Needle biopsy device with exchangeable needle and integrated needle protection

Information

  • Patent Grant
  • 11039816
  • Patent Number
    11,039,816
  • Date Filed
    Wednesday, March 30, 2016
    8 years ago
  • Date Issued
    Tuesday, June 22, 2021
    2 years ago
Abstract
The invention provides device for needle biopsy having a novel delivery handle system for interchangeably delivering needles of various sizes to a biopsy site. The delivery handle system is adjustable in length and includes a proximal slideably disposed over a middle handle member, the middle handle member is slideably disposed over a distal handle member. The proximal handle member includes an inner hub housing component configured to interchangeably receive a needle subassembly that can be inserting into and withdrawn from the proximal handle member. The needle subassembly includes a needle of a plurality of different sizes, a needle luer, a needle hub coupled to a proximal end portion of the needle, and a needle protector subassembly. The needle protector subassembly includes a needle protection hub configured to receive the distal end of a needle.
Description
TECHNICAL FIELD

The present disclosure generally relates to the biopsy devices, and more particularly, needle biopsy devices for collecting tissue, fluid, and cell samples in conjunction with procedures such as endoscopic ultrasound or endoscopic bronchial ultrasound.


BACKGROUND INFORMATION

Endoscopic ultrasounds have been used for more than twenty five years within the field of medicine. These procedures allow clinicians to scan, locate and identify individual layers of the gastrointestinal (GI) tract and determine the location of individual mucosal and submucosal layers. As a result, appropriate therapeutic modes of treatment for malignancies and various abnormalities may be determined.


Endoscopic Ultrasound-Guided Fine-Needle Aspiration (“EUS—FNA”) and Endobronchial Ultrasound-Guided Fine-Needle Aspiration (“EBUS—FNA”) are currently standard modes of treatment in the field of GI Endoscopy and Bronchoscopy with high yields of sensitivity and specificity in the management of indications/diseases such as esophageal cancer, pancreatic cancer, liver mass, non-small cell lung cancer, pancreatic mass, endobronchial mass, and intra-abdominal lymph nodes.


A typical endoscopic ultrasound procedure consist of several steps. First, a clinician sedates a patient and inserts a probe via esophagogastroduodenoscopy into the patient's stomach and duodenum. Second, an endoscope is passed through the patient's mouth and advanced to the level of the duodenum. Third, from various positions between the esophagus and duodenum, organs or masses outside the gastrointestinal tract are imaged to determine abnormalities. If any abnormalities that are present, the organs and/or masses can be biopsied through the process of “fine needle aspiration” (FNA).


Endoscopic ultrasounds and endoscopic bronchial ultrasounds through fine needle aspiration are presently the standard modes of diagnosis and/or treatment in the field of gastrointestinal endoscopy and bronchoscopy. These procedures traditionally result in high yields of sensitivity and specificity in the management of indications of diseases such as esophageal cancer, pancreatic cancer, liver mass, non-small cell lung cancer, pancreatic mass, endobronchial mass, and intra-abdominal lymph nodes.


An endoscopic ultrasound through fine needle aspiration requires a device that is attached to the luer port or working channel of a typical echoendoscope. Prior art devices utilize a series of push and pull handles to control the axial movement of the catheter shaft of the device and the depth of needle penetration. These devices, however, suffer from several drawbacks.


One primary drawback of current FNA devices, concerns the lack of “Needle Safe Preventative” design features which protect the end user from inadvertent needle penetration and the transfer of blood-borne pathogens from patient subject to attending medical staff (Ref: The Needle-stick Safety and Prevention Act (HR 5178)—OSHA Regulation).


One of the primary issues still facing the medial device industry concerns the propensity for “Needle Stick”. The Occupational Health and Safety Administration (OSHA) has warned that most needle destruction devices (NDDs) are “not compliant” with the Bloodborne Pathogens Standard, which are defined as “ . . . controls (e.g., sharps disposal containers, self-sheathing needles, safer medical devices, such as sharps with engineered sharps injury protection and needleless systems) that isolate or remove the bloodborne pathogens hazard from the workplace.” To comply with the OSHA standard, an employer must use engineering and work practice controls that will “eliminate or minimize employee exposure” (OSHA Sec. 1910.1030(d)(2)(i)). OSHA's compliance directive explains that under this requirement “the employer must use engineering and work practice controls that eliminate occupational exposure or reduce it to the lowest feasible extent” (OSHA CPL 2-2.69 § XIII, D.2.). The employer's exposure control plan is to describe the method the employer will use to meet the regulatory requirement. The plan must be reviewed and updated at least annually to reflect changes in technology that will eliminate or reduce exposure (Sec. 1910.1030(c)(1)(iv)).


In the case of currently available FNA medical devices for both EUS and EBUS, once the sample has been aspirated from the desired anatomical location, the FNA catheter is removed from the echoendoscope and handed to the cytopathologist for sample extraction/preparation. The user is instructed to “re-sheath” the needle (i.e. retract the needle into the catheter sheath) prior to detachment from the echoendoscope.


However, in many instances, this does not occur. As such, the needle sharp of the device is exposed during removal and transfer of the FNA device among medical staff in the EUS/EBUS suite with increased risk of “needle sticking” and blood borne pathogen contamination/exposure to same.


Therefore, a need exists for an improved device for use in endoscopic ultrasound procedures which address the lack of adherence to OSHA HR 5178, of current EUS and EBUS Fine Needle Aspiration devices.


Additionally, prior FNA devices in the art are not designed to individually accommodate needles of various diameters. Prior art fine needle aspiration device design used in the field of endoscopic ultrasound sample acquisition, are designed such that the sampling needle is fully integrated into the handle drive mechanism of the device. Specifically, in the case of prior art devices, the full system needle biopsy device (handle and integrated needle) must be removed from an endoscope during a procedure if a clinician chooses to utilize needles of different sizes. In this instance, the sample aspirate is removed from the needle of the device with an en-suite cytopathologist. The removal and prepping of the aspirated sample is time consuming and results in significant wait-time for the clinician between needle biopsy system passes and sampling.


Another drawback of current FNA devices known in the art is that if the same needle biopsy system (as in the case of the prior art) is used throughout a procedure for sampling at numerous anatomical locations, the durability of both the needle and the stylette components of the device frequently become compromised (i.e. the needle and/or stylette components may take a “shape-set”, kink or fracture). This results in a prolonging of the procedure for the clinician, hospital staff and prolonged periods of sedation for the patient with a reduction in overall procedural efficiency.


In this instance, the clinician must remove the needle biopsy system from the endoscope; open a second new device of different needle size; re-insert the new device into the endoscope and re-confirm position of the endoscope and needle relative to the intended sampling site, before acquiring the sample. In many instances, the device may be un-useable after successive needle passes. In this instance, no alternative exists for the clinician but to utilize a new device for the remainder of the procedure.


A further drawback of prior art fine needle biopsy devices used in endoscopic and endobronchial ultrasound procedures concerns the lack of flexibility provided to the clinician during a procedure.


Current EUS-FNA needle biopsy systems are commercially available in needle sizes of 19, 22 and 25 gauge, with integrated handle and needle embodiments. In many instances the endoscopist or pulmonologist may desire to utilize a different size needle during a procedure. For example, a clinician may begin an endoscopic ultrasound or endobronchial ultrasound procedure with: (1) a device having a needle biopsy system with a diameter of 19 AWG; (2) aspirate the sample; (3) remove the needle biopsy system from the endoscope; (4) attach and lock a new needle biopsy device (for example, 22AWG size) to the endoscope and continue the procedure. This results in a loss of procedural efficiency for the clinician, patient and hospital and also increases procedural costs through the utilization of a second, new needle biopsy device.


Therefore, a need exists for an improved device for use in endoscopic ultrasound and endobronchial procedures which increases procedural efficiency, reduces procedural costs and improves procedural economics.


SUMMARY OF THE INVENTION

The invention provides a device for needle biopsy that includes a novel for a delivery handle system for interchangeably delivering needles of various sizes to a biopsy site. The delivery handle system has an adjustable length, a longitudinal axis defining a lumen extending therethrough, and includes a proximal handle member, a middle handle member and a distal handle member. The proximal handle member is slideably disposed over at least a portion of the middle handle member, the middle handle member is slideably disposed over at least a portion of the distal handle member. The proximal handle member includes an inner hub housing component having an internally cylindrical shape configured to interchangeably receive a needle subassembly that can be inserted into and withdrawn from the proximal handle member.


The needle subassembly for insertion into and withdrawal from the delivery handle system includes an aspiration needle of a plurality of different sizes, each needle having a proximal end portion and a distal end portion. Preferably, the aspiration needle ranges in size from a 15 AWG to a 28 AWG aspiration needle (e.g., 19 AWG, 22 AWG or 25AWG). A needle luer and a needle hub are coupled to the proximal end portion of the needle, the needle hub being configured for coupling with the inner hub housing component of the proximal handle member. The needle subassembly further includes a needle protector subassembly configured for coupling to the distal end portion of the needle. The needle protector subassembly includes a needle protection hub having a lumen extending therethrough configured for receiving the distal end portion of the needle, a deformable O-ring axially disposed within the lumen of the needle protection hub, and a tubular sheath defining a lumen extending from a distal end of the needle protection hub. The lumen of the tubular sheath is in communication with the lumen of the needle protection hub for receiving the needle when inserted into the needle protection hub. In one embodiment of the invention, the tubular sheath distally extending from the needle protector subassembly includes an internally tapering distal end.


In a preferred embodiment, the aspiration needle of the needle subassembly includes a collet surrounding the distal end portion of the needle. The collet has a diameter larger than the diameter of the deformable O-ring of the needle protection hub, such that the collet traverses the deformable O-ring when the needle is inserted into or withdrawn from the lumen of the needle protection hub, thereby locking the needle protector subassembly onto the distal end portion of the needle during insertion and withdrawal of the needle subassembly from the delivery handle system. The collet preferably chamfered at the proximal and distal ends to provide a smooth interface with the needle protector subassembly during needle exchange.


The aspiration needle of the needle subassembly also preferably includes a distal tip having four distinct angular bevel grinds, including a primary angle relative to the needle shaft, a secondary angle relative to the needle shaft, and a back-cut angle relative to the secondary angle for providing a smooth needle passage during needle insertion and withdrawal during a biopsy procedure.


The lumen extending through the delivery handle system includes an inner hypotube component at least partially disposed within the proximal handle member and an outer hypotube component disposed at least partially within the middle handle member. The inner hypotube is coupled to the outer hypotube and configured to longitudinally slide within the outer hypotube when the proximal handle member is distally advanced or proximally retracted over the middle handle member. The lumen further includes a tubular catheter sheath coupled to a distal end of the outer hypotube. The inner hypotube, outer hypotube and catheter sheath are in constant communication with each other.


Preferably, the catheter sheath includes a helically braided reinforcement structure and has an outer diameter ranging from 0.05 inches to 0.140 inches, and an inner diameter ranging from 0.05 inches to 0.120 inches. In certain embodiments, the catheter sheath includes a tapered distal tip having an outer and inner diameter that is smaller than the outer and inner diameters of the remaining length of the catheter sheath. In certain embodiments, the inner diameter of the distal tip ranges from 0.020 inches to 0.060 inches.


The delivery handle system of the invention further includes an inner handle member disposed within an inner portion of the middle handle member. The inner handle member is coupled to a proximal portion of the catheter sheath and a distal portion of the outer hypotube, such that the catheter sheath is distally extended into the distal handle member when the middle handle member is distally advanced over the distal handle member.


The delivery handle system of the invention further includes a first locking mechanism configured to prevent the proximal handle member from longitudinally sliding over the middle handle member, and a second locking mechanism configured to prevent the middle handle member from longitudinally sliding over the distal handle member. The first locking mechanism includes a first ring slideably disposed around at least a portion of the middle handle member. A screw is threaded within the first ring for locking the first ring in a fixed position along the middle handle member. The second locking mechanism includes a threaded insert disposed along a distal portion of the middle handle member. The threaded insert is coupled to a screw for tightening the threaded insert to lock middle handle member in a fixed position along the distal handle member.


The proximal handle member of the delivery handle system of the invention includes an inner retention collar disposed at a distal end of the inner hub housing component. The inner retention collar is configured to receive the needle protection hub coupled to the needle. At least a portion of the retention collar is recessed, and the deformable O-ring component is disposed within the recessed portion for securing the needle protection hub within the retention collar upon insertion of the needle subassembly into the proximal handle member.


In certain embodiments, the O-ring of the retention collar has a diameter smaller than a diameter of the needle protection hub, such that the needle protection hub traverses the deformable retention collar O-ring when the needle subassembly is inserted into or withdrawn from the proximal handle member thereby locking the needle protector subassembly onto the proximal handle portion during insertion and withdrawal of the needle subassembly from delivery handle system.


The proximal handle member further includes a locking mechanism for releasably locking the needle hub within the inner hub housing component of the proximal handle member. The locking mechanism includes a depressible latch component securely coupled to the proximal handle member. The latch includes a deflectable hinge coupled to a barb component, that is coupled to the inner hub housing component and disposed within an interior portion of the proximal handle member.


The needle hub of the needle subassembly includes an internal land ring for interacting with the deflectable hinge and barb component of the locking mechanism. The internal land ring traverses the deflectable hinge of the latch component when the needle subassembly is inserted into the lumen of the proximal handle member, thereby causing the deflectable hinge to deflect against the barb component during insertion. The deflectable hinge returns to a home position once the internal land ring has cleared the deflectable hinge to prevent the needle hub from moving backwards. The needle subassembly is released from the inner hub housing component of the proximal handle member by depressing the latching component to cause the deflectable hinge to deflect against the barb component to allow the internal land ring to clear the deflectable hinge and barb.


In certain embodiments, the inner hub housing component of the proximal handle member includes a plurality of depressions spaced around an internal circumference of the hub housing component and the needle hub comprises a plurality of protrusions. The plurality of depressions are configured to receive the plurality of protrusions to prevent the needle hub from rotating relative to the hub housing component. Alternatively, the inner hub housing component includes a smooth internal circumference and the needle hub comprises a smooth outer surface to allow the needle hub rotate relative to the hub housing component.


In certain embodiments, the delivery handle system of the invention includes a luer holder coupled to a distal end of the distal handle member for coupling the distal handle member to a working channel port of an endoscope. In such embodiments, the luer holder includes a luer lock for locking the distal handle member in a fixed position relative to the working channel of the endoscope to prevent the delivery handle system from rotating about the working channel.


These and other aspects of the invention are described in further detail in the figures, description, and claims that follow.





BRIEF DESCRIPTION OF DRAWINGS

In the following description, various embodiments of the present invention are described with reference to the following drawings that illustrate exemplary embodiments of the invention. Together with the description, the drawings serve to explain the principles of the invention. In the drawings, like structures are referred to by like numerals throughout the several views. Note that the illustrations in the figures are representative only, and are not drawn to scale, the emphasis having instead been generally placed upon illustrating the principles of the invention and the disclosed embodiments.



FIG. 1 is an assembly drawing depicting the present invention incorporating the delivery system handle, catheter sheath and aspiration needle for the intended field of use.



FIG. 2 is a drawing of the aspiration needle sub-assembly of the present invention.



FIG. 3 is a cross sectional drawing of the needle protector embodiment of the present invention shown in FIG. 2.



FIG. 4 is a cross sectional drawing of the proximal end of the aspiration needle sub-assembly shown in FIG. 2



FIG. 4A is a drawing of an alternate preferred embodiment of the proximal end of the aspiration needle sub-assembly with strain relief;



FIG. 4B is a cross sectional drawing of the proximal end of the aspiration needle sub-assembly with strain relief.



FIGS. 5A through 5D depict various enlarged views of a thumb latch component included in the proximal portion of the delivery system handle of the invention.



FIG. 5 is a cross sectional drawing of the delivery system handle of the present invention.



FIG. 6 is an enlarged view of encircled Portion A shown in FIG. 5, and depicts a cross sectional drawing of the needle locking mechanism of the delivery system handle of the present invention.



FIG. 7 is an enlarged view of encircled Portion B shown in FIG. 5, and depicts cross sectional drawing of the needle extension length adjustment mechanism of the delivery system handle of the present invention.



FIG. 8 is an enlarged view of encircled Portion C shown in FIG. 5, and depicts a cross sectional drawing of the catheter sheath extension length adjustment mechanism of the delivery system handle of the present invention.



FIG. 9 is an enlarged view of encircled Portion D shown in FIG. 5, and depicts a cross sectional drawing of the distal end of the assembled delivery system handle of the present invention, incorporating the mechanism for attachment to the endoscope.



FIGS. 10A through 10O depict exemplary embodiments of an echogenically enhanced region at the distal end of an aspiration needle for use in the devices of the invention.



FIG. 10 is a drawing of the distal end of the needle with mounted needle collet.



FIG. 11 is a drawing of the extreme distal end of the needle.



FIG. 12 is a drawing of the bevel detail of the needle of the present invention, incorporating primary angle, secondary angle, tertiary and back-cut angle elements.



FIG. 13 is a cross sectional drawing of the bevel detail of the needle of the present invention, illustrating the tertiary angle of the grind detail.



FIG. 14 is a cross sectional drawing of the proximal end of the needle protector hub sub-assembly.



FIG. 15 is a drawing of the intended functionality of the needle protector assembly.



FIG. 16 is a drawing of the intended functionality of the needle protector and aspiration needle assemblies during needle exchange and more specifically, during needle insertion.



FIG. 17 is a drawing of the intended functionality of the needle protector and aspiration needle assemblies during needle exchange and more specifically, during needle insertion and locking in the device handle.



FIG. 18 is a drawing of the locking functionality of the needle protector and aspiration needle sub-assemblies in the hub housing components of the device handle.



FIG. 19 is a cross-sectional drawing of locking functionality between the needle hub, thumb latch and hub housing components.



FIG. 20 is a drawing of the hub needle hub and hub housing with interlocking capability to ensure non-rotation.



FIG. 21 is an alternate embodiment of the present invention, to facilitate rotation between needle hub and hub housing components.



FIG. 22 is a drawing of the intended functionality of the present invention to withdraw the aspiration needle sub-assembly from the delivery system handle during needle exchange.



FIG. 23 is a drawing of the intended functionality of the needle collet during needle exchange and more specifically, during needle extraction from the device handle.



FIG. 24 is a drawing of the intended functionality of the needle collet during needle exchange and more specifically, during needle extraction from the device handle.



FIG. 25 is a drawing of the needle protector sub-assembly secured to the end of the aspiration needle, and the intended functionality of the needle sheath of the present invention.



FIG. 26 is a drawing of the distal end of the aspiration needle sub-assembly housed in the catheter sheath of the delivery system of the present invention.



FIG. 27 is a drawing of the distal end of the aspiration needle sub-assembly extending from the catheter sheath of the delivery system of the present invention.



FIG. 28 is a drawing of the intended functionality of the present invention, and more specifically of the intended functionality of the catheter sheath of the present invention.



FIG. 29 is a drawing of the construction of the catheter sheath component of the present invention.





DETAILED DESCRIPTION

The invention provides a device for needle biopsy for collecting tissue, fluid, and cell samples in conjunction with procedures such as an endoscopic ultrasound (EUS) or endoscopic bronchial ultrasound (EBUS).


An exemplary embodiment of the proposed device assembly is illustrated in FIG. 1. The device design consists of a handle mechanism (delivery system handle 10) and aspiration needle sub-assembly 15. The delivery system handle 10 includes a proximal handle member 10a, a middle handle member 10b, and a distal handle member 10c. The proximal, middle and distal handle members each include an inner lumen and are coupled together to define a longitudinal axis such that the inner lumens are in constant communication and extends throughout the length of the coupled handle members. Proximal handle member 10a is slideably disposed over at least a portion of the middle handle member 10b, and middle handle member 10b is slideably disposed over at least a portion of distal handle member 10c. The proximal handle member 10a includes proximal handle grip 10a1 a distal handle grip 10a2. The delivery handle system 10 further includes an inner handle member 10d disposed within the inner lumen of the middle handle member 10b (shown in FIGS. 5 and 7). The delivery system handle 10 also incorporates a catheter sheath 14 component coupled to the distal end of the distal handle member 10c. This component provides a conduit between the delivery system handle 10 and the target sampling site during the exchange of aspiration needles. The device design is modular in that the needle sub-assembly 15 can be detached from the proximal handle 10a of the device for each individual “pass” or aspirated sample taken by the endoscopist at the site of the lesion or abnormality.


The delivery system handle 10 incorporates two length adjustment features actuated via adjustment of two thumbscrew locking mechanisms. A threaded proximal thumbscrew 12 and locking ring 33 are moveably disposed around the middle handle member 10b; the proximal thumbscrew 12 is loosened to loosen locking ring 33, locking ring 33 is moved distally along the middle handle member 10b and tightened in the desired position along middle handle member 10b via proximal thumbscrew 12 to allow the user to establish a set depth of needle penetration beyond the end of the catheter sheath 14. A threaded distal thumbscrew 13 is transversely disposed at the distal portion of the middle handle member 10b; the distal thumbscrew 13 is loosened to move the middle handle member 10b distally and/or proximally and tightened to allow the user to establish a set depth of catheter sheath 14 extension beyond the end of the endoscope.


The needle sub-assembly 15 consists of the needle shaft 21(which can range in length from 500 mm up to 2500 mm, but which more preferably ranges in length between 1640 mm to 1680 mm) and is beveled at the distal needle end to enhance tissue penetration during sample acquisition; needle hub 17; needle luer 18; needle collet 19; needle protector sub-assembly 9; stylette hub 20 and stylette shaft 22. The needle component itself can be manufactured from a number of metallic based (Stainless steel or alloys thereof; Nitinol or Alloys thereof etc . . . ) or Polymeric Based materials including, but not limited to Poly-ether-ether ketone, Polyamide, Poyethersulfone, Polyurethane, Ether block amide copolymers, Polyacetal, Polytetrafluoroethylene and/or derivatives thereof).



FIG. 2 illustrates the aspiration needle sub-assembly 15 of the present invention. This sub-assembly is inserted into and removed from the lumen of the delivery system handle 10 in acquiring tissue samples. The sub-assembly 15 consists of a stylette hub 20 and stylette shaft 22 components which are securely locked on the needle luer 18 of the aspiration needle via conventional internal luer threads (as is know to persons skilled in the art). The stylette hub 20 may be attached to the stylette shaft 22 via a number of processing techniques such as adhesive bonding or insert injection molding. The female luer of the aspiration needle incorporates a mating luer thread detail, onto which the stylette hub 20 may be tightened. The needle luer 18 element of the present invention may be attached to the proximal end of the needle shaft via a number of processing techniques such as adhesive bonding or insert injection molding.


The aspiration needle sub-assembly 15 also incorporates a needle collet 19 (previously described as “needle protrusion(s) and shown in FIGS. 3 and 10 of Applicant's co-pending application (U.S. Ser. No. 12/243,367, published as US2010/0081965). The function of this needle collet 19 is to (1) provide a means to center the needle shaft component in the catheter sheath of the delivery system during needle exchange (2) provide a mechanism or securing and locking the needle protector sub-assembly to the distal end of the aspiration needle once the needle has been unlocked and withdrawn from the delivery system handle. The needle collet 19 of the present invention may be attached to the distal end of the needle shaft 21 via a number of processing techniques such as adhesive bonding, laser welding, resistance welding, or insert injection molding. The needle collet 19 may be fabricated from metals materials such as stainless steel, nickel titanium or alloys thereof or polymer materials such as, but not limited to, Polyacetal, polyamide, poly-ether-block-amide, polystyrene, Acrylonitrile butadiene styrene or derivatives thereof. The needle collet 19 is located at a set point distance from the extreme distal end of the beveled needle. The distance from the extreme distal end of the needle bevel to the proximal collet position on the needle may be within the range of 6 cm to 12 cm but is more preferably in the range of 7 cm to 9 cm and ore preferably is located 8 cm from the end of the needle. This ensures that when the needle is extended to it's maximum extension distance relative to the distal end of the catheter sheath (i.e. 8 cm), the collet 19 does not exit the end of catheter sheath 14.



FIGS. 3 and 14 illustrate the needle protection sub-assembly 9 design embodiment of the current invention, in the locked position at the distal end of the needle. The needle protection sub-assembly 9 consists of two needle protector (NP) hub halves (collectively 23), which are adhesively bonded to each other, on the proximal end of the needle protector (NP) sheath component 24. Alternately, these NP hub halves 23 may be snap fit together or may be insert injection molded over the NP sheath 24 to provide a secure bond/attachment between these components in the assembly. The needle protection sub-assembly 9 also incorporates a needle protector (NP) hub O-Ring component 25. This component resides in a recessed cut-out in the center of the assembled NP hub halves 23. This NP hub O-Ring 25, in conjunction with the needle collet 19 which is securely attached to the distal end of the needle shaft 21 of the sub-assembly 9, provides a mechanism for locking the NP sub-assembly 9 onto the end of the needle. In this way, the bevel of the needle is protected, covered and shielded once the needle has been removed from the delivery system handle. It is desired that the NP sheath 24 of the present invention be manufactured from a translucent polymer such as, but not limited to polyurethane, polyamide and derivatives thereof.


The needle hub 17 embodiment of the aspiration needle sub-assembly as shown in FIG. 2 and FIG. 4 of the present invention, provides a mechanism which (1) locks the aspiration needle sub-assembly 15 into the delivery system handle 10 by means of the hub housing 27 and thumb latch 28 components (as will be described later in this disclosure) and (2) provides a means to lock the needle protection sub-assembly 9 embodiment shown in FIG. 3, into the delivery system device handle 10, as will be described later. As shown in FIG. 4, the needle hub component 17 is securely attached to the needle luer 18 and needle shaft 21 components of the aspiration needle sub-assembly 15. The needle hub element 17 of the present invention may be attached to the distal end of the needle luer component 18 via a number of processing techniques such as adhesive bonding or insert injection molding.


An alternate preferred embodiment of the proximal end of the aspiration needle sub-assembly 15 is shown in FIGS. 4A and 4B. This embodiment incorporates a strain relief component 26, which extends from the distal end of the needle luer component 18, through the body of the needle hub component 17, to extend beyond the distal end of the needle hub 17. This tubular strain relief component 26 is intended to provide a more gradual stiffness transition between the needle hub 17 and needle shaft 21 components, particularly in the case of smaller needle gauge sizes (such as 22A WG and 25A WG). This strain relief component 26 may range in length from 10 mm to 50 mm but is more preferably in the range of 25 mm to 35 mm. The diameter of this strain relief component 26 must be sufficiently small so that it fits through the proximal end of the needle protection sub-assembly 9 (as shown in FIG. 3) and does not impair the ability for the NP sub-assembly 9 to slide back and forth on same. This strain relief component 26 may range in outer diameter from 0.020 inches to 0.060 inches but is more preferably in the range of 0.026 inches to 0.045 inches. This tubular strain relief 26 may be fabricated from metal based materials, such as but not limited to stainless steel, nickel titanium or alloys thereof or polymer materials such as, but not limited to, Polyacetal, polyamide, poly-ether-block-amide, polystyrene, Acrylonitrile butadiene styrene or derivatives thereof.



FIG. 5 is a sectional view of the delivery system handle 10 for the present invention, without the aspiration needle sub-assembly 15 loaded therein. FIG. 6 (Detail A from FIG. 5) illustrates a sectional view of the proximal end 10a of the assembled device handle. This proximal portion of the handle (also shown in FIG. 16 and FIG. 18) contains elements to ensure secure, yet releasable locking of the aspiration needle sub-assembly 15 in the delivery system handle 10. The hub housing component 27 is secured to the proximal delivery system handle halves 10a via adhesive bonding or ultrasonic welding techniques. The thumb latch component 28 is securely locked into the hub housing component 27 via a one-way keying action. Once the thumb latch component 28 is inserted into the hub housing component 27, the thumb latch 28 cannot be disassembled and may only be moved in the transverse direction to actuate the assembled mechanism.



FIGS. 5A, 5B, 5C, and 5D depict various views of an exemplary embodiment of the thumb latch component 28 of the delivery system handle 10. The thumb latch component 28 represents a mechanism to releasably lock the needle hub 17 of aspiration needle sub-assembly 15 within the hub housing 27 of the proximal handle member 10a of the delivery device. Thumb latch 28 may be, for example, a push-button, that activates the use of a deflectable hinge member 28a to provide for a return to the “home” position once external force is not applied to release thumb latch 28. Hinge member 28a can elastically deform to provide for the opening and closing of the “lock” during removal of the aspiration needle sub-assembly 15 from the delivery system handle 10. In one embodiment, thumb latch 28 incorporates an external coupler housing 28b and a push button design mechanism. FIGS. 5C and 5D illustrates thumb latch 28 in the CLOSED and OPEN positions during a typical actuation cycle.


Referring to FIGS. 5A and 5B, thumb latch 28 and external coupler housing 28b may be manufactured from a range of rigid, non-deformable, thermoplastic or thermoset materials such as, acrylonitrile butadiene styrene (ABS), styrene acrylonitrile (SAN), polystyrene or rigid derivatives thereof, polyamide, polyethylene, polyurethane, and polycarbonate. In an embodiment, the materials of manufacture have a durometer in the range of 35-120 Shore D, but more preferably in the range of 80-110 Shore D.


Hinge member 28a may be manufactured from a range of rigid, thermoplastic or thermoset materials such as, acrylonitrile butadiene styrene (ABS), styrene acrylonitrile (SAN), polystyrene or rigid derivatives thereof, polyamide, polyethylene, polyurethane, and polycarbonate. In an embodiment, the materials of manufacture shall be capable of deformation in bending under the application of an applied load, such as is encountered during a typical “Open and Close” cycle for the needle biopsy device without crazing, fatigue or cracking.


The proximal portion of the proximal handle member 10a of the delivery system handle 10, incorporates a retention collar 29 and a retention collar O-ring component 30. The retention collar component 29 resides in a cut out nest in the proximal handle half, and is in communication with inner hub housing component 27. The retention collar 29 is a cylindrical component, which is internally tapered and recessed to provide an internal, recessed shelf. The retention collar O-ring component 30 resides in this recessed shelf and is secured in position through the assembly of both halves of the delivery system handle halves. The purpose of this retention O-Ring component 30 is to provide a method to lock and maintain the needle protector hub sub-assembly 9 of the aspiration needle sub-assembly 15, securely in the handle 10 of the delivery system while the tissue sample site is being accessed by the clinician, as described in detail below. The functionality and operation of this retention collar O-Ring component 30 is the same as described in FIGS. 41 and 42 and associated abstract of the specification of Applicant's co-pending patent application U.S. Ser. No. 12/607,636 (published as US2010/0121218).


As shown in FIG. 6, the delivery system handle assembly 10 of the present invention incorporates an inner hypotube component 31. It is the design intent of this component to provide a conduit between the proximal handle member 10a of the delivery system, and the outer hypotube component 32 shown in FIG. 7. The inner hypotube component 31 may be fabricated from metal based materials, such as but not limited to stainless steel, nickel titanium or alloys thereof or polymer materials such as, but not limited to, Polyacetal, polyamide, poly-ether-block-amide, polystyrene, Acrylonitrile butadiene styrene or derivatives thereof. The inner hypotube 31 is secured to the assembled handle halves of the device via adhesive bonding or insert injection molding techniques. During needle advancement, the proximal handle member 10a of the delivery system is distally advanced, in order to advance the distal end of the needle into the desired tissue sampling site. When the proximal handle member 10a is distally advanced, the inner hypotube 31 is also advanced in unison in a distal direction. The inner hypotube component 31 is in constant longitudinal communication with the outer hypotube component 32 and is designed to telescope inside the outer hypotube component 32 at all times. This ensures that needle passage during needle exchange into and out of the delivery system, is not impaired.


Referring now to FIG. 7 (Detail B from FIG. 5), a cross sectional view of the distal end of the proximal handle member 10a and the middle handle member 10b is illustrated. During a typical EUS FNA procedure, the locking ring component 33 is loosened via proximal thumbscrew 12, moved distally and set to a pre-established depth by the clinician, dependent upon depth of needle penetration required. Once the locking ring 33 has been moved distally (via the proximal thumbscrew) and locked to the required depth of penetration, the proximal handle member 10a of the delivery system is advanced. During advancement, the proximal handle member 10a moves in a longitudinal direction over the middle handle member 10b and inner handle member assembly 10d. The inner handle member 10d and middle handle member 10b components are securely bonded to each via adhesive bonding or ultrasonic welding techniques and remain in a stationary, locked position during needle advancement via proximal handle 10a actuation in a distal direction.


As shown in FIG. 7, the outer hypotube component 32 is also in constant communication with the catheter shaft component 14 of the delivery system. The proximal end of the catheter shaft component 14 is flared in an outward direction. The distal end of the outer hypotube component 32 is inserted into flared end of the catheter shaft 14 and secured thereto via adhesive bonding or insert injection molding techniques. The inner handle member 10d is bonded to both the proximal end of the catheter shaft 14/outer hypotube 32 assembly via adhesive bonding or insert injection molding techniques. In this way, the inner hypotube 31, outer hypotube 32 and catheter sheath 14 are in constant communication, ensuring for smooth needle passage during needle exchange. This design embodiment, also ensures that the catheter sheath 14 my be advanced through the distal handle member 10c as required.



FIGS. 8 and 9 illustrate the design assembly embodiments for catheter sheath extension length adjustment in the case of the present invention. Referring to FIG. 8, the distal end of the middle handle member 10b incorporates a threaded insert 7 and distal thumbscrew 13. The catheter sheath extension distance beyond the end of the endoscope may be adjusted by loosening the distal thumbscrew 13 and advancing the middle handle member 10b in a distal direction over the distal handle member 10c. The distal handle member 10c and middle handle member 10b are in constant longitudinal communication with each other.


Referring to FIG. 9, the distal end of the delivery system handle assembly 10 is illustrated. The distal handle member 10c is secured to a recess in the distal luer holder 6 via adhesive bonding or ultrasonic welding techniques. The distal luer holder component 6 is securely attached to the scope luer lock component 5 via adhesive bonding or insert injection molding techniques. The distal handle member 10c is designed in such a way that once the device handle is attached to the working channel port of the endoscope, the assembly cannot rotate independently of assembled scope luer lock 5 and distal luer holder 6 components. Once the entire delivery system handle 10 (as shown in FIG. 1 and cross sectional view FIG. 5) has been locked onto the endoscope via the scope luer lock 5, the catheter sheath length and needle penetration extension length may be established as previously described.



FIG. 10 is an illustration of the distal end of the aspiration needle of the present invention, with needle collet (referred to as “needle protrusions” in Applicant's co-pending patent application U.S. Ser. No. 12/607,636, published as US2010/0121218) secured on the needle. It is preferable that the length of this needle collet 19 be in the range of 2 mm to 10 mm, but more preferably in the range of 3.5 mm to 5 mm. It is preferable that the outer diameter of the needle collet 19 be in the range of 0.030 inches to 0.080 inches, but more preferably in the range of 0.040 inches to 0.070 inches. This needle collet component 19 (see also FIG. 14 and FIG. 26) is also chamfered at the proximal and distal ends of same. It is preferable that the chamfer angle of the needle collet be in the range of 15 degrees to 80 degrees, but more preferably in the range of 30 degrees to 60 degrees. This chamfer on both ends of the needle collet 19 is intended to provide smooth locking and unlocking with the needle protector sub-assembly 9 during needle exchanges.


As depicted in FIG. 10, and FIGS. 10A through 10O, the distal end of the needle of the present invention incorporates an embodiment to enhance the echogenic signature of the needle. In the case of the present invention, this echogenically enhanced region 34 can be fabricated by, but not limited to roughening the end of the needle over a pre-defined length close to proximal end of the needle bevel 35. It is preferable that the length of this echogenically enhanced region 34 be in the range of 2 mm to 20 mm, but is more preferably in the range of 10 mm to 15 mm. In the case of the present invention, the echogenic enhanced pattern is imparted to the needle via a micro-blasting process which roughens the surface of the needle over a specific length, improving the visibility of the needle under endoscopic ultrasound.


In certain aspects of the invention, the echogenically enhanced region of the needle is achieved through the removal of material from the surface of the needle to provide greater reflectivity and strengthened reflected signal. It is contemplated that the removal of material does not, however, reduce the performance of the needle from a pushability perspective or deter its ability to acquire a desired sample.


Referring now to FIG. 10A, a perspective view of an embodiment of a needle 600 is presented. Needle 600 is comprised of a plurality of depressions 602. Depressions 602 may be, but are not limited to, circular, concave, cylindrical, helical, oval, rectangular, and square elements that take the form of indentations on the surface of needle 600. Depressions 602 may be arranged in a helical (spiral) fashion around the circumference of the distal needle end. These indentations may extend to the extreme end of the bevel or may end at a specific distance from the bevel of needle 600. The length of the distal end of needle 600 containing these depressions may be, for example, from one to twenty centimeters. In another embodiment, the length is between five to ten centimeters. Referring to FIGS. 10B and 10C, depression 602 have a concave detail 604. Referring to FIGS. 10D and 10E, depressions 602 have a square base edge 606. Referring to FIGS. 20F and 20G, depressions 602 have a hemispherical base detail 608.


Referring now to FIG. 10H, a perspective view of another embodiment of a needle 610 is presented. Needle 610 is comprised of elliptical depressions 612 around the circumference of the distal end of needle 610. Referring to FIG. 10I, a perspective view of an embodiment of a needle 614 having square depressions 616 is presented. Depressions 616 may extend to the extreme end of the bevel or may end at a specific distance from the bevel of needle 614. Referring to FIGS. 10J and 10K, embodiments of needle 614 including spiral depressions 620 and helical depressions 622 are presented. Referring to FIG. 10L, a depression 624 has a concave detail. Referring to FIG. 10M, a depression 626 has a square base edge. Referring to FIG. 10N, a depression 628 has a hemispherical base detail.


Referring now to FIG. 10O, a diagram of ultrasound waves impinging upon a needle depression at angles of α1630 and β1632 respectively are presented. In an embodiment, a wave strikes the base of the depression and is reflected upwards at angle of reflection of α2634 and β2636 respectively, which are equal to the angles of incidence of α1630 and β1632 respectively. This reflected beam is reflected a second time off the adjacent wall of the depression at an angle of reflection of α3638 and β3640 respectively, which are equal to the angles of incidence, α1630 and β1632 respectively and the angles of first reflection α2634 and β2636 respectively. In this manner, the reflected wave becomes reflected along the same angle of incidence as the initially propagated incident beam back to the transducer of the ultrasound device. In an embodiment, a square edge depression design may provide for more efficient remittance of ultrasound waves during the procedure.



FIGS. 11 and 12 are drawings of the distal end of the needle of the current invention. The distal end of the needle 35 of the current invention is beveled to enhance the ability of the needle to penetrate tissue during sample acquisition. The bevel detail 35 of the present invention incorporates four angular bevel grinds, which, in addition to enhancing tissue penetration, also ensure the smooth passage of the needle down the catheter sheath of the delivery system during needle exchange. Referring to FIG. 12, the needle bevel grind of the current embodiment incorporates a primary angle (“A”), a secondary angle (“B”), a back-cut angle (“C”) and tertiary angles (“D”), as shown in FIG. 13. It is preferable that the primary angle be in the range of 10 degrees to 25 degrees, but more preferably in the range of 12 degrees to 18 degrees. It is preferable that the secondary angle be in the range of 15 degrees to 35 degrees, but more preferably in the range of 22 degrees to 28 degrees. It is preferable that the tertiary angle be in the range of 15 degrees to 35 degrees, but more preferably in the range of 22 degrees to 28 degrees. It is preferable that the back-cut angle be in the range of 15 degrees to 70 degrees, but more preferably in the range of 25 degrees to 45 degrees.


During needle exchange, it is important that the aspiration needle (with pre-loaded stylette 2) can be passed through the internal diameter of the catheter sheath 14 without catching on the internal wall of same. In order to achieve this, the bevel grind of the current invention incorporates a back-cut grind detail. This back-cut detail acts as a “bumper” during needle passage through the sheath. As the needle advances, the heel of the back-cut comes in contact with the internal diameter of the sheath and reduces the friction between needle end 35 and catheter sheath 14 components. In this way, the needle can be smoothly tracked through the catheter sheath to exit the end of the catheter sheath 14.



FIG. 14 and FIG. 15 illustrate the method of engagement and disengagement between the aspiration needle sub-assembly 15 with mounted collet 19 and the needle protector (“NP”) sub-assembly 9. Referring to FIG. 14, the NP hub 23 is locked onto the needle collet 19 at the distal end of the needle shaft 21 by inserting the shaft 21 into the NP hub 23. As the needle/NP protector assembly is inserted into the handle of the delivery system, the needle 21 and needle collet 19 are advanced such that the needle collet 19 traverses the deformable NP Hub O-Ring 25. The internal diameter of the NP Hub O-Ring 25 in the non-deformed state, is smaller than the outer diameter of the needle collet 19. Due to the soft durometer and elastic nature of the NP Hub O-Ring 25, as the needle 21 and attached needle collet 19 are moved distally, the NP O-Ring 25 deforms allowing the collet to traverse the NP O-ring 25 under applied longitudinal force. Once the needle collet 19 has traversed the NP O-ring 25, the needle 21 with pre-mounted collet 19 are tracked through the catheter sheath 14 to the intended target site. This aspect of the current invention is also illustrated in FIG. 23.



FIGS. 16, 17 and 18 illustrate the mechanism by which the aspiration needle sub-assembly 15 is locked into the handle 10 of the delivery system. First, the aspiration needle sub-assembly 15 is pre-mounted with needle protection sub-assembly 9, as previously described. As shown in FIG. 16, at the start of a needle insertion cycle, the aspiration needle/protection assembly is inserted into the proximal handle member 10a of the delivery system handle 10. As the needle/protection assembly is advanced, the needle protector hub 23 contacts the retention collar o-ring 30. Under application of additional force (as illustrated per FIGS. 14 and 15) the needle collet 19 traverses the internal NP Hub O-ring 25 and advances distally down the catheter sheath 14, as described above. As the needle hub 17 component is advanced into the hub housing component 27 of the proximal handle member 10a, the distal end of the needle hub 17, contacts the proximal end of the NP sub-assembly 9. Continually inserting the needle hub 17, pushes the NP sub-assembly 9 forward so that the NP hub 23 traverses the deformable retention collar o-ring 30 until it comes to rest. At this juncture, the NP hub 23 and sub-assembly 9 are locked in position within the proximal handle member 10a and do not move. Simultaneously, the needle hub 17 deflects the thumb latch component 28. Once the NP sub-assembly 9 has traversed the retention collar o-ring 30 (as shown in FIG. 18), the needle hub 17 is securely locked into the hub housing 27 by traversing an internal land ring 36 on the needle hub component 17, as shown in Detail F of FIG. 19.



FIG. 19 illustrates a sectional view of the aspiration needle locked into the thumb latch 28/hub housing 27 components of the delivery system handle 10. As the needle hub 17 is advanced into the hub housing 27 in the handle, the hub 17 contacts the internal taper of the thumb latch 28 at the thumb latch distal end. This causes the thumb latch 28 distal end to move laterally and also causing the deflectable hinge 28a of the thumb latch 28 (see FIG. 22 also) to deform under plastic deformation, against the hub housing barb 37. Once the needle hub 17 is completely advanced into the hub housing 27, the distal end portion of the thumb latch 28, returns to the home position. The interference between the internal land ring 36 on the needle hub 17 and the thumb latch distal end, ensures that the needle hub 17 will not move backwards.


An intended functionality of thumb latch 28 is to prevent the aspiration needle subassembly 15 from being removed from the proximal handle member 10a without applying force to release thumb latch 28. As shown in FIG. 22, the aspiration needle may be exchanged or withdrawn from the delivery system handle 10 by depressing the thumb latch component 28 and withdrawing the needle hub 17 from the hub housing 27. As the thumb latch 28 is depressed, the deflectable hinge 28a of the thumb latch 28 contacts the hub housing barb 37. The thumb latch 28 moves in a lateral direction. This action clears the interference between the internal needle hub land ring 36 and distal end of the thumb latch component 28. In this way, the aspiration needle can be removed un-impaired from the delivery system handle. Additionally, follow-up samples may be acquired using the same or a virgin aspiration needle sub-assembly.



FIG. 20 illustrates the preferred embodiments of the hub housing 27 and needle hub 17 embodiments of the present invention. In this instance, the hub housing component 27 contains depressed female détentes 40 on the inner diameter of the hub housing 27. These détente features 40 are equispaced around the internal circumference of the hub housing body. It is preferable that the number of détente features be in the range of 2 to 15, but more preferably in the range of 6 to 10. These détente features provide a mechanical lock with corresponding interlocking barb features 41 on the external surface of the needle hub barrel 17. Once the needle hub 17 is securely locked in the hub housing component 27 in the device handle, the interlocking barbs 41 on the needle hub 17 become seated in the détente features 40 of the hub housing. This mechanical lock prevents the needle hub 17 from rotating relative to the needle hub housing 27 and delivery system handle 10, during a typical endoscopic ultrasound procedure. Alternatively, the inner surface of the hub housing component 27 can be a smooth inner surface 27a. Likewise, the external surface of the needle hub 17 is smooth external surface 17a, to allow the needle hub 17 to rotate relative to the needle hub housing 27 and delivery handle system 10 during an endoscopic ultrasound procedures (FIG. 21).


During aspiration needle exchange, and more specifically during needle insertion, the needle collet component 19 disengages from the NP Hub O-ring 25 by traversing the NP Hub O-ring 25 as explained above. FIGS. 23 and 24 illustrate the engagement of the needle collet 19 with the needle protector sub-assembly 9 upon needle extraction post sample acquisition. As the aspiration needle is continually withdrawn from the delivery system handle 10, the needle collet 19 contacts the NP hub O-ring 25 as shown in FIG. 23. As the aspiration needle is continually withdrawn, the needle collet 19 traverses the NP hub O-ring 25 as shown in FIG. 24. As the needle is further withdrawn, the needle protector hub 23 traverses the retention collar O-ring 30 and the needle can be completely removed from the system, with the needle protector sub-assembly 9 encasing the distal bevel of the needle 35 to prevent inadvertent “needle sticking”, as illustrated in FIG. 25 and Detail G.


In the case of the present invention, the needle protector sheath 24 is internally tapered 24a at the distal end (FIG. 25). It is preferable that length of this internal taper be in the range of 1 mm to 10 mm but more preferably in the range of 3 mm to 6 mm. It is also preferable that the internal taper angle on the distal end of the needle protector sheath be in the range of 2 degrees to 30 degrees, but more preferably in the range of 5 degrees to 15 degrees.



FIG. 26 is an illustration of the distal end 14a of the catheter sheath 14 of the delivery system (not shown) with aspiration needle loaded in the device handle, with the device handle in the fully retracted position. In this instance, the distal end of the needle lies proximal to the distal tapered end 14a of the catheter sheath 14. FIG. 27 illustrates the position of the needle 21 and needle collet 19 relative the catheter sheath 14 when the needle is in it's fully extended position. In the fully extended position, the needle collet 19 remains housed inside catheter sheath 14, proximal to the tapered distal tip.


In the case of the present invention, the catheter shaft component 14 is manufactured from a thermoplastic polymer such as, but not limited to Polyurethane, Polyamide and derivatives thereof, Ether block amide copolymers, Polyimide, Placental, Polyethylene and derivatives thereof, Poly-tetrafluoroethylene. The preferred embodiment of the catheter shaft 14 (as shown in FIG. 29) is that the catheter shaft 14 incorporates a helically braided reinforcing structure 45 housed between inner 46a and outer polymer 46b layers, of outer thermoplastic material such as those mentioned above with a lubricious inner liner or core. In the case of the present invention, the helically braided reinforcement 45 is fabricated from stainless steel wire. It is preferable that the diameter of this reinforcing braid wire be in the range of 0.0005 inches to 0.010 inches but more preferably in the range of 0.0015 inches to 0.005 inches It is preferable that the outer diameter of the catheter sheath 14 be in the range of 0.050 inches to 0.140 inches but more preferably in the range of 0.085 inches to 0.0105 inches. It is preferable that the inner diameter of the catheter sheath 14 be in the range of 0.050 inches to 0.120 inches but more preferably in the range of 0.065 inches to 0.085 inches.


In the case of the present invention (and as illustrated in FIGS. 26 and 27), it is preferable that the distal end 14a of the catheter sheath 14 be tapered to reduce both the outer diameter and the internal diameter of the catheter sheath tip. This taper may be imparted to the distal end of the catheter sheath 14 via swaging or thermal heat forming techniques. It is preferable that the inner diameter of the catheter sheath 14 be tapered at the distal end 14a to an internal diameter in the range of 0.020 inches to 0.060 inches but more preferably in the range of 0.040 inches to 0.050 inches.


Referring now to FIG. 28, An aspect of the present invention which provides the clinician with improved procedural performance over prior art devices, concerns the ability of the tapered catheter sheath 14 of the present invention to keep the aspiration needle of the device centered in the working channel conduit of the endoscope. Due to the increased outer diameter of the catheter sheath 14 of the present invention (in the range of 6.5 French to 8 French) compared to that of the prior art (approximately 5 French to 5.4 French), the catheter sheath reduces the annular clearance between the catheter sheath 14 and the inner diameter of the endoscope working channel. By reducing the annular clearance with the working channel of the endoscope, the angle of exit of the catheter sheath 14 of the present invention is co-axial to working channel. This ensures that as the needle exits the distal end of the catheter sheath, the needle will exit the distal end of the catheter in a more “normal” plane relative to the longitudinal axis of the endoscope. The inclusion of an internal taper on the distal end of the catheter sheath, also ensures that the needle exits the catheter in a more “normal” plane than in the case of prior art devices.


Certain embodiments according to the invention have been disclosed. These embodiments are illustrative of, and not limiting on, the invention. Other embodiments, as well as various modifications and combinations of the disclosed embodiments, are possible and within the scope of the disclosure.

Claims
  • 1. A device for needle biopsy comprising: an adjustable delivery handle system, at least a portion of the delivery handle system comprising an inner lumen configured to interchangeably receive a needle subassembly;a proximal handle member disposed at a proximal end of the delivery handle system; anda needle subassembly removably disposed within the inner lumen and comprising an interchangeable needle having a protruded portion at a distal end portion of the interchangeable needle, wherein the needle subassembly further comprises a needle protector subassembly having an internal protruded portion that is configured to engage with the protruded portion of the interchangeable needle and lock onto the protruded portion at the distal end portion of the interchangeable needle in response to withdrawing the needle subassembly from the delivery handle system such that the distal end portion of the interchangeable needle transitions from an unshielded configuration to a shielded configuration within the proximal handle member upon engaging the internal protruded portion of the needle protector subassembly with the protruded portion at the distal end portion of the interchangeable needle within the proximal handle member, wherein the needle protector subassembly and the interchangeable needle are reinsertable into the delivery handle system,wherein the protruded portion of the interchangeable needle is configured to traverse the internal protruded portion of the needle protector subassembly in response to applying a longitudinal force to the interchangeable needle when the interchangeable needle is reinserted into the delivery handle system such that the internal protruded portion transitions from a deformed state to an undeformed state upon applying the longitudinal the force, thereby unlocking the protruded portion from the internal protruded portion within the proximal handle member in response to reinserting the needle subassembly into the delivery handle system.
  • 2. The device of claim 1, wherein the interchangeable needle comprises a distal tip having four distinct angular bevel grinds.
  • 3. The device of claim 2, wherein the four distinct angular bevel grinds of the distal tip of the interchangeable needle comprise a primary angle relative to a needle shaft, a secondary angle relative to the needle shaft, and a back-cut angle relative to the secondary angle for providing a smooth needle passage during needle insertion and withdrawal during a biopsy procedure.
  • 4. The device of claim 3, wherein the distal tip of the interchangeable needle comprises an enhanced echogenicity or acoustic reflection region.
  • 5. The device of claim 1, wherein the delivery handle system has an adjustable length, a longitudinal axis defining a lumen extending therethrough, and comprising the proximal handle member, a middle handle member and a distal handle member, the proximal handle member being slideably disposed over at least a portion of the middle handle member, the middle handle member being slideably disposed over at least a portion of the distal handle member, the proximal handle member comprising an inner hub housing component comprising an internally cylindrical shape configured to interchangeably receive the needle subassembly configured for inserting into and withdrawing from the proximal handle member.
  • 6. The device of claim 5, wherein the interchangeable needle comprises: a proximal end portion and the distal end portion;a needle luer coupled to the proximal end portion of the needle; anda needle hub coupled to the proximal end portion of the needle, the needle hub configured for coupling with the inner hub housing component of the proximal handle member.
  • 7. The device of claim 6, wherein the needle protector subassembly comprises: a needle protection hub having a lumen extending therethrough configured for receiving the distal end portion of the needle;the internal protruded portion comprises a deformable O-ring axially disposed within the lumen of the needle protection hub; anda tubular sheath defining a lumen extending from a distal end of the needle protection hub, the lumen of the tubular sheath in communication with the lumen of the needle protection hub for receiving the needle when inserted into the needle protection hub.
  • 8. The device of claim 7, wherein the protruded portion at the distal end portion of the interchangeable needle comprises a collet surrounding the distal end portion of the needle, the collet comprising a diameter larger than the diameter of the deformable O-ring of the needle protection hub such that the collet traverses the deformable O-ring when the needle is inserted into or withdrawn from the lumen of the needle protection hub, thereby locking the needle protector subassembly onto the distal end portion of the needle during insertion and withdrawal of the needle subassembly from the delivery handle system.
  • 9. The device of claim 8, wherein the collet is chamfered at a proximal end and a distal end of the collet to provide a smooth interface with the needle protector subassembly during needle exchange.
  • 10. The device of claim 7, wherein the proximal handle member further comprises an inner retention collar disposed at a distal end of the inner hub housing component, the inner retention collar configured to receive the needle protection hub coupled to the needle, at least a portion of the inner retention collar being recessed, and a deformable O-ring component disposed within a recessed portion for securing the needle protection hub within the inner retention collar upon insertion of the needle subassembly into the proximal handle member.
  • 11. The device of claim 10, wherein the O-ring component of the inner retention collar has a diameter smaller than a diameter of the needle protection hub, such that the needle protection hub traverses the deformable O-ring when the needle subassembly is inserted into or withdrawn from the proximal handle member thereby locking the needle protector subassembly onto the proximal handle member during insertion and withdrawal of the needle subassembly from delivery handle system.
  • 12. The device of claim 7, wherein the proximal handle member further comprises a locking mechanism for releasably locking the needle hub within the inner hub housing component of the proximal handle member.
  • 13. The device of claim 12, wherein the locking mechanism comprises a depressible latch component securely coupled to the proximal handle member, the latch component comprising a deflectable hinge coupled to a barb component, the barb component coupled to the inner hub housing component, disposed within an interior portion of the proximal handle member.
  • 14. The device of claim 13, wherein the needle hub of the needle subassembly further comprises an internal land ring for interacting with the deflectable hinge and barb component of the locking mechanism, whereby the internal land ring traverses the deflectable hinge of the latch component when the needle subassembly is inserted into the lumen of the proximal handle member, thereby causing the deflectable hinge to deflect against the barb component during insertion, the deflectable hinge returning to a home position once the internal land ring has cleared the deflectable hinge to prevent the needle hub from moving backwards, and whereby the needle subassembly is released from the inner hub housing component of the proximal handle member by depressing the latch component to cause the deflectable hinge to deflect against the barb component to allow the internal land ring to clear the deflectable hinge and barb.
  • 15. The device of claim 7, wherein the inner hub housing component comprises a plurality of depressions spaced around an internal circumference of the inner hub housing component and the needle hub comprises a plurality of protrusions, the plurality of depressions configured to receive the plurality of protrusions to prevent the needle hub from rotating relative to the inner hub housing component.
  • 16. The device of claim 7, wherein the inner hub housing component comprises a smooth internal circumference and the needle hub comprises a smooth outer surface to allow the needle hub rotate relative to the inner hub housing component.
  • 17. The device of claim 5, wherein the inner lumen, extending through the adjustable delivery handle system, comprises: an inner hypotube component at least partially disposed within the proximal handle member;an outer hypotube component disposed at least partially within the middle handle member, the inner hypotube component being coupled to the outer hypotube component and configured to longitudinally slide within the outer hypotube component when the proximal handle member is distally advanced or proximally retracted over the middle handle member; anda tubular catheter sheath coupled to a distal end of the outer hypotube component, wherein the inner hypotube component, outer hypotube component, and tubular catheter sheath are in constant communication with each other.
  • 18. The device of claim 17, further comprising an inner handle member disposed within an inner portion of the middle handle member, the inner handle member coupled to a proximal portion of the tubular catheter sheath and a distal portion of the outer hypotube component, such that the tubular catheter sheath is distally extended into the distal handle member when the middle handle member is distally advanced over the distal handle member.
  • 19. The device of claim 17, wherein the tubular catheter sheath comprises an outer diameter ranging from 0.05 inches to 0.140 inches, and an inner diameter ranging from 0.05 inches to 0.120 inches.
  • 20. The device of claim 17, wherein the tubular catheter sheath comprises a tapered distal tip comprising an outer diameter and an inner diameter, wherein the outer diameter and the inner diameter of the tapered distal tip are smaller than an outer diameter and an inner diameter of the tubular catheter sheath, respectively.
CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation of U.S. Ser. No. 13/297,766, filed Nov. 16, 2011, which is a continuation-in-part of U.S. Ser. No. 13/029,593 filed Feb. 17, 2011, which claims priority to U.S. Ser. No. 61/305,304, filed Feb. 17, 2010, and U.S. Ser. No. 61/305,396 filed Feb. 17, 2010. U.S. Ser. No. 13/297,766 is also; a continuation-in-part of U.S. Ser. No. 12/607,636, filed Oct. 28, 2009 (now U.S. Pat. No. 8,068,210), which claims priority to U.S. Ser. No. 61/117,966, filed Nov. 26, 2008, and U.S. Ser. No. 61/152,741, filed Feb. 16, 2009. U.S. Ser. No. 13/297,766 is also; a continuation-in-part of U.S. Ser. No. 12/243,367, filed Oct. 1, 2008 (now U.S. Pat. No. 9,186,128). The entire contents of each of the above-mentioned applications are incorporated by reference herein.

US Referenced Citations (737)
Number Name Date Kind
3612050 Sheridan Oct 1971 A
3666808 Meek May 1972 A
4160450 Doherty Jul 1979 A
4249541 Pratt Feb 1981 A
4356828 Jamshidi Nov 1982 A
4467816 Schluter et al. Aug 1984 A
4655226 Lee Apr 1987 A
4819637 Dormandy, Jr. et al. Apr 1989 A
4838280 Haaga Jun 1989 A
4857057 Sanagi Aug 1989 A
4861341 Woodburn Aug 1989 A
4893635 de Groot et al. Jan 1990 A
4903523 Flynn Feb 1990 A
4966162 Wang Oct 1990 A
4995866 Amplatz et al. Feb 1991 A
5054310 Flynn Oct 1991 A
5057085 Kopans Oct 1991 A
5111829 Alvarez de Toledo May 1992 A
5131393 Ishiguro et al. Jul 1992 A
5215528 Purdy et al. Jun 1993 A
5257628 Ishiguro et al. Nov 1993 A
5266359 Spielvogel Nov 1993 A
5277199 DuBois et al. Jan 1994 A
5281408 Unger Jan 1994 A
5300045 Plassche, Jr. Apr 1994 A
5333613 Tickner et al. Aug 1994 A
5368036 Tanaka et al. Nov 1994 A
5376075 Haughton Dec 1994 A
5380292 Wilson Jan 1995 A
5419310 Frassica et al. May 1995 A
5458112 Weaver Oct 1995 A
5470308 Edwards et al. Nov 1995 A
5471988 Fujio et al. Dec 1995 A
5480389 McWha et al. Jan 1996 A
5490521 Davis et al. Feb 1996 A
5526822 Burbank et al. Jun 1996 A
5595724 Deutsch et al. Jan 1997 A
5601588 Tonomura et al. Feb 1997 A
5607389 Edwards et al. Mar 1997 A
5609850 Deutsch et al. Mar 1997 A
5636255 Ellis Jun 1997 A
5681348 Sato Oct 1997 A
5688490 Tournier et al. Nov 1997 A
5695491 Silverstein Dec 1997 A
5775333 Burbank et al. Jul 1998 A
5800445 Ratcliff et al. Sep 1998 A
5810806 Ritchart et al. Sep 1998 A
5820609 Saito Oct 1998 A
5848978 Cecchi Dec 1998 A
5888201 Stinson et al. Mar 1999 A
5902310 Foerster et al. May 1999 A
5919172 Golba, Jr. Jul 1999 A
5921933 Sarkis et al. Jul 1999 A
5928164 Burbank et al. Jul 1999 A
5938635 Khule Aug 1999 A
5941890 Voegele et al. Aug 1999 A
5944673 Gregoire et al. Aug 1999 A
5947964 Eggers et al. Sep 1999 A
5964740 Ouchi Oct 1999 A
5967988 Briscoe et al. Oct 1999 A
5968022 Saito Oct 1999 A
5980469 Burbank et al. Nov 1999 A
6019733 Farasconi Feb 2000 A
6045497 Schweich, Jr. et al. Apr 2000 A
6077248 Zumschlinge Jun 2000 A
6080115 Rubinstein Jun 2000 A
6106473 Violante et al. Aug 2000 A
6106524 Eggers et al. Aug 2000 A
6117108 Woehr et al. Sep 2000 A
6126633 Kaji et al. Oct 2000 A
6133316 Ostensen et al. Oct 2000 A
6149598 Tanaka Nov 2000 A
6161034 Burbank et al. Dec 2000 A
6168779 Barsky et al. Jan 2001 B1
6171249 Chin et al. Jan 2001 B1
6174291 McMahon et al. Jan 2001 B1
6179809 Khairkhahan et al. Jan 2001 B1
6193692 Harris et al. Feb 2001 B1
6221622 Love Apr 2001 B1
6228039 Binmoeller May 2001 B1
6228049 Schroeder et al. May 2001 B1
6231515 Moore et al. May 2001 B1
6261302 Voegele et al. Jul 2001 B1
6273861 Bates et al. Aug 2001 B1
6280399 Rossin et al. Aug 2001 B1
6287304 Eggers et al. Sep 2001 B1
6312428 Eggers et al. Nov 2001 B1
6323335 Huang Nov 2001 B1
6328701 Terwilliger Dec 2001 B1
6333155 Lockhart et al. Dec 2001 B1
6334067 Brabrand Dec 2001 B1
6336812 Cooper et al. Jan 2002 B1
6337994 Stoianovici et al. Jan 2002 B1
6338968 Hefti Jan 2002 B1
6340563 Finkelstein et al. Jan 2002 B1
6340565 Oliner et al. Jan 2002 B1
6340568 Hefti Jan 2002 B2
6344316 Lockhart et al. Feb 2002 B1
6344317 Urnovitz Feb 2002 B2
6347240 Foley et al. Feb 2002 B1
6347241 Burbank et al. Feb 2002 B2
6350244 Fisher Feb 2002 B1
6350274 Li Feb 2002 B1
6350583 Cohen et al. Feb 2002 B1
6351660 Burke et al. Feb 2002 B1
6355033 Moorman et al. Mar 2002 B1
6355275 Klein Mar 2002 B1
6355424 Lorincz et al. Mar 2002 B1
6356782 Sirimanne et al. Mar 2002 B1
6361499 Bates et al. Mar 2002 B1
6361948 Tricoli et al. Mar 2002 B1
6364526 Ivan et al. Apr 2002 B2
6365362 Terstappen et al. Apr 2002 B1
6365712 Kelly Apr 2002 B1
6368280 Cermak et al. Apr 2002 B1
6368292 Ogden et al. Apr 2002 B1
6368792 Billing-Medel et al. Apr 2002 B1
6368795 Hefti Apr 2002 B1
6368799 Chee Apr 2002 B1
6369195 An et al. Apr 2002 B1
6371904 Sirimanne et al. Apr 2002 B1
6371917 Ferrara et al. Apr 2002 B1
6372431 Cunningham et al. Apr 2002 B1
6372444 Powers et al. Apr 2002 B1
6374135 Bucholz Apr 2002 B1
6375634 Carroll Apr 2002 B1
6375953 Srivastava et al. Apr 2002 B1
6376258 Hefti Apr 2002 B2
6379671 Colpitts Apr 2002 B1
6379672 Srivastava et al. Apr 2002 B1
6383484 Achen et al. May 2002 B1
6383491 Srivastava et al. May 2002 B1
6383492 Srivastava et al. May 2002 B1
6383493 Srivastava et al. May 2002 B1
6387056 Kieturakis May 2002 B1
6387374 Srivastava et al. May 2002 B1
6387629 Schneider et al. May 2002 B1
6391306 Srivastava et al. May 2002 B1
6391542 Anderson et al. May 2002 B1
6391543 Billing-Medel et al. May 2002 B2
6394965 Klein May 2002 B1
6395480 Hefti May 2002 B1
6398737 Moore et al. Jun 2002 B2
6399069 Srivastava et al. Jun 2002 B1
6399070 Srivastava et al. Jun 2002 B1
6399371 Falduto et al. Jun 2002 B1
6402701 Kaplan et al. Jun 2002 B1
6403095 Srivastava et al. Jun 2002 B1
6405733 Fogarty et al. Jun 2002 B1
6407125 Fernandez-Pol Jun 2002 B1
6409664 Kattan et al. Jun 2002 B1
6410028 Srivastava Jun 2002 B1
6410229 Lockhart et al. Jun 2002 B1
6413751 Benkovic et al. Jul 2002 B1
6416484 Miller et al. Jul 2002 B1
6421559 Pearlman Jul 2002 B1
6423081 Lee et al. Jul 2002 B1
6423313 Esmon et al. Jul 2002 B1
6423489 Anderson et al. Jul 2002 B1
6423494 Jin et al. Jul 2002 B1
6423503 Mikolajczyk et al. Jul 2002 B1
6426195 Zhong et al. Jul 2002 B1
6426367 Das Jul 2002 B1
6427081 Burbank et al. Jul 2002 B1
6427089 Knowlton Jul 2002 B1
6428463 Ravins et al. Aug 2002 B1
6428479 Aksnes et al. Aug 2002 B1
6428487 Burdorff et al. Aug 2002 B1
6432035 Ravins et al. Aug 2002 B1
6432053 Fecht et al. Aug 2002 B1
6432065 Burdorff et al. Aug 2002 B1
6432700 Henderson et al. Aug 2002 B1
6434415 Foley et al. Aug 2002 B1
6436054 Viola et al. Aug 2002 B1
6436120 Meglin Aug 2002 B1
6436394 Henderson et al. Aug 2002 B1
6436404 Srivastava et al. Aug 2002 B1
6436411 Riordan et al. Aug 2002 B1
6440086 Hohenberg Aug 2002 B1
6440147 Lee et al. Aug 2002 B1
6440151 Cragg et al. Aug 2002 B1
6440153 Cragg et al. Aug 2002 B2
6443960 Brabrand et al. Sep 2002 B1
6445767 Karellas Sep 2002 B1
6447477 Burney et al. Sep 2002 B2
6447534 Cragg et al. Sep 2002 B2
6447780 Srivastava et al. Sep 2002 B1
6447781 Srivastava Sep 2002 B1
6447997 Los et al. Sep 2002 B1
6448020 Toftgard et al. Sep 2002 B1
6450973 Murphy Sep 2002 B1
6455027 Barsky et al. Sep 2002 B1
6455048 Srivastava et al. Sep 2002 B1
6455251 Waldman Sep 2002 B1
6459925 Nields et al. Oct 2002 B1
6461615 Srivastava Oct 2002 B1
6463319 Bucholz Oct 2002 B1
6464648 Nakamura Oct 2002 B1
6465181 Billing-Medel et al. Oct 2002 B2
6465183 Wolber Oct 2002 B2
6468985 Huang Oct 2002 B1
6470217 Fenn et al. Oct 2002 B1
6471659 Eggers et al. Oct 2002 B2
6471678 Alvarez de Toledo Oct 2002 B1
6471700 Burbank et al. Oct 2002 B1
6471709 Fawzi et al. Oct 2002 B1
6472518 Ribot et al. Oct 2002 B1
6475732 Shayesteh et al. Nov 2002 B1
6475789 Cech et al. Nov 2002 B1
6477426 Fenn et al. Nov 2002 B1
6482182 Carroll et al. Nov 2002 B1
6482599 Mikolajczyk et al. Nov 2002 B1
6485308 Goldstein Nov 2002 B1
6485436 Truckai et al. Nov 2002 B1
6485905 Hefti Nov 2002 B2
6488636 Bryan et al. Dec 2002 B2
6489097 Hirose et al. Dec 2002 B2
6489113 Traish Dec 2002 B1
6490467 Bucholz et al. Dec 2002 B1
6491699 Henderson et al. Dec 2002 B1
6491702 Heilbrun et al. Dec 2002 B2
6492115 Guida et al. Dec 2002 B1
6494844 Van Bladel et al. Dec 2002 B1
6494859 Love et al. Dec 2002 B2
6494879 Lennox et al. Dec 2002 B2
6495130 Henderson et al. Dec 2002 B1
6496717 Cox et al. Dec 2002 B2
6497706 Burbank et al. Dec 2002 B1
6500622 Bruchez, Jr. et al. Dec 2002 B2
6500938 Au-Young et al. Dec 2002 B1
6505125 Ho Jan 2003 B1
6506156 Jones et al. Jan 2003 B1
6506607 Shyjan Jan 2003 B1
6507748 Selland Jan 2003 B2
6508755 Ravins et al. Jan 2003 B1
6508789 Sinnott et al. Jan 2003 B1
6509458 Afar et al. Jan 2003 B1
6509514 Kneteman et al. Jan 2003 B1
6514248 Eggers et al. Feb 2003 B1
6514251 Ni et al. Feb 2003 B1
6514685 Moro Feb 2003 B1
6514695 Barsky et al. Feb 2003 B1
6517498 Burbank et al. Feb 2003 B1
6521211 Unger et al. Feb 2003 B1
6524800 Lockhart et al. Feb 2003 B2
6527731 Weiss et al. Mar 2003 B2
6530888 Smith et al. Mar 2003 B2
6535756 Simon et al. Mar 2003 B1
6537761 Shayesteh et al. Mar 2003 B1
6538119 Billing-Medel et al. Mar 2003 B2
6540694 Van Bladel et al. Apr 2003 B1
6540695 Burbank et al. Apr 2003 B1
6544236 Cragg et al. Apr 2003 B1
6544544 Hunter et al. Apr 2003 B2
6546787 Schiller et al. Apr 2003 B1
6548257 Lockhart et al. Apr 2003 B2
6551255 Van Bladel et al. Apr 2003 B2
6551784 Fodor et al. Apr 2003 B2
6552164 Colpitts et al. Apr 2003 B1
6552181 Dean et al. Apr 2003 B1
6554779 Viola et al. Apr 2003 B2
6558407 Ivanko et al. May 2003 B1
6558916 Veerapandian et al. May 2003 B2
6562562 Casu' et al. May 2003 B2
6564087 Pitris et al. May 2003 B1
6564806 Fogarty et al. May 2003 B1
6566078 Raitano et al. May 2003 B1
6566079 Hefti May 2003 B2
6567214 Lorincz May 2003 B2
6567689 Burbank et al. May 2003 B2
6568941 Goldstein May 2003 B1
6572551 Smith et al. Jun 2003 B1
6572578 Blanchard Jun 2003 B1
6577904 Zhang et al. Jun 2003 B1
6579891 Fernandez-Pol Jun 2003 B1
6580938 Acker Jun 2003 B1
6582368 Holdaway et al. Jun 2003 B2
6582426 Moorman et al. Jun 2003 B2
6585968 Little et al. Jul 2003 B2
6586713 Essenfeld et al. Jul 2003 B2
6587578 Godik et al. Jul 2003 B2
6589240 Hinchliffe Jul 2003 B2
6592508 Ravins et al. Jul 2003 B1
6592530 Farhadi Jul 2003 B1
6599247 Stetten Jul 2003 B1
6602659 Waldman et al. Aug 2003 B1
6604404 Paltieli et al. Aug 2003 B2
6605294 Sawhney Aug 2003 B2
6607561 Brannon Aug 2003 B2
6608191 Anderson et al. Aug 2003 B1
6608310 Soluri et al. Aug 2003 B2
6610016 Violante et al. Aug 2003 B1
6610499 Fulwyler et al. Aug 2003 B1
6610839 Morin et al. Aug 2003 B1
6612991 Sauer et al. Sep 2003 B2
6613740 Gozes et al. Sep 2003 B1
6614921 Chung et al. Sep 2003 B1
6617110 Chech et al. Sep 2003 B1
6617137 Dean et al. Sep 2003 B2
6623437 Hinchliffe et al. Sep 2003 B2
6626832 Paltieli et al. Sep 2003 B1
6626848 Neuenfeldt Sep 2003 B2
6626850 Chau et al. Sep 2003 B1
6626903 McGuckin, Jr. et al. Sep 2003 B2
6626930 Allen et al. Sep 2003 B1
6627414 Billing-Medel et al. Sep 2003 B2
6627461 Chapman et al. Sep 2003 B2
6629959 Kuracina et al. Oct 2003 B2
6631204 Smith Oct 2003 B1
6632183 Bowman et al. Oct 2003 B2
6638234 Burbank et al. Oct 2003 B2
6638719 Gunderson et al. Oct 2003 B1
6638727 Hung et al. Oct 2003 B1
6645731 Terstappen et al. Nov 2003 B2
6647285 Da Silva et al. Nov 2003 B2
6649420 Cantor Nov 2003 B1
6652520 Moorman et al. Nov 2003 B2
6652859 Afar et al. Nov 2003 B1
6653080 Bruchez et al. Nov 2003 B2
6653129 Bander et al. Nov 2003 B1
6654120 Ban Nov 2003 B2
6654629 Montegrande Nov 2003 B2
6656132 Ouchi Dec 2003 B1
6659105 Burbank et al. Dec 2003 B2
6660834 Billing-Medel et al. Dec 2003 B2
6662041 Burbank et al. Dec 2003 B2
6663560 MacAulay et al. Dec 2003 B2
6666811 Good Dec 2003 B1
6670122 Rosenow et al. Dec 2003 B2
6673023 Pflueger Jan 2004 B2
6673914 Hoon Jan 2004 B1
6675037 Tsekos Jan 2004 B1
6676610 Morton et al. Jan 2004 B2
6676658 Burbank et al. Jan 2004 B2
6676935 Henderson et al. Jan 2004 B2
6676984 Sharp et al. Jan 2004 B1
6677157 Cohen Jan 2004 B1
6678545 Bucholz Jan 2004 B2
6678552 Pearlman Jan 2004 B2
6679851 Burbank et al. Jan 2004 B2
6680178 Harris et al. Jan 2004 B2
6689062 Mesallum Feb 2004 B1
6689065 Aksnes et al. Feb 2004 B2
6689067 Sauer et al. Feb 2004 B2
6689071 Burbank et al. Feb 2004 B2
6689072 Kaplan et al. Feb 2004 B2
6689073 Quay Feb 2004 B2
6689744 Gao et al. Feb 2004 B2
6689787 McKeam et al. Feb 2004 B1
6690371 Okerlund et al. Feb 2004 B1
6690966 Rava et al. Feb 2004 B1
6690976 Fenn et al. Feb 2004 B2
6692467 McFarlane Feb 2004 B2
6692724 Yang et al. Feb 2004 B1
6692736 Yu et al. Feb 2004 B2
6695779 Sauer et al. Feb 2004 B2
6697665 Rava et al. Feb 2004 B1
6699205 Fulton, III et al. Mar 2004 B2
6702749 Paladini et al. Mar 2004 B2
6702761 Damadian et al. Mar 2004 B1
6702831 Lee et al. Mar 2004 B2
6703216 Parsons et al. Mar 2004 B2
6705994 Vortman et al. Mar 2004 B2
6709408 Fisher Mar 2004 B2
6709816 Huang et al. Mar 2004 B1
6712773 Viola Mar 2004 B1
6712785 Morton et al. Mar 2004 B2
6714808 Klimberg et al. Mar 2004 B2
6716179 Burbank et al. Apr 2004 B2
6722371 Fogarty et al. Apr 2004 B1
6723052 Mills Apr 2004 B2
6723106 Charles et al. Apr 2004 B1
6723498 Shyjan et al. Apr 2004 B1
6725080 Melkent et al. Apr 2004 B2
6725083 Burbank et al. Apr 2004 B1
6725095 Fenn et al. Apr 2004 B2
6726651 Robinson et al. Apr 2004 B1
6728334 Zhao Apr 2004 B1
6730042 Fulton et al. May 2004 B2
6730045 Finer May 2004 B2
6731966 Spigelman et al. May 2004 B1
6733969 Mack May 2004 B2
6738663 Schroeppel et al. May 2004 B2
6746844 Oliner et al. Jun 2004 B2
6750015 Horwitz et al. Jun 2004 B2
6752154 Fogarty et al. Jun 2004 B2
6752767 Turovskiy et al. Jun 2004 B2
6752768 Burdorff et al. Jun 2004 B2
6752769 Alberico Jun 2004 B2
6753138 Schneider et al. Jun 2004 B1
6758848 Burbank et al. Jul 2004 B2
6764449 Lee et al. Jul 2004 B2
6764495 Lee et al. Jul 2004 B2
6766186 Hoyns et al. Jul 2004 B1
6767704 Waldman et al. Jul 2004 B2
6768925 Fenn et al. Jul 2004 B2
6770066 Weaver et al. Aug 2004 B1
6770070 Balbierz Aug 2004 B1
6770435 Billing-Medel et al. Aug 2004 B1
6770770 Baumann et al. Aug 2004 B1
6773903 Bova Aug 2004 B2
6776757 Larson et al. Aug 2004 B2
6780984 Wang et al. Aug 2004 B2
6785410 Vining et al. Aug 2004 B2
6786870 Miyaki et al. Sep 2004 B2
6788977 Fenn et al. Sep 2004 B2
6790185 Fisher et al. Sep 2004 B1
6797477 Guida et al. Sep 2004 B2
6805669 Swanbom Oct 2004 B2
6805869 Guo Oct 2004 B2
6806712 Akgun Oct 2004 B2
6807444 Tu et al. Oct 2004 B2
6808878 Gray et al. Oct 2004 B1
6818184 Fulwyler et al. Nov 2004 B2
6818750 Reed Nov 2004 B2
6819785 Vining et al. Nov 2004 B1
6821725 Carrasco et al. Nov 2004 B1
6824780 Devaux et al. Nov 2004 B1
6824974 Pisharody et al. Nov 2004 B2
6824995 Wu Nov 2004 B1
6827692 Castellacci Dec 2004 B2
6831059 Donovan Dec 2004 B2
6832111 Tu et al. Dec 2004 B2
6833373 McKeam et al. Dec 2004 B1
6833438 Afar et al. Dec 2004 B1
6835183 Lennox et al. Dec 2004 B2
6835572 Mountford et al. Dec 2004 B1
6838243 Lai et al. Jan 2005 B2
6840952 Saker et al. Jan 2005 B2
6841350 Ogden et al. Jan 2005 B2
6843980 Green Jan 2005 B2
6844153 Waldman et al. Jan 2005 B2
6846320 Ashby et al. Jan 2005 B2
6846650 Recipon et al. Jan 2005 B2
6846911 Kelly Jan 2005 B2
6847841 El Hatw Jan 2005 B1
6849080 Lee et al. Feb 2005 B2
6850588 Arenson et al. Feb 2005 B2
6852528 Yu et al. Feb 2005 B2
6855517 Salceda et al. Feb 2005 B2
6855554 Fritsche et al. Feb 2005 B2
6858412 Willis et al. Feb 2005 B2
6858598 McKeam et al. Feb 2005 B1
6858711 McGall et al. Feb 2005 B2
6859049 Khatchatrian et al. Feb 2005 B2
6860855 Shelby et al. Mar 2005 B2
6860860 Viola Mar 2005 B2
6863676 Lee et al. Mar 2005 B2
6864224 Sedivy et al. Mar 2005 B1
6866630 Larson et al. Mar 2005 B2
6866993 Williamson Mar 2005 B1
6866994 Morton Mar 2005 B2
6867016 Billing-Medel et al. Mar 2005 B1
6867753 Chinthammit et al. Mar 2005 B2
6871086 Nevo et al. Mar 2005 B2
6872184 Brannon Mar 2005 B2
6872185 Fisher Mar 2005 B2
6872389 Fads Mar 2005 B1
6875182 Wardie et al. Apr 2005 B2
6875184 Morton et al. Apr 2005 B2
6883194 Corbeil et al. Apr 2005 B2
6883958 Mayer Apr 2005 B2
6884578 Warington et al. Apr 2005 B2
6884605 Hermonat et al. Apr 2005 B2
6887210 Quay May 2005 B2
6888919 Graf May 2005 B2
6890308 Islam May 2005 B2
6890309 Fisher May 2005 B2
6890311 Love et al. May 2005 B2
6890749 Billing-Medel et al. May 2005 B2
6893818 Afar et al. May 2005 B1
6893868 Packard et al. May 2005 B2
6894026 Quay May 2005 B1
6899696 Morton et al. May 2005 B2
6900015 Avihingsanon et al. May 2005 B2
6900049 Yu et al. May 2005 B2
6901278 Notelovitz May 2005 B1
6904305 Tsekos Jun 2005 B2
6904309 Derendorf et al. Jun 2005 B2
6905475 Hauschild et al. Jun 2005 B2
6908440 Fisher Jun 2005 B2
6913882 Glynne et al. Jul 2005 B2
6914130 Gao et al. Jul 2005 B2
6916800 McKearn et al. Jul 2005 B2
6916918 Yu et al. Jul 2005 B2
6918881 Miller et al. Jul 2005 B2
6919176 Yang et al. Jul 2005 B2
6920347 Simon et al. Jul 2005 B2
RE38776 Bauer Aug 2005 E
6923809 Eggers et al. Aug 2005 B2
6924094 Gingeras et al. Aug 2005 B1
6925389 Hitt et al. Aug 2005 B2
6926893 Hansen Aug 2005 B1
6927032 Lockhart et al. Aug 2005 B2
6933105 Jin Aug 2005 B2
6936014 Vetter et al. Aug 2005 B2
6936416 Zhu et al. Aug 2005 B2
6936687 Komoriya et al. Aug 2005 B1
6942985 Waldman Sep 2005 B2
6943236 Xu et al. Sep 2005 B2
6944505 Zhang et al. Sep 2005 B2
6945942 Van Bladel et al. Sep 2005 B2
6947584 Avila et al. Sep 2005 B1
6949357 Billing-Medel et al. Sep 2005 B2
6953691 Reed et al. Oct 2005 B2
6954667 Treado et al. Oct 2005 B2
6955653 Eggers Oct 2005 B2
6965793 Treado et al. Nov 2005 B2
6994712 Fisher et al. Feb 2006 B1
D518175 Hardin, Jr. et al. Mar 2006 S
7014610 Koulik Mar 2006 B2
7025765 Balbierz et al. Apr 2006 B2
7067111 Yang et al. Jun 2006 B1
7067274 Fairbrother et al. Jun 2006 B2
7070816 Newmark et al. Jul 2006 B2
7072704 Bucholz Jul 2006 B2
7074600 Dean et al. Jul 2006 B2
7077842 Cosman Jul 2006 B1
7079132 Sauer et al. Jul 2006 B2
7081340 Baker et al. Jul 2006 B2
7083547 LaStayo et al. Aug 2006 B2
7083985 Hefti et al. Aug 2006 B2
7087393 Billing-Medel et al. Aug 2006 B2
7089121 Wang Aug 2006 B1
7090845 Fong et al. Aug 2006 B2
7090862 Barrett-Reis et al. Aug 2006 B2
7091047 Serrero Aug 2006 B2
7094233 Desinger Aug 2006 B2
7101663 Godfrey et al. Sep 2006 B2
7101862 Cochrum et al. Sep 2006 B2
7108969 Warrangton et al. Sep 2006 B1
7115368 Powers et al. Oct 2006 B2
7118876 Tyner et al. Oct 2006 B2
7118910 Unger et al. Oct 2006 B2
7122011 Clifford et al. Oct 2006 B2
7122653 Cohen et al. Oct 2006 B2
7125836 Woodward Oct 2006 B2
7125969 Benz et al. Oct 2006 B1
7128877 Quay et al. Oct 2006 B2
7128893 Leamon et al. Oct 2006 B2
7129048 Bruchez et al. Oct 2006 B2
7131951 Angel Nov 2006 B2
7135333 Waldman et al. Nov 2006 B1
7139601 Bucholz et al. Nov 2006 B2
7141019 Pearlman Nov 2006 B2
7144950 Bazan et al. Dec 2006 B2
7153700 Pardee et al. Dec 2006 B1
7156814 Williamson, IV et al. Jan 2007 B1
7156815 Leigh et al. Jan 2007 B2
7160292 Moorman et al. Jan 2007 B2
7161057 Kneteman et al. Jan 2007 B2
7169114 Krause Jan 2007 B2
7172558 Olson, Jr. Feb 2007 B2
7172739 Maughan Feb 2007 B2
7175839 Hiserodt Feb 2007 B1
7183251 Russo et al. Feb 2007 B1
D538933 Andrade Mar 2007 S
7186522 Lapen et al. Mar 2007 B2
7189206 Quick et al. Mar 2007 B2
7189207 Viola Mar 2007 B2
7190378 Sauer et al. Mar 2007 B2
7192570 Maecke et al. Mar 2007 B2
7195774 Carvalho et al. Mar 2007 B2
7195868 Iartchouk et al. Mar 2007 B2
7195911 Cech et al. Mar 2007 B2
7196182 Reed et al. Mar 2007 B2
7198896 Rush et al. Apr 2007 B2
7199234 Morin et al. Apr 2007 B2
7204988 Cheung Apr 2007 B2
7207985 Duong et al. Apr 2007 B2
7208146 Denney, Jr. Apr 2007 B2
7208267 Salceda et al. Apr 2007 B2
7211398 Astle et al. May 2007 B2
7214489 Bazan et al. May 2007 B2
7217276 Henderson et al. May 2007 B2
7217394 Studer May 2007 B2
7218959 Alfano et al. May 2007 B2
7220258 Myhr May 2007 B2
7220891 Barsky et al. May 2007 B2
7223238 Swanbom May 2007 B2
7223380 Yang et al. May 2007 B2
7223540 Pourmand et al. May 2007 B2
7223542 Raitano et al. May 2007 B2
7226731 Chuaqui et al. Jun 2007 B1
7227009 Craik et al. Jun 2007 B2
7229413 Violante et al. Jun 2007 B2
7229417 Foerster et al. Jun 2007 B2
7229439 Burbank et al. Jun 2007 B2
7229604 Yang et al. Jun 2007 B2
7229774 Chinnaiyan et al. Jun 2007 B2
7231015 Kumakhov Jun 2007 B2
7235047 MacAulay et al. Jun 2007 B2
7236816 Kumar et al. Jun 2007 B2
7241736 Hunter et al. Jul 2007 B2
7244619 Contreras et al. Jul 2007 B2
7245748 Degani et al. Jul 2007 B2
7245958 Navab et al. Jul 2007 B1
7247426 Yakhini et al. Jul 2007 B2
7250180 Arellano Jul 2007 B2
7250264 Fong et al. Jul 2007 B2
7250551 Tsai et al. Jul 2007 B2
7251352 Sauer et al. Jul 2007 B2
7251568 Pittman et al. Jul 2007 B2
7252935 Sidransky Aug 2007 B2
7252946 Szasz Aug 2007 B2
7252948 Gingeras et al. Aug 2007 B2
7258973 Astle et al. Aug 2007 B2
7261712 Burbank et al. Aug 2007 B2
7261875 Li et al. Aug 2007 B2
7262288 Cech et al. Aug 2007 B1
7264947 Gozes et al. Sep 2007 B2
7270956 Bazan et al. Sep 2007 B2
7271187 Neuberger et al. Sep 2007 B2
7274810 Reeves et al. Sep 2007 B2
7314481 Karpiel Jan 2008 B2
7608056 Kennedy, II Oct 2009 B2
8109953 King, III et al. Feb 2012 B1
D657461 Schembre et al. Apr 2012 S
8162958 Takahashi et al. Apr 2012 B2
8187203 McClellan May 2012 B2
8262680 Swain et al. Sep 2012 B2
8328772 Kinast et al. Dec 2012 B2
8357193 Phan et al. Jan 2013 B2
8361041 Fang et al. Jan 2013 B2
8454632 Binmoeller et al. Jun 2013 B2
8486010 Nomura Jul 2013 B2
D690009 Schembre et al. Sep 2013 S
8968210 Mugan et al. Mar 2015 B2
9186128 Mugan et al. Nov 2015 B2
20010007925 Ritchart et al. Jul 2001 A1
20010023322 Espositio et al. Sep 2001 A1
20010047183 Privitera et al. Nov 2001 A1
20010056218 Hogendijk et al. Dec 2001 A1
20020035324 Sirimanne et al. Mar 2002 A1
20020082519 Miller et al. Jun 2002 A1
20020156395 Stephens et al. Oct 2002 A1
20020169418 Menzi et al. Nov 2002 A1
20030078502 Miyaki et al. Apr 2003 A1
20030093007 Wood May 2003 A1
20030105488 Chu Jun 2003 A1
20030139752 Pasricha et al. Jul 2003 A1
20030163142 Paltieli et al. Aug 2003 A1
20030181823 Gatto Sep 2003 A1
20030195436 Van Bladel et al. Oct 2003 A1
20030204137 Chesbrough et al. Oct 2003 A1
20030208134 Secrest et al. Nov 2003 A1
20030208219 Aznolan et al. Nov 2003 A1
20030212394 Pearson et al. Nov 2003 A1
20030233101 Lubock et al. Dec 2003 A1
20040073219 Skiba et al. Apr 2004 A1
20040077948 Violante et al. Apr 2004 A1
20040153005 Krueger Aug 2004 A1
20040167429 Roshdieh et al. Aug 2004 A1
20040236212 Jones et al. Nov 2004 A1
20040249395 Mikkaichi et al. Dec 2004 A1
20040260199 Hardia et al. Dec 2004 A1
20040260274 Hardin et al. Dec 2004 A1
20050021003 Caso et al. Jan 2005 A1
20050022493 Olinger et al. Feb 2005 A1
20050061697 Moberg Mar 2005 A1
20050113715 Schwindt et al. May 2005 A1
20050143753 Whitmore et al. Jun 2005 A1
20050159676 Taylor et al. Jul 2005 A1
20050192535 Takagi et al. Sep 2005 A1
20050197623 Leeflang et al. Sep 2005 A1
20050228311 Beckman et al. Oct 2005 A1
20050228312 Surti Oct 2005 A1
20050228413 Binmoeller et al. Oct 2005 A1
20050251111 Saito et al. Nov 2005 A1
20050256426 Brugge Nov 2005 A1
20050272975 McWeeney et al. Dec 2005 A1
20060052750 Lenker et al. Mar 2006 A1
20060100654 Fukuda et al. May 2006 A1
20060116605 Nakao Jun 2006 A1
20060142789 Lehman et al. Jun 2006 A1
20060155210 Beckman et al. Jul 2006 A1
20060167416 Mathis et al. Jul 2006 A1
20060189891 Waxman et al. Aug 2006 A1
20060235298 Kotmel et al. Oct 2006 A1
20060247530 Hardin et al. Nov 2006 A1
20060258955 Hoffman et al. Nov 2006 A1
20060264919 Schaaf Nov 2006 A1
20070023304 Joyce et al. Feb 2007 A1
20070032741 Hibner et al. Feb 2007 A1
20070038089 Hatano et al. Feb 2007 A1
20070055173 DeLonzor et al. Mar 2007 A1
20070056360 Grant et al. Mar 2007 A1
20070060837 Cho et al. Mar 2007 A1
20070118049 Viola May 2007 A1
20070123799 Meireles May 2007 A1
20070123800 Nishtala et al. May 2007 A1
20070149893 Heske et al. Jun 2007 A1
20070177009 Bayer et al. Aug 2007 A1
20070179403 Heske et al. Aug 2007 A1
20070185411 Hibner Aug 2007 A1
20070213633 McClellan Sep 2007 A1
20070213634 Teague Sep 2007 A1
20070299306 Parasher et al. Dec 2007 A1
20080058637 Fischell et al. Mar 2008 A1
20080097344 McKinnon et al. Apr 2008 A1
20080146962 Ritchie et al. Jun 2008 A1
20080200912 Long Aug 2008 A1
20080294111 Tal et al. Nov 2008 A1
20080300462 Intoccia et al. Dec 2008 A1
20080319341 Taylor et al. Dec 2008 A1
20090054773 Shizuka Feb 2009 A1
20090069679 Hibi Mar 2009 A1
20090099414 Goto et al. Apr 2009 A1
20090177114 Chin et al. Jul 2009 A1
20090182200 Golden et al. Jul 2009 A1
20090264794 Kodama Oct 2009 A1
20090312645 Weitzner et al. Dec 2009 A1
20100010453 Riemelmoser Jan 2010 A1
20100081965 Mugan et al. Apr 2010 A1
20100121218 Mugan et al. May 2010 A1
20100274085 Mugan et al. Oct 2010 A1
20110054381 Van Dam et al. Mar 2011 A1
20110071350 Van Dam et al. Mar 2011 A1
20110137394 Lunsford et al. Jun 2011 A1
20110152886 Sato et al. Jun 2011 A1
20120029278 Sato et al. Feb 2012 A1
20120116248 McWeeney et al. May 2012 A1
20120136426 Phan et al. May 2012 A1
20120157880 Haselby et al. Jun 2012 A1
20120245486 Melchiorri et al. Sep 2012 A1
20120253228 Schembre et al. Oct 2012 A1
20120296257 Van Dam et al. Nov 2012 A1
20130041286 Theobald et al. Feb 2013 A1
20130110141 Chmura May 2013 A1
20130131547 Hardert et al. May 2013 A1
20130131548 McGhie et al. May 2013 A1
20130253546 Sander et al. Sep 2013 A1
20130253550 Beisel et al. Sep 2013 A1
20130310833 Brown et al. Nov 2013 A1
20130325038 Sato Dec 2013 A1
20140005478 Kennedy, II et al. Jan 2014 A1
20140088684 Paskar Mar 2014 A1
Foreign Referenced Citations (20)
Number Date Country
0704189 Apr 1996 EP
0738501 Oct 1996 EP
0739640 Oct 1996 EP
1870051 Dec 2007 EP
1870051 Dec 2007 EP
2030574 Mar 2009 EP
2030574 Apr 2009 EP
06189965 Jul 1994 JP
7116169 May 1995 JP
8-38482 Mar 1996 JP
9-135836 May 1997 JP
2005058431 Mar 2005 JP
9204062 Mar 1992 WO
2000033909 Jun 2000 WO
2000033909 Jun 2000 WO
2005060835 Jul 2005 WO
2005096953 Oct 2005 WO
2005096963 Oct 2005 WO
2012112202 Aug 2012 WO
2013074653 May 2013 WO
Non-Patent Literature Citations (17)
Entry
Patent Examination Report No. 1 for Patent Application No. 2012339659, dated Sep. 22, 2016, from Australian Government IP Australia.
Notice of Allowance for JP 2014-542405 dated Oct. 6, 2016 from the Japanese Patent Office.
Creganna Needle Brochure, published Jan. 16, 2008.
Iglesias-Garcia, 2011, Feasibility and Yield of a New EUS Histology Needle: Results From a Multicenter, Pooled, Cohort Study, Gastrointestinal Endoscopy 73(6); 1189-1196.
Iwashita, 2013, High Single-Pass Diagnostic Yield of a new 25-Gauge Core Biopsy Needle for EUS-Guided FNa biopsy in Solid Pancreatic Lesions, Gastrointestinal Endoscopy 77(6); 909-915.
Kahaleh, 2013, Endoscopic Ultrasonography guided biliary drainage: Summary of consortium meeting, May 7, 2011 Chicago, World Journal of Gastroenterology, 19(9); 1372-1379.
Khashab, 2013, EUS-Guided biliary Drainage by Using a standardized approach for Malignant Biliary Obstruction: Rendezvous Versus Direct Transluminal techniques, Gastrointestinal Endoscopy; 1-8.
Park, 2011, EUS-guided Biliary Drainage with Transluminal stenting after Failed ERCP: predictors of Adverse Events and Long-Term Results, Gastrointestinal Endoscopy 74(6); 1276-1284.
Park, 2013, Prospective Evaluation of a Treatment Algorithm With Enhanced Guidewire Manipulation Protocol for EUS-Guided Biliary Drainage After failed ERCP, Gastrointestinal Endoscopy 78(1); 92-101.
Pelaez-Luna, 2008, Interventional EUS Guided Cholangiography. First Description in Mexico of a Novel, Secure and Feasible Technique. A Case Report, Caso Clinico.
Patent Examination Report No. 1 from the Australian Patent Office for Patent Application No. 2015207938 dated Jul. 9, 2016.
Canadian Office Action for App. No. 2,744,612 from the Canadian Intellectual Property Office dated Oct. 27, 2016.
Notice of Reasons for Rejection for JP App. No. 2014-236354 dated Dec. 9, 2015.
Examination report from Canadian Intellectual Property Office for App. No. 2,899,073 dated May 6, 2016.
Notice of Reasons for Rejection, dated Jun. 17, 2016, for Japanese Patent Application No. 2014-542405, from Japanese Patent Office.
Examiner's Report for Canadian Application No. 2,995,281 dated Oct. 19, 2018.
Examination Report for Canadian App. No. 2,856,060 dated Aug. 15, 2019 from the Canadian Intellectual Property Office.
Related Publications (1)
Number Date Country
20160206294 A1 Jul 2016 US
Provisional Applications (4)
Number Date Country
61305304 Feb 2010 US
61305396 Feb 2010 US
61117966 Nov 2008 US
61152741 Feb 2009 US
Continuations (1)
Number Date Country
Parent 13297766 Nov 2011 US
Child 15084851 US
Continuation in Parts (3)
Number Date Country
Parent 13029593 Feb 2011 US
Child 13297766 US
Parent 12607636 Oct 2009 US
Child 13029593 US
Parent 12243367 Oct 2008 US
Child 12607636 US