WO2022023089A1 - Method for supporting wound healing - Google Patents

Method for supporting wound healing Download PDF

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Publication number
WO2022023089A1
WO2022023089A1 PCT/EP2021/070041 EP2021070041W WO2022023089A1 WO 2022023089 A1 WO2022023089 A1 WO 2022023089A1 EP 2021070041 W EP2021070041 W EP 2021070041W WO 2022023089 A1 WO2022023089 A1 WO 2022023089A1
Authority
WO
WIPO (PCT)
Prior art keywords
wound
air
tubing
flow
pump
Prior art date
Application number
PCT/EP2021/070041
Other languages
French (fr)
Inventor
Frank Sams-Dodd
Jeanette SAMS-DODD
Original Assignee
Sams Dodd Frank
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sams Dodd Frank filed Critical Sams Dodd Frank
Publication of WO2022023089A1 publication Critical patent/WO2022023089A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/02—Enemata; Irrigators
    • A61M3/0233—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs
    • A61M3/0254—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs the liquid being pumped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/84—Drainage tubes; Aspiration tips
    • A61M1/85—Drainage tubes; Aspiration tips with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/02—Gases
    • A61M2202/0208—Oxygen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/07—General characteristics of the apparatus having air pumping means

Definitions

  • the field of invention is the treatment and management of wounds.
  • Current approaches mainly focus on maintaining a moist wound environment, usually by occluding the wound.
  • the invention is a method of treating wounds by actively providing a flow of air to a wound or an area of a wound.
  • a wound is understood as breakage, disruption or opening of the moisture barrier of a body surface in direct or indirect contact with the external environment. This includes body surfaces covered by cutaneous membranes (skin) and mucosal (mucous) membranes.
  • the types of breakage include, but are not limited to trauma and surgical wounds, abscesses, furuncles and carbuncles, ulcers such as diabetic foot, venous leg and pressure ulcers, wounds and burns caused by thermal, radiation, and chemical exposure, wounds caused by infection and conditions such as acne, psoriasis, eczema, dermatitis, cancer, hidradenitis suppurativa and pyoderma gangrenosum.
  • the skin or a wound Under natural conditions, the skin or a wound will be exposed to air.
  • the movement of air prevents the establishment of micro-conditions with low oxygen levels, which can benefit anaerobic bacteria, and it assists in reducing the moisture level at the wound surface.
  • the wound may be in a location, where the free movement of air is not possible, e.g. in a shoe, or the wound may be deep, whereby flow of air is reduced. This will result in the formation of micro-climate conditions with reduced air-circulation and this can benefit the presence of anaerobic bacteria, which can be responsible for or exacerbate many wound infections.
  • the active delivery of a flow of air can reduce this formation of micro-climates with reduced oxygen levels and/or high moisture levels.
  • the flow of air can be achieved by a pump, which delivers air at a pressure into a tubing, which delivers the air to the desired area or location on the wound, either directly from the opening of the tubing or the tubing can be connected to an end-piece from which the air is finally delivered to the wound.
  • a pump is understood in the normal sense of the word as well as any other apparatus or mechanism that can deliver air or a gas at a pressure.
  • Tubing is understood to include a pipe, a tube, a hose, ducting, and any other method to transport air from the pump to the wound area.
  • End-piece is understood to include any method for concentrating, distributing or changing the flow of air after exiting the tubing and before delivering the air to the wound.
  • the delivery can be to a wound surface, into a cavity or into subsections of the wound, e.g. sinuses, tracts or tunnels.
  • the natural flow of air to a wound or an area of a wound is often restricted, e.g. if the person is forced to sit on the area, e.g. a wound on the sacrum or buttocks, or if the wound is deep with sinuses, cavities or tracts.
  • Current wound treatments do not consider the flow of air to a wound of importance for healing, but clinical observations using an air-pump to provide such flow have confirmed the importance of this.
  • the invention is therefore the use of a pump and tubing to deliver a flow of air to a wound or section of a wound to support healing.
  • the invention may be used alone or in combination with other treatments, e.g. micropore-particle-technology (MPPT) (Sams-Dodd & Sams-Dodd 2018).
  • MPPT micropore-particle-technology
  • a pump delivers air into a tubing; the tubing leads the air or the gas a distance; and the air or the gas is released directly from the tubing to the wound or through an end-piece to the wound.
  • the intake of the pump can either be air or a gas.
  • Figure 2 The invention used in the treatment of a shallow wound. The air is released from the end of the tubing or an end-piece onto the wound surface.
  • Figure 3 The invention used in the treatment of a deep wound with a cavity.
  • the tubing terminates within the wound cavity and air is released directly into the cavity.
  • Figure 4 The invention used in the treatment of a deep wound with sinuses or tracts.
  • the tubing terminates within the individual tunnels, tracks and sinuses and air is released directly into these.
  • Figure 5 The invention used in the treatment of a wound in a place that often will have limited airflow.
  • the tubing delivers directly or using a diffusing mechanism air to the wound surface.
  • Figure 6 The invention used in the treatment of a wound located on the foot.
  • the tubing or the end-piece delivers air to the wound.
  • An embodiment is the use of a mechanical pump to pump air through tubing, for example silicone tubing, to a wound or an area of a wound.
  • the tubing can terminate at or close to the wound surface or opening, or it can terminate inside the wound in a wound cavity, tunnel, sinus or similar.
  • the preferred embodiment is the delivery of air at a flow-rate of 1.0 to 5.0 litre to each area of the wound in need of this treatment.
  • the invention can be used for the delivery of a gas containing between 15% and 100% oxygen (by volume) to areas of the wound in need of this treatment.
  • the invention can also be used in combination with other wound treatment approaches such as micropore- particle technology (Sams-Dodd 2018).
  • Other wound treatment approaches such as micropore- particle technology (Sams-Dodd 2018).
  • the use of the invention would be similar.
  • the preferred embodiment in combination with micropore particle technology is a pump with a flow-rate of 1.0 to 5.0 litre of air per minute through tubing.
  • the air can be replaced by a gas containing between 15% and 100% oxygen (by volume).
  • Example 1 An 86 year old paraplegic woman had a chronic pressure ulcer on the ischial tuberosity with confirmed underlying osteomyelitis.
  • the skin opening was 6 cm x 2 cm leading into expanding 10 cm deep cavity that leads into 2 additional wide 3 cm deep tunnels in both directions along palpable bone.
  • the soft tissue was infected.
  • the patient received daily MPPT applications into the wound and using an air pump with a flow-rate of 1.2 litre/min air was provided through pharma-grade silicone tubing to the bottom of the wound.
  • the treatment resulted in a reduction of the wound to a skin opening of 1.5 cm x 0.5 cm leading into 3 narrow 3-4 cm deep tunnels down to the level of the bone as well as the removal of the soft tissue infection.
  • Example 2 A paraplegic man with a recurrent pressure ulcer in the gluteal fold was using MPPT for treating the wound, but due to the wound's position, air-flow was restricted and the wound was only healing slowly. A pump with tubing exiting close to the wound opening was put in place and was used during day-time, when the person was in his chair, and during the night. The result was a rapid improvement in the healing.
  • Example 3 A tetraplegic woman with a recurrent sacral pressure ulcer was using MPPT for treating the wound. Due to her condition, it was difficult to expose the wound to air unless she had to maintain bed rest for extended periods of time. A pump was used to supply a constant flow of air to the wound. The result was a rapid improvement in healing.
  • Example 4 A 65 year old tetraplegic man had a chronic pressure ulcer on the ischial tuberosity with confirmed underlying osteomyelitis. The wound was treated with MPPT, but insufficient air was reaching the wound area. First, one pump providing a constant air-flow to the wound was used and an improvement in healing was seen. At a later date a second pump was installed and a further improvement in healing was observed.

Abstract

The invention relates to the field of wound treatment. It discloses the use of a pump to deliver through tubing a flow of air or gas to a wound or an area of a wound to be used in the treatment of the wound..

Description

Method for supporting wound healing
Field
The field of invention is the treatment and management of wounds. Current approaches mainly focus on maintaining a moist wound environment, usually by occluding the wound. The invention is a method of treating wounds by actively providing a flow of air to a wound or an area of a wound.
Background
A wound is understood as breakage, disruption or opening of the moisture barrier of a body surface in direct or indirect contact with the external environment. This includes body surfaces covered by cutaneous membranes (skin) and mucosal (mucous) membranes. The types of breakage include, but are not limited to trauma and surgical wounds, abscesses, furuncles and carbuncles, ulcers such as diabetic foot, venous leg and pressure ulcers, wounds and burns caused by thermal, radiation, and chemical exposure, wounds caused by infection and conditions such as acne, psoriasis, eczema, dermatitis, cancer, hidradenitis suppurativa and pyoderma gangrenosum.
Winter (1962) found that preventing scab formation by maintaining a moist wound surface assists the migration of epithelial cells across the wound surface. This discovery resulted in wound treatment products aiming to maintain a moist wound surface, i.e. using different approaches to occlude the wound to retain moisture naturally coming from the wound. It was, however, also realised that a wet wound surface would cause maceration and another line of approach was the removal of fluid by absorption or using a vacuum pump. Finally, many approaches have involved the use of antimicrobials to reduce the presence of microorganisms. None of the approaches have relied on or involved the active delivery of a flow of air as a method to support wound healing.
Under natural conditions, the skin or a wound will be exposed to air. The movement of air prevents the establishment of micro-conditions with low oxygen levels, which can benefit anaerobic bacteria, and it assists in reducing the moisture level at the wound surface. However, the wound may be in a location, where the free movement of air is not possible, e.g. in a shoe, or the wound may be deep, whereby flow of air is reduced. This will result in the formation of micro-climate conditions with reduced air-circulation and this can benefit the presence of anaerobic bacteria, which can be responsible for or exacerbate many wound infections. The active delivery of a flow of air can reduce this formation of micro-climates with reduced oxygen levels and/or high moisture levels. The flow of air can be achieved by a pump, which delivers air at a pressure into a tubing, which delivers the air to the desired area or location on the wound, either directly from the opening of the tubing or the tubing can be connected to an end-piece from which the air is finally delivered to the wound. A pump is understood in the normal sense of the word as well as any other apparatus or mechanism that can deliver air or a gas at a pressure. Tubing is understood to include a pipe, a tube, a hose, ducting, and any other method to transport air from the pump to the wound area. End-piece is understood to include any method for concentrating, distributing or changing the flow of air after exiting the tubing and before delivering the air to the wound. The delivery can be to a wound surface, into a cavity or into subsections of the wound, e.g. sinuses, tracts or tunnels.
Summary of the Invention
The natural flow of air to a wound or an area of a wound is often restricted, e.g. if the person is forced to sit on the area, e.g. a wound on the sacrum or buttocks, or if the wound is deep with sinuses, cavities or tracts. Current wound treatments do not consider the flow of air to a wound of importance for healing, but clinical observations using an air-pump to provide such flow have confirmed the importance of this. The invention is therefore the use of a pump and tubing to deliver a flow of air to a wound or section of a wound to support healing. The invention may be used alone or in combination with other treatments, e.g. micropore-particle-technology (MPPT) (Sams-Dodd & Sams-Dodd 2018).
Brief Description of the Drawing
The figures are non-limiting examples of the implementation of the invention.
Figure 1: A pump delivers air into a tubing; the tubing leads the air or the gas a distance; and the air or the gas is released directly from the tubing to the wound or through an end-piece to the wound. The intake of the pump can either be air or a gas.
Figure 2: The invention used in the treatment of a shallow wound. The air is released from the end of the tubing or an end-piece onto the wound surface.
Figure 3: The invention used in the treatment of a deep wound with a cavity. The tubing terminates within the wound cavity and air is released directly into the cavity.
Figure 4: The invention used in the treatment of a deep wound with sinuses or tracts. The tubing terminates within the individual tunnels, tracks and sinuses and air is released directly into these. Figure 5: The invention used in the treatment of a wound in a place that often will have limited airflow. The tubing delivers directly or using a diffusing mechanism air to the wound surface.
Figure 6: The invention used in the treatment of a wound located on the foot. The tubing or the end-piece delivers air to the wound.
A Detailed Description
An embodiment is the use of a mechanical pump to pump air through tubing, for example silicone tubing, to a wound or an area of a wound. The tubing can terminate at or close to the wound surface or opening, or it can terminate inside the wound in a wound cavity, tunnel, sinus or similar.
The preferred embodiment is the delivery of air at a flow-rate of 1.0 to 5.0 litre to each area of the wound in need of this treatment.
The invention can be used for the delivery of a gas containing between 15% and 100% oxygen (by volume) to areas of the wound in need of this treatment.
The invention can also be used in combination with other wound treatment approaches such as micropore- particle technology (Sams-Dodd 2018). The use of the invention would be similar.
The preferred embodiment in combination with micropore particle technology is a pump with a flow-rate of 1.0 to 5.0 litre of air per minute through tubing. The air can be replaced by a gas containing between 15% and 100% oxygen (by volume).
Examples
Example 1: An 86 year old paraplegic woman had a chronic pressure ulcer on the ischial tuberosity with confirmed underlying osteomyelitis. At start of treatment, the skin opening was 6 cm x 2 cm leading into expanding 10 cm deep cavity that leads into 2 additional wide 3 cm deep tunnels in both directions along palpable bone. The soft tissue was infected. The patient received daily MPPT applications into the wound and using an air pump with a flow-rate of 1.2 litre/min air was provided through pharma-grade silicone tubing to the bottom of the wound. The treatment resulted in a reduction of the wound to a skin opening of 1.5 cm x 0.5 cm leading into 3 narrow 3-4 cm deep tunnels down to the level of the bone as well as the removal of the soft tissue infection. Example 2: A paraplegic man with a recurrent pressure ulcer in the gluteal fold was using MPPT for treating the wound, but due to the wound's position, air-flow was restricted and the wound was only healing slowly. A pump with tubing exiting close to the wound opening was put in place and was used during day-time, when the person was in his chair, and during the night. The result was a rapid improvement in the healing.
Example 3: A tetraplegic woman with a recurrent sacral pressure ulcer was using MPPT for treating the wound. Due to her condition, it was difficult to expose the wound to air unless she had to maintain bed rest for extended periods of time. A pump was used to supply a constant flow of air to the wound. The result was a rapid improvement in healing.
Example 4: A 65 year old tetraplegic man had a chronic pressure ulcer on the ischial tuberosity with confirmed underlying osteomyelitis. The wound was treated with MPPT, but insufficient air was reaching the wound area. First, one pump providing a constant air-flow to the wound was used and an improvement in healing was seen. At a later date a second pump was installed and a further improvement in healing was observed.
References
Sams-Dodd J & Sams-Dodd F (2018) Time to Abandon Antimicrobial Approaches in Wound Healing: A Paradigm Shift. Wounds, 30(11): 345-352.
Winter GD (1962) Formation of the scab and the rate of epithelization of superficial wounds in the skin of the young domestic pig. Nature 193: 293-4.

Claims

Claims
1. A method of treating a wound comprising the use of a pump to deliver through tubing a flow of air to a wound or an area of a wound.
2. The method of claim 1 with said pump delivering a flow of between 1.0 to 5.0 litre of air per minute into a tubing.
3. A method of treating a wound comprising the use of a pump to deliver through tubing a flow of a gas containing a concentration of oxygen between 15% and 100% by volume to a wound or an area of a wound.
4. The method of claim 3 with said pump delivering a flow of between 1.0 to 5.0 litre of air per minute into a tubing.
5. A method of supporting the treatment of a wound receiving micropore particle technology, comprising the use of a pump to deliver through tubing a flow of air to a wound or an area of a wound.
6. The method of claim 5 with said pump delivering a flow of between 1.0 to 5.0 litre of air per minute into a tubing.
7. The method of claim 5 with a gas mixture containing a concentration of oxygen between 15% and 100% by volume.
PCT/EP2021/070041 2020-07-26 2021-07-16 Method for supporting wound healing WO2022023089A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202063056645P 2020-07-26 2020-07-26
US63/056,645 2020-07-26

Publications (1)

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WO2022023089A1 true WO2022023089A1 (en) 2022-02-03

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Country Status (1)

Country Link
WO (1) WO2022023089A1 (en)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150290364A1 (en) * 2012-02-13 2015-10-15 Integrated Healing Techologies Multi-modal wound treatment apparatus
US20160256638A1 (en) * 2015-03-03 2016-09-08 Neogenix, Llc Therapy gas storage and delivery apparatus

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150290364A1 (en) * 2012-02-13 2015-10-15 Integrated Healing Techologies Multi-modal wound treatment apparatus
US20160256638A1 (en) * 2015-03-03 2016-09-08 Neogenix, Llc Therapy gas storage and delivery apparatus

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
NATURE, vol. 193, pages 293 - 4
REFERENCES SAMS-DODD JSAMS-DODD F: "Time to Abandon Antimicrobial Approaches in Wound Healing: A Paradigm Shift", WOUNDS, vol. 30, no. 11, 2018, pages 345 - 352
SAMS-DODD JEANETTE ET AL: "Time to Abandon Antimicrobial Approaches in Wound Healing: A Paradigm Shift", WOUNDS (KING OF PRUSSIA, PA.), 1 November 2018 (2018-11-01), United States, pages 345 - 352, XP055838935, Retrieved from the Internet <URL:http://www.ncbi.nlm.nih.gov/pubmed/30418163> [retrieved on 20210908] *

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