U.S. patent application number 11/193576 was filed with the patent office on 2007-02-01 for medical electrical lead connector ring.
Invention is credited to Paul M. Becker, Thomas C. Bischoff, Mary L. Cole, Jordon D. Honeck, James M. Iknayan.
Application Number | 20070027517 11/193576 |
Document ID | / |
Family ID | 37179077 |
Filed Date | 2007-02-01 |
United States Patent
Application |
20070027517 |
Kind Code |
A1 |
Bischoff; Thomas C. ; et
al. |
February 1, 2007 |
Medical electrical lead connector ring
Abstract
A medical electrical device that includes an elongated body
extending from a proximal end to a distal end having an inner
surface forming an elongated body lumen, a conductor extending
through the elongated body lumen, and an electrode positioned along
the distal end of the elongated body and electrically coupled to a
distal end of the conductor. A connector ring is coupled to a
proximal end of the elongated body and electrically coupled to a
proximal end of the conductor, and includes an inner surface
forming a connector ring lumen extending along the connector ring.
A first flange extends from the inner surface to a first flange
distal end and forms a conductor channel extending along the inner
lumen to position the conductor within the connector ring and to
form the electrical coupling of the connector ring and the proximal
end of the conductor.
Inventors: |
Bischoff; Thomas C.;
(Minneapolis, MN) ; Iknayan; James M.; (Andover,
MN) ; Becker; Paul M.; (Cedar, MN) ; Cole;
Mary L.; (St. Paul, MN) ; Honeck; Jordon D.;
(Maple Grove, MN) |
Correspondence
Address: |
MEDTRONIC, INC.
710 MEDTRONIC PARK
MINNEAPOLIS
MN
55432-9924
US
|
Family ID: |
37179077 |
Appl. No.: |
11/193576 |
Filed: |
July 29, 2005 |
Current U.S.
Class: |
607/122 |
Current CPC
Class: |
Y10T 29/49181 20150115;
Y10T 29/49002 20150115; Y10S 439/909 20130101; Y10T 29/49194
20150115; A61N 1/056 20130101; Y10T 29/49128 20150115; Y10T
29/49117 20150115; Y10T 29/49218 20150115 |
Class at
Publication: |
607/122 |
International
Class: |
A61N 1/00 20060101
A61N001/00 |
Claims
1. A medical electrical device, comprising: an elongated body
extending from a proximal end to a distal end having an inner
surface forming an elongated body lumen; a conductor extending
through the elongated body lumen, the conductor having a proximal
end and a distal end; an electrode positioned along the distal end
of the elongated body and electrically coupled to the distal end of
the conductor; a connector ring coupled to the proximal end of the
elongated body and electrically coupled to the proximal end of the
conductor, the connector ring including an inner surface forming a
connector ring lumen extending along the connector ring; and a
first flange extending from the inner surface to a first flange
distal end and forming a conductor channel extending along the
inner lumen to position the conductor within the connector ring and
to form the electrical coupling of the connector ring and the
proximal end of the conductor.
2. The device of claim 1, further comprising a second flange
extending from the inner surface of the connector ring to a second
flange distal end engaged against the first flange distal end,
wherein the conductor channel is formed by the first flange and the
second flange.
3. The device of claim 2, wherein the first flange distal end is
spaced from the second flange distal end prior to the conductor
being positioned within the conductor channel and the first flange
distal end is advanced toward the second flange distal end
subsequent to the conductor being positioned within the conductor
channel.
4. The device of claim 1, wherein the conductor channel extends the
entire length of the connector ring.
5. The device of claim 1, wherein the first flange distal end is
spaced from the inner surface prior to the conductor being
positioned within the conductor channel and the first flange distal
end is advanced toward the inner surface subsequent to the
conductor being positioned within the conductor channel.
6. The device of claim 1, wherein the first flange distal end is
chamfered.
7. The device of claim 2, wherein the first flange distal end and
the second flange distal end are chamfered.
8. The device of claim 3, wherein the first flange distal end and
the second flange distal end are formed to generate a crimp joint
between the first flange distal end and the second flange distal
end.
9. The device of claim 3, further comprising a tool having a notch
for receiving to the first flange distal end and the second flange
distal end to advance the first flange distal end toward the second
flange distal end.
10. A connector ring of a medical electrical device, comprising: an
inner surface forming a connector ring lumen extending along the
connector ring; and a first flange extending from the inner surface
to a first flange distal end and forming a conductor channel
extending along the inner lumen to position a conductor within the
connector ring and to electrically couple the connector ring and
the conductor.
11. The connector ring of claim 10, further comprising a second
flange extending from the inner surface of the connector ring to a
second flange distal end engaged against the first flange distal
end, wherein the conductor channel is formed by the first flange
and the second flange.
12. The connector ring of claim 11, wherein the first flange distal
end is spaced from the second flange distal end prior to the
conductor being positioned within the conductor channel and the
first flange distal end is advanced toward the second flange distal
end subsequent to the conductor being positioned within the
conductor channel.
13. The connector ring of claim 10, wherein the conductor channel
extends the entire length of the connector ring.
14. The connector ring of claim 10, wherein the first flange distal
end is spaced from the inner surface prior to the conductor being
positioned within the conductor channel and the first flange distal
end is advanced toward the inner surface subsequent to the
conductor being positioned within the conductor channel.
15. The connector ring of claim 10, wherein the first flange distal
end is chamfered.
16. The connector ring of claim 11, wherein the first flange distal
end and the second flange distal end are chamfered.
17. The connector ring of claim 12, wherein the first flange distal
end and the second flange distal end are formed to generate a crimp
joint between the first flange distal end and the second flange
distal end.
18. A method of forming a medical electrical device, comprising:
machining an inner surface of a connector ring to form an inner
lumen having a first flange extending from the inner surface;
positioning a conductor within the connector ring; and advancing a
first distal end of the first flange to form a conductor channel to
fixedly position the conductor within connector ring and to
electrically couple the connector ring and the conductor.
19. The method of claim 18, further comprising advancing a second
distal end of a second flange extending from the inner surface to
fixedly engage the first distal end and the second distal end to
form the conductor channel.
20. The method of claim 18, wherein the first distal end is
advanced to be engaged against the inner surface subsequent to the
positioning of the conductor within the connector ring.
Description
TECHNICAL FIELD
[0001] The invention relates to implantable medical devices, and,
more particularly, to configurations of implantable medical lead
connectors.
BACKGROUND
[0002] In the medical field, implantable medical leads are used
with a wide variety of therapeutic or monitoring devices. For
example, implantable leads are commonly used to form part of
implantable cardiac pacemaker systems that provide therapeutic
stimulation to the heart by sensing electrical activity of the
heart and delivering pacing, cardioversion, or defibrillation
pulses via electrodes disposed on the leads, typically near the
distal ends of the leads. Electrodes or sensors carried by the lead
are generally coupled to a conductor extending to a proximal
connector assembly for facilitating electrical coupling of the
electrodes or sensors to a therapy delivery or monitoring device. A
number of challenges exist with respect to such medical leads. As
implantable medical device technology continues to be downsized and
more advanced therapeutic techniques are developed, new lead
arrangements are required. As such, new configurations for
electrically coupling an electrode or other sensor carried by a
lead to an associated monitoring or therapy delivery device are
needed. In particular, electrical coupling configurations are
needed that are reliable and can be manufactured in a
cost-effective manner.
BRIEF DESCRIPTION OF THE DRAWINGS
[0003] Aspects and features of the present invention will be
readily appreciated as the same becomes better understood by
reference to the following detailed description when considered in
connection with the accompanying drawings, in which like reference
numerals designate like parts throughout the figures thereof and
wherein:
[0004] FIG. 1 is a plan view of a medical electrical device
according to an embodiment of the present invention;
[0005] FIG. 2 is an end view of a connector ring according to an
embodiment of the present invention included in the medical
electrical device of FIG. 1;
[0006] FIG. 3 is a side, cut-away view of a connector ring
according to an embodiment of the present invention;
[0007] FIG. 4 is a side cut-away view of a connector ring according
to an embodiment of the present invention;
[0008] FIG. 5 is an end view of a connector ring according to an
embodiment of the present invention;
[0009] FIG. 6 is a side view of the connecter ring of FIG. 5;
[0010] FIG. 7A is an end view of a connector ring according to an
embodiment of the present invention;
[0011] FIG. 7B, is an end view of a connector ring according to an
embodiment of the present invention;
[0012] FIG. 8 is an end view of a connector ring of a medical
electrical device according to an embodiment of the present
invention; and
[0013] FIG. 9 is a flow chart of a method for manufacturing a
medical electrical device according to an embodiment of the present
invention.
DETAILED DESCRIPTION
[0014] The following detailed description provides a practical
illustration for implementing various embodiments of the invention
and is not intended to limit the scope, applicability, or
configuration of the invention in any way.
[0015] FIG. 1 is a plan view of a medical electrical device
according to an embodiment of the present invention. As illustrated
in FIG. 1, a medical electrical device according to an embodiment
of the present invention includes a lead 10 embodied as a cardiac
pacing lead having electrodes that can be used for sensing cardiac
electrogram signals and delivering electrical stimulation pulses to
myocardial tissue for pacing, cardioverting or defibrillating the
heart. Lead 10 includes an elongated lead body 12 having a proximal
end 14 and a distal end 16. Lead 10 is provided with a distal tip
electrode 18 located at or near distal end 16 of lead body 12, a
ring electrode 20 located proximal to tip electrode 18, and two
coil electrodes 22 and 24. Distal tip electrode 18 and ring
electrode 20 are commonly used for pacing and sensing the heart.
Coil electrodes 22 and 24 are commonly used for delivering
high-voltage cardioversion and defibrillation pulses to the heart.
While a particular electrode arrangement is shown in FIG. 1, it is
recognized that various embodiments of the invention may include a
variety of lead types, including neuromuscular stimulation leads,
monitoring leads, or any other medical electrical leads. Such leads
may be provided with a variety of electrode arrangements, which may
include one or more electrodes included on lead body 12.
Furthermore, different types of electrodes, such as an active
fixation electrode, or any other electrode or sensor known for use
with implantable medical leads may be included on lead 10.
[0016] Lead body 12 includes at least one lumen 13 through which
insulated conductors 15 extend between each of the respective
electrodes 18, 20, 22, and 24 and a proximal connector assembly 28
located at proximal body end 14. Connector assembly 28 is adapted
for connection to a connector bore included in an associated
medical device, such as a pacemaker or neurostimulator device. Such
connector assembly configurations for mating with a medical device
connector bore are known in the art.
[0017] Connector assembly 28 includes a pin connector 30 and three
ring connectors 32, 34 and 36. Each of pin connector 30 and ring
connectors 32, 34 and 36 are coupled to a respective conductor
extending to one of tip electrode 18, ring electrode 20 and coil
electrodes 22 and 24 such that each electrode is electrically
coupled to one of pin connector 30 or ring connectors 32, 34 and 36
but remain electrically isolated from each other. Upon proper
insertion of connector assembly 28 into an associated medical
device connector bore, electrodes 18, 20, 22, and 24 become
electrically coupled to the medical device circuitry via the
respective pin connector 30 and ring connectors 32, 34, and 36 and
associated insulated conductors extending between the connectors
and the electrodes.
[0018] Connector assembly 28 includes an insulative sheath 35
mounted around connector pin 30 and terminating prior to a proximal
end 31 of connector pin 30. Connector rings 32, 34, and 36 are
mounted on insulative sheath 35 and are thereby insulated from
connector pin 30. Connector rings 32, 34 and 36 are insulated from
each other by intervening insulative segments 38, which may include
sealing rings 39 for forming fluid-tight seals with a corresponding
connector bore between each of connector rings 32, 34 and 36. It is
recognized that connector assembly 28 may be embodied in a variety
of ways, including varying configurations of insulative members for
supporting and insulating the required number of connectors needed
to electrically couple electrodes or sensors carried by the lead to
an associated medical device. Examples of arrangements of a
connector pin and one or more connector rings on a connector
assembly are generally disclosed in U.S. Pat. Nos. 4,951,687 issued
to Ufford et al., and 5,007,435 issued to Doan et al.
[0019] FIG. 2 is an end view of a connector ring according to an
embodiment of the present invention included in the medical
electrical device of FIG. 1. Connector ring 32 is a generally
cylindrical member having an outer diameter 40 and inner diameter
42. Connector ring 32 is formed with a conductor channel 44
extending longitudinally along the inner diameter 42 of connector
ring 32. Conductor channel 44 is provided for receiving an
uninsulated proximal portion of a conductor. The term "channel" as
used herein refers to a passage having one open side, such as a
generally "U"-shaped or "C"-shaped passage, in contrast to a fully
enclosed or annular passage, such as a generally "O"-shaped or
"D"-shaped passage. In FIG. 2, conductor channel is shown as a
generally "U"-shaped passage formed by two flanges 46 and 48
adapted to be crimped closed around a conductor extending through
conductor channel lumen 50. Thus the conductor channel 44 is
provided initially as an open passage having open side 49 formed by
flanges 46 and 48. The closed side 52 of channel 44 can be formed
as a generally curved surface as shown in FIG. 2. Conductor channel
lumen 50 is sized to approximately match the outer diameter of a
conductor. The proximal portion of the conductor can be positioned
in conductor channel 44 by either threading the conductor into
conductor channel lumen 50 or by threading the conductor through
lumen 82 of connector ring 32 then dropping the conductor down into
conductor channel 44 through open side 49.
[0020] Connector ring 32 is fabricated from a conductive material,
such as MP35N, titanium, or stainless steel. Connector ring 32 is
formed during a machining process that includes machining the inner
diameter 42 from round stock. In one method, a pilot hole is
machined so that an electrical discharge machining wire burner can
be threaded through the round stock. The wire burner is then used
to form inner diameter 42 and conductor channel 44 in one machining
process. The use of EDM wire burner for machining conductor channel
44 reduces the number of machining steps required to machine
connector rings as compared to past practice, which used EDM hole
popper methods. The EDM wire burner step for forming conductor
channel 44 can be performed on multiple, stacked connector ring
piece parts to further reducing manufacturing time.
[0021] FIG. 3 is a side, cut-away view of a connector ring
according to an embodiment of the present invention. Conductor
channel 44 is shown extending longitudinally along substantially
the entire length of connector ring 32. In alternative embodiments,
conductor channel 44 may extend along the inner diameter 42 of
connector ring 32 for any portion of the length of connector ring
32. Connector ring 32 may be provided with a contoured outer
diameter 41 to accommodate outer insulation sheaths used in
assembling a lead connector.
[0022] FIG. 4 is a side cut-away view of a connector ring according
to an embodiment of the present invention. As illustrated in FIG.
4, according to an embodiment of the present invention, flange 46
of conductor channel 44 may be formed to include chamfered ends 54
and 56. Similarly, flange 48, not seen in the cut away view of FIG.
4, would also be formed to include chamfered ends similar to ends
54 and 56 of flange 46. In a manufacturing process that involves
threading the proximal end of a conductor into conductor channel
lumen 50, the threading step may be more readily performed when
ends 54 and 56 are chamfered since the end openings 51 and 53 to
conductor channel lumen 50 will have a larger cross-sectional area
than when distal ends of the flanges extend straight up as shown in
FIG. 3.
[0023] A conductor may be threaded into lumen 50 through either
conductor channel end opening 51 or 53. As shown in FIGS. 3 and 4,
connector ring 32 provided as a piece part with identically
machined ends does not have a designated proximal or distal end. In
FIG. 4, flange 46 is provided with chamfered ends 54 and 56 at both
end openings 51 and 53. During an assembly process, which may be
manual or automated, the connector ring 32 can be oriented in
either direction when a conductor is threaded into either end
opening 51 or 53 of conductor channel 44. In particular, automated
assembly of a conductor onto connector ring 32 is facilitated by
providing connector ring 32 with identically machined ends 51 and
53. It is recognized, however, that in other embodiments flanges 46
and 48 can be provided with chamfered ends at only one end opening,
51 or 53. During assembly, the connector ring would need to be
properly oriented for a conductor to be threaded into the chamfered
end 51 or 53.
[0024] FIG. 5 is an end view of a connector ring according to an
embodiment of the present invention. As illustrated in FIG. 5,
according to an embodiment of the present invention, a connector
ring 80 is formed as described above, with a conductor 60
positioned to extend through lumen 50 of conductor channel 44.
Conductor 60 is shown as a cable conductor, however, connector ring
sub-assembly 80 may be formed using other conductor types, such as
a wire, stranded, bundled, or coiled conductor. A crimping tool 70
is pressed down over conductor channel 44 to advance flanges 46 and
48 together such that a distal end 72 of flange 46 id positioned
adjacent to or engaged against a distal end 74 of flange 48 to
close formerly open side 49 (shown in FIG. 2). Conductor 60 becomes
enclosed within conductor channel lumen 50 such that conductor 60
and connector ring 40 are electrically and mechanically
coupled.
[0025] Crimping tool 70 is an elongated tool that can be inserted
through connector ring lumen 82. Crimping tool 70 is provided with
a crimping notch 76 that extends along crimping tool 70 for a
length corresponding to the length of conductor channel 44.
Crimping notch 76 is sized such that when crimping tool 70 is
pressed down over conductor channel 44, flanges 46 and 48 will be
crimped together within notch 76 along the entire length of
conductor channel 44. A mechanical and electrical crimp joint
between conductor ring 32 and conductor 60 is thereby formed,
extending approximately the entire length of conductor channel 44,
which has been shown to extend approximately the entire length of
connector ring 32. It is expected that by providing a crimp joint
extending the entire length of connector ring 32, a reliable
mechanical and electrical coupling between connector ring 32 and
conductor 60 can be formed which is capable of withstanding a
higher tensile force than a crimp joint extending along only a
portion of connector ring 32. However, depending on the
application, a crimp joint that extends only a portion of the
length of connector ring 32 may also provide adequate tensile
strength for acceptable lead reliability.
[0026] After crimping conductor channel 44 around conductor 60,
inspection of the crimp joint is performed. The crimp joint is
readily verified by inspecting if distal ends 72 and 74 meet along
the entire length of conductor channel 44.
[0027] FIG. 6 is a side view of the connecter ring of FIG. 5.
Crimping tool 70 may be inserted into lumen 82 of connector ring 32
from either end 84 or 86 for crimping conductor channel 44 around
conductor 60. The proximal portion of conductor 60 that extends
through lumen 50 of conductor channel 44 is stripped of insulation
64. Connector ring 80 can be utilized in manufacturing a medical
electrical lead.
[0028] FIG. 7A is an end view of a connector ring according to an
embodiment of the present invention. As illustrated in FIG. 7A,
according to an embodiment of the present invention, a connector
ring 100 is provided with a conductor channel 102 having a
generally "C"-shaped cross-section with open side 106, and
extending along connector ring inner surface 101. A flange 104
forms a conductor channel lumen 108 through which a conductor 110
is threaded. As shown in FIG. 7B, an end 105 of flange 104 is
advanced toward inner surface 101 to close open side 106, thereby
enclosing conductor 110 within lumen 108 and forming a mechanical
and electrical coupling between connector ring 100 and conductor
110.
[0029] FIG. 8 is an end view of a connector ring of a medical
electrical device according to an embodiment of the present
invention. Connector ring 32 of the embodiment of FIG. 8 is shown
having a generally "U"-shaped conductor channel 44 adapted for
crimping around a conductor extending through conductor channel
lumen 50. In this embodiment, flanges 46 and 48 are provided with
beveled distal ends 120 and 122, respectively. The distal ends 120
and 122 may be provided as rounded, beveled, canted or otherwise
modified tips to promote complete and stable closure of open side
49 of conductor channel 44 after crimping. In particular, when
connector ring 32 is fabricated from Titanium, beveled distal ends
120 and 122 promote a more reliable crimp joint.
[0030] FIG. 9 is a flow chart of a method for manufacturing a
medical electrical device according to an embodiment of the present
invention. At step 202, fabrication of a connector ring is
initiated, including machining the inner diameter and outer
diameter contours of the connector ring from solid, round stock of
a selected, conductive metal material. At step 204, partially
machined connector rings can be stacked for machining the conductor
channel into multiple connector rings simultaneously at subsequent
step 206. At step 206, the conductor channel is machined on the
inner diameter of the connector ring using an EDM wire burner
method.
[0031] After completion of connector ring fabrication, a connector
ring sub-assembly is assembled. At step 208, a proximal,
uninsulated portion of a conductor is inserted through the lumen of
the conductor channel. This insertion step may be performed by
threading the conductor through an open end of the conductor
channel lumen or by threading the conductor through an open end of
the connector ring lumen then dropping the conductor down into the
conductor channel through the open side of the conductor
channel.
[0032] After inserting the conductor in the conductor channel, a
crimping tool is used to crimp the conductor channel to close the
open side of the conductor channel at step 210. The resulting crimp
joint formed between the conductor and the conductor channel
provides mechanical and electrical coupling between the connector
ring and the conductor. The connector ring sub-assembly is then
ready to use in assembling a lead connector assembly at step 212.
The lead connector assembly can then be used in assembling a
medical electrical lead at step 214.
[0033] Thus, a connector ring and associated methods for assembling
a connector ring sub-assembly, a connector assembly and a medical
electrical lead including the connector ring, have been presented
in the foregoing description with reference to specific
embodiments. It is appreciated that various modifications to the
referenced embodiments may be made without departing from the scope
of the invention as set forth in the following claims.
* * * * *