U.S. patent application number 11/986939 was filed with the patent office on 2008-03-27 for methods and devices for treating obesity, incontinence, and neurological and physiological disorders.
Invention is credited to Hans Mische.
Application Number | 20080077174 11/986939 |
Document ID | / |
Family ID | 46302047 |
Filed Date | 2008-03-27 |
United States Patent
Application |
20080077174 |
Kind Code |
A1 |
Mische; Hans |
March 27, 2008 |
Methods and devices for treating obesity, incontinence, and
neurological and physiological disorders
Abstract
Methods and devices are disclosed that provide therapeutic
benefit and treatment for a variety of neurologic and physiologic
conditions that include obesity, urinary incontinence, and sensory
system disorders.
Inventors: |
Mische; Hans; (St. Cloud,
MN) |
Correspondence
Address: |
HANS MISCHE
32 HIGHBANKS PLACE
ST. CLOUD
MN
56301
US
|
Family ID: |
46302047 |
Appl. No.: |
11/986939 |
Filed: |
November 26, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10843828 |
May 11, 2004 |
7300449 |
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11986939 |
Nov 26, 2007 |
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09457971 |
Dec 9, 1999 |
6375666 |
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11986939 |
Nov 26, 2007 |
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10056323 |
Jan 24, 2002 |
6764498 |
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11986939 |
Nov 26, 2007 |
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11602714 |
Nov 21, 2006 |
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11986939 |
Nov 26, 2007 |
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11504514 |
Aug 14, 2006 |
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11986939 |
Nov 26, 2007 |
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Current U.S.
Class: |
606/198 |
Current CPC
Class: |
A61B 2017/00247
20130101; A61N 1/36082 20130101; A61M 2210/0693 20130101; A61B
17/320725 20130101; A61F 2/0004 20130101; A61F 2/88 20130101; A61B
2017/32096 20130101; A61M 29/02 20130101; A61F 5/0036 20130101;
A61F 5/003 20130101; A61N 1/36017 20130101; A61F 5/0026 20130101;
A61F 5/0089 20130101; A61N 1/36025 20130101; A61F 2/90 20130101;
A61M 25/10 20130101; A61B 2018/00392 20130101; A61B 2017/2945
20130101; A61F 2/2493 20130101; A61M 25/0069 20130101; A61B
2017/00256 20130101 |
Class at
Publication: |
606/198 |
International
Class: |
A61M 29/00 20060101
A61M029/00 |
Claims
1. A method for treating obesity comprising: positioning a
mechanical device on or near a vagus nerve of an obese patient at a
location of the vagus nerve defining an innervation pathway between
the brain and at least one of a plurality of alimentary tract
organs; and treating the patient's obesity by applying a mechanical
force with the mechanical device to, at least in part, to block
neural activity on the vagus nerve.
2. A method of claim 1 wherein the mechanical device is
biodegradable.
3. A method of claim 1 wherein the mechanical device is connected
to a source of electrical energy.
4. A method of claim 1 wherein the mechanical device is on the
outside of an alimentary organ.
5. A method of claim 1 wherein the mechanical device is located
within an alimentary organ.
6. A method for treating urinary incontinence comprising:
positioning a mechanical device proximate a sacral nerve of a
patient at a location of the sacral nerve defining an innervation
pathway between the brain and the urinary bladder; and treating the
patient's urinary incontinence by applying a mechanical force with
the mechanical device to, at least in part, block nerve impulses on
the sacral nerve.
7. A method of claim 6 wherein the mechanical device is
biodegradable.
8. A method of claim 6 wherein the mechanical device is connected
to a source of electrical energy.
9. A method of claim 6 wherein the mechanical device is on the
outside of an alimentary organ.
10. A method of claim 6 wherein the mechanical device is located
within an alimentary organ
11. A method for treating obesity comprising the steps of:
surgically accessing the vagal nerve on the stomach, positioning a
mechanical device an MSD proximate to the vagal nerve, whereby the
vagal nerve conduction is blocked.
12. A method as in claim 11, wherein the MSD is biodegradeable
13. A method as in claim 11, wherein the MSD is placed with the aid
of laparoscopic surgical procedures.
14. A method as in claim 11, wherein the MSD is placed with the aid
of laproscopic surgical equipment.
15. A method as in claim 11, wherein the MSD is energized by an
electrical generator.
16. A method as in claim 11, wherein the MSD is in the form of an
injectable substance.
17. A method as in claim 11, wherein the MSD is introduced from
within the stomach.
18. A device as in claim 16, wherein nerve blocking agents are
additives.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation-in-part of application
Ser. No. 09/457,971 filed Dec. 9, 1999, now U.S. Pat. No.
6,375,666; application Ser. No. 10/056,323 filed Jan. 24, 2002, now
U.S. Pat. No. 6,764,498; application Ser. No. 10/843,828 filed on
May 11, 2004, application Ser. No. 11/602,714 filed on Nov. 21,
2006, application, and Ser. No. 11/504,514 filed on Aug. 14, 2006.
In addition, this application claims the benefit of, and
incorporates by reference the following applications: provisional
application with Ser. No. 60/727,446 filed on Oct. 17, 2005,
provisional application with Ser. No. 60/708,357 filed on Aug. 15,
2005, provisional application with Ser. No. 60/738,892, filed Nov.
22, 2005, and provisional Ser. No. 60/171,687 filed on Dec. 21,
1999, utility application with Ser. No. 09/733,775 filed on Dec. 8,
2000, and utility application with Ser. No. 09/444,273 filed on
Nov. 19, 1999, and provisional applications with Ser. Nos.
60/169,778; 60/181,651; 60/191,664; 60/181,445; 60/171,760 and
60/183,706.
FIELD OF INVENTION
[0002] The present invention relates generally to the modification
of electrical conduction properties within the body for therapeutic
purposes. The device and methods are disclosed in the context of
treating neurological and physiological disorders that affect a
variety of anatomical organs and tissues.
BACKGROUND OF THE INVENTION
[0003] The current methods of treating a range of neurological and
physiological disorders include the use of systemic drugs, surgical
procedures, tissue ablation, electrical stimulation and gene
treatments. Many of these disorders are manifested by gross
conduction defects or nervous system dysfunction. These
neurological disorders are may affect many types of anatomical
organs and tissues such as brain, heart, muscle, nerves and organ
tissues.
SUMMARY
[0004] In contrast to the prior art, the present invention proposes
treatment of neurological disorders by subjecting selected tissues
to localized mechanical stress. It is difficult to quantify the
level of stress applied to the tissue; operable values will vary
from low levels to high levels dependent on the type and location
of tissue to be treated. The tissues treated can be of many types
within the body such as the brain, heart, muscles, nerves or
organs.
[0005] The invention is disclosed in the context of neurological
disorders but other the inventive technology can also be used to
treat a wide variety of organs and anatomical tissues, and the
treatments of other types of ailments are contemplated as well.
[0006] For example, other applications of this invention include
placement in the pituitary, thyroid, and adrenal glands or in a
variety of organs. In addition, placement of the inventive device
in tumors may suppress growth due to nerve and vascular
compression. The later may prevent blood-born metastasis to other
parts of the body. Likewise, hemorrhaging can be stopped or reduced
by vascular compression using the invention. Pain management in all
parts of the body can be achieved by placement of the inventive
device adjacent to selected nerves. Positioning an inventive
stress-inducing device within the bone can accelerate healing of
broken bones. Disclosure of this invention for neurological and
neuromuscular applications is intended to be illustrative and not
limiting.
[0007] In the treatment of treating cardiac arrhythmias, sometimes
the result of a neuromuscular disorder, the inventive device can be
positioned within, on, through, or adjacent to heart tissue in
order to affect or block electrical conductions that cause symptoms
such as atrial fibrillation, pacing defects, hypotension and
hypertension. The inventive devices and methods can replace the
current practice of RF ablation, surgical procedures (such as the
Maze procedure) and anti-arrhythmia drugs.
[0008] Proper shape, geometry, and placement of the devices can
result in treating the tissue in a similar shape and fashion as
those in the aforementioned treatments. The shape of the treatment
of the typical Maze procedure can be replicated with the proper
physical shape and placement of the inventive device. One
embodiment of a device for a method of treating cardiac arrhythmia
is a device similar to a rivet. The first end of the rivet would
pass through the desired location of the myocardium and be
positioned or seated on the external or internal surface, depending
on approach. The second end of the rivet combination would be slid
along the shaft of the rivet and seated on the opposite side of the
myocardium as the first end of the rivet. The first and second end
would then be advance towards each other resulting in compression,
elongation or mechanical stressing of the myocardial tissue between
and proximate to the rivet. The amount of mechanical stressing
would be controlled by the distance form the first end to the
second end.
[0009] The inventive devices and methods can be used in the
treatment of cardiomyopathy. A primary cause of cardiomyopathy is a
lack of the proteins dystrophin and collagen, the same protein
deficiency that exists in the skeletal muscles and leads to
generalized weakness, wasting and respiratory complications.
Dystrophin and collagen is also needed by cardiac muscle, and its
lack can lead to the loss of cardiac muscle cells under the stress
of constant contraction. It is know that mechanical forces on
tissues can generate increased deposition of collagen fibers within
muscular tissues and strengthen these tissues. In the treatment of
cardiomyopathy, the inventive devices can provide methods of
selectively, broadly or focally, generating mechanical stresses
that result in the therapeutic deposition or increased formation of
collagen fibers. These fibers can then strengthen myocardial
tissues muscle and retard or reversing the effects of
cardiomyopathy. This phenomenon can also be used to treat other
diseases and illnesses that affect tissue strength and connective
tissue orientation, density and volume. In addition, the deposition
or formation of collagen in a predetermined formation or matrix can
allow of nerve growth along the collagen fibers. This can be useful
in forming circuitry for heart conduction pathways as well as the
growth of new nerves to treat spinal injuries or paralysis.
[0010] Many neurological disorders are a result of improper
conduction of electrical currents in various brain tissues. In the
case of Parkinson's disease, the conduction currents in the
thalamus tissues become disorganized and cause conditions
associated with the disease. Likewise, in epilepsy errant currents
cause various levels of seizures. In cases of dystonia, errant
currents originate in the basal ganglia. Depression and
schizophrenia are associated with various electrochemical defects
in other portions of the brain. Also, pain symptoms such as
trigeminal neuralgia are associated with multiple sclerosis.
Paralysis is normally a condition that results from brain injury,
nerve damage, or nerve severing.
[0011] The localized stresses generated by the inventive device
called a Mechanical Stress Device (MSD), will control, inhibit and
direct current conduction by reorienting and/or reorganizing the
electrical bias of the neurological tissues. In addition,
applications for the MSD include compression of selected nerves in
order to control, mediate, or suppress conduction along the nerve
fibers and bundles that are associated with certain neurologic
disorders. The localized stresses also can affect activate or
suppress baroreceptors within arteries, veins, heart tissue and
other tissues and organs. Affecting the baroreceptors can allow
control of various physiologic functions such as sinus rhythm,
sympathetic nervous system, blood pressure, hormonal activity and
metabolism as examples. The inventive devices and methods can
affect the wall of the carotid sinus, a structure at the
bifurcation of the common carotid arteries. This tissue contains
stretch receptors that are sensitive to mechanical and electrical
forces. These receptors send signals via the carotid sinus nerve to
the brain, which in turn regulates the cardiovascular system to
maintain normal blood pressure. The proper method of use and
placement of the inventive device can manipulate the baroreceptors
and achieve regulation of the cardiovascular system in order to
control blood pressure levels. For example, when place proximate to
the carotid sinus, the MSD will apply localized stresses that
modify or modulate the stretch baroreceptors. The MSD can be
complemented with electrical properties and features that can
provide additional affects to the baroreceptors function.
[0012] The MSD can be placed internal or external to arteries and
veins in order to achieve desired activation of baroreceptors. MSD
can be attached to external body plane; skin.
[0013] The MSD can also be utilized as an electrically conductive
device that creates an electrical connection or "bridge" between
targeted anatomical tissues. This technique may facilitate
tissue-to-tissue communication, aid in regenerating nerve
connections, or affect the electrical conduction between the SA and
AV nodes of the heart to overcome pacing defects. Likewise, an MSD
may be placed proximate to the pulmonary vein in order to quell,
block or mitigate abhorrent conduction currents that cause atrial
fibrillation.
[0014] In the case of Parkinson's disease, an MSD is implanted in
the tissues proximate to the thalamus and induce localized stresses
that cause depolarization of the thalamus tissue and thus eliminate
or reduce the symptoms of the disease. In Dystonia, the MSD is
positioned proximately to the basal ganglia and disrupts the
electrical disturbances associated with this disorder.
[0015] The same effect is utilized in the treatment of epilepsy and
other tissues when the MSD is installed in the targeted brain
tissues. An MSD may be place on or adjacent to the vagus nerve in
order to mechanically and or electrically cause stimulation. This
stimulation of the vagus nerve can provide therapeutic treatment of
epilepsy and depression. In addition, MSD stimulation of the vagal
nerve can provide treatment for heart function such as cardiac
ventricular output, rhythm, and systemic blood pressure. The
devices and methods associated with the MSD can also be utilized in
the sinuses and various ventricles of the brain to treat
personality disorders such as schizophrenia or depression.
Additionally, migraine headaches and Tourette's Syndrome may be
treated with the MSD technology. In general, the methods of the
invention guide the placement of the device to ensure a therapeutic
effect from the device.
[0016] In another application, Vestibular disorders, which may
interact with blood pressure and heart rate control, can be treated
and controlled. The vestibular system is one source of information
about uprightness and the system has an affect on the
cardiovascular system. Proper placement and manipulation of the
vestibular nerve with one or more of the MSD design embodiments can
alleviate or control heart rate and blood pressure, as well as
physical balance.
[0017] The MSD technology may also be used to affect the neurologic
response of the digestive system in order to control appetite,
digestion or metabolism. In addition, using the previously invented
methods and devices in this and the cross referenced patent and
applications by Mische, the MSD technology can be used to treat
urge or stress incontinence by affecting nerve conduction and
neuromuscular function. Also, the neurological and neuromuscular
function of the reproductive system can be treated and controlled
by using the MSD technology to modify transport and expression of
hormones, sperm, ovum, and fluids.
[0018] The MSD can be permanently implanted or used acutely and
then removed. Likewise, the device can be fabricated of
biodegradable materials that are placed chronically and allowed to
biodegrade over time.
[0019] The devices and methods can be used alone of in conjunction
with other therapies.
[0020] Examples of electrical therapy with various MSD embodiments
are given and they include pacing, depolarization, ablation, and
tissue alteration.
[0021] MSD devices can be configured so that they deliver treatment
on a temporary basis and are then removed or disabled. For example,
a device such as in FIG. 7 could be used for a temporary treatment
regimen or method. The device would be deployed, positioned,
expanded for a period of time and then retracted and removed when
desired. It could also be used in conjunction with an electrical
stimulator. In another embodiment, the device could be a balloon
construction that is inflated for the treatment period and then
deflated and removed. Additionally, the balloon construction could
also have one or an array of electrodes on the surface, as well be
made of electrically conductive polymers. The treatment regimen
would cease when desired, or if undesired clinical results are
observed. The long term result could be attained when the tissues
which caused the negative illness state were "retrained" by the MSD
type device and further treatment would not be necessary.
Additionally, physical remodeling of the tissue may be the result
of a temporary treatment regimen.
[0022] In some therapeutic cases it may be beneficial to treat in a
method that allows the MSD to be placed at the treatment site and
the delivery system is left engaged for a period of time. This
period of time could be used to observe, measure the effectiveness
of the treatment and/or allow a modification to the treatment
parameters during this period of time.
[0023] MSD devices can be configured so that upon delivery to the
desired location within the tissue or body, they are detached from
the delivery device by unscrewing, detent release, release of
compression or adhesive, or release of other means of securing the
MSD to the delivery device. Other means of securing the MSD to the
delivery device includes forceps, graspers, swaging, jamming,
wedging, friction, tying, magnetics, electrical discharge, melting,
fusing, defusing, grapples, etc.
[0024] MSD devices can be configured so as to release a therapeutic
substance or drug when activated by external or in situ mechanical,
chemical or electrical stimuli. These stimuli can actually be
provided and distributed by the treated/malfunctioning tissues or
tissues proximate to the treated/malfunctioning tissue. The stimuli
can be provided by the tissue from localized spasms originating
from tissue, muscle or organs, as well as abhorrent electrical
signals or biochemical release generated by the diseased/affected
tissues. Delivery of the therapeutic substances could continue
until the tissues are inactivated and associated symptoms are thus
relieved.
[0025] In some clinical cases, it may be necessary to contract a
volume of tissues. Instead of a device being therapeutic in its
expansive state, it may also provide therapy during volumetric
contraction. One example could be a device, similar to FIG. 7, with
grapples or hooks that are placed within a brain ventricle. Upon
activation, the device could grab the walls of the ventricle and
collapse or contract volumetrically. Another embodiment would be a
device that is expanded in order to grasp tissue and then retracted
to contract, elongate or stretch the tissue in a predetermined
direction and stress strain parameters. This invention could be
used in other types of ventricles, cavities or openings. This can
also be used in solid tissues, bones, and organs. MSD technology
can be used to expand ventricles and ducts within brain tissues and
organs so as to improve drainage of fluids, relief of
tissue-to-tissue interface, and to relieve or improve physiologic
pressures within a ventricle, or between a ventricle or duct. For
example, an expandable MSD can provide a device technology and a
treatment method for opening brain ducts and draining excess CSF
from the brain.
[0026] MSD's can provide a form of mechanical dilatation of tissue.
Means of creating tissue dilatation include dilator tools that are
on a shaft with the treatment end having physical features that can
be one or more of the following: diametrically tapered, rounded,
blunt, inverted, or expansive.
[0027] MSD's can provide a substrate for carrying neurons or other
biologic compositions. These types of devices can also be used to
treat many other types of neurologic or physiologic disorders.
[0028] MSD's can use their inherent geometries to prevent migration
after placement at the treatment site. Additionally, complementary
features can be incorporated to the device so that they do not
migrate after placement. These complementary features can include
spikes, hooks, sutures, bumps, voids, threads, barbs, inverted
wedges, filaments, coarse surfaces, adhesives, etc.
[0029] MSD's can be constructed so as to be affected by the change
in temperature of the tissues proximate to the treatment sites. In
some cases, these temperatures may be a result of abhorrent
electrical signals, chemical response or mechanical forces within
the tissues proximate of the treatment site. When the temperature
changes, the physical properties of the MSD changes, as well as the
affects of to the brain (i.e., localized stresses and strains).
This can be accomplished by the use of temperature sensitive
materials such as Nitinol or bi-metallic structures. Other
embodiments may use polymers and metals which change shape when
affected by electrical, chemical, light, or mechanical energy.
[0030] An MSD can be controlled utilizing thermally, pneumatically,
or with magnetostrictive properties of the construct.
[0031] An expandable preformed MSD can be shaped appropriately
(i.e., trapezoid, rectangular, tubular, conical, curved, etc) in
order to bias the therapeutic stresses to tissues and avoid
imparting stressed to tissues. A MSD's expansion can be controlled
by magnetic coupling to a jack, screw or ratcheting mechanism. An
external magnet outside of the body would be manipulated to cause
an interaction with the implanted MSD. The external magnet may spin
and, via coupling, cause a screw to turn and effect the sizing of
the MSD, modifying the stresses imparted to the tissue. Likewise, a
miniature motor assembly in the MSD can be used to drive the
expansion or contraction of the MSD. The expansion and contraction
can be modulated one-time, many times over a period, or at a
repetitive frequency that causes sustained or short term
vibrations. The motor can be operated by an implantable battery
system, utilize a hardwire connection to a generator, coupled
inductively or capacitively, or magnetically
[0032] It has been shown that stress to tissues can result in
localized increase of collagen deposits. These collagen deposits
can improve tissue strength as well as create a matrix for nerve
regeneration. The orientation of stresses created by the MSD
devices can predetermine the deposition of collagen and nerves.
[0033] This phenomena can be use to reconnect severed nerves or
reroute nerves and electrical conduction pathways within tissues
such as the brain and heart.
[0034] MSD can physically, biologically, mechanically, chemically
or electrically modify production of detrimental biochemical/brain
chemistry such as dynorphin or a chemical in the brain called CREB
or cyclic AMP responsive element binding protein, which can cause
depression, anxiety or other maladies. Biological and chemical
additives to the MSD can scavenge or modify detrimental
biochemical/brain chemistry such as dynorphin that can cause
depression or other maladies. Likewise, MSD's can modify the action
potential of the brain cellular make-up by reversal of the
electrical potential in the plasma membrane of a neuron that occurs
when a nerve cell is stimulated; by changing the membrane
permeability to sodium and potassium.
[0035] MSD technology in the form of a balloon can provide a number
of design alternatives and treatment methodologies. For example, a
balloon that conforms to the cortical surface of the brain can
provided constant or variable localized stresses that provide
therapy. The balloon surface could be smooth or flat, or could have
projections or bumps that contact the brain tissue in a
predetermined fashion. This allows for distinct and focal stresses
and strains on brain tissue. The MSD balloon can be controlled by
the connection to an implantable pump mechanism. The pump regulates
the expansion and deflation of the balloon in order to customize
the size and shape of the balloon. This allows for varying levels
of stress to the tissue. The pump can be controlled by a wireless
remote control via the likes of inductive coupling, RF or Digital
communications, etc. Also, the pump could be controlled by hardwire
connection to a control module. The pump could be controlled by
health care personnel or by the patient. A balloon can be shaped
appropriately (i.e., trapezoid, rectangular, tubular, conical,
curved, etc) in order to bias the therapeutic stresses to tissues
and avoid imparting stressed to tissues.
[0036] An MSD can be placed anywhere in the body so that it impacts
neurologic tissues and provides therapy. These areas include Area
25 in the brain to aid in treating depression. A MSD can be placed
proximate the pudenal nerve to treat incontinence.
[0037] All MSD designs can be positioned within tissues in a remote
location from the region where an abhorrent signal is originating.
In this case, the MSD can interrupt a signal pathway, circuit, or
transmission line. For example, an MSD can be placed on the
cortical surface of the brain. Placement and stress applied in the
proper location can treat/control a number of physiologic functions
(i.e., atrial fibrillation, pain, incontinence, blood pressure,
hormonal activity, etc). For example, proper placement on the
cortical surface can help treat Parkinson's tremors by interrupting
or modifying the corto-basal ganglia motor control loop. An MSD may
be formed in a Cartesian coordinate fashion so as to be able to
program the affect to the tissue in the most desirable fashion.
[0038] A MSD can be positioned on the spinal column, spinal nerve
or vertebral nerves to block or dissipate abhorrent signals and/or
pain in remote regions of the body.
[0039] An MSD can be used to treat sciatica by placement directly
on the sciatic nerve or in the spinal column nerve bundle.
Likewise, scoliosis may be treated by selective treatment of nerves
and/or nerve bundles with a MED. Additionally, an MSD can provide
treatment of atrial fibrillation by placing a MSD in the proper
location of the spinal nerve/bundle column to control the
fibrillations
[0040] A MSD in the form of an expandable Deep Brain Stimulator
(DBS) lead can be used to apply controlled stresses, record EEG and
other parameters, connect to generator for stimulus. These actions
can be done simultaneously, sequentially, or in an order determined
by the operator. A MSD in the form of a DBS lead can be used
temporarily or implanted permanently. The expansion of the MSD at
the tip of the lead can be controlled at the proximal end of the
lead by pulling, pushing, twisting, sliding, and mechanisms. The
sizing of a MSD can be controlled by power or information provided
by a DBS or electrical generator. A separate "communication"
channel can be used to send signals or power to the MSD that
dictate the expansion, contraction or vibration of the MSD. The
generator/MSD configuration would thus provide the ability to treat
the patient with complementary effects. An MSD can be configured in
such a fashion so as to accept or "dock" with a standard DBS lead.
Likewise, it can be configured so as be disengaged or
"undocked".
[0041] MSD's that pinch neurologic tissues (brain, connective
tissues, nerves, muscles, organs, etc) alter the electrical and/or
chemical properties. This phenomenon is useful in treating
disorders. MSD's can be implanted that electrically or chemically
neutralize tissue to treat disorders. The tissues electrical
potential can be "grounded" to dissipate the abhorrent signals. The
tissues chemical potential can be changed by affecting the pH of
certain regions by inserting chemicals, drugs, or elements that
modify these regions pH. These substances can be inserted alone or
be part of a complex treatment regimen or on a device (permanent
implant or temporary implant). An MSD device can also be useful in
suppressing or deterring the formation of lesions associated with
multiple sclerosis.
[0042] The MSD can be a partial or complete band or hoop that goes
on or around a portion of the brain or the entire circumference.
The MSD may be activated manually through the skull by having a
portion of the MSD protruding from the skull bone that is manually
activated by the patient or medical personnel. The manually
activated portion can be under the scalp or protrude from the
scalp.
[0043] A MSD can be used to treat ulcer (stomach, intestinal,
diabetic, etc) when placed proximate an ulcer and cutting off blood
flow and neurologic activity. The MSD can be placed endoscopically
or angiographically if needed.
[0044] An MSD electrode can be made with moveable sheath that
allows controlled exposure of one or more electrode elements as
necessary. Exposure may occur by the projection or expansion of the
electrode element(s) in a radially, axial, or longitudinal fashion.
Electrode construction with multiple barbs that project in a
racially and/or longitudinal or axial direction. If desired,
barbs/projections can be electrically and mechanically independent
from each other. An MSD electrode with a moveable sheath will
provide variable exposure and expansion of electrode element. An
MSD electrode can be made so that the operable portion is biased in
a predetermined radial direction from the axis. The radial
direction can encompass from 0 to 360 degrees. In alternative
embodiments, there may be a number of elements that are
independently controllable in order to customize the electrodes
projections and effects.
[0045] As discussed in the previously in the applications and
patents by Mische and Mische et al that this application claims the
benefit of and incorporates by reference, the MSD technology
application can be used to treat a number of physiologic disorders
and provide therapeutic methods for syndromes. These previous
applications and patents teach one skilled in the art the following
methods and devices which are being claimed.
Urinary Disorders
[0046] One particular application is in the treatment of urinary
disorders such as urge urinary incontinence, hyperreflexia of
detrusor (over-active bladder), and vesical-sphincter dyssynergia
as examples. Urge incontinence is associated with persistent
sensation that the person needs to urinate. It causes much
discomfort and anxiety for the sufferer. Current treatment regimens
include the implantation of neurostimulation devices that connect
to the sacral nerve via an electrode, surgical nerve disconnect,
drugs, botox injections and capsaicin injections. All of these
current treatments result in the prevention or blockage of signal
transmission between the bladder nerves and the brain. The
neurostimulators create a nerve block that prevents the urge
sensation from being transmitted to the brain. One of the problems
with the neurostimulator technology is the price, component
reliability, electrode failure, battery life, and the implantation
of an large electrical generator. Treatments with agents and drugs
are not usually a permanent solution. Cutting nerves (e.g.
vagotomy) is permanent. The MSD technology can provide an effective
nerve block by creating a total or partial mechanical nerve block
when placed proximate to the sacral nerve. The block occurs when
the MSD imparts creates localized or direct mechanical stress,
strain or forces on the target nerve or innervation zone. The
mechanical force can result when the nerve or innervation zone is
compressed, expanded, elongated as examples. The implantation
method can be surgical or endoscopically. Other urinary bladder
disorders that may be treated with the inventive method and devices
include non-obstructive urinary retention and urgency-frequency. In
a preferred procedural embodiment, the MSD would be place adjacent,
around, or within the sacral nerve sheath or nerve bundle. The
procedural method would preferably include a test sequence in order
to identify the appropriate nerve site.
[0047] A test stimulation can be applied to the site with
electrical stimulation via an electrode or with mechanical
stimulation. The device used for test stimulation may in fact be
the MSD or a portion of the MSD. When the physician identifies the
nerve site, an MSD can then be advanced to the site. An MSD that
has an adjustable physical profile can then be either adjusted or
left in place for future adjustment. As previously disclosed in the
applications and patents that this patent claims benefit to, the
MSD may be connected to an electrical generator, incorporate an
electrical generator, or be activated by an external electrical
generator. For one skilled in the art, it is apparent that other
forms of activation or complementary therapies and technologies can
be implemented with the MSD and are also incorporated by reference
and claim benefit of the previously disclosed applications and
patents. The sacral nerve can be accessed near the sacrum either
surgically or preferably percutaneously. Sympathetic nerve fibers
coming from the hypogastric plexus of nerves or parasympathetic
nerves traveling to the bladder with pelvic splanchnic nerves can
also be directly affected within the body or near the bladder with
surgical techniques or with minimally invasive methods such as
laparoscopy. The MSD can be implanted through a needle, catheter or
cannula. The MSD can be in many forms as previously described. The
MSD may impinge, pinch, clamp, wrap, stretch, elongate, compact, or
compress the nerve. The MSD fashioned from biodegradable,
bioerodable, or absorbable materials can provide for a
predetermined treatment time-frame. This may allow for the
"retraining" or "reprogramming" of tissues, organs or the
neurologic system and negate or reduce the need for further
therapy. The MSD technology may also be used by placing the MSD
directly into the bladder and expanding it. The stresses imparted
to the bladder wall affects the bladder innervation and relives
symptoms of urge and the affects of diseases such as interstitial
cystitis. The MSD may be place surgically or introduced through the
urethra or through the ureters. The affects may be similar to the
outcomes of hydrodistension of the bladder, although the results
would last as long as the MSD device is left in the bladder. The
MSD for this application can be self-expanding or expanded with a
device such as a balloon catheter. The MSD could be further
activated by heat, electrical energy, or other methods discussed
previous, in order control the expansion or contraction of the
device as needed. The MSD could also be applied or wrapped around
the outer surface of the bladder.
Eating Disorders
[0048] Another embodiment includes the treatment of eating
disorders such as obesity and bulimia. In the treatment of obesity,
the stomach triggers hunger pangs that are transmitted to the brain
telling the person to eat. When the stomach transmits these signals
too often, the person eats to often and thus gains weight due to
the over consumption of food. Current treatments include stomach
surgery to reduce its volume and neurostimulators that stimulate
the vagal nerve. In this type of therapy, the neurostimulators
again are providing treatment by causing a nerve block. The implant
procedure again requires surgery and the implantation of an
expensive electrical generator.
[0049] The MSD technology can provide an effective nerve block by
creating a mechanical nerve block, or down-regulation of the neural
activity, when placed proximate to the vagal nerve near the stomach
or other organ of the gastrointestinal tract. If so desired, the
forces applied to the nerve can be adjusted or predetermined in
order to selectively affect the afferent and efferent nerve
activity, as well at to generally affect the nerve synapses,
neurotransmitters, mechanosensory properties as well as
specifically affect the nerves homotropic and heterotropic
modulation characteristics. It should be noted that the splanchnic
nerve, or splanchnic nerves, may also be the target nerve for MSD
application in the treatment of obesity. Therefore, it should be
understood by one skilled in the art that the MSD inventions,
methods, and devices can be utilized to provide beneficial therapy
my manipulation of the splanchnic nerve or other nerves. In fact,
the vagal, splanchnic nerve, or other nerves may be targeted at the
same time for a combinatory result. Likewise, the celiac ganglia
may also be targeted.
[0050] The MSD implantation method can be performed surgically or
with minimally invasive procedures such as endoscopically or
laparoscopically. Although the following describes treating a vagal
nerve with an MSD, it is also intended to illustrate the use for
other nerve-target application. In the endoscopic embodiment, the
doctor would use many of the same tools to perform the MSD
implantation that are currently used for endoscopic procedures. In
one embodiment, the doctor would utilize a system comprising of an
endoscope and a trocar or hollow needle that pierces the nerve
bundle. Once the needle has penetrated the covering, the MSD is
then advanced through the needle and proximate the vagal nerve, or
within the vagal nerve bundle. Likewise, it can be placed within or
adjacent to the nerve and vascular sheaths. It can also be
implanted on or within the organs, muscle, and vascular system. The
MSD can be a solid, static device that fills a volume or an
expandable device. In either case, the MSD imparts mechanical
stress to the nerve and results in a blocking of nerve
transmission. One or more MSD's can be positioned at varying
intervals along or proximate to the nerve. The MSD can have means
to anchor in place, Such means can be barbs or tines, The MSD can
be connected to an electrical generator or drug pump in order to
get complementary therapeutic responses. As previously discussed,
the MSD can be in the form of an inflatable balloon that
compresses, impinges or stretches nerves in order to create nerve
block or down-regulation. The balloon can be made of an elastomeric
or a non-compliant material. An elastomeric balloon would allow for
varying geometries as the amount of inflation media is injected.
Also, the balloon can be readily adjusted as needed to vary the
treatment level. As discussed previously, the balloon can be
controlled by an internal or external pump. The balloon can also be
placed and operated within the gastrointestinal tract. The balloon
may also be in a tubular form so as to allow passage of food, fluid
and particles through the digestive tract. The MSD can also take
place as injectables such a slurry, paste, gel, liquid, foam, or
dispersions that are injected within or around the nerve bundles.
The injectables can also be loaded with other substances such as
Botox, anesthetics (e.g. lidocaine), stimulants, irritants, or
other substances that can aid in blocking the nerve conduction. As
previously mentioned, the MSD can be made of a biodegradable
material that degrades over a prescribe time in order to regulate
the time period that the nerve is blocked or down-regulated, and
thus regulate the time period of treatment. This inventive method
of treatment allows for a therapeutic time-frame that is a function
of the biodegradable rate of the MSD. For the sufferers of obesity,
the therapeutic timeframe may be of length so that the patient
loses a sufficient and healthy amount of weight. This may allow for
the person to regain an active and healthy lifestyle that may aid
in maintaining a healthy body mass. In another embodiment, the MSD
may provide a partial block of vagal nerve function so that the
intensity of the nerve signals is reduced. This may minimize the
level of hunger that the person experiences thus they may not
ingest as much food.
[0051] In another embodiment, the method of treatment would include
an MSD that is implanted on the stomach and proximate to the vagal
nerve. As the stomach expands with food intake, the MSD in pushed,
pressed, compresses or elongates the vagal nerve so as to affect
the block the conduction, or block, of the nerve. An MSD can be in
the form of a "Chinese finger-lock", a braided-tubular structure.
This type of structure decreases in diameter as its ends are pulled
apart, and expands in diameter as the ends or pushed together. It
can then be placed around the vagal nerve on the surface of the
stomach and fixated at both ends. As the stomach fills with food
and expands, the ends of the MSD structure move apart and its
tubular diameter decreases. As it decreases in diameter, the MSD
compresses the nerve, creates a nerve block, and subsequently the
person feels hunger satiate and reduces or stops eating. This
structure can also be made in a scale large enough to fit over a
portion of the entire stomach. Again, as the person eats and the
stomach fills, the can compress or restrict the stomach and cause
satiety of hunger. Using the expansive properties of this type for
therapeutic purposes allows it to be placed within an organ such as
on the internal wall of the stomach. If the device is attached to
the stomach wall, it will expand as a function of the stomachs
expansion as food is ingested. Therefore, as the stomach expands,
the device expands and exerts force on and through the stomach
lining and affecting the innervation of the stomach. This will
cause mechanical nerve blocks and provide a sense of satiety to the
patient. Again, this device can be made of materials that are
biodegradable, bioerodable or digestible so that the therapy is not
permanent. The remnants can be pass through the intestinal tract or
defecated. Selecting the appropriate materials will allow a for a
predetermined treatment timeline. This device can be inserted
within the stomach surgically, gastropically, endoscopically or
swallowed by the patient. In the embodiment where the device is
swallowed, the expanding MSD can be compacted and coated with a
restricting material, formed into a pill or inserted into a pill
capsule. Upon residing in the stomach, the device would deploy when
the coating, pill or capsule disintegrate in the environs of the
stomach. As it expands, it conforms to the stomach form. It may be
important to have the patient drink enough fluid to expand the
stomach prior to swallowing the MSD. Magnetic materials may be a
component of the MSD so as to interact with a magnetic device in
order to provide the ability to properly orient the swallowed MSD
within the stomach. He magnetic device can be operated outside or
inside the stomach. The swallowed MSD may also be of the form of a
compressed foam material that expands when released. The foam
material could be swallowed in similar formats or delivered by
other aforementioned methods. As the foam form expands, it would
fill a predetermined volume of the stomach and limit food intake,
as well as providing down-regulation or nerve blocking of the
stomachs vagal innervation as it provides mechanical stresses as it
expands. The expanding foam material could actually be taken as a
supplement before or during meals. In a preferred embodiment, the
material could be biodegradable or digestible so that it is not
permanently installed. It can follow the digestion schedule of
co-ingested food and pass through the intestinal tract with the
digested food. The foam material can also have nutritional
supplements, medicines, or diagnostic materials as components.
Medicines within the foam MSD can be beneficial to locally delivery
therapy to stomach ulcers or other alimentary organ maladies. The
foam material may be composed of cellulose bases or other
materials. The foam MSD may expand or swell when chemically
activated by the gastric fluids within the stomach. Another
embodiment can use the foam as substantially tubular form that
approximates a lining of the stomach. The thickness of this lining
can be predetermined. It may also be formed in situ using a
delivery system that injects a form around a balloon that is
inserted within the stomach. The balloon is then collapsed leaving
the formed lining in place. Other methods and devices may be used
to create this lining without departing from the inventive intent.
This type of lining may also be used to treat nasal sinus disorders
while maintaining air flow or to bridge anastomosis (connection) of
various organs and biologic conduits. Although the use of the
expanding foam MSD form has been discussed for use within the
stomach, it is apparent to one skilled in the art and technology
that is cal be used to provide treatment to other body organs,
orifices, and physiology. It can be inserted or injected in, on or
near selected nerves, blood vessels, tracts (i.e, urinary,
reproductive, digestive tracts) and biologic structures.
Alternative geometries, structure, materials and designs can also
be implemented designed in order to achieve similar outcomes. For
example, expanded Teflon, similar to that used for vascular grafts,
can be used to achieve similar results. Metals, polymers, fabrics,
balloon-structures, or combinations of these can be used. The MSD
can also be a dissolvable or metabolizable substance or material.
The MSD technology can also be used to treat the over-production of
acids within the stomach by affecting the conduction of the vagal
nerve structure. Too much stomach acid causes ulcers and stomach
irritations. In all the cases, the procedure can actually be done
in a minimally invasive fashion by accessing the vagal nerve from
within the stomach. In this case, gastroscopy could be utilized to
access the interior stomach and identify the proper location of the
vagal nerve. Once located, the MSD could be advanced in to, or
through the stomach, and proximate to the vagal nerve. MSD designs
such as a clip, a suture or a loop could embrace and compress the
nerve. This method and devices can also be used to treat other
organs with examples such as the urinary bladder, liver, prostate,
and uterus. In another embodiment, the MSD may be a structure that
is inserted within various locations of the gastrointestinal tract
and expands against the internal walls of the selected alimentary
organ. The force applied to the wall affects the vagal nerves
branding into the organ and affects the conduction. In particular
embodiment, the MSD can be permanent, biodegradable or digestible.
The MSD can extend into the esophagus and intestinal tract if so
required. In all of the aforementioned embodiments, the MSD can
function as an electrode, or have one or more discrete electrodes
incorporated for monitoring, stimulation, or both. In all
embodiments, the MSD can be activated or coupled with
electromagnetic or magnetic energy from an external source. The
source may be directed coupled to the MSD or coupled wirelessly via
inductive, capacitive, magnetic and other external energies.
[0052] The MSD technology and methods may also be used to treat
certain types of fecal incontinence by blocking afferent or
efferent nerve conduction between the intestinal tract sphincters
and the brain. Although the nerve of choice would again be the
sacral nerve, other nerves may also be targeted for the
treatment.
[0053] As previously disclosed, the MSD can also be designed to
react with body fluids in order to generate therapeutic results. In
this case, the gastric acids of the gastrointestinal tract can
react with the MSD in a therapeutic fashion.
[0054] The MSD technology and methods can also be used to prevent
vomiting and nausea by affecting the Vagal nerve conduction. This
may be beneficial in the treatment of bulimia and self-induced
vomiting. The MSD can also be used to block or desensitize the
nerves and constrictor muscle within the throat. This would prevent
or limit the ability of the person to cause self-induced vomiting.
The procedure can be easily performed by inserting or injecting an
MSD into the nerves or constrictor muscle via the mouth or nasal
sinus. The same type of MSD devices and methods can be used to
treat persistent or psycogenic coughing. Again, the MSD can be
permanent, temporary or biodegradable. In an alternative
embodiment, the MSD tubular structures can be used to reduce nerve
compression when place around the nerve and the MSD expands
radially, the pressure is removed from the nerve. Carpal tunnel
syndrome may be treated with this method and devices.
[0055] As previously disclosed in the applications and patents that
this patent claims benefit to, the MSD may be connected to an
electrical generator, incorporate an electrical generator, or be
activated by an external electrical generator. For one skilled in
the art, it is apparent that other forms of activation or
complementary therapies and technologies can be implemented with
the MSD and are also incorporated by reference and claim benefit of
the previously disclosed applications and patents.
[0056] Another debilitating neurologic disorder is palmar
hyperhidrosis. This disorder causes the sufferer to have sweaty
palms. Current treatments are similar to the aforementioned
disorders and include a surgical procedure called sympathectomy;
cutting of the sympathetic nerve. Another method that is less
invasive uses phenol to kill the nerve. Using MSD technology and
methods and previously discussed, a permanent or temporary
manipulation of the sympathetic nerve may be prove beneficial.
Again, the preferred embodiment would include minimally invasive
procedures and devices. The placement of the MSD could be guided by
imaging technologies such as CT fluoroscopy. One target for
implantation on could be proximate of the sympathetic junction at
the third vertebra. The MSD can be in the form of a clip or a
device that impinges or pinches the nerve to cause a block. If
necessary the procedure can be reversed by simply removing the MSD.
Individual sympathetic nerve innervation crossing the second rib
level be divided and isolated with the MSD. The Kuntz nerves can be
an isolated nerve target for MSD treatment.
[0057] Other ailments that may benefits from the MSD technologies
ability to block, down-regulate neural activity, inhibit
inflammatory processes include pancreatitis, colitis, irritable
bowel syndrome, dyspepsia, sciatica, ileus, Crohn's disease,
diabetes, dysfunctional valves and sphincters of the alimentary
organs, and gastroesophageal reflux disease (GERD) as examples. The
enteric nervous system, as whole or portions thereof, may also be
manipulated by the MSD technologies. The MSD can also affect the
neurologic function and secretion function of the pancreas, liver
and gall bladder. In addition to providing therapeutic affects, the
MSD technologies may also protect other organs by preventing
antidromic responses or to block adverse side effects of the
signals from electrical-based neurostimulation, drugs, and other
treatments on proximate organs such as coronary, respiratory,
adrenal, and others.
[0058] As mentioned previously, MSD technology can be used to
compress the vascular to control bleeding or hemorrhaging. This is
particularly valuable for the treatment of bloody noses. As shown
in FIG. 2, the MSD can be in a tubular form and similar to a
vascular stent, placed into the nasal and sinus passages, expanded
(e.g. self-expanding, balloon-expanded) at the sight of bleeding
and causing tamponade of the bleeding vascular tissue. The MSD can
coatings such as drugs, minerals, gauze, fabric, lubricants, or
other materials that assist in causing hemostasis. A tubular form
would allow air passage through the MSD and maintain patient
comfort; however other forms can are anticipated. The MSD can also
be connected to an RF cautery generator to assist in creating
coagulation and hemostasis.
[0059] In addition, as FIG. 2 further illustrates and educates one
skilled in the art, the MSD devices and methods can also be used
for rhinoplasty and septoplasty as well as to treat perforated
septum's, sinusitis, and other nasal sinus obstructions. Further
support for devices and methods similar to MSD is covered by Mische
in the pending U.S. patent application Ser. No. 09/733,775 that
claims the benefit of provisional applications with Ser. No.
60/169,778, 60/181,651 and 60/191,664, which discloses devices and
methods for the treatment and support of broken noses and sinus
cavities, and which all are hereby incorporated by reference
herein.
[0060] The MSD technology and methods can treat other neurologic or
physiologic disorders such as Tourette's Syndrome, muscle spasms
and contraction, nerve compression, nausea, tinnitus, vertigo,
Meniere's Disease, Raynaud's Disease, Facial Blushing
(erythrophobia), burning face (hyperpyrexia), rosacea, tardive
dyskinesia, oropharyngeal and other dysphagia, achalasia, sphincter
contractions, pancreatitis, vomiting, persistent or psycogenic
cough. The treatment of these diseases is illustrative and is not
meant to be limiting. With the foregoing detailed description of
the present invention, it has been shown how the objects of the
invention have been attained in a preferred manner. Modifications
and equivalents of disclosed concepts such as those which might
readily occur to one skilled in the art are intended to be included
in the scope of the claims which are appended hereto.
BRIEF DESCRIPTION OF THE DRAWINGS
[0061] Throughout the several views of the drawings several
illustrative embodiments of the invention are disclosed. It should
be understood that various modifications of the embodiments might
be made without departing from the scope of the invention.
Throughout the views identical reference numerals depict equivalent
structure wherein:
[0062] FIG. 1. is a schematic diagram of the head showing
mechanical stress devices implanted within brain tissue.
[0063] FIG. 2. is a schematic diagram of the head showing
mechanical stress devices implanted in the frontal sinus, lateral
ventricle of brain, and between the skull and brain tissue;
[0064] FIG. 3. is a schematic diagram of the head showing the
mechanical stress device delivery system;
[0065] FIG. 4. is a schematic diagram of the head showing the
mechanical stress device delivery system;
[0066] FIG. 5. is a schematic diagram of the head showing the
mechanical stress device delivery system;
[0067] FIG. 6. shows a variety of MSD designs;
[0068] FIG. 7. depicts an MSD, which is manually expanded
contracted;
[0069] FIG. 8. depicts various MSD designs affecting the nerves of
the urinary bladder;
[0070] FIG. 9. depicts various MSD designs affecting the nerves of
the stomach;
[0071] FIGS. 10A, 10B, and 10C shows an MSD being advanced through
the wall of an organ and around a nerve on the organ.
[0072] FIG. 11. shows a variety of additional MSD designs.
DETAILED DESCRIPTION
[0073] The device and methods, which are similar to those discussed
in the patent application with Ser. No. 09/444,273 filed on Nov.
19, 1999 by Mische entitled, "Mechanical Devices for the Treatment
of Arrhythmias" which is incorporated by reference herein.
[0074] Throughout the description the term mechanical stress device
MSD refers to a device that alters the electrical properties or
chemical properties of physiologic tissues. The device may be made
of metal such as Nitinol or Elgiloy and it may form an electrode
for electrical stimulation. One or more electrodes may be
associated with it. The MSD may incorporate fiber optics for
therapeutic and diagnostic purposes. The device may also be made
from a plastic or other non-metallic material. The MSD may also
incorporate a covering of polymer or other materials. The MSD may
also be a composition of different materials. The MSD may be smooth
or have cutting or abrasive surfaces. The MSD may have, but not
limited to, other elements that protrude from the contour of the
surfaces such as spindles, splines, ribs, points, hooks, wires,
needles, strings, and rivets.
[0075] The MSD may be implanted for chronic use or for acute use.
Biodegradable materials that degrade or dissolve over time may be
used to form the MSD. Various coatings may be applied to the MSD
including, but not limited to, thrombo-resistant materials,
electrically conductive, non-conductive, thermo-luminescent,
heparin, radioactive, or biocompatible coatings. Drugs, chemicals,
and biologics such as morphine, dopamine, aspirin, lithium, Prozac,
genetic materials, and growth factors can be applied to the MSD in
order to facilitate treatment. Other types of additives can be
applied as required for specific treatments.
[0076] Electrically conductive MSDs, or MSDs with electrode
elements, may be used with companion pulse generators to deliver
stimulation energy to the tissues. This electrical therapy may be
used alone or in combination with other therapies to treat the
various disorders. Electrical therapies may be supplied from
implantable devices or they may be coupled directly to external
generators. Coupling between the MSD and external generators can be
achieved using technologies such as inductive, capacitive or
microwave coupling as examples. The MSD may also be designed of
geometries or materials that emit or absorb radioactive
energies.
[0077] FIG. 1 is a schematic diagram showing several possible
locations and geometries for the mechanical stress device (MSD)
within the brain 10. A multi-element splined MSD 12 is positioned
proximate to the thalamus 14. In this case, the treatment is for
Parkinson's disease. A coil MSD 16 is positioned proximate to the
trigeminal nerve 18 for treatment of trigeminal neuralgia. A wire
form MSD 11 is positioned adjacent to the spinal cord 13.
[0078] FIG. 2. is a schematic diagram of the head showing 20
various locations of MSDs of a tubular mesh form. An MSD 22 is
located in the lateral ventricle of the brain 24. Another MSD 26 is
positioned between the skull 28 and the brain 24. Within the
frontal sinus 21 an MSD 23 is positioned. To one skilled in the
art, it is obvious that this inventive form of MSD in the nasal
sinuses can be to treat symptoms of sinusitis, maintain
passageways, treat deviated septums and other nasal sinus ailments.
The previously discussed balloon form of MSD can provide an
alternative or additional form of therapy within the same sinus
treatment realm. In addition, heart rhythms may be affected by
proper placement of an MSD within the nasal sinus.
[0079] FIG. 3 and FIG. 4 should be considered together. Together
the two figures show the deployment of an MSD.
[0080] FIG. 3 is a schematic diagram of a tubular mesh type MSD
delivery system. The tubular catheter 32 delivers the tubular mesh
MSD 34. The first stage of implantation is navigation of the device
to the selected site through the skull 36.
[0081] FIG. 4 shows the tubular mesh 42 expanding into position as
it emerges from the lumen of the delivery catheter 44. In the
self-expanding case, the tubular mesh has a predetermined maximum
expandable diameter. The mesh can be made of a shape-memory
material such as Nitinol so that when subjected to body temperature
the structure expands. With shape memory materials, the shape of
the expanded device can be predetermined. Additionally, the device
can be retrieved, repositioned, or removed by using its shape
memory characteristics. In general the MSD may be used acutely or
chronically depending on the disease state of the patient.
[0082] FIG. 5 shows an alternate balloon expanded MSD 52. In this
alternate embodiment a balloon 54 may be used to expand the device
within or proximate to selected tissues. In the balloon expandable
case, the balloon may have a predetermined minimum or maximum
diameter. In addition, the balloon shape can be made to provide
proper placement and conformance of the device based on anatomical
requirements and location. The balloon may be covered with
electrically conductive material. The balloon may be inflated via a
syringe 56 and a pressure gauge 58. For example an electrode site
53 may be connected to a remote pulse generator (not shown) to
stimulate or ablate the site. The stimulator may activate the
electrode either chronically or acutely.
[0083] FIG. 6 shows a variety of possible MSD shapes and
geometries. A tubular mesh 62, a multi-element spline 64, a coil
66, a wire 68 are all acceptable shapes for the MSD although each
shape may be specifically adapted to a particular disease state.
Other anticipated geometries include clam shells, spherical shapes,
conical shapes, screws, and rivets. Although the preferred
embodiments consider expandable geometries, alternate geometries
can be constructed that retract, compress, collapse, crimp,
contract, pinch, squeeze or elongate biologic and physiologic
tissues as long as they provide one or more of the desired
mechanical, electrical or chemical effects on the selected tissue.
Delivery methods for the different possible geometries are
anticipated, too.
[0084] FIG. 7 shows two states of a manually expandable MSD device
71. The device consists of a coaxial shaft 72 and tube 73
arrangement. Attached to the distal end of the shaft 72 and the
tube 73 is a braided mesh tube MSD 71. When the shaft 72 and tube
73 are moved opposite of the other by manipulating the proximal
ends, the MSD 71 expands 75 or contracts 76. In this case, the MSD
71 can be made of any structure that expands and contracts such as
a coil, splined-elements, etc. The various methods of expanding and
contracting these structures are, but not limited to, push-pull,
rotation, and balloon manipulation. In this type of device, direct
connection to either an electrical generator, laser, or monitoring
system can be made. In addition, it be envisioned that a device of
similar nature be connected to a mechanical energy source, such as
rotational or vibrational, in order to increase localized
stresses.
[0085] The MSD can also utilize devices such as a balloon catheter,
expanding devices, or wedges that impart stress or certain levels
of localized trauma to selected tissues. The resultant stress and
trauma affect the tissues so that current conduction in modified.
It is envisioned that any of these devices can be used alone or in
conjunction with other treatment modalities in order to provide the
desired therapeutic result.
[0086] FIG. 8 show a diagram of the urinary bladder 80, its major
nerves, and various designs of MSD's in place. The sacral nerve 81
and pudendal nerve 82 are shown being treated with various MSD
devices. MSD 83 is placed adjacent to the sacral nerve. MSD 84 is a
substantially tubular device that is placed around the sacral nerve
and impinges on it as it retracts in diameter. MSD 85 is a coiled
structure that is placed around the pudendal nerve and can retract
onto the nerve as well act an an electrical inductor and receive RF
energy from an external source. MSD 86 is a solid structure that is
inserted within the pudendal nerve bundle. Like other MSD designs,
this type of structure can be injected within the nerve bundle for
a more direct impact. Like other MSD embodiments, tt can be
permanent or biodegradable. MSD 87 is an expandable form of design
that is inserted within the nerve bundle. MSD 88 is a form that is
wrapped or place around the urethra and pudendal nerve. It can
simultaneously treat urge and can also be used to support the
urethra to treat other types or incontinence such as stress
incontinence. MSD 89, in its implanted state, is a substantially
tubular device that contracts and affects the external innervation
of the bladder. It can also be activated by internal or external
energy sources. A similar type of geometry can be placed within the
bladder and affects the bladder innervation as it expands against
the internal bladder wall.
[0087] In FIG. 9, the stomach 90 is shown at the junction with the
esophagus with its major vagal innervation; anterior vagal nerve
bundle 91 and posterior vagal nerve bundle 92. MSD 93 is placed
around the stomach 90 and the nerve bundles (91 and 92) affecting
the nerve conduction or providing satiety, or both. Similar results
are gained by MSD 94 which impinges on the stomach innervation and
causes a mechanosensory affect with mechanical forces that modifies
the nerve conduction between the stomach and brain. This mechanical
affect blocks or reduces the intensity of the "hunger signal" or
creates the sense of satiety. A structure similar to 94, albeit in
an expanding state, can be placed within the stomach or other
portions of the digestive tract in order to therapeutically impact
the digestive tracts innervation and sensory pathways. MSD 95 is
placed adjacent to a nerve bundle and projects mechanical forces
affecting nerve conduction. MSD 96 is a contracting tubular device
place around a nerve bundle that creates a nerve block as it
impinges on the nerve bundle. MSD 97 is a tubular coil structure
placed around the nerve bundle and, similar to MSD 85, can interact
with RF energy sources. MSD 98 is placed within the nerve bundle.
An electrical connection 99 is shown between MSD 96 and MSD 98.
This is illustrative of the ability to use multiple and various
MSD's designs in a treatment regimen, as well as to exploit a
benefit by electrically interconnecting them.
[0088] FIGS. 10A, 10B, and 10C shows a sequence of placing an MSD
device around a nerve bundle on the surface of an organ. FIG. 10A
shows a delivery device 101 loaded with an MSD 102. The delivery
device has been advanced to either the internal or external wall of
the organ 104. Nerve bundle 103 is located on the opposite side of
the organ wall 104. In FIG. 10B, MSD 102 has been pushed out of the
delivery device 101, through the organ wall 104 and around the
nerve 103. FIG. 10B shows MSD 102 wrapped around the nerve bundle
103 and partially imbedded within the organ wall. In an alternative
embodiment, the MSD 102 can also maintain a portion of itself on
the wall surface of introduction. The MSD 102 can be made of a
preformed material that takes it shape from its inherent elastic or
spring properties. Likewise, it can take its shape by utilizing
shape memory materials or by mechanical deformation. As previously
mentioned, the MSD 102 may also be in the form of a suture, a solid
device such as MSD 86, or other MSD designs previously discussed or
anticipated. In a slight modification to this embodiment, instead
of being advanced through the organ wall 104 and around the nerve
bundle 103, the MSD 102 can be installed directly around the nerve
bundle 103 from the nerve bundle side of the organ wall 104.
[0089] FIG. 11 shows a variety of MSD designs including a cone (1),
cylinder (2), screw (3), pointed rod (4), U-clamp (5), dart (6),
tined rod (7), cylinder with bristles (8), random coil (9),
parallel electrical circuit (10), series electrical circuit (11),
multi-segment form (12), round washer form (13), and a 2 piece
rivet form (14).
[0090] In general, the MSD will have a relaxed or minimum energy
state. However the device or the implantation procedure should
stretch or stress the device so that it applies a persistent force
to the tissues to alter conduction in the strained tissues. In this
sense the implanted MSD is not in a fully relaxed state after
implantation. In some instances the MSD will cause the tissues to
yield or tear generating altered conduction.
[0091] Preferably, the MSD is delivered in a minimally invasive
procedure such via a catheter or other device. X-ray imaging,
fluoroscopy, MRI, CAT scan or other visualization means can be
incorporated into the procedural method. In general the devices
maybe introduced with cannulas, catheters or over guidewires
through naturally occurring body lumens or surgically prepared
entry sites. It should be apparent that other surgical and
non-surgical techniques can be used to place the devices in the
target tissue.
[0092] It should be apparent that various modifications might be
made to the devices and methods by one of ordinary skill in the
art, without departing from the scope or spirit of the
invention.
[0093] In another embodiment, MSD's may also be designed in order
to optimize coupling with external sources of electromagnetic
energies via inductive or capacitive coupling. These energies can
be utilized to electrically activate the MSD in order to impart
voltages and currents to tissues to augment the mechanoelectric and
or mechanochemical effects of the MSD. The MSD can be designed in
such a fashion where it acts similarly to an implanted antenna.
Likewise, the MSD may function primarily as an antenna with little,
if any, mechanoelectric effects. The coupled electrical energy to
this MSD antenna can be directly imparted to the tissues adjacent
to the implanted. The received energy may be used to charge a
circuit that is integrated into the MSD structure that discharges
at a certain level, directing electrical energy to the desired or
adjacent tissue. For example, the circuit may consist of resistors,
capacitors, inductors, waveguides, amplifiers, diodes or other
components that assist in producing the desired function and
effects. The circuit may consist of separate nodes for input and
output voltages or it may have one node for both input and output.
The MSD may also have a discrete antenna, antenna-circuitry or
waveguide for receiving or transmitting energy and/or
information.
[0094] In another embodiment, the MSD may consist of circuitry that
can automatically treat the neurological defects by utilizing the
electrical energy generated by the physiologic tissues in which the
MSD is implanted. In the case of epilepsy, focal tissues generate
errant currents that result in seizure activity. These affected
focal tissues are readily identified with standard CAT or MRI
imaging systems and an MSD can then be implanted into these
tissues. When the errant currents are generated, these currents
charge the circuitry in the MSD. When the circuitry is charged to a
predetermined level, it discharges back into the affected focal
tissues and resolves the errant currents. A RC time constant
circuit can be utilized for this MSD version. Amplifiers, signal
generators and other processing circuitry can be incorporated into
an MSD in order to increase or modify the output.
[0095] In another embodiment, the MSD has a covering to increase
the surface area of the device. The covering can encompass the
entire device or selected portions and can be positioned on the
outside or inside surface. Such a covering can be made of polymers
such as Teflon, polyethylene, polyurethane, nylon, biodegradable
materials or other polymeric materials. The covering can also be
made of a fine metal or polymeric mesh. In all cases, the covering
can be bonded to the surface of the MSD or applied as a loose
sheath-type covering. The covering can have therapeutic materials
applied or incorporated into the covering material itself. Examples
of the therapeutic materials include drugs, stem cells, heparin,
biologic materials, biodegradable compounds, collagen,
electrolytes, radiopaque compounds, radioactive compounds,
radiation-activated substances, or other materials that enhance the
clinical effects and/or procedures.
[0096] In another embodiment, the MSD may have a material that
substantially fills its interior space. Such a material would
prevent formation of spaces or voids once an expandable MSD is
placed. The materials may be fibrous, gels, porous, foam or
sponge-like and may be incorporated with polymers, glass, metals,
radioactive compounds, biologic tissues, drugs, or other suitable
materials that may enhance clinical effective and/or procedures.
The materials would be flexible enough to allow expansion of the
MSD and can be made of polymers, glass, metal, biologic tissues,
drugs, or other suitable materials. Although not limited to,
examples of biologic materials include stem cells, brain cells and
matter, thalamic tissues, and collagen.
[0097] The use of appropriate materials may also provide certain
electrical properties to the MSD that enable it to receive, store
and/or transmit electrical energy. The dielectric properties of
these materials would provide electrical capacitor properties and
function to the MSD. This provides the benefit of creating an
electrical circuit that can receive, store and discharge energy
from various sources. The source may be external generators that
couple capacitively, inductively or magnetically, RF energy from a
predetermined portion of the electromagnetic spectrum to the MSD.
In addition, the source may be an electrical generator connected by
a wire or a cable to the MSD.
[0098] Another means of generating therapeutic electrical energy is
to utilize galvanic effects. Proper material selection and
interaction with physiologic fluids and tissues would result in
galvanic currents or electrochemical reactions being generated by
the MSD. Generally, dissimilar metals or materials would be used in
order to optimize the generation of galvanic currents. These
currents could provide constant therapeutic electrical energy
levels to the desired tissues. This could potentially benefit
patients suffering from Parkinson's, epilepsy, pain, depression,
migraines, etc. The galvanic currents can also be used to energize,
activate, or charge circuits or batteries that provide monitoring,
diagnostic or therapeutic effects. This technology could also be
used for intravascular devices such as stents in order to prevent
thrombosis or hyperplasia or to energize implantable sensors or
monitoring devices. Galvanic devices can also be used to treat
peripheral pain, generate revascularization of myocardial tissues,
treat tumors, provide electrical potential for drug transport into
tissues, treat endometriosis, or to power, energize, activate,
operate or charge other medical devices such as cardiac pacemakers,
defibrillators or other electrical generator based systems.
[0099] In another embodiment, the MSD may be a structure that
completely or partially slices into tissue. The slicing action
cleaves or separates the tissue physically breaking the electrical
conduction paths. In this case, the MSD can reach complete or
partial state of expansion. In the case of complete expansion, the
residual stress to the tissue would be approaching zero, while the
partial expansion would result in a combined clinical effect via
part mechanical stress and part slicing of tissue.
[0100] Additional methods of constructing MSD's include using
three-dimensional structures such as wedges, slugs, clips, rivets,
balls, screws, and other structures that impart stress to the
tissues. Materials such as open-cell polymers, gels, liquids,
adhesives, foams can also be inserted or injected into tissue and
tissue spaces in order to generate the desired amount of stress.
These types of material could also have the additional benefit of
being therapeutic agents or carriers for therapeutic agents.
[0101] Another MSD structure can consist of a balloon that is
positioned at desired location, inflated within the tissue, and
then detached and left in an inflated state. Examples of inflation
media can be fluids, gels, foams, pharmaceuticals, and curable
resins.
[0102] Other embodiments of MSD composition include construction
using magnet and magnetic materials that complement the localized
effects of the MSD by controlling the electrical properties of the
tissues using gradients and fields. In the case where the MSD is
composed of magnet materials, the magnetic field emanating from the
magnetic materials would bias electric fields within the tissues.
This effect can control the direction of current conduction within
the tissues. In the case where the MSD is composed of magnetic
materials that interact with magnetic gradients and fields, an
external magnet placed proximate to the head can physically
manipulate the MSD. Movement of the magnetic would cause movement
of the MSD. The manipulation would result in dynamic stresses to
the tissues adjacent to the MSD, thus affecting the electrical
properties of the tissues and potentially resolving seizures or
tremors.
[0103] Other MSD can be built with an integrated circuit consisting
of a resistor, capacitor, and an inductor. The inductor couples
with the external electromagnetic energy and the resulting current
generated in the inductor charges the capacitor. Based on the RC
time constant of the circuit, the capacitor charges to a certain
level and then discharges directly to the desired tissues and the
errant currents are disrupted by this discharge. A combination of
electromagnetic coupling and direct connection incorporates a
generator with a transmission coil and a ground connection made
directly to the patient, providing a closed-loop circuit. The
ground connection can be made directly to the skin of the patient
using a clip or a grounding pad such as used during electrosurgical
procedures. The pad may be applied to the patient with tape, bands
or adhesives. The ground connection may also be implanted on or
within tissue. External generators may be manually operated by the
patient or other person or may be automatically operated utilizing
monitoring systems that identify seizures or tremors and energize
the MSD. Likewise, automatic circuitry such as the aforementioned
RC-timing circuit can be used. The generators may also be
programmed to energize at a certain predetermined sequence, rate
and level. In the treatment of mania, depression, schizophrenia or
similar disorders, the generator may provide a constant output to
maintain a consistent state of electrical condition of the tissues.
For convenience, the external generators may be attached directly
to the head or incorporated into a hat, helmet, or band.
Alternately, the transmission coil separately may be attached
directly to the head or incorporated into a hat, helmet, scarf or
band. The coil may encompass the entire head or specific portions
in order to attain desired coupling with the MSD. In addition,
strain gauge technology can be incorporated that can measure and
correlate the amount of mechanical stress and strain imparted to
tissues or stress and strains imparted to the device by tissues and
active organs such as vessels, hearts, valves, and other organs and
tissues. Such data can be used to provide a feedback means by which
to control the MSD in order to provide treatment as necessary based
on the physiologic response or activation.
[0104] Likewise, as mentioned previously, the electrical energy
inherent in physiologic tissue may also be the source that
energizes the circuit. Again, it should be noted that various
modifications might be made to the devices and methods by one of
ordinary skill in the art, without departing from the scope of the
invention.
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