Patent Application
20210228258
The invention relates to a portable wound treatment system.
The treatment of wounds, both acute and chronic, involves various practices to remove barriers that impair wound healing. For example, a treatment may include wound bed preparation, debridement, control of the bacteria load in the wound, and management of exudate from the wound. Debridement generally describes the removal of devitalized tissue and removal of bacterial biofilm that increases bacterial resistance to antibiotics as well as the patient's immune response. The purpose of debridement is to restore the wound environment to that of an acute wound that is able to naturally progress toward complete healing. Although many approaches to debridement exist, surgical debridement remains the most common method. Surgical debridement generally involves the use of steel tools such as a curette, scissors, or scalpel that are used to clean or scrape the wound along with water for cleaning the wound. While current methods of surgical debridement remove visible necrotic tissues, such treatment methods may be painful and require anesthesia, and which may result in additional trauma to the wound environment and subsequent injury and/or infection, as well as incomplete healing.
Hydro-debridement is another debridement technique that involves use of a high pressure fluid stream running parallel to the wound surface to draw devitalized soft tissues into a cutting chamber for excision and removal. While seen as an improvement to surgical debridement, hydro-debridement has been found to contribute to bacteria aerosol spread due to the horizontal movement of fluid particles across the surface of the wound. Thus, current debridement techniques still result in inadequate biofilm control, recurrent infections that necessitate repetitive antibiotic treatments, hindered re-epithelialization, and ultimately, delayed healing and wound closure.
Wound healing involves a complex and dynamic process of angiogenesis, cell proliferation, deposition of an extracellular matrix, and wound contraction. In this process devitalized tissue acts as a physical barrier to re-epithelialization and prevents applied topical therapeutics from directly contacting the target tissue to provide its beneficial properties. As an example of devitalized tissue, the presence of necrotic tissue in the wound environment prevents angiogenesis, granulation tissue formation, epidermal regeneration, and normal extracellular matrix (ECM) formation. Further, devitalized tissue can serve as a nutrient source for bacteria, which assists in biofilm formation and resistance to antibiotics. Thus, debridement is an important step in wound treatment and preparation of the target tissue for re-epithelialization.
The present invention involves a portable wound treatment system that includes a disposable treatment device and a portable generator. The portable wound treatment system provides coagulation and/or ablation of a target tissue to thereby promote wound healing and facilitate debridement of the target tissue to remove devitalized tissue, remove bacterial biofilm, and control the bacterial load. As such, a portable wound treatment system may according to the invention help to accelerate wound closure by promoting dermal cell proliferation, collagen synthesis, and epidermal regeneration.
The treatment device includes a handle, an interior cavity for receiving a conductive fluid (e.g., a saline solution), a conductive element disposed within the interior cavity, and a plurality of apertures configured to allow passage of the conductive fluid from the interior cavity. The portable generator of the portable wound treatment system is configured to generate and transmit energy to the conductive element such that the conductive element conducts energy to be carried by the conductive fluid passing through one or more of the plurality of apertures to treat a target tissue contacted by that conductive fluid.
In one example, the portable generator may generate radiofrequency (RF) energy and the conductive element may be a bipolar helical coil. In this example, the portable wound treatment system may be employed to provide non-heat driven soft tissue dissolution using bipolar RF energy through a conductive fluid (e.g., a saline solution), although other suitable biocompatible conductive fluids that can effectively carry energy from the conductive element to the target tissue may be used. When a current from the portable generator is transmitted to the bipolar helical coil in the interior cavity of the treatment device, the current breaks the saline into sodium and chloride ions, which then form a plasma field about the plurality of apertures. The plasma field produced by these highly energized ions is sufficiently strong to break organic molecular bonds within soft tissue to thereby cause its dissolution. Accordingly, the portable wound treatment system may dissolve and remove devitalized or necrotic tissue, as well as bacterial biofilm, with limited thermal effect, resulting in minimal or no collateral damage to tissues adjacent to the target tissue.
Current plasma-mediated coagulation/ablation technologies typically employ RF generators that are large, heavy, and not portable. For example, current RF generators may be about 45 pounds or greater, or about 26 pounds or greater, and may be mounted to a wheeled cart due to their weight and bulk. Such RF generators may have dimensions of, for example, about 24 inches in height, 12 inches in length, and 14 inches in depth, or greater. As such, patients may only benefit from current plasma-mediated coagulation/ablation technologies by traveling to a hospital or clinic setting to receive the treatment. This limitation makes such treatments expensive and often restricts or prevents patient access to its wound-healing benefits.
In contrast, the present portable wound treatment system enables patients to receive plasma-mediated coagulation/ablation treatments in many settings, such as home visits by a nurse or even by the patients themselves with proper instruction. In various embodiments, the portable generator may have a weight of about 10 pounds or less, or about 5 pounds or less. Also, in some embodiments, the portable generator may have dimensions of about 5 inches in height, 10 inches in length, and 8 inches in depth, or less, or dimensions of about 3 inches in height, 8 inches in length, and 6 inches in depth, or less.
The portable generator may include a thermoplastic housing as opposed to the metal housings currently used for generators. The portable generator also includes an improved transformer that weighs less than a traditional transformer. Also, the portable generator may include a shortened power cable that is about 3 feet long to carry the RF energy from the portable generator to the treatment device. This is an improvement over current RF generators that often have power cables of over 10 feet in length because approximately 10% of energy is lost for every foot of cable used, resulting in great energy inefficiency and making it necessary for the generator to be more powerful (and consume more energy) to compensate for the loss of transmitted energy due to the cable.
In various embodiments, each of the apertures are sized such that the conductive fluid does not flow from the plurality of apertures due to gravity alone. For example, each of the plurality of apertures may be sized such that the surface tension of the conductive fluid prevents droplets of the fluid from passively exiting the apertures. In one example, the portable wound treatment system further includes a reservoir operable to contain the conductive fluid and to convey the conductive fluid to the conductive element. In this example, the portable wound treatment system may include an actuator operable to control pressurized flow of the conductive fluid to the conductive element from the reservoir. For instance, the actuator may be a foot pedal, a control panel, a button, a motorized dispensing device, or any other device operable to control pressurized flow of the conductive fluid from the reservoir to the conductive element. In certain embodiments, the conductive fluid may only pass through one or more of the plurality of apertures when pressurized flow of the conductive fluid to the conductive element is provided.
The treatment device may be disposable such that the a nurse may select a treatment device among a variety of different sized and/or shaped treatment devices, each customized to treat a particular body part, type of tissue, or type of wound, for example. Because the portable wound healing system is designed to be used outside of an operating room or other treatment facility (and thus typically is not used in a sterile field), making the treatment device disposable helps prevent contamination and inadvertent spread of bacteria amongst patients or amongst wounds. Thus, the treatment device should be made as inexpensively as possible, such as from a biocompatible plastic or like materials, in order to make the treatment device lightweight and also disposable.
In certain embodiments, the treatment device may further include a plate coupled to a distal end of the handle and enclosing the interior cavity to thereby retain conductive fluid within the interior cavity, in which the plate has an exterior surface and comprises the plurality of apertures. In such embodiments, the exterior surface of the plate may contact and provide treatment to a target tissue adjacent to the exterior surface. Accordingly, in certain embodiments, the treatment device may be formed as a single disposable piece. In other embodiments, the treatment device may be formed as a handle and a separate plate that is then coupled to the handle.
In one example, the exterior surface of the plate further comprises protrusions that facilitate debridement of the target tissue as the exterior surface of the plate contacts the target tissue. The protrusions may of any shape such as contoured studs, lines, or staggered rows. As the exterior surface of the plate passes over a target tissue, the protrusions may mechanically assist in removal of biofilm and devitalized tissue that would hinder wound healing and closure.
In one example, the portable wound treatment system further comprises a non-conductive pad coupled to the exterior surface of the plate, in which the non-conductive pad includes an opening shaped or sized to correspond to a surface area of the target tissue or a dressing applied to the target tissue. The non-conductive pad may be provided without an existing opening such that a nurse or patient may cut an opening appropriately shaped or sized to correspond to a wound on a target tissue. Alternatively, the non-conductive pad may be provided with one or more existing openings and a non-conductive pad may be selected based on characteristics of the wound, the target tissue, or the treatment plan. By coupling the non-conductive pad to the exterior surface of the plate prior to treatment, the treatment device may selectively treat only a portion of a target tissue at a time (i.e., the portion of the target tissue corresponding to the position of the opening).
In some embodiments, the portable wound treatment system further includes a foam dressing that is applied to cover the target tissue prior to treatment with the wound treatment system, and to thereby improve conductivity to the target tissue, through the foam dressing. For example, a foam dressing shaped as an oval may be used to cover a generally oval shaped wound on a target tissue. In this example, a conductive medium, such as a 0.9% saline gel, may be applied to the foam dressing to improve conductivity between the exterior surface of the plate and the target tissue, through the foam dressing. The saline gel may also be selectively applied to only certain portions of the foam dressing to improve conductivity to only those portions.
The portable wound treatment system can include a suction device in fluid connection with the interior cavity via tubing coupled to the interior cavity. Any suitable tubing may be used to place the suction device in fluid connection with the interior cavity, such as rubber tubing, polyurethane tubing, PVC tubing, nylon tubing, polyethylene tubing, PTFE tubing, and the like. The portable wound treatment system may further include a controller operable to adjust negative pressure produced by the suction device. Any suitable controller that allows modulation of the negative pressure applied by the suction device to the treatment device may be used. For example, the controller may be a foot pedal, a knob, a control panel, a button, a joystick, or the like. In certain embodiments, the suction device is operable to remove debris from the target tissue, as the target tissue is treated by the wound treatment system, by applying negative pressure to the treatment device. For example, such debris may include devitalized tissue, necrotic tissue, biofilm, bacterial colonies, exudate from the wound, and the like. Similarly, the suction device may be used to remove excess conductive fluid from the target tissue.
Features and advantages of the claimed subject matter will be apparent from the following detailed description of embodiments consistent therewith, which description should be considered with reference to the accompanying drawings.
For a thorough understanding of the present disclosure, reference should be made to the following detailed description, including the appended claims, in connection with the above-described drawings. Although the present disclosure is described in connection with exemplary embodiments, the disclosure is not intended to be limited to the specific forms set forth herein. It is understood that various omissions and substitutions of equivalents are contemplated as circumstances may suggest or render expedient.
The invention relates to a portable wound treatment system that includes a treatment device and a portable generator. The treatment device may be a disposable handheld device that includes a handle, an interior cavity for receiving a conductive fluid (e.g., a saline solution), a conductive element disposed within the interior cavity, and a plurality of apertures configured to allow passage of the conductive fluid from the interior cavity. The portable generator (e.g., a portable RF generator) of the portable wound treatment system is configured to generate and transmit energy to the conductive element such that the conductive element conducts energy to be carried by the conductive fluid passing through one or more of the plurality of apertures to treat a target tissue contacted by that conductive fluid. Accordingly, the portable wound treatment system may provide coagulation and/or ablation of a target tissue adjacent to the plurality of apertures.
The portable wound treatment system provides coagulation and/or ablation of a target tissue to thereby promote wound healing and provide debridement of the target tissue to remove devitalized tissue and bacterial biofilm, and to control the bacterial load. Accordingly, the portable wound treatment system may accelerate wound closure by promoting dermal cell proliferation, collagen synthesis, and epidermal regeneration. In addition, the portable wound treatment system may provide such coagulation and/or ablation treatment to a target tissue in various settings that do not require the patient to travel to a hospital or a clinic. For example, the portable generator may have a weight of about 5 pounds or less and dimensions of about 3 inches in height, 8 inches in length, and 6 inches in depth, or less. Thus, the treatment device, portable generator, and other components described herein may easily be transported and used in a home environment, improving patient access to the benefits of wound treatment by plasma-mediated coagulation and/or ablation.
A detailed description of the present invention is disclosed herein. It should be understood that the embodiments described are exemplary and should not be interpreted as limiting the scope of the invention. The detailed description disclosed herein is merely intended to teach one skilled in the art how to make and/or use the invention.
The portable generator 120 is operable to generate and transmit energy to a conductive element of treatment device 105 such that the conductive element conducts energy to be carried by the conductive fluid contained within an interior cavity of the treatment device and passing through one or more of the plurality of apertures, as described below, for coagulation and/or ablation of a target tissue adjacent to the plurality of apertures.
In this illustration, the portable wound treatment system 100 is positioned on a table or flat surface and may be used in an at-home setting to treat target tissue 180 of patient 185, even though standard dressing 190 (e.g., a foam bandage). Although treatment device 105 is shown being used by nurse or medical practitioner, the patient 185 may also perform the treatment themselves, with proper instruction, and without traveling to a hospital or clinic.
As shown, the treatment device 105 is connected to a portable generator 120 by power cables 122 and 124, which are connected at junction 126. In certain embodiments, the portable generator 120 may generate and transmit radiofrequency (RF) energy to a conductive element housed within the interior cavity 112 of the treatment device 105. The conductive element may then conduct the RF energy to conductive fluid that is initially contained within reservoir 130, and conveyed to the conductive element of the treatment device 105 via fluid line 132.
Also, as shown, the reservoir 130 resembles a syringe containing a saline solution, and the syringe is coupled to an actuator 135. In this example, the actuator 135 is a plunger that may be depressed to control pressurized flow of the conductive fluid to the conductive element from the reservoir 130. When pressurized flow of conductive fluid is provided to the treatment device 105, the conductive fluid may pass through one or more of the plurality of apertures 116 of the plate 114.
In this example, treatment device 405 is connected to a reservoir (not shown) via fluid line 432 such that conductive fluid may be conveyed to interior cavity 412, wherein a conductive element is contained. Treatment device 405 is also connected to a portable generator (not shown) via a power cable 424 such that energy may be transmitted from the portable generator to a conductive element of treatment device 405, and carried by the conductive fluid passing through one or more of the plurality of apertures 416 of plate 414 for coagulation and/or ablation of a target tissue adjacent to the exterior surface 415 of the plate.
As shown, the treatment device 505 includes a bipolar helical coil as a conductive element 518 contained within the interior cavity 512, within which conductive fluid 592 may also be held. The conductive fluid may be conveyed to the interior cavity 512 from a reservoir via fluid line 532, as described above. The treatment device 505 may receive energy, such as RF energy from a portable generator and convey that energy to conductive element 518 and to the conductive fluid 592 contained within interior cavity 512. The RF energy may be carried by the conductive fluid passing through one or more of the plurality of apertures 516 for coagulation and/or ablation of a target tissue adjacent to the plurality of apertures 516 (i.e., the exterior surface 515 of the plate 514).
In this embodiment, treatment device 605 includes a plate 614 coupled to the distal end of the handle, in which the plate 614 further includes one or more protrusions 619 that facilitate debridement of a target tissue as the exterior surface 615 of the plate 614 contacts the target tissue. The protrusions 619 may of any shape such as contoured studs, lines, or staggered rows. As the exterior surface 615 of the plate 614 passes over a target tissue, the protrusions 619 may mechanically assist in removal of biofilm and devitalized tissue that would hinder wound healing and closure. In certain embodiments, the suction device is operable to remove debris from the target tissue, as the target tissue is treated by the wound treatment system, by applying negative pressure to the treatment device, such as the exterior surface 615 of the plate 614. For example, such debris may include devitalized tissue, necrotic tissue, biofilm, bacterial colonies, exudate from the wound, and the like.
The portable wound treatment system may further include a controller operable to adjust negative pressure produced by the suction device. Any suitable controller that allows modulation of the negative pressure applied by the suction device to the treatment device may be used. For example, the controller may be a foot pedal, a knob, a control panel, a button, a joystick, or the like. Similarly, the suction device may be used to remove excess conductive fluid from the target tissue.
As described above, the treatment device provides coagulation and/or ablation of a target tissue to thereby promote wound healing by forming a plasma field about the plurality of apertures of the plate. The energy in the plasma field formed is sufficiently strong to break organic molecular bonds within soft tissue to thereby cause its dissolution. Accordingly, the portable wound treatment system is able to coagulate and/or ablate through existing dressings due to this virtual electrode design, in which energy is conducted to the target tissue without direct contact between the conductive element and the target tissue.
As described above, current plasma-mediated coagulation/ablation technologies typically employ RF generators that are large, heavy, and not portable. As a result, many patients lack access to this expensive and limited, but beneficial, technology that is generally restricted to use in a hospital or clinic setting. However, the portable generator 920 is an RF generator that is relatively small and lightweight, and that minimizes energy inefficiency compared to current RF generators. The portable generator 920 may easily be carried to a home environment for a treatment at the same time as other components of the portable wound treatment system described herein.
For example, the portable generator 920 may include a thermoplastic housing as opposed to the metal housings currently used for generators and a modern transformer that weighs less than traditional transformers. Also, the portable generator 920 may include a shortened power cable that is about 3 feet long to carry the RF energy from the portable generator to the treatment device. This is an improvement over current RF generators that often have long power cables (e.g., 10 feet long or greater) because approximately 10% of energy is lost for every foot of cable used, resulting in great energy inefficiency and making it necessary for the generator to be more powerful (and consume more energy) to compensate for the loss of energy transmitted.
The portable generator 920 may have a weight of about 10 pounds or less, or about 5 pounds or less. Also, in some embodiments, the portable generator 920 may have dimensions of about 5 inches in height, 10 inches in length, and 8 inches in depth, or less, or dimensions of about 3 inches in height, 8 inches in length, and 6 inches in depth, or less.
In one embodiment, the portable generator 920 has a line frequency of 50-60 Hz, an output frequency of 348-460 kHz, a line voltage of 100-240 VAC, an output power of bipolar energy of 40-60 watts, and a passive cooling system. In this example, the portable generator 920 may provide treatment to a target tissue at an output of about 50 watts, a peak max voltage of 950-2900 volts, a crest factor of 5.5+/−20%, and a frequency of 343-460 kHz+/−10%.
Accordingly, the portable generator 920 and the portable wound treatment system, as described above, enables patients to receive plasma-mediated coagulation or ablation treatment, depending on the voltage applied by the portable generator, in many settings, such as home visits by a nurse or even by patients themselves. Thus, the portable wound treatment system improves patient access to treatments that promote control of the bacterial load, re-epithelialization, neovascularization, and ultimately, earlier wound healing and closure.
Various modifications of the invention and many further embodiments of the portable treatment device, in addition to those shown and described herein, will become apparent from the foregoing description and the following claims. Those modifications and additional embodiments are considered to be disclosed and incorporated herein.
This application claims the benefit of, and priority to, U.S. Provisional Application No. 62/681,352, filed Jun. 6, 2018, the content of which is hereby incorporated by reference herein in its entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2019/035780 | 6/6/2019 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62681352 | Jun 2018 | US |
