U.S. patent application number 17/487291 was filed with the patent office on 2022-01-13 for medical devices including connector enclosures with feedthrough passageways.
The applicant listed for this patent is MEDTRONIC, INC.. Invention is credited to Jeffrey J. Clayton, Steven T. Deininger, Charles E. Peters.
Application Number | 20220008735 17/487291 |
Document ID | / |
Family ID | |
Filed Date | 2022-01-13 |
United States Patent
Application |
20220008735 |
Kind Code |
A1 |
Deininger; Steven T. ; et
al. |
January 13, 2022 |
MEDICAL DEVICES INCLUDING CONNECTOR ENCLOSURES WITH FEEDTHROUGH
PASSAGEWAYS
Abstract
Medical devices provide metallic connector enclosures. The
metallic connector enclosures may be constructed with relatively
thin walls in comparison to polymer connector enclosures to aid in
miniaturizing the medical device. The metallic connector enclosures
may be constructed with interior surfaces that deviate less from an
ideal inner surface shape in comparison to polymer connector
enclosures to allow for better concentricity of electrical
connectors. The metallic connector enclosures may include a panel
that allows access to the cavity of the connector enclosure where
set screw blocks, lead connectors, spacers, seals, and the like may
be located. Furthermore, the lead connectors within the metallic
connector enclosures may be separated from the metallic connector
enclosure by being positioned within non-conductive seals that
reside within features included in cavity walls of the connector
enclosure. Similarly, set screw blocks may be separated from the
metallic connector enclosure by non-conductive spacers present
within the cavity.
Inventors: |
Deininger; Steven T.;
(Blaine, MN) ; Clayton; Jeffrey J.; (Ramsey,
MN) ; Peters; Charles E.; (Blaine, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
MEDTRONIC, INC. |
Minneapolis |
MN |
US |
|
|
Appl. No.: |
17/487291 |
Filed: |
September 28, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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17027487 |
Sep 21, 2020 |
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17487291 |
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15885243 |
Jan 31, 2018 |
10780284 |
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17027487 |
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15613263 |
Jun 5, 2017 |
9907964 |
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15885243 |
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15210645 |
Jul 14, 2016 |
9669228 |
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15613263 |
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14865458 |
Sep 25, 2015 |
9393431 |
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15210645 |
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13976401 |
Sep 17, 2013 |
9144689 |
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PCT/US2011/065858 |
Dec 19, 2011 |
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14865458 |
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61427717 |
Dec 28, 2010 |
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International
Class: |
A61N 1/375 20060101
A61N001/375; B23K 26/24 20060101 B23K026/24; B23K 26/32 20060101
B23K026/32 |
Claims
1. An implantable medical device comprising: a can that houses
medical circuitry; a connector enclosure that includes an opening
and a base, the base including a plurality of feedthrough pin
passageways spaced longitudinally, the connector enclosure defining
a cavity; lead connectors within the cavity and aligned with the
opening; a plurality of feedthrough pins electrically connected to
the lead connectors, each of the plurality of feedthrough pins
passing through a respective one of the plurality of feedthrough
pin passageways; a ground pin at the base; and a flex circuit
extending within the can, the flex circuit including electrical
contacts, each of the electrical contacts connected to a respective
one of the plurality of feedthrough pins such that the flex circuit
electrically connects the plurality of feedthrough pins and the
medical circuitry, the flex circuit electrically connected to the
ground pin to provide a ground connection for the medical
circuitry.
2. The device of claim 1, wherein the ground pin is in electrical
connection with the base, and wherein the base is in electrical
connection with the can.
3. The device of claim 2, wherein the base comprises a metallic
material, and wherein the can comprises a metallic material.
4. The device of claim 1, wherein the base further comprises a
ground pin passageway, wherein the ground pin extends from the
electrical connection to the flex circuit within the can to the
ground pin passageway and terminates within the ground pin
passageway, and wherein the plurality of feedthrough pins extend
beyond the ground pin, through the opening of the connector
enclosure, and to the respective lead connectors within the cavity
of the connector enclosure.
5. The device of claim 4, wherein the ground pin passageway has a
smaller cross-sectional area than each of the plurality of
feedthrough pin passageways.
6. The device of claim 1, wherein each of the electrical contacts
is electrically connected to the respective one of the plurality of
feedthrough pins within the can, and wherein the flex circuit is
electrically connected to the ground pin within the can.
7. The device of claim 6, wherein each of the electrical contacts
is electrically connected to the respective one of the plurality of
feedthrough pins and the flex circuit is electrically connected to
the ground pin at a common elevation within the can.
8. The device of claim 1, further comprising: an antenna pin at the
base, the flex circuit electrically connected to the antenna pin
such that the flex circuit electrically connects the antenna pin
and the medical circuitry.
9. The device of claim 8, further comprising: an antenna conductor
at an antenna support, the antenna support extending along an outer
portion of the connector enclosure opposite the base.
10. The device of claim 9, further comprising: an antenna
connecting pin that electrically connects the antenna pin to the
antenna conductor, wherein the antenna connecting pin extends
perpendicular to the antenna pin and toward a perimeter of the
connector enclosure.
11. The device of claim 1, further comprising: a filter plate
adjacent the base, the filter plate including at least one
conductive trace extending within the filter plate and electrically
connected to at least one of the plurality of feedthrough pins.
12. The device of claim 11, wherein the filter plate include a
ceramic material, wherein the at least one conductive trace extends
through the ceramic material to an edge of the filter plate, and
wherein the edge of the filter plate is electrically coupled to the
base so that the at least one conductive trace is electrically
coupled to the base.
13. The device of claim 11, wherein the filter plate includes a
plurality of feedthrough pin passageways axially aligned with the
plurality of feedthrough pin passageways of the base such that the
plurality of feedthrough pins extend through the plurality of
feedthrough pin passageways of the base and the plurality of
feedthrough pin passageways of the filter plate in a parallel
orientation.
14. The device of claim 13, wherein the at least one conductive
trace is present at at least one of the plurality of feedthrough
pin passageways of the filter plate such that at least one of the
plurality of feedthrough pins is electrically connected to the at
least one conductive trace at the at least one of the plurality of
feedthrough pin passageways of the filter plate.
15. The device of claim 11, further comprising: an antenna pin at
the base, the flex circuit electrically connected to the antenna
pin such that the flex circuit electrically connects the antenna
pin and the medical circuitry, wherein the antenna pin is spaced
apart from the filter plate.
16. An implantable medical device comprising: a can that houses
medical circuitry, the can defining a longitudinal axis; a
connector enclosure that includes an opening and a base, the
connector enclosure defining a cavity, the base including a first
group of a plurality of feedthrough pin passageways and a second
group of a plurality of feedthrough pin passageways, the first
group of the plurality of feedthrough pin passageways aligned on a
first axis extending perpendicular to the longitudinal axis of the
can and the second group of the plurality of feedthrough pin
passageways aligned on a second axis, spaced apart from the first
axis, extending perpendicular to the longitudinal axis of the can;
a first group of lead connectors within the cavity, wherein the
first group of lead connectors are aligned with both the opening
and the first group of the plurality of feedthrough pin
passageways, and wherein the first group of lead connectors are
offset from the second group of the plurality of feedthrough pin
passageways; a first group of lead connector seals disposed between
the first group of lead connectors; a first group of a plurality of
feedthrough pins electrically connected to the first group of lead
connectors, each of the first group of the plurality of feedthrough
pins passing through a respective one of the first group of the
plurality of feedthrough pin passageways; a ground pin at the base;
and a flex circuit extending within the can, the flex circuit
including electrical contacts, each of the electrical contacts
connected to a respective one of the first group of the plurality
of feedthrough pins such that the flex circuit electrically
connects the first group of the plurality of feedthrough pins and
the medical circuitry, the flex circuit electrically connected to
the ground pin to provide a ground connection for the medical
circuitry.
17. The device of claim 16, further comprising: a second group of
lead connectors within the cavity, wherein the second group of lead
connectors are aligned with both the opening and the second group
of the plurality of feedthrough pin passageways, and wherein the
second group of lead connectors are offset from the first group of
the plurality of feedthrough pin passageways.
18. The device of claim 17, further comprising: a second group of a
plurality of feedthrough pins electrically connected to the second
group of lead connectors, each of the second group of the plurality
of feedthrough pins passing through a respective one of the second
group of the plurality of feedthrough pin passageways.
19. The device of claim 18, wherein each of the electrical contacts
is connected to a respective one of the first group of the
plurality of feedthrough pins and the second group of the plurality
of feedthrough pins such that the flex circuit electrically
connects the first group of the plurality of feedthrough pins and
the second group of the plurality of feedthrough pins to the
medical circuitry.
20. The device of claim 19, wherein the electrical contacts of the
flex circuit include a first group of electrical contacts aligned
longitudinally with the first axis and a second group of electrical
contacts aligned longitudinally with the second axis such that the
flex circuit electrically connects the first group of the plurality
of feedthrough pins to the medical circuitry at a first position
within the can that is offset in a direction perpendicular to the
longitudinal axis of the can from a second position within the can
at which the flex circuit electrically connects the second group of
the plurality of feedthrough pins to the medical circuitry.
Description
TECHNICAL FIELD
[0001] Embodiments relate to medical devices that have connector
enclosures that receive medical leads. More particularly,
embodiments relate to medical devices that have metallic connector
enclosures.
BACKGROUND
[0002] Medical devices including those that may be implanted and
those that are worn externally on the body of the patient utilize
medical leads to carry signals between circuitry within the medical
device and electrodes on distal ends of the medical leads. The
medical leads may be used to deliver electrical stimulation pulses
from the medical circuitry to the tissue and/or to sense
physiological signals from the tissue and convey those signals to
the medical circuitry.
[0003] Typically, the medical lead is a separate item from the
medical device. The lead is routed within, the body of the patient
to the area where stimulation or sensing is to occur. A proximal
end of the lead is connected to the medical device by inserting the
lead into a connector enclosure of the medical device. The
connector enclosure established electrical contact between
electrical connectors on the lead and corresponding lead connectors
within the connector enclosure. The connector enclosure may provide
seals that engage the medical lead and prevent, body fluids from
entering into the connector enclosure of the medical device.
[0004] The connector enclosure of the medical device is often a
polymer which is formed over the lead connectors and lead frames
that provide a conductor from the electrical connector to
electrical contacts on the base of the connector enclosure. The
medical device also includes a hermetically sealed can that is
typically constructed of a metal such as titanium. The can has
feedthrough pins exiting a top of the can that are attached to the
electrical contacts of the connector enclosure during assembly of
the medical device to complete the electrical pathways from the
medical circuitry to the lead connectors of the connector
enclosure.
[0005] The polymer connector enclosure may have various drawbacks.
For instance, the polymer connector enclosure typically requires a
significant volume to provide adequate strength. The polymer wall
thicknesses are necessarily large enough to adequately support the
lead connectors and lead frames present within the connector
enclosure, which may inhibit the ability to further miniaturize the
medical device. Furthermore, the inner surfaces of the connector
enclosure that engage the lead connectors have a relatively large
deviation from an ideal inner surface shape. These deviations cause
the longitudinal sequence of lead connectors to have relatively
large variations in concentricity, which leads to a relatively
large lead insertion force and that contributes to lead damage
during insertion.
SUMMARY
[0006] Embodiments address issues such as these and others by
provide a medical device that has a metallic connector enclosure.
The inherent strength of the metal allows the connector enclosure
to be made with relatively thin walls to aid in miniaturization of
the medical device. Furthermore, the precision that is achievable
when creating the inner surfaces of the connector enclosure such as
by machining allows the deviation from an ideal shape to be
relatively small to better align components so as to aid in
reducing insertion force. To allow access to the interior of the
connector enclosure for assembly purposes, a cavity may be created
with an open area that can be covered by a panel that is bonded in
place. Furthermore, to isolate lead connectors from the metallic
connector enclosure, non-conductive lead connector spacers may be
included within the cavity of the metallic connector enclosure.
[0007] Embodiments provide a method of constructing a medical
device. The method involves providing a can that houses medical
circuitry and providing electrical connectors within the can and
electrically connected to the medical circuitry. The method further
involves providing a metallic connector enclosure comprising a
metallic body defining a cavity and a metallic panel welded to the
metallic body and covering the cavity, the body including an
opening to the cavity. The method involves providing lead
connectors within the cavity and in alignment with the opening, the
lead connectors being positioned between the metallic body and the
metallic panel and providing electrical conductors that are
electrically connected to the lead connectors within the cavity and
that are electrically isolated from the metallic connector
enclosure while being exposed outside of the metallic connector
enclosure. The method involves placing a portion of the can in
contact with a metallic edge of the metallic connector enclosure
such that the electrical connectors within the can and the
electrical conductors exposed outside the metallic connector
enclosure are in contact and are contained by a housing created by
the contact of the can and the metallic connector enclosure and
creating a bond at the contact of the portion of the can and the
metallic edge of the metallic connector enclosure.
[0008] Embodiments provide a method of constructing a medical
device. The method involves providing a can that houses medical
circuitry and providing electrical connectors within the can and
electrically connected to the medical circuitry. The method further
involves providing a metallic connector enclosure defining a cavity
and including an opening to the cavity, the metallic connector
enclosure including walls with portions of at least one wall having
a thickness of 25 thousandths of an inch or less. The method
involves providing lead connectors within the cavity and in
alignment with the opening and providing electrical conductors that
are electrically connected to the lead connectors within the cavity
and that are electrically isolated from the metallic connector
enclosure while being exposed outside of the metallic connector
enclosure. The method involves placing a portion of the can in
contact with a metallic edge of the metallic connector enclosure
such that the electrical connectors within the can and the
electrical conductors exposed outside the metallic connector
enclosure are in contact and are contained by a housing created by
the contact of the can and the metallic connector enclosure and
creating a bond at the contact of the portion (f the can and the
metallic edge of the metallic connector enclosure.
[0009] Embodiments provide a method of constructing a medical
device. The method involves providing a can that houses medical
circuitry and providing electrical connectors within the can and
electrically connected to the medical circuitry. The method further
involves providing a metallic connector enclosure having, internal
walls defining a cavity with the metallic connector enclosure
including an opening to the cavity. The method further involves
providing a plurality of lead connectors within the cavity and in
alignment with the opening, each of the lead connectors being
surrounded by a seal, each of the seals separating the lead
connectors from the internal walls where a centerline of each lead
connector varies by 8 thousandths of an inch or less from the
centerline of every other lead connector. The method involves
providing electrical conductors that are electrically connected to
the lead connectors within the cavity and that are electrically
isolated from the metallic connector enclosure while being exposed
outside of the metallic connector enclosure. The method involves
placing a portion of the can in contact with a metallic edge of the
metallic connector enclosure such that the electrical connectors
within the can and the electrical conductors exposed outside the
metallic connector enclosure are in contact and are contained by a
housing created by the contact of the can and the metallic
connector enclosure and creating a bond at the contact of the
portion of the can and the metallic edge of the metallic connector
enclosure.
[0010] Embodiments provide a method of constructing a medical
device. The method involves providing a can that houses medical
circuitry and providing electrical connectors within the can and
electrically connected to the medical circuitry. The method further
involves providing a metallic connector enclosure comprising a
metallic body defining a cavity, the body including an opening to
the cavity, the cavity having a recess and providing non-conductive
lead connector spacers within the recess. The method further
involves providing lead connectors within the cavity and in
alignment with the opening, the lead connectors being disposed
within the non-conductive lead connector spacers and providing
electrical conductors that are electrically connected to the lead
connectors within the cavity and that are electrically isolated
from the metallic connector enclosure while being exposed outside
of the metallic connector enclosure. The method involves placing a
portion of the can in contact with a metallic edge of the metallic
connector enclosure such that the electrical connectors within the
can and the electrical conductors exposed outside the metallic
connector enclosure are in contact and are contained by a housing
created by the contact of the can and the metallic connector
enclosure and creating a bond at the contact of the portion of the
can and the metallic edge of the metallic connector enclosure.
[0011] Embodiments provide a medical device that includes a can
that houses medical circuitry and electrical connectors within the
can and electrically connected to the medical circuitry. The
medical device includes a metallic connector enclosure comprising a
metallic body defining a cavity and a metallic panel welded to the
metallic body and covering the cavity, the body including an
opening to the cavity. The medical device includes lead connectors
within the cavity and in alignment with the opening, the lead the
connectors being positioned between the metallic body and the
metallic panel, and includes electrical conductors that are
electrically connected to the lead connectors within the cavity and
that are electrically isolated from the metallic connector
enclosure while being exposed outside of the metallic connector
enclosure. A portion of the can is in contact with a metallic edge
of the metallic connector enclosure such that the electrical
connectors within the can and the electrical conductors exposed
outside the metallic connector enclosure are in contact and are
contained by a housing created by the contact of the can and the
metallic connector enclosure, and a bond is present at the contact
of the portion of the can and the metallic edge of the metallic
connector enclosure.
[0012] Embodiments provide a medical device that includes a can
that houses medical circuity and electrical connectors within the
can and electrically connected to the medical circuitry. The
medical device includes a metallic connector enclosure defining a
cavity and including an opening to the cavity, the metallic
connector enclosure including walls with portions of at least one
wall having a thickness of 25 thousandths of an inch or less. The
medical device includes lead connectors within the cavity and in
alignment with the opening and electrical conductors that are
electrically connected to the lead connectors within the cavity and
that are electrically isolated from the metallic connector
enclosure while being exposed outside of the metallic connector
enclosure. A portion of the can is in contact with a metallic edge
of the metallic connector enclosure such that the electrical
connectors within the can and the electrical conductors exposed
outside the metallic connector enclosure are in contact and are
contained by a housing created by the contact of the can and the
metallic connector enclosure, and a bond is present at the contact
of the portion of the can and the metallic edge of the metallic
connector enclosure.
[0013] Embodiments provide a medical device that includes a can
that houses medical circuitry and electrical connectors within the
can and electrically connected to the medical circuitry. The
medical device further includes a metallic connector enclosure
having internal walls defining a cavity with the metallic connector
enclosure including an opening to the cavity. The medical device
further includes a plurality of lead connectors within the cavity
and in alignment with the opening, each of the lead connectors
being surrounded by a seal, each of the seals separating the lead
connectors from the internal walls where a centerline of each lead
connector varies by 8 thousandths of an inch or less from the
centerline of every other lead connector. The medical device
includes electrical conductors that are electrically connected to
the lead connectors within the cavity and that are electrically
isolated from the metallic connector enclosure while being exposed
outside of the metallic connector enclosure. A portion of the can
is in contact with a metallic edge of the metallic connector
enclosure such that the electrical connectors within the can and
the electrical conductors exposed outside the metallic connector
enclosure are in contact and are contained by a housing created by
the contact of the can and the metallic connector enclosure, and a
bond is present at the contact of the portion of the can and the
metallic edge of the metallic connector enclosure.
[0014] Embodiments provide a medical device that includes a can
that houses medical circuitry and an electrical connector within
the can and electrically connected to the medical circuitry. The
medical device includes a metallic connector enclosure comprising a
metallic body defining a cavity, the body including an opening to
the cavity, the cavity having a recess and a non-conductive lead
connector spacer within the recess. The medical device includes a
lead connector within the cavity and in alignment with the opening,
the lead connector being disposed within the non-conductive lead
connector seal and an electrical conductor that is electrically
connected to the lead connector within the cavity and that is
electrically isolated from the metallic connector enclosure while
being exposed outside of the metallic connector enclosure. A
portion of the can is in contact with a metallic edge of the
metallic connector enclosure such that the electrical connector
within the can and the electrical conductor exposed outside the
metallic connector enclosure are in contact and are contained by a
housing created by the contact of the can and the metallic
connector enclosure, and a bond is present at the contact of the
portion of the can and the metallic edge of the metallic connector
enclosure.
DESCRIPTION OF THE DRAWINGS
[0015] FIG. 1 shows a front perspective view of a medical system
includes a medical device example according to various embodiments
and a medical lead.
[0016] FIG. 2 shows a rear perspective view of the medical device
example.
[0017] FIG. 3 shows a rear view of the medical device example with
a roar portion of a can and a rear panel removed.
[0018] FIG. 4 shows a rear view of the medical device example with
an isolation cup removed.
[0019] FIG. 5 shows a front view of the medical device example with
the can removed.
[0020] FIG. 6 shows a bottom perspective view of a connector
enclosure example of the medical device with the panel removed,
[0021] FIG. 7 shows a top perspective view of the connector
enclosure example of the medical device with an antenna support
cover removed.
[0022] FIG. 8 shows a rear view of the connector enclosure example
of the medical device with set screw blocks and a set screw spacer,
a front seal, and an antenna support removed.
[0023] FIG. 9 shows a rear perspective view of the connector
enclosure of the medical device with lead connectors, spacers, and
feedthrough pins removed.
[0024] FIG. 10 shows an interior side of the panel of the connector
enclosure.
[0025] FIG. 11 shows a perspective view of a base of the connector
enclosure.
DETAILED DESCRIPTION
[0026] Embodiments provide for medical devices that have a can
housing medical circuitry and have a connector enclosure with a
metallic weld to the can. In one or more embodiments, the metallic
weld provides a relatively strong attachment between the connector
enclosure and the can even where medical adhesive is not used to
aid in attaching the connector enclosure to the can. In one or more
embodiments the metallic weld provides a hermetic seal for the can.
Furthermore, in one or more embodiments, the connector enclosure
may have a relatively small size such as where the can omits barbs,
pins, straps, and other features ordinarily used to attach a
connector enclosure to a can.
[0027] FIG. 1 shows an example of a medical system 100 that
includes an embodiment of a medical device 102 and a corresponding
medical lead 104. The medical device 102 includes a can 106 that
houses medical circuitry and also includes a connector enclosure
IOS that is attached to the can 106 and houses the electrical
connections to the lead 104. The connector enclosure 108 includes
one or more openings 114 that receive the proximal end of the
medical lead 104. The connector enclosure 108 of this particular
example includes a connector enclosure body 112 where the openings
114 are located and a connector enclosure base 110 upon which the
connector enclosure body 112 is mounted. An antenna cover 116 that
may be constructed of materials such as polysulfone or polyurethane
is mounted atop the connector enclosure 108 as the antenna cover
116 resides atop the connector enclosure body 112.
[0028] As shown in FIG. 2, the connector enclosure 108 may also
include additional features. For instance, a connector enclosure
panel 118 covers a cavity within the connector enclosure body 112
which is discussed in more detail below. In this particular
example, the panel 118 includes an outwardly protruding region 132
that accommodates items located within the cavity being covered by
the panel 118. Also in this example, a seal 120 that is constructed
of a material such as liquid silicone rubber or a medical adhesive
creates a seal between the screw block and grommet covered set
screws 122 are present.
[0029] A set screw block discussed below is present within the set
screw block spacer, also discussed below, that underlies the seal
120 where the openings 114 lead to passages in the set screw block.
The lead 104 passes through the passages in the set screw block,
and a clink 126 of the lead 104 resides within the set screw blocks
upon full insertion of the lead 104. The set screw 122 is tightened
against the clink 126 to secure the lead 104 within the connector
enclosure 108. Thus, the set screw block within the spacer 180 may
also act as a lead connector. Conventional seals may be present
within the openings 114 to seal against the clink 126 and resist
the entry of bodily fluids into the openings 114.
[0030] The medical lead 104 includes a lead body 128 typically
constructed of a polymer followed by the metal clink 126 and then
an alternating series of non-conductive spacers 130 typically
constructed of a polymer and electrical connectors 124 that am
typically metal. The electrical connectors 124 and in some examples
the clink 126 are connected to electrical conductors within, the
lead body 128 that extend to a distal end where electrodes are
present at the stimulation/sensing site. Upon insertion of the lead
104 into the connector enclosure 108, the electrical connectors 124
align with lead connectors that are electrically connected to the
medical circuitry within the can 106.
[0031] In the example shown in FIGS. 1-11, it may be desirable that
the connector enclosure 108 be bonded to the can 106 by a metallic
weld. In that case, at least a top edge of the can 106 is a metal
such as various grades of titanium while at least a bottom edge of
the connector enclosure 108 is also a metal such as various grades
of titanium. In the example shown, the entire can 106 is a metal
such as grade 5 titanium while at least the connector enclosure
base 110 of the connector enclosure 108 is also entirely a metal
such as grade 5 titanium.
[0032] As shown in FIGS. 3 and 4, wherein a mar half of the can 106
is removed for purposes of illustration while a front half 136 of
the can 106 remains, the connector enclosure base 110 of this
example includes a lower edge 166 of a lip that the upper edge of
the can 106 resides against. Accordingly, ti metallic weld, such as
a laser scam weld, may be performed along the lower edge 166 of the
lip to create the bond between the connector enclosure base 110 and
the can 106. For embodiments where the bond is other than a
metallic weld, such as where conventional mounting techniques and
medical adhesives are used instead, the upper edge of the can 106
and/or the lower edge of the connector enclosure 108 may be
materials other than metal.
[0033] The can 106 of this example also includes an open top. The
connector enclosure base 110 mates to the open top with the top
edge of the open top of the can 106 meeting the lower edge 166 of
the lip on the connector enclosure base 110. Thus, the connector
enclosure base 110 acts as a lid to close the open top of the can
106, and upon being metallically welded together, creates a
hermetically sealed enclosure.
[0034] The panel 118 may be metallic as may be the connector
enclosure body 112. Thus, where the connector enclosure base 110 is
also metallic, particularly for embodiments where the connector
enclosure 108 is bonded by a metallic weld to the can 106, the
entire connector enclosure 108 may be metallic. For instance, the
connector enclosure body 112 may be a grade 5 titanium while the
panel 118 may be a grade 1 titanium that is stamped rather than
machined, or a grade 5 titanium that is also machined. An entirely
metallic connector enclosure 108 may be relatively strong while
being small and with relatively precise features as discussed in
more detail below.
[0035] Where the connector enclosure 108 includes a metal connector
enclosure base 110, a metal connector enclosure body 112, and a
metal connector enclosure panel 118, each of these pieces may be
welded together to complete the enclosure. The bonds between the
body 112, the base 110, and/or the panel 118 may alternatively be
other than metallic welds particularly for embodiments where the
body 112, the base 110, or the panel 118 is other than a metal. For
instance, the bond between the body and the base 110 may utilize
medical adhesive barbs, straps, and the like for embodiments where
one or both of the base 110 and body 112 are not metal.
[0036] The panel 118 is removed for purposes of illustration in
FIGS. 3 and 4, where the connector enclosure body 112 of this
particular example includes a slight indention 168 within which the
panel 118 rests. Thus, the panel 118 may be bonded to the body 112
by a metallic weld such as a laser seam weld along the edge of the
indention 168. Similar to the alternative bonds between the base
110 and the body 112, alternative manner of joining the panel 118
to the body 112 may also be used, such as medical adhesive barbs,
straps, and the like, especially for embodiments where one or both
of the panel 118 and body 112 are not metal.
[0037] During assembly of the connector enclosure 108, the panel
118 may be left aside while components are installed into the
cavity within the connector enclosure body 112. These components
may include the setscrew block spacer 180, a set of lead connectors
146, lead connector seals 14S disposed between the lead connectors
146, and end seals 142. Feedthrough pins 144 which are electrical
conductors that carry individual electrical signals between the
interior of the can 106 and the interior of the connector enclosure
108 may also be positioned within the cavity and bonded to the lead
connectors 146 such as by a resistance weld or other weld.
[0038] The feedthrough pins 144 exit the connector enclosure 108
via feedthrough passageways 200 within the connector enclosure base
110 as shown in FIG. 10. These feedthrough passageways 200 may
provide a seal against the feedthrough pins 144, as show in FIG. 6,
by including ferrules 178 that the feedthrough pins 144 pass
through that are filled with a glass or other non-conductor 176
that creates a seal and also gives the feedthrough pins a fixed
position relative to the base 110. This seal to the feedthrough
pins 144 allows the can 106 to achieve the hermetic seal upon the
connector enclosure base 110 being mounted and bonded to the can
106.
[0039] As shown in FIGS. 4 and 5, the exposed tip 156 of the
feedthrough pins 144 are bonded to electrical contacts 158 of a
flexible circuit connector 170 which is shown transparently for
purposes of illustration. The flexible circuit connector 170
extends down to meet electrical connections of medical circuitry
152. The medical circuitry 152 may include such items as a
microcontroller device, a memory device, stimulation capacitor, a
telemetry device, a battery 141, and the like.
[0040] As shown in FIG. 3, the medical circuitry 152 is contained
within an isolation cup 138 that is constructed of a material such
as a liquid crystal polymer, polypropylene, and the like and that
is removed fir purposes of illustration in FIGS. 4 and 5. The
isolation cup 138 fits within the can 106 and may have a physical
connection to the connector enclosure base 110. For instance, in
some embodiments the connector enclosure base 110 may include feet
140 as shown in FIG. 5, and the isolation cup 138 may have an
interference or snap fit to the feet 140. A desiccant may also be
present within the can 106 such as within a pocket of the isolation
cup 138, while a rubber bumper 172 or bumper of other similar
material nay be present within the can 106 below the isolation cup
138 so that the isolation cup 138 comes to rest in a fixed and
supported position within the can 106.
[0041] As shown in FIGS. 4 and 5, a coil assembly 154 may be
included together with the medical circuitry 152 within the
isolation cup 138. This coil assembly 154 may be used for various
purposes. For instance, the coil assembly 154 may be used to
receive recharge energy and/or provide near field telemetry. The
coil assembly 154 may include a coil housing that is constructed of
a material such as a liquid crystal polymer, polypropylene, and the
like with the coil wound within the housing.
[0042] The coil assembly 154 and the frequency at which the coil
assembly 154 operates are less affected by surrounding metal than
the telemetry antenna so the coil assembly 154 is included within
the can 106 of this embodiment. The telemetry antenna is positioned
atop the connector enclosure 108 where it is not surrounded by
metal, as discussed further below in relation to FIG. 7.
Consequently, in this particular embodiment, the coil assembly 154
and the telemetry antenna are physically separated from one
another. However, it will be appreciated that where the coil
assembly 154 and the telemetry antenna operate in frequency bands
that are significantly spaced from one another, the physical
separation between the two is less a factor when using both
simultaneously.
[0043] In the particular example shown in FIG. 4, the connector
enclosure base 110 provides an integrated filtered feedthrough
utilizing monolithic capacitors. One or more filter plates 150 are
attached to the underside of the connector enclosure base 110 such
as by medical adhesive, soldering, and the like. In this example,
the filter plates 150 are constructed of ceramic with wire traces
present within the ceramic that establish electrical continuity
with the feedthrough pins 144 while also establishing capacitance
within the conductive path of the traces. The wire traces of the
filter plates 150 are electrically coupled to the connector
enclosure base 110 by soldering of the edges of the filter plates
150 for embodiments where the connector enclosure base 110 is metal
to effectively ground the feedthrough capacitors to the base 110,
as well as to the can 106 for embodiments where the connector
enclosure base 110 is welded or otherwise conductively attached to
the can 106.
[0044] As can be seen in FIG. 6, the connector enclosure base 110
of this example includes a recessed area 174 which provides a
location for installation of the filter plates 150. FIG. 6 and FIG.
4 also show a ground pin 160 that is present within the connector
enclosure base 110. This ground pin 160 also electrically connects
to the flexible circuit connector 170 to provide a ground
connection for the medical circuitry 152. The ground pin 160 is
then welded or otherwise bonded to the connector enclosure base 110
the embodiments where the connector enclosure base 110 is a metal
to thereby establish the ground with the body of the patient and
the metallic portions of the can 106.
[0045] Additionally, for embodiments where a telemetry antenna 183
as seen in FIG. 7 is provided atop the connector enclosure 108, an
antenna pin 162 may be included that passes through the connector
enclosure base 110 and connects to the flexible circuit connector
170. As shown in FIG. 6, the antenna pin 162 may be isolated from
the base 110 via a ferrule filled with a glass or other
non-conductor as with the other feedthrough pins 144. However, the
antenna pin 162 is not filtered by the filter plates 150 so that
the telemetry signals are not subject to attenuation from the
capacitive filters of the filter plates 150. A connecting portion
164 of the antenna 183 as shown FIGS. 4 and 7 may then connect the
antenna pin 162 to the antenna conductor present within the 183
cover 116. The connecting portion 164 may be an integral section of
the conductor forming the telemetry antenna 183 as shown in FIG. 7
or may be a separate conductor bridging the telemetry antenna 183
to the antenna pin 162.
[0046] The connector enclosure base 110 may include features to aid
in the construction of the medical device 102. For instance, the
connector enclosure base 110 may provide the feet 140 that extend
into the isolation cup 138 to provide a snug fit of the isolation
cup 138 to the connector enclosure base 110 prior to the connector
enclosure base 110 being bonded to the can 106. Additionally, in
this example where the telemetry antenna 183 is positioned atop the
connector enclosure 108, the connector enclosure base 110 includes
a slot 134 that receives a foot of the antenna cover 116 to aid in
holding the antenna cover 116 and the antenna 183 within the
antenna cover 116 in place.
[0047] FIG. 7 provides a view of the feedthrough pins 144 passing
through the feedthrough passageways 200 that include the ferrules
178 from a top perspective. Here, it can be seen that the lead
connectors 146 are positioned in longitudinal alignment with
corresponding feedthrough passageways 200 of the enclosure base
110. This longitudinal alignment allows the feedthrough pins 144 to
be straight in the longitudinal dimension which facilitates
assembly and reduces feedthrough pin length. The feedthrough pins
144 of this example have bends in the transverse dimension which
allows the feedthrough pins 144 to mount to the lead connectors 146
at the outer sides while returning to a more central location where
the feedthrough passageways 200 are located. This configuration
aids in assembling the stacked configuration of lead bores as
shown.
[0048] In this particular example, the lead connectors 146 for a
top lead passageway are offset in the longitudinal direction
relative to the lead connectors 146 for a bottom lead passageway.
This allows the feedthrough pins 144 for the lead connectors 146 of
the top lead passageway to pass by the non-conductive lead
connector seals 148 for the lead connectors 146 of the bottom lead
passageway. In this manner the feedthrough pins 144 of the top lead
passageway do not interfere with the lead connectors 146 or
feedthrough pins 144 of the bottom lead passageway. Furthermore,
the feedthrough pins 144 are spaced from the walls of the cavity
formed in the connector enclosure body 112 which may be metal so
that the electrical signals are not short circuited to ground and
are not attenuated to a degree that might affect operation of the
medical device 102.
[0049] FIG. 7 also provides a view of the cavity within the
connector enclosure 108 where the set screw block spacer 180 is
removed for purposes of illustration to reveal a recess 186 of the
cavity that is machined or otherwise manufactured to have inner
surfaces that accommodate and secure the set screw block spacer
180. This spacer 180 may be constructed of a non-conductive rigid
material such as polysulfone which may directly contact metal walls
of the cavity within the connector enclosure body 112 while
supporting the set screw blocks and isolating the set screw blocks
from the metal walls so that electrical, signals are not short
circuited to ground and are not attenuated to a degree that might
affect operation of the medical device 102. Other machined or
otherwise manufactured inner surface features are discussed further
below with reference to FIG. 9.
[0050] To ensure that the seat 120 will properly adhere to the set
screw block spacer 180, the set screw block spacer 180 may be
manufactured such as by applying a coating of siloxane. The
siloxane layer may then be primerized with a layer of silicone
medical adhesive which may be diluted with a heptanes solvent. The
seal 120 may then be applied atop the medical adhesive primer
layer, such as by applying liquid silicone rubber to form the seal
120.
[0051] FIG. 7 also shows an antenna support 184 that the antenna
conductor 183 may rest upon or be encased by, and the antenna
support 184 lies within the antenna cover 116 which has also been
removed for purposes of illustration. In this particular example,
the connector enclosure body 112 includes an arced top upon which
the antenna cover 116 rets. The antenna support 184, which may be
constructed of materials such as polysulfone, polyurethane, and the
like, isolates the antenna conductor 183 from the connector
enclosure body 112, which is particularly of interest for
embodiments that include a metallic connector enclosure body 112.
The antenna support 184 may be coated in the same manner discussed
above for the set screw block spacer 180 so that portions of the
antenna support 184 that extend into the cavity of the cavity of
the connector enclosure body 112 may adhere to the liquid silicone
rubber that has been inserted into the cavity of the connector
enclosure body 112.
[0052] The antenna cover 116 and/or the antenna support 184 may
provide a sealed passageway for the connecting pin 164 to pass from
the portion of the cavity behind the end seal 142 to the interior
of the antenna support 184 where contact with the antenna conductor
183 is made. The antenna support 184 includes suture holes 187
which align with suture holes that may also be included in the
antenna cover 116 that allow the medical device 102 to be sutured
in place within the body of the patient.
[0053] The connector enclosure base 110 of this example includes a
lip with an upper edge 182. The panel 118 rests at the upper edge
182 of the lip where a laser seam weld may be created to attach the
bottom edge of the panel 118 to the upper edge 182 of the lip. As
discussed above, the lower edge 166 of the lip on the connector
enclosure base 110 rests against an upper edge of the can 106 where
a laser seam weld may be created to attach the connector enclosure
base 110 to the can 106.
[0054] In FIG. 8, the antenna support 14 is removed for purposes of
illustration. The outer surface 185 of the connector enclosure body
112 where the antenna cover 116 rests can be seen. The antenna
cover 116 includes longitudinal ribs that slide into longitudinal
grooves 189 formed into the top of the connector enclosure body
112. These grooves 189 hold the antenna cover 116, and hence the
antenna support 184, in a fixed position relative to the connector
enclosure body 112. The connector enclosure base 110 may be
subsequently moved into position relative to the connector
enclosure body 112 which involves placing the end of the antenna
cover 116 into the slot 134 in the connector enclosure base 110.
The slot 134 runs orthogonally to the grooves 1849 such that the
antenna cover 116 and antenna support 184 are locked in place on
the connector enclosure 108.
[0055] FIG. 9 shows the connector enclosure body 112 mounted to the
connector enclosure base 110 but with all other components removed
for purposes of illustration. The features of the interior walls
within the cavity of the enclosure body 112 are in view.
Considering that the connector enclosure body 112 and the interior
walls of the cavity in particular may be constructed of metal, the
features of the interior walls may be machined or otherwise
manufactured to include a variety of features to accommodate the
components that reside within the connector enclosure 108.
[0056] In this example, additional recesses 190 that accommodate,
align, and secure the lead connectors 146 and lead connector seals
148 can be seen. The recess 190 align with the openings 114 to
provide longitudinal passageways where the lead connectors 146 and
lead connector seals 148 are present as shown in the preceding
figures to ultimately receive the leads 104.
[0057] As shown in FIG. 8, the lead connector seals 148, which may
be constructed of non-conductive materials such as liquid silicone
rubber, urethane, and the like, operate as spacers to both separate
the lead connectors 146 from the interior walls of the cavity
formed in the connector enclosure body 112 and to separate one lead
connector 146 from an adjacent lead connector. In one particular
example, the lead connectors 146 may be canted coil spring
connectors such as those available from the Bal Seal Engineering
company.
[0058] The seals 148 may create various nearest edge to nearest
edge spacing between the connectors 146, for instance from 16
thousandths of an inch for some embodiments to 33 thousandths of an
inch for others. Furthermore, the seals 148 may create various
spacing between the cavity walls and the nearest edge of the
connectors 146, for instance from 10 thousandths of an inch for
some embodiments to 15 thousandths of an inch for others. The
non-conductive seals 148 effectively isolate the electrical
connectors 146 from the metal walls and adjacent electrical
connectors 146 so that electrical signals are not shorted to ground
and are not attenuated to a degree that affects operation of the
medical device 102.
[0059] The alignment of the lead connector seals 148 and the lead
connectors 146 directly impact the amount of insertion force
necessary to insert a lead 104. The proximal end of the lead 104
passes through each lead connector 146 until the lead 104 is fully
inserted into the connector enclosure 108. As the proximal end of
the lead 104 approaches the fully inserted position, all lead
connectors 146 of a given lead passageway are engaging the lead
body and/or connectors 124. Each lead connector 146 thereby causes
friction with the lead 104 during insertion which results in a
given insertion force. The les the concentricity from one lead
connector 146 to the next varies, the smaller the amount of
insertion force required to insert the lead. A smaller amount of
insertion force has a smaller likelihood of damaging the medical
lead 104.
[0060] In the example shown in FIG. 9, the lead passageway recesses
190 are formed by machining or other precision method such that the
centerline of each lead connector 146 in the longitudinal direction
varies by 8 thousandths of an inch or less from the centerline of
every other lead connector 146 in some embodiments, for instance 4
thousandths of an inch or less for embodiments with walls
constructed of various grades of titanium or similar metals. For
instance, the connector enclosure body 112 may be titanium and the
recesses 190 may be machined into the titanium to provide this
degree of concentricity for the lead connectors 146.
[0061] A recess 188 that accommodates and secures the end seal 142
can also be seen in FIG. 9. In this example, the end seal 142 shown
in FIG. 8 is a double seal that captures the most proximal lead
connector 146 for both the upper and the lower lead passageways. It
will be appreciated that individual end seals could be used in
place of a double seal for two lead passageways, such as where
multiple recesses 188 may be present to accommodate and secure each
end seal or where a single recess 188 as shown accommodates two
individual end seals in a stacked configuration. The end seal 142,
which may also be constructed of a non-conductive material such as
a liquid silicone rubber, urethane, and the like, effectively
isolates the final electrical connectors 146 from the metal walls
so that electrical signals are not shorted to ground and are not
attenuated to a degree that affects operation of the medical device
102.
[0062] In this example shown in FIG. 9, the connector enclosure
body 112 also includes a set of recesses 192 that align with
feedthrough passageways 200 in the connector enclosure base 110.
These recesses allow the feedthrough pins 114 of that side of the
connector enclosure body 112 to pass into the feedthrough
passageways 200 without obstruction while retaining a robust lower
support for the lead connector seals 148 of the lower lead
passageway.
[0063] Where the connector enclosure body 112 is constructed of a
material that is relatively sturdy, such as titanium or other
biocompatible metals, the walls of the enclosure body 112 may be
made relatively thin which allows for an overall reduction in the
volume of the connector enclosure 108. For instance, in this
example where the connector enclosure body 112 is constructed of a
metal such as titanium, the walls for the recesses 186 and 188 are
the thinnest walls for the enclosure body 112 and may be machined
or otherwise formed so that the thickness is on the order of 25
thousandths of an inch or less in some embodiments, such as 8
thousandths of an inch tor various grades of titanium and similar
metals. Other embodiments may provide for the thinnest walls to be
in other locations within the cavity in addition to or as an
alternative to the recesses 186 and 188 having the thinnest
walls.
[0064] In this embodiment where the telemetry antenna 183 sits atop
the connector enclosure 112, the connecting pin 164 passes through
a seal that is mounted within an opening 194 present within the
connector enclosure body 112 to enter the antenna support 184. The
antenna cover 116 may have the seal integrally formed so that upon
mounting the antenna cover 116, the seal is disposed within the
opening 194. In this particular example, the antenna pin 162
extends from the feedthrough passageway of the connector enclosure
base 110 into a region between the end seal 142 and the opening
194, as shown in FIG. 8. With the opening 194 on the end of the
connector enclosure 108 opposite the lead passageway openings 114,
the conduction path from the antenna pin 162 to the antenna 183
within the housing 184 avoids intersections with other feedthrough
pins 144, lead connectors 146, set screw blocks, and the leads 104
themselves.
[0065] FIG. 10 shows the inner side of the connector enclosure
panel 118. The panel 118 includes a peripheral surface that rests
against the indention 168 of the connector enclosure body 112 once
the panel 118 is bonded in place by a laser seam weld or other
bond. The panel 118 of this embodiment includes the region 132 that
is concave when viewed on the inner side as shown in FIG. 10. This
region 132 accommodates the seals 148 and lead connectors 146
forming the lead passageways as well as the feedthrough pins 144
present between the seals 148 and the panel 118. This concavity
allows the width of the connector enclosure body 12 to be less than
the width needed for clearance in the region 132 to thereby reduce
the overall volume of the connector enclosure 108.
[0066] The panel 118 also includes an opening 16 where the set
screw block is exposed to insert the set screws and set screw
grommets 122 into the set screw block and where the seal 120 can be
added to seal the junction of the opening 196 and grommets to the
set screw spacer and set screw block. The opening 196 of this
embodiment is also present within a concavity that allows the
connector enclosure body 112 to have a width that is less than the
width needed for clearance of the set screw block spacer 180 to
further reduce the overall volume of the connector enclosure
108.
[0067] Where the panel 18 is welded to the connector enclosure body
112, the panel 118 may be constructed of various biocompatible
metals. For instance the panel 118 may be constructed of various
grades of titanium such as grades 1 or 5. However, constructing the
panel 118 of a grade 1 titanium allows the panel to be stamped more
easily although the panel 118 may be manufactured in other ways
such as by machining. The thickness of the panel 118 may be
relatively small, similar to the thinnest walls of the connector
enclosure base 112, because of the inherent strength in a metal
panel 118. The panel 118 may have a thickness on the order of 25
thousandths of an inch or less for some embodiments that use metal,
such as 8 to 12 thousandths of an inch for various grades of
titanium and similar metals.
[0068] FIG. 11 shows an example of the connector enclosure base 110
with other elements of the connector enclosure 108 removed. In this
example, the connector enclosure base 110 includes an upper edge
198 of the lip where the convector enclosure body 112 may be seated
and ultimately welded in place. The connector enclosure base 110
provides the feedthrough passageways 200 and also provides a ground
pin passageway 202. The ground pin 160 terminates within the ground
pin passageway 202 where it is welded to the connector enclosure
base 110.
[0069] The connector enclosure base 110 may be constructed of
various materials. For embodiments where the connector enclosure
base 110 is welded to the top edge of the can 106 and/or welded to
the connector enclosure body 112, the connector enclosure base 110
is constructed of a biocompatible metal. For instance, the
connector enclosure base 110 may be constructed of grade 5 titanium
that is machined to provide the features as shown.
[0070] One manner of assembling the example of the connector
enclosure 1014 shown in FIGS. 1-11 may proceed as follows. The
connector enclosure base 110, feedthrough pins 144, filter plates
150, ground pin 160, and antenna pin 162 may be pieced together and
bonded physically and electrically as appropriate. The lead
connectors 146, seals 148, and end seal 142 may be pieced together
and placed into the recesses 188 and 190 of the connector enclosure
body 112. The set screw block spacer 180 containing the set screw
blocks may be placed into the recess 186 with the feedthrough pins
144 corresponding to the set screw blocks being welded to the set
screw blocks while the seals for the openings 114 may be
inserted.
[0071] Prior to bringing the connector enclosure body 112 together
with the connector enclosure base 110, the antenna cover 116
including the antenna support 184 the antenna conductor 183, and
the antenna connecting pin 164 are pieced together and joined to
the connector enclosure body 112. As discussed above, in this
example the antenna cover 116 slides onto the grooves 189 of the
connector enclosure body 112 while the connecting pin 164 and
related portion of the antenna cover 116 pass into the opening 194
of the connector enclosure body 112.
[0072] The connector enclosure base 110 is then mounted to the
connector enclosure body 112 by sliding the connector enclosure
base 110 transversely into position relative to the body 112 and
then bonded the two such as by a metallic weld. In doing so, the
feedthrough pins 144 move into contact with corresponding
feedthrough plate passages while being accommodated by the recesses
192. Likewise, the antenna pin 162 moves into contact with the
connecting pin 164 while the bottom of the antenna cover 116 slides
into the slot 134 of the connector enclosure base 110. The
feedthrough pins 144 may then be welded to the lead connectors 146
while the antenna pin 162 may be welded to the connecting pin
164.
[0073] The components within the cavity of the connector enclosure
body 112 an complete. The panel 118 is then placed over the cavity
and welded into place within the indention 168 of the connector
enclosure body 112 which holds the end seal 142 and the set screw
block spacer 180 into place and thereby assists in holding the lead
connectors 146 and seals 14 in place within the cavity. The panel
118 is bonded to the connector enclosure body 112 and connector
enclosure base 110, such as by a metallic weld to complete the
assembly of the connector enclosure 108. A filler material such as
liquid silicone rubber is injected within the cavity of the
connector enclosure body 112 through a remaining passageway to fill
the cavity and the passageway. The grommets may be installed and
the seal 120 is poured into place.
[0074] One manner of assembling the medical device 102 may proceed
as follows. The connector enclosure 108 is assembled as dis cussed
above. The medical circuitry 152, coil assembly 154, battery 141,
flexible circuit connector 170, and bumper 172 are pieced together
and the exposed ends 156 of the feedthrough pins 144, ground pin
160, and antenna pin 162 are bonded to conductive pads 158 on the
flexible circuit connector 170. The isolation cup 138 is then
placed around the medical circuitry 152, coil assembly 154, battery
141 and flexible circuit connector 170, with the isolation cup 138
being fitted to the feet 140 of the connector enclosure base
110.
[0075] The isolation cup 138 and those items within the isolation
cup 139 are deposited into the top opening of the can 106. The
isolation cup 138 and those items within the isolation cup 138
slide down into the can 106 until the bumper 172 contacts the
bottom interior wall of the can 106. At that time, the top edge of
the can 106 engages the lower edge 166 of the lip around the
connector enclosure base 110. The top edge of the can 106 is then
bonded at the point of contact to the connector enclosure bae 110
such as by a metallic weld to complete the assembly of the medical
device 102.
[0076] While embodiments have been particularly shown and
described, it will be understood by those skilled in the art that
various other changes in the form and details may be made therein
without departing from the spirit and scope of the invention.
* * * * *