Patent Application
20230310219
None
None.
The present invention is directed toward a PVA wound dressing for the treatment of wounds containing a pump which administers negative pressure to the wound site.
Negative pressure wound therapy (NPWT) has long been used in the treatment of wounds and improves the rate of wound healing while removing fluid, exudates, bacteria and other healing inhibiting substances from the wound site. Extensive studies of both continuous and intermittent treatment of wounds under negative pressure were conducted in the 1980′s and 1990′s in various Russian institutions. This testing demonstrated that slow healing wounds healed substantially faster with negative pressure. It was also shown that treatment of wounds with negative pressure produced an antibacterial effect. These studies are described in articles in the Russian medical journal Vestnik Khirurgil. It is believed that such negative pressure wound therapy hastens wound closure by speeding migration of epithelial and subcutaneous tissue adjacent the wound towards the center and away from the base of the wound until the wound closes.
Negative pressure therapy also known as suction or vacuum therapy has been used in treating and healing wounds. Application of negative pressure, e.g. reduced or subatmospheric pressure (pressure below normal atmospheric pressure), to a localized reservoir over a wound has been found to assist in closing the wound by promoting blood flow to the area, stimulating the formation of granulation tissue, and encouraging the migration of healthy tissue over the wound. This technique has proven particularly effective for chronic or healing-resistant wounds, and is also used for other purposes such as post-operative wound care.
Thus, it is known that negative pressure wound therapy assists in the closure and healing of many forms of “hard to heal” wounds by reducing tissue edema, encouraging blood flow and granular tissue formation, and/or removing excess exudate and can reduce bacterial load (and thus infection risk).
Generally, negative pressure therapy provides for a wound to be covered to facilitate suction at the wound area. A conduit is introduced through the wound covering to provide fluid communication to an external vacuum source. Atmospheric gas, wound exudates, or other fluids may thus be drawn from the reservoir through the fluid conduit to stimulate healing of the wound. Exudates drawn from the reservoir may be deposited in a collection canister or container.
U.S. Pat. No. 3,572,340 issued Mar. 23, 1971 discloses a pump in the form of an elastically compressible body made of an open celled foam material, preferably polyurethane foam which body also serves as a receptacle for fluid drained from a wound. The pump is said to have a capacity to maintain a negative pressure of 15-80 mmHg for over 48 hours. A drain placed in the wound pocket and is connected to the pump by a tube.
See also U.S. Pat. No. 4,525,166 issued Jun. 25, 1985 which uses laminaria (kelp) instead of foam. Laminaria swells by absorption of liquid and does not release the liquid.
U.S. Pat. No. 7,569,742 issued Aug. 4, 2009 discloses a wound dressing apparatus using a micro pump system housed within or above a wound dressing member. The micro-pump includes a miniature pump that applies a sub-atmospheric pressure to the wound to draw wound fluid or exudate away from the wound bed while allowing patient mobility.
U.S. Pat. No. 9,084,845 issued Jul. 21, 2015 discloses a number of pump assemblies for reduced pressure wound therapy which are battery powered. The embodiments show a housing, a pump, a flow pathway through the pump, one or more valves in communication with the housing and a one way pressure sensor in communication with a fluid pathway.
In U.S. Pat. No. 9,974,890 issued May 22, 2018 discloses a portable system for sub-atmospheric pressure therapy in connection with healing a surgical wound, including a wound dressing dimensioned for positioning relative to a wound bed of a subject and a sub-atmospheric pressure mechanism carried or worn by the subject. The sub-atmospheric pressure mechanism includes a housing having a control unit adapted to draw a vacuum and a canister associated with the housing. The canister has a collection bag disposed therein, which is in fluid communication with the wound dressing to receive exudates from the wound bed. The collection bag is adapted to expand upon receipt of the fluids and releases gas with operation of the control unit.
U.S. Pat. No. 10,046,096 issued Aug. 14, 2018 discloses a number of embodiments, some of which have a pump assembly mounted to or supported by a dressing for reduced pressure wound therapy. The dressing can have visual pressure, saturation, and/or temperature sensors to provide a visual indication of the level of pressure, saturation, and/or temperature within the dressing. The pump assembly can have a controller supported within or by the housing, the controller being configured to control one or more operations of the pump. The pump is configured to be sterilized.
U.S. Pat. Application Publication No. 2010/0324510 published Dec. 23, 2010 disclosed a number of embodiments for treating wounds with reduced pressure. The preferred device is a sealing film which covers the wound as well as a tube which connects a space over the wound and beneath the sealing film to the negative pressure source which is preferably a pump. An open foam hydrophilic material of polyurethane is cut to the shape of the wound to fill the wound pocket. See also U.S. Pat. Application Publication No. 2011/0178451 published Jul. 21, 2011 which is directed to foam wound inserts having high density and low density regions which are subjected to negative pressure.
Current negative pressure wound therapy (NPWT) systems are generally comprised of a wound dressing, a canister to collect wound exudate, and a pump or a vacuum source. The SNAP system relies on a mechanical vacuum source and a canister to collect exudate (see U.S. Pat. Application Publication No. 2011/0230849 published Sep. 22, 2011), while the PICO system (see U.S. Pat. Application Publication No. 2010/0160881 published Jun. 24, 2010) relies on an electrical vacuum source and uses the dressing to collect the exudate. In these cases, a therapeutically useful reduced pressure (i.e. vacuum or negative pressure) is achieved through the vacuum source.
There are numerous problems with the current prior art. The vacuum source is far from the wound bed, creating a need for tubing that is uncomfortable and unsightly for the patient, leading to compliance issues. Tubing can be crimped or clogged leading to failure. In subfreezing climates, the tubing can freeze and as a result, clog leading to failure. The pump must reduce the pressure requiring large mechanical or electrical units that can be bulky and noisy. This is further exacerbated by long lengths of tubing that result in greater pressure drop over distance, in turn requiring a larger and more powerful pump. A separate wound dressing is used with the prior art negative pressure pumps and the dressing itself is not actively used to treat the wound with natural capillary pressure or kill bacteria, prevent bacteria reproduction or inhibit or destroy biofilm forming within the wound.
The present invention describes a medical wound dressing device in the field of wound care treatment and is comprised of a porous PVA sponge material dressing having a natural capillary pressure. The device is also provided with a biocide. The device is also provided with a sealing drape covering the porous PVA sponge dressing material, an auxiliary vacuum generator mechanism such as a negative pressure pump connected to them porous PVA sponge dressing material and a fluid removal path with an optional fluid return path back to the dressing. The device enables the application of negative pressure to the porous PVA dressing material and the adjacent wound while covering the wound.
It is an object of the invention to provide a constant source of low negative pressure on the wound through the natural capillary pressure of the porous sponge dressing material while systematically providing a second higher negative pressure on the wound by applying a secondary negative pressure.
It is another object of the invention to provide a natural capillary pressure wound dressing material to a wound and applying additional negative pressure to the dressing material and wound by a vacuum mechanism which heals and closes a wound in quicker time than conventional wound dressings.
It is still another object of the invention to provide a wound dressing material having a natural capillary pressure and providing additional mechanical negative pressure to the dressing material which is superior to only mechanically produced negative pressure application to a wound.
It is another object of the invention to provide a wound dressing device which is disposable;
The present invention will be described with reference to the appended Figures, in which:
These and other objects, advantages, and novel features of the present invention will become apparent when considered with the teachings contained in the detailed disclosure along with the accompanying drawings.
The present invention is a negative pressure wound therapy (NPWT) system where the reduced atmospheric pressure on the wound is achieved by two sources, (1) a porous sponge dressing material and (2) an auxiliary vacuum unit, e.g. a pump. The porous sponge dressing material is a PVA foam which provides a natural capillary pressure of about -20 mmHg to about -72 mmHg on the wound. The auxiliary pump can further reduce the pressure to maintain a therapeutic benefit, e.g. down to about -120 mmHg. The result is a NPWT system that is portable by the user and is significantly smaller than prior art devices and with minimal to no tubing required to connect the dressing to the auxiliary vacuum source.
As is used herein, reduced or negative pressure levels, such as -X mmHg, represent pressure levels relative to normal ambient atmospheric pressure, which corresponds to 760 mmHg (or 1 atm, 29.93 inHg, 101.325 kPa, 14.696 psi, etc.). Accordingly, a negative pressure value of -X mmHg reflects absolute pressure that is X mmHg below normal ambient atmosphere pressure of 760 mmHg or, in other words, an absolute pressure of (760 mmHg -X mmHg). In addition, negative pressure that is “less” or “smaller” than the X mmHg negative pressure corresponds to pressure that is closer to atmospheric pressure.
The present invention describes a medical dressing device for the field of wound care of patients and is comprised of a porous sponge dressing material 10, preferably PVA foam sponge material 12, a sealing drape or cover 20, a fluid removal path 30, and a vacuum producing mechanism 40 as seen in
The porous sponge dressing material of the invention is preferably PVA foam sponge material 12 and acts as a source for negative pressure through its natural capillary action and as a wound exudate collection vehicle. The term PVA foam refers to one or more of the following: Polyvinyl formal, Polyvinyl acetal, PVA copolymers of vinyl esters and PVA copolymers of ethylene-containing repeat units. Copolymers with PVA may be random, block, alternating, periodic or graft. The acetal group may have one or two substituents such as aliphatic or aromatic groups which may be further substituted. Foams may further be comprised of blends of above PVA based polymers with non-PVA polymers. The porous PVA sponge 12 has a surface chemistry and porosity that create capillary flow properties, which in turn provide for a natural capillary pressure leading to exudate being drawn from the wound into the porous material. The reduced pressure created by the capillary action of the porous material enables the auxiliary vacuum unit or vacuum producing mechanism 40 as shown in
While the porous sponge dressing material is generally referred to by the numeral 10 and the PVA sponge dressing material is referred to by the numeral 12, these numbers can be interchanged as necessary as both refer to the sponge dressing material.
The PVA porous dressing material 12 acts as a dressing to the wound surface 14. This material is polymeric in composition where the polymer can be a synthetic substance, a natural substance or combinations thereof. In the preferred embodiment, the polymer is foamed PVA with positive and negative biocidal dyes which impregnate or bind to the sponge receptor sites. The porous PVA sponge dressing material has a morphology characterized by an average pore throat diameter of 10 - 500 pm, a fluid retention of 5.5 - 300 mL fluids/g porous material, a density of 0.05 - 0.15 g polymer/cm3 porous material, and a porosity of 60 - 99.5%. The cell structure is characterized as open / interconnected with through pores that can be evaluated by techniques such as capillary flow porometry and liquid extrusion porosimetry. The natural capillary pressure of the PVA sponge or foam dressing material ranges from about -20 mmHg to about -70 mmHg. This natural capillary pressure ranges and falls within the low to mid-range settings of presently used mechanical vacuum machines.
Without wishing to be bound by theory, the porous PVA sponge dressing material has one or more material properties which in combination afford fluid flow through the material to create a natural capillary pressure. Material properties may include the pore properties above, surface chemical structure, surface roughness and the resultant interfacial tensions arising from the porous PVA material surface and the fluid surface in contact with other. Porous PVA materials with natural capillary pressure may be differentiated from porous materials without natural capillary flow by their simplified diffusion coefficient (D) which can be calculated from the general form of the Washbum equation:
where (L) is the wicking distance of the liquid at time (t).
In a preferred embodiment the porous PVA sponge dressing material having natural capillary pressure has a simplified diffusion coefficient greater than 0.3 cm2 1 second; in a more preferred embodiment greater than 0.4 cm2 / second, and in a most preferred embodiment greater than 0.5 cm2 / second. As shown in Table 1, dressings used in the field today have little to no natural capillary pressure as measured by their simplified diffusion coefficient whereas the porous PVA foam of the present invention surprisingly has an almost 4-5X ability.
The simplified diffusion coefficient may be determined to suspending a swatch of the dressing (0.5” × 0.25” × 3.0”) in a normal saline solution to allow vertical wicking through the dressing material. Prior to evaluation, all materials are conditioned at ambient temperature for at least 24 hours. The test article is then attached to a suspension fixture and lowered into a test beaker containing saline solution such that one end is slightly submerged in the saline solution. The vertical wicking distance is recorded after 45 seconds. This wicking distance is then corrected to account for the initial height of saline, and the diffusion coefficient is calculated from the corrected wicking distance and wicking time period.
A biofilm enzymatic solution can also be incorporated into the porous sponge dressing material during the same manufacturing process that binds the antibacterial agents but after addition of the antibacterial agents. During this process, Methylene Blue, Crystal Violet, and biofilm prevention enzyme solution is introduced and allowed to uniformly impregnate or bind to the foam matrix. The product is then dried and processed to final specification and sterilization.
The porous sponge dressing material may further have agents that bind and/or eliminate toxins from the exudate, e.g. bacteria, mold, spores, endotoxins. The present invention uses foamed polyvinyl alcohol which is treated to open up the binding sites of the foam. The washed foam is soaked with one or more gram positive dyes selected from a group of dyes consisting of Gentian Violet dye, also called Crystal Violet dye, Malachite Green dye, Brilliant Green dye, Quinacrine dye and Acriflavin dye and one or more gram negative dyes selected from a group of dyes consisting of Methylene Blue dye, Dimethyl Methylene Blue dye, New Methylene Blue dye. The preferred dyes used in the invention are Methylene Blue dye and Gentian or Crystal Violet dye are attached to a finite number of the binding sites in the foam. Generally, electronegative (acidic) dyes are more effective on Gram-negative bacteria and electropositive (basic) dyes are more effective on Gram positive bacteria such as Staphyloccus aureus.
The porous sponge dressing material may be shaped if desired to be conformable to the shape of the wound bed. The porous sponge dressing material may have a surface porosity on the surface distal to the wound that allows for moisture transmission outwards but is impermeable to air (inwards). As a result, the porous sponge dressing material can self-rejuvenate until it is fully loaded with exudate, up to 5x, 10x or even 15x its weight in exudate fluid, at which time the dressing would be replaced.
This sponge material of the invention may further be combined with clinically safe agents, e.g. saline, hydration fluids, antimicrobial agents, softening agents, stiffening agents, or wetting agents. The agents may be preloaded prior to clinical use or may be loaded by a clinician at the time of clinical use.
In another example, the synthetic polymer can be polyvinyl formal. The natural polymer material can be either animal or plant derived, for example, collagen, chitosan, or polyethylene terephthalate.
The sealing layer, drape or cover 20 acts to form a vacuum seal over the dressing 12 to the wound perimeter. The sealing layer 20 may be polymeric in composition where the polymer can be a synthetic substance, a natural substance or combinations thereof. The sealing layer may also be metallic in composition. The sealing layer may be comprised of multiple polymeric and or metallic layers and may further have adhesives on its surfaces or between layers.
The vacuum connection assembly 30 acts to apply auxiliary vacuum through the sealing layer 20 to the sponge dressing 12 from the vacuum mechanism 40 via plastic conduits 82 and 80 as seen in
The vacuum mechanism 40 provides a clinically beneficial negative pressure (up to -120 mm Hg) to the wound site 14 through the porous foam dressing material 10/12. The vacuum mechanism 40 may be affixed external to the sealing layer 20, positioned adjacent the sealing layer or be imbedded within the sealing layer and draws fluid away from the porous foam sponge material through one or more paths. The vacuum or negative pressure is achieved and controlled through many methods known to those skilled in the art. In one embodiment, the vacuum is achieved through an energized device. In another embodiment, the vacuum is achieved through a manual process such as a syringe or squeeze bulb. Preferably, the device is a mechanical pump which is energized or powered by batteries. The vacuum mechanism may allow for filtration of fluid prior to entering the fluid return path. The vacuum mechanism may allow for the addition of clinically safe agents to the fluid prior to entering the fluid return path.
The medical device described in this invention may be single use and thus disposable or one or more of its components may be reusable. It is envisioned that all components will be disposable and that a whole unit will be disposable as medical waste. The device may be fully assembled when received by the customer or may require assembly at the point of care.
The NPWT system of the invention may optionally have a sealing layer 20 as shown in
As previously noted, the inventive assembly may have a vacuum connection component 30. This component would be located between the auxiliary vacuum unit 40 and the foamed porous material dressing 10/12. In one embodiment of the invention, the vacuum connection component has baffles or channels that aid in equilibrating the vacuum from the auxiliary vacuum unit 40 to the porous material 10/12 or aid in distributing filtered exudate back to the porous material. One or a plurality of fluid removal and/or fluid return chambers may be used where each chamber has one or more of the functions listed above.
The vacuum connection component may also be provided with a vacuum port/valve. This port/valve component is gas permeable but not liquid permeable and acts to protect the auxiliary vacuum unit from being fouled by exudate. In another embodiment, the assembly may be provided with a check valve to prevent back flow of air into the vacuum connection component and/or the porous sponge material. In yet another embodiment, the vacuum connection component may have a length of tubing to separate the auxiliary vacuum unit from the porous sponge material. One or a plurality of vacuum port/valves may be used where each unit has one or more of the functions listed above.
The auxiliary vacuum unit 40 of the invention (see vacuum motor 78 in
As previously noted, the auxiliary vacuum unit can be powered by a mechanical action, e.g. a syringe force. The auxiliary vacuum unit (pump) is preferably powered with an electrical supply, most preferably a battery. Examples of battery powered pumps that could be used in the auxiliary vacuum unit include Models Compact/OEM and KPV-14A available from Cole Parmer, Model NMP 03 KP DC-S available from KNF Neuberger, Inc. and Model SX-1 from Binaca Products.
While the auxiliary vacuum unit 40 can sit on the distal (outward) facing surface of the porous material 10/12, the auxiliary vacuum unit 40 can be embedded or encased in the porous material 10/12 to provide a low-profile system.
The auxiliary vacuum unit 40 may have addition features including:
The auxiliary vacuum unit 40 is provided with an integral motor 78 and can also be provided with a vacuum exhaust component that allows escape of air and moisture vapor that has traveled through the auxiliary vacuum unit. The vacuum exhaust component may sit on the surface of the auxiliary vacuum unit or be attached to the auxiliary vacuum unit through a length of tubing. One or a plurality of vacuum exhausts may be used. The auxiliary vacuum unit may also serve as a check valve to prevent back flow of air into the auxiliary vacuum unit.
The NPWT system may further have a sealing drape layer 20. The sealing drape layer 20 acts to seal the wound bed in an airtight manner. It can also act as the moisture vapor transmission layer described above. In this case, the sealing layer may cover the auxiliary vacuum unit, porous material and other components of the device. In another modification, the sealing drape layer is non-permeable. In this case it would run from the healthy skin to the moisture vapor transmission layer, or it would still cover the entire NPWT system where moisture transmission would be through the auxiliary vacuum unit or vacuum exhaust component.
The overall system is a single use, disposable product. The system is supplied sterile and have a useful lifetime of approximately 1 day, more preferably 2-3 days, and most preferably up to 7 days depending upon the type and severity of the wound.
The control system 70 as schematically shown in
The clinically therapeutic negative pressure range for the device is about -60 mmHg to about -120 mmHg which is shown in
The negative pressure cut-off value for the device is about -120 mmHg. Beyond this value, the patient experiences discomfort.
The push button and three LED’s provide the device user interface. When the push button is first pushed, the device starts up, performs an initial operational check and indicates it is ready for operation by illuminating a green LED. The second time the push button is pushed, the device initiates treatment and starts monitoring operational status. Good status is indicated by an illuminated green light. Warning status is indicated by an illuminated yellow light and a unique tactile feedback pattern. Error status is indicated by an illuminated red light and a different unique tactile feedback pattern.
Having separate ambient and vacuum absolute pressure sensors have advantages over a single differential sensor common the state of the art. Differential pressure sensors require that the path to the ambient pressure be physically adjacent to the path to the vacuum pressure. Separate sensors allow the paths to be physically separated. Differential pressure sensors are bulky and difficult to mount, whereas absolute pressure sensors are small with a wide variety at mounting options. The ambient pressure sensor provides barometric pressure, which can provide an input to the volume calculations to determine the operational status.
At the onset of treatment with the dressing properly secured with no leaks, the device undergoes initial start-up. The vacuum motor 78 will turn on and remain running until it reaches the upper therapy threshold, at which point the vacuum motor is turned off and the pressure control will start.
Pressure control consists of reading the ambient and vacuum pressure sensors periodically. Each time a sensor is read, the vacuum level is calculated as the difference between the ambient and vacuum pressure sensors. If the vacuum is at or below the lower therapy threshold, the vacuum motor is turned on. When the vacuum subsequently reaches the upper therapy threshold, the vacuum motor is turned off.
Research has shown that a variable vacuum level may provide more effective therapy than a constant vacuum level. During the course of therapy, the microcontroller may optionally change the upper and lower threshold values in a redetermined pattern over the course of several minutes to improve the therapy effectiveness. In another embodiment, the pressure is held constant.
Operational status monitoring will run continuously once the NPWT device is started with the first push of the button. The status monitoring will include battery level, leak detection, microcontroller health, blockage detection, loss of volume capacity and device lifetime. The battery level will be monitored using both coulomb counting methods, and voltage level measurements. A warning level and error level will be established for battery monitoring based on battery characteristics. Leak rate will be calculated by summing the time of the ramp up (A in
The principles, preferred embodiments and modes of operation of the present invention have been described in the foregoing specification. However, the invention should not be construed as limited to the particular embodiments which have been described above. Instead, the embodiments described here should be regarded as illustrative rather than restrictive. Variations and changes may be made by others without departing from the scope of the present invention as defined by the following claims:
This application is a continuation application of Application No. 16/602,519, filed Oct. 24, 2019, which is a utility patent application claiming priority and benefit from U.S. Provisional Pat. Application No. 62/749,902 filed Oct. 24, 2018, the contents of which in their entirety are herein incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 62749902 | Oct 2018 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16602519 | Oct 2019 | US |
| Child | 18196079 | US |
