Intravascular imaging devices

The telescoping and nesting assembly design in intravascular imaging devices addresses navigation and signal interference issues, enhancing imaging clarity and efficiency in complex vasculature.

JP7842252B2Active Publication Date: 2026-04-07BOSTON SCIENTIFIC SCIMED INC
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Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Filing Date
2023-05-05
Publication Date
2026-04-07

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Abstract

An intravascular imaging apparatus and methods of making and using the intravascular imaging device are disclosed. An exemplary intravascular imaging device can include a catheter shaft assembly including a telescoping assembly and a catheter body. The catheter body can include an imaging window and a distal end region having a first guidewire lumen formed therein. An imaging core can be disposed within the catheter shaft assembly. A distal shaft member can be disposed along an outer surface of the catheter body. The distal shaft member can have a second guidewire lumen formed therein. The intravascular imaging device can 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.
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Description

Technical Field

[0001] The present disclosure relates to medical devices and methods for manufacturing medical devices. More particularly, the present disclosure relates to an elongated intravascular imaging device.

Background Art

[0002] A wide variety of medical devices have been developed for medical applications, such as intravascular applications. Some of these devices include guidewires, catheters, and the like. 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. Each of the known medical devices and methods has certain advantages and disadvantages. There is always a need to provide alternative medical devices and alternative methods for manufacturing and using medical devices.

Summary of the Invention

Means for Solving the Problems

[0003] The present disclosure 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 including a telescoping assembly and a catheter body, the catheter body including an imaging window and a distal end region having a first guidewire lumen formed therein; an imaging core disposed within the catheter shaft assembly; and a distal shaft member disposed along an outer surface of the catheter body and having a second guidewire lumen formed therein, the distal shaft member having a rod having a first end region coupled to the distal shaft member and a second end region coupled to the telescoping assembly.

[0004] Instead of or in addition to any of the above-described embodiments, the imaging core is translatable within the catheter shaft assembly. In addition to or instead of any of the embodiments described above, the imaging core includes an ultrasonic transducer.

[0005] In addition to or instead of any of the embodiments described above, the imaging core includes an optical coherence tomography imaging device. In place of or in addition to any of the embodiments described above, the nesting assembly includes a first shaft connected to the proximal end region of the catheter body and a second shaft connected to the imaging core and movable relative to the first shaft.

[0006] In addition to or instead of any of the embodiments described above, the second end region of the rod is connected to the second shaft. In place of or in addition to any of the embodiments described above, the nesting assembly includes an inner shaft coupled to the first shaft.

[0007] In addition to or instead of any of the embodiments described above, the inner shaft defines a first lumen, which is configured to receive an imaging core therein. In addition to or instead of any of the embodiments described above, the inner shaft defines a second lumen configured to receive a rod therein.

[0008] In addition to or instead of any of the embodiments described above, the rod includes a ribbon-shaped wire. An intravascular imaging device is disclosed. The intravascular imaging device comprises: a catheter shaft including an imaging window and a distal end region; a nesting shaft assembly coupled to the catheter shaft, comprising an inner shaft, an intermediate shaft, and an outer shaft, the inner shaft being coupled to the outer shaft; an imaging core disposed within the catheter shaft, comprising a drive shaft and an ultrasonic transducer coupled to the drive shaft, the imaging core being coupled to the intermediate shaft; a distal shaft member disposed along the outer surface of the catheter shaft, having a first lumen and a second lumen configured to receive the imaging core; and a rod having 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.

[0009] In addition to or instead of any of the embodiments described above, 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.

[0010] In addition to or instead of any of the embodiments described above, the distal shaft member is configured to translate along the catheter shaft. In addition to or instead of any of the embodiments described above, the second lumen extends to a position proximal to the distal end of the distal shaft member.

[0011] In addition to or instead of any of the embodiments described above, the rod includes a ribbon-shaped wire. In addition to or instead of any of the embodiments described above, the hub is coupled to the imaging core.

[0012] In addition to or instead of any of the embodiments described above, the intermediate shaft is connected to the hub. In addition to or instead of any of the embodiments described above, the rod is connected to the hub.

[0013] A method for imaging a blood vessel is disclosed. The method includes the steps of positioning an intravascular imaging device within a blood vessel, the intravascular imaging device comprising: a catheter shaft including an imaging window and a distal end region; a nesting shaft assembly coupled to the catheter shaft, comprising an inner shaft, an intermediate shaft and an outer shaft, the inner shaft being coupled to the outer shaft; an imaging core positioned within the catheter shaft, comprising a drive shaft and an ultrasonic transducer coupled to the drive shaft, the imaging core being coupled to the intermediate shaft; a distal shaft member positioned along the outer surface of the catheter shaft and having a first lumen and a second lumen configured to receive the imaging core; a rod having 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; and translating the imaging core relative to the catheter shaft.

[0014] In addition to or instead of any of the embodiments described above, translating the imaging core relative to the catheter shaft includes translating the distal shaft member relative to the catheter shaft.

[0015] The above summary of some embodiments is not intended to describe each disclosed embodiment or all implementations of this disclosure. The following drawings and detailed description illustrate these embodiments more specifically. [Brief explanation of the drawing]

[0016] [Figure 1] This is a side view of an exemplary medical device. [Figure 2] This is a side view of another exemplary medical device. [Figure 3]A perspective view of the medical device of FIG. 2 in a retracted configuration. [Figure 4] A perspective view of the medical device of FIG. 2 in an extended configuration. [Figure 5] A cross-sectional view taken along line 5-5 of FIG. 5. [Figure 6] A cross-sectional view taken along line 6-6 of FIG. 5. [Figure 7] A cross-sectional view taken along line 7-7 of FIG. 5. [Figure 8] A cross-sectional view taken along line 8-8 of FIG. 5. [Figure 9] A cross-sectional view taken along line 9-9 of FIG. 5. [Figure 10] A cross-sectional view taken along line 10-10 of FIG. 5. [Figure 11] A cross-sectional view taken along line 11-11 of FIG. 5. [Figure 12] A cross-sectional view taken along line 12-12 of FIG. 5. [Figure 13] A side view of a part of an example of an intravascular imaging device. [Figure 14] A side view of a part of an example of an intravascular imaging device.

Mode for Carrying Out the Invention

[0017] The present disclosure can be more fully understood in consideration of the following detailed description in relation to the accompanying drawings. The present disclosure can accept various modified forms and alternative forms, the details of which are shown as examples in the drawings and described in detail. However, it should be understood that the present invention is not limited to the specific embodiments described. On the contrary, the present invention includes all modified forms, equivalents, and alternative forms that fall within the spirit and scope of the present disclosure.

[0018] For the terms defined below, these definitions shall apply unless different definitions are given in the claims or elsewhere in this specification. All numerical values ​​herein are assumed to be modified by the term “about,” whether expressly indicated or not. The term “about” generally refers to a range of numbers that a person skilled in the art would consider equivalent to (e.g., having the same function or result as) the cited value. Often, the term “about” may include numbers rounded to the nearest significant figure.

[0019] A numerical range referenced by an endpoint includes all numbers within that range (for example, 1-5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). As used herein and in the appended claims, the singular forms “a,” “an,” and “the” refer to multiple subjects unless the context clearly indicates otherwise. As used herein and in the appended claims, the term “or” is generally used to include “and / or” unless the context clearly indicates otherwise.

[0020] Please note that references in this specification to “one embodiment,” “several embodiments,” and “other embodiments” indicate that the embodiments described may include one or more specific features, structures, and / or characteristics. However, such descriptions do not necessarily mean that all embodiments include specific features, structures, and / or characteristics. In addition, when specific features, structures, and / or characteristics are described in relation to one embodiment, please understand that such features, structures, and / or characteristics may also be used in relation to other embodiments, whether explicitly described or not, unless explicitly stated otherwise.

[0021] The following detailed description should be read with reference to the drawings, where similar elements in different drawings are numbered the same. The drawings are not necessarily to a specific scale and illustrate exemplary embodiments; they are not intended to limit the scope of the invention.

[0022] Figure 1 is a side view of an exemplary medical device 10. In at least some examples, 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 blood vessels. The structure / morphology of the medical device 10 can vary. In some examples, the medical device 10 may include an elongated shaft 12 having a proximal end region 14 and a distal end region 16. A proximal hub or connector 18 may be coupled to the proximal end region 14, or otherwise positioned adjacent to the proximal end region 14. A tip member 20 may be connected to the distal end region 16, or otherwise positioned adjacent to the distal end region 16. The tip member 20 may include a guidewire lumen 30 having a guidewire exit port 32, an atraumatic distal end 34, one or more radiopaque markers 36, and / or other features. In some embodiments, the tip member 20 may extend at an angle that is non-parallel to the proximal end region 14 of the elongated shaft 12. The imaging assembly 22 may be located within the lumen of the shaft 12. Generally, the imaging assembly may be used to capture / generate images of blood vessels. In some examples, the medical device may include devices and / or features similar to those disclosed in U.S. Patent Application Publication 2012 / 0059241 and U.S. Patent Application Publication 2017 / 0164925, the entire disclosure of which is incorporated herein by reference. In at least some examples, the medical device 10 may be similar to and / or include similar features to the OPTICROSS® Imaging Catheter, marketed by Boston Scientific Corporation (Marlborough, Massachusetts).

[0023] The imaging assembly 22 may include a drive cable or shaft 24, a housing 26, and an imaging member or transducer 28 coupled to the drive cable 24 and / or housing 26. In at least some examples, the transducer 28 includes an ultrasonic transducer. Other transducers are also conceivable. The transducer 28 may be rotatable and / or axially translatable relative to the shaft 12. For example, the drive cable 24 may be rotated and / or translated in order to rotate and / or translate the transducer 28 (and housing 26).

[0024] Although not explicitly shown in Figure 1, the medical device 10 may include a telescoping section configured to allow the operator of the medical device to move the drive shaft 24, which includes the imaging assembly 22, proximal and distally within the catheter without having to move the entire catheter within the patient's body. This allows the catheter operator to easily change the position of the imaging assembly or other medical devices within the patient's body. For example, the telescoping section may be actuated to change the position of the imaging assembly 22 within the elongated shaft 12.

[0025] Furthermore, when using the medical device 10, it may be desirable to prepare and / or clean the shaft 12. To clean the medical device 10, a fluid can be injected onto the hub 18 or into a cleaning port located in the hub 18. The fluid can be drained out of the medical device through a vent (not shown) adjacent to the distal end of the housing 26. In some cases, bubbles may form within the shaft 12 as a result of the cleaning process. Since bubbles can reflect / interfere with signals from the transducer 28 (e.g., ultrasound signals) and interfere with images, it may be desirable to clean the medical device 10 to reduce bubble formation and / or remove / interfere with any bubbles that have formed. While flushing is generally effective in removing bubbles, some bubbles may still be trapped within the shaft 12. Disclosed herein are medical devices designed to help reduce bubble formation within the medical device.

[0026] Figure 2 shows a side view of another exemplary medical device (e.g., a nesting catheter 100). The catheter 100 extends from a proximal end region 102 to a distal end region 104. A proximal hub 106 may be attached adjacent to the proximal end region 102. The proximal hub 106 may include a check valve and a lavage port 108. Fluid can be injected through the lavage port 108 to lavage the catheter 100. The catheter 100 may further include a nesting section 110 that extends from a proximal end region 113 to a distal end region 115 and is positioned between the proximal end region 102 and the distal end region 104 of the catheter 100. An elongated shaft 112 extends distally from the distal end region 115 of the nesting section 110. The elongated shaft 112 may include a tip member 114 adjacent to the distal end region 104 of the catheter 100. The tip member 114 may be similar in form and function to the tip member 20 described with respect to Figure 1. For example, the tip member 114 may include a guidewire lumen having a guidewire exit port, a non-traumatic distal end, one or more radiopaque markers, and / or other features.

[0027] The imaging assembly 116 (see, for example, Figure 3) may be 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 housing 122. The imaging assembly 116 is intended to include, but is not limited to, another medical device such as a cutting head or other device, or to be replaced by another medical device. The specific device selected for the drive cable 120 may be selected based on the desired function for the catheter 100. The drive cable 120 may extend proximal from the imaging member 118 through a nested section 110 to a proximal hub 106. The proximal hub 106 may contain components adapted to interface the drive cable 120 with a power supply and / or other electronic couplings. In some cases, the proximal end of the drive cable 120 may be affixed to the proximal hub 106. Although not explicitly stated, the drive cable 120 may optionally include a single outer jacket or coating, or a double outer jacket or coating. If provided in this manner, the outer jacket may extend for the entire length of the drive cable 120 or less than the entire length of the drive cable 120.

[0028] The nesting section 110 may include a first or intermediate sheath 124, a second or outer sheath 126, and a third or inner sheath 128. Generally, the outer sheath 126 may be positioned to cover the intermediate sheath 124, and the intermediate sheath 124 may be positioned to cover the inner sheath 128. The intermediate sheath 124 may be displaced axially and / or rotatably relative to the outer and inner sheaths 126, 128 so that the movement of the proximal hub 106 is converted into movement of the intermediate sheath 124 and the drive cable 120. The distal hub 138 may be positioned adjacent to the distal end region 115 of the nesting section 110. The distal hub 138 may include a distal strain relief section 139 configured to be coupled to an elongated shaft 112. Furthermore, the distal ends of the outer sheath 126 and the inner sheath 128 may be fixedly attached to the distal hub 138, respectively.

[0029] The intermediate sheath 124 extends distally from a proximal end region 130 connected to the proximal strain relief region 132 to a distal end 134 extending into the outer sheath 126. The intermediate sheath 124 may, but is not required, have a constant diameter from the proximal end region 130 to the distal end 134. The proximal strain relief region 132 is connected to the proximal hub 106. The intermediate sheath 124 is movable relative to the inner sheath 128 and the outer sheath 126 such that the distal end 134 of the intermediate sheath 124 is movable between the distal hub 138 and the housing 142. The intermediate sheath 124 defines a lumen extending from its proximal end region 130 to its distal end 134. The lumen may receive and / or house the drive shaft 120 and / or a portion of the inner sheath 128.

[0030] The outer sheath 126 extends distally from the housing or receptacle 142 to the distal end (for example, it may be fixed to the distal hub 138). The outer sheath 126 defines a lumen that extends from the proximal end region to the distal end. The lumen may receive or house a portion of the inner sheath 128 and / or the intermediate sheath 124.

[0031] The inner sheath 128 extends distally from the proximal end region to the distal end fixed to the distal hub. The inner sheath 128 defines a lumen extending from the proximal end region to the distal end. The lumen may receive or house a portion of the drive shaft 120. For example, the inner sheath 128 may be configured to support the drive shaft 120 when the intermediate sheath 124 is displaced proximal (see, for example, Figure 4). In some embodiments, the proximal end region of the inner sheath 128 may be located adjacent to the proximal end region of the outer sheath 126. In other embodiments, the proximal end region of the inner sheath 128 may be distal to the proximal end region of the outer sheath 126.

[0032] Figure 3 shows a perspective view of the nested catheter of Figure 2, with the proximal hub 106 and intermediate sheath 124 (and therefore the drive shaft 120) in their distalmost position. This configuration can be considered fully retracted, as the catheter 100 has the shortest length. In Figure 3, the elongated shaft 112 is not shown to more clearly illustrate the structure of the imaging assembly 116. In the embodiment of Figure 3, the intermediate sheath 124 is advancing distally within the lumen of the outer sheath 126. The distal movement of the intermediate sheath 124 may be limited by a mechanical stop generated between the proximal strain relief section 132 and the housing 142. When the proximal hub 106 and intermediate sheath 124 are in their distalmost position, most of the total length of the lumen 136 of the intermediate sheath 124 may surround the inner sheath 128.

[0033] Figure 4 shows a perspective view of the proximal portion of the nested catheter of Figure 2, with the proximal hub 106 and intermediate sheath 124 (and therefore the drive shaft 120) near the proximal most position. This configuration can be considered fully extended, as the catheter 100 has its maximum length. In the embodiment of Figure 4, the intermediate sheath 124 is displaced proximal within the lumen of the outer sheath 126. The proximal movement of the intermediate sheath 124 may be limited by a mechanical stop generated between mating features on the distal end region of the intermediate sheath 124 and the housing 142. When the proximal hub 106 and intermediate sheath 124 are in the proximal most position, most of the total length of the lumen 136 of the intermediate sheath 124 may surround the drive cable 120.

[0034] Figures 3 and 4 show the approximate extremes of movement of the nested section 110, although the proximal hub 106 and intermediate sheath 124 may be positioned at any location in between. When the drive cable 120 is connected to the proximal hub 106, the proximal and distal movements are translated into the drive cable 120 and the imaging assembly 116, making it possible to move the imaging assembly without moving the entire catheter 100. The rotational motion of the proximal hub 106 is also translated into the drive shaft 120 and the imaging assembly 116, further intended to allow rotation of the imaging assembly 116 within the elongated shaft 112.

[0035] During coronary intervention, imaging devices may navigate through tortuous anatomical structures. In such situations, the imaging device may twist or deform in a way that could interfere with its function. Disclosed herein are intravascular imaging devices that include structural features to the device that, for example, help reduce twisting and provide additional desired advantages.

[0036] Figure 5 is a partial side view of an exemplary 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 end region 256, and a nesting 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, and / or equivalents. The imaging core 260 may be used to image blood vessels in a manner similar to those disclosed herein. The distal end region 256 may define a guidewire lumen 262, configured to have a guidewire 264 extending through its interior.

[0037] With respect to the catheter assembly 250, several arrangements and / or configurations are possible. For example, in some examples, the nesting assembly 258 is located at or near the proximal end of the catheter assembly 250. The catheter body 252 may generally be a region of the catheter assembly 250 located distal to the nesting assembly 258. In some examples, the imaging window 254 and / or distal end region 256 may be considered part of the catheter body 252. In other examples, the imaging window 254 and / or distal end region 256 may be a separate part / region of the catheter assembly 250 located distal to and attached to the catheter body 252.

[0038] The nesting 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 fixed axially relative to the outer shaft 270. In other words, the inner shaft 266 may be configured so that it does not move relative to the outer shaft 270. The intermediate shaft 268 may be slidable (e.g., translationally movable) relative to the inner shaft 266 and the outer shaft 270. In at least some examples, the intermediate shaft 268 may be fixed axially relative to the imaging core 260. In other words, the intermediate shaft 268 may be configured such that movement of the intermediate shaft 268 results in corresponding movement of the imaging core 260. The intermediate shaft 268 may be slidable relative to the inner shaft 266 and the outer shaft 270, or it may be fixed axially relative to the imaging core 260. Therefore, movement of the intermediate shaft 268 causes the intermediate shaft 268 and the imaging core 260 to move relative to the inner shaft 266 and the outer shaft 270 (for example, translationally).

[0039] The distal shaft member 272 may be positioned along the catheter assembly 250. The distal shaft member 272 may take the form of a sleeve or sheath positioned around the catheter body 252. In some cases, the distal shaft member 272 may be positioned adjacent to the distal end region 256 of the catheter assembly 250. A rod 278 may be connected to the distal shaft member 272. The rod 278 may be configured to connect the distal shaft member 272 to the intermediate shaft 268 and / or the imaging core 260, as described in more detail herein.

[0040] The distal shaft member 272 and the rod 278 can provide a number of desirable features to the intravascular imaging device 210. For example, the distal shaft member 272 may provide additional bulk and / or structural support that can help enable the clinician to advance the intravascular imaging device 210 more efficiently toward the target and / or help reduce twisting. In some examples, the distal shaft member 272 may include a guidewire lumen (e.g., guidewire lumen 276 shown in Figure 7) that can help provide further structural support to the intravascular imaging device 210 while tracking along the guidewire. In at least some examples, the rod 278 may be sufficiently rigid to improve or otherwise assist in providing structural support. The rod 278 may take the form of a wire (e.g., circular cross-section, non-circular cross-section, polygonal cross-section, ribbon shape, etc.) that helps to hold and support the distal shaft member 272. The rod 278 may extend to the proximal end of the catheter assembly 250.

[0041] When the distal shaft member 272 is positioned adjacent to the distal end region 256 of the catheter assembly 250, it should be understood that the distal shaft member 272 may obstruct or obscure the imaging core 260 when the imaging core 260 is translated (for example, during a pullback procedure). For this reason, it may be desirable for the distal shaft member 272 to move together with the imaging core 260 (for example, translationally). For example, in some examples, the imaging core 260 may extend to a position distal to the distal shaft member 272. During a translational procedure (for example, a pullback procedure), the distal shaft member 272 may move together with the imaging core 260 and be configured to maintain its position such that the distal end of the imaging core 260 maintains its position distal to the distal shaft member 272. Therefore, when the imaging core 260 is retracted proximal, the distal shaft member 272 retracts together with the imaging core 260. This helps prevent the distal shaft member 272 from blocking or obscuring the imaging core 260.

[0042] The hub 280 may be located at the proximal end of the catheter assembly 250. The intermediate shaft 268 can be coupled to the hub 280. In some and other examples, the rod 278 may be coupled to the hub 280. In some and other examples, the imaging core 260 may be coupled to the hub 280. The hub 280 may be used to shift (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 the imaging procedure. In some examples, the hub 280 may include a translational device or “pullback” device configured to translate the imaging core 260 (as well as the intermediate shaft 268 and rod 278) relative to the inner shaft 266 and the outer shaft 270.

[0043] Some of the various structures and / or arrangements of the catheter assembly 250 can be seen more clearly in Figures 6-12. For example, Figure 6 shows the distal portion of the catheter assembly 250. Here, it can be seen that the imaging core 260 may be located within the imaging window 254. The imaging window 254 may be formed from a material that is substantially transparent to the energy used for imaging. For example, the imaging window 254 may be transparent to acoustic or ultrasonic energy when an ultrasonic transducer is used for imaging. The guidewire 264 can be seen along the outside of the imaging window 254.

[0044] Figure 7 shows a portion of the catheter assembly 250 proximal to the portion shown in Figure 6. Here, it can be seen that the distal shaft member 272 may be positioned to cover the imaging window 254. In some examples, the distal shaft member 272 includes a guidewire portion 274 that defines the guidewire lumen 276. This may allow the distal shaft member 272 to be tracked along the guidewire 264 during the imaging procedure.

[0045] Referring now to Figure 8, we can see that the imaging core 260 may be located within the inner shaft. In addition, the inner shaft 266 is manufactured by cutting / slitting, skiving, or other methods such that, as shown in Figure 8, it has a planarization region 282 in which the rod 278 extends along the outside of the inner shaft 266. The planarization region 282 may also be described as a portion of the inner shaft 266 (e.g., a portion having secondary lumens) being removed from the inner shaft 266. The inner shaft 266 can then transition into multi-lumen regions or sections along its entire length. For example, a more proximal region of the inner shaft 266 may include a secondary lumen region 286 defining secondary lumens 288. The rod 278 may extend within the secondary lumens 288, as shown in Figure 9.

[0046] As the catheter assembly 250 moves proximal, the inner shaft 266 may extend into the outer shaft 270, as shown in Figure 10. Further proximal, the intermediate shaft 268 may be positioned between the inner shaft 266 and the outer shaft 270, as shown in Figure 11. Finally, near the proximal end of the catheter assembly 250, the intermediate shaft 268 may be positioned around the imaging core 260, as shown in Figure 12. At the proximal end of the catheter assembly 250, the imaging core 260, the intermediate shaft 268, and the rod 278 may be connected to each other, for example, by coupling each to a hub 280.

[0047] Figures 13 and 14 schematically illustrate a part of the imaging procedure. In such a procedure, the imaging core 260 may be translated along the catheter assembly 250 (for example, during a retraction procedure). At that time, the hub 280 may also be translated (for example, while stably holding the inner shaft 266 and outer shaft 270), which results in the imaging core 260 moving within the catheter assembly 250. Since it may be desirable to avoid the distal shaft member 272 obstructing or otherwise obscuring the imaging core 260, the distal shaft member 272 may be translated along the catheter assembly 250 together with the imaging core 260 (and together with the intermediate shaft 268), as shown in Figure 14.

[0048] It should be understood that this disclosure is illustrative in many respects. Modifications can be made in detail, particularly with respect to shape, size, and step arrangement, without exceeding the scope of this disclosure. This includes, to a reasonable extent, using any feature of one exemplary embodiment in other embodiments. The scope of the invention is, needless to say, defined by the wording of the appended claims.

Claims

1. An intravascular imaging device, A catheter shaft assembly comprising a nesting assembly and a catheter body, wherein the catheter body includes an imaging window and a distal end region having a first guidewire lumen formed therein, An imaging core disposed within the catheter shaft assembly, A distal shaft member arranged along the outer surface of the catheter body, the distal shaft member having a second guidewire lumen formed therein, A rod having a first end region coupled to the distal shaft member and a second end region coupled to the nesting assembly, An intravascular imaging device equipped with the following features.

2. The intravascular imaging device according to claim 1, wherein the imaging core is translatably movable within the catheter shaft assembly.

3. The intravascular imaging device according to claim 1 or 2, wherein the imaging core includes an ultrasonic transducer.

4. The intravascular imaging device according to claim 1 or 2, wherein the imaging core includes an optical coherence tomography imaging device.

5. The intravascular imaging device according to claim 1 or 2, wherein the nesting assembly includes a first shaft coupled to the proximal end 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 device according to claim 5, wherein the second end region of the rod is coupled to the second shaft.

7. The intravascular imaging device according to claim 5, wherein the nesting assembly includes an inner shaft coupled to the first shaft.

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

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

10. The intravascular imaging device according to claim 1 or claim 2, wherein the rod includes a ribbon-shaped wire.

11. The intravascular imaging device according to claim 1 or claim 2, wherein the rod is slidable relative to the catheter body.

12. An intravascular imaging device, A catheter shaft including an imaging window and a distal end region, A nesting shaft assembly coupled to the catheter shaft, 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, 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 arranged along the outer surface of the catheter shaft, having a first lumen configured to receive the imaging core and a second lumen, A rod having a first end region connected to the distal shaft member and a second end region extending through the second lumen of the distal shaft member and connected to the intermediate shaft, An intravascular imaging device equipped with the following features.

13. The intravascular imaging device according to claim 12, wherein 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.

14. The intravascular imaging device according to claim 12 or 13, wherein the distal shaft member is configured to move translationally along the catheter shaft.

15. The intravascular imaging device according to claim 12 or 13, wherein the second lumen extends to a position proximal to the distal end of the distal shaft member.

16. The intravascular imaging device according to claim 12 or 13, wherein the rod includes a ribbon-shaped wire.

17. The intravascular imaging device according to claim 12 or 13, wherein the rod is slidable relative to the catheter shaft.

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