Device for needle biopsy with integrated needle protection

DEVICE FOR NEEDLE BIOPSY

1ÙUL

SGRATED NEEDLE PROTECTION

This application is a division of Canadian Serial No. 2,744,612, filed November 24, 2009.

BACKGROUND

1. Background of Invention

Endoscopic ultrasound procedures 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 a patient's gastrointestinal tract to determine the location of individual mucosal and sub-mucosal layers. Once identified, appropriate therapeutic modes of treatment for malignancies and various abnormalities may be determined by a clinician.

An endoscopic ultrasound procedure may consist of several steps. For example, a clinician may sedate a patient and insert a probe via esophagogastroduodenoscopy into the patient's stomach and duodenum. An endoscope may then be passed through the patient’s mouth and advanced to the level of the duodenum. From various positions between the esophagus and duodenum, organs or masses outside the gastrointestinal tract may be imaged to determine abnormalities. If any abnormalities are present, toe organs or masses can be biopsied through fine needle aspiration. Organs such as the liver, pancreas and adrenal glands arc easily biopsied as are any abnormal lymph nodes. A patient’s gastrointestinal wall can also be imaged to determine toe presence of any abnormalities. For example, abnormal thickness within a patient’s gastrointestinal wall may be suggestive of inflammation or malignancy.

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The quality of images produced via endoscopic ultrasounds is directly proportional to the level of frequency used. Although a high frequency ultrasound can produce a higher image quality, high frequency ultrasounds do not penetrate organ walls as well as lower frequency ultrasound. As a resuh, the examination of the nearby organs is not possible.

Mediastinoscopy is a prevailing method for determining the presence of nodal metastases in the mediastinum. Generally performed as an outpatient surgical procedure, mediastinoscopy is associated with a low rate of serious adverse effects and is considered to be highly accurate. Endobronchial ultrasound guided fine needle aspiration biopsy of mediastinal nodes offers a less invasive alternative for histologic sampling of the mediastinal nodes. Endobronchial ultrasound has been widely adopted by pulmonologists and is poised to replace mediastinoscopy in the future. For thoracic surgeons, endobronchial ultrasound can be easily learned and it may be important to do so if their specialty is to maintain the traditional and important role in the diagnosis and staging of thoracic malignancies.

During endobronchial ultrasound, a clinician can perform needle aspiration on lymph nodes using a bronchoscope inserted through the mouth. For an endobronchial ultrasound procedure, an endoscope fitted with an ultrasound processor and a fine-gauge aspiration needle is guided through a patient’s trachea. Once appropriately positioned, the needle portion of the fine needle aspiration device is advanced into the lymph node, the sample aspirated, and device is removed from the bronchoscope.

Endoscopic ultrasounds and endoscopic bronchial ultrasounds through fine needle aspiration are presently standard inodes of 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 fine needle aspiration device that is attached to the luer port or working channel of a typical echo

CA 2995281 2018-02-14 endoscope. Traditional devices utilize a series of push and pull bandies to control the axial movement of the catheter shaft of the device and the depth of needle penetration. These device, however, suffer from several drawbacks.

For example, the means of attaching a device to an echo-endoscope is cumbersome. Devices presently utilize male fitting adapters that must be screwed onto a female luer port of an endoscope. In addition, these devices provide sub-optimal ergonomics of use. More specifically, a clinician must actuate a number of handles independently and lock respective bandies in position via cap screw arrangement to secure the device. The cumulative actions required by a clinician result in significantly drawn out procedures. Further, needles commonly kink or deform during removal from a device causing numerous delays and failures. Moreover, multiple passes per procedure arc required, which prolong the procedure and result in a clinician needing to reconfirm the location of a needle relative to a desired aspiration site with each new pass.

Another drawback involving a typical echoendoscope concerns the lack of needle safe preventative design features which protect the clinician from inadvertent needle penetration and the transfer of blood-bome pathogens from a patient to attending medical staff. In the case of currently available fine needle aspiration medical devices for both endoscopic ultrasound and endo-bronchial ultrasound, once a sample has been aspirated from the desired anatomical location, the fine needle aspiration catheter is removed from the echoendoscope and handed to die clinician for sample extraction and preparation. The clinician is instructed to “re-sheath” the needle (i.e. retract the needle into the catheter sheath) prior to detachment from the echo-endoscope. However, in many instances, this does not occur. As such, die needle sharp of the device is exposed during removal and transfer of the fine needle aspiration device among medical staff in the endoscopic ultrasound and endo-bronchial ultrasound suite with increased risk of “needle sticking” and blood borne pathogen contamination and exposure to same.

Additionally, needles are commonly used in medical procedures, with biopsy being a primary field of use for such devices. In the case of Endoscopic Ultrasound (EUS) and Endo-bronchial Ultrasound (EBUS), the efficiency of the ultrasonic procedure

CA 2995281 2018-02-14 relies on the ability to direct the needle component to the desired site of sample acquisition. Smooth cylindrical surfaces of needles are unfortunately very difficult to image using ultrasonography due to the specular (mirror-like) surface finish of the needle in the untreated state. To address this problem, various techniques have been developed to enhance the echogenicty or ultrasonic visibility of needles. Various techniques (sandblasting, surface etching and coating of surfaces) have been used to “roughen the surfàce of a needle component with limited success. This surface roughening results in a scattering of rays from the ultrasound. However, some of the drawbacks of the aforementioned techniques concern the angle of incidence (sound waves from the ultrasonic transducer) and the angle of reflection (sound waves reflected back to the transducer array). It is important that the method and design of surface finish and surface deformation imparted to the needle of the biopsy device maximize the percentage of waves reflective which can be picked up by the ultrasonic array.

Therefore, a need exists for improved devices for use in endoscopic ultrasound procedures.

SUMMARY

According to an aspect of the present disclosure, a device for needle biopsy is presented. The needle biopsy device is comprised of a handle member, a proximal handle member, a distal handle member, a sheath lumen, a needle housing member, a needle, a stylet, and ergonomic design features, including a conical grip, to enhance the maneuverability and operation of the device.

According to another aspect of the present disclosure, a device for needle biopsy is presented. The needle biopsy device is comprised of a handle member, a proximal handle member, a distal handle member, a sheath lumen, a needle housing member, a needle, a needle protection adaptor, and a needle protection member.

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In one embodiment, the present invention provides a device for needle biopsy, comprising: a handle member having proximal and distal portions; a proximal handle member disposed to the proximal portion of the handle member; a distal handle member disposed to the distal portion of the handle member, a sheath lumen disposed within the handle member and extending from the distal portion of the handle member; a needle housing member partially disposed within the proximal handle member, including a needle disposed within the sheath lumen; a needle protection member partially disposed within the proximal handle member for receiving the needle, the needle protection member including a needle protection hub and a needle protection shaft; and an engageable member disposed within the proximal handle member for facilitating the engagement of the needle protection member within the proximal handle member. Upon retraction of the needle housing member from the device, at least one protrusion of the needle engages the needle protection hub and upon engagement of the needle protection hub, the needle protection hub disengages from the at least one engageable member as the needle is continually retracted and die needle protection shaft covers a distal portion of the needle.

According to another aspect of the present disclosure, a device for needle biopsy is presented. The needle biopsy device is comprised of a handle member, including an engageable member, a proximal handle member, a distal handle member, a sheath lumen, a needle housing member, a land ring, a strain relief member, a needle containing a

4a

CA 2995281 2019-02-28 plurality of protrusions disposed thereon, a needle protection member, a needle protection hub, and a needle protection shaft.

According to yet another aspect of the present disclosure, a device for needle biopsy is presented. The needle biopsy device is comprised of a handle member, a proximal handle member, a distal handle member, a sheath lumen, a needle housing member, and a needle including a plurality of depressions to enhance echogenicity and ultrasonic visibility.

According to yet another aspect of the present disclosure, a device for needle biopsy is presented. The needle biopsy device is comprised of a handle member, a proximal handle member, a distal handle member, a sheath lumen, a needle housing member, and, a needle including a plurality of protrusions disposed thereon and a joint permitting detachment of the distal portion of the needle.

According to another aspect of the present disclosure, a device for needle biopsy is presented. The needle biopsy device is comprised of a handle member, a proximal handle member that is configured for slideable engagement and includes at least one guide-rail along its longitudinal axis to engage at least one recessed groove to control slideable movement, a distal handle member that is configured for slideable engagement and includes at least one guide-rail along the longitudinal axis to engage at least one recessed groove to control slideable movement, a sheath lumen, a needle housing member, and a needle.

According to another aspect of the present disclosure, a device for needle biopsy is presented. The needle biopsy device is comprised of a handle member, a proximal handle member, a distal handle member, a sheath lumen, a needle housing member, a needle, and a needle lock member.

BRIEF DESCRIPTION OF THE DRAWINGS

The objecte and features of the present disclosure, which are believed to be novel, are set forth with particularity in the appended claims. The present disclosure, both as to its organization and manner of operation, together with further objectives and advantages,

CA 2995281 2018-02-14 may be best understood by reference to the following description, taken in connection with the accompanying drawings as set forth below:

Figure 1 is a cross-sectional view of an embodiment of a needle protection member, according to the present disclosure;

Figure 2 is a cross-sectional view of an embodiment of a needle protection member, according to the present disclosure;

Figure 3 is a cross-sectional view of another embodiment of a needle protection member, according to the present disclosure;

Figure 4 is a perspective view of an embodiment of a needle protection adapter, according to the present disclosure;

Figure 5 is a perspective view of an embodiment of a luer adapter, according to the present disclosure;

Figure 6 is a perspective view of an embodiment of a luer adapter, according to the present disclosure;

Figure 7 is a cross-sectional view of an embodiment of a needle protection member, according to the present disclosure;

Figure 8 is a cross-sectional view of an embodiment of a needle protection member, according to the present disclosure;

Figure 9 is a perspective view of an embodiment of a needle protection member, according to the present disclosure;

Figure 10 is a perspective view of an embodiment of a needle biopsy device, according to the present disclosure;

Figure 11 is a perspective view of an embodiment of a needle protection member, according to the present disclosure;

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Figure 12 is a perspective view of an embodiment of a needle protection member, according to the present disclosure;

Figure 13 is a perspective view of an embodiment of a needle protection member, according to the present disclosure;

Figure 14 is a perspective view of an embodiment of a needle protection member, according to the present disclosure;

Figure 15 is a perspective view of an embodiment of a needle protection member, according to the present disclosure;

Figure 16 is a perspective view of an embodiment of a needle protection member, according to the present disclosure;

Figure 17A is a perspective view of an embodiment of a needle lock member, according to the present disclosure;

Figure 17B is a perspective view of an embodiment of a needle lock member, according to the present disclosure;

Figure ISA is a perspective view of an embodiment of a needle protection member, according to the present disclosure;

Figure 18B is a perspective view of an embodiment of a needle protection member, according to the present disclosure;

Figure 19 is a perspective view of an embodiment of a needle biopsy device, according to the present disclosure;

Figure 20A is a perspective view of an embodiment of a needle, according to the present disclosure;

Figure 20B is a perspective view of an embodiment of a needle, according to the present disclosure;

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Figure 20C is a perspective view of an embodiment of a needle, according to the present disclosure;

Figure 20D is a perspective view of· an embodiment of a needle, according to the present disclosure;

Figure 20E is a perspective view of an embodiment of a needle, according to the present disclosure;

Figure 20F is a perspective view of an embodiment of a needle, according to the present disclosure;

Figure 20G is a perspective view of an embodiment of a needle, according to the present disclosure;

Figure 21 is a perspective view of an embodiment of a needle, according to the present disclosure;

Figure 22 is a perspective view of an embodiment of a needle, according to the present disclosure;

Figure 23 A is a perspective view of an embodiment of a needle, according to the present disclosure;

Figure 23B is a perspective view of an embodiment of a needle, according to the present disclosure;

Figure 23C is a perspective view of an embodiment of a needle, according to the present disclosure;

Figure 23D is a perspective view of an embodiment of a needle, according to the present disclosure;

Figure 23E is a perspective view of an embodiment of a needle, according to the present disclosure;

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Figure 24 is a flow diagram of ultra-sound waves, according to the present disclosure;

Figure 25 is a perspective view of an embodiment of a needle, according to the present disclosure;

Figure 26 is a perspective view of an embodiment of a needle, according to the present disclosure;

Figure 27 is a perspective view of an embodiment of a needle, according to the present disclosure;

Figure 28 is a perspective view of an embodiment of a needle biopsy device, according to the present disclosure;

Figure 29 is a perspective view of an embodiment of a needle biopsy device, according to the present disclosure;

Figure 30 is a perspective view of an embodiment of a needle biopsy device, according to the present disclosure;

Figure 31 is a perspective view of an embodiment of a needle biopsy device, according to the present disclosure;

Figure 32A is a perspective view of an embodiment of a needle biopsy device, according to the present disclosure;

Figure 32B is a perspective view of an embodiment of a needle biopsy device, according to the present disclosure;

Figure 32C is a perspective view of an embodiment of a needle biopsy device, according to the present disclosure;

Figure 32D is a perspective view of an embodiment of a needle biopsy device, according to the present disclosure;

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Figure 33 is a perspective view of an embodiment of a needle biopsy device, according to the present disclosure;

Figure 34 is a perspective view of an embodiment of a needle biopsy device, according to the present disclosure;

Figure 35 is a perspective view of an embodiment of a needle biopsy device, according to the present disclosure;

Figure 36 is a perspective view of an embodiment of a needle biopsy device, according to the present disclosure;

Figure 37 is a perspective view of an embodiment of a needle biopsy device, according to the present disclosure;

Figure 38A is a perspective view of an embodiment of a needle biopsy device, according to the present disclosure;

Figure 38B is a perspective view of an embodiment of a needle biopsy device, according to the present disclosure;

Figure 39A is a perspective view of an embodiment of a needle biopsy device, according to the present disclosure;

Figure 39B is a perspective view of an embodiment of a needle biopsy device, according to the present disclosure;

Figure 40 is a perspective view of an embodiment of a needle biopsy device, according to the present disclosure;

Figure 41 is a perspective view of an embodiment of a needle biopsy device, according to the present disclosure;

Figure 42 is a perspective view of an embodiment of a needle biopsy device, according to the present disclosure;

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Figure 43 is a perspective view of an embodiment of a needle biopsy device, according to the present disclosure;

Figure 44 is a perspective view of an embodiment of a needle biopsy device, according to the present disclosure; and

Figure 45 is a perspective view of an embodiment of a needle biopsy device, according to the present disclosure.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

The exemplary embodiments of the present disclosure are discussed in terms of needle biopsy devices for collecting tissue, fluid, and cell samples from a patient in conjunction with an endoscopic ultrasound or endoscopic bronchial ultrasound. It is contemplated that various embodiments of needle biopsy devices may include a modular design. For example, the needle biopsy device may include a needle housing member that detaches from the proximal handle member of the device for each individual pass or aspirated sample taken by a clinician at the site of lesion or abnormality. In addition, potential design embodiments are disclosed herewith that facilitate needle sharp safety and protection thereof, when combined with devices that incorporate an integrated catheter drive, needle advancement, needle retraction mechanism, and needle in the same device.

It is envisioned that the present disclosure finds application to a wide variety of biopsy devices for the collection of samples from a patient. It is also envisioned that the present disclosure may be employed for collection of body fluids including those employed during procedures relating to phlebotomy, digestive, intestinal, urinary, and veterinary. It is contemplated that the present disclosure may be utilized with other needle biopsy applications including, but not limited to, fluid collection, catheters, catheter introducers, spinal and epidural biopsy, aphaeresis, and dialysis.

In the discussion that follows, the term “proximal” refers to a portion of a structure that is closer to a clinician, and the term “distal” refers to a portion that is further from the clinician. According to the present disclosure, the term “clinician” refers

CA 2995281 2018-02-14 to an individual performing sample collection, installing or removing a needle from a needle biopsy device, and may include support personnel. Reference will now be made in detail to exemplary embodiments of the disclosure, which are illustrated in the accompanying figures.

Referring now to Figures 1 and 2, cross-sectional views of embodiments of a needle protection member 100 utilized with a luer port 108 of an echo-endoscope 110 is presented. Needle protection member 100 is comprised of a needle protection shaft 102 and a needle protection hub 104. The length of needle protection shaft 102 may be, for example, between four (4) to twenty (20) centimeters in order to protect a clinician from inadvertent piercing by a needle 114. Needle protection hub 104 is located at the proximal portion of needle protection member 100. In an embodiment, needle protection hub 104 is comprised of at least one engagable member 116. At least one engagable member may be, for example, a flange.

Needle protection member 100 may be manufactured from a compressible material such as polyurethane, polyetheramide or copolymers thereof, silicone, neoprene rubber, polyvinylchloride or copolymers thereof, polyethylene or derivatives thereof or other commercially available, low durometer polymers materials. The material of manufacture shall provide a compressible fit between needle protection member 100 and luer port 108 at the proximal end of echo-endoscope 110.

Needle protection member 100 resides over a sheath lumen 106. Needle protection member 100 is free to move over sheath lumen 106 at the proximal end of echo-endoscope 110. In an embodiment, needle protection member 100 is secured in position against luer port 108 as a clinician attaches a needle biopsy device (not shown in Figure) to echo-endoscope ! 10 by means screwing the luer lock adaptor of the needle biopsy device (not shown in Figure) onto luer port 108. Needle protection member 100 is held in position once the luer lock adaptor of the needle biopsy device is tightened onto luer port 108.

Sheath lumen 106 may consist of a polymer extruded component that is rigid in nature. Sheath lumen 106 may be comprised of, for example, thermoplastic materials.

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The thermoplastic materials may be, but are not limited to, polyurethane, polyamide and derivatives thereof, ether block amide copolymers, polyimide, polyethylene and dérivâtes thereof, and polytetrafluoroethyelene. Sheath lumen 106 may also be comprised of a helically braided configuration of outer thermoplastic materials with a lubricious inner core.

Sheath lumen 106 incorporates at least one engagable member 112 that is complimentary to at least one engagable member 116 of needle protection member 100. Engagable member 112 represents a transition in the outer diameter of the distal portion of sheath lumen 106. The outer diameter of engagable member 112 may be, for example, of the order of0.002” to 0.050” in outer diameter as well as of the order of0.005” 0.020”.

In an embodiment of the present disclosure, a clinician may take measures to protect from inadvertent needle piercing by retracting sheath lumen 106 in a proximal direction. During the step of retraction, engagable member 112 communicates with engagable member 116. As engagable member 112 communicates with engagable member 116, needle protection member 100 disengages from luer port 108 and covers the distal portion of needle 114. Needle protection member 100 covers needle 114 even when needle 112 is at its maximum length of extension from the distal end of catheter sheath 106.

Referring to Figure 3, a cross-sectional view of another embodiment of needle protection member 100 is presented. Needle protection member 100 consists of a compressible and deformable element 104 at its proximal end to provide for compression when inserted inside a luer port of an echo-endoscope (not shown in Figure). Needle protection member 100 further includes a needle protection shaft 118 and a land insert 120.

Needle protection shaft 118 may be manufactured from a rigid polymer such as polyurethane, polyamide and derivatives thereof, ether block amide copolymers, polyimide, polyethylene and dérivâtes thereof, polytetrafluoroethyelene, or metal based elements such as stainless steel or derivatives thereof. In another embodiment, needle

CA 2995281 2018-02-14 protection shaft 118 is manufactured from a stainless steel type material to provide a clinician with the ability to straighten a needle for re-insertion in the event that the needle becomes damaged as a result of continuous usage and passage during the acquisition of multiple samples. Needle protection shaft 118 may be over-molded to combine the requirements of compressibility with the rigidity of land insert 120.

Referring to Figure 4, a perspective view of a needle protection adapter 200 is presented. Needle protection adaptor 200 is attached proximally to a luer adapter 202 and distally to a needle biopsy device 204. Needle protection adaptor 200 is comprised of a needle protection member 206, a needle protection shaft 208, an adapter member > 210, and at least one engagable member 212.

Needle protection member 206 may be over-molded from thermoplastic material such as acrylonitrile butadiene styrene, polystyrene and derivatives thereof, polyetherkcytone, polyamide, polyethersulfone, polyurethane, ether block amide copolymers, polyacetal, polycarbonate and derivatives thereof. In an embodiment, needle protection shaft 208 consists of a stainless steel hypo-tube to provide rigidity and the ability to straighten a needle in die event that the needle may have become kinked during successive passages.

Adapter member 210 and engagable member 212 facilitate the engagement between luer adapter 202, needle protection adapter 200, and needle biopsy device 204.

> Adapter member 210 and engagable member 212 may be, for example, a screw thread or a snap-fit type of arrangement.

In an embodiment, needle protection adapter 200 is permanently attached to luer adapter 202. In another embodiment, luer adaptor 202 is connected to an echo-endoscope (not shown in Figure) via a screw thread type arrangement. Luer adapter 202 may be an over-molded component manufactured from a rigid or semi-rigid thermoplastic type polymer material such as acrylonitrile butadiene styrene, polystyrene and derivatives thereof, polyetherkeytone, polyamide, polyethersulfone, polyurethane, ether block amide copolymers, polyacetal, and derivatives thereof.

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Referring to Figures 5 and 6, perspective views of embodiments of luer adapter 202 are presented. Luer adapter 202 may be attached to needle protection adaptor 200 via snap fit connections 214 and 216. Snap fit connections 214 and 216 allow a clinician to disengage an echo-endoscope (not shown in Figure) from luer adapter 202 with relative ease. For example, once a sample has been aspirated from a desired anatomical site, an echo-endoscope may be detached from the distal end of luer adapter 202.

Referring to Figures 7 and 8, cross-sectional views of embodiments of needle protection adapter 200 are presented. Needle protection adapter 200 is comprised of a needle protection member 206 that extends from the middle portion of needle protection adapter 200 through the distal portion of needle protection adapter 200. Needle protection member 206 i$ comprised of a needle protection shaft 208 and at least one engagable member 222 on its internal diameter.

In an embodiment of the present disclosure, as a clinician retracts a sheath lumen 218 in a proximal direction, engagable member 222 communicates with a complimentary engagable member 220 located on the distal portion of sheath lumen 218. For example, sheath lumen 218 reaches a junction when engagable member 220 contacts engagable member 222 at the proximal end of needle protection member 206. At this juncture, a clinician may detach needle protection adapter 200 from luer adapter 202 as a needle 224 is completely protected within needle protection shaft 208. In this manner, needle protection shaft 208 can cover the distally protruding portion of needle 224 even when needle 224 is at its maximum length of extension from the distal end of needle protection member 206.

Referring to Figures 9 through 12, perspective views of embodiments of a needle protection member 300 and a needle biopsy device 310 are presented. Needle protection member 300 is comprised of a needle protection hub 302 and a needle protection shaft 304. Needle protection hub may be manufactured from, for example, rigid or semi-rigid thermoplastic materials such as acrylonitrile butadiene styrene, polystyrene and derivatives thereof, polyetherkeytone, polyamide, polyethersulfone, polyurethane,

CA 2995281 2018-02-14 polyethylene, ether block amide copolymers, polyacetal, polycarbonate and derivatives thereof.

Needle biopsy device 310 is comprised of a needle housing member 312, a proximal handle member 314, a handle member 316, and a distal handle member 318. In an embodiment of the present disclosure, needle protection member 300 is pre-mounted distally on needle housing member 312. As needle housing member 312 is advanced into proximal handle member 314, needle protection hub 302 and needle protection shaft 304 are secured between engagable members 320. For example, needle protection hub 302 may be substantially secured between engagable members 320 that are snap-fit arrangements in proximal handle member 314.

Referring now to Figures 13 through 16, perspective views of embodiments of needle protection hub 302 and needle protection shaft 304 are presented. Needle protection hub 302 and needle protection shaft 304 may be injection molded components that are molded from a range of commercially available rigid or semi-rigid thermoplastic materials. These materials may be, are not limited to, acrylonitrile butadiene styrene, polystyrene and derivatives thereof polyetherkeytone, polyamide, polyethersulfone, polyurethane, ether block amide copolymers, polyacetal, polycarbonate and derivatives thereof. In an embodiment, needle protection hub 302 and needle protection shaft 304 are also comprised of materials that are transparent or translucent in nature, such as • polystyrene, polycarbonate, and styrene acrylonitrile. It is envisioned that the transparent or translucent function provides clinicians with visual feedback as to the location of a needle 324 relative to tire distal portion of the needle protection shaft 304.

In an embodiment of the present disclosure, needle 324 includes engagable members 322 that are separated at a specific distance from the distal portion of needle ; 324. The location of engagable members 322 along needle 324 correspond to the maximum allowable length for needle penetration during sample acquisition. Engagable members 322 may be, for example, extruded polymeric spacers. As a clinician retracts needle 324 through needle protection shaft 322, needle protection hub 302 remains locked in proximal handle member 314 until at least one engagable member 322 engages

CA 2995281 2018-02-14 a corresponding engagable member within needle protection hub 302. At this juncture, as the clinician applies additional retraction force, needle protection hub 302 disengages from engagement member 320 and needle 324 is encased as it is retracted from proximal handle member 314, thereby preventing inadvertent needle stick.

Referring to Figures 17A and 17B, perspective views of embodiments of a needle lock member are presented. In an embodiment of the present disclosure, needle lock member is comprised of a compression gasket 400, a compression fitting hub 410, and a cylindrical barrel 412. A needle 402 is partially disposed within compression gasket 400 and cylindrical barrel 412. Compression gasket 400 is partially disposed within compression fitting hub 410 and cylindrical barrel 412 is partially disposed within compression gasket 400. Compression gasket 400 may be, for example, manufactured from silicone and other soft deformable polymeric or rubber materials that can be compressed or decompressed as desired.

In an embodiment, compression gasket 400 may be in a compressed state 404 or an uncompressed state 405. Referring now to Figure 17A, in compressed state 404, compression gasket 400 is in contact with a portion of needle 402, thereby preventing needle 402 from being advanced or retracted out of the distal end of a catheter sheath 406. At this juncture, die clinician may attach an adaptor 408 to an echo-endoscope by engaging the luer component of the working channel of the scope (not shown in Figure) with adaptor 408. Referring now to Figure 17B, the clinician may then rotate compression fitting hub 410, thereby connecting compression fitting hub 410 onto adaptor 408. This rotational motion results in compression gasket 400 being displaced in a distal direction. This rotation also results in the displacement of cylindrical barrel 412 through compression gasket 400 at its proximal aid. At this juncture, once compression fitting hub 410 and adaptor 408 are secured in place, compression gasket 400 is no longer in contact with needle 402. Needle 402 may then advance or retract freely to acquire a desired sample.

Referring to Figures 18A and 18B, perspective views of embodiments of needle protection mechanisms for use with a needle biopsy device 500 and 510 are presented.

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Needle biopsy device 500 is comprised of a needle housing member 502, a proximal handle member 504, and a handle member 506. Needle housing member 502 includes a needle therein. Needle biopsy device 510 is comprised of a proximal handle member 512 and a handle member 516.

(n an embodiment, needle housing member 502 is fully inserted into proximal handle member 504 to allow the needle to extend from the distal end of the sheath lumen (not shown in Figure). In this regard, once a clinician has acquired a tissue sample, the clinician may retract proximal handle 504 to its maximum stroke to ensure that die needle becomes housed within the distal portion of the sheath lumen. In order to facilitate this process, needle biopsy device 500 incorporates a first engagable member 508 at the proximal end of proximal handle member 504, a second engagable member 514, and a third engagable member 518 at the proximal end of the handle member 516. The use of such engagable members prevents proximal handle member 504 from moving forward without the application of force by the clinician. This feature also provides tactile feedback to alert the clinician that the needle is locked because the clinician can feel engagable members 508,514, and 518 clicks into position. It is contemplated that this design feature also ensures that the clinician is not solely reliant on having to lock the locking slide ring in place prior to removal of sheath lumen 506. It is further contemplated that incoiporating a self-locking mechanism such as engagable members ¹ 508,514, and 518 also eliminates the need for the clinician to lock the locking slide ring in place, thereby also increasing procedural efficiency. Furthermore, by leaving the locking ring locked at a specific location on handle member 504, the clinician can maintain needle penetration settings between successive needle passes in acquiring multiple tissue samples.

Referring to Figure 19, a perspective view of another embodiment of a needle biopsy device 520 is presented. Needle biopsy device 520 is comprised of an adaptor 522, a proximal handle member 524, ergonomic design features 526 and 528 disposed on proximal handle member 524 and distal handle member (not shown in Figure), a locking ring 532, and a needle 530. In an embodiment, needle biopsy device 520 does not

CA 2995281 2018-02-14 facilitate catheter shaft adjustment when needle biopsy device 520 is attached to an echoendoscope.

Proximal handle member 524 incorporates ergonomic design features 526 and 528 in order to provide a clinician with enhanced feel of needle biopsy device 520. Ergonomic features 526 and 528 may be, for example, a conical grip or depressions suitable for a thumb or forefinger. Locking ring 532 allows a clinician to lock the depth of needle extension from the end of toe sheath lumen of the device. Locking ring 532 may be moved distally or proximally and can be locked in position via tightening.

Referring now to Figures 20A through 24, perspective views of embodiments of a design feature for needles are presented. The needle incorporates echogenic features over its length of the distal end when exposed to its maximum extension length. This functionality 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 Figure 20A, a perspective view of an embodiment of a needle 600 is presented. Needle 600 is comprised ofa plurality of depressions 602. Depressions 602 may be, but are not limited to, circular, concave, cylindrical, helical, oval, rectangular, and square elements that take die 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 Figures 20B and 20C, depression 602 have a concave detail 604. Referring to Figures 20D and 20E, depressions 602 have a square base edge 606. Referring to Figures 20F and 20G, depressions 602 have a hemispherical base detail 608.

Referring now to Figure 21, a perspective view of another embodiment of a needle 610 is presented. Needle 610 is comprised of elliptical depressions 612 around

CA 2995281 2018-02-14 the circumference of the distal end of needle 610. Referring to Figure 22, a perspective view of an embodiment of a needle 614 having square depressions 616 is presented. Depressions 616 may extend to die extreme end of the bevel or may end at a specific distance from the bevel of needle 614. Referring to Figures 23A and 23B, embodiments of needle 614 including spiral depressions 620 and helical depressions 622 are presented. Referring to Figures 23C, a depression 624 has a concave detail. Referring to Figures 23D, a depression 626 has a square base edge. Referring to Figures 23E, a depression 628 has a hemispherical base detail.

Referring now to Figure 24, a diagram of ultrasound waves impinging upon a needle depression at angles of al 630 and βΐ 632 respectively are presented. In an embodiment, a wave strikes the base of the depression and is reflected upwards at angle of reflection of a2 634 and β2 636 respectively, which are equal to the angles of incidence of al 630 and βΐ 632 respectively. This reflected beam is reflected a second time off die adjacent wall of the depression at an angle of reflection of a3 638 and β3 640 respectively, which are equal to the angles of incidence, al 630 and βΐ 632 respectively and the angles of first reflection a2 634 and β2 636 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.

Referring now to Figures 25 through 27, perspective views of an embodiment of another design feature for a needle 700 are presented. Needle 700 is comprised of a filter element 702, at least one protrusion 706, a joint 708, and is housed within a needle protection member 704.

In an embodiment of the present disclosure, joint 708 permits a clinician to detach the distal portion of needle 700 from the main body of needle 700. Joint 708 may be, for example, a lap, snap-fit, or adhesive joint arrangement. It is envisioned that joint 708 shall not compromise die pushability or kink resistance of needle 700 during sample extraction.

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Filter element 702 acts as a membrane to capture ceils acquired during an aspiration process. During a procedure, post-aspiration, a clinician may detach the needle housing member from the handle of the needle biopsy device at the proximal handle end. Once completely retracted, the sharp end of needle 700 is protected by needle protector 704. Once a clinician detaches needle 700 at joint 708, he or she may safely insert needle 700 into a vile for laboratorial analysis. In this manner, the efficiency of a fine-needle aspiration procedure may be improved by eliminating sample prep time in the EUS or EBUS suite, which is normally taken up with waiting for the sample to be removed from needle 700 before a successive needle pass may be made.

Referring now to Figures 28 through 45, various embodiments of a needle biopsy device with an exchangeable needle housing member are presented. Referring to Figures 28 and 29, a needle biopsy device 800 is presented. Needle biopsy device 800 is comprised of a proximal handle member 802, a proximal inner handle member 804, a proximal guide-rail 805, a stop member 806, a distal guide-rail 807, a distal inner handle member 808, a distal handle member 810, a needle housing member 812, a stylet 814, a release member 816, a sheath lumen 818, a needle protection hub 820, a needle protection shaft 822, a ring engagable member 824, a proximal inner handle shaft 826, and a needle 828.

Proximal handle member 802 is used to provide a slideable method to advance and retract needle 828 along proximal inner handle member 804. For example, proximal guide-rail 805 located at the distal end of the proximal inner handle member 804 provides recess grooves to allow movement of needle 828 into and out of a tumerous location.

Distal handle member 810 is used to provide a slideable method to adjust the protrusion depth of sheath lumen 818 relative to the extended length of needle 828 along distal inner handle member 808.

In an embodiment, needle housing member 812 is pre-loaded with an integrated needle protection mechanism (not shown in Figure). It is contemplated that once a clinician has acquired a cellular sample, needle housing member 812 may be unlocked from proximal handle member 802 by depressing release member 816. Release member

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816, may be, for example, an external push-button hinge. The act of manipulating release member 816 allows a clinician to unlock needle housing member 812 and retract the needle from device 800.

Referring to Figures 30 and 31, a perspective view of an embodiment of proximal handle member 802 is presented. Proximal handle member 802 is comprised of recessed portions 830 to allow for the positioning of ring engagable member 824 and proximal guide rails 805. Proximal handle member 802 is free to slide forward and backward along proximal guide rail 805, thus allowing the clinician to advance or retract the needle during a procedure. It is contemplated that the distal handle member (not shown in Figure) is free to slide forward and backward along the distal guide-rail, allowing to clinician to adjust the depth of sheath lumen 818 extension beyond the end of an echoendoscope.

Referring to Figures 32A through 32D, perspective views of components of the handle members are presented. Distal handle member 810 is comprised of at least one bore recess 834, a locking engagement bore 836, and a luer recess 838. In an embodiment, a threaded spacer may be inserted into bore recess 834 and secured in position. The step of securing may be performed by, for example, a mechanical press-fit or via the use of adhesive.

Proximal inner handle member 804 and distal inner handle member 808 are separated by a stop member 806. Stop member 806 acts as a divider to control toe advancement and retraction of the handle member components along proximal inner handle member 804 and distal inner handle member 808. In an embodiment, stop member 806 is secured to a proximal member recess 840. It is contemplated that stop member 806 does not interfere with toe functionality of a tapered passage 842 for needle exchange and a land bore 844.

Referring now to Figure 33, a perspective view of an embodiment of needle housing member 812 is presented. Needle housing member 812 is comprised of a land ring 813 and a stylet 814. Land ring 813 functions in conjunction with release member 816. The functional aspects of land ring 813 are described in further detail below.

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Referring now to Figure 34, a cross-sectional view of an embodiment of needle bousing member 812 is presented. Needle housing member 812 is comprised of ring engagable member 824, a needle luer hub 840, an inner housing 842, a needle strain relief member 844. In an embodiment, inner housing 842 incorporates a shelf that engages and disengages with release member 816 (as shown in Figure 29). This design feature provides the clinician with a smooth locking response when securing the needle housing member to the assembly of release member 816. Needle luer hub 840 may be secured to needle housing member 812 via various securing means, such as adhesive bonding, welding, brazing or soldering techniques. Inner housing 842 serves as a coupler to hold needle strain relief member 844 in position.

Referring now to Figures 35 through 37, perspective views of embodiments of needle protection hub 820 for use with needle housing member 812 are presented. Needle protection hub 820 includes an engagable member 846. Engagable member 846 communicates with protrusions 848 at the distal end of the needle. As a needle is continually retracted, the most proximal protrusion 848 interfaces with engagable member 846 and becomes mechanically locked thereto. At this juncture, as the clinician retracts the needle housing member from the proximal handle, needle protection hub 820 remains locked to protrusion 848, thus encasing the sharp bevel of the needle and protecting the clinician after the needle has been removed from the patient.

Needle protection hub 820 may be manufactured from, for example, a rigid, nondeformable metallic, thermoplastic or thermoset materials such as aluminum, stainless steel, acrylonitrile butadiene styrene (ABS), styrene acrylonitrile (SAN) or rigid derivatives thereof, polyamide, polyethylene, polyurethane, and polycarbonate. In an embodiment, these materials shall have a durometer in the range of 35-120 Shore D, but more preferably in the range of 80 -110 Shore D.

It is envisioned that engagablc members 846 may be manufactured from a range of low durometer, thermoplastic or thermoset materials such as, but not limited to, polyurethane and derivatives thereof, polyethcr amide block copolymers, polyamide, styrene butadiene rubber and/or alternate derivatives of styrene based polymers,

CA 2995281 2018-02-14 neoprene, and polyethylene and derivatives thereof. In an embodiment, the materials of manufacture shall have a durometer in the range of70 - 120 Shore A, but more preferably in the range of 70 - 90 Shore A.

Referring now to Figures 38A through 39B, various views of an embodiment of release member 816 are presented. Release member 816 represents a mechanism to attach the needle housing member to the proximal handle member of the needle biopsy device. Release member 816 may be, for example, a push-button, that activates the use of a hinge member 850 to provide for a return to the “Home” position once external force is not applied to release member 816. Hinge member 850 can elastically deform to provide for the opening and closing of the “lock” during removal of the needle housing member. In an embodiment, release member 816 incorporates an external coupler housing 852 and a push button 816 design mechanism. Referring now to Figures 39A and 39B, release member 816 illustrates release member 816 in the CLOSED and OPEN positions during a typical actuation cycle.

Referring now to Figures 38A and 38B, release member 816 and external coupler housing 852 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 850 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.

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Referring to Figures 40 through 42, perspective views of embodiments of needle protection member 820 in use with a needle biopsy device are presented. In an embodiment, the needle housing member is pre-mounted with needle protection hub 820 and needle protection shaft 822. Thereafter, die needle housing member is inserted into the proximal end of the proximal handle member with release member 816. The needle housing member is continually advanced until the taper portion of needle protection hub 820 is seated against ring engagable member 824. The application of additional force pushes needle protection hub 820 forward and ring engagable member 824 deforms until comes to rest. At this juncture, needle protection hub 820 is locked in position and does not move. In addition, the land ring of the needle housing member actuates the release member 816 until release member 816 crosses a land ring” detail on the external surface of a coupler. At equilibrium, release member 816 is in its fully extended state and the coupler is locked in position.

An intended functionality of release member 816 is to prevent the needle housing member from being removed from the proximal handle member without applying force to release member 816. For example, once a sample has been aspirated from an intended site, release member 816 is actuated and the needle retracted. The needle is continually retracted until the most proximal engageable member 848 engages with needle protection hub 820. Retracting the needle still further with die application of additional force can cause the proximal radius of the taper to contact the ring engagable member 824. Ring engagable member 840 elastically distends and needle protection hub 820 traverses ring engagable member 840. As a result, the needle housing member can now be fully retracted from the device with the distal sharp of the needle protected from inadvertent sticking. Additionally, follow-up samples may be acquired using the same or a virgin needle housing member. Once the needle housing member has been loaded and locked into the coupler, the needle sub-assembly may be rotated. It is envisioned that the ability to core tissue during acquisition, by rotating and advancing and retracting the needle in short strokes, may be provided for.

Referring to Figure 43, a perspective view of an embodiment of a coupler 854 is presented. In an embodiment, coupler 854 may utilize an Ο-Ring to provide for smooth /

CA 2995281 2018-02-14 locking of the needle housing member to the release member mechanism. In another embodiment, the Ο-Ring may be removed and the needle housing member may be utilized without such a component.

Referring now to Figure 44, a perspective view of an embodiment of the needle biopsy device is presented. Proximal inner handle member 804 and distal inner handle member 808 provide for use of locking adjustment mechanisms, such threaded thumb screws to provide a frictional lock to the proximal and distal inner handle member components to lock both needle penetration depth and sheath lumen penetration depths respectively.

Referring now to Figure 45, a perspective view of an embodiment of a ring engagable member 856 incorporated as part of the proximal inner handle member 804 is presented. In an embodiment, ring engagable member 856 is located in a recessed circular slot in the proximal inner handle member 804. During advancement and retraction of proximal handle member 802 in distal and proximal directions, the proximal inner handle member 804 slides distal and proximal to the inner member across ring expandable member 856. In this instance, ring expandable member 856 provides frictional force resistance between the proximal inner handle member 804 and proximal handle member 802. It is envisioned that when the clinician removes his/her hand from proximal handle member 802, ring expandable member 856 creates sufficient frictional force with the proximal inner handle member 804 that proximal handle member 802 remains at its location and is fixed to proximal inner handle member 804. In this way, the clinician may stop advancement or retraction of the proximal handle member 802 and the handle remains at that location.

Ring expandable member 856 may be manufactured from a range of low durometer, deformable, thermoplastic or thermoset materials such as, but not limited to polyurethane and derivatives thereof, polyether amide block copolymers, polyamide, styrene butadiene rubber and/or alternate derivatives of styrene based polymere, neoprene, and polyethylene and derivatives thereof. In an embodiment, the materials of manufacture have a durometer in the range of70 -120 Shore A, but more preferably in

CA 2995281 2018-02-14 the range of70 - 90 Shore A. Such Ο-Ring components are readily available from a range of companies such as McMaster-Carr by means of an example.

It will be understood that various modifications may be made to die embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplifications of the various embodiments of the invention. Those skilled in the art will envision other modifications within die scope of the claims appended hereto.