U.S. patent application number 14/689455 was filed with the patent office on 2015-10-22 for medical devices for therapeutic heat treatments.
This patent application is currently assigned to Boston Scientific Scimed, Inc.. The applicant listed for this patent is Boston Scientific Scimed, Inc.. Invention is credited to JAMES M. ANDERSON, CASS ALEXANDER HANSON, PATRICK A. HAVERKOST, JOSEPH ALAN KRONSTEDT, TIMOTHY A. OSTROOT, DEREK C. SUTERMEISTER, JAN WEBER, MARTIN R. WILLARD.
Application Number | 20150297281 14/689455 |
Document ID | / |
Family ID | 53008934 |
Filed Date | 2015-10-22 |
United States Patent
Application |
20150297281 |
Kind Code |
A1 |
SUTERMEISTER; DEREK C. ; et
al. |
October 22, 2015 |
MEDICAL DEVICES FOR THERAPEUTIC HEAT TREATMENTS
Abstract
An expandable balloon catheter having an elongate shaft having a
distal end region and an expandable balloon coupled to the distal
end region of the elongate shaft is disclosed. One or more cutting
members are attached to the expandable balloon, wherein at least a
portion of each of the one or more cutting members comprises a
Curie material having a Curie temperature between 60.degree. and
400.degree. Celsius.
Inventors: |
SUTERMEISTER; DEREK C.; (HAM
LAKE, MN) ; KRONSTEDT; JOSEPH ALAN; (NEW HOPE,
MN) ; OSTROOT; TIMOTHY A.; (COKATO, MN) ;
HAVERKOST; PATRICK A.; (BROOKLYN CENTER, MN) ; WEBER;
JAN; (MAASTRICHT, NL) ; ANDERSON; JAMES M.;
(CORCORAN, MN) ; HANSON; CASS ALEXANDER; (ST.
PAUL, MN) ; WILLARD; MARTIN R.; (BURNSVILLE,
MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Boston Scientific Scimed, Inc. |
Maple Grove |
MN |
US |
|
|
Assignee: |
Boston Scientific Scimed,
Inc.
Maple Grove
MN
|
Family ID: |
53008934 |
Appl. No.: |
14/689455 |
Filed: |
April 17, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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61980952 |
Apr 17, 2014 |
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61981003 |
Apr 17, 2014 |
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61980936 |
Apr 17, 2014 |
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61980995 |
Apr 17, 2014 |
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Current U.S.
Class: |
606/45 ;
606/49 |
Current CPC
Class: |
A61B 2018/1465 20130101;
A61B 2018/00714 20130101; A61K 47/6957 20170801; A61B 2018/00434
20130101; A61B 18/082 20130101; A61B 18/1492 20130101; A61M 25/0082
20130101; A61N 1/406 20130101; A61B 2018/00148 20130101; A61B
2018/0016 20130101; A61B 2018/00011 20130101; A61B 2018/00267
20130101; A61P 35/00 20180101; A61B 2018/00125 20130101; A61B
2018/00577 20130101; A61B 2018/00595 20130101; A61M 25/0043
20130101; A61M 2025/105 20130101; A61B 2018/0022 20130101; A61B
2018/00815 20130101; A61B 2018/087 20130101; A61B 2018/00154
20130101; A61B 2018/00642 20130101; A61M 2025/0042 20130101; A61B
17/320725 20130101; A61B 2017/22061 20130101; A61K 41/0052
20130101; A61M 2025/1086 20130101; A61M 37/00 20130101; A61B 18/04
20130101; A61B 2018/00136 20130101; A61B 2018/00511 20130101; A61B
2018/00404 20130101; A61M 2025/1081 20130101; A61B 18/14 20130101;
A61B 2018/00178 20130101; A61B 2017/00088 20130101; A61B 2018/00601
20130101; A61B 2018/00214 20130101 |
International
Class: |
A61B 18/08 20060101
A61B018/08; A61B 18/14 20060101 A61B018/14 |
Claims
1. An expandable balloon catheter comprising: an elongate shaft
having a distal end region; an expandable balloon coupled to the
distal end region of the elongate shaft; and one or more cutting
members attached to the expandable balloon, wherein at least a
portion of each of the one or more cutting members comprises a
Curie material having a Curie temperature between 60.degree. and
400.degree. Celsius.
2. The expandable balloon catheter of claim 1, further comprising
an electromagnetic coil disposed around the distal end region of
the elongate shaft and within an interior portion of the expandable
balloon.
3. The expandable balloon catheter of claim 2, further comprising a
power and control unit in electrical communication with the
electromagnetic coil.
4. The expandable balloon catheter of claim 1, wherein the at least
a portion of the one or more cutting members comprising the Curie
material is formed from the Curie material.
5. The expandable balloon catheter of claim 1, wherein the at least
a portion of the one or more cutting members comprising the Curie
material comprises a coating of the Curie material.
6. The expandable balloon catheter of claim 5, wherein the coating
includes a polymeric base and a plurality of magnetic
nanoparticles.
7. The expandable balloon catheter of claim 6, wherein the magnetic
nanoparticles comprise less than 10% of the coating by weight.
8. The expandable balloon catheter of claim 1, wherein the Curie
material has a Curie temperature between 100.degree. and
400.degree. Celsius.
9. The expandable balloon catheter of claim 1, wherein the Curie
material is selected from the group consisting of MnBi, MnSb,
CrO.sub.2, MnOFe.sub.2O.sub.2, Nickel, and combinations
thereof.
10. The expandable balloon catheter of claim 1, wherein the one or
more cutting members each define a base and a tip, the tip
comprising the Curie material.
11. The expandable balloon catheter of claim 10, wherein the base
of the one or more cutting members is ceramic or stainless
steel.
12. The expandable balloon catheter of claim 1, further comprising
an adhesive pad disposed between each of the one or more cutting
members and the expandable balloon.
13. The expandable balloon catheter of claim 1, further comprising
a fluid circulation system, the fluid circulation system configured
to cool the coagulation device.
14. The expandable balloon catheter of claim 1, wherein the one or
more cutting members comprises at least three cutting members.
15. The expandable balloon catheter of claim 1, further comprising
a thermal insulator disposed between each of the one or more
cutting members and the expandable balloon.
16. An expandable balloon catheter comprising: an elongate shaft
having a distal end region; an expandable balloon coupled to the
distal end region of the elongate shaft; and at least one cutting
member attached to the expandable balloon, wherein the at least one
cutting member comprises a base and a tip, the tip formed from a
Curie material having a Curie temperature between 60.degree. and
400.degree. Celsius; a thermally insulating pad member disposed
between the at least one cutting member and the expandable balloon;
and an electromagnetic coil disposed around the distal end region
of the elongate shaft and within an interior portion of the
expandable balloon.
17. The expandable balloon catheter of claim 16, wherein the Curie
material is selected from the group consisting of MnBi, MnSb,
CrO.sub.2, MnOFe.sub.2O.sub.2, Nickel, and combinations
thereof.
18. An expandable balloon catheter comprising: an elongate shaft
having a distal end region; an expandable balloon coupled to the
distal end region of the elongate shaft; and at least one cutting
member attached to the expandable balloon, wherein the at least one
cutting member comprises a base and a tip, the tip coated with a
Curie material having a Curie temperature between 60.degree. and
400.degree. Celsius; a thermally insulating pad member disposed
between the at least one cutting member and the expandable balloon;
and an electromagnetic coil disposed around the distal end region
of the elongate shaft and within an interior portion of the
expandable balloon.
19. The expandable balloon catheter of claim 18, wherein the Curie
material is selected from the group consisting of MnBi, MnSb,
CrO.sub.2, MnOFe.sub.2O.sub.2, Nickel, and combinations
thereof.
20. The expandable balloon catheter of claim 18, wherein the
coating comprises a polymeric base and a plurality of magnetic
nanoparticles.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The following commonly assigned patent applications are
incorporated herein by reference, each in its entirety:
[0002] U.S. Pat. App. Ser. No. 61/980,995 (Sutermeister et al.),
entitled DEVICES AND METHODS FOR THERAPEUTIC HEAT TREATMENT, filed
on Apr. 17, 2104.
[0003] U.S. Pat. App. Ser. No. 61/980,952 (Sutermeister et al.),
entitled MEDICAL DEVICES FOR THERAPEUTIC HEAT TREATMENTS, filed on
Apr. 17, 2014; and
[0004] U.S. Pat. App. Ser. No. 61/981,003 (Sutermeister et al.),
entitled COMPOSITIONS FOR THERAPEUTIC HEAT DELIVERY, filed on Apr.
17, 2014 and
[0005] U.S. Pat. App. Ser. No. 61/980,936 (Sutermeister et al.),
entitled DEVICES AND METHODS FOR THERAPEUTIC HEAT TREATMENT, filed
on Apr. 17, 2104.
TECHNICAL FIELD
[0006] The present disclosure pertains to medical devices, systems,
and methods for using the medical devices. More particularly, the
present disclosure pertains to medical devices that can provide a
therapeutic treatment using heat.
BACKGROUND
[0007] Therapeutic heat treatment can be used to treat a wide
variety of medical conditions such as tumors, fungal growth, etc.
Heat treatments can be used for treating medical conditions
alongside other therapeutic approaches or as a standalone therapy.
Heat treatment provides localized heating and thus lacks any
cumulative toxicity in contrast to other treatment methods such as
drug-based therapy, for example.
[0008] Known heat treatments, however, suffer from certain
drawbacks. For example, using known treatments, it can be difficult
to control the amount of heat delivered to a target area, which can
cause undesired damage. Also, known treatment methods can be less
focused, leading to damage of surrounding healthy tissue.
[0009] Therefore, a need remains to develop devices and methods for
providing homogeneous and more controlled therapeutic heat
treatments.
SUMMARY
[0010] In at least one embodiment, a topical product comprises a
base emulsion and a plurality of nanoparticles. Desirably, the
nanoparticles are homogeneously distributed within the base
emulsion to comprise at least 2% of the product by weight. The
nanoparticles have a Curie temperature between 37.degree. and
60.degree. Celsius.
[0011] In at least one embodiment, a medical device coating
comprises a polymeric base and a plurality of nanoparticles. The
nanoparticles are homogeneously distributed within the polymeric
base and comprise less than 10% of the coating by weight. The
nanoparticles have a Curie temperature between 37.degree. and
140.degree. Celsius.
[0012] In at least one embodiment, an expandable balloon catheter
has an elongate shaft including a distal end region and an
expandable balloon coupled to the distal end region of the elongate
shaft. One or more cutting members are attached to the expandable
balloon, wherein at least a portion of each of the one or more
cutting members comprises a Curie material having a Curie
temperature between 60.degree. and 400.degree. Celsius.
[0013] The above summary of some embodiments is not intended to
describe each disclosed embodiment or every implementation of the
present disclosure. The Figures and Detailed Description, which
follow, more particularly exemplify these embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] A detailed description of the invention is hereafter
described with specific reference being made to the drawings.
[0015] FIG. 1 is a perspective view of a body surface that is being
treated with an embodiment of a topical product.
[0016] FIG. 2 is a perspective view of a coated medical device.
[0017] FIG. 3 is a partial view of an embodiment of an embodiment
of a coagulation device.
[0018] FIG. 3A is a cross-sectional view of the embodiment of FIG.
3.
[0019] FIG. 4 illustrates a method of treating a tumor using the
coagulation device of FIGS. 3 and 3A.
[0020] FIG. 5 a side view of a portion of another illustrative
coagulation device.
[0021] While the disclosure is amenable to various modifications
and alternative forms, specifics thereof have been shown by way of
example in the drawings and will be described in detail. It should
be understood, however, that the intention is not to limit the
invention to the particular embodiments described. On the contrary,
the intention is to cover all modifications, equivalents, and
alternatives falling within the scope of the disclosure.
DETAILED DESCRIPTION
[0022] Definitions are provided for the following defined terms. It
is intended that these definitions be applied, unless the context
indicates otherwise.
[0023] The recitation of numerical ranges by endpoints includes all
numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75,
3, 3.80, 4, and 5).
[0024] As used herein, the singular forms "a", "an", and "the"
include plural references unless the context clearly evidences or
indicates otherwise. As used herein, the term "or" is generally
employed in its sense including "and/or" unless the context clearly
evidences or indicates otherwise.
[0025] References herein to "an embodiment," "some embodiments,"
"other embodiments," etc., indicate that an embodiment includes a
particular feature, structure, or characteristic, but not every
embodiment necessarily includes the particular feature, structure,
or characteristic. Moreover, such phrases do not necessarily refer
to the same embodiment. Further, when a particular feature,
structure, or characteristic is described in connection with an
embodiment (or more embodiments), it should be understood that such
feature, structure, or characteristic may also be used in
connection with other embodiments, whether or not explicitly
described, unless clearly evidenced or stated to the contrary.
[0026] "Curie temperature" is defined as the temperature at which
permanent magnetic properties of a material convert into induced
magnetic properties, or vice versa.
[0027] "Curie materials" refer to those metals or metal alloys that
exhibit magnetic properties based on selected Curie temperatures.
Curie temperature of a Curie material may be altered by using
composite materials, which may or may not be ferromagnetic. Changes
in doping, additives, composites, alloying, size, and density of
Curie materials can alter the structure and behavior of the Curie
material and alter the Curie temperature.
[0028] The following detailed description should be read with
reference to the drawings in which similar elements in different
drawings are numbered the same. The drawings, which are not
necessarily to scale, depict illustrative embodiments and are not
intended to limit the scope of the disclosure.
[0029] FIG. 1 is a perspective view depicting a body surface 100
with a topical product 102 applied to it. In some embodiments, the
body surface 100 may include any external or internal surface of a
patient such as skin, fingernail, toenail, mucus membranes, etc. As
illustrated, the topical product 102 is applied to a treatment area
101 on the body surface 100, for example to treat a skin disease
such as fungal infection, or the like. The topical product 102,
which may be formulated as creams, foams, gels, lotions, ointments,
or other suitable formulations, in turn, provides a therapeutic
heat treatment to the treatment area 101, as discussed in greater
detail below.
[0030] In some embodiments, the topical product 102 includes a base
emulsion 104 and plurality of nanoparticles 106. For simplicity, a
single nanoparticle 106 is labeled in the drawings, however, it
should be understood that the topical product 102 may comprise any
suitable number of nanoparticles 106 such as two, four, six, eight,
twenty, forty, one hundred, one thousand, more than one thousand,
or any number therebetween. In some embodiments, the percentage of
nanoparticles 106 in the base emulsion 104 (e.g., by weight
percent) may depend on a variety of factors, for example: (1) the
type of treatment, (2) the amount of heat required for treatment,
(3) the type of body surface 100, etc. In some embodiments, the
nanoparticles 106 comprise at least 2% of the topical product 102
by weight. In some embodiments, however, the nanoparticles 106
comprise at least 3% of the topical product 102 by weight. Other
suitable percentages of the nanoparticles 106 in the topical
product 102 may include at least 4%, 5%, 8%, 15%, or more, by
weight. It should be noted that any other suitable percentage of
the nanoparticles 106 may also be contemplated, without departing
from the scope of the present disclosure.
[0031] In some embodiments, the nanoparticles 106 are homogeneously
distributed within the base emulsion 104. The homogenous
distribution of the nanoparticles 106 in the base emulsion 104 may
be used to achieve a homogeneous mixture forming the topical
product 102. The homogeneous distribution of the product 102 may
provide ease of application on the treatment area 101. However,
this is not required.
[0032] In some embodiments, the base emulsion 104 is an oil-based
or water-based emulsion. In some embodiments, the base emulsion 104
includes petroleum jelly and/or polyethylene glycol.
[0033] In some embodiments, the nanoparticles 106 are made from
Curie materials having magnetic properties. Under influence of a
desired electric or magnetic field, the nanoparticles 106 deliver
heat therapy to the body surface 100 (e.g., skin, nails, etc.). In
some embodiments, the nanoparticles 106 are heated to their Curie
temperature. In particular, in some embodiments, the magnetic
nanoparticles 106 are subjected to an alternating field. Upon
application of the alternating field, the magnetic nanoparticles
106 begin to heat. Generally, at temperatures less than the Curie
temperature (T<T.sub.c), the magnetic nanoparticles 106 (and/or
compositions thereof) are ferro- (or ferri-) magnetic and
transition into paramagnetic phase upon reaching the Curie
temperature (T.sub.c). Also upon reaching the Curie temperature,
however, an applied AC field no longer induces a temperature rise
due to the loss of magnetic susceptibility at the Curie
temperature. Thus, the temperature of the nanoparticles 106 is
stabilized to within a small temperature range at or near the
predetermined Curie temperature.
[0034] Further, the heating of the topical product 102 may be
controlled by controlling intensity, frequency, or other related
parameters of the electro-magnetic field applied to the topical
product 102 or more specifically to the magnetic nanoparticles 106.
Once the temperature of nanoparticles 106 reaches its Curie
temperature, heating stops, avoiding any unwanted damage to the
treatment area 101.
[0035] In some embodiments, the magnetic nanoparticles 106 have a
composition such that the Curie temperature (T.sub.c) is in the
range between about 37.degree. Celsius to about 60.degree. Celsius.
In some embodiments, the Curie temperature is in the range between
about 40.degree. Celsius to about 50.degree. Celsius. And, in some
embodiments, the Curie temperature is 43.degree. Celsius to about
48.degree. Celsius, for example.
[0036] Therapeutic heat treatments in one or more embodiments may
be performed using magnetic nanoparticles 106 having Curie
temperatures between about 37.degree. Celsius to about 60.degree.
Celsius. Such nanoparticles 106 are configured to treat the body
surface 102, such as skin and/or nails, without causing inadvertent
damage to the non-target body regions. In some embodiments, the
Curie material may include GaMnN (gallium manganese nitride) and/or
ZnO (zinc oxide) or other materials. Other examples of suitable
materials include Manganese Arsenide having a Curie temperature
about 45.degree. Celsius.
[0037] The topical product 102 can be used to treat a wide variety
of ailments. For example, the topical product 102 may be used to
treat warts, lesions, parasitic infections, skin cancer, or the
like. In some embodiments, the treatment area 101 is an area with a
fungal infection beneath a finger nail and the treatment area is to
be heated at a temperature ranging between about 40.degree. Celsius
to about 60.degree. Celsius in order to disrupt fungal growth. In
some embodiments, the topical product 102 is in the form of a nail
polish that can be applied to the nail by the patient in their
home. Upon application of the topical product 102 to the nail
surface, it can be used to disrupt fungal grown underneath the nail
upon application of a suitable electric or magnetic field. The
target temperature for heat treatment may be in the range of about
37.degree. Celsius to about 60.degree. Celsius.
[0038] In some embodiments, the topical product 102 is applied to a
mucous membrane of the patient to treat a variety of diseases. For
instance, the topical product 102 may be applied to the mucosal
wall of trachea or other regions of the respiratory tract such as
bronchus, nasal cavity, bronchioles, etc. In some embodiments, the
product 102 is used as a mucolytic agent to heat treat excess
mucous production. Further, in some embodiments, the topical
product is employed to treat one or more other symptoms of airway
related diseases such as chronic pulmonary obstructive disease
(COPD).
[0039] In some embodiments, the nanoparticles 106 include a
therapeutic drug. Such drug may be selected to treat a particular
ailment. For example, drugs, including anti-fungal agents such as
salicylic acid, polyenes, imidazoles, triazoles, thiazoles, etc.
may be incorporated. Those skilled in the art may select the
appropriate one or more drugs for a particular patient or ailment.
In some embodiments, the drug is released as disclosed in the
co-filed application entitled, "DEVICES AND METHODS FOR THERAPEUTIC
HEAT TREATMENT", U.S. Pat. App. Ser. No. 61/980,936 (Sutermeister
et al.), filed on Apr. 17, 2014, which is herein incorporated by
reference. Additionally, the contents of the co-filed application
entitled, "COMPOSITIONS FOR THERAPEUTIC HEAT DELIVERY", U.S. Pat.
App. Ser. No. 61/981,003 (Sutermeister et al.), also filed on Apr.
17, 2014, are herein incorporated by reference.
[0040] One or more medical devices may also incorporate Curie
nanoparticles for delivering therapeutic heat treatment. For
example, FIG. 2 shows a medical device 200 coated with Curie
nanoparticles in accordance with an embodiment of the present
disclosure. In some embodiments, the medical device 200 includes an
elongated member 202 having a coating 204 applied on its outer
surface 205. In some embodiments, the elongated member 202
comprises an inflatable medical balloon. However the elongated
member 202 can further comprise any other suitable device adapted
to be introduced inside a patient's body such as, but not limited
to a stent, inflatable medical balloon, catheter, basket, or the
like. The coating 204 may be applied to a portion of the outer
surface 205 of the elongated member 202 or over the entire outer
surface of the elongated member 202. In some embodiments, the
elongated member 202 has a distal end region 201 and a proximal end
region 203.
[0041] In some embodiments, the elongated member 202 has a long,
thin, flexible tubular structure. A person skilled in the art will
appreciate that other suitable structures exist such as, but not
limited to, rectangular, oval, irregular, or the like. In some
embodiments, the elongated member 202 is sized and configured to
accommodate passage through the intravascular path, which leads
from a percutaneous access site in, for example, the femoral,
brachial, or radial artery, to a targeted treatment site. In other
embodiments, the elongated member 202 may be sized and configured
to pass through other portions of the anatomy, such as, but not
limited to, the respiratory system, gastrointestinal, urological,
gynecological, etc.
[0042] In some embodiments, the medical device coating 204 includes
a polymeric base 206 and a plurality of magnetic nanoparticles 208.
In an example, the nanoparticles 208 are mixed with the polymeric
base 206 to create a homogenous mixture. Those skilled in the art
will appreciate that any suitable method may be employed to combine
the polymeric base 206 and the nanoparticles 208 to form the
coating 204, for example, conventional methods such as
encapsulation. Once formed, the coating 204 may be applied to the
medical device 200 by various methods such as spraying, painting,
etching, etc. The coating 204 may be applied to a variety of
medical devices, including, but not limited to a stent, inflatable
medical balloon, catheter, basket, cutting members, such as cutting
members 512 described below, coagulation elements, such as
coagulation elements 306 described below, or the like
[0043] The polymeric base 206 may comprise a suitable polymer such
as polyurethane, styrene isobutylene styrene, or other polymers
known to the art. In some embodiments, the polymeric base 206
comprises one or more biodegradable polymers, which may be designed
to degrade within the body. Suitable examples include Polylactides
(PLA), Polyglycolides (PGA), Poly(lactide-co-glycolides) (PLGA),
Polyanhydrides, Polyorthoesters, Polycyanoacrylates,
Polycaprolactone, or the like. In some embodiments, these
degradable polymers are broken down into biologically acceptable
molecules to be metabolized and removed from the body via normal
metabolic pathways.
[0044] In some embodiments, the nanoparticles 208 comprise magnetic
nanoparticles having a selected Curie temperature. In some
embodiments, the magnetic nanoparticles 208 have Curie temperatures
falling in the range between about 37.degree. Celsius to about
140.degree. Celsius. However, it should be noted that any suitable
Curie material having a suitable Curie temperature may also be used
in the coating 206, which may be dictated by the temperature range
required to heat and/or treat a body tissue or region.
[0045] In some embodiments, the magnetic nanoparticles 208 may
comprise less than 10% of the coating 204 by weight. The
nanoparticles 208 may comprise any suitable percentage in the
coating 204 such as, but not limited to, 4%, 8%, 12%, 24%, 48%, or
more. The percentage of the nanoparticles 208 may vary depending on
various factors, for example--a) the amount of heat required for
the therapy, and b) the Curie temperature of the magnetic
nanoparticles 208 used to form the coating 204.
[0046] In some embodiments, the medical device 200 is navigated
through a patient's body to reach a treatment region. In some
instances, the medical device 200 is an inflatable medical balloon
having a coating 204 disposed on its outer surface 205. Upon
reaching the treatment region, the medical device 200 is inflated
using a conventional inflation mechanism (e.g., inflation fluid
such as saline) such that the coating 204, in particular the
nanoparticles 208, come into contact with the surrounding body
tissue. Further, inflation of the balloon allows the nanoparticles
208 to come in close proximity with a desired treatment area. At
this point, a suitable electric or magnetic external field may be
applied, allowing the magnetic nanoparticles 208 to heat.
Alternatively, or additionally, the electric or magnetic field may
be applied from within the medical device 200, as will be described
in more detail with respect to FIG. 5. Once the temperature of the
magnetic nanoparticles 208 reaches its Curie temperature, the
nanoparticles 208 stop heating until the temperature again falls
below the Curie temperature.
[0047] Some embodiments may be used to treat varicose veins. Such
veins may become enlarged and/or tortuous due to one or more
pathological conditions. For treatment purposes, the medical device
200 having a balloon-shaped structure may be employed. In some
embodiments, the balloon has the coating 204 applied to its outer
surface. The balloon may be used to constrict or occlude the
varicose vein by heating it at about 120.degree. Celsius, for
example. To accomplish this, in some embodiments, the balloon is
inserted within the patient's body to reach a target area just
adjacent to or inside the varicose vein. Once the target area is
reached, RF energy or a magnetic field is applied from an external
or internal source, for example, heating the magnetic nanoparticles
208 disposed in the coating 204. The heat may thus occlude the
varicose vein. In such an example, the magnetic nanoparticles 208
may have a Curie temperature of about 120.degree. Celsius.
[0048] Further, in some embodiments, the medical device 200 is used
for nerve treatment for denervation of renal artery, carotid sinus,
splanchnic nerves, bronchial nerves, pulmonary artery denervation,
etc. Furthermore, the device 200 may be used for tissue ablation,
pain mitigation, muscle pacing or relaxation, etc.
[0049] In some embodiments, the nanoparticles 208 include two
different types of nanoparticles, each type having its own Curie
temperature. In some embodiments, the nanoparticles having a lower
Curie temperature have a higher concentration than the
nanoparticles having a higher Curie temperature. Such an
arrangement permits the medical device 200 to have two Curie
temperatures. In this way, using a lower power alternating current
field, for example, the temperature can be raised to the Curie
temperature of the first type of nanoparticles. Using a higher
power AC field, for example, the temperature can be raised to the
second, higher, Curie temperature, which is associated with the
second type of nanoparticles. In some embodiments, the first type
of nanoparticles has a Curie temperature of 40 degrees Celsius and
the second type of nanoparticles has a Curie temperature of 60
degrees Celsius. An embodiment of a medical device 200 utilizing
two such types of nanoparticles may comprise a polymeric implant
which is deformed at the lower Curie temperature and it is heat-set
upon reaching the higher Curie temperature, thereby fixing the
shape of the polymeric implant. Another embodiment utilizing two
such types of nanoparticles may identify the medical device 200 at
the first Curie temperature via magnetic resonance; and, the
medical device 200 can then be raised to the second Curie
temperature once the position within the patient's body is as
intended. For example, a lumen or bodily structure can be ablated
at the second Curie temperature.
[0050] It will be appreciated that nanoparticles having a third
Curie temperature can also be included in yet another
concentration, for example. Each of the two or more types of
nanoparticles can thusly take on a different functionality, such as
drug release and drug destruction, imaging and ablation,
deformation (e.g., weakening) and heat shape setting.
[0051] FIGS. 3 and 3A depict partial and cross-sectional views,
respectively, of a coagulation or cutting device 360. In some
embodiments, the coagulation device 360 comprises a medical balloon
300, which is adapted to be introduced inside a patient's body, in
a similar way as the medical device 200 of FIG. 2.
[0052] In some embodiments, the coagulation device 360 is employed
to cut, cauterize, and/or coagulate the surrounding body tissue,
upon reaching a treatment region within the patient's body. For
instance, the coagulation device 360 may be employed to cut the
tumor 402 (FIG. 4), cauterize a tissue such as to occlude and/or
seal a vessel (e.g., artery or vein), or cut a lesion or stenosis.
In some embodiments, the coagulation device 360 (e.g., medical
balloon 300) includes a central region 302, a thermal insulator
304, and a coagulation element 306, which, in some embodiments is a
cutting member. In some embodiments, however, the thermal insulator
304 is not required. In some instances, the thermal insulator 304
may also function as a bonding pad configured to attach the
coagulation element 306 to the balloon 300.
[0053] In some embodiments, the central region 302 forms the body
of the medical balloon 300. In the illustrated embodiment, the
central region 302 has a substantially tubular geometry with
circular cross-section. Those skilled in the art will appreciate
that the central region 302 may have any suitable cross-sectional
shape such as, but not limited to, rectangular, oval, irregular, or
the like, however. In some embodiments, the thermal insulator 304
is attached to at least a portion of the central region 302.
According to one or more embodiments, the thermal insulator 304
includes a pad, chip, layer, or other suitable structure capable of
being attached to at least a portion of the central region 302. In
the illustrated embodiment, the thermal insulator 304 has a
pad-shaped structure, which may be attached to an outer surface 301
of the central region 302. Some embodiments employ an adhesive to
attach the thermal insulator 304 to the central region 302. The
thermal insulator 304 and/or coagulation element 306 can also be
attached via an adhesive pad, glue, mechanical coupling, injection
molded thermopolymer or thermoset pad, overmolding of the
coagulation element 306, via a composite pad having a polymer or
urethane and a ceramic or other thermo-insulating material, or
other suitable mechanism to attach the structures, such as a
dovetail or keyway slide-in lock or tongue-in-groove. In some
embodiments, a polymeric adhesive pad is employed to attach the
thermal insulator 304 to the central region 302. Such an adhesive
pad may be thermally insulating and thus may be made from a
suitable material. For example, an adhesive pad may be made of
polyolefin, PET, polyimide, silicone, refractory ceramic fiber, or
the like.
[0054] In some embodiments, the coagulation device 360 includes
coagulation element 306, which may be attached to the thermal
insulator. In some embodiments, the coagulation device 360 may
include a plurality of coagulation elements 306. For example, the
coagulation device 360 may include three cutting members 306, which
may be attached to the three thermal insulators 304 at three
portions of the central region 302 of the medical balloon 300, for
example. The coagulation device 360 (e.g., medical balloon 300) may
comprise any suitable number of coagulation elements 306 (e.g.,
cutting members) such as one, two, four, six, or more.
[0055] In some embodiments, the coagulation element 306 has a
substantially triangular shape having a sharp edge and/or tip 309.
Some embodiments may include other suitable shapes of the
coagulation element 306 such as rectangular, or the like.
[0056] In one or more embodiments, the coagulation element 306
includes a blade having a base 307 and a tip 309, where the base
307 is attached to the thermal insulator 304 and the tip 309 is
adapted to cut body tissue. In some embodiments, the base 307 of
the coagulation element 306 is made from ceramic or stainless
steel. The coagulation element 306 may be made from any suitable
material capable of coagulating and/or cutting the surrounding
tissue. In some embodiments, such material should be relatively
rigid and sharp. Suitable examples include ceramic, metal,
bi-metal, or bi-material. Further, in some embodiments, the tip 309
comprises at least one Curie material or element 311. To this end,
in some embodiments, the tip 309 is made of a Curie material or the
tip 309 may have a coating of Curie material, for example coating
204. Such Curie material may include MnBi, MnSb, CrO.sub.2,
MnOFe.sub.2O.sub.2, Nickel, or the like, either in combination or
alone. Those skilled in the art will appreciate that any other
suitable Curie material and/or element may also be employed. When
the coagulation device is suitably deployed adjacent to the desired
treatment region, a suitable electric or magnetic external field
may be applied, allowing the Curie material 311 to heat.
Alternatively, or additionally, the electric or magnetic field may
be applied from within the coagulation device 360, as will be
described in more detail with respect to FIG. 5. Once the
temperature of the Curie material 311 reaches its Curie
temperature, the Curie material 311 stops heating until the
temperature again falls below the Curie temperature.
[0057] Also, in some embodiments, the coagulation device 360 (e.g.,
medical balloon 300) includes a circulatory system 313, as shown in
FIG. 4, which may be adapted to cool the coagulation device 360
during the procedure. The circulation system 313 may be configured
to continuously or intermittently exchange the inflation fluid (or
other fluid) within the balloon 300 for a cool fluid from, for
example, a reservoir configured to remain outside the body. In some
instances, the fluid may be provided at room temperature or chilled
to a temperature lower than room temperature. Such a circulation
system 313 may prevent damage of the coagulation device 360 as well
the surrounding normal tissue (tissue not requiring treatment) from
the heat of the coagulation element 306. Circulatory systems
include a fluid such as cooled saline, contrast, cryogenic system,
etc. In some embodiments, the circulatory system is employed to
inflate and/or deflate the medical balloon 300.
[0058] FIG. 4 illustrates a method of treating a tumor 402 using a
coagulation device 360 in the form of the medical balloon 300.
According to the method, the medical balloon 300 is advanced
through a patient's body to reach a body vessel 404. The medical
balloon 300 may be advanced through the body using an introduction
device such as delivery sheath or catheter (not explicitly shown).
In some embodiments, an operator (e.g., a physician, clinician,
etc.) retracts a portion of the catheter once the medical balloon
300 is disposed within the body vessel 404. Within the vessel 404,
the medical balloon 300 is manipulated such that at least one
coagulation element 306 is generally aligned with the tumor 402.
The balloon 300 may be expanded such that the coagulation element
comes in close proximity to the tumor 402. In some instances,
expansion of the balloon 300 may also expand the body vessel 404.
Subsequently, an external field 406 (e.g., magnetic field) may be
provided to activate the Curie element 311 of the coagulation
element 306. Alternatively, or additionally, the electric or
magnetic field may be applied from within the coagulation device
360, as will be described in more detail with respect to FIG. 5.
Once activated, the curie element 311 begins to heat, which may be
employed by the coagulation element 306 to cut and or treat the
tumor 402.
[0059] In some embodiments, the Curie element 311 has a Curie
temperature in the range between about 60.degree. Celsius to about
400.degree. Celsius and, in some embodiments, between 100.degree.
Celsius to about 400.degree.. A temperature in these ranges may be
used to successfully treat the tumor. During the procedure, in some
embodiments, the medical balloon 300 is rotated by the operator
through its proximal end. The rotating medical balloon 300 may be
beneficial as, in some embodiments, the sharp coagulation element
306 provides mechanical cutting through its sharp tip 309. In some
embodiments, however, the medical balloon 300 is not rotated during
the procedure.
[0060] In addition to treating tumors, the coagulation device 360
may be used for tissue ablation to treat cysts, endometriomas,
cancers, pre-cancerous cells, warts, lesions, endovascular
canalization, annulation, endovascular incision for graft,
interstitial fluid drainage (e.g., lymph), bacterial infection
fluid release, general angioplasty, atherectomy, plaque scoring,
vulnerable plaque ablation, arterial debulking, calcified disease
scoring, crack initiation or propagation, etc. Other applications
may include RF cutting at a controlled temperature, treatment of
hemorrhoids, purposeful scarring of tissue of the cervix or
sphincter bulking through scarring of the esophagus or urethra.
Further, although shown in the context of medical balloon 300, the
coagulation element 306 can be used on or with a surgical tool,
surgical blade, needle, cut/coagulation tool, or in any other
suitable medical device.
[0061] Further, in some embodiments, the coagulation device(s) 360,
such as medical balloon 300, are coated with Curie materials via
Ultrasonic Dispersing equipment. For example, a dispersion of
polyurethane in Methyl Ethyl Ketone (MEK) in a solution of
0.5-0.65% Corethane 50D polyurethane, 1.0-10.0% dimethylacetamide,
and balance tetrahydrofuran can be employed. Alternatively, styrene
isobutylene styrene (SIBS) in toluene may be used in lieu of MEK.
In some embodiments, a solution of the polymer is prepared in a
solvent and is added to 10% by weight of the nanoparticles (NP) of
Curie materials. To keep the Curie nanoparticles well dispensed
throughout the spraying process, an ultrasonic spray system, for
example, SonicSyringe, CSP Flow and SonoFlow CSP from Sono-Tek can
be employed. The balloon or other tubular devices may be sprayed
using such equipment by rotating the balloon in the ultrasonic
spray plume. In some embodiments, the sprayed balloon is then
subjected to infrared (IR) drying to speed the process of coating
the balloon with Curie materials or nanoparticles.
[0062] FIG. 5 illustrates a side view of another illustrative
medical device 300 in partial cross-section. The medical device 500
may include an elongate member or catheter shaft 502, an expandable
member or balloon 504 coupled to a distal end region 522 of the
shaft 502, and an electromagnetic coil 506 disposed around the
distal end region 522 of the elongate shaft 502 and within an
interior portion of the balloon 504. Additional electromagnetic
coils 506 may also be utilized either within the device 500 or at a
location configured to be external to a patient's body. The
electromagnetic coil 506 may be in electrical communication with a
power and control unit configured to remain outside the body. The
power and control unit may supply an electrical current to the coil
506 to generate a magnetic field. It is contemplated that the
electrical current supplied to the coil 506 and/or the size of the
coil 506 may be varied to generate the desired magnetic field. When
in use, the balloon 504 may be filled with an inflation fluid such
as saline to expand the balloon 504 from a collapsed configuration
to an expanded configuration. The inflation fluid may be introduced
through a fluid inlet 508 and evacuated through a fluid outlet 510.
This may allow the fluid to be circulated within balloon 504.
[0063] In some embodiments, the device 500 may include one or more
coagulation elements or cutting members 512 coupled to the balloon
504. The cutting members 512 may vary in number, position, and
arrangement about the balloon 504. For example, the device 500 may
include one, two, three, four, five, six, or more cutting members
512 that are disposed at any position along balloon 504 and in a
regular, irregular, or any other suitable pattern.
[0064] In one or more embodiments, the cutting member 512 includes
a blade having a base 514 and a tip 516. The cutting member 512 may
be secured or attached to the balloon 504 through a pad 520. In
some embodiments, the pad 520 may be a thermal insulator or include
materials having insulating properties. For example, the pad 520
may be similar in form and function to the thermal insulator 304
described above. In some embodiments, the base 514 of the cutting
member 512 is made from ceramic or stainless steel, although this
is not required. The cutting member 512 may be made from any
suitable material capable of coagulating and/or cutting the
surrounding tissue. In some embodiments, the material should be
relatively rigid and sharp. The tip 516 may comprise at least one
Curie material or element 518. For example, the tip 516 may be made
of a Curie material or the tip 516 may have a coating of Curie
material similar to the coating 204 described above. Alternatively,
the cutting member 512 may be formed entirely of a Curie material.
Such Curie materials may include MnBi, MnSb, CrO.sub.2,
MnOFe.sub.2O.sub.2, nickel, or the like, either in combination or
alone. Those skilled in the art will appreciate that any other
suitable Curie material and/or element may also be employed.
[0065] The medical device 500 may be advanced through a patient's
body to reach a target treatment region. The medical device 500 may
be advanced through the body using an introduction device such as
delivery sheath or catheter (not explicitly shown). In some
embodiments, an operator (e.g., a physician, clinician, etc.)
retracts a portion of the catheter once the medical device 500 is
disposed within or adjacent to the target treatment region. Within
the target treatment region, the medical device 500 may be
manipulated such that at least one cutting member 512 is generally
aligned with the target treatment region. The balloon 504 may be
expanded such that the cutting member 512 comes in close proximity
to the target treatment region. Subsequently, an electric or
magnetic field may be applied from within the balloon 504 via coil
506. It is contemplated that placing the electromagnetic coil 506
in close proximity the Cure material 518 may allow for the use of
weaker or smaller magnetic fields. Once activated, the Curie
material 518 begins to heat, which may be employed by the cutting
member to cut and or treat the target treatment region. Once the
temperature of the Curie material 518 reaches its Curie
temperature, the Curie material 518 stops heating until the
temperature again falls below the Curie temperature.
[0066] In some embodiments, the Curie material 518 has a Curie
temperature in the range between about 60.degree. Celsius to about
400.degree. Celsius and, in some embodiments, between 100.degree.
Celsius to about 400.degree.. A temperature in these ranges may be
used to successfully treat the tumor. During the procedure, in some
embodiments, the medical device 500 is rotated by the operator
through its proximal end. The rotating medical device 500 may
provide mechanical cutting with the cutting member 512 through its
sharp tip 516. In some embodiments, however, the medical device 500
is not rotated during the procedure.
[0067] The following documents are incorporated herein by
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[0094] A description of some embodiments of the heat treatments is
contained in one or more of the following numbered statements:
Statement 1
[0095] A coagulation device comprising:
[0096] a central region;
[0097] a thermal insulator attached to at least a portion of the
central region; and
[0098] a coagulation element attached to the thermal insulator, at
least a portion of the coagulation element formed from a Curie
material having a Curie temperature between 60.degree. and
400.degree. Celsius.
Statement 2
[0099] The coagulation device of statement 1, wherein the
coagulation element is configured as a cutting member.
Statement 3
[0100] The coagulation device of any one of the preceding
statements, wherein the Curie material has a Curie temperature
between 100.degree. and 400.degree. Celsius.
Statement 4
[0101] The coagulation device of any one of the preceding
statements, wherein the Curie material is selected from the group
consisting of MnBi, MnSb, CrO.sub.2, MnOFe.sub.2O.sub.2, Nickel,
and combinations thereof.
Statement 5
[0102] The coagulation device of any one of the preceding
statements, wherein the coagulation element has a coating, the
coating comprising the Curie material.
Statement 6
[0103] The coagulation device of statement 5, wherein the coating
includes a polymeric base and a plurality of nanoparticles.
Statement 7
[0104] The coagulation device of statement 6, wherein the
nanoparticles comprise less than 10% of the coating by weight.
Statement 8
[0105] The coagulation device of any one of the preceding
statements, wherein the coagulation element defines a base and a
tip, the tip comprising the Curie material.
Statement 9
[0106] The coagulation device of statement 8, wherein the base of
the coagulation element is ceramic or stainless steel.
Statement 10
[0107] The coagulation device of any one of the preceding
statements further comprising an adhesive pad disposed between the
thermal insulator and the central region, the adhesive pad
attaching the thermal insulator to the central region.
Statement 11
[0108] The coagulation device of any one of the preceding
statements further comprising a circulatory system, the circulator
system configured to cool the coagulation device.
Statement 12
[0109] The coagulation device of statement 2, wherein the cutting
member comprises at least three cutting members.
Statement 13
[0110] The coagulation device of any one of the preceding
statements, wherein the thermal insulator is adhesively attached to
the at least a portion of the central region.
Statement 14
[0111] The coagulation device of any one of the preceding
statements, wherein the coagulation device comprises a medical
balloon.
Statement 15
[0112] The coagulation device of statement 14, wherein medical
balloon has three thermal insulators, each of the thermal
insulators having a cutting member attached thereto.
Statement 16
[0113] A topical product comprising:
[0114] a base emulsion; and
[0115] a plurality of nanoparticles homogeneously distributed
within the base emulsion, the nanoparticles having a Curie
temperature between 37.degree. and 60.degree. Celsius, wherein the
nanoparticles comprise at least 2% of the product by weight.
Statement 17
[0116] The topical product of statement 16, wherein the
nanoparticles comprise at least 3% of the product by weight.
Statement 18
[0117] The topical product of statement 17, wherein the
nanoparticles comprise at least 5% of the product by weight.
Statement 19
[0118] The topical product of statement 18, wherein the
nanoparticles comprise less than 15% of the product by weight.
Statement 20
[0119] The topical product of statement 18, wherein the
nanoparticles comprise less than 8% of the product by weight.
Statement 21
[0120] A medical device coating comprising:
[0121] a polymeric base; and
[0122] a plurality of nanoparticles homogeneously distributed
within the polymeric base, the nanoparticles having a Curie
temperature between 37.degree. and 140.degree. Celsius, wherein the
nanoparticles comprise less than 10% of the coating by weight.
Statement 22
[0123] The medical device coating of statement 21 in combination
with a stent.
Statement 23
[0124] The medical device coating of statement 21 in combination
with an inflatable medical balloon.
Statement 24
[0125] The medical device coating of statement 21 in combination
with a catheter.
Statement 25
[0126] The medical device coating of statement 21, wherein the
polymeric base includes polyurethane.
Statement 26
[0127] The medical device coating of statement 21, wherein the
polymeric base includes styrene isobutylene styrene.
Statement 27
[0128] A coagulation device comprising:
[0129] a central region;
[0130] a thermal insulator attached to at least a portion of the
central region; and
[0131] a coagulation element attached to the thermal insulator, at
least a portion of the coagulation element formed from a Curie
material having a Curie temperature between 100.degree. and
400.degree. Celsius.
Statement 28
[0132] The coagulation device of statement 27, wherein the Curie
material is selected from the group consisting of MnBi, MnSb,
CrO.sub.2, MnOFe.sub.2O.sub.2, Nickel, and combinations
thereof.
Statement 29
[0133] The coagulation device of statement 27, wherein the
coagulation element has a coating, the coating comprising the Curie
material.
Statement 30
[0134] The coagulation device of statement 27, wherein the
coagulation element defines a base and a tip, the tip comprising
the Curie material.
Statement 31
[0135] The coagulation device of statement 30, wherein the base of
the coagulation element is selected from the group consisting of
ceramic or stainless steel.
Statement 32
[0136] The coagulation device of statement 27 further comprising an
adhesive pad disposed between the thermal insulator and the central
region, the adhesive pad attaching the thermal insulator to the
central region.
Statement 33
[0137] The coagulation device of statement 32, wherein the adhesive
pad is polymeric.
Statement 34
[0138] The coagulation device of statement 27 further comprising a
circulatory system, the circulator system configured to cool the
coagulation device.
Statement 35
[0139] The coagulation device of statement 27, wherein the
coagulation element comprises at least three cutting members.
[0140] It should be understood that this disclosure is, in many
respects, only illustrative. Changes may be made in details,
particularly in matters of shape, size, and arrangement of steps
without exceeding the scope of the disclosure. This may include, to
the extent that it is appropriate, the use of any of the features
of one example embodiment being used in other embodiments. The
invention's scope is, of course, defined in the language in which
the appended claims are expressed.
* * * * *
References