U.S. patent application number 15/046556 was filed with the patent office on 2016-12-22 for method for debriding wounds.
The applicant listed for this patent is Eliaz Babaev. Invention is credited to Eliaz Babaev.
Application Number | 20160367282 15/046556 |
Document ID | / |
Family ID | 39668784 |
Filed Date | 2016-12-22 |
United States Patent
Application |
20160367282 |
Kind Code |
A1 |
Babaev; Eliaz |
December 22, 2016 |
METHOD FOR DEBRIDING WOUNDS
Abstract
A method enabling relatively pain-free wound debridement is
provided. The method entails double-delivering ultrasound to the
wound and dissecting material to be debrided with a cutting edge.
Delivering ultrasound energy via a coupling medium to an area of
the wound within the vicinity of the material to be debrided and
exposing the material to be debrided to ultrasound vibrations as to
induce vibrations about the point of dissection, the
double-delivery of ultrasound elicits an effect allowing for
relatively pain-free debridement. While the effect elicited by the
double-delivery is in place, the material to be debrided is
dissected with a cutting edge.
Inventors: |
Babaev; Eliaz; (Minnetonka,
MN) |
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Applicant: |
Name |
City |
State |
Country |
Type |
Babaev; Eliaz |
Minnetonka |
MN |
US |
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|
Family ID: |
39668784 |
Appl. No.: |
15/046556 |
Filed: |
February 18, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14035186 |
Sep 24, 2013 |
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15046556 |
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12060486 |
Apr 1, 2008 |
8562547 |
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14035186 |
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11857162 |
Sep 18, 2007 |
7785278 |
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12060486 |
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11449220 |
Jun 7, 2006 |
7431704 |
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11857162 |
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11880321 |
Jul 20, 2007 |
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12060486 |
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11741726 |
Apr 28, 2007 |
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11880321 |
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11449220 |
Jun 7, 2006 |
7431704 |
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11741726 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/320068 20130101;
A61B 2017/320078 20170801; A61B 17/3205 20130101; A61B 2017/320004
20130101; A61B 2017/320082 20170801; A61B 17/320708 20130101; A61B
2018/1861 20130101 |
International
Class: |
A61B 17/32 20060101
A61B017/32; A61B 17/3207 20060101 A61B017/3207; A61B 17/3205
20060101 A61B017/3205 |
Claims
1. A method of debriding wounds comprising: a. delivering
ultrasound energy via a coupling medium to an area of the wound
within the vicinity of a material to be debrided; b. inducing
vibrations within a confined region of the material about a point
of dissection; and c. dissecting the material to be debrided with a
cutting edge.
2. The method according to claim 1 characterized by inducing the
material to vibrate by exposing the material about the point of
dissection to a majority of radial ultrasonic vibrations.
3. The method according to claim 1 characterized by inducing the
material to vibrate by exposing the material about the point of
dissection to a majority of longitudinal ultrasonic vibrations.
4. The method according to claim 1 characterized by dissecting the
material with a sharpened structure that exposes the material about
the point of dissection to concentrated ultrasonic vibrations.
5. The method according to claim 1 further comprising moistening
the wound.
6. The method according to claim 1 further comprising concentrating
the ultrasound energy delivered to the area of the wound in the
vicinity of the material to be debrided about at least one point
within the wound.
7. The method according to claim 1 characterized by the ultrasound
energy delivered to the wound being released from a horn induced to
vibrate at a frequency between approximately 15 kHz and
approximately 5 MHz.
8. The method according to claim 1 characterized by the ultrasound
energy delivered to the wound being released from a horn induced to
vibrate at an amplitude between approximately 1 and 250
microns.
9. The method according to claim 1 characterized by inducing the
material to vibrate by exposing the material about the point of
dissection to ultrasound vibrations released from a horn induced to
vibrate at a frequency between approximately 15 kHz and
approximately 5 MHz.
10. The method according to claim 1 characterized by inducing the
material to vibrate by exposing the material about the point of
dissection to ultrasound vibrations released from a horn induced to
vibrate at an amplitude between approximately 1 and 250
microns.
11. A method of debriding wounds comprising: a. delivering
ultrasound energy via a coupling medium to an area of the wound
within the vicinity of a tissue to be debrided; b. exposing a
material about a point of dissection to concentrated ultrasonic
vibrations; and c. dissecting the material to be debrided with a
cutting edge.
12. The method according to claim 11 characterized by exposing the
material about the point of dissection to a majority of
concentrated radial ultrasonic vibrations.
13. The method according to claim 11 characterized by exposing the
material about the point of dissection to a majority of
concentrated longitudinal ultrasonic vibrations.
14. The method according to claim 11 further comprising moistening
the wound.
15. The method according to claim 11 further comprising
concentrating the ultrasound energy delivered to the area of the
wound in the vicinity of the material to be debrided about at least
one point within the wound.
16. The method according to claim 11 characterized by the
ultrasound energy delivered to the wound being released from a horn
induced to vibrate at a frequency between approximately 15 kHz and
approximately 5 MHz.
17. The method according to claim 11 characterized by the
ultrasound energy delivered to the wound being released from a horn
induced to vibrate at an amplitude between approximately 1 and 250
microns.
18. The method according to claim 11 characterized by exposing the
material about the point of dissection to concentrated ultrasound
vibrations released from a horn induced to vibrate at a frequency
between approximately 15 kHz and approximately 5 MHz.
19. The method according to claim 11 characterized by exposing the
material about the point of dissection to concentrated ultrasound
vibrations released from a horn induced to vibrate at an amplitude
between approximately 1 and 250 microns.
20. A method of debriding wounds comprising: a. delivering
ultrasound energy via a coupling medium to an area of the wound
within the vicinity of a tissue to be debrided; b. concentrating
the ultrasound energy delivered to the area of the wound in the
vicinity of the tissue to be debrided about at least one point
within the wound; c. exposing a material about a point of
dissection to ultrasonic vibrations concentrated by a sharpened
structure; and d. dissecting the material to be debrided with the
sharpened structure concentrating the ultrasonic vibrations.
21.-27. (canceled)
Description
CROSS REFERENCE TO ELATED APPLICATIONS
[0001] This application is a continuation-in-part of U.S. patent
application Ser. No. 11/857,162 filed Sep. 18, 2007, the teachings
of which are hereby incorporated by reference.
[0002] This application is also a continuation-in-part of U.S.
patent application Ser. No. 11/449,220 filed Jun. 7, 2006, the
teaching of which are hereby incorporated by reference.
BACKGROUND OF THE INVENTION
[0003] Field of the Invention
[0004] The present invention relates to a method for debriding
wounds and/or dissecting tissues from the body.
[0005] Description of the Related Art
[0006] When confronted with wounded tissue, physicians and similar
practitioners of the medical arts may rely on numerous methods to
treat the wound. Despite the repertoire of available techniques,
treating severe and/or chronic wounds can be especially difficult.
To assist in healing, the practitioner may have to resort to
surgical debridement. During debridement, the practitioner removes
material from a wound to expose healthy and/or granulation tissue.
It is generally believed that keeping such tissue exposed expedites
wound healing. However, as wounds begin to heal after debridement,
additional material may collect over the healthy and/or granulation
tissue. Successful treatment, therefore, often requires repeated
debridement.
[0007] A diverse amount of material may be removed from the wound
during debridement. The removed material may include improper
healed, dead, and/or dying tissue. However, the material removed is
not limited to tissue. For instance, foreign substances such as,
but not limited to, dirt, debris, and/or infectious agents may
collect within the wound. In the case of an infectious agent such
as, but not limited to, a bacteria, a bacterial laden biofilm may
develop over the wound covering healthy and/or granulation tissue.
As the infection increases in severity, the wound may become
covered with gangrenous tissue. Exposing healthy and/or granulation
tissue would then require the removal of such containments.
Accordingly, foreign contaminants, biofilms, and/or gangrenous
tissue may represent material that has to be debrided from the
wound.
[0008] In combination or in the alternative, the trauma and/or
pathological conditions creating the wound may generate material
that needs to be removed to expose healthy and/or granulation
tissue. The trauma responsible for creating the wound may fracture
blood vessels supplying tissue surviving the trauma. Fracturing the
blood vessels, the trauma reduces the blood supply to the surviving
tissue creating a region of ischemic tissue. Ischemia may also be
the result of various conditions such as, but not limited, diabetes
and/or various vascular diseases. As the ischemia persists, the
tissue becomes deprived of vital nutrients required for growth
and/or survival, and thus may eventually becomes devitalized.
Failing to receive required nutrients, the devitalized tissue may
eventually slip into a non-viable state. The non-viable tissue may
begin a process of necrosis and/or apoptosis in which the cells of
the non-viable tissue release various factors the digest and/or
degrade the tissue. Destroying itself, the non-viable tissue
becomes necrotic tissue. If the degradation and/or digestive
process continues beyond the point of cellular death, the necrotic
tissue may become slough. However, it is also possible that
digestion and/or degradation stops with cellular death as to create
an eschar over the wound. Regardless of how far the tissue
progresses from ischemia and/or devitalization to slough and/or
eschar, the dead and dying tissue generated from a trauma and/or
pathological condition responsible for the wound should be
removed.
[0009] In combination or in the alternative, the wounds may also
generate material that needs to be removed to expose healthy and/or
granulation tissue. For instance, in response to an inflammation
brought about by the presence of foreign substances and/or trauma
an exudate may be secreted. As the secretion of exudate persists,
the wound may become covered by various proteins and/or other
molecules manufactured by the body. Secretion of a fibrinous
exudate, for example, may lead to a build up fibrin over the wound.
Regardless of the type of exudate secreted and/or built up over the
wound, this body generated material should be removed during
debridement.
[0010] In combination or in the alternative, improperly healed
tissue may have to be removed from the wound. For example, instead
of migrating into the wound, cells responsible for closing the
wound and/or replacing lost tissue may begin to migrate away from
the wound. Such misdirected migration may hinder and/or prevent
proper closure and/or healing of the wound. Placing cellular
migration on the proper path may require removing the tissue
created as a result of the misdirected migration. Otherwise healthy
tissue hindering, preventing, or otherwise retarding proper closure
and/or healing of the wound may appear through other means.
Regardless of its origin and/or condition, tissue retarding closure
and/or healing should be removed during debridement.
[0011] Debriding a wound to expose healthy and/or granulation
tissue and/or remove tissue retarding proper closure and/or healing
is generally done to expedite wound healing. Exposing debrided
wounds to ultrasound has also been shown to expedite wound healing.
As to capitalize on this phenomenon, various debridement techniques
with ultrasonically vibrating instruments have been developed.
Typically these techniques entail removing various materials from
the wound with ultrasonically vibrating dissection devices, while
simultaneously exposing the wound to ultrasound. Accordingly the
wound receives beneficial ultrasound while it is debrided.
SUMMARY OF THE INVENTION
[0012] Treating severe and/or chronic wounds can be especially
difficult. Successful treatment often requires repeated
debridement. The painful nature of surgical debridement, however,
often results in poor patient compliance. Rather than enduring the
pain of treatment, patients opt to leave the wound untreated. In
the case of infected and/or inflamed wounds, surgical debridement
may be even more painful, resulting in lower rates of patient
compliance. An untreated wound becomes at risk for developing an
infection and/or other complications. As the complications increase
in severity, the patient may experience a reduced quality of life.
For instance, an untreated diabetic foot ulcer on a patient's foot
may become so painful that the patient has difficulty walking.
[0013] A method enabling relatively pain-free wound debridement is
provided. The method comprises a double delivery of ultrasound to
the wound and dissection of the material to be debrided with a
cutting edge. The double-delivery of ultrasound elicits an
effecting allowing for relatively pain free debridement by
delivering ultrasound energy via a coupling medium to an area of
the wound within the vicinity of the material to be debrided and
exposing the wound to ultrasound vibrations as to induce vibrations
about the point of dissection. While the effect elicited by the
double-delivery is in place, the material to be debrided is
removed, fragmented, and/or otherwise dissected with a cutting
edge.
[0014] The double-delivery ultrasound exposes one point and/or
region of the wound to ultrasound energy and the material about the
point of dissection to ultrasound vibrations. Collectively, the
double-delivery's dual exposure elicits an effect allowing for
relatively pain-free debridement. Exposing the wound to one of the
ultrasound deliveries without the other will not allow for
relatively pain-free debridement. Consequently, it is the combined
effects elicited by the delivery of ultrasound energy and
ultrasound vibrations at differing points that allows for
relatively pain-free wound debridement. One delivery does not
necessarily have to precede the other. Consequently, the exposure
to ultrasound may occur before, subsequently to, and/or
simultaneously with the exposure to vibrations. Because it is the
additive effect elicited by both deliveries that allows for
relatively pain-free dissection with a cutting edge, the second
delivery should occur before the effects elicited by the first
delivery have dissipated. Likewise, dissection of the material to
be debrided should occur while the effects elicited from the
double-delivery are in place.
[0015] One of the deliveries exposes an area of the wound in the
vicinity of the tissue to be debrided to ultrasound energy.
Accordingly, an area of the wound close to, neighboring, and/or
surrounding the material to be debrided is exposed to ultrasound
energy. When exposing the wound to ultrasound energy it is
important that a sufficient amount of energy is transferred to the
wound without excessively injuring the wound. Injuring the wound
may induce physiological responses, such as, but not limited to,
the release of various inflammatory factors and/or mediators,
counteracting the effects elicited by the double-delivery of
ultrasound. Delivering a sufficient amount of ultrasound energy
without excessively injuring the wound can be accomplished by
delivering the energy via a coupling medium. Any fluid and/or
atomized spray capable of conducting ultrasound energy that is not
unduly toxic to the tissue may be utilized as a coupling medium.
For instance fluids such as, but not limited to, saline, water,
alcohol, corn oil, and/or vegetable oil may be utilized. The
coupling medium acts as a conduit for the transmission and delivery
of ultrasound energy to the wound.
[0016] The other delivery of the double-delivery exposes material
about the point of dissection to ultrasound vibrations. Exposing
the material to ultrasound vibrations induces vibrations within the
material. Confining the vibrations induced may enhance the effects
produced by this delivery. One possible manner of inducing
vibrations within a confined region about the point of dissection
is to expose the material about the point of dissection to
ultrasound vibrations released from an ultrasound horn having a
consistent and narrow diameter. In combination or in the
alternative. vibrations may be induced within a confined region
about the point of dissection by exposing the material about the
point of dissection to concentrated ultrasound vibrations.
Concentrating ultrasound vibrations can be accomplished by inducing
an ultrasound horn with a larger cross section at its proximal end
than its distal end to vibrate. As the vibrations travel from the
horn's wide proximal end to the narrow distal end, the amplitude of
the vibrations increase while their frequency remains constant.
Placing the narrow distal end in contact with the material about
the point of dissection exposes this confined region of the tissue
to ultrasound vibrations. Due to this direct contact exposure,
vibrations are induced in the confined region about the point of
dissection. Accordingly, exposing the wound to concentrated
ultrasound vibrations induces vibrations within a confined region
encompassing the point of dissection.
[0017] The horn utilized to concentrate the ultrasound vibrations
may be constructed from any material capable of conducting
ultrasound vibrations such as, but not limited to, aluminum,
stainless steel, titanium, and any combination thereof. Preferably,
the horn is constructed from titanium alloy Ti 6Al-4V. It is also
preferable that the distal end of the horn used to concentrate the
vibrations contains a sharpened structure such as, but not limited
to, an edge and/or point. Though sharpened to some degree, the
sharpened structure need not be so sharp as to be capable of easily
cutting and/or debriding tissue.
[0018] While the effect elicited by the double-delivery is in
place, the material to be debrided is dissected with a cutting
edge. Any structure containing an edge and/or point sufficiently
fine as to enable dissection may be used as the cutting device.
Accordingly, a horn utilized to expose the material about the point
of dissection to ultrasound vibrations may be used as the cutting
device if it contains a sufficiently fine edge and/or point. An
advantage of using the horn as the cutting devices is that it
simplifies procedure. Possessing a structure sufficiently sharp to
enable dissection, the horn may be used to expose the material
about the point of dissection to ultrasound vibrations and then
used to dissect the material to be debrided. Consequently, the
practitioner debriding the wound need not change instruments as he
transitions between operations of the procedure. The procedure
could be further simplified by utilizing the same structure of a
horn to expose the material about the point of dissection to
ultrasound vibrations and simultaneously dissect the material to be
debrided. According, the practitioner would be able to perform two
operations of the procedure with a single movement. It should be
noted that the vibrations induced in the cutting edge of a horn may
increase the cutting edges ability to dissect tissue, allowing a
blunter edge to be utilized.
[0019] The effects elicited by the double-delivery of ultrasound
reduce the patient's physiological perception pain while the wound
is debrided. However, the perception of pain also involves a
psychological component. For instance, when a patient believes
something will hurt, he may perceive the slightest sensation as
painful. Consequently, if the patient believes debridement will be
painful he will perceive pain though the double-delivery has
diminished the physiological perception of pain. Of course,
comforting words by the medical practitioner may reduce the
patient's expectation of pain. Despite being comforted by the
practitioner, the medical environment in which the invention is
practiced may still make the patient anxious. Unable to overcome
his anxiety, the patient may still perceive pain. However, due to
the physiological effects elicited by the double-delivery the pain
perceived will be primarily psychological. Accordingly, the present
inventions allows for relatively pain-free wound debridement.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] The present invention will be shown and described with
reference to the drawings of preferred embodiments and clearly
understood in its details. Like elements of the various embodiments
depicted within the figures are equivalently numbered.
[0021] FIG. 1 displays a three-dimensional view of a surgical
apparatus that may be used to practice the present invention.
[0022] FIG. 2 depicts practice of the present invention with the
surgical apparatus depicted in FIG. 1.
DETAILED DESCRIPTION OF THE INVENTION
[0023] The method of the present invention will be described with
reference to the surgical apparatus depicted in FIGS. 1 and 2. It
should be appreciated that devices other than the surgical
apparatus depicted in FIGS. 1 and 2 may be used to practice the
invention. For instance, pending U.S. patent application Ser. Nos.
11/449,220 and 11/857,162 depict devices that may be used to
practice the invention, the teachings of which have been previously
incorporated by reference.
[0024] FIG. 1 displays a three-dimensional view of a surgical
apparatus that may be used to practice the present invention. The
advantage of using the surgical apparatus depicted in FIG. 1 is
that the double-delivery of ultrasound and dissection may be
performed with a single motion. The surgical apparatus comprises a
surgical substructure 101 attached to an ultrasound transducer 102
driven by an electrical signal produced by generator 103. Surgical
substructure 101 is comprised of shaft 104 and tip 105. Tip 105, in
turn, comprises radial surface 106 and a cavity 107 containing an
opening 108. Encircling opening 108 are two cutting edges 109 and
110. Radial cutting edge 109 encircles the upper portion of opening
108, while distal cutting edge 110 encircles the distal portion
opening of 108.
[0025] Mechanically coupled to transducer 102 and tip 105, shaft
104 transmits ultrasonic vibrations generated by transducer 102 to
tip 105. Accordingly, when driven or otherwise activated by
generator 103, transducer 102 induces ultrasonic vibrations within
the surgical substructure 101. Inducing vibrations in substructure
101 causes ultrasound to be released from walls of cavity 107 and
cutting edges 109 and 110. Transmitting vibrations and releasing
ultrasound, surgical substructure 101 may be classified as an
ultrasound horn.
[0026] Generator 103 should be capable of producing an electrical
signal of a sufficient voltage to drive transducer 102 to induce
substructure 101 to vibrate, preferably in resonance with the
amplitude of the vibrations being between approximately 1 micron
and approximately 250 microns. Surgical substructure 101 may be
capable of vibrating approximately in resonance at a frequency
between approximately 15 kHz and approximately 5 MHz. Preferably,
substructure 101 should be capable of vibrating approximately in
resonance at a frequency of approximately 30 kHz.
[0027] FIG. 2 depicts practice of the present invention with the
surgical apparatus depicted in FIG. 1. To facilitate the delivery
of ultrasound energy to an area of the wound within the vicinity of
the material to be debrided, a coupling medium 202 is delivered to
cavity 107 through channel 203, which extends through transducer
102 and shaft 104 before opening into cavity 107. After entering
cavity 107 coupling medium 202 is atomized and/or broken into
droplets and sprayed towards the tissue by the ultrasound emanating
from the walls of cavity 107. The spray produced from coupling
medium 202 serves as a conduit for the transmission of ultrasound
energy emanating from walls of cavity 107, thereby delivering
ultrasound energy to the wound. Delivering a sufficient amount of
ultrasound energy to the wound without inducing excessive injury
can also be accomplished by delivering the energy via a coupling
medium that is not atomized and/or broken into droplets.
Accordingly, atomizing and/or breaking the coupling medium into
droplets is not necessary.
[0028] Regardless of whether the coupling medium 202 is atomized or
not, the delivery of ultrasound energy to an area of the wound
within the vicinity of the material to be debrided elicits a
portion of the effects needed for relatively pain-free wound
debridement. Additionally, the delivered ultrasound energy may
enhance debridement by inducing cavitations within the coupling
medium 202 pooling and/or otherwise collecting in and/or over the
wound to be treated. Inducing cavitations in the coupling medium
results in the formation of tiny bubbles. Conceptually, this
phenomenon is similar to inducing water to boil by applying heat.
However, the induction of cavitations within the coupling medium by
the ultrasound energy delivered to the tissue is not dependant upon
heating the coupling medium to its boiling point. As such, the
induction of cavitations is not dependent upon the transfer of
thermal energy to the coupling medium.
[0029] After spontaneously forming within the coupling medium, the
cavitations randomly explode and/or collapse. An exploding and/or
collapsing cavitation releases energy into the coupling medium
surrounding it. Furthermore, the explosion and/or collapse of a
cavitation induces a pressure change within the volume of the
coupling medium surrounding the cavitation. The pressure change
and/or energy released may loosen the tissue to be debrided. In the
alternative or in combination, infectious agent within the vicinity
of the exploding and/or collapsing cavitaiton may be inactivated,
killed, weakened, and/or otherwise compromised.
[0030] If transducer 102 is a piezoelectric transducer and induces
surgical substructure 101 to vibrate approximately in resonance,
then the voltage of the electrical signal supplied by generator 103
will largely control the degree to which the coupling medium 202 is
cavitated and/or atomized. At low voltages coupling medium 202 will
be cavitated to a small degree. As the voltage increases, the
amount of cavitations within coupling medium 202 increases.
Likewise, as the voltage increases the degree to which coupling
medium 202 is atomized will also increase. Regardless, of whether
coupling medium 202 is atomized and/or cavitated, the presence of
coupling medium 202 enables a sufficient amount of ultrasound
energy to be delivered to an area of the wound within the vicinity
of the material to be debrided without excessively injuring the
wound.
[0031] The delivery of ultrasound energy to an area of the wound
within the vicinity of the material to be debrided elicits a
portion of the effects allowing for relatively pain-free wound
debridement. This delivery of ultrasound is suspected, but not
known, to change the permeability of cellular membranes to ions
and/or other molecules within the extracellular environment.
Changing membrane permeability may disrupt ionic and/or other
chemical gradients relied upon by the cells to respond to painful
stimuli. Concentrating the ultrasound energy delivered about a
point within the wound in the vicinity of the material to be
debrided may elicit a greater change in membrane permeability of
cellular structures such as, but not limited to, dendrites, axon,
and/or somas, possibly enhancing one of the elicited effects of the
double-delivery.
[0032] Concentrating the energy delivered to the wound may be
accomplished with any radiation surface from which ultrasonic waves
of converging trajectories are emitted. Ultrasonic waves emanating
from the radiation surface of ultrasound horn carry ultrasound
energy. When one wave crosses the path of another wave the energy
carried by the waves becomes concentrated about the point of
intersection. Accordingly, an ultrasound emitting surface of an
ultrasound horn may be formed in variety of configurations that
allow for the delivery of concentrated ultrasound energy to an area
of the wound within the vicinity of the material to be debrided.
Cavity 107 of the surgical apparatus depicted in FIGS. 1 and 2
illustrates one of the many possible configurations.
[0033] Forming a parabola about two axes, the walls of cavity 107
form a paraboloid structured radiation surface. The paraboloid
structure directs the ultrasound energy emanating the walls of
cavity 107 towards the focal point 204 of the parabola, thereby
concentrating the energy about the focal point 204. The surgical
apparatus, as depicted in FIG. 2, may be oriented such that focal
point 204 is positioned on or below the surface of wound as to
concentrate the ultrasound energy delivered about a point within
the wound in the vicinity of the material to be debrided.
[0034] Delivering concentrated ultrasound energy to the wound does
not necessarily require utilizing a paraboloid structured radiation
surface. Radiation surfaces of various configurations, readily
recognizable by those skilled in the art, may be utilized in
combination with or in the alternative to a paraboloid
configuration.
[0035] Delivering ultrasound energy to an area of the wound within
the vicinity of the material to be debrided only elicits a portion
of effects allowing for relatively pain-free wound debridement. In
and of itself, the delivery of ultrasound energy to an area of the
wound within the vicinity of the material to be debrided is
insufficient to allow for relatively pain-free wound debridement.
Accordingly, it is also necessary to induce vibrations within a
confined region of the material 205 about the point of dissection
206. Directly contacting the material about the point of dissection
206 with vibrating cutting edges 109 and/or 110 induces vibrations
within the confined region 205, thereby accomplishing the other
delivery of the double-delivery.
[0036] When driven or otherwise activated by generator 103,
transducer 102 induces ultrasonic vibrations within the surgical
substructure 101. Mechanically coupled to transducer 102 and tip
105, shaft 104 transmits ultrasonic vibrations generated by
transducer 102 to tip 105. Accordingly, ultrasound vibrations
generated by transducer 102 are channeled into cutting edges 109
and 110. Placing the narrow sharpened edges of cutting edges 109
and/or 110 in close proximity to the point of dissection 206
exposes material within the confined region 205 to ultrasound
vibrations. Due to this direct contact exposure, vibrations
represented by sine wave 207, are induced within the material about
the point of dissection 206. As the vibrations 207 travel away from
the point of exposure their amplitude decreases. Eventually a
distance is reached in which the material is no longer vibrated.
Consequently, the direct exposure to the vibrations released from
cutting edges 109 and/or 110 induces vibrations within confined
region of the tissue 205 about the point of dissection 206.
[0037] The delivery of ultrasound vibrations to the confined region
205 elicits a portion of the effects allowing for relatively
pain-free debridement. Inducing vibrations within the confined
region 205 about the point of dissection 206 is suspected, but not
known to weaken adhesion such as, but not limited to cellular
adhesion, holding the material to be debrided together and/or to
wound. Weakening the adhesion holding the material to the wound may
allow the material to be debrided to be dissected with reduced
levels of tissue and/or cellular damage. In combination or the
alternative, inducing vibrations within the material to be debrided
may weaken the adhesion holding the material together causing the
material to fragment and/or otherwise separate from itself.
Consequently, the induced vibrations 207 may allow the material to
be debrided to be lifted away, pushed aside, fragmented, and/or
otherwise dissected by cutting edges 109 and/or 110.
[0038] The sharpened edges of cutting edges 109 and/or 110 of an
ultrasound horn induce vibrations 207 within confined region 205
about the point of dissection 206 by exposing the material about
the point of dissection 206 to concentrated ultrasound vibrations.
As the vibrations induced in the surgical substructure 101 by
transducer 102 travel into the sharpened edges of cutting edges 109
and 110, they become concentrated. Accordingly, as the vibrations
move towards the sharpened edges, their amplitude increases while
their frequency remains constant. The surgical apparatus depicted
in FIG. 2, therefore, induces vibrations 207 in the confined region
205 about the point of dissection 206 by exposing the material
about the point of dissection 206 to concentrated ultrasound
vibrations. It should be appreciated that exposing the wound to
concentrated ultrasound vibrations is not necessary to effectuate
the delivery of ultrasound resulting in the induction of vibrations
in a confined region about the point of dissection. Rather,
exposing the material about the point of dissection 206 to
concentrated ultrasound vibrations is a consequence of dissecting
the material to be removed with sharpened edges 109 and 110 while
transducer 102 is activated.
[0039] Radial cutting edge 109 and/or distal cutting edge 110 may
be used to dissect the material to be debrided. Because cavity 107
has a general paraboliod configuration, use of either cutting edge
will allow for the delivery of ultrasound energy concentrated about
a point within the wound in the vicinity of the tissue to be
debrided. However, orientated differently with respect to the
propagation path 111 of the ultrasound vibrations traveling through
surgical substructure 101, cutting edges 109 and 110 expose the
material about the point of dissection to different types of
ultrasound vibrations. When transducer 102 is activated, vibrations
are induced in surgical substructure 101. The induced vibrations
travel away from transducer 102 towards the distal end of
substructure 101 along propagation path 111. Orientated completely
orthogonal to propagation 208, cutting edge 110 receives primarily
longitudinal vibrations. According, when cutting edge 110 is used
to dissect material a majority of the ultrasonic vibrations to
which the material about the point of dissection is exposed will be
comprised of longitudinal vibrations. Because the longitudinal
vibrations received by cutting edge 110 will become concentrated as
they travel towards its sharpened edge, a majority of the
ultrasound vibrations to which the material is exposed to will be
concentrated longitudinal vibrations.
[0040] Unlike cutting edge 110, cutting edge 109 is not orientated
as to receive a significant amount of longitudinal vibrations.
Orientated parallel to propagation path 111, vibrations traveling
away from transducer 102 and towards the distal end of substructure
101 will not flow into cutting edge 109. However, this does not
mean that cutting edge 109 is not receiving vibrations that become
concentrated as they travel towards it sharpened edge. The
vibrations induced in substructure 101 by the activation of
transducer 102 cause substructure 101 to expand distally and
rebound proximally. Consequently, the activation of transducer 102
causes substructure 101 to expand and contract about propagation
path 111. As substructure 101 expands forward its width about the y
and z axes decreases. Conversely, as substructure 101 rebounds
backwards its width about the y and z axes increases. With its
width decreasing and increasing, surgical substructure 101
experiences radial deflections about propagation path 111.
Accordingly, the activation of transducer 102 induces longitudinal
vibrations along propagation path 111 and radial vibrations about
path 111 within surgical substructure 101.
[0041] Orientated parallel to propagation path 111, cutting edge
109 is positioned to receive radial vibrations. Propagating towards
the periphery of surgical substructure 101 along paths orthogonal
to propagation path 111, radial vibrations enter the base of
cutting edge 109. According, when cutting edge 109 is used to
dissect material a majority of the ultrasonic vibrations to which
the material about the point of dissection is exposed will be
comprised of radial vibrations. Because the radial vibrations
received by cutting edge 109 will become concentrated as they
travel towards its sharpened edge, a majority of the ultrasound
vibrations to which the material is exposed to will be concentrated
radial vibrations.
[0042] It should be appreciated that a cutting edge which is not
orientated orthogonal to the propagation path of either the
longitudinal or radial vibrations will receive both types of
vibrations. Accordingly, such a cutting edge will expose the tissue
about the point of dissection to both longitudinal and radial
ultrasound vibrations. The proportion of radial and longitudinal
waves to which the tissue about the point of dissection is exposed
will depend on the orientation of the cutting edge. For instance,
if the cutting edge is orientated at an angle of 45.degree. to a
propagation path of radial vibrations and longitudinal vibrations
the edge will receive an equal portion of radial and longitudinal
vibrations. As the vibrations received by the cutting edge travel
towards its sharpened edge, they will become concentrated.
Accordingly, the tissue about the point of dissection will be
exposed to an equal portion of concentrated radial and longitudinal
vibrations. Changing the orientation of the cutting edge will
change the proportion of radial and longitudinal waves to which the
tissue is exposed. As the orientation of the cutting edge becomes
more orthogonal to the propagation path of one type of vibrations
it will receive a larger portion of that type of vibration.
Accordingly, a cutting edge orientated at an angle of 60.degree. to
a propagation path of radial vibrations and 30.degree. to a
propagation of longitudinal vibrations will receive a larger
portion of radial than longitudinal vibrations. Consequently, the
tissue about the point of dissection will be exposed to a larger
portion of concentrated radial than longitudinal vibrations.
[0043] Inducing vibrations 207 within the confined region 205 about
the point of dissection 206, cutting edges 109 and/or 110 are
suspected to weaken adhesion holding the material to be debrided
together and/or the wound. Weakening the adhesion may allow
diseased and/or necrotic tissue 201 to be separated from healthy
and/or viable tissue 208 below the point of dissection 206 with
reduced levels of tissue and/or cellular damage. It should be
appreciated that material other than diseased and/or necrotic
tissue may be dissected. It should also be appreciated that
material other than healthy and/or viable tissue may be spared.
[0044] Regardless of the material to be debrided and/or spared,
moistening the wound with coupling medium 202 and/or any other
fluid not unduly toxic to the tissue may facilitate inducing
vibrations 207. Vibrations 207 are induced in the material about
the point of dissection 206 by transferring the vibrations from
cutting edges 109 and/or 110 to the material about the point of
dissection 206. However, it is possible that the material about the
point of dissection 206 may dampen the vibrations of cutting edges
109 and/or 110. Advancing edges 109 and/or 110 through the material
within the wound may cause the material about the point of
dissection 206 to come into direct contact with their edges. This
will add mass to the cutting edges 109 and 110, thereby dampening
their vibrations. Dampening the vibrations may lessen vibrations
207 transferred to the material about the point of dissection 206.
It may, therefore, be beneficial to isolate at least the sharpened
edges of cutting edges 109 and/or 110 from the material about the
point of dissection 206.
[0045] Isolating cutting edges 109 and/or 110 from the material
about the point of dissection 206 can be accomplished by moistening
the wound. The wound may be moistened with coupling medium 202
and/or any other fluid capable of facilitating the transfer of
vibrations from edges 109 and/or 110 to the material about the
point of dissection 207, not unduly toxic to the tissue, such as,
but not limited to, saline, water, vegetable oil, and/or alcohol.
As cutting edges 109 and/or 110 advances through a moistened wound,
the fluid utilized to moisten the wound flows between the cutting
edges and the material about the point of dissection 206 preventing
direct contact between the edges and the material. This allows
cutting edges 109 and/or 110 to vibrate more freely. In addition to
isolating cutting edges 109 and/or 110 from the material within the
wound, the fluid moistening the wound may act as a conduit carrying
vibrations from the cutting edges to and/or into the material about
the point of dissection 206.
[0046] Exposing the material about the point of dissection 206 to
concentrated ultrasound vibrations and dissecting the material to
be debrided, cutting edges 109 and/or 110 induce vibrations in a
confined region 205 about the point of dissection 206. Though it is
necessary to induce vibrations in this region of the tissue by
exposing the material about the point of the dissection to
ultrasound vibrations in order to allow for relatively pain-free
wound debridement, dissection need not be performed simultaneously
with this ultrasound delivery. Rather, all that is required is that
dissection be performed before the effects elicited by the delivery
of ultrasound vibrations dissipate. Accordingly, the dissection may
be performed after the ultrasound vibrations have been delivered to
the material about the point of dissection.
[0047] If dissection and the delivery of ultrasound vibrations will
not be performed by the same instruments, it may not be necessary
to use the sharpened edge of an ultrasound horn to induce
vibrations in the material about the point of dissection. Instead,
any ultrasound horn allowing for the induction of vibrations within
a confined region about the point of dissection may be utilized to
practice the invention. For instance, an ultrasound horn having a
consistent and narrow diameter may be used to induce vibrations
within the wound confined to the region about the point of
dissection. Consequently, exposing the material about the point of
dissection to concentrated ultrasound vibrations may not be
necessary.
[0048] As with dissection of the material to be debrided, the
delivery of ultrasound inducing vibrations about the point of
dissection does not have to occur simultaneously with the delivery
of ultrasound energy to an area of the wound within the vicinity of
the material to be debrided. Accordingly, one delivery may precede
the other. For example, ultrasound energy may be first delivered to
an area of the wound within the vicinity of the material to be
debrided; then ultrasound vibrations may be delivered to induce
vibrations within a confined region about the point of
debridement.
[0049] Because the deliveries of ultrasound do not necessarily have
to occur simultaneously to practice the invention, different horns
may be utilized for each delivery. For instance, one horn held
stationary above and/or swept over the wound may be used to deliver
ultrasound energy to an area of the wound in the vicinity of the
material to be debrided. A second horn could be placed in contact
with the wound to deliver ultrasound vibrations inducing vibrations
within a confined region about the point of debridement.
[0050] Accordingly, though specific embodiments of apparatuses and
methods have been illustrated and described herein, it will be
appreciated by those of ordinary skill in the art that any
arrangement, combination, and/or sequence that is calculated to
achieve the same purpose may be substituted for the specific
embodiments shown. It is to be understood that the above
description is intended to be illustrative and not restrictive.
Combinations of the above embodiments and other embodiments as well
as combinations and sequences of the above methods and other
methods of use will be apparent to individuals possessing skill in
the art upon review of the present disclosure.
[0051] It should be noted and appreciated that other benefits,
mechanisms of action, and/or mechanisms of operation, in addition
to those listed, may be elicited by methods in accordance with the
present invention. The mechanisms of action and mechanisms of
operation presented herein are strictly theoretical and are not
meant in any way to limit the scope of this disclosure and/or the
accompanying claims.
[0052] It should also be appreciated that elements described with
singular articles such as "a", "an", and/or "the" and/or otherwise
described singularly may be used in plurality. Likewise, it should
be appreciated that elements described in plurality may be used
singularly.
[0053] The scope of the claimed apparatus and methods should be
determined with reference to the appended claims, along with the
full scope of equivalents to which such claims are entitled.
* * * * *