U.S. patent application number 15/234299 was filed with the patent office on 2016-12-15 for method of reducing the occurrence of arrhythmias via photobiomodulation and apparatus for same.
The applicant listed for this patent is St. Jude Medical, Atrial Fibrillation Division, Inc.. Invention is credited to Anders Bjorling, Cecilia Emanuelsson, Karin Jarverud, Kjell Noren.
Application Number | 20160361562 15/234299 |
Document ID | / |
Family ID | 46829084 |
Filed Date | 2016-12-15 |
United States Patent
Application |
20160361562 |
Kind Code |
A1 |
Jarverud; Karin ; et
al. |
December 15, 2016 |
Method of Reducing the Occurrence of Arrhythmias Via
Photobiomodulation and Apparatus for Same
Abstract
In response to local or systemic inflammation in a patient,
photobiomodulation therapy is applied to a cardiac location to
reduce the risk and/or occurrence of cardiac arrhythmia. Once
inflammation is identified, photobiomodulation therapy can be
applied in any suitable fashion (e.g., via a catheter- or
transesophageal probe-mounted photoemitter, via an
externally-applied photoemitter, or via photoemitter incorporated
into an implantable medical device). Photobiomodulation therapy can
also be employed to good advantage in conjunction with
non-photobiomodulation therapy (e.g., traditional cardiac rhythm
management therapies).
Inventors: |
Jarverud; Karin; (Solna,
SE) ; Emanuelsson; Cecilia; (Marsta, SE) ;
Bjorling; Anders; (Solna, SE) ; Noren; Kjell;
(Solna, SE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
St. Jude Medical, Atrial Fibrillation Division, Inc. |
St. Paul |
MN |
US |
|
|
Family ID: |
46829084 |
Appl. No.: |
15/234299 |
Filed: |
August 11, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14933112 |
Nov 5, 2015 |
9440091 |
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15234299 |
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13047983 |
Mar 15, 2011 |
9180307 |
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14933112 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 1/056 20130101;
A61N 2005/0612 20130101; A61N 2005/063 20130101; A61N 2005/0662
20130101; A61B 5/103 20130101; A61N 2005/0626 20130101; A61N 1/00
20130101; A61B 2018/00577 20130101; A61N 5/0613 20130101; A61N 5/06
20130101; A61N 2005/0659 20130101; A61B 18/18 20130101; A61N 5/0603
20130101; A61N 2005/0602 20130101; A61B 5/05 20130101; A61N
2005/0609 20130101; A61B 5/0408 20130101; A61B 18/20 20130101; A61N
1/3629 20170801; A61N 1/30 20130101 |
International
Class: |
A61N 5/06 20060101
A61N005/06; A61N 1/05 20060101 A61N001/05; A61B 18/20 20060101
A61B018/20; A61B 5/0408 20060101 A61B005/0408 |
Claims
1-20. (canceled)
21. An apparatus for cardiovascular treatment, comprising: a
photoemitter; and at least one of a sensor to monitor a physiologic
characteristic of a cardiovascular tissue and a therapy delivery
element to deliver a non-photobiomodulation therapy to the
cardiovascular tissue.
22. The apparatus according to claim 21, wherein the therapy
delivery element comprises an ablation element.
23. The apparatus according to claim 21, further comprising an
elongate body, and wherein the photoemitter is mounted to a distal
portion of the elongate body.
24. The apparatus according to claim 23, wherein the elongate body
comprises a catheter.
25. The apparatus according to claim 23, wherein the elongate body
comprises a transesophageal probe.
26. The apparatus according to claim 21, further comprising a
control system, and wherein the control system is configured: to
receive an input from the sensor; to detect, from the input, a
physiologic characteristic of the cardiovascular tissue indicative
of an arrhythmia risk; and to activate the photoemitter to deliver
photobiomodulation therapy to the cardiovascular tissue to mitigate
the physiologic characteristic indicative of the arrhythmia
risk.
27. The apparatus according to claim 26, wherein the physiologic
characteristic indicative of the arrhythmia risk comprises local
inflammation of the cardiovascular tissue.
28. The apparatus according to claim 27, wherein the cardiovascular
tissue comprises cardiac tissue.
29. An apparatus for cardiovascular treatment, comprising: a sensor
to monitor a physiologic characteristic; a photoemitter; and a
control system that receives an output of the sensor as an input
and that is configured to activate the photoemitter to deliver
photobiomodulation therapy to a cardiovascular tissue in response
to the output of the sensor.
30. The apparatus according to claim 29, further comprising an
elongate body, and wherein the photoemitter is carried by the
elongate body.
31. The apparatus according to claim 30, wherein the elongate body
is one of a catheter and a transesophageal probe.
32. The apparatus according to claim 29, wherein the physiologic
characteristic comprises inflammation of the cardiovascular
tissue.
33. The apparatus according to claim 32, wherein the cardiovascular
tissue comprises cardiac tissue.
34. The apparatus according to claim 29, further comprising a
therapy delivery element to deliver a non-photobiomodulation
therapy to the cardiovascular tissue.
35. The apparatus according to claim 34, wherein the therapy
delivery element comprises an ablation element.
36. A method of cardiovascular treatment, comprising: identifying a
physiologic characteristic indicative of a risk of the patient
developing a cardiovascular abnormality; and applying
photobiomodulation therapy to a cardiovascular tissue in order to
mitigate the physiologic characteristic and inhibit the development
of the cardiovascular abnormality.
37. The method according to claim 36, wherein: the cardiovascular
abnormality comprises cardiac arrhythmia; and the physiologic
characteristic comprises inflammation of the cardiovascular
tissue.
38. The method according to claim 37, wherein the cardiovascular
tissue comprises cardiac tissue.
39. The method according to claim 36, further comprising delivering
non-photobiomodulation therapy to the cardiovascular tissue.
40. The method according to claim 39, wherein delivering
non-photobiomodulation therapy to the cardiovascular tissue
comprises ablating the cardiovascular tissue.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 14/933,112, filed 5 Nov. 2015, now pending, which is a
divisional of U.S. application Ser. No. 13/047,983, filed 15 Mar.
2011, now U.S. Pat. No. 9,180,307. The forgoing applications are
hereby incorporated by reference in their entirety as though fully
set forth herein.
BACKGROUND OF THE INVENTION
[0002] a. Field of the Invention
[0003] The instant invention relates generally to the reduction and
prevention of arrhythmias, such as atrial fibrillation. More
specifically, the instant invention relates to apparatus and
methods for reducing and preventing arrhythmias using
photobiomodulation therapy, either alone or in conjunction with
other therapies.
[0004] b. Background Art
[0005] In photobiomodulation therapy, laser light is applied to
tissue in order to address an abnormal tissue response. In general,
photobiomodulation can be described as the use of light to induce a
biological response in living cells and tissue as a direct result
of the absorbance of light by the living cells and tissue.
[0006] One widespread and widely accepted use of photobiomodulation
therapy is for the reduction of pain. For example,
photobiomodulation has been shown to reduce pain associated with
acute inflammation, for example resulting from acute ankle sprains,
acute Achilles tendonitis, and oral surgery. In these
circumstances, photobiomodulation therapy is presumed to exert
anti-inflammatory effects, for example by reducing the levels of
prostaglandin E.sub.2, tumor necrosis factor-.alpha., and
interleukin-1.
[0007] It is widely accepted that some of the effects of
photobiomodulation are exerted through interaction between the
laser light and an enzyme, cytochrome c oxidase, present in
mitochondria. This enzyme functions as a photoacceptor for light of
certain wavelengths. After absorption of light, energy transfer
occurs. Cytochrome c oxidase is the last enzyme in the cellular
respiratory chain and is crucial for the formation of ATP which, in
turn, provides energy for biochemical processes such as muscle
contraction and metabolic reactions. For example, larger numbers of
non-damaged mitochondria as well as higher levels of ATP have been
observed in the ischemic zone after myocardial infarction in
animals treated with photobiomodulation therapy as compared to
untreated animals.
[0008] Atrial fibrillation is one of the most common cardiac
arrhythmias, affecting millions of people worldwide. The economic
stress of atrial fibrillation on the health care system is
enormous, and, as the western population grows older, the number of
atrial fibrillation patients is predicted to rise.
[0009] It is known that atrial fibrillation results from
disorganized electrical activity in the heart muscle (the
myocardium). The underlying causes of atrial fibrillation, however,
are not completely understood, though it is understood that
hypertensive patients are at a higher risk of developing atrial
fibrillation.
[0010] It is also known that angiotensin II causes inflammation and
vice versa. Further, the induction of atrial fibrosis is
angiotensin II dependent, and atrial fibrosis is thought to be one
of the mechanisms causing atrial fibrillation. Indeed, human atrial
tissue expression of angiotensin II receptors have been linked with
increased cell death and leukocyte infiltration. This may
demonstrate a potential link between the
renin-angiotensin-aldosterone system ("RAAS"), inflammation, and
atrial fibrillation. As known, RAAS inhibition has desirable
effects, both in primary and secondary prevention of atrial
fibrillation.
BRIEF SUMMARY OF THE INVENTION
[0011] The inventors thus suspect that inflammation of cardiac
tissue plays a role in the initiation of certain arrhythmias, such
as atrial fibrillation. Photobiomodulation therapy is useful in the
reduction of inflammation. Accordingly, it is an object of the
present invention to prevent and reduce atrial fibrillation by
addressing cardiac inflammation via the application of, inter alia,
photobiomodulation therapy.
[0012] Disclosed herein is a method of reducing the occurrence of
cardiac arrhythmia, including the steps of: identifying
inflammation indicative of a risk of cardiac arrhythmia in a
patient; and applying photobiomodulation therapy to a cardiac
location in order to reduce a likelihood of a cardiac arrhythmia.
The inflammation may be systemic or local and, if local, may be
either local to cardiac tissue or otherwise. The photobiomodulation
therapy desirably utilizes light having a wavelength between about
600 nm and about 1100 nm, and can optionally be provided in
conjunction with non-photobiomodulation therapy (e.g., cardiac
pacing).
[0013] The photobiomodulation therapy can be applied in a number of
different ways. For example, in one aspect, a catheter having a
photoemitter is navigated through a patient's vasculature to a
position proximate the cardiac location and then the photoemitter
is activated to deliver photobiomodulation therapy to the inflamed
cardiac location.
[0014] In another aspect, a photoemitter is positioned on an
exterior surface of a patient's body proximate the cardiac location
and activated to deliver photobiomodulation therapy to the inflamed
cardiac location.
[0015] In still another aspect, a transesophageal probe having a
photoemitter is deployed to a location proximate the cardiac
location via a patient's esophagus. The photoemitter is then
activated to deliver photobiomodulation therapy to the inflamed
cardiac location.
[0016] In yet another aspect, a medical device including a
photoemitter is implanted at a location proximate the cardiac
location, and the photoemitter is activated to deliver
photobiomodulation therapy to the inflamed cardiac location.
[0017] Optionally, at least one physiologic characteristic is
monitored, and activation of the photoemitter to deliver
photobiomodulation therapy is responsive to the monitored at least
one physiologic characteristic. Suitable physiologic
characteristics include, but are not limited to, pressures and
myocardial wall accelerations. The photoemitter may also be
activated to deliver photobiomodulation therapy "on demand" (e.g.,
responsive to a patient's input) or according to a prescribed or
preselected treatment schedule.
[0018] It is also contemplated that the implanted medical device
can include, in addition to a photoemitter, a lead operable in at
least one of a cardiac sensing mode and a cardiac pacing mode. In
such embodiments, the activation of the photoemitter to deliver
photobiomodulation therapy can be responsive to a signal received
by the lead operating in a cardiac sensing mode.
[0019] Also disclosed herein is a medical device for implantation
into a cardiac tissue in order to reduce occurrence of cardiac
arrhythmias. The device includes a photoemitter configured to
deliver photobiomodulation therapy to the cardiac tissue; and at
least one of a sensor to monitor a physiologic characteristic and a
therapy delivery element to deliver a non-photobiomodulation
therapy to the cardiac tissue. The sensor to monitor a physiologic
characteristic can be a pressure sensor, an accelerometer, or any
other device suitable for use in measuring physiological
characteristics.
[0020] The photoemitter can be an optical fiber coupled to a light
source, a litroenergic material, or any other device suitable for
delivering light of an appropriate wavelength and intensity to
tissue.
[0021] The foregoing and other aspects, features, details,
utilities, and advantages of the present invention will be apparent
from reading the following description and claims, and from
reviewing the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] FIG. 1A illustrates a photoemitter deployed into the right
atrium of a patient's heart via the patient's vasculature.
[0023] FIG. 1B also illustrates a photoemitter deployed into the
right atrium of a patient's heart via the patient's
vasculature.
[0024] FIG. 2 depicts a photoemitter for the external application
of photobiomodulation therapy.
[0025] FIG. 3 depicts a photoemitter deployed
transesophageally.
DETAILED DESCRIPTION OF THE INVENTION
[0026] The present invention provides apparatus and methods for
preventing and reducing the occurrence of cardiac arrhythmias, such
as atrial fibrillation, through the application of, inter alia,
photobiomodulation therapy to inflamed cardiac tissue. Though the
present invention will be described in the context of preventing
and reducing the occurrence of cardiac arrhythmias, it is
contemplated that the teachings herein can be practiced to good
advantage in other settings as well. For example,
photobiomodulation therapy as described herein may also be
practiced in conjunction with spinal cord stimulation, vagal nerve
stimulation, gastric stimulation, or any other therapy delivered
via an implantable pulse generator.
[0027] As described above, the inventors theorize that there is a
link between cardiac inflammation and the risk of developing
cardiac arrhythmia. Thus, methods of preventing and reducing the
occurrence of cardiac arrhythmias according to the present
invention include identifying inflammation that is indicative of a
risk of a patient developing cardiac arrhythmia. For purposes of
this disclosure, inflammation refers not only to local
inflammation, but also to systemic inflammation.
[0028] As described above, there is a relationship between
angiotensin II and inflammation. Thus, when there is a systemic
inflammatory state in a subject, there may also be increased levels
of angiotensin II in the blood. Because angiotensin II acts as a
pro-inflammatory molecule, the increased level of angiotensin may,
in turn, lead to local inflammation in cardiac tissue, thus
increasing the risk of atrial fibrosis and atrial fibrillation. In
other words, whether inflammation is systemic or local (to the
heart or otherwise), the increased levels of angiotensin II will
cause an increased risk for AF.
[0029] Systemic inflammation can be detected in various ways, such
as through analysis of body temperature, blood samples, and IEGM.
For example, the following blood markers often indicate systemic
inflammation: c-reactive protein (CRP), interleukin-6 (IL-6), tumor
necrosis factor-alpha (TNF-.alpha.) and erythrocyte sedimentation
rate. Similarly, Troponin T, troponin I, creatine kinase MB
(CK-MB), and myoglobin are markers of myocardial damage, while
cystatin C is a marker of renal damage, which may occur at
inflammation. In addition, angiotensin-converting enzyme can be
measured in blood as a marker of increased angiotensin II
activity.
[0030] Once inflammation (systemic or local, to the heart or
otherwise) has been identified, photobiomodulation therapy can be
applied in order to reduce local inflammation in cardiac tissue
(e.g., ischemic ventricular regions, infarct ventricular regions).
This, in turn, reduces the patient's risk of developing an
arrhythmia.
[0031] The present invention encompasses any number of
methodologies of delivering photobiomodulation therapy to an
inflamed cardiac location, which will be familiar to those of
ordinary skill in the art. For example, United States patent
application publication no. 2004/0260367, which is hereby
incorporated by reference as though fully set forth herein,
discloses delivery of photobiomodulation to a patient's heart via
an externally-applied device (in FIGS. 2A and 2B), via a catheter
(in FIG. 12), and via a transesophageal probe (in FIGS. 11A and
11B). Similarly, PCT publication WO2008066423, which is hereby
incorporated by reference as though fully set forth herein,
discloses an implantable cardiac device that can also deliver
phototherapy in order to facilitate the healing process associated
with device implantation.
[0032] Neither United States patent application publication no.
2004/0260367 nor PCT publication WO2008066423, however, recognizes
the beneficial, arrhythmia-reducing and arrhythmia-preventing
effects of photobiomodulation therapy. Nonetheless, because various
suitable methods of delivering photobiomodulation therapy will be
familiar to those of ordinary skill in the art, these methodologies
will only be described herein to the extent necessary to understand
the present invention.
[0033] FIGS. 1A and 1B illustrate a first method of delivering
photobiomodulation therapy to an inflamed cardiac location. As
shown in FIGS. 1A and 1B, a catheter 10 having a photoemitter 12 at
a distal end thereof is navigated through the patient's vasculature
to a position proximate the inflamed cardiac location. For the sake
of illustration, catheter 10 is shown as being introduced into the
patient's right atrium via the superior vena cava. It should be
understood, of course, that catheter 10 may be navigated through
the patient's vasculature, using any suitable known technique
(e.g., steerable catheters, non-steerable catheters introduced
through steerable introducer sheaths, catheters introduced over
guidewires, and the like), into any cardiac chamber without
departing from the spirit and scope of the present invention.
[0034] FIG. 2 depicts a second method of delivering
photobiomodulation therapy to an inflamed cardiac location. As
shown in FIG. 2, a photoemitter 12 is positioned on an exterior
surface of the patient's body proximate the inflamed cardiac
location and activated to emit light, thereby delivering
photobiomodulation therapy to the inflamed cardiac location. Such
externally-applied photobiomodulation therapy has the advantage of
being completely non-invasive, but may not be as effective as
internally-applied (e.g., catheter-delivered) photobiomodulation
therapy. In addition, though FIG. 2 depicts the patient on an
examination table, it should be understood that photoemitter 12 may
be provided as part of or on a belt or other wearable device that
permits the patient to stand, and even move about, while undergoing
photobiomodulation therapy.
[0035] FIG. 3 depicts a third method of delivering
photobiomodulation therapy to an inflamed cardiac location. As
shown in FIG. 3, a photoemitter 12 is positioned on a
transesophageal probe 14. Probe 14 is introduced, via the patient's
esophagus, to a location proximate the inflamed cardiac location,
and photoemitter 12 is activated to deliver photobiomodulation
therapy thereto. One of ordinary skill in the art will appreciate
that this method of delivering photobiomodulation therapy is
slightly less invasive than catheter-delivered photobiomodulation
therapy and likely to be more effective than externally-applied
photobiomodulation therapy.
[0036] Photoemitter 12 may include any suitable light source, as
generally known in the photobiomodulation art. For example, in some
embodiments of the invention, photoemitter 12 includes one or more
optical fibers coupled to one or more light sources. In the
embodiment of the invention depicted in FIGS. 1A and 1B, the
optical fibers (and any lenses used in connection therewith) are
connected to catheter 10 so as to be carried by catheter 10 through
the patient's vasculature. Likewise, in the embodiment of the
invention depicted in FIG. 3, the optical fibers (and any lenses
used in connection therewith) are connected to probe 14 so as to be
carried by probe 14 through the patient's esophagus. Typically, the
light source will remain outside the patient's body, but it is
within the scope of the invention to provide a light source that is
sufficiently small to be incorporated into catheter 10 or probe 14
along with the optical fiber assembly.
[0037] In other embodiments of the invention, photoemitter 12 may
include a litroenergic material. Litroenergic materials are
materials that emit light continuously without an external power
source. Suitable litroenergic materials include LITROSPHERES,
manufactured by MPK Co. of Clayton, Wisconsin. Such materials can
be molded into and/or painted onto the distal end of catheter 10,
probe 14, or another suitable device.
[0038] Typically, the light used in photobiomodulation therapy
delivered according to the teachings herein will have a wavelength
of between about 600 nm and about 1100 nm. Of course, these
wavelengths are merely exemplary, and other wavelengths could be
employed, if deemed beneficial to the patient, without departing
from the spirit and scope of the present invention.
[0039] In some embodiments of the invention, one or more medical
devices respectively including one or more photoemitters are
implanted into a patient at locations proximate inflamed cardiac
locations. Methods of implantation of such medical devices are
generally known, for example in connection with the implantation of
cardiac pacing leads.
[0040] An implanted photoemitter can be activated as necessary or
desirable in order to prevent and reduce the occurrence of cardiac
arrhythmia, without necessitating a catheterization procedure every
time photobiomodulation therapy is to be delivered. Photoemitter
implantation may be desirable where a preselected treatment
schedule calls for photobiomodulation therapy to be delivered over
an extended period of time, such as every other day for two
weeks.
[0041] Photoemitter implantation may also be advantageous where
photobiomodulation therapy is delivered "on demand" by the patient.
For example, if the patient experiences symptoms of hypertension,
which may be a precursor to cardiac arrhythmia, the patient can
activate the photoemitter in order to reduce or prevent the
occurrence of an arrhythmia, similar to how a patient might take a
nitroglycerin pill when experiencing symptoms of angina.
[0042] It is also contemplated to incorporate one or more
photoemitters into an implantable cardiac pacing lead, such as a
cardiac resynchronization therapy (CRT), cardiac resynchronization
therapy defibrillator (CRT-D), implantable
cardioverter-defibrillator (ICD), or brady device. Such a
configuration advantageously provides a single device capable of
delivering both traditional cardiac rhythm management therapy and
photobiomodulation therapy.
[0043] An implanted medical device including a photoemitter may
additionally, or alternatively, include a sensor (e.g., a sensing
lead) to enable monitoring of one or more physiologic
characteristics. A control system can be established that activates
the photoemitter in response to the monitored physiologic
characteristics.
[0044] As one example, the photoemitter can be coupled to a
pressure sensor, such as the HeartPOD.TM. implantable heart failure
therapy system, which measures a patient's left atrial pressure. As
another example, the photoemitter can be coupled to a sensor that
measures atrial wall stress. As yet another example, the
photoemitter can be coupled to an accelerometer that measures the
acceleration of the atrial wall. Other suitable sensors include
motion sensors, position sensors, and sensors for measuring cardiac
electrograms.
[0045] The control system can, in response to measurements made by
the sensor or sensors, activate the photoemitter as appropriate in
order to prevent or reduce the occurrence of a cardiac arrhythmia.
For example, in the case where the sensor measures cardiac
electrograms, the control system can activate the photoemitter when
an irregular electrogram is detected.
[0046] Although several embodiments of this invention have been
described above with a certain degree of particularity, those
skilled in the art could make numerous alterations to the disclosed
embodiments without departing from the spirit or scope of this
invention. For example, one of ordinary skill in the art will
readily appreciate that photobiomodulation therapy can be delivered
according to any suitable schedule using any suitable wavelength of
light.
[0047] As another example, it should be understood that sensors
used as part of a control system for the delivery of
photobiomodulation therapy need not be implanted, and may be
external to the patient. For example, rather than using an internal
cardiac sensing lead, the photoemitter may be coupled to the output
of a Holter monitor.
[0048] As still another example, the non-photobiomodulation therapy
is not limited to traditional cardiac rhythm management therapy,
and includes, for example, pharmacologic therapy, ablation therapy,
surgical therapies, and the like.
[0049] All directional references (e.g., upper, lower, upward,
downward, left, right, leftward, rightward, top, bottom, above,
below, vertical, horizontal, clockwise, and counterclockwise) are
only used for identification purposes to aid the reader's
understanding of the present invention, and do not create
limitations, particularly as to the position, orientation, or use
of the invention. Joinder references (e.g., attached, coupled,
connected, and the like) are to be construed broadly and may
include intermediate members between a connection of elements and
relative movement between elements. As such, joinder references do
not necessarily infer that two elements are directly connected and
in fixed relation to each other.
[0050] It is intended that all matter contained in the above
description or shown in the accompanying drawings shall be
interpreted as illustrative only and not limiting. Changes in
detail or structure may be made without departing from the spirit
of the invention as defined in the appended claims.
* * * * *