U.S. patent application number 11/290775 was filed with the patent office on 2007-05-31 for medical device packaging system.
Invention is credited to Paul G. Krause, Brian B. Lee, Steven N. Lu, Sean B. McAdams, G. Jordan Montgomery, William J. Plombon, Judy B. Salzer, Lee Stylos, William K. Wenger.
Application Number | 20070123947 11/290775 |
Document ID | / |
Family ID | 37907650 |
Filed Date | 2007-05-31 |
United States Patent
Application |
20070123947 |
Kind Code |
A1 |
Wenger; William K. ; et
al. |
May 31, 2007 |
Medical device packaging system
Abstract
A system, comprising a sterilizable package; an implantable
medical device placed inside the sterilizable package; and an
electrical interface electrically coupled to the implantable
medical device and extending from inside the sterilizable package
to outside the sterilizable package. In various embodiments, the
interface may include package contacts electrically coupled to
electrode terminals on the implantable medical device, patient
terminals and conductors extending between the package contacts and
the patient terminals.
Inventors: |
Wenger; William K.; (Saint
Paul, MN) ; Krause; Paul G.; (St. Louis Park, MN)
; Plombon; William J.; (Forest Lake, MN) ; Lu;
Steven N.; (Fridley, MN) ; McAdams; Sean B.;
(Minneapolis, MN) ; Lee; Brian B.; (Golden Valley,
MN) ; Stylos; Lee; (Stillwater, MN) ; Salzer;
Judy B.; (Coon Rapids, MN) ; Montgomery; G.
Jordan; (Blaine, MN) |
Correspondence
Address: |
MEDTRONIC, INC.
710 MEDTRONIC PARK
MINNEAPOLIS
MN
55432-9924
US
|
Family ID: |
37907650 |
Appl. No.: |
11/290775 |
Filed: |
November 30, 2005 |
Current U.S.
Class: |
607/32 |
Current CPC
Class: |
A61N 1/372 20130101;
A61B 2050/0065 20160201; A61B 50/30 20160201; A61N 1/37512
20170801; A61N 2001/37294 20130101 |
Class at
Publication: |
607/032 |
International
Class: |
A61N 1/00 20060101
A61N001/00 |
Claims
1. A system, comprising: a sterilizable package; an implantable
medical device placed inside the sterilizable package; and means
for conveying a physiological signal to the implantable medical
device within the sterilizable package without breaching the
implantable medical device sterility.
2. The system of claim 1 wherein the implantable medical device
includes a sensor terminal and the conveying means includes means
for making electrical contact with the sensor terminal.
3. The system of claim 2 wherein the implantable medical device
sensor terminal is adapted for coupling to any of: an electrode, a
blood pressure sensor, an accelerometer, a blood chemistry
sensor.
4. The system of claim 1 wherein the conveying means includes means
for receiving the physiological signal.
5. The system of claim 1 wherein the means for receiving the
physiological signal includes means for connecting a medical sensor
operatively disposed in or on a patient to the receiving means.
6. The system of claim 1 wherein the conveying means includes any
of: an inductive element, a capacitive element, an antenna, and an
optical fiber.
7. The system of claim 1 wherein the conveying means includes a
flexible substrate and, disposed on the flexible substrate, any of:
conductive ink, conductive foil, conductive film, and conductive
tape.
8. The system of claim 1 further including means for transmitting
signals received by the implantable medical device from the
conveying means to an external device.
9. The system of claim 1 further including: a computerized
database; a communication network coupled to the database; means
for transmitting data from the implantable medical device to the
database via the communication network.
10. The system of claim 1 wherein further including means for
processing signals received by the implantable medical device using
the conveying means.
11. The system of claim 10 wherein the implantable medical device
further includes means for generating an signal corresponding to
signals received by the implantable medical device using the
conveying means.
12. The system of claim 1 wherein the sterilizable package includes
an inner surface and an outer surface and wherein the conveying
means is formed on a portion of any of: the inner surface and outer
surface.
13. The system of claim 1 wherein the sterilizable package includes
a device tray and a tray lid sealed to the device tray.
14. The system of claim 1 further including means for generating
pressure for promoting electrical contact between the conveying
means and the implantable medical device.
15. The system of claim 1 wherein the conveying means includes a
template corresponding to the shape of the implantable medical
device.
16. The system of claim 15 wherein the template includes means for
facilitating marking a selected implant arrangement.
17. The system of claim 1 wherein the implantable medical device
includes a connector header having electrical contacts disposed in
a connector bore, and the conveying means includes means for
electrically coupling the conveying means to the connector bore
electrical contacts.
18. The system of claim 1 wherein the conveying means includes a
means for insulating any portion of the conveying means.
19. The system of claim 1 wherein the conveying means includes
means for creating a short circuit across the conveying means for
protecting the implantable medical device from electrical signals
when the conveying means is not in use.
20. The system of claim 1 wherein the conveying means includes
means for relieving mechanical strain across the conveying
means.
21. The system of claim 1 further including an outer carton
containing the sterilizable package means for electrically coupling
to the conveying means from outside of the outer carton.
22. The system of claim 1 wherein the conveying means includes
means for indicating electrical signal conduction by the conveying
means.
23. An electrical interface that allows electrical coupling to an
implantable medical device placed inside a sterilizable package
without breaching the sterility of the sterilizable package,
comprising: package contacts in electrical contact with the
implantable medical device; patient terminals positioned outside
the sterilizable package; and a conductor circuit extending between
the package contacts and the patient terminals.
Description
TECHNICAL FIELD
[0001] The invention relates generally to implantable medical
devices, and, in particular, to configurations of implantable
medical device packaging systems.
BACKGROUND
[0002] Implantable medical devices (IMDs) such as cardiac
pacemakers, implantable cardiovertor defibrillators (ICDs),
implantable loop recorders (ILRs), implantable drug pumps,
neurostimulators, etc. are generally provided by manufactures in a
sterilized package. The package commonly includes an external
carton or container for holding a sterilized inner tray or pouch
containing the IMD. The IMD is sterilized within the inner tray or
pouch using appropriate sterilization methods such as steam, gas or
ultrasonic sterilization. The inner tray or pouch is generally
provided with a peelable or tearable seal that can be opened to
drop the sterile IMD contained therein into a sterile field without
compromising the sterility of the IMD or the sterile field. For
example, an IMD packaging tray having an open top may be sealed
closed with a paper lid that is peeled back at the time of an
implant procedure to allow the IMD to be dropped out of the tray
into the sterile field.
[0003] Some packaging systems may include within the external
carton or container an outer tray or pouch for carrying the
sterilized inner tray or pouch. The inner tray or pouch and device
contained therein may be sterilized within the outer tray or pouch.
The outer tray or pouch may then be peeled open to drop the inner
tray or pouch into the sterile field at the time of implant. An
implanting physician or assistant may then open the inner tray or
pouch within the sterile field.
[0004] Pre-implant testing, electrophysiological mapping, or system
testing is commonly performed at the beginning of an implantation
procedure to ensure that a patient meets implantation criteria
and/or to determine an optimal implant location for the IMD and/or
associated electrodes. Such testing may be performed using the IMD
since using the IMD itself would generally provide the most
reliable test results. However, during pre-implant testing,
considerable care must be taken to ensure that the IMD and
associated leads remain sterile for implantation. Once the IMD is
removed from the sterile packaging, the IMD cannot be re-shelved
should the patient not meet implantation criteria. As such,
external equipment is often substituted for making physiological
measurements or performing electrophysiological mapping. Use of
external equipment for performing testing or mapping includes
certain limitations, however, since the electronics of the external
equipment will generally be different than the electronics of the
IMD. Signals measured by external equipment may not be the same as
signals measured at the same location by the IMD. Even minor signal
differences can limit the usefulness or reliability of such
measurements for the purposes of pre-implant tests.
[0005] Since IMDs tend to be costly devices, it is undesirable to
open the IMD sterile packaging prior to knowing with reasonable
certainty that the IMD is appropriate for the patient and that an
acceptable implantation site for the device and/or leads can be
identified. Furthermore, external equipment needed for performing
pre-implant testing may not be readily available and requires extra
space within the operating theater, which is often already crowded
with equipment and personnel. Often a programmer that supports
surface ECG recording in addition to receiving telemetry signals
from the IMD is needed to perform pre-implant testing. Such
full-function programmers can be bulky and costly to provide to all
clinical centers.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] FIG. 1 is an illustration of one type of IMD in which an
embodiment of the invention may be implemented.
[0007] FIG. 2 is an illustration of an alternative IMD with which
the invention may be practiced.
[0008] FIG. 3 is a functional block diagram representing components
that may be included in an IMD electronics module along with
associated memory.
[0009] FIG. 4A is a block diagram providing an overview of an IMD
packaging system including an electrical interface according to
various embodiments of the invention.
[0010] FIG. 4B is a diagram of an IMD packaging system wherein an
electrical interface is provided in the form of a flexible
circuit.
[0011] FIG. 5 is a perspective view of one type of sterilizable
package that may be used in various embodiments of the
invention.
[0012] FIG. 6A is a side cut-away view of one embodiment of a
packaging system including an electrical interface used for
accessing IMD electronics while the IMD is contained within a
sterile package.
[0013] FIG. 6B is a side, sectional view of an alternative
embodiment of packaging system including a pressure generating
member for promoting reliable electrical contact between an
electrical interface and an IMD enclosed in a sterile package.
[0014] FIG. 6C shows a pressure generating member 121 packaged
within an inner tray, around an IMD and electrical interface for
promoting good electrical contact between the IMD and electrical
interface.
[0015] FIG. 7 is a top view of the packaging system shown in FIG.
6A.
[0016] FIG. 8 is a partial, side, cut-away view of an IMD packaging
system according to an alternative embodiment of the invention
wherein an electrical interface is formed on a substrate that
includes a surface of the sterilizable package.
[0017] FIG. 9 is a bottom view of the inner tray lid shown in FIG.
8.
[0018] FIG. 10A is a top view of an alternative embodiment of a
flexible circuit electrical interface formed on the inner surface
of an inner tray lid.
[0019] FIG. 10B is a top view of the flexible circuit shown in FIG.
10A after folding the flexible substrate along fold lines to
provide insulation to the exterior portions of conductors.
[0020] FIG. 10C is a top view of the electrical interface shown in
FIG. 10B further including elements for protecting the electrical
interface.
[0021] FIG. 11 is a perspective view of an alternative embodiment
of an electrical interface.
[0022] FIG. 12 is a diagram of an alternative embodiment of an
electrical interface used for connecting to IMD electronics while
the IMD is within sterile packaging.
[0023] FIG. 13 is a partial, side cut-away view of a packaging
system according to another embodiment of the invention.
[0024] FIG. 14 is a partial, side cut-away view of an electrical
interface provided with a substrate that extends along the outer
surface of a package tray lid.
[0025] FIG. 15 is a plan view of an IMD in a sterilizable package
provided with an interface for accessing IMD electronics according
to another embodiment of the invention.
[0026] FIG. 16 illustrates a bifurcated electrical interface.
DETAILED DESCRIPTION
[0027] In the following description, references are made to
illustrative embodiments for carrying out the invention. It is
understood that other embodiments may be utilized without departing
from the scope of the invention. For the purposes of illustration,
various embodiments of the invention are described herein in the
context of IMDs used to monitor cardiac function. Such IMDs may or
may not include cardiac stimulation therapy delivery capabilities.
Such devices include, for example, cardiac pacemakers, which may be
used for delivering a wide variety of cardiac stimulation therapies
including, for example, bradycardia pacing, cardiac
resynchronization therapy, extra systolic stimulation, and
anti-tachycardia pacing. Such devices further include
cardiovertor/defibrillators, implantable ECG recorders, and
implantable hemodynamic monitors.
[0028] The scope of the invention is not limited, however, to
devices configured to monitor cardiac signals. Aspects of the
invention may be implemented in any IMD system in which electrical
connection to the IMD electronics, prior to removing the IMD from
sterilized packaging, is desired. Access to the IMD electronics may
be desired for demonstration purposes, for verifying device
functionality, or for performing pre-implant testing. Among the
other types of IMDs in which aspects of the invention may be
implemented are implantable drug pumps and neurostimulators, which
are used for stimulating any portion of the central or peripheral
nervous system. For example, neurostimulators may be used for
controlling pain, reducing tremor, restoring muscle function,
controlling incontinence, treating sleep apnea, treating digestive
disorders or for vagal nerve stimulation for controlling cardiac
function.
[0029] FIG. 1 is an illustration of one type of IMD in which an
embodiment of the invention may be implemented. IMD 10 is shown as
an implantable ECG recorder, also referred to as an implantable
loop recorder (ILR). IMD 10 is provided with a housing 12 for
enclosing an electronics module 16 which controls device function
and associated memory 18 for storing ECG data. IMD 10 includes two
or more electrodes 14 incorporated on IMD housing 12 which function
as subcutaneous ECG electrodes for the recordation of ECG signals
by IMD 10. Electrodes 14 are coupled to the internal electronics
module 16 such that ECG signals may be sensed by electrodes 14 and
stored in memory 18, typically in a continuously looping manner.
Examples of implantable cardiac monitoring devices that may be used
for recording ECG data, as well as other physiological data, are
generally disclosed in U.S. Pat. No. 5,987,352 (Klein et al., Nov.
16, 1999), hereby incorporated herein by reference in its
entirety.
[0030] It can be appreciated that the selection of an implant site
for IMD 10 is important in ensuring that the ECG signal strength is
adequate. Typically, pre-implant mapping is performed using an
external ECG monitor connected to electrodes placed on the surface
of the patient's skin to localize a site corresponding to the
strongest ECG signal strength. Since the electrodes 14 incorporated
on the IMD housing 12 are relatively small compared to typical
surface ECG electrodes, neonatal or pediatric-sized surface
electrodes are commonly used to mimic the size and separation of
the subcutaneous electrodes 14 on IMD housing 12. However, even
when the subcutaneous electrode size and spacing is closely
represented by the surface electrodes used for pre-implant mapping,
the electronics of the external ECG monitor may bear different
mapping results than when the ECG measurements are taken directly
using the IMD electronics module 16.
[0031] FIG. 2 is an illustration of an alternative IMD with which
the invention may be practiced. IMD 20 includes a housing 22 for
enclosing internal electronics 16, and a connector header 24 for
receiving leads 26 disposed in operative relation to a patient's
heart. Leads 26 are illustrated as transvenous leads which
generally carry endocardial electrodes at or near a distal lead
end. A variety of lead configurations are available for use with an
IMD, which may include one or more unipolar, bipolar, or multipolar
leads carrying endocardial, epicardial, subcutaneous, or other
types of electrodes and/or other physiological sensors such as
blood pressure sensors, pH sensors, accelerometers, etc.
[0032] Leads 26 are each provided with a proximal connector
assembly having connectors corresponding to each of the
electrodes/sensors carried by the individual lead. Connector header
24 includes electrical contacts which become electrically coupled
to the lead connectors when the lead connector assembly is fully
inserted in the connector header 24. Electrical contacts included
in connector header 24 provide electrical connection between the
lead connector assembly and the internal IMD electronics 16.
Connection methods for connecting leads to an IMD are known in the
art. An IMD may alternatively be provided with any combination of
electrodes or sensors adapted for subcutaneous or non-subcutaneous
implantation, either on the device housing as shown in FIG. 1 or
carried by leads extending from the IMD, as generally illustrated
in FIG. 2.
[0033] FIG. 3 is a functional block diagram representing components
that may be included in an IMD electronics module along with
associated memory. An IMD, such as IMD 10 or IMD 20 shown in FIGS.
1 and 2 respectively, is generally provided with an electronics
module 16 including timing and control circuitry 32 and an
operating system that may employ microprocessor 30 or a digital
state machine for timing sensing and therapy delivery functions in
accordance with a programmed operating mode. Microprocessor 30 and
associated memory 18 are coupled to the various components of the
IMD via a data/address bus 35. If the IMD is configured to deliver
a therapy, a therapy delivery unit 34 is provided which may include
a pulse generator for delivering electrical stimulation or a drug
reservoir and pump for delivering a drug therapy. Therapy delivery
unit 34 delivers therapies as needed under the control of timing
and control 32. In the case of electrical stimulation therapies,
such as cardiac stimulation therapies, therapy delivery unit 34 is
typically coupled to two or more electrode terminals 15, optionally
via a switch matrix 36. Switch matrix 36 may be used for selecting
which electrodes and corresponding polarities are used for
delivering electrical stimulation pulses. The appropriate number of
electrode terminals 15 is electrically coupled to electronics
module 16 via feedthrough according to methods known in the art.
Electrode terminals 15 may be embodied as electrodes 14
incorporated in the housing of the IMD, as shown in FIG. 1, or
contacts which become electrically coupled to lead connectors as
described in conjunction with FIG. 2.
[0034] Terminals 15 may also be used for coupling electrodes used
for sensing electrical signals within the body to the electronics
module 16. With regard to the cardiac monitoring IMD 10 shown in
FIG. 1, electrode terminals 15 are embodied as subcutaneous
electrodes 14 to deliver ECG signals to signal processor 38. In
other embodiments, combinations of multiple subcutaneous and/or
cardiac electrodes may be used for acquiring multiple ECG vectors
using electrode terminals 15. Such signals may be stored in memory
18 on a continuous, periodic or triggered basis for use in
diagnosing or monitoring a disease state. For example, in an ILR,
heart rate and/or arrhythmia information may be determined from
stored ECG signals. In devices that include therapy delivery
capabilities, such as IMD 20 of FIG. 2, sensed cardiac electrical
signals are also used for determining when an electrical
stimulation therapy is needed and in controlling the timing of
stimulation pulses.
[0035] Electrodes used for sensing and electrodes used for
stimulation may be selected via switch matrix 36. When used for
sensing, electrode terminals 15 are coupled to signal processing
circuitry 38 via switch matrix 36. Signal processor 38 includes
sense amplifiers and may include other signal conditioning
circuitry and an analog to digital converter. Electrical signals
may then be used by microprocessor 30 for detecting physiological
events, such as detecting and discriminating cardiac arrhythmias.
In other embodiments, electrical signals sensed at electrode
terminals 15 may be used for measuring impedance signals for
monitoring edema, respiration or heart chamber volume.
[0036] One or more physiological sensors 41 may optionally be
included. Such sensors may include pressure sensors,
accelerometers, impedance sensors, flow sensors, blood chemistry
sensors, activity sensors or other physiological sensors known for
use with IMDs. Sensors 41 are coupled to electronics module 16 via
a sensor interface 40 which provides sensor signals to signal
processing circuitry 38. Sensor signals are used by microprocessor
30 for detecting physiological events or conditions. For example,
an IMD may monitor heart wall motion, blood pressure, blood
chemistry, respiration, or patient activity. Monitored signals may
be used for sensing the need for delivering a therapy under control
of the operating system.
[0037] The operating system includes associated memory 18 for
storing a variety of programmed-in operating mode and parameter
values that are used by microprocessor 30. The memory 18 may also
be used for storing data compiled from sensed physiological signals
and/or relating to device operating history for telemetry
transmission upon receipt of a retrieval or interrogation
instruction. These functions and operations are known in the art,
and are generally employed to store operating commands and data for
controlling device operation and for later retrieval to diagnose
device function or patient condition.
[0038] Telemetry circuitry 42 is typically provided to enable
bidirectional communication between the IMD and an external
programmer, home monitor, patient activator, or other external
device, according to methods and apparatus known in the art.
Programming commands or data are transmitted during uplink or
downlink telemetry between IMD telemetry circuitry 42 and external
telemetry circuitry included in a programmer or monitoring unit.
According to one embodiment of the invention, pre-implant test data
is obtained using a packaging system that enables connection to
electronics module 16 through a sterile IMD package. Pre-implant
test data so obtained can be transmitted in real time, or at a
delayed time, to an external monitor/programmer using telemetry
circuitry 42. Telemetry circuitry 42 may correspond to telemetry
systems known in the art, and may be configured for long-range
telemetry communication with a monitor/programmer. Long-range
telemetry systems are generally disclosed in U.S. Pat. No.
6,482,154 issued to Haubrich et al., incorporated herein by
reference in its entirety.
[0039] In some embodiments, an alert unit 44 is provided for
generating an audible tone or sound. As will be described in
greater detail below, electronics module 16 may be used to perform
pre-implant testing using a flexible circuit or other coupling
appliance for connecting external electrodes to terminals 15
without compromising the sterility of IMD within a sterile package.
Microprocessor 30 may process signals received at terminals 15 for
determining if implantation criteria are met or for identifying an
optimal implantation location or orientation. Alert unit 44 may be
used to generate an audible tone or sound to indicate to a
clinician that a particular test location or orientation meets or
does not meet implant criteria or acceptable signal quality.
[0040] It is recognized that the overall complexity of electronics
module 16 and other IMD components may vary depending on the
functionality provided by the IMD. Functional units may be added or
removed from the block diagram represented in FIG. 3 according to a
particular application. For example, IMD 10 shown in FIG. 1 may be
used for ECG monitoring without therapy delivery capabilities in
which case electronics module 16 is provided without therapy
delivery unit 34. In other embodiments, a leadless IMD
incorporating electrodes in the IMD housing may include pacing
and/or cardioversion/defibrillation capabilities in which case
therapy delivery unit 34 would include a low-voltage pulse
generator and/or high-voltage capacitors with associated capacitor
charging and high-voltage output circuitry as is known in the
art.
[0041] FIG. 4A is a block diagram providing an overview of an IMD
packaging system according to various embodiments of the invention.
The packaging system 62 includes a sterilizable package 60 for
containing an IMD 10. Packaging system 62 further includes an
electrical interface 50 that allows electrodes or other sensors
placed on or in a patient 66 to be coupled to electronics module 16
while IMD 10 remains with sterilizable package 60, without
compromising the sterility of IMD 10.
[0042] Electrical interface 50 includes patient terminals 54,
signal/conduction transmission 56, and package contacts 52. Patient
terminals 54 may be in the form of electrodes adapted for placement
directly on or in patient 66. Alternatively, patient terminals 54
may be provided as connectors, such as snaps or clips, onto which
electrodes or sensors placed on or in patient 66 may be attached
using a cable, extension or lead. One or more package contacts 52
are electrically coupled to IMD electrode terminals 15 (or sensor
terminals 41) included in IMD 10 and thereby electrically coupled
to electronics module 16. As described previously, IMD electrode
terminals 15 may be embodied as electrodes formed in or on the
housing of IMD 10. IMD electrode terminals 15 may alternatively be
embodied as contacts used for electrically coupling lead-based
electrodes and/or sensors to IMD 10. The number of package contacts
and corresponding patient terminals provided will depend on the
application and may correspond to the total number of electrodes
and sensors used by the IMD or a subset of electrodes and sensors
used by the IMD.
[0043] Electrical interface 50 includes signal
conduction/transmission 56 which acts to convey signals received
from the patient at patient terminals 54 to package contacts 52,
across a sterile barrier 61 of package 60. Signal
conduction/transmission 53, generally referred to as "conductor
circuit" hereafter, may include conductors in the form of wires,
foils, conductive tape, film or ink. However, it is recognized that
conductor circuit 53 is not limited to include only conductive
elements. In various embodiments, conductor circuit 53 may include
inductive elements, capacitive elements, antennas, optical fibers,
or any other elements appropriate for conducting or transmitting a
physiological signal received at patient terminals 54 to package
contacts 52. Alternatively, signals may be transmitted from IMD
electronics module 16 to patient 66 using electrical interface 50.
Depending on the type of sensors used by IMD 10, electrical
excitation signals may be required and transmitted to a sensor
operatively positioned in patient 66 via electrical interface 50.
During some pre-implant testing, system tests or demonstration
procedures, electrical pulses, for example stimulation pulses, may
be transmitted from electronics module 16 to patient terminals
54.
[0044] FIG. 4B is a diagram of an implantable medical device
packaging system wherein electrical interface 50 is provided in the
form of a flexible circuit that allows access to the IMD
electronics module 16 while the IMD 10 is enclosed in a
sterilizable package 60. The packaging system includes electrical
interface 50 extending from outside sterilizable package 60 to
inside sterilizable package 60. Electrical interface 50 includes
one or more package contacts 52 each coupled to individual
conductors 56 included in conductor circuit 53, and one or more
patient terminals 54. Each of conductors 56 extend across sterile
barrier 61, between an interior end 59 coupled to a package contact
52 and an exterior end 57 coupled to a patient terminal 54.
[0045] In the embodiment shown, package contact 52 is disposed over
a subcutaneous electrode 14 located on IMD housing 12 while the IMD
remains in package 60. Package contact 52 makes electrical
connection with electrode 14 thereby allowing electrical connection
to the electronics contained in IMD 10 using patient terminal 54,
located outside of sterilizable package 60. In various embodiments,
package contact 52 may be adapted for electrical coupling to any
electrode or any electrode/sensor terminal or contact incorporated
in or on IMD 10.
[0046] Sterilizable package 60 is provided as a tray, pouch or
other container for enclosing and maintaining sterility of IMD 10.
Sterilizable package 60 is typically sealed closed after receiving
IMD 10 to form sterile barrier 61 and submitted to a sterilization
method appropriate for the particular IMD contained therein, e.g.,
steam, gas, or ultrasonic sterilization. Electrical interface 50
conveys electrical signals received at patient terminals 54 across
sterile barrier 61 without compromising the integrity of the sealed
package 60 or the sterility of the IMD 10.
[0047] Electrical interface 50 may be fabricated as a flexible
circuit using conductive ink (e.g., silver-silver chloride ink or a
carbon-based ink) printed on a flexible, insulative substrate 55 to
form conductors 56, package contacts 52 and patient contacts 54.
Alternatively, any of conductors 56, package contacts 52 and
patient contacts 54 may be formed by laminating or adhering
electrically conductive materials in the form of wires, foils,
film, or tape, onto flexible substrate 55. As will be described in
greater detail below, in some embodiments flexible substrate 55
includes a portion of sterilizable package 60 wherein electrical
interface 50 is formed on a surface of package 60.
[0048] Patient terminals 54 may be provided for direct placement on
a patient's skin. Electrical body signals may then be provided to
IMD 10 via electrical interface 50. Electrical interface 50 is
provided with a "neck" 64 along which conductors 56 extend. Neck 64
may be provided with any length to facilitate unencumbered
placement of patient terminals 54 on a patient. Alternatively,
patient terminals 54 may be embodied as coupling terminals or
contacts to which electrode cables or extensions 80 may be attached
to thereby allow greater maneuverability and flexibility during
pre-implant testing, without patient-to-IMD distance limitations.
Electrode extensions 80 may be standard surface electrode cables
carrying surface electrodes 82, which may be standard "off-the
shelf" electrodes, adapted for placement on a patient's skin.
[0049] Patient terminals 54 may alternatively be adapted for
electrical coupling to patient leads or lead extensions. For
example, extensions 80 may be provided with snaps, alligator clips,
manufacturer-provided connectors, or other electrical connectors
for facilitating electrical connection to patient terminals 54 at
one end of an extension 80 and to a connector assembly of an
implanted lead at the other end of an extension 80. Extensions 80
may be provided in a sterile condition to allow connection to
implanted sterile leads. It is recognized that numerous
configurations may be used for connecting patient terminals 54 to a
patient, either directly or indirectly using extensions and/or
leads, and such embodiments may include any number of electrodes
and/or sensors positioned on or in the patient.
[0050] A template 84 may be provided for guiding placement of
surface electrodes 82 to correspond to the separation distance of
IMD electrodes 14. Alternatively, electrode extensions 80 and
surface electrodes 82 may be custom components, provided with
template 84 for mimicking the size and separation of IMD electrodes
14. Patient terminals 54 may be provided as snaps, clips, or any
other mechanism for mechanically and electrically coupling
electrode extensions 80. Template 84 may include labeling to
indicate which patient terminals 54 correspond to which IMD
electrode terminals 15 and/or sensor terminals 41.
[0051] During pre-implant testing, signals obtained during
placement of patient terminals 54 at different body locations and
orientations may be stored and analyzed by IMD 10 for determining
an optimal implant location. Alternatively or additionally, IMD 10
may transmit signals received using electrical interface 50 to an
external programmer/monitor 70 via a telemetry connection 71.
[0052] External programmer/monitor 70 may correspond generally to
programmer/monitors known in the art and typically includes
telemetry circuitry 72, a microprocessor-based control system 74, a
display 76, and a user-interface 78, which may be embodied as a
graphical user interface. Display 76 may be in the form of an LCD
screen or other graphical or video display that allows a clinician
to observe displayed signal data, for example ECG signals, while
patient terminals 54 are positioned at different body locations or
orientations. The clinician may manually select an optimal implant
location based on observed data.
[0053] Alternatively, external programmer/monitor 70 or IMD 10 may
analyze received signals using a programmed signal evaluation
routine and automatically recommend an implant site or at least
indicate when a location or orientation meets signal quality or
other implant criteria. Such information can be displayed
graphically or using text messages on display 76. Alternatively,
display 76 may be embodied as an LED display which indicates
through color or number of LEDs illuminated acceptable on
unacceptable signal quality. In yet another embodiment, display 76
may include a speaker for broadcasting sound messages indicating
acceptable or unacceptable signal quality. As described previously,
alert circuitry 44 may generate a signal indicating acceptable or
unacceptable signal quality. A signal evaluation routine may
determine signal features, signal-to-noise ratio, or other signal
characteristics for determining if the signal quality meets
predefined acceptance criteria.
[0054] Display 76 may further be used to prompt a clinician or
other user to move patient terminals 54 to a number of body
locations or orientations while IMD 10 and/or external
monitor/programmer 70 collects signal data corresponding to each
location. The clinician or other user may use user interface 78 to
indicate to IMD 10 or external monitor/programmer 70 when patient
terminals 54 are being moved to a new location and thereby indicate
when IMD 10 or external monitor/programmer 70 should begin a new
signal evaluation routine. When multiple electrodes or sensors are
available and coupled simultaneously to IMD 10 using patient
terminals 54, the IMD 10 may select different sensing vectors using
switching circuitry 36 (shown in FIG. 3), either automatically or
in response to programmed-in commands.
[0055] External programmer/monitor 70 may vary in functionality and
complexity in different embodiments. For example, in some
embodiments, external programmer/monitor 70 may receive signal data
using telemetry circuit 72, process signal data using
microprocessor 74, and display pre-implant test results on display
76. External programmer/monitor 70 may include a data storage
module for printing or storing received data and/or test results
electronically. In other embodiments, external programmer/monitor
70 may be interfaced with a monitoring device 94 used for
displaying and/or storing signal data obtained using electrical
interface 50.
[0056] In still other embodiments, external programmer/monitor 70
may serve as a communication conduit between IMD 10 and a
computerized database 90. Database 90 may be a web-based patient
management system or implemented on a personal computer. Database
90 is coupled to a communication network 92, which may be a
wireless network, enabling communication between database 90 and
external programmer/monitor 70. Signal data received by external
programmer/monitor 70 is transmitted to database 90 via
communication network 92. As such, signals obtained using
electrical interface 50, or test results based on such signals, may
be transmitted directly to database 90 for further analysis and/or
viewing by a user. Database 90 may be accessible on a local or
remote computer, allowing pre-implant testing to be performed in a
time and place independent manner. Database 90 and external
programmer/monitor 70 may be provided according to known patient
management systems, such as those generally disclosed in U.S. Pat.
No. 6,250,309 (Krichen, et al.) and U.S. Pat. No. 6,622,045 (Snell
et al.), both of which patents are incorporated herein by reference
in their entirety.
[0057] FIG. 5 is a perspective view of one type of sterilizable
package that may be used in various embodiments of the invention.
Package 60 includes a tray 104, typically provided with a cavity
106 formed to match the contours of an IMD to be placed therein.
Package tray 104 has an inner surface 110 and an outer surface 111
which, in addition to cavity 106, may form other cavities or
recesses for containing accessories, tools or other components
packaged with the IMD for use during implantation procedures. Tray
104 is fabricated using thermoforming, injection molding or other
appropriate processing of a material that withstands sterilization
procedures used to sterilize the IMD contained therein and acts as
a sterile barrier there after. Packaging tray 104 is commonly
fabricated from high-density polyethylene.
[0058] Tray 104 includes a seal area 108 along inner surface 110
onto which a tray lid 102 is sealed after the IMD and any other
package contents are placed in tray 104. Tray lid 102 includes an
outer surface 105 and an inner surface 103 and is commonly
fabricated from coated paper or a high-density woven or non-woven
polymer material. Tray lid 102 and tray 104 are typically sealed
together along seal area 108 using an appropriate adhesive for
forming a reliable sterile barrier. After undergoing sterilization,
package 60 is placed in any desired outer packaging, which is
typically a box or carton provided with appropriate labeling. In
some embodiments, the packaging system may include an outer tray
and outer tray lid for containing inner tray 104 sealed with inner
tray lid 102. Inner tray 104 may be sterilized within the outer
tray, and the outer tray is placed in the desired outer
packaging.
[0059] FIG. 6A is a side cut-away view of one embodiment of a
packaging system including an electrical interface used for
accessing IMD electronics while the IMD is contained within a
sterile package 60. Sterile package 60 includes an inner tray 104
and outer tray 114. IMD 10 rests in cavity 106 of inner tray 104.
An electrical interface 50 in the form of a flexible circuit 50 is
placed over IMD 10 such that package contact 52 is electrically
coupled to IMD electrode 14. Inner tray 104 is sealed closed with
inner tray lid 102 along seal area 108. Inner tray 104 is placed
within a tray cavity 116 of outer tray 114. Outer tray 114 is
sealed closed with outer tray lid 112 along outer tray seal area
118. The neck 64 of electrical interface 50 is sealed between inner
tray lid 102 and inner tray 104 and between outer tray lid 112 and
outer tray 114 and extends outside of package 60. Patient terminals
54 are located at the exterior ends 57 of conductors 56 extending
along neck 64. Patient terminals 54 are thus available outside of
package 60 for use in coupling a patient to the electronics module
contained within IMD 10, without compromising the sterility of IMD
10 within package 60.
[0060] The depth of IMD cavity 106 in inner tray 104 is dimensioned
appropriately to cause electrode 14 to come into contact with
package contact 52 when the packaging system 62 is assembled. To
promote reliable coupling between package contact 52 and IMD
electrode 14, the thickness 115 of substrate 55, at least in the
area of package contact 52, is provided to create pressure between
contact 52 and IMD electrode 14. Package contacts 52 may be formed
as blisters or buttons, having a generally hemispherical shape, for
example, which protrudes from flexible circuit substrate 55 to
thereby promote reliable electrical contact with IMD electrodes
14.
[0061] Additionally or alternatively, a compressible element 120
may be included or incorporated in inner tray 104. Physical contact
between package contact 52 and IMD electrode 14 should be adequate
to create an electrical connection between contact 52 and electrode
14 without causing mechanical damage to electrode 14. As shown,
compressible element 120, which may be embodied as a compressed
foam member, is placed between the inner surface 110 of inner tray
104 and IMD 10. Compressible element 120 generates pressure between
IMD electrode 14 and package contact 52 to promote reliable
electrical contact there between. Compressible element 120 could
alternatively be positioned between the inner surface 103 of inner
tray lid 102 and electrical interface 50 or along the outer surface
105 of inner tray lid 102, between inner tray lid 102 and outer
tray lid 112. Compressible element 120 may alternatively be
enclosed in an outer carton containing package 60 and positioned to
generate pressure in the area of package contact 52 and IMD
electrode 14.
[0062] FIG. 6B is a side, sectional view of an alternative
embodiment of packaging system including a pressure generating
member 121 for promoting reliable electrical contact between
electrical interface 50 and IMD 10 enclosed in sterile package 60.
In FIG. 6B, pressure generating member 121 is provided as a
generally U-shaped clip having a closed side 119 and an open side
117. Pressure generating member 121 is adapted for positioning
around the outside of outer tray 114 and outer tray lid 118 to
generate positive pressure in the area of package contact 52 and
IMD electrode 14 to promote good electrical contact there
between.
[0063] Pressure generating member 121 may be packaged in an outer
carton along with sterile package 60 and placed in the position
shown in FIG. 6B by a user as needed at the time of testing.
Alternatively, pressure generating member 121 may be packaged with
sterile package 60 already positioned around sterile package 60 as
shown in FIG. 6B. In other embodiments, pressure generating member
121 may be positioned within outer tray 114, around inner tray 104
and inner tray lid 102 to promote good electrical contact between
package contact 52 and IMD electrode 14. Pressure generating member
121 could alternatively be packaged within inner tray 104, around
IMD 10 and electrical interface 50 as shown in FIG. 6C. In this
embodiment, electrical interface 50 would not be sealed along its
entire periphery between inner tray lid 102 and inner tray 104 in
order to allow pressure generating member 121 to be fitted over one
side or end of electrical interface 50 as shown. Pressure
generating member 121 may also act to stabilize the position of
electrical interface 50 relative to IMD 10.
[0064] Pressure generating member 121 may be formed of a relatively
rigid polymeric or metal material which may be flexible along
closed side 119 to allow open side 117 to be opened wider to enable
member 121 to be slid over the outside of sterile package 60 (or
inner tray 104 and tray lid 102 or IMD 10 and electrical interface
50). It is recognized that pressure-generating member 121 may be
provided in numerous configurations for promoting good contact
between electrical interface 50 and IMD 10. For example, pressure
generating member 121 may alternatively be formed having a
"clam-shell" shape, having a hinged or spring-loaded side or sides,
or having latching mechanisms. Pressure generating member 121 may
be used alone or in combination with compressible element 120.
Pressure generating member 121 and/or compressible element 120 may
be designed to create a predetermined, constant pressure at the
contact point between IMD 10 and electrical interface 50.
[0065] FIG. 7 is a top view of the packaging system shown in FIG.
6A. Electrical interface 50 includes a flexible substrate 55 that
may be formed to match the outer contours of the inner tray 104.
Substrate 55 becomes sealed between inner tray 104 and inner tray
lid 102 (shown in FIG. 6A) along the entire seal area 108.
Providing substrate 55 along the entire seal area 108 may prevent
thickness differentials along seal area 108 that might otherwise
leave discreet openings along the seal area 108 which could lead to
contamination of the inner tray contents. Alternatively substrate
55 may be formed such that substrate 55 is sealed between inner
tray 104 and inner tray lid 102 along any portion of seal area 108,
as long as a reliable seal is formed between tray 104 and tray lid
102 for maintaining sterility of IMD 10 and any other packaged
components. Generally, substrate 55 will be sealed between tray 104
and lid 102 at least along the area where neck 64 of electrical
interface 50 traverses inner seal area 108
[0066] Conductors 56 may be insulated by a dielectric layer 124
formed over conductors 56. Dielectric layer 124 may additionally
extend over any portion or all of substrate 55, while leaving
package contacts 52 and patient contacts 54 exposed. Dielectric
layer 124 may extend over the entire inner tray seal area 108 to
promote a uniform, reliable seal. Dielectric layer 124 may be
formed from any dielectric polymeric material including polyesters,
ethylene-vinyl acetate copolymers, terpolymers such as
acrylonitrile-butadiene styrene, or polyvinyl chloride and its
copolymers. Alternatively, conductor circuit 53 may include
shielded conductors and contacts to protect the IMD and/or patient
from electrical noise.
[0067] The exterior end of substrate 55 may be formed into a
template 84 upon which patient contacts 54 are mounted. Template 84
corresponds to the size and shape of IMD 10 with patient contacts
54 sized and spaced relative to one another to mimic the size and
spacing of IMD electrodes 14. Once an optimal implant site is
identified through pre-implant testing, the site may be marked or
traced using template 84. Template 84 may be provided having
stencil openings 122 to facilitate marking a selected implant site
on a patient.
[0068] In FIG. 7, conductor circuit 53 is shown to include LEDs 128
along each conductor 56. LEDs 128 may be used to indicate that an
electrical circuit has been completed and signals received at
patient terminals 54 are being conducted to IMD 10. In some
embodiments, the IMD 10 may transmit signals to patient terminals
54, such as sensor excitation signals or electrical stimulation
pulses. As such, LEDs 128 may be used to indicate that electrical
signals from IMD 10 are being conducted to patient terminals
54.
[0069] After completing pre-implant testing, the outer tray lid may
be removed from outer tray 114. Neck 64 of electrical interface 50
may be provided with notches or perforations 126 to facilitate
tearing of the electrical interface 50 just outside of inner tray
104. Tearing of electrical interface 50 allows inner tray 104 to be
removed from outer tray 114 without hindrance due to attachment of
electrical interface 50 to outer tray 114 along outer tray seal
area 118.
[0070] FIG. 8 is a partial, side, cut-away view of an IMD packaging
system according to an alternative embodiment of the invention
wherein an electrical interface is formed on a substrate that
includes a surface of the sterilizable package. In this example,
inner surface 103 of inner tray lid 102 serves as a substrate for
electrical interface 50. In this embodiment, conductors 56 and
package contacts 52 are shown printed or laminated to inner surface
103 of inner tray lid 102. Conductors 56 may be insulated by a
dielectric layer 124.
[0071] FIG. 9 is a bottom view of the inner tray lid shown in FIG.
8. Tray lid 102 is provided with a shape that mates with the seal
area 108 of inner tray 104 (shown in FIG. 5) and serves as a
substrate for electrical interface 50. Inner tray lid 102 is formed
with neck 64 extending there from with patient terminals 54 coupled
to the exterior ends 57 of conductors 56. Inner tray lid 102 may be
fabricated from paper or a high-density, woven or non-woven
polymer, such as a high-density polyethylene. Conductors 56,
patient terminals 54 and package contacts 52 may be printed on
inner tray lid 102 using a conductive ink or may be provided as
foil, tape, film conductive material laminated to tray lid 102. In
some embodiments, the inner surface 103 of inner tray lid 102, or
any other substrate onto which electrical interface 50 is formed,
may be bonded or treated with a coating to promote good adhesion of
the conductive material on the substrate. The tray lid 102 is
coated with an adhesive along seal area 108 for sealing lid 102 to
inner tray 104.
[0072] FIG. 10A is a top view of an alternative embodiment of an
electrical interface formed on the inner surface of an inner tray
lid. The substrate 55 is formed with lateral flaps 130 along neck
64 which can be folded along fold lines 132 over elongated
conductors 56 thereby providing insulation to conductors 56.
Lateral flaps 130 are formed having patient electrode windows 134
such that when lateral flaps 130 are folded along fold lines 132,
patient electrodes are exposed and not insulated by lateral flaps
130. A portion 136 of neck 64 corresponding to the seal area 108 of
an outer tray, when used, is provided without lateral flaps 130.
The portions of conductors 56 that become enclosed within inner
tray 104, inner tray seal area 108, and outer tray seal area 118
may not need to be insulated and may remain exposed. FIG. 10B is a
top view of the electrical interface shown in FIG. 10A after
folding substrate 55 along fold lines 132 to provide insulation to
the portions of conductors 56 which will be located outside of an
outer tray.
[0073] FIG. 10C is a top view of the electrical interface shown in
FIG. 10B further including elements for protecting the electrical
interface. In some embodiments, a removable patient terminal
insulator 137 may be provided for protecting patient terminals 54
from mechanical damage or wear and/or to prevent unwanted
electrical signals to be coupled through to the IMD electronics via
terminals 54. Removable patient terminal insulator 137 may be
provided, for example, in the form of a removable tape that is
pulled away to expose patient terminals at the time of pre-implant
testing or other use of electrical interface 50. Patient terminal
insulator 137 may be provided as a replaceable element such that
after testing is completed, insulator 137 may be placed back over
patient terminals 54.
[0074] A removable short circuit element 138 may be provided across
conductors 56 so as to prevent unwanted electrical signals from
reaching the IMD electronics. Short circuit element 138 may be
provided, for example, as a strip of conductive tape extending
across conductors 56 which can be removed at the appropriate time
to enable pre-implant testing or other use of electrical interface
50. Short circuit element 138 may be provided as a replaceable
element such that after testing is completed, short circuit element
138 can be put back in place to create a short across conductors
56.
[0075] FIG. 11 is a perspective view of an alternative embodiment
of an electrical interface. Substrate 55 is provided with a single
lateral flap 130 along neck 64 sized to cover and insulate
conductors 56 after folding lateral flap 130 along folding line
132. Windows 134 are provided in lateral flap 130 such that patient
terminals 54 remain exposed after folding lateral flap 130 over
conductors 56. Lateral flap(s) 130 as shown in FIGS. 10B and 11 may
be laminated to neck 64 or sealed to neck 64 using the same method
for sealing inner tray lid 102 to an inner tray. In FIG. 11,
patient terminals 54 are shown to include connection members 135,
which may be in the form of snaps or clips, to facilitate
connection of electrode leads or cable extensions as described
previously.
[0076] While FIGS. 8 through 11 depict electrical interface 50
formed on an inner surface of inner tray lid 102, it is recognized
that electrical interface 50 may be formed on any inner surface of
package 60 so long as package contacts 52 become electrically
coupled to IMD electrodes 14. For example, in some embodiments, the
IMD may be configured and contained within an inner tray such that
contact with an electrode terminal 15 (shown in FIG. 4A) is best
made from an inner surface of the inner tray rather than the tray
lid. In such a configuration, package contact 52 and a portion of
the conductor circuit 53 may be formed on an inner surface of the
inner tray instead of the tray lid.
[0077] FIG. 12 is a diagram of an alternative embodiment of an
electrical interface used for connecting to IMD electronics while
the IMD is within sterile packaging. Conductor circuit 53 includes
conductors 56 and capacitive elements 140 used to conduct signals
across seal area 108 of package 60. It is recognized that
conductive circuit 53 may include any circuitry used to convey
signals sensed using patient terminals 54 to package contacts 52. A
capacitive element 140 may be used to conduct signals across a
sterile barrier of package 60. The inner tray wall or the seal area
108 may serve as a dielectric in the capacitive element 140. A
conductor circuit 53 including a capacitive element 140 may protect
the patient and/or IMD from noise or signal baseline variation that
may be induced on conductors 56.
[0078] FIG. 13 is a partial, side cut-away view of a packaging
system according to another embodiment of the invention. Package 60
includes sterilizable inner tray 104 containing IMD 10 having
subcutaneous electrode 14. Inner tray 104 is sealed closed along
seal area 108 with tray lid 102. Tray lid 102 serves as the
substrate for electrical interface 50 including package contact 52
positioned to provide electrical contact with electrode 14.
Electrical interface 50 further includes elongated conductors 56 as
shown previously extending to patient terminal 54. Electrical
interface 50 is shown in a folded arrangement over an outer tray
lid 112 sealed to outer tray 114, containing inner tray 104. An
outer carton 150 is provided for containing outer tray 114 and
electrical interface 50.
[0079] A strain relief member 165 is shown in FIG. 13 extending
from neck 64 to an outer surface of outer tray 114. Strain relief
member 165 may be coupled to any portion of package 60 to provide
strain relief to the portion of neck 64 crossing seal areas 118 and
108. Strain relief member 165 may prevent inadvertent breach of the
outer tray seal or inner tray seal when patient terminals 54 are
being attached or repositioned on a patient.
[0080] Outer carton 150 has an inner surface 154 and an outer
surface 152 which form a recess 156 in which a carton contact 160
is mounted on a compressible member 162. When carton contact 160 is
pressed down, carton contact 160 makes electrical contact with
patient terminal 54. Carton contact 160 may be provided with a snap
or clip member to facilitate attaching an external electrode
extension or cable. Connection to the electronics within IMD 10 is
thereby made possible via carton electrode 160 and electrical
interface 50 while IMD 10 remains inside sterilized inner tray 104,
outer tray 114 and outer carton 150. It is recognized that in
various embodiments, other signal conveying elements may be added
to or substituted for carton electrode 160, such as capacitive
elements, inductive elements, optical fibers, or antennas.
[0081] Carton 150 may be formed with a closing member 158, such as
a closable flap or resealable tape that can be closed over recess
156 to protect carton electrode 160. It is recognized that numerous
configurations may be conceived for incorporating a carton
electrode 160 in outer carton 150. For example, in other
embodiments, carton electrode 160 may be located along outer
surface 152 extending through to inner surface 154 without being
positioned in a recess 156. It is further recognized that a
removable insulating layer may be provided over carton electrode
160. In some embodiments, compression member 162 may not be
provided, and the normal position of carton contact 160 may be in
electrical contact with patient terminal 54. An insulating material
over carton contact 160 may or may not be used.
[0082] FIG. 14 is a partial, side cut-away view of an electrical
interface 50 provided with a substrate 55 that extends along the
outer surface 105 of tray lid 102. Electrical interface 50 includes
a package contact 52 formed extending through tray lid 102 to make
electrical contact with IMD subcutaneous electrode 14. In an
alternative embodiment, a separate substrate 55 is not used and
electrical interface 50 is formed on the outer surface 105 of tray
lid 102. Conductor 56 would extend along tray lid outer surface 105
to package contact 52 which would extend through tray lid 102 to
make electrical contact with IMD electrode 14. Alternatively,
elongated conductor 56 may extend through tray lid 102. Conductor
56 may be provided as a conductive wire, foil, or film that
penetrates tray lid 102 or may include an capacitive or inductive
element for conveying current across tray lid 102. It is recognized
that in various embodiments, any element of electrical interface 50
may extend across a sterile barrier, i.e., from an outer surface to
an inner surface of a sterilizable IMD package, along any portion
of the package and is not limited to extending across a seal area
of the package.
[0083] Furthermore, the electrical interface 50 may be formed on a
substrate extending along any outer or inner surface of the
sterilizable IMD package, including an outer or inner surface of
any tray, tray lid, pouch or other sterilizable IMD package.
Alternatively, electrical interface 50 may be fabricated using a
separate substrate 55, which likewise may extend along any outer or
inner surface of the sterilizable IMD package. The exact
configuration of electrical interface 50 with respect to the IMD
package 60 may vary from embodiment to embodiment depending on the
orientation of the IMD within the package and the resulting
location of IMD electrodes or electrode terminals with which
package contact(s) 52 are to be electrically coupled.
[0084] FIG. 15 is a plan view of an IMD in a sterilizable package
provided with an electrical interface for accessing IMD electronics
according to another embodiment of the invention. Some IMDs may be
used in conjunction with electrodes carried by leads extending from
the IMD rather than being incorporated on the IMD housing. IMD 20
is shown having connector header 24 provided with a connector bore
200 adapted for receiving a connector assembly of a lead carrying
one or more electrodes or other sensors. Connector header and lead
connector assembly configurations are known in the art. In the
example shown, connector bore 200 is provided with contacts 202 and
204 for coupling with connectors included on a lead connector
assembly.
[0085] To facilitate electrical connection to electrical interface
50, IMD 20 may be packaged within sterilizable package 60 with a
connector appliance 210 inserted into connector bore 200. Connector
appliance 210 is provided with a connector assembly 212 adapted for
insertion into connector bore 200. Connector assembly 212 includes
two connectors 214 and 215 separated by an insulating segment 216.
Connectors 214 and 215 align with and become electrically coupled
to contacts 202 and 204 when connector assembly 212 is fully
inserted in connector bore 200. Connector assembly 212 of connector
appliance 210 generally corresponds to a connector assembly
provided on a lead intended for use with IMD 20. Connector
appliance 210 is provided with electrode contacts 220 which are
separately coupled to each of connectors 214 and 215 by conductors
217 extending through appliance 210. Package contacts 52 included
on electrical interface 50 are positioned over electrode contacts
220 such that patient terminals 54, located outside of package 60,
can be coupled to the electronics included in IMD 20 via connector
appliance 210. Alternatively, conductors 217 may extend along a
substrate to the outside of package 60 directly to patient
terminals 54, without the use of package contacts 52.
[0086] Patient terminals 54 may be positioned on or in a patient or
coupled to electrodes or any other physiological sensors positioned
on or in a patient via appropriate leads or extension cables. As
such, electrical interface 50 may be used to access IMD electronics
included in an IMD having a connector header 24 with the use of a
connector appliance 210.
[0087] FIG. 16 illustrates a bifurcated electrical interface. In
some embodiments, two or more electrodes carried by branching or
separate leads may be placed independently of each other. An
electrical interface 50 may be provided with a bifurcation 230 such
that patient terminals 54 may be placed at separate, spaced apart
locations. It is recognized that substrate 55 may be provided with
numerous shapes or configurations for allowing placement of patient
terminals 54 during pre-implant testing in any appropriate manner
that mimics placement of the actual electrodes to be used in
conjunction with the IMD. Alternatively, patient terminals 54 may
be connected to separate electrode extensions that allow
unencumbered placement of electrodes on the patient during
pre-implant testing, as described previously.
[0088] For the sake of illustration, various embodiments described
herein have generally related to an electrical interface that
allows connection to IMD electronics for pre-implant testing
relating to optimizing subcutaneous electrode placement. However,
it is recognized that an electrical interface used to access the
electronics within an IMD still contained in a sterile package may
be designed to mimic electrodes/sensors adapted for other implant
locations, e.g., epicardial, endocardial, sub-muscular, or
otherwise. As such, embodiments that include using an electrical
interface for testing non-subcutaneous implant locations of an IMD
or electrodes/sensors are included in the scope of the invention.
Pre-implant testing using the interface may be performed to
determine if the patient meets implant criteria and/or selecting an
optimal implant site.
[0089] Various embodiments of the electrical interface 50 shown in
FIG. 4A have been described primarily in the context of an
interface used to couple electrodes, for example ECG electrodes, to
an IMD electronics module across a sterile barrier. However, the
electrical interface 50 may be used to couple any type and number
of electrodes and/or sensors to the IMD electronics. Furthermore,
electrical interface 50 may be used for purposes other than
pre-implant testing. Electrical interface 50 may be used, for
example, for performing IMD system tests or for demonstration
purposes.
[0090] Packaging systems having an interface that allows access to
IMD electronics across a sterile barrier have been presented in the
foregoing description with reference to specific embodiments. It is
appreciated that various modifications to the referenced
embodiments may be made without departing from the scope of the
invention as set forth in the following claims.
* * * * *