US20150297281A1

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Publication number: US20150297281A1
Application number: US14/689,455
Authority: US
Inventors: Derek C. Sutermeister; Joseph Alan Kronstedt; Timothy A. Ostroot; Patrick A. Haverkost; Jan Weber; James M. Anderson; Cass Alexander Hanson; Martin R. Willard
Original assignee: Scimed Life Systems Inc
Current assignee: Boston Scientific Scimed Inc
Priority date: 2014-04-17
Filing date: 2015-04-17
Publication date: 2015-10-22
Also published as: US20150297292A1; WO2015161181A9; EP3131489A1; EP3131488A1; WO2015161211A1; WO2015161197A1; CN106456986A; US20150297763A1; CN106413611A; US10543035B2; CN106456987A; CA2945796A1; JP2017517494A; AU2015247450A1; EP3131627A1; WO2015161181A1

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° and 400° Celsius.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

The following commonly assigned patent applications are incorporated herein by reference, each in its entirety:

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.

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

U.S. Pat. App. Ser. No. 61/981,003 (Sutermeister et al.), entitled COMPOSITIONS FOR THERAPEUTIC HEAT DELIVERY, filed on Apr. 17, 2014 and

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

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

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.

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.

Therefore, a need remains to develop devices and methods for providing homogeneous and more controlled therapeutic heat treatments.

SUMMARY

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° and 60° Celsius.

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° and 140° Celsius.

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° and 400° Celsius.

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

A detailed description of the invention is hereafter described with specific reference being made to the drawings.

FIG. 1 is a perspective view of a body surface that is being treated with an embodiment of a topical product.

FIG. 2 is a perspective view of a coated medical device.

FIG. 3 is a partial view of an embodiment of an embodiment of a coagulation device.

FIG. 3A is a cross-sectional view of the embodiment ofFIG. 3.

FIG. 4 illustrates a method of treating a tumor using the coagulation device ofFIGS. 3 and 3A.

FIG. 5 a side view of a portion of another illustrative coagulation device.

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

Definitions are provided for the following defined terms. It is intended that these definitions be applied, unless the context indicates otherwise.

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).

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.

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.

“Curie temperature” is defined as the temperature at which permanent magnetic properties of a material convert into induced magnetic properties, or vice versa.

“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.

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.

FIG. 1 is a perspective view depicting abody surface100 with atopical product102 applied to it. In some embodiments, thebody surface100 may include any external or internal surface of a patient such as skin, fingernail, toenail, mucus membranes, etc. As illustrated, thetopical product102 is applied to atreatment area101 on thebody surface100, for example to treat a skin disease such as fungal infection, or the like. Thetopical product102, which may be formulated as creams, foams, gels, lotions, ointments, or other suitable formulations, in turn, provides a therapeutic heat treatment to thetreatment area101, as discussed in greater detail below.

In some embodiments, thetopical product102 includes abase emulsion104 and plurality ofnanoparticles106. For simplicity, asingle nanoparticle106 is labeled in the drawings, however, it should be understood that thetopical product102 may comprise any suitable number ofnanoparticles106 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 ofnanoparticles106 in the base emulsion104 (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 ofbody surface100, etc. In some embodiments, thenanoparticles106 comprise at least 2% of thetopical product102 by weight. In some embodiments, however, thenanoparticles106 comprise at least 3% of thetopical product102 by weight. Other suitable percentages of thenanoparticles106 in thetopical product102 may include at least 4%, 5%, 8%, 15%, or more, by weight. It should be noted that any other suitable percentage of thenanoparticles106 may also be contemplated, without departing from the scope of the present disclosure.

In some embodiments, thenanoparticles106 are homogeneously distributed within thebase emulsion104. The homogenous distribution of thenanoparticles106 in thebase emulsion104 may be used to achieve a homogeneous mixture forming thetopical product102. The homogeneous distribution of theproduct102 may provide ease of application on thetreatment area101. However, this is not required.

In some embodiments, thebase emulsion104 is an oil-based or water-based emulsion. In some embodiments, thebase emulsion104 includes petroleum jelly and/or polyethylene glycol.

In some embodiments, thenanoparticles106 are made from Curie materials having magnetic properties. Under influence of a desired electric or magnetic field, thenanoparticles106 deliver heat therapy to the body surface100 (e.g., skin, nails, etc.). In some embodiments, thenanoparticles106 are heated to their Curie temperature. In particular, in some embodiments, themagnetic nanoparticles106 are subjected to an alternating field. Upon application of the alternating field, themagnetic nanoparticles106 begin to heat. Generally, at temperatures less than the Curie temperature (T<T_c), the magnetic nanoparticles106 (and/or compositions thereof) are ferro- (or ferri-) magnetic and transition into paramagnetic phase upon reaching the Curie temperature (T_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 thenanoparticles106 is stabilized to within a small temperature range at or near the predetermined Curie temperature.

Further, the heating of thetopical product102 may be controlled by controlling intensity, frequency, or other related parameters of the electro-magnetic field applied to thetopical product102 or more specifically to themagnetic nanoparticles106. Once the temperature ofnanoparticles106 reaches its Curie temperature, heating stops, avoiding any unwanted damage to thetreatment area101.

In some embodiments, themagnetic nanoparticles106 have a composition such that the Curie temperature (T_c) is in the range between about 37° Celsius to about 60° Celsius. In some embodiments, the Curie temperature is in the range between about 40° Celsius to about 50° Celsius. And, in some embodiments, the Curie temperature is 43° Celsius to about 48° Celsius, for example.

Therapeutic heat treatments in one or more embodiments may be performed usingmagnetic nanoparticles106 having Curie temperatures between about 37° Celsius to about 60° Celsius.Such nanoparticles106 are configured to treat thebody surface102, 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° Celsius.

Thetopical product102 can be used to treat a wide variety of ailments. For example, thetopical product102 may be used to treat warts, lesions, parasitic infections, skin cancer, or the like. In some embodiments, thetreatment area101 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° Celsius to about 60° Celsius in order to disrupt fungal growth. In some embodiments, thetopical product102 is in the form of a nail polish that can be applied to the nail by the patient in their home. Upon application of thetopical product102 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° Celsius to about 60° Celsius.

In some embodiments, thetopical product102 is applied to a mucous membrane of the patient to treat a variety of diseases. For instance, thetopical product102 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, theproduct102 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).

In some embodiments, thenanoparticles106 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.

One or more medical devices may also incorporate Curie nanoparticles for delivering therapeutic heat treatment. For example,FIG. 2 shows amedical device200 coated with Curie nanoparticles in accordance with an embodiment of the present disclosure. In some embodiments, themedical device200 includes anelongated member202 having acoating204 applied on itsouter surface205. In some embodiments, theelongated member202 comprises an inflatable medical balloon. However theelongated member202 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. Thecoating204 may be applied to a portion of theouter surface205 of theelongated member202 or over the entire outer surface of theelongated member202. In some embodiments, theelongated member202 has adistal end region201 and aproximal end region203.

In some embodiments, theelongated member202 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, theelongated member202 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, theelongated member202 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.

In some embodiments, themedical device coating204 includes apolymeric base206 and a plurality ofmagnetic nanoparticles208. In an example, thenanoparticles208 are mixed with thepolymeric base206 to create a homogenous mixture. Those skilled in the art will appreciate that any suitable method may be employed to combine thepolymeric base206 and thenanoparticles208 to form thecoating204, for example, conventional methods such as encapsulation. Once formed, thecoating204 may be applied to themedical device200 by various methods such as spraying, painting, etching, etc. Thecoating204 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 cuttingmembers512 described below, coagulation elements, such ascoagulation elements306 described below, or the like

Thepolymeric base206 may comprise a suitable polymer such as polyurethane, styrene isobutylene styrene, or other polymers known to the art. In some embodiments, thepolymeric base206 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.

In some embodiments, thenanoparticles208 comprise magnetic nanoparticles having a selected Curie temperature. In some embodiments, themagnetic nanoparticles208 have Curie temperatures falling in the range between about 37° Celsius to about 140° Celsius. However, it should be noted that any suitable Curie material having a suitable Curie temperature may also be used in thecoating206, which may be dictated by the temperature range required to heat and/or treat a body tissue or region.

In some embodiments, themagnetic nanoparticles208 may comprise less than 10% of thecoating204 by weight. Thenanoparticles208 may comprise any suitable percentage in thecoating204 such as, but not limited to, 4%, 8%, 12%, 24%, 48%, or more. The percentage of thenanoparticles208 may vary depending on various factors, for example—a) the amount of heat required for the therapy, and b) the Curie temperature of themagnetic nanoparticles208 used to form thecoating204.

In some embodiments, themedical device200 is navigated through a patient's body to reach a treatment region. In some instances, themedical device200 is an inflatable medical balloon having acoating204 disposed on itsouter surface205. Upon reaching the treatment region, themedical device200 is inflated using a conventional inflation mechanism (e.g., inflation fluid such as saline) such that thecoating204, in particular thenanoparticles208, come into contact with the surrounding body tissue. Further, inflation of the balloon allows thenanoparticles208 to come in close proximity with a desired treatment area. At this point, a suitable electric or magnetic external field may be applied, allowing themagnetic nanoparticles208 to heat. Alternatively, or additionally, the electric or magnetic field may be applied from within themedical device200, as will be described in more detail with respect toFIG. 5. Once the temperature of themagnetic nanoparticles208 reaches its Curie temperature, thenanoparticles208 stop heating until the temperature again falls below the Curie temperature.

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, themedical device200 having a balloon-shaped structure may be employed. In some embodiments, the balloon has thecoating204 applied to its outer surface. The balloon may be used to constrict or occlude the varicose vein by heating it at about 120° 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 themagnetic nanoparticles208 disposed in thecoating204. The heat may thus occlude the varicose vein. In such an example, themagnetic nanoparticles208 may have a Curie temperature of about 120° Celsius.

Further, in some embodiments, themedical device200 is used for nerve treatment for denervation of renal artery, carotid sinus, splanchnic nerves, bronchial nerves, pulmonary artery denervation, etc. Furthermore, thedevice200 may be used for tissue ablation, pain mitigation, muscle pacing or relaxation, etc.

In some embodiments, thenanoparticles208 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 themedical device200 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 amedical device200 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 themedical device200 at the first Curie temperature via magnetic resonance; and, themedical device200 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.

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.

FIGS. 3 and 3A depict partial and cross-sectional views, respectively, of a coagulation or cuttingdevice360. In some embodiments, thecoagulation device360 comprises amedical balloon300, which is adapted to be introduced inside a patient's body, in a similar way as themedical device200 ofFIG. 2.

In some embodiments, thecoagulation device360 is employed to cut, cauterize, and/or coagulate the surrounding body tissue, upon reaching a treatment region within the patient's body. For instance, thecoagulation device360 may be employed to cut the tumor402 (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 device360 (e.g., medical balloon300) includes acentral region302, athermal insulator304, and acoagulation element306, which, in some embodiments is a cutting member. In some embodiments, however, thethermal insulator304 is not required. In some instances, thethermal insulator304 may also function as a bonding pad configured to attach thecoagulation element306 to theballoon300.

In some embodiments, thecentral region302 forms the body of themedical balloon300. In the illustrated embodiment, thecentral region302 has a substantially tubular geometry with circular cross-section. Those skilled in the art will appreciate that thecentral region302 may have any suitable cross-sectional shape such as, but not limited to, rectangular, oval, irregular, or the like, however. In some embodiments, thethermal insulator304 is attached to at least a portion of thecentral region302. According to one or more embodiments, thethermal insulator304 includes a pad, chip, layer, or other suitable structure capable of being attached to at least a portion of thecentral region302. In the illustrated embodiment, thethermal insulator304 has a pad-shaped structure, which may be attached to anouter surface301 of thecentral region302. Some embodiments employ an adhesive to attach thethermal insulator304 to thecentral region302. Thethermal insulator304 and/orcoagulation element306 can also be attached via an adhesive pad, glue, mechanical coupling, injection molded thermopolymer or thermoset pad, overmolding of thecoagulation element306, 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 thethermal insulator304 to thecentral region302. 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.

In some embodiments, thecoagulation device360 includescoagulation element306, which may be attached to the thermal insulator. In some embodiments, thecoagulation device360 may include a plurality ofcoagulation elements306. For example, thecoagulation device360 may include three cuttingmembers306, which may be attached to the threethermal insulators304 at three portions of thecentral region302 of themedical balloon300, for example. The coagulation device360 (e.g., medical balloon300) may comprise any suitable number of coagulation elements306 (e.g., cutting members) such as one, two, four, six, or more.

In some embodiments, thecoagulation element306 has a substantially triangular shape having a sharp edge and/ortip309. Some embodiments may include other suitable shapes of thecoagulation element306 such as rectangular, or the like.

In one or more embodiments, thecoagulation element306 includes a blade having a base307 and atip309, where thebase307 is attached to thethermal insulator304 and thetip309 is adapted to cut body tissue. In some embodiments, thebase307 of thecoagulation element306 is made from ceramic or stainless steel. Thecoagulation element306 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, thetip309 comprises at least one Curie material orelement311. To this end, in some embodiments, thetip309 is made of a Curie material or thetip309 may have a coating of Curie material, forexample coating204. Such Curie material may include MnBi, MnSb, CrO₂, MnOFe₂O₂, 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 theCurie material311 to heat. Alternatively, or additionally, the electric or magnetic field may be applied from within thecoagulation device360, as will be described in more detail with respect toFIG. 5. Once the temperature of theCurie material311 reaches its Curie temperature, theCurie material311 stops heating until the temperature again falls below the Curie temperature.

Also, in some embodiments, the coagulation device360 (e.g., medical balloon300) includes acirculatory system313, as shown inFIG. 4, which may be adapted to cool thecoagulation device360 during the procedure. Thecirculation system313 may be configured to continuously or intermittently exchange the inflation fluid (or other fluid) within theballoon300 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 acirculation system313 may prevent damage of thecoagulation device360 as well the surrounding normal tissue (tissue not requiring treatment) from the heat of thecoagulation element306. 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 themedical balloon300.

FIG. 4 illustrates a method of treating atumor402 using acoagulation device360 in the form of themedical balloon300. According to the method, themedical balloon300 is advanced through a patient's body to reach abody vessel404. Themedical balloon300 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 themedical balloon300 is disposed within thebody vessel404. Within thevessel404, themedical balloon300 is manipulated such that at least onecoagulation element306 is generally aligned with thetumor402. Theballoon300 may be expanded such that the coagulation element comes in close proximity to thetumor402. In some instances, expansion of theballoon300 may also expand thebody vessel404. Subsequently, an external field406 (e.g., magnetic field) may be provided to activate theCurie element311 of thecoagulation element306. Alternatively, or additionally, the electric or magnetic field may be applied from within thecoagulation device360, as will be described in more detail with respect toFIG. 5. Once activated, thecurie element311 begins to heat, which may be employed by thecoagulation element306 to cut and or treat thetumor402.

In some embodiments, theCurie element311 has a Curie temperature in the range between about 60° Celsius to about 400° Celsius and, in some embodiments, between 100° Celsius to about 400°. A temperature in these ranges may be used to successfully treat the tumor. During the procedure, in some embodiments, themedical balloon300 is rotated by the operator through its proximal end. The rotatingmedical balloon300 may be beneficial as, in some embodiments, thesharp coagulation element306 provides mechanical cutting through itssharp tip309. In some embodiments, however, themedical balloon300 is not rotated during the procedure.

In addition to treating tumors, thecoagulation device360 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 ofmedical balloon300, thecoagulation element306 can be used on or with a surgical tool, surgical blade, needle, cut/coagulation tool, or in any other suitable medical device.

Further, in some embodiments, the coagulation device(s)360, such asmedical balloon300, 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.

FIG. 5 illustrates a side view of another illustrativemedical device300 in partial cross-section. Themedical device500 may include an elongate member orcatheter shaft502, an expandable member orballoon504 coupled to adistal end region522 of theshaft502, and anelectromagnetic coil506 disposed around thedistal end region522 of theelongate shaft502 and within an interior portion of theballoon504. Additionalelectromagnetic coils506 may also be utilized either within thedevice500 or at a location configured to be external to a patient's body. Theelectromagnetic coil506 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 thecoil506 to generate a magnetic field. It is contemplated that the electrical current supplied to thecoil506 and/or the size of thecoil506 may be varied to generate the desired magnetic field. When in use, theballoon504 may be filled with an inflation fluid such as saline to expand theballoon504 from a collapsed configuration to an expanded configuration. The inflation fluid may be introduced through afluid inlet508 and evacuated through afluid outlet510. This may allow the fluid to be circulated withinballoon504.

In some embodiments, thedevice500 may include one or more coagulation elements or cuttingmembers512 coupled to theballoon504. The cuttingmembers512 may vary in number, position, and arrangement about theballoon504. For example, thedevice500 may include one, two, three, four, five, six, ormore cutting members512 that are disposed at any position alongballoon504 and in a regular, irregular, or any other suitable pattern.

In one or more embodiments, the cuttingmember512 includes a blade having a base514 and atip516. The cuttingmember512 may be secured or attached to theballoon504 through apad520. In some embodiments, thepad520 may be a thermal insulator or include materials having insulating properties. For example, thepad520 may be similar in form and function to thethermal insulator304 described above. In some embodiments, thebase514 of the cuttingmember512 is made from ceramic or stainless steel, although this is not required. The cuttingmember512 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. Thetip516 may comprise at least one Curie material orelement518. For example, thetip516 may be made of a Curie material or thetip516 may have a coating of Curie material similar to thecoating204 described above. Alternatively, the cuttingmember512 may be formed entirely of a Curie material. Such Curie materials may include MnBi, MnSb, CrO₂, MnOFe₂O₂, 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.

Themedical device500 may be advanced through a patient's body to reach a target treatment region. Themedical device500 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 themedical device500 is disposed within or adjacent to the target treatment region. Within the target treatment region, themedical device500 may be manipulated such that at least one cuttingmember512 is generally aligned with the target treatment region. Theballoon504 may be expanded such that the cuttingmember512 comes in close proximity to the target treatment region. Subsequently, an electric or magnetic field may be applied from within theballoon504 viacoil506. It is contemplated that placing theelectromagnetic coil506 in close proximity theCure material518 may allow for the use of weaker or smaller magnetic fields. Once activated, theCurie material518 begins to heat, which may be employed by the cutting member to cut and or treat the target treatment region. Once the temperature of theCurie material518 reaches its Curie temperature, theCurie material518 stops heating until the temperature again falls below the Curie temperature.

In some embodiments, theCurie material518 has a Curie temperature in the range between about 60° Celsius to about 400° Celsius and, in some embodiments, between 100° Celsius to about 400°. A temperature in these ranges may be used to successfully treat the tumor. During the procedure, in some embodiments, themedical device500 is rotated by the operator through its proximal end. The rotatingmedical device500 may provide mechanical cutting with the cuttingmember512 through itssharp tip516. In some embodiments, however, themedical device500 is not rotated during the procedure.

The following documents are incorporated herein by reference, each in its entirety:

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A description of some embodiments of the heat treatments is contained in one or more of the following numbered statements:

Statement 1

A coagulation device comprising:

a central region;

a thermal insulator attached to at least a portion of the central region; and

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° and 400° Celsius.

Statement 2

The coagulation device ofstatement 1, wherein the coagulation element is configured as a cutting member.

Statement 3

The coagulation device of any one of the preceding statements, wherein the Curie material has a Curie temperature between 100° and 400° Celsius.

Statement 4

The coagulation device of any one of the preceding statements, wherein the Curie material is selected from the group consisting of MnBi, MnSb, CrO₂, MnOFe₂O₂, Nickel, and combinations thereof.

Statement 5

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

The coagulation device of statement 5, wherein the coating includes a polymeric base and a plurality of nanoparticles.

Statement 7

The coagulation device of statement 6, wherein the nanoparticles comprise less than 10% of the coating by weight.

Statement 8

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

The coagulation device of statement 8, wherein the base of the coagulation element is ceramic or stainless steel.

Statement 10

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

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

The coagulation device of statement 2, wherein the cutting member comprises at least three cutting members.

Statement 13

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

The coagulation device of any one of the preceding statements, wherein the coagulation device comprises a medical balloon.

Statement 15

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

A topical product comprising:

a base emulsion; and

a plurality of nanoparticles homogeneously distributed within the base emulsion, the nanoparticles having a Curie temperature between 37° and 60° Celsius, wherein the nanoparticles comprise at least 2% of the product by weight.

Statement 17

The topical product of statement 16, wherein the nanoparticles comprise at least 3% of the product by weight.

Statement 18

The topical product of statement 17, wherein the nanoparticles comprise at least 5% of the product by weight.

Statement 19

The topical product of statement 18, wherein the nanoparticles comprise less than 15% of the product by weight.

Statement 20

The topical product of statement 18, wherein the nanoparticles comprise less than 8% of the product by weight.

Statement 21

A medical device coating comprising:

a polymeric base; and

a plurality of nanoparticles homogeneously distributed within the polymeric base, the nanoparticles having a Curie temperature between 37° and 140° Celsius, wherein the nanoparticles comprise less than 10% of the coating by weight.

Statement 22

The medical device coating of statement 21 in combination with a stent.

Statement 23

The medical device coating of statement 21 in combination with an inflatable medical balloon.

Statement 24

The medical device coating of statement 21 in combination with a catheter.

Statement 25

The medical device coating of statement 21, wherein the polymeric base includes polyurethane.

Statement 26

The medical device coating of statement 21, wherein the polymeric base includes styrene isobutylene styrene.

Statement 27

A coagulation device comprising:

a central region;

a thermal insulator attached to at least a portion of the central region; and

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° and 400° Celsius.

Statement 28

The coagulation device of statement 27, wherein the Curie material is selected from the group consisting of MnBi, MnSb, CrO₂, MnOFe₂O₂, Nickel, and combinations thereof.

Statement 29

The coagulation device of statement 27, wherein the coagulation element has a coating, the coating comprising the Curie material.

Statement 30

The coagulation device of statement 27, wherein the coagulation element defines a base and a tip, the tip comprising the Curie material.

Statement 31

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

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

The coagulation device of statement 32, wherein the adhesive pad is polymeric.

Statement 34

The coagulation device of statement 27 further comprising a circulatory system, the circulator system configured to cool the coagulation device.

Statement 35

The coagulation device of statement 27, wherein the coagulation element comprises at least three cutting members.

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.