Intravascular imaging device

Abstract

An intravascular imaging device and methods of manufacturing and using the intravascular imaging device are disclosed. An exemplary intravascular imaging device may include a catheter shaft configured to be positioned inside a blood vessel. The catheter shaft may have an imaging window region and an imaging lumen. The imaging lumen is configured to house an imaging assembly within the imaging lumen. A distal tip member may be coupled to the catheter shaft. The distal tip member may have a guidewire lumen formed therein. The imaging window region and the distal tip member may axially overlap.

Description

[Technical Field]

[0001] The present disclosure relates to medical devices and methods for manufacturing the same, and more particularly, to elongated intravascular imaging devices. [Background technology]

[0002] A wide variety of medical devices have been developed for medical use, e.g., intravascular use. 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 different methods. Each of the known medical devices and methods has certain advantages and disadvantages. There is a continuing need to provide alternative medical devices, as well as alternative methods of manufacturing and using the medical devices. Summary of the Invention

[0003] The present disclosure provides design, material, manufacturing, and use alternatives for medical devices. An intravascular imaging device is disclosed. The intravascular imaging device includes a catheter shaft and a distal tip member, the catheter shaft configured to be positioned inside a blood vessel, the catheter shaft having an imaging window region and an imaging lumen configured to house an imaging assembly therein, the distal tip member coupled to the catheter shaft and having a guidewire lumen formed therein, the imaging window region and the distal tip member axially overlapping.

[0004] Alternatively or additionally to any of the above embodiments, the distal tip member includes a distal end region extending distally from the imaging window region, and an overlap region where the imaging window region and the distal tip member axially overlap.

[0005] Alternatively or additionally to any of the above embodiments, the distal end region has a length of about 5 to 25 millimeters.

[0006] Alternatively or additionally to any of the above embodiments, the distal end region has a length of about 10 to 20 millimeters.

[0007] Alternatively or additionally to any of the above embodiments, the overlap region has a length of about 300 millimeters or less.

[0008] Alternatively or additionally to any of the above embodiments, the overlap region has a length of about 15 to 300 millimeters.

[0009] Alternatively or additionally to any of the above embodiments, the imaging lumen is in fluid communication with the guidewire lumen.

[0010] Alternatively or additionally to any of the above embodiments, the distal tip member has an axially extending slit formed therein.

[0011] Alternatively or additionally to any of the above embodiments, the distal tip member has an axially extending channel formed therein.

[0012] Alternatively or additionally to any of the above embodiments, the distal tip member and the imaging window area are integrally formed.

[0013] Alternatively or additionally to any of the above embodiments, the distal tip member and the imaging window region are formed from a single monolithic material.

[0014] Alternatively or additionally to any of the above embodiments, the distal tip member, the imaging window region, or both, comprise a coating.

[0015] An intravascular imaging device is disclosed, comprising a catheter shaft assembly and an imaging core, the catheter shaft assembly including a telescopic region and a catheter shaft extending distally from the telescopic region, the catheter shaft including an imaging window region and a distal tip region having a guidewire lumen formed therein, the distal tip region having a first portion disposed distally of the imaging window region and a second portion disposed along a side of the imaging window region, and the imaging core is disposed within the catheter shaft assembly.

[0016] Alternatively or additionally to any of the above embodiments, the second portion has a length of about 300 millimeters or less.

[0017] Alternatively or additionally to any of the above embodiments, the second portion has a length of about 15 to 300 millimeters.

[0018] Alternatively or additionally to any of the above embodiments, the imaging window area includes an imaging lumen formed therein, the imaging lumen being in fluid communication with the guidewire lumen.

[0019] Alternatively or additionally to any of the above embodiments, the distal tip region has an axially extending slit formed therein.

[0020] Alternatively or additionally to any of the above embodiments, the distal tip region has an axially extending channel formed therein.

[0021] Alternatively or additionally to any of the above embodiments, the distal tip region and imaging window region are integrally formed.

[0022] Alternatively or additionally to any of the above embodiments, the distal tip region and the imaging window region are formed from a single monolithic material.

[0023] Alternatively or additionally to any of the above embodiments, the distal tip member, the imaging window region, or both, comprise a coating.

[0024] A method for imaging a blood vessel is disclosed, the method including: positioning an intravascular imaging device inside a blood vessel; and moving an imaging core relative to a catheter shaft assembly, the intravascular imaging device including the catheter shaft assembly and the imaging core disposed within the catheter shaft assembly, the catheter shaft assembly including a telescopic region and a catheter shaft extending distally from the telescopic region, the catheter shaft including an imaging window region and a distal tip region having a guidewire lumen formed within the imaging window region, the distal tip region including a first portion disposed distal to the imaging window region and a second portion disposed along a side of the imaging window region, and the imaging core disposed within the catheter shaft assembly.

[0025] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The figures and detailed description that follow more particularly exemplify these embodiments. [Brief explanation of the drawings]

[0026] The present disclosure may be more fully understood when considered in conjunction with the following detailed description, in which: [Figure 1] FIG. 1 is a side view of an exemplary medical device. [Figure 2] FIG. 2 is a side view of another exemplary medical device. [Figure 3] FIG. 3 is a perspective view of the medical device of FIG. 2 in a stored configuration. [Figure 4] FIG. 4 is a perspective view of the medical device of FIG. 2 in an extended configuration. [Figure 5] FIG. 5 is a cross-sectional side view of a portion of an exemplary medical device. [Figure 6] FIG. 6 is a cross-sectional view taken along line 6-6 of FIG. [Figure 7] FIG. 7 is a cross-sectional view taken along line 7-7 of FIG. [Figure 7A-7C] 7A-7C are alternative cross-sectional views taken along line 7-7 of FIG. [Figure 8] FIG. 8 is an alternative cross-sectional view of an exemplary medical device. [Figure 9] FIG. 9 is an alternative cross-sectional view of an exemplary medical device. [Figure 10] FIG. 10 is an alternative cross-sectional view of an exemplary medical device. [Figure 11] FIG. 11 is a cross-sectional side view of a portion of an exemplary medical device.

[0027] While the present disclosure is susceptible to modifications and alternative forms, specific examples thereof have been shown by way of example in the drawings and may be described in detail. It is to be understood, however, that there is no intention to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the concept and scope of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0028] For the following defined terms, these definitions shall apply, unless a different definition is given in the claims or elsewhere in this specification.

[0029] All numerical values ​​herein are assumed to be modified by the term "about," whether or not explicitly stated. Generally, the term "about" 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.

[0030] 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).

[0031] 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.

[0032] 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 properties. However, such a description does not necessarily mean that all embodiments include the particular feature, structure, and / or property. In addition, when a particular feature, structure, and / or property is described in combination with one embodiment, it should be understood that such feature, structure, and / or property may also be used in combination with other embodiments, whether explicitly described or not, unless clearly stated to the contrary.

[0033] 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.

[0034] 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 / configuration of the medical device 10 can vary. In some examples, the medical device 10 can include a catheter shaft 12 having a proximal end region 14 and a distal end region 16. A proximal hub or proximal coupling 18 can be coupled to the proximal end region 14 or disposed adjacent the proximal end region 14. A tip member 20 can be coupled to the distal end region 16 or disposed adjacent the distal end region 16. The tip member 20 can include a guidewire exit port 32, an atraumatic distal tip 34, one or more radiopaque markers 36, and / or a guidewire lumen 30 having other features. In some embodiments, the tip member 20 can extend at a non-parallel angle relative to the proximal end region 14 of the catheter shaft 12. The imaging assembly 22 may be disposed within the lumen of the catheter shaft 12. Typically, the imaging assembly may be used to capture / generate images of blood vessels. In some embodiments, the medical device may include devices and / or features similar to those disclosed in U.S. Patent Application Publication No. US2012 / 0059241 and U.S. Patent Application Publication No. US2017 / 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 an OPTICROSS® imaging catheter (commercially available from BOSTON SCIENTIFIC, Marlborough, Massachusetts).

[0035] 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 ultrasound transducer. Other transducers are also contemplated. The transducer 28 may be rotatable and / or axially movable relative to the shaft 12. For example, the drive cable 24 may be rotated and / or moved to rotate and / or move the transducer 28 (and housing 26).

[0036] 1 , the medical device 10 may include a telescoping assembly configured to allow the operator of the medical device to move the drive shaft 24, including the imaging assembly 22, proximally and distally within the catheter shaft 12 without having to move the entire catheter within the patient. This allows the operator of the catheter to easily change the position of the imaging assembly or other medical devices within the patient. For example, the telescoping section may be actuated to change the position of the imaging assembly 22 within the catheter shaft 12.

[0037] 2 shows a side view of another exemplary medical device 100 (e.g., intravascular imaging device 100), which may be similar in shape and function to other medical devices disclosed herein. The medical device 100 extends from a proximal end region 102 to a distal end region 104. A proximal hub 106 may be secured adjacent to the proximal end region 102. The proximal hub 106 may include a check valve and a flushing port 108. A fluid may be injected at the flushing port 108 to flush the medical device 100. The medical device 100 may further include a telescoping portion 110 extending from a proximal end region 113 to a distal end region 115 and disposed between the proximal end region 102 and the distal end region 104 of the medical device 100. An elongate shaft or catheter 112 extends distally from the distal end region 115 of the telescoping portion 110. The elongate shaft 112 may include a tip member 114 adjacent the distal end region 104 of the medical device 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 exit port, an atraumatic distal tip, a guidewire lumen with one or more radiopaque markers, and / or other features.

[0038] An imaging assembly 116 (see, e.g., FIG. 3 ) may be movably disposed within the lumen of the elongate shaft 112. The imaging assembly 116 may comprise 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 comprise or be replaced by 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 of the medical device 100. The drive cable 120 may extend proximally from the imaging member 118 through the telescoping portion 110 to the proximal hub 106. The proximal hub 106 may include components adapted to connect the drive cable 120 to a power source and / or other electrical couplings. In some cases, the proximal end of the drive cable 120 may be fixed to the proximal hub 106. Although not explicitly shown, drive cable 120 may include a single layer outer cover or coating, or a dual layer outer cover or coating, as desired. If so provided, the outer cover may extend the entire length of drive cable 120 or less than the entire length of drive cable 120.

[0039] The telescoping portion 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 over the intermediate sheath 124, which may be disposed over the inner sheath 128. The intermediate sheath 124 may be axially and / or rotatably disposed 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 disposed adjacent the distal end region 115 of the telescoping portion 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 securely secured to the distal hub 138.

[0040] 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 the distal hub 138 and the housing 142. The intermediate sheath 124 defines a lumen extending from the proximal end region 130 to the distal end 134 of the intermediate sheath 124. The lumen may receive and / or house a portion of the drive shaft 120 and / or the inner sheath 128.

[0041] The outer sheath 126 extends distally from the housing or receptacle 142 to a distal end (e.g., the distal end may be secured to the distal hub 138). The outer sheath 126 defines a lumen extending from its proximal end region to its distal end. The lumen may receive or house a portion of the inner sheath 128 and / or the intermediate sheath 124.

[0042] 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 moved 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.

[0043] FIG. 3 shows a perspective view of the medical device 100 of FIG. 2 with the proximal hub 106 and intermediate sheath 124 (and thus the drive shaft 120) in their distal-most positions. This configuration can be considered fully retracted, as the medical device 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 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 formed between the proximal strain relief 132 and the housing 142. When the proximal hub 106 and intermediate sheath 124 are in their distal-most positions, the majority of the length of the lumen 136 of the intermediate sheath 124 may surround the inner sheath 128.

[0044] 4 shows a perspective view of the proximal portion of the medical device 100 of FIG. 2 with the proximal hub 106 and intermediate sheath 124 (and thus the drive shaft 120) near their proximal-most positions. This configuration can be considered fully extended, as the medical device 100 has its maximum length. In the embodiment of FIG. 4, the intermediate sheath 124 is disposed proximally within the lumen of the outer sheath 126. Proximal movement of the intermediate sheath 124 can be limited by a mechanical stop created between a mating feature 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 their proximal-most positions, the majority of the length of the lumen 136 of the intermediate sheath 124 can surround the drive cable 120.

[0045] 3 and 4 show the appropriate degree of movement of the telescoping portion 110, the proximal hub 106 and intermediate sheath 124 can be positioned anywhere in between. Because the proximal hub 106 is coupled to the drive cable 120, its proximal and distal movement is translated relative to the drive cable 120 and the imaging assembly 116, thereby allowing the imaging assembly to move without moving the entire medical device 100. It is further contemplated that rotational movement of the proximal hub 106 is also translated relative to the drive cable 120 and the imaging assembly 116, thereby allowing rotation of the imaging assembly 116 within the elongate shaft 112.

[0046] During coronary interventions, imaging devices may be maneuvered through tortuous tissue structures. In doing so, the imaging device may kink or even deform, thereby interfering with the device's function. Disclosed herein are intravascular imaging devices that include structural features that may help, for example, reduce kinking as well as provide additional desired benefits.

[0047] FIG. 5 is a side view of a portion of another exemplary medical device 200 (e.g., intravascular imaging device 200) similar in shape and function to the medical devices disclosed herein. Here, only a distal portion 216 of an elongate shaft 212 is shown. The elongate shaft 212 may have an imaging lumen 244 formed therein that may house, for example, an imaging assembly or imaging core (not shown in FIG. 5 but that may be similar in shape and function to the imaging assembly 116 disclosed herein) disposed within the imaging lumen 244. The elongate shaft 212 may include an imaging window region 223. In at least some examples, the imaging window region 223 may be adjacent to the distal end region of the elongate shaft 212 and may enable an imaging assembly disposed within the imaging lumen 244 to image a blood vessel. It should be understood that the medical device 200 may also include a telescoping portion (not shown in FIG. 5, but which may be similar in form and function to the telescoping portion 110 disclosed herein).

[0048] The elongate shaft 212 may also include a distal tip member or distal tip region 220. The distal tip member 220 may be similar in shape and function to the distal tip member 20. For example, the distal tip member 220 may include a guidewire lumen 230. In some examples, the distal tip member 220 may be a separate tube or shaft that is coupled to the elongate shaft 212. In other examples, the elongate shaft 212 and the distal tip member 220 may be integrally formed and / or formed from a single monolithic material. For example, the elongate shaft 212 and the distal tip member 220 may be formed (e.g., as a unitary structure) by molding or extrusion. Other processes and configurations are contemplated.

[0049] As suggested herein, it may be desirable to provide structural support for the elongate shaft 212 to improve pushability, reduce kinking, and provide other desired benefits. In some examples, this structural support may be achieved, at least in part, by axially overlapping at least a portion of the elongate shaft 212 and the distal tip member 220 (e.g., by axially overlapping the imaging window region 223 and the distal tip member 220). In FIG. 5 , the overlap region is labeled with reference numeral 231. The overlap region 231 may have a length corresponding to the length of the imaging window. In some of these and other examples, the overlap region 231 may have a length of about 400 millimeters or less, or about 300 millimeters or less, or between about 15 and 300 millimeters. These lengths are merely examples. Other lengths are also contemplated. In some examples, the entire distal tip member 220 may overlap the elongate shaft 212. In other examples, the distal end region 221 of the distal tip member 220 can extend distally from the elongate shaft 212 (and / or the distal end region 221 of the distal tip member 220 can extend distally from the imaging window region 223). The distal end region 221 can have a length of about 5-25 millimeters, or about 10-20 millimeters, or about 15 millimeters. These lengths are merely examples. Other lengths are also contemplated.

[0050] 6-7 are cross-sectional views of elongate shaft 212 and / or distal tip member 220. For example, FIG. 6 is a cross-sectional view illustrating distal tip member 220 and showing guidewire lumen 230. FIG. 7 is a cross-sectional view illustrating distal tip member 220, guidewire lumen 230, distal portion 216 (e.g., of elongate shaft 212), and imaging lumen 244. Also shown is a wall or region 246 typically disposed between guidewire lumen 230 and imaging lumen 244. In some examples, wall 246 may separate guidewire lumen 230 and imaging lumen 244. Other shafts are contemplated, such as elongate shaft 312 shown in FIG. 8. Here, adjacent the distal portion 316 of the elongate shaft 312, at least a portion of the wall (e.g., wall 246) is removed / absent, so that the imaging lumen 344 and the guidewire lumen 330 (e.g., formed in the distal tip member 320) are fluidly connected to each other.

[0051] In some instances, it may be desirable to apply a lubricious liner or coating to elongate shaft 212, such as along guidewire lumen 230, imaging lumen 244, or both. For example, FIG. 7A illustrates an alternative distal portion 216′ of elongate shaft 212 having a first liner or coating 245 disposed along imaging lumen 244 and a second liner or coating 247 disposed along guidewire lumen 230. Suitable materials for coating 245 and coating 247 may include hydrophilic materials, ultra-high molecular weight (UHMW) polyethylene, high density polyethylene (HDPE), polyamide (e.g., polyamide 66 or PA 66), nylon (e.g., nylon 66), silicone, polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), polyether ether ketone (PEEK), polyimide (PI), acetal, polyethylene terephthalate (PET), fluorinated ethylene propylene (FEP), combinations thereof, and the like. In some examples, coating 245 and coating 247 may be applied directly to the surface of elongate shaft 212. In other examples, an intermediate or adhesive layer may be disposed between elongate shaft 212 and coating 245 or coating 247.

[0052] As shown in FIG. 7A, coating 245 and coating 247 may be disposed along both imaging lumen 244 and guidewire lumen 230. In other examples, coating 247 may be disposed along guidewire lumen 230 as shown in FIG. 7B (e.g., of an alternate distal portion 216'' of elongate shaft 212 in which only coating 247 is disposed along guidewire lumen 230). In yet other examples, coating 245 may be disposed along imaging lumen 244 as shown in FIG. 7C (e.g., of an alternate distal portion 216'' of elongate shaft 212 in which only coating 245 is disposed along imaging lumen 244).

[0053] FIG. 9 illustrates a portion of an exemplary elongate shaft 412, which may be similar in shape and function to other shafts disclosed herein. The distal portion 416 of the elongate shaft 412 is shown with an imaging lumen 444. Also shown is a distal tip member 420 having a guidewire lumen 430 formed therein. An axially extending slot 450 may be formed in the distal tip member 420. The axially extending slot 450 may remove at least some material from the distal tip member 420, which may at least partially reduce the impact of the distal tip 420 on imaging. For example, by forming the axially extending slot 450 in the tip member 420, there may be less structure / material along the imaging path, which may allow the imaging assembly to more efficiently image through the imaging window of the elongate shaft 412 and the distal tip member 420. In some examples, the axially extending slot 450 may be described as a channel, a “U-shaped” channel, or the like.

[0054] FIG. 10 illustrates a portion of an exemplary elongate shaft 512, which may be similar in shape and function to other shafts disclosed herein. The distal portion 516 of the elongate shaft 512 is shown with an imaging lumen 544. Also shown is a distal tip member 520 having a guidewire lumen 530 formed therein. An axially extending slit 550 may be formed in the distal tip member 520. The axially extending slit 550 may remove at least some material from the distal tip member 520, which may at least partially reduce the impact of the distal tip member 520 on imaging. For example, by forming the axially extending slit 550 in the distal tip member 520, there may be less structure / material along the imaging path, which may allow the imaging assembly to more efficiently image through the imaging window of the elongate shaft 512 and the distal tip member 520. In some examples, the axially extending slot 550 may be described as a channel, a “C-shaped” channel, or the like.

[0055] FIG. 11 is a side view of a portion of another exemplary medical device 600 (e.g., intravascular imaging device 600) similar in shape and function to the exemplary medical devices disclosed herein. Here, only a distal portion 616 of an elongate shaft 612 is shown. The elongate shaft 612 may have an imaging lumen 644 formed therein, which may house, for example, an imaging assembly or imaging core. The elongate shaft 612 may include an imaging window region 623. In at least some examples, the imaging window region 623 may be adjacent to the distal end region of the elongate shaft 612, allowing an imaging assembly disposed within the imaging lumen 644 to image the blood vessel. The elongate shaft 612 also includes a distal tip member or distal tip region 620. The distal tip member 620 may be similar in shape and function to the distal tip member 20. For example, the distal tip member 620 may include a guidewire lumen 630.

[0056] In some examples, at least a portion of the distal tip member 620 may overlap the elongate shaft 612 (e.g., axially overlapping the distal tip member 620 with the imaging window region 623). In FIG. 11 , the overlap region is labeled by reference numeral 631. The overlap region 631 may have a length corresponding to the length of the imaging window. In some of these and other examples, the overlap region 631 may have a length shorter than the overlap region 231 (e.g., as shown in FIG. 5 ). For example, the overlap region 631 may have a length of about 200 millimeters or less, about 100 millimeters or less, or about 15-100 millimeters. In some examples, the entire distal tip member 620 may overlap the elongate shaft 612. In other examples, the distal end region 621 of the distal tip member 620 may extend distally from the elongate shaft 612 (and / or the distal end region 621 of the distal tip member 620 may extend distally from the imaging window region 623).

[0057] 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 sequence of steps, without exceeding the scope of the present disclosure. This may include, to the extent appropriate, the use of any of the features of the exemplary embodiments used in other embodiments. The scope of the invention will, of course, be defined in the language in which the appended claims are expressed.

Claims

1. 1. An intravascular imaging device comprising a catheter shaft and a distal tip member, the catheter shaft is configured to be placed inside a blood vessel and has an imaging window area and an imaging lumen; the imaging lumen is configured to house an imaging assembly therein; the distal tip member is coupled to the catheter shaft and has a guidewire lumen formed therein; the imaging window area and the distal tip member axially overlap; Intravascular imaging device.

2. The intravascular imaging device of claim 1 , wherein the distal tip member includes a distal end region extending distally from the imaging window region and an overlap region where the imaging window region and the distal tip member axially overlap.

3. The intravascular imaging device of claim 2 , wherein the distal end region has a length of about 5 to 25 millimeters.

4. The intravascular imaging device of claim 2 , wherein the distal end region has a length of about 10 to 20 millimeters.

5. The intravascular imaging device of any one of claims 2 to 4, wherein the overlap region has a length of about 300 millimeters or less.

6. The intravascular imaging device of any one of claims 2 to 4, wherein the overlap region has a length of about 15 to 300 millimeters.

7. The intravascular imaging device of any one of claims 1 to 6, wherein the imaging lumen is in fluid communication with the guidewire lumen.

8. The intravascular imaging device of any one of claims 1 to 7, wherein the distal tip member has an axially extending slit formed therein.

9. The intravascular imaging device of any one of claims 1 to 7, wherein the distal tip member has an axially extending channel formed therein.

10. The intravascular imaging device of any one of claims 1 to 9, wherein the distal tip member and the imaging window region are integrally formed.

11. The intravascular imaging device of any one of claims 1 to 10, wherein the distal tip member, the imaging window region, or both, comprises a coating.

12. 1. An intravascular imaging device comprising a catheter shaft assembly and an imaging core, the catheter shaft assembly includes a flexible region and a catheter shaft extending distally from the flexible region; the catheter shaft includes an imaging window region and a distal tip region having a guidewire lumen formed therein; the distal tip region has a first portion disposed distal to the imaging window region and a second portion disposed along a side of the imaging window region; the imaging core is disposed within the catheter shaft assembly; Intravascular imaging device.

13. The intravascular imaging device of claim 12 , wherein the distal tip region has an axially extending slit formed therein.

14. The intravascular imaging device of claim 12 , wherein the distal tip region has an axially extending channel formed therein.

15. The intravascular imaging device of any one of claims 12 to 14, wherein the distal tip region and the imaging window region are formed from a single monolithic material.

Images