Medical imaging devices with a bubble-reducing element

Abstract

Medical imaging device, comprising: an elongated shaft having a distal end portion and a proximal end portion; a connector connected to the proximal end portion, the connector having a flushing opening; a tip element connected to the distal end region; an imaging assembly disposed in the elongated shaft, the imaging assembly comprising a drive train, a housing connected to the drive train, and a transducer connected to the housing; a vent opening arranged adjacent to the housing so that fluid can be introduced at the flushing opening of the fitting and can exit through the vent opening to flush the stem; and a bubble-reducing element configured to prevent bubbles from moving along the shaft toward the housing and transducer or to reduce bubbles when flushing the shaft.

Description

Cross-Reference to Related ApplicationsThe present application claims the benefit of priority under 35 U.S.C. § 119 to U.S. Provisional Patent Application Serial No. 62 / 975,517, filed February 12, 2020, the entirety of which is incorporated herein by reference.Technical FieldThe present invention relates to medical devices. The present invention relates in particular to medical devices for imaging.BackgroundFor medical use, for example intravascular use, a variety of intracorporeal medical devices have been developed. These devices include, but are not limited to, guidewires, catheters, and the like. These devices are manufactured by any of a variety of different manufacturing methods and may be used according to any of a variety of different methods. Of the known medical devices and methods, each has certain advantages and disadvantages. There is a continuing need to provide alternative medical devices and use medical devices.BRIEF DESCRIPTION OF THE INVENTIONThe present invention provides alternatives to the design, material and use of medical devices. An imaging medical device is disclosed. The medical imaging device includes: an elongate shaft having a distal end portion; an imaging assembly disposed within the elongate shaft, the imaging assembly including a drive cable, a housing connected to the drive cable, and a transducer connected to the housing; and a bubble reducing element disposed proximate the drive cable.Alternatively or in addition to any of the foregoing embodiments, the imaging assembly is rotatable within the elongate shaft.Alternatively or additionally to any of the foregoing embodiments, the imaging assembly is slidable within the elongate shaft.Alternatively or in addition to any of the foregoing embodiments, the bubble reducing element is connected to the drive cable.Alternatively or in addition to any of the foregoing embodiments, the bubble reducing element extends between the drive cable and an inner surface of the elongate shaft.Alternatively or in addition to any of the foregoing embodiments, the bubble reducing element comprises a barrier disc having a plurality of apertures formed therein.Alternatively or in addition to any of the foregoing embodiments, the bubble reducing element comprises a tapered mesh.Alternatively or in addition to any of the foregoing embodiments, the bubble reducing element includes a plurality of axially extending fingers.Alternatively or in addition to any of the above embodiments, the bubble reducing element has a surface treated area.Alternatively or in addition to any of the above embodiments, the bubble reducing element comprises a coating.Alternatively or in addition to any of the foregoing embodiments, the transducer includes an ultrasonic transducer.An imaging medical device is disclosed. The medical imaging device includes: a catheter having a proximal end portion and a distal end portion; an imaging assembly movably disposed within the catheter, the imaging assembly including a drive cable, a housing connected to the drive cable, and an ultrasonic transducer connected to the housing; and a bubble reducing element connected to the drive cable, the bubble reducing element configured to allow a flow of a fluid between the proximal end portion and the distal end portion while disrupting the flow of bubbles between the proximal end portion and the distal end portion.Alternatively or in addition to any of the foregoing embodiments, the imaging assembly is rotatable within the catheter.Alternatively or additionally to any of the foregoing embodiments, the imaging assembly is axially slidable within the catheter.Alternatively or in addition to any of the foregoing embodiments, the bubble reducing element extends between the drive cable and an inner surface of the catheter.Alternatively or in addition to any of the foregoing embodiments, the bubble reducing element comprises a barrier disc having a plurality of apertures formed therein.Alternatively or in addition to any of the foregoing embodiments, the bubble reducing element comprises a tapered mesh.Alternatively or in addition to any of the foregoing embodiments, the bubble reducing element includes a plurality of axially extending fingers.Alternatively or in addition to any of the above embodiments, the bubble reducing element has a hydrophobic region.An imaging medical device is disclosed. The medical imaging device includes: a catheter having a proximal end portion and a distal end portion; an imaging assembly disposed within the catheter, the imaging assembly being rotatable and displaceable relative to the catheter and including a drive cable, a housing connected to the drive cable and an ultrasonic transducer connected to the housing; and a bubble reducing element connected to the drive cable, the bubble reducing element configured to allow flow of a fluid between the proximal end portion and the distal end portion while reducing flow of bubbles between the proximal end portion and the distal end portion.The foregoing brief description of some embodiments is not intended to describe each disclosed embodiment or implementation of the present invention. The figures and the detailed description below illustrate these embodiments in more detail.Brief Description of the DrawingsThe invention may be more fully understood by reference to the following detailed description taken in conjunction with the accompanying drawings, in which: FIG. 1 is a side view of an example of a medical device; FIG. 2 is a side view of a portion of an example of a medical device; FIG. 3 is a partial cross-sectional view of a portion of an example of a medical device; FIG. 4 is a partial cross-sectional view of a portion of an example of a medical device; FIG. 5 is a partial cross-sectional view of a portion of an example of a medical device; and FIG. 6 is a partial cross-sectional view of a portion of an example of a medical device.While the disclosure is susceptible to various modifications and alternative forms, details thereof are shown by way of example in the drawings and will be described in detail. It should be understood, however, that the invention is not intended to be limited to the specific embodiments described. On the contrary, it is intended to cover all modifications, equivalents and alternatives falling within the scope of the invention.DETAILED DESCRIPTIONFor the terms defined below, these definitions are intended to be applied unless a different definition is given in the claims or elsewhere in this specification.All numerical values are herein considered to be modified by the term "about" whether or not expressly stated. The term "about" refers generally to a range of numbers that a person skilled in the art would consider to be equivalent to the stated value (e.g., by which the same function or result is obtained). In many cases, the term "about" may include numbers that are rounded to the next significant location.The indication of numerical ranges by endpoints includes all numbers within this range (e.g., 1 to 5 includes numbers 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).As used in the present specification and the appended claims, the singular forms "a", "an" and "the / s" include the plural form unless the content clearly dictates otherwise. As used in the present specification and the appended claims, the term "or" is used generally in its meaning, including "and / or", unless the content clearly dictates otherwise.It is noted that references in the specification 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 statements do not necessarily imply that all embodiments have the particular features, structures, and / or characteristics. Moreover, when certain features, structures, and / or characteristics are described in connection with one embodiment, it should be understood that these features, structures, and / or characteristics may also be used in connection with other embodiments, whether or not explicitly described, unless expressly stated to the contrary.The following detailed description should be considered with reference to the drawings in which like elements are numbered the same in different drawings. The drawings, which are not necessarily to scale, illustrate exemplary embodiments and are not intended to limit the scope of the invention.FIG. 1 shows a side view of an example of a medical device 10. For example, the medical device 10 may be an intravascular ultrasound (IVUS) device usable for imaging a blood vessel. The structure / shape of the medical device 10 may vary. In some cases, the medical device 10 may include an elongate shaft 12 having a proximal end portion 14 and a distal end portion 16. A fitting 18 may be connected to or otherwise disposed adjacent the proximal end portion 14. A tip member 20 may be connected to or otherwise disposed adjacent the distal end portion 16. The tip member 20 may include a guidewire lumen, an traumatic distal end, one or more radiopaque markers, and / or other features. An imaging assembly 22 may be disposed within the shaft 12. Generally, the imaging arrangement may be used for acquiring / generating images of a blood vessel. In some cases, the medical device may include devices and / or features similar to those described in U.S. Patent Application Publication No. US 2012 / 0059241 and U.S. Patent Application Publication No. US 2017 / 0164925, the entire disclosures of which are incorporated herein by reference. In at least some cases, the medical device 10 may have features similar to and / or those similar to those of the device OPTICROSS™ Imaging Catheter, commercially available from BOSTON SCIENTIFIC, Marlboough, MA.The imaging assembly 22 may include a drive cable or shaft 24, a housing 26, and an imaging element or transducer 28 connected to the drive cable or shaft 24 and / or the housing 26, as shown in FIG. 2. In at least some cases, the transducer 28 includes an ultrasonic transducer. Other transducers are also possible. The transducer 28 may be rotatable and / or axially displaceable relative to the shaft 12. For example, the drive cable 24 may be rotated and / or slid to rotate and / or slide the transducer 28 (and the housing 26).In use of the medical device 10, it may be desirable to prepare and / or rinse the shaft 12. For flushing the medical device 10, a fluid can be introduced at a flushing connection on or at the connecting piece 18. The fluid may exit the medical device at a vent (not shown) near the distal end of the housing 26. In some cases, the flushing process may result in the formation of bubbles in the shaft 12. It may be desirable to rinse the medical device 10 such that formation of bubbles is reduced and / or formed bubbles are removed / destroyed because bubbles may reflect / interfere with a signal (e.g., an ultrasonic signal) from the transducer 28, which interferes with the image. While flushing is generally effective to remove bubbles, some bubbles may nevertheless become trapped in the shaft 12. Disclosed herein are medical devices configured to reduce bubble formation and / or help destroy bubbles that may form within the medical device.FIG. 3 shows a portion of another example of a medical device 110 that may be similar in form and function to other medical devices disclosed herein. The medical device 110 may include an elongated shaft 112. An imaging assembly 122 may be disposed within the shaft 112. The imaging assembly 122 may include a drive cable or shaft 124, a housing 126, and an imaging element or transducer 128 connected to the drive cable between the cable 124 and / or the housing 126.A bubble reducing element 130 may be connected to or otherwise disposed adjacent the drive cable 124. The bubble reducing element 130 may include a barrier or annular portion 132. A plurality of openings 134 may be disposed within the barrier portion 132, as shown in FIG. 4. In FIG. 4, the drive cable 124 is schematically illustrated with a hatching. Generally, the bladder-reducing element 130 is configured such that, upon irrigation of the medical device 110, the bladder-reducing element 130 prevents bladders from moving along the shaft 112 toward the housing 126 and the transducer 128, or reduces bladders. Specifically, the barrier portion 132 serves as a barrier to the flow of bubbles. In at least some cases, the bubble reducing element 130 (e.g., the barrier portion 132) extends between the outer surface 136 of the drive cable 124 and an inner surface 138 of the elongate shaft 112. This may include the barrier portion 132 contacting the inner surface 138 of the shaft 112 or being disposed adjacent the inner surface 138 of the shaft 112.The openings 134 are configured to allow fluid to pass therethrough. For example, the apertures 134 may be sized to allow fluid to pass therethrough while bubbles are either prevented from passing therethrough or torn / destroyed upon passing so as to reduce the effect of the bubbles on imaging. In other words, larger bubbles are substantially prevented from passing through the openings 134, and only smaller bubbles (e.g., bubbles small enough to easily escape from the vent) can pass through the openings. For example, the apertures may have a diameter of about 0.001 to 0.01 inches or about 0.003 to 0.005 inches. Bubbles passing through such openings would likely not adhere to transducer 128 and / or otherwise interfere with transducer 128.In some cases, the bubble reducing element 130 may have a surface treatment and / or other structural feature that also helps reduce bubbles. For example, the bubble reducing element 130 may be surface treated, etched (e.g., chemically etched), treated / coated with a coating such as polytetrafluoroethylene, micro-patterned, coated (e.g., having a coating), or otherwise rendered hydrophobic (e.g., superhydrophobic). This may result in bubbles formed becoming preferentially attached to the surface treated area rather than moving toward the transducer 128.FIG. 5 illustrates a portion of another example of a medical device 210 that may be similar in form and function to other medical devices disclosed herein. The medical device 210 may include an elongated shaft 212. An imaging assembly 222 may be disposed within the shaft 212. The imaging assembly 222 may include a drive cable or shaft 224, a housing 226, and an imaging element or transducer 228 connected to the drive cable or shaft 224 and / or the housing 226.A bubble reducing element 230 may be connected to or otherwise disposed adjacent the drive cable 224. The bubble reducing element 230 may have the shape of a tapered lattice. The bubble reducing element / tapered mesh 230 may function similar to the bubble reducing element 130. For example, the bubble reducing element 230 may extend between the outer surface 236 of the drive cable 224 and an inner surface 238 of the elongate shaft 212 to form a barrier while the grid-like structure (e.g., having openings therein) allows passage of fluid (while substantially preventing passage of bubbles).FIG. 6 shows a portion of another example of a medical device 310, which may be similar in form and function to other medical devices disclosed herein. The medical device 310 may include an elongated shaft 312. An imaging assembly 322 may be disposed within the shaft 312. The imaging assembly 322 may include a drive cable 324, a housing 326, and an imaging element or transducer 328 connected to the drive cable 324 and / or the housing 326.A bubble reducing element 330 may be connected to or otherwise disposed adjacent to the drive cable 324. The bubble reducing element 330 may include a plurality of axially extending fingers 340. The bubble reducing element 330 may function similar to the bubble reducing elements 130 / 230. For example, in at least some cases, the barrier member 330 extends between the outer surface 336 of the drive cable 324 and an inner surface 338 of the elongate shaft 312 to form a barrier. The gaps between the axially extending fingers 340 allow fluid to pass therethrough (while substantially preventing the passage of bubbles).The materials that may be used for the various components of the medical device 10 and / or other medical devices are disclosed herein. For simplicity, the following discussion relates to the medical device 10.The medical device 10 may be made of a metal, a metal alloy, a polymer (some examples of which are disclosed below), a metal-polymer composite, ceramic, combinations thereof, and the like, or another suitable material. Some examples of suitable polymers are polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® from DuPont), polyether block ester, polyurethane (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyetherester (e.g., ARNITEL® from DSM Engineering Plastics), ether- or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalate, and / or other polyester elastomers such as HYTREL® from DuPont), Polyamide (e.g., DURETHAN® from Bayer, or CRISTAMID® from Elf Atochem), elastomeric polyamides, block polyamide / ether, polyether block amide (PEBA, e.g., available under the trade designation PEBAX® ), ethylene-vinyl acetate copolymers (EVA), silicones, polyethylene (PE), high density polyethylene (e.g., MARLEX® high density polyethylene), low density polyethylene (e.g., MARLEX® low density polyethylene), linear low density polyethylene (e.g., REXELL® ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), Polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (such as GRILAMID® from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), polystyrene-b-isobutylene-b-styrene (e.g., SIBS and / or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials or blends, combinations, copolymers thereof, polymer / metal composites, and the like. In some embodiments, the shell may be mixed with a liquid crystal polymer (LCP). For example, the mixture may contain up to about 6 percent LCP.Some examples of suitable metals and metal alloys include stainless steel, such as 304V, 304L, and 316LV stainless steel; mild steel; nickel-titanium alloy, such as linear and / or superelastic nitinol; other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22® UNS: N10276 such as HASTELLOY® C276® other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, and the like), Nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as MP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665, such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as ELGILOY® PHYNOX® and the like); platinum-enriched stainless steel; titanium; Combinations thereof; and the like; or any other suitable material.In at least some embodiments, portions of or all of the medical device 10 may also be doped with, consist of, or otherwise contain an radiopaque material. Radiopaque materials are understood to mean materials that can produce a relatively bright image on a fluoroscopic screen or in another imaging method during a medical procedure. This relatively bright image aids the user of the medical device 10 in determining its position. Some examples of radiopaque materials may include gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with a radiopaque filler, and the like. In addition, other radiopaque marker bands and / or coils may also be incorporated into the construction of the medical device 10 to achieve the same result.In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the medical device 10. For example, the medical device 10 or portions thereof may be made of a material that does not substantially interfere with the image and does not generate substantial artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may not be suitable because they may produce artifacts in an MRI image. The medical device 10 or portions thereof may also be made of a material capable of imaging the MRI device. Materials having these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY® PHYNOX® and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nitinol, and the like, and others.U.S. Patent Application Publication No. US 2012 / 0059241 is incorporated herein by reference.It is to be understood that the present disclosure is illustrative only in many respects. Changes may be made in detail within the scope of the invention, particularly in relation to the shape, size and arrangement of steps. This may include, as appropriate, the use of any of the features of an example embodiment in other embodiments. The scope of the invention is defined by the appended claims.References included in the specificationThis list of documents cited by the applicant has been produced in an automated manner and is only included for the better information of the reader. The list is not part of the German patent application or utility model application. The DPMA does not take any adhesion for any faults or omissions.Patent Literature citedUS 62 / 975,517

[0001] US 2012 / 0059241 [0033, 0049]US 2017 / 0164925

[0033]

Claims

An imaging medical device comprising: an elongate shaft having a distal end portion and a proximal end portion; a connector connected to the proximal end portion, the connector having a flushing opening; a tip member connected to the distal end portion; an imaging assembly disposed in the elongate shaft, the imaging assembly including a drive train, a housing connected to the drive train, and a transducer connected to the housing; a vent opening disposed adjacent the housing such that fluid can be introduced at the flushing opening of the connector and can exit through the vent opening to flush the shaft; and a bubble reducing member configured to prevent bubbles from moving along the shaft toward the housing and the transducer or reduce bubbles upon flushing of the shaft.The medical imaging device of claim 1, wherein the bubble reducing element is adjacent the drive train.The medical imaging device of claim 1, wherein the bubble reducing element is connected to the drive train.The medical imaging device of claim 1, wherein the bubble reducing element extends between the drive train and an inner surface of the elongate shaft.The medical imaging device of claim 1, wherein the bubble reducing element comprises a barrier disc having a plurality of apertures formed therein.The medical imaging device of claim 1, wherein the bubble reducing element comprises a tapered mesh.The medical imaging device of claim 1, wherein the bubble reducing element comprises a plurality of axially extending fingers.The medical imaging device of claim 1, wherein the transducer comprises an ultrasonic transducer.The medical imaging device of claim 1, wherein the imaging assembly is rotatable within the elongate shaft.The medical imaging device of claim 1, wherein the imaging assembly is slidable within the elongate shaft.An imaging medical device (110, 210, 310) comprising: an elongate shaft (112, 212, 312) having a distal end portion (16); an imaging assembly (122, 222, 322) disposed within the elongate shaft, the imaging assembly including a drive train (124, 224, 324), a housing (126, 226, 326) connected to the drive train, and a transducer (128, 228, 328) connected to the housing; and a bubble reducing element (130, 230, 330) configured such that, upon flushing of the medical imaging device, the bubble reducing element (130, 230, 330) prevents bubbles from moving along the elongated shaft (112, 212, 312) toward the housing (126, 226, 326) and the transducer (128, 228, 328) or reduces bubbles, wherein the bubble reducing element (130) has a barrier disk (132) with a plurality of apertures (134) formed therein.The medical imaging device of claim 11, wherein the imaging assembly (122, 222, 322) is rotatable within the elongate shaft (112, 212, 312).The medical imaging device of claim 11 or 12, wherein the imaging assembly (122, 222, 322) is slidable within the elongate shaft (112, 212, 312).The medical imaging device of any of claims 11 to 13, wherein the bubble reducing element (130, 230, 330) is connected to the drive train (124, 224, 324).The medical imaging device of any of claims 11 to 14, wherein the bubble reducing element (130, 230, 330) extends between the drive train (124, 224, 324) and an inner surface (138, 238, 338) of the elongate shaft (112, 212, 312).The medical imaging device according to any one of claims 11 to 15, wherein the bubble reducing member (130, 230, 330) has a surface treatment region.The medical imaging device of any one of claims 11 to 16, wherein the bubble reducing element (130, 230, 330) comprises a coating.The medical imaging device of any of claims 11 to 17, wherein the transducer (128, 228, 328) comprises an ultrasonic transducer.The medical imaging device of any of claims 11 to 18, wherein the elongate shaft (112, 212, 312) further comprises a proximal end portion (14), and wherein the bladder reducing element (130, 230, 330) is connected to the drive train (124, 224, 324) and configured to allow fluid to flow between the proximal end portion (14) and the distal end portion (16) while disrupting the flow of bladders between the proximal end portion (14) and the distal end portion (16).An intravascular ultrasound device (10) for use in imaging a blood vessel, comprising: an elongate shaft (12, 112; 212, 312) having a proximal end region (14) and a distal end region (16); a hub (18, 118, 218, 318) connected to or otherwise disposed adjacent to the proximal end region (14); a tip member (20, 120, 220, 320) connected to or otherwise disposed adjacent to the distal end region (16); an imaging assembly (22, 122, 222, 322) disposed within the elongate shaft (12, 112, 212, 312) and configured to capture and / or generate images of a blood vessel, the imaging assembly including a drive train (24, 124, 224, 324), a housing (26, 126, 226, 326) connected to the drive train, and a transducer (28, 128, 228, 328) connected to the drive cable and / or the housing; wherein the device (10) is configured to be flushed by introducing fluid at a flushing port on or at the fitting (18) and to discharge the fluid at a venting port near the distal end of the housing (26), wherein a bubble reducing element (130, 230, 330) is provided configured such that, upon flushing the medical device, the bubble reducing element prevents bubbles from moving along the shaft towards the housing (126) and the transducer (128), or bubbles are reduced.The medical imaging device of claim 20, wherein the imaging assembly is rotatable within the elongate shaft.The medical imaging device of claim 20 or 21, wherein the imaging assembly is slidable within the elongate shaft.The medical imaging device of any of claims 20 to 22, wherein the bubble reducing element is connected to the drive train.The medical imaging device of any of claims 20 to 23, wherein the bubble reducing element extends between the drive train and an inner surface of the elongate shaft.The medical imaging device of any of claims 20 to 24, wherein the bubble reducing element comprises a barrier disc having a plurality of apertures formed therein.The medical imaging device of any one of claims 20 to 24, wherein the bubble reducing element comprises a tapered mesh.The medical imaging device of any of claims 20 to 24, wherein the bubble reducing element comprises a plurality of axially extending fingers.The medical imaging device according to any one of claims 20 to 27, wherein the bubble reducing member has a surface treatment region.The medical imaging device of any one of claims 20 to 28, wherein the bubble reducing element comprises a coating.The medical imaging device of any of claims 20 to 29, wherein the transducer comprises an ultrasonic transducer.The medical imaging device of any one of claims 20 to 30, wherein the tip member (20) comprises a guidewire lumen, an traumatic distal end, and / or one or more radiopaque markers.

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