WO2016148882A1

WO2016148882A1 - Improved needle scribe at tip

Info

Publication number: WO2016148882A1
Application number: PCT/US2016/020011
Authority: WO
Inventors: Jean Martin BAILLARGEON
Original assignee: SPIRATION, INC., d/b/a OLYMPUS RESPIRATORY AMERICA
Priority date: 2015-03-17
Filing date: 2016-02-29
Publication date: 2016-09-22

Abstract

A needle is provided, comprising an elongated section including one or more first markings and a needle tip including one or more second markings. The one or more first markings and the one or more second markings are echogenic markings. The one or more first markings extend circumferentially around the elongated section and the one or more second markings extend along a portion of the needle tip. Another portion of the needle tip includes a beveled section forming a sharp tip.

Description

IMPROVED NEEDLE SCRIBE AT TIP FIELD

[00011 The present teachings relate to a medical device, and more particularly to a needle including echogenic scribes and a method for making the same.

BACKGROUND

[0002] A biopsy device may include a catheter and a needle moveably supported within the catheter. The needle may include a needle tip for penetrating, cutting, coring, and collecting a tissue sample from a region of interest. The needle, the needle tip, or both may include echogenic features, which may be or may include one or more scribes of various sizes, shapes, and/or geometry. During a tissue sampling procedure, the echogenic features may provide and/or enhance real-time visualization of the needle in the patient. That is, the echogenic features can help determine the location of the needle and/or the needle tip in the patient; can help indicate how deep or how far the needle and/or needle tip is from the region of interest; and/or can help indicate the orientation of the needle and/or the needle tip relative to the region of interest. Some needles also include a lancet tip, which may provide better penetrating, cutting, and tissue sampling from the region of interest. While a needle tip including both echogenic features and a lancet tip may be desirable for use in sampling procedures, such a needle tip may be undesirably thin, delicate, and/or fragile, particularly when producing echogenic features on the needle tip does not take into account where the end of the needle is to avoid creating a notched portion at the needle tip. In other words, during use, such a needle tip may bend or break, which may undesirably result in additional time required to complete the tissue sampling procedure; may be cumbersome to the surgeon performing the tissue sampling procedure; and/or may make the patient feel pain and/or discomfort during and/or after the tissue sampling procedure. Some examples of devices for obtaining tissue samples are disclosed in U.S. Patent Application Publication Number 2009/0248071A1, U.S. Patent Number 8,633,554B2 and WO 2014/152217A1, all three of which are incorporated by reference herein in their entirety for all purposes.

[0003| It would be attractive to have an improved needle with both echogenic features and a lancet tip that is sturdy and will withstand bending and/or breaking during use. It would be attractive to provide a method for making a needle with both echogenic features and a lancet tip that is sturdy and will withstand bending and/or breaking during use. It would be desirable to provide a needle including one or more, or even two or more echogenic markings or scribes at a distal portion or needle tip. It would be attractive to provide a needle that can be mass-produced relatively inexpensively, that has a minimal number of parts, and that is easy to operate.

SUMMARY

[0004| The present teachings meet one or more of these needs by providing an improved needle having echogenic features and a lancet tip that is sturdy and will withstand bending and/or breaking during use. The present teachings provide a method for making a needle including echogenic features and a lancet tip that is sturdy and will withstand bending and/or breaking during use. The present teachings provide a needle including one or more, or even two or more echogenic markings or scribes at a distal portion or needle tip. The present teachings provide a needle that can be mass-produced relatively inexpensively, that has a minimal number of parts, and that is easy to operate.

[0005] The present teachings also provide a needle comprising an elongated section including one or more first markings and a needle tip including one or more second markings. The one or more first markings and the one or more second markings are echogenic markings. The one or more first markings extend circumferentially around the elongated section, and the one or more second markings extend along a portion of the needle tip. Another portion of the needle tip includes a beveled section forming a sharp tip.

[0006| The present teachings further provide a method for forming a needle. The method comprises the steps of securing a needle to a device; forming first echogenic markings on the needle; and forming second echogenic markings on the needle.

BRIEF DESCRIPTION OF THE DRAWINGS

[00071 FIG. 1 illustrates a perspective view of a device including an ultra sound probe and a bronchoscope having a needle and according to the teachings herein;

[0008| FIG. 2A illustrates a partial top view of a needle including an elongated section and a needle tip according to the teachings herein;

[0009| FIG. 2B illustrates a partial top view of a needle including an elongated section and a needle tip according to the teachings herein; [0010] FIG. 2C illustrates a partial side view of a needle including an elongated section and a needle tip according to the teachings herein;

[00111 FIG.2D illustrates a partial perspective view of a needle including an elongated section and a needle tip according to the teachings herein;

[0012| FIG. 3 A illustrates a partial top view of a needle including an elongated section and a needle tip according to the teachings herein;

[0013] FIG. 3B illustrates a partial top view of a needle including an elongated section and a needle tip according to the teachings herein;

[0014] FIG. 3C illustrates a partial side view of a needle including an elongated section and a needle tip according to the teachings herein;

[0015] FIG.3D illustrates a partial perspective view of a needle including an elongated section and a needle tip according to the teachings herein;

[0016] FIG. 4A illustrates a partial top view of a needle including an elongated section and a needle tip according to the teachings herein;

[0017] FIG. 4B illustrates a partial top view of a needle including an elongated section and a needle tip according to the teachings herein;

[0018] FIG. 4C illustrates a partial side view of a needle including an elongated section and a needle tip according to the teachings herein;

[0019] FIG.4D illustrates a partial perspective view of a needle including an elongated section and a needle tip according to the teachings herein;

[0020] FIG. 5A illustrates a partial top view of a needle including an elongated section and a needle tip according to the teachings herein;

[0021] FIG. 5B illustrates a partial top view of a needle including an elongated section and a needle tip according to the teachings herein;

[0022] FIG. 5C illustrates a partial side view of a needle including an elongated section and a needle tip according to the teachings herein;

[0023] FIG. SD illustrates a partial perspective view of a needle including an elongated section and a needle tip according to the teachings herein;

[0024| FIG. 6 illustrates a perspective view of a device for forming scribes on an elongated section of a needle and/or a needle tip according to the teachings herein; and [0025] FIG. 7 illustrates a perspective view of forming scribes on an elongated section of a needle and/or a needle tip according to the teachings herein.

DETAILED DESCRIPTION

[0026| This Application claims priority to U.S. Provisional Application No. 62/134,209, filed on March 17, 2015, the entirety of which is hereby incorporated by reference herein for all purposes. The explanations and illustrations presented herein are intended to acquaint others skilled in the art with the teachings, its principles, and its practical application. Those skilled in the art may adapt and apply the teachings in its numerous forms, as may be best suited to the requirements of a particular use. Accordingly, the specific embodiments of the present teachings as set forth are not intended as being exhaustive or limiting of the teachings. The scope of the teachings should, therefore, be determined not with reference to the description herein, but should instead be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. The disclosures of all articles and references, including patent applications and publications, are incorporated by reference for all purposes. Other combinations are also possible as will be gleaned from the following claims, which are also hereby incorporated by reference into this written description.

[0027| While the teachings herein refer to and reference terms like "bronchoscope", "lymph node", "device", "needle", "sampling needle" and the like, it is understood that these terms are broad, and the teachings herein can be used without limitation. In other words, the teachings herein may be suitable for accessing other vessels, passages, lumens, body cavities, anatomy, tissue, organs, the like, or a combination thereof in humans and animals. The one or more devices may function to obtain tissue samples for biopsy. The one or more devices may function to obtain tissue samples, blood samples, or any other type of sample from internal organs such as the liver, lungs, pancreas, intestines, and kidneys. The one or more devices may function to inject or deliver medicine into the anatomy. The one or more devices may include one or more bronchoscopes.

[0028| The one or more bronchoscopes may be or may provide a device for withdrawing foreign bodies, tissue samples, or both from the anatomy. The one or more bronchoscopes may provide for insertion, manipulation, and operation of various surgical instruments in the anatomy of a patient. The one or more bronchoscopes may provide for delivery of one or more fluids, medicines, pastes, therapies, or a combination thereof into the anatomy. The one or more bronchoscopes may be used to visually inspect a site of interest, like the airways and lungs of a patient. The one or more bronchoscopes may be used to examine, treat, and/or diagnose lung growth, lung problems, lung cancer, lymph node(s), atelectasis, suspected interstitial lung disease, a lung rejection after a lung transplant, and/or to remove fluid or mucus plugs from the airways of a patient. The one or more bronchoscopes may be at least partially flexible, at least partially rigid, or both. The one or more bronchoscopes may include one or more ultrasound probes.

[0029| The one or more ultrasound probes may function to provide a surgeon with the ability to view at least a portion of the device in the anatomy. The one or more ultrasound probes may be used to help indicate depth of penetration of a device, a catheter, a needle, a needle tip, or a combination thereof into a site of interest. The one or more ultrasound probes may function to assist in orienting a device, a catheter, a needle, a needle tip, or a combination thereof relative to a region of interest. The one or more ultrasound probes may function to assist in locating a device, a catheter, a needle, a needle tip, or a combination thereof relative to a site or region of interest. The one or more ultrasound probes may send, deflect, reflect, or provide ultrasound wave energy towards a needle, a catheter, a needle tip, or a combination thereof. The one or more ultrasound probes may include one or more transducers and/or transmitters for transmitting or sending ultrasound waves to or towards a needle, a catheter, a needle tip, or a combination thereof. The needle, the catheter, the needle tip, or one or more echogenic features located thereon may reflect or deflect wave energy back to the one or more ultrasound probes. The one or more ultrasound probes may receive echo signals reflected and or deflected from the echogenic features, the catheter, the needle, the needle tip, or a combination thereof. The one or more bronchoscopes may include one or more catheters.

[0030] The one or more catheters may function to provide a channel, a lumen, an opening, and/or a passageway for one or more devices to be advanced and/or introduced into the anatomy. The one or more catheters may function to introduce into the anatomy one or more medical devices, needles, transbronchial needle aspiration devices, cytology brushes, biopsy forceps, guiding devices, ultrasonic probes, illumination devices, therapies (i.e., chemotherapy, proteinomics, microspheres, etc.), the like, or a combination thereof. The one or more catheters may be used to remove or expel from the anatomy one or more devices, fluids, tissue samples, abnormalities, foreign matter, or a combination thereof. The one or more catheters may each contain one or more lumens. The one or more catheters may be generally rigid, generally flexible, or a combination of both. The one or more catheters may include one or more sections that are generally rigid, one or more sections that are generally flexible, or a combination of both. The one or more catheters may be at least partially flexible, bendable, articulable, or a combination thereof so that access to regions of interest can be easily obtained. The one or more catheters may bend or articulate 15 degrees or more, 45 degrees or more, 60 degrees or more, 90 degrees or more, 110 degrees or more, or even 130 degrees or more. The one or more catheters may be fabricated from a polymer, nylon, silicon, or any other suitable material. The one or more catheters may be elongated tubular members. An outer surface of the one or more catheters may include a lubricant to facilitate insertion into, and removal from, the anatomy, the bronchoscope, a working channel of the bronchoscope, or a combination thereof. The one or more catheters may extend along a longitudinal axis, a catheter axis, or both. The one or more catheters may include a uniform cross section, or the cross section may vary, taper, widen, narrow, or a combination thereof. The cross section of the one or more catheters may be circular, oval, irregular, and/or any other suitable shape or configuration. The cross section of the one or more catheters may be expandable, collapsible, formable, deformable, or a combination thereof. The one or more catheters may be configured to house, contain and/or protect any size or gauge needle. For example, the one or more catheters may house, contain, and/or protect about a 25 gauge needle or more, about a 22 gauge needle, about a 21 gauge needle, about a 19 gauge needle or less, etc. An outer surface of the one or more catheters may include one or more echogenic features or scribes. The one or more catheters may include one or more echogenic features so that the position and orientation of the catheter, the device, the needle, the needle tip, or a combination thereof can be viewed. The one or more catheters may include or define a hole or opening at a distal end, a proximal end, at a region in between, or a combination thereof so that one or more devices or instruments can pass there through. The one or more catheters may include or define an inner surface, an inner diameter, an inner portion, or a combination thereof that is dimensioned to generally conform to the outer diameter of the one or more needles.

[00311 The one or more needles may function to be advanced into the anatomy to penetrate a site or region of interest. The one or more needles may function to puncture a region of interest so that a tissue sample can be obtained. The one or more needles may function to provide medicine, therapy, or both to the anatomy. The one or more needles may function to provide, develop, or have a local vacuum to a distal end or at a distal tip thereof. The one or more needles may be advanced towards and retracted from the region of interest via one or more catheters, bronchoscopes, devices, or a combination thereof. The one or more needles may be at least partially contained within the catheter. The one or more needles may be moved, advanced, retracted, or a combination thereof in the catheter. The one or more needles may have a length that extends along a longitudinal axis, a needle axis, or both. The one or more needles may have a constant cross section, a varying cross section, a tapered cross section, an irregular cross section, or a combination thereof. The cross section of the one or more needles may be generally circular, oval, irregular, or any other suitable shape. The one or more needles may be generally hollow. The one or more needles may include a generally concentric outer diameter and inner diameter. The one or more needles may have an outer diameter and an inner diameter, one or more of which may have a constant size along a length of the needle. The one or more needles may have an outer diameter and an inner diameter, one or more of which may vary, taper, slope, change, or a combination thereof. The one or more needles may be formed from a single material, or may be formed from one or more materials. The one or more needles may be fabricated from any material suitable for use in medical procedures. The one or more needles may be made from a metal or metal alloy, such as stainless steel, nitinol, or the like. The one or more needles may comprise a polymer or other suitable covering. The one or more needles may be generally rigid, generally flexible, or both. The one or more needles may include one or more portions or sections that are generally rigid, one or more portions or sections that are generally flexible, or both. The one or more needles may be at least partially flexible, bendable, articulable, or a combination thereof so that access to regions of interest can be easily obtained. The one or more needles may bend or articulate about 15 degrees or more, about 45 degrees or more, about 60 degrees or more, about 0 degrees or more, about 110 degrees or more, or even about 130 degrees or more. The one or more needles may be constructed from one or more hypotubes. The one or more needles may be constructed from one or more hypotubes that are relatively smooth and able to freely slide, rotate, or otherwise move within a catheter, a bronchoscope, a device, the anatomy, or a combination thereof. The one or more needles may include one or more holes, ports, slots, apertures, openings, the like, or a combination thereof at the distal end, a proximal end, or a location therebetween. The one or more needles may include one or more holes, ports, slots, the like or a combination thereof for tissue sample collection; for introducing one or more devices into the needle; for introducing one or more devices into the anatomy, for introducing medicine or therapy to the anatomy; or a combination thereof.

[0032| The one or more needles may be any size or gauge. That is, the one or more needles may be about 25 gauge or more, about 22 gauge, about 21 gauge, or about 19 gauge or less, etc. The one or more needles may include a combination of two or more gauges. That is, for example, a proximal portion of the needle may be about 21 gauge and a distal portion of the needle may be about 19 gauge, or vice versa. The one or more needles may comprise two or more needle portions that are joined together fixedly, permanently, temporarily, or a combination thereof. The two or more needle portions may be the same gauge, or may be different gauges. One or both of the needle portions may include an interior size or region that is generally the same size as the one or more stylets, sealing members, or both. That is, the one or more stylets, sealing members, or both may substantially occupy some, most, or all of the interior of the one or more needles, needle portions, or both. One or both of the needle portions, the needle, or both may be slightly larger than the one or more stylets, sealing members, or both so that the stylets, the sealing members, or both only occupy some of the interior space or region of the one or more needles, needle portions, or both. The one or more needles may include one or more sample storage areas. The one or more sample storage areas may function to provide an area or location for cut cored, separated, and/or removed tissue or foreign mater separated or obtained from a site or region of interest to be stored. The one or more sample storage areas may function to prove an area for tissue samples, foreign matter, or both to be stored until the needle, catheter, bronchoscope, device, or a combination thereof is removed from the anatomy. The tissue sample, foreign matter, or both may be aspirated into the sample storage area via a local vacuum created at a distal end of the needle, via an ancillary suction device in communication withy the needle, or both. The one or more sample storage areas may be located between a distal end or a distal tip of the needle and a distal end or distal surface of the stylet. The one or more sample storage areas may be located between a distal end or a distal tip of the needle and a distal end or surface of the sealing member. To create the one or more sample storage areas, the one or more stylets, the one or more sealing members, or both may be at least partially withdrawn from the one or more needles. To create a local vacuum, a stylet, a sealing member, or both may be at least partially moved, removed, withdrawn, or a combination therefrom from the catheter. The one or more needles may include an elongated section, member or shaft and a distal tip or needle tip. One or more needle tips may be located at a distal end of the needle, an elongated section of the needle, or both.

[00331 The one or more needle tips may function as a piercing tip or feature so that cells, tissue, foreign matter, or a combination thereof from a site or region of interest can be obtained. The one or more needle tips may be angled, sharply angled, beveled, flat, or a combination thereof so that the tissue samples can be cut, cored, scraped from a site or region of interest. The one or more needle tips may include a notched portion, a recessed portion, and/or a lancet feature. A local vacuum may be created or formed at the needle tip, a distal end of the needle, or both so that tissue samples can be aspirated or moved into the needle, into the sample storage area, or both. The one or more needle tips may be located at a distal end or distal portion of the elongated section, needle, or both. The one or more needle tips may be contained within the one or more catheters as the catheter is advanced through the anatomy towards the site or region of interest. The one or more needle tips may be advanced or extended past a distal end of the one or more catheters when near the region of interest. The one or more needle tips may be generally rigid, flexible, or both. The elongated section or member of the needle, the needle tip, the needle, the catheter, or a combination thereof may include one or more echogenic features or scribes.

[0034] The one or more echogenic features may function to enhance visibility of the catheter, needle, the needle tip, or a combination thereof. The one or more echogenic features may improve visibility on ultrasound images and enable a precise puncture of a lesion or site of interest. Using ultrasonic imaging, the one or more echogenic features may function to create one or more reflections so that a position or location of the needle, the needle tip, or both within the anatomy can be determined. The one or more echogenic features may function to help a surgeon determine the position of the catheter, the needle and/or the needle tip in the patient. The one or more echogenic features may function to help indicate how deep or how far the catheter, the needle and/or needle tip is from the region of interest. The one or more echogenic features may function to help indicate the orientation of the needle and/or the needle tip relative to the region of interest. Each of the one or more echogenic features may provide a distant echogenic reflection, the same or similar echogenic reflection, or a combination thereof. The one or more echogenic features may be one or more signature markers. The one or more echogenic features may be or may include one or more scribes, bands, slots, segments, shapes, surfaces, recesses, roughened surfaces, embedded materials, coatings, projections, serrations, or a combination thereof. The one or more echogenic features may be or may include one or more dimples, scallops, spiral scribes, helixes, squiggles, angled squiggles, jig-saws, symmetrical shapes or patterns, asymmetrical shapes or patterns, irregular shapes or patterns, dots, dashes, lines, formations, serrations, grooves, channels, back-and-forth patterns, or a combination thereof. The one or more echogenic features may include circular scribes radially extending outwardly from a central portion. The one or more echogenic features may include short linear scribes including nodes where the linear scribes change direction. The nodes may be sharp angles. The nodes may be radiuses. The scribes may be linear, rounded, canted, irregular, or a combination thereof. The one or more echogenic features may be engravings into the needle, the needle tip, or both having a uniform depth, or a variable depth. The one or more echogenic features, engravings, or both may have linear walls or edges, or may be curved. The one or more echogenic features, engravings, or both may be covered in another material, a paint, a paste, or a combination thereof. The one or more first markings and the one or more second markings may be connected, or may be separated by an area or portion that does not include any markings, scribes, echogenic features, or a combination thereof. The one or more first markings may be combined and/or at last partially overlap with the one or more second markings. The one or more first markings may be the same as the one or more second markings, or may be different. The one or more first markings may be located on an elongated section of the needle and the one or more second markings may be located on the needle tip, or vice versa. The one or more first markings may be located on the elongated section of the needle and the one or more second markings may begin at a transition or slope between the elongated section and the needle tip and extend toward a distal end of the needle tip

[0035| The size, shape, and/or location of the one or more echogenic features may be uniform, consistent, or may be irregular and vary. The one or more echogenic features may be located around at least a portion of a circumference of the catheter, the needle, the needle tip, or both. The one or more echogenic features may extend partially or completely around a circumference of the catheter, the needle, the needle tip, or both. The one or more echogenic features may extend around a circumference of the needle, the needle tip, or both about 25 degrees or more, about 45 degrees or more, about 60 degrees or more, about 90 degrees or more, about 135 degrees or more, about 180 degrees more, about 270 degrees or more, or about 360 degrees or less. The one or more echogenic features may be at least partially circumferentially continuous, at least partially circumferentially segmented, or both. The one or more echogenic features may be at least partially continuous, at least partially segmented, or both. The one or more echogenic features may be located on, in, or within one or more faces, surfaces, portions, recesses, and grooves of the catheter, the needle, the needle tip or both. The one or more echogenic features may continue along a longitudinal axis of the needle all the way to the distal end of the needle tip, or may stop short of the distal end. The one or more echogenic features may stop short of the distal end of the needle tip by more or less than about 0.001 of an inch, more or less than about 0.002 of an inch, or any other suitable distance. The one or more echogenic features may include one or more first markings and one or more second markings. The one or more first markings, the one or more second markings, or both may be located on an upper portion of the needle, the elongated section of a needle, the needle, tip, a lower portion of the needle tip, an upper portion of the needle tip, or a combination thereof. The one or more first markings may be located proximal the one or more second markings, or vice versa. The one or more first markings may be located closer to a proximal end of the needle than the one or more second markings, or vice versa.

[0036] The one or more echogenic features may be cut, laser cut, laser etched, formed with a laser beam, sanded, grinded, roll formed, chemically etched, spirally or radially scored, bead blasted, or a combination thereof. The one or more first markings and the one or more second markings may be made in the same forming device, or may be made in different forming devices. The one or more echogenic features, the one or more first markings, the one or more second markings, the lancet tip, or a combination thereof may be made during the same manufacturing or forming process or step, or may be made in one or more processes or steps. The one or more devices for forming the echogenic features, the one or more first markings, the one or more second markings, or a combination thereof may be a 3-axis machine, a 4-axis machine, a S-axis machine, or any other suitable machine. The needle may be placed in a device and the one or more first markings may be cut, laser cut, laser etched, formed with a laser beam, sanded, grinded, roll formed, chemically etched, spirally or radially scored, bead blasted, or a combination thereof. The needle may be kept in the same device and the one or more second markings can be cut, laser cut, laser etched, formed with a laser beam, sanded, grinded, roll formed, chemically etched, spirally or radially scored, bead blasted, or a combination thereof onto the needle. The one or more second markings can be formed before, during or after the one or more first markings are formed. The lancet tip may be formed in the same device used to form the one or more first markings, the one or more second markings, or both, or may be placed in a different device. The lancet tip may be formed before, during or after the one or more first markings, the one or more second markings, or a combination thereof are formed. One or more needles may be placed into a device so that the one or more first markings, the one or more second markings, the lancet tip, or a combination thereof can be formed simultaneously, in sequence, or both.

[0037| The one or more needles may be rotated in a jig, a collet, a headstock, a tailstock, or a combination thereof while the one or more first markings, the one or more second markings, the lancet tip, or a combination thereof are formed. The one or more needles may be prevented or restricted from rotating in a jig, a collet, a headstock, a tailstock, or a combination thereof while the one or more first markings, the one or more second markings, the lancet tip, or a combination thereof are formed. The one or more devices for forming the one or more markings, lancet tip, or both may include one or more cutters, lasers, scribing tools, grinders, etching chemicals, or a combination thereof. The one or more cutters, lasers, scribing tools, grinders, etching chemicals, or a combination thereof may be fixed while the one or more needles move or are kept stationary; may move and/or pivot about or along an axis while the one or more needles move or are kept stationary, or a combination thereof.

[0038| The device, the needle, the one or more echogenic features, the needle tip, or a combination thereof may be created using a method. The method steps may be performed in virtually any order. The method steps may include the steps of selecting a mandrel and placing the needle over the mandrel. The method may include a step of securing a first end of the needle or a first end of the mandrel to the device, and/or securing a second end of the needle or a second end of the mandrel to the device. The method may include a step of adjusting and directing a laser beam towards the needle. The method may include a step of moving the needle while maintaining the laser beam generally fixed and forming with the laser beam the one or more first echogenic markings. The method may include a step of moving the needle while maintaining the laser beam generally fixed and forming with the laser beam and forming the one or more second echogenic markings. The method may include the step of maintaining the needle generally fixed while moving the laser beam to form with the laser beam the one or more first echogenic markings, the one or more second echogenic markings, or both. The method may include the step of removing the needle from the device. The method may include the step of notching the needle to form a lancet tip. [0039] FIG. 1 generally illustrates a system 10. The system 10 includes a bronchoscope 12 and an ultrasound probe 14. The system 10 includes an aperture 16 from which a needle 20 sheathed in a catheter 18 extends from. The needle 20 and the catheter 18 are substantially coaxially arranged along a needle axis 22, and are moveable relative to one another along the needle axis 22. Accordingly, a needle tip 24 can be selectively retracted into the catheter 18 and selectively extended beyond a distal end 26 of the catheter 18. The needle 20 includes one or more of the markings described below, which can enhance visualization of the needle 20, the needle tip 24, or both while in the anatomy with the ultrasound probe 14.

[0040] FIG. 2A illustrates a portion of the needle 20. The needle 20 includes an elongated section 28 located proximal to a needle tip 24. At least a portion of the elongated section 28 includes first markings 30, and at least a portion of the needle tip 24 includes second markings 32. With the ultrasound probe 14 shown in FIG. 1 and/or with an external ultrasound transducer, one or both of the markings 30, 32 can assist in providing and/or enhancing visualization of the needle 20, the needle tip 24, or both in the anatomy.

[0041] FIGS. 2B, 2C, and 2D illustrate various views of a portion of the elongated section 28 and the needle tip 24. The first markings 30 are helical and/or spiral markings that extend around a circumference of the elongated section 28. The second markings 32 are markings that extend in a zig-zag, jig-saw, and/or a back-and-forth curved pattern on a portion of the needle tip 24. That is, the second markings 32 extend on an upper portion 40 or face of the needle tip 24 and stop short of the distal end 42 of the needle tip 24. The needle tip 24 may also include a beveled section 36 forming a lancet tip, which may be located on a lower portion 38 or face thereof. Accordingly, the distal end 42 of the needle tip 24 is better suited to withstand bending and/or preventing breaking during use.

[0042] FIG. 3A illustrates a portion of the needle 20. The needle 20 includes an elongated section 28 located proximal a needle tip 24. At least a portion of the elongated section 28 includes first markings 30, and at least a portion of the needle tip 24 includes second markings 32. With the ultrasound probe 14 shown in FIG. 1 and/or with an external ultrasound transducer, one or both of the markings 30, 32 can assist in providing and/or enhancing visualization of the needle 20, the needle tip 24, or both in the anatomy.

[0043] FIGS. 3B, 3C, and 3D illustrate various views of the elongated section 28 and the needle tip 24. The first markings 30 are helical and/or spiral markings that extend around a circumference of the elongated section 28. The second markings 32 are markings that resemble squiggles and/or a back-and-forth curved pattern around at least a portion of the needle tip 24. That is, the second markings 32 extend on an upper portion 40 or face of the needle tip 24 and stop short of the distal end 42 of the needle tip 24. The needle tip 24 may also include a beveled section 36 forming a lancet tip, which may be located on a lower portion 38 or face thereof. Accordingly, the distal end 42 of the needle tip 24 is better suited to withstand bending and/or prevent breaking during use

[0044| FIG. 4A illustrates a portion of the needle 20. The needle 20 includes an elongated section 28 located proximal the needle tip 24. At least a portion of the elongated section 28 includes first markings 30, and at least a portion of the needle tip 24 includes second markings 32. With the ultrasound probe 14 shown in FIG. 1 and/or with an external ultrasound transducer, one or both of the markings 30, 32 can assist in providing and/or enhancing visualization of the needle 20, the needle tip 24, or both in the anatomy.

[0045] FIGS. 4B, 4C, and 4D illustrate various views of the elongated section 28 and the needle tip 24. The first markings 30 are helical and/or spiral markings that extend around a circumference of the elongated section 28. The second markings 32 are markings that resemble squiggles, angled squiggles, and/or a back-and-forth curved pattern around at least a portion of the needle tip 24. That is, the second markings 32 extend on an upper portion 40 or face of the needle tip 24 and stop short of the distal end 42 of the needle tip 24. The needle tip 24 may also include a beveled section 36 forming a lancet tip, which may be located on a lower portion 38 or face thereof. Accordingly, the distal end 42 of the needle tip 24 can withstand bending and/or breaking during use.

[0046| FIG. 5A illustrates a portion of the needle 20. The needle 20 includes an elongated section 28 located proximal the needle tip 24. At least a portion of the elongated section 28 includes first markings 30, and at least a portion of the needle tip 24 includes second markings 32. With the ultrasound probe 14 shown in FIG. 1 and/or with an external ultrasound transducer, one or both of the markings 30, 32 can assist in providing and/or enhancing visualization of the needle 20, the needle tip 24, or both in the anatomy.

[0047| FIGS. 5B, SC, and 5D illustrate various views of the needle tip 24. The first markings 30 are helical and/or spiral markings that extend around a circumference of the elongated section 28. The second markings 32 include a spiral shape extending outwardly from a center portion to an outer portion around at least a portion of the needle dp 24, That is, the second markings 32 extend on an. upper portion 40 or face of the needle tip 24 and stop short of the distal end 42 of the needle tip 24. The needle tip 24 may also include a beveled section 36 forming a lancet tip, which may be located on a lower portion 38 or face thereof. Accordingly, the distal end 42 of the needle tip 24 ^'may be better suited to withstand bending and/or prevent breaking during use.

|0048] FIG. 6 illustrates -an exemplary device.100 for forming, the first and second markings 30, 32 on the needle 20. The device 100 Includes a base 102 with extensions 104 supporting a bridge 106, The extensions 104 and bridge 106 are configured to move along axis 1.08. A carriage 110 supported on the bridge 106 is configured to move along axis 114. The carriage 110 supports a laser 112, which generates a beam 118, The laser 112 is configured to pivot about axis 1 16, The device 100 further includes a taitetock 120 and a head stock 122. A chuck or collet 124 receiving a mandrel 128 (See FIG. 7) is supported on the head stock 322 and rotates about axis 126, ί0045¾ FIG; 7 illustrates' the needle 20 supported on die mandrel 128, while die beam 1 18 forms the second markings 32 on the upper portion 40 of the needle tip 24, While FIG. ? shows the beveled section 36 formed in the lower portion 38 of the needle tip 24, i t is understood, as will be described below, that the notched section 36 can be formed before, during, or after the first and/or second markings 30, 32 arc formed,

|00S0) With reference to the .figures, a method for forming the markings 30, 32 and the notched section 36 on the needle 20 will be described. The headstoek 122, the tailstoek 120,_. or both, are moved on the base 102 along axis 108 to accommodate the needle 20. That is, the headstoek 122, the tailsiock 120, or both can be adjusted to accommodate one or more needles 20 of varying length. The needle 20 is placed over the mandrel 128, and the mandrel 128 may be secured to the device 1.00. That is, the mandrel 128 can be secured to the tailstoek 120, the chock or collet 1.24, the headstoek 122, or a combination thereof. The extensions 104 are moved along axis 108 to position the laser 1 12 relative to needle 20. The carriage 1.10. is moved along axis 1 1.4 to position, the laser 1 12 relative to needle 20, The laser 112 is pivoted about axis 116 so that the beam 118 is positioned towards the needle 20. With the needle 20 and mandrel. 128 secured in the device 100, the chuck or collet 124 can be rotated about axis 126 so that the needle 20 rotates about lis needle axis 20, axis 126, or both. While rotating, the laser 11.2. is activated so that the beam 1 18 can form the .first makings 30. The laser 112 can be deacti vated, and the needle 20 can be moved, repositioned, and/or re-orientated so that the upper portion 40 of the needle tip 24 faces the laser 112. Alternatively, the laser 112 can be moved, repositioned, and/or re-orientated so that the laser 112 is directed towards the upper portion 40 of the needle tip 24. The needle 20 can also be restricted from rotating while the beam 118 forms the second markings 32. That is, the laser 112 can be moved about axis 108, axis 114, axis 116, or a combination thereof so that the beam 118 can form the second markings 32. The beveled section 36 can then be formed on the lower portion 38 of the needle tip 24. It is understood, however, that the notched section 36 can be formed before the first and second markings 30, 32 are formed, after the first markings 30 are formed, before the second markings 32 are formed but after the first markings 30 are formed, or a combination thereof. It is also understood that the second markings 32 can be formed before the first markings 30 are formed. Moreover, it is within the scope of this disclosure that the second markings 32 are formed on the lower portion 38 and the beveled section 36 is formed on the upper portion 40. The notched section 36 can be formed using device 100, or another device. The notched section 36 can be formed using the laser 112, or any other device.

[0051] Any numerical values recited herein include all values from the lower value to the upper value in increments of one unit provided that there is a separation of at least 2 units between any lower value and any higher value. As an example, if it is stated that the amount of a component or a value of a process variable such as, for example, temperature, pressure, time and the like is, for example, from 1 to 90, preferably from 20 to 80, more preferably from 30 to 70, it is intended that values such as IS to 85, 22 to 68, 43 to 51, 30 to 32 etc. are expressly enumerated in this specification. For values which are less than one, one unit is considered to be 0.0001, 0.001, 0.01 or 0.1 as appropriate. These are only examples of what is specifically intended and all possible combinations of numerical values between the lowest value and the highest value enumerated are to be considered to be expressly stated in this application in a similar manner.

[0052] Unless otherwise stated, all ranges include both endpoints and all numbers between the endpoints. The use of "about" or "approximately" in connection with a range applies to both ends of the range. Thus, "about 20 to 30" is intended to cover "about 20 to about 30", inclusive of at least the specified endpoints.

[0053| The term "consisting essentially of to describe a combination shall include the elements, ingredients, components or steps identified, and such other elements ingredients, components or steps that do not materially affect the basic and novel characteristics of the combination. The use of the terms "comprising" or "including" to describe combinations of elements, ingredients, components or steps herein also contemplates embodiments that consist essentially of the elements, ingredients, components or steps. By use of the term "may" herein, it is intended that any described attributes that "may" be included are optional.

[0054| Plural elements, ingredients, components or steps can be provided by a single integrated element, ingredient, component or step. Alternatively, a single integrated element, ingredient, component or step might be divided into separate plural elements, ingredients, components or steps. The disclosure of "a" or "one" to describe an element, ingredient, component or step is not intended to foreclose additional elements, ingredients, components or steps.

[0055] The omission in the following claims of any aspect of subject matter that is disclosed herein is not a disclaimer of such subject matter, nor should it be regarded that the inventors did not consider such subject matter to be part of the disclosed inventive subject matter.

[0056] Listing of Reference Numerals

[00571 10 system

[0058] 12 bronchoscope

[00591 14 ultrasound probe

[00601 16 aperture

[00611 18 catheter

[0062] 20 needle

[00631 22 needle 20 axis

[0064] 24 needle tip

[00651 26 distal end of catheter 18

[00661 28 elongated section of needle 20

[00671 30 first markings on elongated section 28 of needle 20

[0068] 32 second markings on needle tip 24 of needle 20

[00691 36 beveled section

[00701 38 lower portion of needle tip 24

[0071] 40 upper portion of needle tip 24

[00721 42 distal end of needle tip 24

[00731 100 device

[00741 102 base

[0075] 104 extensions

Claims

1 ) A needle comprising:

an elongated section including one or more first markings;

a needle tip including one or more second markings;

wherein the one or more first markings and the one or more second markings are echogenic markings,

wherein the one or more first markings extend circumferentially around the elongated section,

wherein the one or more second markings extend along only a portion of the needle tip, and

wherein another portion of the needle tip includes a beveled section forming a sharp tip.

2) The needle of claim 1, wherein the one or more first markings include a spiral helical pattern.

3) The needle of claim 1 or 2, wherein the one or more second markings include one or more: i) zig-zag markings;

ii) squiggle markings;

iii) angled squiggle markings, and

wherein the one or more second markings extend less than about 180 degrees around a circumference of the needle tip.

4) A method of forming a needle comprising the steps of:

a) securing a needle to a device;

b) forming one or more first echogenic markings on the needle; and

c) forming one or more second echogenic markings on the needle,

wherein the one or more second echogenic markings extend less than about 180 degrees around a circumference of the needle tip.

5) The method of claim 4, wherein the step of a) includes: i) placing the needle over a mandrel;

ii) securing a first end of the needle or a first end of the mandrel to the device; and iii) optionally securing a second end of the needle or a second end of the mandrel to the device.

6) The method of claim 4 or 5, wherein the step of b), c), or both b) and c) includes one or more of the steps of:

iv) directing a laser beam towards the needle;

v) moving the needle while maintaining the laser beam generally fixed and forming with the laser beam the one or more first echogenic markings, the one or more second echogenic markings, or both; and

vi) maintaining the needle generally fixed while moving the laser beam to form with the laser beam the one or more first echogenic markings, the one or more second echogenic markings, or both.

7) The method of any one of claims 4 through 6, wherein the method includes rotating the needle, moving the needle, or both, and/or moving a laser beam so that the one or more first echogenic markings are formed as helical markings extending around an elongated portion of the needle.

8) The method of any one of claims 4 through 7, the method includes rotating the needle, moving the needle, or both, and/or moving a laser beam so that the one or more second echogenic markings include one or more:

I) zig-zags;

II) squiggles;

III) angled squiggles, and

wherein the second echogenic markings are located on an upper portion of a distal tip of the needle.

9) The method of any one of claims 4 through 8, wherein the device is a 4-axis device. 10) The method of any one of claims 4 through 9, wherein the one or more first markings extend about 360 degrees around a circumference of the needle.

11) The method of any one of claims 4 through 10, wherein the method includes:

d) forming a bevel on the distal tip of the needle to form a lancet tip.

12) The method of any one of claims 4 through 11, wherein the step of c) is performed on an upper portion of the distal tip of the needle and the step of d) is performed on a lower portion of the distal tip of the needle, and

wherein the upper portion of the distal tip generally opposes the lower portion of the distal tip.

13) The method of any one of claims 4 through 12, wherein the step of c) is performed before the step of b).

14) The method of any one of claims 4 through 13, wherein the step of d) is performed

- before the step of b);

- before the step of c); or

- before the steps of b) and c).

15) The method of any one of claims 4 through 14, wherein before the step of d), the method includes:

e) removing the needle from the device and

f) securing the needle to another device.