U.S. patent application number 16/399371 was filed with the patent office on 2019-08-22 for wireless tissue electrostimulation.
This patent application is currently assigned to CARDIAC PACEMAKERS, INC.. The applicant listed for this patent is CARDIAC PACEMAKERS, INC.. Invention is credited to John A. Becker, Kevin D. Edmunds, Roger Hastings, Daniel M. Lafontaine, Michael J. Pikus.
Application Number | 20190255336 16/399371 |
Document ID | / |
Family ID | 40513737 |
Filed Date | 2019-08-22 |
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United States Patent
Application |
20190255336 |
Kind Code |
A1 |
Hastings; Roger ; et
al. |
August 22, 2019 |
WIRELESS TISSUE ELECTROSTIMULATION
Abstract
A wireless electrostimulation system can comprise a wireless
energy transmission source, and an implantable cardiovascular
wireless electrostimulation node. A receiver circuit comprising an
inductive antenna can be configured to capture magnetic energy to
generate a tissue electrostimulation. A tissue electrostimulation
circuit, coupled to the receiver circuit, can be configured to
deliver energy captured by the receiver circuit as a tissue
electrostimulation waveform. Delivery of tissue electrostimulation
can be initiated by a therapy control unit.
Inventors: |
Hastings; Roger; (Maple
Grove, MN) ; Becker; John A.; (Delano, MN) ;
Pikus; Michael J.; (Golden Valley, MN) ; Lafontaine;
Daniel M.; (Plymouth, MN) ; Edmunds; Kevin D.;
(Ham Lake, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
CARDIAC PACEMAKERS, INC. |
St. Paul |
MN |
US |
|
|
Assignee: |
CARDIAC PACEMAKERS, INC.
St. Paul
MN
|
Family ID: |
40513737 |
Appl. No.: |
16/399371 |
Filed: |
April 30, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15601583 |
May 22, 2017 |
10307604 |
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16399371 |
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15199089 |
Jun 30, 2016 |
9795797 |
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15601583 |
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14264663 |
Apr 29, 2014 |
9393405 |
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15199089 |
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12361884 |
Jan 29, 2009 |
8738147 |
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14264663 |
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61059993 |
Jun 9, 2008 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 1/057 20130101;
A61N 1/3684 20130101; A61N 1/3622 20130101; A61N 1/3756 20130101;
A61N 1/37223 20130101; A61N 1/0573 20130101; A61N 1/37229 20130101;
A61N 1/3624 20130101; A61N 1/3787 20130101; A61N 1/0565 20130101;
A61N 1/37205 20130101; A61N 1/36842 20170801 |
International
Class: |
A61N 1/378 20060101
A61N001/378; A61N 1/368 20060101 A61N001/368; A61N 1/05 20060101
A61N001/05; A61N 1/375 20060101 A61N001/375; A61N 1/372 20060101
A61N001/372 |
Claims
1. A delivery system for implanting an implantable
electrostimulation device at a target site within a heart of a
patient, the delivery system comprising: a delivery catheter
including a lumen for housing at least part of the implantable
electrostimulation device during delivery to the target site within
the heart; a flexible actuator passing transluminally through the
delivery catheter, wherein the flexible actuator is actuatable
between: a torque transmitting state where the flexible actuator is
capable of transmitting a rotation torque to a retaining structure
of the electrostimulation device in both a clockwise and a
counter-clockwise direction; a released state where the flexible
actuator releases the retaining structure of the electrostimulation
device; and wherein in the released state the flexible actuator is
actuated to define a larger opening for receiving at least part of
the retaining structure of the electrostimulation device, and in
the torque transmitting state the flexible actuator is actuated to
define a smaller opening to capture at least part of the retaining
structure of the electrostimulation device after the at least part
of the retaining structure of the electrostimulation device is
received by the larger opening in the released state.
2. The delivery system of claim 1, further comprising a guide
catheter having a guide lumen, wherein the delivery catheter is
passed transluminally through the guide lumen of the guide
catheter.
3. The delivery system of claim 2, wherein the delivery catheter
can be moved translational along the guide lumen of the guide
catheter.
4. The delivery system of claim 1, wherein the electrostimulation
device comprises a helical tine that, when the electrostimulation
device is rotated by the flexible actuator, the helical tine
penetrates and secures the electrostimulation device to heart
tissue at the target site.
5. The delivery system of claim 1, wherein actuating the flexible
actuator between the torque transmitting state and the released
state comprises axially moving a locking wire.
6. The delivery system of claim 5, wherein the locking wire engages
the retaining structure of the electrostimulation device and helps
deliver torque to the retaining structure of the electrostimulation
device when in the torque transmitting state.
7. The delivery system of claim 6, wherein the locking wire does
not deliver torque to the retaining structure of the
electrostimulation device when in the released state.
8. The delivery system of claim 7, wherein the locking wire does
not engage the retaining structure of the electrostimulation device
when in the released state.
9. The delivery system of claim 1, wherein the flexible actuator
includes a finger adaptor that is actuatable between the torque
transmitting state and the released state.
10. A delivery system for implanting an implantable
electrostimulation device at a target site within a heart of a
patient, the delivery system comprising: a delivery catheter
including a lumen for housing at least part of the implantable
electrostimulation device during delivery to the target site within
the heart; a flexible actuator passing transluminally through the
delivery catheter, wherein the flexible actuator is actuatable
between: a torque transmitting state where the flexible actuator is
capable of transmitting a rotation torque to a retaining structure
of the electrostimulation device in both a clockwise and a
counter-clockwise direction; a released state where the flexible
actuator releases the retaining structure of the electrostimulation
device; and wherein the flexible actuator is actuatable from the
torque transmitting state to the released state by axially moving a
locking wire of the flexible actuator.
11. The delivery system of claim 10, wherein withdrawing the
locking wire of the flexible actuator allows the flexible actuator
to release the retaining structure of the electrostimulation device
and move proximally relative to the retaining structure of the
electrostimulation device.
12. The delivery system of claim 10, wherein withdrawing the
locking wire of the flexible actuator releases an interference
connection between the flexible actuator and the retaining
structure of the electrostimulation device.
13. The delivery system of claim 10, further comprising a guide
catheter having a guide lumen, wherein the delivery catheter is
passed transluminally through the guide lumen of the guide
catheter.
14. The delivery system of claim 13, wherein the delivery catheter
can be moved translational along the guide lumen of the guide
catheter.
15. The delivery system of claim 10, wherein the electrostimulation
device comprises a helical tine that, when the electrostimulation
device is rotated by the flexible actuator, the helical tine
secures the electrostimulation device to heart tissue at the target
site.
16. A delivery system for implanting an implantable
electrostimulation device at a target site within a heart of a
patient, the delivery system comprising: a delivery catheter
including a lumen for housing at least part of the implantable
electrostimulation device during delivery to the target site within
the heart; a flexible actuator passing transluminally through the
delivery catheter, wherein the flexible actuator is actuatable
between: a torque transmitting state where the flexible actuator is
capable of transmitting a rotation torque to a retaining structure
of the electrostimulation device in both a clockwise and a
counter-clockwise direction; a released state where the flexible
actuator releases the retaining structure of the electrostimulation
device; and wherein in the released state a locking wire is moved
axially along the delivery catheter in a first direction to create
a larger opening for receiving at least part of the retaining
structure of the electrostimulation device, and in the torque
transmitting state the locking wire is moved axially along the
delivery catheter in a second opposing direction to shrink the
opening and to capture at least part of the retaining structure of
the electrostimulation device after the at least part of the
retaining structure of the electrostimulation device is received by
the larger opening in the released state.
17. The delivery system of claim 16, wherein moving the locking
wire in the first direction allows the flexible actuator to release
the retaining structure of the electrostimulation device and move
proximally relative to the retaining structure of the
electrostimulation device.
18. The delivery system of claim 16, wherein moving the locking
wire of the flexible actuator in the first direction releases an
interference connection between the flexible actuator and the
retaining structure of the electrostimulation device.
19. The delivery system of claim 16, further comprising a guide
catheter having a guide lumen, wherein the delivery catheter is
passed transluminally through the guide lumen of the guide
catheter, and wherein the delivery catheter can be moved
translational along the guide lumen of the guide catheter.
20. The delivery system of claim 16, wherein the electrostimulation
device comprises a helical tine that, when the electrostimulation
device is rotated by the flexible actuator, the helical tine
secures the electrostimulation device to heart tissue at the target
site.
Description
CLAIM OF PRIORITY
[0001] This patent application is a continuation of U.S.
application Ser. No. 15/601,583 filed on May 22, 2017, which is a
continuation of U.S. application Ser. No. 15/199,089 filed on Jun.
30, 2016, which is a continuation of U.S. application Ser. No.
14/264,663 filed on Apr. 29, 2014, now U.S. Pat. No. 9,393,405,
which is a continuation of U.S. application Ser. No. 12/361,884,
filed on Jan. 29, 2009, which claims benefit to U.S. Provisional
Patent Application No. 61/059,993 filed on Jun. 9, 2008 and to U.S.
Provisional Patent Application No. 61/063,876 filed on Feb. 7,
2008, all of which are hereby incorporated by reference in their
entirety.
CROSS-REFERENCE TO RELATED PATENT DOCUMENTS
[0002] This patent application is related to U.S. patent
application Ser. No. 11/854,844, entitled "Cardiac Stimulation
Using Leadless Electrode Assemblies," filed on Sep. 13, 2007, now
issued as U.S. Pat. No. 8,644,934, and U.S. patent application Ser.
No. 11/511,152, entitled "Cardiac Stimulation System," filed on
Aug. 28, 2006, now issued as U.S. Pat. No. 7,848,823, the entire
contents of both of which are incorporated herein by reference.
BACKGROUND
[0003] A variety of therapeutically-useful intra-body
electrostimulation techniques have been employed by physicians to
treat both acute and chronic patient conditions. Electrostimulation
of soft muscle tissue may be used, for instance, to elicit
contractile behavior, or to inhibit such contractile
activation.
[0004] In particular, electrostimulation is commonly used for
cardiac rhythm management. Cardiac rhythm management devices
include, for example, pacemakers, cardiac re-synchronization
therapy devices, and cardioverter defibrillators. Cardiac rhythm
management devices can be used to treat conditions such as atrial
or ventricular tachycardia, atrial or ventricular fibrillation,
bradycardia, and congestive heart failure.
[0005] An example of an application of a cardiac rhythm management
device includes a battery-operated pulse-generator assembly
subcutaneously implanted in the pectoral region, connected to one
or more implantable leads deployed through the vasculature using a
catheter-based delivery system to locations either within one or
more of the heart chambers, or within one of the great veins of the
heart.
[0006] Implantable flexible leads include one or more exposed
electrodes to directly stimulate cardiac tissue, or to sense
potentials developed across the electrodes by the tissue (e.g., for
sensing intrinsic cardiac activity, or sensing the evoked response
to the application of electrostimulus). Tissue growth occurs, and
frequently surrounds the area of the electrode in contact with
tissue. This may result in the beneficial effect of reducing the
required electrostimulus threshold to achieve the desired response,
but also presents challenges should the necessity arise to
re-position or remove the lead. This may preclude the usage of
multiple leads in certain locations.
[0007] Epicardial stimulus locations are also sometimes used, for
instance during times when acute pacing therapy is desired,
associated with other medical procedures, and where access is
easily obtained to the pericardial cavity.
OVERVIEW
[0008] Some conditions, such as congestive heart failure, benefit
from pacing at multiple cardiac sites in a specially timed manner,
including pacing at a right-ventricular site, and one or more
left-ventricular sites.
[0009] Generally, leads are contra-indicated in the left heart
chambers due to the risk of thrombo-embolism. Also, risk exists of
mechanical dislodgement, due to the more significant motions,
acceleration and impingement of cardiac tissue on the lead and
electrode assembly, if a lead system is implanted endocardially in
the left ventricle or left atrium.
[0010] For the reasons above, left-ventricular pacing is typically
accomplished from a venous site. However, the risk of obstructing a
significant proportion of the venous cross section is great,
compromising blood supply to myocardium. It can be difficult to
pace at more than one left ventricular site. Additionally, the
efficiency of pacing at a venous site can be correspondingly less
desirable than an intra-chamber location such as the
left-ventricular free wall (e.g., the required pacing energy level
to elicit reliable activation or "capture," can be higher at the
venous site than at a corresponding endocardial location wherein
the electrode is directly implanted in the myocardium). The
complexity of lead removal and the limited available area can
preclude the usage of multiple leads to achieve multiple
stimulation sites in the left heart.
[0011] Wireless pacing electrodes can eliminate the need for the
wired connection between the pulse generator assembly and an
electrode assembly at a pacing site, since such wireless assemblies
can fit entirely within a heart chamber, at an endocardial
location. Generally, pacing energy is supplied to the tissue from a
tiny rechargeable battery located in the body of the wireless
pacing electrode. Such a design has the advantage of enabling an
autonomous pacing assembly, but size considerations can result in
frequent (e.g., daily) battery recharge via magnetic induction.
Further, the construction of various wireless pacing devices using
materials with high magnetic permeability, such as ferrite-core
inductors, can present a compatibility problem with magnetic
resonance imaging (MRI) equipment.
[0012] By contrast, among other things, the present system in
certain examples can provide electrostimulation at patient implant
locations, such as an endocardial location, where usage of
lead-wire systems is problematic, and wherein stimulation is
desired at multiple sites separate and distinct from the location
of a therapy control unit and wireless energy source.
[0013] The present system in certain examples can also improve
useful wireless communication range to, for example, several
centimeters in cardiac pacing or other electrostimulation
applications, using one or more inductors including a core material
having a lower relative magnetic permeability than ferrite, or
substantially equal to 1 (e.g., such as air, body tissue, bodily
fluids, or one or more other media), or using a tuned receiver
design. Multiple receivers can be driven by a single inductive
transmit antenna with limited loss in efficiency, as compared to a
single receiver.
[0014] The inductive transmit antenna can be located either
subcutaneously within the patient or included with an external
device, such as a hospital bed, operating table, hand-held device,
hat or clothing, for example.
[0015] In the case of a subcutaneously-implanted therapy control
unit and inductive transmitter (such as a cardiac rhythm management
device), explant might be required to replace the battery. Enhanced
efficiency from resonant coupling or larger air-core loop inductive
antenna structures can facilitate increased operating time between
recharge operations or battery replacement.
[0016] In the case of an external inductive transmitter, a greater
distance between the transmitter and wireless electrostimulation
node "seed" devices can be achieved.
[0017] The wireless electrostimulation node "seed" device can be
implanted at a cardiac location, such as endocardially, entirely
within a heart chamber, and can be configured with an expandable
inductive loop antenna. During the implantation procedure, the
expandable loop can be initially collapsed or folded to allow
easier implant, and then unfolded or expanded to achieve a larger
surface area, and hence greater coupling to the inductive transmit
antenna. In a cardiac pacing example, an inductive transmit antenna
can be incorporated into a cardiac lead system and can be
configured to expand or unfold once implanted in a desired
location.
[0018] In an example, a wireless electrostimulation system can
include a wireless energy transmission source, and an implantable
cardiovascular wireless electrostimulation node. In an example, a
receiver circuit can include an inductive antenna, and the antenna
can be configured to capture magnetic energy to generate a tissue
electrostimulation. In an example, a tissue electrostimulation
circuit, coupled to the receiver circuit, can be configured to
deliver energy captured by the receiver circuit as a tissue
electrostimulation waveform, without requiring a discrete capacitor
or electrochemical storage (e.g., a battery, a capacitor using
bodily fluid or tissue as an electrolyte, or one or more other
storage devices) on-board or conductively coupled to the receiver
circuit. In an example, delivery of tissue electrostimulation can
be initiated by a therapy control unit.
[0019] Example 1 comprises a wireless electrostimulation system. In
this example, the system includes: a wireless energy transmission
source, including an inductive antenna, configured to generate a
time-varying magnetic flux; a cardiovascular wireless
electrostimulation node sized and shaped to be implantable using a
percutaneous transluminal catheter delivery system, the wireless
electrostimulation node comprising: a receiver circuit configured
to capture at least enough inductively-coupled energy from the
inductive antenna to generate a tissue electrostimulation, the
receiver circuit comprising a mechanically-expandable inductive
pickup configured to link the time-varying magnetic flux, the
inductive pickup comprising a core material including a relative
magnetic permeability less than 1.1; a tissue electrostimulation
circuit, coupled to the receiver circuit, configured to deliver
energy captured by the receiver circuit as a specified tissue
electrostimulation waveform, the tissue electrostimulation circuit
comprising at least one tissue electrostimulation electrode; and a
therapy control unit, communicatively coupled to the tissue
electrostimulation node and configured to initiate a delivery of a
tissue electrostimulation by the tissue electrostimulation
electrode.
[0020] In Example 2, the system of Example 1 optionally comprises a
system wherein the cardiovascular wireless electrostimulation node
is configured and sized for intravascular delivery.
[0021] In Example 3, the system of at least one of Examples 1-2
optionally comprises a system wherein the receiver circuit
comprises: an energy storage device configured to store
inductively-coupled energy transferred by the time-varying magnetic
flux; wherein the energy storage device is configured to store at
most 1 milliJoule of energy; and wherein the tissue
electrostimulation is inhibited by a depletion of the energy
storage device no more than 1 minute after the termination of the
inductively-coupled energy transfer.
[0022] In Example 4, the system of at least one of Examples 1-3
optionally comprises a system wherein the tissue electrostimulation
circuit comprises: a rectifier, coupled between the receiver
circuit and the tissue stimulation electrode; a direct-current
blocking device, coupled between the tissue electrostimulation
electrode and the receiver circuit; wherein the at least one tissue
electrostimulation electrode comprises a cathode configured to be
coupled to cardiac tissue; wherein the at least one tissue
electrostimulation electrode comprises an anode configured to be
coupled to cardiac tissue; and wherein the tissue
electrostimulation circuit is configured to be capable of
generating, between the anode and the cathode, an
electrostimulation pulse of at least 2.5V peak amplitude at a pulse
width of 0.4 msec when coupled to a 500 Ohm equivalent load.
[0023] In Example 5, the system of at least one of Examples 1-4
optionally comprises: a mechanically-expandable inductive pickup
comprising: an insulated wire loop; an expandable mechanical
support comprising a loop of shape-memory material mechanically
coupled to the insulated wire loop, wherein at least a portion of
the loop of shape-memory material is non-conductive; a housing
comprising: a receiver circuit electrical charge storage device
conductively coupled to the insulated wire loop; the tissue
electrostimulation circuit; wherein the housing is disposed within
a space encompassed by the loop of shape-memory material; and a
strut, comprised of shape-memory material, configured to secure the
loop of shape-memory material to the cylindrical housing.
[0024] In Example 6, the system of at least one of Examples 1-5
optionally comprises a bio-compatible dielectric encapsulant
configured to encompass at least a portion of the inductive
pickup.
[0025] In Example 7, the system of at least one of Examples 1-6
optionally comprises a system wherein the wireless energy
transmission source is configured to vary a burst pulse duration of
the time-varying magnetic flux, wherein the tissue
electrostimulation circuit comprises a voltage clamping device
coupled to the output of the rectifier, and wherein the energy
content of the electrostimulation pulse is controlled by the burst
pulse duration when a voltage across the voltage clamping device is
substantially equal to or greater than a voltage clamping device
threshold voltage.
[0026] In Example 8, the system of at least one of Examples 1-7
optionally comprises a system wherein the inductive pickup is
configured for a maximum outside diameter, when expanded, of less
than or equal to 2 cm; wherein the housing comprises a cylindrical
diameter less than or equal to 2 mm, and a length less than or
equal to 5 mm; and wherein a total length of the cylindrical
housing and the cardiac tissue attachment mechanism is less than or
equal to a nominal minimum myocardial tissue wall thickness of 10
mm.
[0027] In Example 9, the system of at least one of Examples 1-8
optionally comprises a system wherein the wireless energy
transmission source is configured to generate the time-varying
magnetic flux at a specified receiver resonant frequency within a
range of frequencies from 500 kilohertz to 5 megahertz, inclusive;
and wherein the wireless energy transmission source is configured
to deliver the inductively coupled energy at a power coupling
efficiency of at least 1%.
[0028] In Example 10, the system of at least one of Examples 1-9
optionally comprises a system wherein the wireless energy
transmission source and the therapy control unit are both
configured to be located external to a patient's body containing
the wireless electrostimulation node.
[0029] In Example 11, the system of at least one of Examples 1-10
optionally comprises a battery-powered implantable cardiac rhythm
management unit that includes the wireless energy transmission
source and the therapy control unit.
[0030] In Example 12, the system of at least one of Examples 1-11
optionally comprises a system wherein the wireless energy
transmission source comprises: an implantable flexible lead
comprising: a distal end configured to be located near the
implantable wireless electrostimulation node; a proximal end
configured to be located at or near a housing of the
battery-powered implantable cardiac rhythm management unit; at
least two antenna feed conductors disposed internally to the lead
and conductively coupled to the housing of the battery-powered
implantable cardiac rhythm management unit; the inductive antenna
disposed at the distal end of the lead, and conductively coupled to
the at least two antenna feed conductors at the distal end of the
lead; and the therapy control unit configured to energize the at
least two antenna feed conductors.
[0031] Example 13 describes a method. In this example, the method
comprises: delivering a cardiovascular wireless electrostimulation
node to an intra-body location; expanding a wireless
electrostimulation node inductive pickup; generating a time-varying
magnetic flux; linking the time-varying magnetic flux to the
wireless electrostimulation node inductive pickup; configuring a
wireless electrostimulation node inductive pickup wire loop with a
core material of a relative magnetic permeability less than 1.1;
capturing at least enough inductively-coupled energy to deliver a
tissue electrostimulation; controlling the initiation of the
delivery of a specified tissue electrostimulation waveform; and
delivering a specified tissue electrostimulation waveform in
response to an initiation.
[0032] In Example 14, the method of Example 13 optionally comprises
delivering a cardiovascular wireless electrostimulation node
through a vascular path to an intra-body location.
[0033] In Example 15, the method of at least one of Examples 13-14
optionally comprises: storing the inductively-coupled energy within
an energy storage device included in the wireless
electrostimulation node; inhibiting the storage of more than 1
milliJoule of energy within the energy storage device; terminating
the time-varying magnetic flux; depleting the energy storage
device; and inhibiting the delivery of the tissue
electrostimulation more than 1 minute after the termination of the
time-varying magnetic flux in response to the depleting the energy
storage device.
[0034] In Example 16, the method of at least one of Examples 13-15
optionally comprises: rectifying the time-varying magnetic flux;
coupling a cathode to cardiac tissue; coupling an anode to cardiac
tissue; generating, between the anode and the cathode, an
electrostimulation pulse of at least 2.5V peak amplitude at a pulse
width of 0.4 msec when coupled to a 500 Ohm equivalent load; and
blocking the passage of direct-current between a tissue stimulation
electrode and a receiver circuit.
[0035] In Example 17, the method of at least one of Examples 13-16
optionally comprises: insulating the inductive pickup wire loop;
coupling the inductive pickup wire loop to a shape-memory
mechanical support mechanically; expanding the shape-memory
expandable mechanical support to a specified loop shape proximate
to a cardiac tissue wall; forming a non-conductive portion along
the circumference of the shape-memory expandable mechanical
support; coupling the shape-memory mechanical support to a
cylindrical housing mechanically; and disposing the cylindrical
housing within a space encompassed by the shape-memory mechanical
support.
[0036] In Example 18, the method of at least one of Examples 13-17
optionally comprises: encompassing at least a portion of the
inductive pickup with a bio-compatible dielectric encapsulant.
[0037] In Example 19, the method of at least one of Examples 13-18
optionally comprises: varying a burst pulse duration of the
time-varying magnetic flux; clamping a voltage developed by the
rectifying the time-varying magnetic flux; and controlling the
energy content of the electrostimulation pulse, via the varying of
the burst pulse duration of the time-varying magnetic flux, when a
voltage across a voltage clamping device is substantially equal to
or greater than a voltage clamping device threshold voltage.
[0038] In Example 20, the method of at least one of Examples 13-19
optionally comprises: expanding the inductive pickup to a maximum
outside diameter, when expanded, of less than or equal to 2 cm;
limiting the cylindrical housing to a diameter less than or equal
to 2 mm; limiting the cylindrical housing to a length less than or
equal to 5 mm; and limiting a total length of the cylindrical
housing and a cardiac tissue attachment mechanism to less than or
equal to a nominal minimum myocardial tissue wall thickness of 10
mm.
[0039] In Example 21, the method of at least one of Examples 13-20
optionally comprises: generating the time-varying magnetic flux at
a specified receiver resonant frequency within a range of
frequencies from 500 kilohertz to 5 megahertz, inclusive; and
transferring the inductively-coupled energy at a power coupling
efficiency of at least 1%.
[0040] In Example 22, the method of at least one of Examples 13-21
optionally comprises: generating the time-varying magnetic flux
from a location external to a patient's body; and initiating a
tissue electrostimulation from a location external to the patient's
body.
[0041] In Example 23, the method of at least one of Examples 13-22
optionally comprises: delivering a battery-powered implantable
cardiac rhythm management unit to an intra-body location;
conductively coupling an inductive antenna to the implantable
cardiac rhythm management device; generating the time-varying
magnetic flux using the inductive antenna; and initiating a tissue
electrostimulation using the implantable cardiac rhythm management
unit.
[0042] In Example 24, the method of at least one of Examples 13-23
optionally comprises: locating a distal end of an implantable
flexible lead near to the implantable wireless electrostimulation
node; mechanically coupling the inductive antenna to the distal end
of the implantable flexible lead; locating a proximal end of the
cardiovascular implantable flexible lead at or near to a housing of
the battery-powered implantable cardiac rhythm management unit
therapy control unit; locating at least two antenna feed conductors
within the implantable flexible lead; conductively coupling the at
least two antenna feed conductors from the battery-powered
implantable cardiac rhythm management unit therapy control unit
housing to the inductive antenna; and energizing the at least two
antenna feed conductors.
[0043] Example 25 describes a system. In this example, the system
comprises: means for delivering a cardiovascular wireless
electrostimulation node to an intra-body location; means for
expanding a wireless electrostimulation node inductive pickup;
means for generating a time-varying magnetic flux; means for
linking the time-varying magnetic flux to the wireless
electrostimulation node inductive pickup; means for surrounding a
wireless electrostimulation node inductive pickup wire loop with a
material of a relative magnetic permeability less than 1.1; means
for capturing at least enough inductively-coupled energy to deliver
a tissue electrostimulation;
means for controlling the initiation of the delivery of a specified
tissue electrostimulation waveform; and means for delivering a
specified tissue electrostimulation waveform in response to an
initiation.
[0044] This overview is intended to provide an overview of subject
matter of the present patent application. It is not intended to
provide an exclusive or exhaustive explanation of the invention.
The detailed description is included to provide further information
about the present patent application.
BRIEF DESCRIPTION OF THE DRAWINGS
[0045] In the drawings, which are not necessarily drawn to scale,
like numerals may describe similar components in different views.
Like numerals having different letter suffixes may represent
different instances of similar components. The drawings illustrate
generally, by way of example, but not by way of limitation, various
embodiments discussed in the present document.
[0046] FIG. 1 is a diagram illustrating generally an example of at
least a portion of a wireless electrostimulation system including a
wireless energy transmission source, an implantable flexible lead
comprising an inductive antenna, and multiple wireless
electrostimulation nodes configured at cardiac sites.
[0047] FIG. 2 is a schematic diagram illustrating generally an
example of at least a portion of a wireless electrostimulation
system including a wireless energy transmission source and a
wireless electrostimulation node.
[0048] FIGS. 3A-B are views illustrating generally at least a
portion of an example of a wireless electrostimulation node
included in a wireless electrostimulation system.
[0049] FIGS. 4A-B are similar to FIGS. 3A-B, but illustrate
generally at least a portion of another example of a wireless
electrostimulation node included in a wireless electrostimulation
system.
[0050] FIG. 5 is a partial cross-sectional view illustrating
generally an example of at least a portion of a wireless
electrostimulation system including a delivery catheter containing
a wireless electrostimulation node.
[0051] FIG. 6 is a partial cross-sectional view, similar to FIG. 5,
but illustrating generally an example of at least a portion of a
wireless electrostimulation system including the removal of a pull
wire and the retraction of an actuator and delivery catheter.
[0052] FIG. 7 is a partial cross-sectional view illustrating
generally an example of at least a portion of a wireless
electrostimulation system including a wire loop and a mechanical
support, showing a local encapsulant surrounding the wire loop and
a bulk encapsulant surrounding both the mechanical support and wire
loop.
[0053] FIG. 8 is a diagram illustrating generally a perspective
view of an example of at least a portion of a wireless
electrostimulation system including a spiral wire loop wound
coaxially to encircle a mechanical support.
[0054] FIG. 9 is a diagram, similar to FIG. 8, but illustrating
generally an example of a perspective view of at least a portion of
a wireless electrostimulation system including wire loop wound in a
spiral on one face of a mechanical support.
[0055] FIG. 10 is a diagram, similar to FIG. 1, but illustrating
generally an example of at least a portion of a wireless
electrostimulation system including an external device generating a
time-varying magnetic flux.
[0056] FIG. 11 is a diagram illustrating generally an example of at
least a portion of a process including a wireless stimulation
node.
[0057] FIG. 12 is an example of a plot showing an analysis of the
predicted output voltage developed at an example of a wireless
electrostimulation node inductive pickup receiver, and the
corresponding actual output voltage when measured on a laboratory
model, both plotted versus the separation between an energy
transmission source inductive antenna transmitter and wireless
electrostimulation node inductive pickup receiver.
[0058] FIG. 13 is an example of a plot from an efficiency analysis
showing the computed power coupling efficiency and battery lifetime
associated with a given separation between an example of an energy
transmission source inductive antenna transmitter and an example of
a wireless electrostimulation node inductive pickup receiver.
[0059] FIG. 14 is a diagram, similar to FIG. 1, but illustrating
generally an example of at least a portion of a wireless
electrostimulation system including a subcutaneous inductive
antenna.
DETAILED DESCRIPTION
[0060] FIG. 1 is a diagram illustrating generally an example of at
least a portion of a wireless electrostimulation system 100
including a subcutaneous implantable cardiac rhythm management unit
120, and an implantable flexible lead 106 coupled to an inductive
antenna 108, and multiple implantable wireless electrostimulation
nodes 110A, 110B. FIGS. 3A-B, 4A-B can be referred to for more
detailed views of examples of wireless electrostimulation nodes
110A, 110B.
[0061] The implantable wireless electrostimulation nodes, 110A,
110B, can be implanted entirely within the heart, for example, at
an endocardial site along the left ventricular free wall 102A and
penetrating the myocardium 102E. In the example of FIG. 1, the
combination of the cardiac rhythm management unit 120, flexible
lead 106, and inductive antenna 108 can be configured as a wireless
energy transmission source.
[0062] The wireless electrostimulation nodes or "seeds," 110A,
110B, can be configured to receive inductively-coupled
electromagnetic energy 114 as a time-varying flux generated by the
inductive antenna 108. The energy 114 is captured by expandable
inductive pickups 112A, 112B coupled to each seed 110A, 110B.
[0063] In the example shown in FIG. 1, the inductive antenna 108
can be disposed at the distal end of the implantable flexible lead
106 such as to transmit energy 114 across the ventricular septal
region 102B, with the antenna 108 located near a fixation device
107. The fixation device 107 can be located at or near the apical
region 102C of the right ventricle.
[0064] In an example, the implantable flexible lead 106 can be
configured with at least two internal antenna feed conductors. The
antenna feed conductors can be electrically coupled to an
implantable cardiac rhythm management (CRM) device 120 through a
header block 126A. The header block 126A can be used to
mechanically and electrically couple one or more leads such as 104,
106 to, for example, electronics, control circuitry, or a battery
located within the cardiac rhythm management device 120 therapy
control unit housing 126B.
[0065] The CRM device 120 can be configured to wirelessly control
initiation or timing of electrostimulation via wireless seeds 110A,
110B. The CRM device 120 can also be configured to generate energy
114 and to wirelessly communicate energy to the wireless seeds
110A, 110B such as for use in providing electrostimulation. In
certain examples, the CRM device 120 can also provide
electrostimulation to one or more cardiac sites, such as near 102B,
102C, 102D, such as by using one or more tissue attachment or
fixation devices 105, 107 respectively comprising one or more
conductive electrodes. The electrodes can be conductively supplied
with electrostimulation energy, such as through one or more wires
located internally to one or more of leads 104, 106.
[0066] In certain examples, one or more additional wireless
stimulation nodes, such as 110A, 110B can be located in one or more
other left heart 102 regions, such as the left atrium or left
ventricular septal region. Such locations within or associated with
the left heart 102 can be used, for example, in delivery of
electrostimulation such as for cardiac resynchronization therapy,
or to achieve conversion of atrial or ventricular tachyarrhythmias
through electrostimulation. In examples involving one or more
left-atrially associated seeds, similar to 110A, 110B, a
right-atrial flexible implantable lead 104, and fixation device 105
can incorporate an inductive antenna 108, such as located in the
atrial septal region, or one or more other atrial regions, such as
102D. In other examples, one or more other subcutaneous or external
locations can accommodate the wireless energy transmission source
and inductive antenna 108, including, for example, the vena cava,
pericardial space, or esophageal space. FIG. 10 shows an example of
an external wireless energy transmission source 1040.
[0067] In certain examples, control of initiation, timing, or
delivery of electrostimulation is provided by the CRM device 120
comprising one or more sensing electrodes 122A, 122B disposed on
the housing 126B or header 126A of the CRM device 120. The sensing
electrodes 122A, 122B can, among other things, provide electrogram
sensing of intrinsic cardiac activity, evoked response to
electrostimulation, or parameters related to patient activity level
(e.g., respiration, heart rate). Additionally, in another example,
one or more fixation devices 105, 107 can provide one or more
sensing electrodes, and conductively couple one or more sensed
signals via leads 104, 106 to the CRM device 120.
[0068] In some examples, delivery of multiple seeds can allow
defibrillation or cardioversion to be achieved using
electrostimulation by the seeds, while decreasing, minimizing, or
eliminating pain or patient discomfort. To achieve effective
cardioversion or defibrillation, multiple re-entrancy paths within
the cardiac tissue can be broken, or de-sensitized. The total
delivered energy used to de-sensitize (e.g., inhibit activation of)
enough myocardium, 102E, for instance, can be substantially larger
if only a single defibrillation vector is used (e.g., a single pair
of electrodes), compared to using multiple defibrillation
sites.
[0069] FIG. 2 is a schematic diagram illustrating generally an
example of at least a portion of a wireless electrostimulation
system 200 including a wireless energy transmission source 220 and
a wireless electrostimulation node (seed) 210.
[0070] The example in FIG. 2 shows a wireless energy source 220
that can include a battery 226, voltage regulator 225, and a
microprocessor 224. In certain examples, the microprocessor 224
comprises input-output (I/O) capability such that a switching
structure 228 can be coupled to the microprocessor 224 to control
current flow from the battery 226 or an optional transient energy
storage device such as a capacitor 227 to an inductive antenna 206.
In one example, the inductive antenna is comprised of a wire loop
208. In another example, the inductive antenna 206 comprises of
multiple wire loops 208 that can be configured spatially orthogonal
to one another such as to reduce orientation sensitivity. A tuning
element 229 can be used to allow a range of frequencies to be
selected at which a time-varying magnetic flux 214 will be
generated by the inductive antenna 206. The resulting
inductance-capacitance (LC) circuit forms a resonant "tank"
circuit, which can have an operable range of resonant frequencies
selected from a range of 300 KHz to 10 MHz, but selected below the
self-resonant frequency of the inductor 208 comprising the
inductive antenna 206.
[0071] Some examples of the tuning element 229 can include, but are
not restricted to, a capacitor, a variable-capacitance diode
("varicap" diode), an active circuit modeling a capacitor of a
selected value, etc. In some examples, the switch 228 and tuning
element 229 can be replaced, such as by a combination of a
voltage-controlled oscillator and power amplifier coupled to
directly drive the inductive antenna 206 such as to achieve
generation of magnetic flux 214 at a specified range of
frequencies. The switch 228 can be realized either mechanically as
a microminiature relay device, or as solid-state device (e.g., FET,
BJT, IGBT, SCR, or other thyristor). In some examples, the
regulator 225, microprocessor 224, sensing circuit 223, and
switching device 228 are co-integrated in a single integrated
circuit or multi-chip module package. Note that the term
"microprocessor" can also include, among other things, a
microcontroller device including one or more of volatile or
non-volatile memory, multiple input/output channels,
analog-to-digital conversion devices, power supplies, or
digital-to-analog conversion devices that can be co-integrated in,
for example, a single integrated circuit, single circuit package,
multi-chip module package, hybrid, polyimide flex-circuit assembly,
etc.
[0072] In some examples, the initiation, timing, duration and
frequency range of the generation of magnetic flux 214 is
controlled by the microprocessor 224 wherein the microprocessor 224
is provided with input from a sensing circuit 223. The sensing
circuit 223 can be coupled to, for example, wire leads 204A, 204B
implanted subcutaneously within cardiac tissue 202A. In another
example, the wireless energy transmission source can be external to
the body, and leads 204A, 204B can be coupled to the skin of the
patient (e.g., to measure electrocardiograms). In the example shown
in FIG. 1, the transmission source 220 can comprise one or more
sense electrodes 222A, 222B coupled to the sensing circuit. In one
example, sense electrodes 222A, 222B are disposed on the housing of
wireless energy transmission source 220.
[0073] The time-varying magnetic flux 214 may be generated for
either transferring operating energy 214A to the seed device 210,
or for communication 214B with the seed device 210 (e.g., one range
of frequencies can be established for wireless energy transfer, and
a second range of frequencies can be established for commanding the
seed device 210 to deliver stimulus).
[0074] In the example shown in FIG. 2 filter 209 can discriminate
between power 214A and communication 214B signaling. For example,
filter 209 can be configured to detect a particular range of
frequencies of time-varying flux 214B captured by the seed 210 such
as by using an inductive pickup 212. The filter 209 can be coupled
to stimulus control logic 216. Logic 216 can be configured to
either inhibit or to initiate tissue electrostimulation, such as in
response to the filter 209 detecting a specified signal. Filter 209
can include, in certain examples, a band-pass filter, which can be
coupled to a threshold comparator. In certain examples, the filter
209 can include a digital demodulator. In some examples,
communication signal 214B can be encoded digitally and transmitted
concurrently to, or comprising, power signal 214A. Examples of
digital encoding of communication signal 214B can include, but are
not restricted to, on-off keying, amplitude-shift keying,
phase-shift keying, frequency-shift keying, or the like.
[0075] In some examples, the combination of the capacitance of the
tuning element 229 and actual or parasitic capacitances of the
inductive antenna 206 can vary when the wireless energy
transmission source is implanted in or near tissue 202E. The effect
of tissue interaction with the system can be reduced by at least
partially surrounding the inductive antenna 206 or inductive pickup
212 (see, e.g., FIG. 7) with a protective material or encapsulant.
Such encapsulation can inhibit or prevent tissue 202E or liquid
penetrating into the cavities between individual turns of a
multi-turn inductive pickup 212 or inductive antenna 206, which
would otherwise increase the effective relative dielectric constant
seen by the pickup 212, or antenna 206.
[0076] In some examples, the microprocessor 224 can be configured
to adjust the capacitance of the tuning element 229, or to adjust
the frequency of a corresponding voltage-controlled oscillator,
such as to achieve a desired level of efficiency in coupling to the
implanted seed 210. In an example, cardiac pacing electrostimulus
can be applied using electrodes 250 and 260, and the evoked
response can be observed using either sensing electrodes 205A,
205B, 222A, 222B or an external electrocardiogram sensing
apparatus. Tuning element 229, or a corresponding frequency
synthesizer, can be adjusted by microprocessor 224, such as to vary
the range of frequencies of magnetic flux 214 that are generated,
for example, until a desired or reliable "capture," (e.g.,
activation of cardiac tissue resulting from electrostimulation) is
observed.
[0077] The seed device 210 can include an inductive pickup 212 and
an optional discrete tuning element 211. In an example, the value
of the capacitance of element 211 can be selected before implant of
the seed device, such as to achieve a desired resonant frequency
when implanted, such as surrounded by blood or muscle tissue. In
some examples, to reduce the size of the seed device 210, a
discrete capacitor 211 can be omitted, and the capacitance used to
achieve resonance of the inductive pickup 212 can be the parasitic
capacitance of the physical coil structure of the inductive pickup
212 (for example, the inter-winding capacitance).
[0078] Inductively-coupled energy 214A can be rectified, such as by
a full-wave rectifier 213, as shown in the example in FIG. 2, or by
a half-wave rectifier, which can save space by reducing the number
of diode components used in the seed device 210. Rectified energy
can be stored in an optional energy storage device 215, such as
shown in the example in FIG. 2. In an example, the energy storage
device 215 can act like a filter capacitor, such as to help
suppress ripple voltage. Stimulus control logic 216 can be coupled
to a switch device 217. The switch 217 can include a solid-state
device (e.g., FET, BJT, IGBT, SCR, thyristor, etc.). In an example,
such as to reduce the size of the seed 210, the filter 209, logic
216, switch 217, and rectifier 213 can be co-integrated into a
single integrated circuit package, or for example, into a
multi-chip module, etc. similar to that described above in the
context of the wireless energy source 220.
[0079] In some examples, multiple storage devices 215 and switches
217 can be used, such as to arrange stored voltages in a desired
series, parallel, or series-parallel combination, such as to
achieve an electrostimulus peak voltage in excess of the maximum
voltage stored on a single storage device 215 using the power
signal 214A.
[0080] A direct-current (DC) blocking device 218 can be used to
inhibit a DC-stimulus component from being coupled to
electrostimulus electrodes 250, 260. Electrostimulus electrodes
250, 260 can be conductively coupled to the muscle tissue 202E to
be electrostimulated (e.g., myocardial tissue). In an example,
electrode 250 can be used as the cathode electrostimulation
electrode, and electrode 260 can be used as the anode
electrostimulation electrode.
[0081] The blocking device 218 and the shunt device 219 can form a
high-pass network configured such that the upper cutoff frequency
and resulting time-domain pulse shape can be selected or even
programmably adjusted such as to form a desired electrostimulus
waveform. In an illustrative example, blocking device 218 can be
selected as a capacitor having capacitance of about 1 microFarad,
and shunt device 219 can be selected as an approximately 5 kiloOhm
resistor to achieve a desired cardiac tissue electrostimulation
pacing pulse.
[0082] The present inventor has recognized that, among other
things, tissue and body fluid inductive energy absorption and
dispersive effects can rapidly increase at frequencies greater than
100 KHz. These effects can severely limit the range and maximum
achievable efficiency of typical magnetic coupling schemes. One
technique for decreasing the losses induced by such effects can be
to substantially or completely surround the inductors 208, 212 with
a high relative permeability magnetic material such as an
iron-powder core or a ferrite material or the like. Such materials
can magnify the magnetic flux density seen by wound structures
nearby them, at a given incident magnetic field intensity.
[0083] The high relative magnetic permeability of such materials
can render the resultant implantable device assemblies incompatible
with magnetic resonance imaging (MRI) equipment. Forces or torques
induced locally (e.g., induced in single components) associated
with the strong bias field present near operating MRI equipment
could result in mechanical damage to the inductive antenna 206 or
inductive pickup 212 assemblies if they incorporate a high relative
magnetic permeability material.
[0084] Additionally, operating MRI equipment can induce large
voltages across the terminals of the inductive antenna 206 or
inductive pickup 212, and large currents inducing an internal
temperature rise. These effects can result in irreversible damage
(e.g., electrical short-circuiting or dielectric failure) to the
inductors 208, 212 or to other components electrically coupled to
the inductors 208, 212, and possibly thermal damage to surrounding
tissue 202E.
[0085] Additional protection devices (e.g., discharge tubes, gaps,
solid-state transient-suppression devices) can be included to
inhibit or prevent MRI-related electrical damage. In the case of
the seed device 210, small size is generally desired (e.g., to
allow intravascular introduction and placement) and such additional
protection devices can take up additional space and could fail to
mitigate the MRI-induced forces and torques.
[0086] The present inventor has also recognized, among other
things, that ferrite core materials can also have limitations. For
example, internal loss mechanisms can preclude their usage as core
materials for highly-tuned inductors at frequencies in excess of a
few MHz. This prevents the resonant "tank circuits" in the
inductive transmit network, 229, 208 and inductive receiver network
212, 211, from achieving high power coupling efficiencies, since
the Quality factors ("Q") of both networks are limited by the
resistive damping effects of increasing losses within the ferrite
core material.
[0087] By contrast, the present inventor has recognized that, in a
different approach, the core materials or mechanical supports
surrounding the inductive antenna 206 or inductive pickup 212 can
be selected to have a relative magnetic permeability less than 1.1,
and can be comprised of one or more materials other than ferrites,
or the core material or mechanical support can provide the antenna
206 or the pickup 212 with an effective relative magnetic
permeability substantially equal to 1 (such as by using a
non-magnetic material, such as air, blood, bodily tissue, bodily
fluid, or one or more other materials for the core material or the
mechanical supports).
[0088] Materials, such as shape-memory Nickel-Titanium (NiTi or
Nitinol) compounds, are effectively non-ferromagnetic and can have
other beneficial mechanical properties. For example, the
shape-memory property can be used to expand (e.g., after implant) a
loop antenna 206 or inductive pickup 212. By increasing or
maximizing the area of a loop forming an inductive antenna 206, or
inductive pickup 212, the mutual coupling of two such inductive
devices in proximity can be enhanced. Such materials can also help
mitigate ferrite efficiency loss and allow more efficient coupling
of time-varying magnetic flux through tissue, such as at
frequencies up to several MHz. The term "air core" can be used to
describe the inductive transmitter 208 and receiver 212 structures,
even though the actual construction of such devices might include
non-ferromagnetic metallic support structures and, when implanted,
tissue or bodily fluid may be present within the core of the
inductive transmitter 208 or receiver 212.
[0089] A mathematical analysis of a simplified combination of the
wireless energy source 220 and seed 210 allows power coupling
efficiency, .eta., and electrostimulus output voltage magnitude,
|V.sub.L|, to be computed. The combination of switch 228, and
battery 226 can be represented as an AC voltage source operating at
angular frequency .omega., and peak output voltage V.sub.0. The
inductive antenna 206 can be modeled as a combination of an ideal
inductor 208, as L, in series with a transmit circuit resistance R.
Tuning element 229 can be modeled as a capacitor, C. The transmit
circuit impedance can be represented as Z=R+i(.omega.L-1/.omega.C),
in which i= -1. At resonance, C=1/.omega..sup.2L, and Z=R. The
imaginary components, due to the reactances of the capacitor and
inductor, can cancel each other (unity power factor).
[0090] Similarly, for the circuitry included in seed 210, the
inductor 212 can be modeled as L.sub.1, and its corresponding loss
as resistance "r" in series with L.sub.1. Tuning element 211 can be
modeled as a parallel capacitor C.sub.1, and the tissue load 202E
appearing across electrostimulus electrodes 250, 260 can be modeled
as R.sub.L. Neglecting the rectifier 213, switch 217, shunt
capacitor 215, blocking device 218, and shunt resistor 219, the
receiver inductive pickup impedance can be represented as
Z.sub.1=r+i.omega.L.sub.1 and the impedance associated with the
tissue load and tuning element can be represented as
Z.sub.L=R.sub.L/(1+i.omega.R.sub.LC.sub.1).
[0091] For the seed 210, this corresponds to a lossy inductive
pickup Z.sub.1=r+i.omega.L.sub.1 in parallel with a load comprised
of Z.sub.L=R.sub.L/(1+i.omega.R.sub.LC.sub.1). The total parallel
impedance
Z.sub.2=r+R.sub.L/(1+(.omega.R.sub.LC.sub.1).sup.2)+i[.omega.L.sub.1-.ome-
ga.R.sub.L.sup.2C.sub.1//(1+(.omega.R.sub.LC.sub.1).sup.2]. At
resonance,
1+(.omega.R.sub.LC.sub.1).sup.2=R.sub.L.sup.2C.sub.1/L.sub.1, and
Z.sub.2=r+R.sub.L/(1+(.omega.R.sub.LC.sub.1).sup.2)=r[1+L.sub.1/(rR.sub.L-
C.sub.1)]. The magnitude of Z.sub.L= {square root over
((L.sub.1/C.sub.1))}.
[0092] The mutual inductance, M, of transmit antenna 206 and
inductive pickup 212 can be represented as the product of the self
inductances of the two inductors 208, 212 and a coupling constant,
.kappa.: M.sup.2=.kappa.L L.sub.1. Power coupling efficiency and
peak output voltage at the tissue load 202E can be represented
as:
.eta.=.kappa.QQ.sub.1x/[(1+x)(1+x+.kappa.QQ.sub.1)] (1)
|V.sub.L|= {square root over
((R.sub.L/R).kappa.QQ.sub.1x)}V.sub.0/(1+x+.kappa.QQ.sub.1) (2)
where Q=.omega.L/R=quality factor of transmitter,
Q.sub.1=.omega.L.sub.1/r=quality factor of receiver, and
x=L.sub.1/(rR.sub.LC.sub.1). The following relation can be
obtained:
.kappa.QQ.sub.1>>1+x,.eta..fwdarw.x/(1+x) (3)
and when x>>1, the power coupling efficiency, .eta.,
approaches 1 (corresponding to 100%). Thus, for small values of the
coupling constant, .kappa., if the quality factors are sufficiently
large, the power coupling efficiency can approach unity.
[0093] Generally, the seed 210 receiver resonant frequency and
quality factor Q.sub.1 can vary depending on the specific implant
configuration of the inductive pickup 212, and the resulting tissue
and blood proximity effects on the electrical response of the
inductive pickup 212. However, by actively statically or
dynamically varying the value of tuning element 229 in the wireless
energy source 220, as described previously, the wireless energy
source 220 transmitter resonant frequency can be varied, such as to
compensate for changes in the seed 210 receiver resonant frequency
or to control electrostimulus amplitude or energy achieved at
electrodes 250, 260.
[0094] If the transmitter 220 quality factor, Q, is selected to be
much greater than the receiver quality factor, Q.sub.1, the
receiver can have a broader "tuning envelope" than the transmitter.
With a broader seed 210 receiver response characteristic, the
transmitter tuning element 229 can be adjusted more easily (e.g.,
less precisely) to provide an operating frequency at resonance
corresponding the to resonant frequency of the receiver in seed 210
(e.g., the transmitter can be tuned to be more sharply "peaked" at
resonance than the receiver, and transmitter resonant frequency can
then be swept until centered on receiver resonant frequency).
[0095] In some examples, varying the resonant frequency of the
transmitter by changing the capacitance of tuning element 229 can
also control the magnitude of the electrostimulus voltage coupled
to the tissue load 202E. Selecting a value for tuning element 229
that shifts the resonant frequency of the wireless energy source
220 away from the resonant frequency of the seed 210 can result in
decreasing maximum voltage, |V.sub.L|, coupled to the tissue load
202E. This can reduce the size of the seed 210 by eliminating or
reducing the complexity of logic 216 and the switch device 217 such
as by allowing electrostimulation amplitude control to be
accomplished by the wireless transmission source 220.
[0096] In some examples, power signal 214A can be limited in
duration or maximum amplitude such as to avoid tissue heating or
regulatory limits for average or instantaneous power transmitted
through tissue. The resulting rectified energy can be integrated or
otherwise accumulated by, for example, storage device 215.
|V.sub.L| can, for instance, be established by a series- or
shunt-regulation component such as a Zener diode 230.
[0097] In some examples, Zener diode 230 can be used to simplify or
eliminate stimulus control logic 216 and switch device 217 when a
pulse-width modulation (PWM) scheme is used at the transmission
source 220. A microprocessor, state machine, timing logic, and the
like can be omitted from the seed 210 to reduce complexity,
physical volume, etc.
[0098] In one example, stimulus control logic 216 can still be used
to inhibit electrostimulation delivery to tissue load 202E (e.g.,
by opening switch device 217 when an intrinsic event is sensed),
but is not required to control the level of electrostimulation
energy content delivered to tissue load 202E.
[0099] In some examples, power signal 214A can be established at a
specific burst duration (e.g., a burst can be a square pulse
envelope commencing a sequence of multiple resonant oscillations).
The duration or pulse width of the burst of power signal 214A can
be related to the energy content delivered to the tissue load 202E
when the regulation device 230 is clamping the voltage across the
storage device 215.
[0100] If tissue 202E is modeled as a cardiac tissue load having a
resistance R.sub.L=1 kiloOhm in parallel with a series-combination
of a 1 kiloOhm resistor (r.sub.L) and a 1 microFarad capacitor
(C.sub.L), a cardiac tissue electrostimulation pacing pulse of
greater than 4V peak amplitude, |V.sub.L|, can be achieved using a
resonant frequency of 1 MHz.
[0101] For the leading edge of an example of a cardiac tissue
electrostimulation pulse, the load capacitor can be represented
effectively as a short circuit, and the AC resistance of the model
cardiac tissue load 202E is equal to around 500 ohms (1 kiloOhm in
parallel with 1 kiloOhm).
[0102] In some examples, the burst duration of power signal 214A
can be controlled by the microprocessor 224 and switching element
228 at the transmission source 220 to achieve a desired energy
content coupled to the tissue load 202E.
[0103] A theoretical voltage delivered across a cardiac tissue
capacitance, V.sub.CAP, can be represented as:
V.sub.CAP=V.sub.CLAMP[1-e.sup.-w/r.sup.L.sup.C.sup.L] (4)
[0104] where V.sub.CLAMP represents the voltage clamping threshold
of the regulating device 230, and w represents the burst pulse
duration (in seconds). For small burst pulse durations, V.sub.CAP
can be approximated as:
V.sub.CAP=V.sub.CLAMP[w/r.sub.LC.sub.L] for w<<r.sub.LC.sub.L
(5)
[0105] In an example, V.sub.CLAMP can be 5.6V (e.g., established by
a Zener diode 230), w can be 775 microseconds, r.sub.L=R=1 kiloOhm,
and C=1 microFarad. Using EQUATION 4, V.sub.CAP can be computed as
approximately 3 Volts. In another example, w can be 1250
microseconds, and V.sub.CAP can be computed as approximately 4
Volts.
[0106] In some examples, the volume occupied by seed 210 can be
decreased by limiting the total energy stored, for example, storage
device 215. An estimate of the desired stored energy for various
electrostimulation pulses can be made. For example, if R.sub.L=500
Ohms, and |V.sub.L|=2.5V, a square-wave pulse of duration T=0.4
milliseconds can correspond to a stored electromstimulation energy
of T|V.sub.L|.sup.2/R.sub.L=5 microJoules.
[0107] Storage device 215 can be specified as a capacitor=C.sub.S,
in microFarads. The energy stored in capacitor 215 can be
represented as 1/2 C.sub.S|V.sub.L|.sup.2. The number of
electrostimulation delivery cycles that the energy stored in the
capacitor 215 can deliver can be represented as: the energy stored
on the capacitor=1/2 C.sub.S|V.sub.L|.sup.2, divided by the
electrostimulation energy consumed by a single electrostimulation
cycle delivered to the tissue impedance=T|V.sub.L|.sup.2/R.sub.L.
Thus, the number of cycles that capacitor 215 can supply can be
represented as =R.sub.LC.sub.S/2T.
[0108] Tradeoffs can be made between storage device 215 value
C.sub.S, load resistance R.sub.L and, for example, pulse width, to
achieve a desired seed 210 volume and a desired electrostimulation
duration, for instance, during an interval when inductive power
signal 214A can be inhibited.
[0109] For example, the number of desired electrostimulation cycles
can be =N, and the capacitor value for storage device 215 to
provide N electrostimulation cycles can be represented as
C.sub.S=2TN/R.sub.L. In an example, an electrostimulation pulse
duration can be specified as T=0.4 msec, the load resistance can be
R.sub.L=500 Ohms, and the capacitance C.sub.S can be represented
for N=1 as C.sub.S=1.6 .mu.F. A low voltage 1.6 .mu.F capacitor 215
can be small (e.g., sub-millimeter dimensions on each axis).
[0110] In some examples, back-up storage can be desired for patient
protection (e.g., to provide continued electrostimulation for a
limited duration in the temporary absence of power signal 214A). A
heart rate can be specified=H.sub.R in Hertz, a number of cardiac
cycle to be paced in a total time=T.sub.stored, in seconds, can be
represented=H.sub.RT.sub.stored, and the size of the capacitor to
store a corresponding amount of energy can be represented,
C.sub.S=2TH.sub.RT.sub.stored/R.sub.L. For example, one hour=3600
sec of stored electrostimulation energy and a heart rate of 72
beats per minute or 1.2 Hz can be specified, resulting in, for
example, a number of pacing electrostimulation cycles
H.sub.RT.sub.stored=4320, and a total stored energy=21.6
milliJoules. The tissue impedance R.sub.L can be specified as 500
Ohms and pulse width can be specified as T=0.4 msec, and the
capacitance 215 can be represented C.sub.S=6912 .mu.F. Such a
capacitor can occupy several cubic millimeters of volume in the
receiver circuit.
[0111] In some examples, a compromise between capacitor 215 value
C.sub.S and the physical size of the capacitor 215 can be made. For
example, a capacitor 215 can be specified, C.sub.S=320 .mu.F, and
electrostimulation pulses can be specified, |V.sub.L|=2.5
volts.
[0112] In an example, the total energy stored on capacitor 215 is 1
milliJoule, and can be enough energy to deliver 200
electrostimulation cycles of pulse width T=0.4 msec to into a
tissue load R.sub.L=500 Ohms. In an example, capacitor 215 can be
specified C.sub.S=320 .mu.F and the electrostimulation cycle rate
of 72 electrostimulation cycles per minute can result in continued
electrostimulation delivery, for approximately 2.8 minutes, by seed
210, after energy 214A input to C.sub.S is inhibited.
[0113] Capacitor 215 can also be specified to accommodate the
quiescent power consumed by, for example, stimulus control logic
216 comprising a microprocessor, which can be very small depending
upon the device used, but in some cases can be comparable to, or
larger than, the average pacing power. In some examples, the power
consumed by the receiver circuit 210 can be reduced if stimulus
control logic 216 and filter 209 are omitted and switch 217 is
permanently closed or omitted. For some examples, the capacitor
C.sub.S can be a filter capacitor, and the energy 214A received by
the seed 210 is rectified and delivered directly to the tissue load
(e.g., the delivered electrostimulation pulse width can correspond
to the width of a transmitted energy 214A burst pulse, provided
that the time constant .tau.=C.sub.SR.sub.L is less than about one
half of the pulse width). In some examples, direct conversion of
energy 214A into an electrostimulation delivery can be achieved and
C.sub.S<0.4 .mu.F can be specified (e.g., corresponding to an
electrostimulation pulse width of T=0.4 msec and load R.sub.L=500
Ohms).
[0114] In some examples, sensing circuitry 232 can be coupled to
cardiac tissue 202E to provide signaling to stimulus control logic
216 in response to sensed potentials detected by the sensing
circuitry 232. Signaling to stimulus control logic 216 can occur in
response to intrinsic tissue activity (e.g., sensing circuitry 232
establishes a threshold level or window and intrinsic activity can
cause a voltage fluctuation exceeding a threshold level or window).
Stimulus control logic 216 can inhibit electrostimulation using
switch 217 in response to, for example, detection of sensed events
provided by sensing circuitry 232.
[0115] In some examples, a shunt device 219 can also provide charge
neutralization. Charge neutralization can include providing a path
between the electrostimulus electrodes 250, 260 to slowly discharge
an afterpotential occurring during or after an electrostimulation,
resulting in a net neutral charge delivered by the
electrostimulation electrodes 250, 260. For the example of a pacing
waveform described above, charge neutralization can be observed as
a smaller amplitude negative-phase pulse of longer duration
following the positive-phase cardiac tissue electrostimulation
pulse.
[0116] FIGS. 3A-B are views illustrating generally at least a
portion of an example of a wireless electrostimulation node 110A or
"seed" that can be included in a wireless electrostimulation
system. Wireless electrostimulation node 110A can be configured as
a cardiovascular wireless electrostimulation node fixed to or in
myocardial tissue 102. Inductive energy can be coupled to an
inductive pickup 112 supported by one or more shape-memory or other
mechanical struts 300A, 300B, 300C, 300D. In an example, as shown
in FIG. 3B, the struts 300A, 300C, 300D can be disposed radially
around the cylindrical housing 310 such as at angles of 120 degrees
with respect to each other. FIG. 7 shows an example of a partial
cross section view of the inductive pickup 112 comprising both a
mechanical support and a separate inductive wire loop, attached to
the mechanical support. In another example, the inductive pickup
wire loop itself can serve as both the electrical pickup and
mechanical support, reducing the complexity of the assembly.
[0117] In some examples, a tissue attachment mechanism such as
helical fixation device 255 can secure a cylindrical housing 310 to
myocardial tissue 102. This can pull the cylindrical housing 310 to
a desired depth within myocardial tissue 102 such as with an
objective of leaving as little of the housing 310 protruding out of
the myocardial tissue 102 as possible. This can reduce or minimize
the possibility of impingement against other tissue such as during
a heart contraction. The total length of the seed 110A can be
selected to reduce or minimize the likelihood of penetrating the
far side of the myocardium 102.
[0118] In an example, assuming a nominal minimum myocardial wall
thickness of 10 mm, the cylindrical housing 310 can be configured
to have a diameter of less than or equal to 2 mm, and a length of
less than or equal to 5 mm, such that a total length of the
cylindrical housing 310 plus the anode 260, cathode 250, and
fixation device 255 is less than 10 mm, which is short enough to
avoid piercing the far side of the myocardium. In some examples,
discrete internal electronic components can be included in the
cylindrical housing 310. Housing 310 internal electronic components
can be selected for reduced size, and can include, among other
things, one or more discrete surface-mount capacitors, discrete
surface-mount resistors, or discrete surface-mount diodes, and the
like. In an example, a single diode can be used as a half-wave
rectifier to reduce housing 310 volume.
[0119] A cathode electrode 250 can provide a first
electrostimulation electrode that can be embedded into myocardial
tissue 102. In certain examples, all or a portion of fixation
device 255 can be conductively coupled to electrode 250 such as to
target electrostimulation to a specific depth of myocardial tissue
102. An anode electrode 260 can provide a second electrostimulation
electrode that can be in contact with either other cardiac tissue
102 or blood, for instance to provide a return path to complete the
electrostimulation circuit.
[0120] For example, in an endocardial application, the
cardiovascular wireless electrostimulation node 110A is configured
for intravascular delivery to the interior of the heart, via one or
more blood vessels, such as transluminally through a lumen of a
catheter, and can be embedded in myocardium 102 penetrating an
endocardial wall 102A such as the left ventricular free wall. Blood
in contact with anode 260 can provide a conductive path for
electrostimulation energy allowing contractile electrostimulation
(e.g., pacing) of the myocardium 102 coupled to cathode 250.
[0121] In some examples, a retainer shaft 265 can be included, such
as to allow for manipulation of the seed 110A during implantation
(for instance, to secure an actuator assembly to the seed 110A as
part of an intravascular delivery system).
[0122] Struts 300A-D can be constructed from a spring-like (e.g.,
self-expanding or self-opening) flexible shape-memory material such
as a NiTi (Nitinol) compound, such as to accommodate a desired
insertion depth of the cylindrical housing while flexibly
maintaining an approximately circular loop shape for inductive
pickup 112.
[0123] In some examples, struts 300A-D can be welded or adhered to
an inductive pickup 112 comprising a mechanical support made of a
shape-memory material such as a NiTi (Nitinol) compound.
[0124] FIGS. 4A-B are similar to FIGS. 3A-B, but illustrate
generally at least a portion of another example of a wireless
electrostimulation node 110B that can be included in a wireless
electrostimulation system. The combination of one or more struts
400A-D or barb structures 455A-B can provide fixation of the seed
110B in, for example, cardiac tissue 102. In these examples,
rotation is not required in order to establish a specified depth of
penetration in myocardium 102. Housing 410 can be pushed into
tissue 102 to a desired depth, such as to avoid piercing an
epicardial wall opposite penetration into the myocardium 102. In
the example in FIGS. 4A-B, the housing 410 is shown as cylindrical,
but the actual cross-section of the housing can also be configured
as a polygon such as to inhibit or to prevent rotation within an
implant delivery catheter.
[0125] Implant depth can be controlled or limited such as by
modifying strut structures 400A-D to provide a "J"-shaped loop or
hook extending outwards from housing 410 as shown in the example of
FIG. 4A. As the seed 110B further penetrates myocardium 102,
eventually struts 400A-D can limit further insertion (e.g.,
insertion force increases substantially as "J"-shaped loops impact
heart wall 102A). Side barbs 455A-B can be included such as to
inhibit or prevent removal of seed 110B without substantial force.
In this manner, specified depth can be obtained or maintained. In
some examples, barbs 455A-455B can be configured to expand outward
or retract inward, such as during implantation, such as to
facilitate one or more of implantation, removal or retraction of
seed 110B.
[0126] A variety of different electrostimulus electrode shapes can
be used, including, for example, a point-type cathode electrode 450
such as shown in FIG. 4A, and a corresponding anode electrode
460.
[0127] Struts 400A-D can be mechanically secured to inductive
pickup 112B, such as by wrapping around or encircling the cross
section of inductive pickup 112B, for example, such as shown in
FIG. 4A. Other techniques of mechanically coupling struts 400A-D
can include welding or adhering one or more of the struts 400A-D,
such as to one or more of the housing 410, inductive pickup 112B,
etc.
[0128] Generally, a retainer shaft 465 can be provided, such as to
temporarily secure the seed 110B to an actuator component of an
intravascular delivery system during implant.
[0129] In some examples, one or more elements of the seeds 110A and
110B shown in FIGS. 3A, 3B, 4A, 4B can be coated with an
anti-coagulant or other treatment, such as to suppress clot or
thrombus formation. In some examples, one or more elements of the
seeds 110A, 110B can be finished with a surface treatment, such as
to enhance tissue ingrowth. In some examples, the seed 110A, 110B
can be incorporated into the tissue 102. Such embedding can reduce
the likelihood of thrombo-embolism, and can also reduce the
threshold energy that achieves desired electrostimulation (e.g.,
reduction of myocardial pacing threshold voltage).
[0130] Examples of tissue ingrowth enhancing treatments include
surface roughening or texturing, or one or more other
porosity-enhancement treatments. Examples of elements that can be
treated with a tissue ingrowth enhancing surface finish include the
strut structure(s) 300A-D, 400A-D, the inductive pickup 112A or
112B, cylindrical housing 310 or 410, etc.
[0131] In certain examples, one or more elements of the seeds 110A
and 110B can include one or more materials that can be selected for
radio-opacity, such as to enhance visibility of an implanted
component during radiographic medical imaging.
[0132] FIG. 5 is a partial cross-sectional view illustrating
generally an example of at least a portion of a wireless
electrostimulation system including an elongate intravascular
delivery catheter 570, such as for carrying or passing a wireless
electrostimulation node housing 510 through a lumen 571 formed by
the catheter 570.
[0133] In some examples, venous access can be achieved via the
subclavian vein or femoral artery, and a guide catheter can then be
inserted. For example, once a guide catheter has achieved access to
an endocardial region of the heart 102A, a delivery catheter 570,
for example as shown in FIG. 5, can be passed transluminally
through the lumen of the guide catheter. The delivery catheter 570
can be open at an end near a cardiac tissue target 102. The
delivery catheter 570 can be large enough in hollow cross sectional
area forming the lumen 571 to allow a cardiovascular wireless
electrostimulation node housing 510, expandable inductive pickup
512 and one or more expandable struts 500A, 500B to be routed
through one or more blood vessels via the catheter 571 and
endocardially implanted entirely within the heart at the tissue
target 102.
[0134] The rotational position and position along the length of the
delivery catheter 570 of the seed housing 510 can be manipulated,
in an example, such as by a hollow, flexible actuator 572. The
actuator 572 can be mechanically coupled to a retainer pin 565 that
can be connected to the seed housing 510. A fingered-adaptor 574
can be used to engage the retainer pin 565 and to displace it into
a corresponding recess on the fingered-adaptor 574 such as by using
a locking wire 573.
[0135] At the distal end of the delivery catheter, outside the
body, a plunger or other similar manipulator can be used, such as
to apply rotational or translational (e.g., sliding) force to
actuator 572. For example, if a helical tine fixation device 555 is
used, the actuator 572 can transmit rotational force to the seed
housing 510 to screw the tine 555 into myocardial tissue 102, such
as to achieve a desired depth during implantation of the seed
housing 510.
[0136] During the implant procedure, one or more struts 500A, 500B
can be used to couple the inductive pickup 512 to the mechanical
housing 510 of the seed. The struts 500A, 500B can be delivered in
folded or compressed form, such as to reduce cross-sectional area
during delivery. In an example, such as shown in FIG. 5, the struts
500A, 500B and inductive pickup 512 can be folded linearly parallel
to the body of the housing 510. In another example, to further
reduce the net length of the entire assembly during implant, the
struts 500A, 500B and inductive pickup 512 can be wound spirally
around the housing 510. Once a desired depth of fixation device 555
is achieved, locking pull-wire 573 can be pulled. For example, if
attached to an independent manipulator at the distal end of the
delivery catheter 570, pull-wire 573 can be removed by pulling the
manipulator. Once locking pull-wire 573 has been pulled clear of
retainer pin 565, the entire delivery catheter 570 and actuator rod
572 can be pulled away from cardiac tissue wall 102A. This allows
seed housing 510, and fixation 555 to remain.
[0137] FIG. 6 is a partial cross-sectional view, similar to FIG. 5,
but illustrating generally an example of at least a portion of a
wireless electrostimulation system including the removal of a
pull-wire 573, the retraction of an actuator rod 572 and
fingered-adaptor 574 through the hollow region, such as a lumen
571, of a delivery catheter 570, and the retraction of the catheter
570 from a cardiac tissue wall 102A. In this example, retainer pin
565 is no longer captive, thus seed assembly 110C remains at the
cardiac tissue location 102A, 102.
[0138] In some examples, when delivery catheter 570 is pulled away
from cardiac tissue wall 102A, inductive pickup 512 can expand to
an outer diameter of, for instance, 2 centimeters. The size of the
inductive pickup 512 when folded, as shown in FIG. 5, can be
related to the size of the inductive pickup 512 when expanded, as
shown in FIG. 6. The expanded outer diameter of inductive pickup
512 can be selected to allow for intravascular delivery using
delivery catheter 570.
[0139] Once clear of the hollow region, such as the lumen 571, of
the delivery catheter 570, shape-memory mechanical struts 500A,
500B can expand the inductive pickup 512, such as by using a
self-expanding shape-memory material. In an example, additional
expansion force and shape-memory can be provided by the inductive
pickup 512 itself comprising a mechanical support that can be
separate from the struts 500A-B. See FIGS. 7-9 for examples of
inductive pickup and inductive antenna configurations.
[0140] Similar to FIGS. 3A-B, and FIGS. 4A-B, fixation device 555
can help retain the seed 110C, such as at a specified depth in
myocardial tissue 102. Anode 550 and cathode 560 electrodes provide
electrostimulus energy.
[0141] FIG. 7 is a partial cross-sectional view illustrating
generally an example of at least a portion of a wireless
electrostimulation system including an inductive assembly 700. In
this example, the inductive assembly 700 includes windings of a
wire loop 710A, 710B and a mechanical support 705. In this example,
a local encapsulant 720 can be provided, such as for surrounding
the wire loop windings 710A, 710B. A bulk encapsulant 730 can be
provided, in certain examples, such as for surrounding both the
mechanical support 705 and wire loop windings 710A, 710B. The
cross-sectional view of the assembly 700 can describe either an
inductive pickup included as a portion of a seed device (such as
shown in FIG. 3A-B), or, for example, to an inductive antenna
included as a portion of a wireless energy source (such as shown in
FIG. 1).
[0142] In the example shown in FIG. 7, multiple windings 710A, 710B
can be disposed adjacent to or near a mechanical support 705. The
windings 710A, 710B can be constructed of flexible insulated wire.
Individual windings 710A, 710B, can themselves be constructed of
multiple strands of non-insulated wire, such as for providing
enhanced flexibility. In an example, Litz wire (e.g., comprising
multiple strands of silver wire) can be selected, such as for
providing flexibility and improved magnetic performance, such as
discussed below with respect to the example of FIG. 12. In another
example, insulated silver wire can be used for one or more of the
wire loops 710A, 710B.
[0143] In the example shown, encapsulant 720 can serve to inhibit
or prevent blood or moisture ingress into the inter-winding areas
between individual wire loops 710A, 710B. The encapsulant 720 can
also help adhere winding loops 710A, 710B together, such as to
preserve the relative spacing and position of the winding loops
710A, 710B. Preventing moisture ingress and stabilizing the
windings can help reduce variation in electrical performance, such
as over time or during implant (e.g., the inductance and
inter-winding capacitance of the inductive assembly can remain more
stable).
[0144] To facilitate expansion during implantation, the encapsulant
720 can be selected for elasticity, such as for flexibility, or for
bio-compatibility, such as if no bulk encapsulant 730 is used. A
material for encapsulant 720 such as medical-grade silicone can
provide both elasticity and bio-compatibility.
[0145] In certain examples, the bulk encapsulant 730 can serve both
to protect the inductive pickup assembly 700 and to secure the
inductive wire loops 710A, 710B to mechanical support 705. Examples
of bulk encapsulants can include bio-compatible overmolding
compound, heat-shrink tubing, silicone, or other materials that can
be selected for flexibility and bio-compatibility. The outer-most
exposed surface of the inductive assembly 700, in the example shown
in FIG. 7 the bulk encapsulant 730, can be treated with either a
substance that promotes a tissue ingrowth, or an anti-coagulation
substance or both, similar to such finish or treatment such as
discussed with respect to FIGS. 3A-B, 4A-B. The encapsulant can
include a variety of possible over-molding or sheathing materials.
The encapsulant need not result in an entirely void-free space. For
example, the encapsulant can permit penetration of one or more
other elements of the assembly 700. For instance, in some examples,
one or more strut structures such as described in previous figures,
can penetrate the encapsulant material 730, such as to achieve
mechanical or other affixation to the mechanical support 705. In
certain examples, such a strut structure can be mechanically or
otherwise affixed to the encapsulant material 730. In certain
examples, a porous or roughened outer surface can be intentionally
developed on the encapsulant material 730, such as to promote
tissue ingrowth. In certain examples, only a single insulated wire
winding loop 710A is used without any separate support 705.
[0146] FIG. 8 is a diagram illustrating generally a perspective
view of an example of at least a portion of a wireless
electrostimulation system including a spiral wire loop 802 wound
coaxially to encircle a mechanical support 800 or "core." In this
example, a non-conductive gap or discontinuity 801 is located along
the mechanical support loop 800. The gap 801 can reduce a loss
induced by a "shorted secondary effect" of the core 800 when a
conductive material is used for the core 800. Such a loss can be
due to induced eddy currents in, for example, the mechanical
support loop 800. The shorted secondary effect occurs when the core
800 acts like a shorted transformer winding magnetically coupled to
the wire loop 802. The electrical effect of such losses can include
reduced efficiency or de-tuning of the high-Q inductive
antenna/inductive pickup pair in operation. This can be referred to
as "antenna pulling." Introducing gap 801 breaks up the induced
current loop formed by the core 800 and can reduce loss or antenna
pulling effects.
[0147] FIG. 9 is a diagram, similar to FIG. 8, but illustrating
generally a perspective view of an example of at least a portion of
a wireless electrostimulation system including wire loop 902 wound
in a spiral on a face of a mechanical support 900, and including a
non-conductive gap 901, similar to that discussed above with
respect to FIG. 8. The examples shown in FIGS. 8-9 demonstrate that
different physical arrangements of inductive wire loops 802, 902
can be used, such as with respect to mechanical supports 800, 900.
In some examples, FIGS. 8-9 can be combined with the encapsulant or
surface treatments discussed in FIG. 7, such as to form a
bio-compatible inductive antenna or inductive pickup assembly
capable of being implanted within an endocardial location or within
the coronary vasculature.
[0148] FIG. 10 is a diagram, similar to FIG. 1, but illustrating
generally an example of at least a portion of a wireless
electrostimulation system 1000 including an external device 1040
configured for generating a time-varying magnetic flux 1014 that
can be captured by one or more implantable wireless
electrostimulation nodes 1005A, 1005B at a cardiac location 102
inside a patient body 1010. For example, the external device 1040
can be a physician programmer unit comprising a therapy control
unit and wireless energy transmission source. In certain examples,
the external device 1040 can include a device worn externally by a
patient, such as to provide ambulatory electrostimulation therapy
on demand or according to a program established by the external
device 1040. In certain examples, such as where acute
electrostimulation therapy is desired (e.g., in conjunction with
percutaneous coronary intervention or other related treatment), the
external device 1040 can be incorporated into a bed, vest, hat,
chair, or other apparatus that can be worn by or located near the
patient, such as for the brief period during which electrostimulus
therapy is desired.
[0149] FIG. 11 is a diagram illustrating generally an example of at
least a portion of a process 1100 that can be performed including a
wireless electrostimulation node. In certain examples, the wireless
electrostimulation node can be delivered to a location 1105 within
a patient's body. An inductive pickup can be expanded at the
location 1110, such as using a self-expanding material, or using
one or more manipulators, such as passed through a catheter
delivery system as shown in FIGS. 5-6. Magnetic flux can be
generated by a separate inductive antenna and linked to the
inductive pickup 1115. The resulting voltage induced in the
inductive pickup results in energy capture 1120. The captured
energy can be stored or delivered immediately or upon command. In
certain examples, such as shown in FIG. 11, the wireless
electrostimulation node can wait for a command to initiate tissue
electrostimulation 1125, such as a command from a therapy control
unit. Upon receipt of the command, the wireless electrostimulation
node then delivers tissue electrostimulation 1130. In some
examples, the command and time-varying magnetic flux providing
energy for electrostimulation can be the same (e.g., providing
nearly instantaneous electrostimulation upon receipt of an
appropriate magnetic-flux signal, for instance within a specified
range of frequencies, or for a specified duration, such as
described above with respect to FIG. 2).
[0150] FIG. 12 is a plot showing an example of an analysis of an
output voltage, ("Vcalc"), predicted at a wireless
electrostimulation node inductive pickup receiver. A corresponding
actual measured output voltage, ("Vmeas") can be measured across
the output electrodes of an inductive pickup receiver of an
experimental prototype of the wireless electrostimulation node. The
measured output voltage, ("Vmeas"), corresponds to the peak voltage
measured on the rising edge of a electrostimulation waveform
measured across the wireless electrostimulation node's
electrostimulation electrodes, which are coupled to a test
load.
[0151] Both voltages ("Vcalc," "Vmeas") can be plotted versus the
separation (e.g., in centimeters) between (1) an energy
transmission source inductive antenna (transmitter) and (2) a
wireless electrostimulation node inductive pickup (receiver).
[0152] The materials and electrical parameters used for
constructing by way of example the experimental prototype described
with respect to FIG. 12 are described in TABLE 1. The calculated
predicted output voltage shown in FIG. 12, ("Vcalc"), can be
estimated by computing |V.sub.L| using EQUATION 2 and the
electrical parameters shown in TABLE 1.
TABLE-US-00001 TABLE 1 Electrical and Mechanical Parameters Tested
for an Example Shown in FIG. 12. Wireless Energy 5 cm diameter
circular coil made with 10 turns of AWG#25 Transmission Source
insulated copper. (Transmitter): Total measured series transmitter
resistance (coil, FET driver, and capacitor resistances): R = 2.4
Ohms in EQUATION 2. Measured transmitter inductance L = 11.5 .mu.H
Measured transmitter circuit Q = 30.3 Input voltage amplitude
V.sub.0 = 7.2 Volts (at 1 MHz switched on for 500uS duration at a
repetition rate of 1.2 Hz corresponding to a nominal 72
beat-per-minute pacing rate). Wireless 1.7 cm diameter circular
coil made with 7 turns of 0.005'' silver Electrostimulation Node
Litz wire. Litz wire comprising 6 parallel strands of insulated
(Receiver): 0.002'' silver wire Measured receiver resistance r =
0.33 Ohms Measured receiver inductance L.sub.1 = 2.0 .mu.H Measured
and computed receiver inductance Q.sub.1 = 39 Tuning capacitor
C.sub.1 = 0.0116 .mu.F Load: R.sub.L = 500 Ohms for calculation.
Actual test load is a 1 kOhm resistor in parallel with a
series-combination of a 1 kOhm resistor and 1uF capacitor.
[0153] FIG. 13 is an example of a plot from an efficiency analysis
showing the numerically estimated power coupling efficiency, f, in
percent (%), and battery lifetime (in months) associated with a
given separation between (1) an example of an energy transmission
source inductive antenna (transmitter) and (2) an example of a
wireless electrostimulation node inductive pickup (receiver) The
power coupling efficiency, .eta., can be computed from EQUATION 1,
such as using the electrical parameters of TABLE 1. Assuming an
output voltage of |V.sub.L|=3.6 Volts at a coil separation of, for
example, 8 cm, as a pacing benchmark, the output power can be
computed as |V.sub.L|.sup.2/(2R.sub.L)=.about.0.013 Watts for the
duration of the pacing pulse.
[0154] The average power output can by computed by multiplying this
value by the duty cycle. An example of a cardiac pacing pulse
duration is 500 .mu.sec, and an example of a cycle length is 850
msec (corresponding to .about.70 heart beats per minute). The
resulting duty cycle is 0.00059, and the average output power for a
3.6 volt pacing amplitude is around 7.5 .mu.W.
[0155] The input power can be computed by dividing the computed
output power, for this example 7.5 .mu.W, by the power coupling
efficiency, .eta., computed from EQUATION 1, and adding the
quiescent power consumed by, for example, a microprocessor or
microcontroller in the transmitter. Such a quiescent power can be,
in an illustrative example, 0.425 .mu.W. Assuming a minimum 3.6
volt pacing amplitude, FIG. 12 shows power coupling efficiencies,
.eta., in percent (%), for a range of separations between the
transmitter and receiver coils assuming electrical parameters as
are specified in the example in TABLE 1.
[0156] Dividing a battery Watt-hour capacity by the output power
usage gives an estimate of the battery lifetime. An example of a
25-gram lithium rechargeable battery includes around 12 Watt-hours
of useful (recoverable) energy. FIG. 13 shows battery lifetime (in
months) for various separations between transmitter and receiver
coils assuming electrical parameters as specified in the example in
TABLE 1 and assuming, in an illustrative example, a 12 Watt-hr
charge available to an implantable transmitter battery.
[0157] In the example shown in FIG. 13, battery lifetimes of around
three months or longer can be feasible for receiver separations of
8 cm or less at pacing output voltages of 3.6 volts or less.
[0158] Received power will diminish as the angle between the planes
of the transmit and receive coils deviates from zero degrees
(reducing the coupling coefficient, .kappa.), resulting in
orientation sensitivity. In some examples, multiple transmit coils
in multiple planes, and even multiple coils in a single plane, can
help reduce such orientation sensitivity. Multiple receiver coils
consume little additional energy in the far field of the
transmitter, allowing for examples in which multiple receivers can
operate near an inductive transmitter.
[0159] In certain examples, such as discussed above, a useful range
of 8 cm can be suitable for a transmitter inductive antenna that
can be placed against the right ventricular (RV) septum with one or
more loop receivers that can be located endocardially on the left
ventricular (LV) free wall, for example, even for a dilated heart.
In some examples, an inductive receiver on the apical LV free wall
can be separated by 4-6 cm from a transmitter in the RV or an
external transmitter.
[0160] FIG. 14 is a diagram, similar to FIG. 1, but illustrating
generally an example of at least a portion of a wireless
electrostimulation system including a subcutaneous inductive
antenna. In some examples, an implantable transmitter inductive
antenna 1408 need not be located endocardially within a heart 102,
and may be placed subcutaneously on the chest of a patient 1010, or
in the pericardial space adjacent to the heart 102.
[0161] An inductive antenna feedwire assembly 1406 can be
electrically coupled between (1) an inductive antenna 1408 at a
distal end of the feedwire assembly 1406, and (2) an implantable
cardiac rhythm management device 1420 at a proximal end of the
feedwire assembly 1406. In some examples, an inductive antenna 1408
generates a time-varying magnetic flux to be captured by
electrostimulation electrode assemblies 1005A, 1005B.
[0162] In some examples, the inductive antenna 1408 and feedwire
assembly 1406 can be constructed similarly to, for example, an
endocardial flexible lead system (e.g., a bio-compatible silicone
outer jacket can be selected for an outer surface of the feedwire
assembly 1406, and one or more coiled metallic conductors insulated
from one another can be used internally to the assembly 1406 to
energize an inductive antenna 1408).
Additional Notes
[0163] The above detailed description includes references to the
accompanying drawings, which form a part of the detailed
description. The drawings show, by way of illustration, specific
embodiments in which the invention can be practiced. These
embodiments are also referred to herein as "examples." Such
examples can include elements in addition to those shown and
described. However, the present inventors also contemplate examples
in which only those elements shown and described are provided.
[0164] All publications, patents, and patent documents referred to
in this document are incorporated by reference herein in their
entirety, as though individually incorporated by reference. In the
event of inconsistent usages between this document and those
documents so incorporated by reference, the usage in the
incorporated reference(s) should be considered supplementary to
that of this document; for irreconcilable inconsistencies, the
usage in this document controls.
[0165] In this document, the terms "a" or "an" are used, as is
common in patent documents, to include one or more than one,
independent of any other instances or usages of "a" or "one or
more." In this document, the term "or" is used to refer to a
nonexclusive or, such that "A or B" includes "A but not B," "B but
not A," and "A and B," unless otherwise indicated. In the appended
claims, the terms "including" and "in which" are used as the
plain-English equivalents of the respective terms "comprising" and
"wherein." Also, in the following claims, the terms "including" and
"comprising" are open-ended, that is, a system, device, article, or
process that includes elements in addition to those listed after
such a term in a claim are still deemed to fall within the scope of
that claim. Moreover, in the following claims, the terms "first,"
"second," and "third," etc. are used merely as labels, and are not
intended to impose numerical requirements on their objects.
[0166] Method examples described herein can be machine or
computer-implemented at least in part. Some examples can include a
computer-readable medium or machine-readable medium encoded with
instructions operable to configure an electronic device to perform
methods as described in the above examples. An implementation of
such methods can include code, such as microcode, assembly language
code, a higher-level language code, or the like. Such code can
include computer readable instructions for performing various
methods. The code may form portions of computer program products.
Further, the code may be tangibly stored on one or more volatile or
non-volatile computer-readable media during execution or at other
times. These computer-readable media may include, but are not
limited to, hard disks, removable magnetic disks, removable optical
disks (e.g., compact disks and digital video disks), magnetic
cassettes, memory cards or sticks, random access memories (RAMs),
read only memories (ROMs), and the like.
[0167] The above description is intended to be illustrative, and
not restrictive. For example, the above-described examples (or one
or more aspects thereof) may be used in combination with each
other. Other embodiments can be used, such as by one of ordinary
skill in the art upon reviewing the above description. The Abstract
is provided to comply with 37 C.F.R. .sctn. 1.72(b), to allow the
reader to quickly ascertain the nature of the technical disclosure.
It is submitted with the understanding that it will not be used to
interpret or limit the scope or meaning of the claims. Also, in the
above Detailed Description, various features may be grouped
together to streamline the disclosure. This should not be
interpreted as intending that an unclaimed disclosed feature is
essential to any claim. Rather, inventive subject matter may lie in
less than all features of a particular disclosed embodiment. Thus,
the following claims are hereby incorporated into the Detailed
Description, with each claim standing on its own as a separate
embodiment. The scope of the invention should be determined with
reference to the appended claims, along with the full scope of
equivalents to which such claims are entitled.
* * * * *