Researchers Submit Patent Application, “Negative Pressure Therapy Systems and Sponges”, for Approval (USPTO 20240074909): Patent Application

2024 MAR 26 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- From Washington, D.C., NewsRx journalists report that a patent application by the inventor Rapp, Scott (Cincinnati, OH, US), filed on November 9, 2023, was made available online on March 7, 2024.

No assignee for this patent application has been made.

News editors obtained the following quote from the background information supplied by the inventors: “Wound care is currently a seven-billion-dollar annual market worldwide. With a rapid rise in cases, the U.S. alone is said to spend 1-2 billion dollars on wound care annually. (See, e.g., Bergstrom N, Allman R M, Carlson C E, Eaglstein W, Frantz R A, Garber S L, et al., Pressure ulcers in adults: prediction and prevention. Rockville (Md.): US Department of Health and Human Services, Public Health Service, Agency for Health Care Policy and Research; 1992, p. 1, which is hereby incorporated by reference.) This escalation of costs adds to the ongoing global medical financial burden. Such strain on the medical system even led the Centers for Medicare & Medicaid Services in 2011 to stop reimbursements for certain wounds felt to be iatrogenic. Consequently, much efforts have been dedicated to wound care research and interventions that may lead to rapid recovery and healing.

“The cause behind the rise in the incidence of wounds requiring extended therapy is multifactorial. For example, an acute or chronic wound can result from trauma, infection, malnutrition, vascular insufficiency, prolonged immobility and decreased tissue perfusion pressure, or any combination of the above. Obesity is frequently a contributing factor, and is currently an endemic problem facing an estimated 35%, or 80 million, people in the U.S. alone, with an estimated medical burden of 147 billion dollars. Morbidities associated with obesity include Type II Diabetes Mellitus (20 million sufferers) and peripheral vascular disease (8 million sufferers). Worldwide, it is estimated that diabetes affects 347 million people.

“Common to both diabetes and peripheral vascular disease is the prevalence of chronic skin wounds. Diabetes affects the microvascular patency and results in neuropathies and skin perfusion compromise. Diabetics often suffer from lower extremity wounds due to the decreased sensation preventing trauma and resulting inability to deliver adequate blood supply to the region to heal the wounds. Hyperglycemia also affects wound healing dynamics. Exacerbated by smoking, hypertension, elevated cholesterol, etc., peripheral vascular disease also contributes to a large number of chronic wounds. Ischemia to end organs (i.e., skin) leads to ulceration and tissue breakdown. Again, poor perfusion to the wounds prevents healing capacity.

“Chronic wounds are present in an estimated 6.5 million people in the U.S. The associated direct and indirect costs to the healthcare system is an estimated 25 billion dollars annually. (See, e.g., Sen C K, Gordillo G M, Roy S, et al. Human skin wounds: a major and snowballing threat to public health and the economy; Wound Repair Regen. 2009; 17(6):763-771, which is hereby incorporated by reference.) A subset of peripheral vascular disease includes what is known as chronic venous insufficiency (CVI), which is generally defined as a skin wound that is present usually below the knee for a period of greater than four weeks. It is estimated that these wounds affect 1-4.3% of the Western population, with a greater prevalence in the adult population over the age of 65. The average time to healing of a CVI is approximately 12 months, and approximately 28% of sufferers will experience more than ten episodes of ulceration in their lifetimes. (See, e.g., Graham I D, Harrison M B, Nelson E A, Lorimer K, Fisher A. Prevalence of lower-limb ulceration: a systematic review of prevalence studies; Advances in Skin and Wound Care 2003; 16:305-16, which is hereby incorporated by reference.) (See, e.g., Margolis D J, Bilker W, Santanna J, Baumgarten M (2002) Venous leg ulcer: incidence and prevalence in the elderly. J Am Acad Dermatol 46: 381-386, which is hereby incorporated by reference.) In this regard, the overall 5-year recurrence rate is up to 78%. (See, e.g., Cost-Effective Use of Silver Dressings for the Treatment of Hard-to-Heal Chronic Venous Leg Ulcers. Jemec G B, Kerihuel J C, Ousey K, Lauemoller S L, Leaper D J. PLoS One. 2014 Jun. 19; 9(6):e100582. doi: 10.1371/journal.pone.0100582. eCollection 2014, which is hereby incorporated by reference.) Notably, there is also a 2.5% mortality rate associated with any chronic wound. (See, e.g., Argenta L C, Morykwas M J, Marks M W, DeFranzo A J, Molnar J A, David L R. Vacuum-assisted closure: State of clinic art. Plast Reconstr Surg. 2006; 117(Suppl):127S-142S, which hereby incorporated by reference.)

“The psychological effects from chronic wounds are major inhibitors to a person’s quality of life and intrusion to activities of daily living. Negative impacts include psychological stresses that involve depression, anxiety, fear, and emotional disorders 10. Patients develop a perceived societal marginalization leading to the stigma, social withdrawal and isolation. A lack of intimate relationships, decrease in overall mood and lack of social support contributes to diminished work productivity. There may be difficulties with acquiring healthcare coverage to compound days at work lost. The total economic financial cost of the above is largely incalculable.

“Wounds resulting from prolonged immobility in the operating theater are also frequent. General anesthesia often involves paralysis of the muscles to assist with surgery, and without muscular contraction, it is difficult for the body to prevent ischemia to tissues over areas of bony prominences. Tissue ischemia occurs when perfusion pressures fall below the externally applied pressures. Areas such as the ischium, trochanteric area, elbows, knees, scalp, and heels are particularly prone to ulceration due to ischemia.

“It is generally accepted that tissue ischemia may occur when externally applied pressures are greater than 32 mmHg for over 2 hours on a particular body area. Thus, skin breakdown from ischemia may also result in as little as two hours when a patient is paralyzed by general anesthesia (or otherwise). Preventive techniques associated with ischemia (i.e., with alleviating/preventing the application of excessive externally applied pressures) commonly involve the placement of foam padding, gels and bumps. The particular problem in the operating theater is that trained physicians/ancillary staff often make incorrect subjective assumptions after visual inspection that perfusion pressures to the skin tissue are adequate. Furthermore, longer surgeries tend to lead to a greater likelihood of ulcer formation. For example, it has been suggested that when a surgery lasts for more than four hours, each additional thirty minutes thereafter leads to a 33% increase in ulcer formation. (See, e.g., Schoonhoven L, Defloor T, Grypdonck M H. Incidence of pressure ulcers due to surgery. J Clin Nurs. 2002; 11(4):479-487, which is hereby incorporated by reference.) Neurosurgery cases, in particular, have an estimated 44% incidence of up to grade II ulcers. (See, e.g., Furuno Y, Sasajima H, Goto Y, Taniyama I, Aita K, Owada K, Tatsuzawa K, Mineura K. Strategies to prevent positioning-related complications associated with the lateral suboccipital approach. J Neurol Surg B Skull Base. 2014 February; 75(1):35-40, which is hereby incorporated by reference.)

“Unfortunately, operating room-acquired ulcers are said to cost the U.S. health care system between 750 million and 1 billion dollars annually. (See, e.g., Beckrich K, Aronovitch S A. Hospital-acquired pressure ulcers: A comparison of costs in medical vs. surgical patients. Nurs Econ. 1999; 17:263-2712, which is hereby incorporated by reference.) And, the estimated annual cost associated with a hospital acquired ulcer is estimated to be $43,180 on an individual patient basis. (See, e.g., Armstrong D. G., Ayello E. A., Capitulo K. L., Folwer E., Krasner D. L., Levine J. M., Sibbald R. G., Smith A. P. S. (2008). New opportunities to improve pressure ulcer prevention and treatment: Implications of the CMS inpatient hospital care present on admission (POA) indicators/hospital-acquired conditions (HAC) policy. A consensus paper from the International Expert Would Care Advisory Panel. Journal of Wound, Ostomy and Continence Nursing, 35 (5), 485-492, which is hereby incorporated by reference.) Chronic wounds are often clinically described by an ulcer classification grade. Grade I ulcers are wounds where the skin is intact, but erythematous and red. Usually pressure relief rectifies this ulcer. Grade II ulcers have skin breakdown and dermis exposed. Local wound care is usually all that is needed to treat and prevent infection of such an ulcer. This is usually through dressings and topical antibiotics in a moist atmosphere. An example of a grade II ulcer is blistering and a chronic draining wound. Grade III ulcers are full thickness defects through the skin, and may expose the underlying fascia. Grade IV ulcers occur when there is a wound with a depth through the muscle that is sufficient to expose underlying bone.”

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As a supplement to the background information on this patent application, NewsRx correspondents also obtained the inventor’s summary information for this patent application: “Exemplary negative pressure therapy sponge embodiments according to this application represent an improvement in multiple aspects over existing negative pressure wound therapy or wound VAC technology. The exemplary embodiments described herein embody advances in the design of the adhesive tape used in negative pressure therapy treatments, the sponge that is placed in the wound, the sensing capability of the negative pressure therapy system, and the user interface provided to assist a user in optimizing wound treatment parameters.

“To address the fact that no wound is exactly alike with respect to size, depth, and clinical appearance, exemplary embodiments described herein include a custom-fabricated negative pressure therapy sponge. The creation and use of a custom-fabricated sponge will allow the sponge fill exactly the wound that the associated negative pressure therapy is attempting to treat. Further, instead of using multiple conventional foam sponges to fill deep, irregular or large holes, as is currently required, exemplary sponge embodiments will be able to evenly fill every portion and gap of a wound-even a deep, irregular or large wound (see e.g., FIG. 1). The use of exemplary sponge embodiments will also, among other things, facilitate prevention of foreign body retention in the wound, which may lead to infection or death.

“Other aspects and features of the invention will become apparent to those skilled in the art upon review of the following detailed description of exemplary embodiments along with the accompanying drawing figures.”

The claims supplied by the inventors are:

“1) A negative pressure therapy system for a wound environment comprising: a) a pump adapted to generate a negative pressure for the wound environment; b) a film connected to the pump and positioned outward from a negative pressure sponge conforming to contours of the wound environment; the film forming a seal creating the negative pressure wound environment and further comprising one or more pressure sensors adapted to sense positive, negative and zero pressures associated with the wound environment and communicate wirelessly with a monitor/controller remote from the one or more pressure sensors; and c) the monitor/controller intercommunicating with the one or more pressure sensors and the pump; the monitor/controller comprising software adapted to: i) quantify the positive, negative and zero pressures sensed by the one or more pressure sensors; ii) cause the controller to automatically control the negative pressures supplied by the pump to the wound environment, wherein the controller’s automatic control is dependent on the positive, negative and zero pressures sensed by the one or more pressure sensors; and iii) create a visual graphic depiction on the monitor of simultaneous negative, positive and zero pressures associated with the wound environment, wherein the visual graphic depiction assists a user in remotely and manually controlling the negative, positive and zero pressures of the wound environment and negative pressure supplied by the pump to the wound environment.

“2) The negative pressure therapy system of claim 1 further comprising at least one sensor adapted to sense one or more of the following: a) temperature; b) pH; c) glucose; and/or d) growth factor.

“3) The negative pressure therapy system of claim 2, wherein the negative pressure sponge includes one or more of the following: a) antimicrobials; b) rigidity agents; c) stem cells; d) growth factors; e) wound healing enhancers; f) debriding agents; g) angiogenic agents; h) fibroblastic agents; i) tissue promoting agents; and/or j) pharmaceutical agents.

“4) The negative pressure therapy system of claim 3, wherein a multi-component liquid is delivered to the wound environment to create the negative pressure sponge conforming to contours of the wound environment.

“5) The negative pressure therapy systems of claim 4, wherein the film comprises an injection port.

“6) A negative pressure therapy system for a wound environment comprising: a) a pump adapted to generate a negative pressure for the wound environment; b) a film connected to the pump and positioned outward from a negative pressure sponge conforming to contours of the wound environment; the film forming a seal creating the negative pressure wound environment and further comprising one or more pressure sensors adapted to sense positive, negative and zero pressures associated with the wound environment and communicate wirelessly with a monitor/controller remote from the one or more pressure sensors; and c) the monitor/controller intercommunicating with the one or more pressure sensors and the pump.

“7) The negative pressure therapy system for a wound environment of claim 6, wherein the monitor/controller comprising software adapted to: a) quantify the positive, negative and zero pressures sensed by the one or more pressure sensors; b) cause the controller to automatically control the negative pressures supplied by the pump to the wound environment, wherein the controller’s automatic control is dependent on the positive, negative and zero pressures sensed by the one or more pressure sensors; and c) create a visual graphic depiction on the monitor of simultaneous negative, positive and zero pressures associated with the wound environment, wherein the visual graphic depiction assists a user in remotely and manually controlling the negative, positive and zero pressures of the wound environment and negative pressure supplied by the pump to the wound environment.

“8) The negative pressure therapy system of claim 7 further comprising at least one sensor adapted to sense one or more of the following: a) temperature; b) pH; c) glucose; and/or d) growth factor.

“9) The negative pressure therapy system of claim 8, wherein the negative pressure sponge includes one or more of the following: a) antimicrobials; b) rigidity agents; c) stem cells; d) growth factors; e) wound healing enhancers; f) debriding agents; g) angiogenic agents; h) fibroblastic agents; i) tissue promoting agents; and/or j) pharmaceutical agents.

“10) The negative pressure therapy system of claim 9, wherein a multi-component liquid is delivered to the wound environment to create the negative pressure sponge conforming to contours of the wound environment.

“11) The negative pressure therapy systems of claim 10, wherein the film comprises an injection port.

“12) A system adapted to generate a negative pressure for a wound environment; the system comprising: a) a pump adapted to generate a negative pressure for the wound environment; b) a film connected to the pump and positioned outward from a negative pressure sponge conforming to contours of the wound environment, wherein the film creates a seal for the wound environment; c) one or more pressure sensors attached to the film and adapted to sense positive, negative and zero pressures associated with the wound environment; and d) a monitor/controller intercommunicating wirelessly with the one or more pressure sensors and the pump controlling adjustment of the positive, negative and zero pressures associated with the wound environment.

“13) The system adapted to generate a negative pressure for a wound environment of claim 12, wherein the monitor/controller comprising software adapted to: a) quantify the positive, negative and zero pressures sensed by the one or more pressure sensors; b) cause the controller to automatically control the negative pressures supplied by the pump to the wound environment, wherein the controller’s automatic control is dependent on the positive, negative and zero pressures sensed by the one or more pressure sensors; and c) create a visual graphic depiction on the monitor of simultaneous negative, positive and zero pressures associated with the wound environment, wherein the visual graphic depiction assists a user in remotely and manually controlling the negative, positive and zero pressures of the wound environment and negative pressure supplied by the pump to the wound environment.

“14) The system adapted to generate a negative pressure for a wound environment of claim 13, wherein the film is trimmed to fit the exposed surface area of the wound environment.

“15) The system adapted to generate a negative pressure for a wound environment of claim 13, wherein the one or more pressure sensors is a piezoelectric coating applied to the film.

“16) The system adapted to generate a negative pressure for a wound environment of claim 13, wherein the one or more pressure sensors are embedded in the film.

“17) The system adapted to generate a negative pressure for a wound environment of claim 15, wherein a portion of the film comprises the piezoelectric coating.

“18) The system adapted to generate a negative pressure for a wound environment of claim 16, wherein the one or more pressure sensors are embedded into a portion of the film.”

For additional information on this patent application, see: Rapp, Scott. Negative Pressure Therapy Systems and Sponges. U.S. Patent Application Number 20240074909, filed November 9, 2023 and posted March 7, 2024. Patent URL (for desktop use only): https://ppubs.uspto.gov/pubwebapp/external.html?q=(20240074909)&db=US-PGPUB&type=ids

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