U.S. patent application number 16/897574 was filed with the patent office on 2020-09-24 for lead delivery for his-bundle pacing.
The applicant listed for this patent is Pugazhendhi Vijayaraman, MD, Terrell M. Williams. Invention is credited to Pugazhendhi Vijayaraman, MD, Terrell M. Williams.
Application Number | 20200298009 16/897574 |
Document ID | / |
Family ID | 1000005073977 |
Filed Date | 2020-09-24 |
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United States Patent
Application |
20200298009 |
Kind Code |
A1 |
Williams; Terrell M. ; et
al. |
September 24, 2020 |
Lead Delivery for His-Bundle Pacing
Abstract
A guiding catheter and method of its use are presented wherein
the catheter includes an elongate catheter shaft having a proximal
region and a distal region and a length. The shaft defines a distal
region and includes a distal tip. The distal region defines an arc
of approximately 180 degrees and having a radius of 0.3 inches to
0.6 inches. The distal tip forms a half turn of a left-hand helix
having a pitch of 0 inches to 0.4 inches. The unique shape of the
distal region allows the distal tip be perpendicularly aligned with
the septal wall of the right atrium at the His bundle location when
the catheter is advanced therein.
Inventors: |
Williams; Terrell M.;
(Brooklyn Park, MN) ; Vijayaraman, MD; Pugazhendhi;
(Mountain Top, PA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Williams; Terrell M.
Vijayaraman, MD; Pugazhendhi |
Brooklyn Park
Mountain Top |
MN
PA |
US
US |
|
|
Family ID: |
1000005073977 |
Appl. No.: |
16/897574 |
Filed: |
June 10, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
15267195 |
Sep 16, 2016 |
10737097 |
|
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16897574 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 2001/0585 20130101;
A61M 25/0068 20130101; A61M 2210/125 20130101; A61N 1/37518
20170801; A61M 25/0041 20130101; A61N 1/0573 20130101; A61M 25/0662
20130101; A61N 1/372 20130101 |
International
Class: |
A61N 1/372 20060101
A61N001/372; A61N 1/375 20060101 A61N001/375; A61M 25/00 20060101
A61M025/00; A61M 25/06 20060101 A61M025/06; A61N 1/05 20060101
A61N001/05 |
Claims
1. A method comprising: inserting a catheter into a right
subclavian vein of a patient, the catheter comprising: an elongate
catheter shaft having a proximal region and a distal region along a
length of the catheter, the catheter shaft defining a lumen
extending along the length of the catheter, the catheter shaft
having a default shape wherein the distal region forms a hook
including a curve, wherein the distal region terminates at a distal
tip of the catheter shaft; and advancing the catheter along the
right subclavian vein and into a superior vena cava and finally
into a right atrium of a heart of the patient such that, with the
proximal region braced by a wall of the superior vena cava, the
distal region returns to the default shape, the default shape of
the distal region causing the distal tip of the catheter to align
itself against a septal wall of the right atrium corresponding to a
target site.
2. The method of claim 1, further comprising: advancing a pacing
lead through the lumen of the catheter to the target site; and
implanting the pacing lead through the septal wall and into a
septum at the target site.
3. The method of claim 2, further comprising removing the catheter
from the patient following implantation of the pacing lead.
4. The method of claim 1, wherein the proximal region includes a
bend in the default shape, the bend in the default shape turning in
an opposing direction relative to the curve of the distal region,
and wherein the proximal region further includes a substantially
straight portion having a length of approximately 2.0 inches to 4.0
inches, and extending from a distal end of the bend to a proximal
end of the curve of the distal region.
5. The method of claim 4, wherein the bend of the proximal region
encourages perpendicular alignment of the distal tip with the
target site.
6. The method of claim 4, wherein the bend of the proximal region
is defined by a portion of the catheter shaft having a radius of
approximately 2.0 inches to 4.0 inches and a length of
approximately 2.0 inches to 4.0 inches.
7. The method of claim 6, wherein the substantially straight
portion has a length of approximately 3.0 inches to 4.0 inches.
8. The method of claim 7, wherein the radius of the portion of the
catheter shaft defining the bend is approximately 2.5 inches to 3.5
inches, and wherein the length of the bend is approximately 2.5
inches to 3.5 inches.
9. The method of claim 1, wherein the proximal region is
substantially straight in the default shape.
10. The method of claim 9, wherein a bracing affect provided by the
wall of the superior vena cava imbues the proximal region with a
bend.
11. The method of claim 10, wherein the bend of the proximal region
cooperates with the curve of the distal region to perpendicularly
orient the distal tip with the septal wall.
12. The method of claim 1, wherein the curve of the distal region
has a radius of 0.3 inches to 0.6 inches, and wherein the curve of
the distal region has a pitch between 0.1 and 0.4 inches.
13. The method of claim 12, wherein the radius is approximately
0.35 inches to 0.45 inches, and wherein the pitch is approximately
0.25 inches to 0.35 inches.
14. The method of claim 1, wherein the curve of the distal region
defines an arc of approximately 180 degrees.
15. The method of claim 1, wherein an outer diameter of the
catheter shaft is between 6 French and 14 French.
16. The method of claim 1, wherein an outer diameter of the
catheter shaft is between 6 French and 7.5 French.
17. The method of claim 1, wherein the curve of the distal region
includes a left-hand helix.
18. The method of claim 1, further comprising threading a guidewire
through the lumen of the catheter shaft, wherein inserting the
catheter into the right subclavian vein of the patient includes
inserting the guidewire and the catheter into the right subclavian
vein.
19. The method of claim 1, wherein the default shape of the distal
region causes the distal tip of the catheter to align itself in a
substantially perpendicular orientation against the septal wall of
the right atrium corresponding to the target site.
20. The method of claim 1, wherein the target site is a region of
the septal wall corresponding to and containing a bundle of
HIS.
21. A method comprising: advancing a pacing lead through a lumen of
an elongate catheter shaft, the lumen extending along a length of
the catheter shaft, with a distal tip of the catheter shaft at a
target site at a septal wall within a right atrium of a heart of a
patient, wherein the catheter shaft includes a proximal region and
a distal region adjacent to the proximal region, the catheter shaft
having a default shape wherein the distal region forms a hook
including a curve, wherein the distal region terminates at the
distal tip of the catheter shaft, wherein the proximal region of
the catheter shaft extends through a right subclavian vein and into
a superior vena cava, and wherein the proximal region is braced by
a wall of the superior vena cava such that the default shape of the
distal region aligns the distal tip of the catheter against the
septal wall of the right atrium at the target site; and implanting
the pacing lead, via the distal tip, through a region of the septal
wall corresponding to and containing a bundle of HIS.
Description
RELATED APPLICATION
[0001] This application claims priority to U.S. patent application
Ser. No. 15/267,195, filed Sep. 16, 2016, which is incorporated by
reference herein.
FIELD OF THE INVENTION
[0002] Embodiments of this disclosure relate to catheters and
treatment methods using such catheters to deliver a pacing lead to
the bundle of His by way of right side access to the heart through
the right subclavian vein.
BACKGROUND
[0003] Guiding catheters are well known devices used to locate and
cannulate vessels for a variety of medical procedures. They are of
particular use in cardiac access procedures such as those involved
in the implantation of cardiac pacing leads. Cardiac pacing leads
are flexible, and historically, stylets have been inserted into the
lumen of hollow leads to stiffen and allow the lead to be bent to
aid in lead placement. Stylets are still in common use but are
inadequate to provide precise control to reach and place a lead at
the small target His bundle. Typically, when right side approach is
desired it involves accessing the heart via the left subclavian
vein, the cephalic vein and more rarely the internal or external
jugular vein, or femoral vein. For catheter lead placement, a guide
wire is advanced into the heat from the access site. The guiding
catheter is then advanced through the vasculature and into the
heart over the guidewire; once in position the guidewire is
removed. A pacing lead is then advanced through the guiding
catheter to be deployed at various regions in the heart.
[0004] Typically, pacing leads are deployed to various locations in
the heart depending on the nature of the heart condition
necessitating the pacing procedure. Conventional ventricular pacing
typically involves implanting a lead at the apex of the right
ventricle. This placement is still often utilized today even in the
face of published evidence of the deleterious effects of bypassing
the His/Purkinje system, otherwise known as the cardiac conduction
system.
[0005] Pacemaker lead electrodes have been placed in or on the
heart in a position that bypasses the His/Purkinje system since the
inception of pacing in 1957. Directly stimulating the myocardium is
and has been the standard of care even though His bundle pacing has
been known and tried occasionally. It is believed that His bundle
pacing is not widely practiced because it presents a small target
and is very hard to reach successfully. This increases "fluro time"
which is a detriment to both patient and physician. Another factor
is that there is no wide recognition of the value of His pacing. At
present there is a paucity of catheters that can facilitate His
bundle pacing. When, for various reasons, the pacemaker must be
implanted on the patient's right side and right subclavian vein
used to reach the heart the target is still the myocardium and not
the His bundle. It should be noted for completeness that the His
bundle is accessed on the atrial aspect of the annulus of the
tricuspid valve, just above the attachment of the septal valve
leaflet.
[0006] The present disclosure describes embodiments of a catheter
and method for its use in delivering a pacing lead to the His
bundle at the septal wall. The cardiac conduction system is
comprised in part of His bundle which resides between the
atrioventricular (AV) node, and the bifurcation of left bundle
branch (LBB) and right bundle branch (RBB). This anatomic location
is regarded as a difficult target to reach. Embodiments of the
present invention have overcome this difficulty.
SUMMARY
[0007] Embodiments of the present disclosure are directed to a
unique guiding catheter configuration which allows for the precise
delivery of pacing leads to the septal wall of the right atrium,
above the anterior tricuspid valve septal leaflet, in proximity to
the His bundle and from a right side approach to the heart. The
catheter interacts with the anatomy to allow both precise and quick
access to the His bundle as it presents in the right heart.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1 is a cross-sectional illustration of a human heart
depicting the anatomy of the heart and its electrical system.
[0009] FIG. 2 is a cross-sectional illustration of a human heart
wherein an embodiment of a guide catheter is shown advanced to a
target site within the central fibrous body, between the tricuspid
valve and the aortic valve and corresponding to the bundle of
his.
[0010] FIG. 3 is an anatomical illustration of a patient and the
manner in which the embodiment shown in FIG. 2 initially accesses
the vasculature prior to advancement into the heart.
[0011] FIG. 4 is a detailed view of the distal region and tip of
the catheter shown in FIGS. 2 and 3 at the target site.
[0012] FIG. 5 is a perspective view of the catheter embodiment
shown in FIGS. 2-4 in its preformed or default shape prior to
insertion into a patient.
[0013] FIG. 6 is a side view of the catheter embodiment shown in
FIG. 5 illustrating the angle of the distal tip relative to the
plane defined by the proximal region of the catheter.
[0014] FIG. 7 is a cross-sectional view of the catheter embodiment
shown in FIGS. 5-6.
[0015] FIG. 8 is a side perspective view of an alternative
embodiment of the catheter shown in FIG. 5 having a pre-formed bend
in the proximal region of the catheter shaft.
DETAILED DESCRIPTION
[0016] For contextual understanding, of how embodiments of the
disclosure are intended to function, FIG. 1 is included to
illustrate the structure of a typical human heart 1 with relevant
anatomical features shown. As mentioned, one embodiment of the
disclosure is directed to a method for deploying an electrical lead
to the His bundle 2 at a target site 10 along the septum 3 distal
to the atrioventricular (AV) node 4, but proximal to the left
branch bundle (LBB) 5 and the right branch bundle (RBB) 6. Such a
target site 10 for proper deployment of a pacing lead, is depicted
in FIG. 1 at the crest of the ventricular septum 3 on the atrial
aspect of the annulus of the tricuspid valve septal leaflet 7
within the right atrium 8. The remaining FIGS. 2-7 depict
embodiments of a catheter suitable for accessing the heart and
reaching the target site 10 and the manner in which such a catheter
is used.
[0017] An example of a catheter 20 suitable for use in reaching the
target site 10 from the subclavian vein is illustrated in FIGS.
2-7.
[0018] FIG. 2 is the schematic diagram of FIG. 1 in which a distal
portion or end region 22 of delivery catheter 20 is shown extending
into the right atrium 8 of the heart 1, from the superior vena cava
9 and the right subclavian vein 11, with the distal tip 24
positioned at the target site 10.
[0019] According to one method, an operator/physician positions
guide wire 50 into the heart 1, for example via a "sub-clavian
stick" or central venous access procedure such as is illustrated in
FIG. 3. Accordingly, the catheter 20 is passed over the guide wire
and-advanced into the superior vena cava 9 from the right
subclavian vein 11 and into the right atrium 8 such as is in the
manner shown in FIG. 2. A wall 12 of the superior vena cava 9
provides back-up support for distal portion 22 as the operator
maneuvers tip 24 into a proper substantially perpendicular
orientation with the septum 3 at the target site 10, such as in the
manner shown in FIG. 4.
[0020] In FIG. 4, a close up view of the distal tip 24 is shown
following advancement of medical electrical lead 30 though a lumen
26 of the catheter 20 to the target site 10. The lead 30 is
extended distally from distal tip 24 and implanted into the septum
3 by clockwise rotation of the lead body to provide pacing to the
heart 1 via the bundle of his 2.
[0021] As is shown in FIG. 2, the wall 12 of the superior vena cava
9 acts to provide a stabilizing surface or brace for distal portion
22 so as to direct and force the shaft 28 of the catheter 20 into
the right atrium 8 from the subclavian vein 11. Wall 12 forces a
specialized zone of the catheter 20 to bend with the shape of the
superior vena cava 9. Because the default or at rest shape of the
catheter 20 included a unique shape for aligning the distal tip 24
with the target site 10 (discussed in greater detail below), a
guidewire 50 may be advanced through the lumen 26 to aid in
tracking the catheter 20 through the confines of the vessel
anatomy. Once the distal region 22 of the catheter 20 is within the
right atrium 8 the guidewire 50 is removed.
[0022] The bracing affect provided by the vessel wall 12 imbues the
proximal region 23 of the catheter 20 with a proximal bend 25. This
bend 25 cooperates with the unique shape of the distal region 22
such that once the catheter 20 is advanced from the subclavian vein
11, and through the superior vena cava 9 and into the right atrium
8 the catheter tip 24 is automatically positioned to be
perpendicularly oriented with the septum 3 wall in the area of the
target site 10 such as in the manner shown in FIG. 4.
[0023] As indicated, the shape if the catheter 20 is unique. The
catheter 20, such as is shown in FIGS. 5-7 is an elongate shaft 28,
which defines a central lumen 26 extending along its length, and
having a substantially straight proximal region ("straight" meaning
without bend, or having a curve of essentially infinite radius) 23
and a curved distal region 22. The distal region 22 is of
specialized shape and construction wherein a specific shape and
curve is provided to the distal region 22. As described above, this
pre-formed shape cooperates with surrounding venous and heart
anatomy, to ensure proper orientation and positioning of the distal
tip 24 at the target site 10 when the catheter 20 is advanced into
the right atrium 8 such as by the right side access procedure shown
in FIGS. 2 and 3. It should also be noted that in some embodiments,
the catheter 20 such as is shown in FIGS. 5-7 may also be suitable
for use in a left side access electrode implantation procedure such
as is described in U.S. Pat. No. 8,606,369, issued on Dec. 10,
2013, the entire contents of which is incorporated herein by
reference.
[0024] The particular shape of the distal region 22, is illustrated
in FIG. 5 wherein it may be seen that the catheter 20 in an "at
rest" state (prior to use) has a substantially straight proximal
region 23 and a distal region 22 forming a semi-circular hook or
J-shape. The shape of the distal region 22 defines a centerline
radius a of approximately 180 degrees with a radius (indicated by
line 40) of approximately 0.3-0.6 inches, as measured from the axis
44 of the catheter 20. In at least one embodiment the radius 40 is
0.4 inches. In at least one embodiment radius 40 is 0.5 inches.
[0025] In addition, and as is shown in FIG. 6, the distal tip 24
forms the half turn of a left-hand helix having a pitch 47 of zero
inches to about 0.4 inches as measured from the distal tip 24 to
the plane 46 defined by the surface of the proximal region 23 in
the at rest state and adjacent to the distal region 22. In at least
one embodiment the pitch 46 is 0.3 inches.
[0026] In an alternative embodiment to that in FIGS. 5-6, catheter
20 is provided with a proximal bend 25 when in the pre-insertion or
default formed state. The embodiment shown in FIG. 8 is distinct
from that shown in FIG. 5, as the embodiment shown in FIG. 5
requires the anatomy of the superior vena cava 9 and associated
anatomy to imbue the proximal region 23 of the catheter 20 with the
bend 25, whereas in the embodiment shown in FIG. 8 the proximal
region 23 of the catheter 25 is formed with a bend 25, and which is
apparent even in the pre-insertion state shown.
[0027] The particular characteristic of the bend 25, is that it has
a radius 48 of approximately 2.0 inches to 4.0 inches, along a
length 49 of the proximal region 23 of approximately 2.0 inches to
4.0 inches as well. In at least one embodiment, the radius 48 is
approximately 3.0 inches and the length 49 is also approximately
3.0 inches. The bend 25 begins at a point approximately 3.0 inches
to 4.0 inches distally from the distal region 22; that is to say, a
substantially straight portion 45 of the proximal region 23 extends
3.0 to 4.0 inches between the distal end of the bend 25 and the
distal region 22 of the catheter 20. In at least one embodiment the
length of the substantially straight portion 45 is approximately
3.5 inches.
[0028] In the embodiment shown in FIG. 8 the pitch 47 of the distal
tip 24, may be the same as that in other embodiments and range from
zero to about 0.4 inches; and in at least one embodiment is 0.3
inches. The depiction of this pitch 47 is identical to that shown
in the embodiment of FIGS. 5-6.
[0029] In the embodiment shown in FIG. 8 the bend 25 provides a
shape that encourages the catheter 20 to advance through and around
the anatomy of the right subclavian vein and superior vena cava
with less resistance and ease of advancement in some anatomies. The
preformed bend 25 also encourages perpendicular alignment of the
distal tip 24 with the target site 10 as described above (and
below) and shown in FIG. 4.
[0030] For purposes of describing the shape of the catheter 20,
here the terms "approximately" and "substantially" are used to take
into account minor machine and formation tolerances. When the
values mentioned above are measured with normal instruments readily
available to one of ordinary skill in the art such as a protractor
or ruler the describe values will be accurate.
[0031] The particular combination of the curvature of the distal
region 22 and the out of plane angle of the distal tip 24 enables
the catheter 20 to form a perpendicular angle .gamma. with the
septum 3 such as in the manner shown in FIG. 4. The ability of the
catheter 20 to form a perpendicular angle relative to the septum 3
provides an idealized approach angle for the implantation of the
electrical lead 30, which makes it easier for the helical screw of
the lead 30 to bite into the tough endocardial membrane of the
septum 3 and more easily seat therein. Once the lead 30 is properly
implanted into the septum 3 at the target site 10, the catheter is
removed.
[0032] By more accurately positioning the lead 30 at the target
site 10, and more readily penetrating into the septum 3, the
catheter 20 provides for a safer procedure and a total implant
procedure time and fluoroscopy time that is feasible and acceptable
to pacemaker implanters. In addition, by positioning the lead 30 in
the manner described the lead is more effectively seated within
septum to more efficiently pace the bundle of his. Published
studies find a mean pacing capture thresholds that is one volt
lower than the mean threshold of 2.5 volts that is reported using
prior catheters, those not capable of perpendicular electrode
placement.
[0033] The many features and advantages of the invention are
apparent from the above description. Numerous modifications and
variations will readily occur to those skilled in the art. Since
such modifications are possible, the invention is not to be limited
to the exact construction and operation illustrated and described.
Rather, the present invention should be limited only by the
following claims.
* * * * *