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WO2025003255A1 - Timbre adhésif pour application au niveau d'un site de lésion d'un patient et procédé de surveillance de saignement de fluide à l'aide du même timbre adhésif - Google Patents

Timbre adhésif pour application au niveau d'un site de lésion d'un patient et procédé de surveillance de saignement de fluide à l'aide du même timbre adhésif Download PDF

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Publication number
WO2025003255A1
WO2025003255A1 PCT/EP2024/067997 EP2024067997W WO2025003255A1 WO 2025003255 A1 WO2025003255 A1 WO 2025003255A1 EP 2024067997 W EP2024067997 W EP 2024067997W WO 2025003255 A1 WO2025003255 A1 WO 2025003255A1
Authority
WO
WIPO (PCT)
Prior art keywords
fluid
adhesive patch
adhesive
patient skin
dressing
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/EP2024/067997
Other languages
English (en)
Inventor
Mariusz KRUK
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cardiobotics Sp Z OO
Original Assignee
Cardiobotics Sp Z OO
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 Cardiobotics Sp Z OO filed Critical Cardiobotics Sp Z OO
Publication of WO2025003255A1 publication Critical patent/WO2025003255A1/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/0203—Adhesive bandages or dressings with fluid retention members
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/00051—Accessories for dressings
    • A61F13/00055—Saturation indicators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/05—Bandages or dressings; Absorbent pads specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00089—Wound bandages
    • A61F2013/00182—Wound bandages with transparent part
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00365—Plasters use
    • A61F2013/00412—Plasters use for use with needles, tubes or catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00365—Plasters use
    • A61F2013/00463—Plasters use haemostatic

Definitions

  • Adhesive patch for application at an injury site of a patient and method for monitoring fluid bleeding using the same adhesive patch
  • the present invention relates to an adhesive patch for application at an injury site of a patient and a method for monitoring fluid bleeding using the same adhesive patch.
  • the fluid bleeding can be produced by an object previously inserted in the human body (e.g. needle, syringe, cannula, puncture, etc.) or by an already existing injury (e.g. cut, stab, wound, etc.).
  • an object previously inserted in the human body e.g. needle, syringe, cannula, puncture, etc.
  • an already existing injury e.g. cut, stab, wound, etc.
  • the present invention finds a preferred, although not exclusive, application in the field of management and surveillance of patient body conditions and external wounds healing process, in particular post vascular or catheterization access site, or post-surgical interventions like, for instance, pocket following implantable device insertion.
  • one of the main characteristics of the wounds that can occur in the patient body includes the bleeding or fluid discharge coming from the puncture or insertion or incision site and a tendency to form a subcutaneous hematoma.
  • the subcutaneous hematoma requires, from the operating medical team, a continuously or frequently supervised local actuation of appropriate monitoring methodology and an application, when deemed appropriate, of a specific pressure range in order to simultaneously try to stop the bleeding form the injury site, minimize hematomas formation and minimize the inner pressure on the underneath vessels and tissues with the aim of optimally achieving and maintaining the patient blood flow enhancing the occurring healing processes.
  • An adhesive patch for application at an injury site typically is a device suitable for containing blood bleeding optionally including, for instance, an arc-shaped pressing block with a groove in an inverted U-Shaped.
  • EP 0569565 describes a bandage for fixing a cannula of a catheter to a skin surface part of a person comprising a support sheet of a foil material having opposite first and second side surfaces with an outer rim, an adhesive layer and an absorbing pad.
  • a pressure is applied to the injury site aiming at realizing a homeostasis condition.
  • Such an intervention requires constant visual detection and surveillance and often the dressing, applied around the device in order to keep the device in site, can produce some kind of hindrance to the visual detection of the bleeding evolution through time and/or to the application if the desired pressure.
  • the injury site is either left uncovered by any additional dressing, not guaranteeing the correct position of the device through times and patient movements, or the pressure means are constantly applied directly exerting continuous pressure at the site.
  • an absorbent material is applied at the dressing area or at the puncture/injury site covering the bleeding wound creating the condition that in case of oozing bleeding a meaningful latency in detecting the bleeding can often occur adding the fact that the latency worsens due to the fact that such inefficient solution usually requires more bleeding events in order to be detected due to the fact that the absorbent material will gradually fill up with blood during repeated bleeding episodes showing less and less a immediately detectable visual variation.
  • the term "adhesive patch for application at an injury site” identifies a patch or similar device comprising at least an adhesive portion which is configured to be applied on the skin of a patient.
  • an application is configured in order to be removably applied on the patient skin without producing excessive or any damages on the patient skin.
  • the term "patch” defines a device which is configured to be removably applied on the patient body without necessarily producing any changes in the patient body bio-processes.
  • a patch could be considered also as a medium configured to control and/or handle fluids outside the patient body.
  • the term "patch” can be understood almost as a synonym of the terms band-aid, body plaster, bandage, etc.
  • the terms "when in use” define the moment when the adhesive patch is applied to the patient skin or is in such a close proximity to the skin that allows it to proper function. According to such a definition, the moment when the fluid bleeds outside from the patient body and has some interaction with the adhesive patch defines a condition falling within the meaning of the aforementioned terms "when in use”. It is relevant to notice, anyhow, that the time concurrency of the bleeding while the adhesive patch is in use does not automatically imply a specific role or function activated by the bleeding fluid presence on the adhesive patch. In other words, there are no specific features implicitly or explicitly correlated and required to the fluid bleeding in order to have the adhesive patch of the present invention working.
  • dressing refers to a layer or multilayers structure configured to be adopted in treatment of human fluids and similar substances.
  • fluid bleeding refers to the outcome from an aperture of the patient body of any fluids or liquids, more specifically but not limiting to blood or part of it (e.g. plasma, etc.).
  • the terms "at an injury site” define a condition of direct contact or overlapping or proximity between the injury site and the applied adhesive patch.
  • fluid collection portion have the meaning of a portion which is configured to potentially collect (i.e. receive) any fluid outcoming from the injury site of the patient body.
  • transfer portion identify a part of the device which is aimed at creating a fluid-dynamic connection through which the bleeding fluid or other collected fluid can pass or flow in order to reach a further location that is different form the one where they were collected.
  • fluid-dynamically connected or similar expressions define that two portions or spaces are mutually connected or linked or jointed in such a way to allow fluid passing through them.
  • capillarity refers to the phenomenon producing fluid displacement al least partially due to the width of the channel through which the fluid is moving.
  • interposed space define a space which is comprised between two surfaces and has a volume.
  • Such a volume has a defined value and can be maintained almost fixed over time (also considering its re-shaping) or can be modified through extension or compression.
  • interposed space can be an empty or partially empty space, a niche, a recess, a channel, a canal, a pipe, a chamber, etc.
  • channel is identified a recess that has a longitudinal extension bigger than its lateral extension.
  • internal pressure or volume variation define a condition in which the inner pressure or inner volume of a ambient or space are changed.
  • Non limiting examples of internal volume variation of a space can be the volume reduction of a container via external pressure and modification of its shape or via expansion of a further inner expandable device which occupies part of the inner volume reducing de facto the freely fillable space.
  • a non-limiting example of internal pressure variation can be a suction device fluid- dynamically connected to the container defining the space and creating an inner pressure reduction.
  • the Applicant has finally found that a desired improvement of the above-mentioned devices and processes is achieved by realizing an adhesive patch to be applied at an injury site that allows immediate and easy bleeding detection adding the benefit of being able to displace the bleeding form the injury site in order to keep the wound clean and to efficiently reveal further multiple bleeding events.
  • the invention in a first aspect thereof, relates to an adhesive patch for application at an injury site of a patient and configured to be in contact with the patient skin when in use.
  • the adhesive patch comprises a first dressing.
  • the first dressing includes a main body.
  • the main body comprises an adhesive portion configured for removably attaching said main body of the adhesive patch to the patient skin.
  • the adhesive portion comprises an adhesive surface facing the patient skin when in use.
  • the main body comprises an adhesive material arranged at or on the adhesive surface.
  • the adhesive patch comprises a fluid collection portion which is configured to be placed at the injury site.
  • the fluid collection portion comprises a first portion, free of the adhesive material.
  • the first portion is elastically deformable and configured to define, when in use at the injury site, a first interposed space.
  • the first interposed space is identified between the patient skin and the adhesive patch when the adhesive portion is attached to the patient skin for the collection of the fluid outcoming from the injury site.
  • the adhesive patch comprises a transfer portion.
  • the transfer portion is arranged adjacent to the fluid collection portion.
  • the transfer portion comprises a second portion free of the adhesive material.
  • the adhesive material is elastically deformable and configured to define a second interposed space between the patient skin and the adhesive patch when the adhesive portion is attached to the patient skin.
  • the second interposed space is fluid-dynamically connected to the first interposed space.
  • the second interposed space defines a transfer path for the fluid to flow from the first interposed space to a discharge portion of the transfer portion.
  • the second interposed space is configured to evacuate by internal pressure or volume variation, applied by an automatic device, more preferably by an automatic pressure device, the fluid outside throughout the discharge portion.
  • the Applicant found that it is possible to rapidly and efficiently detect any fluid bleeding event together with the possibility to realize a better supervised local application of appropriate pressure aimed at simultaneously stop the bleeding from the injury site and minimize hematoma formation in the patient by directly and efficiently applying the desired pressure on the underneath vessels and tissues to optimally manage blood flow and the correlated healing processes. More specifically, the disclosed embodiment allows for automatic activation of a device that permit to create the conditions inducing the fluid discharge from the adhesive patch in such a way to be more efficient with respect to the technical solution of the state of the art.
  • an adhesive patch to be used repeatedly without the need to substitute any of its parts whenever a bleeding event happens, specially adapted to allow the medical personnel to proceed to stop the bleeding by compressing either the injury site or its vicinity.
  • the present invention it is possible to clearly detect blood or fluids bleeding and to clean them from the patch avoiding the possibility to form masking stains in some inner parts that would require for medical personnel to take the device away from the patient and separately clean it and/or clean and reset the detection means after each bleeding event.
  • the invention in a second aspect thereof, relates to a method for monitoring fluid bleeding using the adhesive patch comprising at least some of the features previously described.
  • the method comprises applying the first dressing of the adhesive patch at an injury site of a patient skin.
  • the method comprises detecting fluids outside the body of the patient and within the fluid collection portion or the transfer portion.
  • the method comprises evacuating the fluid from the fluid collection portion by reducing the fluid collection portion volume or pressure.
  • the method comprises evacuating the fluid from the fluid collection portion by reducing the fluid collection portion volume or pressure by an automatic pressure device.
  • the present invention may further have at least one of the preferred features described below.
  • the adhesive patch can comprise a medical dressing material such as, optionally, a gauze, lint, cotton wool and the like or an Interactive products such as semi-permeable film dressing.
  • a medical dressing material such as, optionally, a gauze, lint, cotton wool and the like or an Interactive products such as semi-permeable film dressing.
  • the second portion when the adhesive patch is in use and fluid bleeding occurs, defines at least a channel that corresponds to the second interposed space.
  • the channel comprises a first opening defined at the fluid collection portion and a second opening defined at the discharge portion.
  • the channel can be replaced by a recess defined in the second portion.
  • the channel is extended also to the fluid collection portion defining the first interposed space creating a continuous discharging path that can be produce by a unique ablation or moulding process.
  • the minimum extension of a proximal surface of the second portion free of the adhesive material and facing the patient skin when in use is between 0.1 and 10 mm, more preferably between 0.3 and 5 mm, even more preferably around 0.5 mm.
  • the fluid collection portion and/or the transfer portion comprise a resilient polymeric material elastically deformable having an elastic modulus similar to those of the family of polyurethane or silicone or methacrylate, preferably the polymeric family being of the elastomeric type and having an elastic modulus comprised between 10 and 10 4 MPa, more preferably between 500 and 5000 MPa, even more preferably between 1000 and 3000 MPa.
  • Such a condition allows to obtain a good balance between the capability of deforming the material collecting inside the bleeding fluid and allowing a further reversable deformation, produced for instance by an external pressure applied by a medical operator, aimed at easily and efficiently discharging the fluid and to transfer the pressure to the injury site in order to achieve homeostasis conditions.
  • the adhesive patch can be produced as a heterogenic material and preferably as a heterogenic multilayers material.
  • the adhesive patch might have the resilient polymeric material elastically deformable in the aforementioned preferred ranges for the fluid collection portion and/or the transfer portion or also as an average value of the overall comprised materials.
  • the adhesive portion, the adhesive surface and the adhesive material are configured to produce air and liquid tight adhesion on the patient skin when in use.
  • the discharge portion is fluid-dynamically connected to either the outside of the adhesive patch or to an absorbent material comprised in the adhesive patch.
  • the absorbent material is a hydrophilic material.
  • the absorbent material is preferably but not limiting selected for instance among the following materials: cross-linked polyacrylates, cross-linked polyacrylamides, crosslinked maleic anhydride copolymers, starch-acrylonitrile graft copolymers, cellulose fiber, absorbent hydrogels and the like.
  • the fluid collection portion and the transportation portion are made in a material transparent or translucent to visible light so that a user or an optical device can visually detect the fluid in it when in use.
  • Preferred embodiments comprise polymeric materials having at least a significant moiety of amorphic phase.
  • the adhesive patch comprises at least a pressing manual pressure device for creating a pressure increase or volume reduction into the fluid collection portion or in the transfer portion.
  • the adhesive patch comprises at least a pressure device for creating the internal pressure or volume variation in the fluid collection portion or in the transfer portion.
  • the at least a pressure device is an inflatable balloon.
  • the fluid collection portion is substantially at the centre of the adhesive patch and the fluid collection portion and the absorbent material are surrounded by the adhesive material for an extension of at least 1 to 15 mm, preferably from at least 3 mm to 10 mm, more preferably for substantially 5 mm to provide air and liquid tight sealing.
  • the absorbent material is removably attached to the adhesive patch.
  • the adhesive patch comprises a second dressing proximal to the patient skin when in use, wherein the second dressing comprises a lower adhesive surface facing the patient skin when in use, comprises the adhesive material being arranged at or on the lower adhesive surface.
  • the second dressing comprises a trough hole or a recess along its thickness defining a lower opening, facing the patient skin when in use, and an upper opening, opposite to the lower opening and defined at an upper surface of the second dressing distal to the patient skin.
  • the second dressing is configured to define an attachable upper portion on the upper surface for the first dressing of the adhesive patch so that the upper opening is arranged at the fluid collection portion and the second interposed space is defined between the upper surface of the second dressing and the first dressing.
  • the second interposed space is defined on the upper surface of the second dressing and can be more precise than what achievable with respect to the patient skin. Furthermore, adhesion can be improved avoiding possible detachments due to the sweating of the patient skin.
  • the second dressing is a further optional and preferred juxtaposed dressing that collaborates with the first dressing of the invention in issue.
  • the absorbent material is positioned in a peripheral portion of the adhesive patch.
  • the absorbent material is positioned in a peripheral portion of the adhesive patch.
  • the absorbent material is positioned within the adhesive portion, more preferably in a central portion of it. In such a way it is possible to improve the efficiency and compactness of the patch.
  • the adhesive portion comprises two stickers peelable off that allow an easier application of the adhesive patch to the patient body.
  • the second portion comprises an at least two openings chamber or a second recess.
  • the at least two openings chamber or the second recess comprise at least one channel.
  • the transport portion comprises a plurality of channels evenly distributed in the adhesive patch.
  • the adhesive patch comprises a fluid sensor configured to detect the presence of fluid in the fluid collection portion or in the transfer portion.
  • the fluid sensor is an impedance sensor or optic fiber or volumetric sonde (or probe).
  • the fluid sensor is a volumetric sonde (or probe) to be advantageously used in a vessel where the blood lost by the injury and transported by the patch channels would be collected, whenever blood would reach the vessel, the volume collected would be incremented and then the automatic compression mechanism would be initiated.
  • the fluid sensor is an optic fiber being inserted in the adhesive patch in such a way that a spectrometer could detect blood flow or the simple change of colour of a light beam being irradiated on one side of the channel and received by photo detectors on the other side.
  • the absorbent material comprises the fluid sensor. Thanks to this solution it is possible to efficiently detect fluid in the predetermined and designed material.
  • the fluid sensor and the at least a pressing device are operatively connected to an elaboration unit, the elaboration unit being configured to selectively and automatically
  • the predefined pressure can be a value comprised between 40 and 250 mm Hg and for a predetermined time comprised between 1 and 8 hours.
  • the first threshold parameter is defined in such a way that it allows to detect the presence of fluid, such as a volume increase comprised between the 10 and the 80%, more preferably more than 40% when, for instance, the fluid sensor is a volumetric sonde or probe.
  • the first threshold parameter is defined in such a way that it allows to detect the presence of fluid, such as, for instance, L* a* b* colour spatial coordinates variation detected via colorimeter or photodetector in case of simple change of colour of a light beam being irradiated on one side of the channel and received by photo detectors on the other side.
  • fluid such as, for instance, L* a* b* colour spatial coordinates variation detected via colorimeter or photodetector in case of simple change of colour of a light beam being irradiated on one side of the channel and received by photo detectors on the other side.
  • a* parameter which corresponds to red colours when greater than zero.
  • a variation of a* that brings a* > 0 could allow new blood detection. It is apparent that in such conditions the threshold need to be set also as a function of the brightness and condition of the general environment in order to better evaluate the desired bleeding event.
  • the method comprises attaching to the patient skin before applying the first dressing the second dressing that comprises the trough hole in such a way that the trough hole is arranged at the injury site of the patient skin.
  • the method comprises applying the first dressing of the adhesive patch at least partially on the second dressing so that the trough hole of the second dressing and the fluid collection portion of the first dressing are fluid-dynamically connected.
  • thermoplastic material Providing a suitable thermoplastic material,
  • thermoplastic material Injecting the thermoplastic material into the mould,
  • FIG. 1 is a schematic bottom view of an adhesive patch in accordance with the present invention.
  • figure 2 is a schematic view of the section II of figure 1 ;
  • FIG. 3 is a further schematic bottom view of an alternative embodiment of the adhesive patch in accordance with the present invention.
  • FIG. 4 is a schematic top view of an application on a patient body of the adhesive patch adhesive patch in accordance with the present invention.
  • FIG. 5-7 are schematic views of an alternative embodiment of the adhesive patch in accordance with the present invention.
  • FIG. 8 is a schematic top view of an application on a patient body of the adhesive patch adhesive patch in accordance with the present invention.
  • FIG. 9a, 9b are schematic views of a further embodiment of the adhesive patch adhesive patch in accordance with the present invention comprising a first dressing and a second dressing;
  • figure 10 is a schematic bottom view of a second dressing of the adhesive patch in accordance with the present invention;
  • FIG. 11 is a schematic bottom view of a further application of the adhesive patch in accordance with the present invention on a patient body;
  • FIG. 12a and 12b are schematic views of the section XII of figure 10 showing alternative embodiments.
  • 1 denotes an adhesive patch in accordance to the present invention which is suitable for application at an injury site Isi of a patient.
  • the injury site Isi can be a wound on the patient skin S of a patient body.
  • the aforementioned figures are shown examples of possible applications in the arm region of the patient.
  • the adhesive patch 1 is configured to be in contact with the patient skin S when in use. As previously described, the adhesive patch can advantageously be removably attached to the patient skin S several times.
  • the adhesive patch 1 comprises a first dressing 9 which is including a main body 10.
  • the first dressing 9 comprises an adhesive portion 20 configured for removably attaching said main body 10 of the adhesive patch 1 to the patient skin S, comprising an adhesive surface 21 facing the patient skin when in use.
  • the first dressing 9, and more specifically the adhesive portion 20, comprise an adhesive material 28 arranged at or on the adhesive surface 21.
  • the adhesive material 28 is represented by a dotted area and in this specific embodiment is considered as an adhesive layer such as a glue layer which is distributed below the main body 10. It is immediately apparent that several different embodiments of the adhesive portion 20 and of the adhesive surface 21 are to be taken into account in the disclosure of the present invention.
  • Figure 2 represents a schematic sectional view taken exactly at the sectional plane II shown in figure 1.
  • the fluid collection portion 30 configured to be placed at the injury site Isi is shown.
  • the fluid collection portion 30 comprises a first portion 31, free of the adhesive material 28 , elastically deformable and configured to define, when in use at the injury site Isi , a first interposed space 31a between the patient skin S and the adhesive patch 1 when the adhesive portion 20 is attached to the patient skin S for the collection of the fluid outcoming from the injury site Isi.
  • the adhesive material 28 does not extend for all the area of the adhesive patch 1 and such zone free of glue defines the first interposed space 31a of the first portion 31 comprised in the fluid collection portion 30.
  • a transfer portion 40 which is arranged adjacent to the fluid collection portion 30 and which comprises a second portion 41 free of the adhesive material 28 which is elastically deformable and configured to define a second interposed space 41a between the patient skin S and the adhesive patch 1 when the adhesive portion 20 is attached to the patient skin S.
  • FIG 2 is a sectional view of the bottom view of figure 1, it is clear that the second interposed space 41a is fluid-dynamically connected to the first interposed space 31a and that it defines a transfer path Tp for the fluid to flow from the first interposed space 31a to a discharge portion 50 configured to evacuate the fluid outside 0.
  • the transfer path Tp is explicitly shown in figure 3 but is to be considered as portraited in all the represented embodiments of the present invention.
  • the first portion 31 free of the adhesive material 28 has a substantially circular or elliptical or oval shape.
  • Such a shape is chosen in order to facilitate the collection of the fluid, for instance the blood, that is outcoming from the wound at the injury site Isi.
  • Such a shape is advantageous because it allows to collect efficiently the outcoming blood and then to transfer it properly to the discharge portion 50.
  • the first interposed space 31a has the shape substantially of a cylinder with circular or elliptical or oval bases or, in other embodiments of a semi-sphere having a dome-like shape.
  • the first interposed space 31a has the shape of a more elongated structure such as a parallelepiped 3D box or a longitudinal channel that allow and enhance the presence of a plurality of transfer portion 40 in the shape of evenly distributed channel (see figure 7) or of a continuous wide transfer portion (see figure 5).
  • the first interposed space 31a is defined between the main body 10 and the patient skin S by the fact that this portion is free of the adhesive material 28.
  • the first interposed space 31a can be made in a material that can be elastically deformed modifying its shape and, in some cases, even the volume comprised in the first interposed space 31a.
  • the first interposed space 31a could be additionally defined or enhanced by recesses made in the main body 10 that creates some extra cavities to be filled up with blood coming out form the wound.
  • the second interposed space 41a can be produced in the same manner as described for the first interposed space 31a considering that it has, as shown for instance in figures 1, 3, 4, 6, 9a, 9b, the shape of a channel.
  • the second portion 41 when the adhesive patch 1 is in use and fluid bleeding occurs, defines a two openings chamber, and more preferably a channel, that corresponds to the second interposed space 41a, comprising a first opening 411 defined at the fluid collection portion 30 and a second opening 412 defined at the discharge portion 50.
  • the first and second opening 411, 412 can advantageously be designed with similar or different sizes in order to enhance some specific fluid driving forces during blood collection and/or discharge.
  • a second interposed space 41a having a channel-like shape is optimized in order to enhance the transfer of the blood collected in the first portion 31 to the discharge portion 50.
  • the discharging phase through the discharge portion 50 can be efficiently produce for instance by applying an external pressure on the fluid collection portion 30 or on the transfer portion 40 reducing in such a way the internal volume of the first interposed space 31a and/or of the second interposed space 41a obliging the blood to follow the transfer path Tp.
  • the second interposed space 41a can be in the form of a channel having a radius of few tenths of millimetres in order to produce a capillarity effect on the transferring blood so that a reduced or almost null external pressure needs to be applied in order to discharge the blood.
  • the adhesive patch 1 comprises at least a pressure device 70 for creating the internal volume reduction of the first interposed space 31a.
  • the at least a pressure device 70 is an inflatable balloon 71 connected to inflating devices not shown in the figures.
  • the fluid collection portion 30 and/or the transportation portion 40 is/are made in a material transparent or translucent to visible light so that a user or an optical device specifically configured can visually detect the fluid in it when in use.
  • the discharge portion 50 is directly connected to the outside O of the adhesive patch 1.
  • the transfer path Tp ends in an absorbent material 65 fluid-dynamically connected to the discharge portion 50.
  • the absorbent material 65 is advantageously made of cross-linked polyacrylates, crosslinked polyacrylamides, cross-linked maleic anhydride copolymers, starch-acrylonitrile graft copolymers, cellulose fiber, absorbent hydrogels and the like.
  • the absorbent material 65 can be constrained to the main body via removable mediums (such as adhesive portions or frames) in order to make it easily replaceable when filled up or anyhow considered ineffective.
  • the absorbent material 65 is advantageously positioned in a peripheral part of the adhesive patch 1.
  • a fluid sensor 60 comprised in the adhesive patch 1 is shown.
  • the fluid sensor 60 is configured to detect the presence of fluid in the fluid collection portion 30 or in the transfer portion 40.
  • the fluid sensor is represented as located in the main body 10.
  • the fluid sensor 60 can be positioned in the fluid collection portion 30 or in the transfer portion 40.
  • the fluid sensor 60 is inserted in or on the absorbent material 65.
  • the fluid sensor is an impedance sensor or optic fiber or volumetric sonde (or probe).
  • the fluid sensor is a volumetric sonde (or probe) to be advantageously used in a vessel where the blood lost by the injury and transported by the patch channels would be collected, whenever blood would reach the vessel, the volume collected would be incremented and then the automatic compression mechanism would be initiated.
  • the fluid sensor is an optic fiber being inserted in the adhesive patch in such a way that a spectrometer could detect blood flow or the simple change of colour of a light beam being irradiated on one side of the channel and received by photo detectors on the other side.
  • FIG 12a in combination with figure 2 or 3, it is disclosed the fluid sensor 60 and the at least a pressing device 70 operatively connected to an elaboration unit 80.
  • the elaboration unit 80 can be a personal computer, a RAM, a server or a similar device with the capability or receiving, elaborating and sending digital information.
  • the elaboration unit 80 is preferably connected to the fluid sensor 60 and to the at least a pressing device 70 wirelessly.
  • the elaboration unit 80 is configured to selectively and automatically
  • the second dressing (11) comprised in the adhesive patch 1 is proximal (i.e. closer) to the patient skin S when in use with respect to the first dressing 9 which is, thus, at least for a portion distal with respect to the patient skin S.
  • the second dressing 11 comprises a lower adhesive surface 12 facing the patient skin when in use that includes the adhesive material 28 being arranged at or on the lower adhesive surface 12.
  • the second dressing 11 comprises a trough hole 311 along its thickness defining a lower opening 11a, facing the patient skin S when in use, and an upper opening lib, opposite to the lower opening 11a and defined at an upper surface 13 of the second dressing 11 distal to the patient skin S.
  • the second dressing 11 is configured to define an attachable upper portion 13a on the upper surface 13 for the first dressing 9 of the adhesive patch so that the upper opening lib is arranged at the fluid collection portion 30 and the second interposed space 31a is defined between the upper surface 13 of the second dressing 11 and the first dressing 9.
  • trough hole 311 the same geometrical and dimensional features described for the first portion 31 apply, considering anyhow that such element has to be a trough hole fluid-dynamically connected to the first dressing 9 when in use as shown in figures 12a and 12b.
  • figure 12b shows an embodiment in which the first dressing 9 is wider than the second dressing 11 and the overlapping portion almost correspond to the first interposed space 31a and the second interposed space 41a.
  • the present invention further discloses a method 300 (not shown in the figures) for monitoring fluid bleeding using the adhesive patch previously disclosed, comprising
  • the detection of the fluid bleeding can be produced by visual detection or by the fluid sensors 60 previously described.
  • the evaluation step can be performed, for instance, either by applying an external pressure on the adhesive patch (such as a pressing finger of the medical personnel) or by the actuation via the elaboration unit 80 of the automated pressure device 70 (such as the inner balloon 71) via internal volume reduction as previously described.
  • an external pressure on the adhesive patch such as a pressing finger of the medical personnel
  • the actuation via the elaboration unit 80 of the automated pressure device 70 such as the inner balloon 71
  • the method 300 preferably comprises attacking to the patient skin S, before applying the first dressing 9, the second dressing 11 that comprises the trough hole 311 in such a way that the trough hole 311 is arranged at the injury site Isi of the patient skin S, applying the first dressing 9 of the adhesive patch 1 at least partially on the second dressing 11 so that the trough hole 311 of the second dressing 11 and the fluid collection portion 30 of the first dressing 9 are fluid-dynamically connected.
  • the first dressing 9, the second dressing 11 may have the same technical features as previously disclosed.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (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)

Abstract

Timbre adhésif (1) pour application au niveau d'un site de lésion (Isi) d'un patient et configuré pour être en contact avec une peau de patient (S) lors de l'utilisation, comprenant un premier pansement (9) comprenant un corps principal (10), comprenant une partie adhésive (20) configurée pour fixer de manière amovible ledit corps principal (10) du timbre adhésif (1) à la peau de patient (S), une partie de collecte de fluide (30) configurée pour être placée au niveau du site de lésion (Isi), comprenant une première partie (31), exempte du matériau adhésif (28), élastiquement déformable et configurée pour définir un premier espace interposé (31a) entre la peau de patient (S) et le timbre adhésif (1), une partie de transfert (40) comprenant une seconde partie (41) exempte du matériau adhésif (28) élastiquement déformable et configurée pour définir un deuxième espace interposé (41a) entre la peau de patient (S) et le timbre adhésif (1) relié de manière dynamique au fluide au premier espace interposé (31a) et définissant un trajet de transfert (Tp) pour que le fluide s'écoule du premier espace interposé à une partie de décharge (50) de la partie de transfert (40).
PCT/EP2024/067997 2023-06-28 2024-06-26 Timbre adhésif pour application au niveau d'un site de lésion d'un patient et procédé de surveillance de saignement de fluide à l'aide du même timbre adhésif Pending WO2025003255A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT202300013434 2023-06-28
IT102023000013434 2023-06-28

Publications (1)

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WO2025003255A1 true WO2025003255A1 (fr) 2025-01-02

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Family Applications (1)

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PCT/EP2024/067997 Pending WO2025003255A1 (fr) 2023-06-28 2024-06-26 Timbre adhésif pour application au niveau d'un site de lésion d'un patient et procédé de surveillance de saignement de fluide à l'aide du même timbre adhésif

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Country Link
WO (1) WO2025003255A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0569565A1 (fr) 1991-11-29 1993-11-18 Nikomed Aps Bandage permettant de fixer une cannule d'un catheter intraveineux a la surface de la peau d'un patient.
US20100312159A1 (en) * 2005-04-16 2010-12-09 Adel Aali Secondary Wound Dressings for Securing Primary Dressings and Managing Fluid from Wounds, and Methods of Using Same
US20140257242A1 (en) * 2013-03-08 2014-09-11 Ethicon, Inc. All in one antimicrobial dressing for catheter coverage
US20160067106A1 (en) * 2014-09-10 2016-03-10 C. R. Bard, Inc. Protective Dressing For Skin-Placed Medical Device

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0569565A1 (fr) 1991-11-29 1993-11-18 Nikomed Aps Bandage permettant de fixer une cannule d'un catheter intraveineux a la surface de la peau d'un patient.
EP0569565B1 (fr) * 1991-11-29 1996-08-14 Nikomed Aps Bandage permettant de fixer une cannule d'un catheter intraveineux a la surface de la peau d'un patient
US20100312159A1 (en) * 2005-04-16 2010-12-09 Adel Aali Secondary Wound Dressings for Securing Primary Dressings and Managing Fluid from Wounds, and Methods of Using Same
US20140257242A1 (en) * 2013-03-08 2014-09-11 Ethicon, Inc. All in one antimicrobial dressing for catheter coverage
US20160067106A1 (en) * 2014-09-10 2016-03-10 C. R. Bard, Inc. Protective Dressing For Skin-Placed Medical Device

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