WO2016160348A1

WO2016160348A1 - Catheter access device

Info

Publication number: WO2016160348A1
Application number: PCT/US2016/022766
Authority: WO
Inventors: Hugo Xavier Gonzalez; David H. Dillard; Tommy QB. NGUYEN
Original assignee: SPIRATION, INC., d/b/a OLYMPUS RESPIRATORY AMERICA
Priority date: 2015-03-31
Filing date: 2016-03-17
Publication date: 2016-10-06

Abstract

A device (10) including a catheter (18) and a medical instrument (20). The catheter includes an inner portion and a catheter stop (36) within the inner portion. The medical instrument includes an outer portion and a medical instrument stop (38) on the outer portion. The medical instalment is moveably supported in the inner portion of the catheter, and after the medical instrument is moved and the medical instrument stop contacts the catheter stop, further movement of the medical instrument causes the catheter to move with the medical instrument

Description

CATHETER ACCESS DEVICE

FIELD

{0001} The present teachings relate to a device, and more particularly to a medical device and method forintroduemg a catheter into the anatomy.

BACKGROUND

{0002} Needles and catheters have been considered for accessing and testing a region of interest in the anatomy. For example, a needl disposed within a catheter can be inserted into the anatomy and steered towards the region of interest. The needle can be advanced from within the catheter towards the region of interest so that the needle can penetrate, cut, core and/or shear a tissue sample therefrom. Once a sufficient tissue sample is collected, the needle and catheter ca be removed from the anatomy, if the tissue sample collected, is inadequate, contaminated, and/or if another tissue sample is required, the catheter and the needle may need to be reinserted into the anatomy, which may nndesirahi cause trauma to- the patient may be cumbersome for the surgeon perfonnm the procedure, and/or may add additional time to the procedure.

{0003} Needles and catheters have also been considered for a variety of procedures fo delivering medicine to the anatomy. However, a small needle cart restrict the delivery of viscous liquids into the anatomy, while large needle may be difficult to maneuver and orientate in the anatomy. Moreover, it may be difficult to maintain a needle in the anatomy for an extended period of t ime.

{0004} U.S. Patent Application Publication Number 2014 0058357A1 appears to disclose a device and method for piercing a vessel in the anatomy with a needle, dilating the pierced hole with dilator, retracting the needle, inserting catheter into the vessel, and then withdrawing the dilator. However, inserting -multiple devices int the anatomy and then dilating a pierced hole may cause undesirable trauma to the patient, may be cumbersome for the surgeon performing the procedure, and/or may add additional time to the procedure.

{0005} Another problem with current devices is that the catheter and medical instrament are held in alignment with each other at the proximal end outside the anatomy and, consequently, alignment of the features at the distal end inside the anatomy can shift relati ve to each other. This problem becomes much worse the longer the device is. For access into deeper anatomy with greater lengths of catheters a id medical devices, suc as in the lungs, alignment becomes poor m existing design;; and ali nment at the distal end may become a problem.

[009$] What is needed is an improved device and method for placing a catheter into the anatomy. It would be desirable to have a device and metho for placing a catheter into the anatom that can. be used for multiple instamientation procedures, including sampling, draining, and/or delivery of medicine to the anatomy, it would be desirable to have a device and method that has -alignment features provided at a distal end. It would be desirable to have a device and method where the distal end moved in predictable unison- and the resultant positions in the target area that can be precise, it would be attractive to provide a catheter that can be maintained in the anatomy for a period of time so that multiple instementation procedures can be performed without removing and subsequently reintroducing a catheter into the anatomy. It would be desirable to provide a device that can be mass-produced relatively inexpensively, that has a minimal number of parts, and that is easy to operate.

SUMMARY

|ΘΘΘ7] The present teachings meet one or more of these needs by providing a device including a medical instrument disposed within a catheter that together can be inserted into the anatomy, steered around interna! vessels, airways, and organs in the anatomy, and can together pierce a region of interest in the anatomy. The present teachings provide a -medical .instrument can be withdrawn from the catheter of the present teachings, while the catheter at least temporarily remains in the anatomy so that multiple instrumentation procedures can be completed, including sampling, draining, and/or delivery of medicine to the anatomy. The present teachings provide a catheter which can be maintained in the anatomy for a period of time so that multiple instmmentaiion procedures can he performed without removing and ^'subsequently re-introducing a cathete into the anatomy. The present teachings - provide a device that can he mass-produced relatively inexpensively , that has a minimal number of parts, and that is easy to operate.

!9β08_.| The present teachings provide a device comprising a catheter and a medical instrument The catheter ^'includes an inner portion and catheter ^"stop within, the inner portion. The medical instalment includes an outer portion and a medical instrument stop on the outer portion, The medical instrument is moveabSy supported i the inner portion of the catheter, and when the medical instrument is moved and the medical instrument sto contacts the catheter stop, further movement of the medical insiromeni causes the catheter to mo ve with the medical instrument

[0009] The present teachings also provide a method comprising inserting at least a portion of the device of the teachings herein, into- the anatomy: extending the medical instrument lip beyond the distal end of the catheter; engaging the medical Instrument stop against the- catheter stop; piercing the region of interest with the medical instrument tip; moving the medical instrument and the catheter together so that both the medical instrument and the catheter penetrate the region of interest; and withdrawing the medical, instrument f om the catheter.

BRIEF DESCRIPTION OF THE DRAWINGS

{00101 Fig, .1 illustrates a perspective view of a medical system including a medical device with a medical instrument and catheter according to the teachings herein.

[001 ! J Fig. 2 illustrates a cross-sectional view of a medical system including a medical device, a medical nstalment and -Catheter according to the teaching herein.

{0012] Fig. 3 illustrates a cross-sec tional view of a medical instrument and a catheter accordin to the teachings herein.

{ 0013 } Fig. 4 illustrates a cross-sectional view of a medical instrument and a catheter according to the teachings herein,

[ 034} Fig. 5 illustrates a cross-sectional view of a medical instrument and a catheter according to the teac ings herein.

[00.15] Fig, 6 illustrates a partial cross-sectional view of a medical instrument, a catheter, and a feature of interest of the anatomy according to the teachings herein.

[0016] Fig, 7 illustrates a partial cross-sectional view of a medical instrument, a catheter, and a featur of interest of the anatomy according to the teachings herein.

DETAILED DESCRIPTION

{00!?] This Application claims priority to U.S. Provisional Application No. 62/1.40,51 .1 , filed o March 31 , 2015, the entiret of which is hereby incorporated by reference herein for all purposes. {003.8} The explanations and illiistrations presented herein are intended to acquaint -others skilled in the art -with the teachings_* its principles, and its practical application. Those skilled in the art may adapt and apply the teachings in its numerous forms, as may he best suited to the requirements of a particular use. Accordingly, the specific embodiments of the present, teachings as set forth are not intended as being- exhaustive or Knitting of the teachings. The scope of the teachings shoukt therefore, he determined not with reference to the description herein, but should instead be determined with reference to the appended claims, along wit the fall scope of equivalents to which such claims are entitled. The disclosures of all articles and references, including patent applications and publications, are incorporated by reference for all purposes. Other combinations are also possible as will be gleaned from the following claims, which are also hereby incorporated by reference into this written description. The teachings herein may be used without limitation. In other words, the teaching herein may be used in any medical procedure. The teachings herein may be used, for accessing any part of any anatomy. For example, one or more of various vessels, passages, lumens, body cavities, tissue, organs, the l ike, or ^-combination thereof in humans and animals can be accessed, using the teachings herein.

{0019] The teachings herein include one or more medical systems. The one or more medical systems may comprise a medical device, a catheter and any medical instrument. The catheter may include an inner portion and a. catheter stop within the inner portion. The medical instrument may include an outer portion and a medical instrument stop located on the outer portion. The medical instrument may be moveably supported in the inne portion of the catheter. Generally,, when the medical instrument is in the inner portion of the catheter and the medical instrument i moved, the medical instrument stop ca contact the catheter stop so that mrttaer movement of the medical instrument causes the catheter to move with the medical instrument.

(0020) The one or more medical devices may function to be used in any medical procedure. For example, the one or more .medical devices may -function to introduce into an anatomy any medical instrument and/or facilitate removal from any anatomy an medical instrument, materia lis), or objects), Exemplary medical instruments may include one or more needles, coring needles, samplin needles, transbronchial needle aspiration devices, cytology brushes, biopsy forceps, baskets, balloons, guiding devices, ultrasonic probes, illumination devices, energy devices, medicines, therapies (i.e., chemotherapy, proteoniies, microspheres, etc.), materials (i.e., liquids, pastes, markers, etc.), the like, or a combination thereof. In some embodiments the medical device may include one or more needles, for example one or more coring needles, sampling needles, and in sbronehial needle aspiration deviees. Exemplary materia., the medical devices may obtain from the body include tissue samples, blood samples, abnormalities, foreign matter, and/or any other type of sample that may be obtained from the anatom y via the oiie or more medical devices. The one or more medical devices may include one or more bronchoscopes, thoracoscopes, !aporaspeopes, rigid, scopes, flexible scopes, semi-rigid scopes, navigation catheters or guide catheters.

10021} The one or more medical devices may include one or more bronchoscopes. The one or more bronchoscopes may be used in my medical procedure. Fo example, the one or more bronchoscopes ma function to withdrawal objects from the anatomy, Preferably, the one or more bronchoscopes maybe used to withdrawal from the anatomy foreign bodies, tissue samples, blood, or a combination thereof; may be used to visually inspect an internal portion of the anatomy, or both. More preferably, the one or more bronchoscopes may be used for examining, treating, and/or diagnosing king growth, lung problems, lung cancer, lymph nodefs), atelectasis, suspected interstitial lung disease, a king rejection, after a lung transplant, and/or to remove fluid or mucus plugs from the airways of patient. The one or more bronchoscopes ma provide for the insertion, manipul ation, and/or operation of any medical" instrument in the anatomy; delivery of one or more fluids, medicines, pastes, therapies, etc, to the anatomy, or both.

10022) The one or more medical devices may include one or more viewing devices. The one or more viewing devices may function to view or observe an internal portion of the anatomy, view one or more medical Instruments in the anatomy, or both. The one or more viewing devices may function to provide a. surgeon with the ability to observe at least a. portion of a catheter and any medical instrument in the anatomy; help indicate a depth, of penetration o a catheter and any medical instrument into a site of interest in the anatomy; arid/or assist in orienting or locating a catheter, medical instrument, or both relative to a regio of interest in the anatomy . The one or more viewing devices may be any device that may function to transmit and or send one or more signals towards any medical device or medical instrument The one or more viewing deviees may be any device configured to receive echo signals reflected and/or deflected from any markings, scribes, echogenic features, devices,, catheters, medical instruments, or a combination thereof Exemplary viewing device may include one or more ultrasounds, radiographic instruments, fluoroscopic visualizations, X-rays, transducers, transmitters, etc.

3 10023} The one or more devices may include one or more catheters. The one or more catheters may function to; provide a passageway into the anatomy. The ne or more catheters may function to provide for introduction into the anatomy and/or removal therefrom any medical instrument In some embodiments, the one or more catheters may function to receive and engage one or more medical instruments so that the one of more medical instruments cars, move the one or more catheters towards a region of interest in the anatomy. The one or more catheters may receive one or more medical instruments and form a combined catheter and medical instrument. The one or more combined catheter and medical instrument, may be- moved, through a region of interest once any medical instrument pierces or penetrates the region of interest Exem plary regions of interest may include any part of the anatomy, -such, as a tissue wall an ^'airway wall, a lung, a lymph node, a tumor, etc. Preferably, the one or more catheters can at least temporarily engage a portion of the anatomy so that the one or more medical instruments can be withdrawn from the one or more catheters while the one or more catheters remai i the anatomy. Preferably, the one or more catheters may remain in the anatomy for a period of time. For example, the one or more catheters may remain in the anatomy for about: an hour or so, more or less, about 5 hours or more, about a day or more, about 3 days or more, or even about a week or more. The one or more catheters may remain in the anatomy so that any medical instruments, medicines, and/or objects can be inserted into, supplied to, and/or removed from the region of interest one or more times without re-inserting, repositioning, re-orientating, replacing, etc. the one or mot® catheters.

0024] The- one or more catheters ma be fabricated f any materia! suitable for wse in any medical procedure. For example, the one or more catheter* may be fabricated. rom a material that can he inserted into the anatomy while also -performing the previously recited functions. For example, the one or more catheters may .be at least partially resilient, expandable, collapsible, foraiable deformable, or a combination thereof.. Preferably, the one or more catheters may be at least partially flexible, bendable, articulable, or a. combination thereof so that the one or more catheters can be steered around the anatomy and so. that one or more regions of interest in the anatomy can be easily accessed or bypassed. For example, the one or more catheters may bend or articulate about 15 degrees or more, about 45 degrees or more, about 60 degrees or more, about 90 degrees or more, about 1 10 degrees or more, or even about 130 degrees or more. For example, the one or more catheters may bend or articulate about .15 degrees or less, about 45 degrees or less, about 60 degrees or less, about 90 degrees or less, about 1 10 degrees or less, or even about 180 degrees or less. The one or more catheters may be any elongated, tubular member extending along any axis, such as a longitudinal, axis, a catheter axis, a medical instrument axis, or a 'combination thereof. The. .one or more catheters may include any cross section suitable for perfonnrag the previously recited functions. For example, the cross section may be substantially circular, oval, or even irregular. The one or more catheters may include or define an aperture or an opening at distal end, a proximal end, and/or at a region in between so. that any medical instruments), medicme(s), object(s), or a combination thereof can pass there through the one or more catheter and/or extend there out of. The one or more catheters may he made from a single integral component, or may he made from two or more portions. Preferably, the one or more catheters include a first portion and a second portion. The first portion may be located proximal the second portion, or vice versa. The first portion may have a gauge, size, or diameter that is larger than the second portion, or vice versa. The first portion and the second portion may be connected at a intersection or transition.

[ Mi25J The one or more transitions ma function to make a temporary or permanent connection between a first portion and a second portion of the one or more catheters. The one or more transitions may .function, to enhance and/or provide .for insertion of the catheter through the site o interest, in other words, the one or more transitions may function to provide ramped or angled surface so thai a proximal portion of the needle, which may have a larger cross section than distal portion, can be inserted and moved through the anatomy or a region of interest. The one or more transitions may have an shape for performing the previously recited functions. For example, the one or more iraiisitions ma he generally tapered, sloped, slanted, rounded, flat, angled, stepped, or a combination thereof. The one or more .transitions may be fabricated from any suitable material for use in medical procedures that may perform the aforementioned functions. The one or more transitions may be subjected to heat so thai the one or more transitions fo , melt, flow, and/or reflow around the .first portion, the second portion, r both. The one or more iraiisitions may be placed ov er at least a portion of the fir s t portio and the second portion and heat shrunk there over or there around. The one or more transitions may begin to taper any distance from a distal end of the one or more catheters. Preferably, when measured from distal end of the one or more catheters, the one or more transitions may begin to taper at a distance of about 1 inches or more, about 2 inche or more, about and 3 inches o more, or even, about 4 inches or more. Whe measured from a distal end of the one or more, catheters, the one or more transitions may be located at a distance of about 5 laches or less, about 4 inches or less, about 3 inches or less, about 2 inches or less, or even about 1 inch or less.

|W26j The one or mor catheters may include one or more catheter stops. The one or more catheter stops may function to be engaged by any medical msira entfs) so that the one or more catheters can be moved i the anatomy. Preferably, the one or more catheter stops may he engaged by one or more medical instrument stops on a medical instrument that is nioveably supported in the one or more catheters so that the one or more combined catheter and medical instrument ca move through a region of interest in the anatomy via the one or more medical instruments. The one or more catheter stops may be, o may include, any suitable, feature for performing the aforementioned functions, .Exemplary catheter stops may be, or may include, one or more tapered ort ons, edges, collars, projections, grooves, fingers, rings, ledges, nubs, dimples, extensions, tl laments, members, the like, or a combination thereof. The one or more catheter stops may he keyed and engaged by a medical instrument stop including a mating keyed feature. For example, the one or more catheter stops may resemble a helical or threaded portion that is selectively engaged by mating helical or threaded positio located on any medical instrument. The one or more catheter, stops may be located in an inne portion of tire one or more catheters. Preferably, the one or more catheter stops may be disposed within an inner portion of the catheter near a distal end so that the medical instrument can more accurately move, control, articulate, advance, and/or retract the catheter i the anatomy. For example, when measured from -a distal end of the one or more catheters, the one or more catheter stops may be located at about a half_. inch or more, about two inches or more, preferably abou tw and. a half inches or more, or even four inches or more. {0027j The one or more catheters may include one or more retaking features . The one or more retaining features may function to at least temporarily provide for the one or more catheters, combined, catheter and raedical instrument or both to remain in the anatomy. That is, the one or more retaining features may be any feature(s) that may function to at leas temporarily connect, attach, retain, restrain, and/or stabilize the one or more catheters in or at a site of interest in the anatomy. Preferably, the one or more retaining features may be any change in shape on an outer surface of th one or more catheters. For example, the one or more retamm features may he, or may include, one or more legs, arms, feet, prongs, collars, hooks, projections, extensions, rings, abutments, undercuts, mechanical attachments, the like, or a combination thereof. The one or more retaining features may separate at least a portion of the pierced or. penetrated features of interest until the one or more features of interest pass there through . The one or more features of interest ma then close or fold around a portion of the catheter while the one or more retaining feamres are located in the feature of i nterest to at least temporarily retain the catheter therein. The one or more retaining features may iokl expand, expel, or resiSiently expand alter the catheter penetrates the region of interest. For example, a surgeon may activate one or more controls so that the one or more features of interest expand and attached onto the anatomy so that the one or more catheters can be secured to the anatomy. The one or more reta ing features may be located at any position on the catheter so that the catheter can at least temporarily remain in the anatomy. Preferably, the one or more retaining features may be located on an. outer surface. at or near a distal end portion of the one or more catheters, The one or more retaining features may be adjustable so that a length of the catheter in the site of interest ca vary.

|O028j The one or more catheters may include one or more markings. The one or more markings may function to enhance visibility in the anatomy of the catheter, one or more medical instruments, or both. For example, using the one or more viewing devices, the one or more markings may function to provide a surgeon with the ability to observe at least a portion of a catheter and any medical instrument - in any portion of the anatomy; help indicate a depth, of penetration of a catheter and any medical instrument into a site of interest in the anatomy; and/or assist in orienting or locating a catheter, a medical instrument, or both relative to a region of interest. The one or more markings may be any feaiure(s) that performs the aforementioned functions. For example, the one or more markings may be, or may include, one or more eehogenic features, scribes, bands, slots, segments, shapes, surfaces, recesses, roughened surfaces, .embedded, materials, coatings, projections, serrations, or a combination thereof Preferably, the one or more markings ma be painted on at least a portion of the one or more catheters, and may be color coordinated. The one or more color coordinated markings may be any color(s) (i.e., red, green, black, blue, white, clear, etc.). More preferably, the one or more markings may be color- coordinated markings with a protective coating there over. The protective coating may be clear. The one or more markings may be color-coordinated heat shrinks. The one or more markings ma be circumferential bands of about 1mm or more, about 2mm or more, about 3mm or more, or preferably about 5mm or more. The one or more markings may be circumferential bands of about 1 Omni or less, about 8mm. or less, about 6mm or less, preferably about 5mm o less, or even about 4mm or less. The one or more markings may extend around an entire circumference of the one or more catheters. Tire one or more markings- may extend around a portion of th one or more catheters about 25 degrees or mor , about 45 degrees or more, about.60 degrees or more, about 90 degrees or more, about 135 degrees or more, about 180 degrees more, or about 270 degrees or more. The one or more markings may extend around a circumference of the one or more catheters about 360 degrees or less, .270 degrees or less-, abou 180 degrees or- less, about 135 degrees or less, or even about 45 degrees or less,

[0029] The one or more medical instruments may be any medical instrument that may be used in an medical procedure. The one or more medical instruments may be any medical instrument that ma be inserted into the one or more catheters. The one or more medical instruments may be inserted into the one or more catheters to form a combined catheter and medical instrument. The one or ore medical mstrumenis may function to move or steer one or more caiheiers, combined catheter and medical mstrument, or both in the anatomy. .Preferably, the one or more medical instruments ma be inserted into a proximal end of the one or more catheters and moved distally within the one or more catheters until- the one or more medical -instrument stops engage the One or more catheter stops. By-way of the engagement between the one of more- medical instrument stops and the one or more catheter stops, -further movement of the medical instrument (e.g., distal movement of the medical instrument), may cause the medical instalment to move the catheter. Preferably, the one or more medical instruments may function to pierce or puncture any region of interest in the anatomy while also moving the one or more catheters through the region of interest. The one or more medical instruments may he any in.stniment(s) for delivering medicine or therapy to the anatomy, or may be used for obtaining any materials ), sampler^'s), and/or objeet(s) from the anatomy. Exemplary medical instruments may include one or more needles, cytology brushes, biopsy forceps, baskets, balloons, guiding devices, ultrasonic probes, illumination devices, energy devices, the like or a combination thereof. Preferably, the one or more -medical instruments may be any needie{s). For example, the one or more needles may be a coring needle, a sampling needle, a transbronchial aspiration needle, a puncturing needle, a guiding needle, the like, or a combmation thereof

{0030} The one or more medical instruments may include one or more medical instrument stops. The one or more medical instrument stops may function to engage the one or more catheters, or the one or more catheter stops, s tha the medic l instrument can move the catheter in the anatomy. Preferably, the one or more medical instrument stops may function to engage the one or more catheter stops so that the medical instn.iment(s) and the eatheter{s) can move together ia the anatomy and subsequently penetrate a site or region of interest in the anatomy together. That is, by way of the engagement between the one or more medical instrument stops and the one or more catheter stops, any movement of the medical instrument may cause the medical instrument to move the catheter. The one or more medical instrument stops may be any fearureis) for performing the previously received functions. Exemplary medical instrument stops may include one or more tapered portions, edges, collars, projections, grooves, fingers, rings, ledges, nubs, dimples, extensions, filaments, members, the like, or a combination there of. The one or more medical .instrument stops may be keyed and configured to engage a mating keyed portion of the one or more catheter stops. For example, the one or more medical instrument stops may resemble a helical or threaded portion that ma engage a mating helical or threaded position located on the one or more catheter stops. Preferably, the one or more medical instrument stops may be disposed near a distal end of the one or more medical instruments. The one or more medical instrument stops may be located at dista l end or a dis tal portion of the medical instrument so that the medical instmment can more accurately move, control, articulate, advance, retract the catheter in the anatomy. The -one or more medical instrument stops may be located at a suitable distance from a distal end or a distal portion of the medical instmment so that the medical instrument can more accurately move, control, articulate, advance, retract the catheter in the anatomy. For example, when measured. ^'from a distal end^' of the medical instrument,, the one or more medical instrument stops ma be located at about a half inch or more, about two inches or more, preferably about two and a half inches o more, or even tour inches or more. When measured from a distal end of the medical instrument, the one or more needle stops may be located at about a half inch or less, about two inches or less, preferably about two and a half inches or less, or even four inches or less. The one or more medical instrument stops may have a length or width al ong lengt o f the one or more medical instruments* a medical instrument axis, or both on the order of about 0.20 inches or more, about 0,30 inches or more, or even about 0.50 inches or more. The one or more medical instrument stops may have a length or wid th along a length of the medical instrument, the medical instrument axis, or both on the order of about 0.50 inches or less, 0.40 inches or less, preferably 030 inches or less, or even 0,10 inches or less.

[0031 J The one or more medical instruments may include one or more medical instrument tips. The one or more medical instrument tips may function to pierce, puncture, and/or penetrate any part of the anatomy. Preferably, the one or more medical instrument: tips -may -function as a piercing tip so that eel Is, tissue, foreign .matter, or a combination thereof from any site or region of interest can b obtained. The one or mor medical i strument tips may be l cated at a distal end or a distal portion of the medical instruments. Preferably, the one or more medical instrument tip may be contained within the one or more catheters as the catheter Is moved or steered through the anatomy towards the site or region of interest. More preferably, the one or more medical instrument tips may be moved, advanced, and/or extended beyond a distal end of the one o more catheters -when the both the catheter and the medical instrument are near region of interest. The one or more medical instrument tips may have any shape for performing the aforementioned functions. For example, the one or more medical ^'instrument tips may be angled, sharply angled, beveled, at, or a combination thereof so that the tissue samples can. be cut, cored, scraped, and/or obtained from a region of interest. The one or more medical instrument tips may includ - notched portion, a recessed portion, and/or a lancet feature. Preferably, the one or more medical instrument tips ma be one or more needle tips. A local vacuum may be created or formed at the medical instruments t ip, a distal end of the medi cal instrumen ts, or both so that anatomical samples can be aspirated or moved into the medical instruments, the sample storage area, or both,

{0032} The one or more medical rasiratnents may be one or more needles. The one or more needles may be inserted, into, the one or more catheters so that the one or more needles can move independently or the one or more catheters, but also move the one or more catheters. For example, the one or more needles may be inserted into a. proximal end of the one o more catheters and moved disiaUy within the one or more catheters until the one or more medical instrument · stops engage the one or more catheter stops. By way of the engagement between th e one or more medical instrument stops and the one or more catheter stops, further movemen of the needle (e.g., distal movement of the needle) causes the needle to -move the catheter. Once the one or more needles penetrates a region of Interest., movement of the one or more needles into the region of interest also moves the one or more catheters into the region of interest Exemplary needles may include a coring needle, a sampling needle, a transbronehial aspiration needle, a puncturing needle, a guiding needle, the like, or a combination thereof.

|O033] The one or more needles may have any length suitable for use in an medical procedure. The length of the one or .more needles ma extend along any axis, such a a longitudinal axis, a needle ax is, a catheter ax is, or a combination thereof The one or more needles may have any cross section that is suitable. for use in any medical procedure. For example, the cross section of the one or more needles may be constant, may vary, ma taper, may be irregular, may be an shape, or a combination thereof For e ample, the cross section of the one or more needles may be generally circular, oval, irregular,, or any other suitable shape t perform the above recited functions.. The one or more needles may be generall hollow. The one -of more needles may be generally solid. The one or more needles may include one or more sections or portions that are generally solid, generally hollow, or both. The one or more needles ma be formed from an material suitable for use any medical procedures. For example, the one or more needles may be fabricated, from a material, that can be inserted into the anatomy,, can move a catheter in the anatomy, and can also bend, ilex and/or articulate. The one or more needles may be any size or gauge suitable for use in any medical procedure, while still .functioning to perform the above recited Functions. For example, the one or more needles may be about 25 gauge or more, about 22 gauge, about 21 gauge, or about 1 gauge or less, etc. The one or more needles may include a combination of two or more gauges. That is, for example, a proximal portion of the needle may be about 21 gauge and a distal portion of the needle may be about 19 gauge, or vies versa . The one or more needles may i nclude one or more holes, ports, slots, the like or a combination, thereof for tissue sample col lection; for introducing one or more devices into the needle; for introducin one or more devices into the anatomy; for introducing, medicine or therapy to the anatomy, or a combination thereof.

[01134} The one or more medical devices, catheters, medical instruments, or a combination thereof may be used with one or more method steps. The method steps may be performed in virtually any order. At least a. portion of the one or more medical instruments ma be inserted into the one or more catheters. At least a portion of the one or more medical instruments ma be inserted into the one or more catheters to form one or more combined, catheter and medical instrument A distal end of the one or more medical instruments may be inserted i nto a- proximal end of the one or more catheters so that the distal end of the .medical instrument or a. medical instrument tip remains within the catheter. The one or more combined catheter and medical instrument may be inserted into a working channel or port of any device, for example a bronchoscope, A distal end of the one or more combined catheter and medical instrument may be inserted into a working channel of any device, A distal end of the one or more combmed catheter and a medical instrument, may be inserted .into the anatomy. The one or more combmed catheter and medical instalment may be passed through an orifice in the anatomy. For example, the one or more combined catheter and medical instruments may be passed through a patient's mouth or nose, through- the trachea, and into a Iirag of a patient,_. The one or more medical devices and medical instruments may be -moved through the anatomy towards a site or region of interes The one. or more medical devices, combined catheter and medical instrument, or both may be navigated, tracked and/or monitored .through the anatomy with the one of more viewing devices, such as an ultrasound probe or X-ray. The one or more medical instruments may be moved in the one or more catheters. The one or more medical instruments may be dista!ly moved in the one or more catheters until the one or more medical instrument stops engage the one or more catheter stops, A distal end of the one or more medical instruments, a medical instrument tip, or both ma be advanced from the one or more catheters a predetermined distance. The one or more medical instrument tips may penetrate the site of interest. The one or more medical instruments may move the one or more catheters through the penetrated site or region of interest The one or more catheters may follow the one or more ^'medical ns rument into the site of interest due to the engagement between the one or more medical ^'instrument stops and the one or more catheter stops. The one or more retaining features may assist in at leas temporarily securing the one or more catheters or combined catheter and medical instrument in the site of interest. The one or more retaining features may be biased, moved, folded, and or resiliently flexed to engage the site of interest. The one or more medical instruments may be completely withdrawn from the one or more catheters, anatomy, or both. The one or more catheters may remain in the anatomy for a period of time after the one or more medical instruments are removed from the catheter, the anatomy, or both.

{0035] With die one or more catheters remaining at and/or within the site of interest, one or more medical, procedures .may be undertaken. For example, another medical instrument, such as a sampling n eedle may be inserted into a proximal end of the. one or more catheters and advanced to a site of interest for tissue sampling, or one or more therapies may b¾ delivered t the sit of interest via the one or more catheters. Or, one or more other devices (i.e., cytology brushes, biopsy forceps, baskets, balloons, guiding devices, ultrasonic probes, illumination devices, energy devices, etc.), materials (i.e., liquids, pastes, markers, etc.), therapies (i.e., chemotherapy, proteinomies, microspheres, etc.) or a combmation thereof may be passed through the catheter. and into the -anatomy, or passed through, the cathete and removed from the anatomy. The one or more retaining features may be biased, moved, folded, and or resiiiently moved to disengage the site of interest. Th one or more catheters may then he removed f om the site of interest,

|O036j Figs. 1 and 2 generally ^' illustrate a device 10. The device 10 includes a bronchoscope 12 and a viewing device, which may include an ultrasound viewing device 1 A and an optical viewing device 14B. The- device- 10 includes an aperture 16 from where- a medical instrument 20 sheathed in catheter 18 extends from. The medical instrument 20 may he a needle. The medical instrument 20 and the catheter 18 may be substantially eoaxial!y arranged along a medical instruments axis 22, and moveable relative to one another along the medical instruments axis 22» A medical instrument tip 24 can be selectivel extended beyond a distal end 26 of the catheter 18 (FIG. 1) and retracted into the catheter 18 (FIG. 2).

{00371 Fig. 3 illustrates various markings 28 a,b,e,d on the cathete 18. One or more of the markings- 28 a,b_se,d -may be viewed with any device, such as the viewing device 1 A and/or 14B, The markings may be integral or embedded within the catheter material, as in a radiopaque marker band, or an eehogenie feature for ultrasound visualization. The markings ma also be on the medical instrument 20. The medical instrument 20 is moveably supported, within an inner portion of the catheter 18,

{0038} Fig, 4 illustrates the catheter 18 and the medical instrument 20. The catheter 18 includes a first portion 30, a second portion 32, and a transition 34 therebetween. The catheter 18 includes a catheter stop 36 located in an inner portion thereof The medical instrument 20 include a medicai instrument stop 3.8. During use. as the medical instrument 20 is moved dista!!y so that the medical instrument tip 24 extends beyond a distal end 26 of the catheter 18, the medical instrument stop 38 eventually contacts or engages the catheter stop 36 so that the catheter 18 moves with the medical instrument 20. In: other words, .movement of the medicai Instrument 20 causes the medical instrument stop 38 to contact, and pus against the catheter stop 36 so that the catheter 18 moves together with, the medical instrument 20.

{0039} Fig. 5 illustrates the catheter 18 and the medical instrument 20. The catheter 18 includes a first portion 30, a second portion 32» and a transition 34 extending therebetween.

{Θ 0[ Fig. 6 illustrates the bronchoscope 12, the catheter 18 and the medicai instrument 20 at a site of interest -40. The medical instrument tip 24 extends beyond a distal end 26 of the catheter 18 and penetrates the site of interest 40. 10041} Fig. 7 illustrates the bronchoscope 12, the caiheier 18 and ihe medical instrument 20 at a .site of Merest 40» The medical instrument, tip 24 extends beyond a distal, end 26 of the catheter 18 and penetrates the site of interest 40. The medical instrument stop 38 (not shown) may be in contact with the catheter stop 36 (also not shown) so that as the medical instrument 20 is advanced through the site of Interest 40, the catheter 38 moves with the medical instrument 20 through the site of interest 40. The retaining feature 42 engages the site of interest 40 to attach the catheter I S thereto. The markings 44 on die catheter 18 may be viewed via the viewing device .14 A and/or 1 B, so that the orientation, penetration depth, etc, of the catheter 18, medical instrument 20, or both can be viewed from outside the anatomy. While not shown, the medical instrument 20 can men be withdrawn from the catheter 18 and the anatomy, while the catheter 18 remains secured to the anatomy via the retaining feature 42. Accordingly, multiple .instrumentation procedures including sampling, draining, and/or delivery of medicine can be performed without removing and replacing the catheter 18.

(O042J Any -.numerical values recited herein include ail values from the lower^' value to the upper value in increments of one unit, provided that there is a separation of at least 2 units between any lower value and any higher value. As an example, if it is stated that the amount of a component or a value of a process variable such as, for example, . temperature, pressure, tim and the like is, for example, from 1 to 90, preferably from 20 to- 80, more preferably from 30 to 70, it is intended that values such as 15 to 85, 22 to 68, 43 to 51, 30 to 32 etc. are expressly enumerated in this specification. For values which are less than one, one. unit is considered to be 0,0001, 0.001, ,01 or 0, 1 as appropriate. These are only examples of what is specifically intended and all possible combinations of numerical values between the lowest value and the highest value enumerated are to be considered to be expressly stated in this application In a similar manner.

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

{0044] The term "consisting essentiall of^* to describe a combination shall include the elements, ingredients, components or steps identified, and such other elements ingredients, components or steps that do not materially affect the basic and novel characteristics of the combination. The use of the terms "comprising'* or "including" to describe combinations of elements, ingredients, components or steps herein also contemplates embodiments (hat consist essentially of the elements, ingredients components or steps. By use .of the term "m y" herein, it is intended that any described attributes thai "may" he included are optional.

{0045} Plural elements, ingredients, components or steps can be provided by a. single integrated element, ingredient, component or step. Alternatively, a single integrated element, ingredient, component or step might he divided into separate plural elements, ingredients,, components or steps . The disclosure of "a" or "one" to describe an element, ingredient, component or step is not intended to foreclose additional elements, ingredients, components or steps.

10646} The omission in the following claims of any aspect of subject matter that ^'is disclosed herein is not a disclaimer of such subject matter, nor should it be regarded that the inventors did not consider such subject matter to be part of the disclosed inventi ve subject matter.

[004? j Listing of Reference Numerals

100481 10 device

|0O49) 12 bronchoscope

roeso] 14 viewing device

100511 14A ultrasound viewing device

[00523 14B optical viewing device, viewing c

100531 16 aperture

[00541 18 catheter

10055] 20 medical instrument

[O056J 22 longitudinal axis

[00571 24 medical instrument tip

[00581 26 distal end of catheter 18

|0059f 28 a,b,e,d markings on catheter 18

[ O60J 30 first portion of catheter 18

[O0{>tj 32 second portion of catheter

[0062] 34 transition

[0063] 36 catheter stop

10064] 38 medical instrument stop

[0065] 40 site of interest

[00663 42 retaining feature of the catheter 18 0067 J 44 markings on the catheter 18

Claims

.! )· A device comprising:

a catheter including:

L an inner portion; and

it. a catheter sto located within the inner portion; and

a medical instrument including:

i. an outer portion; and

iL a medical instrument stop on the outer portion;

wherein the medical instrument is moveabl supported within the inner portion of the catheter, and

wherein when the medical instrument is moved so that the medical instrument stop contacts the catheter stop, further movement of the medical instrument causes the catheter to move with the medical instrument,

2) The device of Claim 1, wherein the medical instrument stop includes a generally planar face and the catheter stop includes generally planar .face, and

wherein when the planar face of the medical instrument stop contacts the planar face of the catheter slop, further movement of the medical instrument causes the planar lace of the medical instmment stop to push the planar face of the catheter so that catheter moves with the medical instrument,

3) The device of Claim I or Claim 2, wherein an outer portion of the catheter includes one or more markings, and

wherein the one or more markings are monitored with a viewing device so that a positio of the catheter,: the medical instrument, or both relative to a site of interest can be determined.

4) The device of Claim 3, wherein the one or more markings include one or more colored bands circuinferentiaOy extending partiall or completel around the outer portion of the catheter.

5) The device of Claim. 3 or Claim 4, wherein the catheter includes one or more retaining features, and wherein the one or more -retaining -features engage the site of interest so thai :. the catheter is supported, in the site of interest.

6) The device of Claim 5, wherein when the one or more retaining features engage the si te of interest, the medical Instrument can. be withdrawn from within the catheter while the catheter remains engaged at the site of interest.

7) The device of any of the preceding Claims, wherei the catheter includes a first portion, a second portion, and a transition,

wherein the first portion has a cross section that is larger than the second portion, and wherein the transition connects the first portion and. the second portion, and tapers from, the first portion to the second portion.

8) The device of any of the preceding Claims, wherein after the medical instrument sto contacts the catheter stop, a medical instrument ti extends beyond a distal end of the catheter,

9) The device of Claim 8, wherein the medical instrument and the catheter ca bot penetrate the site of interest after the medical instrument distal tip pierces the site of interest and the medical instrument is moved into the site of interest.

1:0) The device of any of the preceding Claims, wherein the medical instrument is a needle.

1 1 } A method comprising:

a) inserting at least a portion of the device of any of the previous Claims into a site of interest;

b) extending the medical instrument tip beyond the di stal end of the catheter; c) engaging the medical instrument stop against the catheter stop:

d) piercing the site of interest with the medical .instrument tip;

e) moving the medical instrument and. the catheter together so thai bot the medical instrument and the catheter penetrate the site of interest; and

f) withdrawing the medical instrument from the catheter. 12) The method of Claim 1 1 , wherein the. ste of withdrawing the medical instrument f om the catheter includes;

g) maintainin the catheter in the site of interest with the one or more retaining features after the medical instrument has been withdrawn from the catheter,

13) The method of any of Cla ms 11-12, wherein the method includes:

h) monitoring a position of the catheter at the site of interest with the viewing device and the one or more markings disposed on an outer portion of tlie catheter.

14) The method of any of Claims 1 1.-13, wherein the method incl udes:

i) inserting one or more .medical devices, therapies, or medicines into the catheter after the medical mstrurne-nt has been withdrawn from tlie catheter.

15) The meihod of any of Claims 11 - 14, wherein before the step of e) the method includes a. step of engaging one or more retaining features of the catheter in the site of interest so that the eatheter is at least temporarily supported in the site of interest