Adhesive patch for application at an injury site of a patient and method for monitoring fluid bleeding using the same adhesive patch

Abstract

Adhesive patch (1) for application at an injury site (Isi) of a patient and configured to be in contact with a patient skin (S) when in use, comprising a first dressing (9) including a main body (10), comprising an adhesive portion (20) configured for removably attaching said main body (10) of the adhesive patch (1) to the patient skin (S), a fluid collection portion (30) configured to be placed at the injury site (Isi), comprising a first portion (31), free of the adhesive material (28), elastically deformable and configured to define a first interposed space (31a) between the patient skin (S) and the adhesive patch (1), a transfer portion (40) comprising a second portion (41) free of the adhesive material (28) elastically deformable and configured to define a second interposed space (41a) between the patient skin (S) and the adhesive patch (1) fluid-dynamically connected to the first interposed space (31a) and defining a transfer path (Tp) for the fluid to flow from the first interposed space to a discharge portion (50) of the transfer portion (40).

Description

[0001] Adhesive patch for application at an injury site of a patient and method for monitoring fluid bleeding using the same adhesive patch

[0002] 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.

[0003] In particular, 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.).

[0004] 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.

[0005] Indeed, in this specific technical field, 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.

[0006] Generally, 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.

[0007] In this context, when referring to "post arterial catheterization puncture sites" the Applicant considers, among the others, at least the following typologies of arterial incision or wounds: radial, femoral, ulnar, axillary, brachial, posteriori tibial, dorsalis pedis, etc. 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.

[0008] An example can be found, for instance, in EP 0569565 that 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.

[0009] Typically, such devices, due to their arch-like shape tend to need a further bandage and / or tourniquet in order to keep the device at the desired position with respect to the injury site. Furthermore, this additional restraining medium tend to make more difficult the fast detection of fluid bleeding outside the injury site, even more in cases where additional and unexpected bleeding events occur.

[0010] In a known process type, in order to reduce the bleeding conditions, a pressure is applied to the injury site aiming at realizing a homeostasis condition.

[0011] 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.

[0012] Thus, quite often, 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.

[0013] In both the aforementioned configurations, it is apparent that in case of oozing bleeding, the blood would outflow in an uncontrolled manner reducing the prescribed hygienic requirements, and, moreover, making it difficult to both early detect further bleeding being unable to quickly and effectively maintain clean the injury site.

[0014] In some other embodiments belonging to the state of the art, 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.

[0015] In this context, 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. For the person skilled in the art it is clear that such an application is configured in order to be removably applied on the patient skin without producing excessive or any damages on the patient skin.

[0016] Furthermore, 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. In other words, such a patch could be considered also as a medium configured to control and / or handle fluids outside the patient body. In this context the term "patch" can be understood almost as a synonym of the terms band-aid, body plaster, bandage, etc.

[0017] In this context, 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.

[0018] In this context, the term "dressing" refers to a layer or multilayers structure configured to be adopted in treatment of human fluids and similar substances.

[0019] In this context, the terms "fluid bleeding" refer 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.).

[0020] In this context, 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.

[0021] In this context, the terms "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.

[0022] In this context, the terms "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.

[0023] In this context, the terms "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.

[0024] In this context, the term "capillarity" refers to the phenomenon producing fluid displacement at least partially due to the width of the channel through which the fluid is moving.

[0025] In this context, the term "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.

[0026] Further non limiting examples of the interposed space can be an empty or partially empty space, a niche, a recess, a channel, a canal, a pipe, a chamber, etc. In this context, with the term "channel" is identified a recess that has a longitudinal extension bigger than its lateral extension.

[0027] In this context, the terms "internal pressure or volume variation" define a condition in which the inner pressure or inner volume of a ambient or space are changed.

[0028] 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.

[0029] 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.

[0030] It is apparent that processes for obtaining internal volume reduction can not produce a concurrent internal pressure reduction and vice versa.

[0031] The Applicant has observed that the devices and processes generally implemented in the technical field of the present invention tend to be not efficiently applicable or usable in order to rapidly detect fluid bleedings and to intervene on them.

[0032] Furthermore, the Applicant has ascertained that often the further occurring of a bleeding event from an injury site could be masked or wrongly estimated due to the limits of the solution in the state of the art.

[0033] Furthermore, the Applicant has noticed that such difficulties further increase in case of presence of catheterization where an effective and rapid bleeding detection is required. The Applicant has therefore perceived that it was advantageous to overcome existing drawbacks in the state of the art designing an adhesive patch that could allow a more efficient detection of one or more bleeding events without requiring the removal or repositioning of patches and / or catheters in order to improve the patient benefit.

[0034] 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.

[0035] In particular, in a first aspect thereof, the invention 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.

[0036] Preferably, the adhesive patch comprises a first dressing.

[0037] Preferably, the first dressing includes a main body.

[0038] Preferably, the main body comprises an adhesive portion configured for removably attaching said main body of the adhesive patch to the patient skin.

[0039] Preferably, the adhesive portion comprises an adhesive surface facing the patient skin when in use.

[0040] Preferably, the main body comprises an adhesive material arranged at or on the adhesive surface.

[0041] Preferably, the adhesive patch comprises a fluid collection portion which is configured to be placed at the injury site.

[0042] Preferably, the fluid collection portion comprises a first portion, free of the adhesive material.

[0043] Preferably, the first portion is elastically deformable and configured to define, when in use at the injury site, a first interposed space.

[0044] Preferably, 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.

[0045] Preferably, the adhesive patch comprises a transfer portion.

[0046] Preferably, the transfer portion is arranged adjacent to the fluid collection portion.

[0047] Preferably, the transfer portion comprises a second portion free of the adhesive material. Preferably, 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.

[0048] Preferably, the second interposed space is fluid-dynamically connected to the first interposed space.

[0049] Preferably, 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.

[0050] Preferably, the second interposed space is configured to evacuate by internal pressure or volume variation the fluid outside throughout the discharge portion.

[0051] Thanks to these characteristics, 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.

[0052] Moreover, according to the present invention is possible to have 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.

[0053] Furthermore, thanks to 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.

[0054] It is thus apparent that such cleaning and resetting operations would imply longer and more frequent maintenance processes inducing a major discomfort for the patient and a waste of time for the medical personnel. In a second aspect thereof, the invention relates to a method for monitoring fluid bleeding using the adhesive patch comprising at least some of the features previously described.

[0055] Preferably, the method comprises applying the first dressing of the adhesive patch at an injury site of a patient skin.

[0056] Preferably, the method comprises detecting fluids outside the body of the patient and within the fluid collection portion or the transfer portion.

[0057] Preferably, the method comprises evacuating the fluid from the fluid collection portion by reducing the fluid collection portion volume or pressure.

[0058] Still, thanks to this solution, it is possible to clean or wipe away any collected trace of blood in the adhesive patch in order to detect efficiently any further bleeding event.

[0059] In at least one of the above-mentioned aspects, the present invention may further have at least one of the preferred features described below.

[0060] Preferably, 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.

[0061] Preferably, 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.

[0062] Preferably, the channel comprises a first opening defined at the fluid collection portion and a second opening defined at the discharge portion.

[0063] In such a way it is possible to increase the collected fluid discharge via a at least partially predetermined shaped medium of discharge.

[0064] Alternatively, the channel can be replaced by a recess defined in the second portion.

[0065] Preferably, 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. Preferably, 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.

[0066] In such a way it is possible to have a sufficiently extended area that is not attached to the patient skin and still can easily deform in order to allow fluid bleeding being moved toward the discharge portion.

[0067] Preferably, 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 104MPa, more preferably between 500 and 5000 MPa, even more preferably between 1000 and 3000 MPa.

[0068] 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.

[0069] It is relevant to notice that the adhesive patch can be produced as a heterogenic material and preferably as a heterogenic multilayers material.

[0070] According to this evaluation, 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.

[0071] Preferably, 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.

[0072] In such a way is possible to guarantee that the fluid will be discharged only via the predetermined discharging portion. Preferably, 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.

[0073] In such a way it is possible to produce an efficient fluid discharge either directly collecting it in a predetermined part of the patch or in an external zone of it.

[0074] Preferably, the absorbent material is a hydrophilic material.

[0075] 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.

[0076] In such a way it is possible to efficiently absorb the fluid outcoming from the patient body.

[0077] Preferably, 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.

[0078] In such a way it is possible to rapidly detect fluid bleeding events.

[0079] Preferred embodiments comprise polymeric materials having at least a significant moiety of amorphic phase.

[0080] Preferably, the adhesive patch comprises at least a pressing manual or automated pressure device for creating a pressure increase or volume reduction into the fluid collection portion or in the transfer portion.

[0081] In such a way it is possible to produce an improved discharging process.

[0082] Preferably, 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.

[0083] In such a way it is possible to efficiently and even automatically induce the fluid discharge from the fluid collection portion.

[0084] Preferably, the at least a pressure device is an inflatable balloon. In such a way by just reducing the inner volume available to the fluid of the fluid collection portion or the transfer portion it is possible to discharge the fluid.

[0085] Preferably, 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.

[0086] In this manner it is possible to guarantee an efficient adhesion to the patient skin while producing a liquid proof condition.

[0087] Preferably, the absorbent material is removably attached to the adhesive patch.

[0088] In this way it is possible to easily substitute the absorbent material once it is considered full or not properly working without removing completely the adhesive patch of the present invention.

[0089] Preferably, 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.

[0090] Preferably, 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.

[0091] Preferably, 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. In such a way the second interposed space is further defined on the upper surface of the second dressing and can be more precise than what achievable with respect to the patient skin.

[0092] Furthermore, adhesion can be improved avoiding possible detachments due to the sweating of the patient skin.

[0093] Moreover, in such a manner is possible to apply the first dressing in a second moment with respect to the second dressing application gaining the possibility to perform desired operations in a further manner. Indeed, in other words, the second dressing is a further optional and preferred juxtaposed dressing that collaborates with the first dressing of the invention in issue.

[0094] Preferably, the absorbent material is positioned in a peripheral portion of the adhesive patch.

[0095] In such a way it is possible to advantageously design the adhesive patch defining precisely the zone where fluids or blood will be collected.

[0096] Preferably, the absorbent material is positioned in a peripheral portion of the adhesive patch.

[0097] Alternatively, the absorbent material is positioned within the adhesive portion, more preferably in a central portion of it.

[0098] In such a way it is possible to improve the efficiency and compactness of the patch.

[0099] Preferably, the adhesive portion comprises two stickers peelable off that allow an easier application of the adhesive patch to the patient body.

[0100] Preferably, the second portion comprises an at least two openings chamber or a second recess.

[0101] Preferably, the at least two openings chamber or the second recess comprise at least one channel.

[0102] Preferably, the transport portion comprises a plurality of channels evenly distributed in the adhesive patch. In such a way it is possible to discharge more efficiently the fluid collected.

[0103] Preferably, the adhesive patch comprises a fluid sensor configured to detect the presence of fluid in the fluid collection portion or in the transfer portion.

[0104] In such a way it is possible to improve the fluid detection via specific sensors that can be automatically operating.

[0105] Preferably, the fluid sensor is an impedance sensor or optic fiber or volumetric sonde (or probe).

[0106] In such a way it is possible to efficiently detect fluid within the fluid collection or transfer portion.

[0107] Preferably, 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. Preferably, 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.

[0108] Preferably, the absorbent material comprises the fluid sensor.

[0109] Thanks to this solution it is possible to efficiently detect fluid in the predetermined and designed material.

[0110] Preferably, 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

[0111] Activate in a continuous or interrupted manner the fluid sensor in order to detect the presence of fluid in the fluid collection portion or in the transfer portion,

[0112] Activate the automated pressure device up to a predefined pressure when a first threshold parameter is detected by the fluid sensor, Deactivate the automated pressure device after a predetermined amount of pressure time or after the fluid sensor second threshold parameter is achieved.

[0113] Thanks to this solution it is possible to automatically detect the fluid bleeding and to act on it discharging the fluid collected in the adhesive patch while blocking the bleeding event.

[0114] Preferably, 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.

[0115] Preferably, 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.

[0116] Preferably, 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. In such a case it might be interesting to evaluate specifically or at least numerical variation of a* parameter which corresponds to red colours when greater than zero. In some preferred embodiments, thus 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.

[0117] In this sense, for instance, also a variation of L* parameter bigger than 10 could be effective as well.

[0118] Preferably, 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. Preferably, 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.

[0119] Also in this way it is possible to define the second interposed space on the upper surface of the second dressing being more precise than what achievable with respect to the patient skin while being able to apply the first dressing in a different moment with respect to the second dressing application gaining the possibility to perform specific operations in an independent manner.

[0120] According to a further aspect of the invention is described a method for producing the adhesive patch, comprising

[0121] Providing a mould configured so as to define an adhesive patch main body,

[0122] Providing a suitable thermoplastic material,

[0123] Injecting the thermoplastic material into the mould,

[0124] Opening the mould and obtaining the adhesive patch main body,

[0125] Applying the adhesive material on the adhesive surface.

[0126] In such a way it is possible to produce the desired adhesive patch via industrially advantageous processes.

[0127] The characteristics and advantages of the invention will become clearer from the detailed description of an embodiment illustrated, by way of non-limiting example, with reference to the appended drawings in which:

[0128] - figure 1 is a schematic bottom view of an adhesive patch in accordance with the present invention;

[0129] - figure 2 is a schematic view of the section II of figure 1;

[0130] - figure 3 is a further schematic bottom view of an alternative embodiment of the adhesive patch in accordance with the present invention;

[0131] - figure 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; - figures 5-7 are schematic views of an alternative embodiment of the adhesive patch in accordance with the present invention;

[0132] - figure 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;

[0133] - figures 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;

[0134] - figure 11 is a schematic bottom view of a further application of the adhesive patch in accordance with the present invention on a patient body;

[0135] - figures 12a and 12b are schematic views of the section XII of figure 10 showing alternative embodiments.

[0136] With initial reference to figure 1, 1 denotes an adhesive patch in accordance to the present invention which is suitable for application at an injury site Isi of a patient.

[0137] As can be seen for instance from figures 4, 8 and 11 the injury site Isi can be a wound on the patient skin S of a patient body. In the aforementioned figures are shown examples of possible applications in the arm region of the patient.

[0138] 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.

[0139] Still with reference to figure 1 and also to figure 2, the adhesive patch 1 comprises a first dressing 9 which is including a main body 10.

[0140] As shown in figure 2 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.

[0141] Furthermore, the first dressing 9, and more specifically the adhesive portion 20, comprise an adhesive material 28 arranged at or on the adhesive surface 21.

[0142] As can be seen from figures 1 and 2, 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.

[0143] Figure 2 represents a schematic sectional view taken exactly at the sectional plane II shown in figure 1.

[0144] Still with reference to figures 1 and 2, a 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.

[0145] Indeed, as can be seen clearly in figure 2, 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. Still with reference to figure 2, it is shown 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.

[0146] Considering that the figure 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 O. By way of a clearer and more intelligible description 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.

[0147] As can be seen from figures 1, 3, 4, 6, 9a, 9b the first portion 31 free of the adhesive material 28 has a substantially circular or elliptical or oval shape.

[0148] 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.

[0149] 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.

[0150] Indeed, considering figure 2 or 12a or 12b, 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.

[0151] In further embodiments, shown for instance in figures 5 and 7, the first interposed space 31a has the shape of a more elongated structure such as a parallelepiped 3D box or a longitudinal channel that allows and enhances 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).

[0152] It is relevant to notice that 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. In further embodiments it is considered that 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. In this sense, according to further embodiments, 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.

[0153] Indeed, it will be helpful to design adhesive patches 1 with different first interposed space 31a (in the shape of channel or recess or similar solutions) in order to properly and efficiently adequate to the injury size and to the expected bleeding amount. Considering the first interposed space 31a size it is apparent that it will allow to be placed in proximity or overlapping alignment with the injury site in order to permit an efficient blood collection from the wound.

[0154] 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.

[0155] In a more general meaning and with reference for example to the embodiments of figures 5-7, 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.

[0156] 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.

[0157] It is immediately apparent that 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.

[0158] The discharging phase through the discharge portion 50 can be efficiently produced 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.

[0159] In some other embodiments, 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. In some other embodiments, shown for instance in the figure 12b, the adhesive patch 1 comprises at least a pressure device 70 for creating the internal volume reduction of the first interposed space 31a. Preferably, the at least a pressure device 70 is an inflatable balloon 71 connected to inflating devices not shown in the figures.

[0160] In such a way by just reducing the inner volume available to the fluid for instance in the fluid collection portion it is possible to discharge the fluid form the adhesive patch.

[0161] In some embodiments, 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.

[0162] As can be seen in figure 1, the discharge portion 50 is directly connected to the outside O of the adhesive patch 1.

[0163] In an alternative type of embodiments, shown for instance in figures 3, 5-7, the transfer path Tp ends in an absorbent material 65 fluid-dynamically connected to the discharge portion 50.

[0164] 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.

[0165] In some embodiments not directly shown, 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.

[0166] With reference to figures 3 and 4, the absorbent material 65 is advantageously positioned in a peripheral part of the adhesive patch 1.

[0167] With reference to figure 1, 3 and 6, a fluid sensor 60 comprised in the adhesive patch 1 is shown.

[0168] The fluid sensor 60 is configured to detect the presence of fluid in the fluid collection portion 30 or in the transfer portion 40. By way of example of figure 1, and in also in order to make the figure quite readable, the fluid sensor is represented as located in the main body 10. According to further alternative embodiments, the fluid sensor 60 can be positioned in the fluid collection portion 30 or in the transfer portion 40.

[0169] In further embodiments, shown for instance in figures 3 and 6, the fluid sensor 60 is inserted in or on the absorbent material 65.

[0170] In some embodiments according to the present invention, the fluid sensor is an impedance sensor or optic fiber or volumetric sonde (or probe).

[0171] In such a way it is possible to efficiently detect fluid within the fluid collection or transfer portion.

[0172] Preferably, 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. Preferably, 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.

[0173] Considering now figure 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.

[0174] With reference to figure 12a, the elaboration unit 80 is preferably connected to the fluid sensor 60 and to the at least a pressing device 70 wirelessly.

[0175] Furthermore, the elaboration unit 80 is configured to selectively and automatically Activate in a continuous or interrupted manner the fluid sensor 60 in order to detect the presence of fluid in the fluid collection portion 30 or in the transfer portion 40 coherently with its position,

[0176] Activate the automated pressure device 70 up to a predefined pressure when a first threshold parameter Tpl is detected by the fluid sensor 60,

[0177] Deactivate the automated pressure device 70 after a predetermined amount of pressure time Pt or after the fluid sensor 60 second threshold parameter Tp2 is achieved.

[0178] In such a way it is possible to efficiently and even automatically induce the fluid discharge from the fluid collection portion 30.

[0179] Now with reference to figures 9a-12b, a first and second dressing 9, 11 are shown.

[0180] Considering figure 9a and 9b, the first dressing 9 and the second dressing 11 are shown from below in a bottom view representing with additional inclined lines the adhesive material 28.

[0181] More specifically, in such embodiments 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.

[0182] With reference to figure 12a, 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.

[0183] Furthermore, 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.

[0184] 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.

[0185] Regarding the 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.

[0186] More specifically, figure 12a shows an embodiment in which the first dressing 9 and the second dressing 11 have substantially the same size and overlap.

[0187] Alternatively, 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.

[0188] The present invention further discloses a method 300 (not shown in the figures) for monitoring fluid bleeding using the adhesive patch previously disclosed, comprising

[0189] - applying the first dressing 9 of the adhesive patch 1 at an injury site of a patient skin,

[0190] - detecting fluids outside the body of the patient and within the fluid collection portion 30 or the transfer portion 40,

[0191] - evacuating the fluid from the fluid collection portion 30 by reducing the fluid collection portion 30 volume.

[0192] More preferably, the detection of the fluid bleeding can be produced by visual detection or by the fluid sensors 60 previously described.

[0193] More preferably, 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. Moreover, 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.

[0194] Also in this case the first dressing 9, the second dressing 11 may have the same technical features as previously disclosed.

Claims

CLAIMS1. Adhesive patch (1) for application at an injury site (Isi) of a patient and configured to be in contact with a patient skin (S) when in use, comprising a first dressing (9) including- a main body (10),• comprising 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,• comprising an adhesive material (28) arranged at or on the adhesive surface (21),- a fluid collection portion (30)• configured to be placed at the injury site (Isi),• comprising 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),- a transfer portion (40)• arranged adjacent to the fluid collection portion (30),• comprising a second portion (41) free of the adhesive material (28) 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), the second interposed space (41a) being fluid-dynamically connected to the first interposed space (31a) and defining a transfer path (Tp) for the fluid to flow from the first interposed space to a discharge portion (50) of the transfer portion (40),• configured to evacuate by internal pressure or volume variation the fluid outside throughout the discharge portion (50).

2. Adhesive patch (1) according to claim 1, wherein the second portion (41), when the adhesive patch (1) is in use and fluid bleeding occurs, defines at least a channel that corresponds to the second interposed space (41a), the channel comprising a first opening (411) defined at the fluid collection portion (30) and a second opening (412) defined at the discharge portion (50).

3. Adhesive patch (1) according to claim 1 or 2, wherein the minimum extension of a proximal surface of the second portion (41) free of the adhesive material (28) and facing the patient skin when in use is 0.5 mm.

4. Adhesive patch (1) according to any of the preceding claims, wherein the fluid collection portion (30) and / or the transfer portion (40) comprise a resilient polymeric material elastically deformable having an elastic modulus (E) comprised between 10 and 104MPa, more preferably between 500 and 5000 MPa.

5. Adhesive patch (1) according to any of the preceding claims, wherein the adhesive portion (20), the adhesive surface (21) and the adhesive material (28) are configured to produce air and liquid tight adhesion on the patient skin when in use.

6. Adhesive patch (1) according to any of the previous claim, wherein the discharge portion (50) is fluid-dynamically connected to either the outside of the adhesive patch (O) or to an absorbent material (65) comprised in the adhesive patch (1).

7. Adhesive patch (1) according to the previous claim, wherein the absorbent material (65) is a hydrophilic material.

8. Adhesive patch (1) according to claim 1, wherein the fluid collection portion (30) and the transportation portion (40) is 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.

9. Adhesive patch (1) according to claim 1, comprising at least a pressure device (70) for creating the internal pressure or volume variation in the fluid collection portion (30) or in the transfer portion (40).

10. Adhesive patch (1) according to the previous claim, wherein the at least a pressure device (70) is an inflatable balloon (71).

11. Adhesive patch (1) according to any of the previous claims, wherein the fluid collection portion (30) is substantially at the centre of the adhesive patch (1) and the fluid collection portion (30) and the absorbent material (65) are surrounded by the adhesive material for an extension of at least 5 mm to provide air and liquid tight sealing.

12. Adhesive patch (1) according to claim 6 to 11 when depending on claim 6, wherein the absorbent material (65) is removably attached to the adhesive patch (1).

13. Adhesive patch (1) according to any of the previous claims, comprising a second dressing (11) proximal to the patient skin (S) when in use, wherein the second dressing (11)- comprises a lower adhesive surface (12) facing the patient skin when in use,- comprises the adhesive material (28) being arranged at or on the lower adhesive surface (12),- 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),- 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 (41a) is defined between the upper surface (13) of the second dressing (11) and the first dressing (9).

14. Method (300) for monitoring fluid bleeding using the adhesive patch (1) of claims from 1 to 13, comprising- applying the first dressing (9) of the adhesive patch (1) at an injury site of a patient skin,- detecting fluids outside the body of the patient and within the fluid collection portion (30) or the transfer portion (40),- evacuating the fluid from the fluid collection portion (30) by reducing the fluid collection portion (30) volume.

15. Method (300) according to the previous claim when depending on claim 13, comprising- 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.

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