Catheter assembly with offset device for tissue sampling

Abstract

A catheter for tissue sampling is provided. [Solution] The disclosed embodiments include a catheter assembly, a system for sampling a target area of ​​tissue, and a method for sampling a target area of ​​tissue. In exemplary, non-limiting embodiments, the catheter assembly includes a catheter defining a lumen therein, a catheter wall defining an opening therein at the distal end of the catheter, a disposable flexible needle in the lumen, and an offset mechanism configured to extend the needle from the opening at the distal end of the catheter at an angle deviating from the axis of the lumen.

Description

Technical Field

[0001] The disclosed embodiments relate to a catheter for tissue sampling.

Background Art

[0002] The description in this section merely provides background information related to the present disclosure and may not constitute prior art.

[0003] Lesions are typically sampled using a needle disposed in a lumen defined within a catheter. When reaching the area of tissue to be sampled, the needle extends from the distal end of the lumen of the catheter. In conventional catheters, the needle extends axially from the distal end of the lumen of the catheter.

[0004] Sampling of tissue areas using conventional catheters and needles is not a problem when the tissue to be sampled is located straight ahead of the distal end of the catheter.

[0005] However, when a straight needle extends from the distal end of the lumen of the catheter, it can be difficult to sample an eccentric tissue area, i.e., a tissue area that is not located straight ahead of the distal end of the catheter or that is located outside the body lumen (such as an airway) where the catheter is placed. In such cases, the user may attempt to angle the conventional catheter and needle to sample the eccentric tissue area. However, it is not known that there is an instrument that can perform such angling accurately and controllably. Therefore, it can be difficult to achieve the desired angling. As a result, multiple attempts during sampling (each of which may involve penetrating the wall of the body lumen) may be made. These multiple attempts can increase the time required for the procedure, and inaccurate and uncontrolled sampling may result in a low yield from the intended target. Attempting these extra or inaccurate samplings can also contribute to an increased likelihood of piercing a blood vessel with the needle. [Overview of the project] [Means for solving the problem]

[0006] The disclosed embodiments include a catheter assembly, a system for sampling a target region of tissue, and a method for sampling a target region of tissue. It will be understood that the target region of tissue may be located coaxially with the body lumen or eccentrically (i.e., adjacent to the body lumen).

[0007] In exemplary, non-limiting embodiments, the catheter assembly includes a catheter defining a lumen therein, the catheter wall comprising a flexible needle configurable in the lumen, and an offset mechanism configured to extend the needle from the opening at the distal end of the catheter at an angle deviating from the axis of the lumen.

[0008] In another exemplary, non-limiting embodiment, a system for sampling a target region of tissue includes a handle assembly and a catheter assembly operably connected to the handle assembly, configured to be insertable into a body lumen toward a target region of tissue to be sampled, and defining a lumen therein, wherein the catheter wall includes a catheter, a flexible needle configurable in the lumen, and an offset mechanism configured to extend the needle from the opening at the distal end of the catheter at an angle deviating from the axis of the lumen.

[0009] In another exemplary, non-limiting embodiment, a method for sampling a target region of tissue includes inserting a catheter into a body lumen toward the target region of tissue to be sampled, extending a flexible needle from the distal end of the catheter at an angle deviating from the axis of the catheter toward the target region of tissue to be sampled, penetrating the tissue with the needle, and sampling the tissue.

[0010] Further features, advantages, and application areas will become apparent from the descriptions provided herein. It should be understood that the descriptions and examples are intended for illustrative purposes only and are not intended to limit the scope of this disclosure.

[0011] The drawings described herein are for illustrative purposes only and are not intended to limit the scope of this disclosure. The elements in the drawings are not necessarily to a specific scale and are primarily intended to illustrate the principles of the disclosed embodiments. [Brief explanation of the drawing]

[0012] [Figure 1A] This is a side plan view of a partially schematic configuration of a system including an exemplary catheter assembly. [Figure 1B] Figure 1A shows a partial schematic and a partially cropped side plan view of a detailed, exemplary embodiment of the catheter assembly. [Figure 2A] Figure 1A shows a partial schematic and a partially cropped side plan view of a detail of another exemplary embodiment of the catheter assembly. [Figure 2B] Figure 1A shows a partial schematic and a partially cropped side plan view of a detail of another exemplary embodiment of the catheter assembly. [Figure 3A] This is a partial side view of an embodiment of the catheter assembly shown in Figure 2A, which includes a flexible needle extended beyond the distal end of the catheter. [Figure 3B]Figure 2B is a partial side view of an embodiment of a catheter assembly, comprising a flexible needle and a curved stylet positioned on the needle extending beyond the distal end of the catheter. [Figure 3C] Figure 1B is a partial side view of an embodiment of a catheter assembly, comprising a flexible needle and a curved stylet positioned on the needle extending beyond the distal end of the catheter. [Figure 4A] This is a flowchart illustrating an exemplary method for sampling target regions within an organization. [Figure 4B] This is a detailed flowchart of the method shown in Figure 4A. [Figure 4C] This is a detailed flowchart of the method shown in Figure 4A. [Figure 4D] This is a detailed flowchart of the method shown in Figure 4A. [Figure 4E] This is a detailed flowchart of the method shown in Figure 4A. [Figure 4F] This is a detailed flowchart of the method shown in Figure 4A. [Modes for carrying out the invention]

[0013] The following descriptions are essentially illustrative and are not intended to limit the scope of this disclosure, application, or use.

[0014] Hereafter, various embodiments of catheter assemblies, systems for sampling targeted tissue regions, and methods for sampling targeted tissue regions will be described with reference to the accompanying figures. The technical terms used in the descriptions presented herein are not intended to be restrictive or limiting. Rather, the technical terms are used simply in conjunction with the detailed descriptions of embodiments of assemblies, systems, methods, and related components. Furthermore, embodiments may include several novel features, none of which alone contribute to their desired properties, nor are they considered essential for carrying out the embodiments disclosed herein. For example, while terms such as “lung,” “airway,” and “nodule” may be used to refer to the use of embodiments described herein, these terms are broad, and the embodiments described may be used non-limitingly and, unless otherwise specified, can be used to enter other blood vessels, nodes, lumens, body cavities, tissues, and organs present in humans and animals. For example, lumens such as those of the gastrointestinal tract (i.e., the intestines) can be entered by embodiments described herein.

[0015] Considered conceptually and with reference to Figures 1A and 1B, exemplary non-limiting embodiments of the catheter assembly 10 are shown. As with other embodiments described herein, as discussed herein, embodiments of the catheter assembly 10 can be used in conjunction with existing systems and methods for locating, navigating to, and biopsying (i.e., sampling) desired eccentric tissue regions (e.g., pulmonary nodules, lymph nodes) and desired concentric tissue. Some disclosed embodiments will be understood to enable sampling of eccentric tissue regions. That is, such disclosed embodiments can enable sampling of tissue regions that are not directly anterior to the distal end of the catheter or that are located outside the body lumen (e.g., airway) where the catheter assembly 10 is placed. Accordingly, the disclosed embodiments provide means (i.e., catheter assemblies and systems) and methods that can help enable the user to angle the catheter and needle for sampling eccentric tissue regions, thereby helping to achieve the desired angle more easily than with conventional catheters. As a result, such disclosed embodiments may help reduce the likelihood of the user making multiple sampling attempts (each of which may require penetrating the wall of a body lumen), thereby helping to reduce the likelihood of puncturing a blood vessel with a needle. It will also be understood that some disclosed embodiments may enable sampling of concentric tissue regions. Details of various disclosed embodiments are described below by non-limiting examples.

[0016] Referring again to Figures 1A and 1B, in an exemplary, non-limiting embodiment of the catheter assembly 10, the catheter 12 defines a lumen 14 within it. The wall 16 of the catheter 12 defines an opening 18 within it at the distal end 20 of the catheter 12. A flexible needle 22 can be positioned within the lumen 14. An offset mechanism 24 is configured to extend the needle 22 from the opening 18 at the distal end 20 of the catheter 12 at an angle that deviates from the axis 26 of the lumen 14.

[0017] It will be appreciated that the offset mechanism 24 can be embodied in a variety of ways. In some embodiments, the offset mechanism 24 can include an inclined path 28 defined in the catheter 12 at the distal end 20 of the catheter 12. In some other embodiments, the offset mechanism 24 can include a shaped and curved stylet 30 coaxially disposed within the needle 22. In some other embodiments, the offset mechanism 24 can include the inclined path 28 and the stylet 30. These embodiments will be discussed below, respectively.

[0018] As noted above and further referring to FIG. 2A, in some embodiments, the offset mechanism 24 can include an inclined path 28 defined in the catheter 12 at the distal end 20 of the catheter 12. In such embodiments, it will be appreciated that the curved stylet 30 (FIG. 1B) is not disposed in the needle 22 or is sufficiently retracted from the distal end of the needle 22 so that the stylet 30 does not extend beyond the distal end 20 of the catheter 12. However, in some embodiments, a straight stylet can be disposed in the needle .................

[0019] In such an embodiment, the ramp 28 has an inclined surface offset from the axis 26 of the lumen 14. Referring to such an embodiment in conjunction with FIG. 3A, the ramp 28 defines an offset angle α from the axis 26 of the lumen 14, in the range of from about 5 degrees to about 25 degrees. In some such embodiments, the offset angle α can be, for example, about 10 degrees. In some embodiments, the offset angle α can be in the range of from about 20 degrees to about 25 degrees. In some such embodiments, the offset angle α can be, for example, about 20 degrees. Regardless of the numerical value of the angle α, when the needle 22 extends towards the distal end 20 of the catheter 12, the needle 22 faces the ramp 28 (i.e., the inclined surface) at the distal end 20 of the catheter 12 and is directed towards the opening 18. The needle 22 exits the opening 18 (and continues in its extended state) at approximately the offset angle α. In some embodiments, the ramp 28 can be made of any suitable rigid plastic, such as polycarbonate.

[0020] Also as described above and further referring to FIG. 2B, in some embodiments, the offset mechanism 24 can include a shaped, curved stylet 30 coaxially disposed within the needle 22. In such an embodiment, it will be appreciated that the ramp 28 (FIGS. 1B and 2A) is not disposed at the distal end 20 of the catheter 12. As a result, the offset of the needle 22 from the axis 26 is provided only by the curvature of the stylet 30. Depending on the amount of curvature set for the stylet 30, such an embodiment can be suitable for applications where concentric regions of tissue are to be sampled, and for applications where eccentric regions of tissue are to be sampled.

[0021] In this embodiment, the shaped, curved stylet 30 is configured to extend from the opening 18 at the distal end 20 of the catheter 12 into the needle 22 (together with the needle 22). Referring to this embodiment and Figure 3B, the stylet 30 is configured to extend from the opening 18 at the distal end 20 of the catheter 12 at an angle β that deviates from the axis 26 of the lumen 14 (and is simultaneously arranged coaxially within the needle 22).

[0022] In various embodiments, a shaped curved stylet 30 is inserted into a flexible needle 22. The stylet 30 causes the needle 22 to follow the curve of the stylet 30. When a composite unit of the needle 22 and stylet 30 (referred to herein as the needle / stylet assembly 34), which is arranged coaxially with the needle 22, is surrounded within the catheter 12, the needle / stylet assembly 34 becomes straight, and thus the needle / stylet assembly 34 can move along the catheter 12. When the needle / stylet assembly 34 extends from the opening 18 at the distal end 20 of the catheter 12, the stylet 30, and consequently the needle / stylet assembly 34, can be curved again.

[0023] It will be understood that the amount of curvature of the stylet 30 is proportional to the length to which the stylet extends beyond the distal end 20 of the catheter 12. Therefore, when the needle / stylet assembly 34 extends from the opening 18, the stylet 30, and consequently the needle / stylet assembly 34, curves, thereby guiding the needle 22 out of the body lumen and off-axis. Since the curvature of the stylet 30 has various inclines, the stylet 30 can curve more as it extends further beyond the distal end 20 of the catheter 12. Therefore, it will be understood that the amount of curvature of the needle / stylet assembly 34 depends in part on the amount to which the tip 42 of the stylet 30 is pulled back from the tip 32 of the needle 22. The smaller the pull back from tip 32 to tip 42, the larger the offset angle from the axis 26. Conversely, the larger the pull back from tip 32 to tip 42, the smaller the offset angle from the axis 26. The amount of retraction from tip 32 to tip 42 is sufficient (the stylet 30 cannot extend the distal end 20 of the catheter far too far), so that a large offset angle cannot be achieved.

[0024] By setting a sufficient amount of curvature in the stylet 30, this curvature guides the needle 22 out of the body's lumen, such as the airway, and allows the needle 22 to penetrate the body's lumen wall, such as the airway wall. Thus, the needle 22 can sample eccentrically located targets. However, if an appropriate amount of curvature is set in the stylet 30, the needle 22 is guided out of the body's lumen by this curvature, while at the same time the needle 22 remains within the body's lumen. This allows the needle 22 to sample concentrically located targets.

[0025] As shown in Figure 3B, angle β will be understood as the initial angle at which the needle / stylet assembly 34 extends from the opening 18. As shown in Figure 3B, the curvature of the stylet 30 has various inclinations, so the angle at which the needle / stylet assembly 34 deviates from the axis 26 can increase as the stylet 30 extends further from the opening 18. For example, as shown in Figure 2B, the distal end of the needle / stylet assembly 34 deviates from the axis 26 by angle χ. It will be understood that angle χ is greater than the angle β achieved at the proximal end of the opening 18.

[0026] As described above and as shown in Figure 1B, in some embodiments the offset mechanism 24 may include a ramp 28 and a stylet 30 (which is coaxially arranged within the needle 22). In such embodiments, as the needle / stylet assembly 34 extends toward the distal end 20 of the catheter 12, the needle 22 faces the ramp 28 (i.e., the inclined surface) at the distal end 20 of the catheter 12, and the needle / stylet assembly 34 moves toward the opening 18.

[0027] Referring to Figure 3C, the needle / stylet assembly 34 exits the opening 18 at an offset angle δ. Since the needle / stylet assembly 34 is aligned with the ramp 28 at an offset angle α before exiting the opening 18, angle δ is greater than angle β, and it will be understood that the stylet 30 causes the needle / stylet assembly 34 to deviate further from the axis 26 by angle β. As shown in Figure 3C and discussed above with reference to Figure 3B, the angle at which the needle / stylet assembly 34 deviates from the axis 26 can increase as the needle / stylet assembly 34 extends further from the opening 18. For example, as shown in Figure 3C, the distal end of the needle / stylet assembly 34 deviates from the axis 26 by angle ε. It will be understood that angle ε is greater than the angle δ achieved at the proximal end of the opening 18 due to the curvature of the stylet 30.

[0028] In such embodiments, it will also be understood that once the needle / stylet assembly 34 has exited the opening 18, the ramp 28 can help to orient the needle / stylet assembly 34 toward the opening 18. In various embodiments, the stylet 30 is circular and therefore not constrained to enter the lumen 14 in any particular direction, thus providing this orientational assistance. For example, the stylet 30 can be coaxially fixed to the needle 22 in one of the following orientations: upward, downward, left, or right (relative to the opening 18). If the curvature (i.e., orientation) of the stylet 30 faces the wrong direction (for example, downward when the ramp 28 is upward), the ramp 28 will orient the stylet 30 again in the correct direction, so that the curvature of the stylet 30 is applied eccentrically toward the ramp 28 at the angle α of the ramp 28. Since the curved portion of the stylet 30 passes through the ramp 28, the stylet 30 is curved in the direction of the ramp 28. Therefore, in this embodiment, the curved stylet 30 is always applied to the angle of the ramp 28.

[0029] In various embodiments, the catheter 12 includes a sheath 36 and a sheath liner 38. As considered in non-limiting examples, the sheath 36 may be braided and may be made from any suitable medical-grade polymer material such as a thermoplastic elastomer. The catheter 12 may be torqued to rotate the opening 18, and it will be understood that the needle 22 will reach the target tissue. Similarly, as considered in non-limiting examples, the sheath liner 38 may be made from any suitable material such as polytetrafluoroethylene (PTFE).

[0030] In various embodiments, the flexible needle 22 may be made from any suitable material that can partially provide a needle 22 having the desired flexibility and sufficient column strength to puncture tissue. Considered in non-limiting examples, in some embodiments, the needle 22 may be made from a plastic such as PEEK or Ultem. Considered in further non-limiting examples, in some embodiments, the needle 22 may be made from a metal or a metal alloy such as stainless steel, Nitinol, or cobalt-chromium, such as American Iron and Steel Institute ("AISI") Type 304 stainless steel.

[0031] In such embodiments, where the needle 22 is made of metal or a metal alloy as shown in Figure 1B, flexibility is imparted to the needle by cuts 40 defined on the needle 22, such as by laser cutting. Similarly, in non-limiting examples, the needle 22 may be made of hypodermic tubing ("hypotubing"). In some such embodiments, the needle 22 may be a 25-gauge hypotubing, depending on the size and flexibility constraints of the particular application. In such embodiments, the hypotubing is preferably configured to be relatively smooth at least along its proximal portion, so that, when introduced into a device such as the lumen 14 of a catheter 12, for example, the hypotubing can slide, rotate, or otherwise move relatively freely along the lumen 14. As considered by illustrative purposes only and not limitations, when the needle 22 is configured to be sized by cuts 40 as described above, in various embodiments, the needle 22 may be understood to be able to bend in a small space at an angle of about 45 degrees, for example.

[0032] As discussed above, the stylet 30 is a shaped curved stylet. In various embodiments, the stylet 30 may be made from any suitable material, such as a shape memory alloy ("SMA"), which imparts the desired shape and curvature to the distal end of the stylet 30. Considering non-limiting examples, in various embodiments, the stylet 30 may be made from an SMA such as nitinol.

[0033] In various embodiments, the stylet 30 is sized such that when the stylet is positioned coaxially with the needle 22, the stylet 30 is inserted into the needle 22, thereby helping to prevent sampling by the needle 22 before the needle 22 is positioned in the desired area of ​​interest. As considered by example only and not limitation, the tip 42 of the stylet 30 can retract by about 0.5 mm or away from the tip 32 of the needle 22 when the needle / stylet assembly 34 is positioned in the lumen 14.

[0034] It will be understood that the curved stylet 30 conforms to the shape of the catheter 12 while the stylet 30 is positioned within the lumen 14. As discussed above, the curved stylet 30, and consequently the needle / stylet assembly 34, bends after the needle / stylet assembly 34 extends from the opening 18. As a result, and as discussed further below, the curved stylet 30 is configured to be withdrawn from the lumen 14, thereby withdrawing the needle 22 and enabling tissue sampling by the needle 22.

[0035] In various embodiments, an exemplary system 50 (Figure 1A) is configured to sample a target area of ​​tissue. The tissue may, without limitation, include lesions located adjacent to lumens of the body, such as airways, and may be located either inside the lumen of the body (i.e., concentric tissue) or outside the lumen of the body (i.e., eccentric tissue). In such embodiments, the system 50 includes a handle assembly 60 (Figure 1A). A catheter assembly 10 is operably connected to the handle assembly 60 and is configured to be insertable into the lumen of the body toward the target area of ​​tissue to be sampled. As discussed above, the catheter assembly 10 includes a catheter 12. Similarly as discussed above, the catheter 12 defines a lumen 14 inside, and the wall 16 of the catheter 12 defines an opening 18 inside at the distal end 20 of the catheter 12. The flexible needle 22 can be positioned in the lumen 14, and the offset mechanism 24 is configured to extend the needle 22 from the opening 18 at the distal end 20 of the catheter 12 at an angle that deviates from the axis 26 of the lumen 14.

[0036] Similarly, as described above, in some embodiments, the offset mechanism 24 may include a ramp 28 defined in the catheter 12 at the distal end 20 of the catheter 12. In some other embodiments, the offset mechanism 24 may include a curved stylet 30 coaxially disposed within the needle 22. In some other embodiments, the offset mechanism 24 may include both the ramp 28 and the curved stylet 30. Details of all these embodiments have been discussed above and do not need to be repeated in order to understand the subject matter disclosed.

[0037] In various embodiments, the handle assembly 60 is multifunctional. For example, in some embodiments, the user can use the handle assembly 60 to apply torque to the catheter 12 and rotate the opening 18, thereby allowing the needle 22 to reach eccentric tissue. Similarly, in some embodiments, the stylet 30 can be removed from the catheter assembly 10 via a Luer connector 66 located at the proximal end 68 of the handle assembly 60. Furthermore, in some embodiments, a vacuum device (not shown), such as a syringe, may be operably connected to the needle 22 via the Luer connector 66 in the handle assembly 60 when the stylet 30 is withdrawn from the lumen.

[0038] Various embodiments of System 50 operate as follows: An endoscope (not shown) or bronchoscope (not shown), suitable for a particular application, is moved to a target position in a lumen of the body. This target is visualized using an imaging system (such as an ultrasound probe, optical channel, fluoroscopy, optical coherence tomography, X-ray computed tomography visualization assistance, and magnetic resonance imaging). The catheter assembly 10 is mounted on the endoscope (or bronchoscope), and the handle assembly 60 is used to torque the catheter 12 so that the opening 18 is aligned with the target.

[0039] In embodiments where the offset mechanism includes only the ramp 28, the needle 22 extends past the distal end 20 of the catheter 12 and toward the target tissue from the opening 18. In some cases, the needle 22 can penetrate the wall of the body lumen. The needle 22 penetrates the target tissue. If desired, the needle 22 can agitate the tissue by repeatedly moving it backward and forward. By using the needle 22 at the target, a vacuum device (not shown), such as a syringe, is operably connected to the needle 22 via a Luer connector 66 in the handle assembly 60. In embodiments where a straight stylet is positioned on the needle 22, the straight stylet is detached from the Luer connector 66 before the vacuum device is operably connected to the needle 22 by the Luer connector 66. The vacuum device draws a vacuum, resulting in sampling of the tissue through the needle 22.

[0040] In embodiments where the offset mechanism 24 includes only a curved stylet 30, and in embodiments where the offset mechanism includes a ramp 28 and a curved stylet 30, the needle / stylet assembly 34 extends past the distal end 20 of the catheter 12 and toward the target from the opening 18. In some cases, the needle / stylet assembly 34 can penetrate the wall of the body lumen. The needle / stylet assembly 34 penetrates the target. If desired, the needle / stylet assembly 34 can agitate the tissue by repeatedly moving the tissue backward and forward. The stylet 30 is removed from the lumen 14 via a Luer connector 66 in the handle assembly 60, and the tissue holds the needle 22 in a suitable position within the tissue. The stylet 30 is removed from the lumen 14, and a vacuum device (not shown), such as a syringe, is operably connected to the needle 22 via a Luer connector 66 in the handle assembly 60. A vacuum device is used to create a vacuum, and as a result, tissue is sampled through the needle 22.

[0041] The following is a series of flowcharts illustrating the implementation. For ease of understanding, these flowcharts are structured such that the first flowchart represents the implementation by the embodiment, and subsequent flowcharts represent alternative implementations and / or extensions of the first flowchart, either as operations on partial components or operations on additional components to one or more previously presented flowcharts. Those skilled in the art will understand that the stylelets of representation used herein (i.e., beginning with a flowchart representing the implementation of the embodiment, followed by additions to subsequent flowcharts, and / or providing further details in these flowcharts) generally enable a quick and easy understanding of the implementation of various methods.

[0042] Referring now to Figure 4A, an exemplary method 100 for sampling a target region of tissue is presented. It will be understood that embodiments of method 100 may be suitable for using various embodiments of the catheter assembly 10 and system 50, without limitation. It will also be understood that the target region has been located before method 100 is initiated.

[0043] Method 100 begins in block 102. In block 104, the catheter is inserted into the body lumen in the direction of the target area of ​​the tissue to be sampled. In block 106, a flexible needle is extended from the distal end of the catheter at an angle deviating from the catheter axis toward the target area of ​​the tissue to be sampled. In block 108, the tissue is penetrated by the needle. In block 110, the tissue is sampled. Method 100 ends in block 112.

[0044] Referring to Figure 4B, in some embodiments, after the catheter is inserted into the body lumen toward the target region of the tissue to be sampled in block 104, and before the flexible needle is extended from the distal end of the catheter at an angle that deviates from the axis of the catheter toward the target region of the tissue to be sampled in block 106, the catheter may be torqued in block 114 so that the opening defined at the distal end of the catheter faces toward the target region of the tissue to be sampled.

[0045] Referring to Figure 4C, in some embodiments, extending a flexible needle from the distal end of the catheter at an angle deviating from the catheter axis toward the target region of tissue sampled in block 106 may include extending the needle from an opening defined at the distal end of the catheter via a ramp defined at the distal end of the catheter, the ramp having an inclined surface deviating from the catheter axis in block 116.

[0046] Referring to Figure 4D, in some embodiments, extending a flexible needle from the distal end of the catheter at an angle deviating from the catheter axis toward the target region of tissue sampled in block 106 may include extending a curved stylet coaxially positioned within the needle from an opening defined at the distal end of the catheter, which, upon exiting the catheter, bends at an angle deviating from the catheter axis, and the curved stylet adapts to the shape of the catheter as it is positioned within the catheter in block 118.

[0047] Referring to Figure 4E, in some embodiments, after the needle has penetrated the tissue in block 108 and before the tissue is sampled in block 110, the curved stylet is removed from the catheter in block 120 and a vacuum device is operably connected to the needle.

[0048] Referring to Figure 4F, in some embodiments, extending a flexible needle from the distal end of the catheter at an angle deviating from the catheter axis toward the target region of tissue sampled in block 106 may include extending the needle and a curved stylet coaxially disposed within the needle from an opening defined at the distal end of the catheter by an inclined path defined at the distal end of the catheter, the inclined path having an inclined surface deviating from the catheter axis in block 122, extending the needle and the curved stylet coaxially disposed within the needle from an opening defined at the distal end of the catheter, the curved stylet bending at an angle deviating from the catheter axis once it exits the catheter, and the curved stylet adapts to the shape of the catheter as it is disposed within the catheter in block 124.

[0049] This description of the biopsy systems, apparatus, and methods described herein for use in the lungs and for use against pulmonary nodules is not limited, and these embodiments will be understood to be usable for biopsy, navigation, and exploration of target areas in other locations of the patient, including the stomach, endoscopically, or other suitable locations. Similarly, bronchoscopy is not required, and other suitable devices that can be adapted to the embodiments described herein, including various endoscopic or laparoscopic cannulas, can also be used, non-limitingly.

[0050] The embodiments for carrying out the invention described above are essentially illustrative, and it will be understood that variations that do not deviate from the spirit and / or intent of the claimed subject matter are intended to be within the scope of the claims. Such variations will not be considered to deviate from the spirit and scope of the claimed subject matter.

Claims

1. A catheter assembly, A catheter that defines a first lumen and a sampling lumen, wherein the catheter includes an opening formed in the side wall at the distal end of the sampling lumen. A flexible needle that can be placed in the sampling lumen, An offset mechanism comprising a ramp within the sampling lumen and a curved stylet that can be coaxially positioned within the flexible needle so as to face the ramp, wherein the ramp has a sloped surface adjacent to the opening and forming the distal end of the sampling lumen, and the ramp and the curved stylet are configured to cooperate in deflecting the flexible needle as it exits the sampling lumen through the opening when the flexible needle is advanced past the distal end of the catheter, and the ramp is configured so as to deflect the flexible needle as it extends toward the distal end of the catheter An offset mechanism is provided, wherein the flexible needle is guided at a first offset angle from the axis of the sampling lumen, and the curved stylet causes the flexible needle to move away from the inclined path and further deviate from the axis of the sampling lumen at a second offset angle when the flexible needle is extended past the distal end of the catheter for sampling of an eccentric tissue region, the second offset angle being greater than the first offset angle, and the curved stylet is configured to conform to the shape of the catheter while being positioned within the sampling lumen. A catheter assembly characterized by comprising the following features.

2. The catheter assembly according to claim 1, characterized in that the distal end of the ramp is aligned with the distal end of the first lumen.

3. The catheter assembly according to claim 1, characterized in that the ramp defines an offset from the axis of the sampling lumen in the range of about 5 degrees to about 25 degrees.

4. The catheter assembly according to claim 1, wherein the curved stylet is configured to extend from the opening into the flexible needle at the distal end of the catheter at an angle that deviates from the axis of the sampling lumen, the amount of curvature of the curved stylet is proportional to the length to which the curved stylet extends past the distal end of the catheter, and the curved stylet is further configured to be withdrawn from the sampling lumen.

5. The catheter assembly according to claim 1, characterized in that the curved stylet is made from a shape memory alloy.

6. A system for sampling a target region of an organization, wherein the system Handle assembly and A catheter assembly is operably connected to the handle assembly and configured to be insertable into a body lumen toward a target region of tissue to be sampled, wherein the catheter assembly is A catheter comprising a catheter that defines a first lumen and a sampling lumen, wherein the catheter includes an opening formed in the side wall of the sampling lumen adjacent to the distal end of the catheter, A flexible needle that can be placed in the sampling lumen, An offset mechanism configured to extend the flexible needle beyond the distal end of the catheter through the opening at an angle that deviates from the axis of the sampling lumen, wherein the offset mechanism A ramp forming the distal end of the sampling lumen, wherein the opening extends proximal to the wall of the sampling lumen forming the proximal end of the opening from the distal leading edge of the ramp, the ramp has an inclined surface facing the opening, the inclined surface is offset from the axis of the sampling lumen to form the distal end of the sampling lumen, and the ramp is configured to move the flexible needle away from the axis of the sampling lumen so that it extends from the opening adjacent to the distal end of the catheter at a first offset angle, A curved stylet that can be coaxially disposed within the flexible needle so as to face the ramp, wherein the curved stylet is configured to extend from the opening into the flexible needle at the distal end of the catheter, and the curved stylet is configured to cause the flexible needle to move away from the ramp and increasingly deviate from the axis of the sampling lumen by a second offset angle when the flexible needle is extended past the distal end of the catheter for sampling of an eccentric tissue region, wherein the second offset angle is greater than the first offset angle, and the curved stylet is configured to conform to the shape of the catheter at the same time as being disposed within the sampling lumen, Includes an offset mechanism, A catheter assembly including, A system characterized by comprising the following features.

7. The system according to claim 6, characterized in that, in cross-section, the ramp is formed in the side wall between the sampling lumen and the first lumen extending through at least a portion of the catheter.

8. The system according to claim 6, characterized in that the distal end of the ramp is aligned with the distal end of the first lumen.

9. The curved stylet is further configured to be withdrawn from the sampling lumen by the handle assembly, and the system A vacuum device in which the curved stylet is withdrawn from the sampling lumen and the handle assembly is operably connected to the flexible needle. The system according to claim 6, further comprising the features described above.

10. The system according to claim 6, characterized in that the handle assembly is configured to apply torque to the catheter.

11. The catheter assembly according to claim 1, characterized in that the inclined surface of the ramp forms a surface that, when viewed in cross-section, is angled with respect to the axis of the sampling lumen.

12. The catheter assembly according to claim 1, characterized in that the cross section of the ramp includes an angled surface extending from a proximal first point to a distal second point, the proximal first point is on the side wall of the sampling lumen, and the distal second point forms the distal end of the opening.

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