U.S. patent application number 12/727009 was filed with the patent office on 2010-07-29 for methods and systems for connecting electrical leads to an implantable medical device.
This patent application is currently assigned to PACESETTER, INC.. Invention is credited to Wisit Lim.
Application Number | 20100191312 12/727009 |
Document ID | / |
Family ID | 42124906 |
Filed Date | 2010-07-29 |
United States Patent
Application |
20100191312 |
Kind Code |
A1 |
Lim; Wisit |
July 29, 2010 |
METHODS AND SYSTEMS FOR CONNECTING ELECTRICAL LEADS TO AN
IMPLANTABLE MEDICAL DEVICE
Abstract
An implantable medical device having a lead retention assembly
is disclosed herein. In one embodiment, the lead retention assembly
comprises at least two receptacles configured to receive a
connective end of a respective electrical lead, a support member, a
first side clamp configured to define a first port in conjunction
with the support member, a second side clamp configured to define a
second port in conjunction with the support member, and a fastener
configured to urge both the first and second side clamps toward the
support member upon actuation of the fastener.
Inventors: |
Lim; Wisit; (Palmdale,
CA) |
Correspondence
Address: |
PACESETTER, INC.
15900 VALLEY VIEW COURT
SYLMAR
CA
91392-9221
US
|
Assignee: |
PACESETTER, INC.
Sylmar
CA
|
Family ID: |
42124906 |
Appl. No.: |
12/727009 |
Filed: |
March 18, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11767322 |
Jun 22, 2007 |
7711429 |
|
|
12727009 |
|
|
|
|
Current U.S.
Class: |
607/72 ;
29/825 |
Current CPC
Class: |
H01R 4/46 20130101; Y10T
29/49117 20150115; A61N 2001/37294 20130101; A61N 1/3752 20130101;
Y10S 439/909 20130101 |
Class at
Publication: |
607/72 ;
29/825 |
International
Class: |
A61N 1/375 20060101
A61N001/375; H01R 43/00 20060101 H01R043/00 |
Claims
1. An implantable pulse generator comprising: a lead retention
assembly for connecting a plurality of electrical leads to an
implantable medical device, the lead retention assembly comprising:
at least two receptacles each configured to receive a connective
end of a respective electrical lead, each receptacle including an
electrical contact for electrically connecting the respective
electrical lead to electrical circuitry of an implantable medical
device; a support member; a first side clamp configured to define a
first port in conjunction with the support and a second side clamp
configured to define a second port in conjunction with the support,
the first and second ports comprising the at least two receptacles;
and a fastener configured to urge both the first and second side
clamps toward the support upon actuation of the fastener and to
thereby clamp the connective ends of the respective electrical lead
bodies within the first and second ports.
2. The implantable pulse generator of claim 1, wherein the fastener
comprises: a first portion configured to engage the first side
clamp; and a second portion configured to engage the second side
clamp; the first and second portions configured to be threadedly
engaged with one another such that rotation of one of the first and
second portions causes the first and second portions to translate
toward one another.
3. The implantable pulse generator of claim 2, wherein at least one
of the first and second portions is retained with the support.
4. The implantable pulse generator of claim 2, wherein one of the
first and second portions is configured to engage the respective
first or second side clamp via a shoulder and to engage the support
via an anchor.
5. The implantable pulse generator of claim 4, wherein the anchor
comprises a radially extending flange configured to engage a
shoulder of the support.
6. The implantable pulse generator of claim 5, wherein the anchor
is fixedly secured to the one of the first and second portions.
7. The implantable pulse generator of claim 2, wherein one of the
first and second portions is configured to engage the respective
first or second side clamp via a threaded connection and to engage
the support via a shoulder.
8. The implantable pulse generator of claim 2, wherein one of the
first and second portions comprises a first threaded section and a
second threaded section separated by a threadless section.
9. The implantable pulse generator of claim 2, wherein one of the
first and second portions comprises a generally outwardly extending
flange, the other of the first and second portions comprises a
generally inwardly extending flange, and the outwardly and inwardly
extending flanges are configured to engage one another to secure
the first and second portions together with a limited relative
movement therebetween.
10. The implantable pulse generator of claim 9, wherein the
inwardly extending flange includes at least one longitudinal slot
that allows at least a portion of the inwardly extending flange to
move outwardly.
11. The implantable pulse generator of claim 9, wherein at least
one of the inwardly and outwardly extending flanges includes a
chamfer that facilitates movement of the flanges past one another
for engagement thereof.
12. A method of connecting a plurality of electrical leads to an
implantable medical device, the method comprising: providing a lead
retention assembly including a support member, a first side clamp
and a second side clamp, a first port and a second port each
defining a respective receptacle in conjunction with the support,
and a fastener configured to urge both the first and second side
clamps toward the support upon actuation of the fastener; providing
at least two electrical lead bodies each including a respective
proximal end portion; inserting the respective proximal end
portions into the respective receptacles to be in electrical
communication with a respective electrical contact in the
respective receptacles; and actuating the fastener to thereby clamp
the proximal end portions of the respective electrical lead bodies
within the first and second ports.
13. The method of claim 12, wherein actuating the fastener
comprises: rotating a first portion of the fastener relative to a
second portion of the fastener such that the first and second
portions to translate toward one another.
14. The method of claim 13, further comprising retaining at least
one of the first and second portions with the support.
15. The method of claim 14, wherein retaining at least one of the
first and second portions comprises securing an anchor to the first
and/or second portions.
16. The method of claim 13, further comprising engaging at least
one of the first and second portions with the respective first or
second side clamp via a threaded connection.
17. The method of claim 13, further comprising connecting the first
and second portions together with a limited relative movement.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a division of copending U.S. patent
application Ser. No. 11/767,322, filed Jun. 22, 2007.
FIELD OF THE INVENTION
[0002] The present invention relates generally to lead retention
assemblies of implantable medical devices and methods for
connecting implantable medical leads to such devices. More
particularly, the present invention relates to methods and
mechanisms for securely locking implantable medical leads within a
lead retention assembly.
BACKGROUND OF THE INVENTION
[0003] Cardiac pacemakers, and other implantable stimulation
devices such as cardioverters and defibrillators, are typically
hermetically sealed within a housing or casing (sometimes also
referred to as a "can") to isolate the electronic circuits
contained within the device from the body environment. Such devices
require that electrical signals be reliably passed between the
hermetically sealed circuitry and external connectors without
compromising the hermeticity of the device. Depending on the
configuration of the implantable device there may be multiple
electrical paths required between the device and its external
connectors for delivering, for example, multi-chamber or multi-site
stimulation and shock therapy, and for receiving sensed cardiac
signals. These paths should be electrically and mechanically
integrated with the device to provide a safe, long-term lead
retention assembly that does not compromise the hermetic
package.
[0004] Typically, a hermetic housing feedthrough electrically
couples the electronic circuits contained within the device housing
to the lead retention assembly. The feedthrough may extend through
the wall of the hermetically sealed casing into the lead retention
assembly so as to couple the electronic circuits within the casing
to lead-receiving receptacles within the lead retention assembly.
Each lead has one or more electrical terminals on a proximal end
thereof, typically in the form of a pin terminal and one or more
conductive ring terminals. Typically, the pin is electrically
coupled to a distal tip electrode and is therefore sometimes called
the "tip terminal." When the proximal end of the lead is inserted
into the lead receptacle of a lead retention assembly, contacts
within the receptacle come into contact with corresponding
terminals on the lead so as to couple the lead to the electronic
circuits within the implantable stimulation device via the
feedthrough assembly. Needless to say, a completely dependable
electrical connection is useful between the lead terminals and the
corresponding lead retention assembly contacts. At the same time,
the lead retention assembly being capable of releasing the lead
from the lead receptacle during explantation or other subsequent
surgical procedure may be useful, as may doing so while remaining
tightly sealed against the entry of body fluids.
[0005] It is known in prior art lead retention assemblies to
electrically and mechanically connect the proximal end of the lead
within a receptacle of the lead retention assembly by a variety of
expedients including captive fastening screw/collet arrangements
and setscrews. In such prior art lead retention assemblies in which
the lead is fixed within the lead receptacle using a setscrew, the
setscrew is often threaded into an electrical connector block
within the lead retention assembly. When the screw is advanced, it
comes into contact with an associated terminal on the proximal end
of the lead, mechanically and electrically coupling the lead and
the lead retention assembly.
[0006] U.S. Pat. No. 6,984,145, issued Jan. 10, 2006, the entirety
of which is incorporated herein by reference, discloses an example
of a lead retention assembly mounted on an implantable cardiac
stimulation device having a side-actuated mechanism for fixing and
tightly sealing electrical leads inserted into lead
receptacles.
SUMMARY
[0007] There is a need in the art for improved systems and methods
for connecting a plurality of electrical leads to an implantable
medical device. Although technology related to connection
assemblies has advanced to provide various approaches, such
approaches tend to be complex and/or expensive. Accordingly, it
would be desirable to provide a lead retention assembly for
connecting a plurality of electrical leads to an implantable
medical device that is more reliable and easier to use.
[0008] Various embodiments of the present invention may provide a
lead retention assembly in which a fastener is configured to urge
both a first side clamp and a second side clamp toward a support
upon actuation of the fastener. Such an approach may reduce a
number of fasteners needed to secure a plurality of electrical
leads.
[0009] Some embodiments may provide a lead retention assembly in
which the various components are held together in an unclamped
state. Such an approach may prevent a loss of parts, and may also
facilitate clamping actuation of the lead retention assembly.
[0010] Embodiments of the present invention may provide a lead
retention assembly for connecting a plurality of electrical leads
to an implantable medical device. The lead retention assembly may
include at least two receptacles each configured to receive a
proximal end portion of a respective electrical lead. Each
receptacle may include an electrical contact for electrically
connecting the respective electrical lead to electrical circuitry
of an implantable medical device. The lead retention assembly may
further include a support member, a first side clamp configured to
define a first port in conjunction with the support, a second side
clamp configured to define a second port in conjunction with the
support and a fastener configured to urge both the first and second
side clamps toward the support upon actuation of the fastener. Such
urging may cause the lead retention assembly to clamp the proximal
end portions of the respective electrical leads within the first
and second ports.
[0011] Embodiments of the present invention may provide a system
for connecting electrical leads in an implantable medical device.
The system may include an implantable medical device including
electrical circuitry and a lead retention assembly configured to be
secured to the implantable medical device. The lead retention
assembly may include a support member, a first side clamp and a
second side clamp. The first and second side clamps may
respectively be configured to define first and second ports in
conjunction with the support, which ports may include respective
receptacles configured to receive a respective electrical lead
body. Each receptacle may include an electrical contact for
electrically connecting the respective electrical lead body to the
electrical circuitry of the implantable medical device. The lead
retention assembly may further include a fastener configured to
urge both the first and second side clamps toward the support upon
actuation of the fastener, to thereby clamp the respective
electrical lead bodies within the first and second ports. The
system may also include at least two electrical leads each
including a proximal end portion configured to be secured in the
first and second ports respectively when the first and second side
clamps are urged toward the support upon actuation of the
fastener.
[0012] Embodiments of the present invention may provide a method
for connecting electrical leads in an implantable medical device.
The method may include providing a lead retention assembly, or
system, such as described above; inserting at least two electrical
lead bodies, each including a respective proximal end portion, into
the respective receptacles to be in electrical communication with a
respective electrical contact in the respective receptacles; and
actuating the fastener to thereby clamp the proximal end portions
of the respective electrical lead bodies within the first and
second ports.
[0013] Disclosed herein is an implantable pulse generator such as a
pacemaker, defibrillator or implantable cardioverter defibrillator
(ICD). The generator is configured to have at least first and
second implantable cardiac electrotherapy leads secured thereto. In
one embodiment, the generator includes a first clamp, a second
clamp and an actuator. The first clamp is configured to secure the
first lead to the generator. The second clamp is configured to
secure the second lead to the generator. The actuator is configured
to cause both clamps to secure their respective leads.
[0014] Disclosed herein is an implantable pulse generator such as a
pacemaker, defibrillator or ICD. The generator is configured to
have at least first and second implantable cardiac electrotherapy
leads secured thereto. In one embodiment, the generator includes a
pair of opposed clamps, a support positioned between the clamps,
and an actuator. Rotation of at least a portion of the actuator
relative to the support causes both clamps to generally
simultaneously increasingly clamp the leads against the front
support portion.
[0015] Disclosed herein is an implantable pulse generator such as a
pacemaker, defibrillator or ICD. The generator is configured to
have at least first and second implantable cardiac electrotherapy
leads secured thereto. In one embodiment, the generator includes a
pair of opposed clamps, a support positioned between the clamps,
and a means for generally simultaneously impacting the positional
relationship of both clamps relative to the front support portion
to secure the leads between the clamps and the support.
[0016] While multiple embodiments are disclosed, still other
embodiments of the present invention will become apparent to those
skilled in the art from the following detailed description, which
shows and describes illustrative embodiments of the invention. As
will be realized, the invention is capable of modifications in
various aspects, all without departing from the spirit and scope of
the present invention. Accordingly, the drawings and detailed
description are to be regarded as illustrative in nature and not
restrictive.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1 is a perspective view of the proximal end portion or
connective end of a known bipolar lead.
[0018] FIG. 2 is a perspective view of an example of a lead
retention assembly.
[0019] FIG. 3 is a side elevation view of the lead retention
assembly depicted in FIG. 2.
[0020] FIG. 4 is a side elevation view of one of the side clamps of
the lead retention assembly of FIG. 2.
[0021] FIG. 5 is a cross-sectional view of the side clamp of FIG.
4, taken along line B-B in FIG. 4.
[0022] FIG. 6 is a side elevation view of the other one of the side
clamps of the lead retention assembly of FIG. 2.
[0023] FIG. 7 is a cross-sectional view of the side clamp of FIG.
6, taken along line C-C in FIG. 6.
[0024] FIG. 8 is a cross sectional view of the lead retention
assembly of FIG. 3 taken along line A-A in FIG. 3.
[0025] FIG. 9 is a partial enlarged view of detail A in FIG. 8.
[0026] FIG. 10 is a side elevation view of one portion of the
fastener of FIG. 8.
[0027] FIG. 11 is a cross-sectional view of the other portion of
the fastener of FIG. 8.
[0028] FIG. 12 is a perspective view of a cardiac
pacemaker/defibrillator unit including an example of a lead
retention assembly.
[0029] FIG. 13 is a cross sectional view of another example of a
lead retention assembly, similar to FIG. 8.
[0030] FIG. 14 is a partial enlarged view of detail A' in FIG.
13.
[0031] FIG. 15 is a side elevation view of one portion of the
fastener of FIG. 13.
[0032] FIG. 16 is a cross-sectional view of another portion of the
fastener of FIG. 13.
[0033] FIG. 17 is an end view of the female fastener portion, as
viewed from the bore end of the female fastener portion.
DETAILED DESCRIPTION
[0034] The following description is of embodiments presently
contemplated for practicing the invention. This description is not
to be taken in a limiting sense but is made merely for the purpose
of describing the general principles of the invention. The scope of
the invention should be ascertained with reference to the issued
claims. In the description of the invention that follows, like
numerals or reference designators will be used to refer to like
parts or elements throughout.
[0035] Although it should be understood that the present invention
is applicable to a variety of implantable medical devices, the
description herein is principally in the context of a specific
example of such devices, namely, an implantable cardiac device,
such as a pacemaker and/or defibrillator. However, such description
is for the sake of understanding only, and is not limiting.
[0036] The disclosed devices, systems and associated methods are
directed at connecting a plurality of electrical leads to an
implantable medical device. Such connection may occur, for example,
before or during implantation of the device, or after the device
has been implanted, for example, to replace one or more leads.
Although the methods contemplated are described in conjunction with
the devices and systems illustrated herein, it should be understood
that numerous variations exist for implementing the methods.
[0037] FIG. 1 shows a proximal end portion or connective end 10 of
a conventional transvenous, bipolar pacing lead. The proximal lead
end portion 10 may be configured to be secured to an implantable
medical device using a lead retention assembly as described further
below. In particular, the proximal lead end portion 10 may include
a pair of coaxial spaced-apart terminals including a tip terminal
12 and a ring terminal 14. The proximal lead end portion 10 may
include one or more features 16 that are configured to be engaged
by a lead retention assembly.
[0038] Such a lead is well known, as is described in the
incorporated U.S. Pat. No. 6,984,145. Thus, further details are not
discussed. It should be understood that the pacing lead is only an
example of an electrical lead that may be used with the devices,
systems and methods described herein. In particular, it should be
understood that the proximal lead end portion of the electrical
lead may or may not include any suitable feature(s) for cooperating
with the lead retention assembly, to provide a mechanical
engagement and/or a friction fit, as appropriate or desired.
[0039] FIG. 2 is a perspective view of an example of a lead
retention assembly 22. The lead retention assembly 22 may include a
plurality of ports that define a first set of receptacles 31, 32,
33 and a second set of receptacles 34, 35, 36. Each of the
receptacles 31-36 may be configured to receive the proximal or
connective ends 10 of electrical leads. Six total receptacles are
shown to illustrate various details. However, it should be
understood that any desired number of receptacles may be used. The
bores of the receptacles may include various features suitable for
engaging and retaining respective electrical leads, in conjunction
with the lead retention assembly 22, as described herein. Further,
one or more electrical contacts may be disposed in the bores of the
receptacles to provide a connection to electrical circuitry of the
implantable medical device to which the lead retention assembly 22
is to be attached.
[0040] The lead retention assembly 22 may include a support 40,
opposed first and second side clamps 42, 44, and one or more
fasteners 45 for securing the side clamps to the support 40 to
clamp the connective ends 10 of the leads in place. The support 40
may be molded of a material such as polysulfone or tecothane. The
side clamps 42, 44 may be molded of material such as polysulfone or
delrin or machined from a material such as titanium or stainless
steel. The support 40 may include a rear portion 50 and a nose or
front portion 52 that is narrower than the rear portion and defines
opposed side recesses 54, 56 for receiving the side clamps 42, 44,
respectively. The rear support portion 50, the front support
portion 52 and the side clamps 42, 44 include curved outer surfaces
that form a substantially continuous, smooth, outer lead retention
assembly surface when the side clamps are in their fully clamped
position, as illustrated in FIG. 2, for example.
[0041] FIG. 3 is a side elevation view of the lead retention
assembly 22. FIG. 4 is a similar view of the first side clamp 42
removed from the lead retention assembly 22. As shown in the
cross-sectional view of the first side clamp 42 in FIG. 5, and with
further reference to FIGS. 6-9, a bore 70 for receiving each
fastener 45 may extend through the side clamps 42, 44 and the front
support portion 52 of the lead retention assembly 22.
[0042] Depending on the embodiment, the lead retention assembly 22
may have one, two or more bores 70 and one, two or more fasteners
45. For example, as can be understood from FIGS. 2-8, in one
embodiment, the lead retention assembly 22 may have two bores 70
with a fastener 45 within each bore 70. While the various
cross-sectional views in the figures are such that only a single
one of the multiple bores 70 and fasteners 45 are portrayed in full
cross-section, it should be understood that, in at least one
embodiment, the configurations of all bores 70 and fasteners 45 of
the lead retention assembly 22 are generally identical. Thus, the
bore and fastener configurations depicted in FIGS. 5 and 7-11, can
be considered to apply equally to all bores 70 and fasteners 45 of
an embodiment of the lead retention assembly 22 employing more than
one bore 70 and fastener 45. Depending on the embodiment, the
statements in this paragraph are also similarly applicable to the
embodiments depicted in FIGS. 12-16.
[0043] As illustrated in FIGS. 4-9, the bores 70 may include
various diameters, threads or other features for cooperating with
the fasteners 45. As shown in FIG. 5, the portion of the bore 70
extending through the first side clamp 42 may provide a first outer
shoulder 71.
[0044] FIG. 6 is a side elevation view of the second side clamp 44.
As shown in the corresponding cross-sectional view of the second
side clamp 44 in FIG. 7, the portion of the bore 70 extending
through the second side clamp 44 may provide a second outer
shoulder 72. The portion of the bore 70 extending through the
second side clamp 44 may further provide an internal clamp thread
73 and a first inner shoulder 74.
[0045] As shown in FIG. 8, and in detail in FIG. 9, the portion of
the bore 70 extending through the front support portion 52 may
provide additional features in the front support portion 52. In
particular, the portion of the bore 70 extending through the front
support portion 52 may define a second inner shoulder 75, a third
inner shoulder 76, and a cavity 220. The fastener 45 may include
corresponding features that cooperate with the features of the bore
70, as described below.
[0046] The fastener 45 may include a first or male fastener portion
46 and a second or female fastener portion 48. FIG. 10 shows
details of the male fastener portion 46. FIG. 11 shows details of
the female fastener portion 48. FIGS. 8 and 9 show the male and
female fastener portions 46, 48 engaged to render the fastener 45
operative in the lead retention assembly 22 such that a portion of
the male fastener portion 46 is received in a portion of the female
fastener portion 48.
[0047] With reference to FIG. 10, the male fastener portion 46 may
include a wide diameter shaft section 199, a narrow diameter shaft
section 64, and a ridge or ring 200 located between the two shaft
sections. In one embodiment, the ring 200 extends circumferentially
about shaft of the male fastener portion 46.
[0048] A free end of the wide diameter shaft section 199 of the
male fastener portion 46 may include a first threaded end 61
configured to engage the internal clamp thread 73 in the second
side clamp 44. The male fastener portion 46 may include a first
shoulder 62 between the first threaded end 61 and the ring 200. The
first shoulder 62 of the male fastener portion 46 may be configured
to abut the first inner shoulder 74 in the second side clamp 44,
for example, when the first threaded end 61 of the male fastener
portion 46 is fully engaged in the internal clamp thread 73 of the
second side clamp 44.
[0049] The ring 200 of the male fastener portion 46 may form a
second shoulder 63 configured to abut the second inner shoulder 75
in the front support portion 52, for example, when the lead
retention assembly 22 is fully opened to the maximum extent, as
depicted in FIG. 9 for one embodiment.
[0050] The narrow diameter shaft section 64 of the male fastener
portion 46 may extend from the ring 200. The free end of the narrow
diameter shaft section 64 may include a second threaded end 65. As
described below and depicted in FIG. 9, the narrow diameter shaft
section 64 may be configured to allow the second threaded end 65 of
the male fastener portion 46 to cooperate with the female fastener
portion 48.
[0051] With reference to FIG. 11, the female fastener portion 48
may include a head 81 configured to engage the first outer shoulder
71 of the first side clamp 42, as depicted in FIG. 9. The head 81
and shoulder 71 engage when the lead retention assembly 22 is fully
closed (clamped). Also, the head 81 engages the shoulder 71 so the
head 81 can drive the first side clamp 42 towards the front support
portion 52 when the first side clamp 42 is being moved towards the
fully clamped state.
[0052] As indicated in FIG. 11, the head 81 also includes a tool
engagement feature 205 for engagably receiving a screwdriver,
wrench, etc. Thus, a tool can be used to cause the female fastener
portion 48 to rotate within the bore 70 and relative to the male
fastener portion 46, thereby causing the male fastener portion 46
to be threadably received within the female fastener portion 48, as
indicated in FIG. 9.
[0053] As shown in FIG. 11, the female fastener portion 48 may
include a cavity or bore 210 extending axially into the female
fastener portion 48. The bore 210 may include a first internal
thread 82 and a second internal thread 83 longitudinally separated
by an unthreaded or threadless portion 84.
[0054] As can be understood from FIG. 9, the male and female
fastener portions 46, 48 may be secured together by threading the
second threaded end 65 of the male fastener portion 46 into the
second internal thread 83 of the female fastener portion 48. By
threading past the second internal thread 83, the second threaded
end 65 of the male fastener portion 46 may be movable within the
unthreaded portion 84 of the female fastener portion 48, for
example, to provide a limited amount of play or relative movement
of the male and female fastener portions 46, 48 while connected.
This amount of play or relative movement of the male and female
fastener portions 46, 48 provides the side clamps 42, 44 with
sufficient play relative to the front support portion 52 to
accommodate a lead connective end 10 without having to rotate the
female fastener portion 48 within the bore 70.
[0055] As illustrated in FIG. 11, the female fastener portion 48
may optionally include a full diameter shaft section 215 and a
reduced diameter shaft section 85. The reduced diameter shaft
section 85 of the female fastener portion 48 may facilitate
connecting an anchor 90 to the female fastener portion 48, as shown
in FIGS. 8 and 9. The anchor 90 may be made of nitinol, for
example, and may be fixedly attached to the female fastener portion
48, for example, by welding. It should be understood that any other
suitable metal or non-metal material may be used for the anchor 90
and that the anchor 90 may be attached in any suitable manner, such
as with a mechanical or frictional engagement, or with
adhesive.
[0056] The anchor 90 may include one or more outwardly extending
flange 92. The outwardly extending flange 92 may be of any suitable
shape and/or size, as may the anchor 90. For example, the anchor 90
and/or the outwardly extending flange 92 may be annular.
Alternatively, the outwardly extending flange 92 may include one or
more protrusions or tabs.
[0057] As shown in FIG. 9, the outwardly extending flange 92 may be
configured to retain the female fastener portion 48 in the cavity
220 inside the support 40 by cooperating with the third inner
shoulder 76. Thus, the first side clamp 42, the front support
portion and the female fastener portion 48 may be held together,
with a suitable amount of play to allow insertion of electrical
leads into the lead retention assembly 22. Further, the outwardly
extending flange 92 of the anchor 90 may be configured to abut the
third inner shoulder 76 on the front support portion 52, for
example, when the lead retention assembly 22 is fully opened to the
maximum extent.
[0058] As can be understood from FIGS. 8 and 9, the second shoulder
63 of the male fastener portion 46 encountering the front support
portion 52, specifically, the second inner shoulder 75, prevents
the second side clamp 44 from overly moving away from the front
support portion 52, thereby preventing the male fastener portion 46
from exiting the bore 70 on the side of the front support portion
52 having the second side clamp 44. Similarly, the flange 92
encountering the front support portion 52, specifically, the third
inner shoulder 76, prevents the first side clamp 42 from overly
moving away from the front support portion 52, thereby preventing
the female fastener portion 48 from exiting the bore 70 on the side
of the front support portion 52 having the first side clamp 42.
[0059] As discussed above and can be understood from FIG. 9, the
male fastener portion 46 may be secured to the second side clamp
44. In one embodiment, this may occur after the male fastener
portion 46 is inserted through the bore 70 of the front support
portion 52 from the side of the first clamp 42. The large diameter
shaft sections 199, 215 of the fastener portions 46, 48 may have
generally the same diameter, which is less than the diameter of the
bore 70. As a result, the fastener portions 46, 48 can be passed
into the bore 70 by entering the bore from the side of the front
support portion 52 having the first side clamp 42. The male
fastener portion 46 is entered into the bore 70 first with the
first threaded end 61 of the male fastener portion 46 leading. The
second shoulder 63 of the male fastener portion 46 encountering the
second inner shoulder 75 in the front support portion 52 prevents
the male fastener portion 46 from overly extending through the bore
70.
[0060] In one embodiment, as can be understood from FIG. 9, the
female fastener portion 48, with the anchor 90 mounted thereon, is
passed anchor end first through the bores 70 of the first side
clamp 42 and the front support portion 52. As the anchor 90 passes
through the bores 70, the flanges 92 deflect against the sides of
the reduced diameter portion 85 of the shaft of the female fastener
portion 48, thereby providing sufficient clearance for the anchor
end of the female fastener portion 48 to extend through the bores
70. When the flanges 92 clear the third inner shoulder 76 of the
front support portion 52 as the anchor end of the female fastener
portion 48 enters the cavity 220 of the front support portion 52,
the flanges 92 bias outwardly to engage the third inner shoulder 76
and prevent the withdrawal of the female fastener portion 48 from
the front support portion 52.
[0061] As indicated in FIG. 9, in one embodiment, the first
threaded end 61 of the male fastener portion 46 is threaded into
the internal clamp thread 73 of the second side clamp 44. Thus, the
male fastener portion 46, the second side clamp 44 and the front
support portion 52 may be held together, with a suitable amount of
play to allow insertion of lead connector ends 10 into the lead
retention assembly 22.
[0062] In another embodiment, the male fastener portion 46 does not
have the first threaded end 61. Instead, the region of male
fastener portion 46 having the first threaded end 61 depicted in
FIG. 10 is without threads. This threadless area of the male
fastener portion 46 is affixed to the hole 73 in the second side
clamp 44, the hole 73 being threadless in this embodiment. In one
embodiment, the fixation between the male fastener portion 46 and
the hole 73 is via adhesive or mechanical or friction fit.
[0063] As shown in FIG. 9, the head 81 of the female fastener
portion 48 engages the first outer shoulder 71 of the first side
clamp 42, and the flange 92 on the shaft of the female fastener
portion 48 engages the third inner shoulder 76 of the front support
portion 52. As a result, the first side clamp 42, the front support
portion 52 and the female fastener portion 48 may be held together,
with a suitable amount of play to allow insertion of lead connector
ends 10 into the lead retention assembly 22.
[0064] As indicated in FIG. 9, in one embodiment, the fastener
portions 46, 48 are engaged with each other with the second
threaded end 65 of the male fastener portion 46 being received in
the bore 210 of the female fastener portion 48. Specifically, a
tool is utilized to rotate the female fastener portion 48 in a
first direction relative to the male fastener portion 46 such that
the second threaded end 65 of the male fastener portion 46
threadably engages the second internal thread 83 of the female
fastener portion 48. Further rotation of the female fastener
portion 48 in the first direction causes the second threaded end 65
of the male fastener portion 46 to extend deeper into the bore 210
of the female fastener portion 48 until the second threaded end 65
enters the threadless region 84 of the bore 210 of the female
fastener portion 48. At this point, the first and second side
clamps 42, 44 are secured to the front support portion 52 in such a
manner that there is a suitable amount of play between the front
support portion 52 and the side clamps 42, 44 to allow insertion of
lead connective ends 10 into the lead retention assembly 22.
[0065] In one embodiment and as can be understood from FIGS. 2, 8
and 9, subsequent to the insertion of lead connective ends 10 into
the appropriate receptacles 31-36, the side clamps 42, 44 are
pressed towards the front support portion 52 to cause the second
threaded end 65 of the male fastener portion 46 to move across the
threadless region 84 of the bore 210 of the female fastener portion
48 to be able to threadably engage the first internal thread 82 of
the female fastener portion 48. Further rotation of the female
fastener portion 48 in the first direction causes the second
threaded end 65 of the male fastener portion 46 to threadably
engage and travel along the first internal thread 82 of the female
fastener portion 46. As a result, both fastener portions 46, 48
converge inwardly towards the cavity 220, drawing the side clamps
42, 44 towards the front support portion 52 and clamping the lead
connective ends 10 within their respective receptacles 31-36. To
release the lead connective ends 10 from their respective
receptacles 31-36, the aforementioned process is reversed.
[0066] The preceding discussion pertains to various embodiments
wherein the female fastener portion 48 includes the head 81 and is
free to rotate relative to the male fastener portion 46, which is
fixed to the second side clamp 44 and prevented from rotating
relative to the front support portion 52. However, in other
embodiments, the male fastener portion 46 includes the head and is
free to rotate relative to the female fastener portion 48, which is
fixed to the first side clamp 42 and prevented from rotating
relative to the front support portion 52.
[0067] The preceding discussion pertains to various embodiments
wherein the male fastener portion 46 includes a ring 200, the
female fastener portion 48 includes an anchor 90 with a flexible
flange 92, and the fastener portions 46, 48 are passed into the
bore 70 of the front support portion 52 via the side of the front
support portion 52 having the first side clamp 42. However, in
other embodiments, the ring 200 of the male fastener portion 46 can
be replaced with an anchor similar to the anchor 90 on the female
fastener portion 48. With such an embodiment, the male fastener
portion 46 could pass into the bore 70 of the front support portion
52 via the side of the front support portion 52 having the second
side clamp 44.
[0068] As can be understood from FIGS. 2, 8 and 9, in one
embodiment, the lead retention assembly 22 is advantageous for a
number of reasons. For example, a physician can cause both side
clamps 42, 44 to generally simultaneously clamp against the front
support portion 52 by applying a tool (e.g., screw drive or wrench)
to the heads 81 of the fasteners 45 on a single side of the lead
retention assembly 22. In other words, each fastener 45 is coupled
to both side clamps 42, 44 such that rotating the head 81 of a
single fastener 45 results in generally simultaneous translation of
both side clamps 42, 44 relative to the front support portion 52.
Thus, connection of lead connective ends 10 to an implantable pulse
generator (e.g., pacemaker, defibrillator, etc.) via the
above-described lead retention assembly 22 is more efficient than
other lead retention assemblies that have head equipped fasteners
on each side clamp and require a physician to rotate fasteners
associated with a first side clamp to cause the first side clamp to
clamp before rotating fasteners associated with a second side clamp
to cause the second side clamp to clamp.
[0069] FIG. 12 shows an example of an implantable medical device 20
incorporating an embodiment of a lead retention assembly 22'. In
this example, the lead retention assembly 22' includes four
ports/receptacles 30', 32', 34', 36'. Further, the lead retention
assembly 22' includes a single fastener 45. As described above, the
single fastener 45 is similar to that depicted in FIGS. 9-11 and
facilitates the generally simultaneous actuation of both side
clamps 42, 44 to clamp lead connector ends 10 into the receptacles
30', 32', 34', 36'. In particular, the clamping action may be
performed by actuating the fastener 45 from only one side such that
both side clamps 42, 44 move toward the front support portion 52
generally simultaneously via rotating engagement of a head 81 of a
single fastener 45. Thus, the number of fasteners needed is
reduced, for example, from two to one, the number fasteners heads
that need to be accessed is reduced, for example, from two to one,
and the number of sides of an lead retention assembly that need to
be accessed is reduced from two to one.
[0070] The mounting of the lead retention assembly 22' on the
implantable medical device 20 may be in any known or hereafter
developed manner, and thus is not described herein. It should be
understood that any suitable location of the lead retention
assembly 22' on the implantable medical device 20 may be employed,
for example, depending on the particular configuration of the
implantable medical device 20.
[0071] FIGS. 13-16 are generally the same views depicted in FIGS.
8-11, except of another embodiment of a lead retention assembly
122. In the embodiment depicted in FIGS. 13-16, various elements
may be substantially identical to the embodiments discussed with
respect to FIGS. 2-12. However, the embodiment depicted in FIGS.
13-16 differs with respect to the fastener and the bore in which
the fastener is inserted. These features of the embodiment depicted
in FIGS. 13-16 are discussed in detail below, with minimal detail
regarding the features similar to the embodiments depicted in FIGS.
2-12.
[0072] As shown in FIGS. 13 and 15, the lead retention assembly 122
may include a plurality of ports that define a first set of
receptacles 131, 132, 133 and a second set of receptacles 134, 135,
136. The lead retention assembly 122 may include a support 140 with
a rear support portion 150 and a front support portion 152, opposed
first and second side clamps 142, 144, and one or more fasteners
145 for securing the side clamps to the front support portion 152
to clamp lead connective ends in place.
[0073] As shown in detail in FIGS. 13-16, a bore 170 for receiving
each fastener 145 may extend through the side clamps 142, 144 and
the front support portion 152 of the lead retention assembly 122.
As shown in FIGS. 13 and 14, the bore 170 may provide a first outer
shoulder 171 in the first side clamp 142 and a second outer
shoulder 172 in the second side clamp 144.
[0074] The bore 170 may provide an internal clamp thread 173 and a
first inner shoulder 174 in the second side clamp 144. The bore 170
may provide a second inner shoulder 175 in the front support
portion 152. The fastener 145 may include corresponding features
that cooperate with the features of the bore 170, as described
below.
[0075] The fastener 145 may include a first or male fastener
portion 146 and a second or female fastener portion 148. FIG. 15
shows details of the male fastener portion 146. FIG. 16 shows
details of the female fastener portion 148. FIGS. 13 and 14 show
the fastener portions 146, 148 engaged to render the fastener 145
operative in the lead retention assembly 122.
[0076] With reference to FIG. 15, the male fastener portion 146 may
include a first threaded end 161 configured to engage the internal
clamp thread 173 in the second side clamp 144. The male fastener
portion 146 may include a first shoulder 162 configured to abut the
first inner shoulder 174 in the second side clamp 144, for example,
when the first threaded end 161 is fully engaged in the internal
clamp thread 173.
[0077] The male fastener portion 146 may also include a ring 200
and a second shoulder 163 configured to abut the second inner
shoulder 175 in the front support portion 152, for example, when
the lead retention assembly 122 is fully opened to the maximum
extent, as depicted in FIG. 13.
[0078] A narrower diameter portion 164 of the male fastener portion
146 may extend from the second ring 200 to provide a second
threaded end 165. As described below, the narrower diameter portion
164 of the male fastener portion 146 may be configured to allow the
second threaded end 165 to cooperate with the female fastener
portion 148. In particular, the narrower diameter portion 164 of
the male fastener portion 146 may include a flange 166 that extends
radially outwardly. The flange 166 may include a chamfer 167.
[0079] With reference to FIGS. 14 and 16, the female fastener
portion 148 may include a head 181 configured to engage the first
outer shoulder 171 of the first side clamp 142, for example, when
the lead retention assembly 122 is fully closed or the head 181 is
driving the first side clamp 142 to the closed or clamped
state.
[0080] As indicated in FIG. 16 and FIG. 17, which is an end view of
the female fastener portion 148 as viewed from the bore end of the
female fastener portion 148, the female fastener portion 148 may
include a bore 210 with an internal thread 182 that is
longitudinally separated from a flanged end 186 by an unthreaded
portion 184. The flanged end 186 includes flanges 235. The
cylindrical shaft portion 230 of the female fastener portion 148
forms unthreaded portion 184 and may include one or more
longitudinal slots 187 that segments the cylindrical shaft portion
230 into two or more radial shaft segments 230a, 230b, 230c, 230d,
as best understood from FIG. 17. The radially segmented
configuration of the cylindrical shaft portion 230 of the female
fastener portion 148 allows the flange 166 of the male fastener
portion 146 to pass the flanges 235 of the flanged end 186 of the
female fastener portion 148, for example, by allowing the flanged
end 186 to flex outwardly. Alternatively, the flanged end 186
and/or the unthreaded portion 184 may be sufficiently flexible for
such purpose and not require the radially segmented configuration
of the cylindrical shaft portion 230 of the female fastener portion
148.
[0081] The flanges 235 of the flanged end 186 of the female
fastener portion 148 may also include chamfers 188 that cooperate
with the chamfer 167 of the flange 166 of the male fastener portion
146 to facilitate insertion of the flange 166 of the male fastener
portion 146 past the flanged end 186 into the unthreaded portion
184 of the female fastener portion 148. Thus, the fastener portions
146, 148 may be secured together by pushing them longitudinally
towards each other. In such a condition, the second threaded end
165 may be movable within the unthreaded portion 184, for example,
to provide a limited amount of play or relative movement of the
fastener portions 146, 148 while connected and, as a result, a
limited amount of movement of the side clamps 142, 144 relative to
the front support portion 152.
[0082] As with the embodiments discussed with respect to FIGS.
2-12, rotating the female fastener portion 148 relative to the male
fastener portion 146, which, in one embodiment, is fixed to the
second side clamp 144, causes the second threaded end 165 of the
male fastener portion 146 to engage the first threaded portion 182
of the female fastener portion 148. Thus, the engaged threads cause
the fastener portions 146, 148 to translate toward each other. Such
translation causes both the first and second side clamps 142, 144
to move toward the front support portion 152 to thereby lead
connective ends 10 that are inserted into the receptacles.
[0083] As can be understood from the preceding discussion, the
fasteners 45 act as actuators 45 for actuating the side clamps 42,
44 to secure the leads to the pulse generator (e.g., defibrillator,
pacemaker, or ICD) 20. Lead connective ends 10 are placed in their
respective receptacles 31-36, and the actuators 45 are manipulated
to cause both of the clamps 42, 44 connected thereto to clamp the
lead connective ends between the front support portion 52 and the
respective clamp. As can be understood from the preceding
discussion, in one embodiment, each actuator 45 is operably coupled
to both clamps 42, 44. Actuation of a single actuator 45 impacts
the positional relationship of both clamps 42, 44 relative to the
front support portion 52. Thus, rotating a single actuator 45 in a
first direction relative to the generator 20 can cause both clamps
42, 44 to generally simultaneously increasingly clamp lead
connective ends 10 against the front support portion 52.
Conversely, rotating a single actuator 45 in a second direction
relative to the generator 20 can cause both clamps 42, 44 to
generally simultaneously decreasingly clamp lead connective ends 10
against the front support portion 52.
[0084] Although the present invention has been described with
reference to particular embodiments, persons skilled in the art
will recognize that changes may be made in form and detail without
departing from the spirit and scope of the invention.
* * * * *