CA2415986A1 - Percutaneous intramuscular stimulation system - Google Patents
Percutaneous intramuscular stimulation system Download PDFInfo
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- CA2415986A1 CA2415986A1 CA002415986A CA2415986A CA2415986A1 CA 2415986 A1 CA2415986 A1 CA 2415986A1 CA 002415986 A CA002415986 A CA 002415986A CA 2415986 A CA2415986 A CA 2415986A CA 2415986 A1 CA2415986 A1 CA 2415986A1
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- pulse train
- stimulation
- select
- intramuscular
- pulse
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- 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
- A61N1/36003—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of motor muscles, e.g. for walking assistance
Abstract
A percutaneous, intramuscular stimulation system for therapeutic electrical stimulation of select muscles of a patient includes a plurality of intramuscular stimulation electrodes (50) for implantation directly into select muscles of a patient and an external battery-operated, microprocessor-based stimulation pulse train generator (10) for generating select electrical. stimulation pulse train signals (T). A plurality of insulated electrode leads (40) percutaneously, electrically interconnect the plurality of intramuscular stimulation electrodes (50) to the external stimulation pulse train generator (10), respectively. The external pulse train generator (10) includes a plurality of electrical stimulation pulse train. output channels (E) connected respectively to the plurality of percutaneous electrode leads (40) and input means (24,26,28) nor operator selection. of stimulation pulse train parameters (PA,PD,PF) for each of the stimulation pulse train output channels (E) independently of the ether channels. visual output means (20) provides visual output data to an operator of the pulse train generator (10). Non-volatile memory means (66,68) stores the stimulation pulse train parameters for each of the plurality of stimulation pulse train output charnels (E). The generator (10) includes means for generating stimulation pulse train signals (100,102) with the selected pulse train parameters on each of the plurality of stimulation pulse train output channels (E) so that stimulus pulses of the pulse train signals having the select stimulation pulse train parameters pass between the intramuscular electrodes (50) respectively connected to the stimulation pulse train output channels (E) and a reference electrode (52).
Description
t NUC 2 O1~
Background of the Invention The present invention relates to the art of therapeutic neuromuscular stimulation. It finds particular application for use by :human patients who are paralyzed or partially paralyzed due to cerebrovascular accidents such as stroke or the like. The invention is useful for retarding or preventing muscle disuse atrophy, maintaining extremity range-of-motion., facilitating voluntary motor function, relaxing spastic muscles, increasing blood flow to select muscles, and the like.
An estimated 555,000 persons are disabled each year ir~ the United States .of America by cerebrovascular accidents (~'VA) such as stroke. Many of these patients are left w~ th partial or compl ete paralysis of an extremity.
rer example, subluxation (incomplete dislocation) of the shoulder joint is a common occurrence and has been associated with chronic and debilitating pain among stroke survivors. In stroke survivors experiencing shoulder pain, motor recovery is frequently poor and rehabilitation is impaired. Thus, the patient may not achieve his/her maximum functional potential and independence. Therefore, prevention and treatment of subluxation in stroke patients is a priority.
There is a general acknowledgment by healthcare professionals of the need for improvement in the prevention and treatment of shoulder subluxation. Conventional interventicr: includes the use of orthotic devices, such as slings and supports, to immobilize the joint in an attempt to maintain normal anatomic alignment. The effectiveness of these orthotic devices varies with the individual.
Also, many authorities consider the use of slings and arm supports to be controversial or even contraindicated because of the potential complicati<ans from immobilization including disuse atrophy and further disabling contractures.
Surface, ...e., transcutaneous, electrical muscular stimulation has been used therapeutically for the treatment of shoulder subluxation a.nd associated pain, as well as for other therapeutic uses. Therapeutic transcutaneous stimulation has not been widely accented in general because of stimulation-induced pain and discomfort, poor muscle selectivity, and difficulty in daily management of electrodes. Tn addition to these electrode-related problems, commercially available stimulators are relatively bulky, have high energy consumption, and use cumbersome connecting wires.
In light of the foregoing deficiencies, transcutaneous stimulation systems are typically limited to two stimulation output channels. The electrodes mounted on the surface of the patient' s skin are not able to select muscles to be stimulated with sufficient particularity and are not suitable for stimulation of the deeper muscle tissue or the patient as required for effective therapy.
Any attempt to use greater than. two surface electrodes on a particular region of a patient's body is likely to result in suboptimal stimulation due to poor muscle selection.
Further, transcutaneous muscle stimulation via surface electrodes commonly induces pain and discomfort.
Studies suggest that conventional interve:.tions are not affective in preventing or reducing long term pain or disability. Therefore, it has been deemed desirable to develop a percutaneous, i.e., through the skin, neuromuscular stimulation system that utilizes temporarily implanted, intramuscular stimulation electrodes connected by percutaneous electrode leads to an external and portable pulse generator.
Background of the Invention The present invention relates to the art of therapeutic neuromuscular stimulation. It finds particular application for use by :human patients who are paralyzed or partially paralyzed due to cerebrovascular accidents such as stroke or the like. The invention is useful for retarding or preventing muscle disuse atrophy, maintaining extremity range-of-motion., facilitating voluntary motor function, relaxing spastic muscles, increasing blood flow to select muscles, and the like.
An estimated 555,000 persons are disabled each year ir~ the United States .of America by cerebrovascular accidents (~'VA) such as stroke. Many of these patients are left w~ th partial or compl ete paralysis of an extremity.
rer example, subluxation (incomplete dislocation) of the shoulder joint is a common occurrence and has been associated with chronic and debilitating pain among stroke survivors. In stroke survivors experiencing shoulder pain, motor recovery is frequently poor and rehabilitation is impaired. Thus, the patient may not achieve his/her maximum functional potential and independence. Therefore, prevention and treatment of subluxation in stroke patients is a priority.
There is a general acknowledgment by healthcare professionals of the need for improvement in the prevention and treatment of shoulder subluxation. Conventional interventicr: includes the use of orthotic devices, such as slings and supports, to immobilize the joint in an attempt to maintain normal anatomic alignment. The effectiveness of these orthotic devices varies with the individual.
Also, many authorities consider the use of slings and arm supports to be controversial or even contraindicated because of the potential complicati<ans from immobilization including disuse atrophy and further disabling contractures.
Surface, ...e., transcutaneous, electrical muscular stimulation has been used therapeutically for the treatment of shoulder subluxation a.nd associated pain, as well as for other therapeutic uses. Therapeutic transcutaneous stimulation has not been widely accented in general because of stimulation-induced pain and discomfort, poor muscle selectivity, and difficulty in daily management of electrodes. Tn addition to these electrode-related problems, commercially available stimulators are relatively bulky, have high energy consumption, and use cumbersome connecting wires.
In light of the foregoing deficiencies, transcutaneous stimulation systems are typically limited to two stimulation output channels. The electrodes mounted on the surface of the patient' s skin are not able to select muscles to be stimulated with sufficient particularity and are not suitable for stimulation of the deeper muscle tissue or the patient as required for effective therapy.
Any attempt to use greater than. two surface electrodes on a particular region of a patient's body is likely to result in suboptimal stimulation due to poor muscle selection.
Further, transcutaneous muscle stimulation via surface electrodes commonly induces pain and discomfort.
Studies suggest that conventional interve:.tions are not affective in preventing or reducing long term pain or disability. Therefore, it has been deemed desirable to develop a percutaneous, i.e., through the skin, neuromuscular stimulation system that utilizes temporarily implanted, intramuscular stimulation electrodes connected by percutaneous electrode leads to an external and portable pulse generator.
Summary of the Invention In accordance with a first aspect of the present invention, a percutaneous, intram~uscular stimulation system for therapeutic electrical stimulation of select muscles of a patient includes a plurality oz intramuscular stimulation electrodes for implantation directly into selected muscles of a patient and an external battery-operated, microprocessor-based stimulation pulse train generator for generating select electrical stimulation pulse train signals. A plurality of insulated electrode leads are used for percutaneously interconnecting the plurality of intramuscular stimulatior_ electrodes to the external stimulation pulse train generator, respectively. The external pulse train generator includes a plurality of electrical stimulation pulse tram output channels connected respectively to the plurality of percutaneous electrode leads and input means for operator selection of stimulation pulse train parameters for each of the stiauiation pulse train output charnels independently of the ot~-~er charnels. The stimulation pulse train parameters include at least pulse amplitude and pulse width or duration for stimulation pulses of the stimulation pulse train, and an interpulse interval between successive pulses of the stimulation pulse train defining a pulse frequency.
Visual output means provides visual output data to an operator of the pulse train generator. The visual output data includes at least the stimulation pulse train parameters for each of the stimulation pulse train output channels. Non-volatile memory means stores the stimulation pulse train parameters for each of the plurality of stimulation pulse train output channels. The generator includes means for generating stimulation pulse train signals with the selected pulse train parameters on each of the plurality of stimulation pulse train output channels so that stimulus pulses of t:~~e pulse train signals having the select stimulation pulse train parameters pass between the intramuscular electrodes respectively connected to the stimulation pulse train output channels and a reference electrode.
Tr_ accordance with another aspect of the invention, a met:od of stimulating select cnuscle tissue of a patient includes programming a patient external stimulatior. pulse generator with at least one stimulation pulse train session including at least one stimulation cycle defining a stimulation pulse train envelope for a plurality of stimulatior_ pulse train. output channels. Each envelope is defined by at least a ramp-up phase of a first select duration wherein pulses of a stimulus pulse tYain progressively increase in charge, a hold phase of a second select duration wherein pulses of the stimulus pulse train are substantially constant charge, and a ramp-down phase o=
a third select duration wherein pulses of the stimulus pulse train progressively decrease in charge. A plurality of intramuscular electrodes are implanted into select muscle tissue of the patient arid electrically connected to the plurality of output channels, respectively, of the pulse train generator. On each of said plurality of stimulation output charnels and in accordance with a respective envelope, stimulation pulse train signals are generated with the generator so that the select muscle tissue of the patiera is stimaaiated in accordance with the at least one stimulatior_ cycle.
One advantage of the present invention is the provision of a therapeutic percu.taneous intramuscular stimulation system that retards or prevents muscle disuse atrophy, maintains muscle range-cf-motion, facilitates voluntary motor a=unction, relaxes spastic muscles, and increases blood flow in selected muscles.
Another advantage of the present invention is that it provides a therapeutic muscular stimulation system that uses intramuscular, rather than skin surface (transcutaneousl electrodes to effect muscle stimul anon of S select patient muscles.
Another advantage of the present invention is that it provides a small, lightweight, and portable battery-operated external pulse generator.
A further advantage of the present invention is that it avoids the use of skin surface electrodes which are inconvenient, not sufficiently selective to stimulate only particular muscles, require daily application by the patient, are subject to patient misapplication, and that have been found to cause pain or discomfort upon muscle stimulation.
Still another advantage of the present invention resides in the provision of a therapeutic stimulation system that allows for precise muscle selection through use ef intramuscul or e1 ectrodes, i n.clud=_rg stimulation of deep muscles not readily stimulated via transcutar~eous stimulation techniques and associated surface mou:~~ed eieCtrodeS.
Yet another advantage of the present invention is that it is "user-friendly," allowing selective variation cf 2S system operational parameters by a therapist or patient without the need for any external programming apparatus such as a personal computer or the )_ike.
A further advantage of the present invention is the provision of a percutaneous stimulation system with low power consumption, long battery life (e. g., up to SO hours of use) .
A still further advar_tage of the present invention is the provision of a percutaneous, intramuscular stimulation system including a "hot-button" for selective instantaneous pulse train generation during system setup to facilitate adjustment of stimulatior; pulse train parameters during system setup.
A yet further advantage of the present invention is found in a percutaneous ir:tramuscular stimulation system which logs patient usage fog subsequent review by a doctor or therapist to ensure patient compliance with prescribed therapeutic stimulation routines.
The foregoing advantages and others will increase patient acceptance, reduce the service time required from clinicians, and prevent secondary patient injury requiring additional medical treatment.
Still further ber:efits and advantages of the present invention will become apparent to those of ordinary skill in the art upon reading and understanding the following detailed description of the preferred embodiments.
Brief Descri~tian of the Drawings The invention may take form in various components and arrangements of components, and in various steps and arrangements of steps. The drawings are only for purposes of illustrating preferred embodiments, and are not to be construed as limiting the invention.
rFIGL'RE IA is a front elevational view of a 2S portable; programmable stimulation pulse train generator in accordance with the present invention;
FTGURES 1B - 1D are top, bottom, and right-side elevational views of the stimulation pulse train generator of FIGURE 1A;
FIGURE 2 illustrates a preferred intramuscular electrode and percutaneous electrode lead;
FIGURE 3 diagrammatically illustrates the structure and operation of t~:e percutaneous intramuscular _ '7 _ stimulation system in accordance with the present invention:;
FIGURE 3A diagrammatically illustrates a preferred pulse amplitude/duration controller, current S driver, and impedance detector circuit in accordance with the present invention; and, rIGL'RE 4 graphically illustrates the stimulation paradigm of the percutaneous intramuscular stimulation system in accordance with the present invention.
Detailed Descrir~tion of the Preferred Embodiments With reference to FIGURES lA-1D, the percutaneous, intramuscular stimulation system in accordance with the z~resent invention includes an electrical sti~r,ulation pulse generator 10. 'Ihe pulse generator 10 includes a lightweight, durable plastic rousing 12 fabricated From a suitable plastic or the _ike.
The case 12 inc~'_udes a clip 14 that allows the pulse generator 10 to be releasably connected to a patient's belt, other clothing, or any other convenient locat_on.
2Q The case 12 also includes a releasable battery access cover 16.
For ou~.'.put of v l sual data to a patient or clinician operating the stimulation system, a visual display 20 is provided. The disLlav 20 is preferably provided by a liauid crystal display, but any ct~_er suitable display means may alternatively be used. A:.-~ audio output device, such as a beeper 22 is also provided.
For user control, adjustment, and selection of eperatiar~al parameters, the stimulation pulse generator l0 includes means for input of data. Preferably, the pulse generator 10 includes an increment switch 24, a decrement switch 26, and a select or "enter" switch 28. The increment and decrement switches 24, 26 are used to cycle r through operational modes or patterns and stimulation parameters displayed on t~e display 20, while the select switch 28 is used to select a particular displayed operational pattern, or stimulation parameter. The select S switch 28 also acts as a power on/off toggle switch. By choosing the appropriate mode, the select switch 28 can be selectively armed as a "hot button." During adjustment of stimulation pulse train parameters, a clinician is able to activate the hot button to test, instantaneously, the effect of the selected stimulation pulse train parameters on the patient's muscles. This facilitates the quick and proper adjustment of the stimulation pulse train parameters without requiring the clinician to exit the setup procedure ;nenu of the stimulation pulse generator 10.
1S For output of electrical stimulation pulse train signals, the pulse train generator 10 includes an external connection socket 30 that mates with a connector of an electrode cable assembly (r:ot shown? to ir_terconr_ect the pulse generator 10 with a plurality of intramuscular electrodes via percutaneous electrode leads. More particularly, the cable assembly connected to the socket 30 includes a second connector ar~ a distal end that mates with a connector attached to the proximal end of each of the percuta:~eous stimulation electrode leads and a rayerence 2S electrode lead.
A preferred intramuscular electrode and percutaneous lead are shown: in .FIGURE 2. The electrode Lead 40 is fabricated. from a 7-strand stainless steel wire insulated with a bioccmpatible polymer. Each individual wire strand has a diameter of 34 ,um and the insulated mufti-strand lead wire has a diameter of 250 ~.m. Tne insulated wire is formed into a spiral or helix as has been found preferred to accommodate high dynamic stress upon muscle flexion and extension, while simultaneously _ g _ retaining low susceptibility to fatigue. The outer diameter of the helically formed electrode lead 40 is approximately 580 ~.m arid it may be encased or filled with silicone or the like.
S As mentioned above, a proximal end 44 of each of the plurality of intramuscular electrode lead wires 40 is located exterior to the patient's body when in use. The proximal end ~44 includes a a.einsulated length for connection to an electrical connector in combination with the remainder of the electrode leads. The distal end 46 of each lead 40, which is inserted directly into muscle tissue, also includes a deinsulated length which acts as the stimulatior_ electrode S0. It is preferred that at least a portion of the deinsuiated length be bent or otherwise deformed into a barb 48 to anchor the electrode in the selected muscle tissue. A taper 52, made from silicone adhesive or the like, is formed between the dei:r~sulated distal end 50 and the insulated portion of the lead 40 to reduce stress concentration.
Unlike surface electrodes which are appl,ect to the surface Of the patient's skin using an adhesive, each of the plurality of percutaneous e?ectrodes SO is surgically implanted into select patient muscle tissue, and the associated electrode lead 40 exits the patient percutaneously, i.e., through the skin, for connection to the stimulation pulse generator 10. Preferably, each of the electrodes 50 is implanted into the select muscles by use of a hypodermic needle. Once all of the electrodes are implanted as desired, their proximal ends are crimped into a common connector that mates with the cable assembly which is, in turn, connected to the pulse generator 10 through the connection socket 30.
FIGURE 3 diagrammatically illustrates the overall percutaneous, intramuscular stimulation system in i~ -accordance with the present invention. Unlike surface stimulation systems which exhibit poor muscle selectivity and are, thus, typically limited to two stimulation electrodes and crannels, the present percutaneous, intramuscular stimulation system allows for precise muscle selection and use of three or mere stimulation electrodes and channels. 'fhe preferred system in accordance with the present invention uses up to eight or more intrarraascular electrodes 50, each connected to an independent electrode o stimulation channel E, and a single reference electrode 52 which may be either an intramuscular or surface electrode.
Those of ordina:-y skill in the art will also recognize that the use of intramuscular electrodes allows for selection and stimulation of deep muscle tissue not practicable by surface stimulation.
'she stimulation pulse generator IO comprises a microprocessor-based stimulation pulse generator circuit 64. The preferred microcontroller is a Motorola 68riC12, although other suitable microcon'rollers may be used without departing from the scope and intent o. the invention. The circuit 60 comprises a central processing unit (CPU) 62 for performir:g all necessary operations.
Random access memory (R.P.wI) 64 is present for teaporary storage of operational data as needed by the CPU 62. A
first nonvolatile memory means, such as electrically erasable programmable read cnly memory (EEPRCM) 66, provides nonvolatile storage as needed for operational.
instructions cr other information, although the first nonvolatile memory r~;eans majr not necessarily be used.
Preferably, flash EPRCM 68 (rather than write-once EPROM) is provided for storage of software operating instructions.
Use of flash EPROM 68 facilitates periodic, ur._limited upgrade of the software operating instructions.
In order to log or record patient usage of the - i~. -stimulation poise generator 1.0, the stimulation circuit 60 includes a real-time clock 70 along with a second nonvolatile rr,emory means such as EEP:~OM 72 to provide sufficient nonvolatile storage for recording and time-s stamping a patient's use of the system. A clinician is thereafter able to access the EEPROM 72 to review the patient's use of the system to ensure patient compliance with the prescribed therapeutic stimulation protocol.
Preferably, the second nonvolatile memory ?2 also provides 1.0 storage for all patient-sz~ecific stimulation protocols.
The increment, decrement, arid select user input switches 24,26,28 are operatively connected into the circuit 60 via an input stage 76. In addi tior,, a serial communication interface (SCi) '78 provides means for 15 selectively connecting an external device, such as a computer, as needed by way of an RS-232 connection 80 or the like for data upload and download. P.~-~ analog-to-diaital converter 84 performs all ai:aloC1-to-digital conversion oL data as needed for processing in the circuit 20 60. A serial peripheral interface (SPI) 85 provides means for connecting peripheral components, such as the display 20, the clock 70, the EEPROU~ 72, anti other components to the microcontroller.
Electrical potential or energy is supplied to the 25 circuit 60 by a battery ~0, preferably AA in size and ranging from a.0 - 1.6 volts. A low-voltage dc-do converter 92 adjusts t:e voltage supplied by the batte~v 90 to a sel ect 1 evel VL, preferably 3 . 3 volts . 'o ml nimize depletion of the battery during periods of inactivity of 30 the pulse generator I0, the circuit 60 is programmed to automatically power-down after a select duration of inactivity. Those skilled in the art will recognize that the R.AM 64 provides volatile storage, and the storage means 66,68,72 provide nonvolatile storage to prevent loss of data upon interruption of power to t:he circuit 60 through malfunction, battery depletion, or the like.
The output VL of the high-voltage dc-do converter 92 is also supplied to a high-voltage dc-do converter 94 which steps-up the voltage to at least 30 volts. The high-voltage output VH of the dc-do converter 94 provides the electrical potential for the stimulation pulse train signals transmitted to the plurality of intramuscular electrodes 50 through a current driver 100. k~lore particularly, an output means 102 of the circuit 60 provides channel selection input to the current driver 100 to control the transmission of the high-voltage electrical potential from the driver 100 to the selected electrodes 50 on a selected one of the plurality of stimulation output channels E. Although only three output channels Examiner are illustrated, those skilled in the art will recognize that a greater number of output channels may be provided. Preferably, eight output channels Examiner are provided.
The electrical current passes between the selected electrodes 50 and the reference electrode 52. A pulse duration timer 106 provides timing input PDC as determined by the CPU 62 to the pulse amplitude/duration controller 110 to control the duration of each stimulation pulse. Likewise, the CPU 62 provides a pulse amplitude control signal PAC to the circuit 110 by way of the serial peripheral interface ~6 to control the amplitude of each stimulation pulse. One suitable circuit means for output of stimulation pulse as described above is in accordance with that described in U.S. Patent 5,167,229.
In order to ensure that an electrode lead is properly transmitting the stimulation pulse trair.~ signals to the select muscle tissue, an impedance detection circuit I20 monitors the impedance of each electrode lead 40. The impedance detection circuit 120 provides an analog impedance feedback signal 122 to the analog-to-digital converter 84 where it is converted into digital data for input to the CPU 62. Upon breakage oz a lead. 40 or other malfunction, the impedance detection circuit detects a charge in impedance, and correspondingly changes the impedance feedback signal 122. The impedance feedback signal 122 allows the microcontroller to interrupt stimulation andjor generate and error signal to a patient or clinician.
FIGURE 3A is a somewhat simplified diagrammatic illustration of a most preferred current driver circuit 200, pulse amplitudejduration control circuit 1.1.0, and impedance detection. circuit 120. The illustrated current driver circuit 100 implements eight output channels EI-E8, each of which is cer:nected to an electrode 50 implanted. in muscle tissue for passing electrical current through the «uscle tissue in conjunction with the reference electrode 52. Accordingly, the patient muscle tissue and implanted electrodes SO are illustrated as a load RL connected to each cha_~:rie1 EI-E8.
Each output channel E1-E8 includes independent electrical charge storage means such as a capacitor SC
which is charged to the high voltage V~ through a respective current limiting diode CD. To generate a stimulation pulse, the microcontroller output circuit 102 provides channel. select input data to switch means SW, such as an ix_tegrated circuit a::al og switch component, as to the particular channel E1-E8 en which the pulse is to be passed. Switch means SW closes the selected switch Swl-SWe accordingly. The microcontroller also provides a pulse amplitude control signal PAC into a voltage-controlled current source VCCS. The pulse amplitude control signal 1~ _ PAC is converted into an analog signal at 130 by the digital-to-analog converter DAC. The analog signal at 130 is supplied to an operational amplifier 136 which, in conjunction with the transistor T1, provides a constant S current output I from the voltage-controlled current source VCCS. Of course, those of ordinary skill in the art will recognize that the particular magnitude of the constant current I is varied depending upon the magnitude oL the voltage signal at I30 input to the OP-AMP 236, i.e., the IO circuit VCCS is provided such that the voltage at point 132 seeks the magnitude of the voltage at point 130. As such, the pulse amplitude control signal PAC cor_trols the magnitude of the current I, and the circuit VCCS ensures that the current I is ccnstant at that select level as 1S dictated by the pulse amplitude control input PAC. For stimulation of human muscle, it is preferable that the current I be wi th.in ar_ a~proxi~nate range of 1mA -20mA.
Upon closing one o~. switches SW,-SWe, the relevant capacitor SC discharges and induces the current I as 20 controlled by the pulse amplitude control signal PAC a:~d a pulse duration control signal PDC. The cor_stant curre=.t I
passes between the reference electrode 52 and the reie'Iarit one of the electrodes 50 to provide a cathodic pulse p:~ase Q~ (see FIGV'RE 4) . The pulse duration PD of the phase Q~ is 25 controlled by the microccntroller through a pulse duration control signal PDC output by the timer circuit 106 into the pulse amplitude/duration control circuit 110. In particular, the pulse duration. control signal PDC is input to a shut-down input of the OP-.A:'~tP 136 to selecti°rely 30 enable or blank the output of the GP-A~~IP 135 as desired, and, thus, allow or stop the flow of current I between the electrodes 50,52.
Upon completicn of the cathodic phase Q~ as controlled by the pulse duration con>trol signal PDC, the ~S
discharged capacitor SC recharges upon opening of the formerly closed one of the switches SW1-Swe. The flow of recharging current to the capacitor SC results in a reverse current flow between the relevant electrode SO and the S reference electrode 52, thus ctefinir~g an anodic pulse phase Qa. The current amplitude in the anodic pulse phase Qa is limited, preferably to 0.5m.A, by the current limiting diodes CD. Of course, the duration of the anodic phase is determined by the charging time of the capacitor SC, and 1D current flow is blocked upon the capacitor becoming fully charged. It should be recognized that the interval between successive pulses or pulse frequency PF is controlled by the CDU 62 directly through output of the channel select, pulse amplitude, and pulse duration control signals as I5 described at a desired frequency PF.
The Impedance detection circuit 220 "detects" the voltage on the active channel E1-E8 (i.a., the charnel on which a pulse is being passed) through implementation of a high-impedance voltage follcwer circuit VF using a 20 transistor Tz. Accordingly, it will be recognized that the voltage at points X22 and 124 will move together.
Accordingly, for example, in the e~Jer~t of breakage of an electrode lead 40, a drop in voltage at point 124 will cause a corresponding drop in voltage at point 122. The 2S voltage signal at point 122 is fed back to the microcor~troller analog-to-digital converter 84 for interpretation :oy the CPU 62 in accordance with stored e;~pected values indicating preferred impedance ranges. At the same time, the CPL 62 knows wZich switch SW1-SW8 is 30 closed. Therefore, the CPU 62 is able to determine the channel EI-E8 on which the lead breakage occurred.
The preferred stimulus pulse train paradigm is graphically illustrated in rIGURE 4. A preferred design implements up to 4 independent preprogrammed patterns. For each pattern, a stimulation session S is pre-programmed into the stimulator circuit 60 by a clinician through use of the input means 24,26,28. Each session. S has a maximum session duration of approximately 9 hours, and a session starting delay D. The maximum session starting delay D is approximately 1 hour. The session starting delay D allows a patient to select automatic stimulation session start at some future time . Wit'r.i n each session S, a plurality of stimulation cycles C are programmed for stimulation of selected muscles. Preferably, each stimulation cycle ranges from 2 - 100 seconds in duration.
With continuing reference to FIGURE 4, a stimulus pulse train T includes a plurality or successive stimulus pulses P. As is described above and in the aforementioned U. S . Patent 5, 167, 229, eac'r_ stimulus pulse P is current-regulated and biphasic, i.e., comprises a catholic charge p :ease Q~ ar:d an anodic charge phase Q ~. The magnitude of the catholic charge phase Q~ is equal to the magnitude of the anodic charge phase Q,. The current-regulated, biphasic pul ses P provide for consister~t muscl a recruitmer:t along with mir_imal tissue damage ar.~ electrode corrosion.
Each pulse P is defined by an adjustable pulse a'«plitude PA ar_d an adjustable pulse duration PD. The pulse frequency PF is also adjustable. Further, the pulse amplitude PA, pulse duration PD, and pulse frequency PF are independently adjustable for each stimulation channel E.
T he amplitude of the ar:odic charge phase Qa is preferably fixed at 0.5 mA, but may be adjusted ii desired.
Pulse "camping" is used at the beginning and er~d of each stimulation pulse train T to generate smooth muscle contraction. Romping is defined herein as the gradual change in catholic pulse charge magnitude by varying at least one of the pulse a.mplit~ade PA and pulse duration PD.
In FIGURE 4, the preferred camping configuration is 1'~
illustrated in greater detail. As mentioned, each of the plurality of stimulation leads/electrodes 40,50 is connected to the pulse generator circuit 60 via a sti~'ulation pulse channel E. As illustrated in FIGURE 4, eight stimulation pulse charnels E1,E2,E8 are provided to independently drive up to eight intramuscular electrodes 50. Stimulation pulse trair_s transmitted on each channel EI-E8 are transmitted within or in accordance with a stimulation pulse train envelope B1-B8, respectively. The characteristics of each envelope BI-B8 are independently adjustable by a clinician for each channel. E1-E8.
Referring particularly to the envelope B2 for the channel E2,~ each envelope B1-B8 is defined by a delay or "off"
phase PDo where no pulses are del i-rered to the electrode I8 connected to t~~.e subject channel, I.e., the pulses have a pulse duration PD of 0. yilereaiter, according tc the parameters programmed into the circuit 60 by a clinician, the pulse duration PD cf each pulse P is increased or "tamped-up" over time during a "ramp-up" phase PD= from a minimum initial value (e. g., 5 .sec) tc a programmed maximum value. In a pulse duration "hold" p~~.a.se PDZ, the pulse duration PD remains constant at the maximum programmed value. Fyr~ally, during a pulse duration"ramn-down" phase PD3, the pulse duration PD of each pulse P is decreased over time to lessen the charge delivered to the electrode 50.
This "tamping up" and "tamping down" is illustrated even further with reference to the stimulation pulse trair~ T which 'is provided in correspondence with the envelobe B8 of the channel E8. In accordance with the envelope B8, the pulses P of the pulse train T first gradually increase in pulse duration PD, then maintain the maximum pulse duration PD for a select duration, and finally gradually decrease in pulse duration PD.
i~ -As mentioned, the pulse amplitude PA, pulse duration PD, pulse frequency PF, and envelope B1-Be are user-adjustable zor every stimulation channel E, independently of the other channels. Preferably, the stimulation pulse generator circuit 60 is pre-programmed with uc to four stimulation catterns which will allow a patient to select the prescribed one et the patterns as required durinc therapy.
Most preferably, the pulse generator 10 includes L0 at least up to eight stimulation pulse charnels E. The stimulation pulse gains T of each channel E are secxue:2tialiy or sL.bstantially simultaneously transmitted to their respective electrodes 50. The pulse frequency PF is p ~r~ Z ~ ' ~ ~~~ n t he range oz appro~ci~~ ~ y r~L_rab_y ad;ustable w_"_i~ < ,~~at~_ 5:z y5 to approximately 50z; th a cathodic ampli rude PA is preferably adjustable ~~rithin the range o~ ac~;r:~ximatel~ i;nA
to ap~ro:~imate~.y 20~r~=.; and, the pul se d~.:r.~..icn PD is preferably adjustable in the range o. approximately 5 sec t0 app~OX=.Uatr-''1~! 20'J;.CSeC, iOr G max=.:ilt;m O.''_ a?JD?:'O:C.;Wate~y r V T~G ~ ~ O r p ~' ~ P " ~, i ~ ~ ~ O
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a._teyat.Ci:S w;. 1 ~ OC~?.;.r tC Oti:e=S uuOn ~SadlnC and L:i:.~,~2;StaPCi.~.C' t~':° DyOCeC'.'~=i2C Cietdll eC".. deSCi-.~ti0::. 1C 1S
2S intended that t:e inve:lticn be construed as including ail such mcdi =ications and al terati cps i>aofar as they come Witnin tL''.e SCOpe Oi t:'le appenCed ClalmS Or the eCUival 2ntS
r to r a ~ .:.. L O L .
Visual output means provides visual output data to an operator of the pulse train generator. The visual output data includes at least the stimulation pulse train parameters for each of the stimulation pulse train output channels. Non-volatile memory means stores the stimulation pulse train parameters for each of the plurality of stimulation pulse train output channels. The generator includes means for generating stimulation pulse train signals with the selected pulse train parameters on each of the plurality of stimulation pulse train output channels so that stimulus pulses of t:~~e pulse train signals having the select stimulation pulse train parameters pass between the intramuscular electrodes respectively connected to the stimulation pulse train output channels and a reference electrode.
Tr_ accordance with another aspect of the invention, a met:od of stimulating select cnuscle tissue of a patient includes programming a patient external stimulatior. pulse generator with at least one stimulation pulse train session including at least one stimulation cycle defining a stimulation pulse train envelope for a plurality of stimulatior_ pulse train. output channels. Each envelope is defined by at least a ramp-up phase of a first select duration wherein pulses of a stimulus pulse tYain progressively increase in charge, a hold phase of a second select duration wherein pulses of the stimulus pulse train are substantially constant charge, and a ramp-down phase o=
a third select duration wherein pulses of the stimulus pulse train progressively decrease in charge. A plurality of intramuscular electrodes are implanted into select muscle tissue of the patient arid electrically connected to the plurality of output channels, respectively, of the pulse train generator. On each of said plurality of stimulation output charnels and in accordance with a respective envelope, stimulation pulse train signals are generated with the generator so that the select muscle tissue of the patiera is stimaaiated in accordance with the at least one stimulatior_ cycle.
One advantage of the present invention is the provision of a therapeutic percu.taneous intramuscular stimulation system that retards or prevents muscle disuse atrophy, maintains muscle range-cf-motion, facilitates voluntary motor a=unction, relaxes spastic muscles, and increases blood flow in selected muscles.
Another advantage of the present invention is that it provides a therapeutic muscular stimulation system that uses intramuscular, rather than skin surface (transcutaneousl electrodes to effect muscle stimul anon of S select patient muscles.
Another advantage of the present invention is that it provides a small, lightweight, and portable battery-operated external pulse generator.
A further advantage of the present invention is that it avoids the use of skin surface electrodes which are inconvenient, not sufficiently selective to stimulate only particular muscles, require daily application by the patient, are subject to patient misapplication, and that have been found to cause pain or discomfort upon muscle stimulation.
Still another advantage of the present invention resides in the provision of a therapeutic stimulation system that allows for precise muscle selection through use ef intramuscul or e1 ectrodes, i n.clud=_rg stimulation of deep muscles not readily stimulated via transcutar~eous stimulation techniques and associated surface mou:~~ed eieCtrodeS.
Yet another advantage of the present invention is that it is "user-friendly," allowing selective variation cf 2S system operational parameters by a therapist or patient without the need for any external programming apparatus such as a personal computer or the )_ike.
A further advantage of the present invention is the provision of a percutaneous stimulation system with low power consumption, long battery life (e. g., up to SO hours of use) .
A still further advar_tage of the present invention is the provision of a percutaneous, intramuscular stimulation system including a "hot-button" for selective instantaneous pulse train generation during system setup to facilitate adjustment of stimulatior; pulse train parameters during system setup.
A yet further advantage of the present invention is found in a percutaneous ir:tramuscular stimulation system which logs patient usage fog subsequent review by a doctor or therapist to ensure patient compliance with prescribed therapeutic stimulation routines.
The foregoing advantages and others will increase patient acceptance, reduce the service time required from clinicians, and prevent secondary patient injury requiring additional medical treatment.
Still further ber:efits and advantages of the present invention will become apparent to those of ordinary skill in the art upon reading and understanding the following detailed description of the preferred embodiments.
Brief Descri~tian of the Drawings The invention may take form in various components and arrangements of components, and in various steps and arrangements of steps. The drawings are only for purposes of illustrating preferred embodiments, and are not to be construed as limiting the invention.
rFIGL'RE IA is a front elevational view of a 2S portable; programmable stimulation pulse train generator in accordance with the present invention;
FTGURES 1B - 1D are top, bottom, and right-side elevational views of the stimulation pulse train generator of FIGURE 1A;
FIGURE 2 illustrates a preferred intramuscular electrode and percutaneous electrode lead;
FIGURE 3 diagrammatically illustrates the structure and operation of t~:e percutaneous intramuscular _ '7 _ stimulation system in accordance with the present invention:;
FIGURE 3A diagrammatically illustrates a preferred pulse amplitude/duration controller, current S driver, and impedance detector circuit in accordance with the present invention; and, rIGL'RE 4 graphically illustrates the stimulation paradigm of the percutaneous intramuscular stimulation system in accordance with the present invention.
Detailed Descrir~tion of the Preferred Embodiments With reference to FIGURES lA-1D, the percutaneous, intramuscular stimulation system in accordance with the z~resent invention includes an electrical sti~r,ulation pulse generator 10. 'Ihe pulse generator 10 includes a lightweight, durable plastic rousing 12 fabricated From a suitable plastic or the _ike.
The case 12 inc~'_udes a clip 14 that allows the pulse generator 10 to be releasably connected to a patient's belt, other clothing, or any other convenient locat_on.
2Q The case 12 also includes a releasable battery access cover 16.
For ou~.'.put of v l sual data to a patient or clinician operating the stimulation system, a visual display 20 is provided. The disLlav 20 is preferably provided by a liauid crystal display, but any ct~_er suitable display means may alternatively be used. A:.-~ audio output device, such as a beeper 22 is also provided.
For user control, adjustment, and selection of eperatiar~al parameters, the stimulation pulse generator l0 includes means for input of data. Preferably, the pulse generator 10 includes an increment switch 24, a decrement switch 26, and a select or "enter" switch 28. The increment and decrement switches 24, 26 are used to cycle r through operational modes or patterns and stimulation parameters displayed on t~e display 20, while the select switch 28 is used to select a particular displayed operational pattern, or stimulation parameter. The select S switch 28 also acts as a power on/off toggle switch. By choosing the appropriate mode, the select switch 28 can be selectively armed as a "hot button." During adjustment of stimulation pulse train parameters, a clinician is able to activate the hot button to test, instantaneously, the effect of the selected stimulation pulse train parameters on the patient's muscles. This facilitates the quick and proper adjustment of the stimulation pulse train parameters without requiring the clinician to exit the setup procedure ;nenu of the stimulation pulse generator 10.
1S For output of electrical stimulation pulse train signals, the pulse train generator 10 includes an external connection socket 30 that mates with a connector of an electrode cable assembly (r:ot shown? to ir_terconr_ect the pulse generator 10 with a plurality of intramuscular electrodes via percutaneous electrode leads. More particularly, the cable assembly connected to the socket 30 includes a second connector ar~ a distal end that mates with a connector attached to the proximal end of each of the percuta:~eous stimulation electrode leads and a rayerence 2S electrode lead.
A preferred intramuscular electrode and percutaneous lead are shown: in .FIGURE 2. The electrode Lead 40 is fabricated. from a 7-strand stainless steel wire insulated with a bioccmpatible polymer. Each individual wire strand has a diameter of 34 ,um and the insulated mufti-strand lead wire has a diameter of 250 ~.m. Tne insulated wire is formed into a spiral or helix as has been found preferred to accommodate high dynamic stress upon muscle flexion and extension, while simultaneously _ g _ retaining low susceptibility to fatigue. The outer diameter of the helically formed electrode lead 40 is approximately 580 ~.m arid it may be encased or filled with silicone or the like.
S As mentioned above, a proximal end 44 of each of the plurality of intramuscular electrode lead wires 40 is located exterior to the patient's body when in use. The proximal end ~44 includes a a.einsulated length for connection to an electrical connector in combination with the remainder of the electrode leads. The distal end 46 of each lead 40, which is inserted directly into muscle tissue, also includes a deinsulated length which acts as the stimulatior_ electrode S0. It is preferred that at least a portion of the deinsuiated length be bent or otherwise deformed into a barb 48 to anchor the electrode in the selected muscle tissue. A taper 52, made from silicone adhesive or the like, is formed between the dei:r~sulated distal end 50 and the insulated portion of the lead 40 to reduce stress concentration.
Unlike surface electrodes which are appl,ect to the surface Of the patient's skin using an adhesive, each of the plurality of percutaneous e?ectrodes SO is surgically implanted into select patient muscle tissue, and the associated electrode lead 40 exits the patient percutaneously, i.e., through the skin, for connection to the stimulation pulse generator 10. Preferably, each of the electrodes 50 is implanted into the select muscles by use of a hypodermic needle. Once all of the electrodes are implanted as desired, their proximal ends are crimped into a common connector that mates with the cable assembly which is, in turn, connected to the pulse generator 10 through the connection socket 30.
FIGURE 3 diagrammatically illustrates the overall percutaneous, intramuscular stimulation system in i~ -accordance with the present invention. Unlike surface stimulation systems which exhibit poor muscle selectivity and are, thus, typically limited to two stimulation electrodes and crannels, the present percutaneous, intramuscular stimulation system allows for precise muscle selection and use of three or mere stimulation electrodes and channels. 'fhe preferred system in accordance with the present invention uses up to eight or more intrarraascular electrodes 50, each connected to an independent electrode o stimulation channel E, and a single reference electrode 52 which may be either an intramuscular or surface electrode.
Those of ordina:-y skill in the art will also recognize that the use of intramuscular electrodes allows for selection and stimulation of deep muscle tissue not practicable by surface stimulation.
'she stimulation pulse generator IO comprises a microprocessor-based stimulation pulse generator circuit 64. The preferred microcontroller is a Motorola 68riC12, although other suitable microcon'rollers may be used without departing from the scope and intent o. the invention. The circuit 60 comprises a central processing unit (CPU) 62 for performir:g all necessary operations.
Random access memory (R.P.wI) 64 is present for teaporary storage of operational data as needed by the CPU 62. A
first nonvolatile memory means, such as electrically erasable programmable read cnly memory (EEPRCM) 66, provides nonvolatile storage as needed for operational.
instructions cr other information, although the first nonvolatile memory r~;eans majr not necessarily be used.
Preferably, flash EPRCM 68 (rather than write-once EPROM) is provided for storage of software operating instructions.
Use of flash EPROM 68 facilitates periodic, ur._limited upgrade of the software operating instructions.
In order to log or record patient usage of the - i~. -stimulation poise generator 1.0, the stimulation circuit 60 includes a real-time clock 70 along with a second nonvolatile rr,emory means such as EEP:~OM 72 to provide sufficient nonvolatile storage for recording and time-s stamping a patient's use of the system. A clinician is thereafter able to access the EEPROM 72 to review the patient's use of the system to ensure patient compliance with the prescribed therapeutic stimulation protocol.
Preferably, the second nonvolatile memory ?2 also provides 1.0 storage for all patient-sz~ecific stimulation protocols.
The increment, decrement, arid select user input switches 24,26,28 are operatively connected into the circuit 60 via an input stage 76. In addi tior,, a serial communication interface (SCi) '78 provides means for 15 selectively connecting an external device, such as a computer, as needed by way of an RS-232 connection 80 or the like for data upload and download. P.~-~ analog-to-diaital converter 84 performs all ai:aloC1-to-digital conversion oL data as needed for processing in the circuit 20 60. A serial peripheral interface (SPI) 85 provides means for connecting peripheral components, such as the display 20, the clock 70, the EEPROU~ 72, anti other components to the microcontroller.
Electrical potential or energy is supplied to the 25 circuit 60 by a battery ~0, preferably AA in size and ranging from a.0 - 1.6 volts. A low-voltage dc-do converter 92 adjusts t:e voltage supplied by the batte~v 90 to a sel ect 1 evel VL, preferably 3 . 3 volts . 'o ml nimize depletion of the battery during periods of inactivity of 30 the pulse generator I0, the circuit 60 is programmed to automatically power-down after a select duration of inactivity. Those skilled in the art will recognize that the R.AM 64 provides volatile storage, and the storage means 66,68,72 provide nonvolatile storage to prevent loss of data upon interruption of power to t:he circuit 60 through malfunction, battery depletion, or the like.
The output VL of the high-voltage dc-do converter 92 is also supplied to a high-voltage dc-do converter 94 which steps-up the voltage to at least 30 volts. The high-voltage output VH of the dc-do converter 94 provides the electrical potential for the stimulation pulse train signals transmitted to the plurality of intramuscular electrodes 50 through a current driver 100. k~lore particularly, an output means 102 of the circuit 60 provides channel selection input to the current driver 100 to control the transmission of the high-voltage electrical potential from the driver 100 to the selected electrodes 50 on a selected one of the plurality of stimulation output channels E. Although only three output channels Examiner are illustrated, those skilled in the art will recognize that a greater number of output channels may be provided. Preferably, eight output channels Examiner are provided.
The electrical current passes between the selected electrodes 50 and the reference electrode 52. A pulse duration timer 106 provides timing input PDC as determined by the CPU 62 to the pulse amplitude/duration controller 110 to control the duration of each stimulation pulse. Likewise, the CPU 62 provides a pulse amplitude control signal PAC to the circuit 110 by way of the serial peripheral interface ~6 to control the amplitude of each stimulation pulse. One suitable circuit means for output of stimulation pulse as described above is in accordance with that described in U.S. Patent 5,167,229.
In order to ensure that an electrode lead is properly transmitting the stimulation pulse trair.~ signals to the select muscle tissue, an impedance detection circuit I20 monitors the impedance of each electrode lead 40. The impedance detection circuit 120 provides an analog impedance feedback signal 122 to the analog-to-digital converter 84 where it is converted into digital data for input to the CPU 62. Upon breakage oz a lead. 40 or other malfunction, the impedance detection circuit detects a charge in impedance, and correspondingly changes the impedance feedback signal 122. The impedance feedback signal 122 allows the microcontroller to interrupt stimulation andjor generate and error signal to a patient or clinician.
FIGURE 3A is a somewhat simplified diagrammatic illustration of a most preferred current driver circuit 200, pulse amplitudejduration control circuit 1.1.0, and impedance detection. circuit 120. The illustrated current driver circuit 100 implements eight output channels EI-E8, each of which is cer:nected to an electrode 50 implanted. in muscle tissue for passing electrical current through the «uscle tissue in conjunction with the reference electrode 52. Accordingly, the patient muscle tissue and implanted electrodes SO are illustrated as a load RL connected to each cha_~:rie1 EI-E8.
Each output channel E1-E8 includes independent electrical charge storage means such as a capacitor SC
which is charged to the high voltage V~ through a respective current limiting diode CD. To generate a stimulation pulse, the microcontroller output circuit 102 provides channel. select input data to switch means SW, such as an ix_tegrated circuit a::al og switch component, as to the particular channel E1-E8 en which the pulse is to be passed. Switch means SW closes the selected switch Swl-SWe accordingly. The microcontroller also provides a pulse amplitude control signal PAC into a voltage-controlled current source VCCS. The pulse amplitude control signal 1~ _ PAC is converted into an analog signal at 130 by the digital-to-analog converter DAC. The analog signal at 130 is supplied to an operational amplifier 136 which, in conjunction with the transistor T1, provides a constant S current output I from the voltage-controlled current source VCCS. Of course, those of ordinary skill in the art will recognize that the particular magnitude of the constant current I is varied depending upon the magnitude oL the voltage signal at I30 input to the OP-AMP 236, i.e., the IO circuit VCCS is provided such that the voltage at point 132 seeks the magnitude of the voltage at point 130. As such, the pulse amplitude control signal PAC cor_trols the magnitude of the current I, and the circuit VCCS ensures that the current I is ccnstant at that select level as 1S dictated by the pulse amplitude control input PAC. For stimulation of human muscle, it is preferable that the current I be wi th.in ar_ a~proxi~nate range of 1mA -20mA.
Upon closing one o~. switches SW,-SWe, the relevant capacitor SC discharges and induces the current I as 20 controlled by the pulse amplitude control signal PAC a:~d a pulse duration control signal PDC. The cor_stant curre=.t I
passes between the reference electrode 52 and the reie'Iarit one of the electrodes 50 to provide a cathodic pulse p:~ase Q~ (see FIGV'RE 4) . The pulse duration PD of the phase Q~ is 25 controlled by the microccntroller through a pulse duration control signal PDC output by the timer circuit 106 into the pulse amplitude/duration control circuit 110. In particular, the pulse duration. control signal PDC is input to a shut-down input of the OP-.A:'~tP 136 to selecti°rely 30 enable or blank the output of the GP-A~~IP 135 as desired, and, thus, allow or stop the flow of current I between the electrodes 50,52.
Upon completicn of the cathodic phase Q~ as controlled by the pulse duration con>trol signal PDC, the ~S
discharged capacitor SC recharges upon opening of the formerly closed one of the switches SW1-Swe. The flow of recharging current to the capacitor SC results in a reverse current flow between the relevant electrode SO and the S reference electrode 52, thus ctefinir~g an anodic pulse phase Qa. The current amplitude in the anodic pulse phase Qa is limited, preferably to 0.5m.A, by the current limiting diodes CD. Of course, the duration of the anodic phase is determined by the charging time of the capacitor SC, and 1D current flow is blocked upon the capacitor becoming fully charged. It should be recognized that the interval between successive pulses or pulse frequency PF is controlled by the CDU 62 directly through output of the channel select, pulse amplitude, and pulse duration control signals as I5 described at a desired frequency PF.
The Impedance detection circuit 220 "detects" the voltage on the active channel E1-E8 (i.a., the charnel on which a pulse is being passed) through implementation of a high-impedance voltage follcwer circuit VF using a 20 transistor Tz. Accordingly, it will be recognized that the voltage at points X22 and 124 will move together.
Accordingly, for example, in the e~Jer~t of breakage of an electrode lead 40, a drop in voltage at point 124 will cause a corresponding drop in voltage at point 122. The 2S voltage signal at point 122 is fed back to the microcor~troller analog-to-digital converter 84 for interpretation :oy the CPU 62 in accordance with stored e;~pected values indicating preferred impedance ranges. At the same time, the CPL 62 knows wZich switch SW1-SW8 is 30 closed. Therefore, the CPU 62 is able to determine the channel EI-E8 on which the lead breakage occurred.
The preferred stimulus pulse train paradigm is graphically illustrated in rIGURE 4. A preferred design implements up to 4 independent preprogrammed patterns. For each pattern, a stimulation session S is pre-programmed into the stimulator circuit 60 by a clinician through use of the input means 24,26,28. Each session. S has a maximum session duration of approximately 9 hours, and a session starting delay D. The maximum session starting delay D is approximately 1 hour. The session starting delay D allows a patient to select automatic stimulation session start at some future time . Wit'r.i n each session S, a plurality of stimulation cycles C are programmed for stimulation of selected muscles. Preferably, each stimulation cycle ranges from 2 - 100 seconds in duration.
With continuing reference to FIGURE 4, a stimulus pulse train T includes a plurality or successive stimulus pulses P. As is described above and in the aforementioned U. S . Patent 5, 167, 229, eac'r_ stimulus pulse P is current-regulated and biphasic, i.e., comprises a catholic charge p :ease Q~ ar:d an anodic charge phase Q ~. The magnitude of the catholic charge phase Q~ is equal to the magnitude of the anodic charge phase Q,. The current-regulated, biphasic pul ses P provide for consister~t muscl a recruitmer:t along with mir_imal tissue damage ar.~ electrode corrosion.
Each pulse P is defined by an adjustable pulse a'«plitude PA ar_d an adjustable pulse duration PD. The pulse frequency PF is also adjustable. Further, the pulse amplitude PA, pulse duration PD, and pulse frequency PF are independently adjustable for each stimulation channel E.
T he amplitude of the ar:odic charge phase Qa is preferably fixed at 0.5 mA, but may be adjusted ii desired.
Pulse "camping" is used at the beginning and er~d of each stimulation pulse train T to generate smooth muscle contraction. Romping is defined herein as the gradual change in catholic pulse charge magnitude by varying at least one of the pulse a.mplit~ade PA and pulse duration PD.
In FIGURE 4, the preferred camping configuration is 1'~
illustrated in greater detail. As mentioned, each of the plurality of stimulation leads/electrodes 40,50 is connected to the pulse generator circuit 60 via a sti~'ulation pulse channel E. As illustrated in FIGURE 4, eight stimulation pulse charnels E1,E2,E8 are provided to independently drive up to eight intramuscular electrodes 50. Stimulation pulse trair_s transmitted on each channel EI-E8 are transmitted within or in accordance with a stimulation pulse train envelope B1-B8, respectively. The characteristics of each envelope BI-B8 are independently adjustable by a clinician for each channel. E1-E8.
Referring particularly to the envelope B2 for the channel E2,~ each envelope B1-B8 is defined by a delay or "off"
phase PDo where no pulses are del i-rered to the electrode I8 connected to t~~.e subject channel, I.e., the pulses have a pulse duration PD of 0. yilereaiter, according tc the parameters programmed into the circuit 60 by a clinician, the pulse duration PD cf each pulse P is increased or "tamped-up" over time during a "ramp-up" phase PD= from a minimum initial value (e. g., 5 .sec) tc a programmed maximum value. In a pulse duration "hold" p~~.a.se PDZ, the pulse duration PD remains constant at the maximum programmed value. Fyr~ally, during a pulse duration"ramn-down" phase PD3, the pulse duration PD of each pulse P is decreased over time to lessen the charge delivered to the electrode 50.
This "tamping up" and "tamping down" is illustrated even further with reference to the stimulation pulse trair~ T which 'is provided in correspondence with the envelobe B8 of the channel E8. In accordance with the envelope B8, the pulses P of the pulse train T first gradually increase in pulse duration PD, then maintain the maximum pulse duration PD for a select duration, and finally gradually decrease in pulse duration PD.
i~ -As mentioned, the pulse amplitude PA, pulse duration PD, pulse frequency PF, and envelope B1-Be are user-adjustable zor every stimulation channel E, independently of the other channels. Preferably, the stimulation pulse generator circuit 60 is pre-programmed with uc to four stimulation catterns which will allow a patient to select the prescribed one et the patterns as required durinc therapy.
Most preferably, the pulse generator 10 includes L0 at least up to eight stimulation pulse charnels E. The stimulation pulse gains T of each channel E are secxue:2tialiy or sL.bstantially simultaneously transmitted to their respective electrodes 50. The pulse frequency PF is p ~r~ Z ~ ' ~ ~~~ n t he range oz appro~ci~~ ~ y r~L_rab_y ad;ustable w_"_i~ < ,~~at~_ 5:z y5 to approximately 50z; th a cathodic ampli rude PA is preferably adjustable ~~rithin the range o~ ac~;r:~ximatel~ i;nA
to ap~ro:~imate~.y 20~r~=.; and, the pul se d~.:r.~..icn PD is preferably adjustable in the range o. approximately 5 sec t0 app~OX=.Uatr-''1~! 20'J;.CSeC, iOr G max=.:ilt;m O.''_ a?JD?:'O:C.;Wate~y r V T~G ~ ~ O r p ~' ~ P " ~, i ~ ~ ~ O
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a._teyat.Ci:S w;. 1 ~ OC~?.;.r tC Oti:e=S uuOn ~SadlnC and L:i:.~,~2;StaPCi.~.C' t~':° DyOCeC'.'~=i2C Cietdll eC".. deSCi-.~ti0::. 1C 1S
2S intended that t:e inve:lticn be construed as including ail such mcdi =ications and al terati cps i>aofar as they come Witnin tL''.e SCOpe Oi t:'le appenCed ClalmS Or the eCUival 2ntS
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Claims (19)
1. A percutaneous, intramuscular stimulation system for therapeutic electrical stimulation of select muscles of a patient, said stimulation system comprising:
a plurality of intramuscular stimulation electrodes for implantation directly into selected muscles of a patient, each electrode including an insulated percutaneous lead;
an external battery-operated, microprocessor-based stimulation pulse train generator for generating select electrical stimulation pulse trains, said external pulse train generator including:
a plurality of electrical stimulation pulse train output channels connected respectively to said plurality of percutaneous electrode leads;
an input device for operator selection of stimulation pulse train parameters for each of said stimulation pulse train output channels independently of the other channels, said stimulation pulse train parameters including at least a pulse amplitude and pulse duration for stimulation pulses of said stimulation pulse train, and an interpulse interval between successive pulses of said stimulation pulse train defining a pulse frequency;
a visual output display which provides visual output data to an operator of the pulse train generator, said visual output data including at least said stimulation pulse train parameters for each of said stimulation pulse train output channels;
a non-volatile memory which stores said stimulation pulse train parameters for each of said plurality of stimulation pulse train output channels; and, a pulse train generation system for generating stimulation pulse train signals with the select pulse train parameters on each of said plurality of stimulation pulse train output channels so that stimulus pulses of said pulse train signals having the select stimulation pulse train parameters pass between the intramuscular electrodes respectively connected to said stimulation pulse train output channels and a reference electrode.
a plurality of intramuscular stimulation electrodes for implantation directly into selected muscles of a patient, each electrode including an insulated percutaneous lead;
an external battery-operated, microprocessor-based stimulation pulse train generator for generating select electrical stimulation pulse trains, said external pulse train generator including:
a plurality of electrical stimulation pulse train output channels connected respectively to said plurality of percutaneous electrode leads;
an input device for operator selection of stimulation pulse train parameters for each of said stimulation pulse train output channels independently of the other channels, said stimulation pulse train parameters including at least a pulse amplitude and pulse duration for stimulation pulses of said stimulation pulse train, and an interpulse interval between successive pulses of said stimulation pulse train defining a pulse frequency;
a visual output display which provides visual output data to an operator of the pulse train generator, said visual output data including at least said stimulation pulse train parameters for each of said stimulation pulse train output channels;
a non-volatile memory which stores said stimulation pulse train parameters for each of said plurality of stimulation pulse train output channels; and, a pulse train generation system for generating stimulation pulse train signals with the select pulse train parameters on each of said plurality of stimulation pulse train output channels so that stimulus pulses of said pulse train signals having the select stimulation pulse train parameters pass between the intramuscular electrodes respectively connected to said stimulation pulse train output channels and a reference electrode.
2. The percutaneous, intramuscular stimulation system as set forth in claim 1 wherein said pulse train generator further includes:
a data recorder for recording data describing prior use of said pulse train generator in said non-volatile memory, said data recorder connected to said visual output display so that an operator of said pulse train generator can selectively visually display said pulse train generator use data using said visual output display to ensure compliance with prescribed stimulation therapy.
a data recorder for recording data describing prior use of said pulse train generator in said non-volatile memory, said data recorder connected to said visual output display so that an operator of said pulse train generator can selectively visually display said pulse train generator use data using said visual output display to ensure compliance with prescribed stimulation therapy.
3. The percutaneous, intramuscular stimulation system as set forth in claim 2 wherein said data recorder further includes a real-time clack to provide time data to be recorded with said pulse train generator use data.
4. The percutaneous, intramuscular stimulation system as set forth in claim 1 wherein, said input device includes means for defining a stimulation pulse train envelope independently for each of said stimulation pulse train output channels, said envelope controlling a stimulation pulse train signal ramping paradigm including at least an initial ramp-up phase of a first select duration, an intermediate hold phase of a second select duration, and a terminal ramp-down phase of a third select duration, wherein, for each of said plurality of channels, stimulation pulses of said stimulation pulse train signal transmitted therein progressively increase in charge during said ramp-up phase, maintain a substantially constant charge during saved hold phase, and progressively decrease in charge during said ramp down phase.
5. The percutaneous, intramuscular stimulation system as set forth in claim 4 wherein said charge of said stimulation pulses is varied by controlling at least one of the pulse duration and pulse amplitude of each of said pulses.
6. The percutaneous, intramuscular stimulation system as set forth in claim 1 wherein said stimulation pulses are constant-current pulses having a catholic phase and an anodic phase of opposite polarity but substantially equal charge.
7. The percutaneous, intramuscular stimulation system as set forth in claim 1 wherein said external pulse generator further includes:
a low-voltage direct-current-to-direct-current converter for connection to a battery for converting electrical potential from the battery into a select operating voltage for said pulse train generator; arid, a high-voltage direct-current-to-direct-current converter connected to said low-voltage converter for converting said operating voltage output by said low-voltage converter into a stimulation voltage of at least 30 volts, said high-voltage converter having an output of said stimulation voltage connected to said pulse train signal generation system.
a low-voltage direct-current-to-direct-current converter for connection to a battery for converting electrical potential from the battery into a select operating voltage for said pulse train generator; arid, a high-voltage direct-current-to-direct-current converter connected to said low-voltage converter for converting said operating voltage output by said low-voltage converter into a stimulation voltage of at least 30 volts, said high-voltage converter having an output of said stimulation voltage connected to said pulse train signal generation system.
8. The percutaneous, intramuscular stimulation system as set forth in claim 7 wherein said pulse train signal generation system includes:
a constant-current source having an input connected to said stimulation voltage output of said high-voltage converter and an output connected to each of said stimulation channels; and, means for selectively connecting said constant-current source to each of said stimulation pulse train output channels in accordance with output channel select data received from cutout channel selection means to generate said stimulation pulse train signals on each of said output channels in accordance with said stored stimulus pulse train parameters for each of said plurality of channels.
a constant-current source having an input connected to said stimulation voltage output of said high-voltage converter and an output connected to each of said stimulation channels; and, means for selectively connecting said constant-current source to each of said stimulation pulse train output channels in accordance with output channel select data received from cutout channel selection means to generate said stimulation pulse train signals on each of said output channels in accordance with said stored stimulus pulse train parameters for each of said plurality of channels.
9. The percutanecus, intramuscular stimulation system as set forth in claim 1, wherein said input device for operator selection of stimulus pulse train parameters comprises:
means to incrementing and dcrementing pulse train parameter data displayed by said visual output display; and, means for selecting pulse train parameter data displayed by said visual output display.
means to incrementing and dcrementing pulse train parameter data displayed by said visual output display; and, means for selecting pulse train parameter data displayed by said visual output display.
10. The percutaneous, intramuscular stimulation system as set forth in claim 1 wherein said pulse train generator further includes:
a switch for instantaneously generating a stimulus pulse train signal on one of said plurality of output channels in accordance with selected stimulus pulse train parameters when said switch is activated.
a switch for instantaneously generating a stimulus pulse train signal on one of said plurality of output channels in accordance with selected stimulus pulse train parameters when said switch is activated.
11. The percutaneous, intramuscular stimulation system as set forth in claim 1, wherein said pulse train generator further includes:
a means for measuring the impedance of each of said intramuscular electrodes and associated percutaneous electrode leads, said impedance measuring means providing feedback signal to a central processing unit of said pulse train generator indicating impedance changes in said electrode and associated electrode lead.
a means for measuring the impedance of each of said intramuscular electrodes and associated percutaneous electrode leads, said impedance measuring means providing feedback signal to a central processing unit of said pulse train generator indicating impedance changes in said electrode and associated electrode lead.
12. The percutaneous, intramuscular stimulation system as set forth in claim 1 wherein said non-volatile memory further includes stimulation session delay data indicating a select time interval after which a stimulation pulse train session is to begin in accordance with the stored stimulation pulse train parameters.
13. A method or stimulating select muscle tissue of a patient comprising:
programming a patient external stimulation pulse generator with at least one stimulation pulse train pattern including at least one stimulation cycle defining a stimulation pulse t rain envelope for a plurality of stimulation pulse train output channels, each of said envelopes defined by at least a ramp-up phase of a first select duration in which the pulses of a stimulus pulse train progressively increase in charge, a hold phase of a second select duration in which the pulses of the stimulus pulse train are substantially constant charge, and a ramp-down phase of a third select duration in which the pulses of the stimulus pulse train progressively decrease in charge;
implanting a plurality of intramuscular electrodes into select muscle tissue of the patient;
electrically connecting said plurality of intramuscular electrodes implanted into patient muscle tissue to said plurality of output channels, respectively;
and, for each of said plurality of stimulation output channels and respective envelope, generating stimulation pulse train signals with said generator so that said select muscle tissue of said patient is stimulated in accordance with said at least one stimulation cycle.
programming a patient external stimulation pulse generator with at least one stimulation pulse train pattern including at least one stimulation cycle defining a stimulation pulse t rain envelope for a plurality of stimulation pulse train output channels, each of said envelopes defined by at least a ramp-up phase of a first select duration in which the pulses of a stimulus pulse train progressively increase in charge, a hold phase of a second select duration in which the pulses of the stimulus pulse train are substantially constant charge, and a ramp-down phase of a third select duration in which the pulses of the stimulus pulse train progressively decrease in charge;
implanting a plurality of intramuscular electrodes into select muscle tissue of the patient;
electrically connecting said plurality of intramuscular electrodes implanted into patient muscle tissue to said plurality of output channels, respectively;
and, for each of said plurality of stimulation output channels and respective envelope, generating stimulation pulse train signals with said generator so that said select muscle tissue of said patient is stimulated in accordance with said at least one stimulation cycle.
14. The method of stimulating select muscle tissue of a patient as set forth in claim 13 wherein said step of programming a pulse train generator with a least one stimulation pulse train pattern includes:
programming at least pulse amplitude, pulse duration, and pulse frequency data for said plurality of stimulation pulse train output channels, said step of generating stimulation pulse train signals for each output channel including generating said signals to have said programmed pulse amplitude, pulse duration, and pulse frequency, said method further including:
monitoring the impedance on each of said stimulation output channels;
comparing the monitored impedance with a select impedance range; and interrupting a stimulation pulse train signal on a channel having a monitored impedance not within the select impedance range.
programming at least pulse amplitude, pulse duration, and pulse frequency data for said plurality of stimulation pulse train output channels, said step of generating stimulation pulse train signals for each output channel including generating said signals to have said programmed pulse amplitude, pulse duration, and pulse frequency, said method further including:
monitoring the impedance on each of said stimulation output channels;
comparing the monitored impedance with a select impedance range; and interrupting a stimulation pulse train signal on a channel having a monitored impedance not within the select impedance range.
15. The method of stimulating select muscle tissue of a patient as set forth in claim 13 wherein said method further includes recording time data and use data indicating a patient's use of said pulse train generator.
16. The method of stimulating select muscle tissue of a patient as set forth in claim 13 wherein said method further includes visually displaying stimulation pulse train parameters to an operator of said pulse train generator.
17. The method of stimulating select muscle tissue of a patient as set forth in claim 13 wherein said step of implanting a plurality of intramuscular electrodes into patient muscle tissue includes implanting up to eight intramuscular electrodes.
18. The method of stimulating select muscle tissue of a patient as set forth in claim 13 wherein said step of programming an external pulse train generator includes, for each of said plurality of stimulation cutout channels a) displaying a stimulation pulse train parameter to be programmed and a value for said parameter;
b) using at least one of an increment switch and a decrement switch to increase arid decrease the value of the displayed parameter, respectively, to a select value;
c) using a select switch to save the displayed select value of said parameter; and, d) repeating steps a) - c) until at least pulse amplitude, pulse duration, and pulse frequency are selected for each of said plurality of stimulation output channels.
b) using at least one of an increment switch and a decrement switch to increase arid decrease the value of the displayed parameter, respectively, to a select value;
c) using a select switch to save the displayed select value of said parameter; and, d) repeating steps a) - c) until at least pulse amplitude, pulse duration, and pulse frequency are selected for each of said plurality of stimulation output channels.
19. The method of stimulating select muscle tissue of a patient as set forth in claim 18 wherein said programming step further comprises storing said selected stimulation pulse train parameters in non-volatile memory to prevent loss of said parameters.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US8999498A | 1998-06-03 | 1998-06-03 | |
| US09/089,994 | 1998-06-03 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002292526A Division CA2292526A1 (en) | 1998-06-03 | 1999-05-10 | Percutaneous intramuscular stimulation system |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2415986A1 true CA2415986A1 (en) | 1999-12-09 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002292526A Withdrawn CA2292526A1 (en) | 1998-06-03 | 1999-05-10 | Percutaneous intramuscular stimulation system |
| CA002415986A Abandoned CA2415986A1 (en) | 1998-06-03 | 1999-05-10 | Percutaneous intramuscular stimulation system |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002292526A Withdrawn CA2292526A1 (en) | 1998-06-03 | 1999-05-10 | Percutaneous intramuscular stimulation system |
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| US (3) | US20020077572A1 (en) |
| EP (1) | EP0999872B1 (en) |
| CN (1) | CN1272798A (en) |
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| CA (2) | CA2292526A1 (en) |
| DE (1) | DE69928748T2 (en) |
| NZ (1) | NZ501422A (en) |
| WO (1) | WO1999062594A1 (en) |
Families Citing this family (137)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7483748B2 (en) * | 2002-04-26 | 2009-01-27 | Medtronic, Inc. | Programmable waveform pulses for an implantable medical device |
| US7813809B2 (en) | 2004-06-10 | 2010-10-12 | Medtronic, Inc. | Implantable pulse generator for providing functional and/or therapeutic stimulation of muscles and/or nerves and/or central nervous system tissue |
| US8467875B2 (en) | 2004-02-12 | 2013-06-18 | Medtronic, Inc. | Stimulation of dorsal genital nerves to treat urologic dysfunctions |
| US8086318B2 (en) * | 2004-02-12 | 2011-12-27 | Ndi Medical, Llc | Portable assemblies, systems, and methods for providing functional or therapeutic neurostimulation |
| US7376467B2 (en) * | 2004-02-12 | 2008-05-20 | Ndi Medical, Inc. | Portable assemblies, systems and methods for providing functional or therapeutic neuromuscular stimulation |
| US7120499B2 (en) * | 2004-02-12 | 2006-10-10 | Ndi Medical, Llc | Portable percutaneous assemblies, systems and methods for providing highly selective functional or therapeutic neuromuscular stimulation |
| US20080161874A1 (en) * | 2004-02-12 | 2008-07-03 | Ndi Medical, Inc. | Systems and methods for a trial stage and/or long-term treatment of disorders of the body using neurostimulation |
| US9533164B2 (en) | 2004-04-12 | 2017-01-03 | Advanced Neuromodulation Systems, Inc. | Method for providing multiple voltage levels during pulse generation and implantable pulse generating employing the same |
| EP1744810B1 (en) | 2004-04-12 | 2018-06-06 | Advanced Neuromodulation Systems, Inc. | Active discharge systems and methods |
| US7751879B2 (en) | 2004-04-12 | 2010-07-06 | Advanced Neuromodulation Systems, Inc. | Fractional voltage converter |
| US8165692B2 (en) | 2004-06-10 | 2012-04-24 | Medtronic Urinary Solutions, Inc. | Implantable pulse generator power management |
| US8195304B2 (en) | 2004-06-10 | 2012-06-05 | Medtronic Urinary Solutions, Inc. | Implantable systems and methods for acquisition and processing of electrical signals |
| US7761167B2 (en) | 2004-06-10 | 2010-07-20 | Medtronic Urinary Solutions, Inc. | Systems and methods for clinician control of stimulation systems |
| US9308382B2 (en) | 2004-06-10 | 2016-04-12 | Medtronic Urinary Solutions, Inc. | Implantable pulse generator systems and methods for providing functional and/or therapeutic stimulation of muscles and/or nerves and/or central nervous system tissue |
| US9205255B2 (en) | 2004-06-10 | 2015-12-08 | Medtronic Urinary Solutions, Inc. | Implantable pulse generator systems and methods for providing functional and/or therapeutic stimulation of muscles and/or nerves and/or central nervous system tissue |
| EP1686692A3 (en) * | 2005-01-31 | 2006-08-09 | Advanced Neuromodulation Systems, Inc. | Pulse generator having an efficient fractional voltage converter and method of use |
| US7406351B2 (en) | 2005-04-28 | 2008-07-29 | Medtronic, Inc. | Activity sensing for stimulator control |
| US8108049B2 (en) * | 2005-04-30 | 2012-01-31 | Medtronic, Inc. | Impedance-based stimulation adjustment |
| US9480846B2 (en) | 2006-05-17 | 2016-11-01 | Medtronic Urinary Solutions, Inc. | Systems and methods for patient control of stimulation systems |
| US9072897B2 (en) | 2007-03-09 | 2015-07-07 | Mainstay Medical Limited | Systems and methods for restoring muscle function to the lumbar spine |
| EP2125100B1 (en) | 2007-03-09 | 2021-08-25 | Mainstay Medical Limited | Muscle stimulator |
| US11331488B2 (en) | 2007-03-09 | 2022-05-17 | Mainstay Medical Limited | Systems and methods for enhancing function of spine stabilization muscles associated with a spine surgery intervention |
| US11679261B2 (en) | 2007-03-09 | 2023-06-20 | Mainstay Medical Limited | Systems and methods for enhancing function of spine stabilization muscles associated with a spine surgery intervention |
| US10925637B2 (en) | 2010-03-11 | 2021-02-23 | Mainstay Medical Limited | Methods of implanting electrode leads for use with implantable neuromuscular electrical stimulator |
| US11679262B2 (en) | 2007-03-09 | 2023-06-20 | Mainstay Medical Limited | Systems and methods for restoring muscle function to the lumbar spine |
| US20090062911A1 (en) * | 2007-08-27 | 2009-03-05 | Amo Groningen Bv | Multizonal lens with extended depth of focus |
| US8974526B2 (en) * | 2007-08-27 | 2015-03-10 | Amo Groningen B.V. | Multizonal lens with extended depth of focus |
| US8747466B2 (en) * | 2007-08-27 | 2014-06-10 | Amo Groningen, B.V. | Intraocular lens having extended depth of focus |
| US8740978B2 (en) * | 2007-08-27 | 2014-06-03 | Amo Regional Holdings | Intraocular lens having extended depth of focus |
| US9216080B2 (en) | 2007-08-27 | 2015-12-22 | Amo Groningen B.V. | Toric lens with decreased sensitivity to cylinder power and rotation and method of using the same |
| JP2008100105A (en) * | 2007-12-26 | 2008-05-01 | Ndi Medical Llc | Portable assembly, system and method for providing functional or therapeutic neuromuscular stimulation |
| AU2009214036B2 (en) | 2008-02-15 | 2014-04-17 | Amo Regional Holdings | System, ophthalmic lens, and method for extending depth of focus |
| US8439498B2 (en) | 2008-02-21 | 2013-05-14 | Abbott Medical Optics Inc. | Toric intraocular lens with modified power characteristics |
| US8231219B2 (en) | 2008-04-24 | 2012-07-31 | Amo Groningen B.V. | Diffractive lens exhibiting enhanced optical performance |
| US7871162B2 (en) * | 2008-04-24 | 2011-01-18 | Amo Groningen B.V. | Diffractive multifocal lens having radially varying light distribution |
| CN101564573B (en) * | 2008-04-24 | 2012-04-18 | 李春兰 | Bioelectricity-simulating instrument and method for conditioning human body function |
| US8444267B2 (en) | 2009-12-18 | 2013-05-21 | Amo Groningen B.V. | Ophthalmic lens, systems and methods with angular varying phase delay |
| US8862447B2 (en) | 2010-04-30 | 2014-10-14 | Amo Groningen B.V. | Apparatus, system and method for predictive modeling to design, evaluate and optimize ophthalmic lenses |
| AU2009277036B2 (en) * | 2008-08-01 | 2016-03-03 | Spr Therapeutics, Inc. | Portable assemblies, systems, and methods for providing functional or therapeutic neurostimulation |
| US9409013B2 (en) | 2009-10-20 | 2016-08-09 | Nyxoah SA | Method for controlling energy delivery as a function of degree of coupling |
| US10751537B2 (en) | 2009-10-20 | 2020-08-25 | Nyxoah SA | Arced implant unit for modulation of nerves |
| US10716940B2 (en) | 2009-10-20 | 2020-07-21 | Nyxoah SA | Implant unit for modulation of small diameter nerves |
| US20110106076A1 (en) * | 2009-11-04 | 2011-05-05 | Gregorio Hernandez Zendejas | Myoablation system |
| US11786725B2 (en) | 2012-06-13 | 2023-10-17 | Mainstay Medical Limited | Systems and methods for restoring muscle function to the lumbar spine and kits for implanting the same |
| US9950159B2 (en) | 2013-10-23 | 2018-04-24 | Mainstay Medical Limited | Systems and methods for restoring muscle function to the lumbar spine and kits for implanting the same |
| US9999763B2 (en) | 2012-06-13 | 2018-06-19 | Mainstay Medical Limited | Apparatus and methods for anchoring electrode leads adjacent to nervous tissue |
| US11684774B2 (en) | 2010-03-11 | 2023-06-27 | Mainstay Medical Limited | Electrical stimulator for treatment of back pain and methods of use |
| WO2011112773A2 (en) | 2010-03-11 | 2011-09-15 | Mainstay Medical, Inc. | Modular stimulator for treatment of back pain, implantable rf ablation system and methods of use |
| EP2646872A1 (en) | 2010-12-01 | 2013-10-09 | AMO Groningen B.V. | A multifocal lens having an optical add power progression, and a system and method of providing same |
| US8894204B2 (en) | 2010-12-17 | 2014-11-25 | Abbott Medical Optics Inc. | Ophthalmic lens, systems and methods having at least one rotationally asymmetric diffractive structure |
| US9931200B2 (en) | 2010-12-17 | 2018-04-03 | Amo Groningen B.V. | Ophthalmic devices, systems, and methods for optimizing peripheral vision |
| US9166321B2 (en) | 2011-03-22 | 2015-10-20 | Greatbatch Ltd. | Thin profile stacked layer contact |
| US8996115B2 (en) | 2011-04-07 | 2015-03-31 | Greatbatch, Ltd. | Charge balancing for arbitrary waveform generator and neural stimulation application |
| US8874219B2 (en) | 2011-04-07 | 2014-10-28 | Greatbatch, Ltd. | Arbitrary waveform generator and neural stimulation application |
| US8996117B2 (en) | 2011-04-07 | 2015-03-31 | Greatbatch, Ltd. | Arbitrary waveform generator and neural stimulation application with scalable waveform feature |
| US9656076B2 (en) | 2011-04-07 | 2017-05-23 | Nuvectra Corporation | Arbitrary waveform generator and neural stimulation application with scalable waveform feature and charge balancing |
| CN102958564B (en) * | 2011-06-28 | 2014-08-20 | 中国科学院自动化研究所 | Functional electrical stimulation system |
| WO2013000122A1 (en) * | 2011-06-28 | 2013-01-03 | 中国科学院自动化研究所 | Functional electrical stimulation system |
| US8641210B2 (en) | 2011-11-30 | 2014-02-04 | Izi Medical Products | Retro-reflective marker including colored mounting portion |
| US8661573B2 (en) | 2012-02-29 | 2014-03-04 | Izi Medical Products | Protective cover for medical device having adhesive mechanism |
| AU2013231842A1 (en) * | 2012-03-15 | 2014-10-02 | SPR Therapeutics, LLC. | Systems and methods related to the treatment of back pain |
| US9186501B2 (en) | 2012-06-13 | 2015-11-17 | Mainstay Medical Limited | Systems and methods for implanting electrode leads for use with implantable neuromuscular electrical stimulator |
| US10195419B2 (en) | 2012-06-13 | 2019-02-05 | Mainstay Medical Limited | Electrode leads for use with implantable neuromuscular electrical stimulator |
| US11253712B2 (en) | 2012-07-26 | 2022-02-22 | Nyxoah SA | Sleep disordered breathing treatment apparatus |
| US9907967B2 (en) | 2012-07-26 | 2018-03-06 | Adi Mashiach | Transcutaneous power conveyance device |
| US10052097B2 (en) | 2012-07-26 | 2018-08-21 | Nyxoah SA | Implant unit delivery tool |
| AU2013294705B2 (en) | 2012-07-26 | 2018-02-01 | Nyxoah SA | Implant sleep apnea treatment device including an antenna |
| DE102012025079B4 (en) * | 2012-08-31 | 2016-09-08 | NorthCo Ventures GmbH & Co. KG | Apparatus and method for treating biological tissue with a low pressure plasma |
| BR112015004617A2 (en) | 2012-08-31 | 2017-07-04 | Amo Groningen Bv | systems and methods for extended multi-lens lens extended focus depth |
| US9782587B2 (en) | 2012-10-01 | 2017-10-10 | Nuvectra Corporation | Digital control for pulse generators |
| WO2014087249A2 (en) | 2012-12-04 | 2014-06-12 | Amo Groningen B.V. | Lenses systems and methods for providing binocular customized treatments to correct presbyopia |
| CN103156642B (en) * | 2013-02-05 | 2015-09-09 | 广州曼翔医疗器械有限公司 | A kind of color ultrasound puncture dual-boot system |
| AU2014228357B2 (en) | 2013-03-11 | 2018-08-23 | Johnson & Johnson Surgical Vision, Inc. | Intraocular lens that matches an image surface to a retinal shape, and method of designing same |
| US8870798B2 (en) * | 2013-03-14 | 2014-10-28 | CyMedica, Inc. | Systems and methods for treating human joints |
| CN103212157B (en) * | 2013-04-25 | 2016-01-06 | 中国科学院重庆绿色智能技术研究院 | Bipolar general nerve electric stimulation instrument |
| EP3010583B1 (en) | 2013-06-17 | 2020-08-05 | Nyxoah SA | Dynamic modification of modulation throughout a therapy period |
| EA032658B1 (en) | 2013-07-15 | 2019-06-28 | Вр Электроникс Лимитид | Method for the interactive physiological synchronization of a user with a virtual environment |
| US10020800B2 (en) | 2013-11-14 | 2018-07-10 | Eagle Harbor Technologies, Inc. | High voltage nanosecond pulser with variable pulse width and pulse repetition frequency |
| US10978955B2 (en) | 2014-02-28 | 2021-04-13 | Eagle Harbor Technologies, Inc. | Nanosecond pulser bias compensation |
| WO2015073921A1 (en) | 2013-11-14 | 2015-05-21 | Eagle Harbor Technologies, Inc. | This disclosure relates generally to a high voltage nanosecond pulser. |
| US11539352B2 (en) | 2013-11-14 | 2022-12-27 | Eagle Harbor Technologies, Inc. | Transformer resonant converter |
| US10892140B2 (en) | 2018-07-27 | 2021-01-12 | Eagle Harbor Technologies, Inc. | Nanosecond pulser bias compensation |
| AU2014364933B2 (en) * | 2013-12-19 | 2017-07-27 | Boston Scientific Neuromodulation Corporation | Methods and systems for employing a duty cycle in electrical stimulation of patient tissue |
| US10483089B2 (en) | 2014-02-28 | 2019-11-19 | Eagle Harbor Technologies, Inc. | High voltage resistive output stage circuit |
| US9867693B2 (en) | 2014-03-10 | 2018-01-16 | Amo Groningen B.V. | Intraocular lens that improves overall vision where there is a local loss of retinal function |
| CA2946356C (en) | 2014-04-21 | 2022-09-20 | Amo Groningen B.V. | Ophthalmic devices, system and methods that improve peripheral vision |
| CN111722673A (en) * | 2014-08-06 | 2020-09-29 | 虚拟现实电子工业有限公司 | Method and wearable device for synchronization of a user with a virtual environment |
| WO2016025915A1 (en) | 2014-08-15 | 2016-02-18 | Axonics Modulation Technologies, Inc. | Integrated electromyographic clinician programmer for use with an implantable neurostimulator |
| CA2958199C (en) | 2014-08-15 | 2023-03-07 | Axonics Modulation Technologies, Inc. | Electromyographic lead positioning and stimulation titration in a nerve stimulation system for treatment of overactive bladder |
| JP6878269B2 (en) | 2014-08-15 | 2021-05-26 | アクソニクス モジュレーション テクノロジーズ インコーポレイテッド | Systems and Methods for Nerve Stimulation Electrode Configuration Based on Nerve Positioning |
| US10471268B2 (en) | 2014-10-16 | 2019-11-12 | Mainstay Medical Limited | Systems and methods for monitoring muscle rehabilitation |
| CA2970400C (en) * | 2015-02-20 | 2018-05-15 | Synergia Medical | Photovoltaic electrical stimulation device |
| CN104740766B (en) * | 2015-04-02 | 2017-12-05 | 北京泓润维斯科技有限公司 | Ear is worn through cranium micro-current stimulator |
| JP2016202690A (en) * | 2015-04-24 | 2016-12-08 | 株式会社 Ｍｔｇ | Muscle electrostimulator |
| CN105311749B (en) * | 2015-05-11 | 2018-03-09 | 南京神桥医疗器械有限公司 | A kind of regulation device of implantation type electric stimulation extremity motor function |
| CN106466177B (en) * | 2015-08-17 | 2023-11-17 | 浙江诺尔康神经电子科技股份有限公司 | Artificial cochlea nerve telemetry system comprising pulse width adjustment |
| CN105327450B (en) * | 2015-12-01 | 2017-09-29 | 杭州承诺医疗科技有限公司 | A kind of implanted sacral nerve stimulator |
| AU2017218680B2 (en) | 2016-02-09 | 2021-09-23 | Amo Groningen B.V. | Progressive power intraocular lens, and methods of use and manufacture |
| AU2017230971B2 (en) | 2016-03-11 | 2021-11-11 | Amo Groningen B.V. | Intraocular lenses that improve peripheral vision |
| WO2017165623A1 (en) | 2016-03-23 | 2017-09-28 | Abbott Medical Optics Inc. | Power calculator for an ophthalmic apparatus with corrective meridians having extended tolerance or operation band |
| AU2017237090B2 (en) | 2016-03-23 | 2021-10-21 | Johnson & Johnson Surgical Vision, Inc. | Ophthalmic apparatus with corrective meridians having extended tolerance band by modifying refractive powers in uniform meridian distribution |
| EP3445288B1 (en) | 2016-04-19 | 2020-11-04 | AMO Groningen B.V. | Ophthalmic devices, system and methods that improve peripheral vision |
| CN106075723B (en) * | 2016-06-06 | 2018-12-28 | 清华大学 | A kind of implantation-sticking type electrical stimulation device |
| US10903047B2 (en) | 2018-07-27 | 2021-01-26 | Eagle Harbor Technologies, Inc. | Precise plasma control system |
| US11004660B2 (en) | 2018-11-30 | 2021-05-11 | Eagle Harbor Technologies, Inc. | Variable output impedance RF generator |
| US11430635B2 (en) | 2018-07-27 | 2022-08-30 | Eagle Harbor Technologies, Inc. | Precise plasma control system |
| US10327810B2 (en) | 2016-07-05 | 2019-06-25 | Mainstay Medical Limited | Systems and methods for enhanced implantation of electrode leads between tissue layers |
| AU2017352030B2 (en) | 2016-10-25 | 2023-03-23 | Amo Groningen B.V. | Realistic eye models to design and evaluate intraocular lenses for a large field of view |
| CN106512211B (en) * | 2016-12-13 | 2019-06-18 | 中南大学湘雅三医院 | The electromechanical integration Implanted medical system and its wireless communications method of wireless communication |
| EP4266579A3 (en) | 2017-02-07 | 2023-12-27 | Eagle Harbor Technologies, Inc. | Transformer resonant converter |
| US11497599B2 (en) | 2017-03-17 | 2022-11-15 | Amo Groningen B.V. | Diffractive intraocular lenses for extended range of vision |
| US10739227B2 (en) | 2017-03-23 | 2020-08-11 | Johnson & Johnson Surgical Vision, Inc. | Methods and systems for measuring image quality |
| CN107224670A (en) * | 2017-06-08 | 2017-10-03 | 燕铁斌 | A kind of low-frequency electrical stimulation pulse parameter regulation work station and control method |
| CN107297022A (en) * | 2017-06-20 | 2017-10-27 | 深圳市博昊电子有限公司 | A kind of electric region constructing system of heteropole, method and the electric region bridge system of heteropole |
| US11523897B2 (en) | 2017-06-23 | 2022-12-13 | Amo Groningen B.V. | Intraocular lenses for presbyopia treatment |
| WO2019002384A1 (en) | 2017-06-28 | 2019-01-03 | Amo Groningen B.V. | Diffractive lenses and related intraocular lenses for presbyopia treatment |
| CA3068351A1 (en) | 2017-06-28 | 2019-01-03 | Amo Groningen B.V. | Extended range and related intraocular lenses for presbyopia treatment |
| US11327210B2 (en) | 2017-06-30 | 2022-05-10 | Amo Groningen B.V. | Non-repeating echelettes and related intraocular lenses for presbyopia treatment |
| WO2019023598A2 (en) * | 2017-07-28 | 2019-01-31 | CyMedica Orthopedics, Inc. | Patient therapy systems and methods |
| WO2019040949A1 (en) | 2017-08-25 | 2019-02-28 | Eagle Harbor Technologies, Inc. | Arbitarary waveform generation using nanosecond pulses |
| US11282605B2 (en) | 2017-11-30 | 2022-03-22 | Amo Groningen B.V. | Intraocular lenses that improve post-surgical spectacle independent and methods of manufacturing thereof |
| US10607814B2 (en) | 2018-08-10 | 2020-03-31 | Eagle Harbor Technologies, Inc. | High voltage switch with isolated power |
| US11302518B2 (en) | 2018-07-27 | 2022-04-12 | Eagle Harbor Technologies, Inc. | Efficient energy recovery in a nanosecond pulser circuit |
| US11222767B2 (en) | 2018-07-27 | 2022-01-11 | Eagle Harbor Technologies, Inc. | Nanosecond pulser bias compensation |
| US11532457B2 (en) | 2018-07-27 | 2022-12-20 | Eagle Harbor Technologies, Inc. | Precise plasma control system |
| CN112805920A (en) | 2018-08-10 | 2021-05-14 | 鹰港科技有限公司 | Plasma sheath control for RF plasma reactor |
| WO2020146436A1 (en) | 2019-01-08 | 2020-07-16 | Eagle Harbor Technologies, Inc. | Efficient energy recovery in a nanosecond pulser circuit |
| WO2020242900A1 (en) | 2019-05-24 | 2020-12-03 | Axonics Modulation Technologies, Inc. | Trainer device for a neurostimulator programmer and associated methods of use with a neurostimulation system |
| US11439829B2 (en) | 2019-05-24 | 2022-09-13 | Axonics, Inc. | Clinician programmer methods and systems for maintaining target operating temperatures |
| TWI778449B (en) | 2019-11-15 | 2022-09-21 | 美商鷹港科技股份有限公司 | High voltage pulsing circuit |
| KR20230150396A (en) | 2019-12-24 | 2023-10-30 | 이글 하버 테크놀로지스, 인코포레이티드 | Nanosecond pulser rf isolation for plasma systems |
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| CN111276934B (en) * | 2020-02-27 | 2022-03-01 | 深圳讯丰通医疗股份有限公司 | Electrical stimulation protection device |
| CN113426011A (en) * | 2021-06-23 | 2021-09-24 | 上海沃克森医疗科技有限公司 | Percutaneous implantation electrode |
| CN116943032B (en) * | 2023-09-20 | 2024-01-09 | 江西省精一医疗科技有限公司 | Electrical stimulation generating device, method, electronic device, and storage medium |
Family Cites Families (43)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| US4326534A (en) * | 1979-06-21 | 1982-04-27 | Jens Axelgaard | Transcutaneous electrical muscle stimulation for treatment of scoliosis and other spinal deformities |
| US4408609A (en) * | 1980-04-01 | 1983-10-11 | Professional Staff Association Of The Rancho Los Amigos Hospital, Inc. | Electrical muscle stimulation for treatment of scoliosis and other spinal deformities |
| US4459989A (en) * | 1981-06-30 | 1984-07-17 | Neuromed, Inc. | Non-invasive multiprogrammable tissue stimulator and methods for use |
| US4793353A (en) * | 1981-06-30 | 1988-12-27 | Borkan William N | Non-invasive multiprogrammable tissue stimulator and method |
| AU1573183A (en) * | 1982-06-18 | 1983-12-22 | Biostim Inc. | Biological electrical stimulators |
| US4528984A (en) * | 1983-04-25 | 1985-07-16 | Empi, Inc. | Autoprogrammable functional electrical stimulation apparatus and method |
| US4595010A (en) * | 1984-03-12 | 1986-06-17 | Bio-Research Associates, Inc. | Electrical muscle stimulator |
| US4693254A (en) * | 1984-06-05 | 1987-09-15 | Codman & Shurtleff, Inc. | Transcutaneous nerve stimulation device using a common controller for pulse production and parameter display |
| US4622973A (en) * | 1984-06-15 | 1986-11-18 | Empi, Inc. | Programmable functional electrical stimulation system |
| US4690145A (en) * | 1985-06-17 | 1987-09-01 | Minnesota Mining And Manufacturing Company | Output limited electrical stimulator for biological tissue |
| US4690146A (en) * | 1985-06-17 | 1987-09-01 | Chattanooga Corporation | Neuromuscular stimulating apparatus |
| US4699143A (en) * | 1985-06-17 | 1987-10-13 | Minnesota Mining And Manufacturing Company | Electrical simulator for biological tissue having remote control |
| US4688574A (en) * | 1985-06-17 | 1987-08-25 | Minnesota Mining And Manufacturing Company | Electrical stimulator for biological tissue having mode control |
| US5167229A (en) * | 1986-03-24 | 1992-12-01 | Case Western Reserve University | Functional neuromuscular stimulation system |
| US4998532A (en) * | 1986-05-23 | 1991-03-12 | Lti Biomedical, Inc. | Portable electro-therapy system |
| US4769881A (en) * | 1986-09-02 | 1988-09-13 | Pedigo Irby R | High precision tens apparatus and method of use |
| US4799487A (en) * | 1987-05-11 | 1989-01-24 | Bleicher Joel N | Reanimation device and method for treating the paralyzed face |
| US4841973A (en) * | 1987-09-21 | 1989-06-27 | Stecker Harold D | Electrical stimulators |
| US4926865A (en) * | 1987-10-01 | 1990-05-22 | Oman Paul S | Microcomputer-based nerve and muscle stimulator |
| US4899750A (en) * | 1988-04-19 | 1990-02-13 | Siemens-Pacesetter, Inc. | Lead impedance scanning system for pacemakers |
| GB2223949B (en) * | 1988-09-08 | 1992-07-08 | Orthomedic Electronics Limited | Apparatus for functional electrical stimulation |
| US5041974A (en) * | 1988-10-26 | 1991-08-20 | Walker Judith B | Multichannel stimulator for tuned stimulation |
| JP2801393B2 (en) * | 1988-11-21 | 1998-09-21 | コンスタンティン スツェーレス，ヨーゼフ | Needle for point stimulation and treatment equipment for point stimulation |
| US5092329A (en) * | 1989-04-07 | 1992-03-03 | Sigmedics, Inc. | Microprocessor-controlled multiplexed functional electrical stimulator for surface stimulation in paralyzed patients with safety enhancements |
| US4976264A (en) * | 1989-05-10 | 1990-12-11 | Therapeutic Technologies Inc. | Power muscle stimulator |
| US4996987A (en) * | 1989-05-10 | 1991-03-05 | Therapeutic Technologies Inc. | Power muscle stimulator |
| US5063929A (en) * | 1989-08-25 | 1991-11-12 | Staodyn, Inc. | Electronic stimulating device having timed treatment of varying intensity and method therefor |
| US5048522A (en) * | 1990-04-13 | 1991-09-17 | Therapeutic Technologies, Inc. | Power muscle stimulator |
| ATE160290T1 (en) * | 1990-05-26 | 1997-12-15 | Med El Medical Electronics Ele | DEVICE FOR NEUROMUSCULAR ELECTRICAL STIMULATION |
| US5133354A (en) * | 1990-11-08 | 1992-07-28 | Medtronic, Inc. | Method and apparatus for improving muscle tone |
| WO1993009843A1 (en) * | 1991-11-15 | 1993-05-27 | Schoendorf Erhard | Electrotherapy apparatus |
| US5350414A (en) * | 1991-12-10 | 1994-09-27 | Electro Science Technologies, Inc. | Local application microprocessor based nerve and muscle stimulator |
| US5233986A (en) * | 1992-04-10 | 1993-08-10 | Random Technologies, Inc. | Time domain reflectometer-integrity testing system and method for medical device electrode |
| GB9211085D0 (en) * | 1992-05-23 | 1992-07-08 | Tippey Keith E | Electrical stimulation |
| US5300096A (en) * | 1992-06-03 | 1994-04-05 | Hall H Eugene | Electromyographic treatment device |
| US5514165A (en) * | 1993-12-23 | 1996-05-07 | Jace Systems, Inc. | Combined high voltage pulsed current and neuromuscular stimulation electrotherapy device |
| US5507788A (en) * | 1994-08-11 | 1996-04-16 | The Regents Of The University Of California | Method and apparatus for controlling skeletal muscle fatigue during electrical stimulation |
| US5604976A (en) * | 1994-10-18 | 1997-02-25 | Pi Medical Corporation | Method of making percutaneous connector for multi-conductor electrical cables |
| US5755745A (en) * | 1995-09-29 | 1998-05-26 | International Rehabilitative Sciences, Inc. | Portable muscle stimulator with removable data storage card |
| US6609031B1 (en) * | 1996-06-07 | 2003-08-19 | Advanced Neuromodulation Systems, Inc. | Multiprogrammable tissue stimulator and method |
| US5800458A (en) * | 1996-09-30 | 1998-09-01 | Rehabilicare, Inc. | Compliance monitor for monitoring applied electrical stimulation |
| US5861017A (en) * | 1997-06-06 | 1999-01-19 | Shriners Hospitals For Children | Portable functional electrical stimulation (FES) system for upper or lower extremity applications |
-
1999
- 1999-05-10 AT AT99920422T patent/ATE311927T1/en not_active IP Right Cessation
- 1999-05-10 AU AU37920/99A patent/AU736686B2/en not_active Ceased
- 1999-05-10 WO PCT/US1999/010221 patent/WO1999062594A1/en active IP Right Grant
- 1999-05-10 DE DE69928748T patent/DE69928748T2/en not_active Expired - Fee Related
- 1999-05-10 EP EP99920422A patent/EP0999872B1/en not_active Expired - Lifetime
- 1999-05-10 NZ NZ501422A patent/NZ501422A/en unknown
- 1999-05-10 CA CA002292526A patent/CA2292526A1/en not_active Withdrawn
- 1999-05-10 CA CA002415986A patent/CA2415986A1/en not_active Abandoned
- 1999-05-10 CN CN99800901A patent/CN1272798A/en active Pending
-
2001
- 2001-05-21 US US09/862,156 patent/US20020077572A1/en not_active Abandoned
-
2005
- 2005-09-16 US US11/228,084 patent/US20060009816A1/en not_active Abandoned
-
2007
- 2007-12-18 US US12/002,633 patent/US20080177351A1/en not_active Abandoned
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| Publication number | Publication date |
|---|---|
| EP0999872B1 (en) | 2005-12-07 |
| EP0999872A1 (en) | 2000-05-17 |
| US20020077572A1 (en) | 2002-06-20 |
| US20060009816A1 (en) | 2006-01-12 |
| US20080177351A1 (en) | 2008-07-24 |
| DE69928748T2 (en) | 2006-06-29 |
| ATE311927T1 (en) | 2005-12-15 |
| NZ501422A (en) | 2003-01-31 |
| AU736686B2 (en) | 2001-08-02 |
| WO1999062594A1 (en) | 1999-12-09 |
| AU3792099A (en) | 1999-12-20 |
| CA2292526A1 (en) | 1999-12-09 |
| CN1272798A (en) | 2000-11-08 |
| DE69928748D1 (en) | 2006-01-12 |
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| Date | Code | Title | Description |
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| FZDE | Discontinued |