CA2089869A1 - Method and apparatus for epidural burst stimulation for angina pectoris - Google Patents
Method and apparatus for epidural burst stimulation for angina pectorisInfo
- Publication number
- CA2089869A1 CA2089869A1 CA002089869A CA2089869A CA2089869A1 CA 2089869 A1 CA2089869 A1 CA 2089869A1 CA 002089869 A CA002089869 A CA 002089869A CA 2089869 A CA2089869 A CA 2089869A CA 2089869 A1 CA2089869 A1 CA 2089869A1
- Authority
- CA
- Canada
- Prior art keywords
- activity
- level
- stimulation
- pulse generator
- threshold
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
- A61N1/36071—Pain
Abstract
Method of and apparatus for the treatment of angina pectoris using electrical stimulation within the epidural space of the spinal cord. A sensor is used to trigger stimulation only during periods of activity assumed to be symptomatic. The sensor may measure any of a number of parameters including blood oxygen saturation level or mechanical activity. In the preferred embodiment, a piezoelectric activity sensor is programmed to determine when the level of activity is reached at which angina is expected to occur in a particular patient. This determination is used to trigger an implantable spinal cord pulse generator. Bursts of high frequency stimulation energy are applied by an insulated lead to electrodes implanted in the epidural space at an upper thoracic or lower cervical location. The increased neural activity caused by the stimulation bursts eliminates the pain sensation and allows an equal or higher exercise level of the patient without pain or at a similar pain level. The epidural stimulation does not decrease coronary perfusion at the same exercise level. When sensed body activity decreases below the programmed level, electrical stimulation is inhibited.
Description
WO 92/04075 PCl-/US91/0607S
, 2~893~
METHOD AND APPARATUS FOR
EPIDURAL BURST STIMULATION FOR ANGINA PECTORIS
CROSS REFERENCE TO CO-PENDING APPLICATIONS
U.S. Patent Application Serial Number 07/490,065 filed March 7, 1990, and entitled ~Position Responsive Neuro Stimulator" is assigned to tho ~1gne~ ot the presont 1nvent10n.
BACKGROUND OF THE INVENTION
1. Field of the InYention--The present invention relates ~ -' generally to implantable medical devices, and more particularly, relates to implantable medical dev;-es for the treatment of angina pectoris.
2. DescriDtion of the Prior Art--The high prevalence of angina pectoris in modern society 1s well documented. The current standard therapy usually relies upon nitroglycerine and various vasodilators to increase perfusion and beta-blockers and other chemical agents to control coronary perfusion and pain. Normally surgical intervention or angioplasty is required to chronically increase profusion in those patients for whom such a procedure is indicated.
_A newly discovered technique for angina patients involves electrical stimulation of the spinal cord. D. F. Murphy, et al. describe the clinical results of such a technique in ~Dorsal Column Stimulatlon for Pain Relief from Intractable Angina Pectoris,~ Pain, Volume 28, l987, at 363-368, incorporat~d herein by reference.
- Though the clinical results reported by Murphy, et al. are most encouraging, it is very desirable for optimal pain eontrol on an individual to vary tne degree of eiectrical stimulation with the need of the patient. - - -~,,~',, " ' . . . ,', ~. ' .' ' ' ' ' . , ' ' ' ~' ~ ' ' . . . . . .
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WO 92/04075 PCI`/US91/0607S
,_ 2~9~69 SUMMARY OF THE INVENTION
The present invention overcomes the disadvantages of the prior art by providing a system and method for the treatment of angina pectoris using electrical stimulat~on of the spinal cord which varies with activity level or the pat1ent. A chron1c~11y 1mplantable sensor determ~n~s the relat1ve activ1ty level. Electrical stimulat10n is provided whenever the act1v1ty level exceeds a programmed threshold. An implantable pulse generator produces bursts of st1mulat10n energy, which are applied to the upper sp1nal cord us1ng an 1nsulatet lead. Electrodes implanted in the epidural space transfer the st1mulation bursts to the spinal cord.
~henever the patient is active, this condition is sensed by the -;implanted sensor, and the implanted pulse generator provides stimulation ' bursts to the spinal cord to block angina pain s1gnals to the brain.
This causes, in comparison to the situation w1thout stimulation, a mod~f~ed balance of sy~pathet1c, and parasympathet~c drive to the heart.
Increased parasympathetic dr~ve decreases peripheral resistance lowering the work load of the heart and requiring less perfusion (oxygen consumption). The heart becomes less ischemic. Th1s has occurred during -j-exercise when higher workloads, lower ST segment, longer times to angina pain and shorter recovery times have been observed when spinal cord stimulation is used.
, BRIEF DESCRIPTION OF THE DRA~INGS - ' Other ob~ects of the present invention and many of the attendant advantages of the present invention will be readily appreciated as the saee becomes-'better understood by reference~to 'the following detailed description when consid-red in connection with the accompanying drawings, 1n which 11ke reference numerals designate like parts throughout the ff gur-s th-reof and wher-in:
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WO 92/04075 PCr/US91/0607S
2~9~3 FIG 1 is a schematic view of a patient having a chronically implanted system for the treatment of angina pectoris using electrica1 stimulation of the spinal cord;
FI~. 2 1s a cro~--oct10nal v10w ot th~ sp1nal cort show1ng chron1c implantation of the electrode;
FI6. 3A is a block d~agram of the implantable pulse generator of the present invention;
FI6. 3B is a block diagram of an alternative embodiment of the implantable pulse generator;
FIG. 4A is a graphical representation of the wave forms of various key signals within the implantable pulse generator;
FI6. 4B is a graphical representation of the wave forms of various key signals within an alternative embodiment of the implantable pulse generator;
FI6. 5 is a block diagram of a second alternative embodiment;
FI6. 6 is a graphical representation of the pulse width of the second alternative embodiment; and, FI6. 7 ~s a graph~cal representation of the output of the second alternat~ve embodiment.
- .. . . . .. . ..
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
FI6. 1 is a schemat~c diagram of a patient lO having a chronically ~mplanted system for the treatment of angina pectoris using electrical stimulation of the spinal cord. Electrode 14 ~s implanted in the epidural ... . .. ,~ . ... .. ..
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WO 92/040~ PCI'/US91/0607S
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space of spinal column 12 as is shown below ir, greater detail. Electrode 14 is coupled to implantable pulse generator 20 by insulated lead 16.
Implantable pulse generator 20 contains an activity sensor for determining relative activity level of patient 10.
The various operating parameters of implantable pulse generator 20 are ad~ustable by medical personnel using programmer 18. This permits pulse amplitude, number of pulses per burst, etc. to be modified after implant. Using programmer 18, the threshold is also set for minimum activity to cause generation of stimulation pulses. This threshold will vary from patient to patient and over time for a given patient. Also a switch-off activity threshold could be preprogrammed separately and/or a time after which the stimulation ceases when the activity falls below the shut-off activity threshold level. Alternatively, a fixed length burst can be generated as a result of crossing the turn-on threihold of activity. ~ith current clinical knowledge, these thresholds must be determined empirically. Programmer 18 communicates with implantable pulse generator 20 via radio frequency energy transferred by RF cable 22 and radiated by antenna 24.
FIG. 2 is a cross sectional view of the spinal cord of patient 10.
Electrode 14 is preferably a PISCES SIGMA~ Model 3483 epidural electrode available from Medtronic, Inc. in Minneapolis, Minnesota. It is inserted into epidural space 30 as shown. Electrode 14 is coupled to implantable pulse generator 20 vta insulated lead 16 (see also Fig. 1).
Preferably electrode 14 is implanted at an upper thoracic or lower cervical spinal level. Dura mater 32 is shown to provide orientation of electrode 14 within epidural space 30. Also shown are arachnoid 34 and subarachnoid space 36.
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WO 92/040~5 PCI~/US91/0607S
- 2~~9 FIG. 3A is a block diagram of the electronic circuitry of implantable pulse generator 20. In the preferred embodiment, implantable pulse generator 20 is basically an Itrel II~ neurological pulse generator also available from Medtronic, Inc. F16. 3 presents most prominently those features not available in the commercially available device.
In the preferred embodiment, card~ac requirement is sensed by Xtal 50 which is a piezoelectric device. It is preferably mounted on the housing of implantable pulse generator 20 in the same manner as with the ACTIVITRAX~ implantable pulse generator manufactured and sold by Medtronic, Inc. Xtal 50 generates a signal corresponding to the mechanical vibrations which impinge upon the housing of implantable pulse generator 20. The greater the actlvity of patient 10, the greater the energy of the mechanical vibrations impinging upon the housing of implantable pulse generator 20 and the greater the generated signal.
Sensing of activity in this manner ls by way of example only and is not to be limiting of the present invention. Other sensors, such as blood oxygen saturation, may also be employed.
The signal from Xtal 50 is rectified by diode 52. This rectified signal is integrated by capacitor 54 through resistor 56. Rate of integration is controlled by leakage resistor 58. Experience has shown that lt is desirable to select these components to provide a pass band of about 10 hertz centered on 10 hertz.
, The rectifted and integrated signal is compared to the output of high voltage standard 62 by compare 60. This comparison determines whether the turn-on activity threshold is-reached. To enable comparison against a variable threshold, high voltage standard 62 is programmable by the physician.
~ ~ .
Similarly, compare 61 compares the integrated output with the output of low voltage standard 63. This comparison ~s used to determine when the activity drops below a lower turn-off activity threshold. The turn-on and turn-o-f activity thresholds are selected by programmer 18 (see also FIG.
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208986~
l) and are received as a radio frequency signal on antenna 68. The radio frequency signal is demodulated by receiver 66 and sent as a digital quantity to controller 70 for storage in memory 64.
Memory 64 also stores the other parameters which control generation of the st~mulat10n pulses, wh1ch are supplied to burst generator 72 as shown. The output of compare 60 is high whenever the activity signal exceeds the programmed turn-on activity threshold. It is this signal which sets burst generator 72 to produce a burst of stimulation pulses.
Burst generator 72 is directly coupled to insulated lead 16. ~henever the activity signal drops below the programmed turn-off activity threshold, compare 61 resets the input of burst generator 72, thereby inhibiting output of stimulation pulses. ~henever the activity signal drops below the programmed turn-off activity threshold, compare 61 starts a programmable timer 65, which when it times out, resets the input of burst generator 72, thereby inhibiting output of stimulation pulses.
Alternatively, programmable timer 65 may be turned on at the same time as burst generator 72 is set. This may be accomplished by programming low voltage standard 63 to the same level as high voltage standard 62. This will result in the production of an output burst of fixed length triggered by sensed activity passing the turn-on threshold.
FIG. 3B is a block tiagram of alternative embodiment implantable pulse generator lS0. This circuit employs a second programmable timer 59 on the set ~nput of burst generator 72. This provides a programmable delay before the turn on of stimulation pulses. The remainder of the elements are tS previously described.
. .
. . . .. ... ....... ..
FIG. 4A is a graphical representation of various key signals within implantable pulse generator 20. ~ave form lO0 shows the output of Xtal 50. !~ It var1es nearly randomly and is both positive and negative with respect to baseline 110- The amplitude and frequency of the signal -directly responds to the 1mpingement of mechan1cal energy on the housing of implantable pulse generator 20.
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WO 92/04075 PCI'/US91/0607S
2~9~69 ~ ave form 102 shows signal 114 which is the same as signal 122 after half-wave rectification by diode 52. Not1ce that this signal is never negative with respect to baseline 116.
~ ave form 104 shows the inputs to compare 60 and compare 61. All slgnals are pos1t1ve w1th respect to basel1ne 118. Levels 120 and 124 represent turn-off and turn-on activity threshold levels, respectively.
These are produced by low voltage standard 63 and high voltage standard 62 as discussed above. ~ave form 122 shows the output of integrat1ng capacltor 54. Notice that high voltage standard 62 is programmed to level 124 (i.e. a turn-on activ1ty threshold), and wh1le wave form 122 is below that threshold, no spinal cord st1mulat1On occurs. Low voltage standard 63 is program~ed to turn-off activity threshold level 120. As the current act1v~ty level (1.e. wave form 122) exceeds the programmed turn-on activity threshold (i.e., level 124) the spinal cord is st~mulated.
St1mulat1On cont1nues unt11 the act1v1ty level 122 falls below turn-off activity threshold level 120 when stimulition stops after the time period 121, determined st1mulation stops after the time period 121, determ1ned by programmable timer 65.
If low voltage standard 63 is programmed to the same level as high voltage standard 62, turn-off threshold level 120 and turn-on threshold level 124 are coincident. This produces the spec1al case of a fixed length burst of time per1Od 121 as determined by programmable timers 65.
., .
~ ave form 106 shows the state of burst generator 72 for wave form 104. ~hen the output of compare 60 is high, the trigger of burst generator 72 1s set and rema1ns set until reset by the output of compare 61 (see also FI6. 3). Trigger pulses 126 and 128 are positive w1th regard to bas-l1ne 134.
.
~ ave form 108 shows the output of burst generator 72. Notice that h~gh frequency burst 130 is keyed by trigger pulse 126 and high frequency burst 132 1s keyed by trigger pulse 128.
,.: . . ., . . . - - :.
. ~ , . . . . . .
WO 92/04075 PCI'/US91/06075 20~986~
FIG. 4B is a graphical representation of key signals of the alternative embodiment of implantable pulse generator I50. The output of implantable pulse generator I50 is identical to the output of implantable pulse generator 20 except for programmable delay period II9 which is provided by programmable timer 59. All other referenced elements are as previously descr1bed.
FIG. S is a block diagram of the circuitry of a second alternative embodiment of implantable pulse generator 220. This circuitry is identical to that of implantable pulse generator I50 except that the output of burst generator 72 has parameters which are determined by the sensed activity level. To accomplish this amp 57 supplies the amplified and integrated sensor output to burst altered time base generator 55. The parameters are then supplied to program the output of burst generator 73.
FIG. 6 is a graphical representation of change in one of the output parameters (e.g., pulse width) as a function of measured activity level.
FIG. 7 is a graphical representation of the pulse width of the output of implantable pulse generator 220 as a function of time for a large increase in activ~ty. The shape of the curve is influenced by the component values of the integrator circuit.
Those of skill in the art will readily appreciate that various other embodiments of the present invention may be made from the teachings found herein without deviating from the scope of the claims hereto attached.
: .
, ~ - , . : . , .
, 2~893~
METHOD AND APPARATUS FOR
EPIDURAL BURST STIMULATION FOR ANGINA PECTORIS
CROSS REFERENCE TO CO-PENDING APPLICATIONS
U.S. Patent Application Serial Number 07/490,065 filed March 7, 1990, and entitled ~Position Responsive Neuro Stimulator" is assigned to tho ~1gne~ ot the presont 1nvent10n.
BACKGROUND OF THE INVENTION
1. Field of the InYention--The present invention relates ~ -' generally to implantable medical devices, and more particularly, relates to implantable medical dev;-es for the treatment of angina pectoris.
2. DescriDtion of the Prior Art--The high prevalence of angina pectoris in modern society 1s well documented. The current standard therapy usually relies upon nitroglycerine and various vasodilators to increase perfusion and beta-blockers and other chemical agents to control coronary perfusion and pain. Normally surgical intervention or angioplasty is required to chronically increase profusion in those patients for whom such a procedure is indicated.
_A newly discovered technique for angina patients involves electrical stimulation of the spinal cord. D. F. Murphy, et al. describe the clinical results of such a technique in ~Dorsal Column Stimulatlon for Pain Relief from Intractable Angina Pectoris,~ Pain, Volume 28, l987, at 363-368, incorporat~d herein by reference.
- Though the clinical results reported by Murphy, et al. are most encouraging, it is very desirable for optimal pain eontrol on an individual to vary tne degree of eiectrical stimulation with the need of the patient. - - -~,,~',, " ' . . . ,', ~. ' .' ' ' ' ' . , ' ' ' ~' ~ ' ' . . . . . .
~ ~ . ~ ' ' . , , ' .
; , ' , ' ' ' . . .
": , , ' ~ , . ' .:.
~' ' : ' ' ` ' ~
WO 92/04075 PCI`/US91/0607S
,_ 2~9~69 SUMMARY OF THE INVENTION
The present invention overcomes the disadvantages of the prior art by providing a system and method for the treatment of angina pectoris using electrical stimulat~on of the spinal cord which varies with activity level or the pat1ent. A chron1c~11y 1mplantable sensor determ~n~s the relat1ve activ1ty level. Electrical stimulat10n is provided whenever the act1v1ty level exceeds a programmed threshold. An implantable pulse generator produces bursts of st1mulat10n energy, which are applied to the upper sp1nal cord us1ng an 1nsulatet lead. Electrodes implanted in the epidural space transfer the st1mulation bursts to the spinal cord.
~henever the patient is active, this condition is sensed by the -;implanted sensor, and the implanted pulse generator provides stimulation ' bursts to the spinal cord to block angina pain s1gnals to the brain.
This causes, in comparison to the situation w1thout stimulation, a mod~f~ed balance of sy~pathet1c, and parasympathet~c drive to the heart.
Increased parasympathetic dr~ve decreases peripheral resistance lowering the work load of the heart and requiring less perfusion (oxygen consumption). The heart becomes less ischemic. Th1s has occurred during -j-exercise when higher workloads, lower ST segment, longer times to angina pain and shorter recovery times have been observed when spinal cord stimulation is used.
, BRIEF DESCRIPTION OF THE DRA~INGS - ' Other ob~ects of the present invention and many of the attendant advantages of the present invention will be readily appreciated as the saee becomes-'better understood by reference~to 'the following detailed description when consid-red in connection with the accompanying drawings, 1n which 11ke reference numerals designate like parts throughout the ff gur-s th-reof and wher-in:
- - . - .
. - , ., . , .. . ... : .. . .
:. . . . - , -. .. . .. .
.. .. . . ..
.:: . . -,.. :. ~
. . . -.. . . .
WO 92/04075 PCr/US91/0607S
2~9~3 FIG 1 is a schematic view of a patient having a chronically implanted system for the treatment of angina pectoris using electrica1 stimulation of the spinal cord;
FI~. 2 1s a cro~--oct10nal v10w ot th~ sp1nal cort show1ng chron1c implantation of the electrode;
FI6. 3A is a block d~agram of the implantable pulse generator of the present invention;
FI6. 3B is a block diagram of an alternative embodiment of the implantable pulse generator;
FIG. 4A is a graphical representation of the wave forms of various key signals within the implantable pulse generator;
FI6. 4B is a graphical representation of the wave forms of various key signals within an alternative embodiment of the implantable pulse generator;
FI6. 5 is a block diagram of a second alternative embodiment;
FI6. 6 is a graphical representation of the pulse width of the second alternative embodiment; and, FI6. 7 ~s a graph~cal representation of the output of the second alternat~ve embodiment.
- .. . . . .. . ..
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
FI6. 1 is a schemat~c diagram of a patient lO having a chronically ~mplanted system for the treatment of angina pectoris using electrical stimulation of the spinal cord. Electrode 14 ~s implanted in the epidural ... . .. ,~ . ... .. ..
~, ,,-, - :
. . .. - .. ~ ..
.. - ~ . , . . ~ ,: . . .. ., . .: . . . . ,.. ; . . .
: . . . : , , . .. .. .. . .
: . . : .
, : j .. , . . ~, ~ . - , ~ .
- . , . : ::
.
., . - ... ..
... .. -; . : - -.
.
, . . . .
WO 92/040~ PCI'/US91/0607S
2 ~
space of spinal column 12 as is shown below ir, greater detail. Electrode 14 is coupled to implantable pulse generator 20 by insulated lead 16.
Implantable pulse generator 20 contains an activity sensor for determining relative activity level of patient 10.
The various operating parameters of implantable pulse generator 20 are ad~ustable by medical personnel using programmer 18. This permits pulse amplitude, number of pulses per burst, etc. to be modified after implant. Using programmer 18, the threshold is also set for minimum activity to cause generation of stimulation pulses. This threshold will vary from patient to patient and over time for a given patient. Also a switch-off activity threshold could be preprogrammed separately and/or a time after which the stimulation ceases when the activity falls below the shut-off activity threshold level. Alternatively, a fixed length burst can be generated as a result of crossing the turn-on threihold of activity. ~ith current clinical knowledge, these thresholds must be determined empirically. Programmer 18 communicates with implantable pulse generator 20 via radio frequency energy transferred by RF cable 22 and radiated by antenna 24.
FIG. 2 is a cross sectional view of the spinal cord of patient 10.
Electrode 14 is preferably a PISCES SIGMA~ Model 3483 epidural electrode available from Medtronic, Inc. in Minneapolis, Minnesota. It is inserted into epidural space 30 as shown. Electrode 14 is coupled to implantable pulse generator 20 vta insulated lead 16 (see also Fig. 1).
Preferably electrode 14 is implanted at an upper thoracic or lower cervical spinal level. Dura mater 32 is shown to provide orientation of electrode 14 within epidural space 30. Also shown are arachnoid 34 and subarachnoid space 36.
- . . . .
. ~ ; . ~ ,. . . , ~- , .
. .. - . . . . .
.. . . ..
. , . ~ . ,. :
.
. . . . ..
.
,.
- .
WO 92/040~5 PCI~/US91/0607S
- 2~~9 FIG. 3A is a block diagram of the electronic circuitry of implantable pulse generator 20. In the preferred embodiment, implantable pulse generator 20 is basically an Itrel II~ neurological pulse generator also available from Medtronic, Inc. F16. 3 presents most prominently those features not available in the commercially available device.
In the preferred embodiment, card~ac requirement is sensed by Xtal 50 which is a piezoelectric device. It is preferably mounted on the housing of implantable pulse generator 20 in the same manner as with the ACTIVITRAX~ implantable pulse generator manufactured and sold by Medtronic, Inc. Xtal 50 generates a signal corresponding to the mechanical vibrations which impinge upon the housing of implantable pulse generator 20. The greater the actlvity of patient 10, the greater the energy of the mechanical vibrations impinging upon the housing of implantable pulse generator 20 and the greater the generated signal.
Sensing of activity in this manner ls by way of example only and is not to be limiting of the present invention. Other sensors, such as blood oxygen saturation, may also be employed.
The signal from Xtal 50 is rectified by diode 52. This rectified signal is integrated by capacitor 54 through resistor 56. Rate of integration is controlled by leakage resistor 58. Experience has shown that lt is desirable to select these components to provide a pass band of about 10 hertz centered on 10 hertz.
, The rectifted and integrated signal is compared to the output of high voltage standard 62 by compare 60. This comparison determines whether the turn-on activity threshold is-reached. To enable comparison against a variable threshold, high voltage standard 62 is programmable by the physician.
~ ~ .
Similarly, compare 61 compares the integrated output with the output of low voltage standard 63. This comparison ~s used to determine when the activity drops below a lower turn-off activity threshold. The turn-on and turn-o-f activity thresholds are selected by programmer 18 (see also FIG.
,,, ., .. ~ , .. ~
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208986~
l) and are received as a radio frequency signal on antenna 68. The radio frequency signal is demodulated by receiver 66 and sent as a digital quantity to controller 70 for storage in memory 64.
Memory 64 also stores the other parameters which control generation of the st~mulat10n pulses, wh1ch are supplied to burst generator 72 as shown. The output of compare 60 is high whenever the activity signal exceeds the programmed turn-on activity threshold. It is this signal which sets burst generator 72 to produce a burst of stimulation pulses.
Burst generator 72 is directly coupled to insulated lead 16. ~henever the activity signal drops below the programmed turn-off activity threshold, compare 61 resets the input of burst generator 72, thereby inhibiting output of stimulation pulses. ~henever the activity signal drops below the programmed turn-off activity threshold, compare 61 starts a programmable timer 65, which when it times out, resets the input of burst generator 72, thereby inhibiting output of stimulation pulses.
Alternatively, programmable timer 65 may be turned on at the same time as burst generator 72 is set. This may be accomplished by programming low voltage standard 63 to the same level as high voltage standard 62. This will result in the production of an output burst of fixed length triggered by sensed activity passing the turn-on threshold.
FIG. 3B is a block tiagram of alternative embodiment implantable pulse generator lS0. This circuit employs a second programmable timer 59 on the set ~nput of burst generator 72. This provides a programmable delay before the turn on of stimulation pulses. The remainder of the elements are tS previously described.
. .
. . . .. ... ....... ..
FIG. 4A is a graphical representation of various key signals within implantable pulse generator 20. ~ave form lO0 shows the output of Xtal 50. !~ It var1es nearly randomly and is both positive and negative with respect to baseline 110- The amplitude and frequency of the signal -directly responds to the 1mpingement of mechan1cal energy on the housing of implantable pulse generator 20.
. , ~ , ~ :
.:,. ;
,- .. ~ : . .. .. . ..
, : . . : . ~......... . : ,.
WO 92/04075 PCI'/US91/0607S
2~9~69 ~ ave form 102 shows signal 114 which is the same as signal 122 after half-wave rectification by diode 52. Not1ce that this signal is never negative with respect to baseline 116.
~ ave form 104 shows the inputs to compare 60 and compare 61. All slgnals are pos1t1ve w1th respect to basel1ne 118. Levels 120 and 124 represent turn-off and turn-on activity threshold levels, respectively.
These are produced by low voltage standard 63 and high voltage standard 62 as discussed above. ~ave form 122 shows the output of integrat1ng capacltor 54. Notice that high voltage standard 62 is programmed to level 124 (i.e. a turn-on activ1ty threshold), and wh1le wave form 122 is below that threshold, no spinal cord st1mulat1On occurs. Low voltage standard 63 is program~ed to turn-off activity threshold level 120. As the current act1v~ty level (1.e. wave form 122) exceeds the programmed turn-on activity threshold (i.e., level 124) the spinal cord is st~mulated.
St1mulat1On cont1nues unt11 the act1v1ty level 122 falls below turn-off activity threshold level 120 when stimulition stops after the time period 121, determined st1mulation stops after the time period 121, determ1ned by programmable timer 65.
If low voltage standard 63 is programmed to the same level as high voltage standard 62, turn-off threshold level 120 and turn-on threshold level 124 are coincident. This produces the spec1al case of a fixed length burst of time per1Od 121 as determined by programmable timers 65.
., .
~ ave form 106 shows the state of burst generator 72 for wave form 104. ~hen the output of compare 60 is high, the trigger of burst generator 72 1s set and rema1ns set until reset by the output of compare 61 (see also FI6. 3). Trigger pulses 126 and 128 are positive w1th regard to bas-l1ne 134.
.
~ ave form 108 shows the output of burst generator 72. Notice that h~gh frequency burst 130 is keyed by trigger pulse 126 and high frequency burst 132 1s keyed by trigger pulse 128.
,.: . . ., . . . - - :.
. ~ , . . . . . .
WO 92/04075 PCI'/US91/06075 20~986~
FIG. 4B is a graphical representation of key signals of the alternative embodiment of implantable pulse generator I50. The output of implantable pulse generator I50 is identical to the output of implantable pulse generator 20 except for programmable delay period II9 which is provided by programmable timer 59. All other referenced elements are as previously descr1bed.
FIG. S is a block diagram of the circuitry of a second alternative embodiment of implantable pulse generator 220. This circuitry is identical to that of implantable pulse generator I50 except that the output of burst generator 72 has parameters which are determined by the sensed activity level. To accomplish this amp 57 supplies the amplified and integrated sensor output to burst altered time base generator 55. The parameters are then supplied to program the output of burst generator 73.
FIG. 6 is a graphical representation of change in one of the output parameters (e.g., pulse width) as a function of measured activity level.
FIG. 7 is a graphical representation of the pulse width of the output of implantable pulse generator 220 as a function of time for a large increase in activ~ty. The shape of the curve is influenced by the component values of the integrator circuit.
Those of skill in the art will readily appreciate that various other embodiments of the present invention may be made from the teachings found herein without deviating from the scope of the claims hereto attached.
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Claims (7)
1. An apparatus comprising:
a. a spinal cord electrode;
b. a pulse generator electrically coupled to said spinal cord electrode;
c. means coupled to said pulse generator for measuring cardiac requirements; and d. means coupled to said measuring means and said pulse generator for causing said pulse generator to produce stimulation signals whenever cardiac requirements exceed a given threshold.
a. a spinal cord electrode;
b. a pulse generator electrically coupled to said spinal cord electrode;
c. means coupled to said pulse generator for measuring cardiac requirements; and d. means coupled to said measuring means and said pulse generator for causing said pulse generator to produce stimulation signals whenever cardiac requirements exceed a given threshold.
2. An apparatus according to claim 1 further comprising means for programming said given threshold.
3. An apparatus according to claim 2 wherein said programming means further comprises means for percutaneously programming said given threshold.
4. An apparatus according to claim 3 wherein said causing means further comprises an activity sensor.
5. A method of treating angina comprising:
a. implanting an electrode in the spinal column of a patient;
b. sensing the activity level of said patient; and, c. supplying bursts of stimulation energy to said electrode if said activity level of said patient as determined by said sensing step exceeds a threshold.
a. implanting an electrode in the spinal column of a patient;
b. sensing the activity level of said patient; and, c. supplying bursts of stimulation energy to said electrode if said activity level of said patient as determined by said sensing step exceeds a threshold.
6. A method according to claim 5 further comprising discontinuing said supplying step if said sensing determines that said activity level has dropped below said threshold.
7. A method according to claim 6 further comprising delaying a predetermined amount of time between said sensing that said activity level has dropped below said threshold and said discontinuing of said supplying step.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US07/574,739 US5058584A (en) | 1990-08-30 | 1990-08-30 | Method and apparatus for epidural burst stimulation for angina pectoris |
| US574,739 | 1990-08-30 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2089869A1 true CA2089869A1 (en) | 1992-03-01 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002089869A Abandoned CA2089869A1 (en) | 1990-08-30 | 1991-08-26 | Method and apparatus for epidural burst stimulation for angina pectoris |
Country Status (6)
| Country | Link |
|---|---|
| US (1) | US5058584A (en) |
| EP (1) | EP0546024B1 (en) |
| JP (1) | JP2929316B2 (en) |
| CA (1) | CA2089869A1 (en) |
| DE (1) | DE69105140T2 (en) |
| WO (1) | WO1992004075A1 (en) |
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| RU182181U1 (en) * | 2018-04-14 | 2018-08-06 | федеральное государственное бюджетное образовательное учреждение высшего образования "Саратовский государственный медицинский университет имени В.И. Разумовского" Министерства здравоохранения Российской Федерации (ФГБОУ ВО Саратовский ГМУ им. В.И. Разумовского Минздрава России) | Device for intraoperative monitoring of regional hemoglobin oxygen saturation and vascular tone of the microvasculature |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR94491E (en) * | 1965-10-13 | 1969-08-22 | Philips Massiot Mat Medic | Pacemaker. |
| US3822708A (en) * | 1972-12-07 | 1974-07-09 | Clinical Technology Corp | Electrical spinal cord stimulating device and method for management of pain |
| US4026301A (en) * | 1975-04-21 | 1977-05-31 | Medtronic, Inc. | Apparatus and method for optimum electrode placement in the treatment of disease syndromes such as spinal curvature |
| US4019518A (en) * | 1975-08-11 | 1977-04-26 | Medtronic, Inc. | Electrical stimulation system |
| US4044774A (en) * | 1976-02-23 | 1977-08-30 | Medtronic, Inc. | Percutaneously inserted spinal cord stimulation lead |
| US4735204A (en) * | 1984-09-17 | 1988-04-05 | Cordis Corporation | System for controlling an implanted neural stimulator |
| US4669477A (en) * | 1985-05-20 | 1987-06-02 | Empi, Inc. | Apparatus and method for preventing bruxism |
| DE3709073A1 (en) * | 1987-03-19 | 1988-09-29 | Alt Eckhard | IMPLANTABLE MEDICAL DEVICE |
| US4922930A (en) * | 1989-04-11 | 1990-05-08 | Intermedics, Inc. | Implantable device with circadian rhythm adjustment |
-
1990
- 1990-08-30 US US07/574,739 patent/US5058584A/en not_active Expired - Lifetime
-
1991
- 1991-08-26 DE DE69105140T patent/DE69105140T2/en not_active Expired - Fee Related
- 1991-08-26 CA CA002089869A patent/CA2089869A1/en not_active Abandoned
- 1991-08-26 WO PCT/US1991/006075 patent/WO1992004075A1/en active IP Right Grant
- 1991-08-26 EP EP91915556A patent/EP0546024B1/en not_active Expired - Lifetime
- 1991-08-26 JP JP3514855A patent/JP2929316B2/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| EP0546024A1 (en) | 1993-06-16 |
| DE69105140T2 (en) | 1995-04-13 |
| JP2929316B2 (en) | 1999-08-03 |
| DE69105140D1 (en) | 1994-12-15 |
| WO1992004075A1 (en) | 1992-03-19 |
| JPH06500715A (en) | 1994-01-27 |
| EP0546024B1 (en) | 1994-11-09 |
| US5058584A (en) | 1991-10-22 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued |