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US-20260124149-A1 - MODALITY, METHOD OF PRODUCING MODALITY, AND METHOD OF ADMINISTERING MODALITY INCLUDING POLYHYDRADED IONOGEN SOLUTION IN THE TREATMENT OF CHRONIC WOUNDS

US20260124149A1US 20260124149 A1US20260124149 A1US 20260124149A1US-20260124149-A1

Abstract

A treatment modality for use in the remediation of damaged tissues that involves protease down regulator solution impregnated microspheres, and the methods of production and therapeutic use thereof.

Inventors

  • Timothy Alcorn
  • Anthony Gene Osha Gilstrap
  • Claude Gene Gilstrap
  • Berwin Singh Swami Vetha

Assignees

  • Advanced Healing Technologies, LLC

Dates

Publication Date
20260507
Application Date
20251105

Claims (20)

  1. 1 . A composition for use in the remediation of damaged tissues within a chronic wound comprising: a proteinase down regulator solution for accelerating tissue repair of the damaged tissues within the chronic wound comprising a proteinase down regulator, said proteinase down regulator solution being encapsulated in one or more microspheres, wherein the one or more microspheres comprise a polymer for encapsulating the proteinase down regulator solution.
  2. 2 . The composition of claim 1 wherein said one or more microspheres are fabricated inclusive of constituents selected from a group consisting of Poly(lactic-co-glycolic acid) (PLGA), Polylactic acid (PLA), Polyanhydrides, and Polyorthoesters.
  3. 3 . The composition of claim 1 wherein said one or more microspheres are fabricated inclusive of constituents selected from a group consisting of albumin, gelatin, Chitosan and Alginate.
  4. 4 . The composition of claim 1 further comprising, a bandage into which said microsphere are incorporated embedded to enable application of the one or more microspheres to the damaged tissues within the chronic wound.
  5. 5 . The composition of claim 1 further comprising a solution a constituent of which is said one or more microspheres, for application of said one or more microsphere to the damaged tissues, with said solution residing within an aerosol dosage delivery device.
  6. 6 . The composition of claim 1 wherein said one or more microspheres are fabricated to encapsulate proteinase down regulator constituents selected from a group consisting of Zn 2+ , Rh + , Mg 2+ , Co 2+ , Ca 2+ , Cu 2+ , Fe 2+ , Fe 3+ , Ni 2+ , Ni 3+ , Al 2+ , Mn 2+ , Mn 3+ , Ti 2+ , Ti 3+ , Mo 2+ , and Mo 3+ .
  7. 7 . The composition of claim 1 wherein said microspheres encapsulate proteinase down regulator constituents selected from a group consisting of Br 2+ , Rh + , Mg 2+ , Co 2+ , Ca 2+ , Cu 2+ , Fe 2+ , Fe 3+ , Ni 2+ , Ni 3+ , Al 2+ , Mn 2+ , Mn 3+ , Ti 2+ , Ti 3+ , Mo 2+ , and Mo 3+ .
  8. 8 . The composition of claim 7 further comprising as a constituent of said proteinase down regulator poly-ethylene glycol.
  9. 9 . (canceled)
  10. 10 . A composition for use in the remediation of damaged tissues within a chronic wound comprising: a proteinase down regulator solution comprising water and an organic acid for accelerating tissue repair of the damaged tissues within the chronic wound, said proteinase down regulator solution being encapsulated in one or more microspheres, wherein the one or more microspheres comprise a polymer for encapsulating the proteinase down regulator solution.
  11. 11 . The composition of claim 10 wherein said one or more microspheres are fabricated to encapsulate proteinase down regulator constituents selected from a group consisting of Zn 2+ , Rh + , Mg 2+ , Co 2+ , Ca 2+ , Cu 2+ , Fe 2+ , Fe 3+ , Ni 2+ , Ni 3+ , Al 2+ , Mn 2+ , Mn 3+ , Ti 2+ , Ti 3+ , Mo 2+ , and Mo 3+ .
  12. 12 . The composition of claim 10 wherein said one or more microspheres are fabricated to encapsulate proteinase down regulator constituents selected from a group consisting Br 2+ , Rh + , Mg 2+ , Co 2+ , Ca 2+ , Cu 2+ , Fe 2+ , Fe 3+ , Ni 2+ , Ni 3+ , Al 2+ , Mn 2+ , Mn 3+ , Ti 2+ , Ti 3+ , Mo 2+ , and Mo 3+ .
  13. 13 . A method for treating damaged tissues within a chronic wound comprising the steps of: selecting a proteinase down regulator solution for accelerating tissue repair of the damaged tissues within the chronic wound comprising a proteinase down regulator encapsulated within one or more microspheres, wherein the one or more microspheres comprise a polymer for encapsulating the proteinase down regulator solution; and applying said one or more microspheres having the encapsulated proteinase down regulator solution therein to said damaged tissue within the chronic wound.
  14. 14 . The method of claim 13 wherein said one or more microspheres are fabricated inclusive of constituents selected from a group consisting of Poly(lactic-co-glycolic acid) (PLGA), Polylactic acid (PLA), Polyanhydrides, and Polyorthoesters.
  15. 15 . The method of claim 13 wherein the step of applying said one or more microspheres having the encapsulated proteinase down regulator solution further comprises applying said one or more microspheres through use of a bandage having been impregnated with said one or more microspheres having the encapsulated proteinase down regulator solution therein.
  16. 16 . The method of claim 13 wherein the step of applying said one or more microspheres having the encapsulated proteinase down regulator solution further comprises applying said one or more microspheres through use of an aerosol dosage delivery device in which said one or more microspheres having the encapsulated proteinase down regulator solution therein has been placed for later administration.
  17. 17 . The method of claim 13 wherein said one or more microspheres are fabricated inclusive of one or more proteinase down regulator constituents selected from a group consisting of Zn 2+ , Rh + , Mg 2+ , Co 2+ , Ca 2+ , Cu 2+ , Fe 2+ , Fe 3+ , Ni 2+ , Ni 3+ , Al 2+ , Mn 2+ , Mn 3+ , Ti 2+ , Ti 3+ , Mo 2+ , and Mo 3+ .
  18. 18 . The method of claim 13 wherein said one or more microspheres are fabricated inclusive of one or more proteinase down regulator constituents selected from a group consisting of Br 2+ , Rh + , Mg 2+ , Co 2+ , Ca 2+ , Cu 2+ , Fe 2+ , Fe 3+ , Ni 2+ , Ni 3+ , Al 2+ , Mn 2+ , Mn 3+ , Ti 2+ , Ti 3+ , Mo 2+ , and Mo 3+ .
  19. 19 . The method of claim 13 wherein a constituent of said proteinase down regulator is poly-ethylene glycol.
  20. 20 . A method for producing a treatment modality for treatment of damaged tissues within chronic wound comprising the steps of: producing a proteinase down regulator solution for accelerating tissue repair of the damaged tissues within the chronic wound comprising a custom saline solution acting as a proteinase down regulator; producing one or more microspheres comprising a polymer; and encapsulating portions of the custom saline solution into the one or more microspheres.

Description

CROSS-REFERENCE TO RELATED APPLICATION AND PRIORITY CLAIM This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Ser. No. 63/716,533 filed on Nov. 5, 2024 (Atty. Dkt. No ADVA 90-00002), which is hereby incorporated by reference in its entirety. BACKGROUND OF THE INVENTION Field of the Invention The present disclosure relates to medicaments and treatment regimens in addressing chronic wounds in humans. Background of the Invention Chronic wounds are a significant yet underappreciated health concern, impacting millions of individuals globally. Unlike acute wounds, which typically heal within a predictable timeframe, chronic wounds persist beyond three months and resist conventional treatments. These include diabetic foot ulcers, venous leg ulcers, and pressure ulcers, which are not only physically debilitating but also have severe psychological, social, and financial ramifications. People suffering from chronic wounds experience a range of challenges that go beyond physical discomfort. The persistent pain, immobility, and risk of infection severely diminish their quality of life. Chronic wounds are often accompanied by complications such as cellulitis, osteomyelitis, and sepsis, which can lead to frequent hospitalizations or even amputations, especially in patients with diabetic ulcers. Pain management is another significant challenge. Chronic wound pain can range from mild discomfort to severe, constant agony. Pain during dressing changes is particularly distressing, and patients often live in fear of these routines but necessary interventions. The psychological toll can be severe, leading to depression, anxiety, and social isolation as individuals struggle to cope with the long-term nature of their condition. Treating chronic wounds places a heavy financial burden on both individuals and healthcare systems. In the United States alone, at the time of this writing, the estimated annual cost of chronic wound care ranges from $28 billion to $31 billion. This includes direct medical costs, such as hospital stays, physician services, surgical procedures, medications, wound dressings, and specialized therapies like hyperbaric oxygen treatment. Key factors that drive up these costs include: a. Long-term care: Chronic wounds require ongoing treatment and monitoring, often for years. Regular visits to wound care specialists, repeated debridement (removal of dead tissue), and daily dressing changes all add to the cost burden.b. Complications and comorbidities: Chronic wounds are often complicated by underlying health conditions, such as diabetes, cardiovascular disease, and poor circulation, all of which increase the complexity and expense of treatment.c. Advanced therapies: The use of advanced wound care products and technologies, like negative pressure wound therapy or bioengineered skin substitutes, while effective in some cases, can be costly and are not always covered by insurance. The indirect costs associated with chronic wounds are also significant. Many individuals are unable to work or perform everyday activities due to their wounds, leading to loss of income, reduced productivity, and the need for long-term caregiving. In the case of severe disability, patients may need ongoing assistance with basic tasks, increasing the burden on family members or the need for professional home healthcare services. The societal costs of chronic wounds extend beyond individual suffering and healthcare expenses, affecting public health systems and economies worldwide. Chronic wounds are particularly prevalent among aging populations, individuals with diabetes, and those with limited mobility, all of which are growing demographic in many countries. The increasing prevalence of chronic wounds places a significant burden on healthcare systems, which must allocate substantial resources to wound management. Specialized wound care clinics, inpatient treatments, and the use of advanced wound care technologies require ongoing investment. Hospitals and healthcare professionals are faced with not only treating the wounds but also addressing the underlying conditions, which often complicate care. Chronic wounds often lead to prolonged absenteeism from work, permanent disability, or early retirement, contributing to lost productivity. In particular, people with diabetic foot ulcers face a higher risk of lower extremity amputation, which severely limits their ability to contribute to the workforce. This, in turn, affects businesses and economies by reducing the number of active, able workers. In cases where patients require long-term care due to chronic wounds and associated disabilities, the costs for nursing homes, assisted living facilities, and in-home caregiving can escalate. This puts additional pressure on families, insurance providers, and social welfare programs. SUMMARY OF THE INVENTION In view of the foregoing, it would be advantageous to provide a new and more efficacious treatment regimen for chronic wo