U.S. patent application number 11/877336 was filed with the patent office on 2008-02-14 for lead up-sizing sleeve.
Invention is credited to Vicki L. Bjorklund, Timothy W. Holleman, Jordon D. Honeck, Andrew J. Ries, Harry Schroder, John L. Sommer, Paul M. Stein.
Application Number | 20080039900 11/877336 |
Document ID | / |
Family ID | 21909353 |
Filed Date | 2008-02-14 |
United States Patent
Application |
20080039900 |
Kind Code |
A1 |
Stein; Paul M. ; et
al. |
February 14, 2008 |
LEAD UP-SIZING SLEEVE
Abstract
An improved connection system for coupling a device such as a
pacemaker, cardioverter, defibrillator, nerve stimulator, muscle
stimulator, implantable monitor or other medical device to a
medical lead is disclosed. The connection system includes a
coupling member designed to couple to the proximal end of the lead.
This coupling member, which includes an inner lumen sized to form a
press fit around the proximal end of the lead body, may be of a
generally tubular construction. This coupling member includes
connector means to enable a connector pin at the proximal end of
the lead to mechanically and electrically couple to a device. The
connector means may further include means for coupling both
mechanically and electrically to a ring connector on the proximal
end of a multi-polar lead. An insertion member may also be provided
to allow the lead to be more easily inserted within the inner lumen
of the coupling member.
Inventors: |
Stein; Paul M.; (Maple
Grove, MN) ; Holleman; Timothy W.; (Ham Lake, MN)
; Ries; Andrew J.; (Lino Lakes, MN) ; Schroder;
Harry; (St. Louis Park, MN) ; Honeck; Jordon D.;
(Maple Grove, MN) ; Sommer; John L.; (Coon Rapids,
MN) ; Bjorklund; Vicki L.; (Maple Grove, MN) |
Correspondence
Address: |
MEDTRONIC, INC.
710 MEDTRONIC PARKWAY NE
MINNEAPOLIS
MN
55432-9924
US
|
Family ID: |
21909353 |
Appl. No.: |
11/877336 |
Filed: |
October 23, 2007 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
10983266 |
Nov 8, 2004 |
7287995 |
|
|
11877336 |
Oct 23, 2007 |
|
|
|
10040143 |
Jan 3, 2002 |
6854994 |
|
|
10983266 |
Nov 8, 2004 |
|
|
|
09838814 |
Apr 19, 2001 |
6705900 |
|
|
10040143 |
Jan 3, 2002 |
|
|
|
60270074 |
Feb 21, 2001 |
|
|
|
Current U.S.
Class: |
607/37 |
Current CPC
Class: |
A61N 2001/0578 20130101;
A61N 2001/0585 20130101; H01R 24/58 20130101; H01R 2107/00
20130101; H01R 2201/12 20130101; A61N 1/0573 20130101; H01R 31/06
20130101; H01R 13/5224 20130101; A61N 1/056 20130101; A61N 1/3752
20130101 |
Class at
Publication: |
607/037 |
International
Class: |
A61N 1/375 20060101
A61N001/375 |
Claims
1. A medical electrical lead connector arrangement, comprising: a
non-cylindrically shaped connector pin coupled to a lead conductor
and including a tip having a threaded surface for coupling with a
threaded pull wire; and a connector assembly adapted to receive the
non-cylindrically shaped connector pin into a first end of a bore
of the assembly, the connector assembly including a pull wire
insertion site positioned in proximity to a second end of the
assembly bore and an insert mounted within the assembly bore and
having an axial bore formed therein that complements the shape of
the connector pin; wherein the connector assembly is adapted to
couple the lead connector pin to an implantable medical device when
the pin is received within the insert of the connector
assembly.
2. The lead connector arrangement of claim 1, wherein the
non-cylindrically shaped connector pin comprises at least one
planar surface.
3. The lead connector arrangement of claim 1, wherein the
non-cylindrically shaped connector pin comprises a polygonal shaped
connector pin.
4. The lead connector arrangement of claim 3, wherein the polygonal
shaped connector pin comprises at least one of a triangular,
square, rectangular, and hexagonal shaped connector pin.
5. The lead connector arrangement of claim 4, wherein the axial
bore comprises a polygonal shape that complements the shape of the
polygonal shaped connector pin to reduce axial rotation of the
connector pin within the axial bore of the insert.
6. The lead connector arrangement of claim 4, wherein the axial
bore comprises at least one of a triangular, square, rectangular,
and hexagonal shape that complements the shape of the at least one
of a triangular, square, rectangular, and hexagonal shaped
connector pin to reduce axial rotation of the connector pin within
the axial bore of the insert.
7. The lead connector arrangement of claim 1, wherein the connector
pin comprises an inner threaded recess within a tip of the
connector pin for coupling to a threaded pull tool, and wherein the
pull tool is screwed into the inner threaded recess of the
connector pin and the connector pin is pulled through the connector
sleeve assembly until it is inserted within the axial bore of the
insert.
8. The lead connector arrangement of claim 1, wherein the lead
connector arrangement couples the lead conductor to an implantable
medical device.
Description
CROSS REFERENCE TO PRIORITY APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 10/983,266 filed Nov. 8, 2004, which is a
divisional of U.S. patent application Ser. No. 10/040,143 filed
Jan. 3, 2002, which is a continuation-in-part of U.S. patent
application Ser. No. 09/838,814 filed Apr. 19, 2001, which claims
priority to provisionally-filed U.S. patent application 60/270,074
filed Feb. 20, 2001, all of which are incorporated herein by
reference in their entirety.
TECHNICAL FIELD
[0002] The present invention relates generally to mechanisms for
interconnecting electrical leads and electrical medical devices;
and more particularly, to systems and methods of interconnecting
implantable electrical leads and implantable medical electrical
devices such as pacemakers, nerve stimulators, implantable
defibrillators, implantable monitors, and so forth.
BACKGROUND
[0003] As implantable electrical devices have increased in their
complexity, there has been an increasing variety of electrical lead
systems developed for use in conjunction with these devices.
Nowhere is this more apparent than in the context of implantable
cardioverter/defibrillators, which may include three, four, five,
or more electrodes located on various numbers of implantable
electrical leads. The leads themselves may carry one, two, three,
or more electrodes, and may employ a variety of different
electrical connector configurations and types. As a result,
manufacturers of implantable cardioverter/defibrillators have had
to produce their products with a variety of connector block
configurations, capable of use with different lead systems. For
example, Medtronic, Inc. presently manufactures implantable
cardioverter/defibrillators with four basic connector designs,
designated configurations "B", "C", "D", and "E". The "B"
configuration includes three 6.5 mm connector bores for receiving
high voltage electrical lead connectors of the type used to couple
to cardioversion/defibrillation electrodes and one 3.2 mm in-line
electrical connector bore compatible with the IS-1 connector
standard for receiving an IS-1 electrical lead connector of the
type generally used to couple to cardiac pacing and sensing
electrodes. The "C" configuration includes a single 3.2 mm
connector bore conforming to the DF-1 standard for receiving high
voltage electrical lead connectors used to couple to
cardioversion/defibrillation electrodes. This configuration also
includes a single IS-1 connector bore. The "D" configuration
includes three DF-1 connector bores and one IS-1 connector bore.
The "E" configuration includes two 6.5 mm connector bores and two 5
mm connector bores for receiving electrical lead connectors used to
couple to individual cardiac pacing and sensing electrodes.
[0004] As is apparent from the above discussion, multiple
connectors block types are necessitated both by the use of multiple
connector standards, and also because of the desire to connect a
varying number of lead systems to a given device. The situation is
complicated even further by the use of non-standard connector
systems. For example, it has been increasingly common to utilize
small-diameter guide catheters to deliver leads having a diameter
of 7 French or less to a desired implant site. After lead placement
is completed, the catheter must be withdrawn from the body.
However, if the catheter has a small inner diameter, the inner
lumen of the catheter cannot accommodate a standard-size lead
connector such as one conforming to the IS-1 standard. In this
situation, the catheter must be split or slit into two portions.
Such slittable or splittable catheters are more expensive to
manufacture, and require the additional slitting step to remove. To
remedy this problem, the lead may instead include a small-diameter,
non-standard connector that easily fits within the catheter lumen,
allowing the catheter to be readily withdrawn from the body. This
non-standard connector has the drawback of necessitating the use of
an even larger number of connector block configurations.
[0005] One way to solve the problem is to provide adapters that
adapt one lead connector type to a different connector type on the
device. These adapters may take the form of a relatively short lead
which at one end has a connector assembly which may be inserted
into one or more bores on the connector block on the implantable
device and at the other end has one or more connector bores capable
of receiving the connector assembly or assemblies on the electrical
leads to be used with the device. These adapters are bulky and add
substantially to the size of the pocket in which the device is to
be implanted. In addition, they tend to require a number of
additional steps to be performed by the physician in order to
couple the leads to the implanted device, and are thus seen as
undesirable generally. Such adapters are disclosed in U.S. Pat. No.
5,000,177, issued to Hoffmann, and U.S. Pat. No. 5,328,442, issued
to Levine. Some adapters, such as disclosed in U.S. Pat. Nos.
5,050,602 issued to Osypka and 5,060,649 issued to Hocherl et al.
even required removal of the connector assembly of the lead as part
of the connection process.
[0006] Another approach to resolving lead/device incompatibility
problems involves use of an up-sizing adapter. An up-sizing adapter
is used to convert a smaller-diameter standard or non-standard lead
connector to a larger-sized device connector. This is particularly
useful when dealing with leads having smaller connectors for use
with non-splittable guide catheters. As discussed above, a smaller
lead connector allows guide catheters to be easily withdrawn over
the lead proximal end after the implant procedure is completed.
After the guide catheter has been removed from the body, the
up-sizing adapter may be connected to allow the lead to be coupled
to a device.
[0007] One example of an up-sizing adapter is shown in U.S. Pat.
No. 5,007,864, issued to Stutz Jr. This patent discloses an adapter
to convert a smaller-diameter unipolar lead system to a larger
connector block. Although this system allows a small-diameter lead
to be used with a non-splittable catheter, this system has a
disadvantage of not being adaptable for use with a bipolar
leads.
[0008] Another example of an up-sizing adapter is disclosed in U.S.
Pat. No. 4,583,543 issued to Peers-Trevarton. While this system is
adaptable for use with bi-polar lead systems, it can only be used
with a lead having a connector pin that is smaller than the
connector bore. That is, it is not adaptable for use with a lead
having a standard connector pin size but a non-standard connector
body.
[0009] What is needed, therefore, is an improved system and method
for allowing a lead connector of a first size to couple to a
larger-sized device connector, and that addresses the foregoing
problems.
SUMMARY OF THE INVENTION
[0010] The present invention is an improved connection system for
coupling a device such as a pacemaker, cardioverter, defibrillator,
nerve stimulator, muscle stimulator, implantable monitor or other
device of the sort to a medical lead and which addresses the
lead/device incompatibility issues discussed above while avoiding
at least some of the drawbacks associated with conventional
adapters or converters.
[0011] The current invention provides an up-sizing mechanism that
may be used to size the proximal end of a lead to a predetermined
convention such as the IS-1 standard. The system includes a
coupling member designed to couple to the proximal end of the lead.
This coupling member, which includes an inner lumen sized to form a
press fit around the proximal end of the lead body, may be of a
generally tubular construction. This coupling member includes
connector means to enable a connector pin at the proximal end of
the lead to mechanically and electrically couple to a medical
device. This coupling means may include a positioning lip that
positions the sleeve around the proximal end of the lead in a
manner that allows the lead connector pin to form a stable
mechanical connection with the medical device.
[0012] In another embodiment, the connector means includes means
for coupling both mechanically and electrically to a ring connector
on the proximal end of a bi-polar lead. This coupling mechanism may
include teeth for engaging the ring connector of the lead.
Alternatively, the mechanism may include a multi-beam connector.
Many other types of mechanical and electrical coupling mechanisms
may be adapted for this purpose.
[0013] In one embodiment, the coupling member of the up-sizing
system includes a reinforcing structure such as a coil. This
reinforcing structure prevents the lead from flexing in a manner
that results in lead failures. The coupling member may further
include sealing rings on the exterior surface to provide a
fluid-tight seal with the medical device, and/or sealing rings
within the inner lumen to provide a fluid-tight seal with the lead
body.
[0014] Because of the relatively tight press-fit formed between the
coupling member and the lead body, one embodiment of the system
includes an insertion member to allow the lead to be more easily
inserted within the inner lumen of the coupling member. In one
embodiment, the insertion member is a pull-wire adapted to be
inserted through the inner lumen of the coupling member and coupled
to a connector pin of the lead. Force applied to the pull wire
pulls the lead body into the inner lumen. In a second embodiment,
the insertion member is a split tube that is inserted into the
inner lumen. The lead body is inserted into the split tube, which
is then removed from around the lead body and extracted from the
inner lumen.
[0015] According to yet another embodiment of the current system,
the coupling member of the up-sizing system is a bifurcated member
designed to adapt the proximal end of a lead to more than one
standard connector size. For example, the bifurcated member may
include both a DF-1 and IS-1 connector.
[0016] The up-sizing system of the current invention provides a
mechanism for up-sizing a lead having a non-standard lead body size
and a standard connector pin size. For example, the invention is
particularly suited for small-diameter leads having an in-line
connector pin. Unlike prior art designs, the coupling member of the
current invention allows the connector pin of the lead to be
coupled directly to a medical device, while providing a means to
up-size the proximal end of the lead body. Other advantages of the
inventive connection system will become apparent to those skilled
in the art from the drawings and accompanying description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1A is a side cutaway view of an exemplary unipolar lead
connector of the type that may be employed with the current
inventive system.
[0018] FIG. 1B is a side cutaway view of an exemplary bipolar lead
connector of the type that may be employed with the current
inventive system.
[0019] FIG. 1C is a side cutaway view of yet another exemplary
bipolar lead connector of the type that may be employed with the
current inventive system.
[0020] FIG. 2A is a plan view of one embodiment of an upsizing
sleeve according to the current invention.
[0021] FIG. 2B is a perspective view illustrating the manner in
which the inventive up-sizing sleeve may be used to couple a lead
to a medical device.
[0022] FIG. 3 is a plan view illustrating proximal end of the lead
of FIG. 1C inserted within upsizing sleeve.
[0023] FIG. 4A is a side cutaway view of one embodiment of the
upsizing sleeve of the current invention that may be formed using
an over-molding process.
[0024] FIG. 4B is a cross-sectional view of upsizing sleeve at line
4B-4B of FIG. 4A.
[0025] FIG. 5 is a cutaway side view of another embodiment of the
upsizing sleeve of the current invention.
[0026] FIG. 6 is a cutaway side view of a two-piece sleeve member
that may be assembled over the lead at the time of use.
[0027] FIG. 7 is a cross-sectional view of the sleeve of FIG. 6 at
line 7-7.
[0028] FIG. 8 is a cutaway side view of a bifurcated sleeve that
includes two different connector standards.
[0029] FIG. 9 is a side cutaway view of another embodiment of the
current invention that incorporates both support structures and
sealing grommets.
[0030] FIG. 10A is a side cutaway view showing an embodiment of the
up-sizing sleeve that includes a spring coil to form the electrical
connection between a lead ring connector and a conductive ring
member of the upsizing sleeve.
[0031] FIG. 10B is a side cutaway view of the embodiment of FIG.
10A illustrating the manner in which the spring coil compresses
when the lead is fully inserted within the up-sizing sleeve.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0032] FIG. 1A is a side cutaway view of an exemplary unipolar lead
connector of the type that may be employed with the current
inventive system. The lead includes a connector pin 10 at the
proximal end of the lead. In this view, the connector pin has
substantially the same diameter as the lead body 12, although this
is not necessary. Connector pin has an opening 14 that extends to
inner lumen 16. A portion 18 of inner lumen 16 may be threaded.
[0033] Connector pin 10 couples to conductive member 19 that
extends into lumen 16 and is electrically and mechanically coupled
to at least one conductor 20. In FIG. 1A, conductor 20 is a
conductive coil that extends the length of the lead body 12 to a
tip electrode 24 at the lead body distal tip 26. In other
embodiments, conductor 20 may take the form of a single-filar or
multi-filar stranded conductor.
[0034] Lead body further includes an insulative jacket 28 that may
be formed of a biocompatible polymer such as polyurethane or
silicone. It may be noted that the lead of FIG. 1A is merely
exemplary, and many other leads may be employed with the current
invention. For example, a lead without an inner lumen extending
within lead body 12 may be utilized. Alternatively, having multiple
inner lumens may likewise be utilized.
[0035] FIG. 1B is a side cutaway view of an exemplary bipolar lead
connector of the type that may be employed with the current
inventive system. In FIG. 1B, elements that are similar to those
shown in FIG. 1A are labeled with like designators. The lead of
FIG. 1B includes a connector pin 10 that couples to conductive
member 19. Conductive member 19 is electrically and mechanically
coupled to an insulated coiled conductor 50. This conductor 50
extends the length of lead body 12 and is coupled at the distal tip
26 to tip electrode 24. A second insulated coiled conductor 52 is
also provided to couple ring electrode 54 at the lead distal end to
ring connector 56. In another embodiment, the conductors may be
single or multi-filar stranded conductors.
[0036] FIG. 1C is a side cutaway view of yet another exemplary
bipolar lead connector of the type that may be employed with the
current inventive system. In this embodiment, a connector pin 70 is
shown having an opening 72 that includes an inner, threaded surface
74. A portion of the connector pin is shown surrounded by an
insulative sleeve 75 which may be formed of a polymer. This
insulative sleeve electrically isolates pin from lead body 73, and
provides additional structural support. The connector pin, which
may have dimensions conforming to an IS-1 or another standard,
extends within an inner lumen 76 of the lead body 73. This inner
lumen houses a stranded conductor 80 such as shown in
commonly-assigned U.S. Pat. No. 5,760,341 that is electrically
coupled to tip electrode 82. The conductor 80 may be a single or
multi-filar stranded conductor, or in a different embodiment, may
be a coiled conductor. A second, coiled conductor 84 electrically
couples ring electrode 86 to a connector ring 88. It may be noted
that although the connector pin 70 of this design may be of a
dimension that corresponds to a standard such as an IS-1 connector
pin standard, the overall lead dimensions of the proximal end 90 of
the lead do not necessarily conform to any standard.
[0037] As discussed above, the lead configurations shown in FIGS.
1A, 1B, and 1C have small connector profiles. Therefore, a guide
catheter used to place the leads during an implant procedure may be
readily withdrawn over the connector pin without having to split or
slit the catheter body. However, the connector pin 10 and the
proximal end 11 of the lead body do not conform to a connector
standard such as IS-1, making connection to a standard device
connector block difficult. The upsizing sleeve of the current
invention is provided as a means for facilitating this connection
so that a specialized device connector block is not needed.
[0038] FIG. 2A is a plan view of one embodiment of an upsizing
sleeve 100 according to the current invention. This upsizing sleeve
is a generally tubular member having an inner lumen (not shown in
FIG. 2) that is adapted to receive the proximal end of a lead such
as the lead shown in FIG. 1C. The inner lumen of the upsizing
sleeve is slightly larger than the outer diameter of proximal end
90 of the lead. For example, the proximal end 90 of the lead of
FIG. 1C may be adapted to fit within the inner lumen as indicated
by dashed line 102 such that the lead body forms a press fit with
the surface defined by the lumen. The upsizing sleeve is adapted to
conform to a standard configuration such as an IS-1 standard.
[0039] Upsizing sleeve is shown to include two sets of exterior
sealing rings 104 and 106 adapted to sealingly engage with the
connector port of a device such as pacemaker or defibrillator.
Upsizing sleeve further includes a conductive ring member 109
adapted to electrically couple to connector ring 73 of the lead, as
shown by dashed lines 108 in a manner to be discussed further
below. Conductive ring member 109 is further adapted to
mechanically and electrically couple to a set screw within the
device connector to thereby couple ring connector 73 to a medical
device in a manner dictated by the IS-1 connector standard. Sealing
rings and the portions of upsizing sleeves surrounding conductive
ring member 109 may be formed of one or more polymer structures
such as polyurethane or silicone in a manner to be discussed
further below.
[0040] Because of the relatively tight press-fit between the
proximal end 90 of the lead and the upsizing sleeve 100, a
pull-wire device 110 may be provided to aid in the insertion
process. One embodiment of the pull-wire device 110 includes a
rigid pull-wire 112 and a handle 113. The rigid pull-wire 112 may
include a threaded distal end 114, which is inserted through the
inner lumen of upsizing sleeve 100, as shown by dashed line 116.
The threads of threaded distal end 114 are then positioned to
engage threaded surface 74 (FIG. 1C) of the connector pin 70, as
shown by dashed line 118. This allows the pull-wire 112 to rigidly
engage the proximal end 90 of the lead so that the lead may be
pulled through the inner lumen of the upsizing sleeve 100.
[0041] Although FIG. 2A shows pull-wire 112 including threaded
distal end 114 to engage a lead, other coupling means could be
provided to coupled to the lead, including a spring-loaded clip, or
a plug to form a press-fit with opening 72.
[0042] FIG. 2B is a perspective view illustrating the manner in
which the inventive up-sizing sleeve may be used to couple a lead
to a medical device. The proximal end 90 of a lead such as shown in
FIG. 1C includes a connector pin 70 and connector ring 73. This
lead may be inserted into the inner lumen 120 of sleeve 100 so that
connector ring 73 forms a press fit with conductive ring member
109, with connector pin 70 extending through the proximal end 122
of the sleeve. Connector pin is adapted to be received by port 124
of the medical device 126, which is further maintained by set-screw
128. A second set-screw 130 and washer 132 is provided to form a
connection with conductive ring member 109.
[0043] FIG. 3 is a plan view illustrating proximal end 90 of the
lead of FIG. 1C inserted within upsizing sleeve 100. Connector pin
70 extends through the proximal end of the upsizing sleeve, whereas
the lead body of proximal end extends out the distal end of the
upsizing sleeve.
[0044] FIG. 4A is a side cutaway view of one embodiment of upsizing
sleeve 100. A conductive ring member 150 is provided to couple to a
connector ring such as connector ring 73 (FIG. 1C) of a lead in the
manner discussed above. This ring member may be formed of any
conductive material such as a stainless steal, for example. The
remainder of the upsizing sleeve is an integral structure 152 that
includes sealing rings 154 and 156. This structure may be formed of
a biocompatible polymer such as silicone using a silicone
over-molding process as is known in the art. According to one
aspect of the invention, the upsizing sleeve may be reinforced at
the distal end with a reinforcing member 158 that may be formed of
an insulative coil such as a PTFE coil, a conductor coil that may
or may not be insulated, or any other material having strength
properties that make it suitable for this purpose. This reinforcing
member provides added support to prevent the lead proximal end 90
(FIG. 3) from flexing in a manner that may cause lead failures over
time. In another embodiment, a reinforcing, tubular sleeve member
may be inserted within the distal end of the upsizing sleeve to
provide this type of support.
[0045] Upsizing sleeve may further include interior sealing rings
within the inner lumen 170. For example, upsizing sleeve of FIG. 4A
includes sealing rings 160, 162 and 164 to provide a fluid-tight
seal with a lead inserted within inner lumen 170. Finally, upsizing
sleeve is also show to have a lip 172 at the proximal end which may
be provided to engage a corresponding structure on the lead. In
this manner, upsizing sleeve is positioned over the lead so that
connector pin 70 extends beyond the proximal end of upsizing sleeve
100 a predetermined distance that conforms to a given connector
standard. For example, lip 172 may be adapted to engage the ridge
formed by insulative sleeve 175 where the insulative sleeve meets
the connector 70 (FIG. 1C).
[0046] FIG. 4B is a cross-sectional view of upsizing sleeve at line
4B-4B of FIG. 4A. This view shows conductive ring member 150
including channels adapted to receive a polymer during an
over-molding process such as a silicon over-molding process
discussed above. The flow of a polymer into these channels results
in the formation of the connecting polymer structures 160A, 160B,
160C, and 160D. FIG. 4B further illustrates conductive teeth
members 180 coupled to, or integrally formed, in conductive ring
member 150. These conductive teeth members are adapted to engage a
conductive ring of a lead such as connector ring 73 to from a more
robust electrical connection between the connector ring and
conductive ring member 150. This view further illustrates sealing
rings 156.
[0047] Although teeth members 180 are shown in FIG. 4B to couple
conductive ring member to a connector ring of a lead, many other
mechanisms may be used in the alternative. For example, a keyed
mechanism such as a woodruff or spline key may be used to lock a
lead ring connector to the conductive ring member. Alternatively, a
threaded aperture may be provided in the connective ring member so
that a set-screw from a device connector block may be used to affix
the sleeve to the lead via the threaded aperture. In yet another
embodiment, small ports may be provided in the conductive ring
member to receive conductive adhesive to enhance the electrical and
mechanical contact between the conductive ring member and the lead
ring connector. Alternatively, a hole in the conductive ring member
may be aligned with a corresponding hole or groove in the lead so
that a pin or rivet can be inserted to form a mechanical and
electrical coupling. A thumb-actuated spring and ball-detent
mechanism could be used to couple the sleeve to the lead. Another
embodiment may include a thumb-activated push-collar such as is
provided on steerable stylet handles. Any other type of coupling
mechanisms may be used to form a stable electrical and mechanical
fit between the conductive ring member and the connector ring of a
lead.
[0048] FIG. 5 is a cutaway side view of another embodiment of the
upsizing sleeve of the current invention. In this embodiment, a
first generally tubular member 200 which may be formed of silicone
is bonded to a support member 204 using a first layer 206 of
medical-grade adhesive. Support member, which may be formed of a
material that is more rigid than the silicone such as a higher
durometer polyurethane, is also bonded via adhesive layer 210 to a
second generally tubular member 208, which may also be silicone.
The support member 204 is adapted to provide additional structural
rigidity that is not provided by a sleeve formed entirely of a
lower-durometer material such as silicon. This rigidity is
important to maintain precise sleeve dimensions so that the sleeve
maintains a form that conforms to a predetermined standard even
after undergoing the strain of forming a press fit with a lead.
[0049] A conductive ring member 212 surrounds the support member
204 and is adapted to engage a set-screw of a medical device as is
provided on a standard IS-1 device connector block. In one
embodiment, the conductive ring member 212 includes teeth 214 that
extend through the support member to engage a connector ring of a
bipolar lead. If a unipolar lead is to be employed, these teeth
need not be included in the sleeve, since the ring connector of the
lead need not make an electrical connection with a device connector
block.
[0050] Each of tubular members 200 and 208 includes exterior
sealing rings 220 and 222, respectively, to provide a fluid-tight
seal with a device connector block. Each of the tubular members
further includes interior sealing rings 224 and 226, respectively,
to provide the fluid tight seal with a lead. As discussed above,
preferably tubular members 200 and 208 are formed of a less rigid
material such as silicone so that these sealing rings are more
deformable and better able to provide a seal.
[0051] FIG. 5 also illustrates an alternative mechanism that may be
used to engage a lead with the sleeve. A split tubular member
composed of a material having a lubricious surface such as PTFE
tubing 230 may be inserted in the distal end of the sleeve. The
lubricious outer surface of the tubing allows the tubing 230 to be
readily inserted into inner lumen 231 of the sleeve. A lead 232 may
then be inserted within the inner lumen of the tubing 230 and the
tubing removed. The slit 234 in the tubing allows it to be removed
from around the lead after the lead is attached to the up-sizing
sleeve. The use of this split tubular member thereby provides an
alternative to the pull-wire tool (FIG. 2) as an aid to forming the
press fit between a lead and the sleeve.
[0052] In one embodiment, sleeve may include one or more ports such
as port 234 (shown dashed) to allow a medical-grade adhesive to be
infused or injected between the sleeve and the lead after the lead
is inserted into the sleeve to thereby secure the lead to the
sleeve.
[0053] FIG. 6 is a cutaway side view of a two-piece sleeve member
that may be assembled over a lead such as lead 250 at the time of
use. A first portion of the sleeve includes a less rigid, generally
tubular member 252 that may be formed of silicon, and which is
bonded to a conductive ring 254 via a medical-grade adhesive.
Conductive ring 254, which is formed of a conductive material, is
adapted to electrically and mechanically couple to a connector ring
255 of lead 250 via a second portion of the sleeve, as will be
discussed further below. Conductive ring is further adapted to
electrically couple to a connector block of a medical device, as
may be accomplished using a set-screw.
[0054] In one embodiment, the tubular member 252 includes one or
more lips 256 to engage grooved members 258 in the lead connector
pin 260. This allows the sleeve to be seated over the lead so that
the dimensions of the assembly conform to a predetermined standard
such as IS-1. Lips 256 further provide a fluid-tight seal with lead
250. One of the lips 256 is shown interfacing with a seal zone 257
of the inline connector. As discussed above, tubular member 252 may
be formed of a less rigid material such as silicone to provide
sealing rings that allow for a better fluid-tight seal.
[0055] The two-piece sleeve of FIG. 6 further includes a second
portion that is formed of a second less-rigid tubular member 264
such as silicone. Tubular member 264 is bonded to a connector
member 266, which may be formed of a metal. Connector member 266
has deformable fingers 268 that slide under edge 270 to engage
conductive ring 254 in a snap-fit that provides both a mechanical
and electrical coupling between connector member 266 and conductive
ring 254. Deformable fingers 268 also electrically couple to
connector ring 255 of lead 250 so that an electrical connection is
formed between the connector ring 255 and conductive ring 254 of
the two-piece sleeve. This allows the connector ring 255 of lead
250 to be coupled to a connector block of a device via conductive
ring 254.
[0056] The lead 250 of FIG. 6 may include grooves 272 to engage
inner sealing rings 274, and may further having a shoulder 276 to
engage conductive ring 254 in a manner that further allows the lead
to seat in a position that conforms to a predetermined
standard.
[0057] FIG. 7 is a cross-sectional view of the sleeve of FIG. 6 at
line 7-7. This view shows the deformable fingers 268 electrically
and mechanically engaging conductive ring 254, and further
electrically engaging connector ring 255 of lead 250.
[0058] FIG. 8 is a cutaway side view of a bifurcated sleeve 300
designed to adapt a lead to conform to two different connector
standards. In the embodiment illustrated, lead 301 is shown
engaging a first bifurcation 302 of the bifurcated sleeve that
conforms to the IS-1 standard. This portion of the sleeve may be of
any of the embodiments discussed above. A conductive ring member
306 is provided on bifurcation 302 to engage with a connector ring
307 of lead 301, and to further engage a connector block of a
medical device in the manner discussed above. The pin 308 of the
lead extends through the sleeve as discussed above, and exterior
sealing rings 310 provide a fluid-tight fit with the medical
device. Interior sealing rings 312 and 313 provide a fluid-tight
fit with lead 301. Additional inner sealing rings (not shown) are
provided to engage the proximal end of the lead as discussed
above.
[0059] In this embodiment, pacing and sensing of a patient may be
accomplished via ring connector 306 and pin 308 connectors, which
coupled to tip and ring electrodes (not shown in FIG. 8),
respectively, at the lead tip. Further assume the lead carries a
high-voltage coil electrode that is electrically coupled to ring
connector 306. The additional bifurcation 320 may then be used to
provide a connector for cardioversion/defibrillation purposes. A
high-voltage defibrillation coil 322 connects conductive ring
member 306 with a connector pin 324 that may conform to a second
standard such as a DF-1 standard. This connector pin 324 may be
utilized by a medical device to deliver a
cardioversion/defibrillation shock that is then carried via coil
322 and conductive ring member 306 to conductor ring 307, and
finally to the defibrillation coil electrode as the proximal end of
the lead. This embodiment of the sleeve thereby allows a bipolar
lead having a pace/sense electrode pair and a single shock coil to
be adapted to both IS-1 and DS-1 connector blocks without the need
to slit or split a catheter that is used during lead delivery.
Additionally, the current inventive sleeve eliminates the pocket
bulk associated with traditional longitudinal adaptors.
[0060] Sleeve 300 may be formed of one or more biocompatible
polymers. For example, the hub portion 330 of the bifurcated sleeve
could be formed of a more rigid material such as polyurethane that
provides additional support to the structure and to the proximal
end of the lead. The remainder of the sleeve, including the
portions of the bifurcations 302 and 320 that include the exterior
sealing rings 310 and 326, could be formed of a less rigid material
such as silicone.
[0061] As noted above, the current inventive up-sizing sleeve is,
in its preferred embodiment, designed to conform a lead to a
predetermined connector standard. For this reason, it is important
that the sleeve does not stretch or deform in any manner. To
provide a structure that maintains precise dimensions, more rigid
support structures formed of a material such as polyurethane may be
incorporated into the sleeve. The inclusion of additional sealing
grommets may also be desirable to ensure both a fluid-tight seal,
and the retention of predetermined sleeve dimensions.
[0062] FIG. 9 is a side cutaway view of another embodiment of the
current inventive up-sizing sleeve that incorporates both support
structures and sealing grommets. A first, less-rigid tubular sleeve
member 350 is shown having exterior sealing rings 352 as discussed
above. Tubular member 350, which may be formed of a silicone, is
bonded to a more rigid tubular support member 354, which may be
formed of a polyurethane. Support member 354, is, in turn, coupled
at one end to an exterior conductive ring 355 formed of an
electrically-conductive material that is adapted to make an
electrical connection with a connector block of a medical device,
as is provided by a standard IS-1 connector.
[0063] Conductive ring 355 houses, and is mechanically and
electrically coupled to, a connector member 356 that is also formed
of a conductive material. Connector member 356 is adapted to make
an electrical and mechanical connection with a connector ring of a
lead in a manner similar to that discussed above. Connector member
356 is shown in this embodiment to be a multi-beam connector having
deformable fingers adapted to form a press-fit with a lead
connector ring. Alternatively, connector member 356 may take the
form of any other type of connector known in the art, including any
of the types of connectors discussed above.
[0064] Housed within conductive ring 354 may be a sealing grommet
357 provided to form a superior fluid-tight seal with a lead.
Sealing grommet 357 may be formed of a more deformable material
such a silicone, for example.
[0065] Conductive ring 355 is further bonded or welded to a second
rigid tubular support member 360, which may be formed of a
polyurethane or a metal. This second tubular support member 360 is
also mechanically coupled to a less rigid, tubular sleeve member
362 having sealing rings 364, and which may be formed of silicone.
Tubular support member 360 is bonded to a lip member 366 adapted to
house a second sealing grommet 368. Lip member 366 may be formed of
a rigid polymer such as a polyurethane, whereas the sealing grommet
may be formed of silicone.
[0066] The embodiment shown in FIG. 9 provides a more flexible
design. The length of the sealing grommets may be adjusted to
position the conductive ring 355 based on a selected connector
standard. Moreover, the multi-beam connector shown as connector
member 356 may be adjusted to couple to any lead size requirement.
This design is adaptable for over-the-wire leads, and small
coil-over-cable leads having an outer diameter of 5 French or
less.
[0067] It may be noted that while the multi-beam connector 356 of
FIG. 9 may be adapted to form an electrical connection with a
connector ring of a multi-polar lead, this need not be the case. In
one embodiment, the multi-beam connector 356 may be formed of a
non-conductive material. In this case, the connector 356 is adapted
to form a mechanical connection with a unipolar lead so that the
lead body is maintained in a stable position with respect to the
up-sizing sleeve. In this embodiment, conductive ring 355 may be
omitted if desired, or a similar structure may be provided that is
formed of a non-conductive material.
[0068] FIG. 10A is a side cutaway view showing yet another
embodiment of the up-sizing sleeve that includes a spring coil to
form the electrical connection between a lead ring connector and a
conductive ring member of the upsizing sleeve 400. Up-sizing sleeve
400 includes many of the components described above with respect to
other ones of the embodiments of the invention. For example, the
embodiment of FIG. 10A includes flexible tubular members 401 and
403 which may be formed of a silicone, and which are coupled as
with a medical-grade adhesive to an electrically-conductive ring
member 402. Most notably, in this embodiment, conductive ring
member 402 is electrically and mechanically coupled at one end to a
deformable spring coil 404. Spring coil 404, which is formed of an
electrically-conductive material, may be spot welded or otherwise
coupled to a shoulder 406 of conductive ring member 402. In this
embodiment, lead 410 includes a ring conductor 412 having a lip 414
to engage spring coil 404. In this manner, ring connector 412 is
electrically coupled to the conductive ring member 402, which, in
turn, may be coupled to the connector block of a medical device.
The upsizing sleeve may further include one or more grommets such
as grommet 416, which is maintained in position by a polyurethane
lip member 418 similar to that shown in the embodiment of FIG. 9.
The upsizing sleeve may further include other aspects described
with respect to the embodiments of FIGS. 1-9 as would be apparent
to those skilled in the art.
[0069] FIG. 10B is a side cutaway view of the embodiment of FIG.
10A illustrating the manner in which the spring coil 404 compresses
when the lead is fully inserted within the up-sizing sleeve
400.
[0070] It may be noted that the inventive system and method of
coupling a lead to a medical device as described and illustrated
herein may be adapted for use with any size lead, any type of
connector standard, and any type of medical device. For example,
the up-sizing sleeve may be used with leads for drug delivery
devices, devices adapted for neurological applications, or for any
other type of physiological application requiring a lead coupled to
an implantable or non-implantable device. Thus, many adaptations of
the above-described invention will become apparent to one skilled
in the art, and the description is therefore to be considered not
as limiting, but as exemplary only. Additional scopes and aspects
of the invention are described in attached Appendix A which is
incorporated herein by reference in its entirety.
* * * * *