal components of the heater assembly 760. The sections of the pouch 762 may include various parts/regions, including a foot heater portion 775, a popliteal heater portion 773, and a connector portion 772 that spans between the foot heater portion 775 and the popliteal heater portion 773. The connector portion 772 may also include certain areas/portions, including one or more bends 701, 702, which may allow the connector portion 772 to travel a path between heating pads above/below the portion of the sleeve to which the heating assembly 760 is configured to be coupled. The bend in the connector portion may allow the connector 772 to traverse a non-linear path along one or more portions of the wearable sleeve.
In some embodiments, the heater assembly 760 includes certain control circuitry 771, which can be associated with any of the illustrated components. For example, although the control circuit 771 is shown as being disposed on or near the popliteal heating pad 765, it should be understood that the control circuit 771 may be disposed on or connected to any of the illustrated components. Further, while the control circuit 771 is illustrated as a single block, it should be understood that the control circuit 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 which may be physically and/or electrically separate.
The heating pads 764, 765 may be any type of heating pad, such as a resistive radiant heating pad. For example, the heating pad 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 can be coupled to wires 763, which wires 763 can be electrically coupled to an electrical connector 761. In some embodiments, the electrical connector 761 is a waterproof electrical connector. As shown, the electrical connector 761 can be coupled to the electrical wire 763 via a portion of the electrical wire 708 that extends outward from the connector portion 772 and/or the wiring path of the electrical wire 763.
In some embodiments, heater assembly 760 also includes certain insulation features 778, which may include insulation foam and/or padding. Such insulation features may improve patient and/or physician comfort and/or reduce the risk of injury or damage to the device from the thermal energy from the heating pads 764, 765. The insulating feature 778 may further advantageously present a pressure on the heating pads 764, 765 to urge the heating pads toward the patient, thereby improving contact and heat transfer with the patient.
FIG. 8 is an exploded view of an example heater assembly 860 in accordance with one or more embodiments. Heater assembly 860 may be similar to heater assembly 760 shown in fig. 7. That is, any component shown in fig. 8 should be understood to potentially have similar features, characteristics, and/or functionality as any corresponding/similar component shown in fig. 7 and described above.
The heater assembly 860 includes a receptacle pocket 862, which receptacle pocket 862 may be similar to the heater assembly pockets described in connection with other embodiments herein. The pocket 862 may include a patient facing 862a section/portion and an outward facing 862b section/portion. The heater pocket 862 may include a first heater pad portion 875 and a second heater pad portion 873 separated by a connector portion 872. Although some embodiments of the heater assembly bag disclosed herein include a connector portion having one or more bends along the path between the heating pad portions, as shown in fig. 8, some embodiments include a substantially straight connector portion 872. That is, the connector portion 872 may pass through a substantially straight path between the heater pad portions 875, 873.
Another significant difference between the various components of heater assembly 860 as compared to heater assembly 760 shown in fig. 7 relates to the generally circular shape of some of the components of assembly 860 shown in fig. 8, while the corresponding components shown in fig. 7 are shown as generally rectangular (e.g., square). It should be understood that any of the embodiments disclosed herein may have any shape of component as is suitable or desirable for a particular application. For example, any heating mat, thermal insulation feature, thermal conduction feature, heating mat pouch portion, etc. may have any type of oblong, oval, circular, rectangular, square, triangular, or any other shape or configuration.
The pocket 862 may include an electrical connector portion 879, which may extend perpendicularly from the path of the connector 872, as shown in fig. 8. Although the portion 879 is shown as protruding substantially perpendicularly/orthogonally from the path of the connector portion 872, it should be understood that the electrical connector extension 879 may be formed/positioned at any acute or obtuse angle relative to the elongate dimension/axis of the connector portion 872 of the pocket 862. The connector portion 879 of the bag 862 can have a length dimension D sufficient to extend from the location of the connector portion 872 to an electrical and/or fluidic coupler associated with a sleeve to which the heater assembly 860 is configured to be coupled. For example, in some embodiments, when attached to a sleeve (not shown in fig. 8), connector portion 872 may be located in a region of the sleeve that is typically associated with the posterior side of the patient's lower leg, while the associated electrical and/or fluidic connector to which connector 861 is connected may be removed/offset a distance from the posterior side of the lower leg. For example, the connector of the sleeve or other connector that the electrical connector 861 of the assembly 860 is configured to connect to may be located on a side of the patient's leg or generally toward a side or front side of the patient's leg. Thus, the pocket extension 879 may extend a sufficient distance as necessary or desired to provide the desired fluid seal for the pocket 862 around the wires 808 connected to the connector 861.
Fig. 9 shows a temperature management sleeve 930, including a detailed cross-sectional view of one or more heated portions thereof, in accordance with one or more embodiments of the present disclosure. Temperature management sleeve 930 includes a foot heating pad or portion 934 and a popliteal heating pad or portion 932. For example, foot heating section 934 may be located on or near the sole 3 of a patient's foot 6, while popliteal heating section 932 may be located on or near the popliteal fossa 9 of a patient's leg 10.
The various heating portions of sleeve 930 may be at least partially embodied in a heater portion of a heater assembly, as described in detail in connection with the various embodiments disclosed herein. For example, such a heater assembly may include a foot and popliteal heating portion, with a heating pad or other heating element disposed within the pouch, as shown in fig. 7 and 8 and described in detail above. Detailed image 901 represents a cross-sectional view of an example stack of a heater portion of a heater assembly and an associated portion of a sleeve 930, the sleeve 930 being positioned or disposed about or proximate to a heating pad portion of the heater assembly. As shown in detail image 901, the fabric portion of the sleeve 927 may be disposed against patient tissue/skin 2 in a corresponding heated region of the sleeve 930, wherein the patient facing plastic layer 962a of the heater assembly may be positioned against the fabric layer 927 of the sleeve. In some embodiments, the patient facing layer 962a of the heater assembly may be joined with an outwardly facing plastic layer 962b, with certain components of the heater assembly being contained between the two plastic layers of the heater assembly. A heat transfer medium 974, such as a thermally conductive gel or the like, may be disposed adjacent the plastic layer 962 a. The thermally conductive layer 974 may be disposed on the heating element/pad 960, and the heating element/pad 960 may be configured in accordance with any of the embodiments disclosed herein, and may advantageously be configured to radiate heat in the direction of the patient tissue 2, wherein such radiated heat is conducted through the thermally conductive medium 974.
In some embodiments, a thermistor 968 or a plurality of thermistors is disposed on the patient-facing surface of the heating pad/element 960. Although shown as being in direct contact with the patient facing surface of the heating element/pad 960, it should be understood that the thermistor 968 can be disposed anywhere between the heating pad/element 960 and the patient tissue 2, whether inside the heater assembly pocket or between the heater assembly pocket and the fabric layer 927, or between the fabric layer 927 and the patient tissue 2. In some embodiments, the back side of the heating element/pad 960 (i.e., facing away from the patient) may be thermally buffered by an insulation layer 978, which insulation layer 978 may be disposed/present between the heating pad/element 916 and the outward facing pocket layer 962 b. In some embodiments, the fabric layer 929 is disposed at the outermost portion of the heater assembly. That is, the fabric cover 929 or the like may be placed over the heater assembly when the heater assembly is coupled to the sleeve 930 as desired.
Fig. 10 illustrates a heater assembly including a mechanical use/expiration indicator 1005 in accordance with one or more embodiments of the present disclosure. The usage indicator 1005 may be used to indicate to a user (e.g., a nurse or other technician) that the heater assembly 1060 has reached or is about to reach the end of its useful life, according to some criteria. For example, the heater assembly 1060 may be considered a repositionable device because it may be used for multiple purposes (e.g., multiple patients, multiple procedures, etc.), where the number of uses that may be used is limited in some way. For example, in the exemplary embodiment shown, heater assembly 1060 may be adapted for 10 uses and may be discarded thereafter.
The mechanical use indicator 1005 may include one or more tabs, perforations, etc., where a user may mechanically perforate the feature 1001, thereby creating a hole/opening or other visual feature 1003 indicating the number of uses of the assembly 1060. That is, each time of use, the user may punch one of the indicators 1001 to display the usage count indicator 1003 in a used condition/state indicating that use has occurred or is about to occur. When the expiration indicator 1005 includes only the used condition counter 1003 (i.e., where each usage count indicator 1002 has been punched to become 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.
Fig. 11 illustrates a heater assembly including a power usage/expiration indicator 115 in accordance with one or more embodiments of the present disclosure. The power usage indicator 115 may include one or more lights, such as LED lights or the like, which may be configured to flash and/or provide an output (e.g., a visual and/or audible output) indicating the condition of the heater assembly 1160 with respect to service life and/or the number of uses associated therewith. For example, the heater assembly 1160 may be configured to electrically determine when usage has been initiated or completed, e.g., by determining activation of one or more components of the heater assembly (e.g., a heater), wherein the heater assembly 1160 is configured to track the number of times it is used and provide an indication to a user indicating the status of usage of the heater assembly 1160. For example, in some embodiments, usage indicator 115 may blink and/or illuminate when heater assembly 1160 is at or near the end of its useful life. In some embodiments, the color of light 115 may indicate how close heater assembly 1160 is currently to the end of service life.
FIG. 12 illustrates a side view of a temperature management sleeve system 1230 in accordance with one or more embodiments, the sleeve system 1230 having a heater assembly 1260 secured thereto. As described in detail above, certain heater assemblies contemplated in connection with various embodiments of the present disclosure include two heater portions connected by a connector portion. For example, fig. 12 shows a heater assembly 1260 that includes a first heater portion 1283 and a second heater portion 1282 connected by a connector portion 1281, the connector portion 1281 spanning the distance between the two heater portions. For example, the connector portion 1281 may comprise an elongated portion of the bag of the heater assembly 1260, which may have particular wires and/or other components disposed therein. The shape, form, length, and/or other dimensions or characteristics of the connector portion 1281 may be designed in a convenient and/or intuitive manner to fit within or extend along a path associated with the sleeve 1230 in a manner consistent with the form of the sleeve 1230. For example, connector portion 1281 of heater assembly 1260 may include a first portion 1280 that extends from popliteal heating portion 1283 and along a first line/path, wherein the connector includes a bend 1208 that allows the connector to be redirected along a path that is more aligned with the elongated dimension of patient limb 10 to span the distance between the heater portions of heater assembly 1260.
The connector portion 1281 may include one or more additional bends, such as straps 1207, that may allow the connector portion 1281 to be redirected 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 curved portions that merely represent examples of different routing characteristics/characteristics of the connector portion of the heater assembly according to some aspects of the present disclosure. Accordingly, it should be understood that embodiments of the present disclosure may include heater assemblies having any number and/or configuration of straight, curvilinear, and/or curved portions configured/designed to accommodate a suitable path along a wearable sleeve (e.g., for a leg or other limb) that allows placement and/or coupling to/with the sleeve. For example, the straight, curved, and/or bent portions of the connector 1281 can be configured to bypass a gap or opening 1292 on the 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 the sleeve 1230 to have a desired flexibility. Further, connector portion 1281 may be configured to follow the path of ankle connector portion 1291 of sleeve 1230, wherein ankle connector portion 1291 is routed around ankle opening 1299, which may further provide flexibility and/or comfort to the patient.
The connector portion of a heater assembly according to aspects of the present disclosure may be configured to pass along and/or under certain physical couplers, such as straps. For example, in the embodiment shown in fig. 12, the connector portion 1281 passes at least partially under one or more straps 1242, 1246 of the sleeve 1230, which may allow the straps to secure the connector portion 1281 in place and/or protect the connector portion from physical contact with items in the operating environment that might otherwise displace or interfere with the heater assembly 1260.
FIG. 13A illustrates a temperature management system 1330 with a heater assembly 1360 disposed thereon, in accordance with one or more embodiments. Temperature management system 1330 includes a sleeve structure 1331. Sleeve structure 1331 may include a heater assembly delineation form or region, which may include one or more patches, stitches, wiring pathways or structures, and the like. The heater assembly 1360 may be disposed on and/or within one or more portions of the sleeve structure 1331. For example, the heater assembly 1360 may rest and/or be secured on a heater assembly delineation form or region, as described herein.
The temperature management system 3030 includes a plurality of compression bladders 1338 associated with the lower leg portion 1312 of the sleeve 1331. For example, compression balloon 1338 may include a lower balloon 1338a, an intermediate balloon 1338b, and an upper balloon 1338 c. Although the three bladders are shown in a vertical arrangement relative to the vertical orientation of the leg on which the sleeve 1331 may be placed, it should be understood that a compression bladder assembly according to aspects of the present disclosure may include any number of compression bladders and/or any relative position and/or orientation. Temperature management system 1330 of FIG. 13A advantageously includes inflatable heel pad component 1308. Although heel pad 1308 is shown as having a generally circular shape, it should be understood that heel pads according to aspects of the present disclosure may have any suitable or desired shape/form. In some embodiments, heel pad 1308 is fluidly coupled to one or more compression bladders 1338 and/or fluid input connectors 1335. For example, a fluid passageway 1309 may be coupled between heel pad 1308 and one of the compression bladders 1338 or other fluid passageways, wherein a one-way valve 1307 allows for expansion of heel pad 1308 when the fluid pressure within one or more bladders or passageways is greater than a certain threshold, wherein once heel pad 1308 expands, air within heel pad 1308 may not tend to return through valve 1307 and may be blocked by the one-way nature of valve 1307. When the pressure within the channel 1309 and/or heel pad 1308 is greater than a certain threshold, air from within the bladder 1308 and/or other channels upstream of the valve 1307 generally does not open and/or direct additional fluid into the channel 1309 and/or heel pad 1308. In some embodiments, heel pad 1308 includes a recess, aperture, or other central depression feature 1319 configured to receive the apex/convex surface of the patient's heel when placed on heel pad 1308.
With respect to any of the embodiments of the sleeve and/or heater assembly disclosed herein, such assembly may include an inflatable cushion or other feature configured to press the heating cushion/assembly against the popliteal fossa and/or the sole of the foot to provide increased contact and/or heat transfer. For example, fig. 13A illustrates a heating pad compression feature 1321 disposed generally behind the heating pads 1364, 1365 when the heater assembly 1360 is placed on the sleeve 1330, wherein the compression feature 1321 is configured to apply a force to the heating pads 1364, 1365 in the direction of the patient (i.e., out of the page relative to the orientation shown in fig. 13A).
The heater assembly 1360 may pass along one or more portions of the sleeve 1331, such as along the heel connector portion/path 1391. In some embodiments, heater assembly connector portion 1362 may pass at least partially over a portion of bladder/compression assembly 1338, as shown. As with certain other embodiments disclosed herein, connector portion 1362 of heater assembly 1360 may include one or more straight regions 1303, 1372 and/or curved regions 1301, 1302, which may allow connector portion 1362 to pass through the area on sleeve 1331 between foot heating pad 1364 and popliteal heating pad 1365.
Fig. 13B-13D illustrate views of a fluid connector 1335 of the temperature management system of fig. 13A in accordance with one or more embodiments. Fluid connector 1335 may include a plurality of fluid channels 122, each configured to fluidly couple to a separate bladder of a bladder compression assembly associated with lower leg portion 1312 of sleeve 1331. Connector 1335 may include a flange 125 associated with each fluid passage, and flange 125 may be heat sealed to sleeve 1331 to prevent fluid leakage therefrom and provide a good structural interface between connector 1335 and sleeve 1331. The connector 1335 may also include a merge structure 124, the merge structure 124 configured to contain a proximal portion of the fluid channel 122, such that a single fluid connector associated with a fluid source may be coupled to the structure 124 and provide a fluid coupling between the fluid source and the fluid channel 122.
Fig. 14 illustrates a temperature management sleeve 140 having a heater assembly cover 149 according to one or more embodiments of the present disclosure. The sleeve 140 may have any suitable or desired form factor. For example, the sleeve 140 may have a shape and/or form similar in some respects to any of the embodiments disclosed herein.
The sleeve 140 includes a heater assembly cover 149, and the heater assembly cover 149 may be configured to be placed over at least a portion of the heater assembly 146 to secure and/or position the heater assembly 146 to the sleeve 140/sleeve 140. For example, the cover 149 may include fabric and/or other materials. In some embodiments, the cover 149 includes some attachment means 1403 for securing portions thereof to other portions of the sleeve 140. Such attachment means 1403 may include, for example, strips, bands and/or sections of Velcro or other attachment means. For example, such attachment means 1403 may include one or more snaps, clips, buttons, wraps, folds, hooks, clasps, sutures/sutures, adhesives, adhesive interfaces, and/or other attachment means in addition to or in lieu of Velcro. In some embodiments, a respective attachment device 1402 is associated with the body of the sleeve 140. Attachment device 1402 may be similar in some respects to attachment device 1403; any of the various types of attachment means discussed above with respect to attachment means 1403 may be implemented with respect to attachment means 1402.
In some embodiments, the attachment 1402 is associated with the 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 path similar to the heater assembly between the foot heating pad 141 and the popliteal heel pad 142, whether such path extends substantially in a straight path between the heating pads or in a more curved path/course as shown in fig. 14, wherein the heater assembly 146 includes a connector portion 144, the connector portion 144 having one or more bends to allow the connector portion 144 to extend along the side of the sleeve 140 at least over its length.
Fig. 15 illustrates the temperature management sleeve 140 of fig. 14 with the heater assembly cover 149 in a closed configuration in accordance with one or more embodiments. In the image of FIG. 15, the cover 149 is shown covering substantially the entire heater assembly 146. However, it should be understood that certain covers and/or other coupling features associated with the sleeve may cover only a portion(s) of the heater assembly in accordance with aspects of the present disclosure. For example, in some embodiments, the cover partially covers the heater mat of the heater assembly, while at least a portion of the connector portion of the heater assembly is not covered by the heater assembly cover.
Fig. 16A illustrates a temperature management sleeve 160 having an adhesive coupling feature 168 and a heater assembly 166 associated therewith, according to one or more embodiments of the present disclosure. As described above, certain adhesives may be implemented as attachment means for attaching the heater assembly to the sleeve structure, according to aspects of the present disclosure. The sleeve structure 160 of fig. 16A includes a bonding surface 168 to which the pocket 1601 of the heater assembly 166 can be bonded to couple the heater assembly 166 to the sleeve 160. That is, the adhesive surface 168 may be physically coupled to the sleeve 160 in some manner, such as through the use of one or more adhesives, sutures, and/or other attachment devices in accordance with any of the various types of attachment devices disclosed herein.
Prior to coupling the heater assembly 166 to the sleeve structure 160, the adhesive cover 169 may be removed from the adhesive surface 168, thereby exposing the adhesive surface 168 and allowing coupling therewith. For example, as shown in fig. 16A, the adhesive cover 169 may be peeled off and/or peeled off of the adhesive surface 168, thereby providing exposure.
Fig. 16B illustrates the temperature management sleeve 160 of fig. 16A with a heater assembly 166 secured to an adhesive coupling feature 168 according to one or more embodiments of the present disclosure. In the embodiment shown in fig. 16A and 16B, the surface area of the bonding surface 168 is similar to the surface area of the pocket 1601 of the heater assembly 166. However, it should be understood that the bonding surfaces according to aspects of the present disclosure may have any size, shape, and/or form. For example, in some embodiments, the adhesive surface 168 may be limited to covering only certain portions of the heater assembly pouch 1601. For example, the bonding surface 168 may be limited to the foot and popliteal heating pad 165, 167 heating pad area, wherein at least a portion of the connector portion 164 of the heater assembly 166 may not be bonded to the sleeve 160, but may be held in place by association/coupling with the heating pad portions 161, 162. Although fig. 16A and 16B illustrate heater assembly 166 having a generally linear layout, wherein the heater assembly, when coupled to sleeve 160, extends along a generally linear path between foot portion 165 and popliteal portion 167, it should be understood that connector portion 164 of heater assembly 166 may be formed and/or configured to route in any suitable or desired path between foot heater region 165 and popliteal heater region 167 of sleeve 160, as described in detail herein.
Fig. 17A and 17B illustrate a temperature management sleeve 170 having a heater assembly 176 associated therewith, with heater covers 177, 179 in open and closed configurations, respectively, according to one or more embodiments of the present disclosure. The temperature management sleeve 170 shown in fig. 17A and 17B may advantageously allow the connector portion 175 of the heater assembly 176 to be routed on the patient-facing side of the sleeve 170 (i.e., the side that is visible in fig. 17A and 17B and faces out of the page) as well as the outside (not visible in fig. 17A and 17B; i.e., the side that is generally facing away from the patient when the sleeve assembly 170 is disposed on the limb of the patient). By allowing the connector portion 175 to be routed outside of one or more portions of the sleeve 170, these portions may not directly contact the patient's skin/anatomy in these areas, thereby potentially increasing comfort and/or reducing the risk of damage to the heater assembly. In addition, the inboard/outboard wiring of the heater assembly 176 and its connector portion 175 may be used to secure the heater assembly in a fixed position on the sleeve 170.
In the embodiment shown in fig. 17A and 17B, the connector portion 175 of the heater assembly 176 can pass along the exterior of at least a portion of the shank portion 1703 of the sleeve. For example, the connector 175 may be configured to pass along the outside of the strap 178 or other physical coupling portion/component of the shank portion 1703 of the sleeve 170. Unlike the portion of the connector portion 175 that passes through the exterior of the lower leg portion 1703, the heating pad portions 171, 172 of the heater assembly 176 may generally be configured to be disposed on the patient-facing side of the sleeve 170, thereby improving heat transfer from the heating pad to the patient. The covers 179, 177 may be configured to cover the heating pads 171, 172, respectively, to prevent burns or other injury to the patient when the heating pads are activated. The covers 177, 179 may further be used to secure the heating assembly and/or its heating mat in place.
In some embodiments, the coverings 179, 177 comprise a fabric or other material designed to provide comfort to the patient at the heating pad contact area 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 fig. 17B, including Velcro, adhesives, snaps, the like, hooks, knots, sutures, and the like. The sleeve 170 may include certain grooves or other features into which corresponding heating pad portions of the heater assembly 176 may be placed/disposed. For example, the sleeve 170 may include certain cutouts, depressions, indentations, holes, cutout layers, etc. that correspond to the respective shapes/forms of the heating pad portions 171, 172 of the heater assembly 176 to secure such heating pads in place, guide proper placement of the heating pads, and/or for any other purpose with respect to securing/placing the heating pad portions of the heater assembly 176. In some embodiments, the coverings 179, 177 include a heat transfer medium, which may have characteristics according to any of the heat transfer media described herein, such that the coverings 179, 177 facilitate heat transfer between the heating pads 171, 172 and the patient's skin. For example, the covers 179, 177 may comprise a highly thermally conductive fabric or other material (e.g., a polymer). In some embodiments, a thermally conductive gel may be placed on/in the covers 179, 177.
Fig. 18 illustrates a temperature management sleeve 180 having particular dimensions in accordance with one or more embodiments. The various dimensions shown in fig. 18 correspond to certain components, regions, and/or areas of the sleeve 180 with respect to one or more orientations or dimensions of the sleeve 180. The various sizes shown in fig. 18 may take on certain values depending on whether the sleeve 180 is intended and/or deemed to be a large, medium, or small size sleeve, wherein each of these sizes is suitable for placement on a patient having a corresponding relative size to the population.
As with any of the embodiments of the sleeve disclosed herein, the sleeve 180 may include a foot strap portion 181, which may be configured to wrap at least partially around the foot of the patient. Width dimension D of foot wrapping portion 1811And may be between about 12 "and 16". According to some embodiments, the oversized sleeve may include a foot wrap dimension D of about 15 ″1While a medium size sleeve may include a foot wrap dimension D of about 15 ″1And the smaller size sleeve may include a foot wrap dimension D of about 13 ″1。
Each of the remaining dimensions of the sleeve 180 of fig. 18 are described below and include certain brackets with a listing of four parameters that in turn include the range of values expected for those dimensions, as well as the small, medium, and large sizes expected for those dimensions. Although specific values are listed, it should be understood that these values are only approximate and that actual values may be within about 10% of the recited values while falling within the range of values explicitly contemplated with respect to fig. 18.
Additional dimensions of sleeve 180 include width D of ankle connector portion 1832(2 "-5", 3 ", 4"), the width D of the calf portion 188 at its relatively narrow end or region3(16 "-22", 17 ", 19", 20 "), the width D of the lower leg portion 188 at its relatively wider area/portion4(18 "-28", 19 ", 21", 26 "), a popliteal connector portionWidth D of the section 1845(4 "-6", 4.5 ", 5"), width D of the popliteal wrap 1866(20 "-29", 22 ", 25", 27 "), the overall length D of the sleeve 1807(26 "-37", 28 ", 32", 35 "), the length D of the foot and ankle portions 181, 183 taken together8(11 "-16", 12 ", 13.5", 14.5 "), length D of calf portion 1889(11 "-16", 12 ", 13.5", 14.5 ") and length D of popliteal wrapping 186 and connector 184 together10(3 ' -7 ', 4 ', 5 ', 6 '). In some embodiments, the foot and ankle portions 181, 183 may be detachable from the calf portion 188. In addition, the popliteal portion 186 and connector portion 184 may be detached from the calf portion 188 in some manner.
19-21 illustrate color coordinated temperature management sleeve and heater assemblies in accordance with one or more embodiments. In general, the temperature management sleeve 2030 of fig. 19 and associated heater assembly 206 may correspond to a relatively large size embodiment of the temperature management sleeve and heater assembly. That is, the sleeve 2030 may be sized, dimensioned, and/or configured to be disposed about a lower limb of a relatively larger sized human patient, with the heater assembly 206 also sized to allow placement on the relatively larger sleeve 2030. Thus, the connector portion 204 of the heater assembly 206 may be relatively long compared to smaller sized sleeves and temperature management systems/assemblies.
The heater assembly 206 may include some color-based and/or other type of visual indicator that the heater assembly 206 is intended for use with a relatively larger sleeve (i.e., the sleeve 2030). For example, as shown, portions of the pocket 2062 of the heater assembly 206 may include a colored feature 2002 and/or other visual indicia/indicators that indicate dimensional aspects/properties of the heater assembly 206. The sleeve 2030 may also include some corresponding color or other visual indicator/indicia 2005 for indicating the relative size of the sleeve 2030. For example, the color feature 2005 may indicate that the sleeve 2030 is a relatively large sized sleeve.
As shown in fig. 19, heater assembly 206 may be configured to be physically secured or coupled to sleeve 2030, with its foot heating pad portion 203 positionable/disposed on or near the sole 3 of a patient's foot 6, with the popliteal heater pad 201 configured to be placed/disposed on or near the popliteal region 9 of a patient's limb 10a, as shown. As shown, connector portion 204 of heater assembly 206 may be configured to route along one or more portions of sleeve 2030 between foot heating pad 203 and popliteal heating pad 201. As shown, the heater assembly 206 may include an electrical connector 208, the electrical connector 208 configured to electrically couple to a connector 207 associated with the sleeve 2030.
The temperature management sleeve 2130 and associated heater assembly 216 of fig. 20 may correspond to a medium implementation of the temperature management sleeve and heater assembly. That is, sleeve 2130 may be sized, dimensioned, and/or configured to be disposed about the lower extremities of a medium sized human patient, with heater assembly 216 also sized to allow placement on medium sized sleeve 2130. Thus, connector portion 214 of heater assembly 216 may be relatively longer as compared to smaller sized sleeves and temperature management systems/assemblies, while connector portion 214 may be relatively shorter as compared to larger sized sleeves and temperature management systems/assemblies.
The heater assembly 216 may include some color-based and/or other type of visual indicator that the heater assembly 216 is intended for use with a medium-sized sleeve (i.e., sleeve 2130). For example, as shown, certain portions of the pocket 2162 of the heater assembly 216 may include a colored feature 2102 and/or other visual indicia/indicators that indicate dimensional aspects/attributes of the heater assembly 216. Sleeve 2130 may also include some corresponding color or other visual indicator/indicia 2105 for indicating the relative size of sleeve 2130. For example, the color feature 2105 may indicate that the sleeve 2130 is a medium sized sleeve.
As shown in fig. 20, heater assembly 216 may be configured to be physically secured or coupled to sleeve 2130 with its foot heating pad portion 213 positionable/disposed on or near the sole 3 of a patient's foot 6 with the popliteal heater pad 211 configured for placement/placement on or near the popliteal region 9 of a patient's limb 10b, as shown. As shown, connector portion 214 of heater assembly 216 may be configured to route along one or more portions of sleeve 2130 between foot heating pad 213 and popliteal heating pad 211. As shown, heater assembly 216 may include an electrical connector 218 configured to electrically couple to a connector 217 associated with sleeve 2130.
The temperature management sleeve 2230 and associated heater assembly 226 of fig. 21 can correspond to a relatively smaller sized embodiment of the temperature management sleeve and heater assembly. That is, sleeve 2230 may be sized, dimensioned, and/or configured to be disposed about the lower limb of a relatively smaller sized human patient, with heater assembly 226 also sized to allow placement over the relatively smaller sleeve 2230. Accordingly, the connector portion 224 of the heater assembly 226 may be relatively short compared to larger sized sleeves and temperature management systems/assemblies.
The heater assembly 226 may include some color-based and/or other type of visual indicator that indicates that the heater assembly 226 is intended for a relatively small sleeve (i.e., sleeve 2230). For example, as shown, certain portions of the bag 2262 of the heater assembly 226 may include a colored feature 2202 and/or other visual indicia/indicators that indicate a dimensional aspect/attribute of the heater assembly 226. The sleeve 2230 may also include some corresponding color or other visual indicator/marker 2205 for indicating the relative size of the sleeve 2230. For example, the color feature 2205 may indicate that the sleeve 2230 is a relatively small sized sleeve.
As shown in fig. 21, heater assembly 226 may be configured to be physically secured or coupled to sleeve 2230, wherein foot heating pad portion 223 thereof may be positioned/disposed on or near a sole 3 of a patient's foot 6, wherein popliteal heater pad 221 is configured to be placed/disposed on or near a popliteal region 9 of a patient's limb 10c, as shown. As shown, connector portion 224 of heater assembly 226 may be configured to route along one or more portions of sleeve 2230 between foot heating pad 223 and popliteal heating pad 221. As shown, the heater assembly 226 can include an electrical connector 228, the electrical connector 228 configured to electrically couple to a connector 227 associated with the sleeve 2230.
Temperature management process
Fig. 22 is a flow diagram illustrating a process 2200 for managing a patient's body temperature in accordance with one or more embodiments. At block 2202, the process 2200 includes providing a leg sleeve and heater assembly as described in accordance with various embodiments disclosed herein. For example, in connection with the operations associated with block 2202, the process 2200 may include accessing/providing the sleeve structure and a physically separate heater assembly configured to be physically secured/coupled to the sleeve.
At block 2204, the process 2200 includes securing/attaching the heater assembly to the sleeve. For example, attaching the heater assembly to the sleeve may include engaging or attaching one or more straps on or around one or more portions of the heater assembly, or other attachment means described herein. 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 that physically couples 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, and one or more other portions of the heater assembly may be disposed outside of the heater assembly when the sleeve is attached to a limb of a patient.
At block 2205, the process 2200 includes physically attaching the sleeve to a limb of the patient. For example, attaching the sleeve may include securing one or more straps or other physical attachment devices/mechanisms, as described in detail herein. The attaching may include fastening an attachment device associated with the foot portion, lower leg portion, and popliteal portion of the sleeve.
At block 2206, process 2200 includes coupling one or more electrical and/or pneumatic connectors to the cartridge assembly, where such connectors may be provided by one or more supply units, such as a control unit that provides air pressure and/or electrical resources to the cartridge assembly. Process 2200 may also include inflating an inflatable heel pad associated with the heel portion of the sleeve, as shown in block 2207. For example, inflation of the heel pad can be achieved using air received through one or more connectors coupled with the frame 2206.
In some embodiments, a sleeve assembly to which the heater assembly is attached and/or incorporated may include compression and heating functions. That is, the sleeve structure may include one or more compression bladders, which may be implemented in accordance with the sequential compression process or mechanism disclosed herein. Thus, when the sleeve assembly is disposed about the patient's leg, process 2200 may include heating the popliteal fossa and the sole of the foot using the heating pad/device of the heater assembly, as shown at block 2208, and applying a compressive force to the calf region of the patient's leg using the one or more inflatable compression bladders of the sleeve structure, as shown at block 2210, simultaneously and/or over a common period of time.
Temperature management sleeve size adjustability
The various temperature management sleeve assemblies disclosed herein may be adjusted in various ways to accommodate different sizes of patient limbs/legs. Fig. 23A shows a temperature management sleeve extension member 195 in accordance with one or more embodiments of the present disclosure. The sleeve extension member 195 may be configured and/or shaped/sized for placement on the tibia and/or other portion of the patient's leg to provide an extension of the sleeve to which the extension member 195 is configured to attach. For example, in accordance with one or more embodiments of the present disclosure, the sleeve extension 195 may include an opening/aperture 193, the opening/aperture 193 may be configured to be placed over a knee of a patient, while one or more band portions 198, 194, 196 of the extension member 195 may be designed and/or configured to physically couple to corresponding attachment devices/features of the temperature management sleeve structure.
Fig. 23B and 23C illustrate a temperature management sleeve 190 disposed on a lower limb of a patient according to one or more embodiments, with the sleeve extension member 195 of fig. 23A in a detached and attached configuration, respectively. As shown in fig. 23B and 23C, the extension member 195 may be placed on the patient's leg 10 such that the opening 193 is disposed around the knee 8 of the patient's limb 10. The coupling of the extension member 195 to the sleeve 190 may advantageously provide an extended diameter/width dimension/aspect of the sleeve 190 such that it may be coupled around a leg sized such that the side bands 199, 192, 197 of the sleeve 190 do not completely surround the circumference of the sleeve 190 and/or limb in one or more portions of the leg 10.
Temperature management sleeve assembly
Fig. 24A-24C illustrate the wearable sleeve 230 and the heater assembly 260 in various configurations and/or coupled states according to aspects of the present disclosure. The visible side of the sleeve 230 shown in fig. 24A-24C may be the side facing the patient or, alternatively, the side of the sleeve facing away from the patient when the sleeve 230 is disposed on the limb of the patient.
While certain embodiments are disclosed herein in which the heater assembly includes connector portions that are routed in a relatively tortuous path along a section of the coupling sleeve, the embodiment shown in fig. 24A-24C includes related structures of the heater assembly 260 and the sleeve 230 that allow the connector portion 264 of the heater assembly 260 to take a relatively straight path between the foot heater zone 249 and the popliteal heater zone 247 of the sleeve 230. For example, the path 248 between these seating regions may be substantially straight/linear.
In the embodiment of fig. 24A-24C, as shown in fig. 24B, the heater assembly 260 may be positioned generally along the central band/path of the sleeve 230. For example, the sleeve 230 may include a heater assembly delineation feature 248, and the heater assembly delineation feature 248 may include one or more layers of material and/or other stitching, indentations, raised features, or other features or indicators corresponding to the profile of the heater assembly 260 relative to the desired or intended positioning of the heater assembly 260 on the sleeve 230. In some embodiments, sleeve 230 includes an expandable or non-expandable heel pad 258, which may be generally disposed in the sleeve region between foot portion 251 and lower leg portion 252.
Certain embodiments of the heater assemblies disclosed herein and illustrated in the various figures of the present disclosure include electrical wires and/or connector portions between the various heating pads of the heater assembly that generally extend along a central path between the heating pads. That is, relative to the center of mass of the heating mat of the heater assembly, the wires may be coupled to the respective heating mat in an area generally aligned with the center of mass of the heating mat, and/or the connector may extend along a path generally aligned with the center of mass of the heating mat. Alternatively, as shown in fig. 24A-24C, the wires 263 may be offset from the respective centers of the heating pad 241, 242 areas. For example, as shown, the wires may be coupled to respective heating pads at or near a common side of the heating pads. In some embodiments, as shown, the pocket 265 generally delineates the offset connector portion 264. As shown in fig. 24B, the offset configuration of connector 264 relative to the center of the heating pad may allow connector 264 to be routed at least partially around inflatable heel pad 258.
Fig. 25 shows a temperature management sleeve 2530 disposed on a patient's limb 10, wherein the sleeve 2530 includes separate heater pad and heater assembly connector cover portions 2555, 2556, 2557 in a manner similar to that shown in fig. 24A to 24C. Sleeve assembly 2530 includes a heater assembly 2560, heater assembly 2560 having a foot heater 2534 and a popliteal heater 2532 connected by a connector portion 2564, the connector portion 2564 spanning the portion of sleeve 2530 between foot 6 and popliteal 9. Sleeve 2530 can include a first covering 2555 configured to cover foot heater 2534, a second covering 2557 configured to cover popliteal heater 2532, and a lower leg covering portion 2556 configured to cover at least a portion of connector 2564 of heater assembly 2560 in the lower leg region of the patient.
Additional embodiments
Depending on the embodiment, certain actions, events or functions of any process or algorithm described herein may be performed in a different order, may be added, merged, or omitted altogether. Thus, in some embodiments, not all described acts or events are necessary for the practice of the process.
Conditional language, such as, among others, "may," "can," "might," "may," "e.g.," and similar terms, as used herein, unless otherwise specifically stated or otherwise understood in the context of usage, are intended to be synonymous in a general sense and are generally intended to convey that certain embodiments include certain features, elements, and/or steps, while other embodiments do not include such features, elements, and/or steps. Thus, such conditional language does not generally 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 such 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, used in their ordinary sense, and are used inclusively in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and the like. Furthermore, the term "or" is used in its inclusive sense (and not its exclusive sense) such 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. Unless specifically stated otherwise, conjunctive language such as the phrase "X, Y and at least one of Z" is understood in the context of use to be commonly used to express that an item, term, element, etc. may be 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 be present.
It should be appreciated that in the foregoing 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 requires more features than are expressly recited in that claim. Moreover, any components, features, or steps illustrated and/or described in particular embodiments herein may be applied to or used with any other embodiment. Further, no element, feature, step, or group of elements, features, or steps is essential or essential to each embodiment. Therefore, the scope of the invention disclosed herein 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") are provided for ease of reference and do not necessarily imply a physical characteristic or ordering. Thus, as used herein, ordinal terms (e.g., "first," "second," "third," etc.) used to modify a structure, component, operation, etc., do not necessarily indicate a priority or order of that element relative to any other element, but generally distinguish that element from another element having a similar or identical name (but using the ordinal term). In addition, as used herein, the indefinite articles "a" and "an" may mean "one or more" rather than "one". Further, an operation performed "based on" one condition or event may also be performed based on one or more other conditions or events not expressly 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 will 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 will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.
Spatially relative terms "outer," "inner," "upper," "lower," "below," "over," "vertical," "horizontal," and the like may be used herein to describe a relationship of one element or component to another element or component as illustrated in the figures. It will 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 figures. For example, in the case of a device being turned over as shown in the figures, a device that is "below" or "beneath" another device may be placed "above" the other device. Thus, the illustrative term "below" may include both lower and upper positions. The device may also be oriented in another direction and the spatially relative terms may be interpreted differently depending on the orientation.
Unless expressly stated otherwise, comparative and/or numerical terms, such as "less," "more," "greater," etc., are intended to encompass equivalent concepts. For example, "less than" may mean not only "less than" in the strictest mathematical sense but also "less than or equal to".
Claims (27)
1. A temperature management device, comprising:
a wearable sleeve, comprising:
a foot portion configured to cover at least a portion of a sole of a foot of a patient;
a lower leg portion configured to cover at least a portion of the patient's lower leg, the lower leg portion having one or more compression bladders associated therewith; and
a popliteal portion configured to overlie at least a portion of a popliteal fossa of the patient; and
a heater assembly configured to be removably secured to the wearable sleeve, the heater assembly comprising:
a foot heating pad;
a popliteal heating pad; and
a physical connector extending between the foot heating pad and the popliteal heating pad.
2. The temperature management apparatus of claim 1, wherein the foot portion comprises an inflatable heel pad configured to be fluidly coupled to at least one of the one or more compression bladders.
3. The temperature management apparatus according to claim 2, wherein the inflatable heel pad is fluidly coupled to a channel having a one-way valve associated therewith.
4. The temperature management device of claim 1, wherein the popliteal portion of the wearable sleeve has a knee cut such that the wearable sleeve is open around the knee of the patient.
5. The temperature management apparatus of claim 1, wherein the physical connector of the heater assembly comprises an electrical wire contained within a connector portion of a fluid-tight bag.
6. The temperature management device of claim 1, wherein a lower leg portion of the wearable sleeve is detachable from one or more of the foot portion or the popliteal fossa portion.
7. The temperature management device of claim 1, wherein the foot heating pad has visual indicators corresponding to respective indicators associated with a foot portion of the wearable sleeve.
8. The temperature management device of claim 1, wherein the wearable sleeve comprises a closeable cover configured to overlie one or more portions of the heater assembly when the heater assembly is secured to the wearable sleeve.
9. The temperature management device of claim 1, further comprising an extension component configured to be coupled to the lower leg portion on the patient's tibia.
10. The temperature management device of claim 1, further comprising a fluid interface thermally sealed to the wearable sleeve and comprising three fluid isolation conduits in fluid communication with three of the one or more compression bladders, respectively.
11. The temperature management apparatus according to claim 1, characterized in that:
the heater assembly includes one or more color-coded indicators that indicate a size of the heater assembly; and is
The wearable sleeve includes one or more corresponding color-coded indicators for indicating a size of the wearable sleeve relative to the heater assembly.
12. The temperature management apparatus of claim 1, wherein the wearable sleeve comprises an adhesive tape configured to secure the heater assembly to the wearable sleeve.
13. The temperature management device of claim 1, wherein the wearable sleeve comprises a heater assembly tick pad, the heater assembly configured to be secured on the heater assembly tick pad.
14. The temperature management device of claim 1, wherein 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 heating pad are disposed medial to the wearable sleeve; and is
At least a portion of the physical connector is disposed outside of the wearable sleeve.
15. The temperature management device of claim 14, wherein at least a portion of the physical connector is configured to extend outside of a lower leg portion of the wearable sleeve when the heater assembly is secured to the wearable sleeve.
16. The temperature management device of claim 1, wherein the heater assembly is configured such that the physical connector extends along a front or side of the patient's leg between the foot and popliteal fossa when the heater assembly is secured to the wearable sleeve.
17. A heater assembly, comprising:
a first heating pad;
a second heating pad;
a wire electrically coupling the first heating pad and the second heating pad to an electrical connector; and
a bag, comprising:
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 elongated connector portion extending between the first and second heating pad portions, the elongated connector portion covering at least a portion of the electrical wire.
18. The heater assembly according to claim 17, wherein the electrical connector projects substantially perpendicularly from the connector portion.
19. The heater assembly according to claim 17, further comprising an indication device for indicating use of the heater assembly.
20. The heater assembly according to claim 19, wherein the indicating means comprises a mechanical indicator.
21. The heater assembly according to claim 19, wherein the indicating means comprises one or more light sources.
22. The heater assembly according to claim 17, further comprising a control circuit configured to:
determining a number of uses of the heater assembly; and
activating an indicator in response to determining a number of uses of the heater assembly.
23. The heater assembly according to claim 17, further comprising one or more temperature sensors on a patient facing side of one or more of the first and second heating pads.
24. The heater assembly according to claim 17, further comprising a thermally conductive gel disposed on at least a portion of a patient facing side of one or more of the first and second heating pads.
25. The heater assembly according to claim 17, wherein said first heating pad and said second heating pad comprise a resistive heating device.
26. The heater assembly according to claim 17, wherein said connector portion follows a straight line path between said first heater mat portion and said second heater mat portion.
27. The heater assembly according to claim 17, wherein the connector portion has one or more bends configured to allow the connector portion to traverse a non-linear path.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202063089884P | 2020-10-09 | 2020-10-09 | |
| US63/089,884 | 2020-10-09 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN215688931U true CN215688931U (en) | 2022-02-01 |
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Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202022555920.3U Active CN215688931U (en) | 2020-10-09 | 2020-11-06 | Heater assembly and temperature management device |
| CN202011230229.6A Pending CN114305848A (en) | 2020-10-09 | 2020-11-06 | Temperature management sleeve |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202011230229.6A Pending CN114305848A (en) | 2020-10-09 | 2020-11-06 | Temperature management sleeve |
Country Status (1)
| Country | Link |
|---|---|
| CN (2) | CN215688931U (en) |
-
2020
- 2020-11-06 CN CN202022555920.3U patent/CN215688931U/en active Active
- 2020-11-06 CN CN202011230229.6A patent/CN114305848A/en active Pending
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| Publication number | Publication date |
|---|---|
| CN114305848A (en) | 2022-04-12 |
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