(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(19) World Intellectual Property Organization
`International Bureau
`
`•
`
`I lllll lllllll II llllll lllll llll I II Ill lllll llll lllll 111111111111111111111111111111
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`(43) International Publication Date
`11 July 2002 (11.07.2002)
`
`PCT
`
`(10) International Publication Number
`WO 02/053225 A2
`
`(51) International Patent Classification7:
`
`A61N
`
`North, Plymouth, MN 55442 (US). PERTTU, Joe; 1000
`Lake Susan Drive, chanhassen, MN 55317 (US).
`
`(74) Agents: MCMAHON, Beth, L. et al.; Medtronic, Inc.
`LC340, 710 Medtronic Parkway NE, Minneapolis, MN
`55432 (US).
`
`(81) Designated States (national): CA, JP.
`
`(84) Designated States (regional): European patent (AT, BE,
`CH, CY, DE, DK, ES, Fl, FR, GB, GR, IE, IT, LU, MC,
`NL, PT, SE, TR).
`
`Published:
`without international search report and to be republished
`upon receipt of that report
`
`For two-letter codes and other abbreviations, refer to the "Guid(cid:173)
`ance Notes on Codes and Abbreviations" appearing at the begin(cid:173)
`ning of each regular issue of the PCT Gazette.
`
`(72) Inventors: DAHL, Roger; 112 150th Lane, Andover, MN
`
`iiiiiiii
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`(21) International Application Number: PCT/USOl/49584
`
`(22) International Filing Date:
`28 December 2001 (28.12.2001)
`
`(25) Filing Language:
`
`(26) Publication Language:
`
`English
`
`English
`
`(30) Priority Data:
`60/258,651
`
`29 December 2000 (29.12.2000) us
`
`[US/US]; 710
`INC.
`(71) Applicant: MEDTRONIC,
`Medtronic Parkway NE, Minneapolis, MN 55432 (US).
`
`= 55304 (US). SOUKUP, Thomas, M.; 12435 49th Avenue
`-iiiiiiii
`iiiiiiii --!!!!!!!! -
`--
`!!!!!!!! -iiiiiiii
`iiiiiiii ----
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`~ ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
`
`ln
`M
`M
`ln (54) Title: IMPROVED SYSTEM FOR PROVIDING ELECTRICAL STIMULATION TO A LEFT CHAMBER OF A HEART
`Q
`...........
`~ (57) Abstract: A medical electrical lead is disclosed that is adapted for placement in the coronary sinus, or a branch vein thereof.
`The lead includes a first and second pace/sense electrode. A selection mechanism is provided to select either the first or the second
`0 electrode for use as a cathode, with the other electrode being selected as the anode. According to another aspect of the invention, a
`> high-voltage coil electrode may be provided between the first and second electrodes. The coil electrode may be electrically coupled
`~ to the anode to increase the shadow area of the coil electrode.
`
`Dexcom Inc. v. WaveForm Technologies, Inc.
`IPR2016-01679
`Exhibit 1019
`
`

`

`WO 02/053225
`
`PCT/USOl/49584
`
`1
`
`IMPROVED SYSTEM FOR PROVIDING ELECTRICAL
`
`STIMULATION TO A LEFT CHAMBER OF A HEART
`
`5
`
`The present invention relates generally to an implantable medical electrical lead;
`
`and more particularly, relates to a medical electrical lead system for implantation in a
`
`FIELD OF THE INVENTION
`
`cardiac vein.
`
`BACKGROUND OF THE INVENTION
`
`It has long been known that implantable medical electrical leads may be positioned
`
`10
`
`transvenously within one or more chambers of the heart to provide electrical stimulation
`
`15
`
`20
`
`to, and to monitor signals occurring within, the cardiac tissue. In order to achieve reliable
`
`sensing of the cardiac electrogram and/or to apply stimulation that effectively paces or
`
`cardioverts the heart chamber, it is necessary to accurately position the electrode surface
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`against the endocardium or within the myocardium at the desired site and affix it during an
`acute post-operative phase until fibrous tissue growth occurs. After implantation, the
`
`leads may be coupled to an implantable medical device (IMD) such as a pacemaker or
`
`cardioverter/defibrillator so that the desired stimulation may be provided to the cardiac
`
`tissue.
`
`More recently, endocardial pacing and cardioversion/defibrillation leads have been
`
`developed that are adapted to be advanced into the coronary sinus and branch coronary
`
`veins. During this type of implant procedure, a distal end of a lead is advanced through
`
`the superior vena cava and the right atrium, and through the ostium of the coronary sinus.
`
`The lead may further be advanced within the coronary sinus into one of the branch veins.
`
`Placement of leads within the coronary sinus and branch veins is important
`
`25
`
`because these leads can be located adjacent to the left ventricle or the left atrium of the
`
`heart. Electrical stimulation can then be provided to the left chambers of the heart
`
`without actually placing one or more leads into these chambers. Because the left side of
`
`the heart accounts for the majority of the heart's hemodynamic output, various pathologies
`
`may be better treated through such left-heart stimulation. For example, in patients
`
`30
`
`experiencing conditions associated with heart failure, electrical stimulation of both the
`
`Dexcom Inc. v. WaveForm Technologies, Inc.
`IPR2016-01679
`Exhibit 1019
`
`

`

`WO 02/053225
`
`PCT/USOl/49584
`
`2
`
`right and left sides of the heart can be used to re-synchronize the depolarization of the left
`
`and right ventricles in a manner that increases the cardiac output.
`
`In addition to providing important benefits to heart failure patients, the location of
`
`electrodes within the coronary sinus and branch veins can also reduce defibrillation
`
`5
`
`thresholds. That is, when a shocking electrode is positioned within a left-sided cardiac
`
`vein and used in conjunction with other shocking electrodes placed in more traditional
`
`locations, a lower shock energy may be required during cardioversion and/or defibrillation
`
`therapy. This can reduce the discomfort associated with these therapies.
`
`Several challenges are posed by providing both pacing and defibrillation electrodes
`
`10
`
`within the coronary vasculature. Because of the small vessel size, positioning multiple
`
`leads within the vasculature is difficult. Additionally, the size of coil electrodes of the
`
`type needed for high-voltage therapies may be limited based on the size of the vessels,
`
`thereby limiting the area of the tissue through which current flows during the therapy.
`
`This may limit the efficacy of high-voltage therapies. Finally, locating the leads at a
`
`15
`
`precise location needed to provide adequate tissue stimulation may be difficult given the
`
`problems associated with navigating the torturous vessels such as the coronary sinus and
`
`branch veins.
`
`What is needed, therefore, is an improved system that may be used to provide both
`
`pacing and high-voltage therapy to the left chambers of the heart and that may be reliably
`
`20
`
`fixed within a branch vein of the coronary sinus.
`
`SUMMARY OF THE INVENTION
`
`According to one embodiment of the current invention, a medical electrical lead is
`
`disclosed that is adapted for placement in the coronary sinus, or a branch vein of the
`
`coronary sinus. The lead includes a first electrode located in proximity to the distal end of
`
`25
`
`the lead. A second electrode is located distal to the first electrode. A selection mechanism
`
`is provided to select either the first or the second electrode for use as a cathode, with the
`
`other electrode being selected as the anode. In one embodiment, the selection mechanism
`
`may include a configurable circuit. Alternatively, the selection mechanism may include
`
`selectable electrical configurations provided by an adaptor module. After the selection is
`
`30
`
`complete, relative low-voltage electrical stimulation, including pacing pulses, may then be
`
`delivered between the anode and cathode to a left chamber of the heart.
`
`Dexcom Inc. v. WaveForm Technologies, Inc.
`IPR2016-01679
`Exhibit 1019
`
`

`

`WO 02/053225
`
`PCT/USOl/49584
`
`3
`
`The lead of the current invention may include means to aid in the positioning of the
`
`lead within the coronary sinus or branch veins. For example, the lead may include a
`
`lumen formed within the lead body, or adjacent to an exterior surface of the lead. The
`
`lumen is adapted to receive a guidewire or stylet for use in delivering the lead to a target
`
`5
`
`location during implant. In one embodiment, the lumen is formed of a collapsible tube
`
`such as tubing formed of a porous PTFE tubing material. The tube is carried adjacent to at
`
`least a portion of the outer surface of the lead body.
`
`According to yet another aspect of the current invention, a coil electrode may be
`
`positioned between the first and second electrodes. The coil electrode is adapted to deliver
`
`10
`
`relatively high-voltage therapy such as cardioversion/defibrillation shocks to the heart. In
`
`one embodiment, the coil electrode may be electrically coupled to the electrode selected as
`
`the anode to increase the shadow area of the coil electrode during high-voltage stimulation
`
`therapy.
`
`In another embodiment of the invention, a method of delivering electrical
`
`15
`
`stimulation to a heart is provided. The method includes the step of delivering a lead to a
`
`branch vein of the coronary sinus, wherein the lead includes first and second pace/sense
`
`electrodes coupled to a distal end of the lead. The method further includes selecting one
`
`of the first or the second pace/sense electrode as a cathode, and delivering electrical
`
`stimulation between the cathode and the other pace/sense electrode to a left chamber of the
`
`20
`
`heart. The lead may further include a coil electrode for delivering relatively high-voltage
`
`stimulation to the heart. In this embodiment, the method may further include electrically
`
`coupling one of the pace/sense electrodes to the coil electrode prior to the delivery of the
`
`high-voltage therapy to increase the shadow area of the coil electrode.
`In still another embodiment of the invention, a system is provided delivering
`
`25
`
`electrical stimulation to a heart. The system includes a lead having first and second
`
`pace/sense electrodes, and a coil electrode. The system may further include an adapter for
`
`selecting one of the first and the second pace/sense electrodes as a cathode for delivery of
`
`pacing therapy. The adapter may further couple the other one of the pace/sense electrodes
`
`to the coil electrode for use as the anode, and further for delivery of relatively high-voltage
`
`30
`
`stimulation. As an alternative to the adapter, the system may include an implantable
`
`Dexcom Inc. v. WaveForm Technologies, Inc.
`IPR2016-01679
`Exhibit 1019
`
`

`

`WO 02/053225
`
`PCT/USOl/49584
`
`4
`
`medical device having means for selectably configuring the electrodes in the afore(cid:173)
`
`mentioned manner.
`
`Other scopes and aspects of the current invention will become apparent to those
`
`skilled in the art from the following description and the accompanying drawings.
`
`5
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`Figure 1 is a plan view of one embodiment of the inventive lead system.
`
`Figure 2 is a side cutaway view of one embodiment of the distal portion of the
`
`lead.
`
`Figure 3 is a posterior view of the heart illustrating the inventive lead system
`
`10
`
`implanted within a branch vein of the coronary sinus.
`
`15
`
`20
`
`Figure 4 is a block diagram of an Thill configuration including a programmable
`
`switch as may be used with the lead system of the current invention.
`
`Figure 5 is a side view of a lead that is similar to that shown in Figure 2 including a
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`multi-pin connector as may be used with the current invention.
`
`Figure 6 is an end view of the connector of Figure 5.
`
`Figure 7 is an end view illustrating a mating interface for use with the connector of
`
`Figure 6.
`
`Figure 8 is a side view illustrating use of the mating interface of Figure 7
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`incorporated within an adapter that includes a standard DF-1 connector.
`
`Figure 9 is a side view illustrating use of mating interface incorporated within an
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`adapter that includes a standard IS-1 connector.
`
`Figure 10 illustrates an adapter as shown in Figure 9 coupled to a lead including
`
`the connector shown in Figure 5.
`
`Figure 11 illustrates an adapter such as shown in Figure 9 being coupled to a lead
`
`25
`
`of a type as shown in Figure 5.
`
`Figure 12 is an end view of the connector of Figure 5 being temporarily configured
`
`for threshold testing.
`
`Dexcom Inc. v. WaveForm Technologies, Inc.
`IPR2016-01679
`Exhibit 1019
`
`

`

`WO 02/053225
`
`PCT/USOl/49584
`
`5
`
`DESCRIPTION OF THE INVENTION
`
`The present invention provides a single lead system adapted for placement within a
`
`branch vein of the coronary sinus. This system is specifically sized to fit within the length
`
`and width of the branch vein.
`
`5
`
`Figure 1 is a plan view of one embodiment of the inventive lead system. The lead
`
`includes an elongated body 10 that may be of any conventional lead construction known in
`
`the art. For example, the exterior of lead may be formed of silicone, polyurethane, or a
`
`non-porous or dense PTFE.
`
`The distal end of the elongated body includes a tip electrode 12 for pacing and
`
`10
`
`sensing in the left ventricle. This electrode could be any of the various types of pacing
`
`electrodes known in the art such as a porous platinized electrode assembly. A tip
`
`electrode is shown, although a ring electrode located proximate the distal end of the
`
`elongate body 10 could be used in the alternative. In one embodiment, this electrode is a
`
`steroid-eluting porous pacing electrode, as described in commonly-assigned U.S. Pat. Nos.
`
`15
`
`4,506,680, 4,577,642; 4,606,118 incorporated herein by reference. The electrode may be
`
`constructed of porous, sintered platinum, titanium, or a similar bio-compatible metal.
`
`Tip electrode 12 could include means to aid in fixing the electrode assembly at a
`
`desired site of implant within the branch vein. For example, the electrode could include
`
`flexible tine-like or fin structures. Fixation devices of this nature are disclosed in U.S.
`
`20
`
`Patent Numbers 5,964,795, 6,006,122, and 5,387,233 which are incorporated herein by
`
`reference. Alternatively, the lead body 10 could be shaped to have side-to-side
`
`undulations to wedge the lead within the vessel and aid in retaining the lead body at the
`
`implant site.
`
`Shocking electrode 16, located proximal to tip electrode 12 provides
`
`25
`
`cardioversion/defibrillation stimulation, and, in one embodiment, may be used as an anode
`
`for bipolar pace/sense therapy in conjunction with the pace/sense cathode, as will be
`
`discussed further below. Shocking electrode 16 is a coiled electrode that may be of any
`
`construction known in the art. In one embodiment, the coil is isodiametric with respect to
`
`the lead body. Such isodiametric electrode coils may be molded into the electrode body or
`
`30
`
`the coils may be machined to provide a flush surface. This is described in U.S. Pat. No.
`
`4,161,952, issued to Kinney et al. Similarly, U.S. Patent number 5,957,970 to Shoberg
`
`Dexcom Inc. v. WaveForm Technologies, Inc.
`IPR2016-01679
`Exhibit 1019
`
`

`

`WO 02/053225
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`PCT/USOl/49584
`
`6
`
`discloses an isodiametric defibrillation lead as may be used with the current invention.
`
`The lead described in the '970 patent is manufactured by removing a portion of an
`
`extruded tubular lead body in the region of the coil so that the electrode is flush with the
`
`surface of the lead.
`
`5
`
`Shocking electrode 16 may be encased in a layer of porous PTFE material or
`
`expandable PTFE ( ePTFE), as shown in Figure 2. The porous PTFE jacket 30 is designed
`
`to prevent tissue in-growth around the coils of the shocking electrode. Shocking electrode
`
`16 is electrically coupled to a conductor 23 (shown dashed) extending to a connector pin
`
`45 at the proximal end of the lead. The associated connector 44 may be of any type
`
`10
`
`known in the art, including a DF-1 industry standard connector.
`
`In one preferred embodiment of the current invention, elongate body 10 may
`
`further include a ring electrode 18. In Figure 1, this electrode is shown located just
`
`proximal to the shocking electrode 16, although it may be positioned distal to the shocking
`
`electrode 16 in another embodiment. Pacing pulses may be delivered between tip
`
`15
`
`electrode 12 and ring electrode 18. Additionally, ring electrode 18 may be used as the
`
`pace/sense cathode ifthe location of ring electrode is more favorable for such therapy than
`
`the most distal electrode. If the ring electrode 18 is selected as the pace/sense cathode, tip
`
`electrode 12 may be electrically coupled in common with the shocking electrode 16 to
`
`augment the shadow area of the shocking electrode. Similarly, if the most distal electrode
`
`20
`
`12 is selected to be the pace/sense cathode, the ring electrode 18 may be electrically
`
`coupled with the shocking electrode 16.
`In the illustrated embodiment, conductors 21 and 25 extend to pin connector 49
`
`and ring connector 47, respectively. Connector 46 may be any type of proprietary or
`
`industry-standard connector known in the art. For example, the connector may be an
`
`25
`
`industry-standard IS-1 connector.
`
`As noted above, the construction of the lead body may be of any type known in the
`
`art. Conductors 21, 23, and 25 may be of a cable or coil design, and may reside within
`
`individual lumens formed in the insulation. In another embodiment, one or more of the
`
`conductors may be coils positioned coaxially with respect to each other, with insulation
`
`30
`
`provided between adjacent coils. In yet another embodiment, lead body 10 carries a
`
`drawn brazed stranded (DBS) cable insulated with FEP.
`
`Dexcom Inc. v. WaveForm Technologies, Inc.
`IPR2016-01679
`Exhibit 1019
`
`

`

`WO 02/053225
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`PCT/USOl/49584
`
`7
`
`The lead body may further include a lumen for receiving a sty let. For example,
`
`one of the conductors 21, 23 and 25 may be coiled to define such a lumen, or the lumen
`
`may be formed within the insulation.
`
`In yet another embodiment, the lumen may extend
`
`through the distal end of elongate body 10 and tip electrode 12. In this instance, a
`
`5
`
`guidewire may be advanced beyond the lead distal tip for positioning the lead body within
`
`the coronary sinus or a branch vessel. In this embodiment, a tip seal 13 may be provided
`
`at the distal end of the lumen, as described in commonly-assigned U.S. Patent No.
`
`6,192,280 incorporated herein by reference. This tip seal prevents the ingress of bodily
`
`fluids into the lumen.
`
`10
`
`According to one aspect of the invention, predetermined portions of the elongate
`
`lead body 10 may be coated at one or more locations with a porous
`
`Polytetrafluoroethylene (PTFE) material such as expanded PTFE (e-PTFE). As discussed
`
`in commonly-assigned U.S. Patent Application Serial Number 09/827,103 filed April 5,
`
`2001 entitled "Implantable Medical Device Adapted to Promote Selected Tissue In-
`
`15
`
`Growth and Method for Making the Same", incorporated herein by reference, porous
`
`PTFE having a relatively large pore size may be used to selectively promote tissue in(cid:173)
`
`growth. Because of the tissue in-growth, portions of the lead coated with PTFE swell
`
`after implant. By selectively coating the lead body 10 in predetermined locations such as
`
`at locations 19a and 19b, this swelling effect urges electrodes 12, 16 and 18 against a
`
`20
`
`vessel wall. This promotes capture, and retains the lead at a desired location of implant.
`
`The lead body 10 of Figure 1 is further shown having a side lumen 32 offset from
`
`the surface of the lead body. This side lumen may extend from the proximal lead end to
`
`any desired location at the distal end of the lead body. For example, the lumen may
`
`extend to tip electrode 12. This side lumen 32 may be formed of PTFE such that the
`
`25
`
`inner lumen is collapsible. For example, a PTFE tube may be affixed to the lead body 10
`
`using any type ofbio-compatible adhesive. The lumen expands to fit over a guide wire
`
`positioned in the venous anatomy for the purpose of directing the lead to the site of
`
`implant. When the guide wire is removed, the lumen will collapse or fold down against
`
`the lead body 10. The distal end of the lumen may be closed, or a stop member 33 may be
`
`30
`
`provided at the lumen distal end to prevent a sty let advanced within the lumen from
`
`extending beyond the lumen distal end and possibly damaging tissue.
`
`Dexcom Inc. v. WaveForm Technologies, Inc.
`IPR2016-01679
`Exhibit 1019
`
`

`

`WO 02/053225
`
`PCT/USOl/49584
`
`8
`
`According to yet another aspect of the invention, additional collapsible PTFE
`
`lumens as may be formed of PTFE tubing may be added around the lead body. Each of
`
`these tubes will further selectively promote tissue in-growth, and, may be positioned to
`
`urge one or more of the electrodes against tissue after the implant procedure. These
`
`5
`
`additional lumens may further be used during an implant procedure in conjunction with a
`
`guidewire or stylet to steer a lead around a curve within the vascular system.
`
`In one embodiment, the distal end of the lead body is sized to be positioned within
`
`a branch vein as a means of fixation. In this embodiment, the diameter of lead body 10
`
`may range from approximately .030" to .090'\ and in a more specific embodiment may
`
`10
`
`range from approximately .040" to .065". In such an embodiment, all electrodes have a
`
`diameter similar to that of the lead body to allow for placement of the lead within the
`
`15
`
`20
`
`coronary vessels.
`
`Figure 2 is a side cutaway view of one embodiment of the distal portion of the
`
`lead. The shocking electrode 16 of this embodiment is positioned between tip electrode 12
`
`and ring electrode 18. This electrode may have a length in the range of approximately 2 to
`4 cm and a shadow area in the range of70 to 200 mm2
`electrode 18 may be spaced approximately 8 to12 mm from either end of the shocking
`
`• The tip electrode 12 and ring
`
`electrode in one embodiment of the invention. The length of the tip and ring electrodes
`
`may each range from approximately 4 to 10 mm, although other dimensions may also be
`
`utilized. Each electrode may having a surface area ranging from approximately 20 to 48
`mm2
`
`, although again, other sizes may be utilized Since the shocking electrode16 is
`
`downsized to fit within a branch vein, the electrical coupling of the shocking electrode
`
`with either the tip electrode 12 or the ring electrode 18 provides additional current
`
`distribution during cardioversion/defibrillation to increase shocking efficacy. The entire
`
`25
`
`surface of tip and ring electrodes may be conductive, however zones 50 and 52,
`
`respectively, may be provided on the surfaces of each electrode to create a more
`
`conductive and effective interface with the tissue for pacing. These zones, which may be
`
`annular, have specialized surfaces that may be of a porous and platinized platinum. The
`
`surfaces may also be steroid eluting, as described in U.S. Pat. No. 4,506,680 to Stokes, and
`
`30
`
`related U.S. Pat. Nos. 4,577,642; 4,606,118; and 4,711,251, all commonly assigned to the
`
`assignee of the present invention and incorporated by reference herein in their respective
`
`Dexcom Inc. v. WaveForm Technologies, Inc.
`IPR2016-01679
`Exhibit 1019
`
`

`

`WO 02/053225
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`PCT/USOl/49584
`
`9
`
`entireties. Because the specialized zones 50 protrude radially from the tip and ring
`
`electrodes, these zones come into intimate contact with the heart wall when the lead is
`
`wedged within the confined space of a cardiac vein.
`
`The conductors to each of these electrodes 21 and 25 may be connected directly to
`
`5
`
`the end of the electrodes carrying this specialized surface 50 in order to maintain the best
`
`efficiency in delivering current to these zones for pacing. The length of specialized
`
`surface 50 may range from approximately .5 to 3 mm and the surface area from
`approximately 1 to 6 mm2
`from the specialized zone 50. This tip adds to the shadow area of the electrode 12 in
`
`. Further, tip electrode 12 may have a tapered tip extending
`
`10
`
`order to augment electrode 16 for high voltage shocking if this electrode is selected as the
`
`pacing anode. Moreover, if tip electrode is selected as the cathode, this tip does not drain
`
`excessive current when low voltage pacing pulses are delivered. Similarly, in the case of
`
`ring electrode 18, the portion 18a of the electrode may be a polished conductive surface
`
`that is less conductive and slightly smaller in diameter than ring 52. Portion 18a ofring
`
`15
`
`electrode 18 may augment the electrode for high voltage shocking but does not drain
`
`excessive current from low voltage pacing pulses if ring electrode 18 is selected as the
`
`cathode.
`
`In the embodiment shown in Figure 2, the proximal portion 18a of ring electrode
`
`18 may be formed of a coiled construction that provides better flexibility and strain relief
`
`20
`
`over a longer length, so that the lead body may bend with less stress in the cardiac venous
`
`anatomy. The coil could be made of platinum or platinum clad tantalum or any material
`
`such as is known to the art and would be joined to the ring by a weld such as is known in
`
`the art.
`
`The lead of the current invention may further include one or more radiopaque
`
`25
`
`marker bands at the distal end such as marker band 53. This aids in placing the distal end
`
`of the lead during the implant procedure as discussed below.
`
`Figure 3 is a posterior view of the heart illustrating the inventive lead system
`
`implanted within a branch vein of the coronary sinus. Branch vein 60 may be any of the
`
`branch veins draining into the coronary sinus 62, including the posterior lateral vein
`
`30
`
`(PLV), lateral vein, or great cardiac vein (GCV).
`
`Dexcom Inc. v. WaveForm Technologies, Inc.
`IPR2016-01679
`Exhibit 1019
`
`

`

`WO 02/053225
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`PCT/USOl/49584
`
`10
`
`Positioning of the lead may be completed using several methods. During the
`
`implantation procedure, a guide catheter may be used to cannulate the ostium 64 (shown
`
`dashed) of coronary sinus 62. A guidewire may then be pre-loaded into side lumen 32,
`
`and the guidewire and lead may be delivered within the lumen of the guide catheter into
`
`5
`
`the coronary sinus 62. Thereafter, the guidewire may be advanced beyond the distal tip of
`
`the lead and navigated into the selected branch vein. This process may be aided using
`
`fluoroscopy. A radiopaque marker such as marker 53 (Figure 2) may be provided on a
`
`distal end of the guidewire and/or lead body 10 to aid in this process, for example. The
`
`guide catheter provides back up support for the navigation of the guide wire and lead
`
`10
`
`during the location of the branch vein. After placement of the lead at the target location,
`
`the guidewire and guide catheter may then be removed from the body.
`
`In another embodiment wherein the side lumen 32 includes a closed distal end, a
`
`stylet may be pre-loaded in the lumen, and the lead and stylet combination advanced
`
`within the lumen of the guide catheter to the coronary sinus 62. Thereafter, the sty let may
`
`15
`
`be used to advance the lead distal end past the guide catheter distal end and into the
`
`desired branch vein. The guide catheter and stylet may then be removed from the body.
`
`In yet another embodiment, the lead need not include a side lumen, but instead
`
`includes a lumen within the lead body, as may be defined via a coiled conductor in the
`
`manner discussed above. A sty let may be pre-loaded into this internal lumen so that the
`
`20
`
`lead and stylet may be advanced into the coronary sinus in the manner discussed above,
`
`and thereafter positioned within a branch vein. According to yet another embodiment of
`
`the invention, the internal lead lumen may extend through the distal end of the lead, and a
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`guidewire may be used to place the lead in a manner similar to that discussed above with
`
`respect to the side lumen. That is, after the guidewire and lead are positioned within the
`
`25
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`coronary sinus, the guidewire is advanced to sub-select the branch vein, and the lead is
`
`then tracked over the guidewire to the target destination. The guidewire and guide
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`catheter are thereafter removed from the body.
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`As shown in Figure 3, the distal portion of the lead may be positioned with tip
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`electrode 12 wedged into branch vein such that the shocking electrode 16 extends
`
`30
`
`proximally along the vein and with ring electrode 18 positioned near the location where
`
`the branch vein drains into the coronary sinus. Another lead 70 having a pace/sense
`
`Dexcom Inc. v. WaveForm Technologies, Inc.
`IPR2016-01679
`Exhibit 1019
`
`

`

`WO 02/053225
`
`PCT/USOl/49584
`
`11
`
`electrode pair 72 and a defibrillation coil 74 may be implanted in the right ventricular
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`apex. When a high-voltage shock is deliver, current flows between defibrillation coils 16
`
`and 74 along shock path 76. By electrically coupling either the tip electrode 12 or the ring
`
`electrode 18 to the defibrillation coil during the delivery of the shock, the current path may
`
`5
`
`be widened to affect more tissue, increasing efficacy of the therapy.
`
`After the leads are positioned within the patient, they may be coupled to an
`
`implantable medical device (IMD) 80. The implanting physician may then perform
`
`electrical testing to determine whether tip electrode 12 or ring electrode 18 provides the
`
`best location for bi-ventricular pacing. Temporary contacts can be made with the
`
`10
`
`connectors at the proximal end of the lead to test the most distal electrode 12 versus the
`
`most proximal electrode 18 as the cathode with the other two electrodes serving as the
`
`anode. Selection of the cathode is based on the efficiency of bi-ventricular pacing. This
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`selection can be made by programming the pulse generator, or by providing a separate
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`jumper connector to a pin grid array at the proximal end of the lead body 10.
`
`15
`
`Figure 4 illustrates an IMD configuration including a programmable switch as may
`
`be used with the lead system of the current invention. In this embodiment, IMD includes a
`
`pace/sense circuit 100 to deliver pacing pulses, and to sense cardiac signals. This circuit
`
`may include one or more output amplifiers and input amplifiers, and may be any of the
`
`configurations known in the art. This circuit may further include an analog-to-digital
`
`20
`
`converter to convert sensed analog cardiac signals to digital signals. The IMD further
`
`includes a high-voltage circuit 102 for delivering high-voltage stimulation to a coil
`
`electrode such as shocking electrode 16. This circuit may include one or more high(cid:173)
`
`voltage capacitors and/or charging circuits as is known in the art. The timing, voltage and
`
`current levels, and other parameters associated with pace/sense circuit 100 and high(cid:173)
`
`25
`
`voltage circuit 102 are controlled by control circuit 112.
`
`Both the pace/sense circuit 100 and the high-voltage circuit 102 are coupled to a
`
`select circuit 104, which may be any combination of discrete components, integrated
`
`components, and/or one or more encoders and/or multiplexers. Additionally, or
`
`alternatively, Micro-Electrical-Mechanical systems (MEMs) technology may be
`
`30
`
`incorporated within the switching circuit. MEMs switches are described in commonly(cid:173)
`
`assigned U.S. Patent application serial no. 10/004,025 filed October 31, 2001 and
`
`Dexcom Inc. v. WaveForm Technologies, Inc.
`IPR2016-01679
`Exhibit 1019
`
`

`

`WO 02/053225
`
`PCT/USOl/49584
`
`12
`
`incorporated herein by reference in its entirety. Select circuit 104 electrically couples
`
`lines 106 and 108 selectively to output lines 110. Select circuit 104 may be configured by
`
`control circuit 112.
`
`IMD 80 further includes a processing circuit 114, which may be a microprocessor
`
`5
`
`or another digital or analog processing circuit as is known in the art. Processing circuit
`
`114 is coupled to storage circuit 116, which may include Random Access Memory
`
`(RAM), Read-Only Memory (ROM), and/or any other type of storage circuit known in the
`
`art. This storage circuit may store operational parameters such as stimulation parameters,
`
`and/or programmed instructions executed by processing circuit 116. Processing circuit
`
`10
`
`116 may further be coupled to a communication circuit 120, which may be a telemetry
`
`circuit for performing wireless communication transfers to an external device 122.
`
`External device may be a programmer, or any other type of external device for monitoring,
`
`programming, or in any other way interacting within IMD 80.
`
`As described above, after lead implantation is completed, a physician may conduct
`
`15
`
`testing to determine whether the tip electrode 12 or ring electrode 18 are associated with
`
`better pacing thresholds, and should therefore be selected as the cathode. After this
`
`determination is complete, control circuit 112 can be programmed to configure select
`
`circuit 104 so that sign