阅读说明：本技术 倾斜的活检针装置 (Inclined biopsy needle device ) 是由 希默斯·奥肖内西 科尔比·哈里斯 于 2019-02-26 设计创作，主要内容包括：本发明涉及一种活检针系统,其包括从组织穿刺远端延伸至近端的针。该针限定从远端延伸达至少一部分其长度且容纳靶组织的内腔。该系统还包括细长构件,该细长构建限定经过其中且在近端开放的通道。该通道的尺寸和形状被设计成允许针经其通过。此外,该系统包括联接到细长构件的远端的端盖。该端盖包括延伸经过其侧壁的孔。该孔的尺寸和形状被设计成允许针经其通过。该端盖进一步包括从通道延伸至孔以引导针经过孔的坡道。该坡道相对于细长构件的纵向轴线而倾斜。(A biopsy needle system includes a needle extending from a tissue penetrating distal end to a proximal end. The needle defines a lumen extending from the distal end for at least a portion of its length and accommodating a target tissue. The system also includes an elongated member defining a channel therethrough and open at a proximal end. The channel is sized and shaped to allow passage of a needle therethrough. Further, the system includes an end cap coupled to the distal end of the elongate member. The end cap includes an aperture extending through a sidewall thereof. The aperture is sized and shaped to allow passage of a needle therethrough. The end cap further includes a ramp extending from the channel to the bore to guide the needle through the bore. The ramp is inclined relative to the longitudinal axis of the elongate member.)

1. A biopsy needle system comprising:

a needle extending from a tissue-piercing distal end to a proximal end, the needle defining a lumen extending at least a portion of its length from the distal end and configured to receive a target tissue;

an elongate member extending from a proximal end to a distal end, the elongate member defining a channel therethrough and open at its proximal end, the channel being sized and shaped to allow passage of the needle therethrough; and

an end cap coupled to the distal end of the elongate member, the end cap including an aperture extending through a sidewall thereof, the aperture being sized and shaped to allow the needle to pass therethrough, the end cap further including a ramp extending from the passage of the elongate member to the aperture for guiding the needle through the aperture, the ramp being inclined relative to a longitudinal axis of the elongate member.

2. The system of claim 1, wherein the elongate member is braided to facilitate torque transmission along its length.

3. The system of any of claims 1 or 2, wherein the elongate member comprises a plurality of visual indicia spaced at regular intervals around its circumference, the visual indicia indicating a degree of rotation.

4. The system of claim 3, wherein the elongated marker comprises four visual markers spaced 90 degrees apart around a perimeter of the elongated marker.

5. The system of claim 3, wherein the plurality of markings extend along a length of at least a portion of the elongated member in a direction parallel to a longitudinal axis of the elongated member.

6. The system of any one of claims 1 to 6, wherein the ramp is inclined at an angle of between 5 and 25 degrees relative to a longitudinal axis of the elongate member.

7. The system of any one of claims 1-7, further comprising a retainer extending from a proximal end to a distal end, the retainer configured to be slidably received over the proximal end of the end cap such that the distal end of the retainer extends over the proximal portion of the bore, the retainer having a stiffness greater than the needle such that the distal end of the retainer forms a first point of contact with the needle to deflect the needle without deflecting the catheter.

8. The system of claim 7, wherein the ramp of the end cap is configured to have second and third points of contact with the needle to form a three-point bending system for deflecting the needle without deflecting the catheter.

9. The system of any one of claims 1 to 8, wherein the needle comprises a distal cutting edge that is inclined or ramped relative to a longitudinal axis of the needle.

10. A device for guiding a biopsy needle, comprising:

an elongate member extending from a proximal end to a distal end, the elongate member defining a channel therethrough and open at the proximal end, the channel being sized and shaped to allow passage of a needle therethrough; and

an end cap coupled to the distal end of the elongate member, the end cap including an aperture extending through a sidewall thereof, the aperture being sized and shaped to allow the needle to pass therethrough, the end cap further including a ramp extending from the passage of the elongate member to the aperture to guide the needle through the aperture, the ramp being inclined relative to a longitudinal axis of the elongate member.

11. The system of claim 10, wherein the elongated member is braided to facilitate torque transmission along its length.

12. The system of claim 10 or 11, wherein the elongated indicia comprises a plurality of visual indicia spaced at regular intervals around its circumference, the visual indicia indicating a degree of rotation.

13. The system of claim 12, wherein the elongated marker comprises four visual markers spaced up to 90 degrees around a perimeter of the elongated marker.

14. The system of claim 12, wherein the plurality of markings extend along a length of at least a portion of the elongated member in a direction parallel to a longitudinal axis of the elongated member.

15. The system of any one of claims 10 to 14, wherein the ramp is inclined at an angle of between 5 and 25 degrees relative to a longitudinal axis of the elongate member.

Technical Field

The present disclosure relates to biopsy devices, and more particularly to biopsy devices for use in bronchoscopic and endoscopic procedures.

Background

Tissue samples are often examined to determine the presence of pathological disease inside the lung perimeter. If a tissue mass or tissue nodule smaller than a certain size is identified, the patient may receive a biopsy to determine whether the tissue mass is benign or malignant. The nodules inside the lung may be concentric or eccentric. The concentric nodules completely surround the perimeter of the airway, while the eccentric nodules contact only a portion of the airway perimeter and are primarily adjacent to the airway. Current methods for harvesting tissue in the lung periphery have often resulted in inadequate harvest yields, particularly for eccentric nodules. In addition, current systems require multiple devices to be inserted into the sample tissue off-center from the initial needle placement. However, because such biopsies are often performed "blindly" distally beyond the visual ability of the bronchoscope inserting the needle through the bronchoscope, the thorax physician is often unable to confirm the site of initial needle placement, and therefore often performs multiple passes of the biopsy needle all at the same randomly selected needle location.

Disclosure of Invention

The present disclosure relates to a biopsy needle system, comprising: a needle extending from a tissue-piercing distal end to a proximal end, the needle defining a lumen extending from the distal end for at least a portion of its length and configured to receive a target tissue; an elongate member extending from a proximal end to a distal end, the elongate member defining a passage therethrough and open at the proximal end, the passage being sized and shaped to permit passage of a needle therethrough; and an end cap coupled to the distal end of the elongate member, the end cap including an aperture extending through a sidewall thereof, the aperture being sized and shaped to allow passage of a needle therethrough, the end cap further including a ramp extending from the channel of the elongate member to the aperture for guiding the needle through the aperture, the ramp being inclined relative to a longitudinal axis of the elongate member.

In one embodiment, the elongate member is braided to facilitate torque transmission along its length.

In one embodiment, the elongated indicia includes a plurality of visual indicia spaced at regular intervals around its circumference, the visual indicia representing degrees of rotation.

In one embodiment, the elongated member includes four visual indicia spaced 90 degrees apart around the circumference of the elongated member.

In one embodiment, the plurality of markings extend along at least a portion of the length of the elongate member in a direction parallel to the longitudinal axis of the elongate member.

In one embodiment, the ramp is inclined at an angle of between 5 and 25 degrees relative to the longitudinal axis of the elongate member.

In one embodiment, the system includes a retainer extending from a proximal end to a distal end, the retainer configured to be slidably received over the proximal end of the end cap such that the distal end of the retainer extends over the proximal end of the bore; the retainer has a stiffness greater than a stiffness of the needle such that a distal end of the retainer forms a first contact point with the needle for deflecting the needle without deflecting the catheter.

In one embodiment, the end cap of the ramp is configured to have second and third points of contact with the needle, thereby forming a three-point bending system for deflecting the needle without deflecting the catheter.

In one embodiment, the needle includes a distal cutting edge that is one of inclined or ramped relative to a longitudinal axis of the needle.

The present disclosure also relates to a device for guiding a biopsy needle, comprising: an elongate member extending from a proximal end to a distal end, the elongate member defining a passage therethrough and open at the proximal end, the passage being sized and shaped to permit passage of a needle therethrough; and an end cap coupled to the distal end of the elongate member, the end cap including an aperture extending through a sidewall thereof, the aperture being sized and shaped to allow passage of a needle therethrough, the end cap further including a ramp extending from the channel of the elongate member to the aperture for guiding the needle through the aperture, the ramp being inclined relative to a longitudinal axis of the elongate member.

In one embodiment, the elongate member is braided to facilitate torque transmission along its length.

In one embodiment, the elongated indicia includes a plurality of visual indicia spaced at regular intervals around its circumference, the visual indicia representing degrees of rotation.

In one embodiment, the elongated indicia includes four visual indicia spaced 90 degrees apart around the circumference of the elongated indicia.

In one embodiment, the plurality of markings extend along at least a portion of the length of the elongate member in a direction parallel to the longitudinal axis of the elongate member.

In one embodiment, the ramp is inclined at an angle of between 5 and 25 degrees relative to the longitudinal axis of the elongate member.

The present disclosure also relates to a method for obtaining a biopsy sample, comprising inserting an elongate member into a target region inside a living body, the elongate member extending from a proximal end to a distal end, the elongate member defining a channel therethrough and open at the proximal end, the channel being sized and shaped to allow passage of a needle therethrough, the elongate member further comprising an end cap coupled to the distal end thereof, the end cap comprising an aperture extending through a sidewall thereof, the aperture being sized and shaped to allow passage of a needle therethrough, the end cap further comprising a ramp extending from the channel to the aperture of the elongate member for guiding the needle through the aperture, the ramp being inclined relative to a longitudinal axis of the elongate member so as to advance the needle through the channel of the elongate member until its distal end exits the aperture of the end cap, the needle extending from the proximal end to the distal end, the needle defining a lumen extending from the distal end for at least a portion of its length and configured to receive a target tissue and to puncture the target tissue with the distal end of the needle, a portion of the target tissue is held within the lumen of the needle.

In one embodiment, the method further comprises: proximally withdrawing the needle from the elongate member; rotating the elongate member about its longitudinal axis by a known amount such that the aperture of the end cap is adjacent a second portion of the target tissue different from the first portion; and reinserting the needle through the passageway of the elongate member until the distal end thereof exits the aperture of the end cap so that the needle pierces the second portion of the target tissue.

In one embodiment, the elongated indicia includes a plurality of visual indicia spaced at regular intervals around its circumference, the visual indicia representing degrees of rotation.

In one embodiment, the plurality of markings extend along at least a portion of the length of the elongate member in a direction parallel to the longitudinal axis of the elongate member.

In one embodiment, the method further comprises acquiring a CT scan image of the target region to determine a path within the body from the insertion point to the target tissue.

Drawings

FIG. 1 illustrates a partially transparent perspective view of a biopsy device system according to an exemplary embodiment of the present disclosure;

FIG. 2 shows an endobronchial ultrasound image of a concentric lesion;

FIG. 3 shows an endobronchial ultrasound image of an eccentric lesion;

FIG. 4 illustrates a needle of the biopsy device system of FIG. 1 according to an exemplary embodiment of the present disclosure;

FIG. 5 illustrates a needle of the biopsy device system of FIG. 1 according to a second exemplary embodiment of the present disclosure;

FIG. 6 illustrates a cross-sectional view of a biopsy device according to another exemplary embodiment of the present disclosure;

FIG. 7 shows a perspective view of the biopsy device of FIG. 6;

FIG. 8 shows a cross-sectional view of a biopsy device according to a third exemplary embodiment of the present disclosure;

FIG. 9 shows a partially transparent perspective view of the biopsy device of FIG. 8.

Detailed Description

The present disclosure may be further understood with reference to the following description and the appended drawings, wherein like elements are referred to by the same reference numerals. The present disclosure relates to a biopsy device for obtaining a tissue sample. In particular, the present disclosure relates to a needle biopsy device that provides control of needle position during use of the device. Exemplary embodiments of the present disclosure describe a catheter with a distal needle ramp. It should be noted that the terms "proximal" and "distal" as used herein are intended to refer to a user of the device towards (proximal) and away from (distal).

A biopsy device 10 according to an exemplary embodiment of the present disclosure is depicted in fig. 1. The biopsy device 10 comprises: a catheter 100 inserted into the body via a working channel of an endoscope, bronchoscope, or other access device (e.g., inserted into the body along a tortuous path via a natural body lumen accessed through a naturally occurring body orifice), and a biopsy needle 102 slidably received in the catheter 100. The catheter 100 includes an elongate member extending longitudinally from a proximal end 104 to a distal end 106, and includes a lumen 108 extending therethrough, and having a length selected to enable the distal end of the catheter 100 and needle 102 to reach a target site inside the body that would be inaccessible to the insertion device and thus exceed any visual capabilities of the insertion device. The catheter 100 according to this embodiment is generally tubular and is made of a suitable biocompatible material (e.g., polyurethane, plastic, or any other such material) as will be appreciated by those skilled in the art. Other suitable cross-sectional shapes (e.g., elliptical, oval, polygonal, or irregular) are also contemplated. As will be appreciated by those skilled in the art, the catheter 100 according to the present embodiment is flexible along its entire length, or is adapted for flexing along a selected portion of its length as needed to reach the target tissue. It should be understood that the stiffness of the catheter 100 can be varied to accommodate various lumen diameters and various locations within the body. An end cap 110 is disposed at the distal end 106 of the catheter 100. The catheter 100 includes an opening 112 at the proximal end 104 (or any other location in the proximal end of the catheter 100 suitable for accessing the needle 102 and moving the needle 102 relative to the catheter 100 as desired), the opening 112 opening into the lumen 108 and sized and shaped to slidably receive the biopsy needle 102 therein. In the present exemplary embodiment, catheter 100 is braided to facilitate the transmission of torque along its length such that rotation applied to the proximal end of catheter 100 results in the desired rotation of the distal end of catheter 100. In other exemplary embodiments, the catheter 100 may be helical or may be a hypotube, as will be understood by those skilled in the art.

In the present exemplary embodiment, catheter 100 includes a plurality of visual markers 118 spaced around its circumference to provide a visual indication of the rotational orientation of catheter 100. For example, the catheter 100 may include a band or wire extending longitudinally from the proximal end 104 to the distal end 106. The markers 118 may be of different colors or patterns and spaced, for example, 90 degrees around the circumference of the catheter 100. Alternatively, the wires may be positioned only at the proximal end of the catheter 100, so that rotation of the distal end of the catheter 100 can be inferred by observing rotation of the proximal end of the catheter 100. In the present embodiment, catheter 100 includes four visual markers 118 to help achieve the desired rotation of biopsy needle 102. However, it should be understood that any number of markings 118 may be used so long as they are positioned at regular, known intervals around the circumference of the catheter 100 to indicate to the user a particular rotational orientation of the distal end of the catheter 100. It should be understood that the markers 118 need not extend the entire length of the catheter 100, but may be positioned at the proximal end 104 and the distal end 160 so long as they are visible to a user of the device 100.

The end cap 110 may be integrally formed with the catheter 100, or it may be a separate component that is coupled to the catheter 100 or clipped to the catheter 100, as shown in fig. 1. The end cap 110 may be coupled to the conduit 100 using any suitable method (e.g., welding, interference fit, adhesive, etc.). The end cap 110 defines a beveled lateral opening 114 that opens into the lumen 108 of the catheter 100 and is sized and shaped to allow the biopsy needle 102 to pass therethrough from the lumen 108. This angled lateral opening 114 guides the biopsy needle 102 at an angle towards the airway wall in a direction away from the longitudinal axis of the catheter 100, rather than having the biopsy needle 102 project coaxially with the longitudinal axis of the catheter 100, facilitates positioning of the needle 102 relative to the target tissue, and allows the needle 102 to enter different portions of the lesion spaced from each other around the airway circumference as the catheter 100 and opening 114 are rotated inside the airway. The ramp 116 positioned inside the end cap 110 and passing from the lumen 108 to the lateral opening 114 is inclined toward the lateral opening 114 at an angle relative to the longitudinal axis of the catheter 100 such that as the needle 102 moves distally through the lumen 108, the ramp 114 deflects the needle 102 and guides the needle 102 through the lateral opening 114 of the end cap 110 that is inclined relative to the longitudinal axis of the catheter 100, which is generally parallel to the longitudinal axis of the airway when the catheter 100 is received inside the airway. Thus, the ramp 116 provides for controlled exit of the biopsy needle 102 from the catheter 100 at an angle relative to the airway longitudinal axis and into the diseased portion over all or part of the circumference of the airway at a location that can be varied by rotating the catheter 100 within the airway. In this way, rotation of the catheter 100 allows the user to insert the needle 102 into portions of the target tissue that are circumferentially spaced from each other around the airway by simply rotating the catheter 100 inside the airway. In the exemplary embodiment, ramp 116 is inclined approximately 5-25 degrees relative to longitudinal axis L of conduit 100. However, it will be appreciated by those skilled in the art that the slope of the ramp may be any desired angle based on the procedure and anatomy to be accessed.

The lateral opening 114 provides the user with improved control over the location from which a tissue sample is taken after initial sampling. For example, after an initial tissue sample, the catheter 100 may be rotated prior to each subsequent sample such that the lateral openings 114 are directed at different regions around the airway perimeter so that the needle 102 may be sequentially introduced into each of these different regions. This allows multiple biopsies to be taken of different parts of the tissue without removing the catheter 100 from the airway. Furthermore, angling the needle towards the airway wall allows for enhanced eccentric diseased tissue sampling. In contrast, current biopsy needles typically only allow for collection of sample tissue that can be accessed by passing the needle along the longitudinal axis of the device, so that the needle enters the tissue at a location determined by the airway geometry, and the needle is not easily controlled by the user. These prior devices are able to sample tissue only where the device is directed due to airway geometry if, for example, the device is positioned adjacent to a bend in the airway. As will be appreciated by those skilled in the art, if this location does not correspond to the location of an eccentric lesion, it may be difficult or impossible to obtain a sample with conventional devices.

As can be seen in fig. 2, the concentric lesion 12 or nodule completely surrounds the perimeter of the airway. In this case, conventional coaxial needles are generally capable of taking biopsies of lesions. That is, a needle passing at the lesion location along any axis that is not parallel to the airway axis will always pass through the lesion. Thus, the user may insert the needle into a location in the airway in the curvature of the lesion immediately proximal to the portion of the airway surrounded by the lesion. Since the axis of the airway in this curve is not parallel to the axis of the airway at the lesion, the user should always be able to access a fully circumferential or concentric lesion. However, if the lesion does not extend around the entire perimeter of the airway, this oblique axis may not pass through the lesion. Thus, some eccentric lesions may be unequally reached by conventional needles. Biopsy of an eccentric lesion 16 extending around only a portion of the circumference of the airway 14, as depicted in fig. 3, can be very difficult to achieve with a coaxial needle, resulting in a reduction in yield of about 40%. The device 10 of the present invention directs the needle 102 radially away from the longitudinal axis L of the catheter 100 and toward the airway 14 wall, allowing off-center sampling by simply rotating the needle 100 to align the ramp 116 and the lateral opening 114 in different orientations relative to the airway. In addition, the user can rotate the device 10 with the indicia 118 by a certain known amount in order to perform a subsequent biopsy while leaving the catheter 100 inside the airway 14. By allowing control over the relative needle exit position between biopsies, the device 10 provides the user with the ability to harvest more tissue from different sites (around the circumference of the airway) at the same longitudinal location inside the airway, thereby increasing the confidence and ability to diagnose concentric and eccentric nodules.

Biopsy needle 102 extends from a proximal end 120 to a distal end 122, and is sized and shaped for insertion through lumen 108 of catheter 100. In the present embodiment, this biopsy needle 102 is preferably made of metal or other suitable material and includes an elongated, generally cylindrical body 124, which body 124 terminates in an exemplary embodiment in a tapered distal end 126. In another exemplary embodiment, the outer diameter of the needle 102 is substantially uniform along its length. Distal end 122 includes a tissue-piercing distal tip 128, and tip 128 is configured to insert and pierce tissue to obtain a biopsy sample. The distal end 122 of the present embodiment includes a distal cutting edge 130, the cutting edge 130 may be inclined or ramped relative to the longitudinal axis of the needle 102 and have an opening at the distal end of the needle 102 to allow the penetrated tissue to enter the lumen 132. In one exemplary embodiment, the needle 102 is flexible along its length (or at least at a distal portion thereof) to allow deflection through the opening 114 using the ramp 116. As can be seen in fig. 4, at least a distal portion of the biopsy needle 102 (including the distal end 122) is hollow and open at the distal end 122 of the needle 102 for collecting and holding target tissue. However, in some embodiments, the needle 102 may include a lumen 132 extending therethrough from the proximal end 120 to the distal end 122. The lumen 132 is open at the distal end 122 so that target tissue penetrated by the needle 102 can be received into the distal end 122 of the needle 102. The lumen 132 may also be open at the proximal end 120. In one exemplary embodiment, the proximal end 120 can be configured to be coupled to a suction mechanism or device for withdrawing target tissue from the proximal end 120 through the lumen 132. In this embodiment, the collected tissue may be drawn through the lumen 132 of the needle 102 from the distal end 122 to the proximal end 120, and in some cases into a suction device. In this embodiment, the needle 102 includes a handle or grip at the proximal end 120.

In one exemplary embodiment, the biopsy needle 102 may include a bend 134 adjacent the distal end 122 to more easily pass through the angled lateral bore 114 and achieve a greater angle toward the target tissue. In one exemplary embodiment, the angle of the bend 134 in the needle 102 may be equal to the angle of the ramp relative to the longitudinal axis of the device 10 (i.e., 5 to 25 degrees). In another exemplary embodiment, the angle of the bend 134 may be greater or less than the ramp angle. Because biopsy needle 102 is constructed of a flexible material, during insertion and passage through the lumen 108 of the catheter, needle 102 is constrained by the walls of lumen 108 from a bent configuration away therefrom to a generally flat configuration until a portion of the needle distal of bend 134 transitions onto ramp 116 and then through opening 114, at which point needle 102 returns to its bent configuration under its own natural bias. In one embodiment, the needle 102 may be constructed of a shape memory material (e.g., Nitinol) to allow the needle 102 to return to a bent configuration to which the needle is biased after having been constrained to follow the axis of the catheter 100.

The proximal end 104 of the catheter 100 may include a connector or handle 136 attached thereto that is held by a user during insertion and positioning of the device 10. In an exemplary embodiment, the handle 136 may be used to connect to other treatment devices or provide a port to facilitate other treatments. A lumen 138 extends through the handle and is sized and shaped for passage of the biopsy needle 102 therethrough. In one exemplary embodiment, catheter 100 may be rotated inside the airway by rotating handle 136 a desired amount. However, in some instances, the handle 136 may include a driver for manipulating the catheter 100. For example, the handle may include a drive mechanism for rotating the catheter 100 at certain known intervals.

For example, the device 10/100/102 and/or other components of a biopsy system may be made of metals, metal alloys, polymers, metal-polymer composites, ceramics, combinations thereof, and the like, or other suitable materials.

A biopsy device 20 according to another exemplary embodiment of the present disclosure is depicted in fig. 6-7. The biopsy device 20 includes a catheter 200, a biopsy needle 202, and an end cap 210, and is generally similar to biopsy device 10 except as described herein. Similar to endcap 110, endcap 210 may be integrally formed with conduit 200, or endcap 210 may be a separate component that may be coupled to or clamped to conduit 200. The end cap 210 defines an internal channel 214, the internal channel 214 opening proximally to the lumen 208 of the catheter 200 and distally to the lateral opening 216. The end cap 210 is sized and shaped to allow passage of the biopsy needle 202 (or other elongate member) therethrough from the lumen 208. In the present embodiment, end cap 210 is a rigid end cap made of a high durometer polymer or metallic material (e.g., polycarbonate, glass filled polymers such as Polyetheretherketone (PEEL), Nylon (Nylon), acrylonitrile butadiene styrene terpolymer (ABS), etc.) thus, end cap 210 has a higher stiffness than biopsy needle 202 passing therethrough. in the present embodiment, internal channel 214 is an arcuate channel such that the internal channel has three points of contact with biopsy needle 202 passing therethrough. As depicted in FIG. 6, three points of contact F1, F2, F3 are located along the arc of the internal channel to provide three force loads as can be seen in a three point bending flexure system, as will be understood by those skilled in the art And (4) passing. Thus, the entire bending load is applied to biopsy needle 202 inside end cap 210, thereby ensuring that the deflected element is biopsy needle 202 and not catheter 200 or end cap 210. As noted above, this rigid end cap 210 is advantageous in procedures that require a catheter to be more flexible than the biopsy needle used. In such procedures, the needle is often too stiff to be deflected by a simple angled end cap, resulting in deflection of the catheter instead resulting in a needle exit angle well below the desired angle if any angle is at all available. The end cap 210 with the curved interior passage allows the physician to deflect the needle at a desired angle, even when the needle has a greater stiffness than the catheter through which the needle is passed.

A biopsy device 30 according to another exemplary embodiment of the present disclosure is depicted in fig. 8-9. The biopsy device 30 includes a catheter 300, a biopsy needle 302, and an end cap 310, and is generally similar to biopsy devices 10, 20 except as described herein. Similar to the end caps 110, 210, the end cap 310 may be integrally formed with the conduit 300 or the end cap 310 may be a separate component that is coupled to or clamped to the conduit 300. Similar to device 10, end cap 310 defines an angled lateral opening 314 that opens to lumen 308 of inverted catheter 300, and is sized and shaped to allow passage of biopsy needle 302 therethrough from lumen 308. Specifically, ramp 316 is positioned inside end cap 310 and leads from inner cavity 308 to lateral opening 314. Ramps 316 are angled toward lateral openings 314 such that as needle 302 moves distally through lumen 308, ramps 314 guide needle 302 in a direction toward lateral openings 314 of end cap 310. It should be appreciated that the ramp 316 may extend along a straight or curved path toward the lateral opening 314. In the present embodiment, the end cap 310 is a rigid end cap made of a high durometer polymer or metal material, such as polycarbonate, glass filled polymers (e.g., PEEL, Nylon, ABS, etc.). Thus, end cap 310 has a higher stiffness than biopsy needle 302 passing therethrough. As with device 20, device 30 deflects biopsy needle 302 using three contact points F1, F2, F3. However, in the present embodiment, contact points F1, F3 are formed by ramps 316, and contact point F2 is formed by deflection retainer 340. Tubular deflection retainer 340 of the present embodiment is sized and shaped to be positioned over proximal end 342 of end cap 310 such that distal portion 344 of retainer 340 extends over a proximal portion of lateral opening 314, thereby forming a deflection contact point F2 for biopsy needle 302. Retainer 340 may be positioned over end cap 310 in any known manner. For example, retainer 340 may be slidably positioned over the proximal end of end cap 310 and secured in place using a friction fit, interference fit, or the like. The proximal end of retainer 340 is coupled to the distal end of catheter 300 in any known manner (e.g., friction fit, interference fit, etc.). In this embodiment, lateral opening 314 may be elongated (i.e., elongated in a direction parallel to the longitudinal axis of device 30), as shown in fig. 9, such that the positioning of retainer 340 (i.e., more distally, more proximally) determines the angle at which biopsy needle 302 is deflected. Retainer 340 is a rigid retainer made of a high durometer polymer or metallic material (e.g., polycarbonate, glass filled polymers such as PEEL, Nylon, ABS, etc.) this rigidity of retainer 340 provides sufficient force loading along with deflection of biopsy needle 302 along contact points F1 and F3 of ramp 316 while preventing transfer of deflection forces to catheter 300. however, as seen in FIGS. 8-9, the proximal portion of retainer 340 may be formed with a plurality of slots or notches 346. these notches 346 increase the flexibility of the proximal portion of the retainer, allowing device 30 to more easily pass through tortuous anatomy and reach a target site.

While the biopsy device 10, 20, 30 is described as including only a single passage or opening through the end cap 110, 210, 310, it will be understood by those skilled in the art that the end cap may also include a second passage extending along or parallel to the longitudinal axis of the biopsy device. This allows the user the option of actuating a needle having a straight configuration or a curved configuration. 6-7 depict biopsy device 20 as including a second channel 248 that extends in a manner that is generally parallel to the longitudinal axis of device 20.

In one exemplary method according to the present disclosure, the biopsy needle device 10 may be used in conjunction with Super Dimension (Super Dimension) technology. It should be understood that although reference is made to a biopsy needle device 10, the methods of the present invention may be practiced with any of the disclosed devices 10, 20, 30. In this method, in this case, a CT scan image of the lung is obtained prior to surgery to determine and plan an appropriate path to the nodule/lesion. During surgery, the plan is for the bronchoscope to be guided to a location as close as possible to the biopsy site using standard procedures. With the bronchoscope in place, the distal end 106 of the catheter 100 is inserted and advanced distally therethrough from the distal end of the bronchoscope to a target biopsy site inside the body (e.g., within the airways of the lung). Once the catheter 100 has been positioned inside the airway as desired (e.g., using an external vision system when the distal end of the catheter is no longer visible using the bronchoscope's vision system), the needle 102 is advanced through the lumen 108 of the catheter 100 until its distal end is deflected using the ramp 116 and exits the lateral opening 114 at an angle relative to the catheter 100. The needle 102 is advanced further distally and into a first biopsy site inside the lesion to collect a biopsy sample. After the sample has been obtained, the needle 102 may be withdrawn proximally through the lumen 108, and the sample may be removed and initially examined to determine if the sample is adequate. If more sample tissue is needed, catheter 100, which has been held in the same position inside the airway, is rotated by a desired amount (90 degrees in this embodiment) using visual marker 118, and biopsy needle 102 is reinserted from opening 114 through lumen 108 and into a second biopsy site within the same lesion to collect a second biopsy sample. After the sample has been obtained, the needle 102 may be withdrawn proximally through the lumen 108 and a second sample may be re-examined to determine if more tissue is needed. It will be appreciated by those skilled in the art that alternatively, the tissue sample may be aspirated through a lumen (e.g., lumen 132 of needle 102) and examined without removing needle 102 from the body. If more tissue is needed, the method continues until the biopsy needle 102 has sampled tissue from various locations around the airway perimeter. The needle 102 and catheter 100 are then withdrawn from the bronchoscope and removed from the body.

According to a second exemplary method of the present disclosure, an Olympus radial endobronchial ultrasound (EBUS) technique is employed. First, a guide sheath with an ultrasound probe positioned in its channel is inserted (e.g., through a body lumen) into the lung. The guide sheath with the ultrasound probe therein can be advanced further and into the lung than a typical bronchoscope and used to locate the target nodule. Once the introducer sheath has been positioned within the airway as desired adjacent the target nodule, the ultrasound probe is removed from the introducer sheath and the catheter 100 is advanced through the lumen of the introducer sheath until the distal end 106 is positioned adjacent the target nodule. With the catheter 100 in place, the method proceeds as described above. Specifically, the needle 102 is advanced through the lumen 108 of the catheter 100 until its distal end is deflected by the ramp 116 and exits the lateral opening 114 at an angle relative to the catheter 100. The needle 102 is advanced further distally and into the first biopsy site to collect a biopsy sample. After the sample has been obtained, the tissue sample is observed to determine if additional samples are needed. If more sample tissue is needed, the catheter 100 is rotated with the visual marker by a desired amount and the biopsy needle 102 is reinserted from the opening 114 through the lumen 108 and into a second biopsy site to collect a second biopsy sample, and the method continues until the biopsy needle 102 has obtained sufficient sample tissue from various locations around the airway perimeter. The needle 102 and catheter 100 are then withdrawn from the bronchoscope and sheath and removed from the body. It should be understood that although reference is made to a biopsy needle device 10, the methods of the present invention may be practiced with any of the disclosed devices 10, 20, 30.

It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the inventive concept thereof. It is also to be understood that structural features and methods relating to one embodiment may be incorporated into other embodiments. Therefore, it is to be understood that the inventions are not to be limited to the specific embodiments disclosed and that modifications to the embodiments are intended to be included within the scope of the inventions defined by the appended claims.