US20140276051A1 - Device for Minimally Invasive Delivery of Treatment Substance - Google Patents

Abstract

Systems, methods, and devices for delivering ablation fluid to a location of interest within a body (e.g., a location with the lung) are described herein. Ablation fluid delivery systems and devices can include flexible delivery needles within which a plurality of smaller flexible needles is housed. The smaller flexible needles can be configured to articulate or bend with respect to the flexible delivery needle to increase an effective delivery area for the ablation fluid. The smaller flexible needles can include apertures or other openings to facilitate delivery of the ablation fluid to the location of interest.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• This application claims priority to and the benefit of U.S. provisional patent application Ser. No. 61/779,483 filed on Mar. 13, 2013 entitled “Device for Minimally Invasive Delivery of Treatment Substance,” the entire disclosure of which is hereby incorporated by reference as if set forth in its entirety for all purposes.
BACKGROUND
• 1. Technical Field
• Embodiments of the invention relate generally to the field of medical devices, and in particular, to methods, systems, and devices for navigating to and delivering chemicals or other substances to tissue such as lung nodules or other sites of interest. In particular, certain embodiments described herein use a flexible delivery needle with internal flexible needles to deliver substances to a site of interest within the body.
• 2. Description of the Related Art
• Early diagnosis of potentially cancerous tissue is an important step in the treatment of cancer because, the sooner that cancerous tissue can be treated, and the better the patient's chances are for survival. Typical diagnostic procedures involve biopsying tissue at a site of interest. In the case of lungs, lung cancer can be difficult to diagnose due to the difficulties in accessing airways near areas of interest. Areas of interest may present as lung nodules small tissue masses in the lung that may range in size between 0.5-30 mm—that typically are biopsied to ascertain whether the tissue therein is cancerous or otherwise diseased. In some instances treatment of tissue in an area of interest can include delivery of chemicals (e.g., ablative chemicals) or other substances.
• Existing systems typically are constrained by difficulties in accessing lung nodules, especially in the smaller peripheral airways that may be too narrow to accommodate larger catheters and biopsy/substance delivery apparatuses. Further, the biopsy/substance delivery needles normally are straight and relatively inflexible. Thus, the biopsy/substance delivery needles can limit the articulation of a bronchoscope or can be difficult to pass through a working channel of a bronchoscope when the bronchoscope is articulated around a tight corner. In some instances, the material of the needle may inelastically yield, which can result in a bent needle that is difficult to control. In addition, the straight biopsy needles obtain samples along an axis of the needle through back and forth cycling of the needle. Thus, obtaining multiple samples from different regions of a single nodule, for example, can be difficult and can require repeated repositioning of the bronchoscope or guide sheath, for example. Furthermore, delivery of substances to different regions of a single nodule can be difficult.
SUMMARY
• Accordingly, embodiments described herein relate generally to methods, systems, and devices for navigating to and biopsying tissue at a site of interest. In particular, embodiments described herein may be used for biopsying tissue in a lung (such as lung nodules or lymph nodes) using a flexible transbronchial biopsy aspiration needle system. Certain embodiments provide for the flexible biopsy needle to be steerable or guidable to a location of interest. Further embodiments provide for a visualization system (e.g., ultrasound) to be provided in a flexible, miniaturized configuration, and this visualization system may be combined with the flexible biopsy needle.
• In one embodiment, a system for obtaining a tissue sample in or near an airway comprises:
• a flexible needle with distal and proximal ends, the distal end of the needle comprising a less flexible distal tip region and a more flexible proximal region, the less flexible distal tip region comprising a piercing tip configured to obtain a tissue sample, and the more flexible proximal region configured to bend;
• a catheter, wherein the catheter comprises at least one interior lumen, the flexible needle being slidably received within the at least one interior lumen; and
• a suction source in fluid communication with the flexible needle.
• Additional embodiments comprise a steering mechanism configured to steer the flexible needle toward a site of the tissue to be sampled. The steering mechanism may comprise at least one guidewire extending longitudinally along the exterior of the flexible needle or the at least one interior lumen. In some configurations, the steering mechanism may comprise a guidewire extending within an interior lumen of the flexible needle. In some embodiments, the guidewire is removable from the interior lumen of the flexible needle. The system may also comprise a navigation system. The navigation system can utilize an ultrasound probe. In some embodiments, the ultrasound probe is located at a distal end of the catheter. In some embodiments, the catheter comprises a second lumen and the ultrasound probe is received within the second lumen. In some embodiments, the catheter is received within the working channel of a bronchoscope. Some configurations may provide for the catheter being received within a bronchoscope comprising a second steering mechanism, wherein the second steering mechanism can steer independently of the steering mechanism configured to steer the flexible needle.
• In another embodiment, a method for obtaining a tissue sample in or near an airway comprises:
• identifying a location in the airway in close proximity to a tissue sample site;
• introducing a flexible needle into the airway;
• navigating the flexible needle to the location in the airway;
• articulating the flexible needle in a direction toward a tissue sample site; and
• obtaining a tissue sample from the tissue sample site, wherein the flexible needle pierces into the tissue sample site, and wherein suction is applied to the flexible needle so as to collect tissue from the tissue sample site.
• In some embodiments, the flexible needle is articulated by a steering mechanism. In some embodiments, the flexible needle is inserted into a lumen of a catheter. In some embodiments, the step of navigating comprises locating the flexible needle with a radioopaque marker situated on the flexible needle and/or the catheter. In some embodiments, the flexible needle is inserted into a lumen of a bronchoscope.
• In some embodiments, a flexible needle configured to access a location near an airway, has a length and comprises a proximal end and a distal end comprising a piercing tip. The needle can include a flexible proximal tip region located along the length of the flexible needle between the distal end and the proximal end, the flexible proximal tip region having one or more flexibility increasing features and configured to bend. In some embodiments, the flexible needle includes a flexible distal tip region located along the length of the flexible needle between the flexible proximal tip region and the distal end, wherein the flexible distal tip region is less flexible than the proximal tip region. The flexibility increasing feature can be, for example, one or more cuts in the flexible needle. In some embodiments, the one or more cuts extend in a spiral fashion along flexible proximal tip region. In some embodiments, the one or more cuts are arranged in a jigsaw configuration. In some embodiments, the one or more cuts are arranged in a serpentine configuration. In some embodiments, the one or more cuts comprise an interrupted spiral pattern where the flexible needle has cut and uncut portions along a same spiral path. In some embodiments, the one or more cuts are distributed asymmetrically on a portion of the length of flexible needle such that the cuts are located on only a portion of a radial circumference of the flexible needle.
• According to some embodiments, the flexible needle and any variants thereof can be used in combination with a catheter comprising at least one interior lumen, the flexible needle being slidably received within the at least one interior lumen, and with a suction source in fluid communication with the flexible needle. Such a combination can form a system for accessing tissue near an airway. The system can include a steering mechanism configured to steer the flexible needle toward the tissue sample site. In some embodiments, the steering mechanism comprises at least one guidewire extending longitudinally along the exterior of the flexible needle or the at least one interior lumen. In some embodiments, the steering mechanism comprises a guidewire extending within an interior lumen of the flexible needle. In some embodiments, the guidewire is removable from the interior lumen of the flexible needle. According to some variants, the system includes a navigation system. The navigation system can be an ultrasound probe. The ultrasound probe can be located at a distal end of the catheter. The catheter can include a second lumen and the ultrasound probe is received within the second lumen. In some embodiments, the catheter is received within the working channel of a bronchoscope. In some embodiments, the catheter is received within a bronchoscope comprising a second steering mechanism, and the second steering mechanism can steer independently of the steering mechanism configured to steer the flexible needle.
• In some embodiments, a method of manufacturing a flexible needle can include providing a tube shaped length of resilient material having a distal end and a proximal end, forming an angled tip on the distal end of the tube shaped length of resilient material, and forming one or more flexibility increasing features on the tube shaped length of resilient material, such that the flexible needle has a flexible proximal tip region located along the tube shaped length of resilient material between the distal end and the proximal end, the flexible proximal tip region having one or more flexibility increasing features and configured to bend, and such that a flexible distal tip region located along the tube shaped length of resilient material between the flexible proximal tip region and the distal end, wherein the flexible distal tip region is less flexible than the proximal tip region. In some embodiments, forming the one or more flexibility increasing features includes cutting one or more cuts into a wall of the tube shaped length of resilient material. In some embodiments, cutting the one or more cuts includes water jetting the wall of the tube shaped length of resilient material. In some embodiments, cutting the one or more cuts includes laser cutting the wall of the tube shaped length of resilient material. In some embodiments, cutting the one or more cuts includes chemical etching the wall of the tube shaped length of resilient material.
• A method for obtaining a tissue sample near an airway can include identifying a location in the airway in close proximity to a tissue sample site, introducing a flexible needle into the airway, navigating the flexible needle to the location in the airway, articulating the flexible needle in a direction toward the tissue sample site, and obtaining a tissue sample from the tissue sample site, wherein the flexible needle pierces the airway and into the tissue sample site, and wherein suction is applied to the flexible needle so as to collect tissue from the tissue sample site. The method can include articulating the flexible needle using a steering mechanism. In some embodiments, the flexible needle is inserted into a lumen of a catheter. In some embodiments, the step of navigating comprises locating the flexible needle with a radioopaque marker situated on the flexible needle and/or the catheter. In some embodiments the flexible needle is inserted into a lumen of a bronchoscope.
• Various example embodiments of the disclosure can be described in view of the following clauses:
• Clause 1: a flexible needle configured to access a location near an airway, the flexible needle having a length and comprising: a proximal end; a distal end comprising a piercing tip; a flexible proximal tip region located along the length of the flexible needle between the distal end and the proximal end, the flexible proximal tip region having one or more flexibility increasing features and configured to bend; and a flexible distal tip region located along the length of the flexible needle between the flexible proximal tip region and the distal end, wherein the flexible distal tip region is less flexible than the proximal tip region.
• Clause 2: the flexible needle of Clause 1, wherein the flexibility increasing feature comprises one or more cuts in the flexible needle.
• Clause 3: the flexible needle of Clause 2, wherein the one or more cuts extend in a spiral fashion along flexible proximal tip region.
• Clause 4: the flexible needle of Clause 2, wherein the one or more cuts are arranged in a jigsaw configuration.
• Clause 5: the flexible needle of Clause 2, wherein the one or more cuts are arranged in a serpentine configuration.
• Clause 6: the flexible needle of Clause 2, wherein the one or more cuts are arranged in an interrupted spiral pattern where the flexible needle has cut and uncut portions along a same spiral path.
• Clause 7: the flexible needle of and of Clauses 2-6, wherein the one or more cuts are distributed asymmetrically on a portion of the length of flexible needle such that the cuts are located on only a portion of a radial circumference of the flexible needle.
• Clause 8: a system for accessing tissue near an airway, the system comprising: the flexible needle of Clause 1; a catheter comprising at least one interior lumen, the flexible needle being slidably received within the at least one interior lumen; and a suction source in fluid communication with the flexible needle.
• Clause 9: the system of Clause 8, further comprising a steering mechanism configured to steer the flexible needle toward the tissue sample site.
• Clause 10: the system of Clause 9, wherein the steering mechanism comprises at least one guidewire extending longitudinally along the exterior of the flexible needle or the at least one interior lumen.
• Clause 11: the system of either ofClauses 9 or 10, wherein the steering mechanism comprises a guidewire extending within an interior lumen of the flexible needle.
• Clause 12: the system of Clause 11, wherein the guidewire is removable from the interior lumen of the flexible needle.
• Clause 13: the system of any of Clauses 8-12, further comprising a navigation system.
• Clause 14: the system of Clause 13, wherein the navigation system is an ultrasound probe.
• Clause 15: the system of Clause 14, wherein the ultrasound probe is located at a distal end of the catheter.
• Clause 16: the system of Clauses 14 or 15, wherein the catheter comprises a second lumen and the ultrasound probe is received within the second lumen.
• Clause 17: the system of any of Clauses 8-16, wherein the catheter is received within the working channel of a bronchoscope.
• Clause 18: the system of any of Clauses 9-17, wherein the catheter is received within a bronchoscope comprising a second steering mechanism, and wherein the second steering mechanism can steer independently of the steering mechanism configured to steer the flexible needle.
• Clause 19: a method of manufacturing a flexible needle comprising: providing a tube shaped length of resilient material having a distal end and a proximal end; forming an angled tip on the distal end of the tube shaped length of resilient material; forming one or more flexibility increasing features on the tube shaped length of resilient material, such that the flexible needle comprises: a flexible proximal tip region located along the tube shaped length of resilient material between the distal end and the proximal end, the flexible proximal tip region having one or more flexibility increasing features and configured to bend; and a flexible distal tip region located along the tube shaped length of resilient material between the flexible proximal tip region and the distal end, wherein the flexible distal tip region is less flexible than the proximal tip region.
• Clause 20: the method of Clause 19, wherein forming the one or more flexibility increasing features includes cutting one or more cuts into a wall of the tube shaped length of resilient material.
• Clause 21: the method ofClause 20, wherein cutting the one or more cuts includes water jetting the wall of the tube shaped length of resilient material.
• Clause 22: the method ofClause 20, wherein cutting the one or more cuts includes laser cutting the wall of the tube shaped length of resilient material.
• Clause 23: the method ofClause 20, wherein cutting the one or more cuts includes chemical etching the wall of the tube shaped length of resilient material.
• Clause 24: a method for obtaining a tissue sample near an airway, the method comprising: identifying a location in the airway in close proximity to a tissue sample site; introducing a flexible needle into the airway; navigating the flexible needle to the location in the airway; articulating the flexible needle in a direction toward the tissue sample site; and obtaining a tissue sample from the tissue sample site, wherein the flexible needle pierces the airway and into the tissue sample site, and wherein suction is applied to the flexible needle so as to collect tissue from the tissue sample site.
• Clause 25: the method of Clause 24, wherein the flexible needle is articulated by a steering mechanism.
• Clause 26: the method of any of Clauses 24 or 25, wherein the flexible needle is inserted into a lumen of a catheter.
• Clause 27: the method of Clause 26Error! Reference source not found., wherein the step of navigating comprises locating the flexible needle with a radioopaque marker situated on the flexible needle and/or the catheter.
• Clause 28: the method of Clause 24, wherein the flexible needle is inserted into a lumen of a bronchoscope.
• A needle assembly for delivery a treatment substance to a site within the body can comprise: a delivery needle defining a delivery lumen and having a delivery needle wall, a proximal end, and a distal end, the delivery needle wall having one or more cut patterns to increase the flexibility of the delivery needle; a plurality of internal needles, each internal needle defining an internal needle lumen and having an internal needle wall, a proximal end, and a distal end, the plurality of needles configured to transition between a contracted position and an expanded position; and a treatment substance source in fluid communication with the internal needle lumens of the plurality of internal needles; wherein each of the plurality of internal needles is configured to extend in a distal direction and flare outward from the distal end of the delivery needle when in the extend position and wherein the plurality of internal needles are housed within the delivery lumen when the contracted position. In some embodiments, an internal surface of the delivery needle wall is coated with a substance configured to reduce or eliminate the likelihood that the internal needles will stick to or catch on the delivery needle wall when the internal needles are transitioned between the contracted position and the expanded position. In some embodiments, the internal needles walls of the internal needles include cut features, the cut features facilitating fluid communication between the internal needle lumen and an exterior of the internal needles. According to some variants, the needle assembly comprises a flexible shaft having a distal end and a proximal end, the distal end of the flexible shaft coupled with the proximal ends of the internal needles. In some embodiments, the needle assembly comprises three internal needles. In some embodiments, each of the internal needles had a distal aperture in fluid communication with the internal needle lumen. The distal ends of the internal needles can be sharpened and/or beveled. The distal end of the delivery needle can be sharpened and/or beveled.
BRIEF DESCRIPTION OF THE DRAWINGS
• The foregoing and other features, aspects and advantages of the present disclosure are described in detail below with reference to the drawings of various embodiments, which are intended to illustrate and not to limit the disclosure. The drawings comprise the following figures in which;
• FIG. 1 is a perspective view of a transbronchial needle aspiration system comprising an ultrasound sensor.
• FIG. 2 illustrates a side view of an embodiment of a flexible needle.
• FIGS. 3A-G illustrate various configurations for interruptions that may be made along one or more portions of embodiments of the flexible needles.
• FIG. 4 illustrates a close-up view of the flexible shaft portion of an embodiment of a flexible needle.
• FIG. 5 illustrates a side view of another embodiment of the flexible needle.
• FIGS. 6A-D illustrate schematic cross-section views of different embodiments of a steerable, flexible needle assembly.
• FIG. 7 illustrates a side view of an embodiment of a steerable, flexible needle assembly.
• FIG. 8 illustrates an embodiment of a steerable, flexible needle assembly comprising an inner guidewire.
• FIG. 9 illustrates the proximal end of an embodiment of a flexible needle assembly comprising an inner guidewire.
• FIG. 10 is a fluoroscopy image of an embodiment of a flexible needle with an inner guidewire.
• FIGS. 11A-B illustrate front and side cross sectional views of an embodiment of a multi-lumen, steerable catheter in a relaxed state.FIG. 11C illustrates a side cross sectional view of the catheter in an articulated state.
• FIGS. 12A-C are illustrations of a bronchoscope showing various degrees of articulation achievable without any biopsy needle, with a conventional straight biopsy needle, and with an embodiment of a flexible biopsy needle.
• FIGS. 13A-C are illustrations of an embodiment of a flexible needle with steering wires.
• FIGS. 14A-B are illustrations of an embodiment of a flexible needle inserted into a multi-lumen, steerable catheter.
• FIGS. 15A-C are illustrations of a bronchoscope comprising an ultrasound probe and showing various degrees of articulation achievable without any biopsy needle, with a conventional straight biopsy needle, and with an embodiment of a flexible biopsy needle.
• FIGS. 16A-C are illustrations of an embodiment of a flexible needle.
• FIG. 17 is an illustration of a handle that may be used to manipulate and control embodiments of the flexible needles described herein.
• FIG. 18 is an illustration of an embodiment of a flexible needle showing the distal tip thereof.
• FIG. 19 is a fluoroscopy image of an embodiment of a flexible needle with an inner guidewire.
• FIG. 20A is a partial cross-section view of a delivery needle in which one or more internal needles are positioned.
• FIG. 20B is an elevated end view of the delivery needle ofFIG. 20A from theviewing plane20B-20B ofFIG. 20A.
• FIG. 21A is a partial cross-section view of the delivery needle ofFIG. 20A wherein the one or more internal needles are deployed outside of the delivery needle.
• FIG. 21B is an elevated end view of the delivery needle and one or more deployed internal needles ofFIG. 21A from theviewing plane21B-21B ofFIG. 21A.
• FIG. 22A illustrates a delivery needle in communication with an area of interest within the body.
• FIG. 22B illustrates a delivery needle with deployed internal flexible needles in communication with an area of interest within the body.
• FIG. 23A illustrates an isometric view of a delivery needle with a spiral scribe on the distal tip, which may be used to reflect ultrasound waves.
• FIG. 23B illustrates a side view of a delivery needle with a spiral scribe on the distal tip, which may be used to reflect ultrasound waves.
DETAILED DESCRIPTION
• Various embodiments of a flexible transbronchial needle aspiration system, a minimally invasive substance delivery system, and their related components and parts will now be described with reference to the accompanying figures. The terminology used in the description presented herein is not intended to be interpreted in any limited or restricted manner. Rather, the terminology is simply being utilized in conjunction with a detailed description of embodiments of the systems, methods and related components. Furthermore, embodiments may comprise several novel features, no single one of which is solely responsible for its desirable attributes or is believed to be essential to practicing the disclosure herein described. For example, while references may be made herein to using the embodiments described herein with terms such as “lung,” “airway,” “nodule,” and so forth, these terms are broad and the embodiments described may be used without limitation and unless otherwise indicated can be used to access to other vessels, passages, lumens, body cavities, tissues, and organs present in humans and animals. For example, lumens such as the gastrointestinal system may be accessed with the embodiments described herein.
• Presently, various companies offer products directed to transbronchial needle aspiration systems, some of which include visualization systems to direct the needle to a site to be biopsied. For example, Olympus manufactures an ultrasound system (the Endobronchial Ultrasound Transbronchial Needle Aspiration system (EBUS-TBNA)) substantially as illustrated inFIG. 1. As shown, thesystem100 employs anultrasound probe102 situated at the distal end of aspecialized bronchoscope106. Arigid needle104 extends at an angle from anaperture108. Theneedle104 is sheathed prior to deployment by a catheter orsheath110 that contains coils112. Thecoils112 preferably surround theneedle104 to reduce the likelihood of theneedle104 perforating a working channel of thebronchoscope106. Because theneedle104 is rigid and its range of motion constrained, thesystem100 is limited in the area of tissue that can be easily biopsied. Although some medical practitioners may occasionally bend needles similar to theneedle104 so as to be able to biopsy tissue at larger angles relative to the axis of the bronchoscope, these needles remain rigid (albeit bent) and still limit the area of tissue that can be biopsied.
• FIG. 2 illustrates an embodiment of aflexible needle200. As will be discussed, embodiments of thisflexible needle200, as well as the other embodiments described herein, may be used in conjunction with existing systems and methods (such as thesystem100 illustrated inFIG. 1) for locating, navigating to, and biopsying regions (e.g., lung nodules, lymph nodes) of interest. Use of a flexible needle can permit biopsying tissue and cells in a much larger area and over a wider range of angles compared to existing systems, and certain embodiments allow for greater articulation of a bronchoscope or endoscope so as to gain access to tortuous areas of the anatomy. Accordingly, the use of such embodiments can provide increased sample quality, greater diagnostic yields, and a reduction of erroneous diagnostic results (e.g., false positives or negatives). It will be noted that although bronchoscopes are referred to herein, other endoscopes may be usable (e.g., gastric endoscopes, colonoscopes). As such, other lumens may be explored, navigated to, and biopsied using the embodiments described herein.
• A proximal end of theneedle200 comprises aproximal shaft portion202. The distal end comprises aflexible shaft portion204 that is more flexible than the proximal shaft portion and preferably able to selectively bend, curve, and articulate such that the respective ends of theneedle200 are not necessarily collinear.Flexible shaft portion204 may be provided with a laser cut feature, for example a spiral cut, to improve the flexibility in this region. For example, due to the flexible nature of theneedle200, theneedle200 is capable of at least two different deflections in radial directions to angles that would exceed the yield strength of a solid needle formed of the same material. At the extreme distal end, theflexible shaft portion204 comprises a shortdistal tip portion206. Thisdistal tip portion206 is configured with a piercing tip used to obtain biopsy cell and/or tissue samples. Thedistal tip portion206 preferably is more rigid than theflexible shaft portion204. It is contemplated that the needle is formed unitarily of a single material.
• In some embodiments, theflexible transbronchial needle200 can be advanced to peripheral airways and can easily penetrate into the lung parenchyma. In a preferred configuration, theneedle200 can penetrate tissue at a depth of at least 15 mm. In some embodiments, thedistal end204,206 of theneedle200 can articulate such that it can bend over 90 degrees relative to a more proximal portion. In a preferred embodiment and when inserted into a bronchoscope working channel (such as the BF-P180™ bronchoscope manufactured by Olympus), theneedle200 can articulate at least 130 degrees when theneedle tip206 is flush with the end of the bronchoscope. When inserted into asystem100 similar to that illustrated inFIG. 1, embodiments of theneedle200 can articulate approximately 110 degrees. Due to its relatively low-profile construction, embodiments of theflexible needle200 may be miniaturized, in conjunction with a catheter or guide sheath, so as to fit into working channels (e.g., of a bronchoscope) that are as small as or smaller than 2.0 mm. For example, certain embodiments of theneedle200 can be used with small guide sheaths with a minimum inner diameter of 0.7 mm.
• Theflexible needle200 can be formed from any suitable material. In some configurations, theflexible needle200 may be formed from a metal or metal alloy, such as stainless steel, nitinol or the like. In some arrangements, theflexible needle200 can comprise a polymer or other suitable covering over at least a portion of the length of theflexible needle200. In some configurations, theflexible needle200 can comprise a heat shrink material that covers substantially the entire length of theflexible needle200. In some configurations, one or more of the inner and outer surfaces can receive a coating of any suitable material. The coating can improve the lubricity of the coated surface or increase the smoothness of the coated surface. In some configurations, theflexible needle200 is constructed from a hypotube. Preferably, the hypotube is constructed to be relatively smooth along at least a proximal portion such that when introduced into a device such as a catheter lumen, for example but without limitation, the hypotube is able to relatively freely slide, rotate, or otherwise move along the lumen.
• Embodiments described herein (for example but without limitation, the embodiment illustrated inFIG. 2) may be used with any suitable visualization device, such as theultrasound system100 ofFIG. 1, navigation system or the like. By using theflexible transbronchial needle200, access to regions of interest in the lung or in other tissues can be easier and more straightforward, because theflexible needle200 is able to articulate, bend, and/or curve to a greater degree than a straight, inflexible needle, and independently from the angle or articulation that a bronchoscope or endoscope may have at the same time. This may, for example, enable biopsying of tissue at an angle close to perpendicular from the bronchoscope. In addition, theflexible needle200 can bend in a region between thedistal piecing tip206 and the distal end of any protective guide sheath or catheter. Further, thecoils112 present in thesheath110 of the existingsystem100 can be made shorter or eliminated entirely due to the flexibility of the needle. In other words, the flexibility of thedistal portion204 of theflexible needle200 reduces the likelihood of perforating the working channel of the bronchoscope. The increased flexibility also decreases the radial forces exerted by thedistal tip206 of theneedle200 during navigation through the working channel of the bronchoscope, for example but without limitation.
• In some embodiments, visualization of theneedle200 may be enhanced (in particular for ultrasound) by includingsignature markers2059 that will enhance the visibility of theneedle200, particularly at the distal tip. Signature markers may include forming dimples, scallops, a spiral scribe which may be laser cut, or the like on theneedle200, which dimples, scallops, a spiral scribe which may be laser cut, or the like can reflect ultrasound. Such features provide echogenic surface for detection by ultrasound. Of course, other markers visible for different visualization methods can be used, such as radioopaque markers located on various elements of the catheter or sheath used to deploy theneedle200, as well as theneedle200 itself.
• Although ultrasound has been found to be a preferable system for visualization due to the relatively high penetration depth (10-18 mm) of ultrasound, other systems also may be used. In some configurations, a spiral ultrasound probe can be used to provide improved visualization over an ultrasound probe that provides visualization in only a single plane. Other systems for locating and navigating to tissues of interest, such as lung nodules and lymph nodes, may include using a bronchoscope with an optical channel, fluoroscopy, optical coherence tomography, and magnetic resonance imaging. Any other suitable navigation systems also can be used, including commercial systems using X-ray computed tomography assisted visualization (such as, for example but without limitation, the Bf Navi™ system sold by Olympus and the i-Logic™ system sold by SuperDimension).
• FIGS. 3A-G illustrate various configurations for flexibility increasing features (e.g., slots, openings, or grooves) that may be formed along various regions of transbronchial needles to increase flexibility. For example, such flexibility increasing features may be made into theflexible shaft portion204 ofFIG. 2. Generally, one or more flexibility increasing features, or cut patterns,304 such as cuts for example but without limitation, may be made onto theneedle wall300 of the needle; thesecuts304 may then define one or more regions of increasedflexibility302. Thesecuts304 permit the region of increasedflexibility302 on the flexible shaft portion to selectively articulate and bend more easily and to a greater degree than an equivalent portion that is uncut, thereby permitting navigation and biopsying of tissue in tortuous regions of, for example, an airway, that may not be possible using a traditional rigid needle.
• The flexibility of the region of increasedflexibility302 may be tailored as desired for a particular application. The flexibility can be changed, for example, by modifying the thickness of theneedle wall300, the materials used therein, and the spacing, pitch, and angle between theflexibility increasing features304 in the region of increasedflexibility302. Preferably, thecuts304 extend in a spiral fashion along the region of increasedflexibility302. In preferred embodiments, thefeatures304 are cut with a thickness between about 0.0010 and about 0.0025 inches, and even more preferably a range between about 0.0015 and about 0.0020 inches.
• Additionally, the region of increasedflexibility302 does not need to have features such as the single pitch illustrated inFIG. 3A, but, with reference toFIG. 3B, can instead have features that are of a variable pitch, wherein the spacing or pitch can be changed in a continuous or stepwise fashion, for example but without limitation. Additionally, although the cuts shown in these figures are made in a continuous and single cut, high flexibility regions may be made using one or more discontinuous cuts. In these figures, theflexibility increasing features304 that constitute the region of increasedflexibility302 are made in a “jigsaw” configuration that forms a sawtooth or zigzag pattern. Other possible features can have a pattern that is a “serpentine” configuration where the cuts are smoother, more rounded, and with a longer amplitude than the jigsaw pattern, for example but without limitation. Other types are possible and envisioned, including straight cuts, partial or dashed cuts, zigzag cuts, sinusoidal cuts, and so on. In some configurations, axially asymmetric cuts may be made so as to enhance flexibility in only one direction relative to the axis, for example as discussed below in relation toFIG. 3F. Moreover, continuous patterns are desired over interrupted patterns because of improved resistance to fatigue failures and improved flexure characteristics.
• FIG. 3C illustrates an embodiment of the region of increasedflexibility302 comprising overlapping discontinuousstraight reliefs304, each extending around approximately half of the circumference of theneedle wall300 in the illustrated configuration. In this embodiment, holes306 may be provided at one or more of the ends of each relief. Theholes306 may in some cases be made as part of a laser cutting process used to create thereliefs304, although thereliefs304 and/or theholes306 may be made using any suitable process, for example chemical etching or water jetting. Theholes306 may also be useful in providing additional strength to theneedle wall300, as it is believed that theholes306 may aid in reducing or eliminating the likelihood of crack propagation when theneedle wall300 undergoes various stresses.
• FIG. 3D illustrates an embodiment with a region of increasedflexibility302 comprising a single, continuous spiral cut304.Holes306, similar to those described above, may be present at the respective ends of thecut304. Preferably, and as illustrated here, the pitch is substantially constant throughout the length of thecut304; in some embodiments, however, one or more portions of thecut304 may have a varied pitch. In some embodiments, a region of increasedflexibility302 may be manufactured that resembles the embodiment illustrated here by using a closely-spaced stacked wire, flat wire coil or cable tube. Of course, other embodiments may be manufactured using other types of cutting (e.g., laser cutting) discussed herein.
• FIG. 3E is similar to the embodiment illustrated inFIG. 3C. Here, however, the region of increasedflexibility302 comprises an interrupted spiral pattern where the tube has cut and uncut portions along thesame spiral path304 that have substantially the same pitch along the entire length of theregion302.
• FIG. 3F illustrates an embodiment with an asymmetric region of increasedflexibility302. Here,cuts304 can be positioned along only one side of theneedle wall300; in other words, thecuts304 are arranged such that only a portion of the entire radial circumference along the axial length of theneedle wall300 is interrupted. In other words, when viewed along a certain direction along the axial length of theneedle wall300, thecuts304 forming a region of increasedflexibility302 will be seen along at least a portion of one of the sides, while a side opposite thecuts304 will be substantially lacking cuts. Arranged in this manner, the flexibility of theneedle wall300 along the region of increasedflexibility302 will be asymmetrically flexible so as to permit increased bending or flexibility in one direction or plane while being less flexible in another direction.
• Embodiments ofneedle walls300 with asymmetrical regions of increased flexibility may be useful in conjunction with bronchoscopes or other navigational devices by increasing the maneuverability of theneedle wall300 while in the bronchoscope. In particular, some bronchoscopes may be more adapted to bending in a particular plane—alignment of the asymmetrical region of increasedflexibility302 in this plane may thus be useful. For example, asymmetric bending of theneedle wall300 can force theneedle wall300 to rotate about its longitudinal axis as the navigational device bends and flexes. Such rotation can help to ensure that certain features of the needle could be maintained in a substantially consistent alignment with regard to the navigational device. For example, the bevel of the distal tip of the needle and/or ultrasonic reflective zones of theneedle walls300 could be maintained at a substantially consistent rotational orientation with respect the navigational device (e.g., a bronchoscope). Further, rotation of theneedle wall300 along its axial length may also aid navigation and maneuverability, as certain embodiments with asymmetrical regions of increasedflexibility302 have been demonstrated to rotate in the path of least resistance, typically the smallest possible radius.
• Thecuts304 may not necessarily be straight and perpendicular to the longitudinal axis of theneedle wall300. As illustrated inFIG. 3G, thecuts304 that comprise the asymmetrical region of increasedflexibility302 may be contoured, and may preferably further comprise ahole306 located in at least one of theends310 of one or more of thecuts304.
• Several characteristics of thecuts304 may be altered to tailor the stiffness, bending resistance, torqueability, and other material parameters of the region of increasedflexibility302. For example, the kerf, or cut width, in eachcut304 may be larger at some points than at others, which may enhance flexibility. In some embodiments, the kerf at amidpoint311 of acut304 may be wider than the kerf at one or more of the ends310. In such a configuration, the flexibility may be increased when theneedle wall300 is bent in the direction or plane of the asymmetrical region of increasedflexibility302, while reducing or minimizing flexibility (progressively or in a stepwise manner) as the bend location moves away from the direction or plane of the region of increased flexibility, as a result of the change in kerf toward the ends310. It may also be preferable to have a thinner kerf to reduce the amount of torque that can be applied to theneedle wall300 before the tube interlocks. Additionally, the kerf may be modified along the length of the region of increasedflexibility302. For example, the kerf in a proximal section may be wider and taper to a narrower kerf at the distal end, which may provide for aneedle wall300 that is flexible but that will stiffen when rotated.
• Other characteristics of the region of increasedflexibility302 may be modified. In addition to the kerf, the pitch spacing, the length and/or amount that acut304 extends around theneedle wall300, and the distance betweencuts304 may be modified to tailor thewall300 as desired. In some embodiments, the minimum longitudinal distance point between thecuts304 can be varied along the length of theneedle wall302. In some such embodiments, the flexibility of theneedle wall302 can vary along the length of the needle (e.g., more flexibility as the minimal longitudinal distance between thecuts304 is reduced). Accordingly, the flexibility, torqueability, and other characteristics of the region of increased flexibility may be modified. Further, some embodiments may provide for aneedle wall300 comprising multiple asymmetrical regions of increasedflexibility302. In some embodiments, themultiple regions302 may be staggered at differing orientations, for example in mutually orthogonal directions (i.e., at 90° angles to each other).
• In practice, in tailoring the region of increasedflexibility302 and thereliefs304 that can constitute this region of increasedflexibility302, it may be desirable to find a suitable balance between the flexibility required and the type of relief. For example, while wider or larger reliefs may provide additional flexibility, these may in some cases weaken theneedle wall300 to an unacceptable extent. Different patterns also may perform more or less satisfactorily in fatigue testing. Additionally, certain patterns may cause portions of the region of increasedflexibility302 to abrade the working channel of the catheter or other instrument the needle is inserted in, or else the tissue being biopsied (although this may be desirable in certain applications, as described below). Postprocessing after creation of the reliefs may include steps such as deburring, electropolishing, extrude honing, microblasting, or ultrasonic cleaning, which may at least partially alleviate or reduce such concerns. The type ofreliefs304 described above may also be adjusted in accordance with the length of the one or more regions of increasedflexibility302. Prototypes have been constructed with regions of increased flexibility measuring approximately 3-4 cm. Preferably, the extreme distal end of theneedle wall300 is left uncut or otherwise generally solid to reduce the likelihood of buckling and so that a piercing point can be made onto the needle. In some arrangements, the piercing point is ground or honed and the generally solid portion of the extreme distal end assists in the formation of a point or tip. In some embodiments, the generally solid distal region measures between about 8 mm and about 10 mm. Other configurations are possible.
• FIG. 4 shows an embodiment of a flexible transbronchial needle400 that comprises adistal tip portion402 and aflexible region404. In one embodiment, thedistal tip portion402 has a sharply angled tip to core or scrape cells from tissue to be sampled. Theflexible region404 preferably comprises one or more reliefs or cuts406. In one embodiment, thecuts406 are a jigsaw cut. In other embodiments, thecuts406 may be a different type of cut, for example as described above inFIGS. 3A-G. In one embodiment, a covering408, which may comprise polymer coatings and/or heat shrink wrap, can be used to cover thecuts406 on the needle400. The covering408 may in some embodiments also comprise coils of a resilient material (e.g., metals or polymers) that surround at least a portion of theflexible region404 to provide additional support against buckling or collapse, while remaining flexible enough to provide selective articulation and/or bending of the needle400.
• Obtaining a cored tissue sample may be preferable for pathology or histology samples where a largely-intact sample of tissue is desired. For such applications, the needle is preferably in a relatively larger size range of approximately 17-19 gauge, possibly with a smaller 21 gauge needle within. Such needle sizes have been found to produce a “cored” tissue sample satisfactory for histology applications. Obtaining biopsy cells and fluid for cytology may however use a smaller, non- or minimally-coringdistal tip portion402, for example. Because biopsies for cytological applications typically apply suction while performing agitation (moving back and forth) of the needle in the biopsy site, sharper and/or rougher needles may perform better and obtain additional cells. For such applications, smaller needle sizes in the range of 21-23 gauge may also be preferable. In some embodiments, thedistal tip portion402 may be cut and/or angled differently for different applications. In some applications, a hole, port, slot or other structure also can be provided just proximal of the distal end. In some applications, the hole, port, slot or other structure can be provided on a surface of the needle that is opposite from the surface of the needle having the most proximal portion of the beveled opening formed at the tip. In some applications, the hole, port, slot or other structure is positioned within a region defined between the distal tip and the most proximal portion of the opening formed by the beveled surface of the opening at the tip. A vacuum source may also be provided so as to aspirate a tissue sample or samples. Other configurations also are possible.
• Thecuts406 on theflexible region404 may be suitable for cytological biopsy procedures. Here, a cut may provide rougher edges that can scrape cells along the path of the needle400. For example, when the interrupted surface of the needle is bent, the cuts can create a scalloped surface. In particular, sinusoidal, “jigsaw,” “serpentine,” or zigzag cuts may provide for rougher edges, which—especially when the needle400 is bent or articulated—can abrade the surrounding tissue and thus sample additional cells. These abraded cells can then be aspirated via the needle400 along with any other sample being biopsied. If no coating and/or heat shrinkwrap408 is present over thecuts406, the resulting small openings may also be used to aspirate the abraded cells into the needle400. Such an uncoated portion of thecut section406, if present, is preferably located at the distal end of the needle400 such that surrounding tissue may ingress into the inner lumen during suction.
• To increase this scraping or scalloping effect, several steps may be taken. If thecuts406 are made by water jetting, the needle400 may be extrude honed to push burrs outward, increasing the roughness of theflexible region404. Likewise, laser cutting thecuts406 may in some cases provide additional roughness. In some cases, a polishing or deburring step may be necessary. Dimpling or grinding of thecuts406 and/or theregion404 may also be useful. The kerf (or width) of thecuts406 may also be increased, either in part or in whole, along theflexible region404, which may consequently enhance the scraping or scalloping effect.
• The needle400 may also be flushed after being withdrawn no as to obtain any remaining cells. In some cases, the operator using a needle400 withcuts406 will preferably navigate the needle400 so as to reduce the likelihood of abrading or puncturing blood vessels in the biopsy region, because the resulting jagged edges may take longer to stop bleeding than a cut resulting from a biopsy needle lacking cuts. In some configurations, a dual-needle configuration, with a relatively smooth needle used to puncture into the biopsy site, followed by larger diameter, flexible needle that can include scalloped surfaces that can be used to scrape the tissue. Quick-clotting or cauterizing features could also be incorporated into the needle400 or various other system components to minimize bleeding when piercing tissue.
• FIG. 5 illustrates an embodiment of aflexible transbronchial needle500. Theneedle500 comprises several interconnected portions. A proximal end of theneedle500 comprises a lessflexible shaft portion502. A distal end of theneedle500 comprises a moreflexible shaft portion504. The lessflexible shaft portion502 and the moreflexible shaft portion504 can be connected together by the taperedshaft section524 in the illustrated configuration. In some configurations, however, the lessflexible shaft portion502 and the moreflexible shaft portion504 can be integrally formed. The moreflexible shaft portion504 comprises adistal tip portion508 and acut section510.Cuts512 are located within thecut section510. The cuts can be formed in any suitable manner. In one embodiment, thecuts512 are a “jigsaw” cut, as described above with reference toFIGS. 3A-C. In other embodiments, thecuts512 may be cut differently.
• This embodiment of aflexible transbronchial needle500 has several advantages, as on one hand theneedle500 becomes more torquable and pushable while also retaining flexibility at its distal end. The lessflexible shaft portion502 at the proximal end is preferably more rigid and stiffer than the moreflexible shaft portion504, so as to facilitate torque and force transmission to the thinner, moreflexible shaft portion504. In one embodiment, this is accomplished by constructing theneedle500 so as to become progressively thinner from the proximal end to the distal end, such that theflexible shaft portion504 remains flexible and bendable. By constructing theneedle500 in a manner that it becomes thinner at the taperedshaft portion524, the needle becomes more flexible, while also reducing resistance to rotation in the distal end comprising theflexible shaft portion504. Additionally, the morerigid portion502 is more durable and better able to transmit torque or force, while being situated in a portion of theneedle500 where flexibility is less important.
• The lessflexible shaft portion502 has anoutside diameter D1514. The moreflexible shaft portion504 has anoutside diameter D2516. The taperedshaft section524 has aproximal end518 and adistal end520, with theoutside diameter D3522 being located at the proximal end of the taperedshaft section518 and theoutside diameter D4520 being located at the distal end of the taperedshaft section520. Preferably, theoutside diameter D3522 is equal to theoutside diameter D1514. Theoutside diameter D4520 is preferably equal to theoutside diameter D2516. The outside diameter of the taperedsection524 may vary linearly or nonlinearly between D3 and D4. It will also be understood that in some embodiments, the taperedsection524 may extend into all or part of theflexible shaft portion504 and/or the lessflexible shaft portion502, and that in some embodiments there may be additional tapered sections. Further, although the taperedsection524 reduces in diameter going in a proximal to distal direction, the opposite configuration may be useful in some embodiments.
• Typically, theportions502,524,504 will be constructed from a length of material (e.g., metals such as stainless steel or nitinol) of a substantially uniform thickness, and as such, the inside diameters of the respective portions will generally correlate to the outside diameters referred to above. However, it is contemplated that materials of varying thicknesses may be used to construct the needle, and the thickness defined by the inside and outside diameters may differ along the length of the device. This may be accomplished, for example, by constructing theneedle500 in a piecewise fashion from separate parts, or by drawing out the needle in a single unit so as to create sections of varying thickness. Such varying thicknesses may be used, for example, to tailor factors such as the rigidity, strength, torquability, or flexibility of the resulting needle to the desired application.
• FIGS. 6A-D illustrate different embodiments of steerable, flexible transbronchial needle aspiration assemblies. Such assemblies may be manipulated by an operator to steer the needle to a site identified to be of interest. Preferably, such assemblies may also permit a flexible needle to be steered independently of a bronchoscope or other endoscope. While the examples discussed below inFIGS. 6A-D discuss a needle aspiration assembly, in some embodiments, a guide sheath provided with the steerable features discussed below may also be used. In such an embodiment, a needle, preferably a flexible needle, may be insertable there through.
• InFIG. 6A, a flexible transbronchialneedle aspiration assembly600A comprises aflexible transbronchial needle602A and asteering wire604A. InFIG. 6B, a flexible transbronchialneedle aspiration assembly600B comprises aflexible transbronchial needle602B, afirst steering wire604B and asecond steering wire606B. InFIG. 6C, a flexible transbronchial needle aspiration assembly600C comprises aflexible transbronchial needle602C, afirst steering wire604C, a second steering wire606C and athird steering wire608C. InFIG. 6D, a flexible transbronchialneedle aspiration assembly600D comprises aflexible transbronchial needle602D, afirst steering wire604D, asecond steering wire606D, athird steering wire608D and afourth steering wire610D. These steering wires can be arranged in different manners to achieve different steering characteristics. Certain embodiments provide for the steering wires to angle or bend the needle602 at an angle of up to 45 degrees. Certain embodiments may be small enough to fit within a 2.0 mm working channel of a bronchoscope, and may be miniaturized further.
• In these preceding figures, the steering wires may be manipulated by the operator to guide a flexible transbronchial needle to a site of interest. Preferably, this is accomplished by using the one or more steering wires to pull (and thereby bend) the flexible needle in the direction desired. The wires may be attached to the flexible needle in any suitable manner, on the interior or exterior of the flexible needle. In some configurations, the wires are secured by welding them to the flexible needle. When wires are attached to the interior of the flexible needle, such embodiments may allow for insertion into a smaller sheath or working channel. In certain embodiments, this may be accomplished by having the steering wire comprise one or more pull wires. Bowden cables may be used in some embodiments. Nitinol wires, which contract after being heated past a transition temperature may also be used, possibly in conjunction with a heating element controllable by the operator (for example, by using resistive heating).
• FIG. 7 shows an embodiment of a steerable, flexible transbronchialneedle aspiration assembly700. Theneedle700 comprises aflexible shaft portion702 at the distal end. Theflexible shaft portion702 comprises adistal tip portion704 and aflexible section706 that may be selectively elastically bent or angled such that the respective ends are no longer collinear. Theflexible section706 comprisescuts707 that may be covered and/or sealed with acoating709, for example a polymer and/or heat shrink. Thecuts707 may be of the type previously described, and could be, for example, “jigsaw” cuts.
• In some embodiments, asteering wire708 is located along the exterior of theflexible shaft portion702. In other embodiments,multiple steering wires708 are located along the exterior of theflexible shaft portion702; these may be arranged as depicted above inFIGS. 6A-D. The steering wire orwires708 may, as described inFIGS. 6A-D, be used to guide theneedle700 to the site to be biopsied. Preferably, aseal710 covers at least a portion of the exterior of thesteering wires708 and theflexible shaft portion702 to reduce the likelihood of the steering wires snagging equipment or body tissue, and preferably is constructed from a pliable polymer.
• The proximal end of theneedle700 may be part of or joined to asteel hypotube711. The proximal end of thehypotube711 may also have a connection714 (for example, a luer fitting) so that a source of vacuum (for example, a pump or syringe712) can be used to pull a vacuum along the length of thehypotube711. In a preferred embodiment, thehypotube711 is manufactured from any suitable material.
• FIG. 8 illustrates an embodiment of a flexiblesteerable needle800 comprising aninner guidewire810. Here, theinner guidewire810 can be positioned along a central lumen of an embodiment of aflexible needle800, which may be designed in a similar manner as other embodiments described herein. In some configurations, theguidewire810 has a length that is greater than the length of theneedle800.
• Theneedle800 preferably comprises adistal tip portion802 with adistal opening803. Aflexible section804 preferably is configured to be more flexible than the distal tip portion, and may comprisecuts806 of the type previously described. Thesecuts806 confer additional flexibility to theneedle800 and permit it to bend or curve. In some embodiments, all or part of the flexible section804 (and the cuts806) may be covered with acoating808, which may be a polymer and/or heat shrink, for example but without limitation.
• Theguidewire810 preferably is constructed from a shape memory material (metal or polymer) such as Nitinol. Preferably, theguidewire810 is set in a form that will curve when heated, but is inserted into theneedle800 while in a straightened configuration. While theguidewire810 is inserted into theneedle800, heating of theguidewire810 will cause it to curve, thereby curving theneedle800 along itsflexible section804. In some configurations, theguidewire810 simply is inelastically deformed to provide nonlinear region proximate the distal end. In such configurations, simply inserting theguidewire810 into theneedle800 can cause the needle to bend.
• In use, thecurved guidewire810 can be used to steer theneedle810 by rotating theguidewire810 relative to theneedle810. The curve or bend in theguidewire810 will cause the flexible portion of theneedle810 to deflect such that the direction of theneedle810 can be varied. In some embodiments, rotational alignment of thecurved guide wire810 with respect to theneedle800 can be controlled using an asymmetric distribution of cuts on the needle wall (e.g., as described above with regard toFIGS. 3F and 3G). For example, asymmetric cuts on the needle wall can cause theneedle800 to rotate about its longitudinal axis as theneedle800 bends to conform to the bent shape of theguidewire810. In some embodiments, asymmetric cuts in the needle wall help to ensure that theguidewire810 remains aligned in the same plane of theneedle800 as the bent portion of the guidewire810 passes through theflexible section804 of thewire800. Theguidewire810 may also be used to navigate theneedle800 to the site of interest. Here, theguidewire810 is guided to the region of interest (e.g., a lung nodule), and theneedle810 is then pushed along theguidewire810 until the region of interest has been reached. Theguidewire810 may then be withdrawn so as to permit aspiration and biopsying of the region of interest. Partly because theguidewire810 is located inside theneedle800 and thus provides a very small diameter probe, such a system may be employed to navigate to peripheral lung regions of a reduced diameter and that are inaccessible with a bronchoscope. Additionally, because theguidewire810 is positioned inside of theneedle800, such a configuration may be preferable for biopsying samples via scraping or scalloping of tissue with theflexible section804. When theguidewire810, or another component associated with one or more of theguidewire810 and theneedle800, is radioopaque, fluoroscopy or the like may be used to navigate the guidewire to a region of interest. Typically, theneedle800 and guidewire810 are contained within a catheter or sheath. Upon reaching an airway wall proximate to a region of interest, either theneedle800 or theguidewire810 can be extended into a nodule or other tissue at the region of interest. In some configurations, theneedle800 may extend between 15-20 mm into the adjacent tissue from the end of the catheter or sheath. In some embodiments, theneedle800 may be configured to extend up to about 40 mm into adjacent tissue.
• In certain embodiments, thecurved guidewire810 may be part of a system used for providing repeatable access and/or navigation to regions of the lung. Such embodiments are described in Provisional Application Ser. No. 61/604,462, filed Feb. 28, 2012, titled “PULMONARY NODULE ACCESS DEVICES AND METHODS OF USING THE SAME”, and the application is hereby incorporated by reference in its entirety. Such embodiments are also described in U.S. patent application Ser. No. 13/778,008 (Attorney Docket No. SPIRTN.082A), filed Feb. 26, 2013, titled “PULMONARY NODULE ACCESS DEVICES AND METHODS OF USING THE SAME” and published as U.S. Patent Publication No. US 2013-0226026 A1, and the publication is hereby incorporated by reference in its entirety.
• FIG. 9 illustrates an embodiment similar to that illustrated inFIG. 8. Here, aconnector814 is connected to the proximal end of the hypotube of theneedle800. Theconnector814 used here can be any type of suitable connector, including for example a luer connector. Theguidewire810 is introduced through theconnector814, and at the proximal end of theguidewire810 is ahandle816 that permits theguidewire810 to be pushed, pulled, and rotated with respect to theneedle800. After theguidewire810 has used to guide theneedle800 to the biopsy site, theguidewire810 is removed from theconnector814. A source of vacuum (e.g., a syringe) is then attached to theconnector814 to aspirate the biopsy sample from theneedle800.
• FIG. 10 is an annotated fluoroscopy image of a curved guidewire similar to that described inFIG. 8 being used to biopsy a lung nodule. Here, thecatheter1000 extends from the distal end of a bronchoscope1014. The lung passages here were too small to permit navigation of the bronchoscope to an area near the lung nodule, and as such, thecatheter1000 was advanced via fluoroscopy to the suspectednodule site1012. The distal end of thelumen1002 containing theflexible needle1006 also containscoils1004, which reinforces thelumen1002 while the needle is located within the lumen and also serves as a fiducial radioopaque marker helpful for visualization of thecatheter1000 in relation to thenodule site1012. Additional fiducials may also be added to various components of the catheter1000 (e.g., barium sulfate markers). Extending distally to theneedle1006 is aguidewire1008, which, being curved, aids in guiding theflexible needle1006 to thenodule site1012. In use, theflexible needle1006 is pushed over theguidewire1008 to thenodule1012, theguidewire1008 is withdrawn and biopsy tissue samples are aspirated through theflexible needle1006.
• A method of obtaining a tissue sample may comprise advancing the bronchoscope1014 toward a tissue site (e.g., alung nodule1012 or lymph node). Within the bronchoscope1014, thecatheter1000 may be movably disposed. In some embodiments, and preferably when advancing to tissue regions in small or convoluted airways that may not permit navigation with the bronchoscope1014, a guide sheath surrounding thecatheter1000 may be advanced beyond the bronchoscope1014 instead of or in conjunction with theguidewire1008. In some embodiments, the guide sheath may be used without the bronchoscope1014. The guide sheath may be used in conjunction with a location device, such as fiducial markers (e.g., coils1004) or an ultrasound probe (e.g., as described below inFIGS. 11A-C). Preferably, the location device is present on thecatheter1000, although a location device may be instead or also present on the guide sheath. Once proximate the tissue site, thecatheter1000 may be advanced beyond the guide sheath and navigated to the tissue site (e.g., using the location device placed thereon) so as to obtain a sample with theflexible needle1006. The entire assembly may then be withdrawn, or certain portions thereof (e.g., coils1004) may be implanted proximate the tissue site to serve as a marker.
• FIG. 11A shows a cross section view of an embodiment of a multi-lumen,steerable catheter1100 which may be configured for introduction into a bodily space (for example, pulmonary passages) via an endoscope such as a bronchoscope. Thecatheter1100 preferably comprises afirst lumen1102 and asecond lumen1104, although other embodiments may comprise acatheter1100 with more than two lumens. Thefirst lumen1102 may be larger than thesecond lumen1104. In a preferred embodiment, thefirst lumen1102 may be used to introduce a miniaturized ultrasound probe, which may then be used to provide real-time location information of the bodily tissues to be examined. For example, when used in the lungs an ultrasound probe can be useful to locate nodules or other locations (e.g., lymph nodes) of suspected or actual cancerous tissue which may be difficult or impossible to locate visually. Preferably, thesecond lumen1104 is used to introduce various tools, including but not limited to transbronchial aspiration needles, cytology brushes, biopsy forceps, guiding devices, and so forth.
• Thecatheter1100 also preferably comprises at least onesteering wire1106, which preferably is connected to thesecond lumen1104 to permit selective articulation and bending of the distal end of thesecond lumen1104. Thesteering wire1100 is preferably of the type that may be used in the embodiments described above inFIGS. 11A-D. It is to be noted that whereas the embodiments illustrated inFIG. 8 have aninner guidewire810 introduced within the inner diameter of theneedle800, the embodiments illustrated inFIGS. 11A-C disclose steering wires positioned on the outside of the needle. This is not to say that the two approaches are mutually incompatible—embodiments may be designed using both inner and outer steering.
• FIGS. 11B and C illustrate side views of an embodiment of a multi-lumen,steerable catheter1100. Thiscatheter1100 comprises afirst lumen1102 and asecond lumen1104. Thesecond lumen1104 comprises asteering wire1106.FIG. 11B illustrates thesecond lumen1104 in a relaxed, non-articulated state.
• FIG. 11C shows a side view of an embodiment of a multi-lumen,steerable catheter1100 used to visualize and conduct a biopsy on atarget nodule1112 located behind anairway wall1110. Here, thecatheter1100 is illustrated with anultrasound probe1116 inserted into thefirst lumen1102. Theultrasound probe1116 is preferably a miniaturized ultrasound probe configured to be inserted into a small catheter or endoscope, and can be for example the UM-S20-17S radial endoscopic ultrasound probe manufactured by Olympus. Such miniaturized ultrasound probes may be advantageous for localization and visualization in peripheral lung passages where visual observation (i.e., via a bronchoscope) is extremely difficult due to the small size of such passages. Thesecond lumen1104 is illustrated with aflexible needle1114 inserted therethrough and preferably moveable in a longitudinal back and forth direction so as to biopsy thetarget nodule1112. In the illustration, thesteering wire1106 is pulled, thus selectively articulating thesecond lumen1104 at an angle with respect to thefirst lumen1102. In a preferred embodiment, theneedle1114, when fully extended, can articulate or bend at an angle of about 40 degrees with respect to thefirst lumen1102. In some embodiments, thesteering wire1106 may angle or articulate bothlumens1102 and1104. Some embodiments may also provide formultiple steering wires1106 capable of bothlumens1102 and1104 independently. In further embodiments, the steering wires may be provided directly onto theflexible needle1114 and/orultrasound probe1116.
• Articulating the distal end of thesecond lumen1104 of thecatheter1100 allows tools, in this case distal end of theneedle1114, to be angled toward thetarget nodule1112 while theultrasound probe1116 remains in the airway providing real-time location confirmation that theneedle1114 has reached thetarget nodule1112. Accordingly, the angle of the second lumen604 preferably is adjusted and aligned such that theneedle1114 andnodule1112 simultaneously remain in the field ofview1118 of theultrasound probe1116. Embodiments of thecatheter1100 have been constructed wherein theneedle1114 is able to articulate up to 20 degrees relative to the ultrasound probe. Some embodiments have been constructed that are compatible with a 3.2 mm bronchoscope working channel, and may be miniaturized further.
• FIGS. 12A-C illustrate a bronchoscope in various degrees of articulation.FIG. 12A illustrates the articulation of a bronchoscope without any biopsy needle inserted within. Here, the angle of articulation is approximately 130 degrees.FIG. 12B illustrates the articulation achievable by the same bronchoscope with a conventional straight rigid biopsy needle and catheter inserted therein. The articulation angle here is only about 90 degrees. Finally,FIG. 12C shows the same bronchoscope with an embodiment of a flexible needle inserted therein. The needle may for example be of the type illustrated inFIG. 2. Due to the flexibility of the needle, the articulation angle achieved here is approximately 130 degrees, and the bronchoscope's overall flexibility is minimally altered in comparison to the bronchoscope without any needle inserted.
• FIGS. 13A-C illustrate an embodiment of a flexible needle with steering wires similar to those illustrated inFIGS. 6A-D andFIG. 7.FIGS. 13A-B show that the needle, with the steering wire pulled, can achieve an articulation of approximately 45 degrees.FIG. 13C illustrates a closeup of the distal end of the needle. A polymeric covering coats or covers the distal end just short of the distal tip of the needle and covers the steering wire or wires underneath.
• FIGS. 14A-B illustrate an embodiment of aflexible needle1002 inserted into a multi-lumen,steerable catheter1000 similar toFIG. 11C. Theprobe1006 may be a miniaturized ultrasound probe, and is preferably inserted into one of the catheter lumens. InFIG. 14A, theflexible needle1002 is shown in a retracted configuration and is inside asheath1004.FIG. 14B shows theflexible needle1002 in an extended position and articulated. Theneedle1002 may be articulated, for example, using the steering wires described above in relation to the embodiment inFIG. 11C. Here, the needle can achieve an articulation of approximately 20 degrees relative to the distal end of theprobe1006.
• FIGS. 15A-C illustrate various states of articulation of a bronchoscope comprising an ultrasound probe similar to that illustrated inFIG. 1. First,FIG. 15A shows the articulation of the bronchoscope without any biopsy needle inserted therein. The bronchoscope can achieve an articulation of approximately 110 degrees.FIG. 15B shows the bronchoscope with a conventional straight biopsy needle and catheter inserted therein. The bronchoscope's articulation is reduced to approximately 50 degrees, with the straight needle providing approximately 20 degrees of additional angle (for a total of 70 degrees).FIG. 15C shows the same bronchoscope with a flexible needle and catheter inserted therein similar to the embodiment illustrated inFIG. 2. Here, the bronchoscope can bend to approximately 90 degrees, with the flexible needle providing approximately additional 20 degrees of additional angle (for a total of 110 degrees). It is important to note that the flexible needle illustrated inFIG. 15C is not being articulated independently of the bronchoscope, and an additional independent articulation mechanism (including for example but without limitation the embodiments illustrated inFIGS. 6A-D and/orFIG. 8) can provide for additional angulation and articulation of the needle to permit access to tortuous spaces.
• FIGS. 16A-C illustrate another embodiment of a flexible needle and catheter, of which the needle may be similar to the embodiment illustrated inFIG. 2.FIGS. 16A-B depict the articulation of the needle independent of any steering mechanism, and show that the needle can bend approximately 90 degrees.FIG. 16C is a close up of theflexible needle1002, and illustrates a needle sheath orcatheter1004 covering the more proximal section of theflexible needle1002. Theflexible needle1002 extends past the distal end of thesheath1004, and has a flexible section1008 (similar to theflexible shaft portion204 discussed above) that comprises spiral “jigsaw” cuts covered with a layer of heat shrink material. The extremedistal tip1010 of the flexible needle is uncovered and lacks cuts, and is sharpened so as to pierce into tissue.
• FIG. 17 illustrates ahandle1701 that may be used to manipulate and control embodiments of the flexible needles described herein. Thehandle1701 is connected to acatheter1700 with a flexible needle hypotube within, and thehandle1701 can control the extension of the needle from the catheter.
• FIG. 18 is a closeup view of an embodiment of aflexible needle1802. This embodiment has aflexible section1804 comprising aspiral cut1806, and which extends close to the extremedistal tip1810 of theflexible needle1802. Thedistal tip1810 is preferably beveled and sharpened so as to penetrate into tissue. Theproximal end1809 of the flexible needle may be optionally covered by apolymeric sheath1812 withcoils1814 underneath and overlying the body of theflexible needle1802. Preferably, thecoils1814 provide structural support to theneedle1802 to reduce or eliminate the likelihood that theneedle1802 will prolapse or collapse, in particular when theneedle1802 is bent or articulated.
• FIG. 19 is a fluoroscopy image similar to that illustrated inFIG. 10. Here, a bronchoscope of the right side of the image has a catheter extending from it. The catheter comprises a coil at its distal end that may aid visualization of the device. A flexible needle also extends from the distal end of the catheter and is depicted here piercing into and biopsying a lung nodule (the darker circular object on the left). The flexible needle is guided by an inner guidewire similar to the embodiment illustrated inFIG. 8.
• It will be understood that the present descriptions of the lung biopsy systems, apparatuses, and methods described herein as being used in a lung and for lung nodules are not limiting, and that these embodiments may be used for biopsying, navigating, and locating areas of interest in other locations on a patient, including gastric, endoscopic, or other suitable locations. Similarly, a bronchoscope is not necessary, and other suitable devices capable of accommodating the embodiments described herein may also be used, including without limitation various endoscopes or laparoscopic cannulas.
• As illustrated inFIG. 20A, asubstance delivery system2000 can include adelivery needle2010. In some embodiments, thedelivery needle2010 can be similar to or the same as the flexible TBNA needles described herein. Thedelivery needle2010 can be hollow. In some embodiments, thedelivery needle2010 defines adelivery lumen2012 and has adelivery needle wall2019. The delivery needle wall has aninternal surface2021 and anoutside surface2022. Thedelivery lumen2012 can extend through thedistal end2014 of thedelivery needle2010. In some embodiments, thedelivery lumen2012 extends through the entire length of thedelivery needle2010. Thedelivery needle2010 can include a solid (e.g., without an internal lumen) portion (not shown) at and/or near a proximal end of thedelivery needle2010. In some embodiments, thedistal end2014 of thedelivery needle2010 can be configured to pierce tissue within the body. For example, thedelivery needle2010 can be beveled or otherwise sharpened at itsdistal end2014. Thedelivery needle2010 can be navigated to a site of interest (e.g., a nodule, lesion, or other site of interest) within the body via the working channel of a delivery device (e.g., a bronchoscope, endoscope). In some embodiments, thedelivery needle2010 is navigated to the site of interest using a catheter. Thedelivery needle2010 can be positioned within a sheath to protect thedistal end2014 and/or the working channel of the delivery device or catheter from damage. The sheath can be retracted from thedelivery needle2010 prior to deploying theneedle2010 to the site of interest. In some embodiments, thedelivery needle2010 can be advanced distally past the distal end of the sheath in a manner similar to the needles described above.
• In some embodiments, at least a portion of the length of thedelivery needle2010 is flexible. For example,delivery needle2010 can include flexibility increasing features similar to or the same as those described with respect to the flexible and/or transbronchial needles above. Such flexibility increasing features can include cuts in thewall2011 of thedelivery needle2010. In some embodiments, one or more cut patterns can be cut into portions of thewall2011 of thedelivery needle2010. For example, jigsaw cuts, straight cuts, spiral cuts, interrupted spiral cuts, partial or dashed cuts, zigzag cuts, sinusoidal cuts, and/or any combination of these or similar cuts would be made in a portion of or along the entire length of thewall2011 of thedelivery needle2010.
• According to some variants, thewall2011 of thedelivery needle2010 is coated. For example, the interior surface and/or exterior surface of thewall2011 can include a heat shrink material or some other coating. The coating can be configured to reduce or eliminate the likelihood that fluid would leak through thewall2011 between thedelivery lumen2012 and the surroundings of thelumen2012.
• As illustrated inFIGS. 20A-20B, one or more internalflexible needles2040 can be positioned within thedelivery needle2010. For example, the internalflexible needles2040 can be sized (e.g., have diameters) such that threeinternal needles2040 can be stored within thedelivery needle2010. Many variations in the number ofneedles2040 configured to fit within thedelivery needle2010 are possible (e.g., 2 needles, 4 needles, 6 needles).
• In some embodiments, theinternal needles2040 extend the length of the delivery needle2010 (e.g., from the proximal end of thedelivery needle2010 to thedistal end2014 of the delivery needle2010). Preferably, theinternal needles2040 can be attached to aflexible shaft2030. Theflexible shaft2030 can comprise a tube comprise a polymer tube, a metallic or polymer coil, and/or a laser or chemical cut hypotube. In some embodiments, theinternal needles2040 are attached to the distal end of theflexible shaft2030 via acollar2020. Thecollar2020 can be, for example, an adhesive binding. In some embodiments, thecollar2020 can be constructed from a metallic material onto which theinterior needles2040 can be welded or otherwise adhered. In some embodiments, theinternal needles2040 are coupled with theflexible shaft2030 directly, without the use of acollar2020.
• As illustrated inFIG. 20B, theinternal needles2040 can be hollow and can defineinternal needle lumens2048. Theinternal needle lumens2048 can be in fluid communication with an interior lumen of theflexible shaft2030. In some embodiments, the proximal ends of theflexible shaft2030, theinternal lumen2012, and/orinternal needle lumens2048 are in fluid communication with a delivery fluid source. For example, theinternal needle lumens2048 can be in fluid communication with an external fluid source (e.g., a syringe, a peristaltic pump), either directly or via the interior lumen of theflexible shaft2030.
• Theflexible shaft2030 and/orinternal needles2040 can be configured to move in the distal and/or proximal directions with respect to thedelivery needle2010. For example, theinternal needles2040 can be connected to a proximal handle (not shown), either directly or via theflexible shaft2030. The proximal handle can be configured to move theflexible shaft2030 and/orinternal needles2040 in the proximal and distal directions with respect to thedelivery needle2010. In some embodiments, a first proximal handle can be connected to theflexible shaft2030 and a second proximal handle can be connected to theinternal needles2040. In some embodiments, theinternal needles2040 can be moved in the proximal and distal directions with respect to theflexible shaft2030 and/or thecollar2020. In some embodiments, each of theinternal needles2040 can be individually (or, e.g., in subsets of the whole set of internal needles2040) connected to a proximal handle. In some such embodiments, each (e.g., or each subset) of theinternal needles2040 can be moved in the distal and proximal directions with respect to the otherinternal needles2040.
• Theinternal needles2040 can be constructed from a metal or metal alloy, such as stainless steel, steel, titanium, or some other appropriate material. In some embodiments, theinternal needles2040, or some portion thereof, are constructed from a polymer or other non-metallic material. Preferably, at least a portion of each of theinternal needles2040 is constructed from nitinol or some other shape-memory material.
• In some embodiments, theinternal needles2040 are configured to transition between a contracted position (e.g., as illustrated inFIGS. 20A-20B) and an expanded position (e.g., as illustrated inFIGS. 21A-21B). In the expanded position, theinternal needles2040 can flare out from thedistal end2014 of thedelivery needle2010. In some embodiments, theinternal needles2040 transition from the contracted position to the expanded position as the distal ends2046 of theinternal needles2040 pass thedistal end2014 of thedelivery needle2010. In some embodiments, thewall2011 of thedelivery needle2010 includes one or more apertures through which theinternal needles2040 can pass when transitioning between the contracted position and the expanded position. The extent to which theinternal needles2040 flare out from thedistal end2014 of thedelivery needle2010 can, in some embodiments, be controlled by the relative distal movement of theinternal needles2040 relative to thedelivery needle2010. For example, once past thedistal end2014 of the delivery needle3010 (or, e.g., through the apertures in thewall2011 of the delivery needle2010), the distal ends2046 of theinternal needles2040 can be configured to flare out further from thedelivery needle2010 as theflexible shaft2030 and/orinternal needles2040 are advanced in the distal direction relative to thedelivery needle2010. The interior surface of thewall2011 of thedelivery needle2010 can include a coating to reduce or eliminate the likelihood that theinternal needles2040 would catch on the interior surface of thewall2011 as theinternal needles2040 translate in the proximal and/or distal directions with respect to thedelivery needle2010.
• Theinternal needle lumen2039, havingwalls2041, of theinternal needles2040 can include cut (e.g., laser cut and/or chemical cut) features2042 such as, for example, holes or slits. The cut features2042 can facilitate fluid communication between theinternal needle lumens2048 and the tissue into which theinternal needles2040 are deployed. The cut features2042 can be placed on the sides of theinternal needles2040 that are compressed and stretched as theneedles2040 deploy from thedistal end2014 of thedelivery needle2010 In some embodiments, the cut features2042 are made into the sides of theneedles2040 tangential to the direction of bending as theneedles2040 extend from thedistal end2014 of the delivery needle2010 (e.g., as illustrated inFIG. 21A). According to some variants, the cut features2042 are located at various points around the wall of theneedles2040. In some embodiments, the distal ends2046 of theinternal needles2040 includedistal apertures2044 at a distal end2045 in fluid communication with theinternal needle lumens2048 of theinternal needles2040.
• Theinternal needles2040 and/ordelivery needle2010 can be configured (via, e.g., cut features and/or cut patterns in thewalls2041,2011 of theneedles2040,2010) to be flexible such that thedelivery needle2010 can be navigated to and/or through narrow and/or tortuous lumens within the body. As such, thesubstance delivery system2000 can be delivered to a site of interest within the body using the body's natural orifices (e.g., the mouth). In some embodiments, piercing of tissue within the body (other than piercing an airway wall to access extrinsic areas of interest outside of the airway) can be avoided by using a flexiblesubstance delivery system2000 as described. According to some variants, thedelivery needle2010 andinternal needles2040 can be navigated to the site of interest (e.g., nodule, tumor, lesion) to be treated using a bronchoscope of other delivery device. For example, thedelivery needle2010 can be delivered to a site of interest in the lung via a bronchoscope inserted through the airways of the throat and lung. In some embodiments, thedelivery needle2010 is navigated to the site of interest thoracoscopically (e.g., through an incision in torso of the patient). In some embodiments, thedelivery needle2010 can be navigated to the site of interest using a delivery catheter similar to or the same as thedelivery catheter1100 described above with respect toFIG. 11C. For example, anultrasound probe1116 can be used to navigate thedelivery needle2010 to the site of the interest. Theultrasound probe1116 can facilitate real-time tracking of theneedle2010 as theneedle2010 is navigated to the site of interest.
• FIG. 22A illustrates an embodiment of adelivery needle2010 used to treat an area of interest2002 (e.g., a nodule, tumor, lesion). Used alone, a delivery needle2010 (or other single-lumen needle) can have zone ofefficacy2050 within and/or around the area ofinterest2002. For example, thedelivery needle2010 can be delivered to the area ofinterest2002 and be inserted (e.g., piercably) into the area ofinterest2002. A syringe or other fluid source (not shown) can be connected to theproximal end2015 of thedelivery needle2010 and can be used to introduce a treatment substance (e.g., an ablative chemical solution) to the area ofinterest2002 through theneedle2010. The treatment substance can travel through thedistal end2014 of theneedle2010 to affect a zone ofefficacy2050. The zone ofefficacy2050 can generally comprise the area treated or otherwise affected by the treatment substance.
• As illustrated inFIG. 22B, the use of multipleinternal needles2040 can increase the size of the zone ofefficacy2050acompared to the zone ofefficacy2050 realized using a single-lumen, single needle treatment approach. For example, thedelivery needle2010 can be navigated to the area ofinterest2002. Thedistal end2014 of thedelivery needle2010 can be inserted (e.g., piercably) into the site ofinterest2002. Theinternal needles2040 can be moved distally with respect to thedistal end2014 of thedelivery needle2010 to further penetrate the site ofinterest2002. As described above, theinternal needles2040 can be configured to flare outward from thedistal end2014 of thedelivery needle2010 as theinternal needles2040 are advanced out of thedelivery needle2010 in the distal direction. A syringe or other fluid source can be connected to the proximal end of theinternal needles2040 and/orflexible tube2030 and can be used to introduce a treatment substance (e.g., an ablative chemical solution) to the area ofinterest2002 through theinternal needles2040. In some embodiments, the treatment substance is ethanol, which can be used to treat and/or destroy tumors. The treatment substance can travel through the cut features2042 and/ordistal aperture2044 to disperse the treatment substance and create a zone ofefficacy2050athat can be greater in size than the zone ofefficacy2050 realized using a single lumen, single needle treatment approach.
• Although this invention has been disclosed in the context of certain embodiments and examples, those skilled in the art will understand that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. In addition, while several variations of the invention have been shown and described in detail, other modifications, which are within the scope of this invention, will be readily apparent to those of skill in the art based upon this disclosure. It is also contemplated that various combinations or sub-combinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the invention. It should be understood that various features and aspects of the disclosed embodiments can be combined with, or substituted for, one another in order to form varying modes or embodiments of the disclosed invention. Thus, it is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments described above.

Claims (15)

What is claimed is:

1. A needle assembly for delivery of a treatment substance to a site within the body, the needle assembly comprising:

a delivery needle defining a delivery lumen and having a delivery needle wall, a proximal end, and a distal end, the delivery needle wall having one or more cut patterns to increase the flexibility of the delivery needle;

a plurality of internal needles, each internal needle defining an internal needle lumen and having an internal needle wall, a proximal end, and a distal end, the plurality of needles configured to transition between a contracted position and an expanded position; and

a treatment substance source in fluid communication with the internal needle lumens of the plurality of internal needles;

wherein each of the plurality of internal needles is configured to extend in a distal direction and flare outward from the distal end of the delivery needle when in the expanded position; and

wherein the plurality of internal needles are housed within the delivery lumen when in the contracted position.

2. The needle assembly ofclaim 1, wherein an internal surface of the delivery needle wall is coated with a substance configured to reduce or eliminate the likelihood that the internal needles will stick to or catch on the delivery needle wall when the internal needles are transitioned between the contracted position and the expanded position.

3. The needle assembly ofclaim 1, wherein the delivery needle is coated on an outside surface with quick clotting features, cauterizing features, or both.

4. The needle assemblyclaim 2, wherein the internal surface of the delivery needle wall includes one oe more cut features, the one or more cut features facilitating fluid communication between the internal needle lumen and an exterior of the internal needles.

5. The needle assembly ofclaim 4, wherein the needle assembly further comprises a flexible shaft having a distal end and a proximal end, the distal end of the flexible shaft coupled with the proximal ends of the internal needles.

6. The needle assembly ofclaim 1, wherein the needle assembly comprises three internal needles.

7. The needle assembly ofclaim 6, wherein each of the internal needles has a distal aperture in fluid communication with the internal needle lumen.

8. The needle assembly ofclaim 1, wherein each of the distal ends of the internal needles are sharpened.

9. The needle assembly ofclaim 8, wherein each of the distal ends of the internal needles form a continuous beveled surface, wherein the angle changes continuously along the bevel.

10. The needle assembly ofclaim 1, wherein the distal end of the delivery needle is sharpened.

11. The needle assembly ofclaim 10, wherein the distal end of the delivery needle forms a continuous beveled surface, wherein the angle changes continuously along the bevel.

12. The needle assembly ofclaim 1, wherein the needle assembly further comprises a connection to a suction source, a steering mechanism, or both.

13. A multi-lumen catheter assembly, comprising:

a biopsy needle contained within one lumen;

an ultrasound probe contained within a second lumen; and

a mechanism for adjusting the angle of the distal tip of the biopsy needle, comprising one or more steering wires.

14. The needle assembly ofclaim 13, wherein the one or more steering wires is a bowden wire.

15. A method of obtaining a tissue sample, comprising:

inserting a needle assembly in a bronchoscope;

advancing a one or more flexible needles through a distal tip of the needle assembly;

visualizing the tip position with the aid of one or more signature markers; and

manipulating a position of the distal tip to optimally obtain the tissue sample.

Images