Patent Description:
A wide variety of intracorporeal medical devices have been developed for medical use, for example, intravascular use. Some of these devices include ultrasound catheters, ultrasound devices, and the like. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices as well as alternative methods for manufacturing and using medical devices. In the following, a few examples of developed intracorporeal medical devices will be given.

<CIT>, for example, discloses a flex-PCB catheter device that is configured to be inserted into a body lumen. The flexPCB catheter comprises an elongate shaft, an expandable assembly, a flexible printed circuit board (flex-PCB) substrate, a plurality of electronic components and a plurality of communication paths. The expandable assembly may include a plurality of ultrasound transducers on splines forming a basket array. Distal ends of the splines are connected to a distal end of an inner shaft, which is retracted and advanced to expand and collapse, respectively, the expandable assembly.

<CIT>discloses a multi electrode catheter for non contact mapping of the heart having independent articulation and deployment features.

<CIT> discloses devices and methods for obtaining a three-dimensional image of an internal body site.

The subject devices are elongated structures (e.g., catheters) having a plurality of ultrasonic transducers located at their distal end.

The present invention provides a medical device as defined in appended claim <NUM>. Particular embodiments of the invention are defined in the dependent claims.

This disclosure provides design, material, manufacturing method, and use alternatives for medical devices. An example medical device includes a support member having a proximal end region and a distal end region and a sensing member having a proximal end region and a distal end region, the distal end region of the sensing member coupled to the distal end region of the support member. The medical device also includes one or more ultrasound sensors disposed along the sensing member and a support shaft having a first end coupled to the sensing member and a second end coupled to the support member. Additionally, the sensing member is configured to shift from a first configuration in which the sensing member is adjacent to the support member to a second configuration in which at least a portion of the sensing member extends away from the support member.

Alternatively or additionally, wherein the sensing member forms an arcuate shape in the second configuration.

Alternatively or additionally, wherein rotation of the support member rotates the sensing member around a longitudinal axis of the support member.

Alternatively or additionally, wherein each of the one or more ultrasound sensors are spaced away from one another along the sensing member.

Alternatively or additionally, wherein the distal end of the sensing member is fixedly attached to the distal end region of the support member.

Alternatively or additionally, wherein the second end of the support shaft is fixedly attached to the support member.

Alternatively or additionally, wherein the second end of the support shaft is translatable relative to the support member.

Alternatively or additionally, wherein the second end of the support shaft is coupled to the support member via an attachment collar, and wherein the attachment collar is designed to slide along the support member.

Alternatively or additionally, wherein the proximal end region of the sensing member is coupled to a hub, and wherein manipulation of the hub shifts the sensing member from the first configuration to the second configuration.

Alternatively or additionally, wherein rotation of a portion of the hub rotates the sensing member around a longitudinal axis of the support member.

Another example medical device for imaging the bladder includes a hub member coupled to an ultrasound sensing assembly. The ultrasound assembly includes a support member having a proximal end region and a distal end region and a sensing member having a proximal end region and a distal end region, the distal end region of the sensing member coupled to the distal end region of the support member. The ultrasound assembly also includes one or more ultrasound sensors disposed along the sensing member and a support shaft having a first end coupled to the sensing member and a second end coupled to the support member. Further, the sensing member is configured to shift from a first configuration in which the sensing member is adjacent to the support member to a second configuration in which at least a portion of the sensing member moves away from the support member.

Alternatively or additionally, wherein rotation of a portion of the hub member is designed to rotate the ultrasound assembly around a longitudinal axis of the support member.

Alternatively or additionally, wherein rotation of a portion of the hub member is designed to sweep the sensing member along an inner surface of the bladder when the sensing member is in the second configuration.

An example method for imaging the bladder includes positioning an ultrasound catheter assembly into the bladder. The ultrasound catheter assembly includes a support member having a proximal end region and a distal end region and a sensing member having a proximal end region and a distal end region, the distal end region of the sensing member coupled to the distal end region of the support member. The ultrasound catheter assembly also includes one or more ultrasound sensors disposed along the sensing member and a support shaft having a first end coupled to the sensing member and a second end coupled to the support member. The method also includes translating the sensing member relative to the support member such that at least a portion of the sensing member moves away from the support member.

Alternatively or additionally, the method further comprising rotating the sensing member around a longitudinal axis of the support member, such that the sensing member sweeps around an inner surface of the bladder.

Ultrasound imaging is a medical procedure that may be used to detect and characterize abnormal tissue growth that occurs with a variety of medical conditions. In use, ultrasound medical devices may project sound waves that bounce against organs and reverberate back to a transducer, whereby the transducer processes the reflected waves and converts them into an image of targeted organs or tissues. In some instances, an ultrasound device may be used to mark out the boundaries of a cancer tumor prior to its removal. For example, a physician may utilize ultrasound to visualize and characterize bladder cancer tumors.

A fundamental aspect to treating bladder cancer is establishing proper visualization of the interior of the bladder. Specifically, in some instances it may be desirable to position an ultrasound detection device near the cancer tumors prior to imaging. Imaging cancers tumors in close proximity may provide several advantages over less invasive imaging. Namely, imaging in close proximity may allow the detection of smaller tumors in addition to being able to more accurately assess the depth of a specific tumor.

Therefore, in some instances, it may be desirable to utilize an ultrasound imaging device to image the inner surface of a bladder while in close proximity to the inner surface of a bladder. Some of the medical devices disclosed herein may include utilizing a flexible and expandable ultrasound device, whereby the ultrasound device may be designed to permit a physician to image the interior surface of a bladder while in close proximity to the surface.

<FIG> is a schematic view of an ultrasound medical device <NUM> which may be utilized to access and treat a tissue region in the body. Specifically, <FIG> generally shows the medical device <NUM> deployed within the inner cavity of a bladder <NUM>. However, this is not intended to be limiting. Rather, it can be appreciated the ultrasound medical device <NUM> may be utilized in other regions of the body. For example, while the illustrated embodiment shows the device <NUM> being used for treating the bladder, the device <NUM> (and the methods described herein) may alternatively be configured for use in other tissue applications, such as procedures for treating tissue in the kidney, abdominal organs, upper and lower urinary tract, vagina, uterus, stomach, etc..

As illustrated in <FIG>, in some instances the ultrasound medical device <NUM> may be delivered to a tissue site (e.g., to a cancer site along an inner surface of the bladder <NUM>) via one or more catheters. For example, <FIG> illustrates that the ultrasound device <NUM> may be advanced through the lumen <NUM> of a catheter <NUM>. It is contemplated that the catheter <NUM> may be utilized to both deliver and/or retrieve the ultrasound device <NUM>. For example, the ultrasound device <NUM> may be advanced through the lumen <NUM> of the catheter <NUM> in a collapsed configuration. Further, the ultrasound device <NUM> may be advanced out the distal end of the catheter <NUM>, whereby at least a portion of the ultrasound device <NUM> may shift from a first (e.g., collapsed, pre-deployment, etc.) configuration to a second (e.g., expanded, deployed, etc.) configuration. It is further contemplated that the catheter <NUM> may include a guide catheter, delivery catheter, endoscope, cystoscope, etc..

As discussed above, it can be appreciated that the catheter <NUM> may be utilized to retrieve the ultrasound device <NUM> after a medical procedure is completed. For example, after completion of an ultrasound imaging procedure, a physician may retract the ultrasound device <NUM> in a proximally into the distal end of the catheter <NUM>. While not illustrated in <FIG>, it is contemplated that the catheter <NUM> may include a tapered distal end. It can be appreciated that a tapered end of the catheter <NUM> may be designed to funnel the ultrasound device <NUM> into the lumen <NUM> of the catheter <NUM>.

While <FIG> illustrates the catheter <NUM> including a single lumen <NUM>, it is contemplated that, in some examples, the catheter <NUM> may include two or more lumens designed to permit the ultrasound device <NUM> to be advanced therethrough. For example, in some instances the catheter <NUM> may be an endoscope, cystoscope, etc. which may include a first lumen to permit fluid to be passed therethrough (and into the bladder) and a second lumen (e.g., a working channel) designed to permit the ultrasound device <NUM> to be advanced therethrough.

<FIG> further illustrates that the ultrasound device <NUM> includes a support shaft <NUM> (e.g., catheter, tubular member, etc.) having a proximal end portion and a distal end portion <NUM>. <FIG> illustrates the support shaft <NUM> extending through the lumen <NUM> of the catheter <NUM>. In some instances, the support shaft <NUM> may be a solid member. However, in other examples, the support shaft <NUM> may be defined as a tubular member including a lumen extending therein. In other words, the support shaft <NUM> may include a lumen which extends along the entire length of the support shaft <NUM> or the lumen may extend along only a portion of the support shaft <NUM>. The lumen of the support shaft <NUM> may be sized and/or shaped to accommodate a guidewire to extend therein.

<FIG> further illustrates that the ultrasound device <NUM> includes a sensing member <NUM>. The sensing member <NUM> may include a distal end region <NUM> and a proximal end region. As illustrated in <FIG>, the distal end region <NUM> may be coupled to the distal end region <NUM> of the support shaft <NUM>. In some examples, the distal end region <NUM> of the sensing member <NUM> may be rigidly attached to the distal end region <NUM> of the support shaft <NUM>. In other examples, however, the distal end region <NUM> of the sensing member <NUM> may move with respect to the distal end region <NUM> of the support shaft <NUM>. For example, the distal end region <NUM> of the sensing member <NUM> may be coupled to the distal end region <NUM> of the support shaft via a swivel, collar, or the like.

As illustrated in <FIG>, the sensing member <NUM> includes one or more ultrasound sensors <NUM> disposed along the sensing member <NUM>. The ultrasound sensors <NUM> may be spaced apart from one another along the length of the sensing member <NUM>. Further, in some examples, each of the ultrasound sensors <NUM> may be relatively flat, whereby the outer surface of the sensor is designed to be positioned against (or adjacent) a target tissue site (e.g., cancerous tumor). In other examples, however, the ultrasound sensors <NUM> may be include a variety of shapes and/or configurations. For example, the sensors <NUM> may be embedded within the body of the sensing member <NUM> or may wrap around the body of the sensing member <NUM>. In some examples, the ultrasound sensors <NUM> may include phased array transducers and/or rotational (e.g., spinning) transducers. Further, in other examples the transducers (e.g., phased array, rotational, etc.) may be selected according to the resolution and penetration depth required during an ultrasound procedure.

<FIG> further illustrates that the ultrasound device <NUM> includes a support member <NUM> (e.g., support arm, tether, etc.). The support member <NUM> may include a first end <NUM> and a second end <NUM>. As shown in <FIG>, the first end <NUM> of the support member <NUM> may be coupled to the sensing member <NUM> and the second end <NUM> of the support member <NUM> may be coupled to the support shaft <NUM>.

As will be discussed in greater detail below, in some instances it may be desirable for the support member <NUM> to translate relative to the support shaft <NUM>. Therefore, it can be appreciated that, in accordance with the present invention, the second end <NUM> of the support member <NUM> includes a collar slidably coupled to the support shaft <NUM>. In other words, in some examples, the second end <NUM> of the support member <NUM> may wrap around the outer surface of the support shaft <NUM>, thereby permitting the second end <NUM> of the support member <NUM> to slide proximally and distally along the support shaft <NUM> (e.g., along the longitudinal axis of the support shaft <NUM>).

<FIG> illustrate example steps to position, deploy and manipulate the ultrasound device <NUM> in a bladder. For example, <FIG> illustrates the ultrasound device <NUM> (including the support shaft <NUM>, the sensing member <NUM> and the support member <NUM>) extending through the lumen <NUM> of the catheter <NUM>. Further, <FIG> illustrates that, in some examples, the proximal end of the catheter <NUM> may be coupled to a hub member <NUM>. The hub member <NUM> may include an actuator <NUM>. It can be appreciated that the actuator <NUM> may translate in a channel of the hub member <NUM>. For example, it can be appreciated that the actuator <NUM> may be able to translate in a proximal and/or distal direction within the channel of the hub member <NUM>.

Additionally, <FIG> illustrates that, in some examples, the proximal end of the sensing member <NUM> may be coupled to the actuator <NUM>. Further, <FIG> illustrates that the proximal end of the support shaft <NUM> may be rigidly fixed to a portion of the hub member <NUM>. In some examples, the hub member <NUM> may include a lumen and/or passage extending therethrough which substantially aligns with a lumen of the support shaft <NUM> (for examples in which the support shaft <NUM> includes a lumen). Like that described with respect to the support shaft <NUM>, it can be appreciated that the lumen of the hub member <NUM> may be sized and/or shaped to accommodate a guidewire extending therethrough. It can be further appreciated that the hub member <NUM> may include one or more features which manipulate a least a portion of the ultrasound device <NUM> within a body cavity (e.g., in a bladder). For example, it can be appreciated that via manipulation of the actuator <NUM>, the sensing member <NUM> may be able to translate relative to the support shaft <NUM>.

For example, <FIG> illustrates the actuator <NUM> after having been retracted in a proximal direction within the channel in the hub member <NUM>. It can be appreciated that the proximal retraction of the actuator <NUM> may draw the sensing member <NUM> in a proximal direction such that the sensing member <NUM> is substantially adjacent (e.g., aligned, parallel) to the support shaft <NUM>. Further, proximal retraction of the actuator <NUM> may also result in the rotation (e.g., pivoting, sliding, translation) of the support shaft <NUM> such that the support member <NUM> is substantially adjacent (e.g., aligned, parallel) to the support shaft <NUM> and/or the sensing member <NUM>.

<FIG> illustrates the ultrasound device <NUM> after the actuator <NUM> has been advanced in a distal direction (as shown by arrow <NUM>) within the channel of the hub member <NUM>. <FIG> further illustrates that the distal translation of the actuator <NUM> may result in the sensing member <NUM> to begin to bow away from the support shaft <NUM>. <FIG> illustrates that during this process the sensing member <NUM> begins to form a slight curve. In other words, as the actuator <NUM> is translated distally, at least a portion of the sensing member may move radially away from the support shaft <NUM> (e.g., curving away from the support shaft <NUM>), thereby shifting the ultrasound sensors <NUM> to a position closer to the inner surface <NUM> of the bladder <NUM>. Additionally, <FIG> illustrates that coincident with the movement of the sensing member <NUM>, the support member <NUM> may move (e.g., pivot, rotate, slide) with respect to the sensing member <NUM> and/or the support shaft <NUM>.

<FIG> illustrates the ultrasound device <NUM> after the actuator <NUM> has been further advanced in a distal direction within the channel of the hub member <NUM>. <FIG> further illustrates that the distal translation of the actuator <NUM> may result in the sensing member <NUM> bowing away from the support shaft <NUM> to a greater extent as compared to its position in <FIG>. For example, <FIG> illustrate the sensing member <NUM> having a greater curve as compared to its position as illustrated in <FIG>. Accordingly, it can be appreciated that translating the sensing member <NUM> in a proximal-to-distal direction relative to the support shaft <NUM> may result in the ultrasound sensors <NUM> being shifted to a position closer to the inner surface <NUM> of the bladder <NUM>. Additionally, <FIG> illustrates that translating the sensing member <NUM> in a proximal-to-distal direction relative to the support shaft <NUM> results in the support member <NUM> moving (e.g., pivoting, rotating, sliding) with respect to the sensing member <NUM> and/or the support shaft <NUM>.

<FIG> further illustrates, that in some examples, rotation of at least a portion of the hub member <NUM> may rotate one or more features of the ultrasound device <NUM> within a body cavity (e.g., within the bladder). For example, <FIG> illustrates that rotation of the hub member <NUM> (as shown by the around <NUM>) may rotate the sensing member <NUM>, the support member <NUM> and/or the support shaft <NUM> around the longitudinal axis of the support shaft <NUM>. Rotation of one or more components of the ultrasound device <NUM> within the bladder <NUM> is shown by the arrow <NUM> in <FIG>.

While the above discussion illustrates that rotation of the hub member <NUM> may rotate the ultrasound device <NUM> (including the support shaft <NUM>, the support member <NUM>, the sensing member <NUM> and/or the catheter <NUM>) the within a body cavity (e.g., the bladder), it is not intended to be limiting. Rather, it is contemplated that the ultrasound device <NUM> may include alternative features and/or designs which permit the translation of the sensing member <NUM> with respect to the support shaft <NUM> and/or the rotation of the ultrasound device <NUM> (and components thereof) within the body cavity. For example, in some instances the ultrasound device may include a screw-drive, rack and pinon, or other features which permit the translation of the sensing member <NUM> with respect to the support shaft <NUM> and/or the rotation of the ultrasound device <NUM> (and components thereof) within the body cavity.

<FIG> illustrates a top-view of the ultrasound device <NUM> shown in <FIG> positioned within the bladder <NUM>. For example, <FIG> illustrates the support shaft <NUM> positioned with the lumen of the catheter <NUM>. Additionally, <FIG> illustrates the sensing member <NUM> extending away from the support shaft <NUM> such that the ultrasound sensors <NUM> are positioned adjacent to the inner surface <NUM> of the bladder <NUM>. Further, <FIG> illustrates that the rotation of the sensing member <NUM> (as shown by the arrow <NUM>) may "sweep" the sensing member <NUM> (including the ultrasound sensors <NUM>) along the inner surface <NUM> of the body cavity (e.g., the bladder <NUM>). It can be appreciated that is may be possible to rotate the sensing member through any angle of rotation (<NUM>-<NUM> degrees) around the longitudinal axis of the support member <NUM>. Further, it is contemplated that the sensing member <NUM> may be rotated more than <NUM> degrees around the longitudinal axis of the support member <NUM>.

It can be appreciated from the above discussion (and illustrations shown in <FIG>) that <NUM>-degree rotation of the sensing member <NUM> may permit complete imaging of the inner surface of a body cavity (e.g., the bladder <NUM>). In other words, because the ultrasound sensors <NUM> may extend from the distal end region of the sensing member <NUM> to adjacent the opening of the catheter <NUM>, the sensing member <NUM> may image the inner cavity of the bladder from top to bottom as the sensing member <NUM> is rotated (e.g., swept) through a full <NUM>-degree angle. Further, in some examples, the images acquired from one or more of the sensors <NUM> may be able to be stitched together to create a <NUM>-degree rendering of the bladder, including the specific "depth" of cancerous tumors extending into the bladder wall. However, this is not intended to be limiting. Rather, it is contemplated that, in some instances, the sensing member <NUM> (including the ultrasound sensors <NUM>) may be designed such that individual sensors <NUM> may be activated independent of other sensors <NUM>. Therefore, it is contemplated that, in some examples, a physician may be able to customize an ultrasound imaging pattern via selective activation of sensors <NUM>.

<FIG> illustrates another example medical device <NUM>. Medical device <NUM> may be similar in form and function as the medical device <NUM> described above. For example, the medical device <NUM> includes a sensing member <NUM> (including ultrasound sensors <NUM> disposed thereon) and a support member <NUM> coupled to a support shaft <NUM>. However, <FIG> further illustrates that the sensing member <NUM>, the support member <NUM> and/or the support shaft <NUM> may be positioned within an expandable balloon member <NUM>. Further, <FIG> illustrates that the medical device <NUM> (including the sensing member <NUM>, the support member <NUM>, the support shaft <NUM> and the balloon <NUM>) may be advanced through the lumen <NUM> of a delivery catheter <NUM>.

Additionally, it can be appreciated that, in some examples, the expandable balloon member <NUM> may be inflated with a fluid. Further, it is contemplated that the ultrasound device <NUM> may be rotated (as described above) while positioned in the expandable balloon member <NUM>. Accordingly, the ultrasound transducers <NUM> may be immersed in fluid as they are rotated within the fluid-filled expandable balloon member <NUM>. It can be appreciated that collecting ultrasound images of tissue utilizing sensors <NUM> which are immersed in fluid may be desirable because the fluid may improve the resolution of the ultrasound images.

In the following, examples of medical devices that are not encompassed by the wording of the claims but are considered as useful for understanding the invention will be described with reference to <FIG>.

<FIG> illustrates another example medical device <NUM>. Medical device <NUM> may include an ultrasound catheter. The ultrasound catheter <NUM> may include a shaft <NUM> having a distal end region <NUM> and a proximal end region. The distal end region <NUM> of the medical device <NUM> may include an ultrasound transducer <NUM> disposed along its outer surface. Furthermore, the medical device <NUM> may include a camera <NUM> disposed along a forward-facing portion of the medical device <NUM>. It can be appreciated that, in some examples, the forward-facing camera <NUM> may provide real-time visualization of the portion of the tissue (e.g., inner surface of a bladder) for which ultrasound imaging is being collected (via the ultrasound transducer <NUM>). Providing real-time visualization (via the camera <NUM>) of ultrasound imaging may be desirable because clinicians are often accustomed to direct visualization. Further, coupling ultrasound with real-time camera visualization may allow a clinician to utilize ultrasound to confirm that all tissue was removed/collected after a resection procedure was performed using the real-time camera visualization. Similarly, ultrasound may be utilized to confirm or prevent perforation of a tissue target site during a resection or tumor removal.

<FIG> illustrates another example medical device <NUM>. Medical device <NUM> may include an ultrasound catheter. The ultrasound catheter <NUM> may include a shaft <NUM> having a distal end region <NUM> and a proximal end region. The distal end region of the medical device <NUM> may include an ultrasound transducer <NUM> disposed along a forward-facing portion of the medical device <NUM>. Furthermore, the medical device <NUM> may also include a camera <NUM> disposed along a forward-facing portion of the medical device <NUM>. It can be appreciated that, in some examples, the forward-facing camera <NUM> may provide real-time visualization of the portion of the tissue target site (e.g., inner surface of a bladder) for which ultrasound imaging is be collected (via the ultrasound transducer <NUM>).

<FIG> further illustrates that, in some examples, the ultrasound catheter <NUM> may include a second ultrasound transducer <NUM> positioned on a side portion of the ultrasound catheter <NUM>. Additionally, <FIG> illustrates that the ultrasound catheter <NUM> may include a second camera <NUM> positioned on a side portion of the ultrasound catheter <NUM>. It can be appreciated that, in some examples, having two cameras collecting information from two different orientations (e.g., forward-facing and side-facing) may improve visualization of the body cavity in which the ultrasound catheter <NUM> is positioned. Further, it can be appreciated that both the forward-facing camera <NUM> and the side-facing camera <NUM> may work collaboratively with the forward-facing ultrasound transducer <NUM> and the side-facing transducer <NUM> to confirm that the ultrasound was appropriately deployed to image the entire cavity and/or provide feedback as to areas of the target tissue that were missed during a preliminary ultrasound sweep of the body cavity. In other words, having the camera imaging (e.g., forward-facing, side-facing or both) may correlate with real time ultrasound imaging to help guide resection and/or treatment of tissue sites (e.g., target cancerous tumors).

<FIG> illustrates the example medical device (e.g., ultrasound catheter) <NUM> positioned in a bladder <NUM>. <FIG> illustrates that the ultrasound catheter <NUM> may be advanced through a lumen of a delivery catheter <NUM> to a position within a body cavity (e.g., within a bladder). Additionally, <FIG> illustrates that the ultrasound catheter <NUM> may be advanced such that the ultrasound transducer <NUM> and the camera <NUM> are forward-facing and directed toward the inner surface <NUM> of the bladder while the ultrasound transducer <NUM> and the camera <NUM> are side-facing and directed toward the inner surface <NUM> of the bladder. It can be appreciated that a physician may be able to control the proximity in which both ultrasound transducers <NUM>/<NUM> and both cameras <NUM>/<NUM> are from the inner surface <NUM> of the bladder <NUM> via manipulation of the proximal end of the ultrasound catheter <NUM>. It can be further appreciated that the physician may be able to simultaneously receive both real-time ultrasound imaging and video visualization of a tissue target site via the forward-facing ultrasound transducer <NUM> and camera <NUM> and the side-facing ultrasound transducer <NUM> and camera <NUM>.

<FIG> illustrates another example medical device <NUM>. The medical device <NUM> may include an expandable balloon member <NUM>. The expandable balloon member <NUM> may be advanced through a delivery catheter <NUM> and expanded within a body cavity (e.g., within the bladder <NUM>). Therefore, it can be appreciated that, once expanded, the balloon <NUM> may contact the inner surface <NUM> of the bladder <NUM>.

Additionally, <FIG> illustrates that, in some examples, the medical device <NUM> may include one or more lumens <NUM> (e.g., channels, passages, etc.) extending within the wall of the expandable balloon member <NUM>. These lumens <NUM> may extend vertically from a distal end region of the balloon <NUM> to the proximal end region of the balloon <NUM>. Further, the medical device <NUM> may include one or more features which permit an ultrasound catheter (e.g., an ultrasound catheter including an ultrasound sensor) to be positioned within and translate within) the lumens <NUM>. It can be appreciated that positioning an ultrasound transducer within one or more of the lumens <NUM> may permit the ultrasound transducer to acquire ultrasound images while in close proximity to a target tissue site (e.g., cancerous tumor).

Additionally, <FIG> illustrates that, in some examples, the medical device <NUM> may include a lumen <NUM> (e.g., channels, passages, etc.) extending within the wall of the expandable balloon member <NUM>. The lumen <NUM> may extend helically around the balloon member <NUM> from a distal end region of the balloon <NUM> to the proximal end region of the balloon <NUM>. Further, the medical device <NUM> may include one or more features which permit an ultrasound catheter (e.g., an ultrasound catheter including an ultrasound sensor) to be positioned within and translate within) the lumen <NUM>. It can be appreciated that positioning an ultrasound transducer within the lumen <NUM> may permit the ultrasound transducer to acquire ultrasound images while in close proximity to a target tissue site (e.g., cancerous tumor).

Some example materials that can be used for the various components of the medical device <NUM> (or other components of medical device <NUM>) and other medical devices disclosed are described herein. However, this is not intended to limit the devices and methods described herein. Rather, it is contemplated that a variety of materials may be used for the various components of the medical device <NUM> and other medical devices described herein.

The medical device <NUM> (or other components of medical device <NUM>) and other medical devices disclosed herein may be made from a metal, metal alloy, polymer (some examples of which are disclosed below), a metal-polymer composite, ceramics, combinations thereof, and the like, or other suitable material. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), 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-<NUM> (such as GRILAMID® available from EMS American Grilon®), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like. In some embodiments the sheath can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about <NUM> percent LCP.

Some examples of suitable metals and metal alloys include stainless steel, such as 304V, <NUM>, 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® <NUM>, UNS: N06022 such as HASTELLOY® C-<NUM>®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® <NUM>, NICKELVAC® <NUM>, NICORROS® <NUM>, 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®), 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-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like); platinum enriched stainless steel; titanium; combinations thereof; and the like; or any other suitable material.

In at least some embodiments, portions or all of the medical device <NUM> (or other components of medical device <NUM>) and other medical devices disclosed herein may also 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 the medical device <NUM> (or other components of medical device <NUM>) and other medical devices disclosed herein in determining its location. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with radiopaque filler, and the like. Additionally, other radiopaque marker bands and/or coils may also be incorporated into the design of the medical device <NUM> (or other components of medical device <NUM>) and other medical devices disclosed herein to achieve the same result.

In some embodiments, a degree of Magnetic Resonance Imaging (MRI) compatibility is imparted into the medical device <NUM> (or other components of medical device <NUM>) and other medical devices disclosed herein. For example, the medical device <NUM> (or other components of medical device <NUM>) and other medical devices disclosed herein, or portions thereof, may be made of a material that does not substantially distort the image and create substantial artifacts (e.g., gaps in the image). Certain ferromagnetic materials, for example, may not be suitable because they may create artifacts in an MRI image. The medical device <NUM> (or other components of medical device <NUM>) and other medical devices disclosed herein, 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, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nitinol, and the like, and others.

Claim 1:
A medical device (<NUM>), comprising:
a support shaft (<NUM>) having a proximal end region and a distal end region (<NUM>);
a sensing member (<NUM>) having a proximal end region and a distal end region (<NUM>), the distal end region (<NUM>) of the sensing member (<NUM>) coupled to the distal end region (<NUM>) of the support shaft (<NUM>);
one or more ultrasound sensors (<NUM>) disposed along the sensing member (<NUM>); and
a support member (<NUM>) having a first end (<NUM>) coupled to the sensing member (<NUM>) and a second end (<NUM>) coupled to the support shaft (<NUM>);
wherein the sensing member (<NUM>) is configured to shift from a first configuration in which the sensing member (<NUM>) is adjacent to the support shaft (<NUM>) to a second configuration in which at least a portion of the sensing member (<NUM>) extends away from the support shaft (<NUM>); wherein
the second end (<NUM>) of the support member (<NUM>) is coupled to the support shaft (<NUM>) via an attachment collar, and wherein the attachment collar is designed to slide along the support shaft (<NUM>).