Patent Application
20200155409
This invention generally relates to an intermittent pneumatic compression device for use with limbs to improve venous circulation.
Intermittent pneumatic compression (IPC) devices are used to improve venous circulation in limbs. In most aspects, IPC devices are used to improve venous circulation in the legs of patient suffering edema, or patients who may be at risk for developing blood clots in the deep veins of the leg, typically due to decreased blood flow and a higher likelihood of clotting due to low blood flow. IPC devices intermittently provide high pressure to the tissues of the limb, forcing fluids such as blood and lymph out of the pressurized area. Following the application of high pressure, pressure is reduced allowing blood to flow back into the limb.
While current IPCs help prevent blood clots and improve circulation within limbs suffering edema, these IPCs still have several drawbacks, especially failing to adequately satisfying clinical needs. Many IPC devices are in fact stationary IPC devices. Some IPC devices do not themselves provide pneumatic pressure—they rely on external pneumatic controllers that are connected via a tube to a compression sleeve that provides the pressure to the tissue of the limb of the subject. The design and operation of products that communicate pressure to the sleeve using external tubing requires patients to be attached to an external intermittent pneumatic compression device, which are immobile themselves. This design does present significant inconvenience and risk to both the patient and the hospital staff due to entanglements and the need to manage external cables and conduits. Despite this, hospitals tend to use these devices poses less risk than devices that tether patients to electrical power sources.
Current products use electrical energy to create therapeutic super-atmospheric pneumatic pressure that is applied to the patient. However, many IPC devices do not have their own power sources, and must be connected to electrical outlets. Current products use standard 120 Volt 50/60 Hz AC wall power to operate. These non-mobile versions of IPCs are too bulky, and restrict the movement of the subject to a limited area, or in many cases, a stationary state.
Current mobile IPC devices that tubeless and have their own power sources (e.g., battery powered) provide too weak a pressure to ultimately be effectively, or fail to hold their charge for sufficient lengths of time to apply the needed therapy. The former have inferior clinical outcomes, and the latter cause excessive work for nurse resources who must remove, recharge, and re-apply the IPC device. In addition, most have to be plugged into a wall to be charged. In either case, currently available mobile IPC devices cannot be used continuously for a period of 18 hours in a day efficiently to meet the desired results as planned by physicians prescribing such course of treatment without being recharged while in use, requiring the user to be immobile. In addition, the current IPC devices, mobile and immobile, present the risk of electrocution and other electrical fault conditions because of the need to be connected to wall power for at least time during operation of the IPC device. For mobile patients, being tethered by an electrical cable to wall power is at least inconvenient and defeats the intent of a mobile device. For bedridden patients, having a power source attached to the patient while in the bed and under covers exposes the patient to various electrical risks (electrocution, ground, user entanglement, trip hazards, wire breakage, accidental disconnection, confusion with other lines in the field and other phenomena). Because of these risks, hospitals currently do not use mobile IPC devices where power cables are attached at any point to the patient.
Further, it is important that physicians can make sure that patients are complying with the prescribed treatment plan. In such instances, the IPCs are tethered to a computer in order to ensure that the patient is maintaining the treatment plan, severely impacting the quality of life of the patient.
In addition, many portable IPC devices are only configured to use with a single patient. That is, once an IPC device is been used by a patient, for sanitary purposes, it cannot be used by additional users. These devices are completely disposable and do not enable cleaning or recycling of the components. The single-use nature of these mobile IPC devise requires the use of materials and components that are sourced for low cost and not for reliability or performance. These lower-quality devices tend to have few features, cheap sleeves, and inexpensive controllers that result in variable performance that risk good patient outcomes.
In some mobile IPC devices, controllers can be removably attached to the sleeve, the pneumatic controller is either carried by the patient and is tethered to the sleeve by a pressure conduit or the pneumatic controller is removably attached directly to the sleeve. In such instances, the pneumatic controller can be removed from the sleeve, but requires detaching a pneumatic tether from the controller. The dissembled devise consists of a pneumatic controller and a sleeve with a very long pneumatic conduit hanging off to the side, which is difficult to manage and is a source of irritation to the user.
The mobile pneumatic controllers that are removably attachable to the sleeve use two methods of attachment—hook and loop fasteners and mechanical clasps. The hook and loop fasteners create a mechanical connection between the hook-receptive sleeve and hooks on the bottom surface of the pneumatic controller. These hook and loop portable IPC devices typically have a loose and weak attachment between the pneumatic controller and the sleeve. Such weak connections lead to attachment fails in several mechanical conditions that occur during normal use like vigorous leg movement or when the IPC device bumps into objects during ambulation. Another drawback is that these fails over time lead to the hooks becoming broken or clogged with debris and/or the hook-receptive surface frays and loses the ability to attach to the hooks on the pneumatic controller. The other IPC devices that use mechanical clasps to removably attach the controller to the sleeve suffer from the inconvenience of having to undue multiple mechanical attachments before the pneumatic controller can be removed from the sleeve. The mechanical claps used for some of these devices do not appear to be robust. Overall, the designs used for portable IPC devices allow for too much user error and lead to user frustration.
Most IPC devices utilize a pneumatic bladder to deliver mechanical energy into the underlying tissues to promote circulation within those tissues. In these devices, the bladder is usually contained within a sleeve that is used to attach the bladder to the patient. The sleeve and bladder combinations of the prior art have their drawbacks. The sleeves usually interface with the skin of a patient. Therefore, the sleeves are exposed to heat and moisture from the subject's skin. If the sleeve is not properly constructed to conduct heat and moisture away from the skin, the sleeve can cause the patient great discomfort. If not properly constructed, skin irritations, caused by trapped heat and moisture, can result. Along the same lines, some sleeves have been constructed with extensions or mounts that dig into the skin of the patient, as well as being made out of materials that have a bad chemical reaction with the skin of a patient.
Prior art sleeves have also failed to conform to the complex user anatomy while maintaining sufficient mechanical integrity to hold the bladder in place during use and convey mechanical energy into the underlying tissues. If the sleeve material is too compliant (flexible), the sleeve will stretch when the bladder inflates and the mechanical energy intended for tissue therapy will be made less effective by stretching the fabric instead of compressing the underlying tissues. If the sleeve material is too stiff (rigid), the sleeve will not be able to wrap and accommodate the underlying tissue intending to be treated. In this instance, the sleeve will wrinkle when applied to the complex shape of the user's tissue anatomy. The wrinkled sleeve may enable the pneumatic bladder to migrate within the sleeve when inflated or the bladder could inflate within the wrinkled space and apply energy to the rigid sleeve material instead of the underlying tissues, thus reducing the user's therapeutic experience.
The pneumatic bladders used in intermittent pressure cuff devices (IPCD's) must be contained within the pressure cuff and oriented to the patient's anatomy during use, which can exceed 18 hours in a 24-hour period. The bladder imparts the therapeutic mechanical force into the patient's tissues. A sleeve/cuff holds the bladder in the proper location to deliver the therapy. If the bladder is improperly located or allowed to migrate, the patient will not benefit from the IPCD therapy. Most mechanical cuffs have a pocket to locate the bladder. In some instances, the bladder is fixed inside a form-fitting pocket that enables insertion of the bladder. In other instances, the bladders contain regions within the pressurized area where material has been removed so the cuff material can be sealed within the region to create a spot weld that holds the bladder in place during placement and inflation. In other instances, the bladders contain regions within the pressurized area that enable stitching or piercing of the bladder material to affix the bladder within the cuff. To maintain the pneumatic integrity of the bladder, the regions containing the spot welds and/or stitches must have a perimeter seal. Adding seals constrains the ability of the bladder to inflate to a larger size since the edges are welded together. Adding new weld seals also increases the risk of pneumatic leaks. Another liability of these seals within the bladder's inflated region is the increase in geometric complexity and the likelihood of introducing stress raisers in the inflated envelope that can lead to either burst failures or fatigue failures (cyclic inflation causes mechanical damage due to the presence of a weld that accumulates over time).
A typical pneumatic bladder has a continuous and smooth peripheral weld that defines a region inside the bladder that is the active inflation region. Tubing transcends the peripheral weld (a mandrel weld region) to inflate the bladder. Alternatively, surface mount connectors are used to inflate the bladder and do not interfere with the peripheral weld (not shown). No salvage edge is shown as it is either trimmed or manufactured to be flush with the peripheral weld.
In addition, most sleeve/bladder combinations are done so that the bladder and sleeve are permanently attached to one another. That is, there is no way to remove the bladder from the sleeve and/or the other components of the IPC device, so that when the sleeve fails, the bladder is discarded with the sleeve.
Therefore, there is a need for an IPC device that can provide adequate power and battery life, while being modular such that a nurse can recharge the battery without needing to remove and reapply the sleeve. In addition, there is a need for an IPC device that is reusable while hygienic. Further, there is need for an IPC device that can also ensure that compliance occurs with the prescribed treatment plan. There is also a need for an IPC device that is easy to maintain and is reliable in function.
There is also a need for a sleeve that has a chemical and physical composition of matter that does not irritate an individual's skin. In addition, there is a need for a sleeve that has high breathability, allowing the sleeve to conduct heat and enable the skin to communicate moisture away from the skin-sleeve interface. There is also a need for the sleeve to have sufficient mechanical properties to enable delivery of the therapeutic energy from the bladder to the underlying tissues, maintain the position of the bladder on the targeted region of the patent while also enabling the pressure-delivery system to attach to the bladder. In addition, there is a need for a sleeve that is elastic enough to conform to the anatomy of the patient when in use but rigid enough to ensure that the mechanical energy of the pneumatic bladder is applied to the targeted tissue, and not aware from the tissue. There is also a need for a device with better bladder construction, as well as bladder construction that can be reused when the sleeve has failed.
This invention relates to an intermittent pneumatic compression (IPC) system that is modular in nature and allows mobility for subjects utilizing the system. In an aspect, the IPC system utilizes a mobile IPC device. In an aspect, the mobile IPC device is configured to provide sufficient pressure to extremities to satisfy the need of treatment. The mobile IPC device is an easy to use portable device that can be mounted onto a limb of a subject. The mobile IPC device is prescribed by a physician, and can be used for inpatients and outpatients to help prevent the onset of deep vein thrombosis by stimulating blood flow in the extremities. In such aspects, the IPC device is configured to stimulate blood flow through simulating muscle contractions. The modular mobile IPC device includes an independent power source, allowing subjects to be mobile while the IPC device is operating. In an aspect, the IPC system utilizes a plurality of mobile IPC devices that can be deployed simultaneously to numerous patients as needed.
In an aspect, the mobile IPC device of the IPC system includes a driving component that controls the inflation and deflation of an inflatable sleeve that engages a limb of the subject. The driving component can include housing that contains a pump subsystem, a computing device, and a self-contained power source. The driving component can be removably attached to the inflatable sleeve. The combination of the driving component and the inflatable sleeve of the mobile IPC device allows mobility for the subject. In an aspect, the pump subsystem of the driving component is controlled in operation by the computing device to inflate and deflate the inflatable sleeve. In an aspect, the pump subsystem utilizes a pneumatic pump. The pneumatic pump utilizes air as a fluid to transmit mechanical energy through the inflatable sleeve, which applies the compression to the targeted area of the limb of the subject.
In an aspect, the computing device of the driving component is configured to control the cycle time, display, and pump subsystem. In another aspect, the computing device can include a plurality of sensors that track the activity of the pump subsystem, the status of the self-contained power source, as well as the activity of the subject. In an aspect, the computing device can also include a user interface and/or display that shows the status of treatment (inflation, deflation, how many hours treatment has been applied, etc.). The computing device can also include communication means, allowing the computing device to communicate back the activity of the subject and operation of the IPC device to a remote server or remote computing device to ensure compliance with the prescribed treatment. In another aspect, the mobile IPC device can include several other sensing modalities to aid and refine the monitoring of patient health.
In aspect, the self-contained power source of the mobile IPC device can include a battery. In such aspects, the battery is configured to be rechargeable or easily replaced. In aspects in which the mobile IPC device contains a rechargeable battery, the IPC system can utilize charging stations that can recharge several mobile IPC devices at once. Such a docking/recharging station can be utilized in a hospital or clinic setting, allowing multiple mobile IPC devices to be charging while having others being used by patients.
In another aspect, the mobile IPC device is configured to ensure that the patient is complying with the prescribed treatment schedule, through tracking of actual use of the IPC device over a given time period. For example, the mobile IPC device is configured to keep track of the time the subject wears the mobile IPC device and the application of the prescribed treatment to the subject through the mobile IPC device, as well as how many days the subject has complied with the daily treatment regimen.
In another aspect, the mobile IPC device is configured to work with an inflatable compression sleeve that is placed on a limb of the subject. In an exemplary aspect, the mobile IPC device is configured to be removably connected to the inflatable compression sleeve. In such aspects, the inflatable compression sleeve can assigned to an individual subject, allowing the mobile IPC device to be used by multiple subjects in a hygienic manner.
In an aspect, the pump subsystem can be configured to provide high, intermittent pressure in a regular time frequency. Further, the pump power supply can be battery-powered and can supply power for a suitable clinically recommended daily duration (e.g., 18 to 24 hours per day) of a period of recommended days (e.g., 10-90 days). In an aspect, the power supply is modular and can be disconnected from the sleeve for ease in recharging.
In an aspect, the majority of the functioning components of the IPC (e.g., power supply, pump, hardware, and firmware) are configured to be removable from the compression sleeve. In an exemplary aspect, the bladder can also be configured to be removable from the compression sleeve. In such aspects, the compression sleeve can be disposable, while being able to retain the remaining components of the IPC device for additional uses, saving costs, and reducing the waste stream associated with the use of the system.
In another aspect, the body of the sleeve is comprised of an outer textile that is selected to enhance patient comfort. In such aspects, a portion or the entire portion of the textile configured for contact with the tissue of the patient is lined with a high-durometer material and/or a high co-efficient of friction which prevents the sleeve from migrating on the limb of the patient. In such aspects, the IPC device is smaller, more mobile solution compared to current electrical outlet powered IPC devices, while still providing adequate power, adequate battery life, a bladder in some cases, and hygienic use between several subjects while done so in a costly fashion.
In an aspect, the power supply is configured to be removable from the IPC device. The removable power supply can be enabled as a battery pack. As the power supply is spent operating the IPC, the removable battery pack is removed and replaced by a battery pack with a fresh charge. The removable battery pack can be rechargeable. The IPC device is configured to only be operable by the removable battery packs and no wall-power or charger can be used to operate the IPC device. This design configuration prevents users from risks associated with being tethered to wall power or other power supplies. This design feature also enables the IPC to be used in various operational environments that typically challenge battery operated devices because a cold/hot or failing removable power supply can be replaced by a new removable power supply to ensure continuous operation of the IPC despite the challenging environment.
In an aspect, the mobile IPC device is configured to aid in the prevention of DVT, enhance blood circulation, diminish post-operative pain and swelling, and reduce wound healing time. In an aspect, the mobile IPC device is configured to aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency, and reduction of edema in the lower limbs.
In an aspect, the mobile IPC device utilizes a pneumatic bladder with a continuous and smooth peripheral weld that defines a region inside the bladder that is the active inflation region.
In an aspect, the invention is directed at a mobile intermittent pneumatic compression (IPC) device including a driving component that is removably mounted to an inflatable sleeve. In such aspects, the driving component includes a removable power source, a pump subsystem, a computing device configured to control the pump subsystem; and, housing containing the self-contained power source, the pump subsystem, and the computing device. The pump system can inflate the inflatable sleeve when placed on a subject. In an aspect, the driving component is configured to be operable only with the removable power source is connected to the driving component. In another aspect, the removable power source is only rechargeable when the removable power source is disconnected from the driving component.
In some embodiments, the inflatable sleeve includes a sleeve, an inflatable bladder, and a mounting means to mount the driving component to the sleeve. The inflatable sleeve can include a unique identifying means so that the inflatable sleeve can be assigned to a specific patient. The unique identifying means can include an RFID chip. The sleeve of the inflatable sleeve can include a composite material system. The composite material system can include a stiff fabric and a flexible fabric. In an aspect, the inflatable bladder of the inflatable sleeve includes a salvage edge used for securing the inflatable bladder within the sleeve. In some instances, the inflatable sleeve is configured to be disposable. In such instances, it is possible for the inflatable bladder to be configured to be removed from the sleeve for reuse.
In an aspect, the invention is directed at a mobile IPC device that includes a driving component with a removable battery, a pump subsystem, a computing device configured to control the pump subsystem, and housing to contain those components, as a well as an inflatable bladder that is configured to be inserted into an inflatable sleeve. In such instances, the driving component is configured to be removably inserted and mounted to the inflatable sleeve. In some instances, the driving component is configured to be inoperable when the self-contained removable power source is removed and the self-contained removable power source is configured to be recharged only when removed from the driving component. The computing device can include a compliance meter that reports user compliance for a current 24-hour period and over a sequence of 24-hour periods. In addition, the computing device can be configured to be reset between use sessions or between users. In some instances, the computing device is configured to not store any patient-specific data nor is configurable by the patient. In some instances, the computing device is configured to apply a pre-configured pressure cycle.
Other features and advantages of the invention will become apparent to one with skill in the art upon examination of the following drawings and detailed description. It is intended that all such additional features and advantages be included herein within the scope of the present invention.
Embodiments of the present invention will be described more fully hereinafter with reference to the accompanying drawings, in which embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.
In the following description, numerous specific details are set forth. However, it is to be understood that embodiments of the invention may be practiced without these specific details. In other instances, well-known methods, structures and techniques have been shown in detail in order not to obscure an understanding of this description.
The present invention is directed towards a mobile intermittent pneumatic compression (IPC) device 20, as shown in
In an aspect, the mobile IPC device 20 includes a driving component 100 and an inflatable sleeve 300. In one embodiment, the physical configuration of the IPC device 20 promotes ease of use for low dexterity patients by orienting the sleeve 300 and the driving component 100 such that their proper coupling to one another is facilitated, discussed in detail below. In an aspect, the mobile IPC device 20 is controlled by the driving component 100, which is configured to be removably attached to the inflatable sleeve 300. The inflatable sleeve 300 is configured to be secured on a limb of a subject, and applies the compression to the limb as directed by the driving component 100, both of which are discussed in detail below.
The American College of Chest Physician guidelines recommend that IPC devices should be used by patients undergoing major orthopedic surgery, especially portable, battery powered IPC devices capable of recording and reporting proper wear time on a daily basis for inpatients and outpatients. Efforts should be made to achieve 18 hours of daily compliance. The IPC device 20 of the present invention meets these recommendations, and can be utilized by inpatients and outpatients.
In an aspect, as shown in
The driving component 100 contains the majority of the working components of the mobile IPC device 20 for the IPC system. In an aspect, as shown in
In an aspect, the housing 110 of the driving component 100 is made of a sufficiently hard material, including, but not limited to, ABS, polycarbonate, ASA, semi-rigid polyisoprene, hard rubber, and other plastic materials that are rugged and can be sterilized without becoming compromised. In another aspect, the housing can be made of machined metal alloys. In an aspect, the housing 110 is configured to contain or engage with all of the parts of the driving component 100. In an aspect, the housing can include a body 111 with a first end 114, a second end 116, a top portion 118 and a bottom portion 120 (when the driving component 100 is oriented in a horizontal position). As shown in
In an aspect, the housing 110 of the driving component 100 is rounded at the edges of the top portion 118 and bottom portion 120, which lessens the chance of a sharp edge getting caught on another surface, which could lead to damage as well as the driving component 100 being forced off the sleeve 300 if enough force is applied. In an aspect, the housing 110 has a width and height that is substantially the same throughout its length. In other embodiments, the housing 110 can include a tapered body, as discussed in more detail below in relation to
In an aspect, the bottom portion 120 of the body 111 of the housing 110 is configured to provide a base mount for the internal components of the driving component 100 (see
In another aspect, the body 111 of the housing 110 can ensure that the driving component 100 is mounted in the correct orientation and position on the inflatable sleeve 300, and more specifically, within a mounting means 330 attached to the inflatable sleeve 300, as shown in
In an aspect, the dock 330 can be configured to be permanently attached to the inflatable sleeve 300. In such aspects, the dock 330 can be mounted via adhesives or other fastening means (e.g., RF) on a surface of the inflatable sleeve 300. In another aspect, the dock 330 can be configured to be removably attached to the sleeve 300. While various means of attachment can be used to secure the dock 330 to the inflatable sleeve 300, it is preferable that the dock 330 is attached in a manner that does not cause the subject discomfort. For example, if fasteners, permanent or removable, are used to attach the dock 330, it is preferable that such fasteners do not extend through the inflatable sleeve 300, but only extend through the top layer of the inflatable sleeve 300. In another aspect, the dock 330 includes a mounting extension/anchor portion 331, as shown in
The dock 330 maintains a connection between the driving component 100 and the sleeve 300 that enables the driving component 100, and more specifically the pump subsystem 130, to communicate fluid pressure into a bladder 320 and then to the underlying tissues of the patient. When a bladder 320 is integrated into the sleeve 300, the dock 330 provides a fluid connection enabling the communication of fluid pressure from the driver into the bladder 320. When the bladder 320 is included as a integrated part of the driving component 100, the dock 330 provides the mechanical connection between the driver component 100 and the sleeve 300.
In an aspect, the dock 330 can have a shape that generally corresponds to the shape of the body 111 of the driving component 100, as shown in
In an aspect, the flange portion 350 is configured to be received by a corresponding groove 121 found on the bottom portion 120 of the housing 110 of the driving component 100, as shown in
In addition, the base member 332 of the dock 330 can include a receiving slot 340 configured to receive a latch 124 of the housing 110 of the driving component 100. In an aspect, the latch 124 can be configured to be spring loaded around a pivot mount 125, snapping into place in the receiving slot 340 when the driving component 100 is correctly aligned within the dock 330. By limiting the way in which the latch 124 can be received by the receiving slot 340, the orientation of the driving component 100 can be ensured when mounted onto the dock 330 of the inflatable sleeve 300. The latch 124 can be released by pressing the latch 124 from the back portion of the dock 330, through the fabric sleeve 302 in order to remove the driving component 100 from the dock 330. Such a configuration is not obvious to the user, and prevents removal of the driving component 100 while the sleeve 300 is on the subject.
The flange portion 350 can extend into a dock extension 360 located at a distal end of the dock 330. The dock extension 360 can be raised from the base 332, and can provide housing for a fluid interface 370 that contains fluid communication pathways 372 from the driving component 100 to the bladder 320 of the inflatable sleeve 300, as shown in
In an aspect, the driving component 100 can be mounted to the inflatable sleeve 300, via the dock 330, in the following manner. First, the housing 110 of the driving component 100 is aligned with the general direction of the dock 330 of the inflatable sleeve 300. The tabs 352 of the flange 350 of the dock 330 are aligned and received within the notches 122 of the groove 121 of the housing 110. A distal end of the latch 124 of the housing 110 is inserted into the receiving slot 340 of the dock 330, and slid until the latch 124 snaps into position. As advanced, the extensions 123 of the groove 121 receives the tabs 352 of the flanges 350 of the dock 330. In addition, the fluid communication ports 117 are put in communication with the fluid communication pathways of the inflatable sleeve 300 via the interface 370 and its fluid communication pathway 372. To remove the driving component 100 from the inflatable sleeve 300, the latch 124 is compressed to disengage from the slot 340 of the dock 330 by pressing the latch 124 through the fabric sleeve 302, and the driving component 100 is pulled in the proximal direction so that the tabs 352 exits the notches 122 of the groove 121 of the housing 110.
The orientation of the housing 110 of the driving component 100 and mechanical locking aspects discussed above promote the proper orientation of the fluid communication ports 117 and pathway 372, such that the targeted treatment, compression emanating from the distal portion of the patient extremities, is facilitated. In other aspects, additional ports may be added to the IPC device 20 which would further necessitate the need for proper orienting and interaction of the components. These mechanisms (shape of body, extensions, and flexible tabs) provide an improvement to currently marketed devices which either do not provide a mechanism for attachment and detachment of the sleeve and IPCD devices, making re-use of the IPCD impossible, or do not provide orientation and indication in addition to securement. Especially for aspects of the IPC device 20 with multiple sensors, proper orientation, indication, and device securement may be required for reliable and intended function to occur.
In an aspect, the fluid interface 370 of the dock 330 can include a connector mechanism that seals the air pathways from fluids and particulates when the driving component 100 is not connected to the dock 330. In an aspect, the connector mechanism can includes valve bodies (e.g., one-way valves) that would prevent fluid contamination. The valve bodies would create a fluid-sealed state when the driving component 100 is not connected and establishes fluid communication with the driving component 100, and the pneumatic portions, with the sleeve 300/dock 330 when in a connected state. In such aspects, valve bodies would protect the interior of the sleeve 300, and the pathways 372, from particularly dirty environments when the driving component 100 is not in use. In addition, such valve bodies allow the sleeve 300 to be cleaned without fear of allowing fluid into the interior, allowing for longer uses by the user.
In an aspect, the bottom portion 2120 of the tapered body 2111 of the housing 2110 is configured to provide a base mount for the internal components of the driving component 2100. In another aspect, the tapered body 2111 of the housing 2110 can ensure that the driving component 2100 is mounted in the correct orientation and position on the inflatable sleeve 2300, and more specifically, within a mounting means 2330 attached to the inflatable sleeve 2300. In such aspects, the mounting means 2330 is configured to receive the tapered housing 2111 of the driving component 2110. In an aspect, the mounting means 2330 comprises a dock 2330. The dock 2330 provides a fluid interface for the driving component 2110 and the internal components of the inflatable sleeve 2300.
In an aspect, the dock 2330 can be configured to be attached to the inflatable sleeve 2300. In an aspect, the dock 2330 can be mounted via adhesives or other fastening means on a top surface of the inflatable sleeve 2300. In an aspect, the dock 2330 includes a mounting extension 2331, as shown in
In an aspect, the dock 2330 can have a shape that generally corresponds to the shape of the tapered body 2111 of the driving component 2110, as shown in
The base member 2332 can also include a receiving slot 2340 that is configured to receive a matching tab/extension 2122 of the housing 2111 of the driving component 2110. The receiving slot/groove 2340 includes a distal end 2341 and a proximal end 2342, the proximal end 2342 oriented such that it is closer to the torso of the subject than the distal end 2341 when the inflatable sleeve 2300 is mounted on a limb of the subject. In an aspect, the proximal end 2342 includes an opening 2343 for the groove 2340, with the groove 2340 including a closed end 2344. In an aspect, the receiving slot 2340 is shaped so that there is only one way in which the tab/extension 2122 of the housing 2111 can be received. For example, as shown in
In an aspect, as discussed above and shown in
The flange portion 2350 can extend into a dock extension 2360 located at a distal end of the dock 2330. The dock extension 2360 can be raised from the base 2332, and can provide housing, as well as a fluid interface, for fluid communication pathways of the inflatable sleeve 2300. In an aspect, the dock extension 2360 includes fluid pathway connectors 2362 which match with the fluid pathway ports 2117 of the driving component 2100, putting the pump subsystem 2130 in communication with the interior of the inflatable sleeve 2300.
In an aspect, the driving component 2100 can be mounted to the inflatable sleeve 2300 in the following manner. First, the housing 2110 of the driving component 2100 is aligned with the general direction of the dock 2330 of the inflatable sleeve 2300. A distal end of the tab/extension 2122 of the housing 2110 is inserted at the proximal end 2342 of the receiving groove/slot 2340 of the dock 2330, and slid until the proximal end 2342 reaches the distal end 2344 of the groove 2340. As advanced, the slot 2123 of the tab/extension 2122 receives the flanges 2345 of the dock 2330. As the housing 2110 is advanced, the flange portion 2350 of the dock 2330 apply forces/compresses the compression portions 2125 of the flexible tabs 2124, pushing them into the recesses 2127, until the resting position of the housing 2110 within the dock 2330 is reached. At this point, the flexible tabs 2124 are no longer compressed by the flange 2350, and can extend so that the notches 2128 of the tabs 2124 can engage tabs of the flange portion 2350. In addition, the fluid communication ports 2117 are put in communication with the fluid communication pathways of the inflatable sleeve 2300 (see
The taper and mechanical locking aspects discussed above promote the proper orientation of the fluid communication ports 2117, 2362, such that the targeted treatment, compression emanating from the distal portion of the patient extremities, is facilitated. In other aspects, additional ports may be added to the IPC device 2020 which would further necessitate the need for proper orienting and interaction of the components. These mechanisms (shape of body, extensions, and flexible tabs) provide an improvement to currently marketed devices which either do not provide a mechanism for attachment and detachment of the sleeve and IPCD devices, making re-use of the IPCD impossible, or do not provide orientation and indication in addition to securement. Especially for aspects of the IPC device 20 with multiple sensors, proper orientation, indication, and device securement may be required for reliable and intended function to occur.
In an aspect, the sleeve 300 can include a unique identifying means 311, as represented in
The combination of the unique identifying means associated with the sleeve 300, and not the driving component 100, and the RFID scanner, possibly with the driving component 100, allows information to be reported for the patient—that is the only user of the sleeve 300 as assigned. In such instances, when the patient is first prescribed DVT treatment, a sleeve 300 is registered to that patient. By assigning the sleeve 300 to the patient, any driving component 100 of the IPC device 20 can be used with the sleeve 300, with the driving component 100 identifying the sleeve 300 and associating the unique identifier with the data that the driving component 100 collects during use. The data of the patient, associated with the unique sleeve identifier, can then be transferred to a centralized data center, which can store the data in a database. In such instances, patient compliance can be tracked regardless of which driving component 100 is used because the unique sleeve identifier data would be reported to a central database by any number of driving components 100. This allows hospitals and other large user groups to track individual patient use and compliance data without requiring specific patients to be assigned to the removable driving components 100. Such an aspect is particularly valuable if the driving component 100 does not include a removable battery and recharging a patient-specific component would prevent collection of patient use data.
In addition, by having the patient data linked to a sleeve 300 and not the driving component 100, and having the driving component 100 communicate such data to a centralized repository, the driving component 100, and its computing device 150, including processing means and memory, can be configured to only temporarily retain the patient data. That is, the computing means 150 of the driving component 100 can be configured such that data obtained from the patient, identified by the sleeve identifier, is only stored during the use of the driving component 100 of the patient—after communicating the data throughout use, or at its completion, the patient data is deleted from the computing means 150 of the driving component 100, either automatically (e.g., detachment from sleeve, removal of battery, or placing into charging station), or manually by the caretaker/physician/nurse (via the computer or through interface on component 100). This allows for smaller memory needs and protects the privacy of the patient's data.
In addition, by utilizing a unique device identifier for the sleeve 300 in combination with the driving component 100, it is possible to track additional information. For example, the system 10 can be set up to prevent a sleeve 300 from being recycled. For example, once the sleeve 300 has been assigned to a specific person, the system 10 can be configured to prevent that sleeve 300 from being used with another individual. For example, when a driving component 100 is assigned to patient, the driving component 100 can confirm that the sleeve 300 corresponds to the assigned patient on record. If not, the driving component 100 can alert the system 10, which can then alert an administrator to the problem. In addition, the unique sleeve identifier can be used to prevent a patient from using the wrong driving component based upon their needs, or keep the patient assigned to a specific type or individual driving component 100.
As discussed above, the housing 110 of the driving component 100 contains a pump subsystem 130, as shown in
In an aspect, the fluid pump 132 can comprise a pneumatic pump 132. The pneumatic pump 132 can be a standard use pneumatic pump 132 found in other DVT treatment devices. The pneumatic pump 132 must be powerful enough to provide the needed pressure for applying the compression needed to prevent DVT. In such aspects, the pump 132 should be able to operate at therapeutically appropriate ranges, and should be able to deliver no less than 55 mmHg pressure. The pump 132 and surrounding casing should also minimize and noise/vibration caused by the use of the pump 132. Pump weight and physical size are also minimized to reduce the overall devices weight and bulk. Given this is a wearable device, these considerations are particularly important as they reduce the patient burden to wear the technology and therefore comply with clinically recommended treatment.
The pneumatic pump 132 is in communication with fluid pathway flow ports 117 found within the housing 110. The fluid pathway ports 117 are configured to be in communication with the corresponding air flow pathway(s) 372 found in the mounting means 330 of the inflatable sleeve 300, discussed in detail below. In an aspect, the pneumatic pump 132 is configured to pump air into the inflatable sleeve 300 through one fluid pathway port 117 to the corresponding fluid communication pathway 372 of dock 330 and then to the inflatable sleeve 300. Other matching air flow ports can be configured to monitor the air flow through an air flow sensor.
In an aspect, as shown in
In an aspect, the pump subsystem 130, controlled by the computing device 150, is configured to be able to fill the inflatable sleeve 300 starting in a peristaltic fashion, and be able to achieve a maximum pressure of 55 mHg at the sleeve 300 at the top end. In addition, in some aspects, the maximum pressure is achieved in 10 to 20 seconds, while being able to maintain the highest pressure for up to 5 seconds. In an aspect, the computing device 150 can be configured to apply the compression cyclically for predetermined times at predetermined intervals. In an aspect, the system can be configured to operate on inflation and deflation cycles that occur in less than 60 second intervals. In addition, the computing device 150 is in communication with the sensors, from which the computing devices 150 collects information about the activity of the driving component 100. The sensors can measure the time, amount of pressure, the frequency, and temperature of the subject in order to ensure that the subject is complying with the prescribed treatment program.
In an aspect, the computing device 150 can act as a meter for the patient sticking to the prescribed treatment plan. For example, the computing device 150 can be configured to measure the daily compliance of a user. For example, if a patient is prescribed to use the IPC device 20 for 18 hours a day, the computing device 150 can communicate with the pneumatic pump 132 and sensors to track the time of active use of the device 20. In an aspect, the computing device 150 can also track patient compliance, or the fractional number of days over the treatment term in which the subject has been in 100% daily compliance. In an aspect, the computing device 150 can be configured to store patient data for the duration of the prescribed treatment. In such aspects, the patient data, including compliance, can be stored from 1 day up to 90 days, if desired. As discussed above, the patient data can be uploaded from the computing device 150 to a server 70 associated with the system 10 either through a wired connection or a wireless connection over a network 50 via various radio transmitters known in the art.
In another aspect, the computing device 150 can include a user interface 152. The user interface 152 can include a graphical user interface display 153 (e.g., made of a combination of a LCD screen 153a and a window 153b) and input devices 154 (e.g., buttons in communication with the remainder of the computing device 150, with corresponding inlets in the housing 110 of the top portion 118) that communicates information to the subject, as well as taking input from the user (cycling through information, clearing messages, etc.), as shown in
In an aspect, the user interface 152 can be configured to only display information to the subject, and not let the subject control the operation of the IPC device 20. In an aspect, the IPC device 20 is configured such that only clinical service providers that are trained on the system would be able to reset the operations of the computing device 150. Messages for the providers can also be displayed (e.g., reset the device for a new patient). In such aspects, the provider can reset the compliance meters of the computing device 150. In another aspect, the IPC device 20 can include a remote application that can operate on an individual's local computer or smart phone, delivering the information that would be delivered on a local user interface, with the IPC device communicating via wireless means, discussed below.
In an aspect, the computing device 150 can be configured to have communication means configured to communicate with other devices. For example, the computing device can include radio chips (e.g., Wi-Fi, Bluetooth, etc.) that communicate with other computing devices. In such aspects, the IPC system 10 can include a server (not shown) that is configured to communicate with the individual IPC devices 20 in order to capture patient data, including compliance data. In one aspect, the server is configured to communicate with electronic healthcare records, such that the data collected on the IPC device 20, where appropriate, can be easily entered copied onto a patient's healthcare record. In an aspect, the system 10 can also be configured to provide incentives to subjects for staying in compliance with the prescribed treatment. For example, the system 10 can be gamified, which would remind the subject about staying in compliance as well as rewarding such subjects for compliance. This can be reinforced through sharing messages through the display graphic/user interface. In one configuration, the IPC device 20 may also be paired with an application which would be able to display information about compliance, compliance trends, clinical notification, and the like to either the patient using the system or the care provider responsible for monitoring the patient.
In an aspect, the mobile IPC device 20 is powered by a self-contained power source 180. In an aspect, the power source 180 can include a removable rechargeable battery 180. In an exemplary aspect, the rechargeable battery 180 includes a lithium ion battery. The power source 180 powers the computing device 150, the sensors, and the pump subsystem 130. In an aspect, the power source 180 is configured to run the IPC device 20 for 18 to 24 hours. In an exemplary aspect, the battery 180 can be a 22400 mAh battery, which allows for battery life over twenty hours. However, in aspects where the IPC device 20 is prescribed for continuous use (e.g., 24 hours a day), the power source 180 can include multiple rechargeable batteries 180 that are used to replace each other when their power runs out to ensure continuous operation of the IPC device 20.
In an aspect, the power source 180 is configured to be removed from the driving component 100, as shown in
In an aspect, the power source/battery housing 182 is configured to have a battery connector 186 that engages a corresponding battery connector 162 of the driving component 100. As shown in
The battery 180 can also include computing means (not shown) that monitors the power level of the battery. In an aspect, the battery includes a display 190 to inform the used of the power level of the battery 180. In an aspect, the IPC system includes a battery charger 400, as shown in
In an aspect, the battery 180 can only be charged when removed from the IPC device 20. In such aspects, the mobile IPC device 20 can be configured so that it cannot be powered without any other power source than a rechargeable battery 180. In other words, the IPC device 20 does not function in the absence of the battery 180, and the battery 180 can only be charged when it is removed from the IPC device 20. In an aspect, the battery 180 is mechanically design to contain recharging features that are only accessible when not attached to the driving component 100. In one embodiment, the physical plug connection 186 is only accessible when the battery 180 is removed from the driving component 100. In another aspect, the battery is charged using inductance, and the inductance antennae 186 is only accessible for charging when the battery is removed from the driving component 100, so that the battery 180 can only be charged in a solitary state.
While in the preferred embodiments of the invention, a battery 180 will provide the power needed for the entire prescribed treatment plan (e.g., 18 hours). Upon completion of the treatment plan, the battery 180 is removed and recharged, discussed below. Another charged battery 180 can be inserted to continue operations of the IPC device 20. In an aspect, the mobile IPC device 20 can be configured to monitor the power level of the battery via the display or through communication means.
In an aspect, the mobile IPC device 20 of the IPC system 10 is configured to provide sufficient pressure to extremities, as well as removal of such pressure, in a periodic manner. In such aspects, the mobile IPC device 20 loads and unloads a pre-defined pressure value through a loop of pre-defined duration. In an aspect, the pressure applied is at least 55 mmHg, which was determined through a clinical literature review and evaluation as the required pressure to decrease venous stasis. The loop must allow for venous refill in between compression cycles, which has been found in clinical literature to be approximately 20-30 seconds. In one aspect, programming of the device 20 is controlled through firmware, and cannot be modified or tailored. In another embodiment, RFID tags may be utilized as a means to couple a sleeve 300 and the driving component 100, and may also be used as a method to select parameters about the treatment. In this aspect the RFID code may change settings corresponding to the pressure profile, compliance durations, etc. These RFID systems may also correspond to a particular anatomic region, to which the above mentioned device settings could be tailored.
As discussed above, the inflatable sleeve 300 of the IPC device 20 is configured to engage the limb of a subject. In an aspect, the inflatable sleeve 300 is configured to fit a patient's limb comfortably and enough to fully secure the sleeve 300 on the limb. In such aspects, the sleeve 300 is configured to fit a wide variety of limbs of subjects. In an aspect, the sleeve 300 is comprised of a closed circle of material that slides over the patient's anatomy and closes to accommodate the anatomy. In an aspect, the sleeve 300 has a cylindrical shape, with openings at either end, to fit an individual's appendage. In an aspect, the sleeve 300 can have an increased diameter from one end to the other to accommodate appendages of individuals.
In an aspect, the inflatable sleeve 300 includes a textile/fabric sleeve portion 302 and an air-impermeable bag portion/bladder 320, the textile portion 302 encompassing the impermeable bag portion/bladder 320, as shown in
In such aspects, the textile portion 302 is configured to enable the conduction of heat and moisture from the sleeve-skin interface during us while avoiding any chemical or physical irritation of the user's skin. In an aspect, the textile portion 302 can include porous materials that allow breathability; that is, the material enables ambient air to remove heat and moisture from the skin and sleeve 300 using conduction, convection, and radiation. Such porous materials include, but are not limited to, permeable felts and fabrics, open-cell foams, and composites or laminates of the two materials. Another embodiment would be an otherwise impermeable material with perforations made within the material to create porosity. In other aspects, non-porous materials like polyvinyl chloride or polyester sheets can be used, but with macro-pores added to the material. In an aspect, the textile portion 302 comprises a chemical composition that is in a biocompatibility with the skin of the user. In an aspect, the textile portion 302 is configured to be absent of mechanical features or sources of potential irritation on areas of the sleeve that are in direct contact with the user. (protrusions, abrasions, sharp edges, hard materials, hard edges, geometric features, etc.). In some instances, removal of mechanical irritations requires the use of buffer materials, piping, stand-offs, ribbons, or the like.
In an aspect, the textile portion 302 is a composite material system, made of a combination of a stiff fabric 310 that has little stretch and an elastic/flexible fabric 312. By utilizing a combination of materials, the sleeve 300 is able to conform to the complex user anatomy (compliant enough) but maintain sufficient mechanical integrity (rigid enough) to hold the bladder in place during use and convey mechanical energy into the underling tissues, as shown in
In an aspect, the textile portion 302 is made from a soft textile for the comfort of the patient, such as silicone foam or the like. In one configuration this material can be easily cleanable, or anti-microbial. In an aspect, the textile portion 302 can be configured to include a containing portion 305 that contains the air-impermeable bag/bladder 320, and securing portions 307, 309 that are used to secure the inflatable sleeve 300 on the limb of the subject. In such aspects, the securing portions 307, 309 are found on opposite portions of the containing portion 305. The containing portion 305 fully separates the air-impermeable bag 320 from the securing portions 307, 309, which contain enough fabric to allow for adjustable use of the sleeve to accommodate a variety of sizes of limbs. In an aspect, a sleeve extension 317 can be utilized to connect to the securing portions 307, 309 for patients with larger appendages. In an exemplary aspect, the securing portions 307, 309 make up connectable ends of the inflatable sleeve 300. In an aspect, various connecting means, including, but not limited to, hook and loop fasteners, button fasteners, tab and slot fasteners, and the like, can be used to secure the securing portions 307, 309 of the sleeve 300 to one another, which allows the sleeve 300 to be adjustable to the size of the limb of the subject
In an aspect, the sleeve 300 is configured so that the patient/user can easily mount the sleeve 300 on the patient's appendage. In an aspect, the sleeve includes an attachment mechanism. In an aspect, the attachment mechanism can utilize securing portions 307, 309 of the fabric sleeve 302. In an exemplary aspect, the securing portions 307, 309 employ a hook and loop attachment system, the securing portions 307, 309 including a hook portion and a loop portion. The hook portion and the loop portions are configured to be placed on opposite surfaces and opposite ends of the sleeve securing portions 307, 309 of the fabric sleeve 302 (e.g., top left and bottom right of the sleeve or vice versa) as the sleeve 300 forms a tube when secured on the limb of the subject. The hook portion includes a plurality of hooks, and the loop portion includes a plurality of loops, with the loop portion configured to receive the hook portion. In an aspect, the securing portions 307, 309 can be comprised of a fabric that acts like loop portions, therein only needed hook portions added to a surface. The hook and loop portions can be attached to the sleeve 300 via adhesion, welding, sewing, melted, chemically or otherwise, and other known methods of connection. In other embodiments, other securing mechanisms, including, but not limited to, laces, zippers, buttons, snaps, compression fits, etc., can be utilized. Hooks and loop fasteners, however, offer a continuously variable connection and are convenient.
In one aspect, the securing portions 307, 309 can include one large hook portion and one large loop portion. In another aspect, multiple corresponding hook and loop portions, of matching sizes, can be used, as shown in
In an aspect, the stiff fabric 310 is also used to create a mounting portion for the m mounting of the securing portions 307, 309 of the sleeve 300. In an aspect, the stiff fabric 310 can form a belt 318 of material for attachment locations. In such aspects, the belt 318 can stretch from one attachment locations (hook and loop toe) to an anchoring location. This belt 318 allows for a rigid hoop of material around the critical bladder location. The elastic fabric 312 is used for two other attachment locations and the remaining anchoring locations on either side of the rigid fabric “belt.” In other aspects, different materials of various stiffness can be utilized to inform order of attachment, attachment placement, and attachment strength. For example, a high elastic connection can be made to approximate the sleeve connectors than rigid connections can be made to solidify the overall assembly.
When the sleeve 300 is placed on the user, the securing portions 307, 309, using a hook and loop system, are placed in the desired locations to achieve the desired sleeve tightness and mechanical attachment, putting the hooks and loops into shear while the underlying fabric is placed into plane tension. The net effect is to achieve “hoop stress” within the stiff fabric sleeve material 310 that places a static load on underlying tissues. The plane tension in the fabric creates a mechanical situation where the bladder 320 held within the sleeve 300 is mechanically affixed against the skin so the pneumatic inflation of the balder translates mechanical energy into the underlying tissues.
To place the correct therapeutic treatment, proper placement of the sleeve 300 on the patient and predictable geometric placement of the bladder 320 within the mechanical cuff is needed. The bladder geometric placement must be maintained in both deflated and inflated conditions. In an aspect, the impermeable bag portion/bladder 320 is configured to transfer therapeutic mechanical energy into the tissue underlying the sleeve. During use, the sleeve 300 locates the bladder 320 in a specific anatomical location on the user and the sleeve 300 enables the bladder 320 to inflate without shifting position or examining away from the underlying tissue intended to be treated. The bladder 320 is sized and positioned within the sleeve 300 to transduce pneumatic pressure into mechanical displacement of the tissue under the sleeve. The amount of pressure within the bladder 320 and the position of the bladder 320 are critical for proper therapy. In an aspect, one bladder 320 is utilized. In other aspects, up to three bladders 320 can be used, providing sequential compression and localized therapy.
In an aspect, the bladder includes tabs or windows of material outside of the bladder area defined by the peripheral weld that enable IPCD cuff assembly, orientation, retention, and inflation. The material outside the peripheral weld is sometimes called the “salvage edge” and is considered the excess material that is typically minimized during design and manufacturing. This material exists is to enable a good peripheral weld and is not loaded during normal use and bladder inflation. The present invention eliminates the need for attachment regions within the bladder inflation area. The present invention reduces the number of welded regions within the bladder inflation area. The present invention avoids adding mechanical loads within the bladder inflation area. The present invention does not impact the inflation geometry of the bladder area.
As shown in
In other aspects, the tabs 512 within the salvage edge 510 can contain windows 520, as shown in
Referring back to
In an aspect, the design of the bladder inflation region 702 can define a shape with invaginations or excursions of the continuous peripheral weld 704 to form a mechanical interference fit with the cuff weld 715 surrounding the bladder 700, as show in
Another aspect, as depicted in
Another aspect, as shown in
In another aspect, as shown in
In another aspect, the inflation is modified by changing the peripheral weld: Most peripheral welds are simple geometries—continuous circles or lines joined by arcuate curves. A non-square, non-circular peripheral weld would form an inflation area that is complex at the periphery, but also more complex in the ability to deliver therapeutic mechanical energy to the underlying tissues. As an example, a circular peripheral weld will result in a circular inflated bladder while a long oval peripheral weld will result in a cigar-shaped inflated bladder. As another example, a peripheral weld with a complex geometry will create various inflated shapes. The shape of the inflated bladder suggests where the mechanical therapeutic energy is being applied to the user. The peripheral weld on the bladder can change to reflect the amount of energy being conveyed into the underlying tissues.
In an aspect, the bladder includes a single bladder device that inflates in segments or sequences of segments. A bladder with a single peripheral weld can defines a single bladder, then placing welds within that single bladder that contain a region where inflation gasses get from a first inflated chamber within the bladder to at least one other inflated chamber within the same bladder defined by the same peripheral weld. The region allowing inflation gasses to pass could be a small gap in the weld that acts to limit gasses traveling into the at least one other inflated chamber so that the net effect is that the at least one other inflated chamber fills with gases after the first inflated chamber.
The small gap in the weld may be a tortuous pathway where resistance to gas flow is controlled by the tortuous aspects of the small gap. The small gap in the weld may be an inclusion of another material that prevents the weld from sealing and where the body of the inclusion material acts as a filter to restrict inflation gas from passing into the at least next inflation chamber. In yet another embodiment, the small gap could include a pressure-relief valve that opens once a critical pressure is reached thereby enabling the first chamber to inflate to a predetermined pressure then allowing the at least next chamber to inflate to another pressure. The small gap in the weld could be controlled by mechanical forces applied during inflation of the first inflation chamber (distended bladder material could open a mechanical valve or material crease that becomes a small gap enabling inflation of an at least next inflation chamber). The small gap in the weld could be controlled by electrical forces sent by an inflation control unit. The electrical forces could open a solenoid valve to enable filling of the at least next inflation chamber and be under digital control. The electrical forces could act on a resistance heater that made the bladder weld material warmer and therefore more pliable thereby enabling opening of the small gap to enable inflation of the at least next chamber. These last two embodiments of the small gap in the weld being controlled by electrical forces could be controlled by the pressure-generating unit or by another signal such as a biofeedback signal demonstrating tissue response to the therapy being delivered (in this embodiment, the pressure generating unit is not controlling the distribution of pressures within the multi-inflation chamber bladder, but other external controls are being applied).
The small gap embodiments could be repeated within a single bladder to create a series of linked chambers. These chambers can be filled in series or in parallel, depending on the mechanisms used to pass inflation gasses from one inflation chamber to the at least next inflation chamber. It may be possible to inflate at least several inflation chambers to different ultimate pressures by including pressure relief valves that vent to the atmosphere (pressure environment outside of the bladder assembly) to prevent those chambers from exceeding the pressure defined by the pressure relief valve. It may be possible to have a series of inflation chambers that inflate to a lower inflation pressure because one of these pressure relief vent valves prevents the ultimate pressure from exceeding the pressure defined in the pressure relief valve. This may enable a device to inflate using a pressure source that has a higher-than-desired value, and metering down the pressure to achieve an ideal therapeutic pressure field that inflates in a predetermined sequence over time to predetermined pressures unique to the pressure chambers within the segmented single bladder. This embodiment of a multi-chambered single bladder with small gap inflation designs could mimic the function of more complicated multi-bladder devices that also require multiple inflation devices or electronic inflation control. This multi-chambered inflation bladder would have the benefit of a single inflation source and basic mechanical (not digital or electrical) controls.
The windows are used for attachment, orientation, retention, and breathing. The function of the windows in the bladder material is for fixing the location of the bladder within the sleeve or cuff. Regardless of placement, these windows orient the bladder before and after inflation. The windows can be placed to help direct mechanical energy during inflation of the bladder. The windows also enable underlying tissues to “breath” around the otherwise impermeable bladder materials.
The device can add windows by the use of continuous salvage edge, a tab on a salvage edge, an untrimmed sheet still attached to the salvage edge, and/or a combination of these features. The window may be a complete through-hole. The window could also be a flap or tab (3-sides of a hole where the 4th side allows the hole to be created when the material is folded over where the uncut edge acts as a living hinge that holds the flap of material onto the window).
In an aspect, the impermeable bag portion 320 can form channels 321 that can be inflated by the modular driving component 100. In an aspect, the channels 321 are oriented in such a fashion that when inflated, the channels 321 apply pressure in a proximal direction; i.e., blood within the limb is pushed towards the heart. The channels 321 apply the pressure against the limb of the subject. In an aspect, the channels 321 of the impermeable bag portion 320 are in fluid communication with each other, as well as the fluid communication pathways 372 that are in communication with the fluid pathway ports 117 of the driving component 100, which are in communication with the pump subsystem 130.
In an aspect, the inflatable sleeve 300 includes a top surface 314 and a bottom surface 316. In an aspect, the top surface 314 hosts the driving component 100. The top surface 314 can host the mounting means 330 configured to releasably retain the driving component 100, as discussed above. In such aspects, the mounting means 330 can be made of the same material as used for the housing 110 of the driving component 100. Further, the mounting means 330 can include securing mechanisms that match those found on the housing 110. The mounting means 330 can include an anchor portion 331 that extends through an opening 301 of the sleeve 300 to establish communication with the air impermeable inflatable bag 320. The fluid communication pathways 372 can extend through the anchor portion 331 to connect the pump subsystem 130 to be in communication with the channels 321 of the inflatable bag 320.
In an aspect, the bottom surface 320 of the inflatable sleeve 300 is configured to engage/come in contact with the skin of the subject. In such instances, it is desirable that that the different securing portions 307, 309 are arranged so that any of the securing means do not come in contact with the skin of the individual. For example, in instances where the securing portions 307, 309 are configured to overlap with one another, the securing means (e.g., hook and loop fasteners) are oriented on the bottom surface 316 of the securing portion 307 and the top surface 314 of the other securing portion 309, preventing the securing means from coming in contact with the skin.
In an aspect, the inflatable sleeve 300 further comprises migration preventing regions that prevent the inflatable sleeve 300 from sliding along the skin of the subject. In an aspect, the migration preventing regions are oriented on the bottom surface 320 of the inflatable sleeve 300. In an aspect, such regions are comprised of textile that has a high skin contact coefficient of friction, but are still comfortable for the subject. In an aspect, the regions can be configured to prevent movement through a combination of their orientation (e.g., perpendicular to the direction of the limb) and configured to cover a certain percentage of the fabric that comes in contact with the skin of the subject. In an aspect, the coverage can be configured to cover approximately 30% or less of the surface area.
In an aspect, the mobile IPC device 20 is configured to run in a comfortable manner for the subject. In such aspects, the mobile IPC device is configured to operate quietly. In such aspects, sound dampening materials, and a low-vibration fluid pump, are used to minimize the perceived sound. Further, the mobile IPC device 20 is more comfortable for the subject to wear because it is more stable and secure compared to currently marketed devices. The IPC device uses components which create a minimal footprint, thereby lowering the device footprint and weight, which in combination of the migration preventing regions, prevents constant re-adjustment of the IPC device 20 on the limb of subjects.
In an aspect, as illustrated in
In some aspects in which the bladder 1050 is configured to be removed from the sleeve 1060 for additional uses, the bladder 1050 can be configured to be a more integrated component of the driving component 1070, and more specifically the pump 1080, as shown in
In another aspect, the reusable bladder 1050 is configured to allow easy insertion and removal into the disposable sleeve 1060. The reusable bladder 1050 may contain a stiffening or fixation feature to allow easier insertion into the pocket or sleeve attachment mechanism. For example, the bladder 1050 can include a hard plastic frame 1055 within or around the inflatable bladder 1050, as shown in
In another aspect, as shown in
In another aspect, a combination of a rigid material and a flexible material for use with the bladder can add therapeutic benefit as well, as shown in
A configuration where the inflatable bladder 1300 has a rigid face 1310 and a flexible or elastic face improves the therapeutic benefit of IPC devices. Yet another embodiment of an inflatable bladder 1300 using materials that are effectively rigid may involve the use of mechanical bellows on an otherwise entirely rigid bladder. In this embodiment, the amount of bladder inflation can be designed by varying the mechanical stiffness of the pleats forming the bladder. In this embodiment, the amount of bladder inflation can be controlled around the periphery of the bladder by varying the elasticity of the bellows so the ultimate inflated shape of the bladder may be controlled.
In an aspect, the mobile IPC device is configured to comply with several consensus standards. Such standards include, but are not limited to, the following:
ISO 60601-1: Medical electrical equipment; IEC 60601-1-2 Edition 3:2007-03 Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance —Collateral standard: Electromagnetic compatibility —Requirements and tests. (EN 60601-1-2);
IEC 60601-1-11: 2010—medical electrical equipment—part 1-11: General requirements for basic safety and essential performance—collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (EN 60601-1-11: 2010); IEC 60601-1-6 2010 3rd edition Medical electrical equipment Part 1-6: General requirements for safety—collateral standard: Usability; IEC 62366: 2007+A1: 2014—Medical Devices—Application of usability engineering to medical devices (EN 62366: 2008); ISO 10993: Biological evaluation of medical devices—FDA expects that a device which contacts intact skin for up to 24 hours will have data to support biocompatibility including: 1. Cytotoxicity (Part 5—Tests for in vitro cytotoxicity), 2. Sensitization (Part 10—Tests for irritation and skin sensitization), 3. Irritation or Intracutaneous Reactivity (Part 10—Tests for irritation and skin sensitization); IEC 62304: Software Lifecycle Processes; ASTM D4169−Standard Practice for Performance Testing of Shipping Containers and Systems; ISO 14971: Risk Management; and ISO 13485: Quality Systems.
Having thus described exemplary embodiments of the invention above, it should be noted by those skilled in the art that the within disclosures are exemplary only and that various other alternatives, adaptations, and modifications may be made within the scope of the present invention. Accordingly, the present invention is not limited to the specific embodiments as illustrated herein.
This application claims priority to United Stated Non-Provisional application Ser. No. 16/655,987, filed Oct. 17, 2019, and U.S. Provisional Application No. 62/746,799, filed on Oct. 17, 2018, which are relied upon and incorporated in their entirety by reference.
| Number | Date | Country | |
|---|---|---|---|
| 62746799 | Oct 2018 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16655987 | Oct 2019 | US |
| Child | 16751409 | US |
