Ultrasound equipment

Abstract

An ultrasonic medical device is disclosed, comprising: a support shaft (12) (e.g., a catheter, a tubular member, etc.); a sensing member (16), wherein a distal region (20) of the sensing member is coupled to a distal 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, a tether, etc.), the support member 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 ultrasonic device can be in close proximity to the inner surface of the bladder while, for example, allowing a physician to image the surface.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to 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

[0003] The present disclosure relates to medical devices and methods of making medical devices. More particularly, the present disclosure relates to ultrasound visualization. Background Art

[0004] A variety of in vivo medical devices have been developed for medical use, such as intravascular use. Some of these devices include ultrasound catheters, ultrasound devices, and the like. These devices are manufactured by any of a variety of different manufacturing methods and can be used according to any of a variety of methods. Among the known medical devices and methods, each has certain advantages and disadvantages. There is a continuing need to provide alternative medical devices and alternative methods of manufacturing and using medical devices. Summary of the invention

[0005] The present disclosure provides alternative designs, materials, manufacturing methods, and uses of medical devices. An example medical device includes: a support member 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 member. The medical device also includes: one or more ultrasonic 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 transform 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.

[0006] Alternatively or additionally, wherein the sensing member forms an arcuate shape in the second configuration.

[0007] Alternatively or additionally, wherein rotation of the support member causes the sensing member to rotate about a longitudinal axis of the support member.

[0008] Alternatively or additionally, each of the one or more ultrasonic sensors are spaced apart from one another along the sensing member.

[0009] Alternatively or additionally, wherein the distal end of the sensing member is fixedly attached to the distal region of the support member.

[0010] Alternatively or additionally, wherein the second end of the support shaft is fixedly attached to the support member.

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

[0012] 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.

[0013] Alternatively or additionally, wherein the proximal region of the sensing member is coupled to a hub, and wherein manipulation of the hub transforms the sensing member from the first configuration to the second configuration.

[0014] Alternatively or additionally, wherein rotation of a portion of the hub rotates the sensing member about a longitudinal axis of the support member.

[0015] 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 region and a distal region; and a sensing member having a proximal region and a distal region, the distal region of the sensing member coupled to the distal 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 transform 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.

[0016] Alternatively or additionally, rotation of a portion of the hub member is designed to rotate the ultrasonic assembly about the longitudinal axis of the support member.

[0017] Alternatively or additionally, wherein rotation of a portion of the hub member is designed to scan the sensing member along an inner surface of the bladder when the sensing member is in the second configuration.

[0018] Alternatively or additionally, wherein the sensing member forms an arcuate shape in the second configuration.

[0019] Alternatively or additionally, each of the one or more ultrasonic sensors are spaced apart from one another along the sensing member.

[0020] Alternatively or additionally, wherein the distal end of the sensing member is fixedly attached to the distal region of the support member.

[0021] Alternatively or additionally, wherein the second end of the support shaft is fixedly attached to the support member.

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

[0023] An example method for imaging a bladder includes positioning an ultrasound catheter assembly into a bladder. The ultrasound catheter assembly includes: a support member 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 coupled to the distal 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 so that at least a portion of the sensing member moves away from the support member.

[0024] Alternatively or additionally, the method further comprises rotating the sensing member about the longitudinal axis of the support member such that the sensing member scans around the inner surface of the bladder.

[0025] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The following figures and detailed description more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The present disclosure may be more fully understood upon consideration of the following detailed description in conjunction with the accompanying drawings, in which:

[0027] Figure 1 is a plan view of an example medical device positioned within a bladder;

[0028] Figures 2 to 4 A series of steps are shown illustrating advancement of an example medical device within an exemplary delivery catheter and deployment within a bladder;

[0029] Figure 5 A partial cross-sectional view showing an example medical device being manipulated within a bladder;

[0030] Figure 6 is a plan view of another example medical device positioned within a bladder;

[0031] Figure 7 Another example medical device is shown;

[0032] Figure 8 Another example medical device is shown;

[0033] Fig. 9 Shown is positioned within the bladder Figure 8 The example medical device shown therein;

[0034] Fig.10 Another example medical device is shown;

[0035] Fig.11 Another example medical device is shown.

[0036] Although the present disclosure is applicable to various modifications and alternative forms, the details thereof have been illustrated by the examples in the accompanying drawings and will be described in detail. However, it should be understood that the purpose is not to limit the present invention to the specific embodiments described. On the contrary, the present invention is intended to cover all modifications, equivalents and alternatives that fall within the spirit and scope of the present disclosure. DETAILED DESCRIPTION

[0037] For the following defined terms, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0038] All numerical values ​​herein are considered to be modified by the term "about", whether or not explicitly stated. The term "about" generally refers to a range of numbers that one skilled in the art considers to be equivalent to the recited value (e.g., having the same function or result). In many cases, the term "about" may include numbers that are rounded to the nearest significant figure.

[0039] The recitation of numerical ranges by endpoints includes all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0040] 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.

[0041] Note that references in the specification to "an embodiment," "some embodiments," "other embodiments," etc. indicate that the described embodiments may include one or more particular features, structures, and / or characteristics. However, such a description does not necessarily mean that all embodiments include the particular features, structures, and / or characteristics. Additionally, when particular features, structures, and / or characteristics are described in conjunction with one embodiment, it should be understood that these features, structures, and / or characteristics may also be used in conjunction with other embodiments, whether or not explicitly described, unless explicitly stated to the contrary.

[0042] The following detailed description should be read with reference to the accompanying drawings, in which similar elements in different drawings are numbered alike. The drawings, which are not necessarily drawn to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

[0043] Ultrasound imaging is a medical procedure that can be used to detect and characterize abnormal tissue growths that occur in a variety of medical conditions. In use, an ultrasound medical device can project sound waves that bounce off an organ and reflect back to a transducer, whereby the transducer processes the reflected waves and converts them into an image of the target organ or tissue. In some cases, ultrasound equipment can be used to mark out the boundaries of a cancerous tumor before it is removed. For example, doctors can use ultrasound to visualize and characterize bladder cancer tumors.

[0044] A fundamental aspect of treating bladder cancer is establishing proper visualization of the interior of the bladder. Specifically, in some cases, it may be desirable to position an ultrasound detection device near a cancerous tumor prior to imaging. Imaging a tumor in close proximity may provide several advantages over less invasive imaging. That is, in addition to being able to more accurately assess the depth of a particular tumor, imaging in close proximity may also allow for the detection of smaller tumors.

[0045] Therefore, in some cases, it may be desirable to image the inner surface of the bladder while in close proximity to the inner surface of the bladder using an ultrasound imaging device. Some of the medical devices disclosed herein may include utilizing a flexible and expandable ultrasound device, whereby the ultrasound device may be designed to allow a physician to image the inner surface of the bladder while in close proximity to the surface.

[0046] Figure 1 is a schematic diagram of an ultrasonic medical device 10 that can be used to access and treat tissue regions in the body. Specifically, Figure 1 The medical device 10 is generally shown deployed within the lumen of a bladder 50. However, this is not intended to be limiting. Rather, it will be appreciated that the ultrasonic medical device 10 may be used in other areas of the body. For example, while the illustrated embodiment shows the device 10 as being used to treat the bladder, the device 10 (and the methods described herein) may 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.

[0047] like Figure 1 As shown, in some cases, the ultrasound medical device 10 can be delivered to a tissue site (e.g., to a cancer site along the inner surface of the bladder 50) via one or more catheters. Figure 1The ultrasound device 10 is shown as being 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 guide catheter, a delivery catheter, an endoscope, a cystoscope, etc.

[0048] As discussed above, it will be appreciated that the catheter 28 can be used to retrieve the ultrasound device 10 after a medical procedure is completed. For example, after completing an ultrasound imaging procedure, the physician can retract the ultrasound device 10 proximally into the distal end of the catheter 28. Figure 1 It is not shown, but it is contemplated that the catheter 28 may include a tapered distal end. It is understood that the tapered end of the catheter 28 may be designed to funnel the ultrasound device 10 into the lumen 30 of the catheter 28.

[0049] Although Figure 1 The catheter 28 is shown as including a single lumen 30, but it is contemplated that in some examples, the catheter 28 may include two or more lumens designed to allow advancement of the ultrasound device 10 therethrough. For example, in some cases, the catheter 28 may be an endoscope, cystoscope, etc., which may 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 advancement of the ultrasound device 10 therethrough.

[0050] Figure 1 Also shown is that the ultrasound device 10 can include a support shaft 12 (eg, catheter, tubular member, etc.) having a proximal end portion and a distal end portion 14 . Figure 1 A support shaft 12 is shown extending 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 including a lumen extending therein. In other words, the support shaft 12 can include a lumen extending along the entire length of the support shaft 12, or the lumen can extend along only a portion of the support shaft 12. The lumen of the support shaft 12 can be sized and / or shaped to accommodate a guidewire extending therein.

[0051] Figure 1 It is also shown that the ultrasound device 10 may include a sensing member 16. The sensing member 16 may include a distal region 20 and a proximal region. Figure 1As shown, the distal region 20 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 be movable 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 14 of the support shaft by a swivel joint, a collar, etc.

[0052] like Figure 1 As shown, in some cases, the sensing member 16 may include one or more ultrasonic sensors 18 disposed along the sensing member 16. The ultrasonic sensors 18 may be spaced apart from each other along the length of the sensing member 16. Further, in some examples, each of the ultrasonic sensors 18 may be relatively flat, whereby 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 sensor 18 may include a variety of shapes and / or configurations. For example, the sensor 18 may be embedded in the body of the sensing member 16, or may be wrapped around the body of the sensing member 16. In some examples, the ultrasonic sensor 18 may include a phased array transducer and / or a rotating (e.g., rotating) transducer. Further, in other examples, the transducer (e.g., a phased array transducer, a rotating transducer, etc.) may be selected according to the resolution and penetration depth required during the ultrasound procedure.

[0053] Figure 1 The ultrasound device 10 is also shown to include a support member 22 (e.g., a support arm, a tether, etc.). The support member 22 may include a first end 24 and a second end 26. Figure 1 As shown, a first end 24 of the support member 22 may be coupled to the sensing member 16 , and a second end 26 of the support member 22 may be coupled to the support shaft 12 .

[0054] As will be discussed in more detail below, in some instances, it may be desirable for the support member 22 to translate relative to the support shaft 12. Thus, it will be appreciated that in some examples, the second end 26 of the support member 22 may include a collar that is slidably coupled to the support shaft 12. In other words, in some examples, the second end 26 of the support member 22 may be wrapped around an 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).

[0055] Figures 2 to 4 Example steps for positioning, deploying, and manipulating the ultrasound device 10 in the bladder are shown. For example, Figure 2 The ultrasound device 10 (including the support shaft 12, the sensing member 16, and the support member 22) is shown extending through the inner cavity 30 of the catheter 28. Further, Figure 2 As shown, 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 can be appreciated that the actuator 34 can translate within the channel of the hub member 32. For example, it can be appreciated that the actuator 34 can translate within the channel of the hub member 32 in a proximal and / or distal direction.

[0056] Additionally, Figure 2 As shown, 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 may include an inner cavity and / or passage extending therethrough, which is substantially aligned with the inner cavity of the support shaft 12 (for examples in which the support shaft 12 includes an inner cavity). Similar to what is described with respect to the support shaft 12, it will be understood that the size and / or shape of the inner cavity of the hub member 32 can be determined to accommodate a guidewire extending therethrough. It will also be understood that the hub member 32 may include one or more features for manipulating at least a portion of the ultrasound device 10 within a body cavity (e.g., in a bladder). For example, it will be understood that by manipulating the actuator 34, the sensing member 16 can be translated relative to the support shaft 12.

[0057] For example, Figure 2 The actuator 34 is shown after having been retracted in the proximal direction within the channel in the hub member 32. It can 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 to (e.g., aligned with, parallel to) the support shaft 12. In addition, the proximal retraction of the actuator 34 can also cause the support shaft 12 to rotate (e.g., pivot, slide, translate) so that the support member 22 is substantially adjacent to (e.g., aligned with, parallel to) the support shaft 12 and / or the sensing member 16.

[0058] Figure 3 The ultrasonic device 10 is shown after the actuator 34 has been advanced in the distal direction (as indicated by arrow 36 ) within the channel of the hub member 32 . Figure 3 It is also shown that 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 The sensing member 16 is shown to begin to form a slight bend during this process. In other words, as 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 shifting the ultrasound sensor 18 to a position closer to the inner surface 52 of the bladder 50. Additionally, Figure 3It is shown that in concert with movement of the sensing member 16 , the support member 22 can move (eg, pivot, rotate, slide) relative to the sensing member 16 and / or the support shaft 12 .

[0059] Figure 4 The ultrasonic device 10 is shown after the actuator 34 has been advanced further in the distal direction within the channel of the hub member 32 . Figure 4 It also shows that Figure 3 Distal translation of the actuator 34 may cause the sensing member 16 to bend away from the support shaft 12 to a greater extent than in the position in FIG. Figure 4 Shown with Figure 3 The sensing member 16 has a greater curvature than the position shown. Therefore, it can be appreciated that translating the sensing member 16 in the proximal-to-distal direction relative to the support shaft 12 can cause the ultrasound sensor 18 to be moved to a position closer to the inner surface 52 of the bladder 50. Additionally, Figure 4 It is shown that translating the sensing member 16 in a proximal to distal direction relative to the support shaft 12 causes the support member 22 to move (eg, pivot, rotate, slide) relative to the sensing member 16 and / or the support shaft 12 .

[0060] Figure 4 It is also shown 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 a body cavity (eg, within the bladder). Figure 4 It is shown that rotation of the hub member 32 (as indicated 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 caused by Figure 4 As shown by arrow 38 in FIG.

[0061] Although the above discussion shows that rotation of the hub member 32 can rotate the ultrasound device 10 (including the support shaft 12, the support member 22, the sensing member 16 and / or the catheter 28) within a body cavity (e.g., a bladder), this is not intended to be limiting. Instead, it is contemplated that the ultrasound device 10 may 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 may 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.

[0062] Figure 5 The bladder 50 is shown positioned within Figure 4 FIG. 1 is a top view of the ultrasound device 10 shown in FIG. Figure 5The support shaft 12 is shown positioned with the lumen of the catheter 28. Additionally, Figure 5 The sensing member 16 is shown extending away from the support shaft 12 so that the ultrasound sensor 18 is positioned adjacent to the inner surface 52 of the bladder 50. Further, Figure 5 It is shown that rotation of the sensing member 16 (as indicated by arrow 42) can "scan" the sensing member 16 (including the ultrasound sensor 18) along the inner surface 52 of the body cavity (e.g., bladder 50). It can be appreciated that the sensing member can be rotated through any rotation angle (0 to 360 degrees) about the longitudinal axis of the support member 12. Further, it is contemplated that the sensing member 16 can be rotated more than 360 degrees about the longitudinal axis of the support member 12.

[0063] From the above discussion (and Figures 1 to 4 ), it can be understood from the illustration shown in , that the 360-degree rotation of the sensing member 16 can allow for complete imaging of the inner surface of the body cavity (e.g., bladder 50). In other words, because the ultrasound sensor 18 can extend from the distal region of the sensing member 16 to the opening near the catheter 28, the sensing member 16 can image the inner cavity of the bladder from top to bottom when the sensing member 16 rotates (e.g., scans) through a full 360-degree angle. Further, in some examples, images acquired from one or more of the sensors 18 can be stitched together to create a 360-degree presentation of the bladder, including a specific "depth" of a cancerous tumor extending into the bladder wall. However, this is not intended to be limiting. On the contrary, it is contemplated that, in some cases, the sensing member 16 (including the ultrasound sensor 18) can be designed so that each sensor 18 can be activated independently of other sensors 18. Therefore, it is contemplated that, in some examples, a physician can customize the ultrasound imaging mode by selectively activating the sensor 18.

[0064] Figure 6 Another example medical device 110 is shown. The medical device 110 can be similar in form and function to the medical device 10 described above. For example, the medical device 110 can include a sensing member 116 (including an ultrasound sensor 118 disposed thereon) and a support member 122 coupled to the support shaft 112. However, Figure 6 It is also shown that the sensing member 116, the support member 122 and / or the support shaft 112 can be positioned within the expandable balloon member 144. Further, Figure 6 It is shown that the medical device 110 (including the sensing member 116, the support member 122, the support shaft 112 and the balloon 144) can be pushed through the lumen 130 of the delivery catheter 128.

[0065] Additionally, it will be appreciated that in some examples, the expandable balloon member 144 can be inflated with a fluid. Further, it is contemplated that the ultrasound device 110 can be rotated (as described above) while being positioned in 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 will be appreciated that it may be desirable to collect ultrasound images of tissue using the transducer 118 immersed in the fluid, as the fluid can improve the resolution of the ultrasound image.

[0066] Figure 7 Another example medical device 210 is shown. The medical device 210 may include an ultrasound catheter. The ultrasound catheter 210 may include a shaft 260 having a distal region 214 and a proximal region. The distal region 214 of the medical device 210 may include an ultrasound transducer 262 disposed along its outer surface. In addition, the medical device 210 may include a camera 264 disposed along the forward portion of the medical device 210. It is understood that in some examples, the forward camera 264 may provide real-time visualization of a portion of tissue (e.g., the inner surface of a bladder) for which ultrasound imaging is being collected (via the ultrasound transducer 226). Providing real-time visualization of ultrasound imaging (via the camera 264) may be desirable because clinicians are typically accustomed to direct visualization. Further, combining ultrasound with real-time camera visualization may allow clinicians to use ultrasound to confirm that all tissue is removed / collected after performing a resection procedure using real-time camera visualization. Similarly, during resection or tumor removal, ultrasound can be used to confirm or prevent perforation of a tissue target site.

[0067] Figure 8 Another example medical device 310 is shown. The medical device 310 may include an ultrasound catheter. The ultrasound catheter 310 may include a shaft 360 having a distal region 314 and a proximal region. The distal region of the medical device 310 may include an ultrasound transducer 362 disposed along a forward portion of the medical device 310. Additionally, the medical device 310 may also include a camera 364 disposed along a forward portion of the medical device 310. It will be appreciated that in some examples, the forward camera 364 may provide real-time visualization of a portion of a tissue target site (e.g., the inner surface of a bladder) for which ultrasound imaging is being collected (via the ultrasound transducer 326).

[0068] Figure 8 It is also shown that in some examples, the ultrasound catheter 310 may include a second ultrasound transducer 363 positioned on a side portion of the ultrasound catheter 310. Additionally, Figure 8The ultrasound catheter 310 is shown to include a second camera 365 positioned on a side portion of the ultrasound catheter 310. It will be appreciated that in some examples, having two cameras that collect information from two different orientations (e.g., forward and sideways) can improve visualization of the body cavity in which the ultrasound catheter 310 is positioned. Further, it will be appreciated that the forward camera 364 and the side camera 365 can work in conjunction with the forward ultrasound transducer 362 and the side transducer 363 to confirm that the ultrasound is properly deployed to image the entire body cavity and / or provide feedback on areas of target tissue that were missed during a preliminary ultrasound scan of the body cavity. In other words, camera imaging (e.g., forward, sideways, or both) can be associated with real-time ultrasound imaging to help guide the resection and / or treatment of a tissue site (e.g., a target cancerous tumor).

[0069] Fig. 9 An example medical device (eg, an ultrasound catheter) 310 is shown positioned in the bladder 50 . Fig. 9 It is shown that the ultrasound catheter 310 can be advanced through the lumen of the delivery catheter 328 to a position within a body cavity (e.g., within the bladder). Additionally, Fig. 9 It is shown that the ultrasound catheter 310 can be advanced so that the ultrasound transducer 362 and camera 364 are forward and pointed toward the inner surface 52 of the bladder, while the ultrasound transducer 363 and camera 365 are sideways and pointed toward the inner surface 52 of the bladder. It can be understood that the physician can 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 the physician can simultaneously receive both real-time ultrasound imaging and video visualization of the tissue target site through the forward ultrasound transducer 362 and camera 364 and the side ultrasound transducer 363 and camera 365.

[0070] Fig.10 Another example medical device 410 is shown. The medical device 410 can include an expandable balloon member 468. The expandable balloon member 468 can be advanced through the delivery catheter 428 and expanded within a body cavity (e.g., within the bladder 50). Thus, it can be appreciated that once expanded, the balloon 468 can contact the inner surface 52 of the bladder 50.

[0071] Additionally, Fig.10It is shown that in some examples, the medical device 410 can include one or more lumens 470 (e.g., channels, passages, 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 the lumen 470 and translated within the lumen 470. It can be appreciated that positioning an 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).

[0072] Fig.11 Another example medical device 510 is shown. The medical device 510 can include an expandable balloon member 568. The expandable balloon member 568 can be advanced through the delivery catheter 528 and expanded within a body cavity (e.g., within the bladder 50). Therefore, it can be appreciated that once expanded, the balloon 568 can contact the inner surface 52 of the bladder 50.

[0073] Additionally, Fig.11 It is shown 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 spirally around the balloon member 568 from a distal region of the balloon 568 to a 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 the lumen 570 and translated within the lumen 570. It can be appreciated that positioning an 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).

[0074] Some example materials that can be used for various components of medical device 10 (or other components of medical device 10) and other medical devices disclosed herein are described herein. However, this is not intended to limit the devices and methods described herein. On the contrary, it is contemplated that a variety of materials can be used for various components of medical device 10 and other medical devices described herein.

[0075] The medical device 10 (or other components of the medical device 10) and other medical devices disclosed herein can be made of metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, or the like, 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 Corporation), polyoxymethylene (POM ... ), polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., available from DSM Engineering Plastics ), ether or ester based copolymers (e.g., butylene / poly(alkylene ether) phthalate and / or other polyester elastomers such as those available from DuPont ), polyamide (e.g., available from Bayer or available from Elf Atochem ), elastic polyamides, block polyamide / ether, polyether block amide (PEBA, for example, available under the trade name obtained), 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), polyetheretherketone (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 The company obtained ), perfluoro(propyl vinyl ether) (PFA), ethylene-vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomers, biocompatible polymers, other suitable materials or mixtures, combinations, copolymers, polymer / metal composites, etc. In some embodiments, the cannula can be mixed with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP.

[0076] Some examples of suitable metals and metal alloys include stainless steels, such as 304V, 304L, and 316LV stainless steel; low carbon steel; 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 other 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 steel; titanium; combinations thereof, etc.; or any other suitable material.

[0077] In at least some embodiments, part or all of the medical device 10 (or other components of the medical device 10) and other medical devices disclosed herein may also be doped with, made of, or otherwise include radiopaque materials. Radiopaque materials are understood to be materials that can produce relatively bright images on a fluoroscopic screen or another imaging technique during a medical procedure. This relatively bright image helps users of the medical device 10 (or other components of the medical device 10) and other medical devices disclosed herein to determine their positions. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymer materials loaded with radiopaque fillers, and the like. 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 results.

[0078] In some embodiments, a degree of Magnetic Resonance Imaging (MRI) compatibility is imparted to the medical device 10 (or other components of the medical device 10) and other medical devices disclosed herein. For example, the medical device 10 (or other components of the medical device 10) and other medical devices disclosed herein or portions thereof can be made of materials that do not substantially distort the image 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. The medical device 10 (or other components of the medical device 10) and other medical devices disclosed herein or portions thereof can 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 alloys (e.g., UNS: R30003, such as etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as etc.), Nitinol etc. and others.

[0079] It should be understood that the present disclosure is in many respects merely illustrative. Changes may be made in detail, particularly in shape, size, and arrangement of steps, without exceeding the scope of the present disclosure. To the extent appropriate, this may include using any of the features of an example 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 proximal region and a distal region, the distal region of the sensing member being coupled to the distal region of the support shaft; one or more ultrasonic sensors disposed along the sensing member; as well as a support member having a first end coupled to the sensing member and a second end coupled to the support shaft; wherein the sensing member is configured to transform from a first configuration wherein the sensing member is adjacent the support shaft to a second configuration wherein at least a portion of the sensing member extends away from the support shaft; Wherein the second end of the support member is coupled to the support shaft via an attachment collar, and wherein the attachment collar is designed to slide along the support shaft. 2 . The medical device of claim 1 , wherein the sensing member forms an arcuate shape in the second configuration.

3. The medical device of any one of claims 1 to 2, wherein rotation of the support shaft rotates the sensing member about a longitudinal axis of the support shaft.

4. The medical device of any one of claims 1 to 2, wherein each of the one or more ultrasound sensors are spaced apart from one another along the sensing member.

5. The medical device according to any one of claims 1 to 2, wherein a distal end of the sensing member is fixedly attached to a distal end region of the support shaft.

6. The medical device of any one of claims 1 to 2, wherein the second end of the support member is translatable relative to the support shaft.

7. The medical device of any one of claims 1 to 2, wherein a proximal region of the sensing member is coupled to a hub, and wherein manipulation of the hub transforms the sensing member from the first configuration to the second configuration.

8. The medical device of claim 7, wherein rotation of a portion of the hub rotates the sensing member about a longitudinal axis of the support shaft.

9. A medical device for imaging a bladder, comprising: a hub member coupled to an ultrasonic sensing assembly, the ultrasonic sensing assembly comprising: a support shaft having a proximal region and a distal region; 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; 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 sensing member is configured to transform from a first configuration in which the sensing member is adjacent the support shaft to a second configuration in which at least a portion of the sensing member is moved away from the support shaft; Wherein the second end of the support member is coupled to the support shaft via an attachment collar, and wherein the attachment collar is designed to slide along the support shaft.

10. The medical device of claim 9, wherein rotation of a portion of the hub member is configured to rotate the ultrasound sensing assembly about a longitudinal axis of the support shaft.

11. The medical device of any one of claims 9 to 10, wherein rotation of a portion of the hub member is designed to scan the sensing member along an inner surface of the bladder when the sensing member is in the second configuration.

12. The medical device of any one of claims 9 to 10, wherein the sensing member forms an arcuate shape in the second configuration.

13. The medical device of any one of claims 9 to 10, wherein each of the one or more ultrasound sensors are spaced apart from one another along the sensing member.

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