Ultrasound apparatus

Abstract

Disclosed is an ultrasonic medical device comprising: a support shaft (12) (e.g., a catheter, tubular member, etc.); a sensing member (16), wherein a distal end region (20) of the sensing member is coupled to a distal end region (14) of the support shaft; one or more ultrasonic sensors (18) disposed along the sensing member; and a support member (22) (e.g., a support arm, tether, etc.) having a first end (24) coupled to the sensing member and a second end (26) coupled to the support shaft. The sensing member is configured to transform from a first configuration in which the sensing member is adjacent to the support shaft to a second configuration in which at least a portion of the sensing member extends away from the support shaft. The ultrasound device may, for example, allow a physician to image an inner surface of the bladder while in close proximity to the surface.

Description

[0001] This application is a divisional application of the patent application with the application number "202080047565.9", the application date of "June 26, 2020", and the invention title of "Ultrasonic Device".

[0002] Cross - reference to related applications

[0003] This application claims the priority benefit of U.S. Provisional Application No. 62 / 868,644, filed on June 28, 2019, the entire disclosure of which is incorporated herein by reference. Technical Field

[0004] The present disclosure relates to medical devices and methods of manufacturing medical devices. More particularly, the present disclosure relates to ultrasonic visualization. Background Art

[0005] A variety of in - vivo medical devices have been developed for medical use, such as for intravascular use. Some of these devices include ultrasonic catheters, ultrasonic devices, etc. These devices are manufactured by any one of a variety of different manufacturing methods and can be used according to any one of a variety of methods. In known medical devices and methods, each has certain advantages and disadvantages. There has been a continuing need to provide alternative medical devices and alternative methods of manufacturing and using medical devices. Summary of the Invention

[0006] The present disclosure provides alternative designs, materials, manufacturing methods, and uses for medical devices. Example medical devices include: a support shaft having a proximal region and a distal region; and a sensing member having a proximal region and a distal region, the distal region of the sensing member being coupled to the distal region of the support shaft. The medical device further includes: one or more ultrasonic sensors disposed along the sensing member; and a support member having a first end coupled to the sensing member and a second end coupled to the support shaft. Additionally, the sensing member is configured to transform from a first configuration in which the sensing member is adjacent to the support shaft to a second configuration in which at least a portion of the sensing member extends away from the support shaft.

[0007] Alternatively or additionally, the sensing member forms an arcuate shape in the second configuration.

[0008] Alternatively or additionally, rotation of the support shaft causes the sensing member to rotate about the longitudinal axis of the support shaft.

[0009] Alternatively or additionally, each of the one or more ultrasonic sensors is spaced apart from each other along the sensing member.

[0010] Alternatively or additionally, the distal end of the sensing member is fixedly attached to the distal region of the support shaft.

[0011] Alternatively or additionally, the second end of the support member is fixedly attached to the support shaft.

[0012] Alternatively or additionally, the second end of the support member is translatable relative to the support shaft.

[0013] Alternatively or additionally, the second end of the support member is coupled to the support shaft by an attachment collar, and the attachment collar is designed to slide along the support shaft.

[0014] Alternatively or additionally, the proximal region of the sensing member is coupled to a hub, and manipulation of the hub transforms the sensing member from a first configuration to a second configuration.

[0015] Alternatively or additionally, rotation of a portion of the hub causes the sensing member to rotate about the longitudinal axis of the support shaft.

[0016] Another example medical device for imaging the bladder includes a hub member coupled to an ultrasound sensing assembly. The ultrasound assembly includes: a support shaft having a proximal region and a distal region; and a sensing member having a proximal region and a distal region, the distal region of the sensing member being coupled to the distal region of the support shaft. The ultrasound assembly further includes: one or more ultrasound sensors disposed along the sensing member; and a support member having a first end coupled to the sensing member and a second end coupled to the support shaft. Further, the sensing member is configured to transform from a first configuration in which the sensing member is adjacent to the support shaft to a second configuration in which at least a portion of the sensing member moves away from the support shaft.

[0017] Alternatively or additionally, rotation of a portion of the hub member is designed to cause the ultrasound assembly to rotate about the longitudinal axis of the support shaft.

[0018] Alternatively or additionally, rotation of a portion of the hub member is designed to scan the sensing member along the inner surface of the bladder when the sensing member is in the second configuration.

[0019] Alternatively or additionally, the sensing member forms an arcuate shape in the second configuration.

[0020] Alternatively or additionally, each of the one or more ultrasound sensors is spaced apart from each other along the sensing member.

[0021] Alternatively or additionally, the distal end of the sensing member is fixedly attached to the distal region of the support shaft.

[0022] Alternatively or additionally, the second end of the support member is fixedly attached to the support shaft.

[0023] Alternatively or additionally, the second end of the support member may be translatable relative to the support axis.

[0024] An example method for imaging the bladder includes positioning an ultrasound catheter assembly into the bladder. The ultrasound catheter assembly includes: a support shaft having a proximal region and a distal region; and a sensing member having a proximal region and a distal region, the distal region of the sensing member being coupled to the distal region of the support shaft. The ultrasound catheter assembly further includes: one or more ultrasound sensors disposed along the sensing member; and a support member having a first end coupled to the sensing member and a second end coupled to the support shaft. The method further includes translating the sensing member relative to the support shaft such that at least a portion of the sensing member moves away from the support shaft.

[0025] Alternatively or additionally, the method further includes rotating the sensing member about the longitudinal axis of the support shaft such that the sensing member scans the inner surface of the bladder.

[0026] The foregoing summary of some embodiments is not intended to describe every disclosed embodiment or every implementation of the present disclosure. The following drawings and detailed description more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The present disclosure may be more fully understood in connection with the following detailed description when considered in conjunction with the accompanying drawings, in which:

[0028] Figure 1 is a plan view of an example medical device positioned within a bladder;

[0029] Figures 2 to 4 illustrates a series of steps showing an example medical device being advanced within an exemplary delivery catheter and deployed within the bladder;

[0030] Figure 5 shows a partial cross-sectional view of an example medical device being manipulated within the bladder;

[0031] Figure 6 is a plan view of another example medical device positioned within a bladder;

[0032] Figure 7 illustrates another example medical device;

[0033] Figure 8 illustrates another example medical device;

[0034] Figure 9 illustrates the example medical device shown in Figure 8 being positioned within the bladder;

[0035] Figure 10 illustrates another example medical device;

[0036] Figure 11 Another example medical device is shown.

[0037] Although the present disclosure is applicable to various modifications and alternative forms, details thereof have been shown by way of example in the drawings and will be described in detail. However, it should be understood that the intention is not to limit the invention to the particular embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure. Detailed Description

[0038] For the terms defined below, unless a different definition is given in the claims or elsewhere in this specification, these definitions shall apply.

[0039] All numerical values herein are considered to be modified by the term "about" whether or not explicitly indicated. The term "about" generally refers to a range of numbers that a person of ordinary skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the term "about" may include numbers that are rounded to the nearest significant digit.

[0040] A numerical range recited by endpoints includes all values within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0041] As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its inclusive sense of "and / or" unless the context clearly dictates otherwise.

[0042] Note that references in the specification to "an embodiment", "some embodiments", "other embodiments", etc., indicate that the described embodiment(s) may include one or more particular features, structures, and / or characteristics. However, such recitation does not necessarily mean that all embodiments include the particular features, structures, and / or characteristics. Additionally, when a particular feature, structure, and / or characteristic is described in connection with an embodiment, it should be understood that such feature, structure, and / or characteristic may also be used in connection with other embodiments, whether or not explicitly described, unless expressly stated to the contrary.

[0043] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are identically numbered. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

[0044] Ultrasonic imaging is a medical procedure that can be used to detect and characterize abnormal tissue growths that occur in various medical conditions. In use, an ultrasonic medical device can project sound waves that bounce off an organ and reflect back to a transducer, whereupon the transducer processes the reflected waves and converts them into an image of the target organ or tissue. In some cases, an ultrasonic device can be used to mark the boundaries of a cancerous tumor before it is removed. For example, a doctor can use ultrasound to visualize and characterize a bladder cancer tumor.

[0045] An essential aspect of treating bladder cancer is to establish proper visualization of the interior of the bladder. Specifically, in some cases, it may be desirable to position an ultrasonic detection device near the cancerous tumor before imaging. Imaging the tumor in close proximity can offer several advantages compared to less invasive imaging. That is, in addition to being able to more precisely assess the depth of a particular tumor, imaging in close proximity can also allow for the detection of smaller tumors.

[0046] Accordingly, in some cases, it may be desirable to use an ultrasonic imaging device to image the inner surface of the bladder while in close proximity to it. Some of the medical devices disclosed herein can include a flexible and expandable ultrasonic device, whereby the ultrasonic device can be designed to allow a doctor to image the surface while in close proximity to the inner surface of the bladder.

[0047] Figure 1 is a schematic illustration of an ultrasonic medical device 10 that can be used to access and treat a tissue region in the body. Specifically, Figure 1 is generally shown deployed within the lumen of a bladder 50. However, this is not intended to be limiting. On the contrary, it is understood that the ultrasonic medical device 10 can be used in other regions of the body. For example, while the illustrated embodiment shows the device 10 as being for treating the bladder, the device 10 (and the methods described herein) can alternatively be configured for other tissue applications, such as procedures for treating tissue in the kidneys, abdominal organs, upper and lower urinary tracts, vagina, uterus, stomach, etc.

[0048] As Figure 1 shown, in some cases, the ultrasonic medical device 10 can be delivered to a tissue site (e.g., along the inner surface of the bladder 50 to a cancerous site) via one or more catheters. For example, Figure 1It is shown that the ultrasound device 10 can be advanced through the lumen 30 of the catheter 28. It is contemplated that the catheter 28 can be used to deliver and / or retrieve the ultrasound device 10. For example, the ultrasound device 10 can be advanced through the lumen 30 of the catheter 28 in a collapsed configuration. Further, the ultrasound device 10 can be pushed out of the distal end of the catheter 28, whereby at least a portion of the ultrasound device 10 can be transformed from a first (e.g., collapsed, pre-deployed, etc.) configuration to a second (e.g., expanded, deployed, etc.) configuration. It is also contemplated that the catheter 28 can include a guiding catheter, a delivery catheter, an endoscope, a cystoscope, etc.

[0049] As discussed above, it can be understood that the catheter 28 can be used to retrieve the ultrasound device 10 after a medical procedure is completed. For example, after an ultrasound imaging procedure is completed, the doctor can retract the ultrasound device 10 proximally into the distal end of the catheter 28. Although Figure 1 not shown in the figure, it is contemplated that the catheter 28 can include a tapered distal end. It can be understood that the tapered end of the catheter 28 can be designed to funnel the ultrasound device 10 into the lumen 30 of the catheter 28.

[0050] Although Figure 1 it is shown that the catheter 28 includes a single lumen 30, it is contemplated that in some examples, the catheter 28 can include two or more lumens that are designed to allow the ultrasound device 10 to be advanced therethrough. For example, in some cases, the catheter 28 can be an endoscope, a cystoscope, etc., which can include a first lumen that allows fluid to pass therethrough (and into the bladder) and a second lumen (e.g., a working channel) that is designed to allow the ultrasound device 10 to be advanced therethrough.

[0051] Figure 1 It is also shown that the ultrasound device 10 can include a support shaft 12 (e.g., a catheter, a tubular member, etc.) having a proximal portion and a distal portion 14. Figure 1 It is shown that the support shaft 12 extends through the lumen 30 of the catheter 28. In some cases, the support shaft 12 can be a solid member. However, in other examples, the support shaft 12 can be defined as a tubular member that includes a lumen extending therein. In other words, the support shaft 12 can include a lumen that extends along the entire length of the support shaft 12, or the lumen can only extend along a portion of the support shaft 12. The size and / or shape of the lumen of the support shaft 12 can be determined to accommodate a guide wire that extends therein.

[0052] Figure 1 It is also shown that the ultrasound device 10 can include a sensing member 16. The sensing member 16 can include a distal region 20 and a proximal region. As Figure 1As shown, the distal region 20 of the sensing member 16 can be coupled to the distal region 14 of the support shaft 12. In some examples, the distal region 20 of the sensing member 16 can be rigidly attached to the distal region 14 of the support shaft 12. However, in other examples, the distal region 20 of the sensing member 16 can move relative to the distal region 14 of the support shaft 12. For example, the distal region 20 of the sensing member 16 can be coupled to the distal region of the support shaft 14 through a rotary joint, a collar, etc.

[0053] As Figure 1 shown, in some cases, the sensing member 16 can include one or more ultrasonic sensors 18 disposed along the sensing member 16. The ultrasonic sensors 18 can be spaced apart from each other along the length of the sensing member 16. Further, in some examples, each of the ultrasonic sensors 18 can be relatively flat, such that the outer surface of the sensor is designed to be positioned against (or adjacent to) a target tissue site (e.g., a cancerous tumor). However, in other examples, the ultrasonic sensors 18 can include various shapes and / or configurations. For example, the sensor 18 can be embedded within the body of the sensing member 16, or can be wound around the body of the sensing member 16. In some examples, the ultrasonic sensors 18 can include phased array transducers and / or rotating (e.g., turning) transducers. Further, in other examples, the transducers (e.g., phased array transducers, rotating transducers, etc.) can be selected according to the resolution and penetration depth required during the ultrasonic procedure.

[0054] Figure 1 Also shown is that the ultrasonic device 10 can include a support member 22 (e.g., a support arm, a tether, etc.). The support member 22 can include a first end 24 and a second end 26. As Figure 1 shown, the first end 24 of the support member 22 can be coupled to the sensing member 16, and the second end 26 of the support member 22 can be coupled to the support shaft 12.

[0055] As will be discussed in more detail below, in some cases, it may be desirable for the support member 22 to translate relative to the support shaft 12. Thus, it can be understood that in some examples, the second end 26 of the support member 22 can include a collar slidably coupled to the support shaft 12. In other words, in some examples, the second end 26 of the support member 22 can be wound around the outer surface of the support shaft 12, thereby allowing the second end 26 of the support member 22 to slide proximally and distally along the support shaft 12 (e.g., along the longitudinal axis of the support shaft 12).

[0056] Figures 2 to 4 Examples of steps for positioning, deploying, and manipulating the ultrasonic device 10 within the bladder are shown. For example, Figure 2 shown is the ultrasonic device 10 (including the support shaft 12, the sensing member 16, and the support member 22) extending through the lumen 30 of the catheter 28. Further,Figure 2 It is shown that, in some examples, the proximal end of the catheter 28 can be coupled to a hub member 32. The hub member 32 can include an actuator 34. It will be appreciated that the actuator 34 can translate within the channel of the hub member 32. For example, it will be appreciated that the actuator 34 is capable of translating in the proximal and / or distal directions within the channel of the hub member 32.

[0057] Additionally, Figure 2 It is shown that, in some examples, the proximal end of the sensing member 16 can be coupled to the actuator 34. Further, Figure 2 It is shown that the proximal end of the support shaft 12 can be rigidly fixed to a portion of the hub member 32. In some examples, the hub member 32 can include a lumen and / or passageway extending therethrough that is substantially aligned with the lumen of the support shaft 12 (for examples where the support shaft 12 includes a lumen). Similar to that described with respect to the support shaft 12, it will be appreciated that the size and / or shape of the lumen of the hub member 32 can be determined to accommodate a guide wire extending therethrough. It will also be appreciated that the hub member 32 can include one or more features for manipulating at least a portion of the ultrasound device 10 within a body cavity (e.g., the bladder). For example, it will be appreciated that by manipulating the actuator 34, the sensing member 16 is capable of translating relative to the support shaft 12.

[0058] For example, Figure 2 It is shown that the actuator 34 after having been retracted in the proximal direction within the channel of the hub member 32. It will be appreciated that the proximal retraction of the actuator 34 can pull the sensing member 16 in the proximal direction such that the sensing member 16 is substantially adjacent (e.g., aligned, parallel to) the support shaft 12. Additionally, the proximal retraction of the actuator 34 can also cause the support shaft 12 to rotate (e.g., pivot, slide, translate) such that the support member 22 is substantially adjacent (e.g., aligned, parallel to) the support shaft 12 and / or the sensing member 16.

[0059] Figure 3 It is shown the ultrasound device 10 after the actuator 34 has been advanced in the distal direction (as shown by arrow 36) within the channel of the hub member 32. Figure 3 It is also shown that the distal translation of the actuator 34 can cause the sensing member 16 to begin to bend out away from the support shaft 12. Figure 3 It is shown that during this process the sensing member 16 begins to form a slight bend. In other words, when the actuator 34 translates distally, at least a portion of the sensing member can move radially away from the support shaft 12 (e.g., bend away from the support shaft 12), thereby displacing the ultrasound sensor 18 to a position closer to the inner surface 52 of the bladder 50. Additionally, Figure 3Illustrated is that consistent with the movement of the sensing member 16, the support member 22 can move (e.g., pivot, rotate, slide) relative to the sensing member 16 and / or the support shaft 12.

[0060] Figure 4 Illustrated is the ultrasound device 10 after the actuator 34 has been further advanced distally within the channel of the hub member 32. Figure 4 Also illustrated is that Figure 3 compared to the position in Figure 4 Illustrated is that Figure 3 compared to the position shown in Figure 4 a distal translation of the actuator 34 can cause the sensing member 16 to bend out further away from the support shaft 12. For example,

[0061] Figure 4 Also illustrated is that, in some examples, rotation of at least a portion of the hub member 32 can cause one or more features of the ultrasound device 10 to rotate within the body cavity (e.g., within the bladder). For example, Figure 4 Illustrated is that rotation of the hub member 32 (as shown by the circle 40) can cause the sensing member 16, the support member 22, and / or the support shaft 12 to rotate about the longitudinal axis of the support shaft 12. The rotation of one or more components of the ultrasound device 10 within the bladder 50 is shown by the Figure 4 arrow 38 in

[0062] Although the above discussion illustrates that rotation of the hub member 32 can cause the ultrasound device 10 (including the support shaft 12, the support member 22, the sensing member 16, and / or the catheter 28) to rotate within the body cavity (e.g., the bladder), this is not intended to be limiting. Instead, it is envisioned that the ultrasound device 10 can include alternative features and / or designs that allow the sensing member 16 to translate relative to the support shaft 12 and / or the ultrasound device 10 (and its components) to rotate within the body cavity. For example, in some cases, the ultrasound device can include a threaded drive, a rack and pinion, or other features that allow the sensing member 16 to translate relative to the support shaft 12 and / or the ultrasound device 10 (and its components) to rotate within the body cavity.

[0063] Figure 5 Illustrated is the Figure 4 top view of the ultrasound device 10 shown in Figure 5Shows a support shaft 12 positioned within the lumen of catheter 28. Additionally, Figure 5 Shows a sensing member 16 extending away from support shaft 12 such that ultrasonic sensor 18 is positioned adjacent to inner surface 52 of bladder 50. Further, Figure 5 Shows that rotation of sensing member 16 (as indicated by arrow 42) can “scan” sensing member 16 (including ultrasonic sensor 18) along inner surface 52 of a body cavity (e.g., bladder 50). It can be understood that the sensing member can be rotated through any rotational angle (0 to 360 degrees) about the longitudinal axis of support member 12. Further, it is envisioned that sensing member 16 can be rotated more than 360 degrees about the longitudinal axis of support member 12.

[0064] From the above discussion (and Figures 1 to 4 the illustrations shown therein), it can be understood that 360-degree rotation of sensing member 16 can permit complete imaging of the inner surface of a body cavity (e.g., bladder 50). In other words, because ultrasonic sensor 18 can extend from the distal region of sensing member 16 to near the opening of catheter 28, when sensing member 16 rotates (e.g., scans) through the entire 360-degree angle, sensing member 16 can image the inner lumen of the bladder from top to bottom. Further, in some examples, images obtained from one or more of sensors 18 can be stitched together to create a 360-degree rendering of the bladder, including a particular “depth” of a cancerous tumor extending into the bladder wall. However, this is not intended to be limiting. Instead, it is envisioned that, in some cases, sensing member 16 (including ultrasonic sensor 18) can be designed such that individual sensors 18 can be activated independently of other sensors 18. Thus, it is envisioned that, in some examples, a doctor can customize the ultrasonic imaging mode by selectively activating sensors 18.

[0065] Figure 6 Shows another example medical device 110. Medical device 110 can be similar in form and function to medical device 10 described above. For example, medical device 110 can include a sensing member 116 (including ultrasonic sensors 118 disposed thereon) and a support member 122 coupled to a support shaft 112. However, Figure 6 Also shows that sensing member 116, support member 122, and / or support shaft 112 can be positioned within an expandable balloon member 144. Further, Figure 6 Shows that medical device 110 (including sensing member 116, support member 122, support shaft 112, and balloon 144) can be pushed through the lumen 130 of delivery catheter 128.

[0066] Additionally, it can be understood that, in some examples, the expandable balloon member 144 can be inflated with fluid. Further, it is contemplated that the ultrasound device 110 can rotate (as described above) while being positioned within the expandable balloon member 144. Thus, as the ultrasound transducers 118 rotate within the fluid-filled expandable balloon member 144, they can be immersed in the fluid. It can be understood that it may be desirable to collect ultrasound images of tissue using sensors 118 immersed in the fluid, as the fluid can improve the resolution of the ultrasound images.

[0067] Figure 7 Another example medical device 210 is shown. The medical device 210 can include an ultrasound catheter. The ultrasound catheter 210 can include a shaft 260 having a distal region 214 and a proximal region. The distal region 214 of the medical device 210 can include ultrasound transducers 262 disposed along its outer surface. Additionally, the medical device 210 can include a camera 264 disposed along the forward portion of the medical device 210. It can be understood that, in some examples, the forward camera 264 can provide real-time visualization of the portion of the tissue (e.g., the inner surface of the bladder) for which ultrasound imaging is being collected (via the ultrasound transducer 226). Providing real-time visualization of the ultrasound imaging (by the camera 264) may be desirable because clinicians are generally accustomed to direct visualization. Further, combining ultrasound with real-time camera visualization can allow the clinician to use ultrasound to confirm that all tissue has been removed / collected after performing an excision procedure using real-time camera visualization. Similarly, during excision or tumor removal, ultrasound can be used to confirm or prevent perforation of the tissue target site.

[0068] Figure 8 Another example medical device 310 is shown. The medical device 310 can include an ultrasound catheter. The ultrasound catheter 310 can include a shaft 360 having a distal region 314 and a proximal region. The distal region of the medical device 310 can include ultrasound transducers 362 disposed along the forward portion of the medical device 310. Additionally, the medical device 310 can further include a camera 364 disposed along the forward portion of the medical device 310. It can be understood that, in some examples, the forward camera 364 can provide real-time visualization of the portion of the tissue target site (e.g., the inner surface of the bladder) for which ultrasound imaging is being collected (via the ultrasound transducer 326).

[0069] Figure 8 It is also shown that, in some examples, the ultrasound catheter 310 can include a second ultrasound transducer 363 positioned on the side portion of the ultrasound catheter 310. Additionally, Figure 8It is shown that the ultrasound catheter 310 may include a second camera 365 positioned on a side portion of the ultrasound catheter 310. It can be understood that, in some examples, having two cameras that collect information from two different orientations (e.g., forward and lateral) may improve visualization of the body cavity in which the ultrasound catheter 310 is positioned. Further, it can be understood that the forward camera 364 and the lateral camera 365 may work in conjunction with the forward ultrasound transducer 362 and the lateral transducer 363 to confirm that the ultrasound is properly deployed to image the entire body cavity and / or provide feedback regarding areas of target tissue that were missed during an initial ultrasound scan of the body cavity. In other words, imaging with the cameras (e.g., forward, lateral, or both) may be associated with real-time ultrasound imaging to assist in guiding the resection and / or treatment of a tissue site (e.g., a target cancerous tumor).

[0070] Figure 9 An example medical device (e.g., an ultrasound catheter) 310 positioned within the bladder 50 is shown. Figure 9 It is shown that the ultrasound catheter 310 may be advanced through the lumen of the delivery catheter 328 to a position within a body cavity (e.g., within the bladder). Additionally, Figure 9 It is shown that the ultrasound catheter 310 may be advanced such that the ultrasound transducer 362 and the camera 364 are forward and pointed toward the inner surface 52 of the bladder, while the ultrasound transducer 363 and the camera 365 are lateral and pointed toward the inner surface 52 of the bladder. It can be understood that a doctor is able to control the proximity of both the ultrasound transducers 362 / 363 and the two cameras 364 / 365 to the inner surface 52 of the bladder 50 by manipulating the proximal end of the ultrasound catheter 310. It can also be understood that a doctor is able to receive both real-time ultrasound imaging and video visualization of a tissue target site simultaneously via the forward ultrasound transducer 362 and the camera 364 and the lateral ultrasound transducer 363 and the camera 365.

[0071] Figure 10 Another example medical device 410 is shown. The medical device 410 may include an expandable balloon member 468. The expandable balloon member 468 may be advanced through the delivery catheter 428 and expanded within a body cavity (e.g., within the bladder 50). Thus, it can be understood that once expanded, the balloon 468 may contact the inner surface 52 of the bladder 50.

[0072] Additionally, Figure 10Illustrated is that, in some examples, the medical device 410 can include one or more lumens 470 (e.g., channels, passageways, etc.) extending within the wall of the expandable balloon member 468. These lumens 470 can extend vertically from the distal region of the balloon 468 to the proximal region of the balloon 468. Further, the medical device 410 can include one or more features that allow an ultrasound catheter (e.g., an ultrasound catheter including an ultrasound sensor) to be positioned within and translated within the lumen 470. It can be understood that positioning the ultrasound transducer within one or more of the lumens 470 can allow the ultrasound transducer to acquire ultrasound images while in close proximity to a target tissue site (e.g., a cancerous tumor).

[0073] Figure 11 Another example medical device 510 is illustrated. The medical device 510 can include an expandable balloon member 568. The expandable balloon member 568 can be advanced through a delivery catheter 528 and expanded within a body cavity (e.g., within the bladder 50). Thus, it can be understood that once expanded, the balloon 568 can contact the inner surface 52 of the bladder 50.

[0074] Additionally, Figure 11 Illustrated is that, in some examples, the medical device 510 can include a lumen 570 (e.g., a channel, a passageway, etc.) extending within the wall of the expandable balloon member 568. The lumen 570 can extend helically around the balloon member 568 from the distal region of the balloon 568 to the proximal region of the balloon 568. Further, the medical device 510 can include one or more features that allow an ultrasound catheter (e.g., an ultrasound catheter including an ultrasound sensor) to be positioned within and translated within the lumen 570. It can be understood that positioning the ultrasound transducer within the lumen 570 can allow the ultrasound transducer to acquire ultrasound images while in close proximity to a target tissue site (e.g., a cancerous tumor).

[0075] Some example materials for various components of the medical device 10 (or other components of the medical device 10) and the other medical devices disclosed herein are described. However, this is not intended to limit the devices and methods described herein. Instead, it is envisioned that a variety of materials can be used for the various components of the medical device 10 and the other medical devices described herein.

[0076] The medical device 10 (or other components of the medical device 10) disclosed herein and other medical devices can be made of metal, metal alloy, polymer (some examples of which are disclosed below), metal-polymer composite, ceramic, combinations thereof, etc., or other suitable materials. Some examples of suitable polymers can include polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene copolymer (ETFE), fluorinated ethylene propylene copolymer (FEP), polyoxymethylene (POM, e.g., ) available from DuPont, polyether block ester, polyurethane (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether ester (e.g., ) available from DSM Engineering Plastics, ether or ester group copolymer (e.g., butene / poly(alkylene ether) phthalate and / or other polyester elastomers, such as ) available from DuPont, polyamide (e.g., ) available from Bayer or ) available from Elf Atochem, elastic polyamide, block polyamide / ether, polyether block amide (PEBA, e.g., available under the trade name ), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), high density polyethylene, low density polyethylene, linear low density polyethylene (e.g., ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly(p-phenylene terephthalamide) (e.g., ), polysulfone, nylon, nylon-12 (such as ) available from EMS American ), perfluoro(propyl vinyl ether) (PFA), ethylene-vinyl alcohol, polyolefin, polystyrene, epoxy resin, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ion crosslinked polymer, biocompatible polymer, other suitable materials or mixtures, combinations, copolymers, polymer / metal composites, etc. In some embodiments, the sleeve can be mixed with liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP.

[0077] Some examples of suitable metals and metal alloys include stainless steels such as 304V, 304L, and 316LV stainless steels; low carbon steels; nickel-titanium alloys such as linear elastic and / or superelastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS:N06625 such as 625; UNS:N06022 such as UNS:N10276 such as others alloys, etc.); nickel-copper alloys (e.g., UNS:N04400 such as 400, 400, 400, etc.); nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035 such as etc.); nickel-molybdenum alloys (e.g., UNS:N10665 such as ALLOY ), 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, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS:R30003 such as etc.); platinum-rich stainless steels; titanium; combinations thereof, etc.; or any other suitable material.

[0078] In at least some embodiments, part or all of the medical device 10 (or other components of the medical device 10) disclosed herein and other medical devices may also be doped with radiopaque materials, made of radiopaque materials, or otherwise include radiopaque materials. Radiopaque materials are understood to be materials that can produce a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image helps the user of the medical device 10 (or other components of the medical device 10) and other medical devices disclosed herein to determine its location. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymer materials loaded with radiopaque fillers, etc. Additionally, other radiopaque marker bands and / or coils may also be incorporated into the design of the medical device 10 (or other components of the medical device 10) and other medical devices disclosed herein to achieve the same result.

[0079] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to medical device 10 (or other components of medical device 10) and other medical devices disclosed herein. For example, medical device 10 (or other components of medical device 10) and other medical devices disclosed herein or portions thereof may be made of materials that substantially do not distort images and produce a large number of artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may not be suitable because they may produce artifacts in MRI images. Medical device 10 (or other components of medical device 10) and other medical devices disclosed herein or portions thereof may also be made of materials that can be imaged by an MRI machine. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloy (e.g., UNS: R30003, such as etc.), nickel-cobalt-chromium-molybdenum alloy (e.g., UNS: R30035, such as etc.), nitinol, etc. and others.

[0080] It should be understood that the present disclosure is illustrative in many respects. Changes may be made in the details, especially in the shape, size, and arrangement of steps, without departing from the scope of the present disclosure. To the extent appropriate, this may include using any of the features of one exemplary embodiment in other embodiments. Of course, the scope of the present disclosure is defined by the language of the appended claims.

Claims

1. A medical device, comprising: a support shaft having a proximal region and a distal region; a sensing member having a distal region and a proximal region including a proximal end, wherein the proximal end is coupled to an actuator and the distal region of the sensing member is coupled to the distal region of the support shaft; a support member having a first end coupled to the sensing member and a second end coupled to the support shaft; wherein, distal advancement of the actuator causes the sensing member to bend away from the support shaft; and wherein, proximal retraction of the actuator causes the sensing member to be pulled in the proximal direction such that the sensing member is substantially adjacent to the support shaft.

2. The medical device according to claim 1, wherein, the support shaft extends through the lumen of a catheter; wherein, the proximal end of the catheter is coupled to a hub member; wherein, the hub member includes the actuator.

3. The medical device according to claim 2, wherein, rotation of the hub member causes rotation of the sensing member.

4. The medical device according to claim 2 or 3, wherein, rotation of the hub member causes rotation of the support member.

5. The medical device according to any one of claims 2 - 4, wherein, rotation of the hub member causes rotation of the support shaft.

6. The medical device according to any one of claims 2 - 5, wherein, the hub member includes a passage extending therethrough, the passage being substantially aligned with the lumen of the support shaft.

7. The medical device according to any one of claims 2 - 6, wherein, the actuator translates within a channel of the hub member.

8. The medical device according to any one of the preceding claims, wherein, the second end of the support member includes a collar slidably coupled to the support shaft.

9. The medical device according to any one of the preceding claims, wherein, the sensing member includes one or more ultrasonic sensors disposed along the sensing member.

10. The medical device according to claim 9, wherein, the one or more ultrasonic sensors include a phased array transducer.

11. The medical device according to claim 9, wherein, the one or more ultrasonic sensors include a rotary transducer.

12. The medical device according to any one of claims 9 - 11, wherein, the one or more ultrasonic sensors are spaced apart from each other along the sensing member.

13. The medical device according to any one of the preceding claims, wherein, the support shaft includes a lumen extending along the entire length of the support shaft.

14. The medical device according to any one of the preceding claims, wherein, the distal region of the sensing member is rigidly attached to the distal region of the support shaft.

15. A medical device, comprising: a support shaft having a proximal region and a distal region; a sensing member having a distal region and a proximal region including a proximal end, wherein the proximal end is coupled to an actuator and the distal region of the sensing member is coupled to the distal region of the support shaft; One or more ultrasonic sensors disposed along the sensing member; And A support member having a first end coupled to the sensing member and a second end coupled to the support shaft; Wherein the support shaft is capable of being advanced through the lumen of a catheter having a proximal end to which a hub member is attached; Wherein the hub member includes the actuator; Wherein the sensing member is configured to transform from a first configuration in which the sensing member is adjacent to the support shaft to a second configuration in which at least a portion of the sensing member extends away from the support shaft via actuation of the actuator.

16. The medical device according to claim 15, Wherein, Rotation of the hub member causes rotation of the sensing member.

17. The medical device according to claim 15 or 16, Wherein, Rotation of the hub member causes rotation of the support member.

18. The medical device according to any one of claims 15-17, Wherein, Rotation of the hub member causes rotation of the support shaft.

19. The medical device according to any one of claims 15-18, Wherein, The hub member includes a passage extending therethrough that is substantially aligned with the lumen of the support shaft.

20. The medical device according to any one of claims 15-19, Wherein, The second end of the support member includes a collar slidably coupled to the support shaft.

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