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PATIENT DIRECTED THERAPY
FIELD OF INVENTION
The present invention relates generally to medical implantable devices. More particularly, the invention relates to an apparatus and method for patient directed therapy management of implantable medical devices used to influence the human body. 1°
BACKGROUND OF THE INVENTION
The medical device industry produces a wide variety of electronic and mechanical devices for treating patient medi- 15 cal conditions. Depending upon the medical condition, medical devices can be surgically implanted or connected externally to the patient receiving treatment. Clinicians use medical devices alone or in combination with drug therapies and surgery to treat patient medical conditions. For some 20 medical conditions, medical devices provide the best, and sometimes the only, therapy to restore an individual to a more healthful condition and a fuller life.
Implantable medical devices are commonly used today to 25 treat patients suffering from various ailments. Implantable medical devices can be used to treat any number of conditions such as pain, incontinence, movement disorders such as epilepsy and Parkinson's disease, and sleep apnea. Additionally, use of implantable medical devices appears prom- 3Q ising to treat a variety of physiological, psychological, and emotional conditions.
One type of implantable medical device is an Implantable Neuro Stimulator (INS). The INS is implanted at a predetermined location in the patient's body. The INS generates 35 and delivers mild electrical impulses to neurostimulation areas in the body using an electrical lead. The INS electrical stimulation signals at neurostimulation sites or areas influence desired neural tissue, tissue areas, nervous system and organs to treat the ailment of concern. The stimulation sites 40 can also include the spinal cord, brain, body muscles, peripheral nerves or any other site selected by a physician. For example, in the case of pain, electrical impulses may be directed to cover the specific sites where the patient is feeling pain. Neurostimulation can give patients effective 45 pain relief and can reduce or eliminate the need for repeat surgeries and the need for pain medications.
In the case of an INS, the system generally includes an implantable neuro stimulator (INS) (also known as an implantable pulse generator (IPG)), an external physician or 50 clinician programmer, a patient programmer and at least one electrical lead. An INS is typically implanted near the abdomen of the patient, or other stimulation area as required. The lead is a small medical wire with special insulation and contains a set of electrodes (small electrical contacts) 55 through which electrical stimulation is delivered. The INS can be powered by an internal source such as a rechargeable or non-rechargeable battery or by an external source such as a radio frequency transmitter. The INS contains electronics to generate and send precise, electrical pulses to the stimu- 60 lation area to provide the desired treatment therapy. The clinician programmer is an external device that allows the physician or clinician to create and store preset stimulation therapy to be delivered by the INS. The clinician programmer communicates with the INS using radio waves, for 65 example via telemetry. The patient programmer is an external hand-held device that allows the patient to optimize the
stimulation therapy delivered by the INS. The patient programmer also communicates with the INS using radio waves, such as telemetry.
In existing INS devices, a clinician typically creates and stores preset patient therapy programs that are executed by the INS to deliver therapy to the patient. The preset patient therapy programs include specific therapy parameters that are set and created by a clinicians based on industry or clinician preferences, patient feedback, a patient's test results, or a combination of all of the above. The patient therapy programs are then downloaded into INS memory using the clinician programmer. The patient therapy programs then reside in both clinician programmer memory and INS memory. The stored preset patient therapy programs, which include specific therapy parameters, will allow the INS to generate the appropriate electrical stimulation signals for the patient's specific needs. The stored patient therapy programs contain parameters, including for example, electrode settings, signal intensity or strength (amplitude), the signal duration (pulse width), and the signal timing and cycling (pulse frequency or rate).
In addition, the electrodes associated with a medical device, such as an INS, may be arranged in a predetermined physical array or layout configuration at the stimulation site in the patient. In such a case, certain preset therapy parameters in the stored patient therapy programs will allow the INS to generate electrical stimulation signals at the electrodes in a particular directional sequence and physical direction, relative to their physical placement in the patient's body.
At present, patients do not have the ability to select and assemble the preset therapy programs, which were created by the clinician, or to create his/her own personalized therapy programs. A patient can typically access the stored preset clinician therapy programs but cannot create personalized therapy programs himself/herself. A patient must use and live with the preset therapy programs that have been created by the clinician. Moreover, the stimulation areas targeted by the INS's electrical leads on a patient's body are usually situated to alleviate or address pain or discomfort due to one body position or activity, e.g., sitting compared to walking, jogging or running. As a result, the combination of specifically situated stimulation areas and unchangeable clinician created preset therapy programs can lead to discomfort when a patient engages in activities that were not accounted for or foreseen by the clinician. The inability to modify the stored therapy programs can thus limit the activities that a patient may wish to engage in.
For the foregoing reasons there is a need for an apparatus and method that will allow patients to access stored preset clinician therapy programs so that the patient can create new personalized therapy programs that will enable the patient to participate in a variety of activities without undue discomfort or the need to visit a clinician for additional preset therapy programs.
It is an objective of the present invention to provide an apparatus and method to give patients the ability to assemble, label and store their own personalized therapy programs, on demand, from among the preset clinician therapy programs that are resident in INS memory.
It is an objective of the present invention to provide an apparatus and method to give patients more control to create personalized therapy programs and settings to fit their unique lifestyles thereby increasing patient satisfaction.
SUMMARY OF THE INVENTION
The present invention provides an apparatus and method that allows a patient to select and access stored patient therapy programs, that are resident in the INS device, and 5 modify the stored therapy programs to accommodate his/her particular lifestyle, thereby creating and storing personalized therapy programs. The patient can select and access stored patient therapy programs and combine in an unmodified manner at least two of the accessed therapy programs to 10 create personalized therapy programs. The present invention also gives the patient the ability to select and access stored patient therapy programs, to modify the accessed preset therapy programs and then combine the modified preset therapy programs to create personalized therapy programs. 15
In accordance with the present invention, there is provided a method for patient directed therapy management in an implantable neuro stimulator (INS). The method comprised of: storing preset clinician therapy programs with preset therapy settings in an INS device; accessing the preset 20 clinician therapy programs by the patient, via telemetry communication between the INS device and a patient programmer; modifying at least one of the accessed preset clinician therapy programs on a patient programmer to create at least one personalized therapy program with per- 25 sonalized therapy settings; and storing the personalized therapy program in the INS device for subsequent use by the patient. A patient can then select from the clinician preset therapy programs or from the newly created and stored personalized therapy settings in accordance with the activity 30 and/or preference of the patient.
In accordance with the present invention, there is provided a system for patient directed therapy management that allows a patient to select and access stored patient therapy programs that are resident in the INS device and to modify 35 the stored therapy programs to create and store personalized therapy programs that accommodate the patient's particular lifestyle. The system apparatus is comprised of an implantable neuro stimulator (INS) with memory able to receive, store and execute preset patient therapy programs; a physi- 40 cian or clinician programmer for creating and storing preset patient therapy programs; a patient programmer with a display screen for creating and storing personalized therapy programs; and electrical lead electrodes for delivering therapy signals. In the system for patient directed therapy 45 management, the clinician programmer, the patient programmer and the INS communicate using radio waves, for example, via telemetry.
In other embodiments, the apparatus and method for patient directed therapy management of the present inven- 50 tion can be used with any number of implantable systems requiring the use of preset therapy programs, including, but not limited to, pacemakers, defibrillators, cochlear implants, implantable diagnostic devices for detecting bodily conditions of certain organs, like the brain or the heart, and drug 55 delivery systems having an implantable pump.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 illustrates an implantable medical device as could 60 be implanted in a human body to deliver stimulation therapy.
FIGS. 2A-D illustrate locations where the implantable medical device can be implanted in the human body other than the location shown in FIG. 1.
FIG. 3 is a schematic block diagram of an INS in 65 accordance with a preferred embodiment of the present invention.
FIG. 4 depicts a block diagram that shows a preferred method of the present invention to create personalized therapy programs.
FIG. 5 is a block diagram representation showing in more detail certain steps of FIG. 4 for creating personalized therapy programs.
DESCRIPTION OF THE PREFERRED
The present invention is an apparatus and method that allows a patient to select and access stored preset clinician patient therapy programs from INS memory and to modify the preset clinician therapy programs to create and store personalized therapy programs through the use of a patient programmer. The present invention gives the patient the ability to configure personalized therapy programs that accommodate the patient's particular needs, lifestyle, and desires from combined and/or modified stored preset clinician therapy programs.
FIG. 1 shows a general environment of an Implantable Neuro Stimulator (INS) 5 medical device in a patient 6 including leads 15A and 15B, and lead extensions 10A and 10B. The INS 5 is preferably a modified implantable pulse generator that will be available from Medtronic, Inc. with provisions for multiple pulses occurring either simultaneously or with one pulse shifted in time with respect to the other, and having independently varying amplitudes, pulse widths and directional sequence. The INS 5 contains a power source and electronics to send precise, electrical pulses to the spinal cord, brain, or neural tissue to provide the desired treatment therapy. The INS 5 can be powered by an internal source such as a rechargeable or non-rechargeable battery or by an external source such as a radio frequency transmitter. In a preferred embodiment of the present invention, the INS 5 provides electrical stimulation by way of pulses, however other forms of stimulation may be used such as continuous electrical stimulation.
The INS 5 can use one or more leads 15A and 15B and extensions 10A and 10B for delivering therapy. The leads 15A and 15B, which are surgically implanted, are comprised of one or more insulated electrical conductors with a connector on the proximal end 9A and 9B and electrical contacts or electrodes 20A and 20B on the distal end 16A and 16B. A lead 15A and 15B is a small medical wire with special insulation. Those skilled in the art will appreciate that any variety of leads may be used to practice the present invention.
As shown in FIG. 1, the leads 15A and 15B are implanted and positioned to stimulate a specific site or area. Alternatively, the leads 15A and 15B may be positioned along a peripheral nerve, adjacent neural tissue, positioned to stimulate muscle tissue or other stimulation site chosen by a clinician. The leads 15A and 15B contain one or more electrodes (small electrical contacts) through which electrical stimulation is delivered from the INS 5 to the targeted neural tissue. The electrodes 20A and 20B may be arranged in a predetermined physical layout. For example, where there is more than one electrode 20A and 20B, the electrodes may be arranged in a linear array, in multiple linear arrays, or in a particular geometric array such as a triangle, square, rectangle, circle, etc. In addition, the INS 5 may deliver stimulation therapy signals via the electrodes in a predetermined directional sequence based on the electrode's physical layout in the stimulation area.
FIGS. 2A-D generally illustrate locations where the INS can be implanted in the human body other than the location