WO2023026172A1 - Dispositif de traitement par pression négative de plaies - Google Patents

Dispositif de traitement par pression négative de plaies Download PDF

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Publication number
WO2023026172A1
WO2023026172A1 PCT/IB2022/057863 IB2022057863W WO2023026172A1 WO 2023026172 A1 WO2023026172 A1 WO 2023026172A1 IB 2022057863 W IB2022057863 W IB 2022057863W WO 2023026172 A1 WO2023026172 A1 WO 2023026172A1
Authority
WO
WIPO (PCT)
Prior art keywords
plunger
spring
negative pressure
wound therapy
pressure wound
Prior art date
Application number
PCT/IB2022/057863
Other languages
English (en)
Inventor
Andrea CAZZULANI
Antonio Nunzio D'ANGELO
Original Assignee
Medicud S.R.L.
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 Medicud S.R.L. filed Critical Medicud S.R.L.
Publication of WO2023026172A1 publication Critical patent/WO2023026172A1/fr

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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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/64—Containers with integrated suction means
    • A61M1/67—Containers incorporating a piston-type member to create suction, e.g. syringes
    • 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
    • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/98—Containers specifically adapted for negative pressure wound therapy
    • A61M1/984—Containers specifically adapted for negative pressure wound therapy portable on the body
    • 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
    • A61M2209/00—Ancillary equipment
    • A61M2209/08—Supports for equipment
    • A61M2209/088—Supports for equipment on the body

Definitions

  • the present patent application generally relates to the medical discipline of wound healing.
  • the invention is applicable to any field where such a type of device can be advantageously used, but preferably it relates to the medical field of medical devices for negative pressure wound therapy.
  • Prior art As is well known, most wounds progress rapidly towards healing, but in some patients, despite appropriate treatment, the course is particularly long and complex and does not always progress favorably. In these cases, the wounds can face serious complications, sometimes leading to death. Overall, injuries have a negative impact on the physical and mental health and more generally on the quality of life of patients, causing prolonged hospitalizations and the consumption of important resources, with significant repercussions on the health system in organizational and economic terms.
  • Wounds that are difficult to heal can involve acute or chronic injuries of a different nature and etiology, often associated with chronic diseases, infections or immune diseases as well as acute trauma wounds, burns, necrotizing fasciitis, surgical wounds, chronic wounds from vascular ulcers, pressure sores, diabetic ulcers, dehiscent wounds, infected wounds, post-sternotomy dehiscences, skin and flap transplants, and so on.
  • the use of specific technologies for the treatment of hard-to- heal wounds is of great interest due to the positive impact it could have on the health system, the organization of services, the patients and their families.
  • Negative pressure wound therapy is a controlled and localized application of a sub-atmospheric pressure at the wound site, the device in question has the purpose of removing extra-cellular fluids and exudate, reducing edema and improving local blood flow, thus providing oxygenation and nourishment to tissues at the wound site and enhancing healing process and reducing the bacterial load.
  • Negative pressure is applied in a range of 50-200 mmHg and can be applied intermittently or continuously.
  • the dressing set may contain foam or gauze to be placed on the wound and an adhesive film to seal the wound.
  • Drainage tubes are available in a variety of sizes and gauges, depending on the dressings used or the wounds to be treated.
  • the dressing or filling material
  • the drainage tube is connected to said appropriate dressing.
  • the device comprises a pressure chamber having a substantially airtight plunger and an inlet connected to a first end of a tube.
  • a constant force spring is operably connected to apply a constant force to the plunger while a dressing is in communication with one end of the tube.
  • this device is very complicated as it is made up of multiple component parts, including several valves that must be specifically rotated to achieve the correct functioning of the entire system, requiring a certain skill associated with an excellent technical command, which is generally impossible to find in device users.
  • the object of the present invention is generally to provide a suction device capable of creating an effective sub-atmospheric pressure in a suitable dressing on a wound site, which is designed to solve the above drawbacks, as will appear from the detailed description of an exemplary and non-limiting embodiment thereof, illustrated below.
  • Summary of the invention The present patent application for industrial invention is intended to describe and claim a device provided with at least a new and alternative solution to the solutions known to date and in particular it aims to obviate one or more of the drawbacks or problems referred to above and/or to meet one or more needs perceived in the art and in particular deducible from the above, so as to make said device for negative pressure wound therapy easily usable for the community.
  • the inventors have developed an effective suction device capable of empowering wound healing processes by creating a suitable negative or sub-atmospheric pressure at wound site and therefore suitable for promoting edema reduction, acting on blood and lymphatic vessels and draining excess fluids and substances, lastly creating a humid microenvironment, ideal for stimulating the formation of granulation tissue and neoangiogenesis.
  • the innovative concept underlying the present invention consists in providing a device, composed of very few components, some of them are common components already on the market and therefore a device that is easily achievable both from a production and from an economical point of view.
  • inventive device In reality, what has just been described already constitutes a particularly innovative technical feature, since in the prior art to date there are only apparatuses that are difficult to manufacture and therefore particularly expensive, strongly limiting their use in therapy, preferring standard wound care treatment.
  • a further and no less important technical aspect obtained with the inventive device consists in simplicity and particularly compact conformation making it particularly suitable for portable use, as it can be easily worn with discretion by the patient and can be easily managed by the patient without any practice of the technique simply by reloading it through the use of at least a finger of the user himself/herself.
  • the inventive apparatus comprises as a whole a housing shell which includes a hollow cylindrical body, in which a connection system is made on the lower end of said hollow cylindrical body adapted for implementing a sealed connection with a drainage tube. Inside said hollow cylinder slides a sealed plunger connected to a common constant force spring, the free end of which is constrained to a pin of a tilting element which is in turn constrained to a head portion of the housing shell, while the wrapped portion is installed on a pin located inside the plunger.
  • said sealed plunger after being activated by sliding it towards the lower end by the pressure of at least a finger of one hand, is adapted to create a negative pressure obtained by retracting it by said constant force spring. Said negative pressure is transferred to the wound bed via said common drainage tube connected at one end to the inventive device via said connection system and at the other end to the common negative pressure wound therapy dressing.
  • This solution constitutes an optimal compromise regarding assembly easiness, since the particular three-lobed configuration of the housing shell allows it to be opened at the front, by virtue of the rear living hinges made longitudinally on the housing shell itself, allowing easy insertion therein of the hollow cylindrical element containing the plunger with the spring constrained both to the plunger and to the pin of the tilting element. Consequently, the simple engagement of said pin of the tilting element with the head portion and the closure of the housing shell itself, by means of a common closing mechanism made on the two closing flaps of the front edge, will make the device ready for its use.
  • a further objective is to propose a negative pressure wound therapy device which can be implemented on an industrial scale, whose most of the components are available on the market and whose production is fully sustainable from an economic and environmental point of view.
  • FIGURE 1 is an overall axonometric front-lateral view of the inventive device
  • - FIGURE 2 is a view of the inventive device (A) in perspective section and (B) in lateral section
  • - FIGURE 3 is a perspective view of the exploded view of the inventive device
  • - FIGURE 4 is an overall view of the inventive device shown (A) at the front, (B) at the rear, (C) at the side, (D) at the side, (E) at the bottom and (F) at the top
  • - FIGURE 5 is a view of the hollow cylindrical body with the plunger inserted and the deflected spring shown (A) at the front
  • a device for negative pressure wound therapy is provided, adapted to create a suitable negative or sub-atmospheric pressure at a wound and therefore suitable for promoting a reduction of edema, acting on blood and lymphatic vessels, draining excess fluids and substances and generating a humid microenvironment, ideal to stimulate granulation tissue formation and neoangiogenesis.
  • a negative pressure wound therapy device comprising, as shown in general in Figure 3, a housing shell 100, a hollow cylindrical body 200, a plunger 300, a spring 400 and an absorbent element 500.
  • Said housing shell 100 is adapted to accommodate said hollow cylindrical body 200 and, as can be seen from the plan views of FIGS.
  • the head portion 170 has at the front an opening 175 obtained in the upper portions of the two anterolateral faces 120, suitable for the introduction of at least a finger of a hand.
  • the head portion 170 has at the front an opening 175 obtained in the upper portions of the two anterolateral faces 120, suitable for the introduction of at least a finger of a hand.
  • inside the two upper portions of the two anterolateral faces 120 there are two circular contralateral recesses 180.
  • said hollow cylindrical body 200 is made of a suitable transparent polymeric plastic material and has said connection system 210 on a lower base 220 (Fig.5A-E) located in proximity to the rear edge (Figs.5A-B), suitable for the connection of a common drainage tube while the upper base is open and suitable for the introduction of said plunger 300.
  • Said plunger 300 is adapted to slide inside said hollow cylindrical body 200 in a sealed manner and has a lower circular face 310 and an upper face 320 (Fig. 6A).
  • said plunger 300 is shaped in such a way as to house internally a wrapped portion of a common constant force spring 400 on a pin 300, the spring 400 is wrapped around a spool 480, in order to reduce friction with the pin 330.
  • the free end of said common spring 400 is constrained to a pin 496 made on a tilting element 490, which by means of the ends 495 thereof engages said two circular recesses 180.
  • the aforesaid spring system 400 constitutes the first fundamental aspect of the present invention.
  • a second aspect of the present invention relates to the assembly consisting of the plunger 300, being configured in such a way that it can be easily maneuvered without the need to use additional tools, as well as a part of the prior art apparatus. More specifically, said upper face 320 of the plunger 300, as shown in the sectional views of Fig. 2 and 5C-D, has a frontal zone tailored to apply pressure with a finger 340, ergonomically designed or configured in such a way as to have a perfect correspondence with at least a finger of a hand introduced into said opening 175 and said conformation is designed to not expose user’s finger, pressing the plunger 300, to the edges of said spring 400.
  • said plunger 300 is activated, making it slide towards said lower base 220 through the pressure of at least a finger of a hand on the frontal zone 340, thus being suitable for creating, in its activated condition, a negative pressure suction chamber 350 (see Fig. 5A-D) for a predetermined period of time, which is carried out by retracting it by said constant force spring 400.
  • Said negative pressure is transferred to the wound bed via said common drainage tube connected at one end to the inventive device via said connection system 210 in communication with the suction chamber 350 and at the other end to the common negative pressure wound therapy dressing.
  • the correct operation of the device according to the present invention provides for the presence on said lower face 310 of the plunger 300 of a housing where at least a check valve 370 is located, adapted to allow an air flow coming only from said suction chamber 350 whenever said plunger 300 is activated by sliding it in the hollow cylindrical body 200 actuated by the pressure of at least a finger of a hand and capable of causing the spring 400 to extend.
  • a housing seat 360 is provided (see Fig. 3) placed perimetrically on the lower face 310 and adapted to house a common ring gasket 700.
  • a particularly preferred embodiment provides that said ring gasket 700 has a color such as to be in chromatic contrast with the fluid present in said suction chamber 350 and this in order to be able to represent an index of the position of said plunger 300 in the hollow cylindrical body 200 viewable through said windows 190.
  • Another fundamental feature for the correct functioning of the inventive system consists in the presence, as shown in Figs. 2B and 5, of an absorbent element 500 consisting of a layer of common super absorbent material capable of intercepting and fixing the exudate coming from the wound.
  • said absorbent element 500 is located inside said suction chamber 350 or in any case in a space comprised between the lower face 310 of the plunger 300 and said lower base 220 of the hollow cylindrical body 200.
  • a common hydrophobic filter 380 is provided in said housing of said check valve 370, capable of preventing the exudate, possibly not completely absorbed by the absorbent element 500, from coming into contact with said check valve 370 and therefore causing both the malfunction and eventual exudate to escape from the inventive device.
  • a further alternative embodiment of the present invention in order to achieve the necessary absence of any twisting movement of the plunger 300 both in the deactivated condition and in the activation step of the same, provides that inside the head portion 170 and more specifically in the upper portion of the rear face 110 an alignment triangle 800 is provided having placement, shape and size suitable for precisely coupling a slot with triangular profile 850 made on the upper face 320 of the plunger 300 behind the pin 330 (see Fig.8C).
  • Another particularly innovative aspect according to the present invention consists in that the movement of the plunger 300 is capable of actuating a constant depression over time and this since any twisting moment due to the return of the plunger 300 operated by the spring 400 is eliminated, reducing both the forces exchanged and minimizing the friction between said plunger 300 and said hollow cylindrical body 200.
  • This feature is fundamental since the presence of twisting moments would determine an inevitable and undesired misalignment between the plunger 300 and the internal walls of the hollow cylindrical body 200, causing a possible malfunction due to the jamming of the plunger 300 both in the return step carried out by the force exerted by the spring 400 and during its activation phase.
  • said feature is fundamental for the present invention since unlike the devices present in the art, which use multiple reciprocally balancing springs, it is implemented with the presence of a single spring, which represents an innovative feature in terms of size reduction, simplicity of operation, safety of use and economy of production. In reality, this feature was only implemented in the face of an intense inventive effort necessary during the design step and which resulted in the necessary compliance with conditions aimed at achieving the desired objects.
  • the presence of the two movable elements supporting the spring 400 that is the spool 480 and the tilting element 490, already tends to ensure that the natural profile assumed by the deflected portion 470 of the spring 400 is respected, as shown in the side views of Figs.5C-D, so as to make the movement of the plunger 300 such as to reduce both the forces exchanged and to minimize the friction between said plunger 300 and said hollow cylindrical body 200.
  • the ergonomics allow by virtue of the presence of at least a longitudinal loop 900 on the rear face 110 of the housing shell 100 (Figs.4B-C), suitable, due to shape and size, to let pass through the head of a common tape or belt 950, to effectively wrap the limb or any other portion of the body of a patient so as to keep the inventive device effectively hanging, comfortably and in total discretion.
  • the main objective of the present invention is to have fundamentally reduced to its essential parts the common devices for negative pressure wound therapy existing in the art, making the production thereof particularly cost-effective and therefore allowing in the art a very desired use on a large scale and all this by implementing a particularly efficient device for the purpose for which it was designed.
  • the relative simplicity of use as well as the small and compact dimensions make it particularly suitable for use in the form of a device that can be discreetly worn by the patient under clothing and therefore also used in an out-of-patient setting.
  • the data provided herein are purely illustrative and absolutely non-limiting of the scope of the present invention, since they serve exclusively to enable a person skilled in the art to understand some possible applications and embodiments of the invention.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Massaging Devices (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)

Abstract

L'invention concerne un dispositif de traitement de plaies par pression négative comprenant une coque de boîtier (100) qui reçoit un corps cylindrique creux (200) approprié pour l'introduction d'un plongeur (300) coulissant de manière étanche et comprenant un élément pour appliquer une pression avec un doigt (340) sur lequel la pression exercée par au moins un doigt d'une main introduite dans une ouverture supérieure (175) amène le plongeur (300) à coulisser, ledit plongeur (300) loge à l'intérieur la partie enroulée d'un ressort à force constante (400) qui est contraint par un élément de liaison basculant (490) à la partie supérieure de la coque de boîtier (100) et ledit coulissement du plongeur (300) crée un état activé du ressort (400) qui rappelle ledit plongeur (300), de manière à créer une dépression qui, à travers un tube de drainage, est transférée à un pansement à pression négative commun appliqué à une plaie.
PCT/IB2022/057863 2021-08-24 2022-08-23 Dispositif de traitement par pression négative de plaies WO2023026172A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT102021000022223A IT202100022223A1 (it) 2021-08-24 2021-08-24 Dispositivo per la terapia a pressione negativa
IT102021000022223 2021-08-24

Publications (1)

Publication Number Publication Date
WO2023026172A1 true WO2023026172A1 (fr) 2023-03-02

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PCT/IB2022/057863 WO2023026172A1 (fr) 2021-08-24 2022-08-23 Dispositif de traitement par pression négative de plaies

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IT (1) IT202100022223A1 (fr)
WO (1) WO2023026172A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014145014A1 (fr) 2013-03-15 2014-09-18 Spiracur Inc. Cartouche à vide à valve intégrée
US20160015592A1 (en) 2008-04-03 2016-01-21 The Brigham And Women's Hospital Micromechanical Force Devices for Wound Healing Acceleration
AU2016231470B2 (en) * 2008-05-02 2018-10-18 Solventum Intellectual Properties Company Manually-actuated reduced pressure treatment system having regulated pressure capabilities
EP2941280B1 (fr) * 2013-01-03 2018-10-24 KCI Licensing, Inc. Traitement de plaies par pression négative avec rechargement
US20190269835A1 (en) * 2007-03-14 2019-09-05 Kci Licensing, Inc. Reduced pressure therapy devices

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190269835A1 (en) * 2007-03-14 2019-09-05 Kci Licensing, Inc. Reduced pressure therapy devices
US20160015592A1 (en) 2008-04-03 2016-01-21 The Brigham And Women's Hospital Micromechanical Force Devices for Wound Healing Acceleration
AU2016231470B2 (en) * 2008-05-02 2018-10-18 Solventum Intellectual Properties Company Manually-actuated reduced pressure treatment system having regulated pressure capabilities
EP2941280B1 (fr) * 2013-01-03 2018-10-24 KCI Licensing, Inc. Traitement de plaies par pression négative avec rechargement
WO2014145014A1 (fr) 2013-03-15 2014-09-18 Spiracur Inc. Cartouche à vide à valve intégrée

Also Published As

Publication number Publication date
IT202100022223A1 (it) 2023-02-24

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