U.S. patent application number 11/669047 was filed with the patent office on 2008-07-31 for direct delivery system for transvascular lead.
This patent application is currently assigned to Cardiac Pacemakers, Inc.. Invention is credited to Mark J. Bly.
Application Number | 20080183187 11/669047 |
Document ID | / |
Family ID | 39165821 |
Filed Date | 2008-07-31 |
United States Patent
Application |
20080183187 |
Kind Code |
A1 |
Bly; Mark J. |
July 31, 2008 |
DIRECT DELIVERY SYSTEM FOR TRANSVASCULAR LEAD
Abstract
A lead delivery system for delivering a neurostimulation lead to
a patient's internal jugular vein using a percutaneous stick. The
system comprises a neurostimulation lead adapted to stimulate a
vagus nerve from the internal jugular vein. The lead includes a
proximal end, a distal end, a generally spiral shaped retaining
structure interposed between the proximal and distal ends and
configured to retain the lead in the internal jugular vein, an
electrode coupled to the retaining structure, and a side port
interposed between the retaining structure and the proximal end.
The side port provides access to a lumen extending from the distal
end to the side port. A guidewire is sized to fit within the side
port and lumen and reduce a force exerted by the retaining
structure against the internal jugular vein, thereby allowing
rotation of the lead and orientation of the electrode by applying a
torque to the lead. A catheter has a lumen sized to slideably
receive the medical electrical lead and configured to provide
access to the internal jugular vein from the percutaneous stick
site. A method of delivering a medical electrical lead to a
patient's internal jugular vein.
Inventors: |
Bly; Mark J.; (Falcon
Heights, MN) |
Correspondence
Address: |
FAEGRE & BENSON, LLP;32469
2200 WELLS FARGO CENTER, 90 SOUTH SEVENTH STREET
MINNEAPOLIS
MN
55402-3901
US
|
Assignee: |
Cardiac Pacemakers, Inc.
St. Paul
MN
|
Family ID: |
39165821 |
Appl. No.: |
11/669047 |
Filed: |
January 30, 2007 |
Current U.S.
Class: |
606/129 |
Current CPC
Class: |
A61N 1/36114 20130101;
A61N 1/0558 20130101; A61N 1/057 20130101 |
Class at
Publication: |
606/129 |
International
Class: |
A61N 1/05 20060101
A61N001/05 |
Claims
1. A lead delivery system for delivering a neurostimulation lead to
a patient's internal jugular vein using a percutaneous stick, the
system comprising: a neurostimulation lead adapted to stimulate a
vagus nerve from the internal jugular vein, the lead including a
proximal end, a distal end, a generally spiral shaped retaining
structure interposed between the proximal and distal ends and
configured to retain the lead in the internal jugular vein, an
electrode coupled to the retaining structure, and a side port
interposed between the retaining structure and the proximal end,
the side port providing access to a lumen extending from the distal
end to the side port; a guidewire sized to fit within the side port
and lumen and reduce a force exerted by the retaining structure
against the internal jugular vein, thereby allowing rotation of the
lead and orientation of the electrode by applying a torque to the
lead; and a catheter having a lumen sized to slideably receive the
medical electrical lead and configured to provide access to the
internal jugular vein from the percutaneous stick site.
2. The lead delivery system of claim 1 wherein the distance between
the side port and the generally spiral shaped retaining structure
is a maximum of approximately 5 centimeters.
3. The lead delivery system of claim 1 wherein the lumen extends
beyond the side port.
4. The lead of claim 1 wherein the generally spiral shaped
retaining structure has a diameter of between approximately 5 and
approximately 50 millimeters.
5. The lead of claim 1 wherein the generally spiral shaped
retaining structure has a length of between approximately 30 and
approximately 200 millimeters.
6. The lead of claim 1 wherein the generally spiral shaped
retaining structure has a pitch of between approximately 0
centimeters and approximately 5 centimeters.
7. The lead delivery system of claim 1 wherein the neurostimulation
lead has a diameter of between approximately 3 and approximately 8
French.
8. The lead delivery system of claim 1 wherein the lumen has a
diameter of between approximately 0.014 and approximately 0.042
inch.
9. The lead delivery system of claim 1 wherein the catheter has a
length of between approximately 10 and approximately 20
centimeters.
10. The lead delivery system of claim 1 wherein the guidewire has a
diameter of between approximately 0.012 and approximately 0.040
inch and a length of between approximately 10 and approximately 40
centimeters.
11. A lead delivery system for delivering a neurostimulation lead
to a patient's internal jugular vein using a percutaneous stick,
the system comprising: a neurostimulation lead adapted to stimulate
a vagus nerve from the internal jugular vein, the lead including a
proximal end, a distal end, a retaining structure configured to
retain the lead in the internal jugular vein interposed between the
proximal and distal ends, and a side port interposed between the
retaining structure and the proximal end, the side port providing
access to a lumen extending from the distal end to the side port; a
guidewire sized to fit within the side port and lumen and reduce a
force exerted by the retaining structure against a surface external
to the retaining structure, thereby facilitating advancement and
orientation of the lead; and a catheter having a lumen sized to
slideably receive the medical electrical lead and configured to
provide access to the internal jugular vein from the percutaneous
stick site.
12. The lead delivery system of claim 11 wherein the surface
external to the retaining structure is the catheter.
13. The lead delivery system of claim 11 wherein the surface
external to the retaining structure is the internal jugular
vein.
14. The lead delivery system of claim 11 wherein the retaining
structure has a spiral, dual spiral, or stent-like structure.
15. A method of directly delivering a neurostimulation lead to a
patient's internal jugular vein, the method comprising: inserting a
catheter into the internal jugular vein using a percutaneous stick;
inserting a guidewire into a side port and through a lumen of a
neurostimulation lead, the neurostimulation lead including a
proximal end, a distal end, a retaining structure interposed
between the proximal and distal ends, and an electrode coupled to
the retaining structure, wherein the side port is interposed
between the retaining structure and the proximal end and the lumen
extends from the distal end to the side port; advancing a portion
of the neurostimulation lead through the catheter and orienting the
lead to a desired position in the internal jugular vein; and
removing the catheter and the guidewire.
16. The method of claim 15 wherein advancing a portion of the
neurostimulation lead comprises retaining a portion of the
retaining structure in the catheter and orienting the lead
comprises turning the catheter.
17. The method of claim 15 wherein advancing a portion of the
neurostimulation lead comprises retaining all of the retaining
structure in the catheter and orienting the lead comprises turning
the catheter.
18. The method of claim 15 wherein advancing a portion of the
neurostimulation lead comprises advancing the retaining structure
beyond a distal end of the catheter and orienting the lead
comprises turning the lead.
19. The method of claim 15 further comprising reducing a force
exerted by the retaining structure against a surface external to
the retaining structure by inserting the guidewire through the
lumen.
20. The method of claim 15 wherein orienting the lead comprises
orienting the electrode so the electrode is adjacent to a vagus
nerve.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is related to the following co-pending and
co-owned applications: DUAL SPIRAL LEAD CONFIGURATIONS, filed on
the same day and assigned Ser. No. ______; ELECTRODE CONFIGURATIONS
FOR TRANSVASCULAR NERVE STIMULATION, filed on the same day and
assigned Ser. No. ______; SPIRAL CONFIGURATIONS FOR INTRAVASCULAR
LEAD STABILITY, filed on the same day and assigned Ser. No. ______;
METHOD AND APPARATUS FOR DELIVERING A TRANSVASCULAR LEAD, filed on
the same day and assigned Ser. No. ______; NEUROSTIMULATING LEAD
HAVING A STENT-LIKE ANCHOR, filed on the same day and assigned Ser.
No. ______; TRANSVASCULAR LEAD WITH PROXIMAL FORCE RELIEF, filed on
the same day and assigned Ser. No. ______; and SIDE PORT LEAD
DELIVERY SYSTEM, filed on the same day and assigned Ser. No.
______, all herein incorporated by reference in their entirety.
TECHNICAL FIELD
[0002] The present invention relates to medical electrical leads
for nerve or muscle stimulation. The present invention more
particularly relates to a system for direct delivery of a
neurostimulation lead into an internal jugular vein and adjacent to
a vagus nerve.
BACKGROUND
[0003] A significant amount of research has been directed both to
the direct and indirect stimulation of nerves including the left
and right vagus nerves, the sympathetic and parasympathetic nerves,
the phrenic nerve, the sacral nerve, and the cavernous nerve to
treat a wide variety of medical, psychiatric, and neurological
disorders or conditions. More recently, stimulation of the vagus
nerve has been proposed as a method for treating various heart
conditions, including heart failure. Heart failure is a cardiac
condition characterized by a deficiency in the ability of the heart
to pump blood throughout the body and high filling pressure causing
pulmonary fluid to build up in the lungs.
[0004] Typically, nerve stimulating electrodes are cuff- or
impalement-type electrodes placed in direct contact with the nerve
to be stimulated. These electrodes require surgical implantation
and can cause irreversible nerve damage due to swelling or direct
mechanical damage to the nerve. A less invasive approach is to
stimulate the nerve through an adjacent vessel using an
intravascular lead. A lead including one or more electrodes is
inserted into a patient's vasculature and delivered to a site
within a vessel adjacent a nerve to be stimulated.
[0005] Intravascular leads can be implanted using an over-the-wire
technique where the lead includes a lumen extending the length of
the lead and the lead is advanced over a guidewire to the desired
location in the vein. Current over-the-wire leads, however, have
lumens extending the length of the lead. This requires threading of
the entire lead over the wire and results in a larger than
desirable lead diameter. Furthermore, the lead generally travels an
extensive distance through the vasculature, which requires
navigability and flexibility of the lead. Thus, there is a need in
the art for an intravascular medical electrical lead that can be
implanted using an over-the-wire technique, yet does not require a
lumen extending the length of the lead. There is also a need in the
art for a lead that can be delivered directly to a desired location
in the vasculature.
SUMMARY
[0006] In one embodiment, the invention is a lead delivery system
for delivering a neurostimulation lead to a patient's internal
jugular vein using a percutaneous stick. The system comprises a
neurostimulation lead adapted to stimulate a vagus nerve from the
internal jugular vein. The lead includes a proximal end, a distal
end, a generally spiral shaped retaining structure interposed
between the proximal and distal ends and configured to retain the
lead in the internal jugular vein, an electrode coupled to the
retaining structure, and a side port interposed between the
retaining structure and the proximal end. The side port provides
access to a lumen extending from the distal end to the side port. A
guidewire is sized to fit within the side port and lumen and reduce
a force exerted by the retaining structure against the internal
jugular vein, thereby allowing rotation of the lead and orientation
of the electrode by applying a torque to the lead. A catheter has a
lumen sized to slideably receive the medical electrical lead and is
configured to provide access to the internal jugular vein from the
percutaneous stick site.
[0007] In another embodiment, the present invention is a lead
delivery system for delivering a neurostimulation lead to a
patient's internal jugular vein using a percutaneous stick. The
system comprises a neurostimulation lead adapted to stimulate a
vagus nerve from the internal jugular vein, the lead including a
proximal end, a distal end, a retaining structure configured to
retain the lead in the internal jugular vein interposed between the
proximal and distal ends, and a side port interposed between the
retaining structure and the proximal end. The side port provides
access to a lumen extending from the distal end to the side port. A
guidewire is sized to fit within the side port and lumen and reduce
a force exerted by the retaining structure against a surface
external to the retaining structure, thereby facilitating
advancement and orientation of the lead. A catheter has a lumen
sized to slideably receive the medical electrical lead and is
configured to provide access to the internal jugular vein from the
percutaneous stick site.
[0008] In another embodiment, the present invention is a method of
directly delivering a neurostimulation lead to a patient's internal
jugular vein. The method comprises inserting a catheter into the
internal jugular vein using a percutaneous stick. A guidewire is
inserted into a side port and through a lumen of a neurostimulation
lead. The neurostimulation lead includes a proximal end, a distal
end, a retaining structure interposed between the proximal and
distal ends, and an electrode coupled to the retaining structure.
The side port is interposed between the retaining structure and the
proximal end and the lumen extends from the distal end to the side
port. A portion of the neurostimulation lead is advanced through
the catheter and the lead is oriented to a desired position in the
internal jugular vein. The catheter and guidewire are removed.
[0009] 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.
Accordingly, the drawings and detailed description are to be
regarded as illustrative in nature and not restrictive.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 is a schematic view of a patient's upper torso.
[0011] FIG. 2 is a schematic view of a medical electrical lead
according to one embodiment of the present invention.
[0012] FIG. 3 is a schematic view of a catheter according to one
embodiment of the present invention.
[0013] FIG. 4 is a schematic view of a guidewire according to one
embodiment of the present invention.
[0014] FIG. 5 is a schematic view of a guidewire inserted into a
medical electrical lead according to one embodiment of the present
invention.
[0015] FIG. 6 is a schematic view of a catheter after insertion
into an internal jugular vein according to one embodiment of the
present invention.
[0016] FIG. 7 is a schematic view of a medical electrical lead and
guidewire inserted into a catheter according to one embodiment of
the present invention.
[0017] FIG. 8 is a schematic view of a medical electrical lead
located in a patient's internal jugular vein after removal of the
catheter and guidewire according to one embodiment of the present
invention.
[0018] FIG. 9 is a flowchart illustrating an exemplary method of
implanting a medical electrical lead into an internal jugular vein
according to one embodiment of the present invention.
[0019] While the invention is amenable to various modifications and
alternative forms, specific embodiments have been shown by way of
example in the drawings and are described in detail below. The
intention, however, is not to limit the invention to the particular
embodiments described. On the contrary, the invention is intended
to cover all modifications, equivalents, and alternatives falling
within the scope of the invention as defined by the appended
claims.
DETAILED DESCRIPTION
[0020] FIG. 1 shows a schematic view of a patient's upper torso,
including a heart 10 and the veins of the neck 12 and thorax 14.
The subclavian veins 16 drain blood from the arms 18. The internal
jugular veins 20 drain blood from the head 22 and join the
subclavian veins 16 to form the brachiocephalic or innominate veins
24. The union of the brachiocephalic veins 24 forms the superior
vena cava 26, which returns blood from the head 22, neck 12, arms
18, and thorax 14 to the right atrium 28. A vagus nerve 30 is shown
adjacent to the right internal jugular vein 20. Another vagus nerve
(not shown) is adjacent to the left internal jugular vein 20. A
stimulating device 32 is located in a subcutaneous pocket near the
patient's subclavian vein. The stimulating device 32 is connected
to a medical electrical lead 40. A portion of the medical
electrical lead 40 extends through the internal jugular vein 20 and
the remainder is subcutaneously tunneled to the stimulating device
32. In one embodiment, the stimulating device 32 provides
electrical stimulation to a nerve.
[0021] FIG. 2 is a schematic view of the medical electrical lead 40
of FIG. 1. The medical electrical lead 40 includes a lead body 42
comprised of an electrically insulative material 43 extending from
a proximal end 44 to a distal end 46. The proximal end 44 is
adapted for connection to the stimulating device 32 using
connectors or any other means known in the art. A retaining
structure 48 adapted to exert a force against a surface external to
the retaining structure 48 is located at the distal end 46. In one
embodiment, the retaining structure 48 exerts a force against the
internal jugular vein 20. In another embodiment, the retaining
structure 48 exerts a force against the catheter 60. In yet another
embodiment, the retaining structure 48 exerts a force against both
the catheter 60 and the internal jugular vein 20. The force exerted
by the retaining structure 48 against the internal jugular vein 20
helps retain the electrodes 50 against the internal jugular vein 20
and adjacent to the vagus nerve 30. The retaining structure 48 also
stabilizes the lead 40 within the internal jugular vein 20.
[0022] In the illustrated embodiment, the retaining structure 48
has a generally spiral shape. In one embodiment, the retaining
structure 48 has a spiral shape as disclosed in U.S. patent
application Ser. No. ______, filed ______, ______, 2007, entitled
SPIRAL CONFIGURATIONS FOR INTRAVASCULAR LEAD STABILITY,
above-incorporated by reference in its entirety. In an alternative
embodiment, the retaining structure 48 has the form of a dual
spiral as disclosed in U.S. patent application Ser. No. ______,
filed ______, ______, 2007, entitled DUAL SPIRAL LEAD
CONFIGURATIONS, above-incorporated by reference in its entirety. In
another embodiment, the retaining structure 48 has the stent-like
structure disclosed in U.S. patent application Ser. No. ______,
filed ______, ______, 2007, entitled NEUROSTIMULATING LEAD HAVING A
STENT-LIKE ANCHOR, above-incorporated by reference in its entirety.
In other embodiments, the retaining structure 48 has any shape that
retains an electrode against a vessel.
[0023] The retaining structure 48 can be formed using molded
silicone parts, metal conductor coils, heat formed polyurethane
tubing, or any other method known in the art. The retaining
structure 48 can have a variety of cross-sectional shapes,
including circular or oval. In one embodiment, the retaining
structure 48 is a spiral having a pitch of between approximately 0
and approximately 5 centimeters. In an alternative embodiment, the
retaining structure 48 is a spiral having a diameter of between
approximately 5 and approximately 50 millimeters. In another
alternative embodiment, the retaining structure 48 has a length of
between approximately 30 and approximately 200 millimeters.
[0024] Electrodes 50 are located at the distal end 46. In the
embodiment shown in FIG. 2, the electrodes 50 are coupled to the
retaining structure 48. The electrodes 50 can provide electrical
stimulation, sense electrical activity, or both. The lead 40
includes conductive members (not shown) coupling electrodes 50 to
the stimulating device 32. Although two electrodes 50 are shown in
FIG. 2, the medical electrical lead 40 can include any number of
electrodes 50. In the embodiment illustrated in FIG. 2, the
electrodes 50 are ring electrodes. In other embodiments, the
electrodes have any other configuration known in the art. In one
embodiment, the electrodes 50 are configured according to commonly
assigned U.S. patent application Ser. No. ______, filed ______,
______, 2007, entitled ELECTRODE CONFIGURATIONS FOR TRANSVASCULAR
NERVE STIMULATION, above-incorporated by reference in its
entirety.
[0025] A side port 52 communicates with and provides access to a
lumen 54 extending from the distal end 46 to the side port 52. As
shown in FIG. 2, the lumen 54 extends out of the tip 47 of the
medical electrical lead 40 and terminates at the side port 52. In
another embodiment, the lumen 54 extends beyond the side port 52.
In another embodiment, the lumen 54 extends substantially the
length of the medical electrical lead 40. In yet another
embodiment, the lumen 54 extends the length of the medical
electrical lead 40. In one embodiment, the lumen 54 is separate
from a lumen formed by a conductive coil member. In another
embodiment, all or a portion of the lumen 54 is formed by a
conductive coil member lumen. In yet another embodiment, the lumen
54 is formed from multiple serial lumens. The lumen 54 can extend
through the lead body 42 or through silicone or polyurethane molded
parts in the lead 40. In one embodiment, the electrodes 50 are ring
electrodes having insulated lumens and the lumen 54 is at least
partially formed from the insulated electrode lumens. In another
embodiment, the electrodes 50 are only partially exposed and the
lumen 54 passes through the electrodes 50.
[0026] The side port 52 is interposed between the retaining
structure 48 and the proximal end 44. In one embodiment, the side
port 52 is located a maximum of approximately 5 centimeters from
the retaining structure 48. In one embodiment, the lead 40 has a
length of between about 40 and about 100 centimeters and a diameter
of between about 3 and about 8 French. In one embodiment, the lumen
54 has a diameter of between about 0.014 and about 0.042 inch.
[0027] FIG. 3 depicts an introducer or catheter 60 used to provide
access to the internal jugular vein 20. The catheter 60 has a
proximal end 62, a distal end 64, and a lumen 66. The catheter 60
is sized to slideably receive the medical electrical lead 40 in the
lumen 66 after insertion of the guidewire 70 into the lead 40 (as
shown in FIG. 7). In one embodiment, the catheter 60 is configured
to provide access to the internal jugular vein 20 via percutaneous
stick. The catheter 60 can be made of a polytetrafluoroethylene
(PTFE) or fluoronated ethylene propylene (FEP) inner lining, a 304
V stainless steel braiding, and an outer jacket of Pebax and/or
Nylon. Tungsten wire can optionally be added to the stainless steel
braiding to improve radiopacity of the catheter. In other
embodiments, the catheter 60 is made out of any other material
known in the art. In one embodiment, the catheter 60 has a length
of between about 10 and about 20 centimeters, an outer diameter of
between about 6 and about 14 French, and an inner diameter that is
slightly smaller than the outer diameter. In one embodiment, the
inner diameter is about 0.020 inch smaller than the outer
diameter.
[0028] FIG. 4 depicts a guidewire 70 according to one embodiment of
the present invention. In the illustrated embodiment, the guidewire
70 has a proximal end 74, a distal end 76, and a distal tip 78. The
guidewire 70 allows a clinician to introduce and position a medical
electrical lead 40 in a patient. In one embodiment, the guidewire
70 has a core (not shown), and includes a coating, for example, a
hydrophilic coating. In one embodiment, the wire core is made from
nickel/titanium. In an alternative embodiment, the wire core is
made from stainless steel. In yet another alternative embodiment,
the wire core is made from any other metal known in the art. The
guidewire 70 has an outer diameter that allows it to slide into the
side port 52 and through the lumen 54 of the medical electrical
lead 40. In one embodiment, the guidewire 70 has a diameter of
between approximately 0.012 and approximately 0.040 inch. In one
embodiment, the guidewire 70 includes a grind profile. In one
embodiment, the grind profile is parabolic. In another embodiment,
the guidewire 70 has a length of between about 10 and about 40
centimeters.
[0029] FIG. 5 illustrates the medical electrical lead 40 after
insertion of the guidewire 70 into the side port 52 and lumen 54.
In one embodiment, the lead 40 is advanced over the guidewire 70
during implantation. In another embodiment, the guidewire 70
straightens the retaining structure 48 enough to reduce the force
exerted on the internal jugular vein 20 by the retaining structure
48, thereby facilitating implantation of the lead 40. Although the
medical electrical lead 40 is shown as straight after the insertion
of the guidewire 70 in the illustrated embodiment, in another
embodiment, the guidewire 70 does not completely straighten the
retaining structure 48. The guidewire 70 is used to advance the
medical electrical lead 40 through the catheter 60 and to a desired
location in the internal jugular vein 20.
[0030] FIG. 6 is a schematic view showing the catheter 60 inserted
into the internal jugular vein 20. The catheter 60 provides access
to the internal jugular vein 20 for the lead 40. FIG. 7 is a
cutaway view showing the medical electrical lead 40 and guidewire
70 after advancement through the catheter 60 and into the internal
jugular vein 20. As shown in FIG. 8, after the catheter 60 and
guidewire 70 are removed, the retaining structure 48 retains the
distal end 46 of the lead 40 in the internal jugular vein 20. In
one embodiment, the retaining structure 48 retains the electrodes
50 in a location adjacent to the vagus nerve 30. In one embodiment,
the remainder of the medical electrical lead 40 is subcutaneously
tunneled to the stimulating device 32.
[0031] In one embodiment, a suture 80 secures the distal end 46 of
the medical electrical lead 40 at the site of the percutaneous
stick. In another embodiment, a suture sleeve (not shown) can be
used to protect the lead body 42 when using a suture 80 to secure
the distal end 46. In yet another embodiment, an anchor or any
other securing means known in the art is used to secure the
proximal end 46 of the medical electrical lead 40.
[0032] FIG. 9 depicts an exemplary method 900 for implanting a
medical electrical lead 40. A catheter 60 is inserted into the
internal jugular vein 20 using a percutaneous stick (block 910). A
guidewire 70 (or stylet) is inserted into the side port 52 and
through the lumen 54 of the medical electrical lead 40 (block 920).
The lead 40 is advanced through the catheter 60 into the internal
jugular vein 20 and oriented to a desired position (block 930). The
guidewire 70 and catheter 60 are then removed (block 940). In one
embodiment, the lead 40 is advanced over the guidewire 70 and
through the catheter 60. In another embodiment, the lead 40 and the
guidewire 70 are advanced through the catheter 60 together.
[0033] The lead 40 can be advanced and oriented to a desired
position in a number of ways. For example, in one embodiment, a
portion of the retaining structure 48 is retained in the catheter
60 and the retaining structure 48 exerts a force against the
catheter 60. The lead 40 can be oriented by applying a torque to
the catheter 40 or to the lead body 42. In another embodiment, the
entire retaining structure 48 is retained in the catheter 60 and
the lead 40 is oriented by applying a torque to the catheter 40 or
to the lead body 42. In yet another embodiment, a guidewire 70
inserted into the side port 52 and lumen 54 of the lead 40
straightens the retaining structure 48 to reduce the force exerted
by the retaining structure 48 on the catheter 60. This force
reduction facilitates advancement of the lead 40 through the
catheter 60 and the internal jugular vein 20. The force reduction
also facilitates orientation of the lead 40 in the internal jugular
vein 20. In one embodiment, the lead 40 is advanced and oriented so
that the electrodes 50 are adjacent to the vagus nerve 30.
[0034] In another embodiment, the retaining structure 48 extends
beyond the distal end 64 of the catheter. The lead 40 is oriented
by applying a torque to the lead body 42. In one embodiment, the
guidewire 70 is used to reduce the force exerted by the retaining
structure 48 on the internal jugular vein 20 during implantation of
the lead 40. In another embodiment, the guidewire 70 is retracted
from the retaining structure 48, yet remains in a portion of the
lumen 54, thereby allowing for additional manipulation of the lead
40 using the guidewire 70.
[0035] In one embodiment, removal of the catheter 60 allows the
retaining structure 48 to further expand, causing the retaining
structure 48 to exert a greater force against the internal jugular
vein 20. In one embodiment, the catheter 60 is split or peeled
apart for removal. In another embodiment, the catheter 60 is slid
over the medical electrical lead 40. In one embodiment, a stylet is
inserted into the lumen 54 instead of a guidewire 70. In another
embodiment, the lumen 54 does not extend out of the tip 47 of the
medical electrical lead 40 and a stylet (not shown) is used to push
the lead 40 to the desired position in the internal jugular vein
20. In yet another embodiment, the method 900 includes securing the
distal end 46 of the lead 40 at the stick site using a suture 80.
In another embodiment, the remainder of the lead 40 is
subcutaneously tunneled to a stimulating device 32.
[0036] The invention allows for direct delivery of the medical
electrical lead 40 into the internal jugular vein 20 without
threading the guidewire 70 through the entire length of the lead
40. It is easier to exchange guidewires 70, if necessary, because
the guidewire 70 is not threaded through the entire length of the
lead 40. Additionally, the lead 40 is more easily turned because
instead of turning the entire length of the lead 40, a shorter
length may be turned. In one embodiment, the lead 40 is turned by
applying a torque to the lead body 42 at a region near the side
port 52.
[0037] Although the present invention has been described in
reference to an internal jugular vein, the invention could also be
used to implant a lead 40 in any vessel, such as a vein, artery,
lymphatic duct, bile duct, for the purposes of nerve or muscle
stimulation. The medical electrical lead 40 can include any number
of conductors, electrodes, terminal connectors, and insulators, and
can be used with any combination of catheters, introducers,
guidewires, and stylets.
[0038] Various modifications and additions can be made to the
exemplary embodiments discussed without departing from the scope of
the present invention. For example, while the embodiments described
above refer to particular features, the scope of this invention
also includes embodiments having different combinations of features
and embodiments that do not include all of the described features.
Accordingly, the scope of the present invention is intended to
embrace all such alternatives, modifications, and variations as
fall within the scope of the claims, together with all equivalents
thereof.
* * * * *