SE545528C2 - An interface for providing a controllable spatial relationship between a medical device and a patient´s skin using electrical signals - Google Patents

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

An interface for providing a controllable spatial relationship between a medical device and a gatienfs skin using electrical signals Technical Field The present invention generally relates to interfaces of medical devices and more particularly to an interface for the arrangement of a medical device on a patient.

Background The secure spatial arrangement of a device, such as e.g. a medical device or sensor, onto a bodily part of a patient, is often desired and may be critical. Such medical devices and sensors are typically directly secured to the patient by traditional means, such as bandages, strings and tape. Control of their secure placement is typically achieved by periodic visual inspections. Examples of such medical devices include devices through which a liquid or gas is administered to the patient, e.g. infusion catheters and the like and nasal cannulas, face masks and the like, respectively. The latter sensor may be exemplified by one out of two separate absolute pressure sensors, both being part of a levelling device for vertical positioning of an external medical device as described in SE 1730296-9 filed on Oct. 30"' US 6 064 901 by NDM Inc. discloses a biomedical electrode including a disposable electrode and a reusable leadwire connector. The reusable leadwire includes a stud member which snaps into a standard leadwire connector. Disadvantages of such a biomedical electrode include, for example, the need for an electrical connection between the patient being applied with the biomedical electrode and the standard leadwire connector, in order to collect data.

DE 20 2018 104 191 by Vanguard AG discloses a mounting, comprising a holding down part having a receiving space and a clip closure. A sensor, for reception of electrical currents and/or signals with respect to a body, may be held in the receiving space and locked therein by aid of the clip closure. Disadvantages of this mounting include, for example, a separation between the means by which the sensor is mechanically and electrically connected to or via lO the mounting. The clip closure may thus be open in an unsecure way, while the sensor is electrically connected to the body, without the possibility to detect such a situation by means of the electrical currents and/or signals.

EP 2389860 B1 by Biosense Webster, Inc. discloses a disposable patch assembly for use in a device mapping system used to map the location of a device within the body of a patient. lt comprises an adhesive layer and an engagement element adapted to detachably engage at least a portion of a housing of a reusable sensor cable assembly. Disadvantages of this disposable patch assembly include, for example, a static spatial relationship between the engagement element and the sensor cable assembly when engaged. Hence, a force applied from the side to the sensor cable assembly, or any extension thereof, may lead to the undesired disconnection of the adhesive layer from the patient. lt would be advantageous with an interface for the arrangement of a medical device or sensor in a determinable spatially restricted relationship relative a patient that allows for avoiding some of above-mentioned problems and compromises.

Summary lt is an object of the invention, considering the disadvantages mentioned above, to provide an interface which allows for the provision of an electrical signal being indicative of the spatial relationship between a device or sensor and a patient. lt is another object of the invention, considering the disadvantages mentioned above, to provide an interface which is electrically isolated from a patient and provides electrical isolation from a thereto connected device or senson lt is yet another object of the invention, considering the disadvantages mentioned above, to provide an interface which provides a controlled selective spatial 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 the art, such as the above-identified, singly or in any combination by providing an interface according to the appended patent claims.

According to a first aspect, an interface for the arrangement of a medical device in a determinable spatially restricted relationship relative a patient is provided. The interface comprises a coupling, patient connective means, which means are adapted to secure the interface in a spatially constant relationship relative the thereto most nearby partial outer surface of the patient, and an internal sensor. The interface exists in a connected state, in which the interface is mechanically and electrically connected to the medical device, or in a released state, in which the interface is mechanically and electrically disconnected from the medical device. Transition from the connected state to the released state and from the released state to the connected state is accomplished 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 electrical connector interface, being mechanically and electrically interlocked and engaged, respectively, with the mating surface of the medical device, in the connected state. The engagement surface and the first electrical connector interface have a cross-sectional circular shape along their intersection with the mating surface to allow rotation of the medical device relative a central axis of the coupling, in the connected state. The internal sensor is electrically isolated from the patient, arranged in a fixed position relative the interface and provided with means for the generation of a singularity or plurality of electrical signals being dependent on the spatial relationship between the interface and the patient. These electrical signals are transmittable to the medical device via the first electrical connector interface and the mating surface, in the connected state.

According to a second aspect, a system comprising the interface of the first 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 first aspect 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 due to incorrect positioning relative a patient.

Some examples of the disclosure provide for spatial determination, such as vertical positioning, of a point or volume within the body of a patient.

Some examples of the disclosure provide for a reduced risk of a medical device accidently being dispositioned from its position relative a patient.

Some examples of the disclosure provide for the monitoring of a patients movements.

Some examples of the disclosure provide for facilitated physical replacement of one medical device by another medical device, with a remained spatial relationship relative a patient. lt should be emphasized that the term “comprises/comprising” when used in 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 or more other features, integers, steps, components or groups thereof.

Brief Description of the Drawings These and other aspects, features and advantages of which examples of the invention are capable of will be apparent and elucidated from the following description of examples of the present invention, reference being made to the accompanying drawings, in which; Fig. 1 is a view from the side of an interface 100 according to the invention, comprising patient connective means 101 in the form of an adhesive surface, a bulb shaped coupling 103 having an engagement surface 104 closer to its proximal end than to its distal end and a first electrical connector interface 105, 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 a released 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 device 200 of Fig 2a, being connected to each other in a connected state by an interlock between the engagement surface 104 and the mating surface 201, whereby an electrical signal (dotted arrow) may flow from the internal sensor 102 via the first electrical connector interface, the second electrical connector interface 205, being an opposing corresponding and contacting electrically conductive surface of the mating surface 201, and from this to connected electrical lead traces to the exterior; Fig 3 is a view from the side of the interface 100 and the medical device 200 of Fig 2a, being connected to each other in a connected state, the patient connective means 101 being adhered to the skin of a patient 301 and the medical device 200 being provided with a pressure sensor 202 sensing the internal pressure of the connected tube 203, according to examples of the disclosure.

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

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

The interface 100 of the invention essentially comprise patient connective means 101, a coupling 103, and an internal sensor 102. A suitably arranged medical device 200 may, by user-intervention, be mechanically and electrically connected to the interface 100, whereby the medical device 200 becomes spatially restricted relative a patient 300, onto which the interface 100 has been arranged, as further explained herein below. ln operation, the interface 100 may be fastened to the skin of a patient 300 by the patient connective means 101. The patient connective means 101 are essentially adapted to secure the interface 100 in a spatially constant relationship relative the thereto most nearby partial outer surface of the patient 300, e.g. by a medical adhesive on the outer surface of the interface 100. Such medical adhesives are well known in the art and may typically be arranged with a protective film, which the user removes prior to placement on the patientslO skin. Additional suitable patient connective means 101 include e.g. means to integrate with a bandage or patch, which may have been previously applied to a bodily part of the patient 300 or is applied simultaneously with the patient connective means 101. Examples of such means include stripes of bandage, that may be folded under the patients 300 current bandage in use or around a bodily part of the patient 300. Yet additional suitable patient connective means 101 include e.g. means for forming a direct mechanical bond between the interface 100 and a bandage, already applied on the patient 300, or the skin of the patient 300. Such mechanical bonds include e.g. surgical staples or stitches threaded simultaneously through suitable holes or over extensions near the periphery 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. tissue glue, adhesive strips and suction cups, for direct fastening to the skin of the patient The coupling 103, which may typically be bulb shaped, is forming a releasable mechanical connection and simultaneously releasable electrical connection with the medical device 200. ln a connected state, a mating surface 201 of the medical device 200 interlocks mechanically with a corresponding engagement surface 104 of the coupling 103. The engagement surface 104 may have a cross-sectional circular shape along the intersection with the mating surface 201. The medical device 200 is thus, in the connected state, spatially restricted relative the interface 100. Hence, all relative movements, except for rotation of the medical device 200 around an axis thereof in accordance with some embodiments, which axis coincides with the corresponding central axis of the coupling 103, are prevented. ln the same connected state, the interface 100 may, via a first electrical connector interface 105 of e.g. the engagement surface 104 of the coupling 103, simultaneously be in electrical connection with the medical device 200, via a corresponding second electrical connector interface 205 of the mating surface ln a released state, which may be accomplished by the application of a lifting force onto the medical device 200 in a direction from the interface 100 to gently force a disconnection between the coupling 103 and the mating surface 201, the interface is mechanically and electrically disconnected from the medical device 200. Transition from the connected state to the released state, and from the released state to the connected state, may be accomplished by a disengaging force and an engaging force, respectively, applied to the medical device 200 by a user to disengage and engage, respectively, the coupling 103 from/with the corresponding mating surface 201 of the medical device The internal sensor 102 is essentially electrically isolated from the patient 300 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 may typically be provided with means, well known in the art, for the generation of output data in the form of a singularity or plurality of electrical signals, such as e.g. communicated via one isolated electrical path or two, three, four or more intra-isolated electrical paths, i.e. being all electrically isolated from each other. Such means may, for example, include means known in the art for the determination of the spatial relationship between the interface 100 and the patient 300, e.g. proximity sensing means for detection of proximity, i.e. distance, between the internal sensor 102 and the patient 300. The internal sensor 102 may thus generate output data indicative of the proximity of the interface 100 and the patient 300, e.g. for the determination of whether or not the interface 100 is correctly fastened to the patient 300 and has not accidently been removed therefrom. The electrical signals may be transferred from and to the internal sensor 102, via conductive leads and temporal junctions dependent on the state (connected state: closed temporal junction; and released state: open temporal junction), from and to the medical device 200, e.g. via the first electrical connector interface 105 and via the second electrical connector interface 205 of the mating surface 201. Examples of internal sensors 102, suitable for estimation of the distance between the interface 100 and the patient 300, are sensors well known in the art in which the capacitance of an element of the sensor is dependent on the distance from the patient 300. The internal sensors 102 may also be provided with means well known in the art for the determination of three-dimensional orientation and acceleration, e.g. peak acceleration and/or average acceleration. Examples of the former include sensors generating output dependent on the angle between the central axis of the interface 100 and the vector of the natural gravitational acceleration. Examples of the latter include well known accelerometers, such as e.g. readily available digital micro-accelerometers.

The interface 100 and the medical device 200 may be appropriately designed to interact with each other in an overall system 500. For example, the medical 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 sensors 102 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 system with several advantages. For example, an extra proximity sensor of the medical device 200 enables e.g. determination or estimation of the relative spatial relationship between the interface 100 and the medical device 200. lf both are simultaneously detecting close proximity to the patient 300, it may be concluded that they are engaged in a connected state.

According to one embodiment, the system 500 may comprise a medical device 200 with a mating surface 201 adapted for releasable mechanical locking with the engagement surface 104 of the interface 100. The mating surface 201 may comprise a second electrical connector interface 205 adapted for releasable electrical contact with the first electrical connector interface 105 of the interface According to one embodiment, the medical device 200 of the system 500 may comprise means for the generation of a singularity or plurality of electrical signals being dependent on the angle between the central axis of the medical device 200 and the vector of the natural gravitational acceleration. Such an extra sensor, beside the internal sensors 102 of the interface 100 being e.g. a proximity sensor, advantageously enables determination of the degree of leaning, turning or tilting of the head of a patient 300 carrying such a system on the head, relative a reference angle.

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

According to one embodiment, the medical device 200 of the system 500 may comprise a pressure sensor 202 being in fluid connection with a tube 203 filled with liquid and adapted to detect the pressure thereof. Such a system 500 grants advantages to any setup in which the absolute pressure in an ending of a tube 203 in close proximity to a bodily part of a patient is measured, for example in the setup described in WO2019088902 by Innovation Skåne AB. Thus, for example, 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 the patient According to one embodiment, the system 500 may comprise an optionally separate 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 the medical device 200. The controller 204 may comprise a user interface for control of the sensors and/or for visual or audial output indicative of the status of these, including an alarm status.

The present invention has been described above with reference to specific examples. However, other examples than the above described are equally possible within the scope of the invention. The different features and steps of the invention may be combined in other combinations than those described. The scope of the invention is only limited by the appended patent claims.

More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used.

Claims (13)

C|aims

1. An interface (100), for the arrangement of a medical device (200) in a determinable spatially restricted relationship relative a patient (300), comprising a coupling (103), patient connective means (101), which means being adapted to secure said interface (100) in a spatially constant relationship relative the therete §l - transition from said connected state to said released state and from said released state to said connected state being accomplished by a disengaging force and an engaging force, respectively, applied to said medical device (200) by a userto disengage and engage, respectively, said coupling (103) from/with a corresponding mating surface (201) of said medical device (200); - said coupling (103) being provided with an engagement surface (104) and afthie first electrical connector interfaces (105), being mechanically and electrically interlocked and engaged, respectively, with said mating surface (201) and with correspondinq second electrical connector interfaces (205) of said medical device (200), in said connected state; - said coupling (103) being a bulb shaped rotatable coupling comprising three first electrical connector interfaces (105) electrically isolated from each other by electrical insulators (106) and being adapted to enable mechanical and electrical engagement with said mating surface (201) and corresponding second electrical connector interfaces (205) of said medical device (200); - said engagement surface (104) and said i first electrical connector interfaces (105) having a cross-sectional circular shape along their intersection with said mating surface (201) to allow rotation of said medical device (200) relative a central 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 with means for the generation of a singularity or plurality of electrical signals being dependent on the spatial relationship between said interface (100) and said patient (300), which electrical signals are transmittable to said medical device (200) via said thíree first electrical connector interfaces (105) and said mating surface (201), in said connected state, wherein said internal sensor (102) being provided with means for the generation of a singularity or plurality of electrical signals being dependent on the angle between the central axis of said interface (100) and the vector of the natural gravitational acceleration.

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

3. An interface (100) according to any one of the preceding claims, wherein said singularity or plurality of electrical signals being communicated via said connector 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 said patient connective means (101) comprise an adhesive outer surface adapted to adhere to the skin of said patient (300) when applied thereon.

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

6. An interface (100) according to any one of the preceding claims, wherein said patient 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 said internal sensor (102) being provided with means for the generation of a singularity or plurality of electrical signals being dependent on the distance between said interface (100) and said patient (300).

8. An interface (100) according to claim 7, wherein said electrical signals being dependent 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 said internal sensor (102) being provided with means for the generation of a singularity or plurality of electrical signals being dependent on peak or average acceleration thereof.

10. A system (500) comprising an interface (100) according to any one of claims 1 to 9 and a medical device (200), wherein - said medical device (200) comprises a mating surface (201) adapted for releasable mechanical locking with said engagement surface (104) of said interface (100); and - said mating surface (201) comprises ttiega second electrical connector interface; (205) adapted for releasable electrical contact with said tlífirst electrical connector interfaces (105) of said interface (100), wherein said medical device (200) comprises means for the generation of a singularity or plurality of electrical signals being dependent on the angle between the central axis of said medical device (200) and the vector of the natural gravitational acceleration.

11. A system (500) according to claim 10, wherein said medical device (200) comprises means for the generation of a singularity or plurality of electrical signals being dependent on the peak or average acceleration of said medical device (200).

12. A system (500) according to any one of claims 10 to 11, wherein said medical device (200) comprises a pressure sensor (202) being in fluid connection with a tube (203) filled with liquid, said pressure sensor (202) being adapted to detect the pressure of said liquid.

13. A system (500) according to any one of claims 10 to 12, further comprising a controller (204) being adapted to receive data in the form of electrical signals from said interface (100) and said medical device (200).