DISPOSABLE MEDICAL DEVICE ASSEMBLY WITH SENSOR

Abstract

A disposable medical device assembly for measuring a physiological parameter in a urinary or gastrointestinal tract of a mammal being is disclosed, comprising a probe, such as a catheter, for insertion into a bodily opening of the mammal being. The probe comprises at least one sensor, such as a pressure sensor. The medical device further comprises an energy source, in the form of a biofuel cell, connected to the at least one sensor.

Claims

1. A disposable medical device assembly for measuring a physiological parameter in a urinary or gastrointestinal tract of a mammal being, the assembly comprising: a probe for insertion into a bodily opening of said mammal being, said probe comprising at least one sensor; and an energy source connected to said at least one sensor; wherein said energy source is a biofuel cell.

2. The disposable medical device assembly of claim 1, further comprising an interface arranged to transfer measurement data from said sensor to an external receiver.

3. The disposable medical device assembly of claim 2, wherein the interface comprises a connector arranged to connect to a wire.

4. The disposable medical device assembly of claim 2, wherein the interface is a wireless interface, and comprises a transmitter for wireless communication.

5. The disposable medical device assembly of claim 2, wherein the interface comprises at least one of a display and a speaker.

6. The disposable medical device assembly of claim 1, wherein the probe is made of a biodegradable material.

7. The disposable medical device assembly of claim 1, wherein the biofuel cell comprises a microbial and/or enzymatic solution, and wherein the biofuel cell is an enzymatic fuel cell.

8. The disposable medical device assembly of claim 1, wherein the biofuel cell is made of materials comprising a biodegradable and/or compostable material, and a metal free organic material.

9. The disposable medical device assembly of claim 1, wherein the biofuel cell and/or the probe is made of materials comprising a biobased material.

10. The disposable medical device assembly of claim 1, wherein the at least one sensor is at least one of a pressure sensor, a temperature sensor, a position sensor, an imaging sensor, an accelerometer a gyroscope, a pH sensor or a flow sensor.

11. The disposable medical device assembly of claim 1, wherein the at least one sensor comprises at least one pressure sensor.

12. The disposable medical device assembly of claim 11, wherein the at least one sensor comprises a sensor arranged in the vicinity of an insertable tip of the probe, and the at least one sensor is arranged on an insertable part of the probe at a distance form said insertable tip.

13. The disposable medical device assembly of claim 1, wherein the probe is arranged for insertion into the urethra or rectum of the mammal being.

14. The disposable medical device assembly of claim 1, wherein the probe is arranged for insertion into the urethra of the mammal being, and comprises at least two sensors, one arranged in the vicinity of an insertable tip of the probe, for measurement of a pressure inside the bladder, and at least one sensor arranged on an insertable part of the probe at a distance form said insertable tip, for measurement of a pressure inside the urethra.

15. The disposable medical device assembly of claim 14, wherein the at least one sensor for measurement of the pressure inside the urethra comprises one sensor arranged to measure the pressure in the vicinity of a prostate, and one sensor arranged to measure the pressure inside the urethra at a distance from the prostate.

16. The disposable medical device assembly of claim 1, further comprising a second probe, the second probe also comprising at least one sensor.

17. The disposable medical device assembly of claim 1, wherein the biofuel cell is arranged at a distance from said at least one sensor, and wherein a conductor is provided in the probe forming a conductive path between the biofuel cell and the sensor(s).

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0074] The disclosed technology will be described in more detail with reference to the appended drawings, showing currently preferred embodiments. The drawings illustrate:

[0075] FIG. 1 is a sideview of an embodiment of a probe in the form of a urinary catheter;

[0076] FIG. 2 is a sideview of an embodiment of a probe in the form of a rectal probe;

[0077] FIG. 3 is perspective view of an embodiment of a probe in the form of another type of rectal probe;

[0078] FIG. 4 is a schematic sideview of an embodiment of a probe with a biofuel cell and sensors;

[0079] FIG. 5 is a schematic sideview of another embodiment of a probe with a biofuel cell and sensors;

[0080] FIG. 6 is a schematic perspective view of a control unit with an integrated display in accordance with an embodiment;

[0081] FIG. 7 is a schematic illustration of a disposable medical device in accordance with a first embodiment;

[0082] FIG. 8 is a schematic illustration of a disposable medical device in accordance with a second embodiment;

[0083] FIG. 9 is a schematic illustration of a disposable medical device in accordance with a third embodiment; and

[0084] FIGS. 10a-c are schematic illustrations of three alternative embodiments of biofuel cells.

DETAILED DESCRIPTION

[0085] A disposable medical device assembly is provided, for measuring a physiological parameter in a urinary or gastrointestinal tract of a mammal. In particular, the medical device assembly is suitable for use on human users and patients.

[0086] The disposable medical device assembly comprises a probe for insertion into a bodily opening of the user/patient, such as into the urethra and/or the rectum.

[0087] In one embodiment, as illustrated in FIG. 1, the probe is a urinary catheter 1. The catheter may comprise an elongate shaft 11, forming an insertable part of the catheter. At a non-insertable end 13 of the shaft, a connector, gripping portion or the like may be provided. At the other end of the shaft, a rounded insertable tip 12 may be formed, thereby forming a closed rounded end. The catheter is provided with an internal lumen. One or more drainage openings 14 may be provided close to the insertable tip 12. The internal lumen may extend over essentially the entire length of the shaft, from the drainage opening(s) 14 and to a discharge opening at the non-insertable end 13.

[0088] The probe/catheter may be provided with a coating on an outer surface of the shaft 11, e.g., to reduce the friction during insertion. The coating may e.g., be a hydrophilic coating. The hydrophilic coating can be wetted prior to use, e.g., with water or saline, and thereby swells and obtains lower friction.

[0089] In the embodiment of FIG. 1, a single internal lumen is provided. However, two or more lumens may also be provided. A single internal lumen may be used for a drainage catheter for draining urine from the bladder, and in particular for intermittent urinary catheters. An additional internal lumen may be used as a transfer channel for inserting a fluid into the urethra, such as a medicine. An additional internal lumen may also be used for an inflation fluid, for inflation and deflation of an inflatable retention element. This is particularly useful in case the catheter is intended as an indwelling catheter, for long time use, such as a Foley catheter. An additional lumen may also be used for housing a conducting wire connecting the sensor to the device platform.

[0090] As will be discussed in more detail in the following, the urinary catheter is provided with a biofuel cell and at least one sensor.

[0091] The probe may also be adapted for insertion into the rectum. The probe may e.g., be used for anal irrigation. Such an embodiment is shown in FIG. 2. Here, the probe 1′ comprises an elongate shaft 11′, forming an insertable part of the probe. At a non-insertable end 13′ of the shaft, a connector, gripping portion or the like may be provided. At the other end of the shaft, a rounded insertable tip 12′ may be formed, thereby forming a closed rounded end. The catheter is provided with an internal lumen. One or more discharge openings 14′ may be provided close to the insertable tip 12′, for discharge of an irrigation liquid, such as water. The internal lumen may extend over essentially the entire length of the shaft, from the discharge opening(s) 14′ and to a discharge opening at the non-insertable end 13′.

[0092] This probe may also be provided with a coating on an outer surface of the shaft 11′, e.g., to reduce the friction during insertion. The coating may e.g., be a hydrophilic coating. The hydrophilic coating can be wetted prior to use, e.g., with water or saline, and thereby swells and obtains lower friction.

[0093] Here, the probe is further provided with an inflatable retention element 15, an inflatable balloon, which may be expanded when the probe has been inserted, to maintain the probe in the inserted position. The retention element may be filled with air, liquid, or other fluids. To this end, a second internal lumen may be provided to communicate with the inflatable retention element. Such a probe is suitable for trans-anal irrigation (TAI).

[0094] In the embodiment of FIG. 2, two internal lumens are provided. Three or more lumens may also be provided. However, a probe with only one internal lumen is also feasible. In such embodiments, there may be no retention element, or a retention element which is not inflatable. Such an embodiment is illustrated in FIG. 3, where a retention element 15′ in the form of a cone is provided. The cone is arranged to abut against the rectal opening, thereby forming a stop for too deep insertion. Such a probe is e.g., suitable for enema treatment.

[0095] As will be discussed in more detail in the following, the probes are provided with a biofuel cell and at least one sensor.

[0096] Alternatively, the probe may have no internal lumen. Such a probe may function as an anal plug or urethral plug, to form a stop in the urethra or rectum. Alternatively, such a probe may function only to provide measurements in the urinary or gastrointestinal tract. Such a probe may be formed as a solid probe, or be provided with internal cavities for improved flexibility. The flexibility may further be adjusted by choice of material, manufacturing processes, etc.

[0097] The probe may have an essentially circular cross-sectional shape. Such shapes are of particular advantage when the probe includes one or more internal lumens. However, other shapes are also feasible, such as an oval shape and the like. In other embodiments, in particular where there is no lumen inside the probe, the probe may also have a relatively flat cross-sectional shape, and may e.g., be formed as a rod, a strip, or the like.

[0098] The probe is preferably made of a relatively flexible material, making the probe somewhat bendable. In particular a probe for insertion into the urethra may have properties similar to a conventional urinary catheter. A probe for insertion into the rectum may have similar properties, but may alternatively be larger and somewhat more stiff and rigid, and generally have the properties of a rectal irrigation probe.

[0099] The medical device may comprise a control unit connected to or integrated with the probe. Such embodiments will be discussed in the following.

[0100] In one embodiment, illustrated in FIG. 4, a control unit 2 is arranged as a separate unit, connected to the probe 1 by a wire 4. The control unit is preferably arranged to be connected by the wire to the non-insertable rearward part of the probe. The probe is provided with sensors 3, as will be discussed in more detail in the following. In this embodiment, three sensors 3a-c are provided. The wire 4 connects the control unit 2 to the probe and continues in the probe to the sensors 3a-c. The wire may be arranged internally within the probe, arranged in an internal lumen of the probe or embedded in the material forming the probe. Alternatively, the wire may be arranged attached to an outer surface of the probe.

[0101] The wire may contain one or more conduits. The wire is arranged to convey signals representing measurement readings from the sensor(s) to the control unit. In case the sensors are electrically operated, the wire may further be arranged to supply electrical power to the sensors. The wire may e.g., be realized as a ribbon cable. However, other forms of wired connections are also useable to enable transfer of electricity from the biofuel cell and electrical signals or data signals from the sensors.

[0102] In another embodiment, illustrated in FIG. 5, the control unit 2 is instead formed as an integrated part of the probe, thereby forming a single unit. Also in this embodiment, the control unit is arranged at, or close to, the rearward, non-insertable part of the probe. However, in alternative embodiment, the control unit may also be provided at other positions on the probe, such as being integrated in the insertable part. As in the previously discussed embodiment, the sensors 3a-c of the probe are connected to the control unit 2 by a wire 4.

[0103] With reference to FIG. 7, the control unit comprises a biofuel cell 21, arranged to provide electrical power for operation of the control unit, and possibly also for the operation of the sensor(s) 3. The control unit may also comprise a controller 22, such as a central processing unit (CPU) or a microprocessor, arrange to receive measurement data from the one or more sensor 3, to determine useful information from this measurement data, and to present this in an adequate way to the user. To this end, the control unit may further comprise a user interface, such as a speaker 23, i.e. a sound generator, and/or a display 24. The speaker may also be a buzzer, or other types of sound generating devices. Further, the user interface may, additionally or alternatively, use haptic signals, such as vibrations. The speaker 23 may e.g., be used to issue an alarm when a predetermined event has happened, such as a threshold level being exceeded for a measured parameter. The display 24 may e.g., be used to present the measured data in the form of bars, diagrams, digits and the like. The control unit may, additionally or alternatively, comprise a communication interface for communication with an external unit, such as a personal computer, a tablet, a smartphone, or the like. To this end, the communication unit may comprise a wireless interface 25, comprising a wireless transmitter or transceiver for wireless communication with the external unit. Communication may e.g., occur through Bluetooth or NFC (Near Field Communication), but other communication protocols may also be used. Additionally, or alternatively, the control unit may also comprise a wire interface 26. Such an interface may comprise a connector, such as a plug or a jack, to establish a wired connection between the control unit and the external unit. The control unit may also comprise a memory 27, for storing of measured data. Such stored data may be used for the evaluation of subsequent measurements. The interpretation of the acquired data can be done in multiple ways, e.g., locally by the unit, by the external device where data was transferred, or by a cloud service that receives such data from either the unit or the external device where data was firstly transferred. Finally, the results of such interpretation could be displayed directly in the unit's UI or in a second device, e.g., a mobile app as user interface, a webpage as user interface, a computer application as user interface, an SMS sent containing results, or an email containing results. Those results could be accessed by the patient/user and/or the HCP.

[0104] As would be apparent from the previous discussion, all the discussed elements need not be present in the control unit. In a simple embodiment, the control unit may comprise only a biofuel cell and optionally a controller. In other embodiments, the control unit may in addition comprise either a user interface element, such as a speaker or display, or a communication interface, such as a wire or wireless interface.

[0105] The biofuel cell is preferably arranged to provide all the electrical power needed for the operation of all elements included in the control unit.

[0106] In the embodiment of FIG. 7, all the elements of the control unit are arranged in a separate part forming the control unit. The separate part may, as discussed in the foregoing, be arranged separated from the probe, and connected to the probe by the wire 4, or be arranged fixedly attached to the probe.

[0107] However, it is also possible to arrange one or more elements of the control unit integrated with the probe. It is also feasible to arrange one or more elements of the control unit integrated with the probe and one or more elements of the control unit in a separate control unit, to form a distributed control unit. Such embodiments are schematically illustrated in FIGS. 8 and 9.

[0108] In the embodiment of FIG. 8, the biofuel cell 21 is arranged integrated with the probe, and also a communication interface, such as a wireless interface 25 and/or a wire interface 26. By a wired connection 4, or a wireless connection, this part of the control unit then communicates with another part of the control unit, comprising e.g., a controller 22 and a user interface, such as a speaker 23, buzzer, vibrator and/or a display 24, and optionally also a memory 27. This part of the control unit may be formed as a dedicated control unit, but may also be integrated in a smart phone, tablet, computer or the like.

[0109] In the embodiment of FIG. 9, all the elements of the control unit are arranged integrated with the probe.

[0110] The control unit may e.g., be arranged with an integrated display formed on one of its main surfaces, as illustrated in FIG. 6. The other elements of the control unit, such as the biofuel cell, may be arranged in other layers, to form a sandwiched construction. On the side of the control unit opposite to the display 24, an adhesive layer 28 may be arranged, to enable fastening of the control unit to an external surface, such as to the body of the user.

[0111] The biofuel cell 21 functions as the energy source for the disposable medical device, and preferably as the sole energy source. The biofuel cell may e.g., be made as discussed in any one of the published patent applications.

[0112] The biofuel cell is preferably free of metal, and preferably to a large extent made of biobased, compostable and/or biodegradable materials. In particular, the biofuel cell may be an enzymatic fuel cell, and preferably be paper-based. The biofuel cell may be arranged to use biological catalysts instead of chemical or expensive noble metal catalysts to convert natural substrates such as glucose and oxygen into electricity. The biofuel cell preferably uses biofuel enzyme cells to produce electrical energy from biological substances, such as glucose and oxygen, which are present in some biological fluids, such as blood sweat and urine.

[0113] The biofuel cell may be a single cathode cell (SC), as schematically illustrated in FIG. 10a, where a cathode 210 is positioned between an anode 211 and a support 212.

[0114] Alternatively, as schematically illustrated in FIG. 10b, the biofuel cell may be realized as a single cathode air cell (SABC). In a SABC realization, the support of the SC realization may be replaced with a support 213 which is permeable to air and allows penetration of oxygen. The support 213 may, as in the previous embodiment, be arranged above the cathode 210, and the anode 211 arranged below the cathode 210.

[0115] In yet another alternative, as schematically illustrated in FIG. 10c, the biofuel cell may be realized as a double cathode air cell (DABC). In the DABC realization, the biofuel cell comprises two cathodes 210 arranged on each side of an anode 211, and with permeable support layers 213 arranged on the outside of each of the two cathodes 210.

[0116] However, other realizations of the biofuel cell are also feasible, as is per se known in the art.

[0117] The anode(s) can e.g., be made of a solid agglomerate comprising a conductive material mixed with a first enzyme capable of catalyzing the oxidation of the biofuel. Similarly, the cathode(s) can e.g., be made of a solid agglomerate comprising a conductive material mixed with a second enzyme capable of catalyzing the reduction of oxidant.

[0118] The biofuel cell extracts electrons from oxidative reactions of biological fuels, using body fluid as an electrolyte solution and utilizing biological fuels, such as glucose, and oxygen from the body fluid. Any oxidative enzymes that oxidize biological fuels can be used in the disclosed embodiments. For example, enzymes called oxidases and hydrogenases could be used. If glucose is used as the biological fuel, glucose oxidase and glucose dehydrogenase can be used.

[0119] The one or more sensor(s) is useable to determine one or more physiological parameters in relation to the user. The measured sensor data can be used to monitor physiological parameters, and thereto related health related conditions, over longer or shorter periods of time. The measured sensor data can also be used for diagnostic purposes, and also as an aid in various forms of treatments.

[0120] In case several sensors are provided on the probe, the sensors may be of the same type, such as several pressure sensors, e.g., arranged to measure the same physiological parameter at different positions. However, in alternative embodiments, sensors of different types may also be combined, to enable simultaneous measurement of two or more different physiological parameters.

[0121] The at least one sensor is preferably at least one of a pressure sensor, a temperature sensor and a flow sensor.

[0122] The sensor(s) may be arranged to determine one or more of the following physiological parameters: pressure, fluid flow rate, particle size, particle count, particle distribution, particle concentration, particle characteristics, analyte concentration, refractive index, conductivity, temperature, absorption spectrum, refraction spectrum, viscosity, and pH.

[0123] In one embodiment, the at least sensor comprises at least one pressure sensor, also referable to as a pressure transducer. The pressure sensor can e.g., be a digital or solid state pressure sensor, as is per se known in the art. Such pressure sensors may include, by way of example, any of a piezoelectric electric mechanism, an optical sensing mechanism, or a microelectricalmechanical (MEMS) mechanism.

[0124] In the embodiments of FIGS. 4 and 5, three sensors 3a-c are provided, and separated along the length of the probe 1. The sensors 3a-c may e.g., be pressure sensors. When used in a probe arranged for insertion into the urethra, the sensor 3a may be arranged at, or in the vicinity of, the insertable tip. This sensor may then be used to determine the pressure inside the bladder. The other two sensors are arranged at a distance from the tip. The sensor 3b may here be arranged at a position which corresponds to the location of the prostate when the probe is in the inserted position, and consequently measures the pressure in the vicinity of the prostate. The third sensor 3c may be positioned at a distance from the prostate, and consequently measures the ordinary pressure of the urethra.

[0125] The display of FIG. 6 shows an example of how such a measurement may be presented. Here, the relative pressure (“Rel. P”) is presented in the form of bars, and with one bar for each of the three positions: B=bladder, P=Prostate, and U=Urethra. From this, it is easily determinable whether the pressure differs to any significant degree between the three positions, during micturition, which could be an indication of urine obstruction.

[0126] Other types of sensors may also be used, in addition, or as alternatives, to the above-discussed pressure sensors, temperature sensors and flow sensors. Such sensors are per se known in the art.

[0127] Such other sensors may e.g., be analyte sensors, to determine, quantitatively or qualitatively, the presence of analytes such as pH, a gas, an electrolyte, a metabolic substrate, a metabolite, an enzyme, or a hormone. The analyte to be determined may also comprise one or more of proteins, glucose, hemoglobin, bilirubin, urobilinogen, acetone, nitrite and leucocytes. The analyte to be determined may further be fecal occult blood (FOB).

[0128] In some variations, at least one sensor may comprise one or more of a conductivity sensor, image sensor, accelerometer, and magnetic field transducer.

[0129] The sensors may also be arranged as electrical activity sensors. Such electrical activity sensors may deliver physiologic data such as electromyography (EMG) or electrogastrogram (EGG).

[0130] In some embodiments, the medical device further includes a light source and a light sensor, the sensor configured to capture light emitted from the light source. In some embodiments, by way of example, the light source and the light sensor may be configured to operate as a pulse oximeter, the light sensor being able to deliver a signal that can be transduced into a pulse rate. In another example, the light source and the light sensor may be configured to operate as an analyte sensor.

[0131] The sensor(s) may be arranged on an outer surface of the probe, and may e.g., be affixed to the probe by adhesive or the like. However, additionally or alternatively, sensor(s) may integrated in the probe, and/or be arranged inside the probe, such as in an internal lumen of the probe.

[0132] The disposable medical device may be packed in a sterile package. In use, the medical device, the package is opened, and the sterile probe is then extracted from the package, and inserted into the bodily opening, such as the urethra. The probe is then maintained in the inserted position during the measurement, which may be of a duration of a few seconds, a few minutes, or a few hours, depending on the measurement situation and the physiological parameter to be measured. After the measurement, the single-use device may be retracted and discarded.

[0133] The person skilled in the art realizes that the present invention by no means is limited to the preferred embodiments described above. On the contrary, many modifications and variations are possible within the scope of the appended claims. For example, various types of sensors and probes may be used.

[0134] Such and other obvious modifications must be considered to be within the scope of the present invention, as it is defined by the appended claims. It should be noted that the above-mentioned embodiments illustrate rather than limit the invention, and that those skilled in the art will be able to design many alternative embodiments without departing from the scope of the appended claims. In the claims, any reference signs placed between parentheses shall not be construed as limiting to the claim. The word “comprising” does not exclude the presence of other elements or steps than those listed in the claim. The word “a” or “an” preceding an element does not exclude the presence of a plurality of such elements.