Patent Application
20140066802
As medical device technologies continue to evolve, active implanted medical devices have gained increasing popularity in the medical field. For example, one type of implanted medical device includes neurostimulator devices, which are battery-powered or battery-less devices that are designed to deliver electrical stimulation to a patient. Through proper electrical stimulation, the neurostimulator devices can provide pain relief for patients or restore bodily functions.
There are situations where it is desirable and necessary for healthcare professionals to obtain feedback from a patient to successfully determine a diagnosis or provide a therapy. However, accurate and meaningful feedback requires the patient to have sufficient mental and physical abilities. Therefore, healthcare professionals may implement a series of tests to evaluate the patient's mental and physical abilities. Existing methods and mechanisms for conducting such evaluations may suffer from various drawbacks. The standardized tests are not sufficiently integrated or geared towards medical devices or pain treatment. Also, these tests are not sufficiently embedded into medical devices that provide that type of treatment and check whether the patient is able to use the device, touch screen usage, or other electronic means. And the test, because it is embedded into the device, may be used in an intra-op, pre-op, or post-op, and may be boring to the patient.
Therefore, although existing methods and mechanisms for evaluating a patient's mental and physical abilities have been generally adequate for their intended purposes, they have not been entirely satisfactory in every aspect.
One aspect of the present disclosure involves an electronic device. The electronic device includes: a touchscreen display configured to receive input from a user; a memory storage component configured to store programming code; and a computer processor configured to execute the programming code to perform an evaluation of the user's mental and physical abilities, wherein the evaluation includes: prompting the user to perform a plurality of tasks, wherein at least one of the tasks prompts the user to manipulate one or more graphical models shown on the touchscreen display according to predefined instructions; detecting, via the touchscreen display, responses from the user for the tasks; and determining, based on the detected responses, whether the user is mentally and physically fit to provide reliable feedback to medical personnel.
Another aspect of the present disclosure involves a medical system. The medical system includes: a first communications module configured to instruct a patient to perform a series of tasks designed to evaluate the patient's cognitive and tactile functions; an input detection module configured to detect the patient's performance of the tasks, including detecting clicking and dragging movements made by the patient on a touchscreen; a processing and analysis module configured to analyze the patient's performance of the tasks and in response thereto produce an evaluation of the patient's cognitive and tactile functions; and a second communications module configured to display a representation of the evaluation of the patient's cognitive and tactile functions to a medical professional.
Yet another aspect of the present disclosure involves method of interacting with a user. The method includes: communicating instructions to the user via an electronic device having a touch-sensitive user interface, the instructions requesting the user to manipulate one or more visual objects through the user interface by generating the one or more visual objects, moving the one or more visual objects, or altering an attribute of the one or more visual objects; detecting, via the user interface, input from the user in response to the instructions; and determining whether the user is able to provide dependable medical feedback.
One more aspect of the present disclosure involve a method of evaluating a patient's mental and physical abilities. The method includes: administering, at least in part using an electronic device that contains a touchscreen interface, a series of tests to the patient requesting the patient to perform at least one of the following actions via the touchscreen interface: producing an image having a specified geometry; moving an image from a first location to a specified second location; resizing or reshaping an image; shading an image with a specified color; and clicking on a set of images according to a specified sequence. These actions are performed to see if the patient can recognize the question and translate the question into a drawing on a touchscreen device. These actions are also performed to see if the patient can operate a touchscreen, to manipulate objects using the touchscreen, and to see whether the patient can execute a program (e.g., a program within a pulse generator), or if the patient is capable of portraying pain/stimulation perception into a computerized representation using the touchscreen. The method also includes receiving an evaluation of the patient's mental and physical capabilities based on the patient's response to the series of tests; and determining whether the patient is capable of drawing a pain map or a stimulation map representing pain or stimulation experienced by the patient.
Aspects of the present disclosure are best understood from the following detailed description when read with the accompanying figures. It is emphasized that, in accordance with the standard practice in the industry, various features are not drawn to scale. In fact, the dimensions of the various features may be arbitrarily increased or reduced for clarity of discussion. In the figures, elements having the same designation have the same or similar functions.
It is to be understood that the following disclosure provides many different embodiments, or examples, for implementing different features of the invention. Specific examples of components and arrangements are described below to simplify the present disclosure. These are, of course, merely examples and are not intended to be limiting. Various features may be arbitrarily drawn in different scales for simplicity and clarity.
In recent years, the use of active implanted medical devices has become increasingly prevalent. Some of these implanted medical devices include neurostimulator devices that are capable of providing pain relief by delivering electrical stimulation to a patient. The patient may use an electronic programmer (such as a patient programmer) to configure the neurostimulator device, so that a desired stimulation therapy can be delivered to the patient.
To ensure that the patient is capable of using the programmer to perform certain tasks, such as providing accurate feedback to a surgeon, healthcare professionals may evaluate the patient's mental and physical state through a series of tests. These tests allow the healthcare professionals to assess the patient's cognitive and motor functions. A patient should do well on the tests before he is deemed capable of using the programmer, because a patient with insufficient cognitive abilities and/or motor skills may not be able to provide relevant or reliable feedback to medical personnel. For example, such patient may not be able to generate an accurate pain or stimulation map representing the pain or stimulation experienced by the patient.
Current methods and mechanisms for conducting patient evaluations may suffer from various shortcomings. These shortcomings include:
According to the various aspects of the present disclosure, a two-pronged patient evaluation method is disclosed. One prong of the method involves evaluating the mental functions of a user, for example a user who is a patient (and thereafter referred to as such). Tests may be done to evaluate whether the patient generally has the capability of providing accurate and meaningful feedback (such as recording a pain or stimulation map or responding to questions accurately), and to evaluate specifically whether the patient is sufficiently lucid during or after a medical procedure (e.g., a surgery) to provide such feedback. This prong of the method may be referred to as a “Cognition Evaluation.”
The other prong of the method generally pertains to a patient's ability to use a suitable mechanism to give input or feedback to medical personnel. In particular, tests may be done to assess the patient's ability to use a device through which the patient will provide input or feedback. For example, a patient may be expected to eventually provide feedback such as the location and shape of a pain map or a stimulation map to a surgeon. The patient may be expected to use an electronic programmer such as a clinician programmer or a patient programmer to provide such feedback. In other words, the patient is programming himself/herself. In that case, the patient's ability to use these programmers is tested by this prong. The patient may be prompted to manipulate models in ways that simulate the tasks the patient is expected to perform when he is eventually expected to give feedback. This prong of the method may be referred to as a “Usability Aptitude Evaluation.”
According to various aspects of the present disclosure, both the Cognition Evaluation prong and the Usability Aptitude Evaluation prong can be implemented in a portable handheld electronic device. In other words, the patient will undergo these evaluations by manipulating the electronic device according to a set of instructions. In some embodiments, the electronic device may be an electronic programmer (such as a clinician programmer or a patient programmer) used to configure the implanted medical device. In other embodiments, the electronic device may include a simulator that can simulate the interface of a clinician programmer or a patient programmer to teach or demonstrate the functionality of a programmer to a patient. For example, the electronic device may include a tablet having an electronic user interface that simulates the interface of the clinician or patient programmer. The cognition evaluation and the usability aptitude evaluation will now each be discussed in more detail.
As a part of the Cognition Evaluation, the patient may be presented a standard set of cues and tasks to test the patient's cognitive abilities both verbally and non-verbally. Patient input for the evaluation may include, but is not limited to, tactile (touch screen) input or aural (spoken) input, or external devices such as a patient feedback device. Other methods for transmission and reception of patient input or feedback may include, but are not limited to, eye and eyelid movement, jaw or lingual movement, response to light-emitting diodes (LEDs), video or motion capture, and nascent technologies.
Attending healthcare professionals may be able to view patient input, as well as stimulation parameters or other information, on corresponding monitors. In some embodiments, to capture the patient's attention more fully, the evaluation may be designed to be game-like in form.
A cumulative score with a maximum of X points may be calculated based on patient responses, where X is a function of a series of sub-scores that each measure the result of the patient response to an individual task or test. The sub-scores may or may not be weighted. In some embodiments, scores are viewable by the healthcare professionals but are not viewable by the patient. A cumulative score of Y (where Y<X) or less may indicate cognitive impairment. In certain embodiments, no judgment about patient abilities will be presented to the healthcare professional: only the score shall be presented. The healthcare professional may then determine the patient's mental and physical abilities based on the score received. This approach promotes flexible, yet informed, decisions by healthcare professionals.
The above elements of the Cognition Evaluation are illustrated graphically in
At any time before, during, or after the surgery, the healthcare professional 50 may evaluate the mental state of the patient 30 through an electronic device 60, which is a portable and handheld device in the illustrated embodiment. As discussed above, the electronic device 60 is capable of simulating a user interface through which the patient is expected to eventually provide input or feedback to the surgeon 10 and/or the healthcare professional 50. In some embodiments, the electronic device 60 includes a clinician programmer. In other embodiments, the electronic device 60 may include a patient programmer or a suitable electronic tablet. The patient 30 may undergo the evaluation by performing appropriate manipulations on the electronic device 60. In other alternative embodiments, a device outside of (or external to) the electronic device 60 may be used to perform the cognitive testing as well. For example, stationary or screens embedded into the operating table may be used as such device.
Meanwhile, a monitor 70 may be used to display patient input on the electronic device 60 as well as stimulation parameters or other relevant information. The monitor 70 may include a dual screen (or split screen) display in some embodiments. The monitor 70 is viewable by the surgeon 10 and the healthcare professional 50 but may not be viewable by the patient 30. The monitor 70 may be communicatively coupled to the electronic device 60, for example through a suitable wired or wireless telecommunications protocol. In this manner, the surgeon 10 (or the healthcare professional 50) may be able to view the patient's feedback (for example a drawing of a stimulation map or a pain map) without requiring direct access to the electronic device 60. Additional aspects of the monitor 70 may be found in U.S. patent application Ser. No. 13/638,142, entitled “Clinician Programming System and Method,” and filed on Aug. 31, 2012, the entirety of which is herein incorporated by reference.
Although
If the answer from step 130 is yes, then the method 100 continues at step 135 to in which the patient performs suitable tasks so as to give input or feedback to a surgeon or healthcare professional. For example, the patient may be prompted to draw a pain map and/or a stimulation map. These maps may allow the surgeon to reposition the implanted medical device to optimize its therapeutic effects.
If the answer from step 130 is no, the method 100 proceeds to step 150, in which a decision is made about how to proceed further based on conditions of the specific instance.
Of course, the steps 110-150 illustrated in
According to the various aspects of the present disclosure, the Cognition Evaluation process discussed above may be performed by one or more modules that may each be implemented on a separate device. For example, one of these modules may include a communications module, which may be an electronic device (for example a computer tablet or a similar device) through which instructions can be displayed or verbally communicated to the user or to someone else, such as a medical professional. As another example, another one of these modules may include a user input detection module, which may include a touchscreen display that is configured to detect or receive input from the user. The input from the user may include the user's finger movements on the touchscreen. As another example, another one of these modules may include a processing or analysis module that is configured to analyze the user's input received by the user input module and make an evaluation of the user's abilities based on the user's performance.
Each of the modules may include software code and hardware for storing and executing the software code, for example computer memory (for storing the code) and computer processor (for executing the code). In various embodiments, these modules may be implemented on separate devices or may be implemented on a single device. Also, each of the modules may include multiple sub-modules. For example, the communications module may include a sub-module for communicating with the patient and another sub-module for communicating with the medical professional but not necessarily to the patient.
Referring to
At step 210, a temporal awareness evaluation is administered. The temporal awareness evaluation is designed to determine whether the patient is able to place himself within a context of time. In other words, does the patient generally know when or what time it is? Temporal awareness is a part of the perception portion of the evaluation and is important for recognizing the progression of pain and stimulation over time. In some embodiments, the temporal awareness evaluation is used to assess the patient's ability to identify the current day of the week, date, month, year, and/or season.
For example,
Based on the detected response from the patient, a score is generated. If the response from the patient is correct, then a maximum score of X1 may be generated. If the response is incorrect, then a score less than X1 may be generated. In some embodiments, an incorrect response from the patient yields a zero score. In other embodiments, different scores less than X1 may be generated based on how “close” the patient's response is to the correct response. For example, if the correct answer is the year 2012, then the patient may get a higher score if he chose the year 2011 than if he chose 2009, since the year 2011 is closer to the year 2012 than the year 2009.
Referring back to
Based on the detected response from the patient, a score is generated. If the response from the patient is correct, then a maximum score of X2 may be generated. If the response is incorrect, then a score less than X2 may be generated. In some embodiments, an incorrect response from the patient yields a zero score. In other embodiments, different scores less than X2 may be generated based on how “close” the patient's response is to the correct response. For example, if the correct answer is the country United States, then the patient may get a higher score if he chose Mexico than if he chose United Kingdom, since Mexico is closer to the United States than the United Kingdom.
Referring back to
Based on the detected response from the patient, a score is generated. If the response from the patient is correct, then a maximum score of X3 may be generated. If the response is incorrect, then a score less than X3 may be generated. In some embodiments, an incorrect response from the patient yields a zero score. In other embodiments, different scores less than X3 may be generated based on how “close” the patient's response is to the correct response. For example, if the correct answer is the rectangle, then the patient may get a higher score if he chose the square than if he chose the circle, since the square is closer to the rectangle than the circle.
Based on the detected response from the patient, a score is generated. If the response from the patient is correct, then a maximum score of X4 may be generated. If the response is incorrect, then a score less than X4 may be generated. In some embodiments, an incorrect response from the patient yields a zero score. In other embodiments, different scores less than X4 may be generated based on how “close” the patient's response is to the correct response. For example, since the correct answer is the top right corner, then the patient may get a higher score if he chose the bottom right corner than if he chose the bottom left corner, since the bottom right corner is closer to the top right corner than the bottom left corner.
Referring back to
At some time later, for example a few minutes later, or even after some of the other steps of the evaluation method have been performed, example screenshots of
Based on the detected response from the patient, a score is generated. If the response from the patient is correct, then a maximum score of X5 may be generated. If the response is incorrect, then a score less than X5 may be generated. In some embodiments, an incorrect response from the patient yields a zero score. In other embodiments, different scores less than X5 may be generated based on how “close” the patient's response is to the correct response. For example, if the correct answer is clicking the house, heart, and clock in that specific order, then the patient may get a higher score if he clicked on the house, heart, and clock but not in that specific order, than if he clicked on totally incorrect objects and in a completely random order.
Referring back to
Based on the detected response from the patient, a score is generated. If the response from the patient is correct, then a maximum score of X6 may be generated. If the response is incorrect, then a score less than X6 may be generated. In some embodiments, an incorrect response from the patient yields a zero score. In other embodiments, different scores less than X6 may be generated based on how “close” the patient's response is to the correct response. For example, if the correct answer is clicking the numbers backwards from 8 to 1, then the patient may get a higher score if he clicked the numbers backwards from 8 to 2 than if he clicked on totally different numbers in a random sequence.
Referring back to
Based on the detected response from the patient, a score is generated. Depending on the degree of resemblance between the patient's drawing and the image that was given, a score up to X7 may be generated. For example, if the patient substantially draws two pentagons in substantially the same arrangement as the image on the left, then the maximum score of X7 may be generated. However, if the drawing produced by the patient does not sufficiently resemble pentagons or if they are not in the same approximate relative arrangement as shown in the left side of the screen, then a score less than X7 is generated. If the patient's drawing deviates too far from the image on the left side of the screen, a zero score may be generated.
Referring back to
In any case, according to steps 120-130 of method 100 in
It is understood that the series of cognitive evaluations 210-235 are merely examples. In other embodiments, different standardized evaluation techniques may be employed to design and implement each of the evaluations above, including but not limited to, temporal awareness, spatial awareness, language proficiency, memory capacity, attention and calculation ability, and design and reproduction ability.
The Usability Aptitude Evaluation is used to assess a patient's ability to use a specific method of providing input. Stated differently, the Usability Aptitude Evaluation tests the patient in a manner consistent with the method and technique of providing patient input or feedback to a medical personnel. The paragraphs below describe a suggested test for a specific input technology, for example a model manipulation on a clinician programmer touchscreen, with the possible objective of creating pain and/or stimulation maps. However, the Usability Aptitude Evaluation is not limited to this test or technology. Rather, the Usability Aptitude Evaluation concept is applicable to any method, technology, or means of communication.
According to some embodiments, the clinician programmer touchscreen Usability Aptitude Evaluation includes a three-dimensional (3D) model manipulation and may be referred to as the “Model Usability Aptitude Evaluation” hereinafter. The Model Usability Aptitude Evaluation (and its equivalent score) may include three portions: spatial identification, graphical comprehension, and 3D model shading, as defined in Table 1 below.
In some embodiments, the Usability Aptitude Evaluation may be administered in an environment similar to the one illustrated in
In some embodiments, the Usability Aptitude Evaluation involves assigning the patient (or any other user) a standard set of tasks, and the patient's response to the tasks will be scored. Scores and an assessment about patient ability will then be presented to the healthcare professional. A patient needs to achieve a passing score in order to be deemed as capable of using the programmer. In some embodiments, the patient is not given access to the scores and the assessment. Similar to the Cognition Evaluation, the Usability Aptitude Evaluation may be designed to be game-like so as to better capture the attention of the patient.
To carry out the Usability Aptitude Evaluation process, a method similar to the method 100 of
Referring to
At step 310, a spatial identification evaluation is administered. The spatial identification evaluation is designed to determine the patient's ability to understand and manipulate basic two-dimensional (2D) or three-dimensional (3D) shapes, or any other basic shapes. Spatial identification is employed in many patient input tasks, such as mapping, selecting, and dragging.
For example,
In
Based on the detected response from the patient, a score is generated. If the patient has successfully completed the task, then a maximum score of M1 may be generated. If the patient was unable to complete the task, then a score less than M1 may be generated. In some embodiments, an unsuccessful completion of the task yields a zero score. In other embodiments, different scores less than M1 may be generated based on how well the patient was able to complete the task. For example, even if the patient was not able to perfectly align each shape on the right to its counterpart on the left, he/she may receive a partial score less than M1 if he/she was able to align the shapes close enough.
Referring back to
For example,
In
Based on the detected response from the patient, a score is generated. If the patient has successfully completed the task, then a maximum score of M2 may be generated. If the patient was unable to complete the task, then a score less than M2 may be generated. In some embodiments, an unsuccessful completion of the task yields a zero score. In other embodiments, different scores less than M2 may be generated based on how well the patient was able to complete the task. For example, even if the patient was not able to perfectly balance the scale, he may receive a partial score less than M2 if he was able to achieve a close enough balancing of the scale, or at least improve the balancing of the scale compared to its initial unbalanced state.
Referring back to
In
Based on the detected response from the patient, a score is generated. If the patient has successfully completed the task, then a maximum score of M3 may be generated. If the patient was unable to complete the task, then a score less than M3 may be generated. In some embodiments, an unsuccessful completion of the task yields a zero score. In other embodiments, different scores less than M3 may be generated based on how well the patient was able to complete the task. For example, even if the patient was not able to perfectly shade the polygons according to the model on the left, he/she may receive a partial score less than M3 if he/she was able to achieve a partially correct shading of the polygon mesh (or other two or three dimensional visual objects) on the right.
It can be seen that the 3D model shading evaluation measures the patient's ability to alter an attribute or characteristic of a graphical model or object on the screen. In the example illustrated in
Referring back to
In any case, after the patient's final score M is computed, it is compared to a predetermined threshold score N. If the score M is less than N, that indicates the patient or user has failed the Usability Aptitude Evaluation, which means the patient is not sufficiently able to perform the required tasks involved in providing reliable medical feedback. For example, the patient is unlikely to draw an accurate pain map or a stimulation map representing the pain or stimulation he is experiencing. The healthcare professional may then decide to wait or make other appropriate decisions based on the circumstances.
On the other hand, if the score M is greater than or equal to N, that indicates the patient has passed the Usability Aptitude Evaluation, which means the patient is sufficiently able to perform the required tasks involved in providing reliable medical feedback. The patient may then be asked to carry out one or more of these tasks on an electronic device such as a clinician programmer or a patient programmer, and the results of which will be fed back to the healthcare professional and the surgeon. For example, the patient may be asked to draw a pain map or a stimulation map on a device containing a touchscreen (such as a clinician or patient programmer, or a computer tablet). This pain map or stimulation map may be shown to the healthcare professional administering the evaluations, or the surgeon who is performing the surgical procedure that implants a medical device inside the patient's body. Based on the pain map or stimulation map, the surgeon may adjust the placement or other suitable settings of the implanted medical device to optimize its therapeutic effects for the patient.
It is also understood that the Cognition Evaluation and the Usability Aptitude Evaluation may be performed at a time when the patient is completely sober and alert, for example before surgery. This may be done to establish a “baseline” of the patient's mental and physical capabilities. Thereafter, when the Cognition Evaluation and Usability Aptitude Evaluation are performed again during or after surgery, the healthcare professional may more accurately assess how much, if any, of the patient's mental and physical capabilities have been impaired, and thus how reliable the patient's feedback can be. In some embodiments, the analysis of the comparison between the patient's “baseline” evaluation results and the “impaired” results can be built in to the evaluation program.
It is also understood that although the tests are described above (and shown in
In some embodiments, the instructions are configured to measure one or more of the following cognitive and tactile capabilities of the user: temporal awareness, spatial awareness, language proficiency, memory capacity, attention and calculation ability, design and reproduction ability, spatial identification ability, graphical comprehension ability, and three-dimensional model shading ability. In some embodiments, the touch-sensitive user interface is displayed on a touch-sensitive screen of the electronic device.
The method 400 includes a step 415, in which input from the user in response to the instructions of step 410 is detected via the user interface. In some embodiments, the electronic device is a portable handheld device configured for wireless communications. In some embodiments, the electronic device includes one of: a clinician programmer, a patient programmer, and a computer tablet. In some embodiments, the user is a patient for whom a medical device is being, or has been, implanted inside the patient's body.
The method 400 includes a step 420 in which it is determined whether the user is able to provide dependable medical (or other types of) feedback. In some embodiments, the determination in step 420 is made by: generating a composite score based on the user's input to the instructions, and determining that the user is able to provide dependable medical feedback if the composite score is greater than or equal to a predefined threshold. In some embodiments, the determination in step 420 is made by determining whether the user is able to draw a reliable pain map or a stimulation map using the touch-sensitive screen.
It is understood that additional steps may be performed before, during, or after the steps 410-420 of the method 400. For example, in some embodiments, after the step 420 is performed, the result of the determination in step 420 is communicated to a medical professional. The communication to the medical professional may include electronically sending the result to a monitor external to the electronic device that is viewable by the medical professional but not by the user or patient.
In some embodiments, at least one of the actions performed by the patient indicates one or more of the following cognitive and tactile capabilities of the patient: temporal awareness, spatial awareness, language proficiency, memory capacity, attention and calculation ability, design and reproduction ability, spatial identification ability, graphical comprehension ability, and three-dimensional model shading ability.
The method 450 includes a step 465 in which an evaluation of the patient's mental and physical capabilities is received based on the patient's response to the series of tests.
The method 450 includes a step 470 in which a determination is made as to whether the patient is capable of drawing a pain map or a stimulation map representing pain or stimulation experienced by the patient.
It is understood that additional steps may be performed before, during, or after the steps 460-470 of the method 450. For example, after it has been determined that the patient is capable of drawing a pain map or a stimulation map as a result of the step 470, another step is performed in which the patient is asked to draw the pain map or the stimulation map. An instrument is provided to the patient to draw the pain map or the stimulation map. In some embodiments, the instrument has an interface that is the same as, or substantially similar to, the touchscreen interface of the electronic device. In some embodiments, the instrument is a clinician programmer, a patient programmer, or an electronic tablet.
In some embodiments, the steps 460, 465, and 470 are performed during or after a surgical procedure in which a surgeon implants a medical device inside the patient's body. The surgeon may be asked to adjust the medical device implanted inside the patient's body based on the pain map or stimulation map drawn by the patient. In some embodiments, the steps 460, 465, and 470 are performed in a non-sterile part of an operating room in which the surgical procedure is performed.
As discussed above, some example contexts in which the Cognition Evaluation and the Usability Aptitude Evaluation may take place involves the implantation of a medical device. For example, during or after the surgery in which the surgeon implants a medical device such as a neurostimulator in the patient's body, the patient may undergo the Cognition Evaluation and Usability Aptitude Evaluation. These evaluations are done so that the healthcare professional may evaluate whether the patient has sufficient mental and physical functions to be able to understand and manipulate a programming device used to configure the implanted medical device. As such, the patient may offer the surgeon reliable feedback (e.g., meaningful answers to questions and accurate drawings of pain/stimulation maps) regarding the implanted medical device, for example by drawing pain and/or stimulation maps. That way, the surgeon may adjust the implanted medical device according to the patient's feedback. Also by taking and passing these evaluations, the patient may prove he is able to use the programming device safely, and may therefore be given permission to use it to configure the implanted medical device after surgery.
The external charger 520 of the medical device system 500 provides electrical power to the IPG 550. The electrical power may be delivered through a charging coil 580. The IPG 550 may also incorporate power-storage components such as a battery or capacitor so that it may be powered independently of the external charger 520 for a period of time, for example from a day to a month, depending on the power requirements of the therapeutic electrical stimulation delivered by the IPG.
The patient programmer 530 and the clinician programmer 540 may be portable handheld devices that can be used to configure the IPG 550 so that the IPG 550 can operate in a certain way. The patient programmer 530 is used by the patient in whom the IPG 550 is implanted. The patient may adjust the parameters of the stimulation, such as by selecting a program, changing its amplitude, frequency, and other parameters, and by turning stimulation on and off. The clinician programmer 540 of the medical device system 500 is used by a medical personnel to configure the other system components and to adjust stimulation parameters that the patient is not permitted to control, such as by setting up stimulation programs among which the patient may choose, selecting the active set of electrode surfaces in a given program, and by setting upper and lower limits for the patient's adjustments of amplitude, frequency, and other parameters.
According to the present disclosure, the Cognition Evaluation and the Usability Aptitude Evaluation discussed above with reference to
The CP includes a printed circuit board (“PCB”) that is populated with a plurality of electrical and electronic components that provide power, operational control, and protection to the CP. With reference to
The CP includes memory, which can be internal to the processor 600 (e.g., memory 605), external to the processor 600 (e.g., memory 610), or a combination of both. Exemplary memory include a read-only memory (“ROM”), a random access memory (“RAM”), an electrically erasable programmable read-only memory (“EEPROM”), a flash memory, a hard disk, or another suitable magnetic, optical, physical, or electronic memory device. The processor 600 executes software that is capable of being stored in the RAM (e.g., during execution), the ROM (e.g., on a generally permanent basis), or another non-transitory computer readable medium such as another memory or a disc. The CP also includes input/output (“I/O”) systems that include routines for transferring information between components within the processor 600 and other components of the CP or external to the CP.
Software included in the implementation of the CP is stored in the memory 605 of the processor 600, RAM 610, ROM 615, or external to the CP. The software includes, for example, firmware, one or more applications, program data, one or more program modules, and other executable instructions. The processor 600 is configured to retrieve from memory and execute, among other things, instructions related to the control processes and methods described below for the CP.
One memory shown in
The CP includes multiple bi-directional radio communication capabilities. Specific wireless portions included with the CP are a Medical Implant Communication Service (MICS) bi-directional radio communication portion 620, a WiFi bi-directional radio communication portion 625, and a Bluetooth bi-directional radio communication portion 630. The MICS portion 620 includes a MICS communication interface, an antenna switch, and a related antenna, all of which allows wireless communication using the MICS specification. The WiFi portion 625 and Bluetooth portion 630 include a WiFi communication interface, a Bluetooth communication interface, an antenna switch, and a related antenna all of which allows wireless communication following the WiFi Alliance standard and Bluetooth Special Interest Group standard. Of course, other wireless local area network (WLAN) standards and wireless personal area networks (WPAN) standards can be used with the CP.
The CP includes three hard buttons: a “home” button 635 for returning the CP to a home screen for the device, a “quick off” button 640 for quickly deactivating stimulation IPG, and a “reset” button 645 for rebooting the CP. The CP also includes an “ON/OFF” switch 650, which is part of the power generation and management block (discussed below).
The CP includes multiple communication portions for wired communication. Exemplary circuitry and ports for receiving a wired connector include a portion and related port for supporting universal serial bus (USB) connectivity 655, including a Type A port and a Micro-B port; a portion and related port for supporting Joint Test Action Group (JTAG) connectivity 660, and a portion and related port for supporting universal asynchronous receiver/transmitter (UART) connectivity 665. Of course, other wired communication standards and connectivity can be used with or in place of the types shown in
Another device connectable to the CP, and therefore supported by the CP, is an external display. The connection to the external display can be made via a micro High-Definition Multimedia Interface (HDMI) 670, which provides a compact audio/video interface for transmitting uncompressed digital data to the external display. The use of the HDMI connection 670 allows the CP to transmit video (and audio) communication to an external display. This may be beneficial in situations where others (e.g., the surgeon) may want to view the information being viewed by the healthcare professional. The surgeon typically has no visual access to the CP in the operating room unless an external screen is provided. The HDMI connection 670 allows the surgeon to view information from the CP, thereby allowing greater communication between the clinician and the surgeon. For a specific example, the HDMI connection 670 can broadcast a high definition television signal that allows the surgeon to view the same information that is shown on the LCD (discussed below) of the CP.
The CP includes a touch screen I/O device 675 for providing a user interface with the clinician. The touch screen display 675 can be a liquid crystal display (LCD) having a resistive, capacitive, or similar touch-screen technology. It is envisioned that multitouch capabilities can be used with the touch screen display 675 depending on the type of technology used.
The CP includes a camera 680 allowing the device to take pictures or video. The resulting image files can be used to document a procedure or an aspect of the procedure. Other devices can be coupled to the CP to provide further information, such as scanners or RFID detection. Similarly, the CP includes an audio portion 685 having an audio codec circuit, audio power amplifier, and related speaker for providing audio communication to the user, such as the clinician or the surgeon.
The CP further includes a power generation and management block 690. The power block 690 has a power source (e.g., a lithium-ion battery) and a power supply for providing multiple power voltages to the processor, LCD touch screen, and peripherals.
In one embodiment, the CP is a handheld computing tablet with touch screen capabilities. The tablet is a portable personal computer with a touch screen, which is typically the primary input device. However, an external keyboard or mouse can be attached to the CP. The tablet allows for mobile functionality not associated with even typical laptop personal computers. The hardware may include a Graphical Processing Unit (GPU) in order to speed up the user experience. An Ethernet port (not shown in
Neural tissue (not illustrated for the sake of simplicity) branch off from the spinal cord through spaces between the vertebrae. The neural tissue can be individually and selectively stimulated in accordance with various aspects of the present disclosure. For example, referring to
The electrodes 1120 deliver current drawn from the current sources in the IPG device 1100, therefore generating an electric field near the neural tissue. The electric field stimulates the neural tissue to accomplish its intended functions. For example, the neural stimulation may alleviate pain in an embodiment. In other embodiments, a stimulator may be placed in different locations throughout the body and may be programmed to address a variety of problems, including for example but without limitation; prevention or reduction of epileptic seizures, weight control or regulation of heart beats.
It is understood that the IPG device 1100, the lead 1110, and the electrodes 1120 may be implanted completely inside the body, may be positioned completely outside the body or may have only one or more components implanted within the body while other components remain outside the body. When they are implanted inside the body, the implant location may be adjusted (e.g., anywhere along the spine 1000) to deliver the intended therapeutic effects of spinal cord electrical stimulation in a desired region of the spine. Furthermore, it is understood that the IPG device 1100 may be controlled by a patient programmer or a clinician programmer 1200, the implementation of which may be similar to the clinician programmer shown in
The foregoing has outlined features of several embodiments so that those skilled in the art may better understand the detailed description that follows. Those skilled in the art should appreciate that they may readily use the present disclosure as a basis for designing or modifying other processes and structures for carrying out the same purposes and/or achieving the same advantages of the embodiments introduced herein. Those skilled in the art should also realize that such equivalent constructions do not depart from the spirit and scope of the present disclosure, and that they may make various changes, substitutions and alterations herein without departing from the spirit and scope of the present disclosure.
