throbber
I 1111111111111111 11111 1111111111 lllll lllll 111111111111111 lll111111111111111
`US007591776B2
`
`c12) United States Patent
`Phillips et al.
`
`(IO) Patent No.:
`(45) Date of Patent:
`
`US 7,591,776 B2
`Sep.22,2009
`
`(54) MAGNETIC STIMULATORS AND
`STIMULATING COILS
`
`(75)
`
`Inventors: Mark Phillips, Lampeter Velfry (GB);
`Gary A. Thomas, Cardiff (GB)
`
`(73) Assignee: The Magstim Company Limited,
`Whitland, Dyfed (GB)
`
`( *) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 31 days.
`
`(21) Appl. No.: 10/999,574
`
`(22) Filed:
`
`Nov. 30, 2004
`
`(65)
`
`Prior Publication Data
`
`US 2006/0004244 Al
`
`Jan. 5, 2006
`
`(30)
`
`Foreign Application Priority Data
`
`Jul. 1, 2004
`Oct. 11, 2004
`
`(GB)
`(GB)
`
`................................. 0414909.2
`................................. 0422468.9
`
`(51)
`
`Int. Cl.
`A61N 1100
`(2006.01)
`(52) U.S. Cl. ............................................. 600/13; 600/9
`( 58) Field of Classification Search . ... ... ... ... .. 600/9-15;
`607/155, 152,100, 103-104
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`5,061,234 A *
`5,084,003 A
`5,116,304 A
`5,857,957 A *
`5,984,854 A *
`6,179,770 Bl*
`6,179,772 Bl*
`6,261,221 Bl
`
`10/1991 Chaney ....................... 600/14
`l/ 1992 Susie et al.
`5/ 1992 Cadwell
`1/1999 Lin ............................. 600/13
`1111999 Ishikawa et al.
`. ... ... ... ... .. 600/9
`1/2001 Mould ......................... 600/13
`1/2001 Blackwell .................... 600/13
`7/2001 Tepper et al.
`
`6,641,520 B2 *
`6,770,022 B2 *
`2001/0018547 Al
`2003/0158585 Al*
`
`11/2003 Bailey et al. .................. .
`8/2004 Mechlenburg et al.
`. ....... .
`8/2001 Mechlenburg et al.
`8/2003 Burnett ......................... .
`
`600/9
`600/9
`
`607/2
`
`FOREIGN PATENT DOCUMENTS
`
`GB
`GB
`WO
`WO
`WO
`
`2261820
`2298370
`WO 02/25675
`WO 02/31845
`WO 03/070317
`
`6/1993
`9/1996
`3/2002
`4/2002
`8/2003
`
`OTHER PUBLICATIONS
`
`Weyh T et al., "Marked differences in the thermal characteristics of
`figure-of-eight shaped coils used for repetitive transcranial magnetic
`stimulation", vol. 116, No. 6, Clinical Neurophysiology, Elsevier
`Science,
`Jun. 2005, pp. 1477-1486, XP004946514,
`ISSN:
`1388:2457.
`Al-Mutawaly Net al., "Designing and constructing a magnetic stimu(cid:173)
`lator: theoretical and practical considerations", vol. 1 of 4, Proceed(cid:173)
`ings of the 23rd Annual International Conference of the IEEE Engi(cid:173)
`neering in Medicine and Biology Society, 2001 Proceedings of the
`23rd Annual EMBS International Conference, Oct. 25-28, Istanbul,
`Turkey, Annual International Conference of the IEEE Engineering in
`M., pp. 881-884, XP010593517, ISBN: 0-7803-7211-5.
`
`* cited by examiner
`
`Primary Examiner-Charles A Marmor, II
`Assistant Examiner----Christine D Hopkins
`(74) Attorney, Agent, or Firm-Iandiori Teska & Coleman
`
`(57)
`
`ABSTRACT
`
`A stimulating coil for use in the magnetic stimulation of
`neuro-muscular tissue comprises a self-supporting but flex(cid:173)
`ible conductor in a flexible insulating sheath which can be
`adjusted by hand to conform the coil to the contours of a
`selected part of the human body. The coil is provided with a
`cooling system which includes a conduit disposed adjacent or
`within the coil and a pump for driving coolant through the
`conduit.
`
`7 Claims, 4 Drawing Sheets
`
`HIGH
`VOLTAGE
`POWER
`SUPPLY
`
`+
`
`5
`
`2
`
`6
`
`10a
`
`10b
`
`10c
`
`I
`I
`I
`I
`I
`I
`I
`
`ls ___ J
`I
`
`11
`
`-
`
`Bd
`
`10d
`
`Allergan EX1018
`Page 1
`
`

`

`U.S. Patent
`
`Sep.22,2009
`
`Sheet 1 of 4
`
`US 7,591,776 B2
`
`,--- - - - - - - - - - - -,
`t
`
`I
`I
`
`ro
`C)
`r -
`
`C)
`r -
`
`ro
`CD
`
`<fl
`
`-0
`CD
`
`(9 -LL
`
`..Cl
`C)
`r -
`
`en
`
`+
`
`LLJ
`
`:::r:: ~ex:>(cid:173)
`LLJ __J
`~<!:::,-a....
`::c _J c:::> =
`t--- :::> a....
`-
`c::> CL en
`>
`
`Allergan EX1018
`Page 2
`
`

`

`U.S. Patent
`
`Sep.22,2009
`
`Sheet 2 of 4
`
`US 7,591,776 B2
`
`t'-l
`\J
`Ci:.
`
`.
`~
`\t
`LL
`
`..s
`
`°'
`
`-
`
`11:L
`~
`..__
`.::i.
`
`--
`
`';;,/
`
`~
`
`~
`I.
`t=
`"'
`
`i
`
`t,,..
`
`-
`
`!!
`
`"
`
`=
`
`~""
`'
`s~
`w -
`
`":....
`r\
`
`"'
`t"'4
`
`r
`
`~
`r--..t
`
`~
`Ill
`
`1.
`t- ~
`q:
`)t.
`\Ii
`:i: OJ.
`
`0
`_"t
`
`()0
`
`Allergan EX1018
`Page 3
`
`

`

`U.S. Patent
`
`Sep.22,2009
`
`Sheet 3 of 4
`
`US 7,591,776 B2
`
`.
`~
`\f
`~
`
`\Cl
`
`~
`""-
`
`~
`.
`~
`u..
`
`><
`1
`
`Allergan EX1018
`Page 4
`
`

`

`U.S. Patent
`
`Sep.22,2009
`
`Sheet 4 of 4
`
`US 7,591,776 B2
`
`.
`\r
`lL..
`
`\ -
`
`cJ -
`
`Allergan EX1018
`Page 5
`
`

`

`US 7,591,776 B2
`
`1
`MAGNETIC STIMULATORS AND
`STIMULATING COILS
`
`FIELD OF THE INVENTION
`
`This invention relates to magnetic stimulators, particularly
`for the magnetic stimulation of neuro-muscular tissue. Mag(cid:173)
`netic stimulators of this kind achieve stimulation by the cre(cid:173)
`ation of a rapidly changing magnetic field, for example of the
`order of 20 kilo Tesla per second in the vicinity of the tissue.
`Electric currents thereby induced in the tissue cause stimula(cid:173)
`tion thereof
`
`BACKGROUND TO THE INVENTION
`
`2
`may be driven. The coil could be molded within a flexible
`sheath which has an interface with a cooling jacket.
`According to another aspect of the invention a magnetic
`stimulating coil for the magnetic stimulation of neuro-mus-
`5 cular tissue comprises a flexible conductor in a flexible insu(cid:173)
`lating sheath which can be adjusted by hand to conform the
`coil to the contours of a selected part of the human body.
`The coil may be a multiple tum coil in which the turns are
`disposed to lie generally in a common plane and are supported
`10 by the flexible sheath in that configuration.
`The conductor may be provided with a cooling system as
`previously described.
`The invention will now be described in detail with refer-
`ence to a specific example and with recourse to the accom-
`15 parrying drawings.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`Known magnetic stimulators comprise generally a charg(cid:173)
`ing circuit for a' discharge' capacitor, a discharge control such
`as a controlled rectifier for allowing discharge of the capacitor
`through the stimulating coil, and other circuit elements for
`limiting the effect of undesirable electrical transients. In
`known practice the coil may assume a variety of forms but
`typically comprise a rigid holder or a housing for a multi-turn
`coil which has appropriate connectors for coupling to the
`discharge circuit.
`The object of the invention is to allow a more versatile 25
`application of the stimulating technique and in particular to
`allow the coil to be formed around a patient's limb or other
`part of the human body, particularly to provide a large surface
`area which allows sub-maximal and super-maximal stimula(cid:173)
`tion of both superficial and deep muscles for the purposes of 30
`therapy or rehabilitation.
`
`FIG. 1 is a schematic circuit diagram of a magnetic stimu-
`20 lator.
`FIG. 2 is a schematic illustration of part of a coil cooling
`system
`FIG. 3 is a schematic diagram of one embodiment of the
`invention
`FIGS. 4, 5 and 6 are view ofa coil, shown from the rear, side
`and front respectively
`FIG. 7 is a schematic diagram showing the construction of
`a coil
`FIG. 8 is a diagram illustrating the flexure of the coil.
`
`DETAILED DESCRIPTION
`
`SUMMARY OF THE INVENTION
`
`According to one aspect of the invention, a magnetic stimu(cid:173)
`lator for the magnetic stimulation of neuro-muscular tissue
`comprises a stimulating coil, a charging circuit, a capacitor,
`and a discharge control for allowing discharge of the capaci-
`tor through the stimulating coil. The stimulating coil com(cid:173)
`prises a flexible conductor in a flexible insulating sheath 40
`which can be adjusted by hand to conform the coil to the
`contours of a selected part of the human body.
`Preferably the coil is wound into a multiple tum coil in
`which the turns are disposed to lie generally in a common
`plane and are supported by the flexible sheath in that configu(cid:173)
`ration. The sheath may have a generally flat disc shape.
`The sheath may include at least one sensor for sensing the
`temperature of the coil, and the sensor may be coupled, either
`directly or by way of a control circuit, to prevent current flow
`through the coil on the detection of a temperature above a
`limit. The measurement of temperature is to ensure that the
`possibly large area of the coil in close proximity to the patient
`does not produce a thermally hazardous condition.
`The conductor may be provided with a cooling system,
`preferably a system which drives coolant in proximity to the
`coil. For example the coil may be disposed in an outer tube,
`there being a pump for pumping a coolant through the outer
`tube so as to provide cooling of the conductor constituting the
`coil. The outer tube may be connected to a heat exchanger and
`the pump may be connected to recirculated the coolant 60
`through the heat exchanger and the outer tube. The coolant
`may be water but may be a liquid ofhigh thermal conductivity
`and low electrical conductivity and may be an organic ( car(cid:173)
`bon-based) liquid such as a fluorocarbon. Other forms of
`cooling system are feasible. For example, the whole coil may
`be immersed in a jacket containing coolant. The coil may be
`constituted by a hollow conductor through which coolant
`
`FIG. 1 of the drawings illustrates for the sake of complete-
`35 ness the electrical circuit of one form of magnetic stimulator
`suitable for use in the present invention. The particular
`example is one of several different stimulators which are the
`subject of, and are more fully described in, U.S. Pat. No.
`5,766,124 to Polson, commonly assigned herewith.
`This particular example has a high-voltage power supply 1
`which charges a reservoir capacitor 2. Charge is transferred
`from the reservoir capacitor, substantially independently of
`the charging rate of the reservoir capacitor, via a transfer
`capacitor 5 to a 'discharge' capacitor 9, which at appropriate
`45 intervals is discharged into a stimulating coil 11. The transfer
`capacitor 5 is part of a charge pump which includes a unidi(cid:173)
`rectional switch 3, a series inductor 4, the transfer capacitor 5,
`a reverse diode 6 in parallel with the capacitor 5, a series
`inductor 7 and a switching system 8, which comprises con-
`50 trolled rectifiers Sa, Sb, Sc and Sd. The discharge of the
`capacitor 9 is controlled by the switching system 10 compris(cid:173)
`ing controlled rectifiers 10a.10b.10c and 10d. The discharge
`current may be in either direction through the coil 11, which
`has an earth connection. Discharge pulses, of magnitude and
`55 frequency which are controllable by the switching systems 8
`and 10, flow through the coil 11. Typically the instantaneous
`current may be of the order of 5 kA, i.e. considerably in excess
`of 1 kA; therms value of a typical pulse train may be hundreds
`of amps, such as 400 A.
`FIG. 2 illustrates some of the physical components of the
`system. They are the coil 11, which will be more fully
`described later, a flexible insulating conduit 12, a heat
`exchanger connection box 14 and a conduit 15. The ends of
`the coil inside their cooling tubes (to be described) pass
`65 through the conduit 12 to the box 14 and the coil ends pass
`through the conduit 15 to the rest of the stimulator as
`described with reference to FIG. 1. As will be described later,
`
`Allergan EX1018
`Page 6
`
`

`

`US 7,591,776 B2
`
`3
`in this example the coil is disposed inside a flexible tube
`which conveys a fluid coolant.
`FIG. 3 illustrates the connections between the coil, the heat
`exchanger and the stimulator. The stimulator 16 is for
`example as described with reference to FIG. 1. The conductor 5
`lla constituting the electrical element of the coil 11 is con(cid:173)
`nected as shown in FIG. 1 to the remainder of the stimulator.
`The conductor is preferably self-supporting but flexible. It
`may (for example) be copper wire having a diameter in the
`range 2.5 to 3 mm. The conductor lla, which has an insulat- 10
`ing cover, forms the turns 18 of the coil of the coil 11. Over
`most of its length the conductor lla, which has an insulating
`cover (not shown) is enclosed in a flexible tube 17 which is
`connected to allow a pump 19 to pump fluid coolant through
`the tube 17 and a heat exchanger 20. In this embodiment there 15
`are two segments and to the tube, the conductor at its middle
`part llb coming out of one end of one tube segment and
`entering the other tube segment. Respective ends of the tube
`segments are connected to the pump and the heat exchanger.
`Thus in this example there are two parallel paths for coolant 20
`to flow adjacent the coil, one flow cooling the inner turns of
`the coil and the other flow cooling the outer turns of the coil.
`Coolant from the heat exchanger 20 flows to a reservoir 21
`connected to the pump 19 and is recirculated through the tube
`17 during the operation of the stimulator.
`FIGS. 4-6 are different views of the flexible cooled coil's
`general construction. The conductor lla in its tube extends
`along and within the flexible elongate conduit 15 which com(cid:173)
`prises two end connectors 12a and 12b and an intermediate
`part comprising a ribbed plastics tube 12c. The end connector
`12a is adapted in any convenient manner for connection to the
`connection box. The other end 12b is connected to a generally
`disc-shaped sheath 22 within which the turns of the coil are
`located in the same plane. FIG. 4 illustrates the 'rear' of the
`coil, i.e. that which faces away from the patient in use. FIG. 5 35
`illustrates a side view, showing the flat character of the sheath
`22 in its original unflexed state. FIG. 6 illustrates the coil head
`form the front, i.e. that which is adjacent the patient in use.
`Embedded in the sheath 22 and close to its front surface are
`temperature sensors 23 with electrical connections 24 that 40
`extend back along the conduit to the stimulator. Shown sche(cid:173)
`matically is a safety switch 25 (FIG. 3) which in any conve(cid:173)
`nient marmer can disable the stimulator, to prevent current
`flow through the coil, if the sensed temperature is too high.
`There may be flow detectors within the coolant circuit 45
`comprising the pump, heat exchanger, reservoir and the con(cid:173)
`necting conduits. Accordingly if the coolant flow reduces to
`below some pre-set value the application of current to the
`stimulating coil would be prevented. This is another safety
`feature to ensure that a thermally hazardous condition is 50
`avoided. By way of example a flow detector 26 within the
`coolant circuit is shown diagrammatically at 26 and is
`coupled to the safety switch 25.
`FIG. 7 illustrates the coil in section, the section being taken
`on the line X-X in FIG. 4.
`The coil, comprising the conductor lla and its surrounding
`tube 17 is encapsulated in the flexible, silicone rubber molded
`disc-shaped sheath 22. The tube 17 may be a silicone plastic
`material. The sheath 22 has on its rear side a bulge 26 which
`accommodates the lead-in and lead-out parts of the conductor 60
`in its tube 17. The coolant can flow along the space 27
`between the insulated conductor lla and the surrounding
`tube 17.
`
`4
`Other forms of cooling system may be employed. In the
`particular example, the outer tube is a conduit through which
`coolant is driven to cool the coil. However, the coil may be
`disposed adjacent or within a jacket through which coolant
`may be driven. The coil could be hollow and itself define a
`conduit through which coolant may be driven.
`FIG. 8 illustrates the flexing of the sheath 22 and thereby
`the coil 11 from a flat condition 11-1 thorough a moderately
`flexed condition to a fully flexed condition 11-3. The flexing
`of the head may be plastic, in that it will remain in the
`particular flexed state and not elastically revert to the flat
`un-flexed state. The amount of flexure may be chosen by an
`administrator to suit the contour or shape of the body part
`against which the coil is located. It may be necessary to
`employ straps or other holding means to locate the coil
`securely on the patient.
`Alternatively the flexure may be elastic; in this event the
`use of straps or other holding means is desirable to ensure that
`the coil is maintained in its flexed configuration and in posi(cid:173)
`tion on the patient.
`A variety of materials would be suitable for the sheath 22.
`A silicone rubber compound may be used. The degree of
`hardness of the rubber may be chosen according to the desired
`elasticity of the flexure; a hard silicone rubber would be
`25 appropriate for an elastic sheath and a softer silicone rubber if
`the sheath is intended to flex plastically, the shape being
`maintained by the flexible copper wire inside the sheath.
`The invention claimed is :
`1. A magnetic stimulator for the magnetic stimulation of
`30 neuro-muscular tissue and comprising;
`a stimulating coil;
`a charging circuit;
`a capacitor; and
`a discharge control for allowing discharge of the capacitor
`through the stimulating coil; wherein the stimulating
`coil comprises a flexible conductor enclosed in a flexible
`tube, the flexible tube for allowing the passage of cool(cid:173)
`ant, the stimulating coil being in a flexible insulating
`sheath having a generally flat disc shape which can be
`adjusted by hand to conform the coil to the contours of a
`selected part of the human body, said flexible conductor
`and flexible tube being wound into a multiple tum coil in
`which the turns are disposed to lie generally in a com(cid:173)
`mon plane and are supported by the flexible sheath in
`that plane, and wherein the stimulator further comprises
`a pump for driving coolant through the flexible tube.
`2. A stimulator as in claim 1 wherein said sheath includes
`at least one sensor for sensing the temperature of the coil, and
`said sensor is coupled to prevent current flow through the coil
`on the detection of a temperature above a limit.
`3. A stimulator as in claim 1 wherein the flexible tube is
`connected to a heat exchanger and said pump is connected to
`recirculate the coolant through the heat exchanger and the
`flexible tube.
`4. A stimulator as in claim 1 wherein said coolant is a liquid
`of high thermal conductivity and low electrical conductivity.
`5. A stimulator as in claim 1 wherein said coolant com(cid:173)
`prises water.
`6. A stimulator as in claim 1 wherein said sheath is plasti(cid:173)
`cally flexible.
`7. A stimulator as in claim 1 wherein said sheath is elasti(cid:173)
`cally flexible.
`
`55
`
`* * * * *
`
`Allergan EX1018
`Page 7
`
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket