Surgery – Controlled release therapeutic device or system – Implanted dynamic device or system
Reexamination Certificate
1999-04-30
2003-06-17
Jastrzab, Jeffrey R. (Department: 3734)
Surgery
Controlled release therapeutic device or system
Implanted dynamic device or system
C607S059000
Reexamination Certificate
active
06579280
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to generic building blocks for specifying various modes of treating a patient via drug infusion or electrical nerve stimulation using a generic multi-step treatment protocol including single-execution treatment steps and repeated-execution treatment-step groups.
2. Description of Related Art
Devices and techniques for treating neurological disorders by drug infusion and by electrical stimulation of a person's central nervous system are well known in the prior art. For instance, U.S. Pat. No. 5,713,922 to King, U.S. Pat. No. 5,782,798 to Rise, and U.S. Pat. No. 5,814,014 to Elsberry et al., each assigned to Medtronic, Inc. of Minneapolis, Minn., disclose such devices and techniques and are hereby incorporated by reference.
Such treatment devices and techniques often employ drug-infusion pumps and/or electrical pulse generators that are implanted within a patient's body. Accordingly, available memory for storing the parameters, such as treatment dose, duration, and timing, of various treatment protocols is severely limited. As a result, known implantable treatment devices are capable of storing a treatment protocol via telemetry that implements only a single treatment mode, such as single bolus, simple continuous, periodic bolus, or complex continuous treatment protocols. Single bolus refers to a non-recurring, finite treatment period. Simple continuous is a continuous treatment at a fixed treatment level. Periodic bolus refers to a single periodically recurring finite treatment period. Complex continuous refers to a plurality of treatment periods that periodically repeat themselves.
FIG. 2
depicts a prior art manner of specifying a complex continuous treatment protocol. The vertical axis represents the treatment rate. The horizontal axis represents elapsed time from the treatment protocol having been downlinked to the treatment device. In
FIG. 2
, the location of the vertical axis along the horizontal axis represents the time at which the treatment protocol was downloaded to the treatment device, as depicted at
100
. For each example given in this document, the time at which the treatment prescription was downlinked to the treatment device will be assumed to be 3:00 PM, local time. In
FIG. 2
, a complex continuous treatment protocol is depicted in which a background rate of 20 microliters/hour is infused, as depicted at
102
-
1
through
102
-
8
(collectively
102
). Note that, while the examples refer to infusion protocols, they are equally applicable to stimulation protocols. Background rate
102
is in effect when no treatment step is being performed.
The complex continuous treatment protocol depicted in
FIG. 2
has the additional following attributes: the treatment cycle time is 24 hours; between 6:00 AM and 8:00 AM, 600 microliters is infused; between 11:00 AM and 1:00 PM, 200 microliters is infused; and between 9:00 PM and 11:00 PM, 500 microliters is infused.
In order to program such a treatment protocol using known prior art methods, treatment step
104
-
1
, which corresponds to the 500 microliter treatment step from 9-11 PM, is programmed to start after a delay of 6 hours from the time the protocol is downlinked to the treatment device, namely, 3:00 PM. The treatment rate is determined by dividing the dose by the treatment-step duration, in this case 500 microliters divided by 2 hours, which is 250 microliters/hour. Accordingly, treatment step
104
-
1
would be programmed to include a delay from downlinking of 6 hours, during which the background treatment rate would be in effect, as depicted by
102
-
1
. Treatment step
104
-
1
would also be programmed to provide treatment at 250 microliters/hour for 2 hours. Similarly, treatment step
106
-
1
would be programmed to include a delay from the completion of treatment step
104
-
1
of 7 hours, during which background treatment
102
-
2
would be in effect, and treatment at 300 microliters/hour for 2 hours. Treatment step
108
-
1
would be programmed to include a delay from the completion of treatment step
106
-
1
of 3 hours, during which background treatment
102
-
3
would be in effect, and treatment at 100 microliters/hour for 2 hours. Following the completion of treatment step
108
-
1
, background rate
102
-
4
would be in effect for the remaining 2 hours of the 24-hour treatment cycle.
Then, the 24-hour cycle would repeat itself in perpetuity or until a new treatment protocol is downlinked to the treatment device. Accordingly, background rates
102
-
5
through
102
-
8
of the second 24-hour treatment cycle shown in
FIG. 2
correspond to background rates
102
-
1
through
102
-
4
, respectively, of the first 24-hour treatment cycle shown in FIG.
2
. Similarly, treatment steps
104
-
2
,
106
-
2
, and
108
-
2
of the second 24-hour treatment cycle shown in
FIG. 2
correspond to treatment steps
104
-
1
,
106
-
1
, and
108
-
1
, respectively, of the first 24-hour treatment cycle shown in FIG.
2
.
Such known methods of specifying treatment protocols undesirably require that each time a change from one infusion mode, such as single bolus, simple continuous, periodic bolus, or complex continuous, to another infusion mode is desired, the new treatment protocol must be downlinked to the treatment device. In other words, known implantable treatment devices are incapable of storing multiple treatment-mode protocols. Patients and physician-programmers of such treatment devices are therefore severely inconvenienced by having to re-program such treatment devices each time an infusion mode change is made.
SUMMARY OF THE INVENTION
It is therefore an object of this invention to overcome the shortcomings of the prior art by providing a generic treatment protocol for treating a patient via an implantable treatment device. The generic treatment protocol of this invention provides significantly improved versatility in implementing known treatment protocols, without the inconvenience of re-programming upon transitions between different treatment modes that is required when programming treatment protocols using prior art methods. In addition, the generic manner in which various treatment protocols can be specified using this invention also provides significant advantages for implementing newly created treatment protocols and for altering treatment protocols based on criteria such a patient travel between different time zones.
In one embodiment, the protocol includes a user-selectable number of one or more treatment steps, each having a corresponding duration, and one or more treatment-step groups, each having one or more treatment steps, a user-selectable treatment-step-group repetition count, and a user-selectable treatment-step-group duration. Additional aspects of the generic treatment protocol include: the capability of programming at least one of the treatment-steps to repeat forever; a series of single-execution treatment steps optionally executed initially upon programming the implantable treatment device; at least one of the treatment-step groups including: an absolute start time and an absolute end time, a start delay relative to completion of another treatment step, a user-selectable treatment rate, a user-selectable treatment dose, a patient-activated bolus, and/or a patient-activated rate adjustment.
In another embodiment of this invention, a therapeutic treatment device adapted to be implanted within a patient's body has a computer-readable medium that stores computer-executable instructions for providing a user-selectable number of one or more treatment steps for treating a patient using an implantable treatment device. Each of the treatment steps has a corresponding user-selectable treatment-step duration. In addition, the treatment-device computer-readable medium stores computer-executable instructions for providing one or more treatment-step groups. Each of the treatment-step groups includes: a user-selectable number of treatment steps; a user-selectable treatment-step-group repetition count; and a user
Kovach Peter J.
Lang Craig R.
Ullestad David C.
Banner & Witcoff , Ltd.
Jastrzab Jeffrey R.
Medtronic Inc.
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