Intravascular imaging device

Abstract

Intravascular imaging devices and methods of making and using intravascular imaging devices are disclosed. An example intravascular imaging device may include a catheter shaft assembly including a telescoping assembly and a catheter body. The catheter body may include an imaging window and a distal region having a first guidewire lumen formed therein. An imaging core may be disposed within the catheter shaft assembly. The distal shaft member may be disposed along an outer surface of the catheter body. The distal shaft member may have a second guidewire lumen formed therein. The intravascular imaging device may also include a rod having a first end region coupled to the distal shaft member and a second end region coupled to the telescoping assembly.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 339,159, filed on May 6, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present invention relates to medical devices and methods for making medical devices. More particularly, the present invention relates to elongated intravascular imaging devices. Background Art

[0004] A wide variety of in vivo medical devices have been developed for medical use, such as intravascular use. Some of these devices include guidewires, catheters, 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. Each of the known medical devices and methods has certain advantages and disadvantages. There remains a need to provide alternative medical devices and alternative methods for making and using medical devices. Summary of the invention

[0005] The present invention provides designs, materials, manufacturing methods and use alternatives for medical devices. An intravascular imaging device is disclosed. The intravascular imaging device includes: a catheter shaft assembly, the catheter shaft assembly includes a telescopic assembly and a catheter body; wherein the catheter body includes an imaging window and a distal region, the distal region has a first guidewire cavity formed therein; an imaging core disposed within the catheter shaft assembly; a distal shaft member disposed along an outer surface of the catheter body, the distal shaft member having a second guidewire cavity formed therein; and a rod having a first end region coupled to the distal shaft member and a second end region coupled to the telescopic assembly.

[0006] Alternatively or additionally to any of the above embodiments, the imaging core can translate within the catheter shaft assembly.

[0007] Alternatively or additionally to any of the above embodiments, the imaging core includes an ultrasound transducer.

[0008] Alternatively or additionally to any of the above embodiments, the imaging core includes an optical coherence tomography imaging device.

[0009] Alternatively or additionally to any of the above embodiments, the telescoping assembly includes a first shaft coupled to the proximal region of the catheter body and a second shaft coupled to the imaging core and movable relative to the first shaft.

[0010] Alternatively or additionally to any of the above embodiments, the second end region of the rod is coupled to the second shaft.

[0011] Alternatively or additionally to any of the above embodiments, the telescoping assembly includes an inner shaft coupled to the first shaft.

[0012] Alternatively or additionally to any of the above embodiments, the inner shaft defines a first lumen configured to receive the imaging core therein.

[0013] Alternatively or additionally to any of the above embodiments, the inner shaft defines a second lumen configured to receive the rod therein.

[0014] Alternatively or additionally to any of the above embodiments, the rod comprises a ribbon wire.

[0015] An intravascular imaging device is disclosed. The intravascular imaging device comprises: a catheter shaft, the catheter shaft comprising an imaging window and a distal end region; a telescopic shaft assembly coupled to the catheter shaft, the telescopic shaft assembly comprising an inner shaft, an intermediate shaft and an outer shaft; wherein the inner shaft is coupled to the outer shaft; an imaging core disposed in the catheter shaft, the imaging core comprising a drive shaft and an ultrasonic transducer coupled to the drive shaft; wherein the imaging core is coupled to the intermediate shaft; a distal shaft member disposed along an outer surface of the catheter shaft; wherein the distal shaft member has a first lumen configured to receive the imaging core, and a second lumen; and a rod having a first end region coupled to the distal shaft member and a second lumen extending through the distal shaft member and coupled to the second end region of the intermediate shaft.

[0016] Alternatively or additionally to any of the above embodiments, the distal end region includes a first guidewire lumen, and the distal shaft member includes a second guidewire lumen axially aligned with the first guidewire lumen.

[0017] Alternatively or additionally to any of the above embodiments, the distal shaft member is configured to translate along the catheter shaft.

[0018] Alternatively or additionally to any of the above embodiments, the second lumen extends to a location proximal to the distal end of the distal shaft member.

[0019] Alternatively or additionally to any of the above embodiments, the rod comprises a ribbon wire.

[0020] Alternatively or additionally to any of the above embodiments, the hub is coupled to the imaging core.

[0021] Alternatively or additionally to any of the above embodiments, an intermediate shaft is coupled to the hub.

[0022] Alternatively or additionally to any of the above embodiments, the rod is coupled to the hub.

[0023] A method for imaging a blood vessel is disclosed. The method includes: placing an intravascular imaging device in a blood vessel, the intravascular imaging device including: a catheter shaft, the catheter shaft including an imaging window and a distal end region; a telescopic shaft assembly coupled to the catheter shaft, the telescopic shaft assembly including an inner shaft, an intermediate shaft and an outer shaft; wherein the inner shaft is coupled to the outer shaft; an imaging core disposed in the catheter shaft, the imaging core including a drive shaft and an ultrasonic transducer coupled to the drive shaft; wherein the imaging core is coupled to the intermediate shaft; a distal shaft member disposed along an outer surface of the catheter shaft; wherein the distal shaft member has a first lumen configured to receive the imaging core, and a second lumen; and a rod having a first end region coupled to the distal shaft member and a second lumen extending through the distal shaft member and coupled to a second end region of the intermediate shaft; and translating the imaging core relative to the catheter shaft.

[0024] Alternatively or additionally to any of the above embodiments, translating the imaging core relative to the catheter axis includes translating the distal shaft member relative to the catheter axis.

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

[0026] The present invention may be more fully understood from the following detailed description considered in conjunction with the accompanying drawings, in which:

[0027] Figure 1 is a side view of an example medical device.

[0028] Figure 2 is a side view of another illustrative medical device.

[0029] Figure 3 yes Figure 2 A stereoscopic view of a traditional Chinese medical device in a retracted configuration.

[0030] Figure 4 yes Figure 2 A three-dimensional view of a traditional Chinese medical device in an extended form.

[0031] Figure 5 is through Figure 5 A cross-sectional view taken along line 5-5 in FIG.

[0032] Figure 6 is through Figure 5 A cross-sectional view taken along line 6-6 in FIG.

[0033] Figure 7 is through Figure 5 A cross-sectional view taken along line 7-7 in FIG.

[0034] Figure 8 is through Figure 5 A cross-sectional view taken along line 8-8 in FIG.

[0035] Fig. 9 is through Figure 5 A cross-sectional view taken along line 9-9 in FIG.

[0036] Fig.10 is through Figure 5 A cross-sectional view taken along line 10-10 in FIG.

[0037] Fig.11 is through Figure 5 A cross-sectional view taken along line 11-11 in FIG.

[0038] Fig.12 is through Figure 5 A cross-sectional view taken along line 12-12 in FIG.

[0039] Fig.13 is a side view of a portion of an example intravascular imaging device.

[0040] Fig.14 is a side view of a portion of an example intravascular imaging device.

[0041] Although the present invention is suitable for various modifications and alternative forms, its specific details have been shown in the drawings by way of example and will be described in more detail. However, it should be understood that it is not intended to limit the present invention to the specific embodiments described. On the contrary, it is intended to cover all modifications, equivalents and substitutes that fall within the spirit and scope of the present invention. DETAILED DESCRIPTION

[0042] For the following defined terms, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0043] All numerical values ​​are assumed to be modified by the term "about" herein, whether or not explicitly indicated. The term "about" generally refers to a range of numbers that one skilled in the art considers to be equivalent to the cited value (i.e., having the same function or result). In many cases, the term "about" may include numbers rounded to the nearest significant figure.

[0044] 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).

[0045] 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.

[0046] It should be noted that references to "one embodiment", "some embodiments", "other embodiments", etc. in the specification indicate that the described embodiments may include one or more specific features, structures and / or characteristics. However, such a description does not necessarily mean that all embodiments include the specific features, structures and / or characteristics. Additionally, when specific features, structures and / or characteristics are described in conjunction with one embodiment, it should be understood that such 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.

[0047] The following detailed description should be read with reference to the drawings, in which similar elements in different drawings have the same reference numerals. The drawings, which are not necessarily drawn to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

[0048] Figure 1 1 is a side view of an example medical device 10. In at least some cases, the medical device 10 takes the form of an imaging medical device. For example, the medical device 10 may be an intravascular ultrasound (IVUS) device that can be used to image a blood vessel. The structure / form of the medical device 10 may vary. In some cases, the medical device 10 may include an elongated shaft 12 having a proximal region 14 and a distal region 16. A proximal hub or connector 18 may be coupled to the proximal region 14 or otherwise disposed near it. An end member 20 may be coupled to the distal region 16 or otherwise disposed adjacent to it. The end member 20 may include a guidewire lumen 30 having a guidewire exit port 32, an anti-traumatic distal end 34, one or more radiopaque markers 36, and / or other features. In some embodiments, the end member 20 may extend at an angle that is not parallel to the proximal region 14 of the elongated shaft 12. An imaging assembly 22 may be disposed within the lumen of the shaft 12. Typically, an imaging assembly may be used to capture / generate images of a blood vessel. In some cases, the medical device can include devices and / or features similar to those disclosed in U.S. Patent Application Publication No. US 2012 / 0059241 and U.S. Patent Application Publication No. US2017 / 0164925, the entire disclosures of which are incorporated herein by reference. In at least some cases, the medical device 10 can be similar to and / or include an OPTICROSS available from Boston Scientific Corporation of Marlborough, Massachusetts. TM Characteristics of imaging catheters.

[0049] Imaging assembly 22 may include a drive cable or shaft 24, a housing 26, and an imaging member or transducer 28 coupled to drive cable 24 and / or housing 26. In at least some cases, transducer 28 includes an ultrasonic transducer. Other transducers are also contemplated. Transducer 28 may rotate and / or translate axially relative to shaft 12. For example, drive cable 24 may rotate and / or translate to rotate and / or translate transducer 28 (and housing 26).

[0050] Although Figure 1 Although not explicitly shown in the drawings, the medical device 10 may include a telescoping section configured to allow a medical device operator to move the drive shaft 24 including the imaging assembly 22 proximally and distally within the catheter without having to move the entire catheter within the patient. This allows the catheter operator to easily change the position of the imaging assembly or other medical device within the patient. For example, the telescoping section may be actuated to change the position of the imaging assembly 22 within the elongated shaft 12.

[0051] In addition, when using the medical device 10, it may be necessary to prepare and / or flush the shaft 12. In order to flush the medical device 10, a fluid may be injected into a flushing port on or at the hub 18. The fluid may exit the medical device at a vent (not shown) adjacent to the distal end of the housing 26. In some cases, the flushing process may cause bubbles to form within the shaft 12. It may be necessary to flush the medical device 10 in a manner that reduces bubble formation and / or removes / destroys any bubbles that form, because bubbles may reflect / disrupt signals (e.g., ultrasound signals) from the transducer 28, which may disrupt the image. Although flushing is generally effective in removing bubbles, some bubbles may still be trapped within the shaft 12. Disclosed herein is a medical device designed to help reduce bubble formation within a medical device.

[0052] Figure 2 A side view of another illustrative medical device, such as, but not limited to, a telescoping catheter 100 is shown. The catheter 100 extends from a proximal region 102 to a distal region 104. A proximal hub 106 may be attached adjacent to the proximal region 102. The proximal hub 106 may include a check valve and a flush port 108. In order to flush the catheter 100, a fluid may be injected at the flush port 108. The catheter 100 may also include a telescoping section 110 extending from a proximal region 113 to a distal region 115 and positioned between the proximal region 102 and the distal region 104 of the catheter 100. An elongated shaft 112 extends distally from the distal region 115 of the telescoping section 110. The elongated shaft 112 may include an end member 114 adjacent to the distal region 104 of the catheter 100. The end member 114 may be similar in form and function to that described with respect to Figure 1 The tip member 20. For example, the tip member 114 may include a guidewire lumen having a guidewire exit port, an atraumatic distal end, one or more radiopaque markers, and / or other features.

[0053] Imaging assembly 116 (see e.g. Figure 3 ) is movably positioned within the lumen of the elongated shaft 112. The imaging assembly 116 may include a drive cable or shaft 120, a housing 122, and an imaging member or transducer 118 coupled to the drive cable 120 and / or the housing 122. It is contemplated that the imaging assembly 116 may include or be replaced with another medical device, such as, but not limited to, a cutting head or other device. The specific device selected for the drive cable 120 may be selected based on the desired function of the catheter 100. The drive cable 120 may extend proximally from the imaging member 118, through the telescoping section 110 to the proximal hub 106. The proximal hub 106 may include components suitable for docking the drive cable 120 with a power source and / or other electronic connections. In some cases, the proximal end of the drive cable 120 may be attached to the proximal hub 106. Although not explicitly shown, the drive cable 120 may include a single outer jacket or coating or two outer jackets or coatings as desired. If so configured, the outer jacket may extend the entire length of the drive cable 120 or less than the entire length of the drive cable 120 .

[0054] The telescoping section 110 may include a first or intermediate sheath 124, a second or outer sheath 126, and a third or inner sheath 128. Typically, the outer sheath 126 may be disposed on the intermediate sheath 124, which is disposed on the inner sheath 128. The intermediate sheath 124 may be axially and / or rotationally displaced relative to the outer sheath 126 and the inner sheath 128 such that movement of the proximal hub 106 translates into movement of the intermediate sheath 124 and the drive cable 120. A distal hub 138 may be positioned adjacent the distal end region 115 of the telescoping section 110. The distal hub 138 may include a distal strain relief 139 configured to be coupled to the elongated shaft 112. Additionally, the distal ends of the outer sheath 126 and the inner sheath 128 may each be securely secured to the distal hub 138.

[0055] The intermediate sheath 124 extends distally from a proximal region 130 coupled to a proximal strain reliever 132 to a distal end 134 extending within the outer sheath 126. The intermediate sheath 124 can have a constant diameter from the proximal region 130 to the distal end 134, however this is not required. The proximal strain reliever 132 is coupled to the proximal hub 106. The intermediate sheath 124 can move relative to the inner sheath 128 and the outer sheath 126 such that the distal end 134 of the intermediate sheath 124 can move between the distal hub 138 and the housing 142. The intermediate sheath 124 defines a cavity extending from its proximal region 130 to the distal end 134. The cavity can receive and / or accommodate a portion of the drive shaft 120 and / or the inner sheath 128.

[0056] The outer sheath 126 extends distally from the housing or container 142 to a distal end (e.g., it can be attached to the distal hub 138). The outer sheath 126 defines a cavity that extends from a proximal region to a distal end. The cavity can receive or accommodate a portion of the inner sheath 128 and / or the intermediate sheath 124.

[0057] The inner sheath 128 extends distally from the proximal region to a distal end attached to the distal hub. The inner sheath 128 defines a cavity extending from the proximal region to the distal end. The cavity can receive or accommodate a portion of the drive shaft 120. For example, the inner sheath 128 can be configured to be displaced when the intermediate sheath 124 is in a proximally displaced configuration (see, e.g., Figure 4 ) while supporting the drive shaft 120. In some embodiments, the proximal region of the inner sheath 128 can be positioned adjacent to the proximal region of the outer sheath 126. In other embodiments, the proximal region of the inner sheath 128 can be distal to the proximal region of the outer sheath 126.

[0058] Figure 3 Show Figure 2 1 is a perspective view of a telescoping catheter with the proximal hub 106 and intermediate sheath 124 (and therefore drive shaft 120) in the most distal position. Since the catheter 100 has the shortest length, this configuration can be considered fully retracted. Figure 3 In the figure, the elongated shaft 112 is not shown to more clearly illustrate the structure of the imaging assembly 116. Figure 3 1, the intermediate sheath 124 has been advanced distally within the lumen of the outer sheath 126. Distal movement of the intermediate sheath 124 may be limited by a mechanical stop created between the proximal strain relief 132 and the housing 142. When the proximal hub 106 and the intermediate sheath 124 are in the distal-most position, a majority of the length of the lumen 136 of the intermediate sheath 124 may surround the inner sheath 128.

[0059] Figure 4 Show Figure 2 1 is a perspective view of the proximal portion of the telescoping catheter, wherein the proximal hub 106 and the intermediate sheath 124 (and therefore the drive shaft 120) are proximal to the most proximal position. Since the catheter 100 has a maximum length, this configuration can be considered to be fully extended. Figure 4 14, the intermediate sheath 124 has been displaced proximally within the lumen of the outer sheath 126. Proximal movement of the intermediate sheath 124 may be limited by a mechanical stop created between a distal region of the intermediate sheath 124 and mating features on the housing 142. When the proximal hub 106 and the intermediate sheath 124 are in the proximal-most position, a majority of the length of the lumen 136 of the intermediate sheath 124 may surround the drive cable 120.

[0060] Although Figure 3 and Figure 4Approximate extremes of telescoping section 110 movement are shown, but the proximal hub 106 and intermediate sheath 124 may be positioned anywhere therebetween. When the drive cable 120 is coupled to the proximal hub 106, proximal and distal movement is translated to the drive cable 120 and imaging assembly 116 to allow the imaging assembly to move without moving the entire catheter 100. It is also contemplated that rotational movement of the proximal hub 106 will also be translated to the drive shaft 120 and imaging assembly 116 to allow the imaging assembly 116 to rotate within the elongated shaft 112.

[0061] During coronary interventions, imaging devices may be navigated through tortuous anatomical structures. In doing so, the imaging device may kink or otherwise deform in a manner that may impair the function of the device. Intravascular imaging devices are disclosed herein, including structural features of the device and may help reduce kinking and provide additional desired benefits.

[0062] Figure 5 2 is a side view of a portion of an example intravascular imaging device 210, which may be similar in form and function to other intravascular imaging devices disclosed herein. The intravascular imaging device 210 may include a catheter assembly 250. The catheter assembly 250 may include a shaft or catheter body 252, an imaging window 254, a distal region 256, and a telescoping assembly 258. An imaging core 260 may extend through the catheter body 252. The imaging core 260 may include an ultrasound transducer, an optical coherence tomography imaging device, a combination thereof, or the like. The imaging core 260 may image a blood vessel in a manner similar to that disclosed herein. The distal region 256 may define a guidewire lumen 262, which is configured to have a guidewire 264 extending therethrough.

[0063] A variety of arrangements and / or configurations for the catheter assembly 250 can be envisioned. For example, in some cases, the telescoping assembly 258 is disposed at or near the proximal end of the catheter assembly 250. The catheter body 252 can be a region of the catheter assembly 250 that is generally disposed distal to the telescoping assembly 258. In some cases, the imaging window 254 and / or the distal region 256 can be considered part of the catheter body 252. In other cases, the imaging window 254 and / or the distal region 256 can be a separate portion / region of the catheter assembly 250 that is disposed distal to the catheter body 252 and attached to the catheter body 252.

[0064] The telescoping assembly 258 may include an inner shaft 266, an intermediate shaft 268, and an outer shaft 270. In some cases, the inner shaft 266 may be axially fixed relative to the outer shaft 270. In other words, the inner shaft 266 may be configured such that the inner shaft 266 does not move relative to the outer shaft 270. The intermediate shaft 268 may slide (e.g., translate) relative to the inner shaft 266 and the outer shaft 270. In at least some cases, the intermediate shaft 268 may be axially fixed relative to the imaging core 260. In other words, the intermediate shaft 268 may be configured such that movement of the intermediate shaft 268 causes a corresponding movement of the imaging core 260. Because the intermediate shaft 268 may slide relative to the inner shaft 266 and the outer shaft 270, and because the intermediate shaft 268 may be axially fixed relative to the imaging core 260, movement of the intermediate shaft 268 causes the intermediate shaft 268 and the imaging core 260 to shift (e.g., translate) relative to the inner shaft 266 and the outer shaft 270.

[0065] The distal shaft member 272 can be disposed along the catheter assembly 250. The distal shaft member 272 can take the form of a sleeve or sheath disposed around the catheter body 252. In some cases, the distal shaft member 272 can be disposed adjacent the distal end region 256 of the catheter assembly 250. A rod 278 can be coupled to the distal shaft member 272. The rod 278 can be configured to couple the distal shaft member 272 to the intermediate shaft 268 and / or the imaging core 260, as will be explained in greater detail herein.

[0066] The distal shaft member 272 and the rod 278 can provide a number of desirable features for the intravascular imaging device 210. For example, the distal shaft member 272 can provide additional volume and / or structural support, which can help a clinician more effectively advance the intravascular imaging device 210 toward a target and / or help reduce kinking. In some cases, the distal shaft member 272 can include a guidewire lumen (e.g., such as Figure 7 The guidewire lumen 276 shown in the figure can help provide additional structural support for the intravascular imaging device 210 when tracking over the guidewire. In at least some cases, the rod 278 can have sufficient rigidity to strengthen or otherwise help provide structural support. The rod 278 can be in the form of a wire (e.g., circular in cross section, non-circular in cross section, polygonal in cross section, ribbon-shaped, etc.) that helps maintain support for the distal shaft member 272. The rod 278 can extend to the proximal end of the catheter assembly 250.

[0067] It should be understood that when the distal shaft member 272 is disposed adjacent to the distal region 256 of the catheter assembly 250, the distal shaft member 272 may block or obstruct the imaging core 260, for example, when the imaging core 260 is translated (e.g., during a retraction procedure). Therefore, the distal shaft member 272 may need to move (e.g., translate) with the imaging core 260. For example, in some cases, the imaging core 260 may extend to a position distal to the distal shaft member 272. During a translation procedure (e.g., a retraction procedure), the distal shaft member 272 may be configured to move with the imaging core 260 and maintain its arrangement so that the distal end of the imaging core 260 maintains its position distal to the distal shaft member 272. Therefore, if the imaging core 260 is retracted proximally, the distal shaft member 272 is retracted with the imaging core 260. This helps prevent the distal shaft member 272 from blocking or obstructing the imaging core 260.

[0068] The hub 280 may be disposed at the proximal end of the catheter assembly 250. The intermediate shaft 268 may be coupled to the hub 280. In some of these cases and in other cases, the rod 278 may be coupled to the hub 280. In some of these cases and in other cases, the imaging core 260 may be coupled to the hub 280. The hub 280 may be used to transfer (e.g., translate) the intermediate shaft 268, the distal shaft member 272, the rod 278, and the imaging core 260 relative to the inner shaft 266 and the outer shaft 270. The hub 280 may include an imaging core rotation device 284. The imaging core rotation device 284 may be used to rotate the imaging core 260 during an imaging procedure. In some cases, the hub 280 may include a translation device or a "pullback" device configured to translate the imaging core 260 (and the intermediate shaft 268 and the rod 278) relative to the inner shaft 266 and the outer shaft 270.

[0069] exist Figures 6 to 12 Some of the various structures and / or structural arrangements of the catheter assembly 250 can be more clearly seen in FIG. Figure 6 The distal portion of the catheter assembly 250 is shown. Here, it can be seen that the imaging core 260 can be disposed within the imaging window 254. The imaging window 254 can be formed of a material that is substantially transparent to the energy used for imaging. For example, when an ultrasonic transducer is used for imaging, the imaging window 254 can be transparent to acoustic or ultrasonic energy. A guidewire 264 can be seen along the exterior of the imaging window 254.

[0070] Figure 7 Shown in Figure 6 2. Here, it can be seen that the distal shaft member 272 can be disposed over the imaging window 254. In some cases, the distal shaft member 272 has a guidewire portion 274 defining a guidewire lumen 276. This can allow the distal shaft member 272 to be tracked along the guidewire 264 during an imaging procedure.

[0071] Now turn to Figure 8 , it can be seen here that the imaging core 260 can be disposed within the inner shaft. In addition, the inner shaft 266 can be cut / slit, thinned or otherwise manufactured to have a flat region 282, wherein the rod 278 extends along the exterior of the inner shaft 266, such as Figure 8 As shown. Flat region 282 may also be described as a portion of inner shaft 266 removed from inner shaft 266 (e.g., a portion having a secondary lumen). Inner shaft 266 may then transition to a multi-lumen region or segment along its length. For example, a more proximal region of inner shaft 266 may include a secondary lumen region 286 defining a secondary lumen 288. Rod 278 may extend within secondary lumen 288, as shown. Fig. 9 shown.

[0072] Moving proximally along the catheter assembly 250, the inner shaft 266 can extend within the outer shaft 270, such as Fig.10 Further proximally, an intermediate shaft 268 may be disposed between the inner shaft 266 and the outer shaft 270, as shown. Fig.11 Finally, at a location near the proximal end of the catheter assembly 250, an intermediate shaft 268 may be disposed around the imaging core 260, as shown. Fig.12 At the proximal end of the catheter assembly 250 , the imaging core 260 , the intermediate shaft 268 , and the rod 278 can be coupled to one another, for example, each coupled to a hub 280 .

[0073] Figure 13 to Figure 14 A portion of an imaging procedure is schematically illustrated. During such a procedure, the imaging core 260 may be translated along the catheter assembly 250 (e.g., during a retraction procedure). In doing so, the hub 280 may be translated (e.g., while holding the inner shaft 266 and the outer shaft 270 stable), which causes the imaging core 260 to move within the catheter assembly 250. Because it may be desirable to avoid the distal shaft member 272 blocking or otherwise obstructing the imaging core 260, the distal shaft member 272 may be translated along the catheter assembly 250 along with the imaging core 260 (and along with the intermediate shaft 268), as shown in FIG. Fig.14 shown.

[0074] It should be understood that the present invention is merely illustrative in many respects. Changes may be made in details, particularly in shape, size, and arrangement of steps, without exceeding the scope of the present invention. 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 invention is defined by the language of the appended claims.

Claims

1. An intravascular imaging device, comprising: a catheter shaft assembly, the catheter shaft assembly comprising a telescoping assembly and a catheter body; wherein the catheter body comprises an imaging window and a distal region, the distal region having a first guidewire lumen formed therein; an imaging core disposed within the catheter shaft assembly; a distal shaft member disposed along an outer surface of the catheter body, the distal shaft member having a second guidewire lumen formed therein; as well as A rod has a first end region coupled to the distal shaft member and a second end region coupled to the telescoping assembly.

2. The intravascular imaging device of claim 1, wherein the imaging core is translatable within the catheter shaft assembly.

3. An intravascular imaging device according to claim 1 or 2, wherein the imaging core comprises an ultrasound transducer.

4. The intravascular imaging device according to any one of claims 1 to 3, wherein the imaging core comprises an optical coherence tomography imaging device.

5. The intravascular imaging device according to any one of claims 1 to 4, wherein the telescopic assembly includes a first shaft coupled to the proximal region of the catheter body and a second shaft coupled to the imaging core and movable relative to the first shaft.

6. The intravascular imaging apparatus of claim 5, wherein the second end region of the rod is coupled to the second shaft.

7. The intravascular imaging apparatus of claim 5 or 6, wherein the telescoping assembly comprises an inner shaft coupled to the first shaft.

8. The intravascular imaging device of claim 7, wherein the inner shaft defines a first lumen configured to receive the imaging core therein.

9. The intravascular imaging apparatus of claim 8, wherein the inner shaft defines a second lumen configured to receive the rod therein.

10. The intravascular imaging apparatus according to any one of claims 1 to 9, wherein the rod comprises a ribbon-shaped wire.

11. An intravascular imaging device, comprising: a catheter shaft comprising an imaging window and a distal region; a telescoping shaft assembly coupled to the catheter shaft, the telescoping shaft assembly comprising an inner shaft, an intermediate shaft, and an outer shaft; wherein the inner shaft is coupled to the outer shaft; an imaging core disposed within the catheter shaft, the imaging core comprising a drive shaft and an ultrasound transducer coupled to the drive shaft; wherein the imaging core is coupled to the intermediate shaft; a distal shaft member disposed along an outer surface of the catheter shaft; wherein the distal shaft member has a first lumen configured to receive the imaging core, and a second lumen; as well as A rod has a first end region coupled to the distal shaft member and a second end region extending through the second lumen of the distal shaft member and coupled to the intermediate shaft.

12. The intravascular imaging apparatus of claim 11, wherein the distal region comprises a first guidewire lumen, and the distal shaft member comprises a second guidewire lumen axially aligned with the first guidewire lumen.

13. The intravascular imaging device of claim 11 or 12, wherein the distal shaft member is configured to translate along the catheter axis.

14. The intravascular imaging device according to any one of claims 11 to 13, wherein the second lumen extends to a position proximal to the distal end of the distal shaft member.

15. The intravascular imaging apparatus according to any one of claims 11 to 14, wherein the rod comprises a ribbon-shaped wire.

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