Patent Application
20230310218
The invention set forth in the appended claims relates generally to tissue treatment systems and more particularly, but without limitation, to controlling the leakage of a negative pressure wound therapy system.
Clinical studies and practice have shown that reducing pressure in proximity to a tissue site can augment and accelerate growth of new tissue at the tissue site. The applications of this phenomenon are numerous, but it has proven particularly advantageous for treating wounds. Regardless of the etiology of a wound, whether trauma, surgery, or another cause, proper care of the wound is important to the outcome. Treatment of wounds or other tissue with reduced pressure may be commonly referred to as “negative-pressure therapy,” but is also known by other names, including “negative-pressure wound therapy,” “reduced-pressure therapy,” “vacuum therapy,” and “vacuum-assisted closure,” for example. Negative-pressure therapy may provide a number of benefits, including migration of epithelial and subcutaneous tissues, improved blood flow, and micro-deformation of tissue at a wound site. Together, these benefits can increase development of granulation tissue and reduce healing times.
While the clinical benefits of negative-pressure therapy are widely known, the cost and complexity of negative-pressure therapy can be a limiting factor in its application, and the development and operation of negative-pressure systems, components, and processes continues to present significant challenges to manufacturers, healthcare providers, and patients.
New and useful systems, apparatuses, and methods for maintaining negative pressure in low and high leak conditions in a negative-pressure therapy environment are set forth in the appended claims. Illustrative embodiments are also provided to enable a person skilled in the art to make and use the claimed subject matter.
The reduced pressure provided by a reduced pressure treatment system to a tissue site such as, for example, an incision or a wound, may need to be properly controlled to increase the effectiveness of the reduced pressure treatment. The reduced pressure treatment system may include a pump for providing reduced pressure, a wound dressing disposed adjacent the wound, and a drape that covers both to provide a sealed environment for providing the reduced pressure treatment from the pump to the sealed environment. However, leaks may occur in the dressing and other components of the reduced pressure treatment system such as, for example, leaks between the drape and the tissue site, i.e., system leakage. The system leakage may be a high system leakage or a low system leakage depending on the flow rate of fluids within the system especially adjacent the dressing. In a low system leakage system, it may be necessary to monitor and control the flow rate to ensure that the flow rate does not drop below a minimum value, i.e., a minimum flow rate, to maintain effective treatment of a wound at the tissue site. If the flow rate drops below the minimum flow rate, the system may be configured to increase the flow rate by inducing leakage of air from the external environment into the therapeutic environment of the dressing to maintain effective treatment of the wound.
In one example embodiment, a system for promoting healing of a wound at a tissue site comprises a dressing including a porous pad configured to be positioned at the tissue site and adapted to be covered by a drape to form a therapeutic environment separated from the external environment for maintaining a wound pressure (WP) at the tissue site. The system may further comprise a negative-pressure source including a pump adapted to generate a pump pressure (PP) and further adapted to be fluidly coupled to the porous pad for applying negative pressure to the tissue site. The system may further comprise a flow rate sensor having an input fluidly coupled between the pump and the porous pad and an output for providing a flow-rate signal representing a flow rate (FR) of fluids indicative of leakage between the pump and the porous pad. The system may further comprise a controller having an input coupled to the output of the flow rate sensor and an output. In some embodiments, the controller may be configured to determine a flow rate (FR) based on the flow-rate signal, and then compare the flow rate (FR) measured to a minimum flow rate (MinFR). The controller may be configured further to generate a low-leak signal at the output of the controller when the flow rate (FR) is less than the minimum flow rate (MinFR). The system may further comprise a regulator coupled to the output of the controller that may be adapted to increase the flow rate (FR) by increasing the leakage between the pump and the porous pad in response to the occurrence of a low-leak signal.
In some example embodiments, the flow rate sensor may comprise a first pressure sensor having a first input for sensing the pump pressure (PP) with a first output for providing a signal indicative of the pump pressure (PP), and a second pressure sensor having a second input for sensing the wound pressure (WP) with a second output for providing a signal indicative of the wound pressure (WP). The controller may be electrically coupled to the first output of the first pump and the second output of the second pump and may be configured further to determine the flow rate (FR) based on the difference between pump pressure (PP) and the wound pressure (WP).
In one example embodiment, a method for stimulating healing of a wound at a tissue site may comprise positioning a porous pad at the tissue site and covering the porous pad with a drape to form a therapeutic environment separated from the external environment for maintaining a wound pressure (WP) at the tissue site. The method may further comprise applying negative pressure to the porous pad using a pump to generate a pump pressure (PP) for applying negative pressure to the tissue site. The method may comprise further determining a flow rate (FR) of fluids between the pump and the porous pad indicative of a leak and providing a flow-rate signal, and then comparing the flow rate (FR) to a minimum flow rate (MinFR). If the flow rate (FR) measured is less than the minimum flow rate (MinFR), the method further comprises generating a low-leak signal and increasing the flow rate (FR) in response to the occurrence of a low-leak signal by increasing the leakage between the pump and the porous pad.
Objectives, advantages, and a preferred mode of making and using the claimed subject matter may be understood best by reference to the accompanying drawings in conjunction with the following detailed description of illustrative embodiments.
The following description of example embodiments provides information that enables a person skilled in the art to make and use the subject matter set forth in the appended claims, but may omit certain details already well-known in the art. The following detailed description is, therefore, to be taken as illustrative and not limiting.
The example embodiments may also be described herein with reference to spatial relationships between various elements or to the spatial orientation of various elements depicted in the attached drawings. In general, such relationships or orientation assume a frame of reference consistent with or relative to a patient in a position to receive treatment. However, as should be recognized by those skilled in the art, this frame of reference is merely a descriptive expedient rather than a strict prescription.
The reduced pressure applied to the tissue site 105 may be provided by a reduced pressure source 110. Reduced pressure source 110 may be any type of manually, mechanically, or electrically operated pump. Non-limiting examples of reduced pressure source 110 include devices that are driven by stored energy, and which are capable of producing a reduced pressure. Examples of these stored energy, reduced pressure sources include, without limitation, pumps driven by piezoelectric energy, spring energy, solar energy, kinetic energy, energy stored in capacitors, combustion, and energy developed by Sterling or similar cycles. Still other devices and processes that may be used or included in reduced pressure source 110 include syringes, lead screws, ratchets, clockwork-driven devices, pendulum-driven devices, manual generators, osmotic processes, thermal heating processes, and processes in which vacuum pressures are generated by condensation. In another embodiment, reduced pressure source 110 may include a pump 112 wherein the pump 112 provides negative or reduced pressure, i.e., a pump pressure (PP), to the tissue site 105 that may be driven by a motor 114 electrically coupled to a controller 170 which is also a component of the reduced-pressure therapy system 100, also referred to as a system controller. The motor 114 may be a direct-current motor powered by a DC power supply such as, for example, a battery (not shown). Preferably, the pump 112 uses low amounts of power and is capable of operating for an extended period of time on a single charge of the battery such as, for example, a diaphragm pump.
In one example embodiment, the reduced pressure source 110 comprises a DC motor 114 powered by a battery, i.e., the applied power. The applied power can be varied to control the speed of the motor by varying either the current or the voltage applied to the motor, i.e., the “applied voltage” (VA). The applied voltage (VA) may be varied, for example, by modulating the voltage with a square wave and varying the duty cycle of the square wave to control the speed of the DC motor 114. The reduced pressure source 110 also comprises a pump 112 that provides a reduced pressure or vacuum to the tissue site 105. Consequently, the pump 112 represents the load on the DC motor 114 so that when the therapy requires that the reduced pressure at the tissue site 105 needs to be increased, the applied voltage (VA) provided to the DC motor 114 is increased to achieve the targeted reduced pressure at the tissue site 105. One skilled in the art knows that the DC motor 114 will not run or turn the pump until the applied voltage (VA) is sufficient to overcome the inertia or load of the pump 112, which in this case may be a diaphragm pump.
Referring more specifically to
The specific stall voltage for a specific DC motor used to drive a diaphragm pump can typically be determined by one skilled in the art from the specifications available for the DC motor. The diaphragm pump and DC motor may be and integrated device such as, for example, a Thomas Model No. 30130002 series 4.5 V diaphragm pump for which such information is readily available. (Thomas; thomas.de@gardnerdenver.com) Referring again to
Data from pump specifications is typically limited to the relation of maximum flow to vacuum pressure at maximum pump voltage (e.g., 4.5 V for Thomas pump identified above). Positive pressures are specified in mbar units (mmHg of positive pressure = 0.7500616827042 * mbars) and vacuum pressures are specified in terms of percent vacuum. For example, if 100% maximum vacuum is specified at 760 mmHg, 40% maximum vacuum would be equal to 304 mmHg of vacuum (= 0.4 * 760 mmHg). In this example, the 304 mmHg of vacuum pressure would be the theoretical maximum vacuum pressure that we could attain if the pump was run at 4.5 V and allowed to run until it the DC motor stalls. The graph 301 in
The equation for calculating the stall voltage for this particular pump is as follows: Stall Voltage = 1.638V + (0.006515 V/mmHg * XmmHg), where X is the current vacuum pressure. Therefore, at 50 mmHg of vacuum, the stall voltage equals 1.96 V (1.638 + (0.006515 * 50)); at 125 mmHg of vacuum, the stall voltage equals 2.45 V (1.638 + (0.006515 * 125)) as indicated by the dashed lines 304, 305; and at 175 mmHg of vacuum, the stall voltage equals 2.78 V (1.638 + (0.006515 * 175)) as indicated by the dashed lines 306, 307. Again, the higher the vacuum pressure, the higher the applied voltage that is needed to start the pump. Otherwise, the pump stalls and will not move until the necessary stall will voltage is applied. When the pump stalls, the DC motor simply overheats which can damage the DC motor and reduce battery life.
Referring back to
In one embodiment, manifold 120 is a porous foam and includes a plurality of interconnected cells or pores that act as flow channels. The porous foam may be a polyurethane, open-cell, reticulated foam such as GranuFoam manufactured by Kinetic Concepts, Inc. of San Antonio, Texas. If an open-cell foam is used, the porosity may vary, but is preferably about 400 to 600 microns. The flow channels allow fluid communication throughout the portion of manifold 120 having open cells. The cells and flow channels may be uniform in shape and size, or may include patterned or random variations in shape and size. Variations in shape and size of the cells of manifold result in variations in the flow channels, and such characteristics may be used to alter the flow characteristics of fluid through manifold 120. The manifold 120 may further include portions that include “closed cells.” These closed-cells portions of manifold 120 contain a plurality of cells, the majority of which are not fluidly connected to adjacent cells. Closed-cell portions may be selectively disposed in manifold 120 to prevent transmission of fluids through perimeter surfaces of manifold 120.
Manifold 120 may also be constructed from bioresorbable materials that do not have to be removed from a patient’s body following use of reduced pressure treatment system 100. Suitable bioresorbable materials may include, without limitation, a polymeric blend of polylactic acid (PLA) and polyglycolic acid (PGA). The polymeric blend may also include without limitation polycarbonates, polyfumarates, and capralactones. Manifold 120 may further serve as a scaffold for new cell-growth, or a scaffold material may be used in conjunction with manifold 120 to promote cell-growth. A scaffold is a substance or structure used to enhance or promote the growth of cells or formation of tissue, such as a three-dimensional porous structure that provides a template for cell growth. Illustrative examples of scaffold materials include calcium phosphate, collagen, PLA/PGA, coral hydroxy apatites, carbonates, or processed allograft materials. In one example, the scaffold material has a high void-friction (i.e., a high content of air).
The dressing 115 may also include sealing member 125 also referred to as a drape or cover. Manifold 120 may be secured to tissue site 105 using sealing member 125. Sealing member 125 may be a cover that is used to secure manifold 120 at tissue site 105. While sealing member 125 may be impermeable or semi-permeable, in one example sealing member 125 is capable of maintaining a reduced pressure at tissue site 105 after installation of the sealing member 125 over manifold 120. Sealing member 125 may be a flexible drape or film made from a silicone based compound, acrylic, hydrogel or hydrogel-foaming material, or any other biocompatible material that includes the impermeability or permeability characteristics desired for tissue site 105. Sealing member 125 may be formed of a hydrophobic material to prevent moisture absorption by the sealing member 125. In one embodiment, sealing member 125 is configured to provide a sealed connection with the tissue surrounding manifold 120 and tissue site 105. The sealed connection may be provided by an adhesive (not shown) positioned along a perimeter of sealing member 125 or on any portion of sealing member 125 to secure sealing member 125 to the manifold 120 or the undamaged epidermis peripheral to a tissue site, i.e., the peritissue. The adhesive may be pre-positioned on sealing member 125 or may be sprayed or otherwise applied to sealing member 125 immediately prior to installing sealing member 125.
In general, components of the therapy system 100 may be coupled directly or indirectly. Components may be fluidly coupled to each other to provide a path for transferring fluids (i.e., liquid and/or gas) between the components. In some embodiments, for example, components may be fluidly coupled through a tube. A “tube,” as used herein, broadly refers to a tube, pipe, hose, conduit, or other structure with one or more lumina adapted to convey a fluid between two ends. Typically, a tube is an elongated, cylindrical structure with some flexibility, but the geometry and rigidity may vary. In some embodiments, components may additionally or alternatively be coupled by virtue of physical proximity, being integral to a single structure, or being formed from the same piece of material. Coupling may also include mechanical, thermal, electrical, or chemical coupling (such as a chemical bond) in some contexts
The reduced pressure generated by reduced pressure source 110 may be applied to tissue site 105 through source tube 130 and delivery tube 135. Source tube 130 and delivery tube 135 may be any tube through which a gas, liquid, gel, or other fluid may flow. For example, exudate from tissue site 105 may flow through delivery tube 135. In
Source tube 130 and delivery tube 135 may be made from any material. Source tube 130 and delivery tube 135 may be either flexible or inflexible. Also, source tube 130 and delivery tube 135 may include one or more paths or lumens through which fluid may flow. For example, delivery tube 135 may include two lumens. In this example, one lumen may be used for the passage of exudate from tissue site 105 to canister 140. The other lumen may be used to deliver fluids, such as air, antibacterial agents, antiviral agents, cell-growth promotion agents, irrigation fluids, or other chemically active agents, to tissue site 105. The fluid source from which these fluids originate is not shown in
In one embodiment, delivery tube 135 is coupled to manifold 120 via connection member 145. Connection member 145 permits the passage of fluid from manifold 120 to delivery tube 135, and vice versa. For example, exudates collected from tissue site 105 using manifold 120 may enter delivery tube 135 via connection member 145. In another embodiment, reduced pressure treatment system 100 does not include connection member 145. In this embodiment, delivery tube 135 may be inserted directly into sealing member 125 or manifold 120 such that an end of delivery tube 135 is adjacent to or in contact with manifold 120.
Liquid, such as exudate, from tissue site 105 may flow through delivery tube 135 into canister 140. Canister 140 may be any device or cavity capable of containing a fluid, such as gases and liquids, as well as fluids that contain solids. For example, canister 140 may contain exudates from tissue site 105. Source tube 130 and delivery tube 135 may be directly connected to canister 140, or may be coupled to canister 140 via a connector, such as connector 150, as indicated by arrow 151. The canister 140 may be a flexible or rigid canister, a bag, or pouch fluidly connected to manifold 120 by delivery tube 135. Canister 140 may be a separate canister or may be operably combined with reduced pressure source 110 to collect exudate and fluids.
Reduced pressure treatment system 100 may further comprise a first pressure sensor or wound pressure sensor 155 electrically coupled to the controller 170. Wound pressure sensor 155 detects an actual reduced pressure at or proximate the tissue site 105, i.e., the tissue site pressure or wound pressure (WP). The reference to the word “wound” as part of the term wound pressure (WP) is exemplary only and does not limit the term or description herein as applying to the measurement of pressure at other types of tissue sites such as, for example, incisions or subcutaneous cavities. In one non-limiting example, wound pressure sensor 155 is a silicon piezo-resistive gauge pressure sensor. Wound pressure sensor 155 may be configured to detect the wound pressure (WP) via a control tube 160 fluidly coupled directly to the connection member 145 or indirectly by sections of the control tube 160 through the canister 140. Control tube 160 may include one or more paths or lumens through which fluid may flow.
Reduced pressure treatment system 100 may further comprise a second pressure sensor or pump pressure sensor 156 electrically coupled to the controller 170. Pump pressure sensor 156 may be configured to detect a reduced pressure at or downstream from the canister 140 by control tubes 157 and 158, respectively, i.e., the pump pressure (PP). In other words, the pump pressure sensor 156 may be fluidly coupled directly to the canister 144 by the control tube 157 or the source tube 130 by the control tube 158 to detect the pump pressure (PP). In one example embodiment, the pump pressure sensor 156 may be a silicon piezo-resistive gauge pressure sensor. In yet another example embodiment, the pump pressure (PP) may be determined by the controller 170 analyzing the DC voltage of the pump motor 114 as shown with reference to
Pressure sensors 155 and 156 may be located at alternate locations on or within the reduced pressure treatment system 100. Referring back to
Reduced pressure treatment system 100 may also include a regulator 165 electrically coupled to the controller 170. The regulator 165 may be a valve having an input and an output wherein the input may be fluidly coupled to the external environment as indicated by arrow 166 and an output fluidly coupled to the therapeutic environment of the reduced pressure therapy system 100. For example, the output of the regulator 165 may be fluidly coupled to the canister 140 as indicated by arrow 167. In another embodiment, the output of the regulator 165 may be fluidly coupled to the control tube 160 (not shown). The regulator 165 may be any valve capable of relieving the reduced pressure in the therapeutic environment of the reduced pressure therapy system 100 thereby increasing the flow rate of fluids therein. Non-limiting examples of the regulator 165 include a pneumatic solenoid valve, a proportional valve, or a mechanical valve. In one example, the regulator 165 may be manually controlled by a caregiver. In another example, regulator 165 may be controlled by the controller 170.
In operation, the manifold 120 may be placed within, over, on, or otherwise proximate to a tissue site. The sealing member 125 may be placed over the manifold 120 and sealed to tissue near the tissue site 105. For example, the sealing member 125 may be sealed to undamaged epidermis peripheral to a wound site, i.e., the periwound. Thus, the dressing 115 can provide a sealed therapeutic environment proximate to a tissue site, substantially isolated from the external environment, and the reduced pressure source 110 can reduce the pressure in the sealed therapeutic environment. Reduced pressure applied across the tissue site through the manifold 120 in the sealed therapeutic environment can induce macrostrain and microstrain in the tissue site, as well as remove exudates and other fluids from the tissue site, which can be collected in the canister 140 and disposed of properly.
The fluid mechanics of using a reduced-pressure source to reduce pressure in another component or location, such as within a sealed therapeutic environment, can be mathematically complex. However, the basic principles of fluid mechanics applicable to negative-pressure therapy are generally well-known to those skilled in the art, and the process of reducing pressure may be described illustratively herein as “delivering,” “distributing,” or “generating” negative pressure, for example.
In general, exudates and other fluids flow toward lower pressure along a fluid path. Thus, the term “downstream” typically implies something in a fluid path relatively closer to a reduced-pressure source, and conversely, the term “upstream” implies something relatively further away from a negative-pressure source. Similarly, it may be convenient to describe certain features in terms of fluid “inlet” or “outlet” in such a frame of reference. This orientation is generally presumed for purposes of describing various features and components of reduced-pressure therapy systems herein. However, the fluid path may also be reversed in some applications (such as by substituting a positive-pressure source for a reduced-pressure source) and this descriptive convention should not be construed as a limiting convention.
The term “tissue site” in this context broadly refers to a wound or defect located on or within tissue, including but not limited to, bone tissue, adipose tissue, muscle tissue, neural tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendons, or ligaments. A wound may include chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure, or venous insufficiency ulcers), flaps, and grafts, for example. The term “tissue site” may also refer to areas of any tissue that are not necessarily wounded or defective, but are instead areas in which it may be desirable to add or promote the growth of additional tissue. For example, negative pressure may be used in certain tissue areas to grow additional tissue that may be harvested and transplanted to another tissue location.
“Negative or reduced pressure” generally refers to a pressure less than a local ambient pressure, such as the ambient pressure in a local environment external to a sealed therapeutic environment provided by the dressing 102. In many cases, the local ambient pressure may also be the atmospheric pressure at which a tissue site is located. Alternatively, the pressure may be less than a hydrostatic pressure associated with tissue at the tissue site. Unless otherwise indicated, values of pressure stated herein are gauge pressures. Similarly, references to increases in negative pressure typically refer to a decrease in absolute pressure, while decreases in negative pressure typically refer to an increase in absolute pressure.
A negative-pressure source, such as the reduced pressure source 110, may be a reservoir of air at a reduced pressure, or may be a manual or electrically-powered device that can reduce the pressure in a sealed volume, such as a vacuum pump, a suction pump, a wall suction port available at many healthcare facilities, or a micro-pump, for example. A negative-pressure source may be housed within or used in conjunction with other components, such as processing units, alarm indicators, memory, databases, software, display devices, or user interfaces that further facilitate negative-pressure therapy. For example, the reduced pressure source 110 and the controller 106 may be housed within a therapy control unit. While the amount and nature of negative pressure applied to a tissue site may vary according to therapeutic requirements, the pressure is generally a low vacuum, also commonly referred to as a rough vacuum, between -5 mm Hg (-667 Pa) and -500 mm Hg (-66.7 kPa). Common therapeutic ranges are between -75 mm Hg (-9.9 kPa) and -300 mm Hg (-39.9 kPa).
As indicated above, the applied voltage (VA) provided to the DC motor 114 may be used to control the pump pressure (PP) and ultimately achieve the desired or targeted pressure at the tissue site 105. Correspondingly, the applied voltage (VA) provides an indication of the pump pressure (PP) and may be monitored by the controller 170 which in turn may determine the time rate of change of the applied voltage (VA) that necessarily corresponds to the time rate of change of the pump pressure (PP) in lieu of using the pump pressure sensor 156. The controller 170 may also use this computation for determining the flow rate of air between the reduced pressure source 110 and tissue site 105, i.e., the flow rate (FR). In another embodiment, the reduced pressure treatment system 100 may further comprise a sensing device (not shown) that directly measures the flow rate (FR) such as, for example, a flow-meter or a differential processor for computing the time rate of change in the difference between the wound pressure (WP) and the pump pressure (PP). Otherwise the flow rate (FR) may be determined by computing a pressure differential based on the measurements taken from two pressure sensors such as, for example, pressure sensors 155 and 156 described above.
The flow rate (FR) may be measured, for example, as cubic centimeters of air per minute (cc/min), between the reduced pressure source 110 and the tissue site 105. The flow rate (FR) provides some indication of the extent to which the dressing 115 or other components of the negative pressure system 100 might be leaking (i.e., a system leakage) that reduces the pressure at the tissue site 105 below the desired pressure targeted for therapy. For example, a high flow rate (FR) might indicate that the dressing 115 or other components of the system 100 are considered to have a “high system leakage” or a “high leakage condition” that needs to be remedied by increasing the pump pressure (PP) or adjusting the sealing around the tissue site, for example. On the other hand, a lower flow rate (FR) might indicate that the dressing 115 or other components of the system 100 are considered to have a “low system leakage” or a “low leakage condition” that requires a lower pump pressure (PP) requiring less battery power for driving the DC motor 114 at a lower rate to maintain the desired wound pressure (WP).
The controller 170 may be an integrated or separate component of the reduced-pressure treatment system 100. Controller 170 may be any device capable of processing data, such as data from wound pressure sensor 155 and/or the pump pressure sensor 156. Controller 170 may also control the operation of one or more components of reduced pressure treatment system 100, such as reduced pressure source 110, motor 114, regulator 165, pressure sensors 155 and 156, and indicator 172. The controller 170 may control and receive data from other components (not shown) of the reduced pressure source 110 including the pump 112 and the motor 114. In one embodiment, controller 170 receives and processes data, such as the wound pressure (WP) from the wound pressure sensor 155, the pump pressure (PP) from the pump pressure sensor 156, and the flow rate (FR) from monitoring the applied voltage (VA) to the motor 114 as described above. The controller 170 may also control the operation of one or more components of reduced pressure treatment system 100 to manage the wound pressure (WP) at tissue site 105. In one embodiment, controller 170 may including an input for receiving a desired target wound pressure (TWP) set by a clinician or other user and may be program for processing data relating to the setting and inputting of the target wound pressure (TWP) to be applied to the tissue site 105.
In one example embodiment, the target wound pressure (TWP) may be a fixed pressure value determined by a user/caregiver as the reduced pressure target desired for therapy at the tissue site 105 and then provided as input to the controller 170. The user may be a nurse or a doctor or other approved clinician who prescribes the desired reduced pressure to which the tissue site 105 should be applied. The desired tissue site pressure will vary from tissue site to tissue site, but will generally be chosen based on the type of tissue making up the tissue site, the type of injury or wound (if any), the medical condition of the patient, and the preference of the attending physician. After selecting the desired target wound pressure (TWP), the reduced pressure source 110 is controlled to achieve the target wound pressure (TWP) for application to the tissue site 105.
Referring more specifically to
It should be understood that the increase of the wound pressure (WP) at the tissue site 105 from ambient pressure to the target wound pressure (TWP) is not instantaneous, but rather limited depending on the type of therapy equipment and the dressing. For example, the reduced pressure source 110 and the dressing 115 may have an initial rise time as indicated by the dashed line 407 that may vary depending on the type of dressing and therapy equipment being used. For example, the initial rise time for one therapy system may be in the range between about 20-30 mmHg/second or, more specifically, equal to about 25 mmHg/second, and in the range between about 5-10 mmHg/second for another therapy system. When operating in the intermittent mode, the repeating rise time, line 405, may be substantially equal to the initial rise time, line 407.
The target pressure may also be a variable target pressure (VTP) controlled or determined by controller 170 that varies in a dynamic pressure mode. For example, the variable target pressure (VTP) may vary between a maximum and minimum pressure value that may be set as an input by a user as the range of reduced pressures desired for therapy at the tissue site 105. The variable target pressure (VTP) may also be processed and controlled by controller 170 that varies the target wound pressure (TWP) according to a predetermined waveform such as, for example, a sine waveform or a saw-tooth waveform or a triangular waveform, that may be set as an input by a user as the predetermined or time-varying reduced pressures desired for therapy at the tissue site 105. For example, the variable target pressure (VTP) may be a reduced pressure that provides an effective treatment by applying reduced pressure to tissue site 105 in the form of a triangular waveform varying between 50-125 mmHg with a rise time set at +25 mmHg/min and a descent time set at -25 mmHg/min. In another embodiment of a reduced-pressure therapy system 100, the variable target pressure (VTP) may be a reduced pressure that applies reduced pressure to tissue site 105 in the form of a triangular waveform varying between 25-125 mmHg with a rise time set at a rate of +30 mmHg/min and a descent time set at -30 mmHg/min. Again, the type of system and tissue site determines the type of reduced pressure therapy to be used.
After selecting the target wound pressure (TWP), the reduced pressure source 104 is operated to achieve the desired pressure at the wound site 105 by controlling pressure (PP). In many cases, the reduced pressure source 110 to be operated at a higher pump pressure (PP) than that of the target wound pressure (TWP) due to pressure losses between the reduced pressure source 110 and the tissue site 105. Moreover, the head pressure of exudates and other fluids within the conduits may result in a reduction of vacuum pressure at the tissue site 105. The height of the canister 140 above the tissue site 105 may determine the amount of head pressure imposed on the tissue site 105 by fluid in the conduits. For exudates and fluids with a density similar to water, the head pressure imposed by one foot of fluid is almost 25 mmHg. Some fluids withdrawn from the tissue site 105 may be even heavier or more viscous than water, and therefore have a more pronounced effect on pressure losses at the tissue site 105.
Referring to
The controller 170 may also be programmed and controlled by a user to maintain the target wound pressure (TWP) within an acceptable range of pressures. For example, if the target wound pressure (TWP) is set at 125 mmHg as the desired therapeutic pressure for the tissue site 105, a user may desire that the wound pressure (WP) varies by no more than ±10 mmHg from the desired target wound pressure (TWP) so that the wound pressure (WP) is controlled between a minimum wound pressure value (WPmin) of 115 mmHg and a maximum wound pressure value (WPmax) of 135 mmHg, i.e., a differential wound pressure range (δWP) of about 20 mmHg. Therefore, assuming for this example that there is a head pressure approximately 50 mmHg as described above, the pump pressure (PP) must also be variable by ±10 mmHg from the target pump pressure (TPP) so that the pump pressure (PP) may be varied in a range extending from the minimum pump pressure value (PPmin) of approximately 165 mmHg to the maximum pump pressure value (PPmax) of approximately 185 mmHg, i.e., a differential pump pressure (δTTP) of about 20 mmHg. Controlling the pump pressure (PP) to stay within this range indirectly maintains the wound pressure (WP) within a range extending from the minimum wound pressure value (WPmin) of approximately 115 mmHg to the maximum wound pressure value (WPmax) of approximately 135 mm.
Referring to
The controller 170 may also comprise a bang-bang controller (not shown) which is also referred to as an on-off controller, or a hysteresis controller. The bang-bang controller is a feedback controller that switches abruptly between two states, e.g., between on and off. Essentially, the bang-bang controller may apply an all-or-nothing form of control. A bang-bang controller may be used to generate the pressure variations described generally above in conjunction with
The bang-bang controller switches between these two states wherein the reduced pressure pump 112 is turned on when the wound pressure or the pump pressure drops too low in a descending mode and turns the reduced pressure pump 112 off when the wound pressure or pump pressure rises too high in an ascending mode. Referring more specifically to
The controller 170 may also include a PID controller (not shown) that provides a control loop feedback mechanism that calculates an error value as the difference between a measured process variable and a desired set-point or target, in this case the wound pressure (WP) and the corresponding target wound pressure (TWP) at the wound site 105, respectively. PID controllers are well-known by those skilled in the art as providing proportionality information, historical information, and time rate of change information to maintain the wound pressure (WP) close to the target pressure (TP). The PID summation is used to adjust the process, in this case the reduced pressure therapy process, by a control element such as the power or voltage supplied to a DC motor, i.e. the applied voltage (VA), which is directly related to the pump pressure (PP) as described above. The applied voltage (VA) may be varied as described above by adjusting the pulse-width modulation to achieve the desired pump pressure (PP) necessary to compensate for the leakage of the dressing 115 and/or the pressure head referred to above. The response of the PID controller is dependent on the responsiveness of the controller to an error, the degree to which the controller overshoots the set-point, e.g., the target pressure (TP), and the degree of system oscillation, e.g., the degree of oscillation of the wound pressure (WP) within the acceptable range described above. Although a preferred embodiment of the PID controller is a digital controller, the PID controller may also be an analog controller or a simple RC circuit. The analog or digital PID controller may be implemented in software as part of a program logic controller.
After the wound pressure sensor 155 measures the wound pressure (WP), the PID controller adjusts the pump pressure (PP) by supplying the applied voltage (VA) necessary for adjusting the wound pressure (WP) back to the target pressure (TP), i.e., the pump pressure correction (δPP). The pump pressure correction (δPP) is the additional pressure needed to maintain the wound pressure (WP) at the desired target pressure (TP), e.g., 125 mmHg, and may be calculated every few seconds. Consequently, the PID control varies the applied voltage (VA) to the DC motor 114 to achieve a pump pressure (PP) between a minimum pump pressure value (PPmin) and a maximum pump pressure value (PPmax) which maintains the wound pressure (WP) proximate the target wound pressure (TP).
Referring more specifically to
Unlike the bang-bang controller, the PID controller does not switch the reduced pressure pump 112 on and off, but rather continuously controls the application of the pump pressure (PP) between the maximum and minimum pressure values, (PPmax) and (PPmin), to maintain the wound pressure (WP) at a relatively constant level, e.g., at a target wound pressure (TWP) all of 125 mmHg as shown by the dashed line, rather than allowing it to vary between a maximum and minimum pressure value, (WPmax) and (WPmin) as shown with the bang-bang controller. Therefore, the extent to which the pump pressure (PP) drops towards the minimum pump pressure value (PPmin), the more that the PID controller increases the applied voltage (VA) being provided to the DC motor 114. Correspondingly, the further the wound pressure (WP) varies from the target pressure (TP), the more the PID controller responds by adjusting the applied voltage (VA) being provided to the DC motor 114. The action taken to increase or decrease the applied voltage (VA) is proportional to the degree that the wound pressure (WP) provided by the reduced pressure system diverges from the target wound pressure (TP). The PID controller continuously operates in order to keep the wound pressure (WP) as close to the target wound pressure (TP) as possible, especially for high leakage rates (LR). Consequently, the PID controller causes the reduced pressure therapy system 100 to run smoother than the bang-bang controller as shown when comparing the wound pressure (WP) variations of
When the flow rate (FR) is small enough to indicate a low leakage condition, e.g., when the pump pressure (PP) or the wound pressure (WP) is decreasing at a very slow rate toward their respective minimum pressure values, i.e., (PPmin) or (WPmin), the bang-bang controller may provide a sufficiently smooth wound pressure (WP) during treatment while conserving battery power and reducing noise by virtue of the reduced pressure pump 112 being intermittently turned off during the same treatment period. For example, the DC motor 114 and pump 112 are turned off for a significant percentage of time during the one minute period shown in
Thus, the controller 170 may be programmed to use the bang-bang controller in conjunction with the PID controller operating as described above to enable or disable the PID controller depending on a specific switching condition relating to the amount of system leakage created by the dressing 115 or other components of the reduced pressure therapy system 100 that affect the flow rate (FR). Using such a hybrid controller would be preferable to utilizing only a PID controller which runs continuously during the continuous control mode as described above (or the enabled portions of an intermittent control mode as described above) to more tightly maintain the wound pressure (WP) at the target wound pressure (TP), but may continually generate noise and more rapidly drain the battery driving the motor 114. The hybrid controller may engage the bang-bang controller so that the DC motor 114 is turned on and off to conserve battery power and reduce noise generated by the pump 112 during therapy treatments. The controller 170 may further include an input for a user/caregiver to set one or more target flow rates (TFR).
The user/caregiver may set the target flow rates (TFR) as the switching condition for determining whether the dressing 115 or other components are in a high leakage state or a low leakage state. If the flow rate (FR) is greater than the fixed target flow rate (TFR), i.e., a high leak condition, the bang-bang controller is disabled so that the PID controller takes over in order to keep the wound pressure (WP) as close to the target wound pressure (TP) as possible. However, if the flow rate (FR) is less than or equal to the fixed target flow rate (TFR), i.e., a low leak condition, the bang-bang controller is enabled to contain the wound pressure (WP) within the differential wound pressure (δWP) range while conserving battery power and reducing noise from the pump 112. For example, the fixed target flow rate (TFR) may be 65 cc/min. As indicated above, it is desirable to keep the bang-bang controller running as much as possible during treatments when the dressing 115 is in a low leakage condition. For example, the controller 170 may engage the bang-bang controller when the flow rate (FR) is less than or equal to the fixed target flow rate (TFR), but switch back to the PID controller when the flow rate (FR) is greater than the fixed target flow rate (TFR) as a result of additional leakage that develops in the dressing 115 because the patient moving around which ultimately creates a high leak condition.
In another embodiment, the bang-bang controller may have a dual target flow rate (TFR) capability wherein the controller 170 further includes an input for a user to set two target flow rates (TFR) as switching conditions for determining whether the dressing 115 or other components are in a high leakage state or a low leakage state: an ascending target flow rate (TFRA) when the bang-bang controller is enabled with an increasing flow rate (FR) and a descending target flow rate (TFRD) when the PID controller is enabled with a decreasing flow rate (FR). In one embodiment, both the ascending target flow rate (TFRA) and the descending target flow rate (TFRD) are greater than the fixed target flow rate (TFR) so that the controller 170 switches more quickly from the PID controller to the bang-bang controller and more slowly from the bang-bang controller to the PID controller. For example, the ascending target flow rate (TFRA) and the descending target flow rate (TFRD) may both be set to about 80 cc/min which is higher than the fixed target flow rate (TFR) of 65 cc/min in the previous example. In yet another embodiment, the ascending target flow rate (TFRA) may also be greater than the descending target flow rate (TFRD) so that the controller 170 switches even more quickly from the PID controller to the bang-bang controller and even more slowly from the bang-bang controller to the PID controller. In this case, the controller 170 favors the benefits derived from using the bang-bang controller as opposed to the deficiencies associated with the continuous operation of the PID controller. For example, the ascending target flow rate (TFRA) may be 75 cc/min and the descending target flow rate (TFRD) may be about 85 cc/min. If the PID controller is currently enabled in a high leak condition wherein the flow rate (FR) is decreasing, the descending target flow rate (TFRD) would be set at 85 cc/min rather than 65 cc/min so that the controller 170 switches more quickly from the PID controller to enable the bang-bang controller. Alternatively, if the bang-bang controller is enabled in a low leak condition wherein the flow rate (FR) is increasing, the ascending target flow rate (TFRA) would be set at 75 cc/min rather than 65 cc/min so that the controller 170 switches more slowly to disable the bang-bang controller.
In one embodiment, controller 170 may provide an output signal to the indicator 172 to emit a visual and/or audible signal in response to the wound pressure (WP) at tissue site 105, as measured by wound pressure sensor 155, being nonresponsive to increasing the pump pressure (PP). For example, the indicator may be a light emitting diode (LED) that provides a visual signal. In this embodiment, indicator 172 illuminates in response to the wound pressure (WP) at tissue site 105 being nonresponsive to an increasing pump pressure. In another embodiment, indicator 180 is a sound emitting device, such as a speaker. In this embodiment, indicator 172 emits a sound in response to the wound pressure (WP) at tissue site 105 being nonresponsive to an increasing pump pressure. The controller 170 may provide other output signals indicating whether the negative pressure therapy system is in a low or high leak condition.
Although most reduced pressure therapy systems have some system leakage, improvements in the dressings and other components of the system have greatly reduced system leakages even lower than the low system leakages such as the target flow rates (TFRs) referred to above. For example, sealing members such as sealing member 125 and the adhesives for attaching sealing members to the peritissue have been improved so that they are more airtight and significantly reduce the system leakage from the external environment into the therapeutic environment. In some cases, the wound pressure (WP) might already be equal to the targeted wound pressure (TWP), while the flow rate (FR) at the tissue site 105 may range from less than 50 cc/min down to zero. Flow rates (FR) less than the target flow rates (TFRs) are often too low for healing the wound. Some minimal level of fluid flow is needed at the tissue site to promote adequate healing. For example, a minimum level of fluid flow is needed to remove exudates from the tissue site. If the flow rate (FR) falls below a minimum flow rate (MinFR) necessary for the proper healing of a wound [that in some embodiments is less than the target flow rate (TFR)], it would be desirable to measure the flow rate (FR) associated with the system leakage and increase the flow rate (FR) over and above the system flow rate to an acceptable level (i.e., an “induced leakage”) for healing the wound at the tissue site 105 in an “induced leakage mode.” In some embodiments, the minimum flow rate (MinFR) may be dependent upon or equal to the target flow rate (TFR). In yet other embodiments, the minimum flow rate (MinFR) more dependent on the specific type of dressing and/or the type of wound that needs to be healed.
In some embodiments, the controller 170 may be configured to determine the flow rate (FR) associated with the system leakage and compare it to the minimum flow rate (MinFR) that is desired for a specific type of dressing and/or wound type. The controller 170 may be further configured to increase the leakage by opening the regulator 165 if the flow rate (FR) is less than the minimum flow rate (MinFR). When the regulator 165 opens to induce leakage from the external environment into the therapeutic environment to increase the flow rate (FR) of fluids within the therapy system and ultimately at the tissue site 105, the controller 170 may be further configured to regulate the flow rate (FR) as it increases toward the minimum flow rate (MinFR) and then maintains the flow rate (FR) above the minimum flow rate (MinFR). In some embodiments, the controller 170 may be configured further to include an algorithm for inducing leakage into the therapeutic environment in a controlled fashion. For example, the algorithm may include a ramp function, linear or nonlinear, to increase the flow rate (FR) to the minimum flow rate (MinFR). The algorithm may further comprise a sinusoidal function that maintains the flow rate (FR) above the minimum flow rate (MinFR) by varying the amplitude and/or the frequency. The algorithm may further comprise a digital function that varies the flow rate (FR) by varying the amplitude, the frequency, and/or the duty cycle.
As indicated above, the system 100 may have a system leakage stemming from the dressing and/or other components of the system and the wound itself. Thus, different reduced pressure therapy systems may have different system leakage values depending on these factors. For example, one system may have a low system leakage of 50 cc/min while another system may have a low leakage condition at 100 cc/min. In some embodiments, the low leakage condition may be set as the minimum flow rate (MinFR) which also may vary from 50-100 cc/min, for example. The controller 170 may be configured to open the regulator 165 for inducing leakage into the therapy system 100 when the flow rate (FR) of fluids within the therapy system drops below the minimum flow rate (MinFR).
In one example, a dressing as a minimum flow rate (MinFR) requirement of 100 cc/min, but the controller measures the flow rate (FR) of 50 cc/min wherein the fluids need to be evacuated to a canister two feet above the dressing. The effects of gravity and a thicker fluid because of the exudates, could cause the fluid flow of such a small leak to remain static in the dressing. However, the controller detects that the flow rate (FR) is lower than the minimum flow rate (MinFR) requirement of 100 cc/min, and opens and controls a regulator to induce leakage of airflow into the therapeutic environment of the dressing. The algorithm may further comprise a digital function that varies the flow rate (FR) by varying the amplitude, the frequency, and/or the duty cycle. For example, a minimum flow rate (MinFR) requirement of 100 cc/min equals a drop of 1.0 mmHg/10 seconds and a flow rate (FR) of 50 cc/min equals a drop of 0.5 mmHg/10 seconds. If the algorithm includes a digital function for example, the frequency may be increased to one cycle/5 seconds or 12 cycles/minute with a duty cycle of 20%/cycle, i.e., 1 second width/cycle. This would cause the wound pressure (WP) at the tissue site to decrease (alternatively, cause the pressure decay to increase) and the flow rate (FR) to increase to at least 100 cc/min, thereby overcoming the force of gravity and allowing the canister to be moved 2 feet above the dressing. The bang-bang controller in conjunction with the PID controller may then operate as described above to adjust the wound pressure (WP) as required.
Referring now to
The therapy algorithm 703 begins by determining whether the bang-bang controller is active or not at 713. If the PID controller is engaged and the bang-bang controller is not, a local pump pressure (PPL) is set at a current pump pressure (PPC) at 715. As described above, the PID control adjusts the applied voltage (VA) to the DC motor 114 to achieve a pump pressure (PP) between the minimum pump pressure value (PPmin) and the maximum pump pressure value (PPmax) to maintain the wound pressure (WP) proximate the target wound pressure (TP). Referring back to
When the wound pressure (WP) drops too low in the descending mode, e.g., below the minimum wound pressure value (WPmin) as described above, the reduced pressure pump 112 is turned on with an applied voltage (VA) greater than the stall voltage, i.e., the bang-bang on voltage (VON), to increase the pump pressure (PP) to the maximum pump pressure (PPmax) in the ascending mode. The bang-bang on voltage (VON) continues to be applied until the pump pressure (PP) reaches the maximum pump pressure value (PPmax) as shown, for example, at 501 and 503, or the wound pressure (WP) reaches the maximum wound pressure value (WPmax) as shown, for example, at 502 and 504, whichever occurs first. When the wound pressure (WP) is in the ascending mode, the therapy algorithm 703 sets the local target wound pressure (TPL) at the target wound pressure (TP) plus a hysteresis value (H) at 723. The hysteresis value (H) is the maximum amount of pressure that the wound pressure (WP) should increase above the target wound pressure (TP) when in the ascending mode before the controller 170 turns off the pump 112 to protect the tissue site 105 from an excessive amount of reduced pressure that could be damaging. The hysteresis value (H) sets the upper limit above the target wound pressure (TP) which is the maximum pressure value (WPmax). For example, if the hysteresis value (H) is 10 mmHg, the maximum wound pressure value (WPmax) is set at 135 mmHg as shown in
Correspondingly, when the wound pressure (WP) rises too high in the ascending mode, e.g., above the maximum wound pressure value (WPmax) or the maximum pump pressure value (PPmax) as described above, the reduced pressure pump 112 is turned off so that no pump pressure (PP) is applied allowing the residual pressure in the reduced pressure therapy system 100 to decrease in the descending mode as a result of the leakage in the system. The reduced pressure pump 112 remains off until the wound pressure (WP) is again less than or equal to the minimum wound pressure value (WPmin) is shown, for example, at 508, or the pump pressure (PP) is less than or equal to the minimum pump pressure value (PPmin) as shown, for example, that 507, whichever occurs first. When the wound pressure (WP) is in the descending mode as described above, the therapy algorithm 703 sets the local target wound pressure (TPL) at the target wound pressure (TP) minus the hysteresis value (H) at 721. The hysteresis value (H) is the minimum amount of pressure that the wound pressure (WP) should decrease below the target wound pressure (TP) when in the descending mode before the controller 170 determines that the flow rate (FR) has increased to a flow rate that is large enough to require the PID controller to maintain the wound pressure (WP) closer to the target wound pressure (TP) as described above. Thus, the hysteresis value (H) also sets the lower limit below the target wound pressure (TP) which is the minimum pressure value (WPmin). For example, if the hysteresis value (H) is 10 mmHg, the minimum wound pressure value (WPmin) is set at 115 mmHg as shown in
After the therapy algorithm 703 sets the motor voltage (VM) to equal the applied voltage (VA) at 709 to reenter the therapy loop 700, the therapy loop 700 then reads the current flow rate (FR) measured by the controller 170 at 725 and determines whether or not the current flow rate (FR) is less than the target flow rate (TFR) at 727. If the flow rate (FR) is less than the target flow rate (TFR) indicating a low leakage condition as described above, then the bang-bang controller stays on or is enabled as indicated at 729. However, if the flow rate (FR) is greater than or equal to the target flow rate (TFR) indicating a high leakage condition as described above, then the bang-bang controller stays off or is disabled as indicated at 731. Finally, the therapy loop 700 checks to see if the negative pressure wound therapy system 100 has been turned off at 733 and, if not, continues the therapy loop as indicated at 735. If the negative pressure therapy system 100 has been turned off, the therapy loop ends at 737.
Referring now to
The systems, apparatuses, and methods described herein may provide significant advantages. For example, PID control algorithms constantly adjust a negative-pressure source to maintain pressure within a specified tolerance, which can be inefficient in low-leak applications, drawing more power than a simple hysteresis control algorithm. Conversely, a hysteresis algorithm can work well in low-leak applications and uses relatively little power, but can cause a negative-pressure source to turn off and on frequently in high-leak applications, which can be noisy and increase power consumption. Hybrid control, as described herein, can combine the benefits of PID and hysteresis control algorithms to minimize power consumption and noise. If a negative-pressure therapy application has a low-leak, for example, a hybrid control algorithm can select a hysteresis control algorithm to minimize power consumption. If the application changes or develops a higher leak, a hybrid control algorithm can switch to a PID control algorithm to minimize noise.
While shown in a few illustrative embodiments, a person having ordinary skill in the art will recognize that the systems, apparatuses, and methods described herein are susceptible to various changes and modifications. Moreover, descriptions of various alternatives using terms such as “or” do not require mutual exclusivity unless clearly required by the context, and the indefinite articles “a” or “an” do not limit the subject to a single instance unless clearly required by the context.
The appended claims set forth novel and inventive aspects of the subject matter described above, but the claims may also encompass additional subject matter not specifically recited in detail. For example, certain features, elements, or aspects may be omitted from the claims if not necessary to distinguish the novel and inventive features from what is already known to a person having ordinary skill in the art. Features, elements, and aspects described herein may also be combined or replaced by alternative features serving the same, equivalent, or similar purpose without departing from the scope of the invention defined by the appended claims.
This application claims the benefit of priority to U.S. Provisional Application No. 63/062,218, filed on Aug. 6, 2020, which is incorporated herein by reference in its entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2021/056739 | 7/26/2021 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63062218 | Aug 2020 | US |
