Patient programmer with input and sensing capabilities

A patient programmer can have a progress module, wherein the progress module may obtain progress input from a patient in which the generator is implanted. The progress module may include sensors that are able to obtain progress input based on patient interactions with sensors coupled to the patient programmer. The progress module may also include an interface that poses progress-related questions to the patient and obtains responses to the questions from the patient. The patient programmer is also able to store the progress input for reporting purposes.

BACKGROUND

1. Technical Field

This disclosure generally relates to the treatment and rehabilitation of patients having implanted medical devices. More particularly, the disclosure relates to patient programmers used with implantable neuro-stimulators.

Implantable neuro-stimulators have begun to demonstrate clinical usefulness for a wide variety of conditions such as spinal cord injury, traumatic brain injury (TBI), stroke, Parkinson's disease and Parkinson's tremor. For example, deep brain stimulation (DBS) systems have been used to successfully improve motor control in Parkinson's patients by delivering electrical pulses to selected areas of the brain. While certain developments in neuro-stimulators have advanced rehabilitation and treatment in a number of areas, certain challenges remain.

For example, when a patient having an implanted device is discharged from a medical facility, the patient is often provided with a patient programmer, which gives the patient limited control over the implanted device. Indeed, early patient programmers often only provided the patient with the ability to turn the implanted device on and off. While more recent patient programmers have given patients slightly more control over the functionality of the implanted device, there still remains considerable room for improvement.

DETAILED DESCRIPTION

Embodiments of the present invention provide for a patient programmer having a control module, a communication interface, and a progress module. The control module may generate a control signal and the communication interface can transmit the control signal to a generator of a stimulation signal. The progress module can obtain progress input from a patient in which the generator is implanted.

In another embodiment of the invention, a deep brain stimulation (DBS) patient programmer includes a control module that generates a switching signal, wherein the switching signal instructs a generator of a brain stimulation signal to transition between an on-state and an off-state. A short range wireless interface may transmit the switching signal to the generator. The patient programmer may also include a progress module having a sensor mounted to the patient programmer to obtain a first set of progress inputs from a patient in which the generator is implanted. The progress module can also include a display or other output device that presents a plurality of questions to the patient, and an input device to receive answers to the plurality of questions from the patient. The answers can therefore define a second set of progress inputs. The progress module may further include a memory location to store the first and second sets of progress inputs, wherein the patient programmer can include a wired or wireless interface to transmit report data representing the first and second sets of progress inputs to a clinician programmer.

In yet another embodiment of the invention, a method of operating a patient programmer can provide for generating a switching signal and transmitting the switching signal from the patient programmer to a generator of a brain stimulation signal. The switching signal can instruct the generator to transition between an on-state and an off-state. The method may also provide for using a progress module of the patient programmer to obtain progress input from a patient in which the generator is implanted.

FIG. 1shows a patient programmer10that can generally be used to enhance the treatment and rehabilitation of a patient12having an implanted medical device such as a neuro-stimulation generator14. The generator14may be used to deliver electrical pulses to areas of the patient's body such as, for example, the brain, spinal cord, or other parts of the nervous system, via one or more suitable electrical leads (not shown), which may also be implanted in the patient12. For example, the generator14may be implanted by placing the generator14in a sub-cutaneous pocket created by making a blunt dissection in the subclavicular region, wherein the generator14can include one or more suture holes for securing the generator14to the muscle facia. In addition, the corresponding electrical leads may be tunneled to the distal end of an extension (not shown), and the extension may be tunneled to the generator14using well-known implantation procedures.

In this regard, the generator14may have a wide range of non-invasively programmable parameters and stimulation modes, and can exchange parameter information, via telemetry, with a clinician programmer16and the patient programmer10. Communication with the illustrated patient programmer10is implemented through a communication interface20of the patient programmer10. The stimulation pulses delivered to each lead can be determined by a parameter called a program, wherein a program can be a specific combination of amplitude, rate and pulse width parameters acting on a specific lead electrode set. For the stimulation signals, example amplitudes might range from 0.0-20.0 mA, example pulse widths may range from 10-1000 μsec per phase, example frequencies may range from 1-1200 Hz, and the waveform shape might be square, sine, or triangle wave. Other parameter ranges and characteristics may also be used.

In one embodiment, the clinician programmer16, which typically runs as an application on a laptop- or PC-based platform, can be used to determine which programs are to be run on the generator14and may display instruction prompts for the clinician and show parameter data. The clinician programmer16can also be used to provide stimulation parameters and patient programmer adjustment limits for multiple programs, collect measurements and diagnostic data from the generator14and may be used to switch the generator14on and off, and obtain the battery status of the generator14, which may be powered by a hermetically sealed silver vanadium oxide cell, a lithium ion cell, or other state of the art battery chemistries. In particular, upon interrogation by the clinician programmer16, the generator14might transmit via an RF link to the clinician programmer16for display or printing: patient progress reports received from the patient programmer10, model and serial number identification, programmed parameters and values, generator battery status, number of patient activations (since last reset), total stimulation time (since last reset), elapsed time (since last reset) and verification of program changes. After a program entry, the clinician programmer16can compare stimulation signal parameters, via telemetry, with the entries made during programming.

The illustrated patient programmer10, which may be a relatively small handheld device, has a control module18that generates a control signal such as a switching signal to instruct the generator14to transition between the on and off state based on control input28from the patient12. Thus, the patient12can use the patient programmer10to power the generator14on and off. Other control input28such as selection of program parameters and stimulation modes may also be obtained from the patient12, although it may be desirable to limit such control by the patient12for safety concerns. Likewise, other control signals, such as program parameter and stimulation mode selection signals, may also be generated based on the control input28and transmitted to the generator14. Such control input28may be obtained from the patient12via an appropriate user interface such as a touch screen display, keypad and/or button. A processor26may use the communication interface20to transmit the switching signal to the generator14wirelessly, using a short range wireless interface such as a WPAN (Wireless Personal Area Network; e.g., IEEE 802.15.4) module, a Bluetooth (e.g., IEEE 802.15.1) module, a WiFi (Wireless Fidelity; e.g., IEEE 802.11) module, or an RF (Radio Frequency) module using the MICS (Medical Implant Communication Service; e.g., 47 CFR 95.601-95.673 Subpart E), for example.

The patient programmer10may also include a progress module22that can obtain progress input24from the patient12. Enabling the patient to provide progress input24through the patient programmer10represents a substantial improvement over conventional approaches. For example, the patient programmer10is typically much more accessible to the patient12than other devices such as the clinician programmer16, and the patient programmer10tends to be much more “personal” to the patient. Accordingly, the illustrated patient programmer10can collect progress input24more frequently (e.g., daily) and is more likely to obtain accurate results and/or truthful responses from the patient12. In addition, while the patient programmer10may have substantially more functionality than traditional patient programmers, the programmer10can maintain a desired level of safety by limiting control input28to only certain features such as on/off control and predefined parameter set selection. Meanwhile, the illustrated patient programmer10is able to provide robust progress input24collection and reporting functionality that may significantly enhance patient recovery.

The progress input24may also be used in a closed-loop fashion by the patient programmer10to select and/or modify program parameters and/or stimulation modes in real-time, wherein the patient programmer10can generate the appropriate control signals and transmit them to the generator14. In such a case, certain precautions such as patient authentication features can be implemented in order to better ensure patient safety. Examples of such precautions are described in greater detail below.

The progress input24can include measurements taken from sensors mounted on or otherwise coupled to the patient programmer10, answers to rehabilitation related questions, and so on. The processor26can store the progress input24to a memory location in read only memory (ROM)30, random access memory (RAM)32, or any other suitable memory structure. The progress input24can also be transmitted, via the communication interface20, to the generator14as report data, wherein the clinician programmer16may obtain the report data from the generator14over a long range wireless interface such as an RF telemetry module or a WiMAX (Worldwide Interoperability for Microwave Access; e.g., IEEE 802.16) module, or a short range wireless interface. The clinician programmer16may also obtain the report data directly from the patient programmer10via a short range wireless interface, wired interface such as a USB (Universal Serial Bus) connection or an Ethernet (e.g., IEEE 802.3) connection, or long range wireless interface, depending upon the circumstances. The short and long range wireless interfaces would be suited for communications that take place during office visits, whereas the long range wireless interface could permit more frequent transmissions of data between the generator14, patient programmer10and the clinician programmer16. In addition, the report data may be transmitted to a home monitor and/or Internet connection.

Turning now toFIG. 2, one example of progress input24being obtained from the patient's interaction with a plurality of sensors34(34a-34e) is shown. The illustrated sensors34may be mounted on the patient programmer, wired to the patient programmer or linked to the patient programmer through a wireless connection, and may be used to assess the progress of the patient. In particular, the patient could perform a task with the patient programmer, wherein the sensors34may take measurements associated with the task. For example, the patient could be instructed to manipulate one or more pressure sensors34aso that the amount of pressure exerted by the patient could be measured and tracked over time to show improvement. In another task, the patient could be asked to pull on a strain gauge (not shown) in order to measure the strength of the patient. A temperature sensor34bmay be used to measure body and/or ambient temperature associated with particular tasks and a motion sensor34ccould be used for a motor skills task such as lifting the patient programmer off of a table and raising it above one's head. The motion sensor34cmay therefore track the speed and duration of the task and output this information for storage on the patient programmer and reporting purposes.

The illustrated progress module22also interacts with sensors external to the patient programmer to give a more complete view of the patient recovery. For example, the motion sensor34ccould interact with a sensor held by the patient during rehabilitation tasks. This interaction could indicate the distance traveled by the patient's extremity during the course of a specific rehabilitation task. Another example is that the motion sensor34ccould interact with a sensor implanted in the patient as part of the implantable therapeutic system. One possibility is that the interaction of these sensors could indicate overall movement of the patient in both body and head movement, which could be informative as to the overall rehabilitation status of the patient. Another possibility is that each of the sensors could generate independent readings, wherein the patient programmer conducts an analysis of the readings to obtain information regarding the patient's progress. The illustrated progress module22also includes a heart rate sensor link34dand an EEG sensor link34e, which can receive measurement signals from heart rate and EEG sensors coupled to the patient, respectively. Based on the progress input from the EEG sensors, for example (which could detect brain activity, sleep cycles, etc.), the patient programmer can instruct the patient to perform different tasks. Other sensors, such as chemical pH sensors, may also be used.

FIG. 3Ashows an external view of an example of a patient programmer36. In particular, the patient programmer36may be able to obtain progress input from a patient having an implanted medical device such as a DBS neuro-stimulation generator, store the progress input, and report the progress input to another device such as the generator or a clinician programmer. In the illustrated example, the patient programmer36has a display38, an input device including a plurality of buttons40(40a,40b), and a pressure bar42. The patient programmer36can use the display38and/or other output device such as a speaker to provide instructions and information to the patient. The instructions could be output periodically, such as daily, and/or in a closed-loop fashion in response to progress input already obtained from the patient. For example, the patient programmer36may use the display38to instruct the patient to press on the pressure bar for a certain amount of time, wherein the pressure bar42measures the amount of pressure applied by the patient. This progress input may be registered and time stamped by a processor26and/or progress module22(FIG. 1), and stored to a memory location within the patient programmer36. Tracking such progress input over time and reporting the information back to the clinician programmer enables the medical professional to more readily ascertain the progress of the patient and the effectiveness of the underlying medical treatment. The progress input from the pressure bar42may also be used to select subsequent instructions to be presented to the patient. Examples of instructions include, but are not limited to, instructions to squeeze sensors on the patient programmer36, press down on sensors on the patient programmer36, perform range of motion exercises with the patient programmer36in hand, pick up and put down the patient programmer36, and manipulate a button on the patient programmer36when an object on the display38disappears/appears as part of a reaction time test.

The display38may also be used to present questions to the patient that are tailored to the patient's progress, wherein the patient can provide answers to the questions via the illustrated buttons40. Thus, the progress input may be obtained from the patient through the illustrated buttons40as well as the illustrated pressure bar42. The questions could be related to the patient's perception of improvement, the patient's psychological state, objective yes/no issues, or anything else related to the patient's well-being or state of recovery. In general, questions may be related to quality of life (e.g., physical, emotional, task oriented), object recognition (e.g., display an apple, plane, basketball, etc., and have the patient choose from a multiple choice list what the object is), diary input (e.g., time/date stamp for eating, bathing, voiding), and cognitive state (e.g., IQ).

For example, Table 1 shows a plurality of Barthel Index questions, which may be presented to the patient on display38of the patient programmer36.

Table 2 shows a plurality of Short Form 36 (SF-36) Health Survey questions, which may be presented to the patient on display38of the patient programmer36.

TABLE 2SF-36 Health Survey Question1. In general, would you say your health is:ExcellentVery GoodGoodFairPoor2. Compared to one year ago, how would you rate your healthin general now?Much better now than a year agoSomewhat better now than a year agoAbout the same as one year agoSomewhat worse now than one year agoMuch worse now than one year ago...11. How TRUE or FALSE is each of the following statements for you?a. I seem to get sick a little easier than other peopleDefinitely trueMostly trueDon't knowMostly falseDefinitely falseb. I am as healthy as anybody I knowDefinitely trueMostly trueDon't knowMostly falseDefinitely falsec. I expect my health to get worseDefinitely trueMostly trueDon't knowMostly falseDefinitely falsed. My health is excellentDefinitely trueMostly TrueDon't knowMostly falseDefinitely false

Table 3 shows a plurality of Stroke Specific Quality of Life Scale (SS-QOL) questions, which may be presented to the patient on the display38of the patient programmer36.

TABLE 3SS-QOL ItemScoreEnergy1. I felt tired most of the time.2. I had to stop and rest during the day.3. I was too tired to do what I wanted to do.Family Roles1. I didn't join in activities just for fun with my family.2. I felt I was a burden to my family.3. My physical condition interfered with my personal life.Language1. Did you have trouble speaking? For example, get stuck, stutter,stammer, or slur your words?2. Did you have trouble speaking clearly enough to use thetelephone?3. Did other people have trouble in understanding what you said?4. Did you have trouble finding the word you wanted to say?5. Did you have to repeat yourself so others could understand you?...Work Productivity1. Did you have trouble doing daily work around the house?2. Did you have trouble finishing jobs that you started?3. Did you have trouble doing the work you used to do?

The patient programmer36may also provide instructions for tasks to be performed with other objects, wherein the patient and/or rehab technician may enter performance scores into to the patient programmer. Table 4 shows a plurality of Action Research Arm Test instructions/questions, which may be presented to the patient on the display38of the patient programmer36.

The Action Research Arm Test is ordered so that if the patient passes the first task in a subtest, no more tasks need to be administered and the patient scores top marks for that subtest. If the patient fails the first task and fails the second task, the patient scores zero, and again no more tests need to be performed in that subtest. Otherwise, the patient is instructed to complete all tasks within the subtest.

The illustrated patient programmer36also includes a patient authentication interface such as a fingerprint identification pad43to verify that the individual performing tasks, answering questions, and/or otherwise using the patient programmer36is in fact the patient. Such a solution is particularly advantageous in closed loop situations wherein real-time modification of simulation signal parameters may be possible. Other biometric authentication solutions such as retinal scans and hair follicle analysis may also be used. To further address safety concerns, the patient programmer36may require the patient programmer36and the pulse generator to be maintained in proximity to one another, as well as the maintenance of constant communication between the patient programmer36and the pulse generator while patient progress input is being obtained.

FIG. 3Bshows an alternative design of a patient programmer44. In the illustrated example, the patient programmer44has a display38, a plurality of buttons40and a plurality of force transducers/pressure sensors46(46a,46b), which may be squeezed by the patient to determine, for example, the patient's hand strength before, during, and/or after delivery of stimulation pulses to a desired treatment site within the patient's body. Thus, the patient programmer44may use the display38to instruct the patient to squeeze the pressure sensors46for a certain amount of time, wherein the pressure sensors46measure the amount of pressure applied by the patient. This progress input may be registered and time stamped by a processor26and/or progress module22(FIG. 1), and stored to a memory location within the patient programmer44.

Turning now toFIG. 4, a method50of operating a patient programmer is shown. The method50may be implemented in a patient programmer as a set of processor-executable instructions stored in ROM, RAM, electrically erasable programmable ROM (EEPROM), flash memory, etc., as fixed functionality hardware such as an embedded microcontroller, application specific integrated circuit (ASIC), etc. using complementary metal oxide semiconductor (CMOS) technology or transistor-transistor-logic (TTL), or any combination thereof. In the illustrated processing block52, a switching signal is generated and transmitted to a generator of a stimulation signal, wherein the switching signal instructs the generator to transition between an on state and an off state. Thus, in the illustrated example, the patient programmer is able to power the generator on and off. Block54provides for receiving progress input from the patient and block56provides for storing the progress input to a memory location on the patient programmer.

If a link, such as a short range wireless link, to the generator is detected at block58, report data representing the progress input is transmitted to the generator at block60. Block62provides for determining whether a link to a clinician programmer exists and, if so, report data representing the progress input is transmitted to the clinician programmer at block64. Once the report data is uploaded to the clinician programmer, the data may be analyzed and displayed graphically, and sorted by specific task and/or date. Graphical display of the data could be used to show trends in improvement levels and gauge the amount of patient recovery, and may lead the medical professional to a change in the stimulation parameters.

FIG. 5Ashows one approach to receiving progress input from the patient at block66, in which the progress input is obtained from a sensor of the patient programmer. As already discussed, the sensor may be a wide variety of sensors such as pressure sensors, temperature sensors, motion/acceleration sensors, heart rate sensors, EEG sensors, strain gauges, and so on.

FIG. 5Bshows an approach to receiving progress input from the patient, wherein a question is displayed to the patient at block68. As already discussed, the question could be related to the patient's perception of improvement, the patient's psychological state, objective yes/no issues, or anything else regarding the patient's well-being or state of recovery. Block70provides for receiving an answer to the displayed question and block72provides for determining whether there are any remaining questions. If so, the illustrated process steps through the questions until the last question is completed.

The present invention also provides methods of monitoring the progress of a patient who has been treated with neuromodulation using a patient programmer as described herein. Such a patient programmer can be used to monitor the progress of various different types of patients including those receiving neuromodulation for treatment of stroke, traumatic brain injury, or other conditions.

The terms “connected”, “coupled” and “attached” are used herein to refer to any type of relationship, direct or indirect, between the components in question, and may apply to electrical, mechanical, RF, optical or other couplings, unless otherwise indicated. In addition, the term “first”, “second”, and so on are used herein only to facilitate discussion, and do not necessarily infer any type of temporal or chronological relationship.