US20130006145A1 - Flexible biopsy needle - Google Patents
Flexible biopsy needle Download PDFInfo
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- US20130006145A1 US20130006145A1 US13/526,968 US201213526968A US2013006145A1 US 20130006145 A1 US20130006145 A1 US 20130006145A1 US 201213526968 A US201213526968 A US 201213526968A US 2013006145 A1 US2013006145 A1 US 2013006145A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B10/04—Endoscopic instruments
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
- A61B1/018—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor for receiving instruments
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/273—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the upper alimentary canal, e.g. oesophagoscopes, gastroscopes
- A61B1/2733—Oesophagoscopes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/273—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the upper alimentary canal, e.g. oesophagoscopes, gastroscopes
- A61B1/2736—Gastroscopes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B10/0233—Pointed or sharp biopsy instruments
- A61B10/0266—Pointed or sharp biopsy instruments means for severing sample
- A61B10/0275—Pointed or sharp biopsy instruments means for severing sample with sample notch, e.g. on the side of inner stylet
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B10/0233—Pointed or sharp biopsy instruments
- A61B10/0283—Pointed or sharp biopsy instruments with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/48—Diagnostic techniques
- A61B8/481—Diagnostic techniques involving the use of contrast agent, e.g. microbubbles introduced into the bloodstream
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/32053—Punch like cutting instruments, e.g. using a cylindrical or oval knife
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3494—Trocars; Puncturing needles with safety means for protection against accidental cutting or pricking, e.g. limiting insertion depth, pressure sensors
- A61B17/3496—Protecting sleeves or inner probes; Retractable tips
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B2010/009—Various features of diagnostic instruments
- A61B2010/0093—Various features of diagnostic instruments slide rules
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B10/04—Endoscopic instruments
- A61B2010/045—Needles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
- A61B2017/0034—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means adapted to be inserted through a working channel of an endoscope
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3403—Needle locating or guiding means
- A61B2017/3413—Needle locating or guiding means guided by ultrasound
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Abstract
An endoscopic tissue-sampling needle includes an elongate needle shaft having a proximal and a distal shaft portion. The proximal shaft portion includes an inner tubular core that may be constructed of a same material as the distal shaft potion, having a longer length and a smaller outer diameter than the distal shaft portion. The distal shaft portion extends into and is fixedly attached to an inner diameter of a distal shaft portion lumen. The distal shaft portion lumen is configured for collection of patient tissue, with a distal penetrating tip and/or a side aperture with a cutting edge configured to excise tissue from a target site in a patient body. The proximal shaft portion includes polymer coating around the inner tubular core, which is configured to provide an outer diameter for the proximal shaft portion that may be substantially the same as the outer diameter of the distal shaft portion.
Description
- This application claims priority to U.S. Provisional Application Ser. No. 61/502,086, filed Jun. 28, 2011, which is incorporated herein by reference in its entirety.
- The invention relates generally to medical needles. More particularly, the invention pertains to medical needles configured for ultrasound-guided endoscopic biopsy.
- Endoscopists have developed great expertise in using elongate needles, including echogenic needles viewable under ultrasound, to obtain samples from patients in a minimally invasive manner. In particular, they use devices and techniques that allow carefully targeted collection of samples from deep in patient bodies without any external percutaneous incisions or punctures. Devices such as fine needle aspiration needles and fine needle biopsy needles may be directed through a working channel of an endoscope (e.g., duodenoscope, gastrointestinal end-viewing endoscope) to a target site in a patient body.
- In order to obtain useful samples of tissue suitable for histological and/or cytological analysis, it is desirable to use a large-gauge needle. However, these needles are often considered stiff and unwieldy by some users who find them difficult to insert fully into, for example, a working channel of an endoscopic ultrasound (EUS) endoscope. In addition, as these needles typically include an outer sheath, it may be difficult to advance the penetrating/collecting distal end portion through and out of the sheath. These challenges may be particularly problematic when a user is attempting to access more difficult-to-reach anatomical locations (such as, for example, attempting to access the head of a patient's pancreas from the duodenum).
- It would therefore be advantageous to provide a needle that includes a distal end dimensioned to collect samples of a desirable size while also providing a shaft proximal of that distal end that obviates the present difficulties of advancement and navigation through an endoscope working channel and through patient anatomy. The shaft provided should still provide desirable pushability and trackability so that the needle will be navigable in a manner consistent with the desires and aims of users to accurately obtain samples.
- In one aspect, an endoscopic tissue-sampling needle may be provided including an elongate needle shaft having a proximal shaft portion and a distal shaft portion. The proximal shaft portion includes a tubular body that includes a polymeric material while the distal shaft potion is constructed from a metallic material. The distal shaft portion may extend into and be fixedly attached to an inner diameter of a proximal shaft portion lumen. The distal shaft portion lumen preferably is configured for collection of patient tissue by including a distal penetrating tip and/or a side aperture with a cutting edge configured to excise tissue from a target site in a patient body. The proximal shaft portion may include a proximal metallic shaft portion with an intermediate polymeric portion between it and the distal shaft portion.
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FIG. 1 shows a needle device embodiment with a detail of a distal region thereof; -
FIGS. 1A and 1B show stylet embodiments with portions including smaller outer diameter; -
FIGS. 2A and 2B each show a detail view of a distal region of the needle ofFIG. 1 ; -
FIG. 2C shows a detail view of a distal region of the needle ofFIG. 1 , with a polymer coating of a proximal needle shaft portion removed/absent; -
FIG. 2D is a longitudinal section view ofFIG. 2C ; -
FIGS. 3A and 3B show a notched/apertured embodiment of a needle; -
FIG. 4 shows a needle having a larger diameter proximal polymer coating tapering to an outer diameter of a distal needle shaft portion; -
FIG. 5 shows a titanium nitride-coated needle embodiment; and -
FIG. 6 shows a needle embodiment including a proximal metal portion, an intermediate polymeric portion, and a distal metal portion. - Embodiments are described with reference to the drawings in which like elements are generally referred to by like numerals. The relationship and functioning of the various elements of the embodiments may better be understood by reference to the following detailed description. However, embodiments are not limited to those illustrated in the drawings, and features of various embodiments—whether described in text and/or in drawing figures—may be incorporated into other embodiments within the scope of the present invention. It should be understood that the drawings are not necessarily to scale, and in certain instances details may have been omitted that are not necessary for an understanding of embodiments of the present invention, such as—for example—conventional fabrication and assembly.
- As used in the specification, the terms “proximal” and “distal” should be understood as being in the terms of a physician or other person operating a medical device or on a patient. Hence, the term “distal means the direction or portion of the device that is farthest from the physician or other person and the term “proximal” means the portion of the device that is nearest to the physician or other person.
- An endoscopic
biopsy needle device 100, which may be scaled and configured for use in fine-needle aspiration (FNA) and/or fine-needle biopsy (FNB) procedures, or other tissue-collection procedures, is described with reference toFIG. 1 . Theneedle device 100 is shown here with ahandle 101. Thehandle 101 includes a sheath-attachedhandle member 102 with a needle-attachedhandle member 104 longitudinally slidably disposed on its proximal end. A scope-attachment handle member 106 is slidably attached to the distal end of the sheath-attachedhandle member 102. The sheath-attachedhandle member 102 is attached to theneedle sheath 112 and the needle-attachedhandle member 104 is attached to the needle 120 (which may be configured in the manner of any of the needles disclosed herein or later developed in accordance with principles of the present disclosure). Thesheath 112 may be constructed as a protective sheath configured to cover theneedle 120 while it is being advanced through an endoscope working channel, which sheath will protect both the needle and the working channel from contact that could damage either or both. - The scope-
attachment handle member 106 may be configured for incrementally fixable, longitudinally-adjustable (relative to the other handle components) attachment to the exterior of a working channel of an endoscope such as—for example—an end-viewing gastric endoscope, duodenoscope, or EUS endoscope (not shown) using, for example, a threadedcavity 116. The scope-attachment handle member 106 allows a user to determine the distance by which thesheath 112 will extend from a standard-length endoscope, and it may includenumerical indicia 117 corresponding to that relative length and anadjustable engagement structure 118 allowing a user to select a length and engage the scope-attachment handle member 106 accordingly. - The sheath-attached
handle member 102 includesnumerical indicia 108 and anadjustable ring 109 that limits the movement of the needle-attachedhandle member 104 and provides a way to select the distance to which theneedle 120 may be extended beyond thesheath 112. By way of illustration, the configuration shown inFIG. 1 would allow the sheath to extend 3 units (e.g., inches, cm) beyond the distal end opening of an endoscope working channel, and theneedle 120 would be allowed to extend up to 6 units beyond the distal end of thesheath 112, although its current position would be only about 4 units beyond the distal end of the sheath 112 (based upon the position shown of the needle-attached handle member 104). Astylet 110 extends through a lumen of theneedle 120 and has astylet cap 111 fixed on its proximal end. It should be appreciated that other embodiments of the handle described herein, as well as other handle designs appropriate for use in operating a biopsy needle may be practiced within the scope of the present invention. -
FIG. 1 includes a detail call-out showing the distal portion of theneedle device 100. Theneedle 120 extends distally beyond thedistal end 129 of thesheath 112. As is described below in greater detail, theneedle 120 includes two sections—aproximal portion 122, and adistal portion 124. Thestylet 110 is shown extending from the distal end of the needledistal portion 124. Thestylet 110 is shown as a round-tipped stylet, but it should be appreciated that other stylet designs, including a stylet having a distal end tip beveled or otherwise shaped to match or otherwise complement a distal tip shape and/or geometry of theneedle 120. -
FIG. 1A shows astylet embodiment 180 configured to provide or enhance distal flexibility of a needle that the stylet is supporting. The elongate shaft body of thestylet 180 has a firstouter diameter portion 183 that may have about the same or slightly smaller diameter than the inner diameter of a needle lumen, in the manner typical of needle stylets in the art. Adistal end portion 185 of thestylet body 180 may include a reduced diameter (compared to the larger outer diameter portion 183) that will still provide support for the needle, but that will provide reduced stiffness and improved navigability through, for example, an endoscope working lumen. -
FIG. 1B shows astylet embodiment 190 configured to provide or enhance distal flexibility of a needle that the stylet is supporting. The elongate shaft body of thestylet 190 has a first larger-outer-diameter (“OD”)portion 194 and a second larger-OD portion 196 that each may have about the same or slightly smaller diameter than the inner diameter of a needle lumen, in the manner typical of needle stylets in the art. A distal endintermediate length 195 of thestylet body 190 is disposed between the first and second larger-OD portions intermediate length 195 includes a reduced diameter (i.e., smaller than one or both of the first and second larger-OD portions 194, 196) that will still provide support for the needle, but that will provide reduced stiffness and improved navigability through, for example, an endoscope working lumen. The first larger-OD portion 194 and the second larger-OD portion 196 each will have a larger outer diameter than theintermediate portion 195, but may have the same or different outer diameters relative to each other. -
FIGS. 2A and 2B show more detailed perspective views of theneedle 120 with, and without astylet 110, respectively. Certain embodiments configured for use with astylet 110 may be configured with greater flexibility, as the stylet can be used to provide desirable stiffness, pushability, and trackability when navigating the needle to a target site in a patient body. Thedistal needle portion 124 includes adistal tip 129, which is shown as a beveled needle tip. It should be appreciated that thedistal tip 129 preferably is configured for collecting a tissue sample (e.g., suitable for cytological and/or histological analysis), and may be configured in a variety of ways including with different penetrating needle tip styles known or developed in the art including, for example, Chiba, Franseen, Menghini, Turner, and/or other needle tip types, or it may be constructed as an atraumatic tip (e.g., as in the Cook® ECHO-19-A device). The needle shown includes aneedle lumen 126 through which thestylet 110 is disposed inFIG. 2A . - The
distal needle portion 124 will generally be much shorter than theproximal needle portion 122. Thedistal needle portion 124 will preferably be about 20 mm to about 100 mm in length, with one embodiment being at least about 80 mm in length, while the total length of theneedle 120 preferably will be configured to access a target site in a patient site via an endoscope (e.g., about 100 cm to about 180 cm, exclusive of a handle). Preferred needle designs will include echogenicity-enhancing features such as, for example, surface dimples, laser etching, grit-blasting, or other structures configured to provide desirable ability to visualize the needle under ultrasound, including endoscopic ultrasound. - It should be appreciated that the
proximal needle portion 122 may include apolymer coating 123, as shown inFIGS. 1-2B .FIG. 2C shows a distal region of theneedle 120, including a view of a length of theproximal needle portion 122 with thepolymer coating 123 removed. Theproximal needle portion 122 includes atubular core 121 that preferably is constructed of the same material as, but with a smaller outer diameter than, thedistal needle portion 124. For example, the proximalneedle portion core 121 may be configured as a 22-gauge shaft, while thedistal needle portion 124 may be configured as a 19-gauge shaft. In certain embodiments, the proximalshaft core portion 121 will measure not larger than about 22 gauge, and thedistal shaft portion 124 will measure no less than about 19 gauge. This construction provides advantageous features for a biopsy needle, including providing a more flexible shaft while still providing a large distal end portion configured for obtaining a sample of desirable size. The “stepped” construction provides for manufacturing efficiency by allowing use of two different sizes of components (i.e., smaller OD shaft tube and larger OD distal needle portion) rather than beginning with a typical single diameter shaft and then augmenting or reducing a portion of its diameter. -
FIG. 2D shows a longitudinal section view ofFIG. 2C . The proximalneedle core portion 121 extends into a joint region of thedistal needle portion 124. The proximal anddistal needle portions needle 120 is constructed. For example, the proximal and/ordistal needle portions needle portions - This construction of a smaller diameter
proximal shaft core 121 with an overlayingpolymer coating 123 will provide desirable pushability and trackability similar to an all-metal shaft or thinly-coated shaft of the type known in the art. However, it will not include the stiffness and challenges of navigation associated with those other devices. At the same time, it retains the advantage of including a larger sample-gathering distal tip region. - As shown in
FIGS. 3A and 3B , aneedle 220 may be provided with aproximal portion 222 and adistal portion 224, thedistal needle portion 224 includes a side aperture that may be configured as anotch 232. Thenotch 232 may include acutting edge 234 that is configured to excise (e.g., cut and/or scrape) tissue for collection of histological and/or cytological samples. Thecutting edge 234 is shown inFIG. 3A as facing proximally, but it is known in the art to orient such cutting edges toward the distal end so that distally-directed motion will actuate them, and/or to orient them laterally such that they may be actuated by sideways or rotary motion relative to the longitudinal axis of the needle. These and other aperture cutting edge embodiments may be practiced within the scope of the present invention. - As shown in
FIG. 3B , the notchedneedle 220 may also be used with astylet 210. Theneedle 220 ofFIGS. 3A-3B includes apolymer coating 223 on itsproximal portion 222, while itsdistal needle portion 224 does not have the polymer coating. InFIG. 3A , the distal end of the proximalshaft portion core 221 in the lumen 226 of thedistal shaft portion 224 is visible through thenotch 232. - As shown in
FIGS. 1-2B , thepolymer coating 123 of theproximal needle portion 122 may have an outer diameter the same as, very similar, or substantially similar to the outer diameter of thedistal needle portion 124 where they meet. However, as shown inFIG. 4 , a proximal length of the coatedproximal needle portion 322 of aneedle 320 may include an outer diameter that is greater the outer diameter of thedistal needle portion 324. That is, thepolymeric coating 323 may be constructed such that a length of theproximal needle portion 322 is radially larger than thedistal needle portion 324, and—as shown inFIG. 4 , thepolymeric coating 323 tapers down to match exactly or very nearly the outer diameter of thedistal needle portion 324 where they join. The larger diameter proximal body portion of this embodiment will not pose the stiffness and navigation difficulties of a geometrically similar all-metal needle, because—in this embodiment—it will be most preferable to use apolymer coating 323 that is much more flexible than would be possible to obtain with a metal shaft of the same or even slightly smaller diameter. However, providing a smaller-diameter proximal core shaft (not visible, but similar to thecore 121 inFIGS. 2C-2D ) made of metal or of a stiffer polymer will provide desirable trackability and pushability. In embodiments where the shaft portion is larger in diameter than the needle portion, it is anticipated that only the smaller diameter needle portion may be used to penetrate patient tissue (such as, for example, gastrointestinal submucosa accessed via endoscope where much of the device length remains in a working channel of the endoscope). - In the embodiment shown in
FIG. 5 , thedistal shaft portion 524 includes a titanium nitride-coateddistal cutting tip 529. That is,FIG. 5 illustrates another embodiment of aneedle 520, including the “stepped” construction described above, but with a non-beveleddistal tip end 529. When using a bevel-tipped needle, the target tissue may sometimes be deflected around the distal lumen opening, resulting in what physicians refer to as a “dry tap,” where no sample is obtained. This creates several potential problems: very often the patient must endure another invasive and painful penetrating procedure, and additional time is consumed (and expense created) by the personnel and facilities to repeat the attempt to procure a biopsy. If the guidance is under fluoroscopy, the patient and attending personnel are both subject to increased radiation exposure during the repeated attempt to procure a sample. For body locations and tissue types where there is a known risk of a “dry tap” with a beveled needle, it would be advantageous to provide an endoscopic core biopsy needle that is visualizable under ultrasound and that is configured to minimize the likelihood of a “dry tap.” - Titanium nitride is an extremely hard ceramic material that is used as a coating on sewing needles, drill bits, milling cutters, and hole punches to improve edge retention and corrosion resistance. A thin coating of titanium nitride can be applied to a defined area by plasma vapor deposition. Thereafter, the coated region can be ground to a sharp edge to form the titanium nitride-coated needle
distal tip 529 shown. As in the embodiments described above, this embodiment is shown with a proximalneedle shaft portion 522 that includes a smaller diameter core shaft (not shown) and a larger diameter distalneedle shaft portion 524. - The
distal tip 529 includes a generally circular (that is, exactly circular, nearly circular, oval, elliptical, or the like) end geometry. Thetip 529 is shown as non-beveled—that is, with its distal generally circular cutting end face/tip 529 being substantially perpendicular to the long axis of thedistal shaft portion 524. Although it is described here as being advantageous for use with a non-beveled needle-tip design, it should be appreciated that various beveled and other needle designs (e.g., Westcott, Chiba, Franseen, Menghini) may also be constructed with a titanium nitride coating, and practiced within the scope of the present invention. -
FIG. 6 show shaft portion 620 of an embodiment of a needle device 600 (the entire device of which may look generally like theneedle device 100 ofFIG. 1 ). The shaft portion 620 includes aproximal region 622, anintermediate region 623, and adistal region 624. Thedistal region 624 is constructed from a metallic material (e.g., stainless steel) that may be configured as a sharp penetrating tip such as, for example, a Franseen, Menghini, or lancet tip, or that may be configured as an atraumatic tip, and preferably will be configured for ultrasound/echogenic visualization by dimpling or another method/structure. Theintermediate region 623 is constructed as a flexible polymer tubing that preferably will be constructed in a manner known in the art to provide pushability while including greater flexibility than hypotube or other metallic tubing construction. Those of skill in the art will appreciate that suitable polymers may include PEEK, nylon, and/or combination polymers such as—for example—braided or co-extruded polymers. - Some users of endoscopic needles with metallic shaft bodies have observed that they may be difficult to advance fully into/through an EUS endoscope. The polymer
intermediate region 623 may obviate this by providing a shaft with good pushability that will include greater flexibility than metallic shafts of similar gauge, thereby decreasing potential binding in the endoscope working channel. For example, thepolymer section 623 may include stiffness, pushability, and/or trackability comparable to a 25 ga stainless steel endoscopy needle, while providing a different inner and outer diameter along that section, with—for example—a 19 ga distal needle end for interacting with tissue. This difference in inner diameter may provide for increased ability to direct fluid or apply suction through the needle, while the difference in outer diameter may provide for desirable directability through an endoscope working channel. - The
proximal region 622 may be constructed of metallic tubing in the manner of existing endoscopic needles, the same or a different polymer than theintermediate region 623, and/or a coated metallic tubing. The outer diameter of theintermediate region 623 may be the same, greater than, or less than the outer diameters of theproximal region 622 and thedistal region 624, which may be the same or different than each other. An embodiment with this polymer-only intermediate portion may provide a proximal portion with greater rigidity, an intermediate portion with greater flexibility (than either end portion) while retaining desirable pushability, and a distal end needle portion configured to penetrate or otherwise interact with a target region accessible via an endoscope. The enhanced flexibility of the intermediate portion over current devices may provide advantages in accessing anatomical locations that are not readily accessible to less flexible metal-body cannulas used in many current endoscopic echogenic needle devices. - The length of a “polymer-only”
intermediate region 623 may be relatively short or long in comparison to the overall needle length. For example, in a gastrointestinal endoscopy needle of about 180 to about 320 cm in length, the polymer section may be only about 40 to about 320 mm in length, although the length may be greater or less. For example, in one embodiment of a needle, the intermediate polymer section of a 240 cm needle device is only about 180 mm in length, with a distal metal needle end that is 26 mm in length. However, the distal metal needle length may be less than about 10 mm, such as, for example, about 4 mm. This generally distal location of the enhanced-flexibility polymeric device length may provide desirable flexibility along the portion most likely to be directed through restricted, tortuous, or otherwise difficult-to-navigate paths (e.g., in and/or exiting an endoscope working lumen, in a patient body lumen, extending through body tissue). In this and other embodiments, larger-outer-diameter shaft lengths may be located/configured where they will not penetrate tissue, but will remain in an endoscope working lumen or open body lumen. - Those of skill in the art will appreciate that embodiments not expressly illustrated herein may be practiced within the scope of the present invention, including that features described herein for different embodiments may be combined with each other and/or with currently-known or future-developed technologies while remaining within the scope of the claims presented here. It is therefore intended that the foregoing detailed description be regarded as illustrative rather than limiting. And, it should be understood that the following claims, including all equivalents, are intended to define the spirit and scope of this invention. Furthermore, the advantages described above are not necessarily the only advantages of the invention, and it is not necessarily expected that all of the described advantages will be achieved with every embodiment of the invention.
Claims (20)
1. An endoscopic tissue-sampling needle, comprising:
an elongate tubular needle shaft having a proximal shaft portion and a distal shaft portion;
wherein the distal shaft portion comprises a shorter length than the proximal shaft portion;
wherein a length of the proximal shaft portion comprises a non-metallic polymeric material length disposed immediately proximally adjacent of and securely fixed to the distal shaft portion, said non-metallic polymeric material length comprising a greater flexibility than the distal shaft portion;
wherein the distal shaft portion
comprises a metallic material;
is configured for collection of patient tissue; and
comprises at least one surface feature configured to enhance echogenicity; and
wherein the elongate tubular needle shaft is configured and dimensioned for passage through a working channel of an endoscope to a target site within a patient body.
2. The needle of claim 1 , further comprising a metallic tube length disposed immediately proximally adjacent of and securely fixed to the non-metallic polymeric material length.
3. The needle of claim 2 , wherein the non-metallic polymeric material length comprises a substantially uniform outer diameter that is larger than the outer diameter of the distal shaft portion and that tapers proximally-to-distally to an outer diameter that is about the same as the distal shaft portion outer diameter, which distal shaft outer diameter is substantially uniform along an entire length of the distal shaft portion.
4. The needle of claim 2 , wherein the non-metallic polymeric material length comprises an outer diameter that is substantially the same as the outer diameter of the distal shaft portion, such that the elongate tubular needle shaft comprises a substantially uniform outer diameter along an entire length thereof.
5. The needle of claim 1 , wherein the distal shaft portion comprises a tissue-penetrating distal end tip.
6. The needle of claim 1 , wherein the distal shaft portion comprises a notched aperture in at least one side.
7. The needle of claim 6 , wherein the notched aperture comprises at least one cutting edge configured to enhance collection of sample material from a patient body.
8. The needle of claim 1 , wherein the distal shaft portion is about 20 mm to about 100 mm in length.
9. The needle of claim 1 , wherein the proximal shaft portion includes a proximal shaft lumen, the distal shaft portion includes a distal shaft lumen, and the proximal and distal shaft lumens together provide a continuous shaft lumen.
10. The needle of claim 9 , further comprising a stylet disposed through at least a portion of the continuous shaft lumen, wherein the stylet comprises a proximal length having a first outer diameter and a distal length having a second outer diameter that is less than the first outer diameter.
11. The needle of claim 10 , wherein the stylet further comprises a third outer diameter length that is disposed distal of the second outer diameter distal length, where the third outer diameter is greater than the second outer diameter.
12. The needle of claim 1 , wherein a proximal shaft core portion measures not larger than about 22 gauge, and the distal shaft portion measures no less than about 19 gauge.
13. The needle of claim 1 , wherein a proximal shaft core portion measures about 22 gauge, and the distal shaft portion measures about 19 gauge.
14. The needle of claim 1 , wherein a distal cutting tip of the distal shaft portion comprises a titanium nitride coating.
15. The needle of claim 14 , wherein the distal cutting tip comprises a generally circular, non-beveled cross-sectional geometry.
16. The needle of claim 1 , wherein the proximal shaft portion and the distal shaft portion are each comprised of essentially the same construction material.
17. The needle of claim 1 , wherein at least one of the proximal shaft portion or the distal shaft portion comprises a selected one of a metal alloy or a polymer.
18. The needle of claim 1 , wherein a combined length of the proximal shaft portion and the distal shaft portion is configured to access tissue via passage through at least a patient esophagus and stomach.
19. An endoscopic tissue-sampling needle, comprising:
an elongate needle shaft having a proximal shaft portion and a distal shaft portion;
wherein the proximal shaft portion comprises an inner tubular core constructed of a same material as the distal shaft potion, but including a longer length and a smaller outer diameter than the distal shaft portion;
wherein the distal shaft portion extends into and is fixedly attached to an inner diameter of a distal shaft portion lumen;
wherein the distal shaft portion lumen is configured for collection of patient tissue; and
wherein the proximal shaft portion comprises a polymer coating coaxially disposed around the inner tubular core, which polymer coating is configured to provide an outer diameter for the proximal shaft portion that is substantially the same as or is greater than the outer diameter of the distal shaft portion.
20. An endoscopic tissue-sampling needle, comprising:
an elongate needle shaft having a proximal shaft portion and a distal shaft portion;
wherein the proximal shaft portion comprises an inner tubular core including a longer length and a smaller outer diameter than the distal shaft portion;
wherein the distal shaft portion extends into and is fixedly attached to an inner diameter of a distal shaft portion lumen;
wherein the distal shaft portion lumen is configured for collection of patient tissue, including a distal penetrating tip and a side aperture both configured to contact and excise patient tissue; and
wherein the proximal shaft portion comprises a polymer coating around the inner tubular core, which polymer coating is configured to provide an outer diameter for the proximal shaft portion that is substantially the same as the outer diameter of the distal shaft portion.
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US14/729,860 US10299769B2 (en) | 2011-06-28 | 2015-06-03 | Flexible biopsy needle |
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US201161502086P | 2011-06-28 | 2011-06-28 | |
US13/526,968 US20130006145A1 (en) | 2011-06-28 | 2012-06-19 | Flexible biopsy needle |
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US14/729,860 Continuation US10299769B2 (en) | 2011-06-28 | 2015-06-03 | Flexible biopsy needle |
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US14/729,860 Active 2032-09-05 US10299769B2 (en) | 2011-06-28 | 2015-06-03 | Flexible biopsy needle |
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US10299769B2 (en) | 2019-05-28 |
US20150265258A1 (en) | 2015-09-24 |
WO2013003087A1 (en) | 2013-01-03 |
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Owner name: COOK MEDICAL TECHNOLOGIES LLC, INDIANA Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:COOK IRELAND LIMITED;REEL/FRAME:028444/0950 Effective date: 20110914 Owner name: COOK IRELAND LIMITED, IRELAND Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:TOOMEY, CIARAN;MCGRATH, DARACH;CLANCY, MICHAEL;AND OTHERS;REEL/FRAME:028443/0832 Effective date: 20110914 |
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