U.S. patent application number 13/023110 was filed with the patent office on 2013-08-01 for electromagnetic radiation therapy.
The applicant listed for this patent is Michael J. Horzewski, Jack W. Lasersohn. Invention is credited to Michael J. Horzewski, Jack W. Lasersohn.
Application Number | 20130197612 13/023110 |
Document ID | / |
Family ID | 44022809 |
Filed Date | 2013-08-01 |
United States Patent
Application |
20130197612 |
Kind Code |
A1 |
Lasersohn; Jack W. ; et
al. |
August 1, 2013 |
Electromagnetic Radiation Therapy
Abstract
Apparatuses and methods for the prevention, reduction, or
elimination of tissue injury by the application of electromagnetic
energy. The apparatuses and methods have application for use in
various tissues within diverse regions of the body, including for
the prevention, reduction, or elimination of acute kidney injury,
kidney failure, and contrast-induced nephropathy.
Inventors: |
Lasersohn; Jack W.; (East
Hampton, NY) ; Horzewski; Michael J.; (San Jose,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Lasersohn; Jack W.
Horzewski; Michael J. |
East Hampton
San Jose |
NY
CA |
US
US |
|
|
Family ID: |
44022809 |
Appl. No.: |
13/023110 |
Filed: |
February 8, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61308620 |
Feb 26, 2010 |
|
|
|
Current U.S.
Class: |
607/89 ;
607/100 |
Current CPC
Class: |
A61P 33/02 20180101;
A61K 39/175 20130101; C12N 2750/14334 20130101; C12N 2760/18422
20130101; A61P 37/04 20180101; A61P 31/14 20180101; A61P 31/20
20180101; C07K 14/005 20130101; C12N 2760/18471 20130101; A61N
5/0613 20130101; A61K 2039/55522 20130101; A61P 31/10 20180101;
A61K 2039/552 20130101; C12N 2800/22 20130101; A61K 2039/545
20130101; A61P 31/16 20180101; A61P 31/22 20180101; C12N 2710/24043
20130101; A61K 2039/53 20130101; C07K 14/535 20130101; A61K 39/12
20130101; A61P 31/12 20180101; C12N 2760/18434 20130101; C12N 7/00
20130101 |
Class at
Publication: |
607/89 ;
607/100 |
International
Class: |
A61N 5/06 20060101
A61N005/06 |
Claims
1. A method of preventing or treating kidney injury comprising
subjecting kidney tissue to electromagnetic radiation in the
red-near infrared range for a period of time sufficient to prevent
or reduce injury to the kidney.
2. The method of claim 1 wherein the electromagnetic energy is
laser energy.
3. The method of claim 2 wherein the energy has a wavelength of
about 635 nm to about 1560 nm.
4. The method of claim 1 wherein the electromagnetic energy is
light emitting diode energy.
5. The method of claim 4 wherein the energy has a wavelength of
about 635 nm to about 1560 nm.
6. The method of claim 1 wherein the electromagnetic radiation has
a power density of at least 0.01 mW/cm.sup.2 at the kidney
tissue.
7. The method of claim 1 wherein at least a portion of the
electromagnetic radiation is delivered prior to the injury to the
kidney.
8. The method of claim 7 wherein the injury to the kidney is due at
least in part to a contrast agent.
9. The method of claim 1 wherein at feast a portion of the
electromagnetic radiation is delivered during the injury to the
kidney.
10. The method of claim 9 wherein the injury to the kidney is due
at least in part to a contrast agent.
11. The method of claim 1 wherein at least a portion of the
electromagnetic radiation is delivered after the injury to the
kidney.
12. The method of claim 11 wherein the injury to the kidney is due
at least in part to a contrast agent.
13. The method of claim 1 wherein said kidney injury is induced by
a pre-renal cause.
14. The method of claim 1 wherein said kidney injury is induced by
a renal cause.
15. The method of claim 1 wherein said kidney injury is induced by
a post-renal cause.
16. The method of claim 1 wherein a region of the patient's skin is
cooled.
17. The method of claim 1 wherein the absorption of electromagnetic
radiation in at least a portion of the area exposed to the
electromagnetic radiation is decreased.
18. The method of claim 1 wherein sensing for electromagnetic
radiation is conducted concurrently with the delivery of the
electromagnetic radiation.
19. The method of claim 1 wherein a pharmacologic agent is
administered to the patient to enhance reduction or prevention of
injury to the kidney.
20. The method of claim 19 wherein the pharmacologic agent is
selected from the group of angiotensin II, fenoldopam, dopamine,
calcium-channel blockers, endothelin antagonists, adenosine,
N-acetylcysteine, sodium bicarbonate, and ascorbic acid.
21. The method of claim 1 wherein multiple wavelengths of
electromagnetic radiation are applied to at least a portion of
kidney tissue.
22. The method of claim 1 wherein a non-electromagnetic energy is
applied concurrently with the electromagnetic radiation to at least
a portion of kidney tissue.
23. Apparatus for preventing or treating kidney injury comprising a
source of electromagnetic energy in the red-near infrared range, an
applicator adapted to emit and transmit said electromagnetic energy
to kidney tissue.
24. Apparatus for preventing or treating kidney injury comprising a
source of electromagnetic energy in the red-near infrared range, a
conduit for transmitting said energy and an applicator adapted to
emit and transmit said electromagnetic energy to kidney tissue.
25. The apparatus of claim 23, wherein the energy source is a
laser.
26. The apparatus of claim 23, wherein the energy has a wavelength
of about 635 nm to about 1560 nm.
27. The apparatus of claim 23 wherein the energy source is a light
emitting diode.
28. The apparatus of claim 23, wherein the energy has a power
density of at least 0.01 mW/cm.sup.2 at the kidney tissue.
29. The apparatus of claim 23, wherein the energy is delivered in
pulsed mode at a peak power density of at least 0.01 mW/cm.sup.2 at
the kidney tissue.
30. The apparatus of claim 23, further comprising an element to
measure the temperature near the skin.
31. The apparatus of claim 23, further comprising an element in
contact with the skin. The element adapted to reduce thermal
changes near the skin.
32. The apparatus of claim 23, further comprising an element
adapted to reduce the blood flow near the skin.
33. The apparatus of claim 23, further comprising an element for
sensing electromagnetic radiation.
34. The apparatus of claim 23, further comprising an element for
sealing the applicator to the patient.
35. The apparatus of claim 23, wherein the applicator is secured to
the patient.
36. The apparatus of claim 23, further comprising a controller.
37. The apparatus of claim 23, further comprising two or more
applicators adapted to emit and transmit said electromagnetic
energy to kidney tissue.
38. The apparatus of claim 23, further comprising at least one
applicator capable of transmitting multiple wavelengths of said
electromagnetic energy to kidney tissue.
39. The apparatus of claim 23, further comprising at least one
acoustic energy source of at least one efficacious energy.
40. The apparatus of claim 23, further comprising at least one
magnetic field source of at least one efficacious field strength.
Description
RELATED INFORMATION
[0001] This application claims priority to U.S. provisional patent
application Ser. No. 61/308,620 filed on Feb. 25, 2010, which is
fully incorporated herein by reference.
FIELD OF THE INVENTION
[0002] This invention relates to the use of electromagnetic
radiation for the prevention and treatment of injury to and
disorders of biological issues, and more specifically to novel
apparatuses and methods for the prevention and treatment of kidney
injury and failure.
BACKGROUND OF THE INVENTION
[0003] Acute renal failure or acute kidney injury is characterized
by a rapid reduction in renal function. The causes are numerous and
are commonly categorized as pre-renal, renal or intrinsic, and
post-renal.
[0004] Pre-renal causes are characterized by inadequate blood
perfusion to the kidneys. These include volume depletion; examples
include hemorrhage, loss of intravascular fluid due to ascities,
peritonitis, and burns; low cardiac output due to cardiomyopathy,
myocardial infarction, cardiac tamponade, and pulmonary embolism,
among others; low systemic vascular resistance due to shock, liver
failure, or antihypertensive drugs; increased vascular resistance
caused by hypercalcemia, anaphylaxis, anesthetics, renal artery
obstruction, renal vein thrombosis, sepsis, and hepatorenal
syndrome; and decreased efferent arteriolar tone.
[0005] Renal causes involve intrinsic renal disease or damage to
the kidney itself, most commonly from renal ischemia and
nephrotoxins. Causes include acute tubular injury due to ischemia;
from surgery (blood loss, blood flow reduction-cross clamping),
hemorrhage, arterial or venous obstruction, and cyclosporine,
tacrolimus, and amphotericin B; and toxins, such as radiopaque
contrast agents which lead to contrast-induced nephropathy,
Aminoglycosides, amphotericin B, foscarnet, ethylene glycol,
hemoglobinuria, myoglobinuria, ifosfamide, and heavy metals.
[0006] Acute glomerulonephritis; ANCA associated, anti-GBM
glomerulonephritis, and immune complex; acute tubulointerstitial
nephritis due to drug reactions, pyelonephritis, and papillary
necrosis; acute vascular nephropathy from vasculitis, malignant
hypertension, thrombotic microangiopathies, scleroderma, and
atheroembolism; and infiltrative diseases such as lymphoma,
sarcoidosis, and leukemia constitute renal causes as well.
[0007] Post-renal causes are due to various types of obstruction
within the urinary system. Obstruction can also occur within the
tubules when crystalline or proteinaceous material precipitates.
Examples include: renal calculi; retroperitoneal fibrosis;
prostatic hypertrophy; carcinoma and cervical carcinoma; urethral
stricture; and bladder, pelvic, and/or retroperitoneal
neoplasm.
[0008] The primary treatment for acute kidney injury is correcting
the fluid and electrolyte balances from either fluid depletion or
fluid overload; treatment of the underlying medical condition and
restoration of blood perfusion to the kidneys; and the
discontinuation of potentially deleterious medications.
[0009] Current strategies for the prevention of acute kidney injury
are: maintaining normal fluid balance, blood volume, and blood
pressure in patients with trauma, burns, or major hemorrhage and in
those undergoing major surgery; in cases requiring the use of a
contrast agent, minimizing the volume of contrast agent, using
nonionic and low-osmolar or iso-osmolar contrast agents, and
pretreating with normal saline; and withholding potentially
nephrotoxic drugs, including aminoglycoside antibiotics,
anti-rejection medications, and nonsteroidal anti-inflammatory
drugs.
[0010] Notwithstanding the current therapies, acute kidney injury
remains common in hospitalized patients and carries a poor
prognosis. Non-ICU acute kidney injury carries a mortality rate of
up to 10%. ICU acute kidney injury carries a mortality rate of over
50%.
[0011] Patients receiving intravascular administration of iodinated
contrast media are at risk of developing contrast-induced
nephropathy, the third leading cause of hospital-acquired acute
kidney injury, accounting for approximately 12% of all cases.
Contrast-induced nephropathy is associated with both short- and
long-term adverse outcomes, including the need for renal
replacement therapy, increased length of hospital stay, major
cardiac adverse events, and mortality. The incidence of
contrast-induced nephropathy is estimated to be 1% to 6% in the
general population. However, in patient subgroups with multiple
comorbidities, the risk grows to as high as 50%. Following
percutaneous coronary intervention, in-hospital mortality rates
have been found to be 1% in patients without contrast-induced
nephropathy, approximately 7% for patients with contrast-induced
nephropathy, and up to 36% for patients with contrast-induced
nephropathy requiring dialysis.
[0012] Multiple pharmacologic interventions have been evaluated for
the prevention of contrast-induced nephropathy, including:
angiotensin II, fenoldopam, dopamine, calcium-channel blockers,
endothelin antagonists, and adenosine, though none of these have
been found to be beneficial. The principal intervention is
extracellular volume expansion, primarily with the administration
of intravenous fluid. Other pharmacologic agents, N-acetylcysteine,
sodium bicarbonate, and ascorbic acid have seen mixed results in
clinical trials are still under evaluation to determine if they
provide a beneficial effect.
[0013] In additional to pharmacologic strategies for
contrast-induced nephropathy, attempts are being made to remove
blood, and with it contrast media, directly from the patient's
coronary sinus with interventional catheters. Even with this
invasive approach, not all the contrast media is removed and the
kidneys are therefore still at risk.
[0014] Electromagnetic radiation systems of many different types
are used in a wide variety of medical procedures. Some of the many
types of electromagnetic radiation systems are visible light
systems and infrared systems; some are intended for diagnostic
purposes, such as infrared spectroscopy, and some for therapeutic
purposes including chronic pain management, wound healing, cosmetic
surgery, and dentistry.
[0015] Electromagnetic radiation in the red/near infrared range has
been shown to modulate various biological processes such as
increasing mitochondrial respiration, adenosine triphosphate
synthesis, and preventing apoptosis. This effect has been applied
clinically to facilitate wound healing; promote skeletal muscle
regeneration and angiogenesis; and improve neurologic function in
ischemic brain tissue. However, the mechanism of action in these
uses is not well understood. Furthermore, the problem of
nephropathy caused by contrast agents is distinct from these prior
uses and is itself not well understood.
[0016] Based upon the lack of preventative strategies and the
inadequacies of the currently available therapies, there remains a
strong clinical need for new and improved apparatuses and methods
for the prevention and treatment of kidney injury and failure,
particularly such injury and failure caused by contrast agents.
SUMMARY OF THE INVENTION
[0017] One preferred embodiment of the present invention provides a
method for treating kidney tissue. The method comprises introducing
electromagnetic radiation of at least one efficacious wavelength
and energy to at least a portion of kidney tissue.
[0018] Another embodiment of the present invention provides a
method for treating kidney tissue. The method comprises introducing
electromagnetic radiation of at least one efficacious wavelength
and energy to abdomen, to irradiate at least a portion of kidney
tissue.
[0019] Another embodiment of the present invention provides a
method for treating kidney tissue. The method comprises introducing
electromagnetic radiation of at least one efficacious wavelength
and energy to at least a portion of kidney tissue, to prevent,
reduce, or eliminate injury to the kidney tissue.
[0020] Another embodiment of the present invention provides a
method for treating kidney tissue. The method comprises introducing
electromagnetic radiation of at least one efficacious wavelength
and energy to at least a portion of kidney tissue prior to kidney
injury, to prevent, reduce, or eliminate injury to the kidney
tissue.
[0021] Another embodiment of the present invention provides a
method for treating kidney tissue. The method comprises introducing
electromagnetic radiation of at least one efficacious wavelength
and energy to at least a portion of kidney tissue at least during a
portion of the time of kidney injury, to prevent, reduce, or
eliminate injury to the kidney tissue.
[0022] Another embodiment of the present invention provides a
method for treating kidney tissue. The method comprises introducing
electromagnetic radiation of at least one efficacious wavelength
and energy to at least a portion of kidney tissue, at least during
a portion of the time of and/or after the kidney injury, to
prevent, reduce, or eliminate injury to the kidney tissue.
[0023] Another embodiment of the present invention provides a
method for treating kidney tissue. The method comprises introducing
electromagnetic radiation of at least one efficacious wavelength
and energy to at least a portion of kidney tissue, prior to and/or
at least during a portion of the time of and/or after the kidney
injury, to prevent, reduce, or eliminate injury to the kidney
tissue.
[0024] Another embodiment of the present invention provides a
method for treating kidney tissue. The method comprises introducing
electromagnetic radiation of at least one efficacious wavelength
and energy to at least a portion of kidney tissue, prior to and/or
at least during a portion of the time of a diagnostic procedure, to
prevent, reduce, or eliminate injury to the kidney tissue.
[0025] Another embodiment of the present invention provides a
method for treating kidney tissue. The method comprises introducing
electromagnetic radiation of at least one efficacious wavelength
and energy to at least a portion of kidney tissue, prior to and/or
at least during a portion of the time of an interventional
procedure, to prevent, reduce, or eliminate injury to the kidney
tissue.
[0026] Another embodiment of the present invention provides a
method for treating kidney tissue. The method comprises introducing
electromagnetic radiation of at least one efficacious wavelength
and energy to at least a portion of kidney tissue, concurrently or
independently applying acoustic energy of at least one efficacious
energy to at least a portion of kidney tissue, prior to and/or at
least during a portion of the time of and/or after the kidney
injury, to prevent, reduce, or eliminate injury to the kidney
tissue.
[0027] Another embodiment of the present invention provides a
method for treating kidney tissue. The method comprises introducing
electromagnetic radiation of at least one efficacious wavelength
and energy to at least a portion of kidney tissue, concurrently or
independently applying acoustic energy of at least one efficacious
energy to at least a portion of kidney tissue, prior to and/or at
least during a portion of the time of and/or after the kidney
injury, to prevent, reduce, or eliminate contrast-induced
nephropathy.
[0028] Another embodiment of the present invention provides a
method for treating kidney tissue. The method comprises introducing
electromagnetic radiation of at least one efficacious wavelength
and energy to at least a portion of kidney tissue, concurrently or
independently applying acoustic energy of at least one efficacious
energy to at least a portion of kidney tissue, prior to and/or at
least during a portion of the time of and/or after the introduction
of contrast media to the patient, to prevent, reduce, or eliminate
contrast-induced nephropathy.
[0029] Another embodiment of the present invention provides a
method for treating kidney tissue. The method comprises introducing
electromagnetic radiation of at least one efficacious wavelength
and energy to at least a portion of kidney tissue, concurrently or
independently applying a magnetic field of at least one efficacious
field strength to at least a portion of kidney tissue, prior to
and/or at least during a portion of the time of and/or after the
kidney injury, to prevent, reduce, or eliminate injury to the
kidney tissue.
[0030] Another embodiment of the present invention provides a
method for treating kidney tissue. The method comprises
`introducing electromagnetic radiation of at least one efficacious
wavelength and energy to at least a portion of kidney tissue, prior
to and/or at least during a portion of the time of and/or after the
kidney injury, and administering a pharmacologic agent (e.g.
hydration, volume expansion, N-acetylcysteine, sodium bicarbonate,
ascorbic acid) prior to and/or at least during a portion of the
time of and/or after electromagnetic radiation, to prevent, reduce,
or eliminate injury to the kidney tissue.
[0031] Another embodiment of the present invention provides a
method for treating kidney tissue. The method comprises introducing
electromagnetic radiation of at least one efficacious wavelength
and energy to at least a portion of kidney tissue, prior to and/or
at least during a portion of the time of an interventional
procedure, and administering a pharmacologic agent (e.g. hydration,
volume expansion, N-acetylcysteine, sodium bicarbonate, ascorbic
acid) prior to and/or at least during a portion of the time of
and/or after electromagnetic radiation, to prevent, reduce, or
eliminate injury to the kidney tissue.
[0032] Another embodiment of the present invention provides a
method for treating kidney tissue. The method comprises introducing
electromagnetic radiation of at least one efficacious wavelength
and energy to at least a portion of kidney tissue. The
electromagnetic radiation source comprising a laser and/or at least
one light emitting diode.
[0033] Another embodiment of the present invention provides a
method for treating kidney tissue. The method comprises introducing
electromagnetic radiation of at least one efficacious wavelength
and energy to at least a portion of kidney tissue. Introducing the
electromagnetic radiation through an element in contact with the
skin.
[0034] Another embodiment of the present invention provides a
method for treating kidney tissue. The method comprises introducing
electromagnetic radiation of at least one efficacious wavelength
and energy to at least a portion of kidney tissue. Reducing thermal
changes near the skin.
[0035] Another embodiment of the present invention provides a
method for treating kidney tissue. The method comprises introducing
electromagnetic radiation of at least one efficacious wavelength
and energy to at least a portion of kidney tissue. Sensing for
thermal changes and modifying or ceasing delivery of the
electromagnetic radiation if predetermined thermal changes are
detected.
[0036] Another embodiment of the present invention provides a
method for treating kidney tissue. The method comprises introducing
electromagnetic radiation of at least one efficacious wavelength
and energy to at least a portion of kidney tissue. Sensing for
electromagnetic radiation of at least one efficacious wavelength
and ceasing delivery of the electromagnetic radiation if
electromagnetic radiation of at least one efficacious wavelength is
detected.
[0037] Another embodiment of the present invention provides a
method for treating kidney tissue. The method comprises introducing
electromagnetic radiation of at least one efficacious wavelength
and energy to at least a portion of kidney tissue. Sensing for
electromagnetic radiation of at least one efficacious wavelength
and ceasing delivery of the electromagnetic radiation if
electromagnetic radiation of at least one efficacious wavelength is
detected above a threshold level.
[0038] Another embodiment of the present invention provides a
method for treating kidney tissue. The method comprises introducing
electromagnetic radiation of at least one efficacious wavelength
and energy to at least a portion of kidney tissue, to prevent,
reduce, or eliminate injury to the kidney tissue. Concurrently or
independently of the delivery of electromagnetic radiation
effecting a decrease in the absorption and/or blood flow and/or
blood vessel diameter in at lease a portion of the area exposed to
the electromagnetic radiation.
[0039] Another embodiment of the present invention provides a
method for treating kidney tissue. The method comprises introducing
electromagnetic radiation of at least one efficacious wavelength
and energy to at least a portion of kidney tissue, to prevent,
reduce, or eliminate injury to the kidney tissue. Concurrently or
independently of the delivery of electromagnetic radiation
effecting an increase in the transmission of the electromagnetic
radiation.
[0040] In certain embodiments, the methods encompass using
electromagnetic radiation having at least one wavelength of about
635 nm to about 1560 nm.
[0041] In certain embodiments, the methods encompass using
electromagnetic radiation having at least one wavelength of about
635 nm to about 980 nm.
[0042] In certain embodiments, the methods encompass using
electromagnetic radiation having at least one wavelength of about
700 nm to about 980 nm.
[0043] In certain embodiments, the methods encompass using
electromagnetic radiation having a power density of at least 0.01
mW/cm.sup.2 at the kidney tissue.
[0044] In certain embodiments, the methods encompass using
electromagnetic radiation having an energy density of at least 0.01
J/cm.sup.2 at the kidney tissue.
[0045] In certain embodiments, the methods encompass delivering
electromagnetic radiation in at least continuous wave mode.
[0046] In certain embodiments, the methods encompass delivering
electromagnetic radiation in at least pulsed wave mode.
[0047] Another embodiment of the present invention provides an
apparatus for treating kidney tissue. The apparatus comprises at
least one electromagnetic radiation source of at least one
efficacious wavelength and energy, positioned to irradiate at least
a portion of kidney tissue.
[0048] Another embodiment of the present invention provides an
apparatus for treating kidney tissue. The apparatus comprises at
least one electromagnetic radiation source of at least one
efficacious wavelength and energy, positioned to irradiate at least
a portion of kidney tissue. The apparatus further comprising a
laser and/or at least one light emitting diode as one
electromagnetic radiation source.
[0049] Another embodiment of the present invention provides an
apparatus for treating kidney tissue. The apparatus comprises at
least one electromagnetic radiation source of at least one
efficacious wavelength and energy, positioned to irradiate at least
a portion of kidney tissue. The apparatus further comprises an
element in contact with the skin.
[0050] Another embodiment of the present invention provides an
apparatus for treating kidney tissue. The apparatus comprises at
least one electromagnetic radiation source of at least one
efficacious wavelength and energy, positioned to irradiate at least
a portion of kidney tissue. The apparatus further comprises an
element in contact with the skin. The element adapted to reduce
thermal changes near the skin.
[0051] Another embodiment of the present invention provides an
apparatus for treating kidney tissue. The apparatus comprises at
least one electromagnetic radiation source of at least one
efficacious wavelength and energy, positioned to irradiate at least
a portion of kidney tissue. The apparatus further comprises and
element in contact with the skin. The element adapted to reduce the
temperature near the skin at or near the region of irradiation.
[0052] Another embodiment of the present invention provides an
apparatus for treating kidney tissue. The apparatus comprises
introducing electromagnetic radiation of at least one efficacious
wavelength and energy to at least a portion of kidney tissue. The
apparatus further comprises a sensor for sensing thermal changes
and modifying or ceasing delivery of the electromagnetic radiation
if predetermined thermal changes are detected.
[0053] Another embodiment of the present invention provides an
apparatus for treating kidney tissue. The apparatus comprises at
least one electromagnetic radiation source of at least one
efficacious wavelength and energy, positioned to irradiate at least
a portion of kidney tissue. The apparatus further comprises an
element to reduce or eliminate electromagnetic radiation of at
least one efficacious wavelength from being emitted in at least one
undesirable direction.
[0054] Another embodiment of the present invention provides an
apparatus for treating kidney tissue. The apparatus comprises at
least one electromagnetic radiation source of at least one
efficacious wavelength and energy, positioned to irradiate at least
a portion of kidney tissue. The apparatus further comprises an
element to reduce or eliminate electromagnetic radiation of at
least one efficacious wavelength from being emitted away from the
patient.
[0055] Another embodiment of the present invention provides an
apparatus for treating kidney tissue. The apparatus comprises at
least one electromagnetic radiation source of at least one
efficacious wavelength and energy, positioned to irradiate at least
a portion of kidney tissue. The apparatus further comprises an
element for constraining the electromagnetic radiation of at least
one efficacious wavelength being emitted between the emitting
source and the patient.
[0056] Another embodiment of the present invention provides an
apparatus for treating kidney tissue. The apparatus comprises at
least one electromagnetic radiation source of at least one
efficacious wavelength and energy, positioned to irradiate at least
a portion of kidney tissue. The apparatus further comprises an
element for maintaining position of at least on element of the
apparatus in relation to the patient.
[0057] Another embodiment of the present invention provides an
apparatus for treating kidney tissue. The apparatus comprises at
least one electromagnetic radiation source of at least one
efficacious wavelength and energy, positioned to irradiate at least
a portion of kidney tissue. The apparatus further comprises a
sensor to sense electromagnetic radiation of at least one
efficacious wavelength.
[0058] Another embodiment of the present invention provides an
apparatus for treating kidney tissue. The apparatus comprises at
least one electromagnetic radiation source of at least one
efficacious wavelength and energy, positioned to irradiate at least
a portion of kidney tissue. The apparatus further comprises a
sensor to sense electromagnetic radiation of at least one
efficacious wavelength. The apparatus further comprises an element
or component for ceasing delivery of the electromagnetic radiation
if electromagnetic radiation of at least one efficacious wavelength
is detected.
[0059] Another embodiment of the present invention provides an
apparatus for treating kidney tissue. The apparatus comprises at
least one electromagnetic radiation source of at least one
efficacious wavelength and energy, positioned to irradiate at least
a portion of kidney tissue. The apparatus further comprises a
sensor to sense electromagnetic radiation of at least one
efficacious wavelength. The apparatus further comprises an element
or component for ceasing delivery of the electromagnetic radiation
if electromagnetic radiation of at least one efficacious wavelength
is detected above a threshold level.
[0060] Another embodiment of the present invention provides an
apparatus for treating kidney tissue. The apparatus comprises at
least one electromagnetic radiation source of at least one
efficacious wavelength and energy and at least one acoustic energy
source of at least one efficacious energy. The apparatus further
comprising the delivery of the efficacious energies either
concurrently or independently to at least a portion of kidney
tissue.
[0061] Another embodiment of the present invention provides an
apparatus for treating kidney tissue. The apparatus comprises at
least one electromagnetic radiation source of at least one
efficacious wavelength and energy and at least one magnetic field
source of at least one efficacious field strength. The apparatus
further comprising the delivery of the efficacious energies either
concurrently or independently to at least a portion of kidney
tissue.
[0062] Another embodiment of the present invention provides an
apparatus for treating kidney tissue. The apparatus comprises at
least one electromagnetic radiation source of at least one
efficacious wavelength and energy, positioned to irradiate at least
a portion of kidney tissue. The apparatus further affecting,
concurrently or independently of the delivery of electromagnetic
radiation, a decrease in the absorption and/or blood flow and/or
blood vessel diameter in at least a portion of the area exposed to
the electromagnetic radiation.
[0063] Another embodiment of the present invention provides an
apparatus for treating kidney tissue. The apparatus comprises at
least one electromagnetic radiation source of at least one
efficacious wavelength and energy, positioned to irradiate at least
a portion of kidney tissue. The apparatus further affecting,
concurrently or independently of the delivery of electromagnetic
radiation, an increase in the transmission of the electromagnetic
radiation.
[0064] In certain embodiments, the apparatus encompasses using
electromagnetic radiation having at least one wavelength of about
635 nm to about 1560 nm.
[0065] In certain embodiments, the apparatus encompasses using
electromagnetic radiation having at least one wavelength of about
635 nm to about 980 nm.
[0066] In certain embodiments, the apparatus encompasses using
electromagnetic radiation having at least one wavelength of about
700 nm to about 980 nm.
[0067] In certain embodiments, the apparatus encompasses using
electromagnetic radiation having a power density of a power density
of at least 0.01 mW/cm.sup.2 at the kidney tissue.
[0068] In certain embodiments, the apparatus encompasses using
electromagnetic radiation having an energy density of at least 0.01
J/cm.sup.2 at the kidney tissue.
[0069] In certain embodiments, the apparatus encompasses using
electromagnetic radiation in at least continuous wave mode.
[0070] In certain embodiments, the apparatus encompasses using
electromagnetic radiation in at least pulsed wave mode.
BRIEF DESCRIPTION OF THE DRAWINGS
[0071] FIG. 1 illustrates a system 10 for applying electromagnetic
radiation energy for the prevention, reduction, or elimination of
acute kidney injury and/or kidney failure.
[0072] FIG. 2 illustrates an embodiment of the system 10 with
multiple applicators 30.
[0073] FIG. 3 illustrates a view of the patient side of an
applicator 30.
[0074] FIG. 4 illustrates an embodiment of the system 10 with a
cooling system 90.
[0075] FIG. 5 illustrates an embodiment of a combination system
100.
[0076] FIG. 6 illustrates an embodiment of a multiple source system
200.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0077] Apparatuses and methods will be described for the purpose of
preventing, reducing, or eliminating tissue injury by the
application of electromagnetic energy. The apparatuses and methods
have application for use in various tissues within diverse regions
of the body. According to the present invention, the
electromagnetic radiation energy is desirably indicated, e.g., for
the prevention, reduction, or elimination of acute kidney injury
and/or kidney failure; and/or before, during, or after the acute
kidney injury and/or kidney failure has begun; and/or before,
during, or after a new kidney injury and/or insult has occurred,
e.g. angiographic procedures, surgical procedures,
contrast-enhanced imaging procedures, any introduction of contrast
media to a patient, etc.
[0078] The terms "injury" or "insult" as they relate to the kidneys
shall mean any tissue injury, insult, or damage resulting from any
or all of the following causes: pre-renal, renal or intrinsic, and
post-renal.
[0079] FIG. 1 schematically shows a compact, portable
electromagnetic energy system 10 that makes it possible to apply
electromagnetic energy to a patient. The system 10 enables the
application of electromagnetic radiation energy to a patient at a
designated treatment location. For example, the system 10 will be
described herein for irradiation of the kidneys for the prevention,
reduction, or elimination of acute kidney injury and/or kidney
failure, understanding it is within the scope of the present
invention that the system 10 may be modified for irradiation of
other tissues within the body.
[0080] As FIG. 1 shows, the system 10 includes at least one
electromagnetic radiation energy generating machine 15. The system
10 also includes at least one electromagnetic radiation energy
applicator 30, which is coupled to the machine 15 via at least one
interconnect 40.
[0081] The machine 15 can be sized and shaped to provide a
lightweight and portable unit suited for use in varying locations,
e.g. bedside, catheterization laboratory, surgical suite, etc. The
machine 15 includes a housing 16 which houses an electromagnetic
radiation energy generating source 20 (not shown). The
electromagnetic radiation energy is delivered to the applicator 30
by an interconnect 40. One or more controllers 50 may also be
housed within the housing 16 (but which could be external of the
housing 16, if so desired). Further desirable technical features of
the applicator 30, interconnect 40, and controller(s) 50 will be
described later.
[0082] The source 20, may be, for example at least one light
emitting diode, laser, and/or laser diode, or multiples and/or a
combination of sources, e.g. laser and light emitting diodes.
[0083] Power for the machine 15 may be supplied from an internal
battery (rechargeable and/or removable, if so desired), external
battery, and/or line source. The provision of battery power frees
the machine 15 from dependency upon electrical service. This
feature makes it possible for the machine 15 to operate in multiple
locations and while the patient is being transported between
locations, e.g. from the holding area to the catheterization
laboratory, from the catheterization laboratory to the holding area
or hospital room, etc.
[0084] The applicator 30 can be sized and shaped to provide a
suitable profile and area to enable irradiation of the intended
tissue. For example, the applicator will be described herein for
irradiation of the kidneys, understanding it is within the scope of
this invention that the applicator may be sized and shaped for
irradiation of other tissues within the body. Additionally, two or
more applicators may be used to provide irradiation of each kidney
and/or other target tissues as shown in FIG. 2.
[0085] In this example, the applicator 30 is sized to irradiate at
least both kidneys, taking into account the size and location of
the kidneys, as well as the divergence of the electromagnetic
energy within the tissue. For example, given the average kidney
size of about 11 cm in height, by 6 cm in width, by 5 cm thick, at
a depth of 7.5 cm, with a separation of 11 cm, a location asymmetry
of 1 cm (the right kidney generally being lower than the left), and
divergence of the electromagnetic radiation within the tissue of 15
degrees, an average applicator 30 would be about 20 cm by 9 cm.
Applicators of varying sizes may be provided based on the patient's
characteristics and/or the desired area of irradiation. The desired
area of irradiation may be greater, equal to, or less than the size
of the target tissue.
[0086] The applicator 30 may comprise a separate component within
the energy path that is either reusable or disposable, or contain
one or more components that are reusable or disposable. For
example, a disposable membrane or component may be used for the
portion of the applicator 30 that is in contact with the patient.
This disposable membrane or component may also include the seal 60
and/or seal sensor 65.
[0087] It may be desirable to secure the applicator to the patient.
As shown in FIGS. 1 and 3, all or at least some area of the
applicator may have the ability to maintain attachment to the
patient, e.g. have an adhesive, to minimize or eliminate movement
of the applicator in relation to the patient, which may be called
the seal 60. The seal 60 may be the entire surface in contact with
the patient or just a region, e.g. the outer edge as shown in FIG.
3. Additional embodiments may comprise a strap, band, or wrap
around the patient to secure the applicator 30, or a separate
component (not shown) that covers at least a portion of the
applicator 30 and secures it to the patient, e.g. an adhesive
strip. The securement of the applicator 30 may be designed to apply
pressure to the patient's skin in the region of the applicator 30.
Securement of applicator 30 by the seal 60, band, or other methods
may serve as to direct the electromagnetic radiation energy to the
patient and/or from eliminating any electromagnetic radiation of
emanating into the surrounding area or environment.
[0088] The shape and size of the applicator 30 may also be provided
such that it applies pressure to the patient in the region of the
applicator 30. The thickness of the applicator may be such that
when the patient is laying on their back, e.g. on a catheterization
laboratory table or surgical table, the applicator 30 applies
pressure to the patient's skin.
[0089] It is desirable to apply pressure to the skin in the area of
irradiation to decrease the amount of blood in the skin which
decreases the absorption and increases transmission of the
electromagnetic radiation to the kidney.
[0090] Additional methods and apparatuses to decrease the
absorption and/or amount of blood and/or the blood vessel diameter
in at least a portion of the area of electromagnetic irradiation is
to decrease the temperature in at least a portion of the area. For
example, this can be effected by cooling at least a portion of the
applicator 30, or by use of an independent cooling apparatus, prior
to and/or concurrently with the delivery of electromagnetic
radiation.
[0091] Additional methods to decrease the absorption and/or amount
of blood and/or the blood vessel diameter in at least a portion of
the area of electromagnetic irradiation are to apply an agent to at
least a portion of the area. For example, this can be effected by
applying a vasoconstrictive agent to at least a portion of the area
prior to and/or concurrently with the delivery of electromagnetic
radiation.
[0092] Additional methods to decrease the absorption and/or amount
of blood and/or the blood vessel diameter in at least a portion of
the area of electromagnetic irradiation are to apply an agent to at
least a portion of the area. For example, this can be effected by
administering a vasoconstrictive agent to the patient prior to
and/or concurrently with the delivery of electromagnetic
radiation.
[0093] Additional methods and apparatuses to decrease the
absorption and/or amount of blood and/or the blood vessel diameter
in at least a portion of the area of electromagnetic irradiation
are to apply an energy source to at least a portion of the area.
For example, this can be effected by applying a vasoconstrictive
energy, e.g. electrical stimulation, to at least a portion of the
area prior to and/or concurrently with the delivery of
electromagnetic radiation.
[0094] Additional methods of providing pressure are to fill at
least a portion of the applicator 30 or space between the
applicator 30 and patient with a fluid. This fluid could be used,
for example, thermal maintenance or cooling, to enhance
transmission of the electromagnetic energy, etc. As shown in FIG.
3, the region 70 not covered by the seal 60 may contain a
transmission gel (not shown) to both enhance electromagnetic
radiation transmission and apply pressure to the patient in the
region of the applicator 30. The transmission gel may be cooled
and/or contain a vasoconstrictive agent.
[0095] The applicator 30 may contain a reflective component 80 or
surface to direct electromagnetic radiation energy towards the
patient, e.g. a reflective surface on the applicator 30 as shown in
FIG. 1.
[0096] The applicator 30 may be constructed of materials such that
the applicator 30 is partially or wholly translucent or transparent
under fluoroscopy, as to not completely inhibit visualization in
the catheterization laboratory.
[0097] The applicator 30 and a portion of the interconnect 40 may
be constructed of materials that enable use within a magnetic
field, e.g. an MRI machine.
[0098] The interconnect 40 couples the machine 15 to the applicator
30. The interconnect 40 may be a separate component or it may be
part of the machine 15 and/or part of the applicator 30. The
interconnect 40 enables the transmission of electromagnetic
radiation from the machine 15 to the applicator 30. In addition,
the interconnect 40 may also include electrical and optical
components, as will be described herein. The interconnect 40 may be
sized to enable the applicator 30 to remain within a sterile field
while the machine 15 is outside the sterile field, when used in
sterile settings.
[0099] A controller 50 may have one or more functions. These
functions may include but are not limited to, power on/off control,
set and/or track the time of electromagnetic radiation delivery,
initiate and/or cease electromagnetic radiation delivery, change
the energy of the source 20 based on the applicator connected to
it, control operation of multiple sources 20 (e.g. laser and light
emitting diode sources), monitor and/or control thermal and/or
cooling components and/or modify source 20 output parameters and/or
energy delivery based on feedback from one or more sensors (e.g.
thermal and/or optical sensors), and control continuous and/or
pulsed mode operation. A controller 50 or other component may also
recognize the status of the system 10 connections (e.g. the machine
15 to the interconnect 40 and/or the interconnect 40 to the
applicator 30) and only allow electromagnetic energy delivery when
properly connected. A controller 50 or other component may also
recognize the type and/or status of the applicator 30 and only
allow electromagnetic energy delivery when the proper applicator 30
is connected.
[0100] Total power output may be adjusted to provide for similar
power density at the target tissue. Provided different sized
applicators, the source could deliver a lower amount of power for a
smaller applicator for the same target tissue. This could be
manually changed at a controller 50 or preprogrammed from
recognition of the applicator size and appropriate adjustment of
the output power by a controller 50. Power level may also be
adjusted based on the patient's characteristics, e.g. size, weight,
body mass index, body surface area, etc.
[0101] Thermal sensing at or near the patient interface may be
desirable. Additionally, thermal control of and/or near the
applicator 30 and/or patient interface may also be desirable. The
thermal control may, for example, be a sensor to monitor the
temperature at and/or near the applicator 30, and/or whereby a
controller 50 adjusts the power output of the source 20, operates
an active cooling system (FIG. 4), changes output mode (to/from
continuous to/from pulsed to/from cycled off and on in either
mode), ceases power output.
[0102] A cooling system 90 as shown in FIG. 4, may be incorporated
into the system 10 or be a separate system. The cooling system 90
may be provided to reduce or eliminate thermal increases of at
least a portion of the patient's tissue and/or to maintain a
desirable thermal range. The cooling system 90 may also be used to
decrease the amount of blood and/or the blood vessel diameter in at
least a portion of the region of electromagnetic radiation.
[0103] Thermal control may be passive, for example, a fluid filled
applicator 30 being filled with and/or incorporating a cold liquid,
solid, or gel. The decreased temperature may be from cold storage
of the component, through a chemical reaction, or other mechanism.
The thermal control may be active, e.g. circulating cold fluid
through at least a portion of the applicator 30 or the region of
the patient interface. A sensor may be used as feedback to control
the cooling system to maintain certain parameters, e.g. a specific
temperature or a temperature range.
[0104] It is desirable to eliminate the need to use safety glasses
when using certain wavelengths and/or energy levels of
electromagnetic radiation energy. The system may enable the
detection of specific wavelengths, and/or multiple wavelengths,
and/or a range and/or ranges of wavelengths and/or the detection of
the intensity of the electromagnetic radiation. Upon detection, at
least one additional operation may be conducted by the system 10,
e.g. cease energy delivery and/or provide a warning indicator
(light, tone).
[0105] An example of a detection system is partially shown in FIG.
3, where an optical seal sensor 65 is placed within the seal 60 of
the applicator 30. The seal sensor 65 is connected the machine 15
via the interconnect 40 or a separate interconnect (not shown).
Upon sensing the delivered wavelength(s) with or through the seal
sensor 65, in the case of the seal 60 not containing all the
electromagnetic radiation, the system 10 conducts an additional
operation.
[0106] Another example of a detection system is an electromagnetic
radiation sensor 66 shown in FIG. 1, which detects the delivered
wavelength(s) should the system 10 irradiate an undesirable area,
e.g. towards persons other than the patient, into the
catheterization laboratory, surgical suite, environment, etc. In
this case, if the minimum threshold energy of the delivered
electromagnetic radiation wavelength(s) is exceeded, the system 10
conducts an additional operation. Minimum threshold energy level
may be determine by sensing ambient energy levels prior to the
delivery of electromagnetic radiation, and having the threshold
level set at a value greater than ambient, e.g. 10% above
ambient.
[0107] It is within the scope of the invention that placement and
type of sensor or sensors may be varied as well as the operation or
operations conducted by the sensor, and/or controller 50, and/or
system 10.
[0108] The electromagnetic radiation may also be delivered either
in continuous mode, pulsed mode, or both. In the case of a single
source 20, the output, for example, may alternate between
continuous mode and pulsed mode, or may begin as continuous mode
and in the case of thermal increases, switch to pulsed mode. In the
case of multiple sources 20, sources 20 may operate in continuous
mode and/or pulsed mode and switch between the two. Various
combinations of continuous mode and pulsed mode operation are
within the scope of the present invention.
[0109] The machine 15 provides efficacious electromagnetic
radiation energy preferably at a wavelength within the visible
and/or infrared range, about 380 nm to 1560 nm, and more preferably
within the red and/or near infrared range, about 635 nm to 980 nm.
Most preferably the wavelength is in the near infrared range at
about 808 nm.
[0110] Multiple sources 20 may generate electromagnetic radiation
energy at the same or different wavelengths and the same or
different energy levels, e.g. light emitting diode(s) operating at
635 nm and a laser operating at 808 nm with similar of different
energy levels. Irradiation of the tissue from each source 20 may
occur at separate time points and/or at the same time and/or
combinations thereof. Operating modes for the delivery of
electromagnetic radiation energy may be continuous wave, pulsed
wave, and/or a combination within each source and between
sources.
[0111] It is preferable that the efficacious power density at the
target tissue be at least 0.01 mW/cm.sup.2. More preferably the
power density at the target tissue is 1 mW/cm.sup.2 to 300
mW/cm.sup.2. Most preferably the power density at the target tissue
is 1 mW/cm.sup.2 to 50 mW/cm.sup.2 in continuous mode and in pulsed
mode the peak power density is 5 mW/cm.sup.2 to 250
mW/cm.sup.2.
[0112] The absorption properties of electromagnetic radiation in
living tissue, organs, blood, etc are affected by the wavelength.
The use of electromagnetic radiation with wavelengths of
comparatively higher levels of absorption in human tissue, e.g. 635
nm versus 808 nm, it may be advantageous to deliver pulsed wave
mode electromagnetic radiation as compared to continuous wave mode
to decrease the thermal load and/or enable the use of higher power
densities at the skin surface.
[0113] The use of pulsed mode electromagnetic radiation at higher
power densities at the skin surface enables higher peak power
densities to be achieved at the kidney tissue and/or potentially
expands the range of useful wavelengths able to deliver efficacious
energy to the kidney tissue.
[0114] Using the example of an applicator 30 sized 20 cm by 9 cm,
estimating 10% of the energy at the skin surface delivered to the
opposite side of the kidneys from the applicator (a depth of about
10 cm), a power density of 10 mW/cm.sup.2 at the opposite side of
the kidney from the applicator, and 15 degrees divergence of the
electromagnetic radiation within the tissue, provides the
parameters listed in Table 1.
TABLE-US-00001 TABLE 1 Skin surface Kidney depth Area of
irradiation 180 cm.sup.2 390 cm.sup.2 Power density 217 mW/cm.sup.2
10 mW/cm.sup.2 Total power 39,000 mW 3,900 mW
[0115] Based on these assumptions, to provide a minimum power
density of 10 mW/cm.sup.2 to the, entire area of both kidneys with
a single applicator 30, the source 20 would need to provide 39 W of
power output from the applicator 20.
[0116] In the example above, the power density was measured at the
opposite side of the kidney from the applicator. However, the
efficacious power density range applies to power densities
delivered to the surface of the kidney and/or within the kidney
and/or at the opposite side of the kidney from the applicator.
[0117] The efficacious wavelength and power density ranges are
suitable to prevent, decrease, or eliminate tissue injury or damage
resulting from, for example, ischemia and/or an ischemic event
and/or external and/or intrinsic toxicity. With respect to the
example provided for the prevention, reduction, or elimination of
acute kidney injury and/or kidney failure; and/or before, during,
or after the acute kidney injury and/or kidney failure has begun;
and/or before, during, or after a new kidney injury and/or insult
has occurred, these efficacious wavelength and power density ranges
are suitable to prevent, decrease, or eliminate tissue injury or
damage resulting from pre-renal, renal or intrinsic, and post-renal
causes.
[0118] An alternative embodiment is to introduce electromagnetic
radiation to at least a portion of kidney tissue, prior to and/or
at least during a portion of the time of and/or after the kidney
injury, and administering a pharmacologic agent (e.g. hydration,
volume expansion, N-acetylcysteine, sodium bicarbonate, ascorbic
acid) prior to and/or at least during a portion of the time of
and/or after electromagnetic radiation, to prevent, reduce, or
eliminate injury to the kidney tissue.
[0119] An alternative embodiment is to introduce electromagnetic
radiation to at least a portion of kidney tissue, prior to and/or
at least during a portion of the time of and/or after an
interventional procedure, and administering a pharmacologic agent
(e.g. hydration, volume expansion, N-acetylcysteine, sodium
bicarbonate, ascorbic acid) prior to and/or at least during a
portion of the time of and/or after electromagnetic radiation, to
prevent, reduce, or eliminate injury to the kidney tissue.
[0120] An alternative embodiment is to provide a combination system
100 with the electromagnetic radiation energy source near and/or
adjacent to, and/or being part of the applicator. This combination
source/applicator 130 as shown in FIG. 5, is for example, a light
emitting diode array as part of the applicator. Combination system
100 may contain and/or a combination controller 150, source/power
supply 117 (internal or external), source/power interconnect 140.
All features described as part of the present invention are
applicable to a combination system 100.
[0121] An alternative embodiment is to provide a multiple source
system 200 with two sources, e.g. a laser and a light emitting
diode array as shown in FIG. 6. For example, the multiple source
system 200 may comprise an applicator containing or near or
adjacent to at least one electromagnetic radiation energy source
and/or at least one source not at, near, or adjacent the
applicator. This multiple source/applicator 230 is for example, a
light emitting diode array 226 as part of the applicator and a
laser source 220 with an output window 225 located at, near, or
adjacent the patient. The multiple source/applicator 230 would
provide for irradiation of the patient by both sources, from the
light emitting diode array 226 and from the laser source through
the output window 225. Multiple source system 200 may contain
and/or at least one multiple source controller 250, multiple source
power supply 217, power/electromagnetic radiation interconnect 240.
All features described as part of the present invention are
applicable to a multiple source system 200.
[0122] Electromagnetic radiation energy may be used with other
energy delivery sources at separate time points and/or at the same
time and/or combinations thereof. Examples of such sources are, but
not limited to, acoustic energy (including ultrasound) and magnetic
energy, and electrical energy. Application of multiple energies may
provide an enhanced effect compared to electromagnetic energy
alone.
[0123] Clinical examples using certain embodiments of the
apparatuses and methods are provided. These examples demonstrate
some of the wide range of possible combinations of certain
embodiments of the present invention. The present invention, is, of
course, not limited to these examples and other uses of this
invention will be apparent to those skilled in the art.
EXAMPLE 1
[0124] Angiography: A patient requires an angiogram. Prior to the
angiogram, the patient is determined to be at high risk for kidney
injury due to the use of contrast media. It is determined to use
system 10 to prevent, reduce, or eliminate kidney injury.
[0125] Transmission gel is cooled and applied to the region 70 of
the applicator 30. Applicator 30 is secured to patient's back using
seal 60, in the region of the kidneys (generally located between
T12 to L3). The applicator 30 is connected to interconnect 40 and
machine 15. The patient lies on their back on the catheterization
laboratory table and by design of the applicator 30, pressure is
applied to the patient's skin in the area covered the applicator
30. Continuous mode transmission of electromagnetic energy from
laser source 20 at 808 nm and a power density of 2 mW/cm.sup.2 at
the far side of the kidneys is initiated 15 minutes prior to first
contrast injection and is delivered for a duration of 10
minutes.
EXAMPLE 2
[0126] Angiography 2: A patient requires an angiogram. Prior to the
angiogram, the patient is determined to be at high risk for kidney
injury due to the use of contrast media. It is determined to use
system 10 to prevent, reduce, or eliminate kidney injury.
[0127] The patient receives and angiogram. After the angiogram, a
vasoconstrictive agent is applied to the patient contact surface of
the source/applicator 230. Transmission gel is cooled and applied
to the region 70 of the applicator 30. Applicator 30 is secured to
patient's back using seal 60, in the region of the kidneys
(generally located between T12 to L3) and by design of the
applicator 30, pressure is applied to the patient's skin in the
area covered the applicator 30. The applicator 30 is connected to
interconnect 40 and machine 15. Pulsed mode transmission of
electromagnetic energy from laser source 20 at 635 nm and a power
density of 10 mW/cm.sup.2 at the surface of the kidneys is
delivered for a duration of 2 minutes. Additional irradiations may
occur at various intervals. These include but are not limited to
once only or one or more times per day for one or more days or one
or more times per day with a day or days without irradiation
interspersed between irradiation days, e.g. skip days.
EXAMPLE 3
[0128] Percutaneous transluminal coronary angioplasty: A patient
requires percutaneous transluminal coronary angioplasty (PTCA).
Prior to the PTCA, the patient is determined to be at high risk for
kidney injury due to the use of contrast media. It is determined to
use system 10 to prevent, reduce, or eliminate kidney injury.
[0129] Transmission gel is applied to the region 70 of the
applicator 30. Applicator 30 is secured to patient's back using
seal 60, in the region of the kidneys. The applicator 30 is
connected to interconnect 40 and machine 15 and machine 15 is
plugged into wall power. The patient lies on their back and by
design of the applicator 30, pressure is applied to the patient's
skin in the area covered the applicator 30. Continuous mode
transmission of electromagnetic energy from laser source 20 at 808
nm and a power density of 10 mW/cm.sup.2 at the surface of the
kidneys is delivered for 2 minutes duration, initiated 30 minutes
prior to first contrast injection. Seal sensor 65 continuously
monitors for 808 nm electromagnetic radiation, does not detect any,
and continues delivery of energy. Continuous wave electromagnetic
radiation energy is delivered again at 6 hours post procedure and
twice per day with a 6 hour separation between irradiations for one
or more days following the procedure. System 10 operates on battery
power while patient is moved between areas, where the machine 15
may be plugged back into wall power. The controller 50, if
operating in continuous mode, may switch to pulsed mode and deliver
pulsed mode electromagnetic radiation energy, e.g. if there is an
increase in temperature. Based on the patient's status, delivery of
electromagnetic radiation energy may be cycled on and off by the
controller 50.
EXAMPLE 4
[0130] Coronary artery bypass graft surgery: A patient requires a
coronary artery bypass graft surgery. It is determined to use
combination system 200, incorporating cooling system 90, to
prevent, reduce, or eliminate kidney injury.
[0131] Transmission gel is applied to the region 70 of the multiple
source/applicator 230. Multiple source/applicator 230 is secured to
patient's back using seal 60, in the region of the kidneys (T12 to
L3). The multiple source/applicator 230 is connected to the
power/electromagnetic radiation interconnect 240 and multiple
source power supply 217. Disposable membrane of multiple
source/applicator 230 is fluid filled to exert pressure on the
patient's skin. A transmission gel containing a vasoconstrictive
agent is applied to the patient contact surface of the
source/applicator 230. Continuous mode transmission of
electromagnetic radiation energy from light emitting diode array
226 at 635 nm and 25 mW/cm.sup.2 and pulsed mode electromagnetic
radiation energy is delivered through output window 225 at 808 nm
and a power density of 25 mW/cm.sup.2 at the kidneys. Two minutes
of electromagnetic radiation is delivered 24 hours prior to the
procedure, during which electromagnetic radiation sensor 66
continuously monitors for electromagnetic radiation in the 600 nm
to 900 nm range, does not detect any amount above the threshold
level, and allows delivery of energy. System 10 operates on battery
power in case the patient needs to be moved until the multiple
source power supply 217 is plugged back into wall power. The
multiple source controller 250 may switch off the 808 nm source and
continue delivery of the 635 nm electromagnetic radiation energy,
now switched to pulsed mode. During irradiation, the cooling system
90 is cycled by the multiple source controller 250 to maintain a
preset temperature and reduce blood flow in the area. Based on the
patient's status, electromagnetic radiation energy may be delivered
from either or both sources at a variety of power levels and modes
of operation, or discontinued. Similarly, an additional 2 minutes
of electromagnetic radiation is delivered to the patient during the
procedure and every 24 hours post procedure for an additional three
days.
[0132] Another preferred embodiment of the present invention is a
method for preventing, reducing, or eliminating acute kidney injury
and/or kidney failure by the application of electromagnetic
radiation energy. At least a portion of one kidney is irradiated
with electromagnetic radiation energy at an efficacious wavelength
and power density and/or before, during, or after the acute kidney
injury and/or kidney failure has begun; and/or before, during, or
after a new kidney injury and/or insult has occurred.
[0133] A method is provided for preventing, reducing, or
eliminating acute kidney injury and/or kidney failure by the
application of electromagnetic radiation energy. At least a portion
of one kidney is irradiated with electromagnetic radiation energy
at an efficacious wavelength and power density and/or before,
during, or after surgery.
[0134] A method is provided for preventing, reducing, or
eliminating acute kidney injury and/or kidney failure by the
application of electromagnetic radiation energy. At least a portion
of one kidney is irradiated with electromagnetic radiation energy
at an efficacious wavelength and power density and/or before,
during, or after the introduction of contrast media to the
patient.
[0135] A method is provided for preventing, reducing, or
eliminating contrast-induced nephropathy by the application of
electromagnetic radiation energy. At least a portion of one kidney
is irradiated with electromagnetic radiation energy at an
efficacious wavelength and power density and/or before, during, or
after the introduction of contrast media to the patient.
[0136] A method is provided for preventing, reducing, or
eliminating contrast-induced nephropathy by the application of
electromagnetic radiation energy. At least a portion of one kidney
is irradiated with electromagnetic radiation energy at an
efficacious wavelength and power density and/or before, during, or
after angiography.
[0137] A method is provided for preventing, reducing, or
eliminating contrast-induced nephropathy by the application of
electromagnetic radiation energy. At least a portion of one kidney
is irradiated with electromagnetic radiation energy at an
efficacious wavelength and power density and/or before, during, or
after contrast-enhanced imaging.
[0138] A method is provided for preventing, reducing, or
eliminating acute kidney injury and/or kidney failure by the
application of electromagnetic radiation energy. Prior to the
introduction of contrast media to the patient, the patient is
identified as being at risk of experiencing acute kidney injury
and/or kidney failure. Electromagnetic radiation energy at an
efficacious wavelength and power density is delivered to at least a
portion of the patient's kidney or kidneys before and/or during
and/or after the introduction of contrast media to the patient.
[0139] A method is provided for preventing, reducing, or
eliminating acute kidney injury and/or kidney failure by the
application of electromagnetic radiation energy. Prior to a
diagnostic and/or interventional procedure, the patient is
identified as being at risk of experiencing acute kidney injury
and/or kidney failure. Electromagnetic radiation energy at an
efficacious wavelength and power density is delivered to at least a
portion of the patient's kidney or kidneys before and/or during
and/or after the diagnostic and/or interventional procedure.
[0140] A method is provided for preventing, reducing, or
eliminating acute kidney injury and/or kidney failure by the
application of electromagnetic radiation energy. Prior to surgery,
the patient is identified as being at risk of experiencing acute
kidney injury and/or kidney failure. Electromagnetic radiation
energy at an efficacious wavelength and power density is delivered
to at least a portion of the patient's kidney or kidneys before
and/or during and/or after the surgery.
[0141] A method is provided for preventing, reducing, or
eliminating contrast-induced nephropathy by the application of
electromagnetic radiation energy. Prior to the introduction of
contrast media to the patient, the patient is identified as being
at risk of experiencing contrast-induced nephropathy.
Electromagnetic radiation energy at an efficacious wavelength and
power density is delivered to at least a portion of the patient's
kidney or kidneys before and/or during and/or after the
introduction of contrast media to the patient.
[0142] A method is provided for changing or maintaining the
temperature of at least a portion of the patient's tissue prior to
and/or during and/or after irradiating at least a portion of the
patient's kidney with electromagnetic energy.
[0143] A method is provided for changing the pressure on at least a
portion of the patient's skin and/or tissue prior to and/or during
and/or after irradiating at least a portion of the patient's kidney
with electromagnetic energy.
[0144] A method is provided for decreasing the absorption and/or
amount of blood and/or the blood vessel diameter in at least a
portion of the area of electromagnetic irradiation prior to and/or
during and/or after irradiating at least a portion of the patient's
kidney with electromagnetic energy.
[0145] A method is provided for sensing at least one
electromagnetic energy wavelength and performing an operation if
that at least one wavelength is detected.
[0146] A method is provided for preventing, reducing, or
eliminating acute kidney injury and/or kidney failure by the
application of electromagnetic radiation energy. At least a portion
of one kidney is irradiated with electromagnetic radiation energy
at an efficacious wavelength and power density and at least one
additional energy is delivered to at least a portion of one kidney
and/or before, during, or after the acute kidney injury and/or
kidney failure has begun; and/or before, during, or after a new
kidney injury and/or insult has occurred.
[0147] A method is provided for preventing, reducing, or
eliminating acute kidney injury and/or kidney failure. The method
comprises introducing electromagnetic radiation of at least one
efficacious wavelength and energy to at least a portion of kidney
tissue, prior to and/or at least during a portion of the time of
and/or after the kidney injury, and administering a pharmacologic
agent prior to and/or at least during a portion of the time of
and/or after electromagnetic radiation, to prevent, reduce, or
eliminate injury to the kidney tissue.
[0148] A method is provided for preventing, reducing, or
eliminating acute kidney injury and/or kidney failure. The method
comprises introducing electromagnetic radiation of at least one
efficacious wavelength and energy to at least a portion of kidney
tissue, prior to and/or at least during a portion of the time of an
interventional procedure, and administering a pharmacologic agent
prior to and/or at least during a portion of the time of and/or
after electromagnetic radiation, to prevent, reduce, or eliminate
injury to the kidney tissue.
[0149] The present invention is not to be considered to be limited
to the foregoing examples and description, but is of the full scope
of the appended claims.
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