Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems
Reexamination Certificate
2000-12-11
2003-11-25
Paschall, Mark (Department: 3742)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical therapeutic systems
C607S060000
Reexamination Certificate
active
06654642
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a fully automated patient interactive system for controlling neurostimulation, and more particularly, to a computer controlled system for automatic adjustment of neurostimulation implants used in pain therapy and in treating neurological dysfunction capable of automatically handling inconsistent patient data entries and unexpected conditions such as hardware failures.
Even more particularly, the present invention relates to a patient interactive system operated directly by the patient who may be safely and confidently left alone to work with the computer to obtain reliable data with the goal of maximizing pain relief while minimizing staff time demand. The novel system essentially replaces the physician, or physician's assistant, in the routine and tedious task of adjusting stimulation settings for the neurostimulation procedure.
Moreover, the present invention relates to a patient interactive system comprising a patient interactive pentop tablet computer which may include an RF (radio frequency) interface device integrally built in the pentop tablet computer or in the antenna in combination with patient interactive software and allows signal communication with neurostimulation implants using radio frequency telemetry.
Additionally, the present invention relates to a patient interactive system for controlling neurostimulation which includes a unified user interface in which the body outlines and the patient's drawings are input directly to the computer screen.
The present invention further relates to a patient interactive system having a “universal” transmitter for controlling implantable devices capable of imitating unique codes generated by proprietary neurostimulation systems thereby allowing the system of the present invention to work with a wide variety of implantable devices.
The present invention also relates to a method of controlling the neurostimulation in a neurological stimulation system for collecting data from a patient through a series of steps and further processing the collected data for optimization of the stimulus setting for the most effective pain relief and treatment.
PRIOR ART
Neurostimulators treat chronic pain by stimulating nerves, such as those of the spinal cord, with electrical pulses. Typically, neurostimulator systems comprise an external device which communicates with an implantable device through electromagnetic transmissions. The external device acts as a programmer for the implanted device by means of transmitting radio frequency codes to the implanted device to program its operation.
Neurostimulators have a number of parameters and adjustments that optimize the stimulation for each individual situation. Electrodes have multiple contacts that can have positive, negative, or off-polarity. Common configurations have 4, 8, or 16 electrode contacts within the stimulating bundle. Four electrodes can have 50 separate usable combinations of polarities. Eight electrodes can have 6050 separate usable combinations of polarities. Sixteen electrodes can have over 62,000,000 separate usable combinations of polarities. Beyond this, neurostimulators can set the frequency of stimulation between 1 Hz and 1500 Hz, set the pulse widths of stimulation between 10 and 1000 microseconds, and vary the amplitude of stimulation. These nearly inexhaustible adjustments quickly overwhelm the physical capabilities of medical staff to adjust stimulators through all settings for each patient.
To help with this concern, a computer-controlled neurological stimulation system, U.S. Pat. No. 5,370,672, was developed. The system provides efficient patient interaction, optimizes stimulation automatically, and delivers arbitrary and unique paradigms of stimulation. As shown in
FIG. 1
, an external transmitter
10
and implanted receiver
11
are RF coupled by an antenna
12
. The external transmitter
10
is worn externally by the patient
13
to encode the stimulation parameters and the electrode selections, which are then transmitted to the implanted receiver
11
via the antenna
12
. The implant decodes the transmitted information and generates the desired electrical pulses for stimulating electrodes
14
within the spinal column
15
.
As shown in
FIG. 2
, the computer-controlled neurological stimulation system of the '672 Patent includes a host computer
16
, an interface enclosure
17
coupled by a cable
18
to the host computer
16
, with an output line
19
coupled to an antenna
20
. A graphic tablet
21
is connected by a serial line
22
to the host computer
16
which permits entry to the host computer
16
of the location of stimulation paresthesias and painful areas when a stylus
23
is manipulated over the tablet
21
by the patient. The tablet
21
has an overlay positioned on the top of the tablet
21
and contours of the body are drawn on the overlay. In operation, the physician initiates a session with the patient by calling up the appropriate programs in the host computer
16
. The host computer
16
and interface enclosure
17
control one of several selective transmitters and cause the generation of various stimulation parameters such as frequency, pulse amplitude, width, and electrode combination. The patient at this time is directed via the graphics tablet
21
to interact with the host computer
16
and the interface enclosure
17
to adjust the stimulation amplitude as necessary and to sketch on the tablet
21
the areas of pain and the areas perceived by the patient to be experiencing paresthesias. While useful in reducing the workload of medical staff and automating the data collection, the system still has a number of limitations which include:
1. The patient has to look up to the monitor of the host computer
16
for instructions and then down at the graphics tablet
21
to draw responses and answers which presents a challenge in hand-eye coordination and slows data collection.
2. The overlay on the graphics tablet needs careful adjustment to accurately match its outlines of the body with the host computer's internal representation of those outlines. This calibration is also necessary to match the drawings made by the patient which represent areas of pain and stimulation paresthesia with the host computer's internal representation of the body.
3. The serial communications cable
18
between the host computer
16
and the transmitter enclosure
17
is prone to mechanical as well as electrical failure.
4. The patient is in physical contact with the transmitter interface enclosure
17
and the host computer
16
, both of which are connected to electrical cords and wall outlets. These devices are powered by the building's AC power and consequently have a grounded connection that can provide a leakage path or short circuit to ground.
Another patient interactive computer based neurostimulation system is described in U.S. Pat. No. 5,938,690. This system can assist in the performance of pre-, intra-, and post-operative procedures relating to the determination and optimization of a patient's therapeutic regimen. The system is intended to record and process patient's responses to test stimulation patterns during the operation of placing the electrodes, so as to give the physician real-time information that can be used to effectively position the electrodes within the patient's body. The system also provides computer assisted post-operative presentation and assessment of stimulation settings.
Disadvantageously, the systems of prior art are not truly automated and require frequent attention by clinical staff during operation because either they do not provide automated patient interviews or their unsophisticated the electrodes and the transmitter.
It is therefore clear that despite the advances and improvements in prior art systems for controlling neurostimulators, a novel system which is automated and “universal”, i.e., compatible with a wide variety of different types of implantable devices is needed in the art of neurostimulation. interview schemes are unab
Fowler Kim Randal
Holland Lon Hodges
North Richard Boydston
Sieracki Jeffrey Mark
Bauer Stephen W.
Berry Thomas G.
Medtronic Inc.
Paschall Mark
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