U.S. patent application number 16/865234 was filed with the patent office on 2020-08-20 for cryotherapy device with cryoprotection and methods for performing cryotherapy with cryoprotection.
The applicant listed for this patent is Gary Mayback Kalser. Invention is credited to Gary Kalser, Gregory L. Mayback.
Application Number | 20200261137 16/865234 |
Document ID | 20200261137 / US20200261137 |
Family ID | 1000004808718 |
Filed Date | 2020-08-20 |
Patent Application | download [pdf] |
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United States Patent
Application |
20200261137 |
Kind Code |
A1 |
Kalser; Gary ; et
al. |
August 20, 2020 |
CRYOTHERAPY DEVICE WITH CRYOPROTECTION AND METHODS FOR PERFORMING
CRYOTHERAPY WITH CRYOPROTECTION
Abstract
A method for preventing damage to adjacent tissue at a surgical
site includes locating the tissue to be protected, placing a
cryoprotective device at the tissue to be protected, injecting a
cryoprotective substance (CPS) through the cryoprotective device at
the tissue, at least one of positioning a temperature sensor at the
CPS and positioning a temperature sensor at the tissue, monitoring
a temperature of at least one of the CPS and the tissue with the
temperature sensor, and carrying out cryotherapy at the surgical
site without harm to the tissue.
Inventors: |
Kalser; Gary; (Winter Park,
FL) ; Mayback; Gregory L.; (Cooper City, FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Kalser; Gary
Mayback; Gregory L. |
Winter Park
Cooper City |
FL
FL |
US
US |
|
|
Family ID: |
1000004808718 |
Appl. No.: |
16/865234 |
Filed: |
May 1, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
14709060 |
May 11, 2015 |
10660688 |
|
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16865234 |
|
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61991953 |
May 12, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2090/0463 20160201;
A61B 2018/0293 20130101; A61B 2018/0212 20130101; A61B 2018/00898
20130101; A61B 18/02 20130101; A61B 18/0218 20130101; A61B
2018/00791 20130101; A61B 2018/00547 20130101 |
International
Class: |
A61B 18/02 20060101
A61B018/02 |
Claims
1. A method for preventing damage to adjacent tissue at a surgical
site, which comprises: locating the tissue to be protected: placing
a cryoprotective device at least one of at and adjacent the tissue
to be protected; injecting a cryoprotective substance (CPS) through
the cryoprotective device at least one of at and adjacent the
tissue; at least one of: positioning a temperature sensor at least
one of at and adjacent the CPS; and positioning a temperature
sensor at least one of at and adjacent the tissue; monitoring a
temperature of at least one of the CPS and the tissue with the
temperature sensor; and carrying out cryotherapy at the surgical
site without harm to the tissue.
2. The method according to claim 1, wherein the CPS comprises a
rapid transition polymer.
3. The method according to claim 1, wherein the CPS comprises an
anesthetic.
4. The method according to claim 1, wherein the CPS comprises
dehydrated cells.
5. The method according to claim 4, wherein the dehydrated cells
comprise dehydrated amniotic tissue allograft membranes.
6. The method according to claim 1, which further comprises
repeating the locating, placing, injecting, positioning and
monitoring steps for each area of different tissues to be
protected.
7. The method according to claim 1, which further comprises
injecting further CPS through the cryoprotective device if a preset
temperature limit is exceeded.
8. A method for preventing damage to adjacent tissue at a surgical
site, which comprises: locating the tissue to be protected; placing
a cryoprotective device adjacent the tissue to be protected;
injecting a cryoprotective substance (CPS) through the
cryoprotective device adjacent the tissue; at least one of:
positioning a temperature sensor adjacent the CPS; and positioning
a temperature sensor adjacent the tissue; monitoring a temperature
of at least one of the CPS and the tissue with the temperature
sensor; and carrying out cryotherapy at the surgical site without
harm to the tissue.
9. The method according to claim 8, wherein the CPS comprises a
rapid transition polymer.
10. The method according to claim 8, wherein the CPS comprises an
anesthetic.
11. The method according to claim 8, wherein the CPS comprises
dehydrated cells.
12. The method according to claim 11, wherein the dehydrated cells
comprise dehydrated amniotic tissue allograft membranes.
13. The method according to claim 8, which further comprises
repeating the locating, placing, injecting, positioning and
monitoring steps for each area of different tissues to be
protected.
14. The method according to claim 8, which further comprises
injecting further CPS through the cryoprotective device if a preset
temperature limit is exceeded.
15. A method for preventing damage to adjacent tissue at a surgical
site, which comprises: locating the tissue to be protected; placing
a cryoprotective device at the tissue to be protected; injecting a
cryoprotective substance (CPS) through the cryoprotective device at
the tissue; at least one of: positioning a temperature sensor at
the CPS; and positioning a temperature sensor at the tissue;
monitoring a temperature of at least one of the CPS and the tissue
with the temperature sensor; and carrying out cryotherapy at the
surgical site without harm to the tissue.
16. The method according to claim 15, wherein the CPS comprises a
rapid transition polymer.
17. The method according to claim 15, wherein the CPS comprises an
anesthetic.
18. The method according to claim 15, wherein the CPS comprises
dehydrated cells.
19. The method according to claim 18, wherein the dehydrated cells
comprise dehydrated amniotic tissue allograft membranes.
20. The method according to claim 15, which further comprises
repeating the locating, placing, injecting, positioning and
monitoring steps for each area of different tissues to be
protected.
21. The method according to claim 15, which further comprises
injecting further CPS through the cryoprotective device if a preset
temperature limit is exceeded.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of copending U.S. patent
application Ser. No. 14/709,060 filed May 11, 2015, of which
priority is claimed under 35 U.S.C. .sctn. 120 (which application
claims priority to U.S. Provisional Patent Application No.
61/991,953, filed May 12, 2014); the prior applications are
herewith incorporated by reference herein in their entirety.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
[0002] Not Applicable
FIELD OF THE INVENTION
[0003] The present invention lies in the field of cryotherapy. The
present disclosure relates to a cryotherapy device having
cryoprotection and methods for performing cryotherapy with
cryoprotection, for example, to treat prostate cancer and other
diseases or conditions.
BACKGROUND OF THE INVENTION
[0004] Cryotherapy is a medical procedure used to treat a number of
different diseases. It is also used to treat benign and malignant
lesions. Cryotherapy is used in many of the human organs including
liver, kidney, uterus, heart, eyes, breast, lung, kidney, and
prostate. With regard to the various procedures in which
cryotherapy is used, treatment of prostate cancer is one of the
most common. Accordingly, this example for treatment of prostate
cancer is utilized herein to describe and illustrate the
disadvantages associated with use of cryotherapy, as well as the
advantages of the instant invention, but the invention should not
be considered as limited to this example.
[0005] Prostate cancer is the most common cancer diagnosis in men
(except skin cancer). It is the second-most common cause of cancer
deaths in men over the age of 65 (lung cancer is the most common).
Current methods to treat prostate cancer include prostatectomy
(robotic), radiation therapy, cryotherapy, and watchful waiting.
Robotic prostatectomy and radiation are very expensive and cost
between $40,000 and $60,000. They can have significant morbidity.
Cryotherapy is the least expensive treatment, even less than
watchful waiting. Cure rates are equivalent to radiation and
slightly less than surgery.
[0006] One major complication of cryotherapy is injury to adjacent
normal tissues. For example, in cryosurgery of the prostate used
for treating cancer, the most significant side effect is injury to
the nerves needed for erectile function. This detrimental side
effect is extremely common because injury to these nerves occurs in
80% to 90% of the procedures performed today. The reason why this
injury is so common is because these nerves are in close proximity
to the prostate. Therefore, these nerves are directly exposed to
lethal levels of cold temperature during cryotherapy, resulting in
sexual dysfunction. Currently there is no device/method that
significantly reduces this side effect.
[0007] In the example of a treatment for prostate cancer,
cryotherapy devices insert hollow needles through the perineum,
i.e., the region between the genitals and the anus. Liquid nitrogen
or liquid argon is injected through the needles and is used to
freeze the prostate itself, thereby eradicating the prostate
cancer. Those of skill in the art know how cryotherapy treatment on
the prostate is performed and one excellent exemplary overview of
this procedure is found on the Web at
https://www.youtube.com/watch?v-OnqA-mJDWg&app=desktop, titled
"Overview of Prostate Cryotherapy" by Galil Medical. A needle guide
template having a row-and-column array of needle guide bores is
placed against the perineum with the patient in the lithotomy
position. With ultrasound visualization, the surgeon inserts
cryoablation needles though various bores in the array and into the
prostate. Temperature probes can also be inserted through other
bores to monitor temperature within the prostate or adjacent, such
as at the rectal wall or at the sphincter. Urethral protection is
provided with devices such as a urethral warming catheter. Cycles
of freezing are applied to the prostate under visualization until
treatment has finished. The needles and template are removed after
treatment is completed. An example of such a needle guide template
100 is shown in FIG. 1.
[0008] Present devices used to treat prostate cancer with
cryotherapy are often used in salvage procedures where cancer has
recurred or where other procedures (such as external beam radiation
therapy or high dose rate brachytherapy) have failed. Now,
cryotherapy is being used to treat primary prostate cancer, in
which the entire prostate is treated along with the cancer. This
procedure has beneficial results because it prevents the cancer
from reoccurring in another location subsequently. Another
procedure is becoming popularized--focal cryotherapy of the
prostate. In this procedure, only a quadrant or section of the
prostate that contains the cancer is treated. Focal cryotherapy was
developed to eliminate erectile function injuries to help preserve
erectile function, but it has succeeded only in exchange for an
increase in the possibility of cancer reoccurrence. Focal
cryotherapy is reserved for a select group of patients whose
probability of cancer reoccurrence in another section of the
prostate is minimal.
[0009] As mentioned above, one major side effect of any cryotherapy
to treat the prostate (hindering it from becoming more popular) is
the relatively high incidence of erectile dysfunction from nerve
damage. Yet, another complication of prostate cryotherapy is rectal
injury, which can and does occur because the posterior prostate is
in close proximity to the rectum, e.g., in the Denonvilliers
Fascia. The anterior rectum is at risk for thermal injury when
adequately low temperatures for cell death in the posterior
prostate occur. This risk is especially an issue when treating a
post-radiated prostate because that space has been reduced from
scarring.
[0010] In summary, current cryotherapy devices are not equipped to
prevent nerve damage in a patient, thereby increasing the risk of
impotence.
[0011] There are other ways to treat prostate cancer, for example.
Surgical removal of the prostate, radical prostatectomy, is one
way. However, radical prostatectomy is only effective if the
prostate cancer is organ-confined. Side effects of radical
prostatectomy surgery include temporary or permanent urinary
incontinence and impotence. In addition, even if the patient is not
impotent, removal of the prostate will result in dry orgasms for
the patient. Further, there is a danger that the surgeon could cut
one or more of the nerves, resulting in erectile dysfunction.
[0012] Radiation therapy is another form of treatment for prostate
cancer. Forms of radiation therapy include permanent seed implants,
high dose rate temporary brachytherapy, and external beam radiation
therapy. One form of radiation therapy is the use of permanent seed
implants. When using permanent seed implants therapy, radioactive
seeds are injected into the prostate gland. The seeds are comprised
of radioactive material encased within a titanium shell. A major
disadvantage of seed implant therapy is the fact that it is
difficult to determine whether cancer has spread during the
procedure. In addition, side effects include bowel and bladder
issues.
[0013] High-dose-rate brachytherapy is another treatment type and
uses catheters that are inserted into the prostate and the tumor
with the use of a CAT scan to position the catheters. An insertion
device pushes a radioactive iridium wire into the catheters one by
one to treat the tumor. Although high-dose-rate brachytherapy is
seen as an effective alternative to permanent seed implants, the
equipment and training costs associated with the treatment are very
high. In addition, there is a distinct possibility that the seeds
migrate and, in doing so, ultimately deliver too much radiation,
causing damage to non-cancerous tissues, or deliver too little
radiation, thereby failing to give a lethal dose to the cancer.
[0014] A final treatment type is external beam radiation therapy,
which is used typically in situations where cancer has spread and
is not confined to the prostate. Typical side effects include bowel
and bladder issues because the radiation affects healthy
tissue.
[0015] Each of these forms of treatment has the ability to burn
normal adjacent tissue in a random and uncontrollable way. While
cryotherapy is growing in its use for many procedures, especially
for treatment of prostate cancer, currently, there is no feasible
way to prevent these types of injuries to adjacent nerves/normal
tissue without compromising the cancer-removing operation. One
attempt to do so was through use of helium-warming probes, but that
attempt was unsuccessful for a variety of reasons.
[0016] Thus, a need exists to overcome the problems with the prior
art systems, designs, and processes as discussed above.
[0017] Rapid transition polymers (RTP) are discussed herein and it
is believed that a brief overview would be beneficial. RTP
developed by Pluromed, Inc., are polymers that exist in a liquid
state at low temperatures and at room temperature, but quickly
transition to a gel at body temperature. This phase change is fully
reversible by cooling. It is noted that the polymers cannot
re-solidify once dissolved. Some RTP are able to be injected into a
mammal. One RTP substance was developed as an endovascular
occlusion gel for vascular surgery under Pluromed's trademark
LeGoo.RTM. and is FDA approved. In such use, LeGoo.RTM. is a
viscous liquid at room temperature and becomes a firm plug in the
vessel in which it is injected at body temperature. Once used in
such a vessel-occluding procedure, a cooling mechanism, such as
sterile ice, is applied to the site of the gelled RTP or cold
saline is injected intravascularly until blood flow in the occluded
vessel is restored. This RTP polymer is also FDA approved for the
use in endoscopic urologic surgery to prevent proximal stone
migration under Pluromed's trademark BackStop.RTM.. In particular,
injected BackStop.RTM. forms a plug in the ureter to prevent stone
migration during lithotripsy. BackStop.RTM. is marketed by Boston
Scientific.
SUMMARY OF THE INVENTION
[0018] The invention provides cryoprotection systems and methods
for performing cryotherapy with cryoprotection that overcome the
hereinafore-mentioned disadvantages of the heretofore-known devices
and methods of this general type and that provide such features
with the ability to protect nerves and other healthy tissue at the
surgical site that might be damaged by exposure to the cryotherapy
cold.
[0019] In particular, the cryotherapy devices and methods for
performing cryotherapy with cryoprotection that are described
herein utilize materials (such as rapid transition polymers) having
thermal protective properties in ways not previously known or
described. In particular, the above-described RTP has a freezing
point well below zero degrees Centigrade. Thus, this RTP can be
used as insulation to protect vital tissues (including nerves) from
excessive cold during cryotherapy procedures. As used herein, the
term RTP is defined as set forth above but other substances that
shield one tissue from another adjacent tissue with protection from
cold temperatures caused by cryotherapy are envisioned as equally
applicable to the presently described inventive systems and
methods.
[0020] The set of materials that provide cryoprotection as used
herein is referred to as a cryoprotective substance or "CPS".
Accordingly, if "RTP" is used in a particular exemplary embodiment
hereinbelow, any CPS can be substituted for the RTP and used
similarly and, in so describing this, such alternative materials
are to be considered as in addition to or instead of a described
single one of the cryoprotective materials, such as the RTP.
[0021] In addition to RTP, other CPS that are available and
likewise have cryoprotective properties are referred to in the art
as AminoFix.RTM. and EpiFix.RTM.. These products comprise processed
dehydrated amniotic tissue allograft membranes and are used to
deliver essential growth factors and cytokines. The latter two
proteins are used to promote healing and to prevent inflammation
and scarring. These products are used for a variety of
reconstructive surgical procedures. However, another property of
these materials that was not heretofore known is that a dehydrated
property of these cells is able to provide cryoprotection. While it
is known that dehydrated cells are more tolerant to cold than are
normal hydrated cells, they have not been heretofore used for
protection of adjacent tissues during cryotherapy procedures.
Although AminoFix.RTM. and EpiFix.RTM. are marketed to be used in
many different areas of the body it has never been mentioned for
its cryoprotective properties but such properties exist and this
material can be used instead of or in addition to any of the other
materials described herein for protecting adjacent tissues from
cryotherapy injury. The process for using dehydrated cells such as
AminoFix.RTM. and EpiFix.RTM. for the purpose of cryoprotection is
exactly the same as the process previously described for using RTP
for cryoprotection. This is because, for example, AminoFix.RTM. and
EpiFix.RTM. both come in an FDA-approved injectable form. This
injectable form is used for orthopedic diseases and use of the
dehydrated cells (not growth factors et al.) for cryoprotective
purposes was not discovered until the inventors discovered the
instant cryoprotective systems and processes. As such, the scope of
the inventive systems and methods include any use of a dehydrated
cell for cryoprotective purposes.
[0022] Yet another CPS is made by Augmenix, Inc., which created a
compound called SpaceOAR.RTM.. This compound is a substance used to
prevent radiation injury to the rectum. It utilizes ethylene glycol
to create a space, thereby preventing damage to the rectum during
external radiation beam therapy. In addition, Augmenix, Inc., also
manufactures a product called TraceIT.RTM., which is used to
radiographically mark soft tissue during a surgical procedure. This
compound includes a radiopaque polyethylene glycol hydrogel. The
inventors have discovered that these compounds can be used in the
inventive systems and methods to protect tissue from thermal
injury.
[0023] There are several mechanisms by which the CPS can yield
thermal protection. First, in the example of RTP, when injected
into the body in its liquid state, the RTP liquid creates a space
by its presence to establish a protective boundary around targeted
tissue as it transitions from a liquid to a gel. This space
protects the sensitive tissue not only because it increases the
distance between the sensitive cellular structure and the adjacent
target of the freezing, but it also has "antifreeze" properties
that prevent the protected tissue from cooling to a point where the
cellular structure crystallizes. The active ingredient in the RTP
known in the art as LeGoo.RTM. Endovascular Occlusion Gel that
gives LeGoo.RTM. its antifreeze properties is ethylene glycol. This
molecule has unique cryoprotective properties not previously
described for use in the medical field. The scope of the inventions
described herein include not only LeGoo.RTM. but also any RTP or
other substance that includes ethylene glycol. The systems and
methods also include use of ethylene glycol (or equivalent
materials or compounds) that are both biologically safe and have
antifreeze properties or where such a product is linked or bonded
to another substance that makes the product biologically safe when
used for its antifreeze properties.
[0024] The cryoprotective methods described herein are applicable
to any surgical procedure where cryotherapy is desirable and
adjacent tissues needing protection are present. Cryotherapy has
been used in almost every organ in the body. Examples include, but
are not limited to, procedures involving the skin, the eye, the
esophagus, the stomach, the liver, the rectum, the pancreas, the
heart, the nervous system, and bones. In each of these examples,
there are risks and complications associated with injury to
adjacent vital structures and, therefore, the inventive
cryoprotective systems and methods are equally applicable to such
different procedures even where they are not described in detail
herein. In particular, even though the description herein goes into
detail for removing cancer in a prostate, it is not limited
thereto. Prostate cancer treatment is merely one exemplary use.
Thus, the described systems and methods provide a mechanism by
which standard cryotherapy provides the cooling and the CPS form a
better and safer insulator than air, saline, or any other
material.
[0025] Accordingly, in the example of cryotherapy to remove cancer
in a prostate, injection of the polymer/substance between the
prostate and the erectile nerves increases the space therebetween.
In addition to physical separation, the polymer/substance's
antifreeze properties serve to prevent adjacent cooling from
penetrating into the protected tissue (surrounding the prostate and
including the vascular and nerve structures) to an extent that
would be sufficient to crystallize and, thereby, destroy that
protected tissue. In particular, when the freezing of the target
tissue does comes into contact with the CPS, it is thermally
protected and, in the example of RTP, the gel liquifies from its
outer perimeter inwards, surrounding the tissue/nerves located
inside the gel with "liquid antifreeze" and, thus, protects the
tissue/nerves. This antifreeze property of RTP protects cell
membranes within the gel by preventing the membrane from
fracturing, which occurs when cells are subjected to
crystallization. As such, use of CPS such as RTP in cryotherapy
prostate surgery forms an inventive system and method that prevents
erectile nerve damage and rectal injuries.
[0026] One example use of cryotherapy in the heart is to treat
cardiac arrhythmias. The typical procedure involves placing a
balloon in the pulmonary artery. This balloon is used to freeze and
kill adjacent aberrant nerves that are responsible for the
arrhythmias. A serious complication of this procedure is damage to
the phrenic nerve. If such an injury happens, the diaphragm no
longer is able to contract and the patient is never able to breathe
normally again. As such, injecting the CPS (e.g., RTP) between the
phrenic nerve and the pulmonary artery protects the phrenic nerve
during this form of treatment as described herein with respect to
the other alternative embodiments of use.
[0027] Yet another example how the CPS can be used is in treatment
of tumors and lesions around the eye and the eye orbit. There are
many vital structures that can be in close proximity to a targeted
lesion in the eye, such as the retina, the lacrimal duct, and the
optic nerve. By injecting the CPS (e.g., RTP) between the lesion
and the vital structure, a protective layer is formed and protects
that vital structure from cryotherapy that is performed on the
lesion. Then, cryotherapy treatment of the tumor/lesion can occur
with confidence because of the protection that CPS provides to the
tissue adjacent to that tissue being treated with cryotherapy.
[0028] Yet another use for cryotherapy is in the gastrointestinal
tract. Examples of such uses include the treatment of Barrett's
esophagus as well as tumors and cancers in the esophagus. A serious
and life-threatening complication of cryotherapy in the esophagus
is perforation. Another possible complication is stricture
formation. By placing the CPS (e.g., RTP) between the layers of
muscles and mucosa before cryotherapy begins, injuries to the
adjacent tissues from the cryotherapy can be prevented. In a
similar fashion, cryotherapy is used to treat gastric antral
ectasia and gastric tumors. Again, the CPS (e.g., RTP) is placed
between the targeted lesions and the different layers on the
intestinal wall to prevent perforation that could be caused by
cryotherapy.
[0029] Yet another example of cryotherapy use is in the treatment
of pancreatic diseases. These include the treatment of pancreatitis
and pancreatic tumors. It is known that the pancreas is very
difficult to reach surgically. Therefore, many endoscopic
procedures are being developed using cryotherapy. It is known that
serious complications can occur if the patient's bile duct is
injured but, using the inventive CPS between the bile duct and the
targeted lesion, bile duct injuries are prevented.
[0030] Yet another example of the use of cryotherapy is for pain
control. Certain nerves can be responsible for causing severe pain.
An example of such a disease is trigeinal neuralgia. Accordingly,
ablation of the nerves causing the pain can result in elimination
of the pain. But, such ablation can and does cause injury to the
adjacent tissues. Thus, the CPS (e.g., RTP) can be injected around
the nerve to prevent collateral injury on non-targeted adjacent
nerves and vessels.
[0031] Yet another common use of cryotherapy is in the treatment of
cutaneous lesions. Certain areas of the body such as the hand and
feet are at particular risk for vascular injury due to their lack
of collateral circulation. Vascular necrosis of digits has been
described to occur following these types of procedures. Vascular
necrosis can be prevented with the inventive systems and processes
by injecting the CPS (e.g., RTP) around the targeted lesion prior
to carrying out cryotherapy.
[0032] Yet another use of cryotherapy is in the treatment of rectal
proctitis, which is most commonly caused by radiation. In this
procedure, the CPS (e.g., RTP) is injected underneath the lesion to
prevent perforation and fistula formation when cryotherapy
occurs.
[0033] The examples described above are not to be considered as
limiting the possible uses of the inventive systems and methods
with placement of the CPS to protect ancillary injury caused
previously by cryotherapy. One skilled in the art, therefore, knows
to which procedures the inventive systems and methods can be
extended.
[0034] Different methods of cryotherapy exist and depend upon the
manufacturer of the cryotherapy equipment. This cryoprotective
methods and systems described herein involve pretreatment with the
CPS to protect tissue that is not desired to receive the
cryotherapy treatment (i.e., it is not intended to be destroyed
with cold and, instead, is to be protected). The CPS is injected to
protect the tissue before cryotherapy needles/probes are inserted
and, therefore, which cryotherapy device available in the
marketplace that is used for the surgery becomes irrelevant.
[0035] As detailed herein, one very good exemplary use of the
inventive systems and methods involve protection of nerves
surrounding the prostate. Before describing those systems and
methods, various aspects of prostate cryotherapy are described with
regard to FIGS. 1 to 8.
[0036] FIG. 2 illustrates a transducer guide or ultrasonic probe
200 that is manufactured by Micro Convex. The probe 200 has a
proximal end 220 and a distal end 225. The proximal end 220 of the
probe 200 is a handle for gripping by a user during a procedure.
The distal end 225 of the probe 200 has an acoustic lens 215. The
probe 200 also includes a groove 210 and an opening 205 that are
both used to secure an attachment 400 shown in FIG. 4.
[0037] An ultrasonic generating portion of the probe 200 includes a
transducer, a backing material, an acoustic matching layer, and an
acoustic lens, e.g., lens 215. The transducer or piezoelectric
element (not shown) is used to generate ultrasonic waves. A voltage
is applied to electrodes that are attached to both sides of the
transducer. The transducer oscillates by expanding and contracting,
which, at ultrasonic frequencies, generates an ultrasonic sound
wave. A backing material (not shown) is located behind, i.e., in a
proximal location from, the transducer and is used to prevent
excessive vibration. An acoustic matching layer (not shown) is used
to reduce reflection of the ultrasonic waves. The acoustic lens 215
is used to focus the ultrasonic waves to improve resolution.
[0038] FIG. 3 illustrates another view of probe 200. This view
shows a cord 230 for connection to an ultrasound platform. The
ultrasound platform (not shown) is used to acquire, present, and
analyze data obtained from the probe 200.
[0039] FIG. 4 illustrates the attachment 400 for the probe 200. The
attachment 400 includes an extension 405 on a proximal end 415
thereof. The extension 405 fits into the groove 210 on the probe
200. The attachment 400 also includes a protrusion 410 for
placement into the opening 205 of probe 200. FIG. 5 shows the probe
200 connected to attachment 400. FIG. 6 illustrates a proximal side
of the attachment 400 when it is connected to the probe 200. A
funnel shaped opening 605 on the proximal end of the attachment 400
leads to a channel 610 that runs longitudinally from the proximal
end 415 to the distal end 420 of the attachment 400. The opening
605 and the channel 610 are used to insert and guide surgical
portions of the prior art cryotherapy device.
[0040] FIGS. 7, 8, and 9 show other views of the probe 200 and the
attachment 400. In these views, a cryotherapy catheter 705 is
shown. This exemplary catheter 705 includes a luer connector 710
and a needle guide 715. In the views of FIGS. 7 to 9, the needle
guide 715 has been placed into the funnel 605 and passes entirely
through the channel 610 to exit the other end. In such a position,
when the distal end 225 of the probe 200 has been inserted into the
anus of the patient, the channel 610 is positioned at a spot for
positioning a cryotherapy injection needle 905 to pierce tissue and
approach the prostate and its surrounding areas. The cryotherapy
injection needle 905 can also be referred to as a cryotherapy
probe.
[0041] FIG. 9 shows an example of a cryotherapy injection needle
905 used with the catheter 705 and the attachment 400. The
cryotherapy injection needle 905 includes a proximal connector 910
and a hollow needle shaft 915. In use, the needle shaft 915 is
inserted into a proximal end of the catheter 705 through the
connector 710 and, thereby, through the channel 610 of the
attachment 400. In this way, when the channel 610 is aligned with
the surgical site, the needle shaft 915 can be pushed through the
catheter 705 and into the patient for administering the cryotherapy
treatment.
[0042] During a standard cryotherapy procedure, a temperature probe
is placed wherever the surgeon desires to monitor temperature of
tissue. In particular, during prostate surgery, the surgeon needs
to monitor the temperature of the neuro-vascular tissues. This is
because any damage to the neuro-vascular tissues (caused by the
tissue/nerves receiving cold) can cause erectile dysfunction of the
penis, which is to be avoided. The temperature probe is inserted
through the connector 400 and is left at the prostatic plexis
during prostate cryotherapy. Accordingly, the surgeon slides the
connector 400 back away from the installed temperature probe (not
illustrated) and then uses a cryotherapy connector 400 with the
probe 200 to locate the prostate and perform the cryotherapy. In
particular, the ultra-thin cryotherapy injection needle 905 is
inserted into the prostate gland using an incision in the perineum.
e.g., in an area between the anus and the scrotum. Visualization of
the surgery occurs with the ultrasound probe 200 and with telemetry
from the temperature sensor at the neuro-vascular tissues. The
sensor and/or the probe 200 can include a processor that receives
signals from the sensor/probe and provides information, such as
temperature, to the surgeon using the systems and methods. The
surgeon uses the information from the ultrasound probe 200 to find
and destroy the prostatic tissue and monitors the temperature probe
or the information provided by the processor to make sure the
neuro-vascular tissues remains at a pre-defined safe
temperature.
[0043] With the foregoing and other objects in view, there is
provided, a method for preventing damage to adjacent tissue at a
surgical site including the steps of locating the tissue to be
protected, placing a cryoprotective device at least one of at and
adjacent the tissue to be protected, injecting a cryoprotective
substance (CPS) through the cryoprotective device at least one of
at and adjacent the tissue, at least one of positioning a
temperature sensor at least one of at and adjacent the CPS and
positioning a temperature sensor at least one of at and adjacent
the tissue, monitoring a temperature of at least one of the CPS and
the tissue with the temperature sensor, and carrying out
cryotherapy at the surgical site without harm to the tissue.
[0044] With the objects in view, there is also provided a
cryoprotective device, comprising a hollow cryoprotective probe
having a distal tip, a removable obturator, and at least one
integral temperature sensor monitoring temperature at least
adjacent the distal tip, an injector injecting a cryoprotective
substance (CPS) through the cryoprotective probe and out the distal
tip when the obturator is removed, the CPS preventing freezing of a
substance at which it is injected when adjacent cryotherapy occurs,
and a processor monitoring temperature of the at least one the
temperature sensor.
[0045] In accordance with another feature, the CPS comprises a
rapid transition polymer.
[0046] In accordance with a further feature, the CPS comprises an
anesthetic.
[0047] In accordance with an added feature, the CPS comprises
dehydrated cells.
[0048] In accordance with an additional feature, the dehydrated
cells comprise dehydrated amniotic tissue allograft membranes.
[0049] In accordance with yet another feature, the locating,
placing, injecting, positioning and monitoring steps are repeated
for each area of different tissues to be protected.
[0050] In accordance with yet a further feature, further CPS is
injected through the cryoprotective device if a preset temperature
limit is exceeded.
[0051] In accordance with a concomitant feature, the processor
notifies a user if the temperature monitored by the temperature
sensor exceeds a preset temperature limit.
[0052] Although the invention is illustrated and described herein
as embodied in a cryotherapy device and methods for performing
cryotherapy with thermal protection, it is, nevertheless, not
intended to be limited to the details shown because various
modifications and structural changes may be made therein without
departing from the spirit of the invention and within the scope and
range of equivalents of the claims. Additionally, well-known
elements of exemplary embodiments of the invention will not be
described in detail or will be omitted so as not to obscure the
relevant details of the invention.
[0053] Additional advantages and other features characteristic of
the present invention will be set forth in the detailed description
that follows and may be apparent from the detailed description or
may be learned by practice of exemplary embodiments of the
invention. Still other advantages of the invention may be realized
by any of the instrumentalities, methods, or combinations
particularly pointed out in the claims.
[0054] Other features that are considered as characteristic for the
invention are set forth in the appended claims. As required,
detailed embodiments of the present invention are disclosed herein;
however, it is to be understood that the disclosed embodiments are
merely exemplary of the invention, which can be embodied in various
forms. Therefore, specific structural and functional details
disclosed herein are not to be interpreted as limiting, but merely
as a basis for the claims and as a representative basis for
teaching one of ordinary skill in the art to variously employ the
present invention in virtually any appropriately detailed
structure. Further, the terms and phrases used herein are not
intended to be limiting; but rather, to provide an understandable
description of the invention. While the specification concludes
with claims defining the features of the invention that are
regarded as novel, it is believed that the invention will be better
understood from a consideration of the following description in
conjunction with the drawing figures, in which like reference
numerals are carried forward.
[0055] Although the invention is illustrated and described herein
as embodied in a cryotherapy device, it is, nevertheless, not
intended to be limited to the details shown because various
modifications and structural changes may be made therein without
departing from the spirit of the invention and within the scope and
range of equivalents of the claims. Additionally, well-known
elements of exemplary embodiments of the invention will not be
described in detail or will be omitted so as not to obscure the
relevant details of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0056] The accompanying figures, where like reference numerals
refer to identical or functionally similar elements throughout the
separate views, which are not true to scale, and which, together
with the detailed description below, are incorporated in and form
part of the specification, serve to illustrate further various
embodiments and to explain various principles and advantages all in
accordance with the present invention. Advantages of embodiments of
the present invention will be apparent from the following detailed
description of the exemplary embodiments thereof, which description
should be considered in conjunction with the accompanying drawings
in which:
[0057] FIG. 1 is a photograph of a fragmentary, perspective view of
a prior art cryotherapy needle template and cryotherapy needles
from above a front side thereof;
[0058] FIG. 2 is a photograph of a fragmentary, perspective view of
a prior art ultrasonic probe from above a top side thereof;
[0059] FIG. 3 is a photograph of a fragmentary, perspective view of
the ultrasonic probe of FIG. 1 from above a right side thereof;
[0060] FIG. 4 is a photograph of a fragmentary, perspective view of
the ultrasonic probe of FIG. 1 and a probe attachment from below a
right side thereof;
[0061] FIG. 5 is a photograph of a fragmentary, perspective view of
the attachment and probe of FIG. 4 in an attached configuration
from above a distal end thereof;
[0062] FIG. 6 is a photograph of a fragmentary, perspective view of
the attachment and ultrasonic probe of FIG. 5 from above a proximal
end thereof:
[0063] FIG. 7 is a photograph of a fragmentary, perspective view of
the attachment and ultrasonic probe of FIG. 5 from above a proximal
end thereof with a needle catheter inserted through a guide of the
attachment;
[0064] FIG. 8 is a photograph of a fragmentary, perspective view of
the attachment and probe of FIG. 7 from above a right side
thereof;
[0065] FIG. 9 is a photograph of a fragmentary, perspective view of
the attachment and probe of FIG. 8 with a cryotherapy needle
inserted into the needle catheter from above a left side
thereof;
[0066] FIG. 10 is a photograph of a fragmentary, perspective view
of a cryotherapy pretreatment device in accordance with an
exemplary embodiment;
[0067] FIG. 11 is a sagittal, cross-sectional view through a
cryotherapy treatment area of a prostate and with the probe of FIG.
2 inserted in the anus for ultrasonic visualization of the
treatment area;
[0068] FIG. 12 is a transverse, cross-sectional view through the
cryotherapy treatment area of FIG. 11; and
[0069] FIG. 13 is a block diagram of a method for protecting nerves
during a cryotherapy procedure.
DETAILED DESCRIPTION OF THE INVENTION
[0070] As required, detailed embodiments of the present invention
are disclosed herein; however, it is to be understood that the
disclosed embodiments are merely exemplary of the invention, which
can be embodied in various forms. Therefore, specific structural
and functional details disclosed herein are not to be interpreted
as limiting, but merely as a basis for the claims and as a
representative basis for teaching one skilled in the art to
variously employ the present invention in virtually any
appropriately detailed structure. Further, the terms and phrases
used herein are not intended to be limiting; but rather, to provide
an understandable description of the invention. While the
specification concludes with claims defining the features of the
invention that are regarded as novel, it is believed that the
invention will be better understood from a consideration of the
following description in conjunction with the drawing figures, in
which like reference numerals are carried forward.
[0071] Alternate embodiments may be devised without departing from
the spirit or the scope of the invention. Additionally, well-known
elements of exemplary embodiments of the invention will not be
described in detail or will be omitted so as not to obscure the
relevant details of the invention.
[0072] Before the present invention is disclosed and described, it
is to be understood that the terminology used herein is for the
purpose of describing particular embodiments only and is not
intended to be limiting. The terms "a" or "an", as used herein, are
defined as one or more than one. The term "plurality," as used
herein, is defined as two or more than two. The term "another," as
used herein, is defined as at least a second or more. The terms
"including" and/or "having," as used herein, are defined as
comprising (i.e., open language). The term "coupled," as used
herein, is defined as connected, although not necessarily directly,
and not necessarily mechanically.
[0073] Relational terms such as first and second, top and bottom,
and the like may be used solely to distinguish one entity or action
from another entity or action without necessarily requiring or
implying any actual such relationship or order between such
entities or actions. The terms "comprises," "comprising," or any
other variation thereof are intended to cover a non-exclusive
inclusion, such that a process, method, article, or apparatus that
comprises a list of elements does not include only those elements
but may include other elements not expressly listed or inherent to
such process, method, article, or apparatus. An element proceeded
by "comprises . . . a" does not, without more constraints, preclude
the existence of additional identical elements in the process,
method, article, or apparatus that comprises the element.
[0074] As used herein, the term "about" or "approximately" applies
to all numeric values, whether or not explicitly indicated. These
terms generally refer to a range of numbers that one of skill in
the art would consider equivalent to the recited values (i.e.,
having the same function or result). In many instances these terms
may include numbers that are rounded to the nearest significant
figure.
[0075] It will be appreciated that embodiments of the systems and
methods described herein may be comprised of one or more
conventional processors and unique stored program instructions that
control the one or more processors to implement, in conjunction
with certain non-processor circuits and other elements, some, most,
or all of the functions of the powered injector devices described
herein. The non-processor circuits may include, but are not limited
to, signal drivers, clock circuits, power source circuits, and user
input and output elements. Alternatively, some or all functions
could be implemented by a state machine that has no stored program
instructions, or in one or more application specific integrated
circuits (ASICs) or field-programmable gate arrays (FPGA), in which
each function or some combinations of certain of the functions are
implemented as custom logic. Of course, a combination of these
approaches could also be used. Thus, methods and means for these
functions have been described herein.
[0076] The terms "program," "software," "software application," and
the like as used herein, are defined as a sequence of instructions
designed for execution on a computer system. A "program,"
"software," "application," "computer program," or "software
application" may include a subroutine, a function, a procedure, an
object method, an object implementation, an executable application,
an applet, a servlet, a source code, an object code, a shared
library/dynamic load library and/or other sequence of instructions
designed for execution on a computer system.
[0077] Herein various embodiments of the present invention are
described. In many of the different embodiments, features are
similar. Therefore, to avoid redundancy, repetitive description of
these similar features may not be made in some circumstances. It
shall be understood, however, that description of a first-appearing
feature applies to the later described similar feature and each
respective description, therefore, is to be incorporated therein
without such repetition.
[0078] Described now are exemplary embodiments of the present
invention. Referring now to the figures of the drawings in detail
and first, particularly to FIG. 10, there is provided a cryotherapy
pretreatment device 1005. Like FIG. 9. FIG. 10 shows the ultrasonic
probe 200, the attachment 400, and the cryotherapy catheter 705. In
contrast to the cryotherapy injection needle 905, however, is the
presence of the cryotherapy pretreatment device 1005, which is
inserted through the catheter 705 before cryotherapy begins. It is
noted that, the probe 200 and attachment 400 is only one exemplary
use of the cryoprotective systems and methods described herein and
these systems and methods can uses any ultrasonic visualization
device and associated cryotherapy aligning device (such as the
template 100), and, in addition, provide the cryotherapy
pretreatment device 1005.
[0079] The cryotherapy pretreatment device 1005 includes a proximal
connector 1010 and a hollow needle shaft 1015 that terminates in a
distal tip 1020. In use, the needle shaft 1015 is inserted into a
proximal end of the catheter 705 through the connector 710 and,
thereby, through the channel 610 of the attachment 400. In this
way, when the channel 610 is aligned with the surgical site, the
needle shaft 1015 can be pushed through the catheter 705 and into
the patient for administering the cryotherapy pretreatment.
[0080] In particular regard to administering cryotherapy to a
prostate, the distal end 225 of the probe 200 is placed through the
anus and adjacent the prostate as shown in FIG. 11. With use of the
probe 200 (e.g., with doppler ultrasound), the neuro-vascular
bundle and/or the nerves of the prostatic plexus adjacent the
prostate are located; these structures are close to or adjacent the
seminal vesicle. In particular, the bundle 1200 including the
arteries 1205, the veins 1206, and the nerves 1207 are shown in
FIG. 12 on both the left and right sides of the prostate.
[0081] The distal tip 1020 of the cryotherapy pretreatment device
1005 is guided trans-rectally alongside the nerves (bilaterally) up
to and adjacent the prostatic plexus with an obturator therein to
protect the CPS injection channel. When placed adjacent the
prostatic plexus as shown in FIG. 11, the obturator is removed and
the CPS 1105 is injected through the proximal connector 1010 under
visualization through the cryotherapy pretreatment device 1005 to
form a liquid space surrounding the entirety of the prostatic
plexus or at least the side of the prostatic plexus facing the
prostate. Ideally, both the left and right sides are injected with
the CPS 1105 at the locations shown in FIG. 12 and identified with
numeral 1210. As the CPS 1105 fills up the space at locations 1210,
the bundle 1200 is both moved away from the prostate and protected
from cryotherapy to be performed on the prostate with the
antifreezing properties of the CPS 1105. If desired, the CPS 1105
can also be injected at other areas surrounding the prostate, such
as area 1110 shown in FIG. 11.
[0082] The cryotherapy pretreatment device 1005 also has an
integral temperature sensor 1025 adjacent the distal tip 1020. In
an exemplary embodiment, the integral temperature sensor 1025 can
be a single temperature sensor or a set of spaced apart independent
temperature sensors (not illustrated) located and extending away
from the distal tip 1020. In such a configuration, when
pretreatment using CPS is finished, the cryotherapy pretreatment
device 1005 can be left at the prostatic plexus to place the
temperature sensor near the prostatic plexus and monitor
temperature at and/or near the CPS protective space. One exemplary
embodiment of a cryotherapy pretreatment device 1005 with an
integral temperature sensor 1025 has the temperature sensor as a
fiberoptic sensor(s) having a hollow injection channel with a
distal injection port. The sensor(s) is(are) used to determine
temperature of the area around the prostatic plexus during the
cryotherapy procedure. During the cryotherapy procedure, the freeze
ball will penetrate through the capsule of the prostate and then
encounter the CPS 1105. Because the CPS 1105 surrounds the nerves
1207 (as well as the vessels 1205, 1206), these structures will be
protected and preserved. Additionally, because the cryotherapy
pretreatment device 1005 has an integral injection channel, any
sensing of lowered temperature beyond a pre-set floor can be
counteracted by manually or automatically placing more CPS 1105 in
the target area.
[0083] At the termination of the procedure, the cryotherapy
pretreatment device 1005 is removed, its temperature monitor/sensor
having insured that the targeted tissue (e.g., nerves) have not
been exposed to temperature that would crystallize the respective
tissue.
[0084] In an exemplary embodiment, the cryotherapy pretreatment
device 1005 is approximately 6 mm or 18-French.
[0085] There are several different methods of injecting the CPS
1105. For example, the CPS 1105 can be injected using a standard
transrectal doppler ultrasound probe with a guidance apparatus
attached to the probe. The transrectal doppler ultrasound probe
with the guidance apparatus is placed in the rectum prior to
initiating the cryosurgery. The neuro-vascular bundle 1200 is
identified at its usual location, which is at the apex of the
prostate on both the right and left side of the prostate. An
injection needle, usually 22 gauge, is placed through the guidance
apparatus. Then the injection needle is guided to the space 1210
between the neuro-vascular bundle 1200 and the prostate. The CPS
1105 is injected through the needle, thus creating a protective
space between the neuro-vascular bundle 1200 and the prostate. This
process is performed on both the right and left sides of the
prostate. Afterwards, the cryosurgical procedure can be initiated
in the usual fashion.
[0086] Alternatively, the cryosurgical procedure can be initiated
first. In this exemplary method, a cryogrid (e.g., template 100) is
attached to a stabilizing device. The grid has holes that are used
to stabilize both the cryoprobes and the temperature sensors. The
cryogrid has both an X axis (letters) and a Y axis (numbers), which
gives every hole a specific coordinate. The exact coordinates of
the locations of both the cryoprobes and the temperature sensors
will vary from patient to patient depending on the specific
three-dimensional geometry of the prostate. A transrectal doppler
probe is placed in the rectum and attached to the same stabilizing
unit. The neuro-vascular bundles 1200 are identified using doppler.
A 20-gauge needle is placed through one of the holes in the grid
and is directed to the neuro-vascular bundles 1200 on one side of
the prostate. The CPS 1105 is injected in the space 1210 between
the neuro-vascular bundle 1200 and the prostate. If a temperature
sensor is provided at the distal end thereof, the needle is left in
a position to monitor the temperature of the CPS 1105 or adjacent
the neuro-vascular bundle 1200. This process is repeated for the
neuro-vascular bundle 1200 on the other side of the prostate.
Likewise, the CPS 1105 can also be injected at space between the
rectum and the prostate (Denonvilliers Fascia). The latter will
provide protection of the rectum from thermal injury.
[0087] By having a probe that contains both an injection port for
the CPS and thermal sensors alongside the neuro-vascular bundles
and the prostate, as well as in the space between the rectum and
the prostate, the operating surgeon has the advantage of knowing
the temperature of these critical spaces during cryotherapy, as
well as having the ability to inject more CPS if the temperature of
any becomes too low or if the space becomes too small. This probe
also can be repositioned if necessary without affecting the
surgical procedure. In an exemplary embodiment where the probe is
provided with multiple temperature sensors, the probe will have the
unique ability to measure the temperatures at multiple critical
locations (e.g., in the CPS and outside the CPS) in order to
prevent injury along the entire length of the neuro-vascular bundle
and/or the rectum. After this cryoprotection is performed, standard
cryoprobes are placed through the grid at the appropriate
coordinates to completely ablate the entire prostate or just the
cancerous lesions (focal therapy).
[0088] At the termination of the procedure, all of the probes are
removed and discarded. Doppler ultrasound is then used to document
the integrity of the neuro-vascular bundles by measuring blood
flow.
[0089] FIG. 13 is a block diagram of using the inventive systems
and methods to prevent the freezing of nerves in a neuro-vascular
bundle (e.g., prostatic plexus) during the removal of cancerous
cells from a prostate using cryotherapy. At block 1305, the
neuro-vascular bundle near the prostate is located. In one
exemplary embodiment, the neuro-vascular bundle(s) is(are) located
using doppler ultrasound. At block 1310, once the neuro-vascular
bundle(s) has(have) been found, the cryotherapy pretreatment device
1005 is placed trans-rectally alongside each neuro-vascular bundle
and, in particular, the cryotherapy pretreatment device 1005 is
placed alongside the nerves bilaterally.
[0090] At block 1315, the CPS is injected through the cryotherapy
pretreatment device 1005. The CPS (e.g., RTP or saline) can be
initially placed through the cryotherapy pretreatment device 1005
and alongside the nerves after an obturator is removed from the
needle. In an exemplary embodiment, the CPS can comprise RTP, an
anesthetic, and/or dehydrated cells such as dehydrated amniotic
tissue allograft membranes.
[0091] At block 1320, the cryotherapy pretreatment device 1005
positions the temperature sensor adjacent the bundle protected by
the CPS. In an exemplary embodiment, the temperature sensor is a
fiber optic sensor. It is noted that such temperature sensors are
valuable but are not required for use of the instant systems and
methods for cryotherapy protection.
[0092] At block 1325, a temperature of the area near the
neuro-vascular bundle is monitored using the sensor.
[0093] Steps 1305 to 1320 are repeated (indicated with dashed line)
for each area of tissue to be protected, which can include multiple
sites at a particular area of tissue.
[0094] At block 1330, cryotherapy begins and, if a preset
temperature limit is exceeded, then further CPS is injected to
prevent freezing. During the cryotherapy procedure, a freeze ball
produced by the procedure will penetrate through the capsule of the
prostate and encounter the CPS. If the CPS is RTP, the RTP gel will
liquefy and insulate the protected space from the damaging cold.
Due to the unique properties of the ethylene glycol and the
additional space created by injecting the RTP around the nerves,
these structures are preserved and are not damaged by the adjacent
cryotherapy procedure. Similar protection is provided by other
forms of CPS as described herein. The inventive probe is removed
once the cryotherapy procedure is terminated.
[0095] In an alternative embodiment where the cryotherapy
pretreatment device 1005 has a separate fiber optic sensor as the
temperature sensor, then, at block 1320, a catheter is threaded
through the cryotherapy pretreatment device 1005 to lay alongside
the neuro-vascular bundle.
[0096] Another exemplary embodiment of a method for protecting
tissue during cryotherapy includes placement of a bi-planer
trans-rectal doppler probe in a properly prepared rectum. Using
doppler ultrasound the nerves are identified by locating the
neuro-vascular bundles in both the sagital and transverse planes.
The CPS is prepared pursuant to the manufacturer's instructions, if
any. The cryotherapy pretreatment device 1005 (e.g., a 6-French
needle) is placed through a guidance apparatus. The cryotherapy
pretreatment device 1005 is guided to the/each neuro-vascular
bundle using doppler ultrasound. If RTP is the CPS, then
approximately 5cc of the RTP is injected alongside the
neuro-vascular bundle. This injection is repeated on the
contralateral side. The cryotherapy pretreatment device 1005 is
retracted and repositioned in a space between the prostate and the
rectum (Denonvilliers Fascia) if desired and approximately 5cc of
the RTP is injected into this space as well. The doppler ultrasound
probe is removed and the cryosurgical procedure is initiated in the
typical fashion. If desired, one or more cryotherapy pretreatment
devices 1005 have the integral temperature probes placed adjacent
or in tissue desiring to be protected and the temperature of those
tissues are monitored during the cryotherapy procedure. Upon
termination of the cryosurgical procedure, the neuro-vascular
bundles are rescanned to document acceptable blood flow and,
therefore, identify lack of injury.
[0097] Even though RTP has been described herein as the measures by
which insulation and physical protection of targeted tissue occurs,
saline, which could also contain an anesthetic, can be infused
alternatively and/or additionally during the protective
procedure.
[0098] It is noted that various individual features of the
inventive processes and systems may be described only in one
exemplary embodiment herein. The particular choice for description
herein with regard to a single exemplary embodiment is not to be
taken as a limitation that the particular feature is only
applicable to the embodiment in which it is described. All features
described herein are equally applicable to, additive, or
interchangeable with any or all of the other exemplary embodiments
described herein and in any combination or grouping or arrangement.
In particular, use of a single reference numeral herein to
illustrate, define, or describe a particular feature does not mean
that the feature cannot be associated or equated to another feature
in another drawing figure or description. Further, where two or
more reference numerals are used in the figures or in the drawings,
this should not be construed as being limited to only those
embodiments or features, they are equally applicable to similar
features or not a reference numeral is used or another reference
numeral is omitted.
[0099] The phrase "at least one of A and B" is used herein and/or
in the following claims, where A and B are variables indicating a
particular object or attribute. When used, this phrase is intended
to and is hereby defined as a choice of A or B or both A and B,
which is similar to the phrase "and/or". Where more than two
variables are present in such a phrase, this phrase is hereby
defined as including only one of the variables, any one of the
variables, any combination of any of the variables, and all of the
variables.
[0100] The foregoing description and accompanying drawings
illustrate the principles, exemplary embodiments, and modes of
operation of the invention. However, the invention should not be
construed as being limited to the particular embodiments discussed
above. Additional variations of the embodiments discussed above
will be appreciated by those skilled in the art and the
above-described embodiments should be regarded as illustrative
rather than restrictive. Accordingly, it should be appreciated that
variations to those embodiments can be made by those skilled in the
art without departing from the scope of the invention as defined by
the following claims.
* * * * *
References