U.S. patent application number 10/632026 was filed with the patent office on 2005-02-03 for connector assembly for connecting a lead and an implantable medical device.
Invention is credited to Forsythe, Scott, Lahti, Jay, Ries, Andrew J..
Application Number | 20050027325 10/632026 |
Document ID | / |
Family ID | 34104254 |
Filed Date | 2005-02-03 |
United States Patent
Application |
20050027325 |
Kind Code |
A1 |
Lahti, Jay ; et al. |
February 3, 2005 |
Connector assembly for connecting a lead and an implantable medical
device
Abstract
A connector assembly for detachably connecting a lead to an
implantable medical device and an implantable medical device
capable of being detachably connected to a lead that include one or
more deflectable connector clip and a housing. The connector clip
includes a first arm, a second arm, and a top portion extending
between the first arm and the second arm, and is capable of being
deflected from a first position, corresponding to a first relative
position of the first arm and the second arm, to a second position
corresponding to a second relative position of the first arm and
the second arm. The housing includes a first member and a second
member, the first member formed to be fixedly engaged with the
second member to enclose the connector clip within the housing with
the one or more connector clip being positioned within one of the
first member and the second member.
Inventors: |
Lahti, Jay; (Shoreview,
MN) ; Ries, Andrew J.; (Lino Lakes, MN) ;
Forsythe, Scott; (Walworth, WI) |
Correspondence
Address: |
MEDTRONIC, INC.
710 MEDTRONIC PARKWAY NE
MS-LC340
MINNEAPOLIS
MN
55432-5604
US
|
Family ID: |
34104254 |
Appl. No.: |
10/632026 |
Filed: |
July 31, 2003 |
Current U.S.
Class: |
607/37 |
Current CPC
Class: |
A61N 1/3752 20130101;
H01R 13/5208 20130101; H01R 2201/12 20130101; H01R 13/5224
20130101 |
Class at
Publication: |
607/037 |
International
Class: |
A61N 001/375 |
Claims
1. A connector assembly for detachably connecting a lead to an
implantable medical device, comprising: a deflectable connector
clip including a first arm, a second arm, and a top portion
extending between the first arm and the second arm, the connector
clip capable of being deflected from a first position corresponding
to a first relative position of the first arm and the second arm to
a second position corresponding to a second relative position of
the first arm and the second arm; and a housing having a first
member and a second member, the first member formed to be fixedly
engaged with the second member to enclose the connector clip within
the housing, wherein the connector clip is positioned within one of
the first member and the second member.
2. The connector assembly of claim 1, wherein the first arm extends
from the top portion to a first end and the second arm extends from
the top portion to a second end, and wherein the connector clip
includes a first side wall along the first end and a second side
wall along the second end, the first side wall being adjacent to
and engaged against the second side wall when the connector clip is
in the first position and the first end being engaged against the
second end when the connector clip is in the second position.
3. The connector assembly of claim 1, wherein the housing and the
connector clip are formed of an electrically conductive metal.
4. The connector assembly of claim 3, wherein the electrically
conductive metal is stainless steel.
5. The connector assembly of claim 1, wherein the first member and
the second member form an aperture to receive the lead, the first
arm and the second arm being engaged against the lead as the lead
is advanced through the aperture to further deflect the first arm
and the second arm from the second position to a third position
corresponding to a third relative position of the first arm and the
second arm.
6. The connector assembly of claim 5, wherein the first arm extends
from the top portion to a first end and the second arm extends from
the top portion to a second end, and wherein the connector clip
includes a first side wall along the first end and a second side
wall along the second end, the first side wall being adjacent to
and engaged against the second side wall when the connector clip is
in the first position, the first end being engaged against the
second end when the connector clip is in the second position, and
the first end is extended a distance outward from the second end
when the connector clip is in the third position.
7. The connector assembly of claim 1, wherein the first member
includes a first flange extending outward from a front surface of
the first member to a first flange top portion, and the second
member includes a second flange extending outward from a front
surface of the second member to a second flange top portion, the
first flange top portion being fixedly engaged against the second
flange top portion to enclose the connector clip within the
housing.
8. The connector assembly of claim 7, wherein the first flange and
the front surface of the first member form a first recessed portion
and the second flange and the front surface of the second member
form a second recessed portion, the connector clip being positioned
within one of the first recessed portion and the second recessed
portion and deflected to the second position.
9. The connector assembly of claim 8, wherein the connector clip
includes a bottom portion, the first arm extending from the top
portion to the bottom portion and the second arm extending from the
top portion to the bottom portion, and wherein the top portion is
engaged against one of the first flange and the second flange and
the bottom portion is spaced from the one of the first flange and
the second flange.
10. The connector assembly of claim 8, wherein the front surface of
the first member and the front surface of the second member form an
aperture to receive the lead within the housing, the first arm and
the second arm being engaged against the lead as the lead is
advanced through the aperture to further deflect the first arm and
the second arm from the second position to a third position
corresponding to a third relative position of the first arm and the
second arm.
11. The connector assembly of claim 10, wherein the first arm
extends from the top portion to a first end and the second arm
extends from the top portion to a second end, and wherein the
connector clip includes a first side wall along the first end and a
second side wall along the second end, the first side wall being
adjacent to and engaged against the second side wall when the
connector clip is in the first position, the first end being
engaged against the second end when the connector clip is in the
second position, and the first end is extended a distance outward
from the second end when the connector clip is in the third
position.
12. The connector assembly of claim 1, wherein the first member
includes a first flange extending outward from a front surface of
the first member and the second member includes a second flange
extending outward from a front surface of the second member, the
second flange capable of being fixedly engaged about the first
flange to enclose the connector clip within the housing.
13. The connector assembly of claim 12, wherein the second member
includes a third flange extending outward from the front surface of
the second member, the first flange and the front surface of the
first member forming a first recessed portion and the third flange
and the front surface of the second member form a second recessed
portion, the connector clip being positioned within one of the
first recessed portion and the second recessed portion and
deflected to the second position.
14. The connector assembly of claim 13, wherein the connector clip
includes a bottom portion, the first arm extending from the top
portion to the bottom portion and the second arm extending from the
top portion to the bottom portion, and wherein the top portion is
engaged against one of the first flange and the third flange and
the bottom portion is spaced from the one of the first flange and
the third flange.
15. The connector assembly of claim 13, wherein the front surface
of the first member and the front surface of the second member form
an aperture to receive the lead within the housing, the first arm
and the second arm being engaged against the lead as the lead is
advanced through the aperture to further deflect the first arm and
the second arm from the second position to a third position
corresponding to a third relative position of the first arm and the
second arm.
16. The connector assembly of claim 15, wherein the first arm
extends from the top portion to a first end and the second arm
extends from the top portion to a second end, and wherein the
connector clip includes a first side wall along the first end and a
second side wall along the second end, the first side wall being
adjacent to and engaged against the second side wall when the
connector clip is in the first position, the first end being
engaged against the second end when the connector clip is in the
second position, and the first end is extended a distance outward
from the second end when the connector clip is in the third
position.
17. An implantable medical device capable of being detachably
connected to a lead, comprising: a first deflectable connector clip
including a first arm, a second arm, and a top portion extending
between the first arm and the second arm, the connector clip
capable of being deflected from a first position corresponding to a
first relative position of the first arm and the second arm to a
second position corresponding to a second relative position of the
first arm and the second arm; and a housing having a first member
and a second member, the first member formed to be fixedly engaged
with the second member to enclose the connector clip within the
housing, wherein the connector clip is positioned within one of the
first member and the second member.
18. The device of claim 17, wherein the first arm extends from the
top portion to a first end and the second arm extends from the top
portion to a second end, and wherein the connector clip includes a
first side wall along the first end and a second side wall along
the second end, the first side wall being adjacent to and engaged
against the second side wall when the connector clip is in the
first position and the first end being engaged against the second
end when the connector clip is in the second position.
19. The device of claim 17, wherein the housing and the connector
clip are formed of an electrically conductive metal.
20. The device of claim 19, wherein the electrically conductive
metal is stainless steel.
21. The device of claim 17, wherein the first member and the second
member form an aperture to receive the lead, the first arm and the
second arm being engaged against the lead as the lead is advanced
through the aperture to further deflect the first arm and the
second arm from the second position to a third position
corresponding to a third relative position of the first arm and the
second arm.
22. The device of claim 21, wherein the first arm extends from the
top portion to a first end and the second arm extends from the top
portion to a second end, and wherein the connector clip includes a
first side wall along the first end and a second side wall along
the second end, the first side wall being adjacent to and engaged
against the second side wall when the connector clip is in the
first position, the first end being engaged against the second end
when the connector clip is in the second position, and the first
end is extended a distance outward from the second end when the
connector clip is in the third position.
23. The device of claim 17, wherein the first member includes a
first flange extending outward from a front surface of the first
member to a first flange top portion, and the second member
includes a second flange extending outward from a front surface of
the second member to a second flange top portion, the first flange
top portion being fixedly engaged against the second flange top
portion to enclose the connector clip within the housing.
24. The device of claim 23, wherein the first flange and the front
surface of the first member form a first recessed portion and the
second flange and the front surface of the second member form a
second recessed portion, the connector clip being positioned within
one of the first recessed portion and the second recessed portion
and deflected to the second position.
25. The device of claim 23, wherein the connector clip includes a
bottom portion, the first arm extending from the top portion to the
bottom portion and the second arm extending from the top portion to
the bottom portion, and wherein the top portion is engaged against
one of the first flange and the second flange and the bottom
portion is spaced from the one of the first flange and the second
flange.
26. The device of claim 24, wherein the front surface of the first
member and the front surface of the second member form an aperture
to receive the lead within the housing, the first arm and the
second arm being engaged against the lead as the lead is advanced
through the aperture to further deflect the first arm and the
second arm from the second position to a third position
corresponding to a third relative position of the first arm and the
second arm.
27. The device of claim 26, wherein the first arm extends from the
top portion to a first end and the second arm extends from the top
portion to a second end, and wherein the connector clip includes a
first side wall along the first end and a second side wall along
the second end, the first side wall being adjacent to and engaged
against the second side wall when the connector clip is in the
first position, the first end being engaged against the second end
when the connector clip is in the second position, and the first
end is extended a distance outward from the second end when the
connector clip is in the third position.
28. The device of claim 17, wherein the first member includes a
first flange extending outward from a front surface of the first
member and the second member includes a second flange extending
outward from a front surface of the second member, the second
flange capable of being fixedly engaged about the first flange to
enclose the connector clip within the housing.
29. The device of claim 28, wherein the second member includes a
third flange extending outward from the front surface of the second
member, the first flange and the front surface of the first member
forming a first recessed portion and the third flange and the front
surface of the second member form a second recessed portion, the
connector clip being positioned within one of the first recessed
portion and the second recessed portion and deflected to the second
position.
30. The device of claim 29, wherein the connector clip includes a
bottom portion, the first arm extending from the top portion to the
bottom portion and the second arm extending from the top portion to
the bottom portion, and wherein the top portion is engaged against
one of the first flange and the third flange and the bottom portion
is spaced from the one of the first flange and the third
flange.
31. The device of claim 29, wherein the front surface of the first
member and the front surface of the second member form an aperture
to receive the lead within the housing, the first arm and the
second arm being engaged against the lead as the lead is advanced
through the aperture to further deflect the first arm and the
second arm from the second position to a third position
corresponding to a third relative position of the first arm and the
second arm.
32. The device of claim 31, wherein the first arm extends from the
top portion to a first end and the second arm extends from the top
portion to a second end, and wherein the connector clip includes a
first side wall along the first end and a second side wall along
the second end, the first side wall being adjacent to and engaged
against the second side wall when the connector clip is in the
first position, the first end being engaged against the second end
when the connector clip is in the second position, and the first
end is extended a distance outward from the second end when the
connector clip is in the third position.
33. An implantable medical device capable of being detachably
connected to a lead, comprising: a first deflectable connector clip
and a second deflectable connector clip, each of the first
connector clip and the second connector clip including a first arm,
a second arm, and a top portion extending between the first arm and
the second arm, and capable of being deflected from a first
position corresponding to a first relative position of the first
arm and the second arm to a second position corresponding to a
second relative position of the first arm and the second arm; and a
housing having a first member and a second member, wherein the
first connector clip is positioned within the first member and the
second connector clip is positioned within the second member
generally perpendicular to the first connector clip, and the first
member is formed to be fixedly engaged with the second member to
enclose the first connector clip and the second connector clip
within the housing.
34. The device of claim 33, wherein, for each of the first
connector clip and the second connector clip, the first arm extends
from the top portion to a first end and the second arm extends from
the top portion to a second end, and wherein each of the first
connector clip and the second connector clip include a first side
wall along the first end and a second side wall along the second
end, the first side wall being adjacent to and engaged against the
second side wall when the first connector clip and the second
connector clip is in the first position and the first end being
engaged against the second end when the first connector clip and
the second connector clip is in the second position.
35. The device of claim 33, wherein the housing and the first
connector clip and the second connector clip are formed of an
electrically conductive metal.
36. The device of claim 35, wherein the electrically conductive
metal is stainless steel.
37. The device of claim 33, wherein the first member and the second
member form an aperture to receive the lead, the first arm and the
second arm being engaged against the lead as the lead is advanced
through the aperture to further deflect the first arm and the
second arm from the second position to a third position
corresponding to a third relative position of the first arm and the
second arm.
38. The device of claim 37, wherein the first arm extends from the
top portion to a first end and the second arm extends from the top
portion to a second end, and wherein each of the first connector
clip and the second connector clip include a first side wall along
the first end and a second side wall along the second end, the
first side wall being adjacent to and engaged against the second
side wall when the first connector clip and the second connector
clip is in the first position, the first end being engaged against
the second end when the first connector clip and the second
connector clip is in the second position, and the first end is
extended a distance outward from the second end when the first
connector clip and the second connector clip is in the third
position.
39. The device of claim 33, wherein the first member includes a
first flange extending outward from a front surface of the first
member to a first flange top portion, and the second member
includes a second flange extending outward from a front surface of
the second member to a second flange top portion, the first flange
top portion being fixedly engaged against the second flange top
portion to enclose the first connector clip and the second
connector clip within the housing.
40. The device of claim 39, wherein the first flange and the front
surface of the first member form a first recessed portion and the
second flange and the front surface of the second member form a
second recessed portion, the first connector clip being positioned
within the first recessed portion and deflected to the second
position, and the second connector clip being positioned within the
second recessed portion and deflected to the second position.
41. The device of claim 39, wherein the each of the first connector
clip and the second connector clip include a bottom portion, the
first arm extending from the top portion to the bottom portion and
the second arm extending from the top portion to the bottom
portion, and wherein the top portion of the first connector clip is
engaged against the first flange and the top portion of the second
connector clip is engaged against the second flange, and the bottom
portion of the first connector clip is spaced from the first flange
and the bottom portion of the second connector clip is spaced from
the second flange.
42. The device of claim 40, wherein the front surface of the first
member and the front surface of the second member form an aperture
to receive the lead within the housing, the first arm and the
second arm of each of the first connector clip and the second
connector clip being engaged against the lead as the lead is
advanced through the aperture to further deflect the first arm and
the second arm from the second position to a third position
corresponding to a third relative position of the first arm and the
second arm.
43. The device of claim 42, wherein the first arm of each of the
first connector clip and the second connector clip extend from the
top portion to a first end and the second arm of each of the first
connector clip and the second connector clip extend from the top
portion to a second end, and wherein each of the first connector
clip and the second connector clip include a first side wall along
the first end and a second side wall along the second end, the
first side wall being adjacent to and engaged against the second
side wall when the first connector clip and the second connector
clip is in the first position, the first end being engaged against
the second end when the first connector clip and the second
connector clip is in the second position, and the first end is
extended a distance outward from the second end when the first
connector clip and the second connector clip is in the third
position.
44. The device of claim 33, wherein the first member includes a
first flange extending outward from a front surface of the first
member and the second member includes a second flange extending
outward from a front surface of the second member, the second
flange capable of being fixedly engaged about the first flange to
enclose the first connector clip and the second connector clip
within the housing.
45. The device of claim 44, wherein the second member includes a
third flange extending outward from the front surface of the second
member, the first flange and the front surface of the first member
forming a first recessed portion and the third flange and the front
surface of the second member form a second recessed portion, the
first connector clip being positioned within the first recessed
portion and deflected to the second position, and the second
connector clip being positioned within the second recessed portion
and deflected to the second position.
46. The device of claim 45, wherein each of the first connector
clip and the second connector clip include a bottom portion, the
first arm extending from the top portion to the bottom portion and
the second arm extending from the top portion to the bottom
portion, and wherein the top portion of the first connector clip is
engaged against the first flange and top portion of the second
connector clip is engaged against the third flange, and the bottom
portion of the first connector clip is spaced from the first flange
and the bottom portion of the second connector clip is spaced from
the third flange.
47. The device of claim 45, wherein the front surface of the first
member and the front surface of the second member form an aperture
to receive the lead within the housing, the first arm and the
second arm of each of the first connector clip and the second
connector clip being engaged against the lead as the lead is
advanced through the aperture to further deflect the first arm and
the second arm from the second position to a third position
corresponding to a third relative position of the first arm and the
second arm.
48. The device of claim 47, wherein the first arm of each of the
first connector clip and the second connector clip extends from the
top portion to a first end and the second arm extends from the top
portion to a second end, and wherein the first connector clip and
the second connector clip include a first side wall along the first
end and a second side wall along the second end, the first side
wall being adjacent to and engaged against the second side wall
when the first connector clip and the second connector clip is in
the first position, the first end being engaged against the second
end when the first connector clip and the second connector clip is
in the second position, and the first end is extended a distance
outward from the second end when the first connector clip and the
second connector clip is in the third position.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] Cross-reference is hereby made to commonly assigned related
U.S. Applications, filed concurrently herewith, docket number
P-9173, entitled "CONNECTOR ASSEMBLY FOR CONNECTING A LEAD AND AN
IMPLANTABLE MEDICAL DEVICE" and docket number P-11122, entitled
"SMALL FORMAT CONNECTOR CLIP OF AN IMPLANTABLE MEDICAL DEVICE", and
docket number P10955, entitled "ELECTRICAL CONNECTOR ASSEMBLY FOR
COUPLING MEDICAL LEADS TO IMPLANTABLE MEDICAL DEVICES",
incorporated herein by reference in their entirety.
FIELD OF THE INVENTION
[0002] The present invention relates to medical leads of
implantable medical devices and, more particularly, to a connector
assembly of an implantable medical device that facilitates coupling
between a lead and circuitry of the implantable medical device.
BACKGROUND OF THE INVENTION
[0003] In the medical field, leads are used with a wide variety of
medical devices. For example, leads are commonly implemented to
form part of an implantable medical device (IMD), such as
implantable cardiac pacemakers that provide therapeutic stimulation
to the heart by delivering pacing, cardioversion or defibrillation
pulses. The pulses can be delivered to the heart via electrodes
disposed on the leads, e.g., typically near distal ends of the
leads. In that case, the leads may position the electrodes with
respect to various cardiac locations so that the pacemaker can
deliver pulses to the appropriate locations. Leads are also used
for sensing purposes, or both sensing and stimulation purposes.
[0004] In addition, leads are used in neurological devices such as
deep-brain stimulation devices, and spinal cord stimulation
devices. For example, the leads may be stereotactically probed into
the brain to position electrodes for deep brain stimulation. Leads
are also used with a wide variety of other medical devices
including, for example, devices that provide muscular stimulation
therapy, devices that sense chemical conditions in a patient's
blood, and the like. In short, medical leads may be used for
sensing purposes, stimulation purposes, or both.
[0005] An IMD typically includes one or more leads, a housing that
houses circuitry of the IMD, and a connector block that couples the
lead to the circuitry. In particular, the connector block includes
electrical contact structures for coupling the lead to circuitry
within the housing of the IMD so that therapeutic simulation can be
provided through the lead, or sensed conditions can be recorded by
the circuitry. One challenge in implementing medical leads in a
medical device is the electrical coupling between a respective lead
and circuitry of the IMD.
[0006] Various connection standards have been developed in order to
ensure electrical connections between the IMD circuitry and the
lead are acceptable, while also maintaining a sufficient hermetic
seal between the connector block and the lead to avoid ingress of
body fluids into the housing. These standards continue to evolve to
accommodate new lead designs, such as in-line leads that include a
plurality of electrical contact areas along axial positions of the
lead.
[0007] In general, there remains a need for lead connector
configurations that are simple to use and inexpensive to fabricate.
Improved simplicity can help ensure that physicians can make the
electrical connections during implantation of the IMD with minimal
concern for electrical coupling malfunction. Reduced fabrication
expense can help ensure that patient costs associated with an IMD
can be minimized.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] It is to be understood that the foregoing general
description and the following detailed description are exemplary
and explanatory but are not to be restrictive of the invention. The
accompanying drawings which are incorporated in and constitute a
part of this invention, illustrate one or more of the embodiments
of the present invention, and together with the description, serve
to explain the principles of the invention in general terms.
Additionally, other features which are considered as characteristic
for the invention are set forth in the appended claims. Advantages
and features of the present invention will be readily appreciated
as the same becomes better understood by reference to the following
detailed description when considered in connection with the
accompanying drawings, in which like reference numerals designate
like parts throughout the figures thereof and wherein:
[0009] FIG. 1 is a perspective view of an exemplary implantable
medical device capable of incorporating a connector assembly
according to the present invention;
[0010] FIG. 2 is an exploded view, in perspective, of an embodiment
of a connector assembly according to the present invention;
[0011] FIG. 3A is a plan view of a connector clip utilized in a
connector assembly of the present invention in a non-deflected
position;
[0012] FIG. 3B is a side view of the connector clip of FIG. 3A;
[0013] FIG. 3C is a plan view of a connector clip utilized in a
connector assembly of the present invention in a partially
deflected position;
[0014] FIG. 3D is a side view of the connector clip of FIG. 3C;
[0015] FIG. 4 is a front view of a housing member of a connector
assembly according to the present invention having a connector
clip, in a partially deflected position, positioned within the
housing member;
[0016] FIG. 5A is a side view of an assembled housing of a
connector assembly according to the present invention;
[0017] FIG. 5B is a cross-section side view of the assembled
housing of the connector assembly of FIG. 5A;
[0018] FIG. 5C is a top view of an assembled connector assembly
according to the present invention;
[0019] FIG. 6 is a schematic diagram of a connector assembly
according to the present invention inserted within a connector
cavity and having a lead connector positioned there through;
[0020] FIG. 7 is a schematic diagram of a housing of a connector
assembly, according to an embodiment of the present invention, with
a lead inserted therein;
[0021] FIG. 8A is a schematic diagram of a female member of a
housing of a connector assembly according to an alternate
embodiment of the present invention;
[0022] FIG. 8B is a schematic diagram of a male member of a housing
of a connector assembly according to an alternate embodiment of the
present invention;
[0023] FIG. 9A is a side view of an assembled housing of a
connector assembly according to an alternate embodiment of the
present invention;
[0024] FIG. 9B is a cross-section side view of the assembled
housing of the connector assembly of FIG. 9A; and
[0025] FIG. 9C is a top view of an assembled connector assembly
according to an alternate embodiment of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0026] The present invention relates to an improved connector
assembly for detachably connecting and retaining the terminal pin
of an electrical lead to an implantable medical device. The
invention utilizes one or more resilient connector clips that are
in a partially deflected configuration, or partially loaded state,
such that a relatively constant force is exerted over the full
range of deflection of the spring, and are positioned within a
housing. Since only a small deflection of the spring is necessary
to create significant force of retention on the inserted terminal
pin of the lead, the connector assembly of the present invention
allows for ease in inserting the terminal pin of the lead and
allows for sufficient force to be exerted on the terminal pin for
optimum retention of the lead without damaging it. Furthermore, the
connector assembly of the present invention makes efficient use of
the axial space on the terminal pin, allowing it to be very
compact. Axial space is efficiently used due to the alignment of
the spring contact perpendicular to the inserted lead. The
connector readily accepts insertion of a terminal pin, without the
use of tools, and applies a relatively even force through the
connector clips to maintain a constant electrical contact with the
electrical lead that is not subject to varying impedance. The
connector of the present invention provides the requisite
mechanical and electrical connection functions, using fewer
components and less labor in implementation, yet providing higher
reliability, durability, resistance to breakdown due to reactions
with body fluids, a small size, and efficiency in manufacture.
[0027] FIG. 1 is a perspective view of an exemplary implantable
medical device capable of incorporating a connector assembly
according to the present invention. As illustrated in FIG. 1, an
exemplary implantable medical device (IMD) 1 incorporating a
connector assembly according to the present invention includes a
hermetically sealed, biologically inert housing 5, or "can", that
houses IMD circuitry, one or more leads 2A, 2B (collectively leads
2) that can be implanted in a patient, and a connector block 7 that
receives proximal ends 9A, 9B of leads 2 to couple leads 2 to the
circuitry in housing 5 as leads 2 are inserted within a connector
port 3 formed in connector block 7. Once fully inserted within
connector block 7, leads 2 are further fixedly positioned within
connector block 7 by tightening positioning screws 11 against leads
2.
[0028] As illustrated in FIG. 1, the proximal ends 9A and 9B of
lead 2A and 2B, respectively, include a plurality of electrical
contact areas 8A-8J (collectively contact areas 8). The present
invention facilitates electrical coupling to one or more of contact
areas 8 within connector block 7. Moreover, the present invention
improves such contact for inline configurations like FIG. 1 in
which a plurality of electrical contact areas 8 are positioned
axially along a length of leads 2. In particular, the present
invention allows size reductions of contact areas 8 by improving
electrical coupling clips, described below, that electrically
interface with contact areas 8 inside connector block 7.
[0029] IMD 1 corresponds to any medical device that includes
medical leads and circuitry coupled to the medical leads. By way of
example, IMD 1 takes the form of an implantable cardiac pacemaker
that provides therapeutic stimulation to the heart. Alternatively,
IMD 1 may take the form of an implantable cardioverter or an
implantable defibrillator, or an implantable cardiac
pacemaker-cardioverter-defibrillator. IMD 1 may deliver pacing,
cardioversion or defibrillation pulses to a patient via electrodes
disposed on distal ends of leads 2. In other words, leads 2
position electrodes with respect to various cardiac locations so
that IMD 1 can deliver pulses to the appropriate locations.
[0030] Alternatively, IMD 1 corresponds to a patient monitoring
device, or a device that integrates monitoring and stimulation
features. In those cases, leads 2 include sensors positioned along
distal ends of the respective lead for sensing patient conditions.
The sensors include, for example, electrical sensors,
electrochemical sensors, pressure sensors, flow sensors, acoustic
sensors, optical sensors, or the like. In many cases, IMD 1
performs both sensing and stimulation functions.
[0031] In still other applications, IMD 1 corresponds to a
neurological device such as a deep-brain stimulation device or a
spinal cord stimulation device. In those cases, leads 2 are
stereotactically probed into the brain to position electrodes for
deep brain stimulation, or into the spine for spinal stimulation.
In other applications, IMD 1 provides muscular stimulation therapy,
blood sensing functions, and the like. In short, IMD 1 corresponds
to any of a wide variety of medical devices that implement leads
and circuitry coupled to the leads.
[0032] As outlined in detail below, connector block 7 of the
present invention incorporates various components that improve and
simplify electrical coupling between leads 2 and circuitry in
housing 5. More specifically, an electrical connector clip provides
a conductive interface between a medical lead and IMD circuitry. In
addition, various components that assemble with the connector clip
to form at least a portion of connector block 7 of IMD 1 are also
described. For example, an improved structure having a channel for
mating with one or more of leads 2 is designed for use with the
connector clip so that biasing of the connector clip can be
achieved prior to insertion of one or more leads 2 into the
channel. As described below, such biasing allows for ease of
insertion of one or more of leads 2 into the channel of the
structure that forms at least part of connector block 7. In other
words, the connector clip defines a desired amount of insertion
force for lead pins inserted into connector block 7.
[0033] FIG. 2 is an exploded view, in perspective, of an embodiment
of a connector assembly according to the present invention. As
illustrated in FIG. 2, according to the present invention, a
housing 13 of a connector assembly 10, which is included as a
portion of connector block 7 in direct communication with connector
port 3, includes a female member 14 and a male member 16. A
connector clip 12 is positioned within either female member 14 or
male member 16 of housing 13, or both. In addition, more than one
connector clip 12 may be positioned within female member 14 or male
member 16 or both so that any number of connector clips can be
utilized as desired. In the exemplary embodiment illustrated in
FIG. 2, each of male member 16 and female member 14 include a
connector clip 12 positioned therein, as described below. Connector
clip 12 is resilient and electrically conductive, while housing 13
is sealable and electrically conductive. Furthermore, both female
member 14 and male member 16 form an aperture 18 extending
therethrough for insertion of an electrical lead through housing 13
as the lead is inserted within connector port 3.
[0034] Connector clip 12 is may be used both to provide a means of
retaining a lead (not shown) in place, and as a means of conducting
electricity between contact areas 8 of a terminal pin of the lead,
or both functions together in an electrical apparatus such as a
pacemaker. Connector clip 12 is preferably prepared from a
resilient, high strength, corrosion resistant, biocompatible
material, such as tempered stainless steel. However, other
materials suitable for such applications may be utilized in forming
connector clip 12 employed in the present invention. Connector clip
12 may be stamped or cut from a sheet metal strip or cut and formed
from wire stock. Connector clip 12 resembles a wire in form, and
may be prepared with a number of differing cross-sections, such as
circular or oval, for example, where a cross-section is created by
a plane cutting perpendicular to the long axis of the wire.
[0035] FIG. 3A is a plan view of a connector clip utilized in a
connector assembly of the present invention in a non-deflected
position. FIG. 3B is a side view of the connector clip of FIG. 3A.
FIG. 3C is a plan view of a connector clip utilized in a connector
assembly of the present invention in a partially deflected
position. FIG. 3D is a side view of the connector clip of FIG. 3C.
As illustrated in FIGS. 3A-3D, connector clip 12 is a single
unitary wire formed to generally include a first spring arm 20 and
a second spring arm 22. Both spring arm 20 and spring arm 22
include an upper curved portion 24 that together form a top portion
26 of connector clip 12. Spring arm 20 includes a generally
straight side portion 28 that extends from upper curved portion 24
to a lower curved portion 30, and a generally straight bottom
portion 32 that extends outward from lower curved portion 30 to an
end 34 of spring arm 20 that extends inward toward spring arm 22.
In the same way, spring arm 22 includes a generally straight side
portion 36 that extends from upper curved portion 24 to a lower
curved portion 38, and a generally straight bottom portion 40 that
extends outward from lower curved portion 38 to an end 42 of spring
arm 22 that extends inward toward spring arm 20. As illustrated in
FIGS. 3A and 3B, when connector clip 12 is in the relaxed or
non-deflected position, spring arm 20 and spring arm 22 are biased
inward by the spring action generated at top portion 26 of
connector clip so that bottom portion 32 of spring arm 20 and
bottom portion 40 of spring arm 22 are offset and adjacent to each
other, and a side wall 44 of bottom portion 32 is engaged against a
side wall 46 of bottom portion 40. On the other hand, as
illustrated in FIGS. 3C and 3D, when connector clip 12 is in a
partially deflected position, spring arm 20 and spring arm 22 are
deflected outward from the non-deflected position so that side wall
44 of bottom portion 32 is no longer adjacent to and engaged
against side wall 46 of bottom portion 40. Rather, in the partially
deflected position, spring arm 20 and spring arm 22 are deflected
outward so that end 34 of spring arm 20 is positioned adjacent to
end 42 of spring arm 22. As a result of the spring force generated
by deflection of top portion 26 of connector clip 12, end 34 of
spring arm 20 is fixedly engaged against end 42 of spring arm 22 so
that connector clip 12 is maintained in the partially deflected
position of FIGS. 3C and 3D.
[0036] The dimensions of connector clip 12 may vary widely
depending upon the size of the lead and the size of the cavity
included in the implantable medical device. However, connector
assembly 10 according to the present invention, when included
within a pacemaker device, for example, will generally include
connector clip 12 having a thickness of approximately
0.0100.+-.0.0005 inches, and a distance between top portion 26 and
bottom portion 32 of spring arm 20 bottom portion 40 of spring arm
22 of approximately 0.165 inches, and between an inner portion 43
of side walls 28 and 36 of approximately 0.120 inches when
connector clip 12 is in the partially deflected position of FIGS.
3C and 3D. When in the non-deflected position of FIGS. 3A and 3B,
end 34 of spring arm 20 is spaced approximately 0.030 inches from
end 42 of spring arm 22 and a distance D between an inner portion
45 of spring arm 20 where straight side portion 28 meets upper
curved portion 24 of spring arm 20 and inner portion 45 of spring
arm 22 where straight side portion 36 meets upper curved portion 24
of spring arm 22 is approximately 0.112 inches.
[0037] FIG. 4 is a front view of a housing member of a connector
assembly according to the present invention having a connector
clip, in a partially deflected position, positioned within the
housing member. As illustrated in FIGS. 2 and 4, both female member
14 and male member 16 of housing 13 is formed to position connector
clip 12 therein. In particular, both female member 14 and male
member 16 are formed to be generally circular in shape, forming a
circular central aperture 18 of sufficient size to accept proximal
ends 9A or 9B of leads 2A and 2B. Therefore, embodiments of the
present invention include aperture 18 having a diameter in a range
of approximately 0.05-0.25 inches, although any sized diameter
could be chosen. In one embodiment, for example, aperture 18 has a
diameter of approximately 0.13 inches. An outer rim of female
member 14 and male member 16 forms an annular flange 48 having a
top portion 47 that extends outward from a front surface 50 forming
aperture 18. A side wall 49 of annular flange 48 and front surface
50 form a recessed portion 52 in which connector clip 12 is
positioned while in the partially-deflected position of FIGS. 3C
and 3D, with top portion 26 of connector clip 12 positioned against
side wall 49 of flange 48. In addition, partially deflected
connector clip 12 is positioned within recessed portion 52 so that
side portion 28 of spring arm 20 and side portion 36 of spring arm
22 extend over aperture 18, and both lower curved portion 30,
straight bottom portion 32 and end 34 of spring arm 20 and lower
curved portion 38, straight bottom portion 40 and end 42 of spring
arm 22 are spaced a distance from side wall 49 to enable connector
clip 12 to be advanced from the partially deflected position to a
fully deflected position, described below, when the lead 2 is
advanced through housing 13. Once in the desired position within
female member 14 and/or male member 16, connector clip 12 is
fixedly attached to front surface 50 using known welding techniques
such as a laser beam weld for example, along top portion 26 of
connector clip 12 and front surface 50
[0038] FIG. 5A is a side view of an assembled housing of a
connector assembly according to the present invention. FIG. 5B is a
cross-section side view of the assembled housing of the connector
assembly of FIG. 5A. As illustrated in FIGS. 5A and 5B, once the
desired number of connector clips 12 have been positioned within
female member 14 and male member 16 of housing 13 as described
above, top portion 47 of flange 48 of female member 14 is aligned
with and fixedly positioned against top portion 47 of flange 48 of
male member 16 using known welding techniques, such as laser beam
welding, for example, to form a fully assembled connector assembly
10 that creates a barrier against leakage of fluid through
connector assembly 10 into the implantable medical device 1.
[0039] Finally, FIG. 5C is a top view of an assembled connector
assembly according to the present invention. As illustrated in FIG.
5C, contact points 56 located along spring arms 20 and 22 of
connector clip 12 positioned within female member 14 and of
connector clip 12 positioned within male member 16 forming housing
13 of assembled connector assembly 10 are visible where spring arm
20 and 22 of connector clip 12 extend within aperture 18 created by
housing, with aperture 18 of female member 14 and male member 16 of
housing 13 overlapping in fluid communication to form an opening 58
for receiving a lead with spring arm 20 and spring arm 22 in the
partially deflected position so that lead comes in contact with
spring arm 20 and spring arm 22 at contact points 56. When
connector clip 12 is positioned within female member 14 and male
member 16 and juxtaposed in a perpendicular manner, as illustrated
in FIG. 2, the two connector clips 12 form a square aperture for
receiving a lead wherein the midpoint of each side of the square
forms a potential contact point 56. While not required to practice
the present invention, an embodiment using two,
perpendicularly-placed connector clips 12 provides four contact
points 56 along the four points of the compass. The placement of
two perpendicular connector clips 12 helps to securely contact and
retain the contact areas of a lead, as deviation of the lead in any
particular direction will naturally be countered by the tension
within the connector clips 12. As a result, the connector of the
lead may be oriented in any direction around its central axis and
function equally well.
[0040] Male member 16 and female member 14 of the present invention
are preferably prepared from a high strength, corrosion resistant,
biocompatible material, such as tempered stainless steel. However,
any conductive biocompatible material may be utilized to prepare
housing 13 of the present invention. As previously suggested,
housing serves to position one or more partially deflected
connector clip 12 over aperture 18 to form contact points 56 that
come in contact with a lead as the lead is advanced through
aperture 18. Generally, housing 13 also serves to conduct
electricity from connector clips 12 to another conductor (not
shown), which is connected with the electrical apparatus, such as a
pacemaker.
[0041] FIG. 6 is a schematic diagram of a connector assembly
according to the present invention inserted within a connector
cavity and having a lead connector positioned there through. As
illustrated in FIG. 6, housing 13 also allows connector assembly 10
to be properly positioned within a connector cavity 36, as
illustrated in FIG. 6. While the FIGS. 1-9C illustrate a
cylindrical, disc-shaped connector with a circular aperture,
neither of these structural features are required for the present
invention. For example, if it were desirable to attach a square
lead, a square central aperture would be preferred. Furthermore,
the overall shape of the connector assembly 10 may deviate from the
cylindrical disc illustrated in FIGS. 1-9C without compromising its
function.
[0042] Prior to use of the present invention, one or more connector
clips 12 are placed within housing 13 in the partially deflected
position so as to reduce the force required to insert the lead into
connector assembly 10, with a portion of each spring arm 20 and 22
projecting over circular aperture 18. After such placement of
connector clip 12, connecter assembly 10 is ready to receive and
retain an electrical lead.
[0043] According to the present invention, the connection of lead
2A or 2B to an electrical device may be accomplished by utilizing
one or more of connector assemblies 10 of the present invention. As
illustrated in FIG. 6, several of connector assemblies 10 of the
present invention may be utilized within a connector cavity 36
forming a portion of connector block 7 that conforms with
international standard IS-4 requirements. Use of several connector
assemblies 10 provide a greater number of contact points 56,
resulting in an even more secure and reliable connection to contact
areas 8 of electrical lead 2A or 2B.
[0044] Whether one or more connector assemblies 10 of the present
invention is utilized, each connector assembly 10 is positioned
within connector cavity 36 of a connector region where connector
assembly 10 is coupled with wires or other suitable means such that
connector assembly 10 is in electrical communication with an
electrical source (not shown). The connector region is normally
constructed from plastic, silastic, or other electrically
non-conductive material, and serves to position connector assembly
10 while preventing undesirable leakage of body fluids or electric
current. A wire (not shown) generally runs from connector assembly
10 to the working portion of the apparatus that provides
transmission of electrical current, such as electrical pulses.
Examples of apparatuses for emitting electrical pulses for use with
the present invention may be single or dual chamber pacemakers,
antiarrhythmia pacers, defibrillators, cardiomyoplasty stimulators,
neurostimulators, and other such devices which emit electrical
impulses. Also shown in FIG. 6 are several sealing devices 42,
which help assure that body fluids do not leak into and possibly
clog and/or corrode the connector 10, the contact areas 8 and the
electrical apparatus. Also illustrated in FIG. 6 are several
sealing devices 42, which help assure that body fluids do not leak
into and possibly clog and/or corrode connector assembly 10,
contact areas 8 and the electrical apparatus.
[0045] FIG. 7 is a schematic diagram of a housing of a connector
assembly, according to an embodiment of the present invention, with
a lead inserted therein. While FIG. 7 illustrates connector clip 12
positioned within male member 16 and having lead 2A or 2B inserted
therein, it is understood that when connector assembly is fully
assembled, as in FIGS. 5A-5C, lead 2A or 2B advances through both
female member 14 and male 16, and connector clip 12 in both female
member 14 and male member 16 is advanced from the partially
deflected position to the fully deflected position as described in
reference to FIG. 7, although only male member 16 is illustrated in
FIG. 7 for brevity sake.
[0046] As illustrated in FIGS. 6 and 7, when a physician or other
user of the device wishes to establish an electrical connection
between electrical lead 2A or 2B and the electrical source, the
physician need merely place contact areas 8 of electric lead 2A or
2B within connector cavity 36 by inserting lead 2A or 2B within
connector port 3 of connector block 7 (FIG. 1). Contact area 8A or
8B is then urged into connector cavity 36, where contact areas 8
come in contact with and push against contact points 56 of each
connector clip 12 of connector assembly 10 of the present
invention. As lead 2A or 2B is inserted within connector cavity 36
of connector block 7, lead 2A or 2B advances through aperture 18,
and engages against contact points 56 causing spring arms 20 and 22
of connector clip 12 to be deflected yet further from the partially
deflected position of FIGS. 3C and 3D so that end 34 is advanced a
distance away from and no is longer engaged against end 44 of
connector clip 12, placing connector clip 12 in the fully deflected
position illustrated in FIG. 7. As a result, the spring force of
connector clip 12 is transferred from being engaged at a point of
contact between end 34 and end 44 of respective spring arms 20 and
22 of connector clip 12 to being against contact areas 8 of lead 2A
or 2B. In this way, contact point 56 of each spring arm 20 and 22
is engaged against contact areas 8, causing the spring force to be
applied by spring arms 20 and 22 against inserted contact areas 8,
creating a secure electrical connection at contact points 56. Once
fully inserted, electrical lead 2A or 2B is in a loaded state and
will remain in place, connected to the electrical source.
[0047] Lead 2A or 2B may optionally be provided with grooves (not
shown) positioned at expected contact points 56 that serve to
further secure lead 2A or 2B when connector clip 12 expands into
the space of the groove.
[0048] FIG. 8A is a schematic diagram of a female member of a
housing of a connector assembly according to an alternate
embodiment of the present invention. FIG. 8B is a schematic diagram
of a male member of a housing of a connector assembly according to
an alternate embodiment of the present invention. As illustrated in
FIGS. 8A and 8B, similar to male member 16 and female member 14 of
connector assembly 10 described above, a female member 114 and a
male member 116 of a housing portion 113 of a connector assembly
110 according to an alternate embodiment of the present invention
are formed to be generally circular in shape, forming a circular
central aperture 118 of sufficient size to accept proximal ends 9A
or 9B of leads 2A and 2B. Therefore, embodiments of the present
invention include aperture 118 having a diameter in a range of
approximately 0.05-0.25 inches, although any sized diameter could
be chosen. In one embodiment, for example, aperture 118 has a
diameter of approximately 0.13 inches. However, female member 114
and male member 116 differ from female member 14 and male member 16
in that, as illustrated in FIG. 8B, in addition to an outer rim of
male member 116 forming an outer annular flange 148 having a top
portion 147 that extends outward from a front surface 150, male
member 116 includes an inner flange 151 having a top portion 153
extending outward from front surface 150 a distance less than a
length of a side wall 155 of outer flange 148 so that top portion
153 of inner flange 151 is positioned adjacent to side wall 155 of
outer flange 148. As a result, top portion 153 of inner flange 151
and side wall 155 of outer flange 148 form a lip 157. In addition,
aperture 118 is formed by front surface 150 and a side wall 159 of
inner flange 151 extending from front surface 150 to top portion
153 so that side wall 159 and front surface 150 form a recessed
portion 152 in which connector clip 12 is positioned while in the
partially deflected position of FIGS. 3C and 3D, with top portion
26 of connector clip 12 positioned against side wall 159 of inner
flange 151, as described above, using known welding techniques.
Partially deflected connector clip 12 is positioned within recessed
portion 152 so that side portion 28 of spring arm 20 and side
portion 36 of spring arm 22 extend over aperture 118, and both
lower curved portion 30, straight bottom portion 32 and end 34 of
spring arm 20 and lower curved portion 38, straight bottom portion
40 and end 42 of spring arm 22 are spaced a distance from side wall
159 to enable connector clip 12 to be advanced from the partially
deflected position to a fully deflected position, as described
above, when the lead 2 is advanced through housing 113.
[0049] As illustrated in FIG. 8A, similar to female member 14
described above, female member 114 of the alternate embodiment
includes an annular flange 148, having a top portion 161 that
extends outward from front surface 150 of female member 114.
However, flange 148 of female member 114 is spaced inward from an
outer rim 163 so that a portion of front surface 150 between outer
rim 163 and flange 148 of female member 114 and an outer side wall
165 of flange 148 form a lip 167. In addition, aperture 118 is
formed by front surface 150 and an inner side wall 169 of flange
148 extending from front surface 150 to top portion 161 so that
side wall 169 and front surface 150 form recessed portion 152 in
which connector clip 12 is positioned while in the partially
deflected position of FIGS. 3C and 3D, with top portion 26 of
connector clip 12 positioned against side wall 169 of flange 148,
as described above, using known welding techniques. Partially
deflected connector clip 12 is positioned within recessed portion
152 so that side portion 28 of spring arm 20 and side portion 36 of
spring arm 22 extend over aperture 118, and both lower curved
portion 30, straight bottom portion 32 and end 34 of spring arm 20
and lower curved portion 38, straight bottom portion 40 and end 42
of spring arm 22 are spaced a distance from side wall 169 to enable
connector clip 12 to be advanced from the partially deflected
position to a fully deflected position, as described above, when
the lead 2 is advanced through housing 113.
[0050] FIG. 9A is a side view of an assembled housing of a
connector assembly according to an alternate embodiment of the
present invention. FIG. 9B is a cross-section side view of the
assembled housing of the connector assembly of FIG. 9A. As
illustrated in FIGS. 9A and 9B, once the desired number of
connector clips 12 have been positioned within female member 114
and male member 116 of housing 113 as described above, top portion
147 of outer flange 148 of male member 116 is aligned with and
fixedly positioned within lip 167 of female portion 114 and top
portion 161 of flange 148 of female member 114 is positioned within
lip 157 of male member 116 using known welding techniques, such as
laser beam welding, for example, to form a fully assembled
connector assembly 10 that creates a barrier against leakage of
fluid through connector assembly 10 into the implantable medical
device 1. It is understood that while welding techniques are
described as being utilized to fixedly position female member 11
within female member 114, other fixation mechanisms may also be
utilized. For example, top portion 147 of outer flange 148 of male
member 116 may be aligned with and fixedly positioned within lip
167 of female portion 114 and top portion 161 of flange 148 of
female member 114 may be aligned with and positioned within lip 157
of male member 116 using a press fit mechanism or threaded portions
located along flange 148 of female member 114 and flange 148 of
male member 116.
[0051] Finally, FIG. 9C is a top view of an assembled connector
assembly according to an alternate embodiment of the present
invention. As illustrated in FIG. 9C, similar to connector assembly
10 described above, in connector assembly 110 of the alternate
embodiment of the present invention, contact points 56 of connector
clip 12 positioned within female member 114 and of connector clip
12 positioned within male member 116 forming housing 113 of
assembled connector assembly 110 are visible where connector clip
12 extends within aperture 118 created by housing 113, with
aperture 118 of female member 114 and male member 116 of housing
113 overlapping in fluid communication to form an opening 158 for
receiving a lead with spring arm 20 and spring arm 22 in the
partially deflected position so that lead comes in contact with
spring arm 20 and spring arm 22 at contact points 56. Once
assembled, connector assembly 110 according to the alternate
embodiment of the present invention operates in the same manner as
assembled connector assembly 10 described above, and will not be
repeated for the sake of brevity.
[0052] It is apparent from the foregoing discussion that the
embodiments of the present invention illustrated in FIGS. 1-9C
provides an improved connector assembly 10 or 110 for detachably
connecting contact areas 8 of electrical lead 2A or 2B to an
electrical apparatus. Since connector clips 12 are positioned
within housing 13 or 113 in a partially deflected configuration, a
constant force is exerted over the range of deflection of connector
clip 12. Furthermore, since only a small deflection is necessary to
create a significant force of retention, connector assembly 10 or
110 makes efficient use of the axial space on contact areas 8,
allowing it to be very compact. Connector assembly 10 or 110
readily accepts insertion of contact areas 8, without the use of
tools, and applies even force through connector clips 12 to
maintain a constant electrical contact with an electrical lead that
is not subject to varying impedance.
[0053] Although the invention has been described with reference to
particular embodiments, it is to be understood that such
embodiments are merely illustrative of the application of the
principles of the invention. Numerous modifications may be made
therein, and other arrangements may be devised, without departing
from the true scope and spirit of the invention.
* * * * *