DEVICES FOR AND METHODS OF DIAGNOSIS AND/OR MONITORING DYSPHAGIA

Abstract

The use of a device to measure patient sensory response through the application of an incrementally increased electrical current to the oropharynx.

Claims

1. A catheter comprising: a probe comprising an elongate body having at least one electrode mounted thereon; and a sleeve comprising a hollow elongate body formed from a non-conductive material and configured to receive the probe, and at least one conductive area which, in use, is aligned with the at least one electrode to enable electrical current from the at least one electrode to pass through the at least one conductive area.

2. The catheter according to claim 1, wherein the at least one electrode is terminally located on the probe.

3. The catheter according to claim 2, wherein the at least one conductive area of the sleeve directs electrical current from the at least one electrode in the direction of the longitudinal axis of the catheter.

4. The catheter according to claim 1, wherein the probe is reusable and the sleeve is disposable.

5. A device for determining whether a patient is suffering from dysphagia, the device comprising: a catheter according to claim 1, and a control unit comprising an electrical current generator, a non-volatile memory for storing patient sensory response data and control sensory response data, means for recording the patient's sensory response to the applied electrical stimulation and a processor for comparing the patient's sensory response to a control sensory response stored in the non-volatile memory and determining whether the patient is suffering from dysphagia.

6. A device for monitoring a patient's recovery from dysphagia, the device comprising: a catheter according to claim 1, and a control unit comprising an electrical current generator, a non-volatile memory for storing patient sensory response data and control sensory response data, means for recording the patient's sensory response to the applied electrical stimulation and a processor for comparing the patient's sensory response to a control sensory response stored in the non-volatile to memory and monitoring the patient's recovery from dysphagia.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] FIG. 1 shows a first embodiment of a device according to the present invention;

[0019] FIG. 2 shows a second embodiment of a device according to the present invention;

[0020] FIGS. 3a, 3b and 3c show a third embodiment of a device according to the present invention; and

[0021] FIG. 4 shows sensory threshold levels in treated and untreated subjects over three consecutive days whereby the treated group also improved their swallow function.

DETAILED DESCRIPTION

[0022] FIG. 1 shows a device (10) for diagnosing dysphagia. The device (10) comprises a control unit (12) and a catheter (14). The control unit (12) comprises a variable electric current generating means for delivering electrical current to the catheter (14). The control unit (12) further comprises a non-volatile memory for storing patient sensory response data and/or control sensory response data and a processing means for comparing and/or processing patient sensory response data against said control sensory response data to make a diagnostic determination of whether a patient is suffering from dysphagia and/or monitoring the patient's recovery from dysphagia.

[0023] The catheter (14) has a at least one electrode (16,18) mounted thereon. The at least one electrode (16,18) is electrically connected to the variable electric current generating means of the control unit (12). The catheter (14) may be single use or re-usable.

[0024] In embodiments of the invention described with reference to FIG. 1, the device (10) may be configured to provide Pharyngeal Electrical Stimulation (PES) and to provide a recommendation for further treatment based on patient sensory response.

[0025] FIG. 2 shows a device (100) for diagnosing dysphagia and for providing nutrition. The device (100) comprises a control unit (102) and a catheter (104). The control unit (102) comprises a variable electric current generating means for delivering electrical current to the catheter (104). The control unit (102) further comprises a non-volatile memory for storing patient sensory response data and/or control sensory response data and a processing means for comparing and/or processing patient sensory response data against control sensory response data to make a diagnostic determination of whether a patient is suffering from dysphagia and/or to monitor the patient's recovery from dysphagia.

[0026] The catheter (104) comprises a NG feeding tube (108) and a sleeve (110) selectively movable relative to the NG feeding tube (108). The sleeve (110) carries at least one electrode (112,114) and wiring connecting the at least one electrode (112,114) to the control unit (102).

[0027] Each of the devices (10, 100) of FIGS. 1 and 2 are either provided with a rechargeable battery (not shown) or are electrically connectable to a power source, or both. Each device (10, 100) is also provided with a power selector (20, 118) to turn the device (10, 100) on/off and a control means (22, 116) to select the level of current to be delivered to the at least one electrode (18, 112). In some embodiments a graphical display is provided to visually identify to a medical professional that a patient is suffering from dysphagia and/or to indicate a change in the patient's clinical condition. In other embodiments a speaker is provided to audibly identify to a medical professional that a patient is suffering from dysphagia and/or to indicate a change in the patient's clinical condition. In other embodiments the device (10, 100) is equipped with wireless communications technology to transmit information relating to diagnosis and treatment to a server, network or independent device such as smartphone, tablet or laptop. The wireless communications technology could be WIFI, Bluetooth or GSM, for example, but is not limited thereto.

[0028] Each device (10, 100) has a diagnostic mode for diagnosing whether a patient is suffering from dysphagia and/or for monitoring a change in the patient's clinical condition. The control unit (12, 102) collects patient sensory response data and stores said data against a specific patient record in the non-volatile memory of the device (10, 100). The control unit (12, 102) can therefore compare instantaneous patient sensory response data against control sensory response data to monitor a patient's response to PES over time to determine whether or not further PES is required.

[0029] The device (10, 100) is turned on by activation of the power selector (20, 116). The control means (22, 116) is used to select the current level and is typically set to a current level that is not detectable by a patient, i.e. 1 mA. The catheter is inserted orally or nasally into the patient and the at least one electrode (16,18,112,114) is aligned with the patient's oropharynx.

[0030] The control means (22, 116) is used to activate the at least one electrode (14, 112) and impart the 1 mA electrical current into the patient's tissue. The control means (22, 116) is then used to increase the electrical current in 1 mA increments up to a maximum of 50 mA. After each increment the patient will be requested to confirm whether they can sense the electric current or not. If the patient cannot sense the electric current it will be increased by a further 1 mA. If the patient can sense the electric current the current level will be recorded as patient sensory response data.

[0031] When using the device (10, 100), the patient sensory data will be saved in the non-volatile memory against that individual patient's record. In certain embodiments the non-volatile memory is integral to the device (10, 100) and data contained therein is uploaded to a remote server either wirelessly or by plugging the device (10, 100) into a separate device connected to a server. Such a device (10, 100) can also store patient data uploaded thereto from a server or other device. Such data can be used by the device (10, 100) to compare patient sensory response data against control sensory response data. Such comparison is used by the device (10, 100) to diagnose dysphagia by comparing patient sensory response data to control sensory response data. The device (10,100) can be used to monitor unassisted recovery from dysphagia and recovery as a result of PES.

[0032] FIG. 3 shows a device (200) for applying electrical stimulation to a patient's oropharynx. The device (200) comprises a re-usable probe (202), as detailed in FIG. 3a, and a disposable sleeve (204), as detailed in FIG. 3b. The re-usable probe (202) comprises a tubular body (206), which may be rigid, semi-rigid or flexible, and a pair of terminally located electrodes (208,210). Conducting wires (212,214) are connected between each electrode (208,210) and an electrical current generator (not shown).

[0033] The disposable sleeve (204) comprises a hollow tubular body (216) closed at one end. The closed end of the tubular body includes one or more areas (218,220) that are capable of conducting an electric current from the electrodes (208, 210) through the sheath in the direction of the longitudinal axis of the device (200).

[0034] In use, as shown in FIG. 3c, the probe (202) is inserted into the sleeve (204) so that the pair of electrodes (208,210) are aligned and substantially in contact with the one or more conductive areas (218,220) of the sleeve (204).

Studies

[0035] Studies were conducted in two patient groups; a treatment arm and a control arm. Each patient in the treatment arm received a stimulation level that is specifically tailored to their treatment needs. This level is determined through first establishing their sensory threshold and thereafter their tolerance level (the highest level of applied stimulation the patient can tolerate for the treatment period). A suitable stimulation level is then derived from these two parameters.

[0036] A randomised controlled trial of PES in the control arm consisting of 30 subjects with dysphagia and a tracheotomy was performed to assess whether treatment resulted in sufficient restoration of safe swallowing to allow the tracheotomy cannula to be removed. As part of this study the threshold and tolerance levels of subjects in both the treatment and control arms were recorded.

[0037] FIG. 4 shows the initial and subsequent mean threshold levels for the treatment (Stimulation) arm and the control (Sham) arms. It can be seen that whilst the initial sensory threshold levels were similar, over the course of treatment the sensory threshold levels in the group receiving stimulation decreased whilst those not receiving stimulation actually increased.

[0038] This data suggests that decreasing sensory threshold levels are linked to swallowing recovery and that the trend in sensory level over time may also be indicative of the extent to which the subject is responding to treatment.

[0039] The foregoing description of the embodiments of the invention has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Many modifications and variations are possible in light of this disclosure. It is intended that the scope of the invention be limited not by this detailed description, but rather by the claims appended hereto.