U.S. patent application number 16/108443 was filed with the patent office on 2019-01-03 for leadless cardiac pacing devices including tissue engagement verification.
This patent application is currently assigned to Cardiac Pacemakers, Inc.. The applicant listed for this patent is Cardiac Pacemakers, Inc.. Invention is credited to John M. Edgell, Benjamin J. Haasl, Dana Sachs, Brian L. Schmidt.
Application Number | 20190001119 16/108443 |
Document ID | / |
Family ID | 53051967 |
Filed Date | 2019-01-03 |
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United States Patent
Application |
20190001119 |
Kind Code |
A1 |
Schmidt; Brian L. ; et
al. |
January 3, 2019 |
LEADLESS CARDIAC PACING DEVICES INCLUDING TISSUE ENGAGEMENT
VERIFICATION
Abstract
An implantable leadless cardiac pacing device including a
housing having a proximal end and a distal end, an electrode
positioned proximate the distal end of the housing configured to be
positioned adjacent cardiac tissue, and a tissue anchoring member
extending from the distal end of the housing configured to secure
the housing to cardiac tissue. The device further includes a tissue
engagement verification feature configured to provide feedback upon
engagement of the tissue anchoring member in cardiac tissue.
Inventors: |
Schmidt; Brian L.; (White
Bear Lake, MN) ; Haasl; Benjamin J.; (Forest Lake,
MN) ; Edgell; John M.; (Plymouth, MN) ; Sachs;
Dana; (Pine City, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Cardiac Pacemakers, Inc. |
St Paul |
MN |
US |
|
|
Assignee: |
Cardiac Pacemakers, Inc.
St. Paul
MN
|
Family ID: |
53051967 |
Appl. No.: |
16/108443 |
Filed: |
August 22, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
14698537 |
Apr 28, 2015 |
10080887 |
|
|
16108443 |
|
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|
61985826 |
Apr 29, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 1/059 20130101;
A61B 6/12 20130101; A61N 1/3756 20130101; A61N 1/0573 20130101;
A61B 90/39 20160201; A61B 2090/3966 20160201; A61N 1/37205
20130101 |
International
Class: |
A61N 1/05 20060101
A61N001/05; A61N 1/375 20060101 A61N001/375; A61N 1/372 20060101
A61N001/372; A61B 90/00 20160101 A61B090/00; A61B 6/12 20060101
A61B006/12 |
Claims
1. An implantable leadless cardiac pacemaker comprising: a housing
having a proximal end and a distal end and defining an axis
therebetween; a first electrode positioned proximate the distal end
of the housing, the first electrode configured and adapted to be
positioned against and in electrical contact with cardiac tissue; a
second electrode located on the housing and electrically isolated
from the first electrode; a helical tissue anchor extending from
the distal end of the housing, the helical tissue anchor configured
and adapted to be inserted into the cardiac tissue to secure the
housing to the cardiac tissue; and a tissue engagement member
surrounding the helical tissue anchor, the tissue engagement member
being axially compressible from an axially extended configuration
to an axially contracted configuration upon engagement with the
cardiac tissue, wherein a distal end of the tissue engagement
member is movable relative to the helical tissue anchor and the
housing as the tissue engagement member is axially compressed from
the axially extended configuration to the axially contracted
configuration.
2. The implantable leadless cardiac pacemaker of claim 1, wherein
the tissue engagement member includes an annular ring at the distal
end thereof.
3. The implantable leadless cardiac pacemaker of claim 2, wherein
the tissue engagement member includes one or deflectable struts
extending proximally from the annular ring.
4. The implantable leadless cardiac pacemaker of claim 2, wherein
the annular ring includes a radiopaque material providing visual
indication via fluoroscopy whether the tissue engagement member is
in the axially extended configuration or the axially contracted
configuration.
5. The implantable leadless cardiac pacemaker of claim 1, wherein
the axially extended configuration of the tissue engagement member
is an equilibrium position.
6. The implantable leadless cardiac pacemaker of claim 1, wherein
the tissue engagement member is disposed coaxially around the
helical tissue anchor.
7. The implantable leadless cardiac pacemaker of claim 1, wherein
the helical tissue anchor surrounds the first electrode.
8. The implantable leadless cardiac pacemaker of claim 3, wherein
the helical tissue anchor extends distally beyond the tissue
engagement member in the axially contracted configuration.
9. An implantable leadless cardiac pacemaker comprising: a housing
having a proximal end and a distal end and defining an axis
therebetween; a first electrode positioned proximate the distal end
of the housing, the first electrode configured and adapted to be
positioned against and in electrical contact with cardiac tissue; a
second electrode located on the housing and electrically isolated
from the first electrode; a helical tissue anchor extending from
the distal end of the housing, the helical tissue anchor configured
and adapted to be screwed into the cardiac tissue to secure the
housing to the cardiac tissue; and a tissue engagement member
surrounding the helical tissue anchor, the tissue engagement member
having a proximal end secured to the housing and an opposite distal
end; wherein the distal end of the tissue engagement member is
configured to engage the cardiac tissue as the helical tissue
anchor is screwed into the cardiac tissue;
10. The implantable leadless cardiac pacemaker of claim 9, wherein
the distal end of the tissue engagement member is axially
displaceable relative to the helical tissue anchor and the
housing.
11. The implantable leadless cardiac pacemaker of claim 10, wherein
the distal end of the tissue engagement member is axially movable
from an axially extended configuration in which the distal end of
the tissue engagement member is positioned a first axial distance
from the distal end of the housing to an axially contracted
configuration in which the distal end of the tissue engagement
member is positioned a second axial distance from the distal end of
the housing, the second axial distance being less than the first
axial distance.
12. The implantable leadless cardiac pacemaker of claim 11, wherein
the axially extended configuration is an equilibrium position of
the tissue engagement member.
13. The implantable leadless cardiac pacemaker of claim 9, wherein
the tissue engagement member coaxially surrounds the helical tissue
anchor.
14. The implantable leadless cardiac pacemaker of claim 9, wherein
the helical tissue anchor surrounds the first electrode.
15. The implantable leadless cardiac pacemaker of claim 9, wherein
the distal end of the tissue engagement member is configured to
press against the cardiac tissue when the helical tissue anchor is
screwed into the cardiac tissue.
16. The implantable leadless cardiac pacemaker of claim 9, wherein
the tissue engagement member includes an annular ring at the distal
end thereof.
17. The implantable leadless cardiac pacemaker of claim 16, wherein
the tissue engagement member includes one or deflectable struts
extending proximally from the annular ring.
18. The implantable leadless cardiac pacemaker of claim 16, wherein
the annular ring includes a radiopaque material providing visual
indication via fluoroscopy whether the tissue engagement member is
in engagement with the cardiac tissue.
19. A method of implanting a leadless cardiac pacemaker, the method
comprising: advancing a leadless cardiac pacemaker into a chamber
of a heart while contained within the distal end of a delivery
catheter, the leadless cardiac pacemaker including a housing having
a distal end and a proximal end; screwing a helical tissue anchor
extending from the distal end of the housing into cardiac tissue to
secure the leadless cardiac pacemaker to the cardiac tissue;
axially compressing a tissue engagement member of the leadless
cardiac pacemaker from an axially extended configuration to an
axially contracted configuration via engagement of a distal end of
the tissue engagement member with the cardiac tissue as the helical
tissue anchor is being screwed into the cardiac tissue; and
removing the delivery catheter from the chamber of the heart.
20. The method of claim 19, wherein the tissue engagement member
surrounds the helical tissue anchor.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation application of
U.S. patent application Ser. No. 14/698,537, filed Apr. 28, 2015,
which claims the benefit of U.S. Provisional Application Ser. No.
61/985,826, filed Apr. 29, 2014, the disclosures of which are
incorporated herein in their entirety.
TECHNICAL FIELD
[0002] The present disclosure pertains to medical devices, and
methods for manufacturing medical devices. More particularly, the
present disclosure pertains to leadless cardiac pacing devices
including tissue engagement verification features.
BACKGROUND
[0003] Cardiac pacemakers provide electrical stimulation to heart
tissue to cause the heart to contract and thus pump blood through
the vascular system. Conventional pacemakers typically include an
electrical lead that extends from a pulse generator implanted
subcutaneously or sub-muscularly to an electrode positioned
adjacent the inside or outside wall of the cardiac chamber. As an
alternative to conventional pacemakers, self-contained or leadless
cardiac pacemakers have been proposed. Leadless cardiac pacemakers
are small capsules typically including bipolar pacing/sensing
electrodes, a power source (e.g. a battery), and associated
electrical circuitry for controlling the pacing/sensing electrodes,
and thus provide electrical stimulation to heart tissue and/or
sense a physiological condition. The small capsule is typically
fixed to an intracardiac implant site in a cardiac chamber with a
fixation mechanism engaging the intracardiac tissue.
[0004] Accordingly, it is desirable to provide alternative
structures to facilitate verification of sufficient engagement of
the fixation mechanism into the intracardiac tissue to ensure the
leadless cardiac pacemaker is secured to the intracardiac
tissue.
SUMMARY
[0005] The disclosure is directed to several alternative designs,
materials and methods of manufacturing medical device structures
and assemblies, and uses thereof.
[0006] Accordingly one illustrative embodiment is an implantable
leadless cardiac pacing device including a housing having a
proximal end and a distal end, an electrode positioned proximate
the distal end of the housing configured to be positioned adjacent
cardiac tissue, and a tissue anchoring member extending from the
distal end of the housing configured to secure the housing to
cardiac tissue. The device further includes a tissue engagement
verification feature configured to provide feedback upon engagement
of the tissue anchoring member in cardiac tissue.
[0007] Another illustrative embodiment is an implantable leadless
cardiac pacing device including a housing having a proximal end and
a distal end, an electrode positioned proximate the distal end of
the housing configured to be positioned adjacent cardiac tissue,
and a tissue anchoring member extending from the distal end of the
housing configured to secure the housing to cardiac tissue. The
device further includes a radiopaque marker movable relative to the
housing and a radiopaque reference point stationary relative to the
housing. Displacement of the radiopaque marker relative to the
radiopaque reference point provides visual feedback of engagement
of the tissue anchoring member in cardiac tissue.
[0008] Yet another illustrative embodiment is a method of
implanting a leadless cardiac pacing device. The method includes
advancing the leadless cardiac pacing device into a chamber of a
heart. A tissue anchoring member of the leadless cardiac pacing
device is then engaged into cardiac tissue. While engaging the
tissue anchor member into the cardiac tissue, displacement of a
radiopaque marker of the leadless cardiac pacing device relative to
a radiopaque reference point is fluoroscopically observed to
confirm engagement of the tissue anchoring member in cardiac
tissue.
[0009] The above summary of some example embodiments is not
intended to describe each disclosed embodiment or every
implementation of the aspects of the disclosure.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] The disclosure may be more completely understood in
consideration of the following detailed description in connection
with the accompanying drawings, in which:
[0011] FIG. 1 is a plan view of an exemplary leadless pacing device
implanted within a heart;
[0012] FIG. 2 is a side view of an exemplary leadless pacing
device;
[0013] FIG. 2A is a distal end view of the leadless pacing device
shown in FIG. 2;
[0014] FIG. 2B is a proximal end view of the leadless pacing device
shown in FIG. 2;
[0015] FIGS. 3A-3C illustrate aspects of an exemplary method of
implanting the leadless pacing device shown in FIG. 2 into cardiac
tissue using a delivery catheter;
[0016] FIG. 4A is a side view of another exemplary leadless pacing
device;
[0017] FIG. 4B is a distal end view of the leadless pacing device
shown in FIG. 4A;
[0018] FIGS. 5A-5B illustrate aspects of an exemplary method of
implanting the leadless pacing device shown in FIG. 4A into cardiac
tissue using a delivery catheter;
[0019] FIG. 6A is a side view of another exemplary leadless pacing
device;
[0020] FIG. 6B is a distal end view of the leadless pacing device
shown in FIG. 6A;
[0021] FIGS. 7A-7B illustrate aspects of an exemplary method of
implanting the leadless pacing device shown in FIG. 6A into cardiac
tissue using a delivery catheter;
[0022] FIG. 8 is a side view of another exemplary leadless pacing
device; and
[0023] FIGS. 9A-9B illustrate aspects of an exemplary method of
implanting the leadless pacing device shown in FIG. 8 into cardiac
tissue using a delivery catheter.
[0024] While the disclosure is amenable to various modifications
and alternative forms, specifics thereof have been shown by way of
example in the drawings and will be described in detail. It should
be understood, however, that the intention is not to limit the
invention to the particular embodiments described. On the contrary,
the intention is to cover all modifications, equivalents, and
alternatives falling within the spirit and scope of the
disclosure.
DETAILED DESCRIPTION
[0025] For the following defined terms, these definitions shall be
applied, unless a different definition is given in the claims or
elsewhere in this specification.
[0026] All numeric values are herein assumed to be modified by the
term "about," whether or not explicitly indicated. The term "about"
generally refers to a range of numbers that one of skill in the art
would consider equivalent to the recited value (i.e., having the
same function or result). In many instances, the terms "about" may
include numbers that are rounded to the nearest significant
figure.
[0027] The recitation of numerical ranges by endpoints includes all
numbers within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3,
3.80, 4, and 5).
[0028] As used in this specification and the appended claims, the
singular forms "a", "an", and "the" include plural referents unless
the content clearly dictates otherwise. As used in this
specification and the appended claims, the term "or" is generally
employed in its sense including "and/or" unless the content clearly
dictates otherwise.
[0029] It is noted that references in the specification to "an
embodiment", "some embodiments", "other embodiments", etc.,
indicate that the embodiment described may include one or more
particular features, structures, and/or characteristics. However,
such recitations do not necessarily mean that all embodiments
include the particular features, structures, and/or
characteristics. Additionally, when particular features,
structures, and/or characteristics are described in connection with
one embodiment, it should be understood that such features,
structures, and/or characteristics may also be used connection with
other embodiments whether or not explicitly described unless
clearly stated to the contrary.
[0030] The following detailed description should be read with
reference to the drawings in which similar elements in different
drawings are numbered the same. The drawings, which are not
necessarily to scale, depict illustrative embodiments and are not
intended to limit the scope of the invention.
[0031] Cardiac pacemakers provide electrical stimulation to heart
tissue to cause the heart to contract and thus pump blood through
the vascular system. Conventional pacemakers typically include an
electrical lead that extends from a pulse generator implanted
subcutaneously or sub-muscularly to an electrode positioned
adjacent the inside or outside wall of the cardiac chamber. As an
alternative to conventional pacemakers, self-contained or leadless
cardiac pacemakers have been proposed. A leadless cardiac pacemaker
may take the form of a relatively small capsule that may be fixed
to an intracardiac implant site in a cardiac chamber. It can be
readily appreciated that the implantation of a leadless pacing
device within a beating heart can be difficult. Accordingly, it may
be desirable for a leadless pacing device to include a tissue
engagement verification feature to facilitate verification of
sufficient engagement of the fixation mechanism into the
intracardiac tissue to ensure the leadless cardiac pacemaker is
secured to the intracardiac tissue.
[0032] FIG. 1 illustrates an example implantable leadless cardiac
pacing device 10 implanted in a chamber of a heart H such as, for
example, the right ventricle RV. The device 10 may include a shell
or housing 12 having a distal region 14 and a proximal region 16.
One or more anchoring members 18 may be disposed adjacent to the
distal region 14. The anchoring member 18 may be used to attach the
device 10 to a tissue wall of the heart H, such as intracardiac
tissue, or otherwise anchor the implantable device 10 to the
anatomy of the patient. A docking member 20 may be disposed
adjacent to the proximal region 16 of the housing 12. The docking
member 20 may be utilized to facilitate delivery and/or retrieval
of the implantable device 10.
[0033] Some of the features of the device 10 can be seen in FIG. 2,
FIG. 2A, and FIG. 2B. For example, the device 10 may include a
first electrode 26 positioned adjacent to the distal region 14 of
the housing 12. A second electrode 28 may also be defined along the
housing 12. For example, the housing 12 may include a conductive
material and may be insulated along a portion of its length. A
section along the proximal region 16 may be free of insulation so
as to define the second electrode 28. The electrodes 26/28 may be
sensing and/or pacing electrodes to provide electro-therapy and/or
sensing capabilities. The first electrode 26 may be capable of
being positioned against or otherwise contact the cardiac tissue of
the heart H while the second electrode 28 may be spaced away from
the first electrode 26, and thus spaced away from the cardiac
tissue. The device 10 may also include a pulse generator (e.g.,
electrical circuitry) and a power source (e.g., a battery) within
the housing 12 to provide electrical signals to the electrodes
26/28. Electrical communication between the pulse generator and the
electrodes 26/28 may provide electrical stimulation to heart tissue
and/or sense a physiological condition.
[0034] The docking member 20 may include a head portion 22 and a
neck portion 24 extending between the housing 12 and the head
portion 22. The head portion 22 may be capable of engaging with a
delivery and/or retrieval catheter. For example, the head portion
22 may include a bore or opening 30 formed therein. The ends of the
bore 30 may be open or exposed while a central region of the bore
30 may be covered by a section the 34 of the head portion 22, for
example. During delivery, the device 10 may be secured to a
delivery device by extending a suture through the bore 30.
Additionally or alternatively, a portion of the delivery catheter
may include projections or lugs that may engage the bore 30. Some
additional details of example delivery devices for delivering the
device 10 to cardiac tissue are disclosed herein.
[0035] The docking member 20 may also be engaged if it is desired
to retrieve and/or reposition the device 10. For example, a
retrieval catheter may be advanced to a position adjacent to the
device 10. A retrieval mechanism such as a snare, tether, arm, or
other suitable structure may extend from the retrieval catheter and
engage the head portion 22. When suitably engaged, the device 10
may be pulled from the cardiac tissue and, ultimately, removed from
the patient or repositioned.
[0036] As the name suggests, the anchoring member 18 may be used to
anchor the device 10 to the target tissue. A suitable number of
anchoring members 18 may be used with the device 10. For example,
the device 10 may include one, two, three, four, five, six, seven,
eight, or more anchoring members. In at least some embodiments, the
anchoring member 18 may take the form of a helix or screw.
According to these embodiments, the anchoring member 18 may be
threaded or rotated into cardiac tissue. In other instances, the
anchoring member 18 may include one or more, or a plurality of
tines configured to be anchored into the cardiac tissue. Some
additional details of example mechanisms for threading/anchoring
the device 10 to cardiac tissue are disclosed herein.
[0037] It can be appreciated that in order to securely anchor the
device 10 to cardiac tissue with a helical anchoring member 18 or
other anchoring member, it may be desirable to provide
intraoperative verification of sufficient engagement of the
anchoring member 18 into the cardiac tissue to ensure the device 10
is secured to the cardiac tissue. Accordingly, the device 10 may
include one or more tissue engagement verification features to
provide the medical personnel intraoperative verification of the
degree of tissue engagement of the anchoring member 18 during the
implantation procedure. Thus, the tissue engagement verification
feature may be configured to provide feedback upon engagement of
the tissue anchoring member 18 in cardiac tissue. In some
embodiments, the tissue engagement verification feature may be
movable from a first position relative to the housing 12 to a
second position relative to the housing 12. In some instances, the
first position may be an equilibrium position, and the second
position may be a displaced position through application of an
external force, such as through contact with the cardiac tissue. In
some embodiments, the tissue engagement verification feature may be
arranged with the device 10 such that the tissue engagement
verification feature moves toward the proximal end of the housing
12 as the tissue engagement verification feature moves from the
first position to the second position. The tissue engagement
verification feature may include a radiopaque material to provide
intraoperative visual feedback via fluoroscopy during implantation
of the device 10 in the heart H. The radiopaque material of the
tissue engagement verification feature may be movable relative to
the housing 12, such that the movement of the tissue engagement
verification feature may be viewed using fluoroscopy during the
medical procedure. In some embodiments, the device 10 may include a
radiopaque reference point which is stationary relative to the
housing 12, such that displacement of the radiopaque material of
the tissue engagement verification feature relative to the
radiopaque reference point provides visual feedback of engagement
of the tissue anchoring member 18 in cardiac tissue.
[0038] One exemplary example of tissue engagement verification
features which can be included with the device 10 are illustrated
in FIG. 2, FIG. 2A and FIG. 2B. Tissue engagement verification
features 50 may be fixedly attached to the housing 12 of the device
10. In other words, the tissue engagement verification features 50
may be designed so that during typical use, the tissue engagement
verification features 50 remain attached to housing 12. In some
embodiments, the tissue engagement verification features 50 may
have some freedom of movement relative to the housing 10. For
example, the tissue engagement verification features 50 may be
capable of pivoting, rotating, or otherwise moving relative to
housing 12.
[0039] The form of the tissue engagement verification features 50
may vary. For example, the tissue engagement verification features
50 may take the form of tines 32 projecting from housing 12. In
some instances, the tines 32 may be symmetrically or asymmetrically
arranged around the perimeter of the housing 12 and extend radially
outward therefrom. The tines 32 may extend radially from the
housing 12 in a distal direction in a first, equilibrium position,
shown in FIG. 2.
[0040] The tines 32 may be doped with, made of, or otherwise
include a radiopaque material. In some instances, the tines 32 may
include a radiopaque marker 40, such as at a distal tip of the
tines 32, or along another portion of the tines 32. In other
instances, the tines 32, or a portion thereof, may be formed of a
radiopaque material or be doped with a radiopaque material, and
thus serve as the radiopaque marker. Radiopaque materials are
understood to be materials capable of producing a relatively bright
image on a fluoroscopy screen or another imaging technique during a
medical procedure. This relatively bright image aids the user of
the device 10 visualizing the radiopaque marker (e.g., the tine 32)
using fluoroscopy. Some examples of radiopaque materials can
include, but are not limited to, gold, platinum, palladium,
tantalum, tungsten alloy, polymer material loaded with a radiopaque
filler, and the like.
[0041] In some instances, the device 10 may also include a
radiopaque reference point 60 which is stationary relative to the
housing 12, or be included as part of the housing 12. For example
the radiopaque reference point 60 may be a radiopaque ring
surrounding the housing 12, or another radiopaque structure on the
housing 12, or the material forming the housing 12. Accordingly,
displacement of the radiopaque material of the tines 32 relative to
the radiopaque reference point 60 may provide visual feedback of
engagement of the tissue anchoring member 18 in cardiac tissue.
[0042] The tines 32 may have any desired cross-sectional shape,
such as a generally circular cross-sectional shape. In at least
some embodiments, the tines 32 may be substantially straight. In
other embodiments, the tines 32 may include one or more curves or
bends. A variety of other shapes, forms, and configurations are
also contemplated for the tines 32. In addition, some devices may
include combinations of differently shaped or oriented tines
32.
[0043] FIGS. 3A-3C illustrate aspects of an exemplary method of
implanting the leadless pacing device shown in FIG. 2 into cardiac
tissue using a delivery catheter 100. The catheter 100 may include
a proximal member or region 134 and a distal member or holding
section 136 configured to house the implantable device 10 during a
delivery procedure. A push member 138 may be disposed (e.g.,
slidably disposed) within the proximal region 134. A distal or head
region 139 of the push member 138 may be disposed within the distal
holding section 136. The head region 139 may be capable of engaging
the docking member 20 of the device 10. For example, the head
region 139 may include one or more lugs 140 that are capable of
engaging the bore 30 formed in the docking member 20. When the lugs
140 are engaged with the bore 30, the push member 138 may be
rotated to thread or rotate the anchor member 18 into a target
region 90 (e.g., a region of the heart such as the right
ventricle). In some embodiments, a holding member or suture 144 may
also extend through a lumen formed in the push member 138 and pass
through the bore 30 so as to secure the device 10 to the delivery
catheter 100 during portions or all of the delivery process.
[0044] The catheter 100 may be advanced through the vasculature to
target region 90, with the device 10 positioned in the distal
holding section 136 of the delivery catheter 100. For example, the
catheter 100 may be advanced through a femoral vein, into the
inferior vena cava, into the right atrium, through the tricuspid
valve, and into the right ventricle. The target region 90 may be a
portion of the right ventricle. For example, the target region 90
may be a portion of the right ventricle near the apex of the heart.
In other instances, however, the target region 90 may be in another
portion of the heart, such as in another chamber of the heart, for
example.
[0045] The device 10 may include the anchor member 18 and tissue
engagement verification features, such as the tines 32. During
advancement of the catheter 100 through the vasculature, the tines
32 may be oriented in the distal direction (e.g., toward the distal
end of the device 10 and/or distally from the device 10).
[0046] When the device 10 has been positioned proximate the target
region 90, the device 10 may be expelled from the distal holding
section 136, as shown in FIG. 3B. For example, the device 10 may be
rotated with the push member 138 such that the anchoring member 18
screws into the target region 90 of cardiac tissue. As the
anchoring member 18 is screwed into the target region 90, the
distal ends of the tines 32 may engage the target tissue 90.
Further rotation or screwing of the anchoring member into the
target tissue 90 may cause the tines 32 to move (e.g., deflect)
from the first position, shown in FIG. 3B to a second position,
shown in FIG. 3C. As the tines 32 move (e.g., deflect) via
engagement with the cardiac tissue 90, the free ends of the tines
32 may move toward the proximal end of the housing 12 as the tines
32 move from the first position to the second position. Visual
observation of the movement of the radiopaque material, such as the
radiopaque markers 40, of the tines 32 may provide intraoperative
visual feedback via fluoroscopy during implantation of anchoring
member 18 of the device 10 into the target region 90. In instances
in which the device 10 includes a radiopaque reference point 60
which is stationary relative to the housing 12, displacement of the
radiopaque material 40 of the tines 32 relative to the radiopaque
reference point 60 may provide visual feedback of engagement of the
tissue anchoring member 18 in the cardiac tissue 90. For example,
medical personnel may confirm that the tissue anchoring member 18
is sufficiently anchored in the cardiac tissue 90 when the
radiopaque material (e.g., radiopaque marker 40) of the tines 32
moves to a predetermined distance from the radiopaque reference
point 60 at the second position. The predetermined distance may be
less than the distance from the radiopaque reference point 60 at
the first position.
[0047] FIGS. 4A and 4B illustrate another illustrative example of a
tissue engagement verification feature 150 incorporated with the
implantable leadless cardiac pacing device 10. Tissue engagement
verification features 150 may be fixedly attached to the housing 12
of the device 10. In other words, the tissue engagement
verification features 150 may be designed so that during typical
use, the tissue engagement verification features 150 remain
attached to housing 12. In some embodiments, the tissue engagement
verification features 150 may have some freedom of movement
relative to the housing 10. For example, the tissue engagement
verification features 150 may be capable of pivoting, rotating, or
otherwise moving relative to housing 12.
[0048] The form of the tissue engagement verification features 150
may vary. For example, the tissue engagement verification features
150 may take the form of a compressible member, such as an open
wound coil 132. The open wound coil 132 is shown coaxial with the
helical tissue anchoring member 18, with the open wound coil 132
surrounding the tissue anchoring member 18. However, in other
embodiments, the open wound coil 132 may be positioned within the
helical tissue anchoring member 18, or otherwise disposed. The open
wound coil 132 may extend distally from the distal end of the
housing 12, for example.
[0049] The open wound coil 132 may be constructed such that
adjacent windings of the open wound coil 132 are spaced apart a
first distance when in a first, uncompressed position, and move
closer together with an applied force (e.g., a second, compressed
position), such as upon engagement of the open wound coil 132 with
cardiac tissue.
[0050] The open wound coil 132 may be doped with, made of, or
otherwise include a radiopaque material. In some instances, only a
discrete portion of the open wound coil 132 may include a
radiopaque material, such as at a distal tip of the open wound coil
132, or along another portion of the open wound coil 132, and thus
serve as a radiopaque marker. In other instances, the entire open
wound coil 132 may be formed of a radiopaque material or be doped
with a radiopaque material, and thus serve as a radiopaque marker.
Radiopaque materials are understood to be materials capable of
producing a relatively bright image on a fluoroscopy screen or
another imaging technique during a medical procedure. This
relatively bright image aids the user of the device 10 visualizing
the radiopaque open wound coil 132 using fluoroscopy. Some examples
of radiopaque materials can include, but are not limited to, gold,
platinum, palladium, tantalum, tungsten alloy, polymer material
loaded with a radiopaque filler, and the like.
[0051] In some instances, the device 10 may also include a
radiopaque reference point which is stationary relative to the
housing 12, or be included as part of the housing 12. Accordingly,
displacement of the radiopaque open wound coil 132 relative to the
radiopaque reference point of the housing 12 (e.g., compression of
the open wound coil 132) may provide visual feedback of engagement
of the tissue anchoring member 18 in cardiac tissue.
[0052] FIGS. 5A and 5B illustrate aspects of an exemplary method of
implanting the leadless pacing device shown in FIGS. 4A and 4B into
cardiac tissue using the delivery catheter 100. The delivery
catheter 100, previously described above, may include a distal
member or holding section 136 configured to house the implantable
device 10 during a delivery procedure. Additional features of the
delivery catheter 100 have been described above.
[0053] The catheter 100 may be advanced through the vasculature to
target region 90, with the device 10 positioned in the distal
holding section 136 of the delivery catheter 100. For example, the
catheter 100 may be advanced through a femoral vein, into the
inferior vena cava, into the right atrium, through the tricuspid
valve, and into the right ventricle. The target region 90 may be a
portion of the right ventricle. For example, the target region 90
may be a portion of the right ventricle near the apex of the heart.
In other instances, however, the target region 90 may be in another
portion of the heart, such as in another chamber of the heart, for
example.
[0054] The device 10 may include the anchor member 18 and tissue
engagement verification features, such as the open wound coil 132.
During advancement of the catheter 100 through the vasculature, the
open wound coil 132, which may extend distally from the distal end
of the housing 12, may be in a first, uncompressed position with
adjacent windings spaced from one another.
[0055] When the device 10 has been positioned proximate the target
region 90, the device 10 may be expelled from the distal holding
section 136, as shown in FIG. 5B. For example, the device 10 may be
rotated with the push member 138 such that the anchoring member 18
screws into the target region 90 of cardiac tissue. As the
anchoring member 18 is screwed into the target region 90, the
distal end of the open wound coil 132 may engage the target tissue
90. Further rotation or screwing of the anchoring member into the
target tissue 90 may cause the open wound coil 132 to compress from
the first position, shown in FIG. 5A to a second, compressed
position, shown in FIG. 5B. In some instances, the open wound coil
132 may be wound in an opposite direction than the helical tissue
anchoring member 18 such that rotation of the device 10 with the
distal end of the open wound coil 132 against the cardiac tissue 90
will not cause the open wound coil 132 to penetrate into the
cardiac tissue 90, but rather remain against the surface of the
cardiac tissue 90. As the distal end of the coil 132 moves
proximally relative to the housing 12 (e.g., compresses) via
engagement with the cardiac tissue 90, the spacing between adjacent
windings of the open wound coil 132 will be reduced. Visual
observation of the movement of the radiopaque material, such as the
compression of the open wound coil 132, and thus the diminution of
the spacing between adjacent windings, may provide intraoperative
visual feedback via fluoroscopy during implantation of anchoring
member 18 of the device 10 into the target region 90. For example,
medical personnel may confirm that the tissue anchoring member 18
is sufficiently anchored in the cardiac tissue 90 when the open
wound coil 132 is compressed a predetermined amount and/or the
distal end of the open wound coil 132 moves proximally relative to
the housing 12 a predetermined amount at the second position.
[0056] FIGS. 6A and 6B illustrate another illustrative example of a
tissue engagement verification feature 250 incorporated with the
implantable leadless cardiac pacing device 10. Tissue engagement
verification features 250 may be fixedly attached to the housing 12
of the device 10. In other words, the tissue engagement
verification features 250 may be designed so that during typical
use, the tissue engagement verification features 250 remain
attached to housing 12. In some embodiments, the tissue engagement
verification features 250 may have some freedom of movement
relative to the housing 10. For example, the tissue engagement
verification features 250 may be capable of pivoting, rotating, or
otherwise moving relative to housing 12.
[0057] The form of the tissue engagement verification features 250
may vary. For example, the tissue engagement verification features
250 may take the form of a compressible member, such as one or
more, or a plurality of deflectable struts 232. The annular ring
240 is shown coaxial with the helical tissue anchoring member 18,
with the annular ring 240 surrounding the tissue anchoring member
18. However, in other embodiments, the annular ring 240 may be
positioned within the helical tissue anchoring member 18, or
otherwise disposed. The struts 232 may extend distally from the
distal end of the housing 12, for example. The struts 232 may have
a proximal end secured to the housing 12 and a distal end secured
to the annular ring 240, for example.
[0058] The struts 232 may be configured to deflect, bend, collapse,
or otherwise be altered to move the ends of the struts toward one
another, when subjected to an external force. The struts 232 may be
formed of a flexible material. For example, the struts 232 may be
made from a metal, metal alloy, polymer (some examples of which are
disclosed below), a metal-polymer composite, combinations thereof,
and the like, or other suitable material. Some examples of suitable
metals and metal alloys include stainless steel, such as 304V,
304L, and 316LV stainless steel, a nickel-titanium alloy such as
linear-elastic and/or super-elastic nitinol, other nickel alloys.
Some examples of suitable polymers may include elastomeric
polyamides, polyurethane, polyether block amide (PEBA, for example
available under the trade name PEBAX.RTM.), ethylene vinyl acetate
copolymers (EVA), silicones, polyethylene (PE), as well as other
suitable materials, or mixtures, combinations, copolymers thereof,
and the like.
[0059] The tissue engagement verification feature 250 may be
constructed such that the distal ends of the struts 232 and/or the
annular ring 240 is positioned a first distance from the distal end
of the housing 12 when in a first, uncompressed position, and the
distal ends of the struts 232 and/or the annular ring 240 is
positioned a second distance (e.g., a second, compressed position),
less than the first distance (e.g., moved proximally toward the
distal end of the housing 12), with an applied force, such as upon
engagement of the distal ends of the struts 232 and/or the annular
ring 240 with cardiac tissue.
[0060] The struts 232 and/or the annular ring 240 may be doped
with, made of, or otherwise include a radiopaque material, and thus
serve as a radiopaque marker. For example, the annular ring 240 may
be formed of a radiopaque material or be doped with a radiopaque
material, and thus serve as a radiopaque marker. Radiopaque
materials are understood to be materials capable of producing a
relatively bright image on a fluoroscopy screen or another imaging
technique during a medical procedure. This relatively bright image
aids the user of the device 10 visualizing the radiopaque annular
ring 240 using fluoroscopy. Some examples of radiopaque materials
can include, but are not limited to, gold, platinum, palladium,
tantalum, tungsten alloy, polymer material loaded with a radiopaque
filler, and the like.
[0061] In some instances, the device 10 may also include a
radiopaque reference point which is stationary relative to the
housing 12, or be included as part of the housing 12. For example
the radiopaque reference point 60 may be a radiopaque ring
surrounding the housing 12, or another radiopaque structure on the
housing 12, or the material forming the housing 12. Accordingly,
displacement of the radiopaque material of the struts 232 and/or
the annular ring 240 relative to the radiopaque reference point 60
may provide visual feedback of engagement of the tissue anchoring
member 18 in cardiac tissue.
[0062] FIGS. 7A and 7B illustrate aspects of an exemplary method of
implanting the leadless pacing device shown in FIGS. 6A and 6B into
cardiac tissue using the delivery catheter 100. The delivery
catheter 100, previously described above, may include a distal
member or holding section 136 configured to house the implantable
device 10 during a delivery procedure. Additional features of the
delivery catheter 100 have been described above.
[0063] The catheter 100 may be advanced through the vasculature to
target region 90, with the device 10 positioned in the distal
holding section 136 of the delivery catheter 100. For example, the
catheter 100 may be advanced through a femoral vein, into the
inferior vena cava, into the right atrium, through the tricuspid
valve, and into the right ventricle. The target region 90 may be a
portion of the right ventricle. For example, the target region 90
may be a portion of the right ventricle near the apex of the heart.
In other instances, however, the target region 90 may be in another
portion of the heart, such as in another chamber of the heart, for
example.
[0064] The device 10 may include the anchor member 18 and tissue
engagement verification features, such as the tissue engagement
verification feature 250 including the struts 232 and/or annular
ring 240. During advancement of the catheter 100 through the
vasculature, the struts 232, which may extend distally from the
distal end of the housing 12, may be in a first, uncompressed
position positioning the distal ends of the struts 232 and/or
annular ring 240 a first distance from the distal end of the
housing 12.
[0065] When the device 10 has been positioned proximate the target
region 90, the device 10 may be expelled from the distal holding
section 136, as shown in FIG. 7B. For example, the device 10 may be
rotated with the push member 138 such that the anchoring member 18
screws into the target region 90 of cardiac tissue. As the
anchoring member 18 is screwed into the target region 90, the
distal end of the tissue engagement verification feature 250, such
as the distal ends of the struts 232 and/or the annular ring 240,
may engage the target tissue 90. Further rotation or screwing of
the anchoring member into the target tissue 90 may cause the struts
232 to deflect, bend, collapse or otherwise be altered from the
first position, shown in FIG. 7A to a second, compressed position,
shown in FIG. 7B. As the distal ends of the struts 232 move
proximally relative to the housing 12 (e.g., compress) via
engagement with the cardiac tissue 90, the annular ring 240 will
move closer to the distal end of the housing 12. Visual observation
of the movement of the radiopaque material, such as the distal ends
of the struts 232 and/or the annular ring 240, in relation to the
radiopaque reference point (e.g., the housing 12 or a marker on the
housing 12), may provide intraoperative visual feedback via
fluoroscopy during implantation of anchoring member 18 of the
device 10 into the target region 90. For example, medical personnel
may confirm that the tissue anchoring member 18 is sufficiently
anchored in the cardiac tissue 90 when the distal ends of the
struts 232 and/or the annular ring 240 move proximally a
predetermined amount to the second position, such that the distal
ends of the struts 232 and/or the annular ring 240 are positioned a
predetermined distance from the distal end of the housing 12.
[0066] FIG. 8 illustrates another illustrative example of a tissue
engagement verification feature 350 incorporated with the
implantable leadless cardiac pacing device 10, such as incorporated
with the helical anchoring member 18. The form of the tissue
engagement verification feature 350 may vary. For example, the
tissue engagement verification feature 350 may take the form of a
movable member, such as a bead 340 slidably disposed on the helical
anchoring member 18. The bead 340 is shown surrounding the helical
tissue anchoring member 18. However, in other embodiments, the bead
340, or other movable member, may be otherwise slidably coupled to
the helical tissue anchoring member 18, or otherwise disposed. In
some instances, the helical tissue anchoring member 18 may include
a stop 342 located distal of the bead 340 to prevent disengagement
of the bead 340 from the tissue anchoring member 18. In some
instances, the stop 342 may include an annular rim, a ridge, bump
or other feature configured to contact the bead 340 at a distalmost
end of travel of the bead 340 along the tissue anchoring member 18.
The bead 340 may be configured to travel proximally along the
helical anchoring member 18 from the distalmost end of travel
defined by the stop 342.
[0067] The tissue engagement verification feature 350 may be
constructed such that the bead 340 is positioned on the helical
tissue anchoring member 18 at a first distance from the distal end
of the housing 12 when in a first position, and the bead 340 is
movable along the tissue anchoring structure 18 such that the bead
340 is positioned a second distance less than the first distance in
a second position, as the tissue engagement member 18 is screwed
into cardiac tissue.
[0068] The bead 340 may be doped with, made of, or otherwise
include a radiopaque material, and thus serve as a radiopaque
marker. For example, the bead 340 may be formed of a radiopaque
material or be doped with a radiopaque material, and thus serve as
a radiopaque marker. Radiopaque materials are understood to be
materials capable of producing a relatively bright image on a
fluoroscopy screen or another imaging technique during a medical
procedure. This relatively bright image aids the user of the device
10 visualizing the radiopaque bead 340 using fluoroscopy. Some
examples of radiopaque materials can include, but are not limited
to, gold, platinum, palladium, tantalum, tungsten alloy, polymer
material loaded with a radiopaque filler, and the like.
[0069] In some instances, the device 10 may also include a
radiopaque reference point which is stationary relative to the
housing 12, or be included as part of the housing 12. For example
the radiopaque reference point 60 may be a radiopaque ring
surrounding the housing 12, or another radiopaque structure on the
housing 12, or the material forming the housing 12. Accordingly,
displacement of the radiopaque bead 340 relative to the radiopaque
reference point 60 may provide visual feedback of engagement of the
tissue anchoring member 18 in cardiac tissue.
[0070] FIGS. 9A and 9B illustrate aspects of an exemplary method of
implanting the leadless pacing device shown in FIG. 8 into cardiac
tissue using the delivery catheter 100. The delivery catheter 100,
previously described above, may include a distal member or holding
section 136 configured to house the implantable device 10 during a
delivery procedure. Additional features of the delivery catheter
100 have been described above.
[0071] The catheter 100 may be advanced through the vasculature to
target region 90, with the device 10 positioned in the distal
holding section 136 of the delivery catheter 100. For example, the
catheter 100 may be advanced through a femoral vein, into the
inferior vena cava, into the right atrium, through the tricuspid
valve, and into the right ventricle. The target region 90 may be a
portion of the right ventricle. For example, the target region 90
may be a portion of the right ventricle near the apex of the heart.
In other instances, however, the target region 90 may be in another
portion of the heart, such as in another chamber of the heart, for
example.
[0072] The device 10 may include the anchor member 18 and tissue
engagement verification features, such as the tissue engagement
verification feature 350 including the bead 340 slidably coupled to
the helical anchoring member 18. During advancement of the catheter
100 through the vasculature, the bead 340, which may be positioned
proximate the stop 342, may be in a first position positioning the
bead 340 a first distance from the distal end of the housing
12.
[0073] When the device 10 has been positioned proximate the target
region 90, the device 10 may be expelled from the distal holding
section 136, as shown in FIG. 7B. For example, the device 10 may be
rotated with the push member 138 such that the anchoring member 18
screws into the target region 90 of cardiac tissue. As the
anchoring member 18 is screwed into the target region 90, the bead
340 may engage the target tissue 90, and slide along the anchoring
member 18. Further rotation or screwing of the anchoring member
into the target tissue 90 may cause the bead 340 to move along the
anchoring member 18 from the first position, shown in FIG. 9A to a
second position, shown in FIG. 9B. As the anchoring member 18 is
screwed into the target tissue 90, the bead 340 moves proximally
relative to the housing 12 along the anchoring member 18 via
engagement with the cardiac tissue 90. Visual observation of the
movement of the radiopaque material, such as the bead 340, in
relation to the radiopaque reference point (e.g., the housing 12 or
a marker 60 on the housing 12), may provide intraoperative visual
feedback via fluoroscopy during implantation of anchoring member 18
of the device 10 into the target region 90. For example, medical
personnel may confirm that the tissue anchoring member 18 is
sufficiently anchored in the cardiac tissue 90 when the bead 340
moves proximally a predetermined amount to the second position,
such that the bead 340 is positioned a predetermined distance from
the distal end of the housing 12.
[0074] It should be understood that this disclosure is, in many
respects, only illustrative. Changes may be made in details,
particularly in matters of shape, size, and arrangement of steps
without exceeding the scope of the disclosure. This may include, to
the extent that it is appropriate, the use of any of the features
of one example embodiment being used in other embodiments. The
invention's scope is, of course, defined in the language in which
the appended claims are expressed.
Additional Examples
[0075] A first example is an implantable leadless cardiac pacing
device including a housing having a proximal end and a distal end,
an electrode positioned proximate the distal end of the housing
configured to be positioned adjacent cardiac tissue, and a tissue
anchoring member extending from the distal end of the housing
configured to secure the housing to cardiac tissue. The device
further includes a tissue engagement verification feature
configured to provide feedback upon engagement of the tissue
anchoring member in cardiac tissue.
[0076] Additionally or alternatively, in a second example, the
tissue engagement verification feature is movable from a first
position relative to the housing to a second position relative to
the housing.
[0077] Additionally or alternatively, in a third example, the first
position is an equilibrium position, and the second position is a
displaced position through application of an external force.
[0078] Additionally or alternatively, in a fourth example, the
tissue engagement verification feature moves toward the proximal
end of the housing as the tissue engagement verification feature
moves from the first position to the second position.
[0079] Additionally or alternatively, in a fifth example, the
tissue engagement verification feature includes a radiopaque
material to provide visual feedback via fluoroscopy.
[0080] Additionally or alternatively, in a sixth example, the
radiopaque material is movable relative to the housing.
[0081] Additionally or alternatively, a seventh example includes
radiopaque reference point which is stationary relative to the
housing, wherein displacement of the radiopaque material relative
to the radiopaque reference point provides visual feedback of
engagement of the tissue anchoring member in cardiac tissue.
[0082] Additionally or alternatively, in an eighth example, the
tissue engagement verification feature includes one or more tines
configured to deflect upon engagement with cardiac tissue.
[0083] Additionally or alternatively, in a ninth example, the
tissue engagement verification feature includes a compressible
member configured to compress upon engagement with cardiac
tissue.
[0084] Additionally or alternatively, in a tenth example, the
compressible member includes an open wound coil.
[0085] Additionally or alternatively, in an eleventh example,
adjacent windings of the open wound coil move closer together upon
engagement of the open wound coil with cardiac tissue.
[0086] Additionally or alternatively, in a twelfth example, the
compressible member includes one or more deflectable struts.
[0087] Additionally or alternatively, in a thirteenth example, the
one or more deflectable struts extend between the distal end of the
housing to a ring comprising a radiopaque material.
[0088] Additionally or alternatively, in a fourteenth example, the
tissue engagement verification feature includes a radiopaque member
configured to move along the tissue anchoring member upon
engagement with cardiac tissue.
[0089] Additionally or alternatively, in a fifteenth example, the
radiopaque member includes a bead slidable along tissue anchoring
member.
* * * * *