Patent Application
20240115419
It is generally known to use heat to improve wound healing. Surgical-site complications are relatively common and up to 40% of patients worldwide experience problems with wound healing.
The advantages of this heat treatment may also be applied to many types of surgeries such as abdominoplasties, mastectomy, vascular surgery, breast surgery, caesarean section, spinal surgery, foot surgery, ankle surgery, knee surgery, or wounds following sternotomy, laparotomy, complex free tissue reconstructions or other cosmetic procedures.
In a particular example, patients with breast cancer who undergo mastectomies and reconstructive breast surgery often have issues with skin necrosis. This can have significant effects upon wound healing and eventual scarring of the area. This skin necrosis can result in further operations being necessary which further extend a patient's hospital stay and ultimately result in an inferior cosmetic result. The extension to the hospital stay is both inconvenient for the patient and introduces further pressures on to the health system. Trials such as those in Local Heat Pre-Conditioning in Skin Sparing Mastectomy; a Pilot Study of Mehta et al., 2013 and A randomised controlled feasibility trial to evaluate local heat preconditioning on wound healing after reconstructive breast surgery: the preHEAT trial of Mehta et al., 2019 have shown how a pre-surgery heating regime using hot water bottles and thermometers can reduce the incidents of skin necrosis following mastectomy by as much as 24%.
Heat treatment can also help with the healing of chronic wounds. For example, venous leg ulcers can be healed at a faster rate with heat being applied.
A further particular example where heat application may improve results is following the removal of fat from elsewhere in a patient's body and injection into the face or breast for cosmetic procedures. This transferred fat achieves a more natural and permanent look but needs to establish a blood supply in order to survive. Typically, patients are over-corrected to allow for some of the fat which does not end up receiving a blood supply to be absorbed by the body. Heat pre-conditioning could improve the survival of fat in this region.
An example of known devices for providing a heat treatment is given in WO 2010/088923 A1. A fluid from a thermally insulated storage container is heated and pumped through a network of channels in a pad applied to a user's body for applying a heat to a user. The effect of the device is hard to monitor and must be carried out indirectly by observation. This results in an unreliable and slow system.
There is therefore a need for an improved device for these scenarios.
A heating device according to the present invention is provided according to claim 1. This provides an easy to use device which allows effective targeted heat to be applied to a region of a user's body and for the effects of the heating to be monitored to achieve better healing.
The heat source may be an electric heat source. This is easily controllable and provides an easily wearable device.
The heat source may be configured to maintain a first pre-set temperature of between 40° C. and 50° C.; and a second pre-set temperature of between 30° C. and 40° C. These two temperature ranges may be useful for pre- and post-operative heating.
The heating device may comprise a plurality of blood flow sensors configured to detect a parameter indicative of blood flow at different positions in or adjacent to the region of the user's body. This allows a more detailed and precise profile of blood flow to be derived. The plurality of blood flow sensors can be configured to be positioned on user's body at locations corresponding to the surgical site (and hence the wound healing site) as well as areas of the user's body not on the wound healing site.
Each blood flow sensor may use at least one of plethysmography, acoustic or thermal sensing to detect the parameter indicative of blood flow. These are particularly suitable methods for devices of this size.
The heat source may be configured to apply a pulsatile heating pattern. Such a pattern is beneficial for certain application profiles.
The heating device may further comprise an additional sensor configured to detect the temperature of the region of a user's body. This allows the physical effect of the heating on the user to be determined in order to confirm the effectiveness and regulate temperature.
The wearable layer may comprise a flexible outer layer, a heating layer incorporating the heat source and an inner layer comprising the sensor(s). Such an arrangement provides a flexible, comfortable device. Such a device may more readily conform to parts of the user's body which should receive the heat, for example to the user's breast.
The heating device may be a bandage, face mask or bra cup, or an insert for inserting into a bandage, face mask or bra cup. These devices would particularly benefit from the heat application.
The heating device may be a bra cup or an insert for inserting into a bra cup, and the heating device and blood flow sensor(s) may be arranged to generally surround, in use, a user's areola. This arrangement is useful for heating before and after breast surgery, such as breast reconstruction.
The heating device may comprise a plurality of blood flow sensors arranged in one or more circles generally centered, in use, on a user's areola. This allows blood flow into and out of the breast to be easily and accurately monitored. The innermost circle of blood flow sensors may be arranged to generally align with the outer area of the user's areola. The plurality of blood flow sensors in each circle may be distributed in rotational symmetry.
The blood flow sensor(s) may comprise a first blood flow sensor configured to detect blood flow in a skin flap region and a second blood flow sensor configured to detect blood flow in a free flap region. This allows separate monitoring of the two separate regions, which may have different parameters to monitor. The first flow blood sensor may be configured to detect a parameter to be monitored and the second blood flow sensor may be configured to detect a reference blood flow. The signal from the first blood flow sensor may be compared to signal from the second blood flow sensor. This may illustrate the difference between blood flow in the skin flap region and the free flap region.
A system is provided according to claim 13. This system exhibits the benefits discussed above.
The processor may be a further processor within a remote device in communication with the transmitter (ii). This can allow a user's healthcare professional to receive a notification or alert when the blood flow is not large enough. Additionally, or alternatively, the user can receive an alert or notification when the blood flow is not large enough. The user can then be brought in for further treatment as necessary. Additionally, or alternatively, the user can reposition the heating device if necessary.
A method of heating a region of a user's body is provided according to claim 15. This method provides the benefits discussed above.
The activation of the heat source may be cyclical. Such a pattern is beneficial for certain application profiles. Further heat source profiles can also be used that are suitable for improving wound healing.
The method may be carried out a period of time before surgery, preferably 12 hours. This can improve the outcome for patients after the surgery.
The controller may be configured to maintain the temperature of the heat source to between 40° C. and 50° C. These temperatures have been shown to be particularly effective before surgery.
The activation of the heat source may be generally constant to output a constant temperature. This may be particularly beneficial in certain uses.
The method may be carried out after surgery. This can improve the outcome for patients after the surgery.
The heating device may be configured to maintain the temperature of the heat source to between 30° C. and 40° C. These temperatures have been shown to be particularly effective after surgery.
The heat improves the blood supply to the healing tissue which then aids in the healing process. This is particularly relevant in relation to the healing of skin as this is an “end-organ” which requires optimal blood flow to heal without complication.
A method of heating a region of a user's body is provided according to claim 22. Such a method can stimulate blood-flow in a patient for improved results following the surgery.
The controller may be configured to maintain the temperature of the heat source to between 40° C. and 50° C. before surgery. These temperatures have been shown to be particularly effective before surgery.
The heat source may be activated to apply heat to a region of the user's body to heat the region of the user's body to a supraphysiological level before surgery. Heating to a supraphysiological level can help stimulate additional blood-flow.
The timed periodic pattern may comprise periods of high temperature heating and periods of low temperature heating. Such a pattern can result in good additional blood-flow for the present method.
The heating device may be configured to maintain the temperature of the heat source to between 30° C. and 40° C. after surgery. These temperatures have been shown to be particularly effective after surgery.
The surgery may be one of abdominoplasty, mastectomy, vascular surgery, breast surgery, caesarean section, spinal surgery, foot surgery, ankle surgery, knee surgery, sternotomy, laparotomy, complex free tissue reconstructions or other cosmetic procedures. The method of heating herein may lead to improved results for these types of surgery.
A method of heating a region of a user's body is provided according to claim 28. The cyclical heating before surgery effectively improves blood-flow and hence post-surgical results.
The controller may be configured to maintain the temperature of the heat source to between 40° C. and 43° C. Such temperatures can be effective for stimulating blood-flow.
The heat source may be activated to apply heat to a region of the user's body to heat the region of the user's body to between 40° C. and 45° C. Such temperatures can be effective for stimulating blood blow.
In each period of low temperature heating the temperature of the heat source may be a comfortable body temperature. These temperatures may be effective in a pattern to stimulate blood-flow.
In each period of low temperature heating the temperature of the heat source may be 40° C. This temperature may be effective in a pattern to stimulate blood-flow.
In each period of low temperature heating the heat source may be inactive. An inactive heat source cools down to the lower temperature.
In each period of high temperature heating the temperature of the heat source may be 43° C. This temperature may be effective in a pattern to stimulate blood-flow.
The surgery may be one of abdominoplasty, mastectomy, vascular surgery, breast surgery, caesarean section, spinal surgery, foot surgery, ankle surgery, knee surgery, sternotomy, laparotomy, complex free tissue reconstructions or other cosmetic procedures. The method of heating herein may lead to improved results for these types of surgery.
Each period of low temperature heating may have a duration of at least 5 minutes, preferably at least 8 minutes. This time period can effectively stimulate the increased blood flow, while not overheating the user.
Each period of low temperature heating may have a duration of no more than 10 minutes. This time period can effectively stimulate the increased blood flow, while not overheating the user.
Each period of high temperature heating may have a duration of at least 5 minutes, preferably at least 8 minutes. This time period can effectively stimulate the increased blood flow, while not overheating the user.
Each period of high temperature heating may have a duration of no more than 10 minutes. This time period can effectively stimulate the increased blood flow, while not overheating the user.
In each period of low temperature heating the temperature of the heat source may be at least 37° C. This temperature may be effective in a pattern to stimulate blood-flow.
A heating device is provided according to claim 41. This device allows for cyclical heating before surgery effectively improves blood-flow and hence post-surgical results.
So that the manner in which the above recited features of the present disclosure can be understood in detail, a more particular description of the disclosure, briefly summarized above, may be had by reference to embodiments, some of which are illustrated in the appended drawings. It is to be noted, however, that the appended drawings illustrate only exemplary embodiments and are therefore not to be considered limiting of its scope, may admit to other equally effective embodiments.
The present invention will be described, by way of example only, with reference to the accompanying figures in which:
To facilitate understanding, identical reference numerals have been used, where possible, to designate identical elements that are common to the figures. It is contemplated that elements and features of one embodiment may be beneficially incorporated in other embodiments without further recitation.
In the embodiment of
A switching means 15 is provided for activating and deactivating the generation of heat within the source. The switching means 15 may be manually activated. Alternatively, or in addition, the switching means may be periodically activated by a processor or other timing circuit to deliver a cyclical or timed output of heat from the heat source 12. Such a heating profile may also be described as periodic.
The heating device 100 further comprises one or more sensors 14 configured to detect blood flow in or adjacent to the region of the user's body being heated. While these sensors 14 may directly generate an electrical signal indicative of the blood flow, it is also anticipated that the sensors 14 may generate a signal indicative of a parameter indicative of blood flow. This signal can then be processed by a processor 17 in communication with the sensors 14 to convert the parameter into blood flow. The processor 17 may be a separate component or may be integrated into the sensors 14. For example, the sensors 14 may directly measure temperature and derive the blood flow from this measurement.
The sensors 14 configured to detect blood flow can do so via any known method for determining blood flow. In particular, this may include one or more of plethysmography, photo-plesmography, laser Doppler flowmetry, laser speckle contrast imaging, acoustic or thermal sensing or any other suitable method. Exemplary sensors are disclosed in Epidermal devices for noninvasive, precise, and continuous mapping of macrovascular and microvascular blood flow to Webb et al., 2015. The sensors 14 of Webb et al. comprise a local heat source separate to the main heat source 12, transmission of the local heat is detected as set out in the paper. This local heat source can effectively be superimposed upon the global heating of the main heat source 12. That is, the local heat source heats to a greater temperature than the main heat source 12.
Alternatively, the main heat source 12 may take the place of the local heat sources of Webb et al. In this case, the sensors may generally surround the main heat source 12. In effect, this produces a large version of the sensor disclosed in Webb et al.
Further alternatively, the local heat source of the sensor(s) may form the main heat source 12. This is particularly relevant for an embodiment with multiple sensors where the local heat sources can collectively form the main heat source 12.
It is anticipated that any of these arrangements may be combined to include multiple arrangements of sensors.
In particular embodiments, where the main heat source 12 is being used in a cyclical pattern (a period of heating followed by a period of inactivity) the sensors 14 of Webb et al. may only operate during the period of inactivity of the main heat source 12.
As discussed above, the application of heat to the region of the user's body encourages blood flow to this region. A lower threshold of blood flow is set at a level which is understood to improve the recovery of skin in the area. The sensors 14 detect the blood flow and allow comparison with this threshold to confirm that an improved blood flow is being achieved in the region.
The sensors 14 may further be in communication with a transmitting device 18 for communicating with a remote device 300. The sensors 14 may also be in communication either with a further processor, either locally provided or provided on the remote device. This further processor, and/or the processor 17 may be configured to compare the blood flow to a threshold value. If the signals fall below the threshold value the processor 17 may generate a notification for the user. The notification may be in any suitable form including, but not limited to, auditory, visible, or digital such as a record stored within a database or an alert on a user's mobile device.
The transmitter 18 may transmit the signals from the sensors 14 or processed information thereof from the processor 17. In certain embodiments, there is no processor 17 and the raw signals from the sensors 14 can be transmitted by the transmitter 18. The transmitter 18 communicates with a remote user device 300. In particular, the remote user device 300 may be a device accessible by the user and/or a medical professional, such as a smart phone. The remote user device 300 may comprise its own processor which is able to compare the blood flow to the threshold value in order to generate the notification. The communication between the remote device 300 and the transmitter 18 may be via any known wired or wireless method. In particular, the communication may be via the Bluetooth protocol. The transmission of the data to the remote device 300 allows either the user or the user's medical professional to review the effectiveness of the heating profile being applied to the user. That is, to ensure that the heating profile is acting as intended and there is an increased blood flow in the regions of the user's body which are being heated.
The remote device 300 may alternatively, or additionally, comprise a “cloud” sever remote from the heating device 100. This allows the data generated by the device 100 to be remotely accessed by both the user and the healthcare professional. Alternatively, the remote device 300 may itself further comprise a transmitter which transmits the data to this remote server.
A medical professional reviewing the data can quickly see whether any regions are not receiving satisfactory blood flow and, as necessary, instruct the patient to alter their routine or come in for a further health check-up. This allows live monitoring of the process and hence better outcomes.
The heating device 100 of
While in the example of
The heating device 100 is generally similar to the device 100 of
The heating device 100 may generally comprise an inner region 32 and an outer region. The inner region 32 may be configured in use, to generally align with the user's areola and nipple. The heat source 12 and sensors 14 may or may not extend into this central region 32. In embodiments where the heat source 12 does extend into the central region 32 it may be modified in this region to deliver suitable heat for these areas of the user's body. Likewise, the sensors 14 may be modified in this region to detect blood flow in this region specifically.
The heating device 100 of
During breast reconstruction surgery, skin and fat tissue is generally taken from an abdominal region of a patient. This skin and fat tissue is generally referred to as a “flap” as it comprises its own blood supply (i.e. veins and arteries). Commonly, it is referred to as a “free flap” once it is detached from the abdominal area. The tissue in the patient's breast area which is not removed is referred to as the “mastectomy skin flap”.
This free flap is inserted into the patient's breast through the areola region (the areola and nipple having previously been removed, along with internal breast tissue and fat) to form the reconstructed breast. The epidermal layers of the free flap are removed, except for the region of the flap which aligns with the insertion area. This region will form the patient's replacement areola and nipple. The blood flow passageways of the free flap are connected to the existing passageways in the breast.
In particular embodiments, the sensors 14 of the heating device 100 of
A method of using the heating device 100 is provided before and after a surgery. In particular, this is relevant where the surgery is a breast surgery such as mastectomy.
Before the surgery, the heating device 100 is applied to the user's body and the heat source is activated to apply heat to the user's body in the region of the heating device 100. The application of heat may be in a pulsatile manner. This heat causes enhanced blood flow. That is, the heat may be applied in periods of high temperature heating and periods of low temperature heating.
The period of low temperature heating may have a zero or negligible output from the heat source 12, or may be generally set at a comfortable body temperature. For example, the application of heat may come in periods of activity and inactivity of the heat source 12. For example, the heat source 12 may be active, or in a period of high temperature heating, for 30 minutes, followed by inactivity, or a period of low temperature heating, for 30 minutes, followed by activity, or a period of high temperature heating for 30 minutes and so forth.
In other words, if the desired or output temperature of the heat source 12 was plotted against time then the output may generally be a square wave profile. Of course, it may not be exactly square since there would be time involved in heating up or cooling down the heat source 12.
In certain examples, during the period of low temperature heating the temperature of the heat source 12 may be at least 37° C. For example, this may be between 37° C. and 40° C.
The period of low temperature heating may have a duration of at least 5 minutes, or at least 8 minutes. An upper bound on the period of low temperature heating may be 10 minutes. In certain examples the period of low temperature heating may be exactly 10 minutes.
During the period of high temperature heating the temperature of the heat source 12 may be greater than 40° C. For example, between 40° C. and 43° C. In specific examples, exactly 43° C. In general, this may heat the region of the user's body to a supraphysiological level. The region of the user's body may be heated to 43° C. during the period of high temperature heating.
The period of high temperature heating may have a duration of at least 5 minutes, or at least 8 minutes. An upper bound on the period of high temperature heating may be 10 minutes. In certain examples the period of high temperature heating may be exactly 10 minutes. The period of high temperature heating and the period of low temperature heating may be the same length of time.
In some examples, the period of high temperature heating may exceed 10 minutes. This may be associated with a heating of less than 43° C.—such between 40° C. and less than 43° C., such as less than 42° C.
Such a heating profile has been shown to be particularly useful in patients before surgery takes place. This heating profile may be applied for a period of time such as 12 hours before the surgery. The device may be configured to heat the region of the user's body to between 40° C. and 50° C. during this time, preferably, to 43° C. In general, the pre-surgery heating may be at a supraphysiological level.
The sensors 14 provided in the heating device 100 are able to detect the blood flow in the region of the user's body and process and/or transmit this data. This allows the data to be reviewed by the user and/or the user's medical professional in order to ensure that the device is operated as intended. This allows the user and/or medical professional to have confidence in the desired results of the device.
In the post-operation method a generally constant heat may be provided by the heating device 100. In particular, the heating device 100 may be configured to heat the region of the user's body to between 30° C. and 40° C., preferably to between 36° C. to 38° C. Again, studies have shown that this is an optimal temperature to heat the region of the user's body after surgery in order to have the best post-operation outcomes. This post-operative heating may be to a substantially constant temperature. The post-surgery heating may be at a supraphysiological level.
As noted above, these methods are particularly applicable with the heating device 100 of
The sensors 14 may generally be provided in specific regions where improved blood flow may be beneficial. For example, this may be in or around one or more of the: lower eyelid sulcus, nasolabial folds, upper or lower lips, temporal region, jowl area, and/or malar region.
Again, the wiring for the sensors 14 has been omitted from the Figure for clarity. The data generated by the sensors 14 is generally handled and processed as discussed above with respect to the other embodiments.
The advantages of this heat treatment may also be applied to many types of surgeries such as abdominoplasties, mastectomy, vascular surgery, breast surgery, caesarean section, spinal surgery, foot surgery, ankle surgery, knee surgery, or wounds following sternotomy, laparotomy, complex free tissue reconstructions or other cosmetic procedures.
| Number | Date | Country | Kind |
|---|---|---|---|
| 1901358.0 | Jan 2019 | GB | national |
This is a continuation-in-part application of U.S. patent application Ser. No. 16/777,574 filed on Jan. 30, 2020; which claims benefit of the United Kingdom Patent Application No. 1901358.0, filed Jan. 31, 2019, the entire contents of each of which are incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16777574 | Jan 2020 | US |
| Child | 18542349 | US |
