U.S. patent application number 10/198829 was filed with the patent office on 2002-12-05 for direct drive movement of body constituent.
Invention is credited to Dormer, Kenneth J..
Application Number | 20020183587 10/198829 |
Document ID | / |
Family ID | 23877840 |
Filed Date | 2002-12-05 |
United States Patent
Application |
20020183587 |
Kind Code |
A1 |
Dormer, Kenneth J. |
December 5, 2002 |
Direct drive movement of body constituent
Abstract
A bio-magnetic system for moving a constituent of a human body
includes at least one magnetically responsive member having an
attachment mechanism including collagen which is bound with an
epithelium of a moveable constituent in the human body. A
bio-magnetic drive system for moving a constituent of a human body
includes a plurality of magnetic microbeads connected in vivo to a
moveable constituent of a human body, and it also includes a
magnetic field source disposed in operative association with the
microbeads but remote from the microbeads and the moveable
constituent to provide a magnetic field to move the microbeads. A
method for moving a constituent in a human body includes
transmitting a signal to interact with a plurality of microbeads
connected to a constituent in a human body such that the connected
microbeads and constituent in the human body move in response. A
more particular method includes providing a plurality of microbeads
in vivo to attach to at least one ossicle in an ear of a human; and
processing a sound to drive the microbeads, including transmitting
a signal to interact with the microbeads such that the microbeads
and the at least one ossicle vibrate in response. Also disclosed
are a kit for use in causing a constituent of a human body to move
and in vivo methods of connecting microbeads to a constituent in a
human body.
Inventors: |
Dormer, Kenneth J.; (Edmond,
OK) |
Correspondence
Address: |
MCAFEE & TAFT
TENTH FLOOR, TWO LEADERSHIP SQUARE
211 NORTH ROBINSON
OKLAHOMA CITY
OK
73102
US
|
Family ID: |
23877840 |
Appl. No.: |
10/198829 |
Filed: |
July 19, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10198829 |
Jul 19, 2002 |
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09473017 |
Dec 28, 1999 |
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6436028 |
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Current U.S.
Class: |
600/25 |
Current CPC
Class: |
A61F 11/04 20130101 |
Class at
Publication: |
600/25 |
International
Class: |
H04R 025/00 |
Claims
What is claimed is:
1. In a hearing assist system for a human ear, the improvement
comprising a plurality of microbeads connected to at least one
ossicle in an ear of a human.
2. In a hearing assist system for a human ear, the improvement
comprising at least one magnetically responsive member having an
attachment mechanism including collagen, the collagen naturally
bonded with an epithelium of a vibratory constituent of the human
ear.
3. In a system for inducing the perception of sound in a human, the
improvement comprising a plurality of magnetically responsive
microbeads connected to a constituent of the human hearing
mechanism, the constituent selected from the group consisting of a
tympanic membrane, a middle ear ossicle, a round window, and an
oval window of a human ear.
4. A middle-ear drive system for a human ear, comprising: a
plurality of microbeads connected to a vibratory constituent in an
ear of a human; and a transmitter to transmit a microbead-operative
output signal within effective range of the plurality of microbeads
such that the microbeads move in response.
5. A middle-ear drive system as defined in claim 4, wherein the
microbeads include ferromagnetic material and the output signal
includes an electromagnetic signal.
6. A middle-ear drive system as defined in claim 4, wherein the
output signal drives the microbeads in opposition to ambient noise
affecting the vibratory constituent.
7. A middle-ear drive system as defined in claim 4, wherein the
output signal includes an electromagnetic signal generated by at
least a part of the transmitter spaced from the human.
8. A middle-ear drive system as defined in claim 4, wherein the
transmitter includes an electromagnetic signal generator.
9. A middle-ear drive system as defined in claim 4, wherein the
transmitter includes a static magnetic field source and means for
moving the source relative to the microbeads.
10. A middle-ear drive system as defined in claim 4, wherein the
microbeads include collagen, the collagen bound to the epithelium
of the vibratory constituent.
11. A bio-magnetic system for moving a constituent of a human body,
comprising at least one magnetically responsive member having an
attachment mechanism including collagen, the collagen bound with an
epithelium of a moveable constituent in the human body.
12. A bio-magnetic system as defined in claim 11, wherein the
constituent is selected from the group consisting of a tympanic
membrane, a middle-ear ossicle, a round window membrane, an oval
window membrane, a larynx, an eyelid, a sphincter, wound tissue,
surgically positioned tissue, nerve tissue, and vascular tissue of
the human body.
13. A bio-magnetic system as defined in claim 11, further
comprising means for vibrating the at least one magnetically
responsive member.
14. A bio-magnetic system as defined in claim 13, wherein the means
for vibrating includes an electromagnetic signal generator to
provide an electromagnetic signal to vibrate the at least one
magnetically responsive member.
15. A bio-magnetic system as defined in claim 13, wherein the means
for vibrating includes a magnet and a motor connected to the magnet
to move the magnet relative to the at least one magnetically
responsive member.
16. A bio-magnetic system as defined in claim 11, further
comprising means for moving the at least one magnetically
responsive member into a held position.
17. A bio-magnetic system as defined in claim 16, wherein the means
for moving includes an electromagnetic signal generator to provide
an electromagnetic signal to move the at least one magnetically
responsive member.
18. A bio-magnetic system as defined in claim 16, wherein the means
for moving includes a magnet cooperatively disposed with the at
least one magnetically responsive member such that the magnetic
field of the magnet acts on the at least one magnetically
responsive member to move the at least one magnetically responsive
member to a desired position.
19. A bio-magnetic system as defined in claim 16, wherein the means
for moving includes another at least one magnetically responsive
member having an attachment mechanism including collagen, the
collagen bound with an epithelium of tissue in the human body such
that the magnetically responsive members react to each other to
move.
20. A bio-magnetic system as defined in claim 19, wherein the
magnetically responsive members are magnetic with opposite magnetic
polarities between the first-mentioned at least one magnetically
responsive member and the another at least one magnetically
responsive member.
21. A bio-magnetic system as defined in claim 19, wherein the
magnetically responsive members are magnetic with the same magnetic
polarity between the first-mentioned at least one magnetically
responsive member and the another at least one magnetically
responsive member.
22. A bio-magnetic drive system for moving a constituent of a human
body, comprising: a plurality of magnetically responsive microbeads
connected in vivo to a moveable constituent of a human body; and a
magnetic field source disposed in operative association with the
microbeads but remote from the microbeads and the moveable
constituent to provide a magnetic field to move the microbeads.
23. A bio-magnetic drive system as defined in claim 22, wherein the
magnetic field source is outside the human body.
24. A bio-magnetic drive system as defined in claim 22, wherein the
magnetic field source is inside the human body.
25. A bio-magnetic drive system as defined in claim 22, wherein the
moveable constituent is selected from the group consisting of a
tympanic membrane, a middle-ear ossicle, a round window membrane,
an oval window membrane, a larynx, an eyelid, a sphincter, wound
tissue, surgically positioned tissue, nerve tissue, and vascular
tissue of the human body.
26. A bio-magnetic drive system as defined in claim 22, wherein the
magnetic field source includes an electromagnetic signal generator
to provide an electromagnetic signal to move the magnetically
responsive microbeads.
27. A bio-magnetic drive system as defined in claim 22, wherein the
magnetic field source includes a permanent magnet.
28. A bio-magnetic drive system as defined in claim 27, wherein the
magnetic field source further includes a motor connected to the
magnet to move the magnet relative to the magnetically responsive
microbeads.
29. A bio-magnetic drive system as defined in claim 22, wherein the
magnetic field source includes a magnet cooperatively disposed with
the magnetically responsive microbeads such that the magnetic field
of the magnet acts on the magnetically responsive microbeads to
move the moveable constituent to a desired position.
30. A bio-magnetic drive system as defined in claim 22, wherein the
magnetic field source includes another plurality of magnetically
responsive microbeads having an attachment mechanism including
collagen, the collagen bound with an epithelium of tissue in the
human body such that the magnetically responsive microbeads react
to each other to move.
31. A bio-magnetic drive system as defined in claim 30, wherein the
magnetically responsive microbeads are magnetic with opposite
magnetic polarities between the first-mentioned plurality of
magnetically responsive microbeads and the another plurality of
magnetically responsive microbeads.
32. A bio-magnetic drive system as defined in claim 30, wherein the
magnetically responsive microbeads are magnetic with the same
magnetic polarity between the first-mentioned plurality of
magnetically responsive microbeads and the another plurality of
magnetically responsive microbeads.
33. A kit for use in causing a constituent of a human body to move,
comprising: a plurality of biologically compatible, magnetically
responsive microbeads coated with a composition that connects the
microbeads to a selected constituent of a human body; a signal
processor including a receiver to receive an input signal and
further including a transmitter responsive to the receiver to
transmit a magnetic output signal within effective range of the
plurality of magnetically responsive microbeads; and a package
containing the plurality of microbeads and the signal
processor.
34. A kit as defined in claim 33, further comprising a physiologic
solution and a container having the physiologic solution and the
microbeads admixed and contained therein, wherein the container
with the admixture is disposed in the package.
35. A kit as defined in claim 34, wherein the signal processor is
in the form of a deep canal ear mold.
36. A method for moving a constituent in a human body, comprising
displacing with a magnetic field a plurality of magnetically
responsive microbeads connected to a constituent in a human body
such that the connected microbeads and constituent move in the
human body.
37. A method as defined in claim 36, wherein displacing with a
magnetic field includes generating the magnetic field
electromagnetically.
38. A method as defined in claim 36; wherein displacing with a
magnetic field includes electromagnetically generating a
time-varying magnetic field.
39. A method as defined in claim 36, wherein displacing with a
magnetic field includes generating a moving magnetic field by
moving a static magnetic field relative to the microbeads.
40. A method as defined in claim 36, wherein the magnetic field is
a stationary, static magnetic field.
41. A method as defined in claim 36, wherein the microbeads are
connected by collagen-integrin bonds with the constituent inside
the human body.
42. A method as defined in claim 36, further comprising selecting
the constituent from the group consisting of a tympanic membrane, a
middle-ear ossicle, a round window membrane, an oval window
membrane, a larynx, an eyelid, a sphincter, wound tissue,
surgically positioned tissue, nerve tissue, and vascular tissue of
the human body.
43. A method for moving a constituent in a human body, comprising
transmitting a signal to interact with a plurality of microbeads
connected to a constituent in a human body such that the connected
microbeads and constituent in the human body move in response.
44. A method as defined in claim 43, wherein the microbeads are
connected by collagen-integrin bonds with the constituent inside
the human body.
45. A method of aiding a human to hear, comprising vibrating with
magnetic signal transmission a plurality of magnetically responsive
microbeads connected to at least one human ear constituent.
46. A method as defined in claim 45, wherein the microbeads are
connected by collagen-integrin bonds on the epithelium of the at
least one human ear constituent.
47. A method of aiding a human to hear, comprising: providing a
plurality of microbeads in vivo to attach to at least one ossicle
in an ear of a human; and processing a sound to drive the
microbeads, including transmitting a signal to interact with the
microbeads such that the microbeads and the at least one ossicle
vibrate in response.
48. A method as defined in claim 47, wherein the microbeads include
magnetically responsive material and transmitting a signal includes
propagating a time-varying electromagnetic signal to within
effective range of the microbeads.
49. A method as defined in claim 47, wherein the microbeads include
magnetically responsive material and transmitting a signal includes
moving a permanent magnet such that the magnetic field of the
magnet is moved relative to the microbeads.
50. An in vivo method of connecting microbeads to a constituent in
a human body, comprising: aspirating a plurality of magnetically
responsive microbeads and accompanying physiologic solution into a
syringe from an admixture of magnetically responsive microbeads and
physiologic solution; inserting a needle of the syringe into the
human body toward the constituent; and ejecting at least a portion
of the microbeads and physiologic solution from the syringe onto or
into the constituent.
51. An in vivo method of connecting microbeads to a constituent in
a human body, comprising: moving a brush into an admixture of
magnetically responsive microbeads and physiologic solution such
that a plurality of magnetically responsive microbeads and
accompanying physiologic solution adhere to the brush; inserting
the brush into the human body toward the constituent; and
transferring at least a portion of the microbeads and physiologic
solution from the brush onto the constituent.
Description
BACKGROUND OF THE INVENTION
[0001] This invention relates to a bio-magnetic drive system, kit
and method for moving a constituent in a human body. In a
particular application, the invention relates to a hearing assist
system, device and method, but a number of other applications are
disclosed to exemplify the invention further. The present invention
also relates to a method of connecting magnetically responsive
microbeads to a constituent in a human body.
[0002] Constituents of a human body sometimes need to be moved in
vivo by a force generated other than by the body itself. The
constituents can be any mobile part of the body. Non-limiting
examples include soft or hard body tissue, such as skin, muscle,
vessels, organs, bones, connective matter, nerves, and brain mass.
The movement can be with regard to achieving any desired function.
Non-limiting examples include the following.
[0003] The ossicles of the middle ear are normally moved by changes
in air pressure on the surface of the tympanic membrane, in the
normal hearing transduction mechanism. The tympanic membrane is
connected to the malleus which is connected to the incus which is
connected to the stapes in the middle ear ossicular chain. When
displacement of these is conveyed to the inner ear (cochlea), then
the transduction is made by sensors which convert into nerve action
potentials to the hearing centers of the brain. Amplification of
hearing would be attained if such movements of an ossicle were
amplified. In a damaged middle ear, normal ossiclar displacement or
transmission does not occur and some artificial movement technique
may need to be used.
[0004] The larynx as part of the vocal mechanism contains vocal
folds that normally are held in apposition and with tension such
that passage of air over the vocal folds produces vibration and the
generation of sounds which are shaped as speech by the oral cavity.
Such holding of vocal folds in apposition sometimes fails with
disease and a mechanism to appose the folds would be beneficial in
preserving speech. One prior mechanism includes a piece of silicone
rubber surgically implanted next to the paralyzed vocal fold to
wedge the vocal cords in apposition. The eyelid must close to
cleanse and protect the surface of the eye (cornea) thousands of
times each day. People with motor disease or neurologic problems
often have difficulty closing their eyelids and eyes become prone
to infection and vision is impaired.
[0005] Wound closure for delicate plastic surgical applications is
often accomplished with small sutures that require removal and
often leave their own scars. If the tissue at the wound could be
moved and held together without suturing, no suture scars would
occur and no secondary visit to a surgeon for removal of the
sutures would be needed. Preferably such closures would be more
complete, providing a better barrier against infection and scarring
due to infection.
[0006] In surgical applications, a surgeon may want tissue to
remain in one location (for example, during the healing process,
toward the natural anatomical position of the respective body
part). In middle ear surgery to reconstruct the middle ear by
prostheses or tissue, often large blocks of connective tissue or
gelatin foam are used to form a cast to position and hold a
prosthesis or operated or freed ossicle in place. This technique
requires months of healing for tissue and/or gelatin foam-blood
clots to be removed, so another technique for moving and holding
the tissue is desirable.
[0007] The closure of sphincters in the body can fail. For example,
the lower esophageal sphincter when inadequately closed allows acid
reflux from the stomach and this can cause damage to the esophagus
and lung (aspiration of acid). As another example, the sphincter
for closure of the bladder so as to retain urine sometimes requires
surgery that includes repositioning and twisting of the stomach and
suturing of the lower esophageal sphincter. An improved technique
for operating the sphincter could improve lives by minimizing
invasive surgery.
[0008] Another sphincter application pertains to incontinence
following prostate surgery. Patients can be left incontinent
because of incomplete closure of the sphincter associated with the
prostate. Incontinence may be the result of loss of urinary bladder
control. There is the need for improved means and method for
enabling closure of body openings.
[0009] Another closure application is in erectile dysfunction (ED).
This is a circulatory problem where venous engorgement is required
for penile erection. Presently such venous engorgement (dilation of
veins and filling with blood) is accomplished by a vasodilator such
as Viagra. A more cost-effective and non-pharmacological means for
increasing engorgement is desirable. A means for increasing venous
resistance would cause venous engorgement upstream, resulting in
penile erection with the potential elimination of impotence.
[0010] Very delicate nerve surgery where two ends of a severed
nerve are sewn together is tedious, long and difficult. The sheath
covering the nerve must also be restored for the nerve to live and
grow. It is desirable to have some way to manipulate the severed
nerve and/or its myelin sheath to cause it to be reapposed without
the added insult of needle punctures and sutures adversely
affecting the healing process.
[0011] Another application of the present invention is for opening
(or closing) of channels or pores or blood vessels. Such openings
are important in the circulation of the body as this is the means
of getting nutrients, gases and fluids to the tissues. The opening
of blood vessels is accomplished normally by a pressure from
within, by shear hydrostatic pressures. This does not, however,
always occur. For example, if an atherosclerotic plaque is
partially occluding someone's carotid artery and impedes blood flow
to the head and brain, this vessel needs to be opened immediately
or stroke or brain damage could occur. Atherectomy is a lengthy and
dangerous procedure to remove the plaque. If, however, the lumen of
the vessel could be opened easily and a person treated with lipid
reducing medication, surgery on the neck could possibly be avoided
and a life saved.
[0012] Although any of the foregoing, and others, could be used,
assisting human hearing and moving parts of the human hearing
mechanism will be used as the specific context for further
describing the background of the invention and the preferred
embodiments of the invention itself
[0013] There are many different reasons why some people have
hearing impairment. In general, however, sound entering the outer
ear canal does not get adequately transmitted to the inner ear
and/or transduced, then sent by auditory nerve. In some instances,
this can be solved by amplifying the sound with a hearing aid put
into the outer ear canal. In other cases, a device that
electrically stimulates the auditory nerve directly needs to be
implanted in the cochlea (the inner ear). In still other
situations, a middle ear device that creates mechanical vibrations
is needed. There have been disclosures of such middle ear devices,
including magnetic, electromagnetic and piezoelectric types. A
particular implementation of the present invention pertains to such
middle ear actuation, and specifically magnetic and electromagnetic
middle ear devices.
[0014] A person's normal middle ear includes a chain of three small
bones, or ossicles. The malleus, the incus, and the stapes form
this chain; and when functioning normally, these ossicles transmit
mechanical vibrations from the eardrum, or tympanic membrane, at
the end of the outer ear canal to the oval window, the entrance
into the inner ear. When something is wrong in this ossicular
chain, however, such transmission does not occur sufficiently to
stimulate the cochlea and, therefore, auditory nerve. Another type
of transmission deficiency occurs in sensorineural hearing loss,
where some of the hair cells of the inner ear are not
functioning.
[0015] One general solution to hearing problems caused by middle
ear deficiencies and/or sensorineural hearing loss is to implant a
magnet in the middle ear and to cause the magnet to vibrate in
response to environmental sounds. The magnet is connected, for
example, such that it provides enhanced mechanical vibrations to
the oval window, either through an adequately functioning portion
of the middle ear's ossicular chain to which the magnet is attached
or through an implanted prosthesis carrying the magnet and
communicating with the oval window. Greater vibration of the
ossicles creates greater fluid motion in the cochlea and
amplification of sounds to the person. Such is the function of
implantable hearing devices, that is, greater mechanical vibratory
input from the middle to the inner ear.
[0016] A number of middle ear magnet attachment devices have been
proposed. Some clip to an ossicle, or part of one; others abut
ossicular surfaces. Clamping or clipping onto living bone
(ossicles) can compromise oxygen and nutrient delivery and cause
bone erosion. Some can add mass loading to the ossicles, and some
use probes that require holes placed into ossicles. Some implants
are glued to living bone with a composition that may not be
compatible with living bone and surface tension forces that seek to
hold an implant onto the living epithelium of the round window of
the inner ear. In at least one type, the eardrum is cut and the
incudo-stapedial joint severed to allow a magnetic device to be
hung on the reapposed joint. There is the need for apparatus and
methodology by which the ossicular structure in the ear can be
moved, but without some or all of the aforementioned shortcomings.
In view of the other examples above, there is the broader need for
apparatus and methodology by which other constituents in a human
body likewise can be forcibly moved.
SUMMARY OF THE INVENTION
[0017] The present invention overcomes the above-noted and other
shortcomings of the prior art by providing a novel and improved
hearing assist system, device and method. A particular aspect of
this includes a method of connecting a plurality of microbeads to
an ossicle in an ear of a human; however, the method of the present
invention encompasses connecting to other body constituents as
well. In other broader aspects, the present invention provides a
bio-magnetic system, kit and method for moving a constituent in a
human body. The present invention is applicable for any tissue in
the body that would benefit (e.g., correctively or therapeutically)
by being moved using external means other than the natural body
processes that move the tissue. The present invention enables in
vivo constituents of a human body to be moved in response to forces
generated other than by the body itself. Implanted collagen-coated
magnetically responsive microbeads permit soft tissue to grow onto
and biologically attach to the microbeads as a normal biological
process. These magnetically responsive elements can then be
electromagnetically or magnetically manipulated to directly,
mechanically drive the body constituent(s) to which the microbeads
are attached.
[0018] In the particular implementation related to hearing, the
present invention facilitates implanting magnetically responsive
material in a middle ear of a human. The present invention allows
for biologically compatible, non-necrotizing, lightweight,
encapsulated magnetically responsive material to be implanted onto
the ossicular chain. This can provide reduced loading of the
ossicular chain (e.g., in comparison to magnets in titanium
canisters) and improved magnetic coupling. The ossicular chain does
not need to be severed (thereby simplifying or reducing the
surgical implant procedure), and blood supply/nutrient flow can be
maintained. Such mounting may provide for lifetime implantation on
all or part of an ossicular chain.
[0019] A particular implementation of the present invention can be
defined as an improvement in a hearing assist system for a human
ear. This improvement comprises a plurality of microbeads connected
to at least one ossicle in an ear of a human. Another definition of
the improvement is as a plurality of magnetically responsive
microbeads connected to a constituent of the human hearing
mechanism, the constituent selected from the group consisting of a
tympanic membrane, a middle ear ossicle, a round window, and an
oval window of a human ear.
[0020] The present invention also provides a middle-ear drive
system for a human ear. This comprises a plurality of microbeads
connected to a vibratory constituent in an ear of a human, and a
transmitter to transmit a microbead-operative output signal within
effective range of the plurality of microbeads such that the
microbeads move in response.
[0021] Because the present invention has application beyond use in
the middle ear, the invention can also be described as a
bio-magnetic system for moving a constituent of a human body. This
system comprises at least one magnetically responsive member having
an attachment mechanism including collagen, the collagen bound with
an epithelium of a moveable constituent in the human body.
[0022] Another definition of the present invention, as a
bio-magnetic drive system, includes a plurality of magnetic
microbeads connected in vivo to a moveable constituent of a human
body, and it also comprises a magnetic field source disposed in
operative association with the microbeads but remote from the
microbeads and the moveable constituent to provide a magnetic field
to move the microbeads. The magnetic field source can be either
inside or outside the human body.
[0023] The present invention also provides a kit for use in causing
a constituent of a human body to move. The kit comprises a
plurality of biologically compatible, magnetically responsive
microbeads coated with a composition that connects the microbeads
to a selected constituent of a human body. The kit further
comprises a signal processor that includes a receiver to receive an
input signal and a transmitter responsive to the receiver to
transmit a magnetic output signal within effective range of the
plurality of magnetically responsive microbeads. The kit also
comprises a package containing the magnetic microbeads and the
signal processor. The kit may further comprise a physiologic
solution and a container having the physiologic solution and the
microbeads admixed and contained therein, wherein the container
with the admixture is disposed in the package.
[0024] The present invention also provides methods related to the
above. In one definition, a method for moving a constituent in a
human body comprises transmitting a signal to interact with a
plurality of microbeads connected to a constituent in a human body
such that the connected microbeads and constituent in the human
body move in response. In another definition, the method comprises
displacing with a magnetic field a plurality of magnetically
responsive microbeads connected to a constituent in a human body
such that the connected microbeads and constituent move in the
human body. In a preferred embodiment, the microbeads are connected
by collagen-integrin bonds with the constituent inside the human
body. The methods defined above can further comprise selecting the
constituent from the group consisting of a tympanic membrane, a
middle-ear ossicle, a round window membrane, an oval window
membrane, a larynx, an eyelid, a sphincter, wound tissue,
surgically positioned tissue, nerve tissue, and vascular tissue of
the human body.
[0025] A more particular method of the present invention aids a
human to hear. This method comprises vibrating with magnetic signal
transmission a plurality of magnetically responsive microbeads
connected to at least one human ear constituent. The method of
aiding a human to hear can also be defined as comprising: providing
a plurality of microbeads in vivo to attach to at least one ossicle
in an ear of a human; and processing a sound to drive the
microbeads, including transmitting a signal to interact with the
microbeads such that the microbeads and the at least one ossicle
vibrate in response.
[0026] The present invention further provides an in vivo method of
connecting microbeads to a constituent in a human body, comprising:
aspirating a plurality of magnetically responsive microbeads and
accompanying physiologic solution into a syringe from an admixture
of magnetically responsive microbeads and physiologic solution;
inserting a needle of the syringe into the human body toward the
constituent; and ejecting at least a portion of the microbeads and
physiologic solution from the syringe onto or into the constituent.
The in vivo method can also be defined as comprising moving a brush
into an admixture of magnetically responsive microbeads and
physiologic solution such that a plurality of magnetically
responsive microbeads and accompanying physiologic solution adhere
to the brush; inserting the brush into the human body toward the
constituent; and transferring at least a portion of the microbeads
and physiologic solution from the brush onto the constituent.
[0027] Therefore, from the foregoing, it is a general object of the
present invention to provide a novel and improved hearing assist
system, device and method. A particular aspect of this includes a
method of connecting a plurality of microbeads to an ossicle in an
ear (or to another suitable constituent) of a human. It is a
broader object, however, to provide a bio-magnetic system, kit and
method for moving a constituent in a human body. Other and further
objects, features and advantages of the present invention will be
readily apparent to those skilled in the art when the following
description of the preferred embodiments is read in conjunction
with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0028] FIG. 1 is a block diagram representing a driver and a
constituent of a body to which have been attached microbeads that
move in response to operation of the driver.
[0029] FIG. 2 is a block diagram representing an electromagnetic
transmitter inside or outside a living human body having a
constituent to which magnetically responsive microbeads are
attached.
[0030] FIG. 3 is a block diagram representing a signal processor
that has both a receiver, to receive an external signal, and a
transmitter, to transmit an actuating signal to microbeads on a
constituent.
[0031] FIG. 4 is a block diagram of a signal processor in a hearing
assist system having microbeads connected to an ossicle in a middle
ear of a human.
[0032] FIG. 5 is an illustration of portions of a human ear with
which a hearing assist system of the present invention is used.
[0033] FIG. 6 is an illustration of portions of a human ear with
which a hearing assist system of the present invention is used at a
different locus from that shown in FIG. 5.
[0034] FIG. 7 is an illustration of portions of a human ear with
which a hearing assist system of the present invention is used at
still another site different from those shown in FIGS. 5 and 6.
[0035] FIG. 8 is an illustration of portions of a human ear with
which a hearing assist system of the present invention is used at a
further locus different from those shown in FIGS. 5-7.
[0036] FIG. 9 is an illustration of portions of a human ear with
which a hearing assist system of the prevent invention is used in
conjunction with another middle ear hearing assist device.
[0037] FIG. 10 is a block diagram representing another embodiment
of the present invention including a motor-driven permanent magnet
inside or outside a living human body.
[0038] FIG. 11 is a block diagram representing another embodiment
of the present invention including a permanent magnet inside or
outside a living human body.
[0039] FIG. 12 represents application of the present invention in
tissue-to-tissue movement.
[0040] FIG. 13 represents a vessel (e.g., a vein) to which
microbeads are attached for use in accordance with the present
invention.
[0041] FIG. 14 represents another embodiment of the present
invention used with vascular tissue. FIG. 15 represents a sphincter
with which an embodiment of the present invention is used.
[0042] FIG. 16 is a block diagram illustrating one or more single
member embodiments of the present invention.
[0043] FIG. 17 illustrates a kit of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0044] The present invention permits a constituent (i.e., one or
more constituent if consistent with desired functionality) of a
human body to be directly driven into some form of movement in
response to a signal generated other than by the body itself. The
example most referred to above is the electromagnetic driving of an
ossicle of a middle ear of a human; however, any tissue in the body
that would benefit (e.g., correctively or therapeutically) by being
moved using external means other than the natural body processes
that move the tissue may be suitable for the present invention.
[0045] Other examples of such constituents include other vibratory
constituents of the human ear (including the tympanic membrane
(eardrum), round window membrane, and oval window membrane), vocal
folds of the larynx, eyelid, wound tissue, surgically positioned
tissue, sphincters, vascular tissue, and nerve tissue of the human
body. Particular uses are exemplified above in the background of
the invention.
[0046] There are several possibilities for generating the forces
for wound closure, reapposition of tissue and mechanical movement
of these, and other, body constituents. Preferred embodiments
include one or more magnetically responsive beads. Particular
examples include nonmagnetized, magnetically responsive, microbeads
being affected by a remote or nearby electromagnet or permanent
magnet or the beads themselves being magnetized as north or south
and having immediate attraction to or repulsion from each other.
Magnetic devices creating forces on the microbeads can be from some
device inside of the body and close to the microbeads (as in the
specific ear device application) or the force generating magnetic
field can come from outside of the body. This can be in the form of
a magnetic field that can be shaped to affect the beads in
generating a force in a specific direction, for example. In
general, a magnetic field source and one or more magnetically
responsive members are used. "Magnetically responsive" includes
materials that react to magnetic or electromagnetic fields but do
not themselves inherently provide magnetic fields, and they also
include materials that are themselves magnetic. Examples include
ferromagnetic and paramagnetic materials, with the former
preferred. Other examples include magnetic materials that
inherently provide magnetic fields (e.g., rare earth magnetic
materials).
[0047] That which adapts the aforementioned body constituents to be
used with the preferred embodiment of the present invention is a
capsule or covering of soft tissue. Specifically in the middle ear
embodiment, the soft tissue is an epithelial coating provided by
middle ear mucosa, to which collagen will naturally bond through
integrins, which are receptors located on the surface of the cells
of the mucosal epithelium. It is, however, contemplated that other
bonding mechanisms can be used (e.g., genetic means of inducing
other cell to cell bonding mechanisms).
[0048] Given the adaptability of the aforementioned body
constituents to the present invention, microbeads are attached to
the part or parts to be moved. Microbeads are known products; the
type of the preferred embodiments of the present invention include
ferromagnetic particles (Fe.sub.2O.sub.3) (e.g., 5 micrometers in
diameter) inside pinhole free encapsulating beads. The
encapsulation is to be a type of material and coverage so as to
provide protection against body fluids and be biocompatible
(preferably both for the lifetime of the user). Glass (a type for
use in a human body) is one such material. Technology exists for
coating the beads with collagen (e.g., commercially available
Vitrogen 100) using recombinant DNA techniques. The collagen
attaches to the epithelium of the target tissue by natural cell
proteins called integrins. The beads remain associated with
molecules which link the extracellular matrix of cells to the
constituent cell's cytoskeleton. The beads may become internalized
into the tissue itself. Such internalization into soft tissue is
preferable to only cell surface attachment, as the beads are to be
mechanically vibrated to generate force on the ossicles of the
middle ear. Such soft tissues include epithelia of various types,
fibrous connective tissue and others, each of which may have
variations on cellular connection proteins.
[0049] The epithelial integrins are the most understood at this
time and there has been demonstrated connection for generation of
forces on in vitro cells. See, "A Novel Technique for Investigation
of Mechanotransduction in Airway Epithelial Cells," D.
Tschumperlin, M. Swartz, N. Wang, R. Kamm, J. Drazen, and J.
Fredberg, BED-Vol. 42, 1999 Bioengineering Conference, pp. 521-522
(ASME 1999); and "Integrin-Cytoskeleton Linkages are Important
Pathways for Mechanotransduction," N. Wang, BED-Vol. 42, 1999
Bioengineering Conference, pp. 523-524 (ASME 1999); both of which
are incorporated herein by reference. A commercial source for
microbeads is Miltenyi Biotech Inc. of Auburn, Calif. and it is
contemplated that suitable encapsulation materials and technique
can be readily implemented in place of typical polystyrene coated
beads.
[0050] The aforementioned body constituents and microbeads, and
their interconnection, are represented in FIG. 1 by the block
marked with reference numeral 2. These microbeads and the body
constituent(s) to which they are attached are caused to move by a
drive signal 3 output from a driver 4.
[0051] One preferred type of driver outputs an electromagnetic
signal and so is marked as electromagnetic transmitter 6 in FIG. 2.
Such a transmitter can be part of an analog or digital or hybrid
(i.e., combination of analog and digital processing) signal
processor 8 shown in FIG. 3 as also including a receiver 10. In a
particular embodiment shown in FIG. 4, the signal processor can be
of the type used with other middle ear drive or inner ear drive
systems. The implementation of FIG. 4 includes a microphone 12 that
generates an electric signal in response to ambient sound picked up
by the microphone. A sound processor 14 takes the electrical signal
representing ambient sound and modifies it (e.g., by known signal
compression filtering and noise canceling techniques). The
conditioned signal output by the sound processor 14 is amplified by
a power amplifier 16 to drive a coil 18 at the conditioned
frequencies, amplitudes, etc. The alternating current auditory
signal output from the amplifier 16 drives the coil 18 to generate
electromagnetic signal 20. The time varying drive signal 20 is a
changing electromagnetic field that causes the magnetic microbeads
to vibrate and thereby move the combined body constituent/microbead
structure 2', which structure 2' in the FIG. 4 embodiment is a
middle ear ossicle to which the microbeads have been attached. The
created movement corresponds to the received sound and thereby
produces the perception of sound. A particular implementation of
the foregoing is illustrated in FIG. 5.
[0052] A human ear is represented in FIG. 5. It includes an outer
ear 32, a middle ear 34, and an inner ear 36. The outer ear has an
outer ear canal 38 which is normally closed at its inner end by
tympanic membrane, or eardrum, 40. Also pertinent is an ossicular
chain, which if intact extends from tympanic membrane 40 to oval
window 42 defining an entrance to the inner ear 36. The intact
ossicular chain extends through the middle ear 34 and includes a
malleus 44, an incus 46, and a stapes 48. A properly functioning
ossicular chain transmits vibrations from the tympanic membrane 40
in series through the malleus 44, the incus 46 and the stapes 48 to
the oval window 42. Vibrations at the oval window stimulate the
inner ear 36 whereby the person perceives the sound received in the
outer ear 32.
[0053] With regard to the illustration of FIG. 5, it is assumed
that the inner ear 36 responds to vibrations, or is made to
respond, properly whereby a goal of the depicted embodiment of the
present invention is to provide the vibratory stimulation to the
inner ear 36 when there otherwise is inadequate vibration
transmission in the person's middle ear 34. To accomplish this, the
present invention provides implanted microbeads 50 for the middle
ear in this example. The magnetic microbeads 50 are biologically
attached, in the collagen/integrin manner described above and in
the articles incorporated herein by reference, to the mucous
membrane covering of any functional part of the ossicular chain
communicating with the oval window. In the FIG. 5 illustration, the
microbeads 50 are connected to the malleus, preferably in alignment
with the longitudinal axis of the coil 18' represented in the
drawing. This technology provides the magnetic microbeads and the
coating of such microbeads with collagen such that the natural
collagen is recognized by the living tissue on the ossicular chain,
whereby natural bridges (attachment bonds) are formed with the
collagen surface to attach the microbeads to the mucosal.
(epithelial surface). Such attached magnetic microbeads provide for
omnidirectional response to the driver signal. In FIG. 5, this
driver signal comes from a signal processor in the form of an
electromagnetic coil and ear mold unit 52 of a known type. This
sound processor responds to received environmental sounds by
generating an electrical signal that drives a coil to propagate an
electromagnetic signal. The latter signal drives the microbeads in
an auditory range. Such mechanical motion produces the perception
of sound as the result of standing waves produced in the fluid of
the inner ear.
[0054] Other examples of the present invention as used with the
human ear are shown in FIGS. 6-9. FIG. 6 shows an implanted signal
processor (with coil 18") which drives microbeads 50' connected to
the incus of the ossicular chain. FIG. 7 shows an implanted signal
processor (with differently positioned coil 18'") which drives
microbeads 50" connected to the oval window membrane of the ear (in
this embodiment, as well as others, microbeads should not be on
other constituents (e.g., an ossicle as well as the oval window
membrane) if that produces conflicting movement; however, if
consistent with desired function, the microbeads can be on one or
more constituents). FIG. 8 shows an implanted signal processor
(with suitably positioned coil 18"") which drives microbeads 50'"
connected to the round window membrane 51 of the ear. FIG. 9 shows
a middle ear device 53 described in co-pending U.S. patent
application Ser. No. 09/248,564, incorporated herein by reference,
to which microbeads 50'"' have been attached to improve the
connection of the implanted device to the incudo-stapedial joint.
At least the inner surface of the incudo-stapedial attachment
element of the middle ear device is coated with collagen such that
it bonds with the epithelium to hold the position of the implant,
as determined by the surgeon at the time of implantation, during
the healing process. The microbeads also add to the magnetic
responsiveness to the drive signal. Positioning (location and
orientation) of the signal processor and microbeads (and other
magnetically responsive material, if any) is preferably such as to
optimize the signal coupling with, and resultant movement of, the
microbeads (and other magnetically responsive material, if
any).
[0055] As used in this specification and the claims, reference to
particular parts, such as an ossicle or ossicular chain, includes
portions thereof as well as the whole of the part. For example,
referring to microbeads as attached to an ossicle encompasses
attachment across the entirety of an ossicle and on or in only a
portion of an ossicle as well as on other ossicles or portions
thereof; thus, a coating of microbeads could be on less than an
entire ossicle, or on multiple ossicles simultaneously.
[0056] An alternate driver for implanted microbeads which are
integrated into and attached to the surfaces of cells is a
permanent magnet providing a static magnetic field. The static
field may be used to vibrate the microbeads and attached body
constituent; this can be by moving the magnet by a connected motor,
for example, as illustrated in FIG. 10. In this drawing a magnet 55
is moved back and forth (away from and towards the microbeads) by a
motor 54. The movement of the magnet 55 by the motor 54 can be at
auditory frequencies such as for the aforementioned hearing
applications or at some designated frequency for other applications
(for example, a slow pulsing frequency for the sphincter opening
from the urinary bladder). For a specific example, a piezoelectric
bender bimorph mechanical driver has a magnet attached to the end
of the bender bimorph and this magnet moves in desired frequencies
in close proximity to the implanted microbeads. Thus a DC magnetic
field is influencing the magnetically responsive microbeads. The
movement back and forth of the magnet varies the strength of the
magnetic field and therefore the movement of the microbeads. This
is not an attraction-repulsion type of driving that would be
experienced with a reversing electromagnetic field. There is in
this case a greater then lesser then greater, etc., attractive
force of the moving magnet that is influencing the microbead
population. The greater the population of the microbeads, the
greater the forces of attraction for either of the driving
mechanisms above.
[0057] As another example, the remote magnetic field can come from
a suitably sized magnet 55' that collectively attracts the
microbeads and induces a force in a single direction (see FIG. 11).
One application for this is for the closure of the veins exiting
the penis to compensate for erectile dysfunction.
[0058] A non-time varying electromagnetic field can also be used as
a static magnetic field source (e.g., a direct current can produce
a static electromagnetic field).
[0059] The foregoing examples pertaining to hearing have been
stated with regard to assisting hearing impaired individuals. The
present invention has other hearing applications even for ones who
have no hearing impairment. For example, it may be used in the area
of hearing protection. People working around very noisy sites
(e.g., jet engines) may wear an existing form of protection against
noise-induced hearing loss. They wear headsets that produce sounds
180 degrees out of phase with (i.e., in opposition to) the ambient
noise, thus canceling out each of the two sounds such that movement
of the ossicles is neutralized, protecting the ear from damage by
overdrive. It is contemplated that ossicles coated with microbeads
may be more effectively neutralized by anti-movement produced
electromagnetically or magnetically. This would be a non-obtrusive
implant onto the ossicles (i.e., presence of the microbeads would
not interfere with normal hearing processes because the mass
loading would be so small, such as less than 20 milligrams). On the
other hand, such people would also be susceptible to stray
environmental electromagnetic fields, but this is not contemplated
to be a serious drawback for the anti-noise hearing protection.
[0060] Another specific application is that the microbeads may
provide a covert means of communicating with an individual by
auditory means. Presently, secret service and security personnel
communicate by wireless microphones placed into their ear canals. A
transmitter sends a signal to a receiver which then activates a
speaker in the ear canal. With the microbeads on an ossicle, a room
encircled with an electromagnetic coil could covertly and secretly
communicate to an individual without anyone else being aware of it.
There would be no "giveaway" of an object, visible in a person's
ear canal. The person would be hearing normal sounds as well as the
covert communications. Furthermore, if a room prepared for covert
communication is not available, an individual could wear a large
electromagnetic coil under his or her clothing such that a remote
signal could be received from another source and the hidden body
coil activated and the microbeads moved to produce sound. This coil
under the clothing was the basis of the Ear Lens technology from
Resound Corp. The Ear Lens was a heavy magnet stuck onto the
tympanic membrane by surface tension forces (drop of oil on a
silicone rubber diaphragm to which was attached the magnet).
[0061] Referring next to FIGS. 12-15, examples of other
applications of the present invention will be given; however, these
are not limiting of broader aspects of the invention.
[0062] FIG. 12 represents cases involving tissue to tissue
movement. Parficular examples include:
[0063] (1) The larynx as part of the vocal mechanism contains vocal
folds that normally are held in apposition and with tension such
that passage of air over the vocal folds produces vibration and the
generation of sounds which are shaped as speech by the oral cavity.
Such holding of vocal folds in apposition can be achieved with the
present invention, such as by using two pluralities 56, 58 of
oppositely polarized magnetic microbeads that are placed on the
folds to be apposed so that the two pluralities of microbeads move
toward each other due to the attractive polarities.
[0064] (2) The eyelid must close to cleanse and protect the surface
of the eye (cornea). A bio-magnetic mechanism as described above
for the larynx can be used to hold an eyelid closed or open. One of
the pluralities of microbeads is connected to the eyelid and the
other either below the eye (to close) or above the eye (to
open).
[0065] (3) Wound closure can be obtained by connecting such
oppositely polarized magnetic microbeads 56, 58 on opposite sides
of the open wound tissue so that the attractive magnetic fields
pull the microbeads and connected tissue together.
[0066] (4) In surgical applications, often a surgeon wishes tissue
to remain in one location during the healing process (e.g., toward
the natural anatomical position of the respective body part). With
a magnetic retaining by the magnetic microbeads, positioning can be
obtained and maintained. One of the pluralities of microbeads is
connected to the constituent to be positioned and the other
plurality of microbeads is connected to tissue at the site where
the constituent is to be retained.
[0067] (5) Nerve surgery where two ends of a severed nerve are sewn
together is tedious, long and difficult. The sheath covering the
nerve must also be restored for the nerve to live and grow. Using
the present invention, on the other hand, the polarized microbeads
56, 58 can be placed on the ends of a severed nerve and/or its
myelin sheath causing the ends to be reapposed.
[0068] FIG. 13 represents two pluralities 60, 62 of magnetic
microbeads connected to vascular tissue. If the microbeads are of
the same polarization, repulsion occurs so that the diameter of the
lumen of the vessel enlarges (indicated by the outer set of
arrows). If the microbeads are of different polarities, attraction
occurs so that the lumen diameter decreases (as indicated by the
inner set of arrows pointing towards each other). This latter
technique can be useful where venous engorgement is required for
penile erection. A temporary venous output blockage can be caused
by providing a force on the venous outflow tracks. Such increased
venous resistance (by the bio-magnetic closure means) causes venous
engorgement upstream and penile erection with the potential
elimination of impotence. The former technique (using a repulsive
force) can be used for opening vessels, channels or pores. Such
openings are important in the circulation of the body as this is
the means of getting nutrients, gases and fluids to the tissues.
The opening of blood vessels, for example, is accomplished normally
by a pressure from within. However, blood vessels could be opened
further in diseased states such as atherosclerosis, by the pushing
apart of the external vessel wall or the adventitia surrounding a
blood vessel. Another example for use in opening blood vessels is
with arteries that feed the penis to thereby increase inflow into
the corpus cavemosum (erectile tissue). The foregoing can also be
achieved by using one set of microbeads 64 and a discrete magnetic
field source 66 (e.g., a permanent magnet or an electromagnet) as
represented in FIG. 14. The relative polarizations and positioning
of the magnetic field source determine the direction of movement.
Opening and closing movements can be achieved with other
microbead/magnet combinations as well (e.g., two magnets, each
creating an outward pulling force on a respective set of
microbeads).
[0069] Another particular example is represented in FIG. 15. This
illustrates a sphincter 68 having microbeads 70 connected to one
region of it. A magnetic field source 72, such as mentioned above
for magnetic field source 66, can be used to control the sphincter
to close or open the channel around which the sphincter is located.
Specific, but non-limiting, examples include the lower esophageal
sphincter, the sphincter for closure of the bladder, and urethral
usage for incontinence following prostate surgery.
[0070] A particular example of using the present invention will be
described next with reference to connecting the microbeads to an
ossicle in the middle ear.
[0071] In a sterile culture medium a suitable quantity of glass
coated beads (e.g., 10,000) is coated with 50 mg (milligrams) of
collagen that is commercially available (e.g., Vitrogen100). The
coated beads are stored in physiologic solution and temperature in
sterile vials for protection until surgical application. A
physiologic solution is preferably one that has the same pH and
chemical environment as the intrinsic body fluid. A physiologic
temperature is one at which life can be maintained, and preferably
one at which collagen can survive in the preferred embodiment.
[0072] The slurry of microbeads in physiologic solution may also
contain a biological "enhancer" to facilitate and accelerate the
attachment of beads to the cells of the mucosae. Such enhancer
would be some substance that would make the slurry sticky by either
surface tension forces or sticky in the glue sense, such as fibrin
glue added to the slurry. Fibrin glue is a clinical product (widely
used in Europe) where the natural fibrin from humans is
concentrated and used for holding things in place in the body
(e.g., holding ear prostheses in place during the healing process).
The fibrin glue is removed by natural healing processes over time
(e.g., 2-4 weeks), as scavenger cells called macrophages ingest the
fibrin as it breaks down. The collagen is not ingested, and when
exposed to the surface of the mucosa of an ossicle, it attaches.
The preferred embodiment is for the attachment to take place
instantaneously with first contact of the beads with the cell
surface; however, practical attachment via collagen/integrin bonds
takes hours to days. The quantity of beads placed is dependent on
desired magnetic attraction and percent retention of beads by the
cells. It is also surface area limited, so the preferred
application is for maximum application on the entire surface of the
mucosa, closest to the electromagnetic coil or other magnetic field
source.
[0073] In the operating room a surgeon elevates the tympanomeatal
flap (eardrum) using standard surgical technique, under local
anesthesia. The ossicles are then visualized under an operating
microscope and the beads are aspirated into a microsyringe with
long needle for placement onto the surface of an ossicle. The
needle is introduced through the opening into the middle ear space,
under direct visualization, and the surface of an ossicle is
covered with the solution containing beads. This is accomplished by
ejecting the physiologic solution containing the microbeads (a
slurry of microbeads) onto the surface of the selected ossicle.
This is preferably the surface closest to the electromagnetic coil,
wherever it is located, such that the bead population is in axial
alignment with the electromagnetic coil's axis, plus or minus 30
degrees. The surface tension on the surface of the mucosa
(epithelium) retains the beads while the tympanomeatal flap is
closed and the procedure is complete. Total weight of the bead
complex for an ossicle is preferably 2-10 mg (5 milligrams per
milliliter of physiologic solution with microbeads). This is to
prevent mass loading that could adversely affect natural function
of the ossicle. Over the following 14-17 days the beads become
attached to or integrated into the surface of the mucosal tissue.
The ossicle and therefore ossicular chain is now magnetically
responsive and will move in response to an applied magnetic field.
The magnetic field for hearing use typically moves the microbeads
and attached constituent in a vibratory manner, but in general the
magnetic field is used to displace, whether vibrationally or in
single-direction displacement or otherwise, the microbeads and
connected constituent. The method of the present invention includes
generating the various magnetic fields described above.
[0074] The following gives examples for connecting microbeads in
other contexts, including those described above.
[0075] If microbeads are to be placed onto the surface of a blood
vessel, a syringe needle is introduced under radiological
visualization (fluoroscopy) to approach the blood vessel target.
The target vessel may need to have enhanced visualization by the
use of radioopaque dyes injected into the flow of the bloodstream
through the vessel. With vessel visualization and upon reaching the
target, content of a syringe containing the microbeads is injected
near the surface of the vessel. Repeated penetrations of the skin,
approaching the vessel, take place until a sufficient amount of the
blood vessel surface has microbead placement and the needle is
withdrawn.
[0076] In the event of placing microbeads onto veins draining the
penile corpus cavernosum, a needle approach may also be used;
however, no single vein is the target but rather the effluent
venous complex that if occluded (at least to a sufficient partial
degree) will cause upstream engorgement of the veins and
enlargement of the penis. Injection of beads onto one side of the
venous complex can be made such that an external magnetic field as
in a DC magnet placed on the opposite side of the venous complex
causes the two magnetic entities to attract each other, compress
the venous complex and cause venous engorgement (erection).
[0077] For the placement of microbeads onto one or both of the
vocal folds in the larynx, a simple artist's paintbrush (suitably
sized and sterilized) containing the microbeads may be used to
apply the beads via an oral approach. This may require several
applications over time as the natural swallowing, speaking, and
flow of saliva may wash some of the beads off the vocal folds.
Alternatively, a temporary bonding solution may be used to hold the
beads on the surface of the vocal folds for 7-14 days as the
microbeads become attached. Such biological glue may be
commercially available fibrin glue that is made from the fibrin
extracted from blood. Fibrin is naturally broken down and removed
from a site and is biocompatible.
[0078] In the event of using microbeads in the upper and lower
eyelids to facilitate closure, microbeads may be injected but in
this application there is no need for a target attachment site.
Here the microbeads may be injected in small quantities using the
same technique as in plastic surgical reconstruction when small
volumes of collagen are injected under the skin for filling in
defects. In this instance the microbeads may respond to an
implanted electromagnetic coil implanted in the lower eyelid on the
upper face, or alternatively the microbeads may be polarized and
composed of permanent magnetic material such that there will be a
natural attraction between the upper and lower eyelids and the
resulting force will be sufficient to keep the eye closed. One
particular type of neurological lesion allows a person to open his
or her eyes but not close them. With another type of eye motor
control lesion, the person cannot keep the eyelids open. A similar
arrangement may be made with microbeads in the subforehead region
and in the upper eyelid such that the eyelid is attracted by
magnetic forces upwards and the eye is maintained open.
[0079] In the event of using the forces generated by the present
invention for the control of bladder function (continence), there
is the need for a surgical operation to place (by either the
injection technique or the brush technique) a coating of microbeads
on one side of the sphincter controlling voiding of urine. An
implantable electromagnetic coil can be implanted on the opposite
side of the sphincter. The use of fibrin glue is favorable here
such that the coating of microbeads is held in place on the mucosal
surface coating the sphincter until the attachment occurs and then
the fibrin is removed by natural scavengers that clean the body. An
implanted electromagnetic coil is used to maintain a magnetic
field, thus attracting the microbeads, thus producing a
constrictive force across the sphincter, thus preventing urine from
flowing out of the bladder into the urethra. Alternatively, a
permanent magnet can be placed outside of the body on the opposite
side of the sphincter (controlling voiding of urine) to which
microbeads are permanently attached. Manual removal of this magnet
by a person removes the magnetic attraction and opens the sphincter
so that urine flows to empty the bladder.
[0080] In the application of beads for reapposing two cut ends of a
nerve, the paint brush application is preferred. Likewise in the
closing of wounds without sutures, both sides of the wound are
coated with microbeads from a brush and the beads are held in place
by the natural clotting at the site of wound closure. External
magnets may be used to attract the wound site microbeads and so
create better tissue interface forces for a better and more
complete closure.
[0081] Another format of the present invention includes a whole
magnet that is hermetically sealed against body fluids and then
coated with collagen for attaching (e.g., to naturally bond with an
epithelium of a vibratory constituent of the human ear). In other
words, this provides one large bead with all the considerations
given above. In the human hearing context, for example, such a
magnet can be attached to an ossicle or the round window or the
back side of the tympanic membrane or the front side of the
tympanic membrane. Two such magnets 74, 76 can be used for holding
one or more constituents such as in one or more of the examples
described above (see FIG. 16).
[0082] Still another aspect of the present invention is as a kit 78
for use in causing a constituent of a human body to move. A
particular implementation as a middle ear hearing assist system is
illustrated in FIG. 17. This kit includes a deep canal ear mold 80
of a known type (e.g., having a compartment molded to fit in a
user's outer ear canal, a sound processor 82 with an input signal
receiver including microphone 84 and with a magnetic output signal
transmitter (here including an electromagnetic coil 86), and a
battery 88). The kit 78 also includes a container 90 (such as a jar
or vial) holding a sterile solution of microbeads 92 in physiologic
growth medium 94. The microbeads 92 have living collagen around
glass (or other suitable material as described above) encapsulated
ferromagnetic beads. These are suitably contained (e.g., in
stabilizing packing, material) in a suitable outer package 96, such
as a box.
[0083] Thus, the present invention is well adapted to carry out the
objects and attain the ends and advantages mentioned above as well
as those inherent therein. While preferred embodiments of the
invention have been described for the purpose of this disclosure,
changes in the construction and arrangement of parts and the
performance of steps can be made by those skilled in the art, which
changes are encompassed within the spirit of this invention as
defined by the appended claims.
* * * * *