U.S. patent application number 17/199014 was filed with the patent office on 2021-07-01 for cryogenic kyphoplasty instrument and methods of use.
This patent application is currently assigned to MEDTRONIC HOLDING COMPANY S RL. The applicant listed for this patent is MEDTRONIC HOLDING COMPANY S RL. Invention is credited to Stephen Nash.
Application Number | 20210196339 17/199014 |
Document ID | / |
Family ID | 1000005449557 |
Filed Date | 2021-07-01 |
United States Patent
Application |
20210196339 |
Kind Code |
A1 |
Nash; Stephen |
July 1, 2021 |
CRYOGENIC KYPHOPLASTY INSTRUMENT AND METHODS OF USE
Abstract
A surgical instrument includes an outer shaft defining a
passageway. An inner shaft is disposed within the passageway and
defines a lumen. An expandable structure has a first end coupled to
a second end of the outer shaft and a second end coupled to a
second end of the inner shaft. The expandable member defines a
chamber. A delivery shaft includes a first end positioned within
the passageway and a second end positioned within the chamber. The
delivery shaft defines a channel configured to deliver a coolant
out of an opening in the second end of the delivery shaft and into
the chamber to move the expandable structure from an unexpanded
configuration to an expanded configuration. A variable exhaust
valve is in communication with the passageway and is configured to
regulate pressure within the chamber. Systems and methods are
disclosed.
Inventors: |
Nash; Stephen; (Galway,
IE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
MEDTRONIC HOLDING COMPANY S RL |
TOLOCHENAZ |
|
CH |
|
|
Assignee: |
MEDTRONIC HOLDING COMPANY S
RL
TOLOCHENAZ
CH
|
Family ID: |
1000005449557 |
Appl. No.: |
17/199014 |
Filed: |
March 11, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15921049 |
Mar 14, 2018 |
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17199014 |
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14288437 |
May 28, 2014 |
9936997 |
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15921049 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2018/0293 20130101;
A61B 2018/0022 20130101; A61B 2018/00577 20130101; A61B 2018/00339
20130101; A61B 18/02 20130101; A61B 2090/064 20160201; A61B
2018/00041 20130101; A61B 2018/00791 20130101 |
International
Class: |
A61B 18/02 20060101
A61B018/02 |
Claims
1-20. (canceled)
21. A surgical instrument, comprising: a sleeve defining a
passageway; a shaft disposed within the passageway; a balloon
having a first end coupled to the sleeve and an opposite second end
coupled to the shaft, wherein the shaft is movably disposed within
the passageway to move the instrument between a first orientation
in which a portion of the balloon is positioned outside of the
passageway and a second orientation in which the portion of the
balloon is positioned within the passageway.
22. The surgical instrument recited in claim 21, further comprising
a valve configured to regulate pressure within the balloon.
23. The surgical instrument recited in claim 22, further comprising
a delivery shaft configured to deliver a coolant into the balloon
to expand the balloon.
24. The surgical instrument recited in claim 22, further comprising
a delivery shaft, the delivery shaft comprising a first end
positioned within the passageway and a second end positioned within
the balloon, the delivery shaft being configured to deliver a
coolant into the balloon to expand the balloon.
25. The surgical instrument recited in claim 21, further comprising
a variable exhaust valve configured to regulate pressure within the
balloon.
26. The surgical instrument recited in claim 25, further comprising
a delivery shaft configured to deliver a coolant into the balloon
to expand the balloon.
27. The surgical instrument recited in claim 25, further comprising
a delivery shaft, the delivery shaft comprising a first end
positioned within the passageway and a second end positioned within
the balloon, the delivery shaft being configured to deliver a
coolant into the balloon to expand the balloon.
28. The surgical instrument recited in claim 21, further comprising
a delivery shaft configured to deliver a coolant into the balloon
to expand the balloon.
29. The surgical instrument recited in claim 21, further comprising
a delivery shaft, the delivery shaft comprising a first end
positioned within the passageway and a second end positioned within
the balloon, the delivery shaft being configured to deliver a
coolant into the balloon to expand the balloon.
30. The surgical instrument recited in claim 21, wherein the shaft
defines a lumen, the lumen being in communication with a chamber of
the balloon.
31. A surgical instrument, comprising: a sleeve defining a
passageway; a shaft disposed within the passageway; a balloon
having a first end coupled to the sleeve and an opposite second end
coupled to the shaft, wherein the shaft is movably disposed within
the passageway such that moving the shaft relative to the sleeve
positions at least a portion of the balloon within the
passageway.
32. The surgical instrument recited in claim 31, further comprising
a valve configured to regulate pressure within the balloon.
33. The surgical instrument recited in claim 32, further comprising
a delivery shaft configured to deliver a coolant into the balloon
to expand the balloon.
34. The surgical instrument recited in claim 32, further comprising
a delivery shaft, the delivery shaft comprising a first end
positioned within the passageway and a second end positioned within
the balloon, the delivery shaft being configured to deliver a
coolant into the balloon to expand the balloon.
35. The surgical instrument recited in claim 31, further comprising
a variable exhaust valve configured to regulate pressure within the
balloon.
36. The surgical instrument recited in claim 35, further comprising
a delivery shaft configured to deliver a coolant into the balloon
to expand the balloon.
37. The surgical instrument recited in claim 35, further comprising
a delivery shaft, the delivery shaft comprising a first end
positioned within the passageway and a second end positioned within
the balloon, the delivery shaft being configured to deliver a
coolant into the balloon to expand the balloon.
38. The surgical instrument recited in claim 31, further comprising
a delivery shaft, the delivery shaft comprising a first end
positioned within the passageway and a second end positioned within
the balloon, the delivery shaft being configured to deliver a
coolant into the balloon to expand the balloon.
39. The surgical instrument recited in claim 31, wherein the shaft
defines a lumen, the lumen being in communication with a chamber of
the balloon.
40. A surgical instrument, comprising: an outer member defining a
passageway; an inner member movably disposed within the passageway;
a balloon having a first end coupled to the outer member and a
second end coupled to the inner member; a delivery member
configured to deliver a coolant into balloon, wherein the inner
member is movable relative to the outer member to move the the
balloon from a first orientation in which the balloon is positioned
entirely outside of the passageway and a second orientation in
which at least a portion of the balloon is positioned within the
passageway.
Description
TECHNICAL FIELD
[0001] The present disclosure generally relates to medical devices
for the treatment of musculoskeletal disorders, and more
particularly to a surgical system and method to facilitate
treatment while minimizing pain.
BACKGROUND
[0002] Spinal disorders such as degenerative disc disease, disc
herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis
and other curvature abnormalities, kyphosis, tumor, and fracture
may result from factors including trauma, disease and degenerative
conditions caused by injury and aging. Spinal disorders typically
result in symptoms including pain, nerve damage, and partial or
complete loss of mobility.
[0003] In an effort to more effectively and directly treat
vertebral compression fractures, minimally invasive techniques such
as vertebroplasty and, subsequently, kyphoplasty, have been
developed. Vertebroplasty involves creating a cavity in a
fractured, weakened, or diseased vertebral body. A flowable
reinforcing material, usually polymethylmethacrylate
(PMMA--commonly known as bone cement), is injected into the cavity.
Shortly after injection, the liquid filling material hardens or
polymerizes, desirably supporting the vertebral body internally,
alleviating pain and preventing further collapse of the injected
vertebral body. However, creating the cavity in the fractured,
weakened, or diseased vertebral body may involve pain, if
untreated.
[0004] Traditional cryogenic systems, such as, for example,
cryoablation systems can provide denervation capabilities, but the
procedures can take a considerable amount of time to perform.
Another problem with currently available cryoablation devices is
that they are not cost effective. Further, the health care
practitioner may have difficulty positioning the tip of the device
in the optimal location to get an optimal and consistent clinical
result. This may also result in unwanted necrosis of adjacent
tissue, which can lead to clinical adverse events including
subsequent repair of the necrotic tissue. This disclosure describes
an improvement over these prior art technologies.
SUMMARY
[0005] In one embodiment, a surgical instrument is provided. The
surgical instrument comprises an outer shaft extending along a
longitudinal axis between a first end and an opposite second end.
The outer shaft comprises an inner surface defining a passageway.
An inner shaft is disposed within the passageway. The inner shaft
extends between a first end and an opposite second end. The inner
shaft comprises an inner surface defining a lumen. An expandable
structure has a first end coupled to the second end of the outer
shaft and an opposite second end coupled to the second end of the
inner shaft. The expandable member comprises an inner surface
defining a chamber. A delivery shaft comprises a first end
positioned within the passageway and a second end positioned within
the chamber. The delivery shaft comprises an inner surface defining
a channel configured to deliver a coolant out of an opening in the
second end of the delivery shaft and into the chamber to move the
expandable structure from an unexpanded configuration to an
expanded configuration. A variable exhaust valve is in
communication with the passageway and is configured to regulate
pressure within the chamber. In some embodiments, systems and
methods are provided.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] The present disclosure will become more readily apparent
from the specific description accompanied by the following
drawings, in which:
[0007] FIG. 1 is a side, cross sectional view of components of one
embodiment of a surgical system in accordance with the principles
of the present disclosure;
[0008] FIG. 2 is a cross sectional view of components shown in FIG.
1, taken at Detail A in FIG. 1;
[0009] FIG. 3 is a cross sectional view of components shown in FIG.
1 taken along lines B-B in FIG. 2;
[0010] FIG. 4 is a plan view of components shown in FIG. 1, used in
connection with a surgical procedure;
[0011] FIG. 5 is a plan view of components shown in FIG. 1, used in
connection with a surgical procedure;
[0012] FIG. 6 is a plan view of components shown in FIG. 1, used in
connection with a surgical procedure;
[0013] FIG. 7 is a plan view of components shown in FIG. 1, used in
connection with a surgical procedure;
[0014] FIG. 8 is a plan view of components shown in FIG. 1, used in
connection with a surgical procedure; and
[0015] FIG. 9 is a plan view of components shown in FIG. 1, used in
connection with a surgical procedure.
DETAILED DESCRIPTION
[0016] The exemplary embodiments of a surgical system and related
methods of use disclosed are discussed in terms of medical devices
for the treatment of musculoskeletal disorders and more
particularly, in terms of a surgical system and method to
facilitate treatment while minimizing pain. In one embodiment, the
surgical system includes a surgical instrument that reduces pain
associated with a surgical procedure, such as, for example, a
kyphoplasty procedure. In some embodiments, the instrument includes
a Cryo balloon that is filled and/or inflated using a coolant, such
as, for example nitrous oxide (N.sub.2O). In some embodiments, the
instrument is configured to deform tissue, such as, for example,
create a cavity in cancellous bone. Cryo energy is delivered to
surrounding tissue to lessen pain associated with the procedure. In
some embodiments, the Cryo energy is delivered at the same time the
cavity is created. Once the Cryo energy denervates surrounding
nerves, the cavity is filled with a material, such as, for example,
bone cement. In some embodiments, one balloon is used to create the
cavity. The balloon is removed and another balloon is inserted into
the cavity that emits Cryo energy to nerves surrounding the
balloon. Once the Cryo energy denervates surrounding nerves, the
cavity is filled with a material, such as, for example, bone
cement. In some embodiments, denervation has pain benefits to the
overall spinal pain. In some embodiments, denervation decreases
pain associated with the procedure. In some embodiments,
denervation slows the progression of the compressions.
[0017] In some embodiments, a narrow pathway is made into fractured
bone using a hollow instrument. A small orthopaedic balloon is
guided through the instrument into the vertebral body. In some
embodiments, the incision site is approximately 1 cm (1/3 inch) in
length. In some embodiments, two balloons are used, one on each
side of the vertebral body, to better support the bone as it moves
back into position and increase the likelihood of deformity
correction. In some embodiments, the instrument includes a balloon
capable of very high internal pressures, such as, for example,
pressures equal to or greater than about 400 psi. These high
pressures are required to form a cavity in bone. The cavity
provides space for bone cement. The balloons are carefully inflated
in an attempt to raise the collapsed vertebral body and return it
to its normal position. In some embodiment, a coolant such as, for
example, nitrous oxide is used to fill at least one of the
balloons. In some embodiments, the coolant is delivered into the
balloon as a liquid. Once it enters the balloon, the liquid goes
from an area of high pressure (inside the coolant lumen) to low
pressure (in the balloon chamber). This pressure gradient cause the
liquid to evaporate to a gas, thus inflating the balloon. The
larger the pressure drop, the colder the temperature. The balloon
pressure can be controlled by a pressure regulator and also the
balloon outer diameter can be controlled by the balloon pressure.
Inflation of the balloons creates a cavity (space) within the
vertebral body that compacts the soft, inner bone against the outer
wall. The cavity also functions as a "container" for tile bone
cement. Once the vertebral body is in the correct position, the
balloons are deflated and removed. In some embodiments, the
pressure within the balloons is reduced prior to deflating and/or
removing the balloons. In some embodiments, the pressure within the
balloons is reduced via a variable exhaust valve. As the nitrous
oxide transitions from a liquid to a gas, the nitrous oxide creates
cold energy that denervates surrounding nerves. Following
denervation, the balloon(s) is/are removed and the cavity is filled
with thick bone cement to stabilize the fracture. The bone cement
forms an internal cast that holds the vertebral body in place.
[0018] In some embodiments, the instrument includes a balloon
capable of very high internal pressures, such as, for example,
pressures equal to or greater than about 400 psi. In some
embodiments, the instrument includes a balloon capable of very high
internal pressures, such as, for example, pressures equal to or
greater than about 700 psi. This allows nitrous oxide to be
delivered into the balloon under significant pressure such that the
balloon creates a cavity in bone. Pressure within the balloon is
decreased via a variable exhaust valve. In some embodiments, the
pressure is reduced to between about 5 and about 25 psi to create
cold energy that denervates nerves surrounding the balloon. In some
embodiments, the balloon is a single wall balloon to allow for
efficient energy transfer of the cold energy created by the
pressure reduction within the balloon on the nitrous oxide. In some
embodiments, the nitrous oxide transitions from a liquid to a gas
as a result of the pressure reduction within the balloon. In some
embodiments, exhaust gas is provisionally stored in a handle of the
instrument, but does not exit the system until it reaches a
threshold set by the system. In some embodiments, the threshold is
high for kyphoplasty and is low for denervation. In some
embodiments, the instrument includes a control system that can
toggle between high and low pressure to create a cavity and then
denervate the nerves. In some embodiments, the entire system can be
controlled by a console. In some embodiments, the entire system can
be controlled by a smart handle. In some embodiments, feedback on
temperatures and balloon pressure is monitored for controlled
kyphoplasty/denervation.
[0019] In some embodiments, the balloon can be inflated
incrementally with pressure to control the balloon outer diameter
and thus control the creation of the cavity. This can start at a
low pressure of about 50 psi and rise gradually to about 400 psi.
In some embodiments, the balloon is inflated to have an internal
pressure of about 50 psi to create a cavity within bone and the
pressure within the balloon is reduced to about 10 psi to cause the
nitrous oxide to transition from liquid to gas to create cold
energy to denervate nerves within the bone. In some embodiments,
the balloon is inflated to have an internal pressure of about 100
psi to create a cavity within bone and the pressure within the
balloon is reduced to about 10 psi to cause the nitrous oxide to
transition from liquid to gas to create cold energy to denervate
nerves within the bone. In some embodiments, the balloon is
inflated to have an internal pressure of about 150 psi to create a
cavity within bone and the pressure within the balloon is reduced
to about 10 psi to cause the nitrous oxide to transition from
liquid to gas to create cold energy to denervate nerves within the
bone. In some embodiments, the balloon is inflated to have an
internal pressure of about 200 psi to create a cavity within bone
and the pressure within the balloon is reduced to about 10 psi to
cause the nitrous oxide to transition from liquid to gas to create
cold energy to denervate nerves within the bone. In some
embodiments, the balloon is inflated to have an internal pressure
of about 250 psi to create a cavity within bone and the pressure
within the balloon is reduced to about 10 psi to cause the nitrous
oxide to transition from liquid to gas to create cold energy to
denervate nerves within the bone. In some embodiments, the balloon
is inflated to have an internal pressure of about 300 psi to create
a cavity within bone and the pressure within the balloon is reduced
to about 10 psi to cause the nitrous oxide to transition from
liquid to gas to create cold energy to denervate nerves within the
bone. In some embodiments, the balloon is inflated to have an
internal pressure of about 350 psi to create a cavity within bone
and the pressure within the balloon is reduced to about 10 psi to
cause the nitrous oxide to transition from liquid to gas to create
cold energy to denervate nerves within the bone. In some
embodiments, the balloon is inflated to have an internal pressure
of about 400 psi to create a cavity within bone and the pressure
within the balloon is reduced to about 10 psi to cause the nitrous
oxide to transition from liquid to gas to create cold energy to
denervate nerves within the bone.
[0020] In some embodiments, the present disclosure may be employed
to treat spinal disorders such as, for example, degenerative disc
disease, disc herniation, osteoporosis, spondylolisthesis,
stenosis, scoliosis and other curvature abnormalities, kyphosis,
tumor and fractures. In some embodiments, the present disclosure
may be employed with other osteal and bone related applications,
including those associated with diagnostics and therapeutics. In
some embodiments, the disclosed surgical system may be
alternatively employed in a surgical treatment with a patient in a
prone or supine position, and/or employ various surgical approaches
to the spine, including anterior, posterior, posterior mid-line,
lateral, postero-lateral, and/or antero-lateral approaches, and in
other body regions. The present disclosure may also be
alternatively employed with procedures for treating the lumbar,
cervical, thoracic, sacral and pelvic regions of a spinal column.
The surgical system of the present disclosure may also be used on
animals, bone models and other non-living substrates, such as, for
example, in training, testing and demonstration.
[0021] The present disclosure may be understood more readily by
reference to the following detailed description of the embodiments
taken in connection with the accompanying drawing figures, which
form a part of this disclosure. It is to be understood that this
application is not limited to the specific devices, methods,
conditions or parameters described and/or shown herein, and that
the terminology used herein is for the purpose of describing
particular embodiments by way of example only and is not intended
to be limiting. Also, in some embodiments, as used in the
specification and including the appended claims, the singular forms
"a," "an," and "the" include the plural, and reference to a
particular numerical value includes at least that particular value,
unless the context clearly dictates otherwise. Ranges may be
expressed herein as from "about" or "approximately" one particular
value and/or to "about" or "approximately" another particular
value. When such a range is expressed, another embodiment includes
from the one particular value and/or to the other particular value.
Similarly, when values are expressed as approximations, by use of
the antecedent "about," it will be understood that the particular
value forms another embodiment. It is also understood that all
spatial references, such as, for example, horizontal, vertical,
top, upper, lower, bottom, left and right, are for illustrative
purposes only and can be varied within the scope of the disclosure.
For example, the references "upper" and "lower" are relative and
used only in the context to the other, and are not necessarily
"superior" and "inferior".
[0022] Further, as used in the specification and including the
appended claims, "treating" or "treatment" of a disease or
condition refers to performing a procedure that may include
administering one or more drugs to a patient (human, normal or
otherwise or other mammal), employing implantable devices, and/or
employing instruments that treat the disease, such as, for example,
microdiscectomy instruments used to remove portions bulging or
herniated discs and/or bone spurs, in an effort to alleviate signs
or symptoms of the disease or condition. Alleviation can occur
prior to signs or symptoms of the disease or condition appearing,
as well as after their appearance. Thus, treating or treatment
includes preventing or prevention of disease or undesirable
condition (e.g., preventing the disease from occurring in a
patient, who may be predisposed to the disease but has not yet been
diagnosed as having it). In addition, treating or treatment does
not require complete alleviation of signs or symptoms, does not
require a cure, and specifically includes procedures that have only
a marginal effect on the patient. Treatment can include inhibiting
the disease, e.g., arresting its development, or relieving the
disease, e.g., causing regression of the disease. For example,
treatment can include reducing acute or chronic inflammation;
alleviating pain and mitigating and inducing re-growth of new
ligament, bone and other tissues; as an adjunct in surgery; and/or
any repair procedure. Also, as used in the specification and
including the appended claims, the term "tissue" includes soft
tissue, ligaments, tendons, cartilage and/or bone unless
specifically referred to otherwise.
[0023] The following discussion includes a description of a
surgical system and methods of employing the surgical system in
accordance with the principles of the present disclosure. Alternate
embodiments are also disclosed. Reference will now be made in
detail to the exemplary embodiments of the present disclosure,
which are illustrated in the accompanying figures. Turning to FIGS.
1-9, there are illustrated components of a surgical system 10
including a surgical device, such as, for example, a surgical
instrument 12 in accordance with the principles of the present
disclosure.
[0024] The components of surgical system 10 can be fabricated from
biologically acceptable materials suitable for medical
applications, including metals, synthetic polymers, ceramics and
bone material and/or their composites, depending on the particular
application and/or preference of a medical practitioner. For
example, the components of surgical system 10, individually or
collectively, can be fabricated from materials such as stainless
steel alloys, commercially pure titanium, titanium alloys, Grade 5
titanium, super-elastic titanium alloys, cobalt-chrome alloys,
stainless steel alloys, superelastic metallic alloys (e.g.,
Nitinol, super elasto-plastic metals, such as GUM METAL.RTM.
manufactured by Toyota Material Incorporated of Japan), ceramics
and composites thereof such as calcium phosphate (e.g., SKELITE.TM.
manufactured by Biologix Inc.), thermoplastics such as
polyaryletherketone (PAEK) including polyetheretherketone (PEEK),
polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK
composites, PEEK-BaSO.sub.4 polymeric rubbers, polyethylene
terephthalate (PET), fabric, silicone, polyurethane,
silicone-polyurethane copolymers, polymeric rubbers, polyolefin
rubbers, hydrogels, semi-rigid and rigid materials, elastomers,
rubbers, thermoplastic elastomers, thermoset elastomers,
elastomeric composites, rigid polymers including polyphenylene,
polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone
material including autograft, allograft, xenograft or transgenic
cortical and/or corticocancellous bone, and tissue growth or
differentiation factors, partially resorbable materials, such as,
for example, composites of metals and calcium-based ceramics,
composites of PEEK and calcium based ceramics, composites of PEEK
with resorbable polymers, totally resorbable materials, such as,
for example, calcium based ceramics such as calcium phosphate,
tri-calcium phosphate (TCP), hydroxyapatite (HA)-TCP, calcium
sulfate, or other resorbable polymers such as polyaetide,
polyglycolide, polytyrosine carbonate, polycaroplaetohe and their
combinations. Various components of surgical system 10 may have
material composites, including the above materials, to achieve
various desired characteristics such as strength, rigidity,
elasticity, compliance, biomechanical performance, durability and
radiolucency or imaging preference. The components of surgical
system 10, individually or collectively, may also be fabricated
from a heterogeneous material such as a combination of two or more
of the above-described materials. The components of surgical system
10 may be monolithically formed, integrally connected or include
fastening elements and/or instruments, as described herein.
[0025] Instrument 12 comprises an outer shaft 14 extending along a
longitudinal axis C between an end 16 and an opposite end 18. Shaft
14 has a length defined by the distance between ends 16, 18. In
some embodiments, shaft 14 has a uniform width and/or diameter
along the entire length of shaft 14. Shaft 14 comprises an inner
surface 20 defining a passageway 22 having a cylindrical cross
sectional configuration. End 18 comprises a circular opening 24
that is in communication with passageway 22. Opening 24 is coaxial
with axis C. Passageway 22 has a length defined by the length of
shaft 14. In some embodiments, passageway 22 has a uniform width
and/or diameter along the entire length of passageway 22. In some
embodiments, shaft 14 comprises a flexible material such that shaft
14 can bend without breaking. In some embodiments, shaft 14
comprises a rigid material such that shaft 14 cannot bend without
breaking. In some embodiments, at least a portion of shaft 14 is
transparent or translucent to permit visualization of components
within passageway 22. In some embodiments, passageway 22 and/or
opening 24 may have various cross section configurations, such as,
for example, oval, oblong, triangular, rectangular, square,
polygonal, irregular, uniform, non-uniform, variable, tubular
and/or tapered. In some embodiments, opening 24 may be disposed at
alternate orientations, relative to axis C, such as, for example,
transverse, perpendicular and/or other angular orientations such as
acute or obtuse, co-axial and/or may be offset or staggered.
[0026] An inner shaft 26 is disposed within passageway 22 such that
shaft 26 is coaxial with axis C. Shaft 26 extends between an end 28
and an opposite end 30. Shaft 26 has a length defined by the
distance between ends 28, 30. In some embodiments, shaft 26 has a
uniform width and/or diameter along the entire length of shaft 26.
Shaft 26 comprises an inner surface 32 defining a lumen 34 having a
cylindrical cross sectional configuration. Lumen 34 has a length
defined by the length of shaft 26. In some embodiments, lumen 34
has a uniform width and/or diameter along the entire length of
lumen 34. In some embodiments, shaft 26 comprises a flexible
material such that shaft 26 can bend without breaking. In some
embodiments, shaft 26 comprises a rigid material such that shaft 26
cannot bend without breaking. In some embodiments, at least a
portion of shaft 26 is transparent or translucent to permit
visualization of components within lumen 34. In some embodiments,
end 28 includes a circular aperture 36 an end 30 comprises a
circular aperture 38. Apertures 36, 38 are in communication with
lumen 34 such that a component, such as, for example, a guide wire
can be inserted into aperture 36 and be positioned such that an end
of the guide wire extends through aperture 38. Apertures 36, 38 are
each coaxial with axis C. In some embodiments, end 30 comprises an
end surface extending perpendicular to axis C such that end 30 is
closed. In some embodiments, lumen 34, aperture 36 and/or aperture
38 may have various cross section configurations, such as, for
example, oval, oblong, triangular, rectangular, square, polygonal,
irregular, uniform, non-uniform, variable, tubular and/or tapered.
In some embodiments, lumen 34, aperture 36 and/or aperture 38 may
be disposed at alternate orientations, relative to axis C, such as,
for example, transverse, perpendicular and/or other angular
orientations such as acute or obtuse, co-axial and/or may be offset
or staggered. In some embodiments, shaft 26 is rotatably and/or
slidably disposed within passageway 26. In some embodiments, shaft
26 is fixed relative to shaft 14. For example, in one embodiment,
end 28 extends through an opening 54 in end 16 and is fixed to a
handle 55. End 16 is also fixed to handle 55 to fix shaft 26
relative to shaft 14. In some embodiments, handle 55 is an
ergonomic handle configured to be gripped by hand by a medical
practitioner.
[0027] An expandable structure, such as, for example, a balloon 40
comprises an end 42 coupled to end 18 such that an inner surface 44
of balloon 40 engages an outer surface of shaft 14 and an opposite
end 44 coupled to end 30 such that surface 44 engages an outer
surface of shaft 26. In some embodiments, balloon 40 is attached to
shafts 14, 26 by adhesive bonding, thermal bonding, laser bonding,
or RF bonding. Surface 44 defines a chamber 48 configured for
disposal of a material to increase pressure within chamber 48 to
move balloon 40 from an unexpanded or collapsed orientation, as
shown in FIG. 4, to an expanded or inflated orientation, as shown
in FIG. 5. In some embodiments, balloon 40 is a single wall balloon
made from a compliant material. In some embodiments, balloon 40
comprises a thin, single layer of material configured to permit the
transfer of energy, such as, for example, cold and/or Cryo energy
through the balloon wall. In some embodiments, a tip of shaft 26
extends beyond end 46, as shown in FIG. 1. In some embodiments, the
tip of shaft is flush with end 46, as shown in FIG. 2. In some
embodiments, balloon 40 comprises various compliant and/or
non-compliant materials, for example, latex and/or polyethylene
terephthalate (PET), polyurethane, nylon or polyether block amide.
Other materials are also contemplated. In some embodiments, at
least a portion of balloon 40 comprises a transparent or
translucent material to facilitate visualization of components
disposed within chamber 48. In some embodiments, the shapes and
sizes of balloon 40 when in the expanded orientation can be
selected to provide a desired result during a procedure. For
example, balloon 40 may include shapes such as spheres, cylinders,
multi-lobed shapes, etc. and have different dimensions to make
balloon 40 narrower or wider in a longitudinal direction, or extend
further in a radial direction, etc.
[0028] Chamber 48 is configured to transition between a deflated or
collapsed orientation and an inflated or expanded orientation, as
discussed above. Chamber 48 is shown in the expanded orientation in
FIGS. 1-3, 5 and 6. Chamber 48 is shown in the collapsed
orientation in FIG. 4. To move chamber 48 from the collapsed
orientation to the expanded orientation, a material source, such
as, for example, a coolant source 50, is coupled to instrument 12.
Source 50 includes a delivery shaft 51 comprising an inner surface
defining a channel, such as, for example, an inlet 52. An end of
shaft 51 is directly coupled to source 50 and an opposite end 56 of
shaft 51 is positioned in chamber 48. An intermediate portion of
shaft 51 is positioned in passageway 22. End 56 includes an opening
58 that is in communication with inlet 52 such that a material can
be delivered from source 50, through inlet 52 and exit inlet 52
through opening 58 for disposal in chamber 48. As the material is
introduced into chamber 48, pressure within chamber 48 increases,
causing chamber 48 to transition from the collapsed orientation to
the expanded orientation. Shaft 51 and opening 58 each extend
parallel to axis C and are offset from axis C. In some embodiments,
shaft 51 is directly coupled to the outer surface of shaft 26 such
that shaft 51 is fixed to shaft 26 and/or shaft 51 extends parallel
to axis C. In some embodiments, shaft 51 is removable from shaft 26
and/or is movable relative to shaft 26. In some embodiments, source
50 comprises a heat element 60 comprising at least one heating
and/or cooling element, such as, for example, a thermoelectric
device configured to heat and/or cool the material stored within
source 50 to adjust the temperature of the material, as selected by
a medical practitioner, for example. In some embodiments, the
material stored within source 50 is pressurized. In some
embodiments, the material stored within source 50 comprises a
pressure of at least about 50 psi. In some embodiments, the
material stored within source 50 comprises a pressure of at least
about 100 psi. In some embodiments, the material stored within
source 50 comprises a pressure of at least about 400 psi. In some
embodiments, the material stored within source 50 comprises a
pressure of at least about 700 psi. In some embodiments, the
material stored within source 50 comprises a coolant or
refrigerant, such as, for example, nitrous oxide (N.sub.2O). In
some embodiments, the nitrous oxide is stored within source 50 as a
liquid. In some embodiments, the material stored within source 50
comprises other cryogens and/or liquefied gases, such as, for
example, liquid nitrogen and/or liquid helium.
[0029] Instrument 12 includes a pressure monitor 62 positioned
outside of passageway 26 such that pressure monitor 62 is
accessible and/or viewable by a medical practitioner. Pressure
monitor 62 comprises a conduit 64 comprising an end 66 that extends
through handle 55 and is positioned in passageway 26 and an
opposite end 68 positioned within chamber 48. In some embodiments,
conduit 64 is directly coupled shaft 26 such that an outer surface
of conduit 64 engages the outer surface of shaft 26 and/or conduit
64 extends parallel to axis C. In some embodiments, conduit 64 is
removable from shaft 26 and/or is movable relative to shaft 26.
Conduit 64 comprises an inner surface defining a channel that is in
communication with pressure monitor 62. End 68 comprises an opening
70 that is in communication with the channel defined by the inner
surface of conduit 64 such that pressure within chamber 48 can be
detected by pressure monitor 62. In some embodiments, pressure
monitor 62 includes a display configured to provide a visualization
of the pressure within chamber 48. In some embodiments, pressure
monitor 62 comprises audio and/or visual components, such as, for
example lights or speakers configured to provide alerts when
pressure within chamber 48 reaches and/or exceeds a selected
threshold pressure. For example, a medical practitioner may preset
pressure monitor 62 to provide an alert if and when pressure within
chamber 48 reaches and/or exceeds 700 psi, for example, to avoid
overinflating balloon 40 and/or rupturing balloon 40. As a further
example, a medical practitioner may preset pressure monitor 62 to
provide an alert if and when pressure within chamber 48 reaches
and/or drops below 10 psi, for example, to indicate when pressure
within chamber 48 decreases to a selected threshold.
[0030] Instrument 12 comprises a variable exhaust valve 72
extending through handle 55 such that valve 72 is in communication
with passageway 26. Valve 72 is configured to regulate pressure
within chamber 48. In some embodiments, valve 72 is in
communication with pressure monitor 62. Valve 72 is configured to
open when pressure within chamber 48 reaches a first selected
threshold pressure and to close when pressure within chamber 48
drops to a second selected threshold pressure. For example, valve
72 may be preset to open when pressure within chamber 48 reaches a
first selected threshold pressure, such as, for example, 700 psi.
When valve 72 is open, pressure within chamber 48 decreases.
Pressure within chamber 48 decreases to a second selected threshold
pressure, such as, for example, 10 psi, thus causing valve 72 to
close. When valve 72 is closed, pressure within chamber 48 remains
constant.
[0031] In some embodiments, instrument 12 comprises a thermocouple
74 disposed in lumen 34 configured to detect temperature within
chamber 48. In some embodiments, thermocouple 74 comprises an end
76 coupled to handle 55 and an opposite end 78 positioned in a
portion of lumen 34 that is positioned within chamber 48 such that
thermocouple 74 can detect temperature within chamber 48. In some
embodiments, thermocouple 74 is coaxial with axis C. In some
embodiments, thermocouple 74 is removable from lumen 34.
[0032] In assembly, operation and use, surgical system 10, similar
to that described above, is employed, for example, with a minimally
invasive surgical procedure for spinal and neurosurgical
applications with a patient, as shown in FIGS. 4-9. For example,
during spine surgery, a surgeon will make an incision in the skin
of a patient's back over vertebrae to be treated. One or more
hollow instruments, such as, for example, dilators may be employed
to gradually separate the muscles and create a portal to a surgical
site, such as, for example, a fractured bone, such as, for example,
a fractured and/or collapsed vertebral body VB. In some
embodiments, the incision is about 1 cm (about 1/3 inch) in
length.
[0033] Instrument 12 is positioned adjacent a surgical site over
the incision. Instrument 12 is passed through the incision and
positioned adjacent vertebral body VB. Instrument 12 is positioned
relative to vertebral body VB such that balloon 40 is positioned
within vertebral body VB, with chamber 48 in the collapsed
orientation, as shown in FIG. 4. When balloon 40 is positioned
within vertebral body VB, valve 72 is closed and is preset to open
when pressure within chamber 48, as detected by pressure monitor
62, reaches a first selected threshold pressure, such as, for
example, a pressure within a range of about 50 psi to about 700
psi. Valve 72 is also preset to close when pressure within chamber,
as detected by pressure monitor 62, drops to a second threshold
pressure, such as for example, a pressure within a range of about 5
psi to about 15 psi. In some embodiments, a guide wire GW is
inserted through opening 36 and into lumen 34 such that a tip T of
guide wire GW engages tissue, such as, for example, bone, as shown
in FIG. 4. Instrument 12 is slid along guide wire GW to position
instrument 12 such that balloon 40 is positioned within vertebral
body VB.
[0034] An inflation and/or filler material M, such as, for example,
pressurized liquid nitrous oxide is delivered from source 50
through inlet 52 in the direction shown by arrow D such that
pressurized liquid nitrous oxide M exits opening 58 for disposal
within chamber 48. Pressurized liquid nitrous oxide M continues to
be delivered into chamber 48 until pressure within chamber 48
reaches the first selected threshold pressure. As pressure in
chamber 48 reaches the first selected threshold pressure, chamber
48 moves from the unexpanded or uninflated orientation shown in
FIG. 4 to the expanded or inflated orientation shown in FIG. 5. As
chamber 48 moves from the unexpanded or uninflated orientation to
the expanded or inflated orientation, balloon 40 applies an outward
force on vertebral body VB so as to raise vertebral body VB and
return it to its normal position. As balloon 40 applies an outward
force on vertebral body VB, balloon 40 compacts soft, inner bone
against the outer surface of balloon 40 so as to create a cavity C1
within vertebral body VB, as shown in FIGS. 5 and 7.
[0035] Chamber 48 is filled with pressurized liquid nitrous oxide M
until pressure within chamber 48 reaches the first selected
threshold pressure. When pressure within chamber 48 reaches the
first selected threshold pressure, valve 72 opens. When valve 72
opens, nitrous oxide M moves through passageway 22 in the direction
shown by arrow E such that nitrous oxide M exits instrument 12
through valve 72 to reduce pressure within chamber 48. Valve 72
remains open until pressure within chamber 48 reaches the second
selected threshold pressure. When pressure within chamber 48
reaches the second selected threshold pressure, valve 72 closes,
thus preventing nitrous oxide M from exiting instrument 12 through
valve 72 and maintaining the pressure within chamber 48 at the
second selected threshold pressure. The pressure difference between
the first selected threshold pressure and the second selected
threshold pressure causes nitrous oxide M to evaporate, thus
producing cold energy CE. Cold energy CE is transmitted through the
wall of balloon 40 such that cold energy CE acts on nerves within
vertebral body VB to denervate and/or otherwise numb the nerves, as
shown in FIG. 6.
[0036] In some embodiments, source 50 is in communication pressure
monitor 62 such that when pressure monitor 62 detects that pressure
within chamber 48 reaches the first selected threshold pressure,
pressure monitor 62 sends a signal to source 50 causing a pump of
source 50 to stop pumping nitrous oxide M. In some embodiments,
source 50 is in communication pressure monitor 62 via one or more
wires that connect source 50 with pressure monitor 62. In some
embodiments, source 50 includes a pump that is turned on and off
manually, based upon the pressure within chamber 48, as identified
by a medical practitioner upon viewing and/or hearing pressure
monitor 62. For example, a medical practitioner may turn the pump
of source 50 off when he or she identifies that pressure within
chamber 48 reached the first selected threshold pressure to stop
the pump from pumping nitrous oxide M into chamber 48. In some
embodiments, valve 72 is in communication with pressure monitor 62
such that when pressure monitor 62 detects that pressure within
chamber 48 reaches the first selected threshold pressure, pressure
monitor 62 sends a signal to valve 72 causing valve 72 to open. In
some embodiments, valve 72 is in communication with pressure
monitor 62 via one or more wires that connect pressure monitor 62
with valve 72. Likewise, when pressure monitor 62 detects that
pressure within chamber 48 reaches the second selected threshold
pressure, pressure monitor 62 sends a signal to valve 72 causing
valve 72 to close. In some embodiments, valve 72 is opened and
closed manually when a medical practitioner identifies, via
pressure monitor 62, that pressure within chamber 48 reaches the
first selected threshold pressure or the second selected threshold
pressure.
[0037] Once the nerves within vertebral body VB are sufficiently
denervated and/or numbed, valve 72 is opened, causing nitrous oxide
M within chamber 48 to move through passageway 22 in the direction
shown by arrow E and exit instrument 12 via valve 72. As nitrous
oxide M exits instrument 12, chamber 48 returns to the unexpanded
or uninflated orientation shown in FIG. 2. In some embodiments,
shaft 26 is slidably disposed within passageway 22 such that moving
shaft 26 axially along axis C in the direction shown by arrow E
until at least a portion of balloon 40 is disposed within
passageway 22, as shown in FIG. 7. Instrument 12 is removed from
vertebral body VB with balloon 40 disposed in passageway 22 to
reduce the maximum width and/or diameter of instrument 12 to
facilitate removal thereof. In some embodiments, instrument 12 is
removed without balloon 40 being positioned in passageway 22.
[0038] An instrument, such as, for example, instrument 12 is
introduced into the surgical site and positioned adjacent cavity
C1. A material, such as, for example, bone cement BC is delivered
through instrument 12 for delivery into cavity C1, as shown in FIG.
8. Bone cement BC is delivered into cavity C1 until a selected
amount of bone cement BC is disposed in cavity C1. In some
embodiments, bone cement BC is delivered into cavity C1 until bone
cement BC completely fills cavity C1, as shown in FIG. 9. After
cavity C1 is filled an amount selected by a medical practitioner,
instrument 12 is removed from the surgical site, as shown in FIG.
9. In some embodiments, a source of bone cement BC is coupled to
tube 26 such that bone cement BC is delivered from the source of
bone cement BC through lumen 34 and out of opening 38 for disposal
in cavity C1. In some embodiments, the instrument that is used to
deliver bone cement BC into cavity C1 is different from instrument
12. In some embodiments, the instrument that is used to deliver
bone cement BC into cavity C1 is a cannula. Upon completion of the
surgical procedure, instrument 12 and/or the instrument that is
used to deliver bone cement BC into cavity C1 is removed from the
surgical site.
[0039] In some embodiments, system 10 includes at least two
instruments 12, which may be used simultaneously in the method
discussed above. In one embodiment, a first instrument 12 is
positioned adjacent a first side of vertebral body VB such that
balloon 40 of the first instrument 12 is positioned within the
first side of vertebral body. A second instrument 12 is positioned
adjacent a second side of vertebral body VB opposite the first side
of vertebral body VB such that balloon 40 of the second instrument
12 is positioned within the second side of vertebral body VB.
Balloons 40 of the first and second instruments 12 are inflated
with pressurized liquid nitrous oxide in the manner discussed above
such that the first and second instruments 12 each restore the
height of a respective side of vertebral body VB. Valves 72 on each
of the first and second instruments 12 open when pressure within a
respective chamber 48 reaches a first selected threshold pressure
and the first and second instruments 12 each create a cavity
similar to cavity C1. Valves 72 on each of the first and second
instruments 12 when pressure within a respective chamber 48 drops
to a second selected threshold pressure. As the pressure within
chambers 48 drops to the second selected threshold pressure, the
difference in pressure between the first selected threshold
pressure and the second selected threshold pressure causes nitrous
oxide M to evaporate, thus creating cold energy. Balloons 40 and/or
the first and second instruments 12 may be removed from vertebral
body VB once nerves in vertebral body VB are sufficiently
denervated and/or numbed. The cavities created by the first and
second instruments 12 may then be filled with bone cement BC in the
manner discussed above.
[0040] Instrument 12 may be employed for performing spinal
surgeries, such as, for example, laminectomy, discectomy, fusion,
laminotomy, nerve root retraction, foramenotomy, facetectomy,
decompression, spinal nucleus or disc replacement and procedures
using bone graft and implantable prosthetics including plates,
rods, and bone engaging fasteners.
[0041] It will be understood that various modifications may be made
to the embodiments disclosed herein. Therefore, the above
description should not be construed as limiting, but merely as
exemplification of the various embodiments. Those skilled in the
art will envision other modifications within the scope and spirit
of the claims appended hereto.
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