U.S. patent application number 14/218886 was filed with the patent office on 2014-11-27 for cryogenic blunt dissection methods and devices.
The applicant listed for this patent is MyoScience, Inc.. Invention is credited to John Allison.
Application Number | 20140350536 14/218886 |
Document ID | / |
Family ID | 51538192 |
Filed Date | 2014-11-27 |
United States Patent
Application |
20140350536 |
Kind Code |
A1 |
Allison; John |
November 27, 2014 |
Cryogenic Blunt Dissection Methods and Devices
Abstract
A point of incision is created within tissue, the tissue having
a temporoparietal fascia-deep temporoparietal fascia layer
(TPF-sDTF) beneath skin and a temporal branch of a target nerve
extending along a portion of the TPF-sDTF, the point of incision
being laterally displaced from the target nerve. A cryogenic probe
having a distal tip extending from an elongated body is inserted
into the point of incision. The TPF-sDTF is bluntly dissected using
the cryogenic probe such that a treating portion of the cryogenic
probe is directly adjacent to a first treatment portion of the
target nerve. The cryogenic probe is activated to create a first
treatment zone at the first treatment portion of the target nerve
to cause a therapeutic effect.
Inventors: |
Allison; John; (Los Altos,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
MyoScience, Inc. |
Redwood City |
CA |
US |
|
|
Family ID: |
51538192 |
Appl. No.: |
14/218886 |
Filed: |
March 18, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61801268 |
Mar 15, 2013 |
|
|
|
Current U.S.
Class: |
606/21 |
Current CPC
Class: |
A61B 2018/00452
20130101; A61B 18/02 20130101; A61B 2018/0293 20130101; A61F 7/00
20130101; A61B 2018/00023 20130101; A61B 2018/00321 20130101; A61B
2018/00434 20130101; A61B 2018/0262 20130101 |
Class at
Publication: |
606/21 |
International
Class: |
A61B 18/02 20060101
A61B018/02 |
Claims
1. A method comprising: creating a point of incision within tissue,
the tissue comprising a temporoparietal fascia-deep temporoparietal
fascia layer (TPF-sDTF) beneath skin and a temporal branch of a
target nerve extending along a portion of the TPF-sDTF, the point
of incision being laterally displaced from the TB-FN; inserting a
cryogenic probe having a distal tip extending from an elongated
body into the point of incision; bluntly dissecting the TPF while
moving the cryogenic probe over the sDTF to place a treating
portion of the cryogenic probe adjacent to a first treatment
portion of the target nerve; and activating the cryogenic probe to
create a first treatment zone at the first treatment portion of the
target nerve to cause a therapeutic effect.
2. The method of claim 1, wherein the elongated body is placed such
that it traverses across the first treatment portion of the target
nerve.
3. The method of claim 2, wherein the first treatment zone emanates
from a distinct portion of the elongated body.
4. The method of claim 1, wherein the distal tip is placed such
that it is located at the first treatment portion of the target
nerve.
5. The method of claim 4, wherein the cooling treatment zone
emanates from the distal tip.
6. The method of claim 1, further comprising relocating the
treating portion of the cryogenic probe to a second treatment
portion of the target nerve, and activating the cryogenic probe to
create a second cooling treatment zone at the second treatment
portion of the target nerve to further the therapeutic effect.
7. The method of claim 6, wherein the second treatment zone is
adjacent to the first treatment zone.
8. The method of claim 6, wherein the second treatment zone
overlaps with the first treatment zone.
9. The method of claim 1, wherein the first treatment portion is
directly beneath a visible area of the skin, and wherein the
incision is directly beneath a portion of scalp covered by
hair.
10. The method of claim 1, wherein the target nerve is the temporal
branch of a facial nerve.
11. The method of claim 1, wherein the target nerve is a sensory
nerve.
12. A method comprising: creating a point of incision within
tissue, the tissue comprising a temporoparietal fascia-deep
temporoparietal fascia layer (TPF-sDTF) beneath skin and a temporal
branch of a facial nerve (TB-FN) extending along a portion of the
TPF-sDTF, the point of incision being laterally displaced from the
TB-FN; inserting a cryogenic probe having a distal tip extending
from an elongated body into the point of incision; bluntly
dissecting the TPF-sDTF using the cryogenic probe such that a
treating portion of the cryogenic probe is directly adjacent to the
TB-FN; and repeatedly moving and activating the treating portion of
the cryogenic probe such that a plurality of treatment zones is
created across the TB-FN.
13. The method of claim 12, wherein the elongated body is placed
such that it traverses across the TB-FN.
14. The method of claim 12, wherein the cooling treatment zone
emanates from a distinct portion of the elongated body.
15. The method of claim 12, wherein the distal tip is placed such
that it is located at the first treatment portion of the TB-FN.
16. The method of claim 15, wherein the cooling treatment zone
emanates from the distal tip.
17. The method of claim 12, wherein the plurality of treatment
zones comprises a treatment fence across the TB-FN.
18. The method of claim 12, wherein the plurality of treatment
zones comprises a treatment plane across the TB-FN.
19. The method of claim 12, wherein the plurality of treatment
zones comprises at least two treatment zones.
20. The method of claim 12, wherein each treatment zone of the
plurality of treatment zones is spatially separated from each
other.
21. The method of claim 12, wherein each treatment zone of the
plurality of treatment zones overlaps with one another.
22. The method of claim 12, wherein the first treatment portion is
directly beneath a visible area of the skin, and wherein the
incision is directly beneath a portion of scalp covered by
hair.
23. A system comprising: a probe body; an elongated probe having a
blunt distal tip; and a cryogen supply tube extending within the
elongated probe, wherein the elongated probe and supply tube are
configured to resiliently bend.
24. The system of claim 23, wherein the elongated probe is 15 gauge
or smaller in diameter.
25. The system of claim 23, wherein the elongated probe is 20-30 mm
in diameter.
26. The system of claim 23, wherein the elongated probe is over 30
mm in length.
27. The system of claim 23, wherein the elongated probe is 30-150
mm in length.
28. The system of claim 23, wherein the elongated probe and cryogen
supply tube are configured to resiliently bend at a first portion
of the elongated probe an angle up to 120.degree..
29. The system of claim 28, wherein a second portion of the
elongated probe is configured to resiliently bend to a lesser
degree than the first portion.
30. The system of claim 23, further comprising a coolant supply
source coupled to the supply tube.
31. The system of claim 23, wherein the supply tube comprises a
fused silica tube having a reinforcement portion.
32. The system of claim 23, further comprising a cannula curved to
assist in directing the elongated probe into a desired tissue layer
coincident with predetermined pathway.
33. A method comprising: creating a point of incision within
tissue, the tissue comprising skin, a layer of soft tissue and a
layer of resilient tissue, inserting a cryogenic probe having a
distal tip extending from an elongated body into the point of
incision; bluntly dissecting the soft tissue using the cryogenic
probe such that a treating portion of the cryogenic probe is
directly adjacent to the resilient layer; advancing the cryogenic
probe along the resilient layer; and repeatedly moving and
activating the treating portion of the cryogenic probe such that a
plurality of treatment zones is created across a nerve adjacent to
the resilient layer.
34. The method of claim 33, wherein the soft tissue layer is
comprised of adipose tissue, muscle, and/or subcutaneous
tissue.
35. The method of claim 33, wherein the layer of resilient tissue
is a fascia layer.
36. The method of claim 33, wherein the layer of resilient tissue
is cartilage, periosteum, or bone.
Description
CROSS REFERENCES TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application No. 61/801,268, filed on Mar. 15, 2013, which is
incorporated by reference herein.
BACKGROUND OF THE INVENTION
[0002] The present invention is generally directed to medical
devices, systems, and methods, particularly for cooling-induced
remodeling of tissues. Embodiments of the invention include
devices, systems, and methods for applying cryogenic cooling to
dermatological tissues so as to selectively remodel one or more
target tissues along and/or below an exposed surface of the skin.
Embodiments may be employed for a variety of cosmetic conditions,
optionally by inhibiting undesirable and/or unsightly effects on
the skin (such as lines, wrinkles, or cellulite dimples) or on
other surrounding tissue. Other embodiments may find use for a wide
range of medical indications, for example, such as pain management,
movement disorders, surgical methods, and aesthetic treatments.
Such embodiments can include the treatment of peripheral nerves
positioned within a fascia, such as sensory and motor nerves The
remodeling of the target tissue may achieve a desired change in its
behavior or composition.
[0003] Therapeutic treatment of chronic or acute pain is among the
most common reasons patients seek medical care. Chronic pain may be
particularly disabling, and the cumulative economic impact of
chronic pain is huge. A large portion of the population that is
over the age of 65 may suffer from any of a variety of health
issues which can predispose them to chronic or acute pain. An even
greater portion of the nursing home population may suffer from
chronic pain.
[0004] Current treatments for chronic pain may include
pharmaceutical analgesics and electrical neurostimulation. While
both these techniques may provide some level of relief, they can
have significant drawbacks. For example, pharmaceuticals may have a
wide range of systemic side effects, including gastrointestinal
bleeding, interactions with other drugs, and the like. Opiod
analgesics can be addictive, and may also of themselves be
debilitating. The analgesic effects provided by pharmaceuticals may
be relatively transient, making them cost-prohibitive for the aging
population that suffers from chronic pain. While neurostimulators
may be useful for specific applications, they generally involve
surgical implantation, an expensive which carries its own risks,
side effects, contraindications, on-going maintenance issues, and
the like.
[0005] Chemodenervation and Neurolysis are other techniques for
treating pain in which a nerve is damaged so that it can no longer
transmit signals. The use of neurotoxins (such as botulinum toxin
or BOTOX.RTM.) for Chemodenervation has received some support.
Unfortunately, significant volumes of toxins may be used on a
regular basis for effective Chemodenervation, and such use of
toxins can have significant disadvantages. Neurolysis techniques
may involve injections of phenol or ethyl alcohol or the use of
energy to cause a thermal injury to the nerves such as via the
application of radiofrequency ("RF") energy to achieve ablation, or
the like. While several of these alternative neurolysis approaches
may avoid systemic effects and/or prevent damage, additional
improvements to neurolysis techniques would be desirable.
[0006] The desire to reshape various features of the human body to
either correct a deformity or merely to enhance one's appearance is
common. This is evidenced by the growing volume of cosmetic surgery
procedures that are performed annually.
[0007] Many procedures are intended to change the surface
appearance of the skin by reducing lines and wrinkles Some of these
procedures involve injecting fillers or stimulating collagen
production. More recently, pharmacologically based therapies for
wrinkle alleviation and other cosmetic applications have gained in
popularity.
[0008] Botulinum toxin type A (BOTOX.RTM.) is an example of a
pharmacologically based therapy used for cosmetic applications. It
is typically injected into the facial muscles to block muscle
contraction, resulting in temporary enervation or paralysis of the
muscle. Once the muscle is disabled, the movement contributing to
the formation of the undesirable wrinkle is temporarily eliminated.
Another example of pharmaceutical cosmetic treatment is
mesotherapy, where a cocktail of homeopathic medication, vitamins,
and/or drugs approved for other indications is injected into the
skin to deliver healing or corrective treatment to a specific area
of the body. Various cocktails are intended to effect body
sculpting and cellulite reduction by dissolving adipose tissue, or
skin resurfacing via collagen enhancement. Development of
non-pharmacologically based cosmetic treatments also continues. For
example, endermology is a mechanical based therapy that utilizes
vacuum suction to stretch or loosen fibrous connective tissues
which are implicated in the dimpled appearance of cellulite.
[0009] While BOTOX.RTM. and/or mesotherapies may temporarily reduce
lines and wrinkles, reduce fat, or provide other cosmetic benefits
they are not without their drawbacks, particularly the dangers
associated with injection of a known toxic substance into a
patient, the potential dangers of injecting unknown and/or untested
cocktails, and the like. Additionally, while the effects of
endermology are not known to be potentially dangerous, they are
brief and only mildly effective.
[0010] In light of the above, improved medical devices, systems,
and methods utilizing a cryogenic approach to treating the tissue
have been proposed, particularly for treatment of wrinkles, fat,
cellulite, and other cosmetic defects. These new techniques can
provide an alternative visual appearance improvement mechanism
which may replace and/or compliment known bioactive and other
cosmetic therapies, ideally allowing patients to decrease or
eliminate the injection of toxins and harmful cocktails while
providing similar or improved cosmetic results. These new
techniques are also promising because they may be performed
percutaneously using only local or no anesthetic with minimal or no
cutting of the skin, no need for suturing or other closure methods,
no extensive bandaging, and limited or no bruising or other factors
contributing to extended recovery or patient "down time."
Additionally, cryogenic treatments are also desirable since they
may be used in the treatment of other cosmetic and/or
dermatological conditions (and potentially other target tissues),
particularly where the treatments may be provided with greater
accuracy and control, less collateral tissue injury and/or pain,
and greater ease of use.
[0011] While these new cryogenic treatments are promising, careful
control of temperature along the cryogenic probe is necessary in
order to obtain desired results in the target treatment area as
well as to avoid unwanted tissue injury (tissue blackening) in
adjacent areas. Further, there are challenges associated accuracy
in finding the appropriate depth of target tissue. Thus, it is
desirable to implement devices and methods to mitigate such issues.
Further, it would be advantageous to provide improved devices,
systems, and methods for management of chronic and/or acute pain.
Such improved techniques may avoid or decrease the systemic effects
of toxin-based neurolysis and pharmaceutical approaches, while
decreasing the invasiveness and/or collateral tissue damage of at
least some known pain treatment techniques.
BRIEF SUMMARY OF THE INVENTION
[0012] Embodiments of the invention are related to blunt dissection
devices for laterally traversing a layer beneath skin from an
incision point and treating a portion of tissue laterally displaced
from the incision point.
[0013] Embodiments of the invention relate to certain methods. For
many methods, a point of incision is created within tissue. The
tissue includes skin, a layer of soft tissue and a layer of
resilient tissue. A cryogenic probe having a distal tip extending
from an elongated body is inserted into the point of incision. The
soft tissue is bluntly dissected using the cryogenic probe such
that a treating portion of the cryogenic probe is directly adjacent
to the resilient layer. The cryogenic probe is then advanced along
the resilient layer. The cryogenic probe is then repeatedly moving
and activating the treating portion of such that a plurality of
treatment zones is created across a nerve adjacent to the resilient
layer.
[0014] In many embodiments, the soft tissue layer is comprised of
adipose tissue, muscle, and/or subcutaneous tissue.
[0015] In many embodiments, the layer of resilient tissue is a
fascia layer.
[0016] In many embodiments, the layer of resilient tissue is
cartilage, periosteum, or bone.
[0017] For many methods, a point of incision is created within
tissue, the tissue comprising a temporoparietal fascia-deep
temporoparietal fascia layer (TPF-sDTF) beneath skin and a temporal
branch of a facial nerve (TB-FN) extending along a portion of the
TPF-sDTF. The point of incision is laterally displaced from the
TB-FN. A cryogenic probe having a distal tip extending from an
elongated body is then inserted into the point of incision. The
TPF-sDTF is then bluntly dissected using the cryogenic probe such
that a treating portion of the cryogenic probe is directly adjacent
to a first treatment portion of the TB-FN. The cryogenic probe can
be activated to create a cooling treatment zone at the treatment
portion of the TB-FN and thus cause a therapeutic effect.
Alternatively, the cryogenic probe can also be repeatedly moved and
activated at the treating portion of the cryogenic probe such that
a plurality of treatment zones is created across the TB-FN.
[0018] In many embodiments, the elongated body is placed such that
it traverses across the first treatment portion of the TB-FN.
[0019] In many embodiments, the cooling treatment zone emanates
from a distinct portion of the elongated body.
[0020] In many embodiments, the distal tip is placed such that it
is located at the first treatment portion of the TB-FN.
[0021] In many embodiments, the cooling treatment zone emanates
from the distal tip.
[0022] In many embodiments, methods include relocating the treating
portion of the cryogenic probe to a second treatment portion of the
TB-FN, and activating the cryogenic probe to create a second
cooling treatment zone at the second treatment portion of the TB-FN
to further the therapeutic effect.
[0023] In many embodiments, the second treatment zone is adjacent
to the first treatment zone.
[0024] In many embodiments, the second treatment zone overlaps with
the first treatment zone.
[0025] In many embodiments, the first treatment portion is directly
beneath a visible area of the skin, and wherein the incision is
directly beneath a portion of scalp covered by hair
[0026] Embodiments of the invention relate to certain devices. Such
devices can include a cryogenic probe having a distal tip extending
from an elongated body adapted to laterally traverse a
temporoparietal fascia-deep temporoparietal fascia layer (TPF-sDTF)
beneath skin to a temporal branch of a facial nerve (TB-FN)
extending along a portion of the TPF-sDTF from a point of incision
being laterally displaced from the TB-FN. The distal tip can be
adapted to bluntly dissect the TPF-sDTF such that a treating
portion of the cryogenic probe is directly adjacent to a first
treatment portion of the TB-FN. The elongated body houses a fluid
path for creating a cooling treatment zone at the treatment portion
of the TB-FN to cause a therapeutic effect. However, use of these
devices are not limited to the TPF-sDTF, since in many embodiments,
such devices can be used to traverse along a tissue interface or
fascia conforming to the interface plane by blunt dissection along
the interface in order to position the treatment tip in a desired
tissue plane. For any target peripheral nerve, there exist at least
one tissue interface or fascia layer that can be used as an
internal body surface for deflecting the flexible blunt tip device
so it adheres to the internal body surface for preferred placement.
For example, if the target nerve has a fascia layer immediately
below it, then this fascia is an ideal candidate for deflecting the
flexible blunt tip device into treatment position because it will
help guide the treatment portion of the blunt tip device into
position adjacent to the target nerve.
[0027] Embodiments of the invention relate to systems having a
probe body, an elongated probe extending from the probe body and
having a blunt distal tip. A cryogen supply tube extends within the
elongated probe. The elongated probe and supply tube are configured
to resiliently bend. For example, resiliently bend such that the
blunt distal tip glides along the sDTF while dissecting the
TPF.
[0028] In many embodiments, the elongated probe is 15 gauge or
smaller in diameter.
[0029] In many embodiments, the elongated probe is 20-30 mm in
diameter.
[0030] In many embodiments, the elongated probe is over 30 mm in
length.
[0031] In many embodiments, the elongated probe is 30-150 mm in
length.
[0032] In many embodiments, a first portion of the elongated probe
and cryogen supply tube are configured to resiliently bend at an
angle up to 120.degree.. In further embodiments, a second portion
of the elongated probe and cryogen supply tube are configured to
resiliently bend to a lesser degree than the first portion.
[0033] In many embodiments, a coolant supply source coupled to the
supply tube.
[0034] In many embodiments, the supply tube comprises a fused
silica tube having a reinforcement portion.
[0035] In many embodiments, the flexibility of the elongated probe
can vary from one end to the other end in a continuous or discrete
segments. The advantage of this is to allow the leading portion of
the elongated probe to be less flexible so insertion force can be
translated to the tip more effectively. When the tip encounters
resistance and a lateral force, it is the portion of the needle to
bend adhering to this lateral force while the proximal portion of
the elongated probe deflects less.
[0036] In many embodiments, the system includes a cannula curved to
assist in directing the elongated probe into a desired tissue layer
coincident with predetermined pathway.
BRIEF DESCRIPTION OF THE DRAWINGS
[0037] FIG. 1A is a perspective view of a self-contained subdermal
cryogenic remodeling probe and system, according to an embodiment
of the invention.
[0038] FIG. 1B is a partially transparent perspective view of the
self-contained probe of FIG. 1A, showing internal components of the
cryogenic remodeling system and schematically illustrating
replacement treatment needles for use with the disposable probe,
according to an embodiment of the invention.
[0039] FIG. 2 schematically illustrates components that may be
included in the treatment system, according to an embodiment of the
invention.
[0040] FIG. 3A-3D illustrate exemplary embodiments of a needle
probe, according to embodiments of the invention.
[0041] FIGS. 4A-4C illustrate an exemplary method of introducing a
cryogenic probe to a treatment area, according to embodiments of
the invention.
[0042] FIG. 4D illustrates an alternative embodiment of a sheath,
according to an embodiment of the invention.
[0043] FIG. 5 illustrates an insulated cryoprobe, according to an
embodiment of the invention.
[0044] FIGS. 6-9 illustrate exemplary embodiments of cryofluid
delivery tubes, according to embodiments of the invention.
[0045] FIG. 10 illustrates an example of blunt tipped cryoprobe,
according to an embodiment of the invention.
[0046] FIGS. 11 and 12 illustrate actuatable cryoprobes, according
to embodiments of the invention.
[0047] FIGS. 13A-13D illustrate methods for treating tissue,
according to embodiments of the invention.
DETAILED DESCRIPTION OF THE INVENTION
[0048] The present invention provides improved medical devices,
systems, and methods. Embodiments of the invention will facilitate
remodeling of target tissues disposed at and below the skin,
optionally to treat a cosmetic defect, a lesion, a disease state,
and/or so as to alter a shape of the overlying skin surface.
[0049] Among the most immediate applications of the present
invention may be the amelioration of lines and wrinkles,
particularly by inhibiting muscular contractions which are
associated with these cosmetic defects so as so improve an
appearance of the patient. Rather than relying entirely on a
pharmacological toxin or the like to disable muscles so as to
induce temporary paralysis, many embodiments of the invention will
at least in part employ cold to immobilize muscles. Advantageously,
nerves, muscles, and associated tissues may be temporarily
immobilized using moderately cold temperatures of 10.degree. C. to
-5.degree. C. without permanently disabling the tissue structures.
Using an approach similar to that employed for identifying
structures associated with atrial fibrillation, a needle probe or
other treatment device can be used to identify a target tissue
structure in a diagnostic mode with these moderate temperatures,
and the same probe (or a different probe) can also be used to
provide a longer term or permanent treatment, optionally by
ablating the target tissue zone and/or inducing apoptosis at
temperatures from about -5.degree. C. to about -50.degree. C. In
some embodiments, apoptosis may be induced using treatment
temperatures from about -1.degree. C. to about -15.degree. C., or
from about -1.degree. C. to about -19.degree. C., optionally so as
to provide a permanent treatment that limits or avoids inflammation
and mobilization of skeletal muscle satellite repair cells. In some
embodiments, temporary axonotmesis degeneration of a motor nerve is
desired, which may be induced using treatment temperatures from
about -20.degree. C. to about -100.degree. C. and may be as low as
-140.degree. C. In some embodiments, neurotmesis injury of a motor
nerve is desired, which may be induced using treatment temperatures
below -140.degree. C. and maybe up to temperatures below
-100.degree. C. Hence, the duration of the treatment efficacy of
such subdermal cryogenic treatments may be selected and controlled,
with colder temperatures, longer treatment times, and/or larger
volumes or selected patterns of target tissue determining the
longevity of the treatment. Additional description of cryogenic
cooling for treatment of cosmetic and other defects may be found in
commonly assigned U.S. Pat. No. 7,713,266 (Atty. Docket No.
000110US) entitled "Subdermal Cryogenic Remodeling of Muscle,
Nerves, Connective Tissue, and/or Adipose Tissue (Fat)", U.S. Pat.
No. 7,850,683 (Atty. Docket No. 000120US) entitled "Subdermal
Cryogenic Remodeling of Muscles, Nerves, Connective Tissue, and/or
Adipose Tissue (Fat)", and U.S. patent application Ser. No.
13/325,004, (Atty. Docket No. 002510US) entitled "Method for
Reducing Hyperdynamic Facial Wrinkles", the full disclosures of
which are each incorporated by reference herein.
[0050] In addition to cosmetic treatments of lines, wrinkles, and
the like, embodiments of the invention may also find applications
for treatments of subdermal adipose tissues, benign, pre-malignant
lesions, malignant lesions, acne and a wide range of other
dermatological conditions (including dermatological conditions for
which cryogenic treatments have been proposed and additional
dermatological conditions), and the like. Embodiments of the
invention may also find applications for alleviation of pain,
including those associated with muscle spasms as disclosed in
commonly assigned U.S. Pub. No. 2009/0248001 (Atty. Docket No.
000800US) entitled "Pain Management Using Cryogenic Remodeling" the
full disclosure of which is incorporated herein by reference.
[0051] Referring now to FIGS. 1A and 1B, a system for cryogenic
remodeling here comprises a self-contained probe handpiece
generally having a proximal end 12 and a distal end 14. A handpiece
body or housing 16 has a size and ergonomic shape suitable for
being grasped and supported in a surgeon's hand or other system
operator. As can be seen most clearly in FIG. 1B, a cryogenic
cooling fluid supply 18, a supply valve 32 and electrical power
source 20 are found within housing 16, along with a circuit 22
having a processor for controlling cooling applied by
self-contained system 10 in response to actuation of an input 24.
Alternatively, electrical power can be applied through a cord from
a remote power source. Power source 20 also supplies power to
heater element 44 in order to heat the proximal region of probe 26
thereby helping to prevent unwanted skin damage, and a temperature
sensor 48 adjacent the proximal region of probe 26 helps monitor
probe temperature. Additional details on the heater 44 and
temperature sensor 48 are described in greater detail below. When
actuated, supply valve 32 controls the flow of cryogenic cooling
fluid from fluid supply 18. Some embodiments may, at least in part,
be manually activated, such as through the use of a manual supply
valve and/or the like, so that processors, electrical power
supplies, and the like may not be required.
[0052] Extending distally from distal end 14 of housing 16 is a
tissue-penetrating cryogenic cooling probe 26. Probe 26 is
thermally coupled to a cooling fluid path extending from cooling
fluid source 18, with the exemplary probe comprising a tubular body
receiving at least a portion of the cooling fluid from the cooling
fluid source therein. The exemplary probe 26 comprises a 27 g
needle having a sharpened distal end that is axially sealed. Probe
26 may have an axial length between distal end 14 of housing 16 and
the distal end of the needle of between about 0.5 mm and 5 cm,
preferably having a length from about 3 mm to about 10 mm. Such
needles may comprise a stainless steel tube with an inner diameter
of about 0.006 inches and an outer diameter of about 0.012 inches,
while alternative probes may comprise structures having outer
diameters (or other lateral cross-sectional dimensions) from about
0.006 inches to about 0.100 inches. Generally, needle probe 26 will
comprise a 16 g or smaller size needle, often comprising a 20 g
needle or smaller, typically comprising a 25, 26, 27, 28, 29, or 30
g or smaller needle.
[0053] In some embodiments, probe 26 may comprise two or more
needles arranged in a linear array, such as those disclosed in
previously incorporated U.S. Pat. No. 7,850,683. Another exemplary
embodiment of a probe having multiple needle probe configurations
allow the cryogenic treatment to be applied to a larger or more
specific treatment area. Other needle configurations that
facilitate controlling the depth of needle penetration and
insulated needle embodiments are disclosed in commonly assigned
U.S. Patent Publication No. 2008/0200910 (Atty. Docket No.
000500US) entitled "Replaceable and/or Easily Removable Needle
Systems for Dermal and Transdermal Cryogenic Remodeling," the
entire content of which is incorporated herein by reference.
Multiple needle arrays may also be arrayed in alternative
configurations such as a triangular or square array.
[0054] Arrays may be designed to treat a particular region of
tissue, or to provide a uniform treatment within a particular
region, or both. In some embodiments needle 26 is releasably
coupled with body 16 so that it may be replaced after use with a
sharper needle (as indicated by the dotted line) or with a needle
having a different configuration. In exemplary embodiments, the
needle may be threaded into the body, it may be press fit into an
aperture in the body or it may have a quick disconnect such as a
detent mechanism for engaging the needle with the body. A quick
disconnect with a check valve is advantageous since it permits
decoupling of the needle from the body at any time without
excessive coolant discharge. This can be a useful safety feature in
the event that the device fails in operation (e.g. valve failure),
allowing an operator to disengage the needle and device from a
patient's tissue without exposing the patient to coolant as the
system depressurizes. This feature is also advantageous because it
allows an operator to easily exchange a dull needle with a sharp
needle in the middle of a treatment. One of skill in the art will
appreciate that other coupling mechanisms may be used.
[0055] Addressing some of the components within housing 16, the
exemplary cooling fluid supply 18 comprises a canister, sometimes
referred to herein as a cartridge, containing a liquid under
pressure, with the liquid preferably having a boiling temperature
of less than 37.degree. C. When the fluid is thermally coupled to
the tissue-penetrating probe 26, and the probe is positioned within
the patient so that an outer surface of the probe is adjacent to a
target tissue, the heat from the target tissue evaporates at least
a portion of the liquid and the enthalpy of vaporization cools the
target tissue. A supply valve 32 may be disposed along the cooling
fluid flow path between canister 18 and probe 26, or along the
cooling fluid path after the probe so as to limit coolant flow
thereby regulating the temperature, treatment time, rate of
temperature change, or other cooling characteristics. The valve
will often be powered electrically via power source 20, per the
direction of processor 22, but may at least in part be manually
powered. The exemplary power source 20 comprises a rechargeable or
single-use battery. Additional details about valve 32 are disclosed
below and further disclosure on the power source 20 may be found in
commonly assigned Int'l Pub. No. WO 2010/075438 (Atty. Docket No.
002310PC) entitled "Integrated Cryosurgical Probe Package with
Fluid Reservoir and Limited Electrical Power Source," the entire
contents of which is incorporated herein by reference.
[0056] The exemplary cooling fluid supply 18 comprises a single-use
canister. Advantageously, the canister and cooling fluid therein
may be stored and/or used at (or even above) room temperature. The
canister may have a frangible seal or may be refillable, with the
exemplary canister containing liquid nitrous oxide, N.sub.2O. A
variety of alternative cooling fluids might also be used, with
exemplary cooling fluids including fluorocarbon refrigerants and/or
carbon dioxide. The quantity of cooling fluid contained by canister
18 will typically be sufficient to treat at least a significant
region of a patient, but will often be less than sufficient to
treat two or more patients. An exemplary liquid N.sub.2O canister
might contain, for example, a quantity in a range from about 1 gram
to about 40 grams of liquid, more preferably from about 1 gram to
about 35 grams of liquid, and even more preferably from about 7
grams to about 30 grams of liquid.
[0057] Processor 22 will typically comprise a programmable
electronic microprocessor embodying machine readable computer code
or programming instructions for implementing one or more of the
treatment methods described herein. The microprocessor will
typically include or be coupled to a memory (such as a non-volatile
memory, a flash memory, a read-only memory ("ROM"), a random access
memory ("RAM"), or the like) storing the computer code and data to
be used thereby, and/or a recording media (including a magnetic
recording media such as a hard disk, a floppy disk, or the like; or
an optical recording media such as a CD or DVD) may be provided.
Suitable interface devices (such as digital-to-analog or
analog-to-digital converters, or the like) and input/output devices
(such as USB or serial I/O ports, wireless communication cards,
graphical display cards, and the like) may also be provided. A wide
variety of commercially available or specialized processor
structures may be used in different embodiments, and suitable
processors may make use of a wide variety of combinations of
hardware and/or hardware/software combinations. For example,
processor 22 may be integrated on a single processor board and may
run a single program or may make use of a plurality of boards
running a number of different program modules in a wide variety of
alternative distributed data processing or code architectures.
[0058] Referring now to FIG. 2, the flow of cryogenic cooling fluid
from fluid supply 18 is controlled by a supply valve 32. Supply
valve 32 may comprise an electrically actuated solenoid valve, a
motor actuated valve or the like operating in response to control
signals from controller 22, and/or may comprise a manual valve.
Exemplary supply valves may comprise structures suitable for on/off
valve operation, and may provide venting of the fluid source and/or
the cooling fluid path downstream of the valve when cooling flow is
halted so as to limit residual cryogenic fluid vaporization and
cooling. Additionally, the valve may be actuated by the controller
in order to modulate coolant flow to provide high rates of cooling
in some instances where it is desirable to promote necrosis of
tissue such as in malignant lesions and the like or slow cooling
which promotes ice formation between cells rather than within cells
when necrosis is not desired. More complex flow modulating valve
structures might also be used in other embodiments. For example,
other applicable valve embodiments are disclosed in previously
incorporated U.S. Pub. No. 2008/0200910.
[0059] Still referring to FIG. 2, an optional heater (not
illustrated) may be used to heat cooling fluid supply 18 so that
heated cooling fluid flows through valve 32 and through a lumen 34
of a cooling fluid supply tube 36. Supply tube 36 is, at least in
part, disposed within a lumen 38 of needle 26, with the supply tube
extending distally from a proximal end 40 of the needle toward a
distal end 42. The exemplary supply tube 36 comprises a fused
silica tubular structure (not illustrated) having a polymer coating
and extending in cantilever into the needle lumen 38. Supply tube
36 may have an inner lumen with an effective inner diameter of less
than about 200 .mu.m, the inner diameter often being less than
about 100 .mu.m, and typically being less than about 40 .mu.m.
Exemplary embodiments of supply tube 36 have inner lumens of
between about 15 and 50 .mu.m, such as about 30 .mu.m. An outer
diameter or size of supply tube 36 will typically be less than
about 1000 .mu.m, often being less than about 800 .mu.m, with
exemplary embodiments being between about 60 and 150 .mu.m, such as
about 90 .mu.m or 105 .mu.m. The tolerance of the inner lumen
diameter of supply tubing 36 will preferably be relatively tight,
typically being about +/-10 .mu.m or tighter, often being +/-5
.mu.m or tighter, and ideally being +/-3 .mu.m or tighter, as the
small diameter supply tube may provide the majority of (or even
substantially all of) the metering of the cooling fluid flow into
needle 26. Previously incorporated U.S. Patent Publication No.
2008/0200910 (Attorney Docket No. 025917-000500US) discloses
additional details on the needle 26 along with various alternative
embodiments and principles of operation.
[0060] The cooling fluid injected into lumen 38 of needle 26 will
typically comprise liquid, though some gas may also be injected. At
least some of the liquid vaporizes within needle 26, and the
enthalpy of vaporization cools the needle and also the surrounding
tissue engaged by the needle. An optional heater 44 (illustrated in
FIG. 1B) may be used to heat the proximal region of the needle 26
in order to prevent unwanted skin damage in this area, as discussed
in greater detail below. Controlling a pressure of the gas/liquid
mixture within needle 26 substantially controls the temperature
within lumen 38, and hence the treatment temperature range of the
tissue. A relatively simple mechanical pressure relief valve 46 may
be used to control the pressure within the lumen of the needle,
with the exemplary valve comprising a valve body such as a ball
bearing, urged against a valve seat by a biasing spring. An
exemplary relief valve is disclosed in U.S. Provisional Patent
Application No. 61/116,050, previously incorporated herein by
reference. Thus, the relief valve allows better temperature control
in the needle, minimizing transient temperatures. Further details
on exhaust volume are disclosed in previously incorporated U.S.
Pat. Pub. No. 2008/0200910.
[0061] The heater 44 may be thermally coupled to a thermally
responsive element 50, which is supplied with power by the
controller 22 and thermally coupled to a proximal portion of the
needle 26. The thermally responsive element 50 can be a block
constructed from a material of high thermal conductivity and low
heat capacity, such as aluminum. A first temperature sensor 52
(e.g., thermistor, thermocouple) can also be thermally coupled the
thermally responsive element 50 and communicatively coupled to the
controller 22. A second temperature sensor 53 can also be
positioned near the heater 44, for example, such that the first
temperature sensor 52 and second temperature sensor 44 are placed
in different positions within the thermally responsive element 50.
In some embodiments, the second temperature sensor 53 is placed
closer to a tissue contacting surface than the first temperature
sensor is in order to provide comparative data (e.g., temperature
differential) between the sensors. The controller 22 can be
configured to receive temperature information of the thermally
responsive element 50 via the temperature sensor 52 in order to
provide the heater 44 with enough power to maintain the thermally
responsive element 50 at a particular temperature.
[0062] The controller 22 can be further configured to monitor power
draw from the heater 44 in order to characterize tissue type,
perform device diagnostics, and/or provide feedback for a tissue
treatment algorithm. This can be advantageous over monitoring
temperature alone, since power draw from the heater 44 can vary
greatly while temperature of the thermally responsive element 50
remains relatively stable. For example, during treatment of target
tissue, maintaining the thermally responsive element 50 at
40.degree. C. during a cooling cycle may take 1.0 W initially (for
a needle <10 mm in length) and is normally expected to climb to
1.5 W after 20 seconds, due to the needle 26 drawing in surrounding
heat. An indication that the heater is drawing 2.0 W after 20
seconds to maintain 40.degree. C. can indicate that an aspect of
the system 10 is malfunctioning and/or that the needle 26 is
incorrectly positioned. Correlations with power draw and correlated
device and/or tissue conditions can be determined experimentally to
determine acceptable treatment power ranges.
[0063] In some embodiments, it may be preferable to limit frozen
tissue that is not at the treatment temperature, i.e., to limit the
size of a formed cooling zone within tissue. Such cooling zones may
be associated with a particular physical reaction, such as the
formation of an ice-ball, or with a particular temperature profile
or temperature volume gradient required to therapeutically affect
the tissue therein. To achieve this, metering coolant flow could
maintain a large thermal gradient at its outside edges. This may be
particularly advantageous in applications for creating an array of
connected cooling zones (i.e, fence) in a treatment zone, as time
would be provided for the treatment zone to fully develop within
the fenced in portion of the tissue, while the outer boundaries
maintained a relatively large thermal gradient due to the repeated
application and removal of refrigeration power. This could provide
a mechanism within the body of tissue to thermally regulate the
treatment zone and could provide increased ability to modulate the
treatment zone at a prescribed distance from the surface of the
skin. A related treatment algorithm could be predefined, or it
could be in response to feedback from the tissue.
[0064] Such feedback could be temperature measurements from the
needle 26, or the temperature of the surface of the skin could be
measured. However, in many cases monitoring temperature at the
needle 26 is impractical due to size constraints. To overcome this,
operating performance of the sensorless needle 26 can be
interpolated by measuring characteristics of thermally coupled
elements, such as the thermally responsive element 50.
[0065] Additional methods of monitoring cooling and maintaining an
unfrozen portion of the needle include the addition of a heating
element and/or monitoring element into the needle itself. This
could consist of a small thermistor or thermocouple, and a wire
that could provide resistive heat. Other power sources could also
be applied such as infrared light, radiofrequency heat, and
ultrasound. These systems could also be applied together dependent
upon the control of the treatment zone desired.
[0066] Alternative methods to inhibit excessively low transient
temperatures at the beginning of a refrigeration cycle might be
employed instead of or together with the limiting of the exhaust
volume. For example, the supply valve might be cycled on and off,
typically by controller 22, with a timing sequence that would limit
the cooling fluid flowing so that only vaporized gas reached the
needle lumen (or a sufficiently limited amount of liquid to avoid
excessive dropping of the needle lumen temperature). This cycling
might be ended once the exhaust volume pressure was sufficient so
that the refrigeration temperature would be within desired limits
during steady state flow. Analytical models that may be used to
estimate cooling flows are described in greater detail in
previously incorporated U.S. Patent Pub. No. 2008/0154,254.
[0067] Referring now to FIG. 2, the flow of cryogenic cooling fluid
from fluid supply 18 is controlled by a supply valve 32. Supply
valve 32 may comprise an electrically actuated solenoid valve, a
motor actuated valve or the like operating in response to control
signals from controller 22, and/or may comprise a manual valve.
Exemplary supply valves may comprise structures suitable for on/off
valve operation, and may provide venting of the fluid source and/or
the cooling fluid path downstream of the valve when cooling flow is
halted so as to limit residual cryogenic fluid vaporization and
cooling. Additionally, the valve may be actuated by the controller
in order to modulate coolant flow to provide high rates of cooling
in some instances where it is desirable to promote necrosis of
tissue such as in malignant lesions and the like or slow cooling
which promotes ice formation between cells rather than within cells
when necrosis is not desired. More complex flow modulating valve
structures might also be used in other embodiments. For example,
other applicable valve embodiments are disclosed in previously
incorporated U.S. Pub. No. 2008/0200910.
[0068] Still referring to FIG. 2, an optional cooling supply heater
(not illustrated) may be used to heat cooling fluid supply 18 so
that heated cooling fluid flows through valve 32 and through a
lumen 34 of a cooling fluid supply tube 36. In some embodiments
safety mechanism can be included so that the cooling supply is not
overheated. Examples of such embodiments are disclosed in commonly
assigned Int'l. Pub. No. WO 2010075438, the entirety of which is
incorporated by reference herein.
[0069] Supply tube 36 is, at least in part, disposed within a lumen
38 of needle 26, with the supply tube extending distally from a
proximal end 40 of the needle toward a distal end 42. The exemplary
supply tube 36 comprises a fused silica tubular structure (not
illustrated) having a polymer coating and extending in cantilever
into the needle lumen 38. Supply tube 36 may have an inner lumen
with an effective inner diameter of less than about 200 .mu.m, the
inner diameter often being less than about 100 .mu.m, and typically
being less than about 40 .mu.m. Exemplary embodiments of supply
tube 36 have inner lumens of between about 15 and 50 .mu.m, such as
about 30 .mu.m. An outer diameter or size of supply tube 36 will
typically be less than about 1000 .mu.m, often being less than
about 800 .mu.m, with exemplary embodiments being between about 60
and 150 .mu.m, such as about 90 .mu.m or 105 .mu.m. The tolerance
of the inner lumen diameter of supply tubing 36 will preferably be
relatively tight, typically being about +/-10 .mu.m or tighter,
often being +/-5 .mu.m or tighter, and ideally being +/-3 .mu.m or
tighter, as the small diameter supply tube may provide the majority
of (or even substantially all of) the metering of the cooling fluid
flow into needle 26. Additional details on various aspects of
needle 26 along with alternative embodiments and principles of
operation are disclosed in greater detail in U.S. Patent
Publication No. 2008/0154254 (Atty. Docket No. 000300US) entitled
"Dermal and Transdermal Cryogenic Microprobe Systems and Methods,"
the entire contents of which are incorporated herein by reference.
U.S. Patent Pub. No. 2008/0200910, previously incorporated herein
by reference, also discloses additional details on the needle 26
along with various alternative embodiments and principles of
operation.
[0070] The cooling fluid injected into lumen 38 of needle 26 will
typically comprise liquid, though some gas may also be injected. At
least some of the liquid vaporizes within needle 26, and the
enthalpy of vaporization cools the needle and also the surrounding
tissue engaged by the needle. An optional heater 44 (illustrated in
FIG. 1B) may be used to heat the proximal region of the needle in
order to prevent unwanted skin damage in this area, as discussed in
greater detail below. Controlling a pressure of the gas/liquid
mixture within needle 26 substantially controls the temperature
within lumen 38, and hence the treatment temperature range of the
tissue. A relatively simple mechanical pressure relief valve 46 may
be used to control the pressure within the lumen of the needle,
with the exemplary valve comprising a valve body such as a ball
bearing, urged against a valve seat by a biasing spring. Thus, the
relief valve allows better temperature control in the needle,
minimizing transient temperatures. Further details on exhaust
volume are disclosed in U.S. Patent Publication No. 2008/0200910,
previously incorporated herein by reference.
[0071] Alternative methods to inhibit excessively low transient
temperatures at the beginning of a refrigeration cycle might be
employed instead of or together with the limiting of the exhaust
volume. For example, the supply valve might be cycled on and off,
typically by controller 22, with a timing sequence that would limit
the cooling fluid flowing so that only vaporized gas reached the
needle lumen (or a sufficiently limited amount of liquid to avoid
excessive dropping of the needle lumen temperature). This cycling
might be ended once the exhaust volume pressure was sufficient so
that the refrigeration temperature would be within desired limits
during steady state flow. Analytical models that may be used to
estimate cooling flows are described in greater detail in U.S. Pub.
No. 2008/0154254, previously incorporated herein by reference.
[0072] In the exemplary embodiment of FIG. 3A, probe tip 300
includes a resistive heater element 314 is disposed near the needle
hub 318 and near a proximal region of needle shaft 302. In other
embodiments, the heater may float, thereby ensuring proper skin
contact and proper heat transfer to the skin. Examples of floating
heaters are disclosed in commonly assigned Int'l Pub. No. WO
2010/075448 (Atty. Docket No. 002310PC) entitled "Skin Protection
for Subdermal Cryogenic Remodelling for Cosmetic and Other
Treatments", the entirety of which is incorporated by reference
herein.
[0073] In this exemplary embodiment, three needles are illustrated.
One of skill in the art will appreciate that a single needle may be
used, as well as two, four, five, six, or more needles may be used.
When a plurality of needles are used, they may be arranged in any
number of patterns. For example, a single linear array may be used,
or a two dimensional or three dimensional array may be used.
Examples of two dimensional arrays include any number of rows and
columns of needles (e.g. a rectangular array, a square array,
elliptical, circular, triangular, etc.), and examples of three
dimensional arrays include those where the needle tips are at
different distances from the probe hub, such as in an inverted
pyramid shape.
[0074] A cladding 320 of conductive material is directly
conductively coupled to the proximal portion of the shaft of needle
shaft 302, which can be stainless steel. In some embodiments, the
cladding 320 is a layer of gold, or alloys thereof, coated on the
exterior of the proximal portion of the needle shaft 302. In some
embodiments, the exposed length of cladding 320 on the proximal
portion of the needle is 2-100 mm. In some embodiments, the
cladding 320 can be of a thickness such that the clad portion has a
diameter ranging from 0.017-0.020 in., and in some embodiments
0.0182 in. Accordingly, the cladding 320 can be conductively
coupled to the material of the needle 302, which can be less
conductive, than the cladding 320. The cladding 320 may modify the
lateral force required to deflect or bend the needle 26. Cladding
320 may be used to provide a stiffer needle shaft along the
proximal end in order to more easily transfer force to the leading
tip during placement and allow the distal portion of the needle to
deflect more easily when it is dissecting a tissue interface within
the body. The stiffness of needle 26 can vary from one end to the
other end by other means such as material selection, metal
tempering, variation of the inner diameter of the needle 26, or
segments of needle shaft joined together end-to-end to form one
contiguous needle 26. In some embodiments, increasing the stiffness
of the distal portion of the needle 26 can be used to flex the
proximal portion of the needle to access difficult treatment sites
as in the case of upper limb spasticity where bending of the needle
outside the body may be used to access a target peripheral nerve
along the desired tissue plane.
[0075] In some embodiments, the cladding 320 can include
sub-coatings (e.g., nickel) that promote adhesion of an outer
coating that would otherwise not bond well to the needle shaft 302.
Other highly conductive materials can be used as well, such as
copper, silver, aluminum, and alloys thereof. In some embodiments,
a protective polymer or metal coating can cover the cladding to
promote biocompatibility of an otherwise non-biocompatible but
highly conductive cladding material. Such a biocompatible coating
however, would be applied to not disrupt conductivity between the
conductive block 315. In some embodiments, an insulating layer,
such as a ceramic material, is coated over the cladding 320, which
remains conductively coupled to the needle shaft 302.
[0076] In use, the cladding 320 can transfer heat to the proximal
portion of the needle 302 to prevent directly surrounding tissue
from dropping to cryogenic temperatures. Protection can be derived
from heating the non-targeting tissue during a cooling procedure,
and in some embodiments before the procedure as well. The mechanism
of protection may be providing heat to pressurized cryogenic
cooling fluid passing within the proximal portion of the needle to
affect complete vaporization of the fluid. Thus, the non-target
tissue in contact with the proximal portion of the needle shaft 302
does not need to supply heat, as opposed to target tissue in
contact with the distal region of the needle shaft 302. To help
further this effect, in some embodiments the cladding 320 is
coating within the interior of the distal portion of the needle,
with or without an exterior cladding. To additionally help further
this effect, in some embodiments, the distal portion of the needle
can be thermally isolated from the proximal portion by a junction,
such as a ceramic junction. While in some further embodiments, the
entirety of the proximal portion is constructed from a more
conductive material than the distal portion.
[0077] In use, it has been determined experimentally that the
cladding 320 can help limit formation of a cooling zone to the
distal portion of the needle shaft 302, which tends to demarcate at
a distal end of the cladding 320. Accordingly, cooling zones are
formed only about the distal portions of the needles--in this case
to target a particular sensory nerve branch. Thus, while non-target
tissue in direct contact with proximal needle shafts remain
protected from effects of cryogenic temperatures. Such effects can
include discoloration and blistering of the skin. Such cooling
zones may be associated with a particular physical reaction, such
as the formation of an ice-ball, or with a particular temperature
required to therapeutically affect the tissue therein.
[0078] FIGS. 3C and 3D illustrates a detachable probe tip 322
having a hub connector 324 and an elongated probe 326. The probe
tip 322 shares much of its construction with probe tip 300.
However, the elongated probe 326 features a blunt tip 328 that is
adapted for blunt dissection of tissue. The blunt tip 328 can
feature a full radius tip, less than a full radius tip, or conical
tip. In some embodiments, a dulled or truncated needle is used. The
elongated probe 326 can be greater than 20 gauge in size, and in
some embodiments range in size from 25-30 gauge. As with the
embodiments described above, an internal supply tube 330 extends in
cantilever. However, the exit of the supply tube 330 can be
disposed at positions within the elongated probe 326 other than
proximate the blunt tip 328. Further, the supply tube 330 can be
adapted to create an elongated zone of cooling, e.g, by having
multiple exit points for cryofluid to exit from.
[0079] The elongated probe 326 and supply tube 330 are configured
to resiliently bend in use, throughout their length at angles
approaching 120.degree., with a 5-10 mm bend radius. This is very
challenging considering the small sizes of the elongated probe 326
and supply tube 330, and also considering that the supply tube 330
is often constructed from fused silica. Accordingly, the elongated
probe 326 can be constructed from a resilient material, such as
stainless steel, and of a particular diameter and wall thickness
[0.004 to 1.0 mm], such that the elongated probe in combination
with the supply tube 330 is not overly resilient so as to overtly
resist manipulation, but sufficiently strong so as to prevent
kinking that can result in coolant escaping. For example, the
elongated probe can be 15 gauge or smaller in diameter, even
ranging from 20-30 gauge in diameter. The elongated probe can have
a very disparate length to diameter ratio, for example, the
elongated probe can be greater than 30 in length, and in some cases
range from 30-100 mm in length. To further the aforementioned
goals, the supply tube 330 can include a polymer coating 332, such
as a polyimide coating that terminates approximately halfway down
its length, to resist kinking and aid in resiliency. The polymer
coating 332 can be a secondary coating over a primary polyimide
coating that extends fully along the supply tube. However, it
should be understood that the coating is not limited to polyimide,
and other suitable materials can be used. In some embodiments, the
flexibility of the elongated probe 326 will vary from the proximal
end to the distal end. For example, by creating certain portions
that have more or less flexibility that others. The may be done,
for example, by modifying wall thickness, adding material (such as
the cladding discussed above), and/or heat treating certain
portions of the elongated probe 326 and/or supply tube 330. For
example, decreasing the flexibility of elongated probe 326 along
the proximal end can improve the transfer of force from the hand
piece to the elongated probe end for better feel and easier tip
placement for treatment. The elongated probe and supply line 330
are may be configured to resiliently bend in use to different
degrees along the length at angles approaching 120.degree., with a
varying bend radius as small as 5 mm. In some embodiments, the
elongated probe 326 will have external markings along the needle
shaft indicating the length of needle inserted into the tissue.
[0080] In some embodiments, the probe tip 322 does not include a
heating element, such as the heater described with reference to
probe tip 300, since the effective treating portion of the
elongated probe 324 (i.e., the area of the elongated probe where a
cooling zone emanates from) is well laterally displaced from the
hub connector 322 and elongated probe proximal junction.
Embodiments of the supply tube are further described below and
within commonly assigned U.S. Pub. No. 2012/0089211, which is
incorporated by reference.
[0081] FIGS. 4A-4C illustrate an exemplary method of creating a
hole through the skin that allows multiple insertions and
positioning of a cryoprobe therethrough. In FIG. 4A a cannula or
sheath 1902 is disposed over a needle 1904 having a tissue
penetrating distal end 1908. The cannula may have a tapered distal
portion 1906 to help spread and dilate the skin during insertion.
The needle/sheath assembly is then advanced into and pierces the
skin 1910 into the desired target tissue 1912. The inner pathway of
the cannula or sheath 1902 may be curved to assist in directing the
flexible needle 1904, or other probe, into a desired tissue layer
coincident with the desired needle path in the tissue. Once the
needle/sheath assembly has been advanced to a desired location, the
needle 1904 may be proximally retracted and removed from the sheath
1902. The sheath now may be used as an easy way of introducing a
cryoprobe through the skin without piercing it, and directing the
cryoprobe to the desired target treatment area. FIG. 4B shows the
sheath 1902 in position with the needle 1904 removed. FIG. 4C shows
insertion of a cryoprobe 1914 into the sheath such that a blunt tip
1916 of the cryoprobe 1914 is adjacent the target treatment tissue.
The cryoprobe may then be cooled and the treatment tissue cooled to
achieve any of the cosmetic or therapeutic effects discussed above.
In this embodiment, the cryoprobe preferably has a blunt tip 1916
in order to minimize tissue trauma. In other embodiments, the tip
may be sharp and be adapted to penetrate tissue, or it may be round
and spherical. The cryoprobe 1914 may then be at least partially
retracted from the sheath 1902 and/or rotated and then re-advanced
to the same or different depth and repositioned in sheath 1902 so
that the tip engages a different portion of the target treatment
tissue without requiring an addition piercing of the skin. The
probe angle relative to the tissue may also be adjusted, and the
cryoprobe may be advanced and retracted multiple times through the
sheath so that the entire target tissue is cryogenically
treated.
[0082] While the embodiment of FIGS. 4A-4C illustrate a cryoprobe
having only a single probe, the cryoprobe may have an array of
probes. Any of the cryoprobes described above may be used with an
appropriately sized sheath. In some embodiments, the cryoprobe
comprises a linear or two dimensional array of probes. Lidocaine or
other local anesthetics may be used during insertion of the sheath
or cryoprobe in order to minimize patient discomfort. The angle of
insertion for the sheath may be anywhere from 0 to 180 degrees
relative to the skin surface, and in specific embodiments is 15 to
45 degrees. The sheath may be inserted any depth, but in specific
embodiments of treating lines/wrinkles of the face, the sheath may
be inserted to a depth of 1 mm to 10 mm, and more preferably to a
depth of 2 mm to 5 mm.
[0083] In an alternative embodiment seen in FIG. 4D, the sheath
1902 may include an annular flange 1902b on an outside surface of
the sheath in order to serve as a stop so that the sheath is only
inserted a preset amount into the tissue. The position of the
flange 1902b may be adjustable or fixed. The proximal end of the
sheath in this embodiment, or any of the other sheath embodiments
may also include a one way valve such as a hemostasis valve to
prevent backflow of blood or other fluids that may exit the sheath.
The sheath may also insulate a portion of the cryoprobe and prevent
or minimize cooling of unwanted regions of tissue.
[0084] Any of the cryoprobes described above may be used with the
sheath embodiment described above (e.g. in FIGS. 3B, 4A-4C). Other
cryoprobes may also be used with this sheath embodiment, or they
may be used alone, in multi-probe arrays, or combined with other
treatments. For example, a portion of the cryoprobe 2006 may be
insulated as seen in FIG. 5. Cryoprobe 2006 includes a blunt tip
2004 with an insulated section 2008 of the probe. Thus, when the
cryoprobe is disposed in the treatment tissue under the skin 2002
and cooled, the cryoprobe preferentially creates a cooling zone
along one side while the other side remains uncooled, or only
experiences limited cooling. For example, in FIG. 5, the cooling
zone 2010 is limited to a region below the cryoprobe 2006, while
the region above the cryoprobe and below the skin 2002 remain
unaffected by the cooling.
[0085] Different zones of cryotherapy may also be created by
different geometries of the coolant fluid supply tube that is
disposed in the cryoprobe. FIGS. 6-9 illustrate exemplary
embodiments of different coolant fluid supply tubes. In FIG. 6 the
coolant fluid supply tube 2106 is offset from the central axis of a
cryoprobe 2102 having a blunt tip 2104. Additionally, the coolant
fluid supply tube 2106 includes several exit ports for the coolant
including circular ports 2110, 2112 near the distal end of the
coolant fluid supply tube and an elliptical port 2108 proximal of
the other ports. These ports may be arranged in varying sizes, and
varying geometries in order to control the flow of cryofluid which
in turn controls probe cooling of the target tissue. FIG. 7
illustrates an alternative embodiment of a coolant fluid supply
tube 2202 having a plurality of circular ports 2204 for controlling
cryofluid flow. FIG. 8 illustrates yet another embodiment of a
coolant fluid supply tube 2302 having a plurality of elliptical
holes, and FIG. 9 shows still another embodiment of a coolant fluid
supply tube 2402 having a plurality of ports ranging from smaller
diameter circular holes 2404 near the distal end of the supply tube
2402 to larger diameter circular holes 2406 that are more
proximally located on the supply tube.
[0086] As discussed above, it may be preferable to have a blunt tip
on the distal end of the cryoprobe in order to minimize tissue
trauma. The blunt tip may be formed by rounding off the distal end
of the probe, or a bladder or balloon 2506 may be placed on the
distal portion of the probe 2504 as seen in FIG. 10. A filling tube
or inflation lumen 2502 may be integral with or separate from the
cryoprobe 2504, and may be used to deliver fluid to the balloon to
fill the balloon 2506 up to form the atraumatic tip.
[0087] In some instances, it may be desirable to provide expandable
cryoprobes that can treat different target tissues or accommodate
different anatomies. For example, in FIGS. 11 and 12, a pair of
cryoprobes 2606 with blunt tips 2604 may be delivered in parallel
with one another and in a low profile through a sheath 2602 to the
treatment area. Once delivered, the probes may be actuated to
separate the tips 2604 from one another, thereby increasing the
cooling zone. After the cryotherapy has been administered, the
probes may be collapsed back into their low profile configuration,
and retracted from the sheath.
[0088] In some embodiments, the probe may have a sharp tissue
piercing distal tip, and in other embodiments, the probe may have a
blunt tip for minimizing tissue trauma. To navigate through tissue,
it may be desirable to have a certain column strength for the probe
in order to avoid bending, buckling or splaying, especially when
the probe comprises two or more probes in an array. One exemplary
embodiment may utilize a variable stiff portion of a sleeve along
the probe body to provide additional column strength for pushing
the probe through tissue.
[0089] In many methods, the temporal branch of the facial nerve
which feeds the frontalis, corrugator supercilii, and other facial
muscles, the angular nerve, which enervates the corrugator
supercilii and the procerus muscle, or nerves that enervate other
facial muscles can be temporarily disrupted by applying cold
therapy in anatomically based patterns in the temporal and other
regions of the face. The disruption can be performed by using a
cryoprobe that decreases the local environmental temperature
sufficiently cold to induce a nerve block. The procedure can be
designed to minimize patient discomfort through use of local
anesthetics. Also the procedure can be performed simply with
minimal discomfort and a short procedure time by targeting the
treatment location with appropriate anatomical landmarks and
designing the cryoprobe and cryotherapy to provide optimum
treatment in minimum time.
[0090] In many embodiments, muscle contraction or pain can be
eliminated by using a cryoprobe such as those previously described
above to treat the nerve by identifying anatomical landmarks,
measuring or applying a predetermined template to/from or between
the identified landmarks, and laterally inserting a cryoprobe,
bluntly dissecting tissue using the cryoprobe to reach the desired
treatment location in a pattern that causes a sufficient number of
local facial nerve branches in the target area to be impacted by
the cryotreatment.
[0091] In some embodiments, a method comprises disruption the
conduction a motor nerve in order to minimize the appearance of
hyperdynamic facial wrinkles in the forehead, frown, crow's feet
and other areas of the face. Three examples of diagonal, vertical,
and horizontal treatments, respectively, portions A, B, and C,
lying across portions of the temporal branch of a facial nerve
(TB-FN) are illustrated in FIG. 13A. The treatment of horizontal
forehead wrinkles may be initiated by creating an incision point
beyond the hair line, marked as X, here shown as points A', B', and
C'. In this manner, any temporary scarring caused by exposure to
cold or otherwise is hidden from view. The cryogenic needle probe
array is then inserted into the tissue. In some embodiments, a
sheath can be used as shown in FIGS. 4A-4C, however this is not
required. Generally, the incision point is laterally displaced from
the area of treatment, with respect to the surface of the skin. In
terms of landmarks, the incision point is generally at the scalp in
a region covered by hair, i.e., beyond the hairline (e.g., 1-10
mm), in some cases well beyond the hairline (e.g., >10 mm),
while the treatment area is underneath a visible portion of the
skin.
[0092] In some embodiments, the cryogenic probe can be inserted
through the skin after an incision is made and then advanced
through softer tissue layers such as fat, muscle or other soft
tissue, until a resilient tissue layer or structure is encountered,
for example, such as a fascial layer, cartilage, periosteum, or
bone. The resilient nature of the tissue layer prevents puncture by
a blunt instrument, such as the cryogenic probe. The tip of the
probe can interface with force against the resilient tissue layer,
and then flex along the resilient tissue layer without piercing,
and be advanced there along in a gliding movement until its distal
tip is in close proximity to a target nerve found in close
proximity to a tough protective structure. The nerve can then be
cryogenically treated to create a cosmetically beneficial effect
such as the alleviation of wrinkles or to mitigate pain in the case
of a sensory nerve.
[0093] Skin tissue, including facial tissue, includes many layers.
In simplistic terms, between skin and muscle lies a layer of
subcutaneous tissue, a layer of temporoparietal fascia (TPF), loose
areolar tissue, and then deep temporoparietal fascia (sDTF). For
the purposes of this disclosure, tissue layers between the
subcutaneous tissue and muscle will be referred to as the TPF-sDTF
layer, or simply TPF-sDTF. Nerves of interest for treatment are
generally positioned within the TPF-sDTF, and/or directly adjacent,
i.e., between the TPF-sDTF and subcutaneous tissue depending on the
specific location of the nerve. For example, the TB-FN extends
along a portion of the TPF-sDTF layer. The point of incision is
generally made so that the TPF-sDTF is accessible.
[0094] With attention back to FIG. 13A, after an incision is made,
a cryogenic probe in inserted into the point of incision, to the
depth of the TPF-sDTF, but not past the sDTF. The cryogenic probe
includes a distal tip extending from an elongated body. For
example, the cryogenic probe tip disclosed in FIGS. 3C and 3D can
be used. After insertion, the TPF is then bluntly dissected by
applying physical force to the cryogenic probe, to move the
elongated body along treatment vectors, shown here as dotted lines.
Often, movement of the elongated body is visible underneath the
skin, thereby enabling positioning of the treating portion to a
particular area. It should be understood that the blunt tip and
flexibility of the cryogenic probe enable it to dissect the TPF
while gliding over the sDTF within the TPF-sDTF layer. This is both
a safety and ease-of-use advantage, since piercing the sDTF is very
unlikely due to the blunt tip. Accordingly, the portion of the
elongated probe body within the TPF-sDTF self-aligns to be
substantially parallel to the TPF-sDTF, since it is physically
confined between the sDTF and the upper subcutaneous tissue.
Placement of the blunt tip can be aided by external palpation to
encourage the tip to dissect along convex or concave surfaces and
remain within the desired tissue layer.
[0095] The cryogenic probe dissects the TPF until a treating
portion of the cryogenic probe is directly adjacent to a treatment
portion (e.g., A, B, and C) of a target nerve, such as the TB-FN,
as illustrated in FIG. 13B. The treating portion of the cryogenic
probe is a distinct portion along the elongated body where a
cooling zone emanates from, typically the exit point(s) of an
internal supply tube. In some embodiments the distal tip is the
treating portion of the cryogenic probe, while in other embodiments
a mid-portion of the elongated body is the treating portion. As
shown, a downward force is applied to the handle of the cryogen
probe to longitudinally move the elongated body within the
TPF-sDTF. This is possible due to the self-aligning tendency of the
probe within the TPF-sDTF. Thus, the downward force results in
forward movement along the longitudinal axis of the elongated body.
When applying the downward force, the elongated body can be bent
without rupturing the elongated body or supply tube, due to the
resilient nature of the probe.
[0096] Once the cryogenic probe is positioned, it may be activated
to generate a cooling zone by flowing a cryogenic fluid through the
elongated body, as well described above. The cryogenic probe is
held in place until the desired treatment at the treatment zone is
achieved. The cryogenic probe can then be removed from the body, or
repositioned for additional treatment as further discussed below.
Such methods are advantageous because they help mitigate visible
temporary scaring (i.e, redness, scabs, blackening) that may occur
with use of cryogenic needles, since the point of incision can be
hidden by hair. Also, often only one point of entry is required,
thus greatly reducing the quantity of any temporary scars. Further,
the method mitigates issues associated with nerve depth
variability, which can be the case when approaching from directly
above the treatment portion with a piercing cryogenic needle, since
the target nerve is within the TPF-sDTF that the elongated body
travels within.
[0097] As mentioned above, it may be desirable to create more than
one treatment zone to affect a nerve or cluster of nerves as
depicted in FIGS. 13C and 13D. In FIG. 13C, a plurality of
treatment zones have been created along treatments portions A and C
to create a treatment "fence". This may be achieved by linearly
withdrawing or advancing the cryogenic probe after a treatment is
first performed, and then repeating the treatment at the new
location. As shown, three treatment zones have been created along
treatment portion A, and two treatments zones have been created
along treatment portion C, however, more treatment zones than shown
can be created. The treatment zones may be spatially separated by
some desired distance, lay end-to-end, or overlap.
[0098] An alternative treatment pattern is depicted in FIG. 13D.
Here, the cryoprobe has been adjusted angularly about the incision
point after an initial treatment zone has been created, and then
used for retreatment, thus creating a treatment "plane". Generally
at least two treatment zones are required to create a plane, and
more may be generated as well. As shown, treatment plane has been
created at treatment portions A and C by performing a plurality of
angularly separated treatments at each portion. As with respect to
the method shown in FIG. 13C, treatment zones for creating a
treatment plane may be spatially separated by some desired
distance, lay side-by-side, or overlap. In some embodiments, the
cryoprobe is actuatable, such as the probes shown in FIGS. 11 and
12, and thus actuation of the probes can be performed instead of
angular displacement.
[0099] While the exemplary embodiments have been described in some
detail for clarity of understanding and by way of example, a number
of modifications, changes, and adaptations may be implemented
and/or will be obvious to those as skilled in the art. For example,
while treatment of a motor nerve is demonstrated in FIGS. 13C and
13D, the exemplary methods and devices disclosed herein are also
useable in treating any nerve including peripheral nerves which
will include sensory nerves.
[0100] Further, treatment is not limited to facial tissue, since
the interfaces separating two tissues (e.g. bone, muscle, and
organ) including fascia layers are found throughout the body and
can be used to guide treatment of target nerves. Devices and method
for pain management are disclosed herein as Appendix A, which
consists of U.S. Provisional Application No. 61/800,478, which is
incorporated by reference. Thus, the devices disclosed herein, such
as the one shown in FIGS. 3C and 3D, can be used to treat sensory
nerves disclosed in Appendix A. For example, the device of FIGS. 3C
and 3D can be used to dissect fascia along the first and/or second
lines of the treatment zone depicted in FIG. 6 of Appendix A, and
thus treat sensory nerves that intersect with the treatment
zone.
[0101] Further, the devices, systems, and methods can be used for
management of movement disorders, for example such as: Akathisia,
Akinesia Associated Movements (Mirror Movements or Homolateral
Synkinesis), Athetosis (contorted torsion or twisting), Ataxia
(gross lack of coordination of muscle movements), Ballismus
(violent involuntary rapid and irregular movements), Hemiballismus
(affecting only one side of the body), Bradykinesia (slow
movement), Cerebral palsy, Chorea (rapid, involuntary movement),
Sydenham's chorea, Rheumatic chorea, Huntington's disease, Dystonia
(sustained torsion), Dystonia muscularum, Blepharospasm, Writer's
cramp, Spasmodic torticollis (twisting of head and neck),
Dopamine-responsive dystonia (hereditary progressive dystonia with
diurnal fluctuation or Segawa's disease), Geniospasm (episodic
involuntary up and down movements of the chin and lower lip),
Myoclonus (brief, involuntary twitching of a muscle or a group of
muscles), Metabolic General Unwellness Movement Syndrome (MGUMS),
Mirror movement disorder (involuntary movements on one side of the
body mirroring voluntary movements of the other side), Parkinson's
disease, Paroxysmal kinesigenic dyskinesia, Restless Legs Syndrome
RLS (WittMaack-Ekboms disease), Spasms (contractions), Stereotypic
movement disorder, Stereotypy (repetition), Tardive dyskinesia, Tic
disorders (involuntary, compulsive, repetitive, stereotyped),
Tourette's syndrome, Tremor (oscillations), and Wilson's disease.
It is believed that treatment of nerves associated with such
movement disorders using the methods and systems disclosed herein
can be beneficial. Hence, the scope of the present invention is
limited solely by the independent claims.
* * * * *