U.S. patent application number 13/624841 was filed with the patent office on 2013-10-03 for non-invasive and minimally invasive and tightly targeted minimally invasive therapy methods and devices for parathyroid treatment.
The applicant listed for this patent is Alan N. Schwartz. Invention is credited to Alan N. Schwartz.
Application Number | 20130261368 13/624841 |
Document ID | / |
Family ID | 47914934 |
Filed Date | 2013-10-03 |
United States Patent
Application |
20130261368 |
Kind Code |
A1 |
Schwartz; Alan N. |
October 3, 2013 |
NON-INVASIVE AND MINIMALLY INVASIVE AND TIGHTLY TARGETED MINIMALLY
INVASIVE THERAPY METHODS AND DEVICES FOR PARATHYROID TREATMENT
Abstract
Systems and method for treating organic tissue of a patient's
body in precisely controlled regions of the body such as the
parathyroid glands. The systems and methods include introducing an
energy or substance into contact with target tissue to control
functionality of the target tissue and preventing the energy or
substance from contacting surrounding non-target tissues
sufficiently that functionality of critical non-target tissues is
substantially not affected.
Inventors: |
Schwartz; Alan N.; (Edmonds,
WA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Schwartz; Alan N. |
Edmonds |
WA |
US |
|
|
Family ID: |
47914934 |
Appl. No.: |
13/624841 |
Filed: |
September 21, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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61538708 |
Sep 23, 2011 |
|
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|
Current U.S.
Class: |
600/1 ; 600/9;
601/2; 607/2; 607/88; 607/96 |
Current CPC
Class: |
A61B 2018/00863
20130101; A61B 2018/00994 20130101; A61B 18/06 20130101; A61B
2218/002 20130101; A61N 1/00 20130101; A61N 2/004 20130101; A61B
2018/0022 20130101; A61B 2018/00577 20130101; A61B 2018/0262
20130101; A61M 2025/0046 20130101; A61B 2018/00708 20130101; A61B
2018/00017 20130101; A61B 2018/0293 20130101; A61N 1/406 20130101;
A61B 2018/1472 20130101; A61B 2018/00279 20130101; A61B 2090/3966
20160201; A61N 5/00 20130101; A61B 2018/044 20130101; A61B
2018/00613 20130101; A61B 18/1477 20130101; A61N 5/1027 20130101;
A61B 2018/00839 20130101; A61M 25/0068 20130101; A61B 2017/00743
20130101; A61B 2090/378 20160201; A61N 7/02 20130101; A61B
2090/3908 20160201; A61B 2018/00428 20130101; A61B 2018/00702
20130101; A61B 2018/00642 20130101; A61B 2018/00791 20130101; A61N
2007/025 20130101; A61B 2018/00196 20130101; A61B 18/02 20130101;
A61B 2018/00875 20130101 |
Class at
Publication: |
600/1 ; 600/9;
607/2; 607/88; 607/96; 601/2 |
International
Class: |
A61N 1/00 20060101
A61N001/00; A61N 2/00 20060101 A61N002/00; A61N 5/00 20060101
A61N005/00 |
Claims
1. A method for treating a target tissue, comprising: locating the
target tissue within a patient's body, the target tissue having a
perimeter and surrounding non-target tissue; positioning a delivery
device relative to the target tissue such that the delivery device
is configured to deliver to the target tissue within the perimeter
a predetermined quantity of at least one of energy or substance
sufficient to control a hormonal function of the target tissue
without delivering the predetermined quantity of the at least one
of energy or substance to the surrounding non-target tissue; and
delivering the predetermined quantity of at least one of energy or
substance to the target tissue.
2. The method of claim 1, further comprising: positioning an
insulation device relative to the surrounding non-target tissue;
and insulating the surrounding non-target tissue to prevent the at
least one of energy or substance delivered to the surrounding
non-target tissue from exceeding the predetermined quantity.
3. The method of claim 1, wherein the energy comprises at least one
of electromagnetic energy, kinetic energy, vibrational or
mechanical energy, thermal energy, cryotherapy, hyperthermia,
radiofrequency (RF) energy, microwave energy, infrared radiation
(IR), visible light, ultraviolet radiation, x-ray, gamma ray,
radioactive energy, brachytherapy, electric current, irreversible
electroporation, electrocautery, ultrasound energy, high intensity
focused ultrasound energy (HIFU), magnetic energy or forces, a
vacuum, positive and negative pressure energy or forces.
4. The method of claim 1, wherein the substance includes one or
more of solids, liquids, gels, plasmas, or gases.
5. The method of claim 1, wherein the target tissue comprises a
parathyroid gland and the non-target tissue comprises at least a
laryngeal nerve or a vagus nerve.
6. The method of claim 1, wherein positioning the delivery device
relative to the target tissue comprises: inserting at least one of
a percutaneous member, a subcutaneous member, or a conduit into the
patient's body; and transmitting the at least one of energy or
substance percutaneously or through an incision.
7. The method of claim 1, wherein positioning the delivery device
relative to the target tissue comprises: inserting at least one of
a percutaneous member, a subcutaneous member, or a conduit into the
patient's body; and transmitting the at least one of energy or
substance non percutaneously, laproscopically, angiographically,
endoscopically, or transcutaneously.
8. The method of claim 1, wherein: the delivery device has a
delivery surface area from which the at least one of energy or
substance is delivered; and positioning the delivery device
comprises positioning the delivery surface area completely within
the perimeter of the target tissue.
9. The method of claim 1 further comprising measuring the at least
one of energy or substance delivered to at least one of the target
tissue and the surrounding non-target tissue.
10. The method of claim 9, further comprising controlling the
amount of at least one of energy or substance delivered to at least
one of the target tissue and the surrounding non-target tissue in
response to the measured at least one energy or substance
delivered.
11. The method of claim 10, further comprising maintaining a
temperature of the surrounding non-target tissue below a
predetermined threshold temperature.
12. The method of claim 1, wherein locating the target tissue
comprises at least one of conducting a nuclear medicine study,
using an ultrasound device, using a magnetic resonance imaging
device, using a computed tomography device, or using a thermography
device.
13. The method of claim 1, wherein positioning the delivery device
relative to the target tissue comprises inserting a portion of the
delivery device into the target tissue.
14. The method of claim 1, further comprising monitoring at least
one physical characteristic of the patient as the at least one of
energy or substance is applied to the target tissue, wherein the
physical characteristic comprises at least one of parathyroid
hormone activity, temperature, calcium levels, ionizing calcium,
electrolytes, local temperature around the target tissue, nervous
function, characteristics of the larynx and associated innervation,
respiratory functions, sympathetic and parasympathetic (primary and
secondary) function, arterial flow, venal flow, brain function,
cardiac functions, blood pressure, chromography, and vital,
hormonal, and physiologic measurements, signs and symptoms, and
biological functions.
15. The method of claim 1, wherein the target tissue comprises a
parathyroid gland and the surrounding non-target tissue comprises
neural tissue.
16. A device for delivering at least one of energy or substance to
a target tissue within a patient's body and for insulating
surrounding non-target tissue from contact with the energy or
substance, the device comprising: a delivery device configured to
deliver a predetermined amount of at least one of energy or
substance to a target tissue within the patient's body; and an
insulator positioned around at least a portion of the delivery
device, wherein the insulator is configured to insulate the
surrounding non-target tissue from at least one of the energy or
substance delivered by the delivery device.
17. The device of claim 16, further comprising at least one
measuring device configured to measure the at least one of energy
or substance delivered to the target tissue near the target
tissue.
18. The delivery device of claim 17, further comprising a
controller configured to control the amount of at least one of
energy or substance delivered to the target tissues and to the
non-target tissues in response to the measured energy.
19. The device of claim 18 wherein the insulator comprises one or
more physical, substance, or energy inhibitor to at least one of
energy transmission or substance delivery.
20. The device of claim 16, wherein the insulator is adjustable to
vary at least one of the intensity, duration, direction,
periodicity or frequency of application of the at least one of
energy or substance.
21. The device of claim 16, wherein: the delivery device comprises
an elongated member or conduit having a proximal end and a distal
end; and the insulator comprises a sheath or guide extending
substantially along the delivery device between the proximal end to
the distal end of the delivery device.
22. The device of claim 16, wherein the device further comprises a
second insulator positioned between the insulator and non-target
tissue to inhibit the at least one of energy or substance from
transferring from the target tissue to the non-target tissue.
23. The device of claim 22, wherein the second insulator is
positioned between a portion of the target tissue that receives a
high concentration of the at least one of energy or substance from
the delivery device.
24. The device of claim 16, wherein the delivery device is
configured to deliver energy in the form of at least one of
electromagnetic energy, kinetic energy, vibrational or mechanical
energy, thermal energy, cryotherapy, hyperthermia, radiofrequency
(RF) energy, microwave energy, infrared radiation (IR), visible
light, ultraviolet radiation, x-ray, gamma ray, radioactive energy,
brachytherapy, electric current, irreversible electroporation,
electrocautery, ultrasound energy, high intensity focused
ultrasound energy and/or substance (HIFU), magnetic energy and/or
substance or forces, a vacuum, and positive and negative pressure
energy and/or substance or forces.
25. The device of claim 16, wherein: the delivery device has a
delivery area from which the at least one of energy or substance is
delivered; and the delivery area is smaller than the target
tissue.
26. The device of claim 25, wherein the delivery area is positioned
to contact a sufficiently small quantity of the non-target tissue
such that functionality of the non-target tissue is substantially
not affected.
27. The device of claim 16, further comprising at least one
treatment-inhibiting energy and/or substance delivery conduit or
member configured to deliver at least one of treatment-inhibiting
energy or substance to the non-target tissue.
28. The device of claim 16, wherein the target tissue comprises
parathyroid tissue.
29. The device of claim 16 wherein the predetermined amount of at
least one of energy or substance is sufficient to control hormonal
control of the target tissue.
30. A method of treating a target tissue without substantially
treating surrounding non-target tissue, the method comprising:
positioning a delivery device into operable proximity with the
target tissue of a patient's body; delivering at least one of
energy or substance to the target tissue through the delivery
device sufficiently to at least partially accomplish at least one
of modulate, activate, deactivate, neutralize, partially ablate,
fully ablate, damage, or modify the target tissue; monitoring the
quantity of the at least one of energy or substance at the target
tissue and surrounding non-target tissue; and adjusting the amount
of the at least one of energy or substance delivered through the
delivery device to maintain the energy or substance delivered to
the target tissue within a treatment range in which the treatment
is modulated, activated, deactivated, neutralized, partially
ablated, fully ablated, damaged, or modified and to maintain the at
least one of energy or substance delivered to the surrounding
non-target tissues outside the treatment range to maintain
viability of critical non-target tissue.
31. The method of claim 30, wherein: the treatment range is defined
in terms of temperature; and the treatment range includes 5 degrees
C. and below and 46 degrees C. and above.
32. The method of claim 30, further comprising: monitoring a
biological characteristic of the patient; and controlling the
amount of the at least one of energy or substance applied through
the delivery device as a function of the biological
characteristic.
33. The method of claim 32, wherein the biological characteristic
comprises at least one of parathyroid hormone activity,
temperature, calcium levels, ionizing calcium, electrolytes, local
temperature around the target tissue, nervous function,
characteristics of the larynx and associated innervation,
respiratory functions, sympathetic and parasympathetic (primary and
secondary) function, arterial flow, venal flow, brain function,
cardiac functions, blood pressure, chromography, vital, hormonal,
and physiologic measurements, signs and symptoms, and biological
functions.
34. The method of claim 30, further comprising insulating the
surrounding non-target tissue to prevent the at least one of energy
or substance delivered to the surrounding non-target tissue from
exceeding a predetermined threshold limit.
35. The method of claim 30, wherein the delivery device has a
delivery area sizeable relative to the target tissue such that
delivering the at least one of energy or substance to the target
tissue from the delivery area modulates the functionality of the
target tissue and does not substantially affect surrounding
non-target tissues.
36. The method of claim 30, further comprising controlling
biological functions of the target tissues by applying the at least
one of energy or substance to the target tissue.
37. The method of claim 30, further comprising at least one of
modulating, activating, deactivating, neutralizing, partially
ablating, or fully ablating at least a portion of the target tissue
without modulating, activating, deactivating, neutralizing,
partially ablating, or fully ablating any significant portion of
the non-target tissue.
39. The method of claim 30 wherein delivering at least one of
energy or substance comprises controlling hormonal function of the
target tissue.
40. The method of claim 30 wherein the target tissue comprises
parathyroid tissue
Description
PRIORITY CLAIM
[0001] This application claims the benefit of U.S. Provisional
Application No. 61/538,708 filed on Sep. 23, 2011, the subject
matter of which is incorporated herein by reference in its
entirety.
COPYRIGHT NOTICE
[0002] A portion of this patent document contains material that is
subject to copyright protection. The copyright owner does not
object to the facsimile reproduction of the patent document as it
appears in the U.S. Patent and Trademark Office patent file or
records but otherwise reserves all copyright rights whatsoever.
FIELD OF THE INVENTION
[0003] The present invention relates generally to medical devices,
methods and systems, and in particular for the treatment of
parathyroid glands and parathyroid-based diseases, such as
hyperparathyroidism, hypoparathyroidism and hypercalcemia
BACKGROUND OF THE INVENTION
[0004] In the human body there are four small parathyroid glands.
Each gland typically weighs about thirty 30 to forty 40 mg and is
located near the thyroid. The cells of the parathyroid glands
release parathyroid hormone, which helps maintain serum and bone
calcium homeostasis in the body. The two upper parathyroid glands
are usually located adjacent to the posterior surface of the upper
or middle part, of the thyroid lobe, just anterior to the recurrent
laryngeal nerve as it enters the larynx. The two lower parathyroid
glands are usually found on the lateral or posterior surfaces of
the lower part of the thyroid gland or within several centimeters
of the lower thyroid pole.
[0005] The thyroid gland generally receives innervations from both
the sympathetic and parasympathetic divisions of the autonomic
nervous system. The sympathetic fibers arise from the cervical
ganglia and enter with blood vessels and the parasympathetic fibers
arise from the vagus and reach the thyroid gland via branches of
the laryngeal nerves. The parathyroid and thyroid glands relation
to the recurrent laryngeal nerves and to the external branch of the
superior laryngeal nerves is of major surgical significance because
damage to these nerves can lead to a disability of phonation. Based
on the close anatomic association of the thyroid and parathyroid
glands, it is assumed that the parathyroids are innervated in a
manner similar to that of the thyroid.
[0006] Disorders of the parathyroid gland include
hyperparathyroidism, hypoparathyroidism, osteoporoses, as well as a
myriad of other diseases. Primary hyperparathyroidism exists when a
disorder of parathyroid tissue itself, or a "primary defect,"
results in the release of excessive amounts of Parathyroid hormone.
Among the known causes of primary hyperparathyroidism, as well as
examples of primary defects, are parathyroid adenoma, hyperplasia
and carcinoma. Parathyroid adenomas and hyperplasia and carcinomas
can all overproduce parathyroid hormone or precursors or active
components of the parathyroid hormone. Secondary
hyperparathyroidism is usually a reactive parathyroid hyperplasic
phenomenon accompanying renal failure. Symptoms of secondary
hyperparathyroidism can include nephrolithiasis, bone disease,
peptic ulcer, fatigue, muscle aches, depression and hypertension.
Untreated hyperparathyroidism can result in loss of bone mass due
to hypercalcemia resulting from excessive levels of circulating
Parathyroid. A high level of Parathyroid causes unbalanced
osteoclastic bone reabsorption that can lead to multiple foci of
bone destruction, osteitis fibrosa cystica, or von Recklinghausen's
disease of bone. Excess parathyroid hormone is one of the leading
causes of osteoporosis and it is a primary cause of kidney
stones.
[0007] Current treatment for primary hyperparathyroidism generally
involves surgical removal or resection of all or part of the
abnormal parathyroid tissue. However, parathyroid surgery
(parathryoidectomy) requires exceptional skill because the
parathyroid glands are notoriously variable in location and
intimate knowledge of the intrathroidal, retroesophageal, lateral
neck, and mediastinum anatomy is required. Accordingly, a number of
preoperative tests are usually performed to better define the
position of the abnormal gland or glands, including but not limited
to: thallium-technetium subtraction scans, ultrasound, selective
venous sampling, computed tomography (CT), magnetic resonance
imaging (MRI), scintigraphy with technetium-99m sestamibi
(sestamibi scanning), and arteriography. Despite this, many
parathyroidectomies fail due to failure to localize the parathyroid
on diagnositic examinations or because of surgical failure to
identify and remove the dysfunctional parathyroid gland. Other
complications and attendant risks of surgical treatment of
hyperparathyroidism include excessive removal of parathyroid glands
tissue, hematoma, vocal cord paralysis, hypocalcemia, and
persistent hypercalcemia. Moreover, conventional surgical
techniques typically do not allow for the accurate partial removal
of abnormal parathyroid glands, thus, even when single glandular
disease is involved, a multiple glandular prathryoidectomy is
performed. Other parathyroid-based diseases include primary
hypoparathyroidism, which is caused by deficient Parathyroid
hormone secretions, and which in turn can cause low serum calcium
due to a lack of Parathyroid hormone mediated bone resorption and
calcium reabsorption by the kidneys. Symptoms of hypocalcemia can
include neuromuscular irritability and tetany. Intravenous calcium
is currently the treatment of choice for primary
hypoparathyroidism, but Parathyroid hormone replacement has also
been used to treat primary hypoparathyroidism. However, Parathyroid
hormone replacement therapy is costly and most clinicians lack
clinical experience with this treatment.
[0008] Therefore, what is needed are improved methods, devices and
systems for treating parathyroid-based or related diseases and
conditions. The present invention is directed to meeting these, as
well as other, needs.
SUMMARY OF THE INVENTION
[0009] Accordingly, the invention provides methods, devices and
systems to treat various parathyroid-based diseases, including but
not limited to calcium metabolism, hyperparathyroidism,
hypercalcemia, osteoporosis and the secondary effects related to
the balance of parathyroid hormone and its active elements.
[0010] In an alternative embodiment, the invention provides methods
for the controlled partial or complete ablation of one or more
parathyroid glands.
[0011] In an alternative embodiment, the invention provides a
method for controlling the function of the parathyroid function.
The parathyroid gland can include but is not restricted to the
parathyroid tissue and cells, parathyroid vasculature, parathyroid
nerves and the parathyroid local tissue.
[0012] Controlling the parathyroid gland function can include but
is not restricted to ablating or destroying function or tissue of
part or all of the parathyroid gland and can include methods for
increasing or decreasing or modulating the function of the
parathyroid gland, which can include but is not restricted to
altering the release or function of the parathyroid hormone.
Controlling the parathyroid gland function shall be referred to as
treating the parathyroid gland.
[0013] Although the use of minimally invasive therapy (MIT) has
been used to kill and treat aggressive or malignant tumors that
arise or metastasize to many organs, the use of MIT to treat
hyper-functioning glands has been limited but has been limited
predominantly to the thyroid gland. Ethanol (alcohol) percutaneous
injections have been used to ablate the parathyroid gland.
[0014] Some MIT devices include but are not restricted to
Radiofrequency ablation (RF) and microwave (MW) and laser (L),
Cryotherapy (CryT), Hight Intensity Focused Ultrasound (HIFU),
Radioactive Therapy (Brachytherapy: BrT), Irreversible
Electroporation (IRE), Electrical Current Therapies,
Electrocautery, Medication delivery, Medication packets, blood flow
reduction, Chemical and Medication Ablation, Activation and
Deactivation and Modulation Therapy, Adhesives and Glues and
Molecular Crystal and Lattice therapies, Target Tissue Delivery
Device Therapies, Peptide and Biological Conversion Therapies, MR
and RF and Magnetic External Heating Therapies, Hyperthermia with
Adjuvant Therapy, Hypothermia with Adjuvant Therapy, Local
protective therapy in the Vicinity of the Target Organ Therapy,
Suction and Expansion Therapy, Positive Pressure and Expansion
Therapy, Mechanical Ablation Therapy and Combinations of
Therapies.
[0015] The use of MIT for the parathyroid gland (Parathyroid gland)
has been limited. The use of alcohol ablation has been reported but
is of limited acceptance in part because the use and contact of
alcohol in biological tissue is extremely dangerous and is poorly
controlled. Any leakage of alcohol outside of the target organ,
which in this case is the Parathyroid gland can and will likely
permanently destroy or damage tissue with which it makes contact.
In the case of the parathyroid gland the tissue in the vicinity of
the Parathyroid gland can include but is not restricted to local
nerves such as the Vagus nerve and the Recurrent Laryngeal nerves
and vascular structures such as the Carotid artery and the Jugular
vein as well as local organ tissue such as the esophagus.
[0016] MIT other than alcohol (ETOH) is proposed as a method to
treat the parathyroid gland and hyperparathyroidism. In order to
make MIT most effective adjustments in the therapy are recommended
that achieve full or partial ablation of abnormal parathyroid
tissue or full or partial modulation of parathyroid tissue
function. This means that the MIT must have enough precision that
the targeted tissue such as the parathyroid tissue is treated
effectively and the local tissue is preserved. This will result in
the return of normal function to the parathyroid hormonal balance
while preserving and not damaging the local tissues such as the
nerves and arteries and organs that reside in the vicinity of the
parathyroid glands.
[0017] This more highly focused treatment is referred to as Tightly
Targeted Minimally Invasive Therapy (TTMIT). TTMIT has different
strategies and requires adaptation of present devices and energy
and treatment protocols and treatment delivery methods and patterns
of treatment.
[0018] Minimally invasive therapy often is directed to destroy
tissue such as malignant or aggressive tumors. One of the
objectives is also to damage the local healthy tissue adjacent to
the malignant or aggressive tumor. This is because the adjacent
macroscopically normal tissue often contains microscopic malignant
or aggressive tumor. This same approach is applicable to the heart
and MIT of aberrant nerves and conductive tissue that are
responsible for irregular heartbeats such as atrial fibrillation.
The discrete location of the nerves to be treated is often poorly
defined. As a result MIT is designed to create a penumbra of tissue
damage that extends into the interface between normal and abnormal
tissue.
[0019] The current invention and use of currently available MIT
devices and newly invented MIT devices are designed to limit the
damage or destruction or control or reduction of abnormally
functioning tissue of the Parathyroid gland and minimize or
eliminate the local tissue damage. The techniques and the use of
these MIT devices are designed to restrict the MIT to the
Parathyroid gland and reduce or eliminate the affects of MIT on
local tissue or tissue adjacent to the parathyroid gland. Some of
these techniques and uses will include but are not restricted to
ablation of the vessels serving the abnormal parathyroid by
restricting inflow and/or outflow of blood from the Parathyroid;
severing the neural connection to the Parathyroid gland; and
eliminating some or all of the functioning Parathyroid gland tissue
in the abnormal gland that is producing excess amounts of
Parathyroid gland hormone. Partial or controlled ablation of the
parathyroid glands will be an acceptable endpoint in some patients.
The parathyroid gland is fairly unique in the body. Since there are
four normal gland an individual gland can be destroyed partially or
full and normal parathyroid function can be preserved if at least
one normal gland remains. In addition, in some renal failure
patients all four glands can become abnormal. In those patients the
desired treatment is to remove three of the glands and preserve a
portion of the forth gland. Over time this gland can grow and
produce too much Parathyroid gland hormone. Ablation of a portion
but not all of the remaining Parathyroid gland will become the
objective in follow-up treatments. The desired outcome is not to
remove all parathyroid tissue from the body which is the objective
of malignant tumor removal, but rather the objective is to return
the body to normal endocrine function such as but not restricted to
returning the calcium blood levels and the parathyroid hormone
levels and the parathyroid hormone function back to normal levels
and to accomplish this some parathyroid tissue must persist in the
body.
[0020] Therefore unlike most MIT the treatment objective in the
Parathyroid gland is to be able to tightly titrate the ablation of
parathyroid tissue so that it is controllable such that either a
portion or all of the gland can be rendered non-functioning or
render at least one but less than four of the glands
non-functioning such that by treating one gland the local tissue is
not damaged and the other parathyroid glands are not damaged unless
treatment is directed specifically at that other specific
Parathyroid gland or glands.
[0021] The treatment of the parathyroid gland is unique because
most other hormone producing glands of the body are not
duplicative, more than one gland and most glands do not have a
local environment that contains such vital and neural and vascular
and organ tissue in such close proximity, where the margin of error
in treating that gland is as critical as that of the Parathyroid
gland.
[0022] Tightly Targeted MIT (TTMIT) could theoretically be used for
other hyper-functioning endocrine tissue and may be useful for
ablation of even malignant or aggressive tumor tissue that lies
near or adjacent to vital structures that cannot be damaged by a
penumbra of collateral damage that can be caused by MIT.
[0023] Even the thyroid gland which can develop hyper-functioning
nodules and which has been treated with MIT methods has very
different characteristics than the Parathyroid gland. If the
thyroid develops hyper-functioning nodules currently the treatment
has a much greater latitude for error and the destruction of the
local normal tissue surrounding that abnormal nodule is not a
significant issue because there is usually enough normal thyroid
tissue that is preserved that there is little to no negative effect
in destroying normal tissue and the fact that the abnormal nodules
are embedded in the normal thyroid protects the local neural and
vascular and organ tissue to a much greater degree than treatment
of the Parathyroid gland. The margin of error in the MIT of the
Parathyroid gland is smaller and less forgiving than that of the
thyroid and makes the objectives and treatment requirements very
different between the thyroid and parathyroid glands.
[0024] Also the parathyroid gland has a relatively unique blood
supply. The branch arteries and veins associated with Parathyroid
gland are dedicated to that gland and if these Parathyroid gland
vessels can be targeted specifically and ablated or coagulated or
reduced in function than the functional tissue of the parathyroid
can be manipulated and reduced in that specific Parathyroid gland
without damaging the other parathyroid glands and without damaging
the function of other local tissue or the local thyroid glands.
[0025] The Parathyroid gland is fairly unique because it is
encapsulated and has four stand-alone endocrine glands and one
parathyroid or even a portion of one parathyroid gland can be
adequate to produce enough parathyroid hormone to keep the body in
parathyroid hormone normal homeostasis. Therefore, tightly targeted
MIT with a smaller or no penumbra of collateral damage is the goal
and is optimal for the Parathyroid gland but is less desirable or
even not desired for the standard MIT used to treat aggressive
benign or malignant tumors, which are the primary focus of current
MIT treatment. Such TTMIT may even be less optimal for some other
endocrine hyper-functioning nodules or adenomas such as the thyroid
where the margins of the hyper-functioning nodules or adenomas
integrate themselves into the normal thyroid tissue than it is for
the abnormal parathyroid gland.
[0026] Other endocrine glands that can be hyper-functioning but in
which the preservation of normal functioning tissue is important
can include the adrenals and adenomas of the most superficial
cortical layer, the zona glomerulosa and its production of
mineralocorticoids (e.g., aldosterone); middle cortical layer, the
zona fasciculata and its production of glucocorticoids (e.g.,
cortisol); and the deepest cortical layer, the zona reticularis and
its production of weak androgens (e.g., dehydroepiandrosterone,
adrenosterone).
[0027] Non-endocrine tissue but tissue that is involved with the
production or stimulation or suppression of endocrine tissue can
include neural tissue such as the pituitary and adenomas of the
pituitary such as but not restricted to prolactinomas. Reduction of
the volume of the prolactinoma can both reduce the over-production
of prolactin and reduce the compression of normal pituitary tissue
which is compromised by the large size of the prolactinoma in the
sella which is a limited space and which reduces function of normal
tissue function in the pituitary of other hormone releasing factors
such as but not restricted to thyroid stimulating hormone, and
anti-diuretic hormone.
[0028] Lesions in the brain that are not malignant or aggressive
tumors can include but are not restricted to abnormal foci of
neural activity to include but not restricted to seizure foci,
aggressive behavior sexual and violent and verbal, and traumatic
memories such as memories creating post-traumatic stress disorder
and infectious foci could also be benefited by TTMIT.
[0029] Tissues that over produce hormones and peptides and
chemicals such as but not restricted to over-production of acid in
the stomach by chief cells, or insulin or glucagons as related to
the pancreas could be treated with TTMIT.
[0030] One goal of TTMIT is return to normal function such as but
not restricted to hormonal return to normal function of parathyroid
function. This can be achieved by functional reduction of hormone
producing cells such that ablation or modulation of the tissue
preserves vital normal function but eliminates the excess or
non-vital function especially in hormonal or peptide producing
tissues. It can also be the return of normal function of other
tissues such as neural tissue and remove or reduce the presence of
damaged tissue such as but not restricted to seizure foci or
destructive memories such as but not restricted to traumatic
memories. TTMIT is designed for pinpoint or more restricted and
controlled ablation or down-regulation or decrease in cell function
without creating larger zones of collateral damage.
[0031] Currently, most MIT is designed to fully ablate the tissue
target and often is designed to ablate a margin of tissue often 5
to 10 mm beyond the primary target.
[0032] The parathyroid is unique in that the fact that there are
four parathyroid glands that control calcium metabolism through the
parathyroid hormone. When the parathyroid glands develops
dysfunction, in general one or two glands become abnormal. TTMIT
can be used to treat the abnormal gland and reduce the amount of
abnormal tissue. With renal failure there can be up to four glands
that become abnormal and TTMIT can be used to control abnormal
hormonal secretion and can replace the use of Sensipar, which is a
pharmacologic method for treating hyperparathyroidism and can
replace surgery in which 4 glands need to be surgically approached
which can lead to hypoparthyroidism. The preferred embodiments can
to be used for treating the parathyroid gland and controlling
excess chemical peptide or hormonal secretion. In other
embodiments, the current treatment can be used to control excess
secretion of other hormone or peptide or chemical secreting organs.
The parathyroid glands are relatively unique compared to most
peptide or hormone secreting organs because of their multiplicity
and their tendency to become hyperplastic or adenomatous and offers
an opportunity to control function.
BRIEF DESCRIPTION OR FIGURES
[0033] FIG. 1 is a frontal view, anatomic rendering of the thyroid
and parathyroid glands in the anterior mid neck.
[0034] FIG. 2 is an isolated view of the parathyroid gland.
[0035] FIG. 3 is a rendering of a device that can be used to
penetrate the skin and the subcutaneous tissue to reach the
parathyroid gland.
[0036] FIG. 4 is a rendering of a guiding device with a blunt end.
Inside of the guiding device is a tube/conduit that can have one or
more than one channel.
[0037] FIG. 5 is a rendering of a guiding device penetrating the
parathyroid tissue. In one embodiment the tube can be a needle can
have a thread-like configuration that penetrates the parathyroid
with a screw-like motion or mechanism.
[0038] FIG. 6 is a rendering of a guiding sheath penetrating the
parathyroid gland 30. There can be an additional tube or additional
guiding sheaths, and these conduits can provide for the passage of
a device and the guiding devices can serve multiple functions to
include but not restricted to insulation for the local tissue and
delivery of a substance to the target tissue.
[0039] FIG. 7 is a rendering of a guiding device penetrating the
parathyroid tissue. There can be an additional tube or guiding
device, and these conduits can provides for the passage of a
substance and can serve multiple functions to include but not
restricted to insulation.
[0040] FIG. 8 is a rendering of one embodiment of a transcutaneous
energy delivery device for ablating one or more parathyroid glands,
which can contain a passageway or conduit through the transducer
for the transport of a solid or hollow tube or device or probe or
an additional conduit device. The passageway device through the
transducer can be built into or separate from the transducer.
[0041] FIG. 9 is a rendering of a transcutaneous device and one or
more tubes or devices or delivery systems or conduits such as a
needle or probes that can penetrate the skin and subcutaneous
tissue to reach and can penetrate the target tissue and its
vascular supply and nerves to treat the target tissue, parathyroid
gland, or non-target tissue in the vicinity of the target
tissue.
[0042] FIG. 10 is a sagittal cross-sectional rendering of the
thyroid 20 and a normal superior parathyroid gland, target tissue
and an abnormal inferior parathyroid gland. The trachea lies
adjacent to and posterior to the thyroid and the two parathyroid
glands. A delivery device can include or not include a sensor
sensitive delivery device that can protect the non-target vicinity
tissue and modulate treatment to the target tissue.
[0043] FIG. 11 is a tube or conduit or needle percutanueously
depositing a substance/s, which in the preferred embodiment can
include in standard radioactive seeds for brachytherapy. THE
delivery system can include a needle with a stylet with
interlocking grooves or thread and a method and device for
governing the transit of the stylet and needle for the delivery of
the brachytherapy or non-brachytherapy substances.
[0044] FIG. 12 is an example of a device that can utilize but is
not restricted to electromagnetic or kinetic or thermal or
mechanical energy or methods. The device can be composed of an
elongated member that can a distal component that can deliver the
treatment such as an RF or microwave or laser probe and a second or
component which can be located more proximal to the distal
component that is insulated or prevents the deposition of treatment
to the tissue that is more proximal to the distal component that
can deliver the treatment. Sensors and controls and generators and
feedback mechanisms and loops can be used to regulate treatment to
both the target tissue, parathyroid gland and the local vicinity
tissue.
[0045] FIG. 13 is an embodiment of one or more a tubes or conduits
such as a needle or guiding sheath and each can contain one or more
channels or lumens that extend through at least a portion of or the
entire length of the tube or conduit and can be used to biopsy or
deliver treatment to the target tissue, parathyroid gland, or the
local vicinity tissue. Sensors can be used or be a component of the
tubes or conduits.
[0046] FIG. 14 is an embodiment of a percutaneous device and a
guiding tube that can combine hot thermal and cold thermal energy
for treatment. The combination of differing thermal elements can be
switched on and off to control the precise temperature, and the
device can include a sensing device.
[0047] FIG. 15a is an embodiment of a treatment delivery device to
include but not restricted to a laser, RF, or microwave probe that
can have an energy delivery probe component and an insulating
component that can be fixed or not fixed. In this embodiment an
insulated guiding tube or conduit can assist in altering the energy
delivery. FIG. 15b is an embodiment where the relationship of the
energy delivery device or probe component and the insulating
component and the guide are not fixed and the length or surface
area of the treatment device can be increased and/or decrease which
is done in FIG. 15b is done by rotating or advancing or retracting
or any combination of movements of the insulation or the guide or
the treatment device relative to the each other. In FIG. 15c on
embodiment can include a laser treatment device and two conduits
that contain openings that can include but are not restricted to
slits or holes that serve as fenestrations or windows to the laser
light. When the conduit fenestrations are not aligned the amount of
light or heat escaping the two conduits and reaching the target
tissue is more limited than when the fenestrations are aligned.
[0048] FIG. 16 is an embodiment in which a percutaneously placed
treatment device resides within the target tissue, parathyroid
gland and one or more tubes/conduits/catheters or needles or
devices can be placed into the local vicinity tissue and can
introduce a substance or energy, which can include but is not
restricted to Dextrose 5% water that is chilled prior to
instillation or chilled after or during instillation from a thermal
treatment device, which can include but is not restricted to a
thermal probe or a cooling needle that can include cold or heat and
can be infused or placed into the local vicinity tissue and can
serve as a heat-sink to protect the local vicinity tissue if heat
is the primary thermal treatment to the target tissue or can
include warming to protect the local vicinity tissue if cryotherapy
is the primary thermal treatment to the target tissue.
[0049] FIGS. 17a,b is a simplified diagram of the zone of ablation.
The treatment device is placed into the target tissue and a central
area adjacent to the probe or treatment device is irreversible
ablated. In the MIT there are multiple zones of ablation that are
of intermediate or partial damage to the vicinity tissue beyond the
target tissue and extending into the vicinity or local non-target
tissue. With TTMIT the energy deposition or the substance
deposition or the local protective treatment are designed to reduce
the vicinity or local non-target tissue to as minimal an area as
possible even possible at the reduced effectiveness of the
treatment of the target tissue. FIG. 17a demonstrates MIT with a
zone of ablation that that affects both the parathyroid target
tissue and the vicinity tissue whereas, with FIG. 17b TTMIT only
the parathyroid gland is ablated.
[0050] FIG. 18a is an embodiment of one probe or device or FIG. 18b
multiple probes within the target tissue 1 parathyroid gland.
[0051] FIG. 19 a,b,c is a depiction of the temperatures of heating
and their destructive nature. This can be altered by the duration
of time that the target tissue is exposed to these temperatures and
is dependent on the size and location of the target tissue that is
being treated.
[0052] FIG. 20 is a delivery device that can include but is not
restricted to a tube or catheter or conduit, needle or guide that
can have side-holes or fenestrations of variable size that can be
greater in diameter proximal than distal or greater in diameter
distal than proximal or any combination of sizes of side-holes.
[0053] FIG. 21a is a tube or catheter or conduit, needle or guide,
which can have a variable sized distal end hole or the end of a
conduit can be closed and contain no end-hole and be closed at the
distal end. The conduits can be partially or fully composed of
insulation and the insulation can include but is not restricted to
insulation from electromagnetic, thermal, kinetic or mechanical
forces or energy. In one embodiment a laser energy delivery device
can reside within an insulator tube/catheter or conduit, which can
have a variable sized holes and can modulate or alter the lasers
effect upon the target tissue, including the parathyroid gland. In
FIG. 21b in one embodiment this can use side-holes or fenestrations
that can be of variable size and shape including geometric and
non-geometric and logarithmic and logarithmic paper shapes or
cut-outs on a logarimthic pattern and can include one or more than
one a tube/catheter or conduit, needle or guide, which can have a
variable sized distal hole and a guide or sheath that is closed at
the distal end and in Figure and these insulating tubes or conduits
can move or rotate to expose greater or lesser amounts of the
energy treatment or substance for treatment to the target tissue,
parathyroid gland. This embodiment can include a laser treatment
device and two conduits that contain openings that can include but
are not restricted to slits or holes that serve as fenestrations or
windows to the laser light. When the conduit fenestrations are not
aligned the amount of light or heat escaping the two conduits and
reaching the target tissue is more limited than when the
fenestrations are aligned. This can also be organized on a
logarithmic graph pattern with cut out slits that can tightly
control the amount of light that is emitted to the target
tissue.
[0054] FIG. 22 is a device that delivers a substance to the target
tissue, the parathyroid or the vicinity tissue. The substance is a
substance that can modulate the function of the target tissue, the
parathyroid. The device can include a pump and sensor that responds
to physiologic parameters and the substance delivered can activate
or deactivate the target tissue.
[0055] FIG. 23a is a target tissue marker or localizing device that
can be used to include but not restricted to a surgical marker or
localizing device, a percutaneous treatment marker or localizing
device or a transcutaneous treatment marker or localizing device.
The marker or localizing device can consist of a substance solid or
liquid or gel or gas such as but not restricted to methylene blue
and gentian violet, tattoo inks. In FIG. 23b is a fluorescent or UV
sensitive dyes, or fluorescein or in FIG. 23c an injected material
can be metal or a radio-opaque material or FIG. 23d radioactive
material or in FIG. 23e GPS device or an FIG. 23f LED device. The
marker or localizing device can be constructed to screw into the
target tissue.
[0056] FIG. 24a is a guide/wire/placement device 70, a stylet 57 or
a tube 52 or needle 58 that can leave a marker/localizing device 40
in the target tissue 1, parathyroid. In one embodiment the
marker/localizing device 40 can contain a transitional zone 45 that
contains a transitional state sensitive substance 99 that can be
converted from a solid or liquid/gel material that when exposed to
a substance 99 or an energy source such as but not restricted to
electromagnetic energy, kinetic or mechanical or thermal energy or
forces changes its state and can separate from the a more solid or
gel state to a state where the placement device 70 is separated
from the marker/localizing device 40. In one embodiment the
placement material and the transitional material and the
marker/localizing device can all be metallic and if energy 100 such
as an electrical current or a thermal force is transmitted though
the placement wire the transitional zone 45 will separate from the
marker/localizing device. In another embodiment the placement
device material 70 can be composed of a gel that when cold 96
remains solid but when heated 98 the transitional zone will melt or
dissolve after a given period of time and separate from the
marker/localizing device 40.
[0057] FIG. 24b is a placement device that can have groove/threads
66 that when turned or moved in the proper manner will
unthread.
[0058] FIG. 24 c is an embodiment where the gel can take on
crystalline characteristics and become more rigid or less rigid
when exposed to electromechanical or kinetic or mechanical
energy.
[0059] FIG. 24 d is an embodiment of a marker/localizing device 40
can be placed into the target tissue 1, the parathyroid gland 30
and the marker/localizing device can be attached to a continuous
filament/thread 38 that can be made of a material that can be
organic but not restricted to silk, cotton or hemp or inorganic
such as but not restricted to carbon filaments or metal.
[0060] FIG. 24e is an embodiment of a marker/localizing device 40
can be placed into the target tissue 1, the parathyroid gland 30
that can be changed in shape by and energetic or thermal energy or
substance 99 to include but not restricted to being straight to
pierce the parathyroid 30 target tissue 1 and can take on a shape
that creates resistance to being removed such as a corrugated
shape.
[0061] FIG. 25 is an embodiment in which a guide 50, guide wire 52,
wire/thread 53, placement device 70, a stylet 57 or a tube 52 or
needle 58 or hooks 60 or probes/tines/electrodes 94 can have
transitional physical characteristics similar to and can be
incorporated into the marker/localizing device but can also be used
separately without a marker or localizing device. FIG. 25a depicts
a stylet when exposed to cold becomes rigid and straight and when
exposed to a designated heat becomes flexible. FIG. 25b depicts a
hook that when exposed to cold becomes rigid and straight and when
exposed to a designated heat becomes flexible.
[0062] FIG. 26a is an insulated tube or catheter or conduit, needle
or guide, guide wire, wire or thread, placement device, or a
stylet, the insulation can be an insulation substance; in FIG. 26b
a chamber that can be filled with a substance that can insulate
including a vaccuum; or in FIG. 26c a substance that can circulate
substances to form a heat sink.
[0063] FIG. 27 is an embodiment in which a guide 50, guide wire 52,
wire or thread, placement device, a stylet or a tube or needle is
placed into of adjacent to the target tissue and hooks or
probes/tines/electrodes can be used to maintain the position of the
target tissue, parathyroid gland. In one embodiment FIG. 27a there
can be a form of positive pressure created inside the target tissue
1, parathyroid gland 30. In another embodiment FIG. 27b the
pressure exerted inside of the parathyroid can be negative
pressure.
[0064] FIG. 28 is an embodiment of a guide, guide wire, wire or
thread, placement device, a stylet or a tube or needle or hooks
that can be composed of a carbon-carbon or ceramic based structure
with a tensile strength that can be greater than, less than, or
equal to an equivalent or similar device with the standard metal
qualities for a similar use and that pierces the skin and
subcutaneous tissue can be composed of a cutting material that can
include but is not restricted to diamond or zirconium or hardened
metal and can include but are not restricted to the leading edge or
tip that has a sharpened cutting edge.
[0065] FIG. 29a is an embodiment in which a form of delivery
packets or agitating substance can be delivered percutaneously or
non-percutaneously and can be used to deliver a substance such as
medication to ablate the target tissue. In FIG. 29a the substance
delivered through the delivery packet does not require a second
substance or energy source for activation. In FIG. 29b the
substance delivered through the agitation substance or delivery
packet does require a second substance or energy source for
activation. In FIG. 29c the substance delivered through the
agitation substance or delivery packet does require a second
substance or energy source for activation and the energy source can
through a transcutaneous device such as but not restricted to
ultrasound.
[0066] FIG. 30 is an embodiment of a viewing screen or display. In
one embodiment the screen can be in the form of goggles or mask or
glasses. Data and images can be displayed on the screen or
projected from the goggles to the retina. The data can be
transmitted by hardwiring or by non-wire methods, such as but not
restricted to WI-FI. In addition, the goggles or mask or glasses
display can also protect a portion of the user's body or face from
harmful substances or from energy.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0067] In the current invention, methods for more pinpoint and
precise targeting without heating may be achieved by irreversible
electroporation (IRE) and this may prove an optimal method for
treating the abnormal Parathyroid gland. Methods for more pinpoint
and precise targeting with heating may be effectively used on the
Parathyroid gland using high-intensity focused ultrasound (HIFU).
IRE and HIFU as well as other MIT and TTMIT methods including but
are not restricted to MW, RF, L, CryoT, and chemical ablative
techniques, adjuvant therapy, chemo therapy or radiation or any
combination of these methods can be used in conjunction with but
not restricted to small local incisions or laparoscopy or
percutaneous needle placement in or near or adjacent to the tissue
such as but not restricted to the Parathyroid gland.
[0068] Ischemic ablation is a primary mechanism of Parathyroid
gland treatment. Thrombosing the arterial inflow leads to ischemia
and cell death, while eliminating venous outflow results in
Parathyroid gland interstitial tissue increased pressure and
resultant cell death by osmotic and toxic means and by secondary
ischemia and cell death if the Parathyroid gland intra-gland
pressure exceeds arterial inflow pressure. Ischemic ablation can be
achieved by using high-intensity focused ultrasound (HIFU). IRE and
HIFU as well as other MIT and TTMIT methods including but are not
restricted to MW, RF, L, CT, and chemical ablative techniques,
adjuvant therapy, chemo therapy or radiation or any combination of
these methods or methods described within this patent.
[0069] Strategies for optimally treating the parathyroid gland may
include but are not restricted to modifications of the antenna and
electrode and can include but are not restricted to changing
antenna and electrode length and changing insulation lengths,
limiting the maximal heating of the probe with longer durations of
the pulse, alternating pulses of short and long, creating a probe
in which the insulation or the electrode can be made to vary to be
shorter and longer, adjustments of the pulsing sequence with
feedback from the damage rendered to the gland or the heating or
the cooling in the vicinity tissue, enlargement of the electrode
face or tines, individually retractable tines or electrodes which
can adjust to target tissue shape and response to therapy of the
target tissue and the local vicinity tissue, alternating and
variable heating and cooling and a change and must frequently a
reduction in the ratio of heat or electromagnetic or kinetic energy
delivered to ablate the target tissue compared to heat or
electromagnetic or kinetic energy delivered in the tissue in the
vicinity of the target tissue.
[0070] One embodiment can include hooks to secure the parathyroid
gland and these hooks can be non-heat conducting and insulated or
heat conducting.
[0071] Direct and primary tissue destruction is another primary
mechanism of Parathyroid gland treatment. Mechanisms utilized to
directly destroy a cell can include but are not restricted to heat,
cold, chemical, osmotic, pressure and suction and mechanical,
electromagnetic including but not restricted to casing a current
through the tissue, and nuclear energetic destruction. Delivery and
treatment mechanisms can include but are not restricted to IRE,
HIFU, MW, RF, L, CryoT, chemical and adhesive and osmotic and
packet delivery systems can include but are not restricted to
liposomes and microbubbles and activated and deactivated materials
that can be deactivated or activated by a second substance or
treatment to include but not restricted to de-carboxylation and
de-methylization and activation and inactivation with
electromagnetic energy to include but not-restricted to visible
light and UV to control the degree of tissue damage in the target
organ and in the local environment. Other methods for modulating
tissue exposure to heat and can include but are not restricted to
exposing the tissue and the local tissue and non-target tissue to
cooling solutions such as but not restricted to chilled such as
chilled or frozen distilled water ionic solutions and non-ionic
solutions; ionic solutions such as but not restricted to saline,
non-ionic solution such as but not restricted to 5% Dextrose water
or distilled water.
[0072] In general heating for hyperthermic device have a heat and a
duration of exposure to that heat. Tissue damage can occur at heats
above 46 degrees C. for 60 minutes but other embodiments can
include but are not restricted to heating and duration to include
successful ablation of tissue at 70 degrees C. for 60 seconds as a
single exposure or two 70 degree C. exposures each for 30 seconds.
Generated power can include many different power generated setting
and another embodiment can include but is not restricted to 150
Watts producing 100 degrees for 10 minutes.
[0073] In another embodiment of radiofrequency ablation, a
high-frequency, alternating current with a wavelength of 460-500
kHz can be emitted through an electrode placed within the targeted
tissue Grounding pads applied to the patient's thighs complete the
electrical circuit. Deposition of radiofrequency energy results in
frictional heating from flowing electrons in cells near the site of
energy emission. When living human tissues are heated to more than
49.degree. C., cell death occurs within minutes. Temperatures in
excess of 60.degree. C. can cause immediate cell death. The cell
death is induced by the denaturation of proteins, which results in
the loss of enzymatic function, melting of cell membranes,
mitochondria function and destruction of cytoplasm. These events
result in direct cyto-destruction of the affected cells. Although
some cells are destroyed at temperatures less than 49.degree. C.,
other cells can survive temperatures approaching 49.degree. C.
Alternatively, when temperatures exceed 105.degree. C., cells boil,
releasing gas vapor and causing tissue charring. Gas and charred
tissue inhibit dispersion of radiofrequency energy, which decreases
the effectiveness of some heating and penetration of lethal energy
concentrations. Hence, radiofrequency ablation devices should
ideally induce prolonged heating of target tissue with temperatures
sustained between 50.degree. and 105.degree. C.
[0074] For percutaneous imaging-guided radiofrequency ablation, the
energy is delivered into the target tissue by means of needlelike
electrodes. Radiofrequency ablation electrodes can include but are
not restricted to a range in a diameter from 15 to 17 gauge. Each
of these devices uses a different strategy to maximize the size of
thermal ablation. In one example a system by Radionics can have an
electrode that can be shaped like a standard 17-gauge needle and
delivered as a single electrode or as a unit of three electrodes
arranged in a triangular cluster. The Radionics system increases
ablation lesion size by using two enhancements: electrode cooling
and pulsed energy delivery. The Radionics device consists of a
generator and a 14- or 15-gauge electrode with numerous retractable
tines, which are used to increase the area of ablation. The tines
are advanced into the area of treatment. The LeVeen system uses a
14-gauge electrode with 12 retractable tines that are advanced into
the area of treatment. Each device also uses a slightly different
approach to energy delivery and monitoring for thermal
destruction.
[0075] The theoretical maximum size of the treatment zone has been
calculated in vitro for radiofrequency ablation. In vitro, the
theoretical maximum size of the ablated area is two times the
length of the energy-emitting segment of the electrode for the long
axis of the treatment zone. The transverse axis maximum can be up
to two-thirds of the length of the long axis of the treatment zone.
In vivo, the treatment zone varies and is usually smaller than the
theoretical maximum. The maximum size of the treatment zone can be
increased by inducing ischemia or by treating devascularized
tissue. Alternatively, flowing blood, large fluid-containing
spaces, or circulating air can decrease the effective size of the
treatment zone. The available radiofrequency devices use generators
that deliver 150-200 W of energy.
[0076] These heating characteristics may vary from device to device
but the general principles of cell death apply to multiple forms of
treatment.
[0077] Calculating which treatment is optimal for the given target
tissue, such as the size and location of the Parathyroid gland
adenoma will require a case-by-case individual analysis. A
Parathyroid gland adenoma that is 30.times.12.times.18 mm and is
not near vital arteries or neural structures will need to be
treated with different wattage, and power and maximal heating and
time duration and number of applications or pulses of the treatment
than a Parathyroid gland adenoma that is 10.times.8.times.12 mm and
lies in close proximity to vital arteries or neural structures.
[0078] Thermal Ablation Therapies can include but is not restricted
to the following.
[0079] Thermal ablation requirements for benign tissue that
over-produce hormone such as but not limited to the parathyroid
gland differ from carcinomas and malignant behaving tumors because
if some functioning or over functioning cells remain this does not
pose a serious threat to the survival of the organism being
treated. One example is a parathyroid gland that is 90% ablated may
acceptable and may reduce Parathyroid gland hormone levels back to
a normal or acceptable range, whereas a 90% kill rate of malignant
or aggressive tumor cells would not be acceptable. In addition, if
a Parathyroid gland is found to be over-producing parathyroid
hormone after one treatment, then a second treatment can be
employed whereas that same strategy if applied to an organism with
malignant or aggressive tumors carries increased risk to that
organism when failing to eradicate malignant or aggressive tumor
malignant cells on the first treatment and thus is significantly
different and carries greater risk to an organism with a malignant
or aggressive tumor than the failure to eradicate some percentage
of cells in a benign tumor or mass or adenoma or non-malignant or
aggressive cell population. In fact, treatment of the Parathyroid
and other benign cells that are over-producing hormone may be
treated effectively if not more effectively with multiple
treatments, so as to limit or reduce the risk of damage to the
structures in the vicinity of the target tissue such as but not
restricted to the parathyroid gland. If multiple parathyroid
adenomas are present or if there is a mixture of parathyroid
hyperplasia and adenomas them treating the parathyroid adenoma
first and observing the organisms return to normal calcium
homeostasis and parathyroid gland production may warrant a `watch
and wait` policy and not demand any further treatment until the
organisms calcium homeostasis or parathyroid gland hormone levels
become abnormal. In summary, the treatment of benign parathyroid
tissue that is hyper-producing parathyroid hormone can be treated
with MIT such that the balance of aggressiveness of treatment is on
the side of caution and protection of non-target tissue whereas
with a malignant tumor the balance of aggressiveness is more
heavily weighted toward destroying the malignant or aggressive
tumor.
[0080] In one embodiment thermal ablation therapies can either
increase of decrease the temperature of the tissue being treated of
which the two basic strategies are cryotherapy and hyperthermic
therapy, respectively. These therapies induce cell cytotoxicity,
irreversible cell destruction and death and necrosis.
[0081] The parathyroid gland is unique in that parathyroid hormone
levels can return to normal in 10 to 30 minutes after effective
removal or treatment of the abnormal parathyroid tissue.
[0082] Hyperthermic therapies that induce cytotoxicity are believed
to begin at about 46 degrees Celsius (C) for about 60 minutes
within the tissue.
[0083] Thermal ablation therapies can include but are not
restricted to radiofrequency ablation (RF) and microwave (MW) and
laser (L) utilize an optimal temperature of 50 degrees C. and
heating of tissue to 50 to 54 degrees C. for 4-6 minutes is a
common endpoint for irreversible cytotoxicity. But higher
temperatures are generated by the RF or MW or L devices to include
100 degrees, such that the tissue adjacent to the device can
experience temperatures of 100 degrees C. which coagulates the
adjacent tissue and higher temperatures such as 105 degrees C. to
vaporize the adjacent tissue.
[0084] In the current invention heat-sinking can be used to reduce
local tissue damage. Heat-sinks from blood vessels reduce tissue
damage and reduce tissue temperature. Heat-sinking in the current
techniques is a drawback and reduces effectiveness of MIT. Or a
heat-sink can be created by but not restricted to bathing the
target tissue in cooler solutions. Also the target tissue can be
isolated or insulated from the non-target tissue. Or the target
tissue can be surrounded by a material that reflects or locks-in
the heat on the target but spares surrounding tissue such as but
not restricted to a heat-conducting material on the inside facing
the target and an insulating material on the outside facing the
local tissue to be protected.
[0085] Hypothermic or Cold Therapy or Cryotherapy (CryoT) can
include but is not restricted to:
[0086] In one embodiment hypothermic or Cold or Cryotherapy (CryoT)
is the treatment of tissue with lower than normal organic
temperatures. Temperatures below 0 degrees C. can create freezing
to target tissues. Temperatures of minus 20 to minus 40 degrees C.
represent the lethal isotherm although the temperatures often used
by cryothrapy devices range as low as minus 140 degrees C. inside
the iceball used for treatment or heat-sink of 9 kJ (kilojoules).
Many of the limitations such as clefts that exist with malignant or
aggressive tumor ablation are not relevant with Parathyroid gland
treatment. Needles and probes for treating the Parathyroid gland
can be small, as small as 13-gauge (2.4 mm) or smaller because of
the Parathyroid gland target requirements but larger probes with
size equal to or greater than 15-gauge (1.7 mm) probes may prove
effective in the Parathyroid gland. Cryoprobes are designed to
create a heat sink and gasses and materials such as but not
restricted to Argon, helium and nitrogen can be utilized.
[0087] In another embodiment the use of liquid materials such as
Nitrogen that cool when allowed to return to a gaseous state can
also be precutaneously delivered to the target organ such as the
Parathyroid gland.
[0088] Various cryoprobes exist that include but are not restricted
to reservoirs that contain coolant materials such as but not
restricted to nitrous oxide and needles that serve as heat-sinks
that can use but are not restricted to argon gas.
[0089] In one embodiment, the balloon portion of the catheter is
filled with a coolant which applies subzero Celsius temperatures to
tissue. In another embodiment the temperature can be less than
subzero or alternating temperatures of subzero, zero and above zero
can be applied to control the amount of damage to the target
tissue, such as but not restricted to the Parathyroid gland.
[0090] In another embodiment one or more probes can be used and
separated by a distance to maximize tissue death between the probes
but also taking into account the zone and radius of ablation.
[0091] Or the target tissue can be surrounded by a material that
reflects or locks-in the heat on the target but spares surrounding
tissue such as but not restricted to a heat-conducting material on
the inside facing the target and an insulating material on the
outside facing the local tissue to be protected.
[0092] Chemical and Medication Therapy can include but is not
restricted to the following.
[0093] In one embodiment ethanol has been used to ablate
parathyroid glands but the risk to local tissue damage such as the
neural and vascular and organ tissue is significant because of the
uncontrolled nature of injecting Ethanol because it denatures
living tissue.
[0094] In another embodiment methods whereby substances are
injected around the Parathyroid gland can include but are not
restricted to water, saline, weak bases such as but not restricted
to calcium or sodium bicarbonate can be used to dilute or the
tissue surrounding the Parathyroid gland can be neurtralized by
ethylene glycol or propylene glycol or glycerol or glycerine.
[0095] Other chemicals or sclerosants which have not been used but
may prove more effective because of their less toxic nature and
their greater capacity to be neutralized and can include but are
not restricted to acetic acid and other moderate and weaker acids,
weaker forms of alcohol or diluted forms of alcohol or other
sotradecol.
[0096] Substances that can be injected can be in the solid, liquid,
gel or gaseous states or can form a slurry or a mixture or
combination of the solid, liquid, gel or gaseous states. Other
substances may include but are not restricted to carbon monoxide,
saline or dextrose solutions that are saturated in a manner that
damages the target tissue which can also be optimized or
constructed or delivered to protect the non-target tissue.
[0097] In another embodiment the tissue adjacent to the target
tissue can be treated with a that is substance that is protective
or can dilute the non-target tissue environment and can include but
is not restricted to a the solid, liquid, gel or gaseous states or
can form a slurry or a mixture or combination of the solid, liquid,
gel or gaseous states and that substance is non-toxic and will
serve as an antidote or dilute or neutralize the effects of the
toxic substance injected into the target tissue such that if the
toxic substance leaks out of the target tissue or region the being
treated such as but not restricted to the Parathyroid gland. One
example is injecting carbon monoxide into the Parathyroid gland and
placing oxygen in the adjacent tissue. Another example is injecting
ammonia or urea into the target organ while flooding the adjacent
tissue with saline to dilute the effect of the ammonia or urea.
[0098] Substances that can be injected can be in the solid, liquid,
gel or gaseous states or can form a slurry or a mixture or
combination of the solid, liquid, gel or gaseous states. Other
substances may include but are not restricted to carbon monoxide,
saline or dextrose solutions that are saturated in a manner that
damages the target tissue. Also the tissue adjacent to the target
tissue can be treated with a substance that is in the solid,
liquid, gel or gaseous states or can form a slurry or a mixture or
combination of the solid, liquid, gel or gaseous states and that
substance is non-toxic and will serve as an antidote or dilute or
neutralize the effects of the toxic substance injected into the
target tissue such that if the toxic substance leaks out of the
target tissue or region the being treated such as but not
restricted to the Parathyroid gland. One example is injecting
carbon monoxide into the Parathyroid gland and placing oxygen in
the adjacent tissue. Another example is injecting ammonia or urea
into the target organ while flooding the adjacent tissue with
saline to dilute the effect of the ammonia or urea.
[0099] Other forms of chemicals for cauterizing tissue,
specifically blood vessels can include but is not restricted to
silver nitrate, Trichloroacetic acid and Cantharidin, an extract of
the blister beetle that causes epidermal necrosis and
blistering.
[0100] Electromagnetic therapy can include but is not restricted to
the following.
Radioactive (Brachytherapy)
[0101] Radioactive materials, brachytherapy, can be used to
percutaneously place electromagnetic energy into the target tissue
to modulate control of biological function in tissue that is
functioning in an aberrant manner. In one embodiment bachytherapy
can be used in an hyperactive Parathyroid gland. In one embodiment
the radioactive seeds can be implanted and left in place and the
isotope which uses a low dose of radiation (brachytherapy) with a
limited zone of radiation can be used and can include but is not
restricted to iodine-125 or palladium-103. In another embodiment a
high radiation dose isotope can be inserted into the Parathyroid
gland for a limited period and then removed and this can include
iridium-192 which would be inserted into the Parathyroid gland
percutaneously for less than 15 minutes. The dose is dependent upon
the size of the Parathyroid gland adenoma and the tissue in the
vicinity that may be sensitive to the irradiation. In the preferred
embodiment the radiation would be introduced through a percutaneous
guide and guiding system.
Radiofrequency Therapies
[0102] In one embodiment during Radiofrequency probe ablation an
electrical current oscillates through the ion channels that are
inherently present in biological tissue. Since biological tissue is
an imperfect generator of electrical current, frictional agitation
and heat are produced. This is known as the Joule effect. Tissue
heating is greatest nearest the probe and more distant tissue
receives a thermal conduction and thus heat drops off away from the
probe. Augmentation of the RF effect can be performed by increasing
the probe surface area, pulsing the input power and injecting
saline/ionic solutions.
[0103] RF ablation can use a single or multiple tines. The needles
can be insulated and cooled by water. Tines come in many shapes and
configuration and multiple gauge sizes approximating 14 gauge (2.1
mm) to 17 gauge (1.5 mm) For the purpose of the Parathyroid gland
gland smaller gauge probes, one or two tines and smaller tines may
provide a smaller and more controlled zone of tissue damage.
[0104] The multipolar or bipolar RF probe may prove more effective
than the monopolar probe in the Parathyroid gland. With the
multipolar and bipolar RF probe the current oscilates between the
two electrodes. Saline can be instilled within the Parathyroid
gland to augment the tissue damage between these two electrodes
each of which can be placed at the superior and inferior aspect of
the abnormal parathyroid gland while monitoring needle placement
using imaging guidance techniques to include but not restricted to
real-time ultrasound. Initially, levels of power begin in the 20 to
50 W range but may need to increase dependent on the impedance of
the tissue being treated and the adjuvant such as saline and ionic
solutions administered. Also by pulsing the generator the size of
the tissue lesion can be controlled. Since pulsing algorithms have
been shown to increase ablation zone size and decrease the time for
treatment, the Parathyroid gland gland may be better treated with
an algorithm that decreases the ablation zone and is less concerned
with treatment time.
[0105] RF can be applied in a unipolar or a bipolar or multipolar
fashion and the inter-electrode distances can vary depending on the
tissue and electrode characteristics (e.g. 5 mm, 10 mm) and the
size of the parathyroid target tissue. RF energies can vary (e.g
500 kHz) that are delivered to the target tissue to include but not
restricted to 100 J, 101-200 J, 201-300 J, 301-400 J, 401-500 J,
501-600 J, 601-1000 J, and >1000 J. Results of tissue damage
show that when RF energy is applied in a bipolar fashion, the
lesions are located between and around the electrode and when
applied in a unipolar fashion lesions were found in the
catheter/tissue interface. Bipolar mode increased the length of
ablation and can but is not restricted to allow for one treatment
pulse.
[0106] In another embodiment the tip of the electrode can be
varied. The larger electrode tip appears to create larger lesion.
Therefore depending on the size of the target tissue such as but
not restricted to the Parathyroid gland the size of the electrode
tip will be determined by the size of the needle desired for the
percutaneous approach with a gauge size of 21 (0.72 mm) being
optimal and a size as large as being 15 gauge (1.5 mm) approaching
the maximal size for safe percutaneous procedures. The electrode
tip may be limited by these parameters. In another embodiment a
bipolar or multipolar device can be used where the tines spread out
as they exit the percutaneous introducer.
[0107] In one embodiment anchors or fixation hooks can be employed
to stabilize the target tissue such as the parathyroid gland during
treatment.
[0108] In one example of target tissue ablation the RF energy
sufficient to maintain a highest temperature of 100.degree. C. can
be delivered for 8-10 minutes for each ablation. The impedance
values ranged from 30 to 60.OMEGA.. The diameters of the deployed
hooks varied between 1 and 3 cm, depending on the target tissue's
size and location. The temperature of each hook can be maintained
above 90.degree. C. For masses or lesions smaller than 2 cm in
diameter, the needle tip was placed in the center of the lesion and
the hooks were deployed to reach the deepest margin of the
malignant or aggressive tumor or lesion. One ablation was usually
enough to destroy the entire target tissue. For larger target
tissue, multiple overlapping ablations can be performed (range, two
to six ablations) according to the size and shape of the target
tissue.
[0109] With multi-tined probes a target zone of 3 m can be produced
by three tines 17 gauge spaced 5 mm apart at 200 w for 12 minutes.
This is likely greater than would be safe for a Parathyroid gland
even if it were 3 cm given the collateral zone injury that may
occur and decreased duration or energy would likely be indicated in
vivo for a large Parathyroid gland (3 cm).
Microwave Ablation
[0110] In one embodiment, in the biological system the term
microwave ablation describes electromagnetic energy typically at
either 915 MHz to 2450 Mhz, although microwave refers to
electromagnetic energy between 300 MHz and 300 GHz. If microwave
energy is continuously applied it can result in temperatures
>150 degrees C. in biological tissues. Antennas are needle like
or looped. Current biological systems in general are monpole,
dipole or slotted with the smallest gauge system being 13
gauge.
[0111] Microwave ablation refers to the use of all electromagnetic
methods for inducing lesion or tumor destruction by using devices
with frequencies of at least 900 MHz). Microwave radiation refers
to the region of the electromagnetic spectrum with frequencies from
900 to 2450 MHz. This type of radiation lies between infrared
radiation and radio waves. Water molecules (H2O) are polar; that
is, the electric charges on the molecules are not symmetric. The
alignment and the charges on the atoms are such that the hydrogen
side of the molecule has a positive charge, and the oxygen side has
a negative charge. Electromagnetic radiation has electric charge as
well; the "wave" representation is actually the electric charge on
the wave as it flips between positive and negative.
[0112] For a microwave oscillating at 9.2, 108 Hz, the charge
changes signs nearly 2 billion times a second (9.2 108 Hz). When an
oscillating electric charge from radiation interacts with water
molecule, it causes the molecule to flip. Microwave radiation is
specially tuned to the natural frequency of water molecules of the
parathyroid gland to maximize this interaction. As a result of the
radiation hitting the molecules, the electrical charge on the water
molecule flips back and forth 2-5 billion times a second depending
on the frequency of the microwave energy. Temperature is a measure
of how fast molecules move in a substance, and the vigorous
movement of water molecules raises the temperature of water.
Therefore, electromagnetic microwaves heat matter by agitating
water molecules in the surrounding tissue, producing friction and
heat, thus inducing cellular death via coagulation necrosis.
[0113] One embodiment can include but is not restricted to a thin
(14.5-gauge) microwave antenna is placed directly into the target
tissue, such as the Parathyroid gland. When the antenna is attached
to the microwave generator with a coaxial cable, an electromagnetic
microwave is emitted from the exposed, non-insulated portion of the
antenna. Each generator is capable of producing 60 W of power at a
frequency of 915 MHz and one such percutaneous microwave ablation
system (Vivant Medical, Mountain View, Calif.).
[0114] Different configuration exist for MW antennaes which include
but are not restricted to Tiaxial, Slotted and Choked. Given that
the Choked is 99% efficient and given its profile of ablation and
that it can be produced in 9-10 gauge antennaes this may prove the
current optimal antenna for the Parathyroid gland adenoma.
Laser Ablation
[0115] In one embodiment laser sources include but are not
restricted to neodymium-doped yttrium alunum garnet and
semi-conductor diodes that emit approximately 600-1000 nm
wavelength light energy. Laser may be ideal for the Parathyroid
gland ablation. Limitations and disadvantages that exist for lasers
with lesions and tumors and other tissue applications may prove
beneficial for the Parathyroid gland. Laser light is an efficient
and precise for tissue heating. Laser light when it strikes body
tissue becomes scattered and absorbed rapidly this causes lasers to
have limited energy penetration and thus produce smaller zones of
ablation (10 to 20 mm) than other devices. Light also does not
penetrate charred and damaged tissue. The Parathyroid gland
adenomas are commonly 15 mm or less making laser treatment ablation
optimal for the Parathyroid gland adenomas.
[0116] Medical lasers that can include but are not restricted to
CO2 lasers, diode lasers, dye lasers, excimer lasers, fiber lasers,
gas lasers, free electron lasers, and optical parametric
oscillators.
[0117] In one embodiment laser irradiation can be performed with a
1.064-nm Nd:YAG laser and variable wattage can include 2, 3, 5, or
7 W and total delivered energy of 500, 1,000, 1,500 or 2,000 J,
respectively. One or multiple illuminations can be performed.
Between 600 and 1600 J for a lesion of approximate size of 10 mm
maximal length may prove optimal for the Parathyroid gland of that
length but the treatment parameters will ultimately be dependent on
the actual size of the Parathyroid gland adenoma and its location
to vital neural and arterial structures. Low-energy output (2-5 W
per fiber) close to the implanted fiber tip, the temperature
exceeds 100.degree. C. and results in vaporization of the core of
the lesion. Laser advantages include a precise zone of tissue
damage.
Ultrasound Ablation
[0118] HIFU Ultrasound devises are greater than 13 gauge. HIFU can
be used to trascutaneously ablate lesions. One embodiment can
include but is not restricted to a 1.06 MHz HIFU transducer which
can be used over a treatment diameter of approximately
45.2.times.18 3-mm rectangular opening. The HIFU transducer was
spherically focused, with a 63 t 3 mm geometric focus, 64-mm active
diameter, and an 18.times.45-mm2 rectangular cutout to enable
coaxial placement of a linear array and the transducer can be
driven continuously at its operating frequency increasing uniformly
from 3.6 to 8.0 MPa at variable exposure durations (eg 2, 5, or 10
seconds). Typically the HIFU can generate temperatures between 65
and 85 degrees Celsius. Typical diagnostic ultrasound transducers
deliver ultrasound with time-averaged intensities of approximately
0.1-100 mW/cm2 or compression and rarefaction pressures of
0.001-0.003 MPa, depending on the mode of imaging (B-mode, pulsed
Doppler sonography, or continuous wave Doppler sonography). In
contrast, HIFU transducers deliver ultrasound with intensities in
the range of 100-10,000 W/cm2 to the focal region, with peak
compression pressures of up to 30 Mpa and peak rarefaction
pressures up to 10 MPa.
[0119] Electrical current therapy and Irreversible Electroporation
(IRE) and Electrocautery Therapy can include but are not restricted
to the following.
[0120] In one embodiment Irreversible Electroporation (IRE) may
prove the most effective means of treating Parathyroid gland
adenomas because it produces no excess heat. Cells are eradicated
by using several micro to millisecond pulses of electrical current
and generate fields up to 3 kV/cm, which irreversibly damage cell
membranes and generate apoptosis. IRE is little affected by heat
sinks and creates less damage to collagen tissue and nerves thus is
optimal for the Parathyroid gland which has the Recurrent Laryngeal
nerve and the Vagus in its close vicinity. IRE also can use a thin
19 gauge needle (1.1 mm) that is insulated, larger needles are also
available. A single needle bipole electrode is available or
multiple electrodes can be implanted. The electrical current can
involve high voltage pulses, which are less frequently applied or
lower voltage pulses which may require several hundred pulses.
[0121] Coagulation may be limited with IRE and this injection of
coagulation factors into the Parathyroid gland after the
application of IRE to the Parathyroid gland may be useful adjunct
medication.
[0122] In another embodiment an electrocautery device can be used
smilar to those used in surgery to cauterize blood vessels whereby
an electrical current heats the cautery device and the heated tip
is place on or in the Parathyroid gland and destroys the living
tissue, specifically this can be targeted to the blood vessels of
the Parathyroid gland and can cause electrocoagulation of the
Parathyroid gland blood vessels.
[0123] In another embodiment Electrocautery can be combined with
other treatment modalities to include but not restricted to
Irreversible Electroporation (IRE). IRE does not coagulate vessels
in the same manner as thermal methods of treatment and to decrease
the risk of bleeding from the target tissue such as but not
restricted to the parathyroid gland blood vessels, electrocautery
may be needed to control belleding.
[0124] Parathyroid Arterial Blood flow reduction can include but is
not restricted to the following.
[0125] In one embodiment injection of arterial and arteriolar
vasospastic agents such but not restricted to as epinephrine and
epinephrine-like medications can assist with MIT and TTMIT of the
Parathyroid gland. Additionally other pharmacologic agents designed
to reduce tissue perfusion can include but are not restricted to
halothane and arsenic trioxide and antiangiogenic therapies such as
but not restricted to sorafenib can be used in combination with
TTMIT or alone to treat Parathyroid gland adenomas. All the MIT and
TTMIT modalities can be used alone or in combination to control and
target the target tissue arterial and venous blood flow as the
primary or secondary site for resultant ablation.
[0126] Medication Carrying Packets Therapy can include but is not
restricted to the following.
[0127] In one embodiment medication agents can include but are not
restricted to organic or inorganic agents and pharmacologic agents
and biological agents can be carried in packages that can deliver
these agents to target tissues. This can include but is not
restricted to delivery through the bloodstream, CSF or through
catheters, or needles or other percutaneous methods.
[0128] Carrying packages can include but are not restricted to
liposomes which can include but are not restricted to mulilamellar
vesicles, small unilamellar and large unilamellar vesicles and
microbubbles which are bubbles smaller than a millimeter.
Microbubbles can be filled with perfluorocarbon or air or other
gasses or can be filled with other materials to include but not
restricted to medication agents and pharmacology agents and
biological agents. The microbubble shell can consist of but is not
restricted to lipids or proteins that can include but are not
restricted to serum albumin.
[0129] Carrying packets can be but are not restricted to being
sensitive to mechanical and vibration or electromagnetic energy
including but not restricted to UV or infrared or visible light
sensitvive or they can be temperature dependent (hyper or
hypothermic) exposure or pH or solids or they can be sensitive to
exposure to liquids or gasses or a combination of the above which
can cause the carrying packets to release the contents of the
carrying packet. This may allow the Parathyroid gland tissue to be
effectively treated with a lower energy deposition because the
carrying packet agent/s are augmenting the destruction of the
target tissue to include but not restricted to the Parathyroid
gland tissue, while allowing the local tissue to be exposed to an
energy dose below the local tissues threshold for damage.
[0130] In another embodiment microbubbles can be used to treat the
target tissue. The instillation of microbubbles into the target
tissue which can include but is not restricted to direct
percutanous instillation of the microbubbles into the target
tissue, the Parathyroid gland. Using mechanical or vibrational or
ultrasonic stimulation the microbubbles can interact with the
Parathyroid gland tissue intact or they can release their contents
and this process can modulate the ablation of the Parathyroid gland
tissue by either acting as a secondary adjuvant, or a repressor of
the primary treatment modality. In one example the microbubbles can
interact with the vibrational effect of ultrasound or HIFU and
augment the heating or destruction of the Parathyroid gland. This
may allow the target tissue to include but not restricted to the
Parathyroid gland tissue, to be effectively treated with a lower
energy deposition because the microbubbles are augmenting the
destruction of the tissue, while allowing the local tissue to be
exposed to an energy dose below the local tissues threshold for
damage. Microbubbles can be formed with various materials to
include but not restricted to galactose and other related organic
carbohydrates, proteins and fats as well as other organic and
inorganic compounds.
[0131] Activation and Deactivation and Modulation of the treatment
therapy or device can include but is not restricted to the
following.
[0132] In one embodiment medication agents can include but are not
restricted to electromagnetic and mechanical or kinetic energy and
organic or inorganic agents and pharmacologic agents and biological
agents can be modulated by either activating or deactivating the
agent using one or more additional modulating agents to include but
not restricted to electromagnetic energy such as but not restricted
to ultraviolet light, or radiation; kinetic or thermal energy to
include but not restricted to hyper-thermic delivery systems,
ultrasound energy or vibrational forces; cryotherapy or
hypo-thermic delivery systems; or liquids, fluids, gels or solids
that can include but are not restricted to medications or
solvents.
[0133] Light is a type of electromagnetic radiation and can be used
to activate and deactivate substances. This is a form of
photochemical reaction, and follows the Grothuss-Draper Law.
Photo/Electromagnectic and mechanical/vibration energy can can also
change the configuration of a molecule or molecular configuration
and change its properties enabling on otherwise inaccessible
molecule to become accessible (Woodward-Hoffman selection rules) or
creating an accessible molecule and making it inaccessible. Some of
the most widely used sections of the electromagnetic spectrum are
UV 100-400 nm, visible light 400-700 nm and Near Infrared 700-2500
nm. Examples of photo activation can include but are not restricted
to photosynthesis, Vitamin D conversion, bioluminescence, phenol
and tetraphenylporphorine, hydrocarbon solvents that use short
wavelengths and solvents containing unsaturated bonds that may
require higher wavelengths, cyclohexane, acetone and singlet oxygen
reactions in general. Cis and Trans rotations of the molecule that
can occur in alkenes. Other reactions can include mercaptans,
toluene-chlorine, and metallic reactions like UV irradiation of THF
solution of molybdenum hexacarbonyl. Transform a liquid into a
crystal can be used to alter the internal structure of the
Parathyroid gland. One reaction can include but is not restricted
to photolysis of iron pentacarbonyl. Also carbon nanotubes can be
placed into the target tissue and exposed to an intense pulsed
light from a laser or an arc lamp. This will produce combustion and
temperatures as high as 700 to 1500 degrees C. Another crystal
reaction can include alpha-snatonin when exposed to sunlight
wavelengths.
[0134] The electromagnetic source can include a multichromatic
light source such as mercury vapor lamps or monochromtic light
sources such as LED or Rayonet lamps.
[0135] Some activation examples can include but are not restricted
to ultraviolet activated persulfate oxidation of phenol in the
basic pH conditions. Carbon foam using a coal tar pitch as a
precursor can serve as a support for titanium oxide for the
catalytic degradation of phenol. Activation of medications with
electromagnetic energy or mechanical energy from an activated form
to a deactivated or from a deactivated form to an activated form
for can modulate the rate and speed of the reaction inside of the
target tissue specifically the Parathyroid gland or outside of the
target tissue.
[0136] Adhesives and Glues and Molecular Crystal and Lattice
therapies can include but is not restricted to the following.
[0137] In one embodiment the injection of medical grade adhesive
into the Parathyroid gland can be an effective means for ablating a
part or all of the Parathyroid gland. In the preferred embodiment
the adhesive can be percutaneously instilled into Parathyroid gland
or into the adjacent tissue or the blood vessels associated with
the Parathyroid gland and can include but are not restricted to
cyanoacrylate adhesive. UV-curable adhesive (e.g. Cyberlite U303),
two part filled epoxy (e.g. Cyberpoxy 5895), anaerobic
threadlocking adhesive, which is thixotropic (e.g. Titan 7222),
methyl methacrylate,
[0138] In one embodiment a substance which can include but is not
restricted to a solid, liquid, gel or gas can be injected into the
target tissue that can include but is not restricted to the
Parathyroid gland that is inactive in its primary state but can
become activated if a second substance which can include but is not
restricted to a solid, liquid, gel or gas is added such as but not
restricted to epoxy glues such as but not restricted two part
filled epoxy (e.g. Cyberpoxy 5895).
[0139] In another embodiment electromagnetic energy can be added to
the primary substance, which can include but is not restricted to a
solid, liquid, gel or gas can be activated by an energetic source
that can include but is not restricted to electromagnetic energy,
radiation, heat, kinetic and mechanical energy and can include UV
activated compounds such as but not restricted to UV-curable
adhesive (e.g. Cyberlite U303). Other embodiments can include
combinations of substances and energetic sources as primary or
secondary or additional additives.
[0140] The absence of a substance, which can include but is not
restricted to a solid, liquid, gel or gas can also activate a
primary substance and can include but is not restricted to the
absence of one or more gases such as with anaerobic adhesive.
[0141] In another embodiment is a lattice or compound that can be
placed percutaneously within the target tissue that can contain a
substance which can include but is not restricted to a solid,
liquid, gel or gas which can surpress or activate or treat the
target tissue. One embodiment can include a substance that is
placed into the Parathyroid gland glans and can include but is not
restricted to a lattice such as hydroxyappetitie, Ca5(PO4)3(OH),
Ca10(PO4)6(OH)2, or bone meal, calcium carbonate, hydroxylapatite,
hydroxylapatite hydo-gel or Cinacalcet (Sensipar) or a related
calcimimetic substance or a Parathyroid gland surpressing
agent.
[0142] Target Tissue Delivery Device Therapies can include but is
not restricted to the following.
[0143] In another embodiment a delivery device can be used to
percutaneously deliver a compound that can be directly delivered
within the target tissue such as but not restricted to the
Parathyroid gland and the that substance which can include but is
not restricted to a solid, liquid, gel or gas can surpress or
activate or treat the target tissue.
[0144] In one embodiment a delivery system for the target organ
such as not restricted to the Parathyroid gland can emulate a
diabetic insulin pump that measures glucose blood levels and
delivers insulin to the blood stream. For the Parathyroid gland the
pump would measure Parathyroid gland hormone levels or a form of
calcium levels to include but not restricted to ionized calcium or
bound or unbound calcium in the blood stream and deliver calcium or
a form of calcium or a surpressor or activator of the Parathyroid
gland such as Cinacalcet or related calcimimetic substance or a
Parathyroid gland surpressing agent.
[0145] Other embodiments can include but are not restricted to a
scaffold or holding structure or slow dissolving or time release
substance that can include but is not restricted to a lattices or
crystals that can be injected percutaneously adjacent of within a
lesion or tumor and the crystals or lattices can contain a to
medications to treat the medical malady or lesion or tumor through
the slow release of the compound. In one embodiment the medication
can be placed in the healthy tissue adjacent to the lesion or tumor
and as the tumor attempts to grow the lesion or tumor encounters
the lattice and treating or suppressing or activating medication
that can include but is not restricted to a chemotherapeutic or
anti-angiogenic agent that limits the growth of the malignant or
aggressive tumor beyond or outside its current or natural
confines.
[0146] Another embodiment embodiments can include but are not
restricted to a scaffold or holding structure or slow dissolving or
time release substance that can include but is not restricted to a
lattices or crystals that can be injected percutaneously adjacent
to or within a lesion or tumor and the crystals or lattices can
contain a to medications to treat the medical malady or adenoma or
lesion or tumor through the slow release of the compound. In one
embodiment the medication can be placed in the healthy tissue
adjacent to the lesion or malignant or aggressive tumor and as the
lesion or tumor attempts to grow the lesion or tumor encounters the
lattice and treating or suppressing or activating medication that
can include but is not restricted to a chemotherapeutic or
anti-angiogenic agent that limits the growth of the lesion or tumor
beyond or outside its current or natural confines
[0147] Peptide and Biological Conversion Therapies can include but
are not restricted to the following.
[0148] In another embodiment substances or peptides or peptide
analogs to include but not restricted to portions of the
parathyroid molecule which can include the active portion of the
molecule. Molecule or minerals such as Calcium or organic or
inorganic compounds that can bind to receptors such as Sestimibi,
Sensapar (Cinacalcet) or Calcium analog compounds that are related
to the parathyroid receptors can be used to the parathyroid binding
receptors and can utilize methods for reversible or irreversible
attachment.
[0149] Biological compounds that simulate Parathyroid gland hormone
or its precursors or calcium, Sensapar (Cinacalcet) or Sestimibi
related compounds or compound that do not egress the parathyroid
can be constructed with biological or chemical denaturing agents or
lytic qualities or tissue destructive qualities can be injected
percutaneously into the parathyroid and create Parathyroid gland
cell death. These compounds or substances can include biological
agents that bind to cellular elements to include but not restricted
to cell membranes, nucleus, mitochondria, DNA, RNA, parathyroid
hormone or its precursors, or other cellular structures or cellular
products. This can include but is not restricted to acetylation
with carboxylic acid, formic, acetic, benzoic or other acids and
can include toxic materials such as thalidomide or arsenic. For
peptide modification this can include but is not restricted to
modification at the C-end or the N component of the peptide.
[0150] MR and RF and Magnetic External Heating Therapies can
include but are not restricted to the following.
[0151] In one embodiment ferromagnetic particles can percutaneously
be placed into the Parathyroid gland and the MRI machine sequences
can then be engaged. If Electromagnetic and mechanical and
Radiofrequency Excitation (RF) and SAR (heat depositing sequences)
are used then the ferromagnetic particles will heat up and can
reach temperatures that can be modulated to reach greater than 46
degrees C. Also there will be movement of the ferromagnetic
particles that will create Brownian motion or mechanical movement
of the particles that will mechanically damage the Parathyroid
gland cells. The size of the ferromagnetic particles can be
microscopic and as small as particles that are angstroms or
nanometers to particles that are macroscopic and in the order of
size from micrometers to millimeters. These ferromagnetic particles
can be in the solid, liquid, gel or gaseous states or can form a
slurry or a mixture or combination of the solid, liquid, gel or
gaseous states.
[0152] Hyperthermia with Adjuvant Therapy can include but are not
restricted to the following.
[0153] In another embodiment, non-ferromagnetic substances can be
injected into the Parathyroid gland and the natural heating of the
MRI from the Electromagnetic and mechanical and RF and SAR (heat
depositing sequences) are utilized and focused in the region of the
Parathyroid gland then the target tissue, specifically the
Parathyroid gland can experience heating that damages the
Parathyroid gland.
[0154] Another concept is to lower the boiling point of a substance
such that the substance is injected into the target tissue and then
a hyperthermic source is administered to the target such as the
Parathyroid gland and the amount of heat that is needed to damage
the target tissue because of the presence of the adjuvant substance
which can include but is not restricted to a solid or liquid or gel
or gas is a temperature that creates minimal or no damage to the
adjacent tissue. In another embodiment the a substance can be
injected adjacent to the target tissue that can keep the target
tissue safe from the effects of hyperthermia.
[0155] In one embodiment water or saline can be percutaneously
injected into the target tissue, the Parathyroid gland and the
heating by the MRI RF will heat the tissue of the Parathyroid gland
and destroy the gland. In another example a substance which can
include but is not restricted to a solid or liquid or gel or gas
with a boiling point lower that water can be injected and the MRI
or external RF can be focused onto the Parathyroid gland. At one
atmoshphere some of the compounds with boiling points lower than
water that can be injected include but are not restricted to
Acetaldehyde CH3CHO, Acetone CH3COCH3, Acetylene, Alcohol-ethyl
(grain, ethanol) C2H5OH, Ammonia, Benzene (Benzol) C6H6, Bromine,
Carbon bisulfide, Carbon dioxide, Carbon disulfide CS2, Carbon
tetrachloride CCl4, Chloroform, Cyclohexane, Diethyl ether, Ether,
Ethanol, Ethyl acetate CH3COOC2H3, Ethyl bromide C2H3Br, Hexane-n,
Hydrogen, Methanol (methyl alcohol, wood alcohol), Methyl acetate,
Propane, and Propylene. The heating of the target tissue, the
Parathyroid gland, can include but is not restricted to external
sources as with MRI RF or HIFU or percutaneous or internal body
sources such as but not restricted to RF and microwave. The
internal source of heating can be within the target tissue or in
the vicinity or adjacent to the target tissue.
[0156] In another embodiment the desired goal may be to expose the
target tissue probes or delivery systems and adjuvant substances
that exceed the boiling point of water. This is more likely to
cause damage to the biological tissue. Some examples of injected
substances can include saline water, glycerine, and ethyl
bromide.
[0157] In another embodiment the flashpoint can be used to treat
the target tissue such as but not restricted to the Parathyroid
gland can be injected with a substance which can include but is not
restricted to a solid or liquid or gel or gas and when heated will
attain a flashpoint at or below a temperature that does not damage
tissue adjacent to the target tissue such as but not restricted to
the Parathyroid gland. Substances with low flashpoints that are
still in the safe range for adjacent biological tissue can include
but are not restricted to ethanol.
[0158] Hypothermia with Adjuvant Therapy can include but are not
restricted to the following.
[0159] In another embodiment the concept is inject a substance that
can include a solid, a liquid, a gel or a gas that can lower the
freezing point above that of water (e.g. substance and tissue
freezes at 10 degrees C. rather than 0 degrees C. as occurs with
water) such that the substance is injected into the target tissue
and then a hypothermic therapy is administered to the target tissue
such as the Parathyroid gland and the amount of cold that is needed
to damage the target tissue because of the presence of the adjuvant
substance is a temperature that creates minimal or no damage to the
adjacent tissue. In another embodiment a substance can be injected
adjacent to the target tissue that can keep the target tissue safe
from the effects of hypothermia.
[0160] In one embodiment water or saline can be percutaneously
injected into the target tissue, the Parathyroid gland and cooling
or freezing by cryotherapy and hypothermia of the tissue of the
Parathyroid gland will destroy the gland. In another example a
substance with a freezing point higher that water can be injected
into the targeted tissue and the cryotherapy can be focused onto or
placed into the Parathyroid gland. At one atmosphere some of the
compounds with freezing points higher than water that can be
injected include but are not restricted to Helium, Hydrogen, neon,
fluorine, oxygen, nitrogen, Argon Chlorine, Bromine, acetic acid,
benzene, and phenol.
[0161] In another embodiment the desired goal may be to be lower
than freezing point of water. This is more likely to cause damage
to the biological tissue. Some examples of injected substances can
include but are not restricted to ethanol and water and
glycerol.
[0162] Local protective therapy in the Vicinity of the Target Organ
Therapy can include but is not restricted to the following.
[0163] Multiple examples have been given of local protective
therapies around the target tissue.
[0164] Examples can include but are not restricted to, one example
in which hyperthermia is applied to the target tissue and the
tissue adjacent to the targeted tissue can be bathed in 5% or
greater Dextrose Water.
[0165] In one example a toxic material injected into the target
tissue such as the Parathyroid gland will be a material where the
optimal injected material will be low or no toxicity to the local
biological tissue when the local biological tissue that is not the
target. If the local non-target tissue is diluted or given an
antidote material or if it is heated to a safe level the local
tissue will remain safe even if the toxic material leaks out of the
Parathyroid gland it will have minimal negative biological effect
such as but not restricted to injection of ammonia into the
Parathyroid gland but injection of saline into adjacent tissue;
heating of local tissue to less than cytotoxic levels of heat while
the Parathyroid gland at the same heat levels will experience
cytotoxicity because it received an adjuvant substance into the
Parathyroid gland. These injected substances can be in the solid,
liquid, gel or gaseous states or can form a slurry or a mixture or
combination of the solid, liquid, gel or gaseous states and can
include ferromagnetic substances, saline, water, ammonia, bromine,
carbon dioxide, carbon disufide.
[0166] In another embodiment if hypothermia or cryothermia are used
then the local environment in the vicinity of the target tissue,
which can include but is not restricted to the Parathyroid gland,
can be infused with solutions or substances that depress the
freezing point such as but not restricted to sorbitol, glycerol,
glycogen, glucose, sodium chloride or substances with increased
molality compared to water. These can also include supersaturated
solutions or combinations of these substances.
[0167] Mechanical Ablation Therapy can include but is not
restricted to the following.
[0168] In another embodiment a percutaneous technique can include
placing a needle into the target tissue, such as but not restricted
to the Parathyroid gland. This can include but is not restricted to
a mechanical cutting or ablating or cutting tool or cell
masceration and tissue damaging device. The mechanism of mechanical
damage can include but is but restricted to a blade, a needle, a
burr. a compressive force, a stream or flow of focused material to
include a solid or liquid or a gas or gel to include water, oxygen,
a hydrogel or hot metal or liquid nitrogen.
[0169] Methods of delivering the mechanical force can include but
are not restricted to a needle with one or more end-holes,
side-holes, or combination of these end and side hole and a cutting
device that can include a blade, a needle, a burr. a compressive
force, a rotating force, a stream or flow of focused material to
include a solid or liquid or a gas or gel to include water, oxygen,
a hydrogel or hot metal or liquid nitrogen.
[0170] A negative suction that is continuous or pulsed can remove
tissue that enters the core of the needle.
[0171] Suction and Expansion Therapy can include but is not
restricted to the following.
[0172] In another embodiment a percutaneous technique can include
placing a hollow needle or catheter or guide that lies within or
intimately adjacent to the target tissue, such as but not
restricted to the Parathyroid gland. A negative pressure can be
applied within the needle hollow needle or catheter or guide such
that the blood flow to the parathyroid gland is inhibited and or
ceases and thus creating an ischemic state within the parathyroid
tissue and thus resulting in cell death and cytolysis.
[0173] This negative pressure can be combined with a cutting tool
that can include a side-hole in the needle and a cutting or
mechanical device that can include a burr or a blade that can
remove tissue that enters the core of the needle. The needle or
guide or catheter can have one or more channels and each channel
can be dedicated to the same or different tasks.
[0174] Positive Pressure and Expansion Therapy can include but is
not restricted to the following.
[0175] In another embodiment a percutaneous technique can include
placing a needle into the target tissue, such as but not restricted
to the Parathyroid gland. Positive pressure can be applied within
the needle. This will create positive pressure within the target
tissue such as but not restricted to the Parathyroid gland. To
create the positive pressure a substance can include but not
restricted to a solid, liquid, gel or gas or a combination can form
a slurry or a mixture or combination of the solid, liquid, gel or
gaseous states can be instilled though the needle into the target
tissue. The objective is to create enough positive pressure within
the tissue of the Parathyroid gland to exceed systolic pressure and
prevent the inflow of blood into the parathyroid gland and
secondarily create ischemia within the Parathyroid. In one
embodiment this supra-systolic pressure, pressure above systole in
the target tissue, will be maintained until the target tissue
ischemia is sufficient to achieve cytolysis and target tissue cell
death.
[0176] This positive pressure can be combined with a cutting tool
that can include a side-hole in the needle and a cutting device or
mechanical device that can include a burr or a blade that can
remove tissue that enters the core of the needle. The needle or
guide or catheter can have one or more channels and each channel
can be dedicated to the same or different tasks.
[0177] Combinations of Therapies can include but is not restricted
to the following.
[0178] Therapies can be used in isolation or in combination.
Multiple therapies can be combined such as but not restricted to
hyperthermia with adjuvant therapy and MR heating with
ferromagnetic or HIFU with adjuvant therapy and local protective
therapy.
[0179] Nerve Sensory Device can include but is not restricted to
the following.
[0180] Prior to the procedure a nerve stimulator can be activated
then the therapeutic needle tip or guide or probe is in place and
prior to therapeutic treatment, The stimulator is designed to
determine whether the local nerves adjacent or near to the
Parathyroid gland including but not restricted to the Laryngeal
nerves, the Recurrent Laryngeal nerves and the Sympathetic and
parasympathetic nerves as will as other visceral and pain nerves.
will be affected by the treatment. In one example a low voltage
stimulation can be applied with a lesion generator (e.g. 0.1-0.2 V
at 50 Hz, RFG-3CF, Radionics, Burlington Mass.) to insure that the
adjacent an critical nerves are not stimulated. Motor stimulation
can be applied to the region (e.g. 0.1-0.2 V at 2 Hz).
[0181] Monitoring of laryngeal nerves can also be monitored using
standard forms of intraoperative laryngeal and laryngeal nerve
monitoring and Intraoperative EMG.
[0182] Temperature probes can be utilized to assess the local
tissue environment by percutaneous insertion of a probe or
temperature measuring device. Said measuring device can have the
capacity to turn off the treatment generator and sicontinue or
limit or modulate treatment. The probe can also be located in or on
or adjacent to the trachea, larynx and airway.
[0183] In another embodiment another form of sensory probe can be a
device that senses electromagnetic signals to include but not
restricted to electric current. These can include but are not
restricted to modifications of Hall sensors with field
concentrators, AMR current sensors, magneto-optical and
superconducting current sensors, Hall effect IC sensor, Resistor,
whose voltage is directly proportional to the current through it,
Fiber optic current sensor, using an interferometer to measure the
phase change in the light produced by a magnetic field, Rogowski
coil, electrical device for measuring alternating current (AC) or
high speed current pulses, galvanometer is a type of ammeter: an
instrument for detecting and measuring electric current and
electrometer is an electrical instrument for measuring electric
charge or electrical potential difference. The sensory probe can be
placed in the vicinity of the target tissue and in the case of the
Parathyroid gland can be place adjacent or near the Parathyroid
gland specifically near the neural structures such as the laryngeal
nerves or major blood vessels.
[0184] Needles or percutaneous penetrating cylinder or solid or
hollow tube device can include but is not restricted to the
following.
[0185] In another embodiment is a needle or probe or percutaneous
cylinder or tube (which can be hollow or solid) device (all can be
referred to here as a needle) can be composed of a metallic
substance that can include but is not restricted to stainless
steel, aluminum, iron, titanium or other ferrous materials and
alloy.
[0186] A device that penetrates the skin or passes through human
tissue can be but is not restricted to a needle or probe or tines
or percutaneous tube device and hereafter will be referred to as a
needle. The needle can be made to consist of fully or partially of
optimal insulating materials or can be insulated with a material on
the outside portion of the needle, on the inside portion of the
needle if the needle is hollow, a combination of inside and outside
of the needle, the needle can be composed of multiple metallic and
non-metallic materials to include but not restricted to good
insulators and poor conductors of heat and can also be composed of
materials that can include but are not restricted to ceramic
materials, high aluminum ceramics (Alumina Ceramic), beryllium,
fiberglass, Zirconium, High Zirconium, adhesives and nansulators,
reinforced carbon-carbon fiber construction (aka carbon-carbon,
abbreviated C/C) is a composite material consisting of carbon fibre
reinforcement in a matrix of graphite, Carbon fibre-reinforced
silicon carbide (C/SiC) is a development of pure carbon-carbon
(C/SiC utilises silicon carbide with carbon fibre, and this
compound is thought to be more durable than pure carbon-carbon),
Fibrous refractory composite insulation (FRCI), LI-900 silica
tiles, made from essentially very pure quartz sand,
High-temperature reusable surface insulation (HRSI), Reaction Cured
Glass (RCG) of which tetrasilicide and borosilicate glass are some
of several ingredients to waterproof the coating
dimethylethoxysilane is injected into the coating (densifying the
tile with tetraethyl orthosilicate (TEOS) also helps to protect the
silica and waterproof), RCC (a laminated composite material made
from graphite rayon cloth and impregnated with a phenolic resin.
After curing at high temperature in an autoclave, the laminate is
pyrolized to convert the resin to carbon. This is then impregnated
with furfural alcohol in a vacuum chamber, then cured and pyrolized
again to convert the furfural alcohol to carbon. This process is
repeated three times until the desired carbon-carbon properties are
achieved the outer layers of the RCC are converted to silicon
carbide. The silicon-carbide coating protects the carbon-carbon
from oxidation.
[0187] In one embodiment the needle can contain a diamond or
zirconium tip.
[0188] Needle with chambers that can circulate substances to form a
heat sink can include are but not restricted to solids, liquids and
gels and gasses or a vacuum. These can substances can include but
are not restricted to water, argon, nitrogen, and nitrous oxide or
a vacuum.
[0189] In another embodiment the needle have chambers that contain
substances or vacuum that are non-circulating.
[0190] These needle can be used for additional applications where
insulation is not a requirement.
[0191] In another embodiment the needle can be coated or composed
with a nansulatecoating which can include but is not restricted to
an insulation technology that incorporates a nanocomposite called
Hydro-NM-Oxide, a product of nanotechnology. This material is
documented as having one of the lowest measured thermal
conductivity values. (0.017 W/mK). Nansulate, when fully cured,
contains approximately 70% Hydro-NM-Oxide and 30% acrylic resin and
performance additive. It does not function as a metallic UV
radiator (reflection). The nano-particle in Nansulate act to
inhibit the heat flow much like traditional insulation.
[0192] In another embodiment the needle can have but is not
restricted to an outer or inner coating that provides for decreased
resistance or decreased friction from the tissue through which it
penetrates. This can include but is not restricted to a coating or
composition that can include but is not restricted to a
Polytetrafluoroethylene (PTFE) or fluoropolymer of
tetrafluoroethylene or a hypophillic or hydrophobic material,
ultra-high-molecular-weight polyethylene (UHMWPE) or mineral oil or
molybdenum disulfide embedded as additional lubricants in the
needles matrix.
[0193] In another embodiment the needle can have but is not
restricted to a variable or non-uniform flexibility and tensile
strength within its length or width.
[0194] In another embodiment the needle can have but is not
restricted to a variable width of its wall or lumen. In one example
the wall can be thicker proximal that distal such that the needle
or catheter has the configuration or an a triangle or arrowhead
that allows for easier penetration.
[0195] In another embodiment the needle can have but is not
restricted to a chamber that can be filled with a substance that
can include a solid or liquid or gel or gas that can be filled to
include but not restricted to it being under pressure and causing
the needle or catheter wall to harden or become more firm such that
it can pierce the skin more easily. Once it has reached its target
the chamber material can be withdrawn fully or incompletely or the
nature of the material can be altered. In on example the catheter
or needle chamber can be a nitenol or alloy metal that when cooled
is firm but when heated is soft and pliable and flexible.
[0196] In another embodiment the needle can be composed of but not
restricted to a material to include but not restricted to material
such as nitenol or alloy metal that when cooled is firm but when
heated is soft and pliable and flexible or other materials that
have variable hardness or softness under differing thermal
conditions such as hot or cold, or electromagnetic conditions such
as UV light or the presence or absence of an electric current of a
magnetic force to include but not restricted to Ferrofluids such as
colloidal liquids made of nanoscale ferromagnetic, or
ferrimagnetic, particles suspended in a carrier fluid such as an
organic solvent or water, magnetorheological fluids (MR fluids),
nanoelectromechanical systems, magnetorheological fluid (MRF)
refers to liquids similar to ferrofluids (FF) that solidify in the
presence of a magnetic field. These materials can contain and
include but are not restricted to material that contain magnetite,
hematite or some other compound containing iron that are small
enough for thermal agitation to disperse them evenly within a
carrier fluid, and for them to contribute to the overall magnetic
response of the fluid and can include but is not restricted to the
composition of a typical ferrofluid is about 5% magnetic solids,
10% surfactant and 85% carrier, by volume. In other embodiment the
ferromagnetic particles can be arranged in a manner that can be
circular or spiral or other geometric or non-geometric arrangements
that can alter or vary the shape or firmness or flexibility of the
needle.
[0197] One of the uses for this type of needle can include but is
not restricted to serve as a rigid penetrating device to reach the
target tissue as it penetrates the skin or organs or vessels but
then can become flexible and not damage the tissue any further when
it is changes to a non-rigid device.
[0198] The variable stiffness can include all or only one or more
portions of the needle.
[0199] The needle can include multiple configurations and its cross
section can include a geometric or non-geometric or variable
configuration that can include but is not restricted to a curved or
circle, or ellipse configuration or an angled or straight or,
triangle, rectangle, pentagon, hexagon etc, configuration.
[0200] A stylet or guide or introducers can include but is not
restricted to the following.
[0201] The stylet or guide or introducer in the preferred
embodiment can include but is not restricted to a device that can
be placed within the inside hollow of device such as but not
restricted to a needle or catheter or it can be placed on the
outside of a needle or catheter. Some of the functions of the
stylet or guide or introducer can include but are not restricted to
stiffening the path, protecting, guiding, introducing, or filling
the hollow of the device or needle or catheter or any combination
of uses.
[0202] In another embodiment is a stylet or guide or introducer or
probe or percutaneous cylinder or tube (which can be hollow or
solid) device can be composed of a metallic substance that can
include but is not restricted to stainless steel, aluminum, iron,
titanium or other ferrous materials and alloy.
[0203] A device that penetrates the skin or passes through human
tissue and stiffening the path, protecting, guiding, introducing,
or filling the hollow of the device or needle or catheter or any
combination of uses but not restricted to these uses and can be but
is not restricted to a stylet or guide or introducer or probe or
tines or percutaneous tube device and hereafter will be referred to
as a stylet or guide or introducer. The stylet or guide or
introducer can be made to consist of fully or partially of optimal
insulating materials or can be insulated with a material on the
outside portion of the stylet or guide or introducer, on the inside
portion of the stylet or guide or introducer if the stylet or guide
or introducer is hollow, a combination of inside and outside of the
stylet or guide or introducer, the stylet or guide or introducer
can be composed of multiple metallic and non-metallic materials to
include but not restricted to good insulators and poor conductors
of heat and can also be composed of materials that can include but
are not restricted to ceramic materials, high aluminum ceramics
(Alumina Ceramic), beryllium, fiberglass, Zirconium, High
Zirconium, adhesives and nansulators, reinforced carbon-carbon
fiber construction (aka carbon-carbon, abbreviated C/C) is a
composite material consisting of carbon fibre reinforcement in a
matrix of graphite, Carbon fibre-reinforced silicon carbide (C/SiC)
is a development of pure carbon-carbon (C/SiC utilises silicon
carbide with carbon fibre, and this compound is thought to be more
durable than pure carbon-carbon), Fibrous refractory composite
insulation (FRCI), LI-900 silica tiles, made from essentially very
pure quartz sand, High-temperature reusable surface insulation
(HRSI), Reaction Cured Glass (RCG) of which tetrasilicide and
borosilicate glass are some of several ingredients to waterproof
the coating dimethylethoxysilane is injected into the coating
(densifying the tile with tetraethyl orthosilicate (TEOS) also
helps to protect the silica and waterproof), RCC (a laminated
composite material made from graphite rayon cloth and impregnated
with a phenolic resin. After curing at high temperature in an
autoclave, the laminate is pyrolized to convert the resin to
carbon. This is then impregnated with furfural alcohol in a vacuum
chamber, then cured and pyrolized again to convert the furfural
alcohol to carbon. This process is repeated three times until the
desired carbon-carbon properties are achieved the outer layers of
the RCC are converted to silicon carbide. The silicon-carbide
coating protects the carbon-carbon from oxidation.
[0204] In one embodiment the stylet or guide or introducer can
contain a diamond or zirconium tip.
[0205] Stylet or guide or introducer with chambers that can
circulate substances to form a heat sink can include are but not
restricted to solids, liquids and gels and gasses or a vacuum.
These can substances can include but are not restricted to water,
argon, nitrogen, and nitrous oxide or a vacuum.
[0206] In another embodiment the stylet or guide or introducer have
chambers that contain substances or vacuum that are
non-circulating.
[0207] These stylet or guide or introducer can be used for
additional applications where insulation is not a requirement.
[0208] In another embodiment the stylet or guide or introducer can
be coated or composed with a nansulatecoating which can include but
is not restricted to an insulation technology that incorporates a
nanocomposite called Hydro-NM-Oxide, a product of nanotechnology.
This material is documented as having one of the lowest measured
thermal conductivity values. (0.017 W/mK). Nansulate, when fully
cured, contains approximately 70% Hydro-NM-Oxide and 30% acrylic
resin and performance additive. It does not function as a metallic
UV radiator (reflection). The nano-particle in Nansulate act to
inhibit the heat flow much like traditional insulation.
[0209] In another embodiment the stylet or guide or introducer can
have but is not restricted to an outer or inner coating that
provides for decreased resistance or decreased friction from the
tissue through which it penetrates. This can include but is not
restricted to a coating or composition that can include but is not
restricted to a Polytetrafluoroethylene (PTFE) or fluoropolymer of
tetrafluoroethylene or a hypophillic or hydrophobic material,
ultra-high-molecular-weight polyethylene (UHMWPE) or mineral oil or
molybdenum disulfide embedded as additional lubricants in the
stylet or guide or introducers matrix.
[0210] In another embodiment the stylet or guide or introducer can
have but is not restricted to a variable or non-uniform flexibility
and tensile strength within its length or width.
[0211] In another embodiment the stylet or guide or introducer can
have but is not restricted to a variable width of its wall or
lumen. In one example the wall can be thicker proximal that distal
such that the stylet or guide or introducer or catheter has the
configuration or an a triangle or arrowhead that allows for easier
penetration.
[0212] In another embodiment the stylet or guide or introducer can
have but is not restricted to a chamber that can be filled with a
substance that can include a solid or liquid or gel or gas that can
be filled to include but not restricted to it being under pressure
and causing the stylet or guide or introducer or catheter wall to
harden or become more firm such that it can pierce the skin more
easily. Once it has reached its target the chamber material can be
withdrawn fully or incompletely or the nature of the material can
be altered. In one example the catheter or stylet or guide or
introducer chamber can be a nitenol or alloy metal that when cooled
is firm but when heated is soft and pliable and flexible.
[0213] In another embodiment the stylet or guide or introducer can
be composed of but not restricted to a material to include but not
restricted to material such as nitenol or alloy metal that when
cooled is firm but when heated is soft and pliable and flexible or
other materials that have variable hardness or softness under
differing thermal conditions such as hot or cold, or
electromagnetic conditions such as UV light or the presence or
absence of an electric current of a magnetic force to include but
not restricted to Ferrofluids such as colloidal liquids made of
nanoscale ferromagnetic, or ferrimagnetic, particles suspended in a
carrier fluid such as an organic solvent or water,
magnetorheological fluids (MR fluids), nanoelectromechanical
systems, magnetorheological fluid (MRF) refers to liquids similar
to ferrofluids (FF) that solidify in the presence of a magnetic
field. These materials can contain and include but are not
restricted to material that contain magnetite, hematite or some
other compound containing iron that are small enough for thermal
agitation to disperse them evenly within a carrier fluid, and for
them to contribute to the overall magnetic response of the fluid
and can include but is not restricted to the composition of a
typical ferrofluid is about 5% magnetic solids, 10% surfactant and
85% carrier, by volume. In other embodiment the ferromagnetic
particles can be arranged in a manner that can be circular or
spiral or other geometric or non-geometric arrangements that can
alter or vary the shape or firmness or flexibility of the stylet or
guide or introducer.
[0214] One of the uses for this type of stylet or guide or
introducer can include but is not restricted to serve as a rigid
penetrating device to reach the target tissue as it penetrates the
skin or organs or vessels but then can become flexible and not
damage the tissue any further when it is changes to a non-rigid
device.
[0215] The variable stiffness can include all or only one or more
portions of the stylet or guide or introducer.
[0216] The stylet or guide or introducer can include multiple
configurations and its cross section can include a geometric or
non-geometric or variable configuration that can include but is not
restricted to a curved or circle, or ellipse configuration or an
angled or straight or, triangle, rectangle, pentagon, hexagon etc,
configuration.
[0217] A catheter can include but is not restricted to the
following.
[0218] A catheter can be include but is not restricted to a solid
or hollow cylinder or tube device for use with but not restricted
to percutaneous or transcutaneous or filling or being transmitted
or transported in or within or through a hollow viscous or vascular
structure or an organic or inorganic structure within or outside of
the body.
[0219] In another embodiment is a catheter can be composed of a
non-metallic substance such as but not restricted to rubber, or
plastic or latex or cloth, carbon fibers or carbon-carbon fibers or
or metallic substance that can include but is not restricted to
stainless steel, aluminum, iron, titanium or other ferrous
materials and alloy or any combination of these materials.
[0220] A catheter can be used for but not restricted to the
transportation of substances such as but not restricted to solids
or liquids or gels or gases and can penetrate the skin or pass
through human tissue or transport within human tissue to include
but not restricted to a hollow viscous stricture that can include
but is not restricted to the esophagus, small and large intestine,
stomach, colon, rectum, mouth, trachea, biliary ducts and nostrils
or vascular structure that can include arteries and veins and
lymphapics, or can stiffening the path, protect, guide, introduce,
or filling the hollow of a device or needle or another catheter or
any combination of uses but not restricted to these uses.
[0221] The catheter can be made to consist of fully or partially of
optimal insulating materials or can be insulated with a material on
the outside portion of the stylet or guide or introducer, on the
inside portion of the catheter if the catheter is hollow, a
combination of inside and outside of the stylet or guide or
introducer, the catheter can be composed of multiple metallic and
non-metallic materials to include but not restricted to good
insulators and poor conductors of heat and can also be composed of
materials that can include but are not restricted to ceramic
materials, high aluminum ceramics (Alumina Ceramic), beryllium,
fiberglass, Zirconium, High Zirconium, adhesives and nansulators,
reinforced carbon-carbon fiber construction (aka carbon carbon,
abbreviated C/C) is a composite material consisting of carbon fibre
reinforcement in a matrix of graphite, Carbon fibre-reinforced
silicon carbide (C/SiC) is a development of pure carbon-carbon
(C/SiC utilises silicon carbide with carbon fibre, and this
compound is thought to be more durable than pure carbon-carbon),
Fibrous refractory composite insulation (FRCI), LI-900 silica
tiles, made from essentially very pure quartz sand,
High-temperature reusable surface insulation (HRSI), Reaction Cured
Glass (RCG) of which tetrasilicide and borosilicate glass are some
of several ingredients to waterproof the coating
dimethylethoxysilane is injected into the coating (densifying the
tile with tetraethyl orthosilicate (TEOS) also helps to protect the
silica and waterproof), RCC (a laminated composite material made
from graphite rayon cloth and impregnated with a phenolic resin.
After curing at high temperature in an autoclave, the laminate is
pyrolized to convert the resin to carbon. This is then impregnated
with furfural alcohol in a vacuum chamber, then cured and pyrolized
again to convert the furfural alcohol to carbon. This process is
repeated three times until the desired carbon-carbon properties are
achieved the outer layers of the RCC are converted to silicon
carbide. The silicon-carbide coating protects the carbon-carbon
from oxidation.
[0222] In one embodiment the catheter can contain a diamond or
zirconium tip.
[0223] Catheter with chambers that can circulate substances to form
a heat sink can include are but not restricted to solids, liquids
and gels and gasses or a vacuum. These can substances can include
but are not restricted to water, argon, nitrogen, and nitrous oxide
or a vacuum.
[0224] In another embodiment the catheter have chambers that
contain substances or vacuum that are non-circulating.
[0225] These catheter can be used for additional applications where
insulation is not a requirement.
[0226] In another embodiment the catheter can be coated or composed
with a nansulatecoating which can include but is not restricted to
an insulation technology that incorporates a nanocomposite called
Hydro-NM-Oxide, a product of nanotechnology. This material is
documented as having one of the lowest measured thermal
conductivity values. (0.017 W/mK). Nansulate, when fully cured,
contains approximately 70% Hydro-NM-Oxide and 30% acrylic resin and
performance additive. It does not function as a metallic UV
radiator (reflection). The nano-particle in Nansulate act to
inhibit the heat flow much like traditional insulation.
[0227] In another embodiment the catheter can have but is not
restricted to an outer or inner coating that provides for decreased
resistance or decreased friction from the tissue through which it
penetrates. This can include but is not restricted to a coating or
composition that can include but is not restricted to a
Polytetrafluoroethylene (PTFE) or fluoropolymer of
tetrafluoroethylene or a hypophillic or hydrophobic material,
ultra-high-molecular-weight polyethylene (UHMWPE) or mineral oil or
molybdenum disulfide embedded as additional lubricants in the
stylet or guide or introducers matrix.
[0228] In another embodiment the catheter can have but is not
restricted to a variable or non-uniform flexibility and tensile
strength within its length or width.
[0229] In another embodiment the catheter can have but is not
restricted to a variable width of its wall or lumen. In one example
the wall can be thicker proximal that distal such that the catheter
or catheter has the configuration or an a triangle or arrowhead
that allows for easier penetration.
[0230] In another embodiment the catheter can have but is not
restricted to a chamber that can be filled with a substance that
can include a solid or liquid or gel or gas that can be filled to
include but not restricted to it being under pressure and causing
the catheter or catheter wall to harden or become more firm such
that it can pierce the skin more easily. Once it has reached its
target the chamber material can be withdrawn fully or incompletely
or the nature of the material can be altered. In on example the
catheter or catheter chamber can be a nitenol or alloy metal that
when cooled is firm but when heated is soft and pliable and
flexible.
[0231] In another embodiment the catheter can be composed of but
not restricted to a material to include but not restricted to
material such as nitenol or alloy metal that when cooled is firm
but when heated is soft and pliable and flexible or other materials
that have variable hardness or softness under differing thermal
conditions such as hot or cold, or electromagnetic conditions such
as UV light or the presence or absence of an electric current of a
magnetic force to include but not restricted to Ferrofluids such as
colloidal liquids made of nanoscale ferromagnetic, or
ferrimagnetic, particles suspended in a carrier fluid such as an
organic solvent or water, magnetorheological fluids (MR fluids),
nanoelectromechanical systems, magnetorheological fluid (MRF)
refers to liquids similar to ferrofluids (FF) that solidify in the
presence of a magnetic field. These materials can contain and
include but are not restricted to material that contain magnetite,
hematite or some other compound containing iron that are small
enough for thermal agitation to disperse them evenly within a
carrier fluid, and for them to contribute to the overall magnetic
response of the fluid and can include but is not restricted to the
composition of a typical ferrofluid is about 5% magnetic solids,
10% surfactant and 85% carrier, by volume. In other embodiment the
ferromagnetic particles can be arranged in a manner that can be
circular or spiral or other geometric or non-geometric arrangements
that can alter or vary the shape or firmness or flexibility of the
stylet or guide or introducer.
[0232] One of the uses for this type of catheter can include but is
not restricted to serve as a rigid penetrating device to reach the
target tissue as it penetrates the skin or organs or vessels but
then can become flexible and not damage the tissue any further when
it is changes to a non-rigid device.
[0233] The variable stiffness can include all or only one or more
portions of the stylet or guide or introducer.
[0234] The catheter can include multiple configurations and its
cross section can include a geometric or non-geometric or variable
configuration that can include but is not restricted to a curved or
circle, or ellipse configuration or an angled or straight or,
triangle, rectangle, pentagon, hexagon etc, configuration.
[0235] Combined Hyper and Hypothermic Device can include but is not
restricted to the following.
[0236] In another embodiment the Hyper and Hypothermic devices can
be coupled to control the heating and cooling of tissue. In
addition, the forces and architecture responsible for cell death
differ and the forces and architecture resistant to cell death
differ.
[0237] In one embodiment alternating heating and cooling can create
a synergy that can decrease both the temperature and duration
required for hyper and hypothermia which can prove beneficial to
the adjacent non-targeted tissue thus preserving the living tissue
in the vicinity of the targeted tissue, which can include but is
not restricted to the Parathyroid gland being the targeted tissue
and the neural and vascular structures adjacent to the Parathyroid
gland being spared.
[0238] Markers and Localization Devices and Wires and filaments can
include but is not restricted to the following.
[0239] Currently surgeons that remove Parathyroid gland adenomas
rely on pre-surgical imaging to approximate the location of the
parathyroid gland. Markers can be placed onto the skin but with
flexion and extension of the neck the location of the Parathyroid
gland can move deeper within the neck relative to the skin surface.
This flexion and extension occurs during anesthetic intubation and
can vary from the position that is used for diagnostic imaging and
localization and skin marker placement.
[0240] Methods for marking and localizing the Parathyroid gland can
prove useful. In one embodiment the Parathyroid gland to be removed
can be percutaneously injected into the Parathyroid gland with a
marking material that can include but is not restricted to a solid
or liquid or gel or gas such as but not restricted to methylene
blue and gentian violet, tattoo inks, fluorescent light or UV
sensitive dyes which can include but are not restricted to
nanoparticles to include but not restricted to Solgel derived
silica is an excellent host material for creating fluorescent
nanoparticles by the inclusion of covalently-bound organic dyes,
Flourophores that can be organic or inorganic, Fluorite (also
called fluorspar) is a halide mineral composed of calcium fluoride,
CaF2. Gemstones, minerals, may have a distinctive fluorescence or
may fluoresce differently under short-wave ultraviolet, long-wave
ultraviolet, or X-rays, calcite and amber will fluoresce under
shortwave UV. Rubies, emeralds, and the Hope Diamond exhibit red
fluorescence under short-wave UV light; diamonds also emit light
under X ray radiation, Vitamin B2 (fluoresces yellow), quinine
(blue), ninhydrin. And fluorescein.
[0241] In another embodiment the injected material an be metal
radio-opaque and can be viewed with x-ray and can include but are
not restricted to calcium, iodine, iron and other metals such as
titanium, tungsten, barium sulphate, and zirconium oxide
[0242] In another embodiment the marker or localizing device or
substance can be a radioactive material that is low dose and used
for diagnostic radiology that can include but is not restricted to
Technecium 99m, Iodine 123 and Iodine131 or Sestamibi99 mTc, which
can be percutaneously injected directly into the Parathyroid gland.
A percutaneous injection would have the advantage over intravenous
sestamibi because of the lack of background counts in organs other
than the Parathyroid gland such as the thyroid and fatty tissue and
muscles. A radiation sensitive probe such as a pencil probe can be
used to locate the Parathyroid gland during surgery more
easily.
[0243] The markers and localization devices can contain a GPS
device or contain a material that emits or provides for GPS
detection.
[0244] To place the marker or localizing device a
guide/wire/placement device, a stylet or a tube or needle or a
hollow or solid tube can be used to place the marker or localizing
device in the target tissue, parathyroid. In one embodiment the
marker or localizing device can contain a transitional zone that
contains a transitional state sensitive substance that can be
converted from a solid or liquid/gel material that when exposed to
a substance or an energy source such as but not restricted to
electromagnetic energy, kinetic or mechanical or thermal energy or
forces changes its state and can separate from the a more solid or
gel state to a state where the placement device is separated from
the marker or localizing device device. In one embodiment the
placement material and the transitional material and the marker or
localizing device can all be metallic and if energy such as an
electrical current or a thermal force is transmitted though the
placement wire the transitional zone will separate from the marker
or localizing device. In another embodiment the placement device
material can be composed of a phase transitional gel that when cold
remains solid but when heated the transitional zone will melt or
dissolve after a given period of time and separate from the marker
or localizing device. In another embodiment phase transitional gels
or other materials that can alter the physical state of the gel.
Solvents can be used to alter the physical state of the
material.
[0245] The placement device can have grooves/threads that when
turned or moved in the proper manner that will release/unthread. In
one embodiment the gel can take on crystalline characteristics and
become more rigid or less rigid when exposed to electromechanical
or kinetic or mechanical energy such as liquid crystal (LC) gels
with radial or twisted-radial molecular orientation are fabricated
using a radial electric field generated by an indium-tin-oxide hole
electrode in the bottom substrate. If the top substrate is not
buffed, the radial-type LC gel is formed which can convert linearly
polarized light into axially polarized light. On the other hand, if
the top substrate is homogeneously buffed, then a twisted-radial LC
gel is produced which can convert linearly polarized light into
radially polarized light. These polarization converters are useful
for diffractive optics and optical imaging systems.
[0246] The placement device can be a tube, which is hollow and can
transport a filament that can be organic and include but not be
restricted to silk or cotton or hemp or can be inorganic and can be
composed or synthetic polymers such as but not restricted to nylon,
rayon, or a carbon or carbon-carbon synthetic filament or a
metallic filament. The filament should be flexible enough that it
does not damage the tissue through which it passes such as but not
restricted to the thyroid, fat and skin. The marker or localizing
device can then be attached to the filament and put in place
percutaneously within the target tissue, the parathyroid gland.
[0247] In another embodiment a percutaneous localization device can
be used to assist in removing a parathyroid gland. This technique
is used commonly in breast localizations but the breast tissue is
composed of fat and breast parenchyma and stromal tissue that is
predominantly non-vascular. A localization device for the
parathyroid will likely have to pass through the thyroid gland,
which is highly vascularized. Therefore the guide will have to be
both anchor securely to the parathyroid gland and the wire between
the parathyroid to the skin will have to be both durable and stout
and pliable.
[0248] The localizing wire material can include but is not
restricted to stainless steel, nitenol, titanium, and other metals
and metal alloys that can be both Magnetic Resonance Imaging (MRI)
compatible or not MRI compatible, carbon-carbon fibers, organic and
inorganic material which can be combined or added to create and
maximize flexibility and strength and the localization wire can be
composed different segments that can contain one or a combination
of materials for each segment.
[0249] In one embodiment the wire can be composed with a
transitional material that resides between the skin component and
the target tissue parathyroid gland such that when heat or an
electric current of other electromagnetic or mechanical or kinetic
energy or force is administered to the wire the transitional
component the two segments detach or disengage, leaving the
parathyroid component of the localizing wire separate from the
percutaneous skin component.
[0250] In one preferred embodiment the wire can be composed of a
carbon-carbon matrix that is a segment that is highly flexible and
a more rigid segment that can include but is not restricted to a
hook or anchor that is embedded into or surrounds a portion or the
entirety of the parathyroid gland. These segments can be composed
of the same material or different materials or a combination of
materials.
[0251] The localizing device can include and be composed to include
but not restricted to a solid wire, a braided or woven wire. The
localizing device and wire and the parathyroid anchoring component
can be textured or beaded to increase its detection with
ultrasound. The localizing device and wire and anchor can be MRI or
CT scan visible. The localizing device can be coated with a
material that can provide for improved imaging visualization or for
insulation.
[0252] The localizing device can be can be oriented and configured
from any arc between a 12 o'clock to 12 o'clock full 180 degree arc
or rotation, the anchor can consist of one or multiple tines or
projections, the localizing device can consist of but is not
restricted to a threaded, beaded, barbed, looping, angled, curved
spiral or circular or straight structure. In one embodiment the
localizing device can be screwed into or out of the target tissue
such as the parathyroid gland. In another embodiment the localizing
device can be coated with a material that is organic and
dissolvable or which can be metabolized by the organism over time
and which can also be stripped from the localizing device by a
guiding mechanism preferably percutaneous such that when the
localizing device is implanted it fixes itself in the target tissue
such as the parathyroid gland but if needed the localizing device
can be removed by stripping the localizing device or the localizing
devices coating material with the guiding mechanism and the
stripped material can either be dissolved, metabolized or can be
made of an inert material that can be left in the body without
significant risk to the organism. Some of the coatings can include
but are not restricted to proteins, carbohydrates, fats, minerals,
and other organic or inorganic materials.
[0253] The localizing device can also be used for treatment if the
coating that is stripped from the localizing device is composed of
a material that can suppress the function of the target tissue such
as the parathyroid gland and can consist of but is not restricted
to substances or peptides or peptide analogs to include but not
restricted to portions of the parathyroid molecule which can
include the active portion of the target tissue hormonal gland such
as the parathyroid molecule. For parathyroid function and
homeostasis, molecule or minerals such as Calcium or organic or
inorganic compounds that can bind to receptors such as Sestimibi,
Sensapar (Cinacalcet) or Calcium analog compounds that are related
to the parathyroid receptors can be used to the parathyroid binding
receptors and can utilize methods for reversible or irreversible
attachment.
[0254] The marker or localization device can contain a GPS device
or contain a material that emits or provides for GPS detection.
[0255] The marker can include an LED device.
[0256] The marker or localizing device can have a shape that will
pierce the target tissue but will offer resistance when it is
attempted to remove the marker or localizing device. This can
include but is not restricted to a corrugated shape, a friction
producing shape or a shape where target tissue becomes embedded in
the marker. The resistance can be controlled such that it is not
engaged or activated until the marker or localizing device lies
within the target tissue, parathyroid.
Hooks
[0257] One embodiment can include hooks to secure the parathyroid
gland and these hooks can be non-heat conducting and insulated or
heat conducting. The hooks can include but are not restricted to a
curved single or multi-pronged device that can exit a guiding
needle or catheter and snap open and can also return into the
guiding needle or catheter.
[0258] The hook anchor can be can be oriented and configured from
any arc between a 12 o'clock to 12 o'clock full 180 degree arc or
rotation, the anchor can consist of one or multiple tines or
projections, the hook can consist of but is not restricted to a
threaded, beaded, barbed, looping, angled, curved spiral or
circular or straight structure. In one embodiment the hook can be
screwed into or out of the target tissue such as the parathyroid
gland. In another embodiment the hook can be coated with a material
that is organic and dissolvable or which can be metabolized by the
organism over time and which can also be stripped from the hook by
a guiding mechanism preferably percutaneous such that when the hook
is implanted it fixes itself in the target tissue such as the
parathyroid gland but if needed the hook can be removed by
stripping the hook or the hooks coating material with the guiding
mechanism and the stripped material can either be dissolved,
metabolized or can be made of an inert material that can be left in
the body without significant risk to the organism. Some of the
coatings can include but are not restricted to proteins,
carbohydrates, fats, minerals, and other organic or inorganic
materials.
[0259] Insulating Materials can include but is not restricted to
the following.
[0260] Insulating materials can be used but are not restricted to
the thermal devices, energy delivery, cryo-devices, wires or hooks
or localization devices, or needles, or guiding catheters or
needles or electrodes or antennas and other therapy device or
assisting devices and can include but are not restricted to
vacuums, circulating solids or liquids or gels or gasses, ceramic
materials, high aluminum ceramics (Alumina Ceramic), beryllium,
fiberglass, Zirconium, High Zirconium, adhesives and nansulators,
reinforced carbon-carbon fiber construction (aka carbon-carbon,
abbreviated C/C) is a composite material consisting of carbon fibre
reinforcement in a matrix of graphite, Carbon fibre-reinforced
silicon carbide (C/SiC) is a development of pure carbon-carbon
(C/SiC utilises silicon carbide with carbon fibre, and this
compound is thought to be more durable than pure carbon-carbon),
Fibrous refractory composite insulation (FRCI), LI-900 silica
tiles, made from essentially very pure quartz sand,
High-temperature reusable surface insulation (HRSI), Reaction Cured
Glass (RCG) of which tetrasilicide and borosilicate glass are some
of several ingredients to waterproof the coating
dimethylethoxysilane is injected into the coating (densifying the
tile with tetraethyl orthosilicate (TEOS) also helps to protect the
silica and waterproof), RCC (a laminated composite material made
from graphite rayon cloth and impregnated with a phenolic resin.
After curing at high temperature in an autoclave, the laminate is
pyrolized to convert the resin to carbon. This is then impregnated
with furfural alcohol in a vacuum chamber, then cured and pyrolized
again to convert the furfural alcohol to carbon. This process is
repeated three times until the desired carbon-carbon properties are
achieved the outer layers of the RCC are converted to silicon
carbide. The silicon-carbide coating protects the carbon-carbon
from oxidation.
[0261] Combination and Multiple Devices can be used and can include
but is not restricted to the following.
[0262] In another embodiment multiple devices can be combined to
include but not restricted to hyperthermic devices, hypothermic
devices, mechanical devices, substance delivery such as through a
hollow bore needle, sensory feedback devices and local environment
therapy delivery.
[0263] A Display Screen and/or Protective goggles can include but
are not restricted to the following.
[0264] A viewing screen 105 that can be created to move with and/or
track with the viewers eyes or head or body and in one embodiment
can include but is not restricted to glasses/goggle/mask 105 that
can serve as but is not restricted to a display, screen or visual
representation 110, 102. The visual representation can but are not
restricted to display the images 102 or data 104 from an imaging
device/s 5 or the treatment device/s 75 or diagnostic devices 81.
Imaging sources can include imaging from but not restricted to
ultrasound, MRI, CT scans, thermal or laser imaging. Data sources
can include but are not restricted to energy 100 deposition,
dimensional data such as length and width and depth, temporal data,
devices engaged and sensory feedback 31. The data can be
transmitted by hard-wiring 107 such as but not restricted to cables
and fiberoptics and metal wires or by non-wire sources 103 such as
but not restricted to WI-FI. In addition, the display 105 can have
the form of glasses/goggle/mask 105 that can also protect a portion
of the body or face from in one embodiment the viewers face or
portions of the face 109 from energy 100 or substances 99 that can
include but are not restricted to organic or inorganic substances
99 or energy 100. In one embodiment the protective device 105 and
the viewing device 105 can be combined or can be separate and can
contain unique protections such as but not restricted to
electromagnetic or thermal protections 43. In another embodiment
the protective device 105 and/or the viewing device 105 can
incorporate a seal 112 that can be airtight or watertight or can be
breathable and non-airtight or watertight. The display can be worn
on a portion of the body 107 that can include the face and can be
worn like a helmet of pair of glasses or goggle. In another
embodiment it can be worn and extend from another portion of the
body such as the shoulders or torso or a combination of body parts.
A portion or all of the display/screen/goggles/glasses 105. can be
opaque, transparent or translucent.
[0265] Organism can include but is not restricted to the
following.
[0266] These methods and procedures and uses and devices can be
used for and on and with human and non-human organisms.
[0267] One method for treating the parathyroid gland includes the
use of non-invasive techniques to include but not restricted to
transdermal HIFU and electromagnetic focused energy treatments.
[0268] Another method for treating the parathyroid gland includes
the use of minimally invasive techniques to include but not
restricted to percutaneous techniques that can include but are not
restricted to MW, HIFU, RF, radioactivity, hot and cold lasers.
Medication delivery to include but not restricted to sclerotherapy,
electromagnetic energy and mechanical energy.
[0269] A further object is to provide methods to ablate and control
the parathyroid glands while preserving, or minimally damaging,
adjacent anatomical structures, including vital organs and cellular
tissue, nerves and vessels. In one embodiment, various medications,
radiofrequency (RF) devices and systems, as well as various
therapeutic ultrasound devices and systems can be used alone or
together for the non-invasive or minimally invasive ablation of
parathyroid glands are provided.
[0270] Another method for preserving local tissue while treating
the parathyroid gland can include sensitizing the parathyroid gland
or desensitizing the local tissue with medication and then
subjecting the parathyroid gland to electromagnetic energy that
preferentially treats the parathyroid gland and preserves the
adjacent anatomic structures.
[0271] Another object of the present invention involves the
application of energy or medication or a combination of both to one
or more parathyroid glands to reduce or promote or induce increased
or decreased activity of the treated parathyroid gland as a means
for regulating a patient's hormone and calcium levels and
osteoporosis this can include but is not restricted to placing
pacer wires on the parathyroid gland, placing a catheter in the
parathyroid gland that can increase or decrease blood supply to and
from the parathyroid and thus alter the sensitivity of the
parathyroid hormone release and production.
[0272] Another embodiment includes the localization of the
parathyroid gland for surgery or for non-surgical treatment. One
method can include but is not restricted to the percutaneous
placement of an RF device, a GPS device or a combination of both
for tracing the location of an organ to include but not restricted
to the parathyroid gland. In another method the percutaneous
placement of an electromagnetic energy source, such as a
radiopharmaceutical which can include but is not restricted to Free
Technecium or Technecium bound to Sestamibi or other nucleotides to
include but not restricted to I-123 or I-131, onto or near the
target organ can then be localized using a device to include but
not restricted to a radioactivity detector such as but not
restricted to a pencil probe Geiger counter. In another method the
radioactivity can be combined with another imaging device which can
include but is not restricted to a SPECT-CT or a SPECT-MRI or a
PET-CT. This technique can be used to direct treatment to an
organic structure that can include but is not restricted to the
parathyroid gland.
[0273] Throughout this disclosure the term "treatment" can include
activation, deactivation, modulation, and destruction of organic or
inorganic material. Energy can include any suitable form of energy,
including radiofrequency ablation (RF) and microwave (MW) and laser
(L), Cryotherapy (CryT), Hight Intensity Focused Ultrasound (HIFU),
Radioactive Therapy (Brachytherapy: BrT), Irreversible
Electroporation (IRE), Electrical Current Therapies,
Electrocautery, Magnetic Resonance (MR), Ultrasound, (US). A
deactivating solution is one that diminishes or stops treatment; an
activating substance initiates, augments, or continues treatment;
and a neutralizing substance is one that neutralizes treatments or
eliminates conditions under which treatment may occur. Specific
examples are given throughout without loss of generality. One
example of this is a disclosure that dextrose water can be
delivered via a thermal probe; however, this disclosure is not
limited to the use of a thermal probe. Other suitable means of
delivering dextrose water are also disclosed.
[0274] Throughout this disclosure the following terms are
non-exclusively defined as follows. A sheath can include but is not
restricted to a tube or conduit or guide or guide that may be
hollow or solid. A member can include but is not restricted to a
tube, cylinder, probe wire, guide wire, guide, device and it can be
solid or hollow. A controller can include but is not restricted to
a device that takes an action in response to an input. A measuring
device can include but is not restricted to a sensor, or a device
to measure a quality or quantity of a substance or energy or a
phenomenon or a biological event. A biological function can include
but is not restricted parathyroid hormone activity, temperature,
calcium levels, ionizing calcium, electrolytes, local temperature
around parathyroid, neuronal function (laryngeal nerves), larynx
and innervation, respiratory function, sympathetic and
parasympathetic (primary and secondary) function, arterial flow,
venal flow, brain function, cardiac functions, blood pressure,
chromography, and vital and hormonal and physiologic measurements,
signs and symptoms. Placement of a needle can include but is not
restricted to placement by at least one organism with or without
robotic assistance. The energy delivered and the insulation
experienced at any given moment during treatment by the user's
target and non-target tissue can both vary and can be variable to
include but not restricted to duration, direction, exposure,
periodicity or frequency. The techniques and methods in this
disclosure can be applied to humans or non-human organisms. An
inhibitor is an energy or substance that can alter, modulate,
control, activate, deactivate, or neutralize an energy or a
substance and can include but is not restricted to thermal energy
where an RF device and the heat produced can be inhibited by a cold
or cooled liquid or gel in the vicinity or perimeter tissue or
target tissue; or cold from a cryoprobe device can be inhibited by
a heated liquid or gel or by an RF device that warms the tissue; or
radioactivity from brachytherapy is inhibited by lead or other
elements that restrict radioactivity; or a laser device where the
electromagnetic light energy is inhibited by an opaque or
translucent or semi-opaque material; or an RF device that where the
RF transmission and penetration or inhibited by a substance that
inhibits RF transmission and can include but is not restricted to
Dextrose water or a hydrogel or a low or non-osmolar or non-ionic
compound; or an electrical current that is inhibited by a substance
that prevents electrical transmission that can include but is not
restricted to a non-ionic or low or non-osmolar substance; an acid
that can be inhibited by a base or a base that can be inhibited by
an acid; a sclerosant such as ethanol or sotradecol that can be
inhibited by dilution by saline or water; a carboxylated molecule
that can be inhibited by a decarboxylating enzyme or substance; a
wavelength that can be inhibited by a wavelength with a wavelength
that is has a frequency and amplitude and periodicity that inhibits
the primary or the secondary wavelengths produced that can include
but is not restricted to a second wavelength that is the mirror or
the first wavelength; a phase altering substance that can
metamorphasize from a liquid to a gel and can capture a substance
can include but is not restricted to an enzyme or anti-angiogenic
compound that can be injected into the target tissue and if it
leaks out of the target tissue can then captured and neutralize or
inhibited or denatured; an adhesive that can be deactivated by UV
light; the inhibitor can be at least one energy or a substance that
inhibits the treating energy or a substance. A hormone in its
classic definition refers to a chemical which can be released by a
cell or a gland in one part of the body that sends out signals or
messages or information that can affect cells or tissue or function
in other parts of an organism. A hormone can include but is not
restricted to an organic or inorganic substance or molecule that
can include but is not restricted to a biological substance that
can be produced in an organism from endocrine or exocrine glands,
or from biological tissue that can be ectodermal, mesodermal or
endodermal and which can be composed of or from but not restricted
to any combination of organic substances such as but not restricted
to a peptide, a protein, a fat, a carbohydrate, or a steroid, and
examples can include but are not restricted to parathyroid hormone,
insulin, gastrin, testosterone, estrogen, follicle stimulating
hormone, growth hormone, prolactin; and the hormone can include
inorganic substances that can include but not restricted to a
mineral that can include but is not restricted to Calcium, Zinc,
Iron or Magnesium and said hormone can exhibit or produce or exert
or influence an effect on both local and distance tissue within the
organism.
DETAILED DESCRIPTION OF THE INVENTION AND PREFERRED EMBODIMENT
[0275] Preferred and alternative examples of the present invention
are described in detail below with reference to the following
drawings:
[0276] FIG. 1 is a frontal view, anatomic rendering of the thyroid
and parathyroid glands in the anterior mid neck. There are two
thyroid lobes, which include the right lobe of thyroid 25 and the
left lobe of thyroid 22 and the isthmus of the thyroid 18. Any
portion of the thyroid gland or tissue can be referred to as
thyroid gland or tissue 20. There are four parathyroid glands,
which include the right superior parathyroid gland 10; the right
inferior parathyroid gland 14; the left superior parathyroid gland
12; and the left inferior parathyroid gland 16 or an ectopic
parathyroid gland 15 any individual parathyroid gland or
parathyroid tissue 10 can be referred to include but not restricted
to a normal parathyroid gland or a parathyroid adenoma,
hyperplasia, carcinoma or normal functioning or hypo-functioning or
hyper-functioning parathyroid gland in a typical or an atypical,
ectopic, location. A nerve 19 is depicted on the right specifically
the Recurrent Laryngeal Nerve, but there are numerous nerves 19
bilaterally including the innervating sympathetic and
parasympathetic nerves as well as the traversing Laryngeal Nerves
13 and the Vagus nerve 21, which reside near or in the vicinity 17
of the parathyroid glands 30. The thyroid 20 and parathyroid 30
reside within the neck 03 and are beneath the skin's surface 6 and
are subcutaneous tissue 92. Treatment devices 80 and imaging
devices 5 can be placed on the skin 6 (shown), or through the skin
90 percutaneously (not shown) or non-percutaneously such as but not
restricted to transcutaneously (not shown) in order to treat and or
visualize the target organs, specifically the parathyroid 30 and
the parathyroid tissue 30. Thyroid gland tissue shall generically
be referred to as 20 and Parathyroid tissue or gland shall
generically be referred to as 30.
[0277] FIG. 2 is an isolated parathyroid gland 30 that can
represent but is not restricted to a normal parathyroid gland, an
enlarged normal gland, a hyperplasic gland, an adenomatous gland
and/or a hyper- or hypo or normally functioning functioning gland
30 of the parathyroid 30 or a carcinoma 30. There are arterial
blood vessels that create inflow 32 and veins 34 that provide
outflow of blood from the parathyroid gland 30. The innervating
nerves 19 of the parathyroid 30 are depicted. There is tissue that
surrounds or is in the vicinity 17 of the parathyroid gland 30
[0278] FIG. 3 is a rendering of a device 58 that can be used to
penetrate the skin 90 and the subcutaneous tissue 92 to reach the
parathyroid gland 30. In this embodiment the penetrating device is
configured as a needle, which is pointed or cutting or piercing tip
116 and has a guiding device 50, which can include but is not
restricted to a sheath or catheter that allows repetitive access to
the parathyroid tissue 30.
[0279] FIG. 4 is a rendering of a guiding device 50 with a blunt
end 61 but not restricted to a blunt end. Inside of the guiding
device 50 is a tube/conduit 52 that can have one 54 or more than
one channel 56 for the introduction of substance 99 to include but
not restricted to solids 76, liquids 78 or gasses 77 (not
shown).
[0280] FIG. 5 is a rendering of a guiding device 50 penetrating the
parathyroid tissue 30. There is tube 52, which provides for the
passage of substances 99 to include but not restricted to solids
76, liquids/gels 78 or gases 77 (not shown). The tube/conduit 52 is
in proximity to the parathyroid tissue 30 the artery 32 the nerve
19 and the vein 34. The tube/conduit 52 can include but is not
restricted to a needle, catheter, or a delivery device. In one
embodiment the guide 50, tube/conduit 52 can be a needle 52 can
have but is not restricted to having a groove or mechanical thread
configuration 66 that penetrates the parathyroid 30 with a
screw-like motion or mechanism. The threads/grooves 66 can be on
the inside or the outside or be integral to the structure of all or
a portion of the tube 52, such as but not restricted to the distal
aspect 51 of the tube 52.
[0281] FIG. 6 is a rendering of a guiding sheath 50 penetrating the
parathyroid gland 30. There can be an additional tube 52, which
provides for the passage of substances 99 such as solid 76 or
liquid 78 or gas 77 material(s) and can serve multiple functions to
include but not restricted to insulation for the local tissue. The
tube/conduit 52 is in proximity or can be penetrating the
parathyroid tissue 30) the artery 32 and the vein or nerve (not
shown). The solid device/probe/member 75 can have multiple uses
that include but are not restricted to treatment, localization and
visualization of the parathyroid 30. Treatment device 75 can
include but is not restricted to the delivery of energy 100 such as
but not restricted to electromagnetic energy or mechanical energy
or heat or cold and the viewing or visualizing device 75,81 can
include but is not restricted to a fiberoptic or thermal viewing
device. Traversing or being transported through the tube/conduit 52
can be a solid device/probe/member 75 that can be used to partially
or fully ablate the parathyroid tissue 30 or selectively the
parathyroid arteries 32 or veins or nerves (not shown).
[0282] FIG. 7 is a rendering of a guiding device 50 penetrating the
parathyroid tissue 30. There can be an additional tube 52, which
provides for the passage of a substance 99 to include but not
restricted to a substance to include but not restricted to solids
76, liquids/gels 78 or gases 77 material(s) and can serve multiple
functions to include but not restricted to insulation. The tube 52
is in proximity to the parathyroid tissue 30 the artery 32 and the
vein 34. Traversing the tube/conduit 52 can be a hollow or solid
device 75 that can be used to partially or fully ablate the
parathyroid 30 or the parathyroid arteries 32 or veins 34 or nerves
19 (not shown) that can deliver one or any combination of
substances 99, solids 76, liquids 78 or gasses 77.
[0283] FIG. 8 is a rendering of one embodiment of a transcutaneous
imaging 5 and or energy delivery device 80 for ablating one or more
parathyroid glands 30. The energy transcutaneous delivery device 80
delivers energy 100 through the skin 90 through the subcutaneous
tissue 92 and the target organ 1, the parathyroid gland 30 can be
imaged with a transcutaneous imaging device 5 to ablate parathyroid
tissue 30 preferably while the surrounding tissues 17, anatomical
structures (including, e.g., nerves 19, vessels 32, 34, thyroids
20) are preserved. In one possible embodiment, the transutaneous
energy delivery device 80 can include but is not restricted to HIFU
(is deliverable though a transcutaneous device 80 allowing for the
MIT, TTMIT, or non-invasive, ablation of the parathyroid glands 30.
In this embodiment the device 80 uses energy 100 which can be
electromagnetic or chemical or kinetic energy 100 for either
diagnostic or therapeutic purposes. The treatment device 80 can be
coupled with a diagnostic device 5 or the treatment and the
diagnostic devices that are combined 7 or are not combined. The
energy 100 is directed at the target tissue to include but not
restricted to the parathyroid 30 and can be directed toward its
vascular supply including the arteries 32, veins 34 (not shown) and
the nerves 19. The electromagnetic energy can pass through the skin
90 and subcutaneous tissue 92. A tube or conduit 52, which can
contain one 54 or more 56 channels can be placed through the
transcutaneous imaging 5 or treatment device 80 and within the
tube/conduit 52 can be an additional tube 52, which can be solid or
hollow and can be used for delivery of a substance 99 or energy 100
or can be used for stability or guidance can be or contain a device
75 that can deliver additional substances 99 or energy 100 to the
target tissue 1, the parathyroid gland 30. The tube/conduit 52 can
include and can refer to a but is not restricted to a needle 58, a
stylet 57, a sheath 59, a hook 60, a guide wire 70 a guide sheath
50, a treatment delivery device 75, a sensor 31, a probe 94, or a
percutaneous diagnostic device 81. The term tube 52 or conduit 52
can be used interchangeably and can relate both to a tube 52 or
conduit 52 that can be solid or hollow or a combination of solid
and hollow and can contain one 54 or more channels 56. It is
recognized that a conduit more often can imply a tube that is
hollow and can transport a substance 99 or energy 100 and that a
tube can generically refer to an object that can be either solid or
hollow or a combination of these two elements.
[0284] FIG. 9 is a rendering of a transcutaneous device 80, 5 that
uses electromagnetic or mechanical or kinetic, which can include
but is not restricted to motion and heat thermal energy 100 for
either diagnostic and imaging and visualization or therapeutic
purposes. The energy 100 is directed at the target tissue to
include but not restricted to the parathyroid 30 and can be
directed toward its vascular supply which can include the arteries
32, the veins (not shown) or the nerves 19. The electromagnetic or
mechanical or kinetic energy 100 can pass through the skin 6, 90
and subcutaneous tissue 92. A delivery tube 52 needle 58 or imaging
or treatment device 75 can penetrate the skin 6, 90 and
subcutaneous tissue 92 to reach and can penetrate the target tissue
to include but not restricted to the parathyroid 30 and its
vascular supply 32, and nerves to treat the parathyroid gland 30. A
solid 76, liquid 78 or a gas 77 substance 99 or a combination of
these substances can be delivered to the parathyroid 30. In one
embodiment the guidance of the needle 28, 52 and substance
placement is visualized or measured by the cutaneous 5 imaging
device 80 that can include but is not restricted to an ultrasound,
MR, CT, laser or thermal imager. In another embodiment the device
80 can activate or can deactivate the solid 76, liquid 78 or a gas
77 substance 99. One or more than one device 80 or delivery tube 52
needle 58 or imaging or treatment device 5, 80(shown), 75, 81 can
be used and one or more than one form of energy 100 can be used
alone or in multiple combinations. The local tissue 17 and the
subcutaneous tissue 92 and nerves 19 can be protected from the
delivery of energy 82 or non energetic methods or substances and
can be delivered by multiple methods to include but not restricted
to a delivery tube 52 needle 58 or imaging or treatment device 75
to protect the local tissue 17 in the vicinity of the target tissue
parathyroid 30. A sensor 31 can be used to monitor the local
vicinity non-target tissue 17 or the target tissue 1,30 (not
shown).
[0285] FIG. 10 is a sagittal cross-sectional rendering of the
thyroid 20 and a normal superior parathyroid gland 30 and an
abnormal inferior parathyroid gland 30. The trachea 46 lies
adjacent to and posterior to the thyroid 20 and the two parathyroid
glands 30. The Recurrent Laryngeal Nerve 13 which innervates the
Larynx 47 and the local non target vicinity tissue 17 and organs
46, 15 and nerves 19 can be monitored 31 or protected from the
ablative substances or energetic or non-energetic methods delivered
to the parathyroid gland 30 and the delivery can include but is not
restricted to a tube or conduit 52, needle 58 or imaging or
treatment device 75. A sensing device 31 can include or not include
a sensor sensitive to the delivery device 31 output to inslude but
not restricted to electromagnetic energy or kinetic or mechanical
energy 100 that can include thermal or light or electrical
measurements to include but not restricted to resistance (ohms)
voltage or amperage and said sensor device 31 information and
feedback can be used to protect the non-target vicinity tissue 17
and determine the treatment to the target tissue 1, 30.
[0286] FIG. 11 is a tube or conduit 52, needle 58 for
percutanuously depositing a substance/s 99 to include but not
restricted to solids 76, liquids/gels 78 or gases 77 material(s),
which in the preferred embodiment can include in one embodiment a
standard radioactive seed 63, a radioactive bead 64 that can
measure less than or equal to 1 mm or can be greater than 1 mm or
in another embodiment a biodegradable colloid radioactive 65 for
brachytherapy. In one embodiment there is a stylet 57, which fits
into the hollow needle and in one embodiment governors can be
locking or non-locking and can serve as a delimeter and/or guiding
mechanisms 66 can include but is not restricted to matching treads
53 or ruts, grooves 66 or locking delimeters or governors 67 or can
be without these governors 67 or can be a combination or these
elements such that the stylet can be screwed down or be rotated 36
or advanced 68 into position and can lock and unlock. The stylet 57
and tube/conduit 52 or needle 58 together can have a delimiter or
governor that limits the distance or motion traveled by the stylet
57 and which can adjust to position or seat the treatment substance
99, or brachytherapy 63, 64, 65 into position within the
parathyroid gland 30. A stylet 57 and tube/conduit 52 or needle 58
or device delivery 75 with governors and locking and guiding
mechanisms 66 can be used for non-brachytherapy treatment and
visualization systems.
[0287] FIG. 12 is an example of an energy device 75 that can
utilize but is not restricted to electromagnetic or kinetic or
thermal or mechanical energy or methods and that is composed of an
elongated member that can include but is not restricted to a distal
component where the treatment is delivered and a more mid component
an proximal component that is insulated 43 or where a tube/conduit
52, guiding sheath 50 can be insulated 43.
[0288] The device can penetrate the target tissue, parathyroid
gland 30 and deliver the treatment in a manner that protects the
local vicinity tissue 17. The treatment device 75 can pierce the
skin 90 and subcutaneous tissue 92 in a percutaneuos manner in
order to deliver the treatment. This can be combined with
transcutaneous treatment 80 or imaging device 81 that can include
but is not restricted to diagnostic ultrasound and MR and
thermography and CT or a percutaneous imaging device to include but
not restricted to a fiberoptic or laproscopic or laser imaging
device in order to define the target tissue, parathyroid gland 30.
The energy delivery device 75 can be coupled to energy generator
23. In this embodiment, the energy delivery device 75 and the
energy generator 23 can be coupled together and can receive
feedback or information from a sensing device 31 that can be
integrated into the member of the energy delivery device 75 or the
sensor can be separate from the energy delivery device and can lie
in or near the parathyroid 30 or in the vicinity non-target tissue
17 and the sensor 31 can serve as a controller of the
treatment.
[0289] FIG. 13 is an embodiment of a tube/conduit 52 or needle 58
or guiding sheath 50 that can include one channel/lumen 54 or more
than one channel or lumen 56 that extend through at least a
portion, or the entire length, of the tube/conduit 52 or needle 58
and can contain one or more channels. One or more channels can be
configured as pathways used for the delivery of solids 76, liquids,
gels 78 or gasses 77. Channels 54, 56 can be used for
localization/visualization of tissue 30 or treatment or a
combination of either or both localization/visualization or
treatment and permit the passage or transport of substances 99 or
devices 75, 31, 81 to treat the target tissue parathyroid gland 30
and monitor with a sensor 31 and protect the vicinity non target
tissue 17 with a substance 99.
[0290] FIG. 14 is an embodiment of a percutaneous device 75 and a
guiding tube 50 that can combine hot thermal 98 and cold thermal 96
energy for treatment. The combination of differing thermal elements
can be switched on and off to control the precise temperature,
which can include a sensing device 31.
[0291] FIG. 15 a is an embodiment of an energy delivery device 75
to include but not restricted to a laser, RF, or microwave probe
that can have an energy 100 delivery device probe component 94 and
an insulating 43 component that can be fixed or not fixed. In this
embodiment an insulated 43 guiding tube/conduit 50 can also assist
in altering the energy delivery.
[0292] FIG. 15 b is an embodiment where the relationship of the
energy delivery device 75 or probe component 94 and the insulating
component 43 and the guide 50 are not fixed and the treatment
device 50 can be advanced/retracted 68 or rotated 36 relative to
the insulation 43 and the guide 50 or any combination of movements
of the insulation or the guide or the treatment device relative to
the each other.
[0293] In FIG. 15c one embodiment can include a laser treatment
device 75 and two conduits 52 that are insulated 43 that contain
openings or fenestrations 37 that can include but are not
restricted to slits or holes 37 that serve as fenestrations 37 or
windows 37 to the laser light. When the conduit fenestrations 37
are not aligned the amount of light or heat escaping the two
conduits 52 and reaching the target tissue 30, 1 (not shown) is
more limited than when the fenestrations 37 are aligned. In one
embodiment the two tubes/conduits 52 can be configured in a
logarithmic pattern with strategic cut-outs that can be
moved-linearly 68 or rotated 36.
[0294] FIG. 16 is an embodiment in which the target tissue,
parathyroid gland 30, contains percutaneously place a treatment
device 75 and a tube/conduit/catheter 52 or needle 58 can treat the
local vicinity tissue 17 with a substance 99 or energy 100, which
can include but is not restricted thermal cold 96 or heat 98.
Either with or without the actual treatment of the vicinity tissue
with thermal cold 96 or heat 98, the instillation of a cold 96 or
body temperature or heated 98 substance such as but not restricted
to a liquid 78 such as but not restricted to dextrose water this
method can act as a heat-sink to protect the local vicinity tissue
17.
[0295] FIGS. 17a and b are a simplified diagram of the zone of
ablation. The treatment device is placed into the target tissue 1,
30 and a central area adjacent to the probe 94 or treatment device
75 causes irreversible ablation 38. In the MIT there are multiple
zones of ablation that are of intermediate or partial damage to the
vicinity tissue 17 beyond the target tissue 1, 30 and extending
into the vicinity or local non-target tissue 17. With TTMIT the
energy deposition 100 or the substance deposition 99 (not shown) or
the local protective treatment (not shown) are designed to reduce
the vicinity or local non-target tissue 17 to as minimal an area as
possible even possible at the reduced effectiveness of the
treatment of the target tissue 30,1. In FIG. 17a the zone of
irreversible ablation 38 affects both the parathyroid 30 target
tissue 1 and the vicinity tissue 17. In FIG. 17 b only the
parathyroid 30 target tissue 1 is affect and the parathyroid tissue
may even be incompletely ablated 38 but the vicinity tissue 17 is
partially or completely spared from ablation 38.
[0296] FIG. 18a is an embodiment of one probe or device or FIG. 18b
multiple probes within the target tissue 1 parathyroid gland. This
embodiment can include one or more probes and is dependent on the
size of the target tissue 1, parathyroid gland 30 that is being
treated and on the treatment device being used. In one embodiment
such as but not restricted to Irreversible Electroporation (IRE)
two or more electrodes/probes/members/tines 75, 94 are utilized and
the electromagnetic energy, current, is transmitted between these
electrodes/probes/members/tines 75, 94. Since IRE does not
effectively coagulate blood vessels a second treatment modality and
device 75 such as but not restricted to electro-cautery may be
needed to coagulate the blood vessels such as the arteries 32 and
veins 34.
[0297] FIG. 19a is a depiction of the temperatures of heating and
their destructive nature. This can be altered by the duration of
time that the target tissue 1, 30 is exposed to these temperatures.
In parathyroid gland 30 treatment, the optimal temperature and
duration of exposure and the number of pulses differs from
malignant tissue ablation since the acceptable percentage of cell
cytolysis can be less with the FIG. 19 b benign parathyroid 30
adenomas than with FIG. 19 c a malignant tumor tissue. The zone of
local vicinity tissue 17 exposures and risks for damage to that
tissue from treatment of a malignant tumor is greater with the
malignant tumor tissue than the benign tissue because the benign
target tissue treatment can thus be directed and orchestrated to
optimize the safety of local vicinity tissue 17 compared to target
tissue 1, 30 because it is less necessary/critical to achieve high
kill rates in the benign tissue compared to the malignant tissue
especially with a single treatment. In one embodiment example the
parathyroid gland 30 cytolysis is 70% and heating is 70 degrees C.
for 10 minutes with 3 pulses and the local vicinity tissue damage
is 1% wheresas with the tumor the target tissue 1 for the malignant
tumor killing is 99% and the temperature is 100 degrees C. for 10
minutes with 3 pulses but the local vicinity tissue damage is 30%
or greater. This will vary depending on the size of the parathyroid
gland 30 adenoma and its vicinity to critical local tissue 17 and
the modality chosen to treat the parathyroid 30 adenoma.
[0298] FIG. 19a is a simplified temperature scale depicting that at
approximately 46 degree to 56 degrees Celsius biological tissue
begins to experience lethal thermal effects and sensitivity to cell
death at equal or higher temperatures. At approximately 0 degrees
Celsius or lower biological tissue begins to experience lethal
thermal effects 108 and sensitivity to cell death at equal or lower
temperatures.
[0299] FIG. 19b depicts the pararthyroid gland 30 target tissue 1
that is treated with TTMIT such that the parathyroid gland has 90%
ablation 38 and the ablation 38 remains within the parathyroid
gland 30 and the treatment can be effective and reduces the
parathyroid gland 30 hormone elevated levels.
[0300] FIG. 19c depicts a tumor 109 target tissue 1 that is treated
with MIT such that the tumor 109 to be fully treated or ablated 38
must include a 5-10% rim 110 of normal adjacent tissue 17 in order
to have a reasonable possibility that the tumor has been ablated
38. To achieve this degree of ablation 38 and effective treatment
this results in additional collateral damage to additional vicinity
or local tissue 17 beyond the target tissue 109, 1 and beyond the
5-10% zone or rim 111, 17 around the tumor 109,1. In the treatment
of a parathyroid adenoma 30 this form of MIT treatment would damage
the local vicinity tissue such as non-parathyroid tissue such as
but not restricted to arteries 32, veins 34 and nerves 19 and the
trachea 46 and larynx 47.
[0301] FIG. 20 is a delivery device that can include but is not
restricted to a tube/catheter or conduit 52, needle 58 or guide 50
that can have sideholes 35 of variable size that can be greater in
diameter proximal than distal or greater in diameter distal than
proximal or any combination of sizes of sideholes. In one
embodiment the objective is for the sieholes 35 to be greater
diameter distally and smaller proximally such that if a substance
99 that can include a liquid is transported in the conduit 52 there
will be more resistance to the proximal sidehole 35 than the distal
sideholes 35 for the egress of the liquid/gel out of the conduit
52. In another embodiment the sideholes 35 can be larger proximally
to bath the local non-target tissue 17 with liquid/gel 77 or gas 77
and not deliver as much liquid/gel 77 or gas 77 to the target
tissue 1, parathyroid gland 30. The substance can include but is
not restricted to a solid 76 or liquid/gel 77 or gas 77. The end of
the tube/conduit 52 can be open or closed. One use of this
conduit/tube 52 with variable sideholes 35 can be to deliver
variable amounts of substance 99 or energy 100 to the tissue
adjacent to the conduit/tube 52.
[0302] FIG. 21a is a tube or catheter or conduit, needle or guide,
which can have a variable sized distal end hole or the end of a
conduit can be closed and contain no end-hole and be closed at the
distal end. The conduits can be partially or fully composed of
insulation and the insulation can include but is not restricted to
insulation from electromagnetic, thermal, kinetic or mechanical
forces or energy. In one embodiment a laser energy delivery device
can reside within an insulator tube/catheter or conduit which can
have a variable sized holes and can modulate or alter the lasers
effect upon the target tissue, including the parathyroid gland. In
FIG. 21b in one embodiment there can use side-holes or
fenestrations that can be of variable size and shape including
geometric and non-geometric and logarithmic and logarithmic paper
shapes or cut-outs on a logarimthic pattern an can include one or
more than one a tube/catheter or conduit, needle or guide, which
can have a variable sized distal hole and a guide or sheath that is
closed at the distal end and these insulating tubes or conduits can
move or rotate to expose greater or lesser amounts of the energy
treatment or substance for treatment to the target tissue,
parathyroid gland. This embodiment can include a laser treatment
device and two conduits that contain openings that can include but
are not restricted to slits or holes that serve as fenestrations or
windows to the laser light. When the conduit fenestrations are not
aligned the amount of light or heat escaping the two conduits and
reaching the target tissue is more limited than when the
fenestrations are aligned. This can also be organized on a
logarithmic graph pattern with cut out slits that can tightly
control the amount of light that is emitted to the target tissue. A
tube/catheter or conduit 52, needle 58 or guide 50, which can have
a variable sized distal hole or a sheath 59 closed at the distal
end. The insulation 43 can include but is not restricted to
insulation from electromagnetic, thermal, kinetic or mechanical
forces or energy. In one embodiment a laser energy delivery device
75 can reside within an insulator 43 tube/catheter or conduit 52,
needle 58 or guide 50, which can have a variable sized distal hole
or a sheath 59 closed at the distal end and the insulator 43 can
modulate or alter the lasers effect upon the target tissue 1,
including the parathyroid gland 30. In FIG. 21b in one embodiment
this can be done using sideholes 35 that can be of variable size
and shape including geometric and non-geometric and logarithmic and
logarithmic paper shapes or cut-outs on a logarimthic pattern 61.
One or more than one a tube/catheter or conduit 52, needle 58 or
guide 50, which can have a variable sized distal hole or a sheath
59 closed at the distal end 51 can be used and an insulating 43
device can move or rotate to expose greater or lesser amounts of
the energy 100 or substance 99 treatment to the target tissue 1,
parathyroid gland 30.
[0303] FIG. 22 is a treatment device that delivers a substance 99
to the target tissue 1, the parathyroid or the vicinity tissue 17.
The treatment device 75 can deliver energy and can include a tube
or conduit 52 that can include but is not restricted to a needle 58
or a hollow tube/conduit 52 that can include hole 35 such as
sidehole or endholes that can deliver a substance 99 to the
parathyroid 99, target tissue 1 or the vicinity tissue 17. The
substance 99 is a substance can modulate the function of the target
tissue 1, the parathyroid 30 can include but is not restricted to
peptides or peptide analogs to include but not restricted to
portions of the parathyroid molecule which can include the active
portion of the molecule or minerals such as Calcium or organic or
inorganic compounds that can bind to receptors such as Sensapar
(Cinacalcet), Sestimibi or Calcium analog compounds that are
related to the parathyroid receptors that are the biological
component that can include but are not restricted to the partial or
the full parathyroid hormone or an added component as needed that
can be used on the parathyroid binding receptors and can utilize
methods for reversible or irreversible attachments. The delivery of
the energy 100 or substance 99 can be performed manually or can
include but is not restricted to a delivery device 114 that can
include but is not restricted to contain a sensory controlling
device that receives feedback from the organism's target gland 1,
the parathyroid 30 or from the organism's blood or other organs or
structures that contain biological feedback information with a
sensor 31 that responds the physiologic nature of the organism (not
shown) to include but not restricted to the blood calcium or ionize
calcium levels or parathyroid levels and the delivery device 114
can include a pump 115 that can include a reservoir 112 and can
include an energy generator 23 that can include but is not
restricted to electromagnetic, mechanical, thermal, and kinetic
energy In one embodiment if the parathyroid levels in the blood
increase then a substance 99 such as but not restricted to calcium,
Sestimibi, Sensapar (Cinacalcet) or calcium can be delivered to the
tissue target 1, the parathyroid 30.
[0304] FIG. 23a is a target tissue marker or localizing device that
can be used to include but not restricted to a surgical marker or
localizing device, a percutaneous treatment marker or localizing
device or a transcutaneous treatment marker or localizing device.
The marker or localizing device can consist of a substance solid or
liquid or gel or gas such as but not restricted to methylene blue
and gentian violet, tattoo inks. In FIG. 23b is a fluorescent or UV
sensitive dyes, or fluorescein or in FIG. 23c an injected material
can be metal or a radio-opaque material or FIG. 23d radioactive
material or in FIG. 23e GPS device or an FIG. 23f LED device. The
marker or localizing device can be constructed to screw into the
target tissue. FIG. 23 is a target tissue 1, parathyroid 30
marker/localizing device 40 that can be used to include but not
restricted to a surgical marker/localizing device, a percutaneous
treatment marker/localizing device or a transcutaneous treatment
marker/localizing device. The marker/localizing device 40 can
consist of a substance 99 solid or liquid or gel or gas such as but
not restricted to methylene blue and gentian violet, tattoo inks,
fluorescent light or UV sensitive dyes which can include but are
not restricted to nanoparticles to include but not restricted to
Sol gel derived silica is an excellent host material for creating
fluorescent nanoparticles by the inclusion of covalently-bound
organic dyes, Flourophores that can be organic or inorganic,
Fluorite (also called fluorspar) is a halide mineral composed of
calcium fluoride, CaF2. Gemstones, minerals, may have a distinctive
fluorescence or may fluoresce differently under short-wave
ultraviolet, long-wave ultraviolet, or X-rays, calcite and amber
will fluoresce under shortwave UV. Rubies, emeralds, and the Hope
Diamond exhibit red fluorescence under short-wave UV light;
diamonds also emit light under X ray radiation, Vitamin B2
(fluoresces yellow), quinine (blue), ninhydrin. And fluorescein or
an injected material can be metal or a radio-opaque material that
can be viewed with x-ray and can include but are not restricted to
calcium, iodine, iron and other metals such as titanium, tungsten,
barium sulphate, and zirconium oxide and in another embodiment the
marker/localizing device can be a radioactive material that is low
dose and used for diagnostic radiology that can include but is not
restricted to Technecium 99m, Iodine 123 and Iodine131 or
Sestamibi99 mTc, which can be percutaneously injected directly into
the Parathyroid gland. A percutaneous injection would have the
advantage over intravenous sestamibi because of the lack of
background counts in organs other than the Parathyroid gland 30
such as the local tissue 17, thyroid and fatty tissue and muscles.
A radiation sensitive probe such as a pencil probe can be used to
locate the Parathyroid gland during surgery more easily and the
marker/localizing devices can contain a GPS device or contain a
material that emits or provides for GPS detection.
[0305] The marker can include an LED device.
[0306] The marker or localizing device can have a shape that will
pierce the target tissue but will offer resistance when it is
attempted to remove the marker or localizing device. This can
include but is not restricted to a corrugated or angulated or
curved or spiral shape, a friction producing shape or a shape where
target tissue becomes embedded in the marker. The resistance can be
controlled such that it is not engaged or activated until the
marker or localizing device lies within the target tissue,
parathyroid. In one embodiment the marker can be composed of a
metallic alloy such as nitenol that can straighten when thermally
stressed with hot or cold and at biological temperatures is
corrugated or angulated or curved or spiral in shape.
[0307] The marker or localizing device can be constructed to screw
into the target tissue.
[0308] FIG. 24a is a guide/wire/placement device 70, a stylet 57 or
a tube 52 or needle 58 that can leave a marker/localizing device 40
in the target tissue 1, parathyroid. In one embodiment the
marker/localizing device 40 can contain a transitional zone 45 that
contains a transitional state sensitive substance 99 that can be
converted from a solid or liquid/gel material that when exposed to
a substance 99 or an energy source such as but not restricted to
electromagnetic energy, kinetic or mechanical or thermal energy or
forces changes its state and can separate from the a more solid or
gel state to a state where the placement device 70 is separated
from the marker/localizing device device 40. In one embodiment the
placement material and the transitional material and the
marker/localizing device can all be metallic and if energy 100 such
as an electrical current or a thermal force is transmitted though
the placement wire the transitional zone 45 will separate from the
marker/localizing device. In another embodiment the placement
device material 70 can be composed of a gel that when cold 96
remains solid but when heated 98 the transitional zone will melt or
dissolve after a given period of time and separate from the
marker/localizing device 40.
[0309] FIG. 24b is a placement device that can have groove/threads
66 that when turned or moved in the proper manner will
unthread.
[0310] FIG. 24 c is an embodiment where the gel can take on
crystalline characteristics and become more rigid or less rigid
when exposed to electromechanical or kinetic or mechanical
energy.
[0311] FIG. 24 d is an embodiment of a marker/localizing device 40
can be placed into the target tissue 1, the parathyroid gland 30
and the marker/localizing device can be attached to a continuous
filament/thread 38 that can be made of a material that can be
organic but not restricted to silk, cotton or hemp or inorganic
such as but not restricted to carbon filaments or metal.
[0312] FIG. 24e is an embodiment of a marker/localizing device 40
can be placed into the target tissue 1, the parathyroid gland 30
that can be changed in shape by and energetic or thermal energy or
substance 99 to include but not restricted to being straight to
pierce the parathyroid 30 target tissue 1 and can take on a shape
that creates resistance to being removed such as a corrugated
shape.
[0313] FIG. 24 contains a guide or guide wire or placement device,
a stylet or a tube or needle that can be left in or can leave a
marker/localizing device in the target tissue, the parathyroid
gland. In one embodiment the marker/localizing device can contain a
transitional zone that when exposed to a substance or energy. The
placement device can have groove/threads that when turned or moved
in the proper manner will unthread. In one embodiment the gel can
take on crystalline characteristics and become more rigid or less
rigid when exposed to electromechanical or kinetic or mechanical
energy. In another embodiment a marker/localizing device can be
placed into the target tissue, the parathyroid gland 30 and the
marker/localizing device can be attached to a continuous filament
or thread that can be made of a material that can be organic but
not restricted to silk, cotton or hemp or inorganic material such
as but not restricted to carbon or carbon-carbon filaments, nylon
or rayon, or plastic or metal. A marker or localizing device can
have a shape that will pierce the target tissue but will offer
resistance when it is attempted to remove the marker or localizing
device. This can include but is not restricted to a corrugated or
angulated or curved or spiral shape, a friction producing shape or
a shape where target tissue becomes embedded in the marker. The
resistance can be controlled such that it is not engaged or
activated until the marker or localizing device lies within the
target tissue, parathyroid. In one embodiment the marker can be
composed of a metallic alloy such as nitenol that can straighten
when thermally stressed with hot or cold and at biological
temperatures is corrugated or angulated or curved or spiral in
shape.
[0314] FIG. 25 is an embodiment in which a guide 50, guide wire 52,
wire/thread 53, placement device 70, a stylet 57 or a tube 52 or
needle 58 or hooks 60 or probes/tines/electrodes 94 can have
transitional physical characteristics and can be composed of
transitional materials that can include but are not restricted to
metallic alloys such as but not restricted to nitenol, transitional
gel and can be incorporated into the marker/localizing device 40
but can also be used separately without a marker or localizing
device 40.
[0315] FIG. 25a depicts a tube/catheter or conduit 52, needle 58 or
guide 50, guide 50, guide wire 52, wire/thread 53, placement device
70, or a stylet 57, that can be solid or hollow or can have one or
more channels 54,56 and when exposed to energy 100 or substance 99
that can include thermal energies such as but not restricted to
cold becomes rigid and when exposed to heat becomes flexible.
[0316] FIG. 25b depicts a hook 60 or probes/tines/electrodes 94
that can be solid or hollow or can have one or more channels 54,54
and when exposed to energy 100 or substance 99 that can include
thermal energies such as but not restricted to cold becomes rigid
and when exposed to heat becomes flexible.
[0317] FIG. 26 is an insulated tube/catheter or conduit 52, needle
58 or guide 50, guide 50, guide wire 52, wire/thread 53, placement
device 70, or a stylet 57, the insulation 43 can include but is not
restricted to a vacuum FIG. 26a or a substance solid wall.
[0318] FIG. 26b or a wall with one 54 or more 56 channels. The
insulation 43 can include a vacuum, or gases or liquids or gels or
solids that can include but is not restricted to ceramic materials,
high aluminum ceramics (Alumina Ceramic), beryllium, fiberglass,
Zirconium, High Zirconium, adhesives and nansulators, reinforced
carbon-carbon fiber construction (aka carbon-carbon, abbreviated
C/C) is a composite material consisting of carbon fibre
reinforcement in a matrix of graphite, Carbon fibre-reinforced
silicon carbide (C/SiC) is a development of pure carbon-carbon
(C/SiC utilises silicon carbide with carbon fibre, and this
compound is thought to be more durable than pure carbon-carbon),
Fibrous refractory composite insulation (FRCI), LI-900 silica
tiles, made from essentially very pure quartz sand,
High-temperature reusable surface insulation (HRSI), Reaction Cured
Glass (RCG), a nansulatecoating, Polytetrafluoroethylene (PTFE) or
fluoropolymer of tetrafluoroethylene or a hypophillic or
hydrophobic material, ultra-high-molecular-weight polyethylene
(UHMWPE) or mineral oil or molybdenum disulfide embedded as
additional lubricants in the needles matrix
[0319] FIG. 26c is a chamber that can be filled with a substance 99
that can include a solid or liquid or gel or gas, or chambers that
can circulate substances to form a heat sink can include are but
not restricted to a substance 99 to include solids, liquids and
gels and gasses or a vacuum.
[0320] FIG. 27 is an embodiment in which a guide 50, guide wire 52,
wire/thread 53, placement device 70, a stylet 57 or a tube 52 or
needle 58 is placed into of adjacent to the target tissue a hooks
60 or probes/tines/electrodes 94 can be used to maintain the
position of the target tissue 1, parathyroid gland 30. In one
embodiment a form of positive pressure is created inside the target
tissue 1, parathyroid gland 30. One embodiment can include but is
not restricted to the placement of a substance 99 to include one or
any combination of substances including but not restricted to
solids 76, liquids 78 or gasses 77 or positive or negative pressure
or vacuums into the target tissue 1, parathyroid gland 30. This can
be used in combination or conjunction with an energy 100 device or
source. In another embodiment the pressure exerted inside of the
parathyroid can be negative pressure which can use of a substance
99 to include one or any combination of solids 76, liquids 78 or
gasses 77 or a vacuum 79 exerted upon the target tissue 1,
parathyroid gland 30. This can be used in combination or
conjunction with an energy 100 device or source or a combination of
positive and negative pressure. FIG. 27a represents overall
positive pressure and FIG. 27b is negative pressure.
[0321] FIG. 28 is an embodiment of a a tube or conduit 52 that can
include but is not restricted to a guide 50, guide wire 52,
wire/thread 53, placement device 70, a stylet 57 or needle 58 or
hooks 60 that can be composed of a carbon-carbon or ceramic based
structure with a tensile strength that can be greater than, less
than, or equal to equivalent to a similar device with the standard
metal qualities for a similar use. In one embodiment the
component/s that pierce can be composed of a but not restricted to
diamond or zirconium and can include but are not restricted to the
leading edge or tip 116. The surfaces inner or outer can be
lubricated or made of a material with a low coefficient of friction
117. The transition between the body 118 of the tube or conduit 52
proximal to the tip 116 can be a hardened or reinforced 115
material.
[0322] FIG. 29 is an embodiment in which a form of delivery packets
103 or agitating 104 substance 99 can be used to increase or
decrease the effect of an energy 100 source to the target tissue 1.
parathyroid gland 30. The delivery packets 103 or agitating 104
substance 99 can include but is not restricted to liposomes 101 or
microbubbles 102.
[0323] FIG. 29a is an embodiment in which a form of delivery
packets 106 or agitating substance 106 can be delivered
percutaneously or non-percutaneously and can be used to deliver a
substance 99 such as medication to ablate the target tissue 30,1.
In FIG. 29a the substance delivered through the delivery packet
does not require a second substance 99 or energy source 100 for
activation.
[0324] In FIG. 29b the substance 99 delivered through the agitation
substance 106 or delivery packet 106 does require a second
substance 99 or energy 100 source for activation.
[0325] In FIG. 29c the substance 99 delivered through the agitation
substance 99 or delivery packet 106 does require a second substance
99 or energy source 100 for activation and the energy source can
through a transcutaneous device 80 such as but not restricted to
ultrasound and HIFU. In one embodiment agitation of the delivery
packets 103 can create ablation and treatment of the target tissue
1, the parathyroid gland 30.
[0326] FIG. 30 is an embodiment of a viewing screen 105 that can be
created to move with and/or track with the viewers eyes 120 or head
or body and in one embodiment can include but is not restricted to
glasses/goggle/mask 105 that can serve as but is not restricted to
a display, screen or visual representation 121, 122. The visual
representations can include but are not restricted to displaying
the images 122 or data 123 from an imaging device/s 5, 75,81,80 or
the treatment device/s 75 or diagnostic devices 80, 81 or sensor or
feedback devices 31 into receivers 124. Imaging sources can include
imaging from but not restricted to ultrasound, MRI, CT scans,
thermal or laser imaging. Data sources can include but are not
restricted to energy 100 deposition, dimensional data such as
length and width and depth, temporal data, devices engaged and
sensor feedback 31. The data can be transmitted by hard-wiring 119
such as but not restricted to cables and fiberoptics and metal
wires 119 or by non-wire sources 107 such as but not restricted to
WI-FI. In addition, the display 105 can have the form of
glasses/goggle/mask 105 that can also protect a portion of the
surface or depth of the body or face or of the skin 6, 90. In one
embodiment the viewers face or portions of the face 109 can be
protected from energy 100 or substances 99 that can include but are
not restricted to organic or inorganic substances 99 or energy 100.
In one embodiment the protective device 105 and the viewing device
105 can be combined or can be separate and can contain unique
protections such as but not restricted to electromagnetic or
insulating/thermal protections 43. In another embodiment the
protective device 105 and/or the viewing device 105 can incorporate
a seal or barrier 125 that can lie between the
display/screen/goggles/glasses 105 and the user's skin or body part
that can be airtight or watertight or can be breathable and
non-airtight or watertight but provide a protective cushion or
interface that prevents energy 100 or substances from reaching the
user to include but not restricted to the user's skin 90 or eyes
120 or face or other body parts. A portion or all of the
display/screen/goggles/glasses 105 can be opaque, transparent or
translucent. The goggles can be specially hardened to resist
mechanical debris 99 or energy 100. The display of the imaging of
the parathyroid 30 target tissue 1 or data 123 can include but is
not restricted to the image being displayed or projected on the
screen 105 or can be displayed or projected onto the retina 121 or
can be displayed onto an eternal lens such as but not restricted to
a contact lens 126.
DETAILED DESCRIPTION
[0327] The general location of parathyroid glands inside a
patient's neck skin and trans-cutaneous tissue and nerves. As
illustrated, there are usually four, pea-sized parathyroid glands,
usually located near the thyroids. In the present invention,
devices, systems and methods for applying energy (percutaneously or
transcutaneously) to a treatment location within, or adjacent, to
one or more of these parathyroid gland, in order to ablate them, or
alternatively, to increase glandular functioning (as facilitated by
the application of non-ablative energy to said treatment location)
are provided. These methods, systems and devices can further be
employed as techniques and methods for treating a variety of
parathyroid-based or related diseases, including but not limited
to: hyperparathyroidism, hypercalcemia, and hypoparathyroidism.
[0328] For purposes of this disclosure, the parathyroid glands
shall in general be referenced as 30.
[0329] For purposes of this disclosure, "ablation" refers to one or
more of the following affects, including but not limited to:
thermal tissue damage; tissue destruction; tissue shrinkage; tissue
scarring; tissue swelling; tissue remodeling; resection or any
process that results in the reduction or altered function, membrane
disruption, altered blood flow, cellular death or de-bulking of the
parathyroid gland 30.
[0330] In addition, "energy" refers to any form of energy,
including various forms of electromagnetic energy, such as:
radiofrequency (RF) energy; therapeutic ultrasound energy;
microwave, laser, x-ray, or optical energy; magnetism, head and
cryrotherapy; or any combination thereof. Energy shall also refer
to mechanical energy to include but not restricted to Brownian
movement, heat, freezing, crotherapy, cutting, tearing, crushing,
spinning, piercing, poking prodding, dividing, removing and
segregating or any combination thereof. Nevertheless, for ease of
illustration, and not limitation, the specific devices and systems
facilitating the treatment methods provided herein, in general
employ RF or ultrasound energy or laser or piercing or mechanical
energy to induce the desired effect in one or more glands.
Medication refers to organic and non-organic agents to include but
not restricted to solids 76, liquids 78 or gasses 77 that can
ablate or alter the function of the parathyroid gland 30 directly
or indirectly.
[0331] Altered function refers to either increasing or decreasing
or modulating the function of the parathyroid gland 30.
[0332] Visualization of the anatomy can be performed using an
imaging device 5 that can include but not restricted to ultrasound,
x-ray, CT scans, MRI, visual or not visual light sources. The
imaging device can include but is not restricted to percutaneous or
can be trascutaneous intravascular
[0333] A parathyroid gland 30 can be represented as a normal, an
enlarged gland, a hyperplasic gland, an adenomatous gland and/or a
hyper-functioning gland of the parathyroid 30. There are arterial
blood vessels that create inflow 32 and veins 34 that provide
outflow of blood from the parathyroid gland. The innervating nerves
19 of the parathyroid 30.
[0334] A device can be used to penetrate the skin 90 and the
subcutaneous tissue 92 to reach the parathyroid gland. One
embodiment can include a needle 58, which is pointed and has a
guiding sheath 50, which allows repetitive access to the
parathyroid tissue 30.
[0335] In one embodiment of treatment is percutaneous where a
device punctures the skin 90 to access the parathyroid gland
through the transdermal tissue 92. Such percutaneous access can
utilize but is not restricted to the use of a needle 58 or guiding
sheath/tube/catheter 52. Other forms of percutaneous access can
include but are not restricred to a knife, a probe or a glass or
plastic or fiberoptic tube. The puncture device can be hollow such
as but not restricted to a tube. The puncture device can be solid
such as but not restricted to a pointed needle 58, solid knife,
member or probe.
[0336] A guiding sheath 50 can have a pointed or a blunt end 61.
Inside of the sheath 50 can be a tube 52 that can have one 54 or
more than one 56 channel for the introduction of solids 76, liquids
78 or gasses 77.
[0337] The guide shealth or introduction probe device can have
rounded margins and can be but not restricted to a cylinder or
ellipse or have pointed margins and can include but is not
restricted to a needle 58 or catheter 50. The guide and
introduction probe device can have but is not restricted to
non-rounded margins and can be polygonal with multiple flat
surfaces and can be but not restricted to triangular, a square, a
rectangle or pentagon shaped or can have a combination of rounded
and square surfaces or can be pointed with one of multiple pointed
surfaces or can be pointed with one of multiple flat or blunt
surfaces.
[0338] The guide/introduction probe device 50 can have one 54 or
multiple channels 56. Said channels can be solid or hollow or can
be a combination of solid and hollow. The hollow channel can be
filled with or transmit a solid 76 or liquid 78 or gas 77. Each of
the channels can have the same or different uses and purposes. One
channel can be used for visualization of the parathyroid and the
second channel can be utilized for treatment and/or treatment of
the parathyroid. In another embodiment but not restricted to this
embodiment, there can be two channels with one channel used for
visualization of the parathyroid and the second channel can be
utilized for biopsy of the parathyroid. Channels can have multiple
combinations of uses.
[0339] In another embodiment but not restricted to this embodiment,
there can be two channels one channel can be used for treatment of
the parathyroid and the second channel can be utilized for biopsy
of the parathyroid. In this example shown the visualization is
external and one channel 54 is used for biopsy and the other
channel is used for introduction of medication 99.
[0340] In another embodiment but not restricted to this embodiment,
there can be more than two channels in which one channel can be
used for treatment of the parathyroid and the second channel can be
utilized for biopsy of the parathyroid and a third channel can be
used for visualization (not shown). This visualization can be with
a fiberoptic tube/camera, an ultrasound probe but is not restricted
to ultrasound and/or fiberoptic visualization.
[0341] A guiding sheath 50 penetrating the parathyroid tissue 30
can have an accessory tube 52, which provides for the passage of
solids 76, liquids 78 or gasses 77 material(s) 99. The tube 52 is
in proximity to the parathyroid tissue 30 the artery 32 the nerve
19 and the vein 34. This provides for direct insinuation of the
solids 76, liquids 78 or gasses 77 material into the parathyroid
tissue 30 without leakage outside of the parathyroid gland 30. The
tubes, which can include but are not restricted to the guiding
sheath 50 and accessory tube 52 can, include methods for securing
the tube to the tissue including permanent or retractable
burs/projections and screw like threads.
[0342] In association with the sheath 50 there can be an additional
tube 51, which provides for the passage of solid 76 or liquid 78 or
gas 77 material(s) and can serve multiple functions to include but
not restricted to insulation. The tube 52 is in proximity to the
parathyroid tissue 30 the artery 32 and the vein or nerve (not
shown). The solid device/probe/member can have multiple uses that
include but are not restricted to treatment, localization and
visualization of the parathyroid 30. Traversing the tube/conduit 52
is a solid device/probe/member that can be used to partially or
fully ablate the parathyroid tissue 30 or the parathyroid arteries
32 or veins or nerve (not shown).
[0343] Methods for external device and internal probe/member/device
75 visualization can include but are not restricted to fiber-optic,
ultrasound, thermographic, motion detection chromographic, blood
flow detection, x-ray, ultraviolet, infrared as well as other
detectors using the electromagnetic spectrum or kinetic/mechanical
imaging or measuring devices. The visualization of the parathyroid
30 can occur on the skin 90 or within the body to include but not
restricted to the subcutaneous tissue 92, blood vessels (34,32),
hollow organs, orifices and other body parts (not shown) that can
serve as windows of visualization.
[0344] The abnormal parathyroid 30 glands are usually an orange
color and this unique quality can be used to visualize the abnormal
parathyroid gland using a color/chromographic detection technology
to include but not restricted to transcutaneous, precutaneous,
within the body or a combination of the above forms of imaging. The
color identification system can involve using a light or energy
source that is external or internal and that can be detected
externally or internally or any combination of the above.
[0345] One method depicted in FIG. 6, is a probe/member/device 75
that can be used as a method for treatment of the parathyroid
tissue 30 that can utilize a probe/member/device 75 that can
include but not restricted to electromagnetic energy;
radiofrequency energy; photoelectric energy; laser energy to
include but not be restricted to hot lasers and cold lasers and
intermediate lasers; ultraviolet energy, infrared energy,
radioactive energy or x-ray energy in its various
configurations.
[0346] In another method a probe/member/device 75 that can be used
as a method for treatment of the parathyroid tissue 30 that can
utilize a probe/member/device 75 that can include but not
restricted to the forms of mechanical/kinetic energy including but
not restricted to ultrasound energy including but not restricted to
high frequency ultrasound (HIFU); heat, including but not
restricted to laser directed heating; a direct heat source
including but not restricted to metal or ceramic materials or a
combination of different metals and ceramic materials; cold,
including but not restricted to laser directed cooling or freezing
device; a direct cooling or freezing source including but not
restricted to metal or ceramic materials or a combination of
different metals and ceramic materials; dry ice, hot or cold solids
76, liquids 78 or gasses 77.
[0347] With a sheath 50 penetrating the parathyroid tissue 30,
there can be an additional tube 52, which provides for the passage
of solids 76, liquids 78 or gasses material(s) and can serve
multiple functions to include but not restricted to insulation. The
tube 52 is in proximity to the parathyroid tissue 30 the artery 32
and the vein 34. Traversing the tube/conduit 70 can be a hollow
device 75 that can be used to partially or fully ablate the
parathyroid 30 or the parathyroid arteries 32 or veins (not shown)
that can deliver one or any combination of solids 76, liquids 78 or
gasses 77.
[0348] One method can include parathyroid treatment that can
utilize but not restricted to the many forms of chemical agents to
include solids 76, liquids 78 or gasses 77 that can include but are
not restricted to sclerosing agents that can include but are not
restricted to ETOH, Bleomycin, Tetracycline and Doxycycline;
chemical reactions that induce heat or cold; direct injection or
heated materials to include but not restricted to heated metal;
direct injection of cooling or freezing agents to include but not
restricted to dry ice solid carbon dioxide and liquid nitrogen; the
expansion of tissue interrupting blood flow by increasing the
tissues internal pressure such that the tissue pressure approached
or exceeds arterial systolic and diastolic pressure or whereby the
venous channels become obliterated thus trapping blood and
preventing egress of blood outside of the parathyroid tissue thus
decreasing both venous outflow and arterial inflow with agents to
include but not restricted to water or gels (not shown) or solids
76, liquids 78 or gasses 77 to include but not restricted to
oxygen, carbon dioxide and nitrogen. Agents that can poison the
parathyroid tissue 30 can include but are not restricted to solids
76, liquids 78 or gasses 77 including but not restricted to
ammonia, arsenic, acids and bases. The agents and techniques
described in FIG. 7 can be directed to other tissue in the vicinity
of the target tissue to include but not restricted to nerves 19 or
subcutaneous tissue 92 to obtain similar effects.
[0349] Another method is the treatment of the parathyroid tissue,
by introducing the treatment agent to the parathyroid gland 30 and
local tissue 92, or at or in the parathyroid tissue 30 or the
parathyroid feeding vessels 32,34 and nerves 19, including but not
restricted to the arteries and veins can utilize but not restricted
to bleeding agents and devices, such that the bleed occurs inside
of the parathyroid and increases the pressure inside of the
parathyroid and perturbs blood flow into or out of the parathyroid
and ultimately destroys either a part or all of the parathyroid
gland.
[0350] In another method, treatment of the parathyroid tissue can
include introducing the treatment agent to the local tissue, or at
or in the parathyroid tissue or the parathyroid feeding vessels
32,34, including but not restricted to the arteries 32 and veins 34
can utilize but not restricted to clotting agents and devices, such
that the clot occurs inside of the parathyroid and increases the
pressure inside of the parathyroid and perturbs blood flow into or
out of the parathyroid and ultimately destroys either a part or all
of the parathyroid gland 30.
[0351] In another method the treatment of the parathyroid tissue
30, by introducing the treatment agent to the local tissue 92, or
at or in the parathyroid tissue 30 or the parathyroid feeding
vessels (32, 34) or nerves 19, can utilize but not restricted to
the many forms of poisoning of the parathyroid tissue to include
but not restricted to chemical agents both inorganic and organic
agents to include but not restricted to biological agents such as
but not restricted to parathyroid directed antibodies or antibodies
to the agents specific to the parathyroid; serum or blood that has
incompatibility with the patient such as but not restricted to
blood type A, B, O, AB or RH factors positive or negative;
biochemical agents such as but not restricted to angio-toxic agents
that damage blood vessels such as but not restricted to
thalidomide; and inert agents to include but not restricted to
chemical poisons such as but not restricted to arsenic, and sulfur.
Expansile agents such as but not restricted to hydro-gels; bleeding
agents such as platelet and clotting factor inhibitors; clotting
agents such as but not restricted to kaolin and zeolite.
[0352] Another method is the treatment of the parathyroid tissue
30, by introducing the treatment agent to the local tissue 92, or
at or in the parathyroid tissue 30 or the parathyroid feeding
vessels (32, 34) or nerves 19, can utilize but not restricted to
the many forms of macro, micro, and nano technology whereby the
parathyroid tissue is disturbed in a manner that makes it
non-functioning by using masceration of tissue, grinding of tissue,
destruction of tissue through friction or cutting or piercing
through mechanic methods or through the deposition of energy that
can include but is not restricted to electromagnetic and
kinetic/mechanical energy.
[0353] The treatment of the parathyroid tissue 30, by introducing
the treatment agent to the local tissue 92, or at or in the
parathyroid tissue 30 or the parathyroid feeding vessels (32, 34)
or nerves 19, can utilize but not restricted to inject of
antibodies in the blood stream that target the parathyroid 30.
Organic and inorganic agents can be used that modulate or poison or
make the parathyroid gland inactive or destroys a component or all
of the parathyroid gland 30.
[0354] In another method the abnormal parathyroid gland 30 can be
exposed to one of more treatment agent that can be activated when
exposed to another treatment agent. In one example a energy
activated poison can be activated when the parathyroid tissue 30 is
exposed to energy that can include energies such as but not
restricted to electromagnetic energy and kinetic/mechanical energy
and can include but are not restricted to the photo sensitive or
radioactive, ultrasonic or heat or cold sensitive poisons that are
exposed to the proper electromagnetic spectral wavelength,
ultrasonic wavelength, heat or cold from an external device (5, 80)
or an internal device 75. In another example one agent can be
protective and can modulate the treatment agent while the other
agent can be the active treatment that. In another example one
agent can be an adjuvant facilitating or increasing the
effectiveness of the treating agent. In another example one agent
can slow or stop the reaction of the treating agent.
[0355] In one embodiment the treatment of the parathyroid 30 can be
performed using a coagulation agent's device. The coagulation
agent's device can be on the skin 6 the coagulation agents device
can be external and separated from the skin with or without a
membrane or substance that bridges the coagulation agents and the
skin 6. The coagulation agent's device can be internal relative 92
to the body and below the surface of the skin 90. Coagulation
agent's device can lie on or near the surface of the parathyroid in
order to treat the parathyroid 30. The coagulation agent's device
can puncture the parathyroid 30 to treat the parathyroid 30. The
coagulation agent's device device can lie on or near the surface of
a parathyroid artery 32 or vein 34 in order to ablate the
parathyroid blood flow. The coagulation agent's device 75 can
puncture a parathyroid artery 32 or vein 34 in order to ablate the
parathyroid blood flow. The coagulation agent's device can fully or
partially ablate the parathyroid. The coagulation agent's device
can fully or partially ablate the artery 32 or vein 34 to the
parathyroid.
[0356] Antibody agent (antiparathyroid antibody either produced
from patients parathyroid or generic). In one embodiment the
parathyroid treatment can be performed using an antibody agent. The
antibody agent delivery device 75 can puncture the parathyroid to
ablate the parathyroid. The antibody agent delivery device 75 can
lie on or near the surface of a parathyroid artery 32 or vein 34 in
order to treat the parathyroid blood flow. The antibody agent can
puncture a parathyroid artery 32 or vein 34 in order to ablate the
parathyroid blood flow. The antibody agent can fully or partially
ablate the parathyroid the antibody agent can fully or partially
ablate the artery or veins to the parathyroid. The antibody agent
can be delivered systemically to include but not restricted to
being delivered in an artery 32 or vein 34.
[0357] In one embodiment the treatment of the parathyroid 30 can be
performed using a medication delivery system device (75, 77, 80).
Medication can include but is not restricted to sclerosing agents,
sensipar, antibodies, modulating agents to include but not
restricted to agents that stimulate the parathyroid genome, and
Calcium and Vitamin D that suppress the protective agents such as
but not restricted to anti-radiation and anti-oxidation agent,
bases and acids. The medication delivery system device (75, 80) can
be on the skin. The medication delivery system device (75,80) can
be external and separated from the skin with or without a membrane
or substance that bridges the medication delivery system device
(75, 80) and the skin 90. Medication delivery system device (75,
77, 80) can be internal relative to the body 92 and below the
surface of the skin 90. Medication delivery system device (75, 80)
can lie on or near the surface of the parathyroid in order to
ablate the parathyroid. The medication delivery system device (75,
80) can puncture the parathyroid to ablate the parathyroid 30. The
medication delivery system device (75, 80) can lie on or near the
surface of a parathyroid arteries 32 or veins 34 in order to ablate
the parathyroid blood flow. The medication delivery system device
(75, 80) can puncture a parathyroid arteries 32 or veins 34 in
order to ablate the parathyroid blood flow. The medication delivery
system device (75, 80) can fully or partially ablate the
parathyroid the medication delivery system device (75, 80) can
fully or partially ablate the artery or veins to the parathyroid.
The medication delivery system device (75, 80) can deactivate the
parathyroid either by destroying the gland rapidly or over a more
prolonged period of time. The medication delivery system can
decrease parathyroid functions without destroying the gland. The
medication can be titrated to insure proper parathyroid levels
within the body. The medication delivery device can treat the local
tissue 92, the nerves 19, the arteries 32 or veins 34. The
medication can be protective to the parathyroid 30 or it can
modulate function or it can be destructive.
[0358] One embodiment can include but is not restricted to an
energy delivery device 75, 80 for ablating one or more parathyroid
glands 30. The energy delivery device 75, 80 delivers energy 100 to
ablate parathyroid tissue 30 preferably while surrounding tissues
17, anatomical structures (including, e.g., nerves 19, vessels 32,
thyroids 20) are preserved. In one possible embodiment, energy
delivery device 75, 80 comprises an elongated member having an
energy 100 delivery member disposed at a distal end thereof. In one
possible implementation, one or more lumens extend through a
portion, or the entire length, of elongated member and are
configured as pathways for the used for the delivery of delivery of
solids 76, liquids 78 or gasses 77. The energy delivery device is
deliverable though a transcutaneous device 80 allowing for the
minimally invasive, or non-invasive, ablation of the parathyroid
glands 30. The energy delivery member can be coupled to energy
generator 23. In this embodiment, the energy delivery device 80 and
the energy delivery device can be coupled together. In this
embodiment, energy delivery device 26 comprises other device
components; including controller 7 coupled to feedback sensors
disposed on the distal end of energy delivery device.
[0359] In one embodiment the device uses electromagnetic energy 100
for either diagnostic or therapeutic purposes. The energy is
directed at a body tissue to include but not restricted to the
parathyroid 30 and can be directed toward its vascular supply
including the arteries 32, veins (not shown) and the nerves. The
electromagnetic energy can pass through the skin 6 and subcutaneous
tissue 92. In one embodiment one of the channels can be used for
localization/visualization of tissue 27.
[0360] In one embodiment of an energy delivery device delivers
energy to ablate tissue of the target tissue, preferably while
surrounding tissues, anatomical structures (including, e.g., nerves
19, vessels 32, thyroids 20, 22) adjacent glands 30 are
preserved.
[0361] In one possible embodiment, the energy delivery device 80
comprises an elongated member having an energy delivery member that
can be exposed at its distal end. In one possible implementation
the active component of the energy delivery probe can use cables or
connectors, catheters, guidewires, pullwires, insulated wires,
optical fibers, and/or imaging devices, feedback systems, to expose
the energy delivery component relative to the insulated component.
In a preferred embodiment, the energy delivery device is
deliverable though an imaging device through a tube or conduit 52
or guide 50 and can include but is not restricted to an endoscope,
catheter, and introducer device, allowing for the tightly targeted
minimally invasive, or non-invasive, ablation of target tissue 1.
The energy delivery probe can be coupled to an energy generator
23.
[0362] In one embodiment, an energy delivery member, or at least a
portion or that device, can be directly inserted into gland 30 to
facilitate contact between the delivery device probe and the target
tissue 1, the parathyroid gland.
[0363] In another embodiment, energy delivery member may be a RF
probe comprising a monopolar or bipolar or multipolar electrode(s)
coupled to a distal end of a probe. The distal end of the RF probe
can be configured to be directly inserted into parathyroid gland 30
facilitating direct contact between the one or more RF electrodes
and glandular tissue 30.
[0364] As will be readily appreciated by one skilled in the art,
several techniques can be implemented to facilitate identification
and location of glands 30 to be treated or ablated. In one possible
implementation, and as a described in U.S. Pat. No. 6,263,232,
glands 30 may be identified and located through radio-labeling and
employing one or more radioactivity sensors coupled to energy
delivery device to detect them. In the present, preferred
embodiment, energy delivery device comprises one or more
radioactivity sensors coupled to the distal end; thus allowing for
detection of a radiolabel administered to the patient prior to, or
during, the treatment procedure and accumulated in glands 30
facilitating identification, location and treatment thereof.
[0365] In yet another possible implementation, standard
visualization techniques, including: ultrasound; MRI; and/or CT
imaging (just to name a few), can be separately or simultaneously
employed to aid in the identification and location of parathyroid
glands 30 to be treated or ablated. In this embodiment, the energy
delivery device is image-guided to the appropriate location where
energy delivery can be initiated. A user viewable monitor is
coupled to energy delivery device to facilitate image-guidance of
energy delivery device.
[0366] In yet another embodiment, image and radio-guidance
techniques can be implemented together to ensure identification,
location and position of energy delivery device.
[0367] In yet another embodiment, energy delivery device comprises
other device components, including controller coupled to feedback
sensors disposed on the distal end of energy delivery device.
Controller is configured to receive and process one or more signals
from feedback sensors disposed on the distal end of energy delivery
device. Feedback sensors provide signals, which can be processed to
regulate one or more of the following processes, including but not
limited to: energy delivery; extent of tissue ablation; termination
of energy delivery, etc. Said feedback sensors can be configured to
detect, and/or, monitor, for example, tissue temperatures, tissue
impendence, electrical signals or nerve impulses. Yet another
feedback mechanism, which can be employed to regulate one or more
of the processes described above, includes periodic vocalization
from the patient, before, during or after the treatment. As will be
readily appreciated by those skilled in the art, period
vocalization can be used to ensure no or minimal vocal cord
paralysis as a result of treatment.
[0368] In a further embodiment, a patient's parathyroid hormone
serum levels and/or calcium levels can also be monitored (before,
during and/or after treatment) to assist in the regulation of the
energy delivery process, as well as, determine the appropriate
extent of tissue ablation or stimulation. For instance, parathyroid
gland 30 can be ablated until a detectable decrease in a patient's
parathyroid hormone or calcium levels are reached. Alternatively,
glands 30 can be stimulated until an increase in a patient's
parathyroid hormone levels are detected.
[0369] One general method of using energy delivery device includes
advancing a guiding catheter, endoscope, introducer or other like
device through, a preferably small puncture or incision on the
patient's skin until the distal tip of said
catheter/endoscope/introducer is seated adjacent to the parathyroid
gland 30 to be treated. Image and/or radio-guidance, as provided
above, can be employed to position said
catheter/endoscope/introducer adjacent gland 30 to be treated.
[0370] Energy delivery device is then introduced though the
catheter/endoscope/introducer and the distally located energy
delivery member positioned to affect ablation or treatment of the
parathyroid gland 30. When energy delivery device or energy
delivery member is adequately positioned, energy, for example high
frequency electrical energy, to include but not restricted to MW,
IRE, laser and in the RF range, is directed through energy delivery
member to the one or more RF electrodes or probes to the
parathyroid gland 30 to ablate the target tissue or form an
ablative lesion of a desired size and shape. Typically high
frequency electrical energy levels of about 5 to about 100 Watts,
preferably about 30 to about 70 Watts, are suitable to ablate
tissue. Typical lesions formed are about 3 mm to about 20 mm in
diameter and about 3 mm to about 20 mm in length. As will be
readily apparent to one skilled in the art, these operational
parameters can be modified and the system configured in order to
facilitate the suitable partial or whole ablation of one or more
parathyroid glands. Other generally suitable devices and system
that can also be employed are described in U.S. Pat. No. 6,016,452,
U.S. application Ser. No. 10/621,839, U.S. Pat. No. 6,494,886 the
contents of which are hereby incorporated by reference. As
discussed, various feedback sensors and monitoring techniques may
be employed to regulate or monitor energy delivery.
[0371] Another implementation of energy delivery device for the
partial or complete ablation of one or more parathyroid glands 30.
In this embodiment, energy delivery device is configured as a
percutaneously inserted probe 24 as described in co-pending U.S.
patent application Ser. No. 10/671,417 filed Sep. 24, 2003, the
contents of which are hereby incorporated by reference in their
entirety. Similar to energy delivery device, probe is preferably
configured to be introducible though an endoscope, catheter,
introducer or other like device to facilitate the non-invasive, or
minimally invasive, delivery of said probe. As further described in
co-pending U.S. patent application Ser. No. 10/671,417, insertable
probe 24 can be used to ultrasonically ablate tissue using
therapeutic ultrasound energy or high intensity focused ultrasound
energy ("HIFU" energy). As described above, the probe, is image
and/or radio-guided to glands 30 and one or more feedback
mechanisms is employed for purposes of: controlling energy
delivery, ensuring controlled ablation of tissue, determining an
endpoint of the treatment, etc. as provided above. The probe can
house at a minimum therapeutic acoustic transducers (or emitters),
which, when actuated by an energy generator 23, transmit
therapeutic ultrasound or HIFU energy sufficient to ablate
glandular tissue.
[0372] Another embodiment of energy delivery device allows for the
transcutaneous ablation of the parathyroid gland 30. As will be
readily appreciated by one skilled in the art, one of the design
advantages of utilizing therapeutic ultrasound energy or high
intensity focus ultrasound ("HIFU") is that the ultrasound energy
may be deposited to a remote location without damaging intervening
tissues or structures. This is accomplished by focusing the
therapeutic ultrasound energy or HIFU to a focal location as
generally HIFU employs high-intensity convergent, or "focused,"
ultrasound energy, or beams (generated by a high power ultrasound
transducers or therapeutic tranducers), to affect tissue heating
and ablation. In this implementation, HIFU is intended to allow
ablation of parathyroid tissue without damaging intervening and
surrounding tissue, eliminating the need for incisions or insertion
of devices, etc. and any resulting complications. Moreover, the
size or volume of tissue to be ablated may be optimized and/or
changed depending on the specific operational parameters
(frequency, phasing/timing, voltages) or drive strategies employed
to activate the high power or therapeutic transducer. General
descriptions of various therapeutic or HIFU devices and systems
that generally may be adopted to ultrasonically ablate a
parathyroid gland are provided in U.S. Pat. Nos. 5,354,258;
5,150,711; 6,685,639; 6,508,774; 6,217,530; 5,995,875; 6,016,452;
6,666,835; and 6,656,136 the entire contents of which are hereby
incorporated by reference.
[0373] An energy delivery device is adapted to transcutaneously
focus therapeutic ultrasound energy to a focal location within a
parathyroid gland to ablate tissue. In this embodiment, energy
delivery device generally comprises an ultrasound applicator
housing at least one ultrasound transducer or transducer assembly
configured to emit therapeutic ultrasound energy or HIFU when
actuated by an energy generator. The ablative therapeutic
ultrasound energy or HIFU energy is delivered through a patient's
skin to the treatment location on the gland. The treatment, or
duration in which energy is applied, can change or be optimized
according to the amount, extent or volume of tissue 30 to be
ablated. Generally, the ultrasound applicator is placed against the
patient's neck and configured to be hand-held for easy
manipulability.
[0374] As with the other devices, the transcutaneous energy
delivery device can incorporate various other devices and system
components which may aid in the identification and localization of
glands and/or for the controlled delivery of ablative energy. In
one embodiment, energy delivery device can be configured to allow
for image-guidance of the therapeutic ultrasound energy to the
gland 30. In yet another embodiment, radio-guidance of the
therapeutic ultrasound energy may be implemented. Various
strategies that can be further implemented for directing the
appropriate amount or dose of therapeutic ultrasound energy to
treat or ablate one or more glands 30 are provided in U.S. Pat.
Nos. 4,922,917; 6,425,867; and 6,726,627 the entire contents of
which are hereby incorporated by reference.
[0375] In accordance with yet another aspect of the invention,
devices and systems described herein can be adapted to allow for
the delivery of non-ablative energies thus facilitating the
stimulation of glandular function and providing a treatment for
hyperparathyroidism.
[0376] While the present invention has been described in detail
with reference to preferred embodiments thereof, it will be
apparent to one skilled in the art that various changes can be
made, and equivalents employed, without departing from the scope of
the invention. For example, the described methods can be
implemented for the treatment of other glands, such as the adrenal
gland.
[0377] In another embodiment a device that uses electromagnetic or
mechanical energy for either diagnostic or therapeutic purposes.
The energy is directed at a body tissue to include but not
restricted to the parathyroid 30 and can be directed toward its
vascular supply which can include the arteries 32, the veins (not
shown) or the nerves 19. The electromagnetic or mechanical energy
82 can pass through the skin 90 and subcutaneous tissue 92. A
delivery tube/needle 84 can penetrate the skin 90 and subcutaneous
tissue 92 and the target tissue to include but not restricted to
the parathyroid 30 and its vascular supply and nerves (not shown,
in this embodiment the arteries 32. A solid 76, liquid 78 or a gas
77 substance or a combination of these substances can be delivered
to the parathyroid. In one embodiment the guidance of the needle
and substance placement is visualized or measured by the device 80.
In another embodiment the device 80 can activate or deactivate the
solid 76, liquid 78 or a gas 77 substance. More than one device or
delivery tube/needle can be used or multiple combinations of these
devices or delivery tube/needles 52,58 or electromagnetic or
mechanical energies 80 can be used (not shown). The local
subcutaneous tissue 92 and nerves 19 can be modified using by the
delivery of energy 80 or substance 99, non-energetic methods to
protect the local tissue which in this embodiment is the
subcutaneous tissue.
[0378] In one embodiment the parathyroid gland may be over
functioning, normal functioning or under functioning. A method for
modulation which can include stimulation or reduction or cessation
of the parathyroid gland 30 is described which can be temporary or
permanent. A form of parathyroid pacemaker can be used to modulate
the parathyroid function. This can be used for the treatment of an
overactive parathyroid causing osteoporosis or an under-active
parathyroid or a normal parathyroid that needs to be stimulated to
induce bone growth and development. Even though the parathyroid
gland when over-active will reduce bone mineral, the parathyroid
gland 30 does control osteoclast and osteoblast activity and when
timed and dosed in the proper many can induce an equilibrium that
may increase bone growth. This can be done using parathyroid
hormone release alone or in combination with organic substances
such as but not restricted to parathyroid hormone, calcitonin,
growth hormone, peptides, hydroxyapetitie and can be use with
inorganic substances such as but not restricted to Calcium,
Phosphorus and other bone minerals. The substances and the
stimulation can be used together in multiple combinations and with
multiple temporal relations or stimulation and delivery.
[0379] In one embodiment energy which can include but is not
restricted to electromagnetic and mechanical energy and can be used
to stimulate the parathyroid gland 30. This can be performed by
stimulating the nerves 19, the arteries 32, the veins 34 and the
parathyroid tissue 30 or any combination of these structures.
[0380] In one embodiment, non energy substances, which can include
but is not restricted to parathyroid hormone, a component of the
parathyroid hormone, a new derivative peptide with the elements of
the parathyroid hormone and contains the active amino acid
sequence, and neurotransmitters can be used to stimulate the
parathyroid gland 30. This can be performed by stimulating the
nerves 19, the arteries 32, the veins 34 and the parathyroid tissue
30 or any combination of these structures.
[0381] The modulation, activating and de-activating methods which
include but are not restricted to medication/substance or energy
source can be instilled into the parathyroid or around the
parathyroid or from the skin in a transcutaneous manner.
[0382] In one embodiment the energy source and the energy can be
placed on the skin or near the skin but not through the skin near
the parathyroid.
[0383] In this embodiment a substance/medication that has been
delivered to the parathyroid must be activated or de-activated by
the energy source. The delivery method of the substance can be but
is not restricted to a delivery method that includes through a
blood vessel (intravenous or intra-arterial); or through a needle
to include through the skin or subcutaneous tissue; or via a
transcutanous method. The substance/medication 99 can utilize and
organic substance such as but not restricted to a targeted antibody
or cell receptor; or a non organic substance such as but not
restricted to an element or molecule such as but mot restricted to
Calcium; a medication to include but not restricted to sestamibi or
Sensipar (cinacalcet).
[0384] In one embodiment there can be more than one substance that
must act in concert with the energy to prevent local tissue damage.
These substances can be dependent upon each other for activation
prior to, after or during energy activation.
[0385] In another embodiment the energy source and the energy can
be placed or delivered to or near the parathyroid using a
percutaneous; transcutaneous technique such that the energy source
is within; or in direct contact with the parathyroid; or intimate
but not into or in direct contact with the parathyroid gland.
[0386] In another embodiment, the energy source and the energy can
be placed through a blood vessel and delivered to or near the
parathyroid using a technique such that the energy source is
within; or in direct contact with the parathyroid; or intimate but
not into or in direct contact with the parathyroid gland.
[0387] In one embodiment there can be one or multiple energy
sources.
[0388] In another embodiment there can be one or multiple
medication/substances.
[0389] By combining one or a combination of substances and one or a
combination of energies or energy sources or one or more delivery
systems the parathyroid can be modulated, activated, de-activated
or even ablated over time from disuse and the ablation can be
partial or complete or the parathyroid can be induce to grow and
increase its function especially in patients with under-active
parathyroid glands which can occur but not restricted to aggressive
surgical resection, transplantation of the parathyroid gland 30, or
prior radiation that damages the parathyroid gland 30.
[0390] One embodiment can include a method to activate or
de-activate the treatment effect on the parathyroid 30 and
surrounding tissue 17 or can have any combination or modulation or
variation of activation and deactivation on the parathyroid 30 or
local tissue 17 by altering the effects of the medication/substance
or energy source on the parathyroid 30 or local tissue 17. The
treatment agent can be energy and can include but is not be
restricted to electromagnetic or mechanical/kinetic energy. The
treatment agent can be a substance that can be but is not
restricted to a medication that can be but is not restricted to
organic or non-organic and can be instilled into the parathyroid
gland 30 or around the parathyroid local tissue 17 by using a
method that can be but is not restricted to a percutaneous
technique to include but not restricted to a needle; an osmotic
method to include but not restricted to DMSO or ultrasonic
activated lipophilic packets or UV light on a cement-like or glue
like material to include UV light and glass ionomer cement (GIC).
In one embodiment, the energy source and the energy and the
treatment agent can be placed on the skin 6 or near the skin but
not through the skin 6, 90.
[0391] In another embodiment, the energy source and the energy and
the treatment agent can be placed through the skin/percutaneous. In
another embodiment, the energy source and the energy and the
treatment agent can be placed in any combination of through the
skin/percutaneous 92 or not through the skin but rather on the skin
(6, 90). In one embodiment a treating substance/medication that has
been delivered to the parathyroid must be de-activated by the
energy source. The delivery method of the substance can be but is
not restricted to a delivery method that includes through a blood
vessel (intravenous or intra-arterial); or through a needle to
include through the skin or subcutaneous tissue; or via a
transcutanous method. The substance/medication can utilize and
organic substance such as but not restricted to a targeted antibody
or cell receptor; or a non organic substance such as but not
restricted to an element or molecule such as but mot restricted to
Calcium; a medication to include but not restricted to sestamibi or
Sensipar (cinacalcet).
[0392] In one embodiment there can be more than one substance that
must act in concert with the energy to activate or deactivate or
cause or prevent local tissue damage. These substances can be
dependent upon each other for activation or deactivation. Prior to
or after or during energy application.
[0393] In another embodiment, The energy source and the energy can
be placed or delivered to or near the parathyroid using a
percutaneous; transcutaneous technique such that the energy source
is within the parathyroid tissue 30; or in direct contact with the
parathyroid gland 30; or intimate but not into or in direct contact
with the parathyroid gland 30.
[0394] In another embodiment The energy source and the energy can
be placed through a blood vessel and delivered to or near the
parathyroid using a technique such that the energy source is
within; or in direct contact with the parathyroid; or intimate but
not into or in direct contact with the parathyroid gland.
[0395] In one embodiment there can be one or multiple energy
sources.
[0396] In another embodiment there can be one or multiple
medication/substances.
[0397] By combining one or a combination of substances and one or a
combination of energies or energy sources, the parathyroid 30 can
be ablated partially or completely, the parthyroid 30 can be
activated or de-activated or the surrounding tissue 92 and vital
structures to include but not restricted to the vital nerves 19 can
be protected or partially or completely ablated or injured.
[0398] One embodiment uses a protective material in the zone around
the parathyroid 30 that can be activated with or without another
substance/medication or energy and facilitates the protection of
the local tissue 17 which can include but is not restricted to a
weak base if an acid is used to ablate the parathyroid 30.
[0399] One embodiment uses a destructive material in the
parathyroid 30 that can be activated with or without another
substance/medication or energy and facilitated the destruction of
the parathyroid which can include but is not restricted to UV light
and glass ionomer cement to ablate the parathyroid 30.
[0400] In one embodiment the treatment can be performed by Radio
Frequency Ablation Device (RFAD). Utilizing parathyroid imaging
including an internal device 75 or an external device 80 that can
include but is not restricted to ultrasound device directed to
identify the hyper-functioning parathyroid gland 30.
[0401] Examples of methods of treatment can include but are not
restricted to:
[0402] In one embodiment the treatment device can include but is
not restricted to an RF treatment device in which the energy is
directed into the body utilizing imaging that can include but is
not restricted to ultrasound and the RF energy is focused to treat
the organ to include but not restricted to the parathyroid gland
30.
[0403] In one embodiment the treatment can be performed using an
internal device 75. The Radiofrequency device can be internal
relative to the body and below the surface of the skin (6, 90) and
within the body parts that can include but is not restricted to
subcutaneous tissue, hollow organs. blood vessels, orifices and
other body parts or a combination of these body parts that provide
access to the parathyroid 30. The Radiofrequency device can lie on
or near the surface of the parathyroid in order to treat the
parathyroid 30. The Radiofrequency device 75 can puncture the
parathyroid 30 to treat the parathyroid or it can enter a body part
that is a hollow organ or orifice or a combination of these body
parts. The Radiofrequency device can lie on or near the surface of
a parathyroid artery or vein in order to treat the parathyroid 30.
The Radiofrequency device can puncture a parathyroid artery or vein
in order to ablate the parathyroid blood-flow. The Radiofrequency
device can fully or partially ablate the parathyroid 30 The
Radiofrequency device can fully or partially ablate the artery or
veins or nerves to the parathyroid or damage the local tissue in
and near the parathyroid 30.
[0404] In another embodiment the Radiofrequency device 75 can be on
the skin. The Radiofrequency device 75 can be external 80 and
separated from the skin with or without a membrane or substance
that bridges the Radiofrequency and the skin.
[0405] In one embodiment the treatment can be performed by High
Frequency Ultrasound (HIFU) utilizing parathyroid imaging including
an internal device 75 or an external device 80 that can include but
is not restricted to ultrasound device directed to identify the
hyper-functioning parathyroid gland 30.
[0406] In one embodiment the treatment device can include but is
not restricted to an HIFU treatment device in which the energy is
directed into the body utilizing imaging that can include but is
not restricted to ultrasound and the HIFU energy is focused to
treat the organ to include but not restricted to the parathyroid
gland 30.
[0407] In one embodiment the treatment can be performed using an
internal device 75. The HIFU device can be internal relative to the
body and below the surface of the skin (6, 90) and within the body
parts that can include but is not restricted to subcutaneous
tissue, hollow organs. blood vessels, orifices and other body parts
or a combination of these body parts that provide access to the
parathyroid 30. The HIFU device can lie on or near the surface of
the parathyroid in order to treat the parathyroid 30. The HIFU
device 75 can puncture the parathyroid 30 to treat the parathyroid
or it can enter a body part that is a hollow organ or orifice or a
combination of these body parts. The HIFU device can lie on or near
the surface of a parathyroid artery or vein in order to treat the
parathyroid 30. The HIFU device can puncture a parathyroid artery
or vein in order to ablate the parathyroid blood-flow. The HIFU
device can fully or partially ablate the parathyroid 30 The HIFU
device can fully or partially ablate the artery or veins or nerves
to the parathyroid or damage the local tissue in and near the
parathyroid 30.
[0408] In another embodiment the HIFU device can be on the skin.
The HIFU device can be external and separated from the skin with or
without a membrane or substance that bridges the HIFU and the
skin.
[0409] An Electromagnetic device (EMD) can include but is not
restricted to Radiofrequency ablation (RF) and microwave (MW) and
laser (L), Cryotherapy (CryT), Hight Intensity Focused Ultrasound
(HIFU), Radioactive Therapy (Brachytherapy: BrT), Irreversible
Electroporation (IRE), Electrical Current Therapies,
Electrocautery, Magnetic Resonance (MR), Ultrasound, (US), Thermal
energies both heat 98 and cold 96. And EMD can be used with
mechanical or kinetic energies and with adjuvant combinations that
can include but are not restricted to medication delivery,
Medication packets, blood flow reduction, Chemical and Medication
Ablation, Activation and Deactivation and Modulation Therapy,
Adhesives and Glues and Molecular Crystal and Lattice therapies,
Target Tissue Delivery Device Therapies, Peptide and Biological
Conversion Therapies, MR and RF and Magnetic External Heating
Therapies, Hyperthermia with Adjuvant Therapy, Hypothermia with
Adjuvant Therapy, Local protective therapy in the Vicinity of the
Target Organ Therapy, Suction and Expansion Therapy, Positive
Pressure and Expansion Therapy, Mechanical Ablation Therapy and
Combinations of Therapies.
[0410] In one embodiment the ablation can be performed using an
Electromagnetic Energy Delivery Device (EMED). The EMED can deliver
continuous energy The EMED can deliver non-continuous energy to
included but not restricted to pulsed energy. The EMED can deliver
continuous energy that can be modulated to increase of decrease the
energy delivered. The EMED can deliver non-continuous energy that
can be modulated to increase of decrease the energy delivered.
[0411] In one embodiment the treatment can be performed by (EMED)
utilizing parathyroid imaging including an internal device 75 or an
external device 80 that can include but is not restricted to
ultrasound device directed to identify the hyper-functioning
parathyroid gland 30.
[0412] In one embodiment the treatment device can include but is
not restricted to an EMED treatment device in which the energy is
directed into the body utilizing imaging that can include but is
not restricted to ultrasound and the EMED energy is focused to
treat the organ to include but not restricted to the parathyroid
gland 30.
[0413] In one embodiment the treatment can be performed using an
internal device 75. The EMED device can be internal relative to the
body and below the surface of the skin (6,90) and within the body
parts that can include but is not restricted to subcutaneous
tissue, hollow organs. blood vessels, orifices and other body parts
or a combination of these body parts that provide access to the
parathyroid 30. The EMED device (75,80) can lie on or near the
surface of the parathyroid in order to treat the parathyroid 30.
The EMED device 75 can puncture the parathyroid 30 to treat the
parathyroid or it can enter a body part that is a hollow organ or
orifice or a combination of these body parts. The EMED device can
lie on or near the surface of a parathyroid artery or vein in order
to treat the parathyroid 30. The EMED device can puncture a
parathyroid artery or vein in order to ablate the parathyroid
blood-flow. The EMED device can fully or partially ablate the
parathyroid 30 The EMED device can fully or partially ablate the
artery or veins or nerves to the parathyroid or damage the local
tissue in and near the parathyroid 30.
[0414] In another embodiment the EMED device 80 can be on the skin.
The EMED device can be external and separated from the skin with or
without a membrane or substance that bridges the EMED and the
skin.
[0415] In one embodiment the ablation can be performed using a
laser device. The laser device can be a Laser (Hot or Cold or
Intermediate) Device.
[0416] In one embodiment the treatment can be performed by a laser
utilizing parathyroid imaging including an internal device 75 or an
external device 80 that can include but is not restricted to
ultrasound device directed to identify the hyper-functioning
parathyroid gland 30.
[0417] In one embodiment the treatment device can include but is
not restricted to an laser treatment device in which the energy is
directed into the body utilizing imaging that can include but is
not restricted to ultrasound and the laser energy is focused to
treat the organ to include but not restricted to the parathyroid
gland 30.
[0418] In one embodiment the treatment can be performed using an
internal device 75. The laser device can be internal relative to
the body and below the surface of the skin (6, 90) and within the
body parts that can include but is not restricted to subcutaneous
tissue, hollow organs, blood vessels, orifices and other body parts
or a combination of these body parts that provide access to the
parathyroid 30. The laser device 75 can lie on or near the surface
of the parathyroid in order to treat the parathyroid 30. The laser
device 75 can puncture the parathyroid 30 to treat the parathyroid
or it can enter a body part that is a hollow organ or orifice or a
combination of these body parts. The laser device can lie on or
near the surface of a parathyroid artery or vein in order to treat
the parathyroid 30. The laser device can puncture a parathyroid
artery or vein in order to ablate the parathyroid blood-flow. The
laser device can fully or partially ablate the parathyroid 30 The
LASER device can fully or partially ablate the artery or veins or
nerves to the parathyroid or damage the local tissue in and near
the parathyroid 30.
[0419] In another embodiment the laser device 80 can be on the
skin. The laser device can be external and separated from the skin
with or without a membrane or substance that bridges the laser and
the skin.
[0420] In one embodiment the ablation can be performed using a
mechanical/kinetic/vibrational energy (KME) device which can
include but is not restricted to the use or production of heat 98
or cold 96 or brownian or vibrational motion.
[0421] In one embodiment the treatment can be performed by (KME)
utilizing parathyroid imaging including an internal device 75 or an
external device 5 that can include but is not restricted to
ultrasound device directed to identify the hyper-functioning
parathyroid gland 30.
[0422] In one embodiment the treatment device can include but is
not restricted to an KME treatment device in which the energy is
directed into the body utilizing imaging that can include but is
not restricted to ultrasound and the KME energy is focused to treat
the organ to include but not restricted to the parathyroid gland
30.
[0423] In one embodiment the treatment can be performed using an
internal device 75. The KME device can be internal relative to the
body and below the surface of the skin (6,90) and within the body
parts that can include but is not restricted to subcutaneous
tissue, hollow organs, blood vessels, orifices and other body parts
or a combination of these body parts that provide access to the
parathyroid 30. The KME device 75 can lie on or near the surface of
the parathyroid in order to treat the parathyroid 30. The KME
device 75 can puncture the parathyroid 30 to treat the parathyroid
or it can enter a body part that is a hollow organ or orifice or a
combination of these body parts. The KME device can lie on or near
the surface of a parathyroid artery or vein in order to treat the
parathyroid 30. The KME device can puncture a parathyroid artery or
vein in order to ablate the parathyroid blood-flow. The KME device
can fully or partially ablate the parathyroid 30 The KME device can
fully or partially ablate the artery or veins or nerves to the
parathyroid or damage the local tissue in and near the parathyroid
30.
[0424] In another embodiment the KME device 80 can be on the skin.
The KME device 80 can be external and separated from the skin with
or without a membrane or substance that bridges the KME and the
skin.
[0425] In one embodiment the ablation can be performed using a
Thermal device which can be a heating energy device. In one
embodiment the method of therapy is to cauterize the parathyroid
and/or the parathyroid feeding arteries.
[0426] In one embodiment the treatment can be performed by heating
or warming utilizing parathyroid imaging including an internal
device 75 or an external device 5 that can include but is not
restricted to ultrasound device directed to identify the
hyper-functioning parathyroid gland 30.
[0427] In one embodiment the treatment device can include but is
not restricted to an heating treatment device in which the energy
is directed into the body utilizing imaging that can include but is
not restricted to ultrasound and the heating energy is focused to
treat the organ to include but not restricted to the parathyroid
gland 30.
[0428] In one embodiment the treatment can be performed using an
internal device 75. The heating device can be internal relative to
the body and below the surface of the skin (6,90) and within the
body parts that can include but is not restricted to subcutaneous
tissue, hollow organs, blood vessels, orifices and other body parts
or a combination of these body parts that provide access to the
parathyroid 30. The heating device can lie on or near the surface
of the parathyroid in order to treat the parathyroid 30. The
heating device 75 can puncture the parathyroid 30 to treat the
parathyroid or it can enter a body part that is a hollow organ or
orifice or a combination of these body parts. The heating device
can lie on or near the surface of a parathyroid artery or vein in
order to treat the parathyroid 30. The heating device can puncture
a parathyroid artery or vein in order to ablate the parathyroid
blood-flow. The heating device can fully or partially ablate the
parathyroid 30 The heating device can fully or partially ablate the
artery or veins or nerves to the parathyroid or damage the local
tissue in and near the parathyroid 30.
[0429] In another embodiment the heating device can be on the skin.
The heating device can be external and separated from the skin with
or without a membrane or substance that bridges the HEATING and the
skin.
[0430] In one embodiment the treatment can be performed using a
thermal device to include a cooling/freezing device.
[0431] In one embodiment the treatment can be performed by a
cryotherapy or cooling/freezing device utilizing parathyroid
imaging including an internal device 75 or an external device 80
that can include but is not restricted to ultrasound device
directed to identify the hyper-functioning parathyroid gland
30.
[0432] In one embodiment the treatment device can include but is
not restricted to a cooling/freezing treatment device in which the
energy is directed into the body utilizing imaging that can include
but is not restricted to ultrasound and the cooling/freezing energy
is focused to treat the organ to include but not restricted to the
parathyroid gland 30.
[0433] In one embodiment the treatment can be performed using a
internal device 75. The cooling/freezing device can be internal
relative to the body and below the surface of the skin (6,90) and
within the body parts that can include but is not restricted to
subcutaneous tissue, hollow organs, blood vessels, orifices and
other body parts or a combination of these body parts that provide
access to the parathyroid 30. The cooling/freezing device can lie
on or near the surface of the parathyroid in order to treat the
parathyroid 30. The cooling/freezing device 75 can puncture the
parathyroid 30 to treat the parathyroid or it can enter a body part
that is a hollow organ or orifice or a combination of these body
parts. The cooling/freezing device can lie on or near the surface
of a parathyroid artery or vein in order to treat the parathyroid
30. the cooling/freezing device can puncture a parathyroid artery
or vein in order to ablate the parathyroid blood-flow. The
cooling/freezing device can fully or partially ablate the
parathyroid 30 the cooling/freezing device can fully or partially
ablate the artery or veins or nerves to the parathyroid or damage
the local tissue in and near the parathyroid 30.
[0434] In another embodiment the cooling/freezing device can be on
the skin. The cooling/freezing device can be external and separated
from the skin with or without a membrane or substance that bridges
the cooling/freezing and the skin (6,90).
[0435] In one embodiment the treatment can be performed by a
mechanical ablation device utilizing parathyroid imaging including
an internal device or an external device that can include but is
not restricted to ultrasound device directed to identify the
hyper-functioning parathyroid gland 30.
[0436] In one embodiment the treatment device can include but is
not restricted to an mechanical ablation treatment device in which
the energy is directed into the body utilizing imaging that can
include but is not restricted to ultrasound and the mechanical
ablation energy is focused to treat the organ to include but not
restricted to the parathyroid gland 30.
[0437] In one embodiment the treatment can be performed using an
internal device 75. The mechanical ablation device can be internal
relative to the body and below the surface of the skin (6,90) and
within the body parts that can include but is not restricted to
subcutaneous tissue, hollow organs, blood vessels, orifices and
other body parts or a combination of these body parts that provide
access to the parathyroid 30. The mechanical ablation device can
lie on or near the surface of the parathyroid in order to treat the
parathyroid 30. The mechanical ablation device 75 can puncture the
parathyroid 30 to treat the parathyroid or it can enter a body part
that is a hollow organ or orifice or a combination of these body
parts. The mechanical ablation device can lie on or near the
surface of a parathyroid artery or vein in order to treat the
parathyroid 30. The mechanical ablation device can puncture a
parathyroid artery or vein in order to ablate the parathyroid
blood-flow. The mechanical ablation device can fully or partially
ablate the parathyroid 30 the mechanical ablation device can fully
or partially ablate the artery or veins or nerves to the
parathyroid or damage the local tissue in and near the parathyroid
30.
[0438] In another embodiment the mechanical ablation device can be
on the skin. The mechanical ablation device can be external and
separated from the skin with or without a membrane or substance
that bridges the mechanical ablation and the skin (6,90).
[0439] The mechanical ablation device can be formed such that the
majority of sharp or cutting edges are enclosed and that only a
small element or aspect of the cutting surface is exposed this can
include but is not restricted to a tube with a side hole where the
mechanical ablation occurs. The mechanical ablation can include
blades, cutting elements to include but not restricted to diamonds
or other gems or stones, other solids liquids or gasses. These
ablative tools can be performing their task under equal, greater or
less pressure than the body's internal pressure.
[0440] Parathyroid ablation can be directed at the parathyroid
tissue, at the local tissue, to the nerves or at or to the
parathyroid feeding vessels, including but not restricted to the
parathyroid tissue, arteries and veins.
[0441] In one embodiment the ablation can be performed using a
radioactive substance/radioactive seeds device.
[0442] In one embodiment the treatment can be performed using a
radioactive substance including but not restricted to radioactive
seeds device (63,64,65).
[0443] In one embodiment the treatment can be performed by a
radioactive substance including but not restricted to radioactive
seeds device utilizing parathyroid imaging including an internal
device or an external device that can include but is not restricted
to ultrasound device directed to identify the hyper-functioning
parathyroid gland 30.
[0444] In one embodiment the treatment device can include but is
not restricted to an radioactive substance including but not
restricted to radioactive seeds treatment device in which the
energy is directed into the body utilizing imaging that can include
but is not restricted to ultrasound and the radioactive substance
including but not restricted to radioactive seeds energy is focused
to treat the organ to include but not restricted to the parathyroid
gland 30.
[0445] In one embodiment the treatment can be performed using an
internal device 75. The radioactive substance including but not
restricted to radioactive seeds device can be internal relative to
the body and below the surface of the skin (6,90) and within the
body parts that can include but is not restricted to subcutaneous
tissue, hollow organs, blood vessels, orifices and other body parts
or a combination of these body parts that provide access to the
parathyroid 30. The radioactive substance including but not
restricted to radioactive seeds device can lie on or near the
surface of the parathyroid in order to treat the parathyroid 30.
The radioactive substance including but not restricted to
radioactive seeds device 75 can puncture the parathyroid 30 to
treat the parathyroid or it can enter a body part that is a hollow
organ or orifice or a combination of these body parts. The
radioactive substance including but not restricted to radioactive
seeds device can lie on or near the surface of a parathyroid artery
or vein in order to treat the parathyroid 30. The radioactive
substance including but not restricted to radioactive seeds device
can puncture a parathyroid artery or vein in order to ablate the
parathyroid blood-flow. The radioactive substance including but not
restricted to radioactive seeds device can fully or partially
ablate the parathyroid 30 the radioactive substance including but
not restricted to radioactive seeds device can fully or partially
ablate the artery or veins or nerves to the parathyroid or damage
the local tissue in and near the parathyroid 30.
[0446] In another embodiment the radioactive substance including
but not restricted to radioactive seeds device can be on the skin.
The radioactive substance including but not restricted to
radioactive seeds device can be external and separated from the
skin with or without a membrane or substance that bridges the
radioactive substance including but not restricted to radioactive
seeds and the skin (6,90).
[0447] In one embodiment the ablation can be performed using a
laproscopic removal system device, which can include but is not
restricted to laparoscopic surgery. The laparoscopic system can
utilize but is not restricted to an led to light the field and
fiber-optic viewing, fiber-optic lighting and viewing
simultaneously, a tube or channel placed percutaneously.
[0448] In one embodiment the treatment can be performed using a
laparoscopic removal system device.
[0449] In one embodiment the treatment can be performed by using a
laparoscopic removal system device, utilizing parathyroid imaging
including an internal device or an external device that can include
but is not restricted to ultrasound device directed to identify the
hyper-functioning parathyroid gland 30.
[0450] In one embodiment the treatment device can include but is
not restricted to an laparoscopic removal system treatment device
in which the energy is directed into the body utilizing imaging
that can include but is not restricted to ultrasound and the
laparoscopic removal system energy is focused to treat the organ to
include but not restricted to the parathyroid gland 30.
[0451] In one embodiment the treatment can be performed using an
internal device. The laparoscopic removal system device can be
internal relative to the body and below the surface of the skin 6
and within the body parts that can include but is not restricted to
subcutaneous tissue, hollow organs, blood vessels, orifices and
other body parts or a combination of these body parts that provide
access to the parathyroid 30. The laparoscopic removal system
device can lie on or near the surface of the parathyroid in order
to treat the parathyroid 30. The laparoscopic removal system device
can puncture the parathyroid 30 to treat the parathyroid or it can
enter a body part that is a hollow organ or orifice or a
combination of these body parts. The laparoscopic removal system
device can lie on or near the surface of a parathyroid artery or
vein in order to treat the parathyroid 30. The laparoscopic removal
system device can puncture a parathyroid artery or vein in order to
ablate the parathyroid blood-flow. The laparoscopic removal system
device can fully or partially ablate the parathyroid 30 the
laparoscopic removal system device can fully or partially ablate
the artery or veins or nerves to the parathyroid or damage the
local tissue in and near the parathyroid 30.
[0452] In another embodiment the laparoscopic removal system device
can be on the skin. The laparoscopic removal system device can be
external and separated from the skin with or without a membrane or
substance that bridges the laparoscopic removal system and the skin
6,90.
[0453] In one embodiment the treatment can be performed using a
pressure/suction ablation system device.
[0454] In one embodiment a pressure device is constructed to create
negative pressure on the parathyroid gland 30. This negative
pressure reduces the venous 34 outflow from the parathyroid gland
30 and increases the capillary bed pressure and decreases arterial
32 inflow. As a result, the parathyroid tissue 30 will undergo
necrosis from a loss of arterial 32 inflow and tissue edema and
loss of venous 34 outflow, which creates cell death and
necrosis.
[0455] In another embodiment a pressure device is constructed to
create positive pressure on the parathyroid gland 30. This positive
pressure reduces the venous 34 outflow from the parathyroid gland
30 and increases the capillary bed pressure and decreases arterial
32 inflow. As a result, the parathyroid tissue 30 will undergo
necrosis from a loss of arterial 32 inflow and tissue edema and
loss of venous 34 outflow, which creates cell death and
necrosis.
[0456] In one embodiment the treatment can be performed by a
pressure/suction ablation system device utilizing parathyroid
imaging including an internal device or an external device that can
include but is not restricted to ultrasound device directed to
identify the hyper-functioning parathyroid gland 30.
[0457] In one embodiment the treatment device can include but is
not restricted to an pressure/suction ablation system treatment
device in which the energy is directed into the body utilizing
imaging that can include but is not restricted to ultrasound and
the pressure/suction ablation system energy is focused to treat the
organ to include but not restricted to the parathyroid gland
30.
[0458] In one embodiment the treatment can be performed using an
internal device 75. The pressure/suction ablation system device can
be internal relative to the body and below the surface of the skin
6, 90 and within the body parts that can include but is not
restricted to subcutaneous tissue, hollow organs, blood vessels,
orifices and other body parts or a combination of these body parts
that provide access to the parathyroid 30. The pressure/suction
ablation system device can lie on or near the surface of the
parathyroid in order to treat the parathyroid 30. The
pressure/suction ablation system device 75 can puncture the
parathyroid 30 to treat the parathyroid or it can enter a body part
that is a hollow organ or orifice or a combination of these body
parts. The pressure/suction ablation system device can lie on or
near the surface of a parathyroid artery or vein in order to treat
the parathyroid 30. the pressure/suction ablation system device can
puncture a parathyroid artery or vein in order to ablate the
parathyroid blood-flow. The pressure/suction ablation system device
can fully or partially ablate the parathyroid 30 the
pressure/suction ablation system device can fully or partially
ablate the artery or veins or nerves to the parathyroid or damage
the local tissue in and near the parathyroid 30.
[0459] In another embodiment the pressure/suction ablation system
device can be on the skin. The pressure/suction ablation system
device can be external and separated from the skin with or without
a membrane or substance that bridges the pressure/suction ablation
system and the skin 6.
[0460] In one embodiment, the coordination of robotic surgery with
the above techniques and imaging can be combined.
[0461] In another embodiment, a method for treatment of the
parathyroid gland can include implanting a substance into the
parathyroid gland 30 which can include but not restricted to a
ferromagnetic substance which when stimulated by an outside energy
source to include but not restricted to magnetic resonance
ultrasound, electromagnetic energy, which can be external to the
skin 6 or percutaneous. The substance in the preferred embodiment
can create heat and cauterize the injected tissue
[0462] The primary substance can also be non-active in its primary
state but when exposed to an outside energy source is activated
either by an organic or non organic reaction which can include but
is not restricted to forming a new compound or creating energy
within the parathyroid gland 30 that can include but is not
restricted to heat or a mechanical ablative process such as
gyration or vibration. The energy source, activating compound, the
primary substance or any combination of the above can be delivered
external to the skin 6. The energy source can be delivered internal
to the skin 92 within the body. The delivery can include but is not
restricted to percutaneous.
[0463] In another embodiment a nanotechnology device can be
implanted into the parathyroid gland 30 that can perform the
treatment of the parathyroid gland 30 and can be used in
combination with but not restricted to Radio Frequency Ablation
Device (RFAD) Ultrasound High Frequency, Ultrasound (HIFU) Device,
Electromagnetic Energy/Wave Delivery Device, Laser (Hot or Cold or
Intermediate) Device, Mechanical/kinetic Energy/Vibration Device,
Heating Energy/Cauterizing Device, Cooling/Freezing Device,
Medication, Sclerosing Device.
[0464] In another embodiment to protect the local tissue an
introducer 50 for the guidance or delivery system can be composed
of material that insulates the surrounding tissue from the
treatment agent to include but not restricted to insulation of the
surrounding tissue from Radio Frequency Ablation Device (RF, RFAD),
Ultrasound High Frequency Ultrasound (HIFU) Device, Electromagnetic
Energy/Wave Delivery Device, Laser (Hot or Cold or Intermediate)
Device, Mechanical/kinetic Energy/Vibration Device, Heating
Energy/Cauterizing Device, Cooling/Freezing Device, Medication and
Sclerosing Device.
[0465] In another embodiment the treatment system can be combined
with a guidance system to include but not restricted to:
Ultrasound, Computerized Tomography (CT), Magnetic Resonance
Imaging (MR/MRI), X-ray and other Electromagnetic Energy imaging
methods to include but not restricted to: Ultraviolet and Infrared,
Thermography/Heat Detection, Blood Flow detection devices, Positron
Emission Tomography, Nuclear Medicine Imaging, Magnetic Imaging, Or
a combination of any of the listed methods.
[0466] In another embodiment, prior to the parathyroid treatment a
percutaneous biopsy can be performed. The introducer 50 can be used
to facilitate the biopsy such that the biopsy and ablation are all
performed through the introducer 50 or channels (54, 56).
[0467] In another embodiment, an Abnormal Parathyroid Gland 30 can
be detected when it has a rich blood supply and with this produces
greater proportional heat, which can be measured with a
thermographic image detector.
[0468] In another embodiment, an Abnormal Parathyroid Gland 30 can
be detected when it has a rich blood supply and utilizes a greater
proportionate oxygen, which can be measured with a O2 image
detector.
[0469] In another embodiment, an Abnormal Parathyroid Gland 30 can
be detected when it has a rich blood supply and with this produces
and because of this produce an orange color greater than local
tissue.
[0470] In another embodiment, an Abnormal Parathyroid Gland 30 can
be detected when it has a rich blood supply and the greater blood
flow and color Doppler flow signals than local tissue.
[0471] In another embodiment, an Abnormal Parathyroid Gland 30 has
a lower echo texture than local tissue and can have a well defined
capsule and increased blood flow and this pattern can be used to
identify the parathyroid during ablation and treatment of the
parathyroid.
[0472] The methods of treatment can be used alone or in multiple
combinations and can apply to multiple biological structures and
tissue to include but not restricted to the parathyroid gland 30
and parathyroid tissue 30. In one example, a method of combination
can include but is not restricted to the use of negative
pressure/suction to alter the parathyroids blood flow using a
pressure device 75. In this example negative pressure is utilized
which will alter the blood flow to the parathyroid gland 30. This
will make the parathyroid tissue 30 more susceptible to cell damage
or cell death. In this example, a second method of treatment can
include but is not restricted to a cold laser delivery device 75.
By combining the negative pressure to the parathyroid gland 30 and
the cold laser to the parathyroid tissue 30 the time for effective
ablation can be significantly reduced. This will spare the local
tissue from any collateral damage that may be caused by the use of
the cold laser.
[0473] The trachea lies adjacent to and posterior to the thyroid 20
and the two parathyroid glands 30. The Recurrent Laryngeal Nerve
13, which innervated the Larynx can be monitored or protected from
the ablative energetic or non-energetic methods (not shown). Nerves
can either be treated such as the parathyroid nerves 19 or
protected such as the Recurrent Laryngeal Nerve 13.
[0474] In one embodiment a monitoring device 31 is used to protect
afferent or efferent nerves 19 or structure innervated or in
association with the nerve 19. The monitoring device 31 can be
placed on or near a nerve 19, or on or near the structure 17
innervated or associated with the nerve 19. In one embodiment, the
monitoring device 31 can be used but not restricted to parathyroid
gland 30 and can involve but not restricted to monitoring of the
recurrent laryngeal nerve 13 and the larynx 15. The monitoring
device can measure but is not restricted to the measurement of
either the parathyroid gland 30, local tissue environment or the
nerve 19 or the structure associated with or innervated by the
nerve or a combination of the above, and the monitoring can include
but is not restricted to the monitoring of heat, cold, acid or base
pH, electromagnetic energy or kinetic energy. The monitoring device
31 can automatically control the treatment delivery device 75 or
can inform the user of the treatment delivery device 75 that an
action needs to be taken to avoid damage to vital structures. The
monitoring device 31 can be used to insure adequate treatment but
also to avoid excessive damage to the structure or structures being
monitored and can regulate the treatment delivery device 75.
[0475] In another embodiment the monitoring device 31 can be used
to monitor the effectiveness of treatment of the target organ to
include but not restricted to the parathyroid 30. The monitoring
device can measure but is not restricted to the measurement of
either the parathyroid gland 30, local tissue environment or the
nerve 19 or the structure associated with or innervated by the
nerve or a combination of the above, and the monitoring can include
but is not restricted to the monitoring of heat, cold, acid or base
pH, electromagnetic energy or kinetic energy. The monitoring device
31 can automatically control the treatment delivery device 75 or
can inform the user of the treatment delivery device 75 that an
action needs to be taken to avoid damage to vital structures. The
monitoring device 31 can be used to insure adequate treatment but
also to avoid excessive damage to the structure or structures being
monitored and can regulate the treatment delivery device 75.
[0476] A method for localizing the parathyroid gland for a
treatment to but not restricted to surgical removal of the target
tissue to include but not restricted to parathyroid tissue 30. A
needle/tube (52, 58, 70, 84), sheath 50, or device (75, 24) can be
used to localize the site of the target organ to include but not
restricted to the parathyroid gland 30.
[0477] In one embodiment, the method for localization can be using
a radioactive tracer which can include but is not restricted to
radioactive tecnecium Tc-99, or Iodine I-123, I-131. These isotopes
can be used in the unbound or bound for to include but not
restricted to technecium bound to a molecule to include but not
restricted to Sestamibi and albumin, or it can be bound to a solid
or gel that can include but mot restricted to a biodegradable gel,
surgical colloidal, a radioactive bead or clip or seed. The
radioactivity can be placed within the body using a method that can
reach the target organ to include but not restricted to the
parathyroid 30 which can include but not restricted to percutaneous
techniques, endoscopy, laparoscopy, catheterization and
angiography. The radioactive isotope can be identified using a
localizing device (5, 75, 80), to include but not restricted to a
Geiger counter or radioactivity detecting probe which can direct
therapy from or external to the skin to include but not restricted
to SPECT-CT, PET-CT, SPECT-MRI, ultrasound, surgery, or within the
body to include but not restricted to a percutaneous device 75 or a
device that lies within the body by other means such as but not
restricted to endoscopy, laparoscopy, catheterization and
angiography. The localizing substance 99 can be implanted or left
in position prior to, during or after the procedure. The localizing
substance 99 can be used to guide external, internal or any
combination of external and internal treatment modalities.
[0478] In another embodiment the localizing substance 99 can be a
Global Positioning Satellite device, a Local Positioning Device
(LPD) that can use a specialty built localizing device for the
treatment room and can measure distances in measuring quantities
less than 1 cm.
[0479] In another embodiment the localizing substance 99 can be an
inert, organic, non-organic, biodegradable or non-biodegradable
device.
[0480] In another embodiment the localizing substance 99 can be a
device that can externally or internally be monitored to local the
target organ that can include but is not restricted to a GPS
device, an LPD, and RF localization device.
[0481] In another embodiment the localizing device can be a wire or
thread-like substance that can be straight and pass through tissue
to include but not restricted to the thyroid 20 or can be flexible
and can be maneuvered around tissue to include but not restricted
to the thyroid 20.
[0482] The localizing device and use any combination of localizing
elements and methods.
[0483] A method for treating the target organ can include but not
restricted to the parathyroid the method can deliver the treatment
externally or internally to include but is not restricted to
percutanous laporascopic methods or surgery.
[0484] Another method for treatment is to deliver an ablative
substance to the target organ that can include but is not
restricted to the parathyroid. The ablative substance or device can
be inserted into the target preferentially by a needle
percutaneously but also to include but not restricted to by
laproascope. The ablative substance or device can include but is
not restricted to an RF receiver that can be implanted into the
target organ to include but not restricted to the parathyroid.
[0485] In another method microscopic ferrous particles can be
inserted into the parathyroid and the neck 3 and parathyroid 30
placed into an MRI device that can heat and mechanically ablated
the parathyroid tissue 30.
[0486] A needle for percutanuously depositing the localizing
substance 99, which in the preferred embodiment can include a
radioactive biodegradable colloid with a titanium bead that
measures less than 1 mm. The internal surface of the needle can
include but is not restricted to threads. The stylet 57 which fits
into the hollow needle 58 can have multiple shapes to include but
not restricted to tips with points, blunt tips, matching treads or
grooves with the needle in which the stylet can be screwed down
into position. The stylet 57 and needle together can have a
delimiter or governor 55 that limits that adjusts to seat the
localizing substance 99 into position within the parathyroid gland
30.
[0487] Other embodiments of this needle can include grooves to
include but are not restricted to horizontal or vertical grooves or
threads or any combination of grooves that can be locked and
unlocked into place to seat and deliver the localizing substance 99
into the target organ.
[0488] Another embodiment includes a membrane inside of the needle
on one or both sides of the localizing substance 99, which can be
pushed through the needle 58 and delivered to the target tissue to
include but not restricted to the parathyroid tissue 30.
[0489] In another embodiment the localizing substance 99 can be
deposited into the needle after the needle is secured to the target
tissue 30 and one or more stylets 57 can be used.
[0490] A sheath can include but is not restricted to a tube or
conduit or guide or guide and it can be hollow
[0491] A member can include but is not restricted to a tube,
cylinder, probe wire, guide wire, guide, device and it can be solid
or hollow.
[0492] Controller can include but is not restricted to a device
that takes an action in response to an input.
[0493] A measuring device can include but is not restricted to a
sensor, or a device to measure a quality or quantity of a substance
or energy or a phenomenon or a biological event.
[0494] Biological function can include but is not restricted
parathyroid hormone activity, temperature, calcium levels, ionizing
calcium, electrolytes, local temperature around parathyroid,
neuronal function (laryngeal nerves), larynx and innervation,
respiratory function, sympathetic and parasympathetic (primary and
secondary) function, arterial flow, venal flow, brain function,
cardiac functions, blood pressure, chromography, and vital and
hormonal and physiologic measurements, signs and symptoms
[0495] A substance can include but is not restricted to solids or
liquids or gels or plasmas or gases to include but not restricted
to organic and inorganic materials such as but not restricted to
medications, pharmaceuticals, adhesives, glues, metals, alloys,
plastics, carbo-carbon fibers, oxygen, argon, nitrogen, carbon
monoxide, ferromagnetic materials, alchohols, peptides, fats,
proteins, nucleic acids, or carbohydrates.
[0496] Energy can refer to any form of energy, including various
forms of electromagnetic energy, such as: radiofrequency (RF)
energy; therapeutic ultrasound energy; microwave, laser, x-ray, or
optical energy; magnetism, head and cryrotherapy; or any
combination thereof. Energy shall also refer to mechanical energy
to include but not restricted to Brownian movement, heat, freezing,
crotherapy, cutting, tearing, crushing, spinning, piercing, poking
prodding, dividing, removing and segregating or any combination
thereof. Energy can include an energy from a device to include but
not restricted to an Electromagnetic device (EMD) which can include
but is not restricted to Radiofrequency ablation (RF) and microwave
(MW) and laser (L), Cryotherapy (CryT), Hight Intensity Focused
Ultrasound (HIFU), Radioactive Therapy (Brachytherapy: BrT),
Irreversible Electroporation (IRE), Electrical Current Therapies,
Electrocautery, Magnetic Resonance (MR), Ultrasound, (US), Thermal
energies both heat and cold or can include but is not restricted to
forces such but not restricted to suction, positive and negative
pressure, or forces or not exerted by a vacuum.
[0497] Placement of the needle can include but is not restricted to
placement by at least one organism with or without robotic
assistance.
[0498] Treatment and Insulation and protection of the target and
non-target vicinity tissue can include the delivery and the removal
of energy and/or substances.
[0499] The energy delivered and the insulation experienced at any
given moment during treatment by the user's target and non-target
tissue can both vary and can be variable to include but not
restricted to duration, direction, exposure, periodicity or
frequency.
[0500] The following methods and devices and applications can be
applied to Humans or Non-human.
[0501] While the preferred embodiment of the invention has been
illustrated and described, as noted above, many changes can be made
without departing from the spirit and scope of the invention.
Accordingly, the scope of the invention is not limited by the
disclosure of the preferred embodiment. Instead, the invention
should be determined entirely by reference to the claims that
follow.
* * * * *