Device for debridement of wounds

Abstract

The present invention relates to a medical device for debridement of wounds, such as chronic wounds. The device comprising an end effector mounted on a robotic arm, wherein a control unit control the operation and movement of the end effector. The end effector comprises a fluid dispensing system comprising at least a nozzle for dispensing a jet of fluid onto a surface to be treated, a debridement light source for emitting a light beam onto the surface to be treated, a distance sensor for measuring the distance from the end effector to the surface to be treated, and an optical array comprising at least a colour camera for capturing images of the wound area in visible wavelengths.

Description

[0001] DEVICE FOR DEBRIDEMENT OF WOUNDS

[0002] Technical field

[0003] The present invention relates to a medical device for cleaning and debriding wounds such as chronic wounds. In particular, the invention relates to a device comprising an end effector configured to be mounted on a robotic arm, where the end effector comprises a debridement light source, a fluid jet and means for automatic treatment of a wound.

[0004] The invention further relates to a method of debriding wounds using the device mentioned above.

[0005] Background of the invention

[0006] Currently, 1-2% of the global population develops a chronic wound, accounting for 3-6% of total healthcare expenditures. Chronic wounds are on the rise because of an aging population and a rapid increase in diabetics. Chronic wounds care is outdated compared to the strides we have made in healthcare over the years. Several studies have shown that debridement of the wound is the most effective treatment and that it significantly improves healing outcomes for chronic wounds. Debridement is the medical removal of dead, damaged, or infected tissue to improve the healing potential of the remaining healthy tissue. Conservative sharp debridement uses scalpels, curettes, or scissors. As a minor bedside surgery, it can be performed by a family physician, nurse, dermatologist, or podiatrist.

[0007] Traditionally, patients with chronic wounds are treated at a hospital or wound clinic by a doctor or a specialized nurse. The diagnosis relies on the training and experience of the doctor who makes the diagnosis. The most common form of treatment involves cleaning and debridement of the wound (the removal of non-viable tissue from the wound using a scalpel), which is a manual process that is time-consuming, imprecise and repetitive for the clinics to administer and there is a risk debridement of the wounds using a scalpel can spread infections in the wound as the scalpel moves across the surface layer and the wound bed.

[0008] This traditional method creates a bottleneck in the health system as only doctors and specialized nurses are allowed to perform debridement operations, and they mostly use traditional manual debridement methods (scalpels and no modern tools to assist) which are relatively time consuming. Wound clinics also have a hard time recruiting chronic wound doctors, resulting in a bottleneck situation where not enough debridement operations can be performed.

[0009] The doctor only knows how much tissue to cut away by visual clues or when the wound starts to bleed. This is suboptimal as the doctor might leave dead and infectious tissue that should be removed to ensure the best treatment. In some cases, doctors cut too much tissue just to be on the safe side. Because blood indicates that healthy tissue has been damaged, the patient has to expend energy on healing the tissue again. As debridements are done by simple observation of the wound some areas will be over or under-debrided. Additionally, patients can find that current best practices, like sharp debridement, are too painful, leading to a lack of compliance with treatment. This can affect the ability or willingness of healthcare professionals to debride as often as the optimal treatment suggests to patients with significant pain, potentially leading to poorer outcomes.

[0010] Studies have shown that frequent debridement of a wound can be beneficial for several reasons and vastly improve healing rates. Firstly, frequent debridement can help prevent the buildup of biofilm, which can impede the healing process. Secondly, it can help to remove excess exudate, which can cause maceration and delay healing. Additionally, more frequent debridement can help to identify and treat underlying infections, which can also hinder the healing process.

[0011] As such, regular debridement plays an important role in promoting wound healing and preventing complications, but it is rarely done because of the manual and labour-intensive process and high pain to the patient.

[0012] WO 2011 / 130231 Al discloses a method of debridement using laser ablation, where a XeCI excimer laser emitting a first laser beam at 308nm is moved along the tissue followed by a ArF excimer laser emitting a second laser beam at 193nm. A CCD colour camera is positioned is used to capture images of the treated area, which is displayed to an operator on a monitor. A mechanical or robotic arm is used to move the laser sources and the control system into position relative to the tissue.

[0013] The termination point for the first laser beam may be determined by analysing the images to measure an optical signature reflected from the tissue. A titanium-sapphire laser or a thermally tuned diode laser emitting an infrared light at 838nm or 859nm or an ultraviolet light at 233nm is used to detect chlorine atoms in the underlying viable tissue or blood.

[0014] US 2015 / 0216597 Al discloses a method of debridement using multiple laser sources connected to a handheld piece, which is positioned relative to the wound manually by an operator of the system. A first laser beam is emitted at 940nm from a diode laser source, while at the same time a third laser beam is emitted at 630 / 810 / 940nmfrom another diode laser source. A second laser beam is emitted at 2.78pm from a solid state laser source within a time period after applying the first and third laser beams.

[0015] In some operation modes, the first and third laser emissions are operated in continuous modes where the first laser beam is emitted with an output power of 9W or 10W and the third laser beam is emitted with an output power between 50mW to lOOOmW. Further, the second laser emission is operated in a pulsed mode where the second laser beam is emitted with an output power of 10W and a pulse frequency of 15Hz or 20Hz. In these modes, an air flow and a water flow are applied to the wound from the handpiece via dedicated air and water supply lines.

[0016] If the first laser beam is emitted with an output power of 1W and the second laser beam is emitted with an output power of 2W and a pulse frequency of 5Hz Hz instead, then no air flow and no water flow are required.

[0017] US 2018 / 0000501 Al discloses a robotic apparatus for debridement of wounds, where the apparatus comprises a self-propelling locomotive mechanism for moving the apparatus along the body of the patient. The apparatus comprises a debriding tool and a debris disposal device for removal of the debrided tissue. The apparatus is powered by a local power source and controlled by a local control system. Sensors are used to detect viable tissue and nonviable tissue, where a blade is used to scrap or cut necrotic tissue away from the wound. Alternatively, a small laser source may be used to cut the tissue.

[0018] The apparatus further comprises a reservoir for storing a debriding agent or water or saline, which is applied to the wound, e.g. under pressure.

[0019] Object of the invention

[0020] One object of the invention is to provide a device and method that overcomes the shortcomings of the abovementioned prior art or at least provide an alternative solution. One object of the invention is to provide a device and method that allows for debridement of wounds at regular intervals.

[0021] One object of the invention is to provide a device and method that provides a non-invasive and less painful treatment of wounds.

[0022] Summary of the invention

[0023] The device, according to the present invention, may allow automatic debriding of wounds while maximizing tissue preservation. The procedure is less painful for patients and will improve the workflow for the medical practitioner.

[0024] One object of the present invention is achieved by a device, according to claim 1, for debridement of wounds, such as chronic wounds, comprising :

[0025] - an end effector with a front surface configured to face a wound to be treated during operation, the end effector is configured to be mounted to a free end of a robotic arm, wherein the end effector comprises

[0026] - a debridement light source configured to emit a light beam onto a surface to be treated,

[0027] - a distance sensor configured to measure the distance from the end effector to the surface to be treated, and

[0028] - an optical array, the optical array comprises at least a colour camera configured to capture images of the wound area in visible wavelengths, and

[0029] - a control unit connected to the end effector and configured to receive inputs from at least the distance sensor and the optical array, wherein the control unit is configured to control the operation of at least the end effector, wherein the end effector further comprises a fluid dispensing system comprising a nozzle connected to a fluid supply line, wherein the nozzle is configured to dispense a jet of fluid onto the surface to be treated.

[0030] This provides a device that allows for allows automatic debriding of wounds while maximizing tissue preservation. With the present device, an improved treatment can be achieved that is far less painful compared to the current surgical debridement methods. By reducing the pain for patients, medical practitioners are able to debride their wounds more often and thereby increasing the healing rate of the wound and improving the overall wound care stewardship.

[0031] With the present device, the patient is able to experience a better wound care, a more gentle and less painful treatment, a faster healing rate and a lower risk of complications and amputation.

[0032] Thus, a first aspect of the present invention relates to a device for debridement of wounds comprising an end effector comprising a front surface directed toward a wound during operation, the end effector is mounted on a robotic arm and the end effector comprises

[0033] - means to create a fluid jet,

[0034] - a debridement light source,

[0035] - a distance sensor measuring the distance to a surface to be treated, and

[0036] - a RGB camera or visible camera capturing pictures in visible wavelengths.

[0037] The device may use a robot unit comprising a robotic arm having a free end and one or more moveable joints to move the end effector into a selected position. The robotic arm has multiple degrees of freedom (DOF), preferably at least 6 DOF. A tracking unit may be used to track the movement of the robotic arm. Any known tracking unit or sensors may be used to register the movement of the robotic arm. This allows for the best possible access for the end effector during the debridement procedure. The opposite end of the robotic arm may be mounted to a base unit, e.g. a moveable base unit, via matching first coupling elements. Similarly, the end effector may be mounted to the free end of the robotic arm via matching second coupling elements. Alternatively, the robotic arm may be permanently attacked to the base unit and / or to the end effector. This allows for easy assembly or disassembly of the device during maintenance or installation.

[0038] Electrical control cables and power cables may be connected to the debridement light source and further to a suitable power source and the control unit. The control unit may be arranged within the base unit, in which the power source may also be arranged.

[0039] Alternatively, the base unit may be connected to a separate power source. Various sensors may be arranged on the device, where the sensor outputs are inputted to the control unit. This allows the control unit to monitor and control the operation of the device.

[0040] The control unit comprises a memory in which a program configured to execute the debriding process is stored. A processor of the control unit is used to execute the program to control the operation of the device. The control unit may further comprise a communications module for transmitting and receiving data from an external device, e.g. a remote computing unit. A user terminal, e.g. a touchscreen or a display with controls, may be arranged on the base unit and connected to the control unit. This allows the medical practitioner to interact with the device.

[0041] A multiple of cameras arranged in an optical array is arranged within the front surface of the end effector. The optical array of cameras comprises different types of cameras capturing different images of the wound area. A distance sensor is arranged relative to these cameras to measure the distance from the end effector to the surface to be treated. Alternatively, the processor may calculate the distance from the captured colour images.

[0042] The optical array comprises at least one colour camera, e.g. a RGB or 3D camera, configured to capture a coloured image, e.g. a RGB or 3D-image, of the wound and the surrounding tissue. The resolution, frame speed, focus point, shutter speed and other camera settings (e.g. number of spectral bands) may be selected based on the application and usage of the imaging device. For example, but not limited to, the colour camera may be a hyperspectral camera configured to capture a number of spectral images within a number of spectral bands, said number of spectral images and thus spectral bands being about 10, but could also be less than or greater than 10. This allows the medical practitioner to capture a detailed image of the wound area suitable for further processing in the processor.

[0043] According to any embodiment of the first aspect of the present invention, the optical array further comprises a fluorescent camera configured to detect microorganisms optically. The device may comprise a fluorescent optical system configured to excite bacteria in the wound so that they can be visually detected in the captured image data. Preferably, the fluorescent optical system may comprise one or more light sources configured to emit light at a predetermined wavelength and intensity onto the wound. The wavelength and intensity may be selected based on the fluorescent properties of a single or group of bacteria.

[0044] One or more optical filters may be arranged relative to the colour camera, alternatively a second colour camera. The optical filters may be used to detect the reflected light from the excited bacteria so that the light is identifiable in the image data. This allows the medical practitioner to visually determine if bacteria loads are present in the wound or not. Detecting regions of these harmful bacteria provide the medical practitioner with an indication of the state of the wound. Preferably, the bacteria loads may be detected in real time or near-real time.

[0045] According to any embodiment of the first aspect of the present invention, the optical array further comprises a near-infrared camera configured to detect light reflected from the wound, where the reflected light is indicative of an oxygenation level in the tissue.

[0046] The device may also comprise a near-infrared (NIR) optical system configured to detect haemoglobin oxygen saturation in and around the wound, preferably in real time or near-real time. The NIR optical system may comprise one or more light sources configured to emit near-infrared light at a predetermined wavelength and intensity onto the wound. The wavelength and intensity may be selected based on the properties of the haemoglobin in the blood.

[0047] One or more NIR-cameras, e.g. a haemoglobin camera or a near-infrared optical scanner (NIROS), may be arranged relative to the NIR-light source and configured to capture images of the reflected light. The processor may be configured to analyse these images to determine the intensity of the oxygen saturation and optionally the blood flow. This enables non- invasive monitoring of the oxygenation level in the tissue in the wound and of the surrounding tissue.

[0048] The output of the NIR-cameras provide information on what tissue is still healthy and receives blood for healing and what tissue is not beneficial for the healing process. Based on this information, it may be determined how much tissue to debride.

[0049] According to any embodiment of the first aspect of the present invention, the optical array further comprises a thermal camera configured to configured to detect a temperature or temperature gradient either inside the wound or outside the wound or between the inside of the wound and surrounding tissue. The device may further comprise a thermal optical system configured to detect one or more temperature gradients of the wound and the surrounding tissue. One or more thermal cameras may be arranged at the front end of the device to capture thermal image data of the wound and the surrounding tissue. The processor may be configured to analyse these images to determine the temperature at one or more predetermined spots. The processor may further calculate the temperature gradients between spots within the wound or between spots in the wound and spots in the surround tissue. This enables non-invasive monitoring of the temperature, which may indicate the state of the wound.

[0050] The temperature gradient may be indicative of whether the wound is healing, stagnating, or expanding, which is used by the medical practitioner when determining how much tissue to debride.

[0051] According to any embodiment of the first aspect of the present invention, the device further comprises a suction system configured to remove contaminated fluid and / or aerosols from the treated surface, preferably the suction system comprises a suction tube connected to a suction inlet arranged in proximity to the nozzle.

[0052] A suction system is further arranged in the device to prevent fluid spills and aerosol contamination. The suction system may comprise one or more suction inlets arranged in proximity to, e.g. close to, the nozzle(s) of the fluid dispensing system. The suction inlets may be connected to suction tubes, which may further be connected to one or more contaminated fluid reservoirs. The contaminated fluid reservoirs may be removeable, or each reservoir may comprise a drainage element for emptying the reservoirs. The suction system may comprise a suction pump configured to generate a predetermined suction force at the suction inlet.

[0053] Preferably, the nozzle may be angled relative to the surface to be treated so that the exiting fluid beam may travel at a predetermined angle over a soft tissue surface of the wound. For example, the fluid beam may travel tangentially or perpendicularly or at a sloping angle over the soft tissue surface. This creates a smooth wound bed while maximizing dermal preservation. The fluid dispensing system may comprise a fluid pump configured to generate a pressure in the fluid so that it exits the nozzle at a predetermined pressure and / or flow rate.

[0054] Similarly, the suction inlets may be angled relative to the surface to be treated so that they are able to collect the contaminated fluid and / or aerosols from the treated surface. For example, the suction inlets may be arranged tangentially or perpendicularly or at a sloping angle relative to the soft tissue surface. Preferably, the suction inlets may be angled relative to the nozzles to achieve optimal suction of the contaminated fluid and / or aerosols. According to any embodiment of the first aspect of the present invention, the fluid dispensing system further comprises means for injecting a gas into the fluid, thereby creating bubbles in the fluid stream and / or means for injecting particles into the fluid, thereby creating an increased abrasion of the fluid stream exiting the nozzle.

[0055] The fluid dispensing system may further comprise means for injecting a gas, such air, into the fluid, thereby creating bubbles in the exiting fluid stream. The bubbles may result in a more effective fluid jet for cleaning the wound due to a higher energy transfer compared to a solid fluid stream.

[0056] Alternatively or additionally, the dispensing system may further comprise means for injecting particles into the fluid, thereby creating an increased abrasion of the exiting fluid stream.

[0057] The particles may result in a thermal ablation, and thus removal of burned tissue in the wound.

[0058] Instead of particles, a powder suitable for debriding tissue may be used. The fluid and particles / powder may be mixed at a predetermined ratio selected based on a particular application or usage of the device.

[0059] According to any embodiment of the first aspect of the present invention, the control unit comprises a vision system configured to receive inputs from the distance sensor, the colour camera and from a tracking unit configured to track movements of the robotic arm, wherein the vision system is configured to create an output defining position and size of the wound, optionally the output is displayed as a 3D-topographical landscape of the wound and / or used for further analysis of the wound.

[0060] The control unit may comprise a vision system, e.g. a 3D-vision system, configured to receive inputs from the distance sensor, the colour cameras and the tracking unit. The vision system may be configured to generate a topographic landscape or map of the wound area based on the image data. Preferably, the topographic landscape or map is a 3D-landscape or map. Alternatively, the wound location may be superimposed onto a 3D-model of the patient, or a part thereof. This gives the medical practitioner the best anatomical context of the placement of the wound. As the wound is healing in many vectors and not only from the outside in, it is a helpful for the medical practitioner to view a landscape or map the wound. So in order to measure the healing rate correctly and provide the robot with the most accurate data, we need to take that into account.

[0061] When the wound is mapped, other camera images may be accurately overlayed onto the wound, thereby giving the medical practitioner the information needed to make the best decisions for the treatment. According to any embodiment of the first aspect of the present invention, the vision system is configured to further receive inputs from the fluorescent camera, the near-infrared camera and / or the thermal camera, where the vision system to overlay the image data from these cameras onto the coloured image to display additional information such as infected area(s) and / or area(s) of healing or decaying or dead tissue or debris.

[0062] The vision system may further be configured to overlay additional information onto the landscape or map of the wound. The information from the fluorescent camera, the nearinfrared camera and / or the thermal camera may be overlayed onto the original landscape or map. This gives the medical practitioner the information needed to make the best decisions for the treatment.

[0063] According to any embodiment of the first aspect of the present invention, the control unit is configured to determine a suitable path along which the nozzle and the debridement light source of the end effector is to be moved relative to the wound, and to determine the intensity of the fluid jet exiting the nozzle and the intensity of the light beam exiting the debridement light source at each position along this path.

[0064] The control unit may be configured to plot a path of movement over the wound so that the optical array of cameras is moved over the entire area of the wound. The plan of movement may be displayed to the medical practitioner on the screen. The medical practitioner is then able to move the end effector along the wound following this plan.

[0065] In an automated mode, the control unit may use this plan of movement to move the end effector along the plan of movement by operating the robotic arm.

[0066] According to any embodiment of the first aspect of the present invention, the control unit is configured to perform an automatic debridement of the wound, where the control unit is configured to move the end effector along the wound following this path.

[0067] By equipping doctors and nurses with automated tools to take charge of wound care treatments that are formerly done manually, it is possible to improve the workflow of hospitals and clinics for the benefit of patients' quality of life and medical practitioners' costs. Our ability to automate the treatment of wounds alleviates some of the healthcare system's capacity problems.

[0068] The control unit may be programmed to stop the debridement procedure, if the control unit determines that the patient moves beyond safe operating conditions. An inertial measurement unit (IMU) may be arranged in the device, e.g. on the front end. The IMU may comprise at least a gyroscope configured to measure the orientation, e.g. angular position, of the device. The output of this IMU may be used to adjust the position and orientation of the device relative to the wound and / or to detect unsafe movements of the patient. Alternatively, the optical array of cameras may be used to detect unsafe movements of the patient.

[0069] According to any embodiment of the first aspect of the present invention, the debridement light source is a YAG (Yttrium Aluminium Garnett) laser.

[0070] A surgical grade laser unit may advantageously be implemented into the end effector and connected to a suitable power source. The control unit may control the power output of the laser unit and thus light intensity at which the light beam, e.g. the laser beam, may be emitted from the front end of the debridement light source, e.g. the laser unit. The control unit may further control the wavelength of the light beam as well as the profile of the emitted light, e.g. continuous light or pulsed light. The light intensity, pulse rate, duty cycle, wavelength, dwell time and other light settings may be selected based on a particular application or usage of the present device.

[0071] Solid state type lasers are successfully in medical treatment applications, where the laser medium is comprised of a solid host crystalline or glass structure that includes at least one dopant material. Particular dopant materials and the corresponding emission wavelengths are well known in the art.

[0072] One object of the present invention is achieved by a method of debriding wounds such as chronic wounds, according to claim 12, comprising the following steps:

[0073] 1) positioning an end effector as described above relative to a wound so that the front surface of the end effector faces a surface to be treated,

[0074] 2) scanning the wound area using the optical array by moving the end effector along the wound,

[0075] - creating a topographical landscape of the wound, by a vision system, based on inputs from the distance sensor, the colour camera and from a tracking unit,

[0076] 3) debriding the wound to a predetermine depth by emitting a light beam onto the surface to be treated using the debridement light source whilst moving the end effector along the wound,

[0077] - cleaning the debrided area by dispensing a jet of fluid onto the surface to be treated using the nozzle, wherein steps 2) and 3) are repeated until it is determined that conditions for terminating the debridement process are met.

[0078] This provides an improved treatment of wounds that is far less painful compared to the current surgical debridement methods. By reducing the pain for patients, it is possible to debride their wounds more often and thereby increasing the healing rate of the wound and improving the overall wound care stewardship. The present method allows patient to experience a better wound care, a more gentle and less painful treatment, a faster healing rate and a lower risk of complications and amputation.

[0079] Thus, a second aspect of the present invention relates to a method of debriding wounds, such as chronic wounds, comprising the steps of

[0080] - positioning the end effector, as described above, at a distance above a wound to be treated,

[0081] - scanning the wound area using the optical array of cameras by moving the end effector along the wound,

[0082] - debriding the wound by emitting a light beam onto a surface to be treated whilst moving the end effector along the wound, and

[0083] - optionally, cleaning the treated surface by ejecting a fluid jet supplied from a fluid source onto the surface to remove contaminants and / or aerosols, preferably during the debriding process.

[0084] Initially, the medical practitioner moved the end effector into position above the wound to be treated via the robotic arm. The front surface of the end effector is then orientated correctly so that the optical array of cameras is facing the surface of the wound area.

[0085] An initial scan is performed by moving the end effector along the wound area, where the optical array of cameras captures a set of hyperspectral images of the wound and the surrounding area. The colour images captured by the colour camera is inputted to a vision system in the control unit. The distance measurement and / or the measured position of the end effector is / are further inputted to the vision system. A topographic landscape or map of the wound area is generated by the vision system, preferably generating a 3D-topographic landscape or map, based on the colour images, the distance measurement and / or the position measurement. Thereby creating an accurate model, e.g. an 3D-model, of the wound that becomes the framework for accurately displaying the needed information to the medical practitioner.

[0086] The debridement light source is then programmed to perform a debridement of one or more areas of interest in the wound. The control parameters for controlling the emitting light beam may be entered or selected by the medical practitioner via a graphic user interface of the control unit. The debridement light source is moved into a starting position relative to a first area of interest, and the debriding process is started. The debridement light source and thus the end effector is moved along the wound area during the debriding process. Once all selected areas are treated, then the debridement light source is turned off. After or during debridement of the selected area, the fluid dispensing system is activated so that the fluid is dispensed onto the treated surface. This removes contaminants and / or aerosols from the treated surface area. Preferably, the fluid beam travels at a predetermined angle over the soft tissue surface and creates a smooth wound bed while maximizing dermal preservation.

[0087] Once the cleaning of the debrided wound is complete, then the optical array of cameras is moved over the wound area again in a subsequent scan. An updated topographic landscape or map of the wound area is generated by the vision system. The medical practitioner may then evaluate this updated topographic landscape or map to determine if additional debridement of the wound is needed or not.

[0088] If needed, then the debriding and cleaning processes are repeated. Afterwards, another scan of the wound area is performed and another updated topographic landscape or map of the wound area is generated. Again, the medical practitioner may evaluate this updated topographic landscape or map to determine if additional debridement of the wound is needed or not.

[0089] If not needed, then a wound dressing may be applied over the wound to promote the healing process.

[0090] According to any embodiment of the second aspect of the present invention, the step of cleaning the debrided area further comprises removing contaminated fluid and / or aerosols from the debrided area via the suction inlet of the end effector using the suction system.

[0091] To prevent fluid spills and aerosol contamination during the cleaning of the debrided area, the suction system may be activated simultaneously with the fluid dispensing system. Any contaminated fluids and / or aerosols may be sucked away from the debrided area via the suction inlet. The contaminated fluids and / or aerosols may be collected in a contaminated fluid reservoir within the device or separate from the device. This prevents discomfort for the patient and eliminates the need for a separate suction system that takes up space within the room.

[0092] According to any embodiment of the second aspect of the present invention, an automatic debridement of the wound is performed, by the control unit, where the debridement light source and the nozzle of the end effector are moved along a path over the wound area.

[0093] To further reduce the human interaction during the treatment, the control unit may be configured to perform a semi-automated or fully automated debriding process. The input from the colour camera and the tracked movement of the robotic arm may be used by the control unit to guide the robotic arm during its movement during the procedure. The input from the distance sensor may be used to ensure that the debridement light source, the optical array of cameras, the fluid jet and the suction inlet are accurately relative to the surface intended to be treated.

[0094] The control unit may control the parameters for emitting the light beam onto the surface to be treated and the parameters for dispensing the fluid and the suction force for removal the contaminations and / or aerosols. The control unit may select a set of default settings for these controllable parameters. Optionally, the medical practitioner may adjust one or more of these default parameters if needed.

[0095] Preferably, the present device and method described above is used to treat chronic wounds, preferably of a human body.

[0096] Within this context, the term "chronic wound" should be understood as a wound that fails to progress through a normal, orderly, and timely sequence of repair, or in which the repair process fails to restore anatomic and functional integrity after three months. See for example the article: "Chronic wound pathogenesis and current treatment strategies: a unifying hypothesis" by Thomas A Mustoe, et aL, published in Plastic and Reconstruction Surgery, June 2006; 117(7 suppl) : 35S-41S.

[0097] Brief description of the figures

[0098] Figure 1 shows an example of a wound before, during and after debridement with a sharp tool.

[0099] Figure 2 shows a prior art graph showing the proportion of cured wounds in relation to the time to heal.

[0100] Figure 3 shows an assembly comprising an embodiment of a device for automatic debridement according to the invention.

[0101] Figure 4 shows a front view of an embodiment of the end effector shown in figure 3.

[0102] Figure 5 shows an exploded view of a configuration of the device mounted on a base unit.

[0103] Figure 6 shows an example of an embodiment of the end effector in communication with the control unit.

[0104] The invention will now be described in further detail in the following.

[0105] Detailed description of the invention

[0106] Figure 1 shows an example of a wound 1 before, during and after debridement with a sharp tool. The wound area is defined by a wound edge 3 extending along the circumference of the wound 1. The wound edge 3 indicates the transition from the soft tissue inside the wound area to the harder, surrounding tissue 2.

[0107] Figure la shows the wound 1 before the debridement procedure, where the wound 1 comprises a lot of nonviable tissue indicated as white areas within the wound 1. Figure lb shows the wound 1 during the debride procedure, where some of the nonviable tissue has been removed. The underlaying healthy tissue can be partly seen as dark areas within the wound 1. Figure lc shows the wound 1 after the debridement procedure, where the healthy tissue is visible in the entire wound area.

[0108] Figure 2 shows a prior art graph showing the proportion of cured wounds in relation to the time to heal. Studies have shown that frequent debridement of a wound can be beneficial for several reasons and vastly improve healing rates. Firstly, frequent debridement can help prevent the buildup of biofilm, which can impede the healing process. Secondly, it can help to remove excess exudate, which can cause maceration and delay healing. Additionally, more frequent debridement can help to identify and treat underlying infections, which can also hinder the healing process.

[0109] As such, regular debridement plays an important role in promoting wound healing and preventing complications, but it is rarely done because of the manual and labour-intensive process and high pain to the patient.

[0110] The first graph shows the proportion of cured wounds relative to the time heal when performing regular debridement within 7 days. As illustrated, 99% of the wounds were cured after 100 days. The second graph shows the proportion of cured wounds relative to the time heal when performing regular debridement within 7 to 14 days. As illustrated, 99% of the wounds were cured after 400 days. The third graph shows the proportion of cured wounds relative to the time heal when performing infrequent debridement at intervals greater than 14 days. As illustrated, 99% of the wounds were cured after 500+ days.

[0111] Figure 3 shows an assembly comprising an embodiment of a device for automatic debridement according to the invention. The device 7 comprises an end effector 8 mounted to a robotic arm 9 via matching coupling elements 9a. The robotic arm 9 has multiple DOFs so that the end effector 8 can be accurately positioned relative to the wound 1. The movement of the robotic arm 9 is tracked by sensors, which are connected to a tracking unit in a control unit (shown in fig. 6).

[0112] A debridement light source 10 is arranged in the end effector 8, where the debridement light source 10 is connected to the control unit and to a power source via electrical cables 11. The debridement light source 10 is configured to emit a light beam onto the surface to be treated, where the total energy per unit area applied by the light beam to a point on the surface of the wound is controlled by the control unit.

[0113] A fluid dispensing system is further arranged in the end effector 8, where at least one nozzle 12 is connected to fluid supply lines 13. Here, the fluid supply lines 13 are further connected to a fluid reservoir 15 in which the fluid is stored. Here, the fluid is water, but other fluid may also be used.

[0114] A suction system is further arranged in the end effector 8, where at least one suction inlet 16 is connected to suction lines 14.

[0115] Figure 4 shows a front view of an embodiment of the end effector shown in figure 3. The end effector 8 has a front surface indented to face the wound 1 during operation. Both the front end of the debridement light source 10, the nozzles 12 and the suction inlets 16 are arranged in this front end so that they are facing the wound 1 during operation.

[0116] Further, an optical array 17 of cameras is arranged in the front surface, e.g. at the centre of the front surface. The optical array 17 of cameras comprises different types of cameras configured to capture different types of images of the wound area and the surrounding tissue 2.

[0117] Figure 5 shows an exploded view of a configuration of the device mounted on a base unit. The robotic arm 9 is removable connected to the base unit 20 by matching coupling elements as illustrated. The robotic arm 9 comprising a handle 19 for moving the robotic arm in and out of engagement with the base unit 20. Further, the robotic arm 9 comprise a set of coupling elements 18 for connecting the electrical cables 11, the fluid supply lines 13 and the suction lines 14 located on the robotic arm 9 to further electrical cables 11, further fluid supply lines 13 and further suction lines 14 located on the base unit 20.

[0118] The control unit is implemented in the base unit 20 and is connected to a user terminal in the form of a screen 21 on the casing. Here, the user terminal is a touchscreen enabling the user of the device to interact with the control unit.

[0119] The base unit 20 further comprises at least one clean fluid reservoir 22 for storing the fluid of the fluid dispensing system. The base unit 20 further comprises at least one contaminated fluid reservoir 23 for storing the contaminated fluid and / or aerosols of the suction system. Here, one or both reservoirs 22, 23 in configured as removeable reservoirs so that the reservoirs can be removed and emptied or filled.

[0120] Figure 6 shows an example of an embodiment of the end effector in communication with the control unit. Here, the end effector 8 has a communications module (not shown) configured to communicate with a communications module in the control unit 28. This allows the control unit 28 to transmit and receive data from the end effector 8 either wirelessly or via a wired connection.

[0121] Here, only the front surface of the end effector 8 is shown for illustrative purposes. The optical array 17 of cameras comprising two stereo colour cameras 24 for capturing coloured images, e.g. 3D-images, of the wound area. A fluorescent optical system comprising a fluorescent light source is also arranged within the end effector. Here, the colour cameras may also capture fluorescent images of the wound area. Further, a near-infrared camera 25 is used to capture near-infrared images of the wound area. Also, a thermal camera 26 is used to capture thermal images of the wound area.

[0122] A distance sensor 27 is arranged within the front surface of the end effector 8. The distance sensor 27 is configured to measure the distance between the end effector 8 and the surface of the wound 1.

[0123] The control unit 28 comprises a memory for receiving and storing the set of hyperspectral images captured by the optical array 17 of cameras. Further, the measured distance and movement of the robotic arm 9 are also stored in the memory. The processor is configured to analyse and process the received data from the end effector 8, where the tracking unit 30 is configured to track the movement of the robotic arm 9.

[0124] The control unit 28 comprises a vision system 29 configured to generate a topographic landscape or map of the wound area. Preferably, a 3D-landscape or map. The generated topographic landscape or map is either displayed on the user terminal 21 or transmitted to an external computing unit of the user, e.g. a stationary computer, a laptop or a smartphone.

[0125] The control unit 28 is configured to control the operation of the debridement light source 10, the fluid dispensing system and the suction system to perform an automatic debriding procedure.

Claims

Claims1. A device for debridement of wounds, such as chronic wounds, comprising- an end effector (8) with a front surface configured to face a wound (1) to be treated during operation, the end effector (8) is configured to be mounted to a free end of a robotic arm (9), wherein the end effector (8) comprises- a debridement light source (10) configured to emit a light beam onto a surface to be treated,- a distance sensor (27) configured to measure the distance from the end effector (2) to the surface to be treated, and- an optical array (17), the optical array (17) comprises at least a colour camera (24) configured to capture images of the wound area in visible wavelengths, and- a control unit (28) connected to the end effector (8) and configured to receive inputs from at least the distance sensor (27) and the optical array (17), wherein the control unit (28) is configured to control the operation of at least the end effector (8), characterised in that the end effector (8) further comprises a fluid dispensing system comprising a nozzle (12) connected to a fluid supply line (13), wherein the nozzle (12) is configured to dispense a jet of fluid onto the surface to be treated.

2. A device according to claim 1, characterised in that the optical array (17) further comprises a fluorescent camera configured to detect microorganisms optically.

3. A device according to any one of claims 1 to 2, characterised in that the optical array (17) further comprises a near-infrared camera (25) configured to detect light reflected from the wound (1), where the reflected light is indicative of an oxygenation level in the tissue.

4. A device according to any one of claims 1 to 3, characterised in that the optical array (17) further comprises a thermal camera (26) configured to configured to detect a temperature or temperature gradient either inside the wound (1) or outside the wound (1) or between the inside of the wound (1) and surrounding tissue (2).

5. A device according to any one of claims 1 to 4, characterised in that the device (7) further comprises a suction system (14, 16, 22) configured to remove contaminated fluid and / or aerosols from the treated surface, preferably the suction system comprises a suction tube (14) connected to a suction inlet (16) arranged in proximity to the nozzle (12).

6. A device according to any one of claim 1 to 5, characterised in that the fluid dispensing system further comprises means for injecting a gas into the fluid, thereby creating bubbles in the fluid stream and / or means for injecting particles into the fluid, thereby creating an increased abrasion of the fluid stream exiting the nozzle (12).

7. A device according to any one of claims 1 to 6, characterised in that the control unit (28) comprises a vision system (29) configured to receive inputs from the distance sensor (27), the colour camera (24) and from a tracking unit (30) configured to track movements of the robotic arm (9), wherein the vision system (29) is configured to create an output defining position and size of the wound (1), optionally the output is displayed as a 3D-topographical landscape of the wound (1) and / or used for further analysis of the wound (1).

8. A device according to claim 7, characterised in that the vision system (29) is configured to further receive inputs from the fluorescent camera, the near-infrared camera (25) and / or the thermal camera (26), where the vision system (29) is configured to overlay the image data from these cameras (24, 25, 26) onto the coloured image to display additional information such as infected area(s) and / or area(s) of healing or decaying or dead tissue or debris.

9. A device according to any one of claims 1 to 8, characterised in that the control unit (28) is configured to determine a suitable path along which the nozzle (12) and the debridement light source (10) of the end effector (8) is to be moved relative to the wound (1), and to determine the intensity of the fluid jet exiting the nozzle (12) and the intensity of the light beam exiting the debridement light source (10) at each position along this path.

10. A device according to claim 9, characterised in that the control unit (28) is configured to perform an automatic debridement of the wound (1), where the control unit (28) is configured to move the end effector (8) along the wound (1) following this path.

11. A device according to any one of claims 1 to 10, characterised in that the debridement light source (10) is a YAG (Yttrium Aluminium Garnett) laser.

12. A method of debriding wounds, such as chronic wounds, comprising the following steps:1) positioning an end effector (8) according to any one of claims 1 to 11 relative to a wound (1) so that the front surface of the end effector (8) faces a surface to be treated,2) scanning the wound area using the optical array (17) by moving the end effector (8) along the wound (1),- creating a topographical landscape of the wound (1), by a vision system (29), based on inputs from the distance sensor (27), the colour camera (24) and from a tracking unit (30),3) debriding the wound (1) to a predetermine depth by emitting a light beam onto the surface to be treated using the debridement light source (10) whilst moving the end effector (8) along the wound (1),- cleaning the debrided area by dispensing a fluid beam onto the surface to be treated using the nozzle (12).wherein steps 2) and 3) are repeated until it is determined that conditions for terminating the debridement process are met.

13. A method according to claim 12, characterised in that the step of cleaning the debrided area further comprises removing contaminated fluid and / or aerosols from the debrided area via the suction inlet (16) of the end effector (8) using the suction system.

14. A method according to any one of claims 12 to 13, characterised in that an automatic debridement of the wound (1) is performed, by the control unit (28), where the debridement light source (10) and the nozzle (12) of the end effector (8) are moved along a path over the wound area.

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