Intravascular imaging device

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.

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to medical devices and methods for manufacturing medical devices. More particularly, the present disclosure relates to elongated intravascular imaging devices. [Background technology]

[0002] A wide variety of intracorporeal medical devices have been developed for medical applications, such as intravascular applications. Some of these devices include guidewires, catheters, and the like. These devices can be manufactured by any one of a variety of different manufacturing methods and 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 a constant need to provide alternative medical devices and alternative methods for manufacturing and using medical devices. Summary of the Invention [Means for solving the problem]

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

[0004] Alternatively or additionally to any of the above described embodiments, the imaging core is translatable within the catheter shaft assembly. Alternatively or additionally to any of the above described embodiments, the imaging core includes an ultrasound transducer.

[0005] Alternatively or additionally to any of the above described embodiments, the imaging core includes an optical coherence tomography imaging device. Alternatively or in addition to any of the above described embodiments, the nested 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.

[0006] Alternatively or additionally to any of the above described embodiments, the second end region of the rod is connected to a second shaft. Alternatively or additionally to any of the above described embodiments, the telescoping assembly includes an inner shaft coupled to the first shaft.

[0007] Alternatively or additionally to any of the above described embodiments, the inner shaft defines a first lumen configured to receive the imaging core therein. Alternatively or additionally to any of the above embodiments, the inner shaft defines a second lumen configured to receive a rod therein.

[0008] Alternatively or additionally to any of the above embodiments, the rod comprises a ribbon-shaped wire. An intravascular imaging device is disclosed that includes a catheter shaft including an imaging window and a distal end region; a telescoping shaft assembly coupled to the catheter shaft, the telescoping shaft assembly including 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, the imaging core including a drive shaft and an ultrasound transducer coupled to the drive shaft, the imaging core being coupled to the intermediate shaft; a distal shaft member disposed along an outer surface of the catheter shaft, the distal shaft member 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] 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.

[0010] Alternatively or additionally to any of the above described embodiments, the distal shaft member is configured to translate along the catheter shaft. Alternatively or additionally to any of the embodiments described above, the second lumen extends to a location proximal to the distal end of the distal shaft member.

[0011] Alternatively or additionally to any of the above embodiments, the rod comprises a ribbon-shaped wire. Alternatively or additionally to any of the above described embodiments, a hub is coupled to the imaging core.

[0012] Alternatively or additionally to any of the above described embodiments, the intermediate shaft is connected to the hub. Alternatively or additionally to any of the above described embodiments, the rod is connected to a hub.

[0013] A method of imaging a blood vessel is disclosed that includes the steps of placing an intravascular imaging device in a blood vessel, the intravascular imaging device including a catheter shaft including an imaging window and a distal end region, a telescoping shaft assembly coupled to the catheter shaft, the telescoping shaft assembly including 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, the imaging core including a drive shaft and an ultrasound transducer coupled to the drive shaft, the imaging core being coupled to the intermediate shaft, a distal shaft member disposed along an outer surface of the catheter shaft and having 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 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] Alternatively or additionally to any of the above described embodiments, translating the imaging core relative to the catheter shaft includes translating a distal shaft member relative to the catheter shaft.

[0015] 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]

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

[0017] The present disclosure may be more fully understood in consideration of the following detailed description in conjunction with the accompanying drawings. While the present disclosure is susceptible to various modifications and alternative forms, details thereof have been shown by way of example in the drawings and will be described in detail. It is to be understood, however, that the invention is not limited to the particular embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.

[0018] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. All numerical values ​​are assumed to be modified herein by the term "about," whether or not expressly indicated. The term "about" generally refers to a range of numbers that one of ordinary skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the term "about" may include numbers that are rounded to the nearest significant figure.

[0019] The recitation of numerical ranges by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). 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 used in its sense including "and / or" unless the content clearly dictates otherwise.

[0020] It should be noted that references herein to "one embodiment," "some embodiments," "other embodiments," etc., indicate that the described embodiment 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 feature, structure, and / or characteristic. In addition, when a particular feature, structure, and / or characteristic is described in connection with one embodiment, it should be understood that such feature, structure, and / or characteristic may also be used in connection with other embodiments, whether or not explicitly described, unless expressly stated otherwise.

[0021] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

[0022] FIG. 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 can be an intravascular ultrasound (IVUS) device that can be used to image blood vessels. The structure / form of the medical device 10 can vary. In some examples, the medical device 10 can include an elongate shaft 12 having a proximal end region 14 and a distal end region 16. A proximal hub or connector 18 can be coupled to or otherwise disposed adjacent the proximal end region 14. A tip member 20 can be coupled to or otherwise disposed adjacent the distal end region 16. The tip member 20 can 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 elongate shaft 12. The imaging assembly 22 may be disposed within the lumen of the shaft 12. In general, the imaging assembly may be used to capture / generate images of the blood vessel. In some examples, the medical device may include devices and / or features similar to those disclosed in U.S. Patent Application Publication Nos. 2012 / 0059241 and 2017 / 0164925, the entire disclosures of which are incorporated herein by reference. In at least some examples, the medical device 10 may be similar to and / or include features similar to the OPTICROSS™ Imaging Catheter available from BOSTON SCIENTIFIC (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 the housing 26. In at least some examples, the transducer 28 includes an ultrasound transducer. Other transducers are also contemplated. 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 to rotate and / or translate the transducer 28 (and the housing 26).

[0024] 1, the medical device 10 may include a telescoping section configured to allow an operator of the medical device 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's body. This allows the operator of the catheter 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 elongate shaft 12.

[0025] Additionally, when using the medical device 10, it may be desirable to prime and / or clean the shaft 12. To clean the medical device 10, fluid may be injected into a flushing port on or at the hub 18. The fluid may be flushed out of the medical device at a vent (not shown) adjacent the distal end of the housing 26. In some cases, the cleaning process may result in air bubbles forming within the shaft 12. Because air bubbles can reflect / interfere with signals (e.g., ultrasound signals) from the transducer 28 and interfere with images, it may be desirable to flush the medical device 10 to reduce air bubble formation and / or to remove / interfere with any air bubbles that do form. Although flushing is generally effective at removing air bubbles, some air bubbles may still become trapped within the shaft 12. Disclosed herein is a medical device designed to help reduce the formation of air bubbles within the medical device.

[0026] 2 illustrates a side view of another exemplary medical device, such as, but not limited to, a telescoping 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 an irrigation port 108. Fluid may be injected at the irrigation port 108 to irrigate the catheter 100. The catheter 100 may further include a telescoping section 110 extending from a proximal end region 113 to a distal end region 115 of the catheter 100 and positioned between the proximal end region 102 and the distal end region 104 of the catheter 100. An elongate shaft 112 extends distally from the distal end region 115 of the telescoping section 110. The elongate shaft 112 may include a tip member 114 adjacent 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, an atraumatic distal tip, one or more radiopaque markers, and / or other features.

[0027] An imaging assembly 116 (see, e.g., FIG. 3 ) may be movably positioned within the lumen of the elongate 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 particular device selected for the drive cable 120 may be selected based on the desired functionality for 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 contain components adapted to interface the drive cable 120 with a power source 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 shown, drive cable 120 may include a single layer outer jacket or coating, or two layers of outer jacket or coating, as desired. If so provided, the outer jacket may extend the entire length of drive cable 120 or less than the entire length of drive cable 120.

[0028] The nestable section 110 may include a first or middle sheath 124, a second or outer sheath 126, and a third or inner sheath 128. In general, the outer sheath 126 may be disposed over the middle sheath 124, which may be disposed over the inner sheath 128. The middle sheath 124 may be axially and / or rotationally displaced relative to the outer and inner sheaths 126, 128 such that movement of the proximal hub 106 translates to movement of the middle sheath 124 and the drive cable 120. A distal hub 138 may be positioned adjacent the distal end region 115 of the nestable section 110. The distal hub 138 may include a distal strain relief 139 configured to be coupled to the elongate shaft 112. Additionally, the distal ends of the outer sheath 126 and the inner sheath 128 may each be fixedly attached to the distal hub 138.

[0029] The intermediate sheath 124 extends distally from a proximal end region 130 coupled to a proximal strain relief 132 to a distal end 134 extending within the outer sheath 126. The intermediate sheath 124 may have a constant diameter from the proximal end region 130 to the distal end 134, but this is not required. The proximal strain relief 132 is coupled 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 a distal hub 138 and a 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 a portion of the drive shaft 120 and / or the inner sheath 128.

[0030] The outer sheath 126 extends distally from the housing or receptacle 142 to a distal end (which may, for example, be secured to the distal hub 138). The outer sheath 126 defines a lumen that extends from a 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 a proximal end region to a distal end secured 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 in a proximally displaced configuration (see, e.g., FIG. 4). In some embodiments, the proximal end region of the inner sheath 128 may be disposed 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] FIG. 3 shows a perspective view of the nested catheter of FIG. 2 with the proximal hub 106 and the mid-sheath 124 (and thus the drive shaft 120) in their distalmost positions. This configuration can be considered fully retracted as the catheter 100 has its shortest length. In FIG. 3, the elongate shaft 112 is not shown to more clearly show the structure of the imaging assembly 116. In the embodiment of FIG. 3, the mid-sheath 124 is advanced distally within the lumen of the outer sheath 126. Distal movement of the mid-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 mid-sheath 124 are in their distalmost positions, the majority of the overall length of the lumen 136 of the mid-sheath 124 may surround the inner sheath 128.

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

[0034] 3 and 4 show the approximate extremes of movement of the nested section 110, the proximal hub 106 and intermediate sheath 124 may be located anywhere in between. 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, allowing the imaging assembly to move without moving the entire catheter 100. It is further contemplated that rotational movement of the proximal hub 106 is also translated to the drive shaft 120 and imaging assembly 116, allowing rotation of the imaging assembly 116 within the elongate shaft 112.

[0035] During coronary interventions, imaging devices may be navigated through tortuous anatomical structures, where the imaging device may become kinked or otherwise deformed in a manner that may impede the function of the device. Disclosed herein are intravascular imaging devices that include structural features to the device that, for example, help to reduce kinking and may provide additional desirable benefits.

[0036] 5 is a side view of a portion of an exemplary intravascular imaging device 210 that 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, combinations thereof, and / or the like. The imaging core 260 may be used in a similar manner as disclosed herein to image blood vessels. The distal end region 256 may define a guidewire lumen 262 configured to have a guidewire 264 extending therethrough.

[0037] Several arrangements and / or configurations are contemplated for the catheter assembly 250. For example, in some instances, the nestable assembly 258 is located at or near the proximal end of the catheter assembly 250. The catheter body 252 may generally be the region of the catheter assembly 250 that is located distal to the nestable assembly 258. In some instances, the imaging window 254 and / or the distal end region 256 may be considered to be part of the catheter body 252. In other instances, the imaging window 254 and / or the distal end region 256 may be a separate portion / region of the catheter assembly 250 that is located distal to and attached to the catheter body 252.

[0038] The nested assembly 258 may include an inner shaft 266, a middle 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 middle shaft 268 may be slidable (e.g., translatable) relative to the inner shaft 266 and the outer shaft 270. In at least some examples, the middle shaft 268 may be axially fixed relative to the imaging core 260. In other words, the middle shaft 268 may be configured such that movement of the middle 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, and the intermediate shaft 268 may be axially fixed relative to the imaging core 260, such that movement of the intermediate shaft 268 causes the intermediate shaft 268 and the imaging core 260 to move (e.g., translate) relative to the inner shaft 266 and the outer shaft 270.

[0039] The distal shaft member 272 may be disposed along the catheter assembly 250. The distal shaft member 272 may take the form of a sleeve or sheath disposed around the catheter body 252. In some cases, the distal shaft member 272 may be disposed adjacent the distal end region 256 of the catheter assembly 250. A rod 278 may be coupled to the distal shaft member 272. The rod 278 may be configured to couple the distal shaft member 272 to the midshaft 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 allow a clinician to more efficiently advance the intravascular imaging device 210 towards a target and / or help reduce kinking. In some examples, the distal shaft member 272 can include a guidewire lumen (e.g., guidewire lumen 276 shown in FIG. 7) that can help provide additional structural support to the intravascular imaging device 210 while tracking over a guidewire. In at least some examples, the rod 278 can be sufficiently rigid to enhance or otherwise aid in providing structural support. The rod 278 can take 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 to hold and support the distal shaft member 272. The rod 278 can extend to the proximal end of the catheter assembly 250.

[0041] It should be appreciated that when the distal shaft member 272 is disposed adjacent the distal end region 256 of the catheter assembly 250, the distal shaft member 272 may block or obscure the imaging core 260, for example, when the imaging core 260 is translated (e.g., during a pullback procedure). For this reason, it may be desirable for the distal shaft member 272 to move (e.g., translate) with the imaging core 260. For example, in some instances, the imaging core 260 may extend to a position distal to the distal shaft member 272. During a translation procedure (e.g., a pullback procedure), the distal shaft member 272 may be configured to move with the imaging core 260 and maintain its alignment such that the distal end of the imaging core 260 maintains its position distal to the distal shaft member 272. Thus, when the imaging core 260 is retracted proximally, the distal shaft member 272 retracts 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 disposed at the proximal end of the catheter assembly 250. The mid-shaft 268 may be coupled to the hub 280. In some of these and other examples, the rod 278 may be coupled to the hub 280. In some of these 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 mid-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 examples, the hub 280 may include a translation device or “pullback” device configured to translate the imaging core 260 (as well as the middle shaft 268 and rod 278 ) relative to the inner shaft 266 and outer shaft 270 .

[0043] Some of the various structures and / or arrangements of structures of the catheter assembly 250 can be seen more clearly in Figures 6-12. For example, Figure 6 shows a distal portion of the catheter assembly 250. 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 from a material that is substantially transparent to the energy utilized for imaging. For example, the imaging window 254 can be transparent to acoustic or ultrasonic energy when an ultrasound transducer is used for imaging. A guidewire 264 can be seen along the exterior 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 disposed over the imaging window 254. In some examples, the distal shaft member 272 includes a guidewire portion 274 that defines a guidewire lumen 276. This may allow the distal shaft member 272 to be tracked along the guidewire 264 during an imaging procedure.

[0045] 8, it can be seen that the imaging core 260 can be disposed within the inner shaft. Additionally, the inner shaft 266 can be cut / slit, skived, or otherwise manufactured to have a flattened region 282 with the rod 278 extending along the exterior of the inner shaft 266, as shown in FIG. 8. The flattened region 282 can also be described as a portion of the inner shaft 266 (e.g., the portion having the secondary lumen) being removed from the inner shaft 266. The inner shaft 266 can then transition to a multi-lumen region or section along its entire length. For example, a more proximal region of the inner shaft 266 can include a secondary lumen region 286 that defines a secondary lumen 288. The rod 278 can extend into the secondary lumen 288, as shown in FIG. 9.

[0046] Moving proximally along the catheter assembly 250, the inner shaft 266 may extend into the outer shaft 270, as shown in Figure 10. Further proximally, the mid-shaft 268 may be disposed between the inner shaft 266 and the outer shaft 270, as shown in Figure 11. Finally, at a location near the proximal end of the catheter assembly 250, the mid-shaft 268 may be disposed around the imaging core 260, as shown in Figure 12. At the proximal end of the catheter assembly 250, the imaging core 260, the mid-shaft 268, and the rod 278 may be coupled to one another, for example, by each being coupled to a hub 280.

[0047] 13-14 show a schematic representation of a portion of an imaging procedure. In such a procedure, the imaging core 260 may be translated along the catheter assembly 250 (e.g., during a pullback procedure). The hub 280 may then be translated (e.g., while holding the inner shaft 266 and the outer shaft 270 steady), 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 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 FIG.

[0048] It will be understood that this disclosure is in many respects merely illustrative. Changes may be made in details, particularly in matters of shape, size and arrangement of steps, without exceeding the scope of the disclosure. This includes, to the extent appropriate, using any of the features of one illustrative embodiment in other embodiments. The scope of the invention is, of course, defined by the language of the appended claims.

Claims

1. 1. An intravascular imaging device, comprising: 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; a distal shaft member disposed along an exterior 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 telescoping assembly; An intravascular imaging device comprising:

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

3. The intravascular imaging device of claim 1 or 2, wherein the imaging core includes an ultrasound transducer.

4. The intravascular imaging device of claim 1 , wherein the imaging core includes an optical coherence tomography imaging device.

5. The intravascular imaging device of any one of claims 1 to 4, wherein the telescoping assembly includes a first shaft coupled to a 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 of claim 5 , wherein the second end region of the rod is coupled to the second shaft.

7. The intravascular imaging device of claim 5 or claim 6, wherein the telescoping assembly includes 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 device of claim 8 , wherein the inner shaft defines a second lumen configured to receive the rod therein.

10. The intravascular imaging device of claim 1 , wherein the rod comprises a ribbon-shaped wire.

11. 1. An intravascular imaging device, comprising: a catheter shaft including an imaging window and a distal end region; a telescoping shaft assembly coupled to the catheter shaft, the telescoping shaft assembly including 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, the imaging core including a drive shaft and an ultrasound transducer coupled to the drive shaft, the imaging core coupled to the intermediate shaft; a distal shaft member disposed along an outer surface of the catheter shaft, the distal shaft member having a first lumen configured to receive the imaging core and a second lumen; 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; An intravascular imaging device comprising:

12. The intravascular imaging device of claim 11 , 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.

13. The intravascular imaging device of claim 11 or 12, wherein the distal shaft member is configured for translational movement along the catheter shaft.

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

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

Images