SE2030365A1

SE2030365A1 - Novel interface for the arrangement of a medical device on a patient

Info

Publication number: SE2030365A1
Application number: SE2030365A
Authority: SE
Inventors: Posaric David Wensbo; Jonathan Ahlse; Robert LINDE
Original assignee: Innovation Skaane Ab
Priority date: 2020-12-18
Filing date: 2020-12-18
Publication date: 2022-06-19
Also published as: WO2022132017A1; SE545528C2

Abstract

An interface (100) for the arrangement of a medical device (200) in a determinable spatially restricted relationship relative a patient is disclosed. The interface (100) comprises an engagement surface (104), for mechanical and electrical releasable engagement with a corresponding mating surface (201) of the medical device (200), patient connective means (101), which means are adapted to secure the interface (100) in a spatially constant relationship relative the thereto most nearby partial outer surface of the patient, and an internal sensor (101).

Description

Novel interface for the arrangement of a medical device on a patient Technical Field The present invention generally relates to interfaces of medical devicesand more particularly to an interface for the arrangement of a medical device ona patient.

Background The secure spatial arrangement of a device, such as e.g. a medical device orsensor, onto a bodily part of a patient, is often desired and may be critical. Suchmedical devices and sensors are typically directly secured to the patient bytraditional means, such as bandages, strings and tape. Control of their secureplacement is typically achieved by periodic visual inspections. Examples of suchmedical devices include devices through which a liquid or gas is administered tothe patient, e.g. infusion catheters and the like and nasal cannulas, face masksand the like, respectively. The latter sensor may be exemplified by one out oftwo separate absolute pressure sensors, both being part of a levelling device forvertical positioning of an external medical device as described in SE 1730296-9filed on Oct. 30"" 2017.

US 6 064 901 by NDl\/I Inc. discloses a biomedical electrode including adisposable electrode and a reusable leadwire connector. The reusable leadwireincludes a stud member which snaps into a standard leadwire connector.Disadvantages of such a biomedical electrode include, for example, the needfor an electrical connection between the patient being applied with thebiomedical electrode and the standard leadwire connector, in order to collectdata.

DE 20 2018 104191 by Vanguard AG discloses a mounting, comprising aholding down part having a receiving space and a clip closure. A sensor, forreception of electrical currents and/or signals with respect to a body, may beheld in the receiving space and locked therein by aid of the clip closure.Disadvantages of this mounting include, for example, a separation between themeans by which the sensor is mechanically and electrically connected to or viathe mounting. The clip closure may thus be open in an unsecure way, while the lO sensor is electrically connected to the body, without the possibility to detectsuch a situation by means of the electrical currents and/or signals.

EP 2389860 B1 by Biosense Webster, lnc. discloses a disposable patchassembly for use in a device mapping system used to map the location of adevice within the body of a patient. lt comprises an adhesive layer and anengagement element adapted to detachably engage at least a portion of ahousing of a reusable sensor cable assembly. Disadvantages of this disposablepatch assembly include, for example, a static spatial relationship between theengagement element and the sensor cable assembly when engaged. Hence, aforce applied from the side to the sensor cable assembly, or any extensionthereof, may lead to the undesired disconnection of the adhesive layer from thepatient. lt would be advantageous with an interface for the arrangement of amedical device or sensor in a determinable spatially restricted relationshiprelative a patient that allows for avoiding some of above-mentioned problemsand compromises.

Summary lt is an object of the invention, considering the disadvantages mentionedabove, to provide an interface which allows for the provision of an electricalsignal being indicative of the spatial relationship between a device or sensorand a patient. lt is another object of the invention, considering the disadvantagesmentioned above, to provide an interface which is electrically isolated from apatient and provides electrical isolation from a thereto connected device orsenson lt is yet another object of the invention, considering the disadvantagesmentioned above, to provide an interface which provides a controlled selectivespatial relationship between a device or sensor and a patient.

Accordingly, examples of the present invention preferably seek to mitigate,alleviate or eliminate one or more deficiencies, disadvantages or issues in theart, such as the above-identified, singly or in any combination by providing aninterface according to the appended patent claims. lO According to a first aspect, an interface for the arrangement of a medicaldevice in a determinable spatially restricted relationship relative a patient isprovided. The interface comprises a coupling, patient connective means, whichmeans are adapted to secure the interface in a spatially constant relationshiprelative the thereto most nearby partial outer surface of the patient, and aninternal sensor. The interface exists in a connected state, in which the interfaceis mechanically and electrically connected to the medical device, or in areleased state, in which the interface is mechanically and electricallydisconnected from the medical device. Transition from the connected state tothe released state and from the released state to the connected state isaccomplished by a disengaging force and an engaging force, respectively,applied to the medical device by a user to disengage and engage, respectively,the coupling from/with a corresponding mating surface of the medical device.The coupling is provided with an engagement surface and a first electricalconnector interface, being mechanically and electrically interlocked andengaged, respectively, with the mating surface of the medical device, in theconnected state. The engagement surface and the first electrical connectorinterface have a cross-sectional circular shape along their intersection with themating surface to allow rotation of the medical device relative a central axis ofthe coupling, in the connected state. The internal sensor is electrically isolatedfrom the patient, arranged in a fixed position relative the interface and providedwith means for the generation of a singularity or plurality of electrical signalsbeing dependent on the spatial relationship between the interface and thepatient. These electrical signals are transmittable to the medical device via thefirst electrical connector interface and the mating surface, in the connectedstate.

According to a second aspect, a system comprising the interface of thefirst aspect and a medical device, is provided.

Further examples of the invention are defined in the dependent claims,wherein features for the second aspect of the disclosure are as for the firstaspect mutatis mutandis.

Some examples of the disclosure provide for the provision of an alarm-signal, should e.g. the intended function of a medical device be adventured dueto incorrect positioning relative a patient.

Some examples of the disclosure provide for spatial determination, suchas vertical positioning, of a point or volume within the body of a patient. lO Some examples of the disclosure provide for a reduced risk of a medicaldevice accidently being dispositioned from its position relative a patient.

Some examples of the disclosure provide for the monitoring of a patient"smovements.

Some examples of the disclosure provide for facilitated physicalreplacement of one medical device by another medical device, with a remainedspatial relationship relative a patient. lt should be emphasized that the term "comprises/comprising" when usedin this specification is taken to specify the presence of stated features, integers,steps or components but does not preclude the presence or addition of one ormore other features, integers, steps, components or groups thereof.

Brief Description of the Drawings These and other aspects, features and advantages of which examples ofthe invention are capable of will be apparent and elucidated from the followingdescription of examples of the present invention, reference being made to theaccompanying drawings, in which; Fig. 1 is a view from the side of an interface 100 according to theinvention, comprising patient connective means 101 in the form of an adhesivesurface, a bulb shaped coupling 103 having an engagement surface 104 closerto its proximal end than to its distal end and a first electrical connector interface105, and an internal sensor, according to examples of the disclosure; Fig. 2a is a view from the side of the interface 100 of Fig. 1, being in areleased state from a medical device 200 equipped with mating surface 201,having a bulp shaped form, according to examples of the disclosure; Fig. 2b is a view from the side of the interface 100 and the medical device200 of Fig 2a, being connected to each other in a connected state by aninterlock between the engagement surface 104 and the mating surface 201,whereby an electrical signal (dotted arrow) may flow from the internal sensor102 via the first electrical connector interface, the second electrical connectorinterface 205, being an opposing corresponding and contacting electricallyconductive surface of the mating surface 201, and from this to connectedelectrical lead traces to the exterior; Fig 3 is a view from the side of the interface 100 and the medical device200 of Fig 2a, being connected to each other in a connected state, the patient lO connective means 101 being adhered to the skin of a patient 301 and themedical device 200 being provided with a pressure sensor 202 sensing theinternal pressure of the connected tube 203, according to examples of thedisclosure.

Fig 4 is a cut through view from the side of a bulb shaped rotatablecoupling 103, comprising three first electrical connector interfaces 105electrically isolated from each other by electrical insulators 106, which coupling103 being mechanically and electrically engaged with a mating surface 201 andcorresponding second electrical connector interfaces 205, respectively, of amedical device 200, enabling electrical signaling through three separateelectrical paths E1, E2 and E3, according to examples of the disclosure.

Detailed Description Specific examples of the invention will now be described with reference tothe accompanying drawings. This invention may, however, be embodied inmany different forms and should not be construed as limited to the examplesset forth herein; rather, these examples are provided so that this disclosure willbe thorough and complete, and will fully convey the scope of the invention tothose skilled in the art. The terminology used in the detailed description of theexamples illustrated in the accompanying drawings is not intended to be limitingof the invention. ln the drawings, like numbers refer to like elements.

The interface 100 of the invention essentially comprise patient connectivemeans 101, a coupling 103, and an internal sensor 102. A suitably arrangedmedical device 200 may, by user-intervention, be mechanically and electricallyconnected to the interface 100, whereby the medical device 200 becomesspatially restricted relative a patient 300, onto which the interface 100 has beenarranged, as further explained herein below. ln operation, the interface 100 may be fastened to the skin of a patient 300by the patient connective means 101. The patient connective means 101 areessentially adapted to secure the interface 100 in a spatially constantrelationship relative the thereto most nearby partial outer surface of the patient300, e.g. by a medical adhesive on the outer surface of the interface 100. Suchmedical adhesives are well known in the art and may typically be arranged witha protective film, which the user removes prior to placement on the patient"s 300 lO skin. Additional suitable patient connective means 101 include e.g. means tointegrate with a bandage or patch, which may have been previously applied to abodily part of the patient 300 or is applied simultaneously with the patientconnective means 101. Examples of such means include stripes of bandage,that may be folded under the patient"s 300 current bandage in use or around abodily part of the patient 300. Yet additional suitable patient connective means101 include e.g. means for forming a direct mechanical bond between theinterface 100 and a bandage, already applied on the patient 300, or the skin ofthe patient 300. Such mechanical bonds include e.g. surgical staples or stitchesthreaded simultaneously through suitable holes or over extensions near theperiphery of the interface 100 and the bandage or the skin of the patient 300.Yet more additional suitable patient connective means 101 include e.g. tissueglue, adhesive strips and suction cups, for direct fastening to the skin of thepatient 300.

The coupling 103, which may typically be bulb shaped, is forming areleasable mechanical connection and simultaneously releasable electricalconnection with the medical device 200. ln a connected state, a mating surface201 of the medical device 200 interlocks mechanically with a correspondingengagement surface 104 of the coupling 103. The engagement surface 104may have a cross-sectional circular shape along the intersection with the matingsurface 201. The medical device 200 is thus, in the connected state, spatiallyrestricted relative the interface 100. Hence, all relative movements, except forrotation of the medical device 200 around an axis thereof in accordance withsome embodiments, which axis coincides with the corresponding central axis ofthe coupling 103, are prevented. ln the same connected state, the interface 100may, via a first electrical connector interface 105 of e.g. the engagementsurface 104 of the coupling 103, simultaneously be in electrical connection withthe medical device 200, via a corresponding second electrical connectorinterface 205 of the mating surface 201. ln a released state, which may be accomplished by the application of alifting force onto the medical device 200 in a direction from the interface 100 togently force a disconnection between the coupling 103 and the mating surface201, the interface is mechanically and electrically disconnected from themedical device 200. Transition from the connected state to the released state,and from the released state to the connected state, may be accomplished by adisengaging force and an engaging force, respectively, applied to the medical lO device 200 by a user to disengage and engage, respectively, the coupling 103from/with the corresponding mating surface 201 of the medical device 200.

The internal sensor 102 is essentially electrically isolated from the patient300 and arranged in a fixed position relative the interface 100, such as e.g.being integrated in the inner volume thereof. The internal sensor 102 maytypically be provided with means, well known in the art, for the generation ofoutput data in the form of a singularity or plurality of electrical signals, such ase.g. communicated via one isolated electrical path or two, three, four or moreintra-isolated electrical paths, i.e. being all electrically isolated from each other.Such means may, for example, include means known in the art for thedetermination of the spatial relationship between the interface 100 and thepatient 300, e.g. proximity sensing means for detection of proximity, i.e.distance, between the internal sensor 102 and the patient 300. The internalsensor 102 may thus generate output data indicative of the proximity of theinterface 100 and the patient 300, e.g. for the determination of whether or notthe interface 100 is correctly fastened to the patient 300 and has not accidentlybeen removed therefrom. The electrical signals may be transferred from and tothe internal sensor 102, via conductive leads and temporal junctions dependenton the state (connected state: closed temporal junction; and released state:open temporal junction), from and to the medical device 200, e.g. via the firstelectrical connector interface 105 and via the second electrical connectorinterface 205 of the mating surface 201. Examples of internal sensors 102,suitable for estimation of the distance between the interface 100 and the patient300, are sensors well known in the art in which the capacitance of an element ofthe sensor is dependent on the distance from the patient 300. The internalsensors 102 may also be provided with means well known in the art for thedetermination of three-dimensional orientation and acceleration, e.g. peakacceleration and/or average acceleration. Examples of the former includesensors generating output dependent on the angle between the central axis ofthe interface 100 and the vector of the natural gravitational acceleration.Examples of the latter include well known accelerometers, such as e.g. readilyavailable digital micro-accelerometers.

The interface 100 and the medical device 200 may be appropriatelydesigned to interact with each other in an overall system 500. For example, themedical device 200 of such a system 500 may be provided with a sensor, e.g.an internal sensor, which is the same as or corresponds to the internal sensors102 of the interface 100, described and taught herein above. Such an extra lO sensor, beside the internal sensors 102 of the interface 100, grants the systemwith several advantages. For example, an extra proximity sensor of the medicaldevice 200 enables e.g. determination or estimation of the relative spatialrelationship between the interface 100 and the medical device 200. lf both aresimultaneously detecting close proximity to the patient 300, it may be concludedthat they are engaged in a connected state.

According to one embodiment, the system 500 may comprise a medicaldevice 200 with a mating surface 201 adapted for releasable mechanicallocking with the engagement surface 104 of the interface 100. The matingsurface 201 may comprise a second electrical connector interface 205 adaptedfor releasable electrical contact with the first electrical connector interface 105of the interface 100.

According to one embodiment, the medical device 200 of the system 500may comprise means for the generation of a singularity or plurality of electricalsignals being dependent on the angle between the central axis of the medicaldevice 200 and the vector of the natural gravitational acceleration. Such anextra sensor, beside the internal sensors 102 of the interface 100 being e.g. aproximity sensor, advantageously enables determination of the degree ofleaning, turning or tilting of the head of a patient 300 carrying such a system onthe head, relative a reference angle.

According to one embodiment, the medical device 200 of the system 500may comprise means, e.g. an accelerometer, for the generation of a singularityor plurality of electrical signals being dependent on the peak or averageacceleration of said medical device 200. Such means advantageously enablese.g. determination of the degree of acceleration of the head of a patient 300carrying such a system on the head. On the occasion of the determinedacceleration exceeding a predetermined threshold value, an alarm signalindicative of e.g. an unintentional released state or a dangerous movement ofthe patient 300, may be generated.

According to one embodiment, the medical device 200 of the system 500may comprise a pressure sensor 202 being in fluid connection with a tube 203filled with liquid and adapted to detect the pressure thereof. Such a system 500grants advantages to any setup in which the absolute pressure in an ending of atube 203 in close proximity to a bodily part of a patient is measured, for examplein the setup described in WO2019088902 by lnnovation Skàne AB. Thus, forexample, the medical device 200 may be rotated around the central axis of the lO device 200, to allow the tube 203 to exit in a more optimal direction relative thepatient 300.

According to one embodiment, the system 500 may comprise an optionallyseparate controller 204. The controller 204 may be adapted to receive data, e.g.in the form of electrical signals or wirelessly from the interface 100 and/or themedical device 200. The controller 204 may comprise a user interface forcontrol of the sensors and/or for visual or audial output indicative of the status ofthese, including an alarm status.

The present invention has been described above with reference to specificexamples. However, other examples than the above described are equallypossible within the scope of the invention. The different features and steps ofthe invention may be combined in other combinations than those described.The scope of the invention is only limited by the appended patent claims. l\/lore generally, those skilled in the art will readily appreciate that allparameters, dimensions, materials, and configurations described herein aremeant to be exemplary and that the actual parameters, dimensions, materials,and/or configurations will depend upon the specific application or applicationsfor which the teachings of the present invention is/are used.

Claims

1. An interface (100), for the arrangement of a medical device (200) in adeterminable spatially restricted relationship relative a patient (300), comprisinga coupling (103), patient connective means (101), which means being adaptedto secure said interface (100) in a spatially constant relationship relative thethereto most nearby partia| outer surface of said patient (300), and an internalsensor (102), wherein - said interface (100) exists in a connected state, in which said interface (100) ismechanically and electrically connected to said medical device (200), or in areleased state, in which said interface (100) is mechanically and electricallydisconnected from said medical device (200); - transition from said connected state to said released state and from saidreleased state to said connected state being accomplished by a disengagingforce and an engaging force, respectively, applied to said medical device (200)by a user to disengage and engage, respectively, said coupling (103) from/witha corresponding mating surface (201) of said medical device (200); - said coupling (103) being provided with an engagement surface (104) and afirst electrical connector interface (105), being mechanically and electricallyinterlocked and engaged, respectively, with said mating surface (201) of saidmedical device (200), in said connected state; - said engagement surface (104) and said first electrical connector interface(105) having a cross-sectional circular shape along their intersection with saidmating surface (201) to allow rotation of said medical device (200) relative acentral axis of said coupling (103), in said connected state; and - said internal sensor (102) being electrically isolated from said patient,arranged in a fixed position relative said interface (100) and provided withmeans for the generation of a singularity or plurality of electrical signals beingdependent on the spatial relationship between said interface (100) and saidpatient (300), which electrical signals are transmittable to said medical device(200) via said first electrical connector interface (105) and said mating surface(201 ), in said connected state.

2. An interface (100) according to claim 1, wherein said first electrical connectorinterface (105) being arranged on said engagement surface (104). lO

3. An interface (100) according to any one of the preceding claims, wherein saidSingularity or plurality of electrical signals being communicated via saidconnector interface (105) by one electrical path or two, three or four intra-isolated electrical paths.

4. An interface (100) according to any one of the preceding claims, wherein saidpatient connective means (101) comprise an adhesive outer surface adapted toadhere to the skin of said patient (300) when applied thereon.

5. An interface (100) according to any one of the preceding claims, wherein saidpatient connective means (101) comprise means to integrate with a bandage orpatch applied to a bodily part of said patient (300).

6. An interface (100) according to any one of the preceding claims, wherein saidpatient connective means (101) comprise means for fastening of said interface(100) to the skin of said patient (300) by surgical stitches, staples, tissue glue,or adhesive strips.

7. An interface (100) according to any one of the preceding claims, wherein saidinternal sensor (102) being provided with means for the generation of asingularity or plurality of electrical signals being dependent on the distancebetween said interface (100) and said patient (300).

8. An interface (100) according to claim 7, wherein said electrical signals beingdependent on the distance between said interface (100) and said patient (300),being dependent on the capacitance of said internal sensor (102).

9. An interface (100) according to any one of the preceding claims, wherein saidinternal sensor (102) being provided with means for the generation of asingularity or plurality of electrical signals being dependent on the anglebetween the central axis of said interface (100) and the vector of the naturalgravitational acceleration.

10. An interface (100) according to any one of the preceding claims, whereinsaid internal sensor (102) being provided with means for the generation of asingularity or plurality of electrical signals being dependent on peak or averageacceleration thereof. lO

11. A system (500) comprising an interface (100) according to any one of claims1 to 10 and a medical device (200), wherein - said medical device (200) comprises a mating surface (201) adapted forreleasable mechanical Iocking with said engagement surface (104) of saidinterface (100); and - said mating surface (201) comprises a second electrical connector interface(205) adapted for releasable electrical contact with said first electrical connectorinterface (105) of said interface (100).

12. A system (500) according to claim 11, wherein said medical device (200)comprises means for the generation of a singularity or plurality of electricalsignals being dependent on the angle between the central axis of said medicaldevice (200) and the vector of the natural gravitational acceleration.

13. A system (500) according to any one of claims 10 to 12, wherein saidmedical device (200) comprises means for the generation of a singularity orplurality of electrical signals being dependent on the peak or averageacceleration of said medical device (200).

14. A system (500) according to any one of claims 10 to 13, wherein saidmedical device (200) comprises a pressure sensor (202) being in fluidconnection with a tube (203) filled with liquid, said pressure sensor (202) beingadapted to detect the pressure of said liquid.

15. A system (500) according to any one of claims 10 to 14, further comprisinga controller (204) being adapted to receive data in the form of electrical signalsfrom said interface (100) and said medical device (200).