Field of the Invention The present invention relates generally to medical devices and, more particularly, to intracorporal medical device, such as a guidewire, catheter, or the like having electroactive polymers.

Background The use of intravascular medical devices has become an effective method for treating many types of vascular disease. In general, one or more suitable intravascular devices are inserted into the vascular system of the patient and navigated through the vasculature to a desired target site. Using this method, virtually any target site in the patient's vascular system may be accessed, including the coronary, cerebral, and peripheral vasculature. Examples of therapeutic purposes for intravascular devices include percutaneous transluminal angioplasty (PTA) and percutaneous transluminal coronary angioplasty (PTCA).

When in use, intravascular devices, such as a catheter, may enter the patient's vasculature at a convenient location and then can be advanced over a guidewire to a target region in the anatomy. The path taken within the anatomy of a patient may be very tortuous, and as such, it may be desirable to combine a number of performance features in the intravascular device to aid in advancing the catheter over the guidewire. For example, it is sometimes desirable that the catheter has a relatively high level of pushability and torqueability. It is also sometimes desirable that a catheter is relatively flexible, for example, to aid in advancing the catheter over the guidewire to access a treatment site. For some applications, catheters may also be expected to exhibit tensile and/or compressive strength in certain regions.

A number of different elongated medical device structures, assemblies, and methods are known, each having certain advantages and disadvantages. However, there is an ongoing need to provide alternative elongated medical device structures, assemblies, and methods. In particular, there is an ongoing need to provide alternative medical devices including structure or assemblies configured to aid in advancing a catheter over a guidewire in a vessel of a patient and to aid in treating a treatment site of a patient, and methods of making and using such structures and/or assemblies.

Brief Summary The invention provides design, material, manufacturing method, and use alternatives for medical devices. An activation circuit for selectively providing an electrical current to one or more electroactive polymers (EAPs) in a medical device is disclosed. The activation circuit may include a sensor for sensing a measure related to a parameter of an elongated member and/or a balloon of the medical device. The electrical current may be provided to the one or more EAPs according to the sensed parameter of the elongated member and/or the balloon of the medical device. In some cases, the activation circuit may include a comparator for comparing the sensed measure to a threshold to determine when the electrical current is applied to the EAPs.

In some cases, the parameter may be a pressure, a fluid flow, and/or a temperature. In one embodiment, the medical device may include a rotatable balloon including EAP collars including EAP layers. In another embodiment, the medical device may include a drug delivery balloon including an EAP layer disposed about at least a portion of the balloon to selectively release one or more drugs into a vessel.

The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present invention. The Figures, and Detailed Description, which follow, more particularly exemplify these embodiments.

Brief Description of the Drawings The invention may be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which:

Figure 1 is a schematic diagram of an illustrative balloon catheter including a stent; Figure 2 is a perspective view of the distal end of the illustrative catheter of

Figure 1;

Figures 3 and 4 are a longitudinal cross-sectional views of the catheter of Figure 2 disposed within a vessel adjacent to a bifurcation; Figure 5 is a block diagram of an illustrative embodiment of an activation circuit for activating the EAP layers of collars of the catheter of Figure 1 ;

Figure 6 is a schematic diagram of an illustrative circuit of a Schmitt trigger that may be included in the comparator of Figure 5; Figure 7 is an illustrative graph showing the output voltage of the circuit of

Figure 6 as a function of the input voltage;

Figure 8 is block diagram of another illustrative embodiment of an activation circuit; and

Figure 9 is a longitudinal cross-sectional view of an illustrative embodiment of a catheter including a drug delivery balloon.

While the invention 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 spirit and scope of the invention.

Detailed Description

For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. All numeric values are herein assumed to be modified by the term "about," whether or not explicitly indicated. The term "about" generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the terms "about" may include numbers that are rounded to the nearest significant figure. 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 in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. 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 invention.

Figure 1 is a perspective view of an illustrative embodiment of a balloon catheter 10 including a stent 26. In the illustrative embodiment, the balloon catheter 10 may include an elongated shaft 11 having a proximal end, a distal end, and one or more lumens extending therebetween. In the illustrative example, the one or more lumens may include an inflation lumen, a guidewire lumen, or any other lumen, as desired. An inflatable balloon 14 may be disposed adjacent to the distal end of the elongated shaft 11. As illustrated, the balloon 14 may be a stent delivery balloon. However, it is contemplated that the balloon 14 may be a typical angioplasty or other inflatable member, as desired.

A hub assembly 12 may be connected to the proximal end of the elongated shaft 11 to facilitate connection to an inflation device for inflating/deflating the balloon 14, and/or to facilitate insertion of a guidewire or other medical device therein. In some cases the inflatable balloon 14 may be fluidly connected to the hub assembly 12 via an inflation lumen of the elongated shaft 11.

In some embodiments, the elongate shaft 11 may include one or more sections to help achieve desired pushability, torqueability, and/or flexibility in the elongated shaft 11. As illustrated, the elongated shaft 11 may include a proximal section 16, a midshaft section 18, and a distal section 20. However, it is contemplated that the elongate shaft 11 may include a single section or any number of sections, as desired.

In the illustrative example, the proximal section 16 of the elongated shaft 11 may include an elongated tubular member having a lumen extending therethrough. In one example, the proximal section 16 of the elongated shaft 11 may include a hypotube, but this is not required. In some cases, the proximal section 16 may include one or more openings, slits, or other features to achieve a desired stiffness and flexibility, as desired. In some embodiments, the proximal section 16 may include a material to impart flexibility and stiffness characteristics according to the desired application. In the illustrative embodiment, the proximal section 16 may include a material to impart stiffness and pushability in the catheter 10. For example, the proximal section 16 may include a rigid and resilient material. In such an embodiment, the proximal section 16 may be made from a metal, a metal alloy, a polymer, a metal-polymer composite, and the like, or any other suitable material. Some examples of suitable metals and metal alloys include stainless steel, such as 304V, 304L, and 316LV stainless steel; mild steel; nickel-titanium alloy such as linear-elastic and/or super-elastic nitinol; other nickel alloys such as nickel- chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 such as HASTELLOY® ALLOY B2®, and the like), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, and the like; cobalt alloys, such as cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R3OOO3 such as ELGILOY®, PHYNOX®, and the like); platinum enriched stainless steel; combinations thereof; and the like; or any other suitable material. However, this is not meant to be limiting and it is to be understood that the proximal section 16 may include any suitable material described herein with reference to any other catheter component, such as, for example, a polymer or polymer blend discussed below, or any suitable material commonly used in medical devices, as desired. In the illustrative embodiment, the midshaft section 18 of the elongate shaft 11 may be disposed distally of the proximal section 16. For example, the midshaft 18 may include a proximal end disposed adjacent to the distal end of the proximal section 16, a distal end, and one or more lumens extending therethrough. In some cases, the proximal end of the midshaft section 18 may be coupled to or otherwise connected to the distal end of the proximal section 16. There are numerous materials that can be used for the midshaft of catheter 10 to achieve the desired properties that are commonly associated with medical devices. Some example materials can include, but is not limited to, stainless steel, metal, nickel alloy, nickel-titanium alloy, hollow cylindrical stock, thermoplastics, high performance engineering resins, polymers, fluorinated ethylene propylene (FEP), polyethylene (PE), polypropylene (PP), polyvinylchloride (PVC), polyurethane, polytetrafluoroethylene (PTFE), polyether- ether ketone (PEEK), polyimide, polyamide, polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polysufone, nylon, perfluoro(propyl vinyl ether) (PFA), polyoxymethylene (POM), polybutylene terephthalate (PBT), polyether block ester, or other polymer blends. For example, the polymer blend may include polyoxymethylene blended with a polyether polyester such as ARNITEL® available from DSM Engineering Plastics or HYTREL® available from DuPont. Other suitable polymers that may be blended with polyoxymethylene include polyether block ester, polyether block amide (PEBA, for example available under the trade name PEBAX®), polyetheretherketone (PEEK), polyetherimide (PEI), and the like. A suitable polyoxymethylene is commercially available under the trade name Delrin™ commercially available from DuPont Wilmington, DE. In some cases, the midshaft section 18 is manufactured so as to maintain the desired level of stiffness, flexibility, and torqueability according to multiple embodiments of the current invention and includes multiple layers over at least portions of its length which provide selected flexibility. However, it is to be understood that the above mentioned materials are not meant to be limiting and it is to be understood that the midshaft 18 may include any suitable material described herein with reference to any other catheter component or any suitable material commonly used in medical devices, as desired.

In the illustrative embodiment, the distal section 20 of the elongate shaft 11 may be disposed distally of the midshaft section 18. For example, the distal section 20 may include a proximal end disposed adjacent to the distal end of the midshaft section 18, a distal end, and one or more lumens extending therethrough. In some cases, the inflatable balloon 14 may be disposed about at least a portion of the distal section 20 adjacent to the distal end. The distal section 20 may include those materials that are commonly used in medical devices. Some example materials can include, but is not limited to, stainless steel, metal, nickel alloy, nickel-titanium alloy, hollow cylindrical stock, thermoplastics, high performance engineering resins, polymers, fluorinated ethylene propylene (FEP), polyethylene (PE), polypropylene (PP), polyvinylchloride (PVC), polyurethane, polytetrafluoroethylene (PTFE), poly ether-ether ketone (PEEK), polyimide, polyamide, polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polysufone, nylon, perfluoro(propyl vinyl ether) (PFA), polyoxymethylene (POM), polybutylene terephthalate (PBT), polyether block ester, or other polymer blends. For example, the polymer blend may include polyoxymethylene blended with a polyether polyester such as ARNITEL® available from DSM Engineering Plastics or HYTREL® available from DuPont. Other suitable polymers that may be blended with polyoxymethylene include polyether block ester, polyether block amide (PEBA, for example available under the trade name PEBAX®), polyetheretherketone (PEEK), polyetherimide (PEI), and the like. A suitable polyoxymethylene is commercially available under the trade name Delrin™ commercially available from DuPont Wilmington, DE. In some cases, the distal section 20 is manufactured so as to maintain the desired level of stiffness, flexibility, and torqueability according to multiple embodiments of the current invention and includes multiple layers over at least portions of its length which provide selected flexibility. However, this is not meant to be limiting and it is to be understood that the distal section 20 may include any suitable material described herein with reference to any other catheter component or any suitable material commonly used in medical devices, as desired.

Furthermore, it should be understood that other suitable structures or components, may be incorporated into the elongate shaft 1 1 of the catheter 10. For example, a braided member, one or more coils, and/or marker members, or the like may be disposed along a portion of or the entire length of the elongated shaft 11. In example cases when a braided member is provided, the braided member may be provided in the proximal section 16, in the midshaft 18, in the distal section 20, or any combination thereof, as desired. The braided member may take on a number of forms. Typically the braided member will include a lubricious inner layer and a polymeric outer layer, with a braid composed of a number of filaments or strands braided between the inner and outer layers. A helical, double helical, coiled, or woven member may be used in place of the braid, if desired.

Additionally, the foregoing elongated member 1 1 is merely illustrative and is not meant to be limiting in any manner. It is to be understood that any suitable elongated member may be used in the catheter 10, as desired. In the illustrative embodiment, a guidewire 28 may be slidably disposed through a lumen of the elongate member 11. As illustrated, the guidewire 28 may be disposed in a first port at the distal end of the catheter 10 and through a second port 24 shown in the elongate shaft 11. As illustrated, the guidewire port 24 is provided in the midshaft section 18, however, the guidewire port 24 may be provided in the proximal section 16, the distal section 20, as well as in any other suitable location of the elongated member 11 , as desired.

Figure 2 is a perspective view of the distal end 13 of the illustrative catheter 10 shown in Figure 1. In the illustrative embodiment, the elongated member 1 1 may include an inner shaft 36 and an outer shaft 33. The balloon 14 may be rotatably disposed about the elongated member 11 and configured to engage one or both of the inner shaft 36 and the outer shaft 33. As illustrated, the inner shaft 36 may include a lumen 38 defining a guidewire lumen of the elongate shaft 11 and the outer shaft 33 may include a lumen 34 defining an inflation lumen of the elongate shaft 11. In the illustrative embodiment, the balloon 14 may include a proximal waist

44 and a distal waist 46 configured to engage a portion of the elongated shaft 11. As illustrated, the proximal waist 44 may be disposed about a collar 40 and the distal waist 46 may be disposed about a collar 42. In the illustrative embodiment, collar 40 and collar 42 may include an electroactive polymer (EAP) actuator that is actuatable between an expanded state and a contracted state. In some cases, the expanded state may be an activated state and the contracted state may be a non-activated state. In the contracted or non-activated state, the proximal waist 44 and the distal waist 46 of the balloon 14 may be rotatable about collar 40 and collar 42, respectively. In some cases, in the contracted or non-activated state, the balloon 14 may be fluidly unsealed. In the expanded or activated state, the proximal waist 44 and the distal waist 46 of the balloon 14 may be configured to be fluidly sealed to and/or non-rotatable about collars 40 and 42, respectively.

EAPs are polymers that are characterized by their ability to change shape in response to an electrical stimulus. For example, in some embodiments the EAP material may expand about 0.5% to about 20% when exposed to an electric current of 0.001 microAmps to 1 milliAmps (-2 to +2 V). Some examples of materials that may be used in EAPs may include, but is not limited to, polypyrroles, polyanilines, polythiophenes, polyethylenedioxythiophenes, poly(p-phenylene vinylene)s, polysulfones, polyacetylenes, Nafion, Bucky paper and any other ionic electro-active polymer that is considered to have low voltage, low speed, high stress (up to 500 MPa), characteristics. Furthermore, it is contemplated that any electroactive polymer that exhibits contractile or expansile properties may be used in connection with the various active regions of the invention, including those listed above.

These EAPs may have a number of properties that make them attractive for use in the medical devices such as, for example, they are lightweight, flexible, small and easily manufactured; energy sources are available which are easy to control, and energy can be easily delivered to the EAPS; small changes in potential (e.g., potential changes on the order of IV) can be used to effect volume change in the EAPs; they are relatively fast in actuation (e.g., full expansion/contraction in a few seconds); EAP regions can be created using a variety of techniques, for example, electrodeposition; EAP regions can be patterned, for example, using photolithography; and many other properties. EAP materials and some of their notable characteristics are described in an article entitled Electro-Active Polymer Actuators for Planetary Applications by Y. Bar-Cohen et al. and published in Paper No. 3669-05 of the Proceedings of SPIE Annual International Symposium on Smart Structures and Materials, March 1999, Newport Beach, Calif. SPIE Copyright 1999, the entire contents of which being incorporated herein by reference.

In the illustrative embodiment, the catheter 10 may include a secondary tubular member 32 including a proximal end, a distal end, and a secondary guidewire lumen 48 configured to receive a second guidewire 30 therethrough. In some embodiments, the secondary tubular member 32 may be configured to engage a portion of the balloon 14. However, it is also contemplated that the secondary tubular member 32 may engage a portion of the elongated member 11, if desired. Although not illustrated, in some cases, it is contemplated that two or more secondary tubular members 32 may engage a portion of the balloon 14. In this case, the two or more secondary tubular members 32 may be disposed about one another to provide a variety of flexibility, hardness, and/or stiffness characteristics as desired. As such the secondary tubular member may be constructed of any of a wide variety of materials including, but not limited to, metal(s), polymer(s), natural rubber, silicone, multilayer materials, urethanes, PEBAX, HDPE, etc.

In the illustrative embodiment, stent 26 may be disposed about at least a portion of balloon 14 and/or secondary tubular member 32. As illustrated, a proximal portion 52 of stent 26 may be disposed about both the balloon 14 and the secondary tubular member 32 and a distal portion of the stent 26 may be disposed about only the balloon 14. In this configuration, a distal end 50 of the secondary tubular member 32 may extend through an intermediate opening 54 of the stent 26. In the illustrative example, the intermediate opening 54 of the stent 26 may be provided at any suitable location between a distal end and a proximal end of the stent 36, as desired. In some cases, stent 26 may be at least partially constructed of a plurality of interconnected struts, connectors, or other members. The stent 26 defines a proximal opening, a distal opening, and a flow path therebetween. The intermediate opening 54 may also be in fluid communication with the flow path, if desired. In some embodiments, the stent 26 may be a standard "single vessel" stent that is provided with an intermediate opening in the manner described above, or the stent 26 may also be a bifurcated stent having a trunk and/or stem portion, with one or more leg portions and/or branch openings adjacent thereto, through which the secondary guidewire 30 may be passed. Such bifurcated stents and stent assemblies are well known in the art. Furthermore, it is contemplated that the stent 26 may be a standard single vessel stent with no intermediate opening 54 or any other suitable stent, as desired. In some situations, it is contemplated that the catheter may not include the secondary tubular member 32, if desired.

In the illustrative embodiment, guidewire 30 may be slidably disposed through the lumen 48 of the secondary tubular member 32. However, in some cases, the guidewire 30 may be merely slid between the balloon 14 and the stent 26 without the use of the secondary tubular member 32, if desired. In some embodiments, where the stent 26 is to be positioned substantially proximal to a side branch of the bifurcation, the guidewire 30 and/or secondary tubular member 32 may be configured to extend under the entire length of the stent 26.

In the illustrative dual guidewire embodiment, in operation, the guidewire 28 may be initially advanced through a vessel distal of a side branch of a bifurcation and the secondary guidewire 30 may be advanced through the vessel and into the side branch of the bifurcation. The catheter 10 may then be advanced along the guidewires 28 and 30 through the vessel until the balloon 14 and the stent 26 reach a desired position in the vessel, such as, for example, adjacent to the side branch of the bifurcation. While advancing the catheter 10 over the guidewires 28 and 30, the balloon 14 may be in a rotatable and/or non-fluidly sealed state allowing the balloon 14 to rotate relative to the elongated shaft 11 of the catheter 10. In particular, the catheter 10 may be advanced over crossed or otherwise twisted guidewires 28 and 30. In addition, the balloon 14 and stent 26 may be rotated to align the intermediate opening 54 of the stent 26 with the side branch vessel at the bifurcation while being advanced over the guidewires 28 and 30. Once properly positioned, the EAP of collars 40 and 42 may be actuated to a fluidly sealed and/or rotatably fixed state, as will be described in further detail. In some cases, inflating the balloon 14 may deploy the stent 26 and/or fluidly seal the balloon 14. However, any other suitable deployment may be used, as desired.

Figure 3 is a longitudinal cross-sectional view of the catheter 10 of Figure 2 disposed within a vessel 80 adjacent to a bifurcation. In the illustrative embodiments, collar 40 and collar 42 are shown in a contracted or a non-activated state. In this state, collar 40 and collar 42, including EAP material, are not exposed to an electrical current sufficient to activate the EAP material 74 of the collars 40 and 42. As illustrated, collars 40 and 42 include a work electrode 72 and an EAP coating or layer 74. A counter electrode 68 can be provided to a return path to complete the circuit.

In the illustrative embodiment, actuation of the EAP material of collars 40 and 42 may utilize the following elements: a source of electrical potential, an active region that includes the EAP 74, counter electrode 68, and an electrolyte in contact with the active region and/or the counter electrode 68. In the illustrative embodiment, the source of electrical potential may be a battery provided in the hub 12 (shown in Figure 1). However, it is contemplated that any suitable source of electrical potential may be used, as desired. Additionally, the source of electrical potential may be provided in other location of the catheter 10, such as, for example, in or on the elongated shaft 11, or any suitable location remote of the catheter 10, as desired. In the illustrative embodiment, the EAP layer 74 and/or work electrode 72 of collars 40 and 42 may be electrically connected to the electrical potential, such as, for example, the battery provided in the hub by an electrical conductor line 60. Example conductor lines are disclosed in Application No. (Atty. Docket No. 204-010-

0001) entitled "Electrically Conductive Pathways in Medical Devices", filed on the even date herewith, which is hereby incorporated by reference.

The work electrode 72 may be disposed about at least a portion of the elongate shaft 11 and in contact with the EAP layer 74. For example, for collar 40, the work electrode 72 may be disposed about a portion of the outer shaft 33 and, for collar 42, the work electrode 72 may be disposed about a portion of the inner shaft 36. The work electrode 72 formed from any suitable electrical conductive material or materials and is preferably biocompatible. For example, a conducting polymer, a conducting gel, or a metal, such as stainless steel, gold, silver, platinum, nitinol, or any other conductive metal, as desired.

In some cases, EAP layer 74 may be disposed about at least a portion of work electrode 72. In one example, the EAP layer 74 may completely encapsulate the work electrode 72, if desired. The active region including the EAP layer 74 may be a polypyrrole-containing active region. Polypyrrole-containing active regions can be fabricated using a number of known techniques, for example, extrusion, casting, dip coating, spin coating, or electro-polymerization/deposition techniques. Polypyrrole- containing active regions can also be patterned, for example, using lithographic techniques, if desired.

The electrolyte, which may be in contact with at least a portion of the EAP layer 74 of the active region, allows for the flow of ions and thus acts as a source/sink for the ions. The electrolyte may be, for example, a liquid, a gel, or a solid, so long as ion movement is permitted. Where the electrolyte is a liquid, it may be, for example, an aqueous solution containing a salt, for example, an NaCl solution, a KCl solution, a sodium dodecylbenzene sulfonate solution, a phosphate buffered solution, physiological fluid, and so forth. Where the electrolyte is a gel, it may be, for example, a salt-containing agar gel or polymethylmethacrylate (PMMA) gel. Where the electrolyte is a solid, it may be, for example, a polymer electrolyte. In some embodiments, a saline or other fluid 66 of an electrically conductive nature used to expand the balloon 14 may electrically connect the work electrode 72 and/or EAP layer 74 to a counter electrode 68 positioned within the interior of balloon 14. In some embodiments, one or more marker bands 62 may be used as the counter electrode 68, if desired. A conductor wire 61 may be connected to counter electrode 68 to electrically complete the circuit. In some embodiments, the conductive nature of some bodily fluids may be utilized to complete the circuit.

In some examples, the EAP layer 74 may be configured to expand in at least one radial dimension (i.e., in at least one dimension that is orthogonal to the longitudinal axis of the device) upon activation of the active region. In other examples, the EAP layer 74 may be configured to expand in at least one axial dimension (i.e. in at least one dimension parallel to the longitudinal axis of the device) upon activation of the active region. Furthermore, it is contemplated that the EAP layer 74 may be configured to expand in at least one radial dimension and at least one axial dimension upon activation of the active region, as desired. Furthermore, upon the deactivation of the active region (i.e. removal of electrical potential), the EAP layer 74 may be configured to contract in the at least one radial dimension and/or at least one axial dimension. Some examples of suitable techniques, methods, and structures for EAPs are disclosed in Application No. 10/763,825 titled "Electrically Actuated Medical Devices", which is hereby incorporated by reference.

In the illustrative embodiment, upon activation of the active region, or EAP layer 74, the collars 40 and 42 may be configured to expand in a radial and/or an axial direction. In this activated state, collars 40 and 42 may contact one or more of proximal waist 44 and/or distal waist 46. Upon contact, the collars 40 and 42 may fluidly seal the rotatable balloon 14. Additionally, in some cases, the contact may inhibit and/or prevent rotation of the balloon 14 relative to the elongate shaft 11, if desired. In some cases, the collars 40 and 42 may cause a friction fit with proximal waist 44 and/or distal waist 46.

When activated, battery may transmit an electric current through wires 60 to the collars 40 and 42. The current may cause the EAP layer 74 of the collars 40 and 42 to expand in an axial and/or radial dimension engaging the proximal waist 44 and/or the distal waist 46 of the balloon 14, respectively. The electric circuit may be completed as the result of a saline or other fluid 66 of an electrically conductive nature used to expand the balloon 14. The fluid 66 may electrically connect the collars 40 and 42 to a conductive member or conductor 68 positioned within the interior of balloon 14. In some embodiments, the conductor 68 may be in electric communication with one or more marker bands 62. The conductor wire 61 may be connected to counter electrode 68 to electrically complete the circuit.

Figure 4 is a longitudinal cross-sectional view of the catheter 10 of Figure 3 in an activated state. As illustrated, the EAP layer 74 of collar 40 and collar 42 may be activated to be in an expanded state fluidly sealing and/or rotatably fixing the balloon 14 to the elongate shaft 1 1. In some embodiments, the EAP layer 74 may be automatically activated and expanded when the balloon is inflated. For example, an activation circuit may be provided between the source of electrical potential, such as the battery, and the EAP layers 74 to selectively provide an electrical current to the EAP layer 74. In some embodiments, the activation circuit may be provided in or adjacent to the hub 12, in or adjacent to the elongated shaft 11, or in or adjacent to the balloon 14, as desired.

While the EAP layer 74 in Figures 3 and 4 is shown as being disposed on an outer surface, a proximal surface, and a distal surface of the work electrode 72, it is contemplated that any suitable shape and/or size EAP layer 74 may be used, as desired. Example medical devices including EAP layers are disclosed in Application No. 10/915,209, titled "Rotatable Catheter Assembly" and Application No. 10/785449 titled "Rotatable Catheter Assembly", which are hereby incorporated by reference.

Figure 5 is a block diagram of an illustrative embodiment of an activation circuit 90 for activating the EAP layers 74 of collars 40 and 42 of the catheter 10 of Figure 1. In the illustrative embodiment, activation circuit 90 may include a sensor block 92 for sensing a measure related to a parameter of the inflation fluid 66 (shown in Figures 3 and 4) and/or catheter 10, a threshold block 94 for setting one or more parameter activation and/or deactivation thresholds, and a comparator block 96 for comparing the sensed measure relating to the parameter of the inflation fluid and/or catheter to the one or more parameter activation and/or deactivation thresholds. In some embodiments, the measure related to a parameter of the inflation fluid 66 and/or catheter may include a pressure, a rate of flow, a temperature, a change in concentration of a chemical substance, as well as any other suitable parameter, as desired. In the illustrative embodiment, sensor block 92 may sense a measure related to a parameter of the inflation fluid and may provide an electrical output signal to the comparator block 96 corresponding to the sensed measure. In some embodiments, the sensor block 92 may include a microelectromechanical system (MEMS) sensor having a piezoelectric or other material with a resistivity sensitive to changes in the measure related to the parameter of the inflation fluid and/or catheter. For example, if the parameter to be sensed is the pressure of the inflation fluid and/or pressure of a portion of the catheter, such as, for example, the inflation lumen, and a MEMS pressure sensor is used, the resistance of the piezoelectric or other material may be a function of the pressure. When a current is passed through the pressure sensitive MEMS sensor, the output voltage may vary in response to a change in pressure.

Furthermore, it is contemplated that the sensor block 92 may include a pressure sensor, a flow sensor, a temperature sensor, and/or any other suitable sensor to measure any desired parameter of the inflation fluid, as desired. For example, the flow sensor may measure the flow rate of the inflation fluid in a portion of the catheter, such as in the hub, in the lumen of the elongated shaft, and/or in the balloon. In some cases, the temperature sensor may sense a temperature of a portion of the catheter. For example, the temperature sensor may sense a temperature of at least a portion of the inflation lumen of the catheter so that when the inflation fluid is provided to inflate the balloon, the temperature sensor may sense a temperature change in the inflation lumen. In some embodiments, the sensor block 92 may be provided in or adjacent to the hub 12, in or adjacent to the elongated shaft 11, and/or in or adjacent to the balloon 14 to sense the measure related to the inflation fluid and/or catheter. In the illustrative embodiment, the threshold block 94 may include a predetermined or predefined threshold value. The threshold block 94 may provide an output signal having a voltage corresponding to the predetermined or predefined threshold value. Example threshold pressures may include, but are not limited to, 2 standard atmospheres (ATM), 3 ATM, 4 ATM, 5 ATM, 6 ATM, 7 ATM, 8 ATM, 9 ATM, 10 ATM, or any other suitable pressure, as desired. For example, if the balloon has a target inflation pressure of about 20 ATM, the threshold pressure may be set to any pressure lower than the target inflation pressure.

In the illustrative embodiment, the comparator block 96 may include a first input connected to the sensor block 92 and a second input connected to the threshold block 94. An output of the comparator may be electrically connected to the collars 40 and 42 via wires 60 (shown in Figures 3 and 4) to selectively activate the EAP layer 74 of the collars 40 and 42. In some cases, the comparator block 96 may include an operational amplifier to compare the sensor block 92 output voltage to the threshold block 94 output voltage. The operational amplifier may output a voltage level according to the compared voltages. For example, if the sensor block 92 output voltage is greater than the threshold block 94 output voltage, the operational amplifier may output a high voltage, or a voltage sufficient to activate the EAP layers 74 of the collars 40 and 42. In some cases, if the sensor block 92 output voltage is less than the threshold block 94 output voltage, the operational amplifier may output a low voltage, or a voltage about zero volts or other voltage that is insufficient to activate the EAP layers 74 of the collars 40 and 42.

In some embodiments, it is contemplated that the activation circuit 100 may include multiple thresholds, such as, for example, a turn on threshold and a turn off threshold. The turn on threshold may be a threshold used to switch the operational amplifier from the low to the high (i.e. turn on) and the turn off voltage may be a threshold to switch the operational amplifier from high to low (i.e. turn off). In some cases, the turn on threshold may be greater than the turn off threshold. In the illustrative embodiment, the multiple threshold voltages may provide an amount of hysteresis for the operational amplifier.

Additionally, it is contemplated that the comparator block 96 may include any suitable switch or switching mechanism to switch the output of the comparator block 96 from low to high and high to low according to a sensed measure related to a parameter of the inflation fluid and/or catheter, as desired. Furthermore, while the activation circuit 90 has been described with reference to sensing a measure related to a parameter of the inflation fluid, it is contemplated that other parameters of the catheter 10 may be sensed to activate the EAP layers. For example, it is contemplated that a stress/strain of the elongated shaft and/or balloon may be sensed to activate the EAP layers, if desired.

Figure 6 is a schematic diagram of an illustrative circuit 100 of a Schmitt trigger that may be included in the comparator 96 of Figure 5. As illustrated, the circuit may include a voltage input VIN connected to a first side of resistor 104. The second side of resistor may be connected to a positive input 116 of an operational amplifier 102. A negative input 118 of the operational amplifier 102 may be connected to ground via a resistor 108. An output 120 of the operational amplifier 102 may be connected to a first side of resistor 1 10. A second side of resistor 110 may be an output for the circuit 100 having an output voltage VOUT- A resistor 106 may have a first side connected to the positive input 1 16 of the operational amplifier 102 and a second side connected to the output of the circuit 100. A pair of zener diodes 1 12 and 114 may be connected between the output of the circuit 100 and ground. Zener diode 1 12 may have a cathode connected to the output of the circuit and an anode connected to an anode of zener diode 1 14, which may have a cathode connected to ground. In the illustrative embodiment, when the input voltage VIN is greater than a turn on threshold voltage (i.e. positive input 1 16 is greater than negative input 1 18), the output voltage VOUT may be high. When the input voltage is less than a turn off threshold voltage (i.e. positive input 116 is less than the negative input 1 18), the output voltage VOUT may be low. When the input voltage VIN is between the turn on threshold voltage and the turn off threshold voltage, the output voltage VOUT will retain the previous voltage level. In this example, the circuit 100 may have an amount of hysteresis, which may be controlled by resistances of resistors 104 and 106. In other words, the output voltage VOUT will switch from low to high when the input voltage VIN becomes greater than the turn on threshold voltage and will switch from high to low when the input voltage VIN drops below the turn off threshold voltage.

Figure 7 is an illustrative graph showing the output voltage VOUT of the circuit 100 of Figure 6 as a function of the input voltage VIN. AS illustrated, the circuit may include an amount of hysteresis. As illustrated, the circuit may turn on at a first input voltage and turn off at a second input voltage that is less than the first input voltage. The different between the turn on voltage and the turn off voltage may be adjusted according to resistors 104 and 106 of Figure 6.

Figure 8 is block diagram of another illustrative embodiment of an activation circuit 97. The illustrative activation circuit 97 may be similar to the activation circuit 90 of Figure 5 with the addition of a timer block 98. The timer block 98 may include an input coupled to the output of the comparator block 96 and an output coupled to the collars 40 and 42. In some embodiments, the timer may be programmed or otherwise configured to activate the one or more EAP layers 74 for a period of time when the sensed measure related to a parameter of the inflation fluid and/or catheter is greater than the threshold value. In some cases, the timer may be programmed or otherwise configured to activate the one or more EAP layers 74 at intervals of time when the sensed measure related to a parameter of the inflation fluid and/or catheter is greater than the threshold value. For example, when the output of the comparator block 96 switches to a high output, the timer block 98 may be reset to zero and may start counting. The timer block 98 may transmit the high output of the comparator block 96 to the collars 40 and 42 for a period of time until the timer block 98 reaches a time limit. In some cases, the time limit may be 5 seconds, 10 seconds, 20 seconds, 30 seconds, or any other amount of time, as desired. In some cases, once the time limit of the timer block 98 is reached, the timer block 98 may prevent a voltage from being applied to the collars 40 and 42 until the timer block 98 is reset when the comparator block 96 output switches from low to high. Alternatively, in some cases, the timer block 98 may apply the high output of the comparator block 96 to the collars 40 and 42 at intervals. For example, the timer block 98 may initially transmit the high output of the comparator block 96 for a first interval of time, then the timer block 98 may not transmit the high output for a second interval of time, then the timer block 98 may transmit the high output for a third interval of time, and so forth. The first interval of time, the second interval of time, and the third intervals of time may be the same or different intervals, as desired. In some cases, the first interval of time may be longer than the third interval of time. However, any suitable intervals of time may be used, as desire.

Figure 9 is a longitudinal cross-sectional view of an illustrative embodiment of a catheter 100 including a drug delivery balloon 101 in a vessel 80. In the illustrative embodiment, drug delivery balloon 101 may be disposed about a portion of the elongated shaft 11. As illustrated, a proximal waist 108 of balloon 101 may be disposed about the outer shaft 33 of the elongated shaft 11 and a distal waist 106 of balloon may be disposed about the inner shaft 36 of the elongated shaft 1 1. As illustrated, the proximal waist 108 and the distal waist 106 may be fixed or otherwise secured to the outer shaft 33 and the inner shaft 36, respectively. However, it is contemplated that the proximal waist 108 and the distal waist 106 may be rotatably secured to the outer shaft 33 and the inner shaft 36, if desired.

In the illustrative embodiment, the drug delivery balloon 101 may include an inner inflatable balloon portion 1 10, a conductive plating 102 disposed about at least a portion of the inner balloon portion 1 10, and an EAP layer 104 disposed about at least a portion of the conductive plating 102. As illustrated, the conductive plating 102 is shown disposed about the entire inner balloon portion 1 10, however, it is contemplated that the conductive plating may be provided about only a portion of the inner balloon portion 1 10, in strips about the inner balloon portion 1 10, or in any other suitable location to provide an electrical current to activate the EAP layer 104, as desired.

Similar to catheter 10 described above, conductive wires 60 may be provided to electrically connect the EAP layer 104 and/or conductive layer 102 to the activation circuit. In the illustrative embodiment, it is contemplated that one of wires 60 may provide the current to the EAP layer 104 and/or conductive layer 102 and a second one of wires 60 may provide the return path to complete the circuit. Additionally, although not illustrated in Figure 9, it is contemplated that one or more markers similar to those shown and described with reference to Figure 3 may be provided with a wire to provide the return path for the current. Also, the fluid 66 may be utilized in the circuit, if desired. In the illustrative embodiment, the EAP layer 104 may be loaded with drugs for releasing within vessel 80. Upon activation or deactivation of the EAP layer 104, the drugs may be released in to the vessel 80. Furthermore, it is contemplated that the activation circuit for activating EAP layer 104 may or may not include hysteresis, as desired. It is also contemplated that activation circuit 90 or activation 97 may be used to activate the EAP layer, as desired. It is also contemplated that instead of timer 98, shown in Figure 8, circuit 97 may include an element (not shown) that measures the current that has been provided to the EAP layer. In one example, the element may measure the current in Coulombs. In this case, a second comparator (not shown) may be used to switch off the electrical supply to the collars 40 and 42 once a predefined or predetermined charge level has been reached and/or exceeded. In some cases, the charge may be directly correlated to the amount of drug molecules being expelled from the EAP layer and, as such, measuring the charge may provide a precise or accurate determination of the amount of drugs released. Example drugs that may be released in the vessel 80 by the EAP layer 104 may include an anti-thrombogenic drug, such as heparin; low molecular weight heparin, e.g., ENOXAPRIN; aspirin; phe-L-pro-L-arginyl chloromethyl ketone (PPACK); hirudin, HIRULOG.RTM.; Warfarin; Argatroban; or tissue factor pathway inhibitor (TPFI). The drug may also be a thrombolytic drug, such as urokinase; pro- urokinase; streptokinase; tissue plasminogen activator; anisolated plasminogen streptokinase activator complex (APSAC), e.g., EMINASE.RTM.; an inhibitor of PAI-I, TA plasminogen; or cathepepsin D. Anti-platelet agents, such as chimeric 7E3 antibody (Reopro); Ticolpidine; Integrilin; TP9201; nitric oxide (NO) and derivatives thereof, e.g., protein-linked NO; Iloprost, or MK383, may be similarly delivered and triggered. Other drugs suitable for delivery in this manner include protein and polypeptide drugs, e.g., angiogenesis factors including but not limited to fibroblast growth factor (FGF), vascular endothelial growth factor (VEGF), transforming growth factor-beta, (TGF.beta.), platelet-derived growth factor (PDGF), epidermal growth factor (EGF), and urokinase. Other drugs to be delivered include those to treat benign hyperplasia, e.g., PROSCAR.RTM., and HYTRIN.RTM.. Other drugs include antiproliferative drugs, such monoclonal antibodies capable of blocking smooth muscle cell proliferation, e.g., anti-PDGF and anti-FGF; tyrosine kinase inhibitors, e.g., tyrophosphins, antisense oligonucletides to c-myc, c-myb; NO; gene encoding thymidine kinase (TK); fusion toxins, e.g., DAB389 -EGF; immunotoxins, angiopeptin; antioxidant drugs, e.g., probudol, lovastatin, vitamin C and vitamin E; calcium channel blockers, e.g., nificitine, veratimil, ACE inhibitors, fofinopril and cilazapril. Chemotherapeutic drugs to treat various forms of cancer, e.g., HLB-7; granulocyte macrophage colony stimulating factor (GM-CSF); interferon.gamma.; immunotoxins, e.g., BMS- 18224801, and BR-96-DOX; ONCOLYSIN.RTM.; fusion toxins, e.g., DAB ₃₈ 9 -IL-2, and DAB ₃₈ 9 -EGF; 5-Fluorouracil; methotrexate; and TAXOL.RTM. However, any suitable drug may be released by the EAP layer 104, as desired.

In at least some embodiments, portions or all of catheters 10 and/or 100, or other components that are part of or used in the device, may be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids the user of devices 10 and/or 100 in determining its location. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with a radiopaque filler, and the like. Additionally, radiopaque marker bands and/or coils may be incorporated into the design of catheters 10 and/or 100 to achieve the same result.

In some embodiments, a degree of MRI compatibility is imparted into catheters 10 and/or 100. For example, to enhance compatibility with Magnetic Resonance Imaging (MRI) machines, it may be desirable to make elongated shaft 11, inflatable balloon 14, and/or inflatable balloon 101, or other portions of the medical devices 10 and/or 100, in a manner that would impart a degree of MRI compatibility. For example, elongated shaft 11, inflatable balloon 14, and/or inflatable balloon 101, or portions thereof, may be made of a material that does not substantially distort the image and create substantial artifacts (artifacts are gaps in the image). Certain ferromagnetic materials, for example, may not be suitable because they may create artifacts in an MRI image. Elongated shaft 11, inflatable balloon 14, and/or inflatable balloon 101, or portions thereof, may also be made from a material that the MRI machine can image. Some materials that exhibit these characteristics include, for example, tungsten, Elgiloy, MP35N, nitinol, and the like, and others.

In some embodiments, a sheath and/or coating, for example a lubricious, a hydrophilic, a protective, or other type of material may be applied over portions or all of the elongated shaft 11, inflatable balloon 14, and/or inflatable balloon 101, or other portions of devices 10 and/or 100. Some examples of suitable polymer sheath materials may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRTN® available from DuPont), polyether block ester, polyurethane, polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low density polyethylene (for example REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR®), polysulfone, nylon, nylon- 12 (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like.

In some embodiments sheath material can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP. This has been found to enhance torqueability. By employing selection of materials and processing techniques, thermoplastic, solvent soluble, and thermosetting variants of these and other materials can be employed to achieve the desired results. Some examples of suitable coating materials may include silicone and the like, hydrophilic polymers such as high-density polyethylene (HDPE), polytetrafluoroethylene (PTFE), polyarylene oxides, polyvinylpyrolidones, polyvinylalcohols, hydroxy alkyl cellulosics, algins, saccharides, caprolactones, and the like, and mixtures and combinations thereof. Some coating polymers may be blended among themselves or with formulated amounts of water insoluble compounds (including some polymers) to yield coatings with suitable lubricity, bonding, and solubility. Some other examples of such coatings and materials and methods used to create such coatings can be found in U.S. Patent Nos. 6,139,510 and 5,772,609, which are incorporated herein by reference.

A coating and/or sheath may be formed, for example, by coating, extrusion, co-extrusion, interrupted layer co-extrusion (ILC), or fusing several segments end-to- end. The layer may have a uniform stiffness or a gradual reduction in stiffness from the proximal end to the distal end thereof. The gradual reduction in stiffness may be continuous as by ILC or may be stepped as by fusing together separate extruded tubular segments. The outer layer may be impregnated with a radiopaque filler material to facilitate radiographic visualization. Those skilled in the art will recognize that these materials can vary widely without deviating from the scope of the present invention.

In some cases, elongated shaft 11 can be made of the same material along its length, or in some embodiments, can include portions, sections, or layers made of different materials. In some embodiments, the material used to construct elongated shaft 11 are chosen to impart varying flexibility, torqueability, and stiffness characteristics to different portions of elongated shaft 11.

The present invention should not be considered limited to the particular examples described above, but rather should be understood to cover all aspects of the invention as fairly set out in the attached claims. Various modifications, equivalent processes, as well as numerous structures to which the present invention may be applicable will be readily apparent to those of skill in the art to which the present invention is directed upon review of the instant specification. 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 invention. For example, although set forth with specific reference to catheters in some of the example embodiments shown in the Figures and discussed above, the invention may relate to virtually any medical device that may aid a user of the device in advancing a device in a vessel. For example, the invention may be applied to medical devices such as a guidewire, a balloon catheter, an atherectomy catheter, a drug delivery catheter, a stent delivery catheter, an endoscope, a fluid delivery device, other infusion or aspiration devices, delivery (i.e. implantation) devices, and the like. Thus, while the Figures and descriptions above are directed toward a catheter, in other applications, sizes in terms of diameter, width, and length may vary widely, depending upon the desired properties of a particular device. The scope of the invention is, of course, defined in the language in which the appended claims are expressed.

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 invention. The invention's scope is, of course, defined in the language in which the appended claims are expressed.