Catheter assembly with deflection device for tissue sampling

Abstract

The present invention is entitled "Catheter Assembly with Deflection Device for Tissue Sampling". The disclosed embodiments include a catheter assembly, a system for sampling a targeted tissue area, and a method for sampling a targeted tissue area. In an exemplary, non-limiting embodiment, the catheter assembly includes: a catheter, the catheter defining a lumen therein, the wall of the catheter defining an opening therein at the distal end of the catheter; a flexible needle that can be disposed in the lumen; and a deflection mechanism that is configured to urge the needle to extend from the opening at the distal end of the catheter at an angle that deviates from the axis of the lumen.

Description

Technical Field

[0001] The disclosed embodiments relate to catheters for tissue sampling. Background Art

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

[0003] The lesion is usually sampled using a needle disposed in a lumen defined in the catheter. When the needle reaches the tissue region to be sampled, the needle extends from the distal end of the catheter lumen. In conventional catheters, the needle extends axially from the distal end of the catheter lumen.

[0004] Sampling a region of tissue using a conventional catheter and needle does not present challenges when the tissue to be sampled is located just in front of the distal end of the catheter.

[0005] However, the needle extends straight out of the distal end of the catheter lumen, which can present challenges when sampling eccentric tissue areas—those that are not directly in front of the distal end of the catheter or outside the body cavity (such as the airway) where the catheter is placed. In such cases, the user may attempt to sample the eccentric tissue area by angling the conventional catheter and needle. However, there are no known tools that accurately and controllably achieve this angulation. Therefore, it may be difficult to achieve the desired angulation. Therefore, multiple sampling attempts may be made (each attempt may require puncturing the wall of the body cavity). Multiple attempts can increase the amount of time for the procedure, and inaccurate, uncontrollable sampling can result in a low yield from the intended target. These additional or inaccurate sampling attempts can also increase the probability of the needle poking into a blood vessel. Summary of the invention

[0006] The disclosed embodiments include catheter assemblies, systems for sampling a targeted tissue region, and methods of sampling a targeted tissue region.It should be understood that the targeted tissue region may be positioned concentrically in a body lumen or eccentrically (ie, adjacent to the body lumen).

[0007] In an exemplary, non-limiting embodiment, a catheter assembly includes: a catheter defining a lumen therein, a wall of the catheter defining an opening therein at a distal end of the catheter; a flexible needle that can be disposed in the lumen; and an offset mechanism configured to urge the needle to extend from the opening at the distal end of the catheter at an angle that deviates from the axis of the lumen.

[0008] In another exemplary, non-limiting embodiment, a system for sampling a targeted tissue area comprises: a handle assembly; and a catheter assembly operably connected to the handle assembly, the catheter assembly being configured to be insertable into a body cavity toward the targeted tissue area to be sampled, the catheter assembly comprising: a catheter defining a lumen therein, a wall of the catheter defining an opening therein at a distal end of the catheter; a flexible needle that can be disposed in the lumen; and an offset mechanism configured to push the needle out of the opening at the distal end of the catheter at an angle that deviates from the axis of the lumen.

[0009] In another exemplary, non-limiting embodiment, a method for sampling a targeted tissue area includes: inserting a catheter into a body cavity toward the targeted tissue area to be sampled; extending a flexible needle from a distal end of the catheter toward the targeted tissue area to be sampled at an angle offset from the axis of the catheter; puncturing tissue with the needle; and sampling the tissue.

[0010] Other features, advantages, and scope of applicability will become apparent from the description provided herein.It should be understood that the detailed description and specific examples are for illustrative purposes only and are not intended to limit the scope of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The drawings described herein are for illustrative purposes only and are not intended to limit the scope of the present disclosure in any way. The components in the drawings are not necessarily drawn to scale, but emphasis is placed on illustrating the principles of the disclosed embodiments. In the drawings:

[0012] Figure 1A is a side plan view, in partial schematic form, of a system including an exemplary catheter assembly.

[0013] Figure 1B yes Figure 1A Details of an exemplary embodiment of a catheter assembly are shown in partial schematic form and in side plan view in partial cross-section.

[0014] Figure 2A yes Figure 1A A detail of another exemplary embodiment of a catheter assembly is shown in partial schematic form and in side plan view in partial cross-section.

[0015] Figure 2B yes Figure 1A A detail of another exemplary embodiment of a catheter assembly is shown in partial schematic form and in side plan view in partial cross-section.

[0016] Figure 3A yes Figure 2A A side view of a portion of an embodiment of a catheter assembly in which the flexible needle extends beyond the distal end of the catheter.

[0017] Figure 3B yes Figure 2B A side view of a portion of an embodiment of a catheter assembly in which a flexible needle and a curved stylet disposed in the needle extend beyond a distal end of the catheter.

[0018] Figure 3C yes Figure 1B A side view of a portion of an embodiment of a catheter assembly in which a flexible needle and a curved stylet disposed in the needle extend beyond a distal end of the catheter.

[0019] Figure 4A is a flow chart of an exemplary method for sampling a targeted tissue region.

[0020] FIG. 4B to FIG. 4F yes Figure 4A Flow chart of the details of the method. DETAILED DESCRIPTION

[0021] The following description is merely exemplary in nature and is not intended to limit the present disclosure, application, or uses.

[0022] Various embodiments of the catheter assembly, the system for sampling the target tissue area, and the method for sampling the target tissue area will now be described with reference to the accompanying drawings. The terms used in the description proposed herein are not intended to be interpreted in any limiting or restrictive manner. On the contrary, the term is simply used in conjunction with the detailed description of the embodiment of the assembly, system, method, and related parts. In addition, the embodiment may include several novel features, none of which can determine its required attributes alone or is believed to be indispensable for implementing the disclosed embodiments described herein. For example, although it may be mentioned herein that the embodiments described herein are used together with terms such as "lung", "airway", "nodule", these terms are broad, and the embodiments can be used without restriction, and unless otherwise specified, can be used to enter other blood vessels, channels, lumens, body cavities, tissues, and organs present in humans and animals. For example, lumens (such as those lumens in the gastrointestinal system (i.e., intestines)) can be entered with the embodiments described herein.

[0023] Given in summary form and see Figure 1A and Figure 1B, an exemplary, non-limiting embodiment of a catheter assembly 10 is shown. As will be discussed herein, the embodiment of the catheter assembly 10 and other embodiments described herein can be used in conjunction with existing systems and methods for locating, navigating to and biopsying (i.e., sampling) an eccentric tissue region of interest (e.g., lung nodules, lymph nodes) and a concentric tissue region of interest. It should be understood that some disclosed embodiments may allow sampling of eccentric tissue regions. That is, such disclosed embodiments may allow sampling of tissue in a region that is not located directly in front of the distal end of the catheter or outside the body cavity (such as an airway) where the catheter assembly 10 is placed. Therefore, the disclosed embodiments may provide tools (i.e., catheter assembly and system) and methods that may help allow a user to sample an eccentric tissue region by angling the catheter and the needle, thereby helping to more easily achieve the desired angulation than conventional catheters. Therefore, such disclosed embodiments may help reduce the possibility of multiple sampling attempts by the user (each attempt may require puncturing the wall of the body cavity), thereby helping to reduce the probability of the needle poking into a blood vessel. It should also be understood that some disclosed embodiments may allow sampling of concentric tissue regions. Details regarding various disclosed embodiments are set forth below by way of non-limiting examples.

[0024] Still see Figure 1A and Figure 1B In an exemplary, non-limiting embodiment of the catheter assembly 10, the catheter 12 defines a lumen 14 therein. A wall 16 of the catheter 12 defines an opening 18 therein at a distal end 20 of the catheter 12. A flexible needle 22 may be disposed in the lumen 14. The biasing mechanism 24 is configured to push the needle 22 out of the opening 18 at the distal end 20 of the catheter 12 at an angle offset from an axis 26 of the lumen 14.

[0025] It should be understood that the biasing mechanism 24 can be embodied in various ways. In some embodiments, the biasing mechanism 24 can include a ramp 28 defined in the catheter 12 at the distal end 20 of the catheter 12. In some other embodiments, the biasing mechanism 24 can include a shaped curved stylet 30 coaxially disposed within the needle 22. In some other embodiments, the biasing mechanism 24 can include a ramp 28 and a stylet 30. Each of these embodiments will be discussed below.

[0026] As above and see also Figure 2A In some embodiments, the biasing mechanism 24 may include a ramp 28 defined in the catheter 12 at the distal end 20 of the catheter 12. It should be understood that in such embodiments, the curved stylet 30 ( Figure 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 may be disposed in the needle 22 to tighten the needle 22, if desired. Thus, the offset of the needle 22 from the axis 26 is imparted only by the bevel 28. Due to the range of offset angles achievable in such embodiments (as discussed below), such embodiments may be suitable for applications where concentric tissue regions are to be sampled and for applications where eccentric tissue regions are to be sampled.

[0027] In such embodiments, the bevel 28 has an inclined surface that is offset from the axis 26 of the lumen 14. In such embodiments and see also Figure 3A , the bevel 28 defines an offset angle α with the axis 26 of the lumen 14 in the range of about 5 degrees to about 25 degrees. In some such embodiments, the offset angle α may be about 10 degrees or so. In some embodiments, the offset angle α may be in the range of about 20 degrees to about 25 degrees. In some such embodiments, the offset angle α may be about 20 degrees or so. When the needle 22 extends toward the distal end 20 of the catheter 12, regardless of the value of the angle α, the needle 22 encounters the bevel 28 (i.e., the inclined surface) at the distal end 20 of the catheter 12 and is pushed toward the opening 18. The needle 22 leaves the opening 18 (and continues to extend) at approximately the offset angle α. In some embodiments, the bevel 28 may be made of any suitably hard plastic (such as polycarbonate, etc.).

[0028] Also as above and see also Figure 2B In some embodiments, the biasing mechanism 24 may include a shaped curved stylet 30 coaxially disposed within the needle 22. It should be understood that in such embodiments, the bevel 28 ( Figure 1B and Figure 2A ) is not provided in the distal end 20 of the catheter 12. Thus, the offset of the needle 22 from the axis 26 is imparted solely by the bend in the stylet 30. Depending on the amount of bend built into the stylet 30, such embodiments may be suitable for applications where concentric tissue regions are to be sampled and for applications where eccentric tissue regions are to be sampled.

[0029] In such embodiments, the shaped curved stylet 30 is configured to extend from the opening 18 at the distal end 20 of the catheter 12 within (along with) the needle 22. In such embodiments and see also Figure 3B , the stylet 30 is configured to extend from the opening 18 at the distal end 20 of the catheter 12 (while being coaxially disposed within the needle 22 ) at an angle β offset from the axis 26 of the lumen 14 .

[0030] In various embodiments, a shaped curved stylet 30 is inserted into the flexible needle 22. The stylet 30 causes the needle 22 to follow the curve of the stylet 30. When the composite unit of the needle 22 and the stylet 30 coaxially disposed in the needle 22 (referred to herein as the needle / stylet assembly 34) is enclosed within the catheter 12, the needle / stylet assembly 34 is straight, thereby allowing the needle / stylet assembly 34 to be advanced through the catheter 12. When the needle / stylet assembly 34 extends through the opening 18 in the distal end 20 of the catheter 12, the stylet 30, and thus the needle / stylet assembly 34, may become curved again.

[0031] It should be understood that the amount of curvature of the stylet 30 is proportional to the length that the stylet extends beyond the distal end 20 of the catheter 12. To this end, as the needle / stylet assembly 34 extends through the opening 18, the stylet 30 and, therefore, the needle / stylet assembly 34 becomes curved, thereby causing the needle 22 to be off-axis from the body cavity. Since the curvature of the stylet 30 has a varying slope, the further the stylet 30 extends beyond the distal end 20 of the catheter 12, the more curved the stylet 30 may become. Therefore, it should be understood that the amount of curvature of the needle / stylet assembly 34 depends in part on the amount of retraction of the tip 42 of the stylet 30 from the tip 32 of the needle 22. Less retraction of the tip 42 from the tip 32 results in a greater offset angle from the axis 26. Conversely, greater retraction of the tip 42 from the tip 32 results in a smaller offset angle from the axis 26. Where the amount of retraction of the tip 42 from the tip 32 is sufficiently great that the stylet 30 may not extend significantly beyond the distal end 20 of the catheter, no significant offset angle may result.

[0032] When the amount of bend set into the stylet 30 is large enough, the bend causes the needle 22 to be off-axis with the body cavity (such as the airway) and enables the needle 22 to puncture the wall of the body cavity (such as the airway wall), thereby enabling the needle 22 to sample an eccentrically positioned target. However, it should be understood that an appropriate amount of bend can be set into the stylet 30 so that when the bend causes the needle 22 to be off-axis with the body cavity, the needle 22 remains within the body cavity, thereby enabling the needle 22 to sample a concentrically positioned target.

[0033] It should be understood that Figure 3B As shown, angle β is the initial angle at which the needle / stylet assembly 34 extends from the opening 18. Figure 3B As shown, because the bend of the stylet 30 has a varying slope, the angle at which the needle / stylet assembly 34 deviates from the axis 26 may increase as the stylet 30 extends further from the opening 18. Figure 2B As shown, the distal end of the needle / stylet assembly 34 is offset from the axis 26 at an angle x. It should be understood that the angle x is greater than the angle β achieved proximal to the opening 18.

[0034] As mentioned above and Figure 1B As shown, in some embodiments, the biasing mechanism 24 may include a bevel 28 and a stylet 30 (which is coaxially disposed within the needle 22). In such embodiments, when the needle / stylet assembly 34 is extended toward the distal end 20 of the catheter 12, the needle 22 encounters the bevel 28 (i.e., an inclined surface) at the distal end 20 of the catheter 12 and the needle / stylet assembly 34 is pushed toward the opening 18.

[0035] See also Figure 3C , the needle / stylet assembly 34 exits the opening 18 at an offset angle δ. It will be appreciated that the angle δ is greater than the angle β because the needle / stylet assembly 34 is pushed along the ramp 28 at an offset angle α before exiting through the opening 18, and the stylet 30 then causes the needle / stylet assembly 34 to additionally deviate from the axis 26 at an angle β. Figure 3C As shown and as referred to above Figure 3B As discussed above, as the needle / stylet assembly 34 extends further from the opening 18, the angle at which the needle / stylet assembly 34 deviates from the axis 26 may increase. Figure 3C As shown, the distal end of the needle / stylet assembly 34 is offset from the axis 26 at an angle ε. It will be appreciated that the angle ε is greater than the angle δ achieved proximal to the opening 18 due to the curvature of the stylet 30.

[0036] It should also be understood that in such embodiments, once the needle / stylet assembly 34 has exited the opening 18, the bevel 28 can help orient the needle / stylet assembly 34 toward the opening 18. This orientation aid occurs because, in various embodiments, the stylet 30 is round and, therefore, is not limited to entering the lumen 14 in a particular direction. For example, the stylet 30 can be coaxially fitted into the needle 22 in an orientation that is any of upward, downward, left, or right (relative to the opening 18). If the bend (i.e., orientation) of the stylet 30 faces the wrong direction (such as, for example, downward when the bevel 28 is upward), the bevel 28 will force the stylet 30 to reorient to the correct orientation, such that the bend of the stylet 30 follows the orientation of the bevel 28 and adds eccentricity to the angle α of the bevel 28. As the curved portion of the stylet 30 passes the bevel 28, the stylet 30 is forced to bend in the direction of the bevel 28. Thus, in such embodiments, bending the stylet 30 always increases the angle of the bevel 28.

[0037] In various embodiments, the catheter 12 includes a sheath 36 and a sheath hub 38. By way of non-limiting example, the sheath 36 may be braided and may be made of any suitable medical grade polymer material, such as a thermoplastic elastomer. It should be appreciated that the use of a braided material for the sheath 36 may provide sufficient rigidity so that the catheter 12 may be twisted to rotate the opening 18, and thus the needle 22, to the target tissue. Also by way of non-limiting example, the sheath hub 38 may be made of any suitable material, such as polytetrafluoroethylene (PTFE), etc.

[0038] In various embodiments, the flexible needle 22 can be made of any suitable material that can provide, in part, the desired flexibility and sufficient strut strength for piercing tissue to the needle 22. By way of non-limiting example, in some embodiments, the needle 22 can be made of a plastic such as PEEK, polyetherimide, etc. As another non-limiting example, in some embodiments, the needle 22 can be made of a metal or metal alloy such as stainless steel (e.g., American Iron and Steel Institute ("AISI") Type 304 stainless steel), Nitinol, cobalt chromium alloy, etc.

[0039] In such embodiments where the needle 22 is made of a metal or metal alloy, such as Figure 1B As shown, flexibility is imparted to the needle via an incision 40 defined in the needle 22 (such as by laser cutting). Also as a non-limiting example, the needle 22 may be made of hypodermic tubing ("hypotube"). In some such embodiments, the needle 22 may be a 25-gauge hypotube, etc., depending on the size and flexibility constraints of the particular application. In such embodiments, the hypotube may be appropriately constructed to be relatively smooth along at least the proximal portion, so that when introduced into a device (such as the lumen 14 of the catheter 12), for example (but not limited to this), the hypotube can slide, rotate or otherwise move relatively freely along the lumen 14. Given only by way of illustration and not limitation, it should be understood that when the needle 22 is sized and configured with the incision 40 as described above, in various embodiments, the needle 22 may be able to bend about 45 degrees in a short space.

[0040] As discussed above, the stylet 30 is a shaped, curved stylet. In various embodiments, the stylet 30 can be made of any suitable material, such as a shape memory alloy ("SMA"), which imparts the desired shape and bending properties to the distal end of the stylet 30. Given by way of non-limiting example, in various embodiments, the stylet 30 can be made of an SMA (such as Nitinol, etc.).

[0041] In various embodiments, the stylet 30 is sized so that the stylet 30 is inserted into the needle 22 when the stylet is coaxially disposed in the needle 22, thereby helping to prevent the needle 22 from sampling before the needle 22 is located in the desired area of ​​interest. By way of illustration only and not limitation, when the needle / stylet assembly 34 is disposed in the lumen 14, the tip 42 of the stylet 30 can be retracted from the tip 32 of the needle 22 by about 0.5 mm or so.

[0042] It should be understood that when the curved stylet 30 is disposed within the lumen 14, the stylet 30 conforms to the shape of the catheter 12. As discussed above, the curved stylet 30 and, therefore, the needle / stylet assembly 34 becomes curved after the needle / stylet assembly 34 extends through the opening 18. Therefore, and as discussed further below, the curved stylet 30 is configured to be removed from the lumen 14, thereby removing the needle 22 and allowing sampling of tissue via the needle 22.

[0043] In various embodiments, an exemplary system 50 for sampling a targeted tissue region is provided. Figure 1A ). It should be understood that the tissue may include, but is not limited to, a lesion located near a body cavity (such as an airway), and may be located within the body cavity (i.e., concentric tissue) or outside the body cavity (i.e., eccentric tissue). In such embodiments, the system 50 includes a handle assembly 60 ( Figure 1A ). The catheter assembly 10 is operably coupled to the handle assembly 60, and the catheter assembly 10 is configured to be inserted into a body cavity toward a targeted tissue area to be sampled. As discussed above, the catheter assembly 10 includes a catheter 12. Also as discussed above, the catheter 12 defines a lumen 14 therein, and a wall 16 of the catheter 12 defines an opening 18 therein at a distal end 20 of the catheter 12. A flexible needle 22 may be disposed in the lumen 14, and an offset mechanism 24 is configured to push the needle 22 out of the opening 18 at the distal end 20 of the catheter 12 at an angle that deviates from an axis 26 of the lumen 14.

[0044] As also discussed above, in some embodiments, the biasing mechanism 24 may include a bevel 28 defined in the catheter 12 at the distal end 20 of the catheter 12. In some other embodiments, the biasing mechanism 24 may include a curved stylet 30 coaxially disposed within the needle 22. In some other embodiments, the biasing mechanism 24 may include a bevel 28 and a curved stylet 30. The details of all of these embodiments have been discussed above and need not be repeated for an understanding of the disclosed subject matter.

[0045] In various embodiments, the handle assembly 60 performs multiple functions. For example, in some embodiments, the user can use the handle assembly 60 to twist the catheter 12 to rotate the opening 18 and thus the needle 22 to an eccentrically positioned tissue. In addition, in some embodiments, the stylet 30 can be removed from the catheter assembly 10 via a Luer connector 66 disposed at the proximal end 68 of the handle assembly 60. Furthermore, in some embodiments, a vacuum device (not shown) such as a syringe can be operatively coupled to the needle 22 via the Luer connector 66 in the handle assembly 60 in the event that the stylet 30 is removed from the lumen.

[0046] Various embodiments of the system 50 operate as follows. An endoscope (not shown) or bronchoscope (not shown) (depending on the specific application) is driven to the target location in the body cavity. The target is visualized using an imaging system (such as an ultrasound probe, an optical channel, fluoroscopy, optical coherence tomography, X-ray computed tomography assisted visualization, and magnetic resonance imaging). The catheter assembly 10 is loaded into the endoscope (or bronchoscope), and the handle assembly 60 is used to twist the catheter 12 so that the opening 18 is aligned with the target.

[0047] In the embodiment where the offset mechanism includes only the bevel 28, the needle 22 passes through the opening 18, exceeds the distal end 20 of the catheter 12, and extends toward the target tissue. In some cases, the needle 22 may puncture the wall of the body cavity. The needle 22 punctures the target tissue. If necessary, the needle 22 can be agitated by repeatedly moving back and forth in the tissue. With the needle 22 in the target, a vacuum device (not shown) such as a syringe is operatively connected to the needle 22 via the Luer connector 66 in the handle assembly 60. In the embodiment where the straight-through tube wire is disposed in the needle 22, the straight-through tube wire is removed by the Luer connector 66 before the vacuum device is operatively connected to the needle 22 via the Luer connector 66. The vacuum device draws a vacuum, thereby sampling the tissue via the needle 22.

[0048] In the embodiment where the offset mechanism 24 includes only the curved stylet 30 and in the embodiment where the offset mechanism includes the bevel 28 and the curved stylet 30, the needle / stylet assembly 34 passes through the opening 18, exceeds the distal end 20 of the catheter 12, and extends toward the target. In some cases, the needle / stylet assembly 34 can puncture the wall of the body cavity. The needle / stylet assembly 34 punctures the target. If necessary, the needle / stylet assembly 34 can agitate the tissue by repeatedly moving back and forth in the tissue. The stylet 30 is removed from the lumen 14 by the Luer connector 66 in the handle assembly 60, and the tissue holds the needle 22 in the appropriate position in the tissue. In the case where the stylet 30 is removed from the lumen 14, a vacuum device (not shown) such as a syringe is operatively connected to the needle 22 via the Luer connector 66 in the handle assembly 60. The vacuum device draws a vacuum, thereby sampling the tissue via the needle 22.

[0049] Below is a series of flow charts depicting embodiments. For ease of understanding, these flow charts are organized so that an initial flow chart presents an embodiment via an exemplary embodiment, and then subsequent flow charts present alternative embodiments and / or extensions of the initial flow charts as subcomponent operations or additional component operations built on one or more previously presented flow charts. It should be understood by those skilled in the art that the presentation format utilized herein (i.e., initially presenting a flow chart of an exemplary embodiment, and then providing supplementary and / or further details in subsequent flow charts) generally makes the various process embodiments quick and simple to understand.

[0050] See now Figure 4A , an exemplary method 100 for sampling a targeted tissue region is provided. It should be understood that embodiments of the method 100 may be adapted to use (but not limited to) various embodiments of the catheter assembly 10 and the system 50. It should also be understood that the targeted region is located before the method 100 begins.

[0051] The method 100 starts at frame 102. At frame 104, a catheter is inserted into a body cavity toward a target tissue area to be sampled. At frame 106, a flexible needle is extended from a distal end of the catheter toward the target tissue area to be sampled at an angle offset from the axis of the catheter. At frame 108, the tissue is penetrated with the needle. At frame 110, the tissue is sampled. The method 100 stops at frame 112.

[0052] See also Figure 4B And in some embodiments, after the catheter is inserted into the body cavity toward the target tissue area to be sampled at frame 104 and before the flexible needle is extended from the distal end of the catheter toward the target tissue area to be sampled at an angle deviating from the axis of the catheter at frame 106, at frame 114, the catheter can be twisted so that the opening defined in the distal end of the catheter is oriented toward the target tissue area to be sampled.

[0053] See also Figure 4C And in some embodiments, extending the flexible needle from the distal end of the catheter toward the targeted tissue area to be sampled at an angle deviating from the axis of the catheter at frame 106 may include pushing the needle out of an opening defined in the distal end of the catheter through a bevel defined in the distal end of the catheter at frame 116, the bevel having an inclined surface deviating from the axis of the catheter.

[0054] See also Figure 4DAnd in some embodiments, extending the flexible needle from the distal end of the catheter toward the targeted tissue area to be sampled at an angle deviating from the axis of the catheter at frame 106 may include extending the needle and a curved stylet coaxially disposed within the needle from an opening defined in the distal end of the catheter at frame 118, the curved stylet being bent at an angle deviating from the axis of the catheter when leaving the catheter, the curved stylet conforming to the shape of the catheter when disposed within the catheter.

[0055] See also Figure 4E And in some embodiments, after penetrating the tissue with the needle at block 108 and before sampling the tissue at block 110 , at block 120 , the curved stylet is removed from the catheter and a vacuum device is operatively coupled to the needle.

[0056] See also Figure 4F And in some embodiments, extending the flexible needle from the distal end of the catheter toward the targeted tissue area to be sampled at an angle deviated from the axis of the catheter at frame 106 may include pushing the needle and a curved stylet coaxially disposed in the needle out of an opening defined in the distal end of the catheter through a bevel defined in the distal end of the catheter at frame 122, the bevel having an inclined surface deviated from the axis of the catheter, and extending the needle and a curved stylet coaxially disposed in the needle out of the opening defined in the distal end of the catheter at frame 124, the curved stylet being bent at an angle deviated from the axis of the catheter when leaving the catheter, the curved stylet conforming to the shape of the catheter when disposed in the catheter.

[0057] It should be understood that the present invention described herein as a biopsy system, device and method for lung and lung nodules is non-limiting, and these embodiments can be used for biopsy, navigation and positioning of areas of interest in other locations of the patient, including the stomach, endoscope or other suitable locations. Similarly, a bronchoscope is not required, and other suitable devices that can accommodate the embodiments described herein can also be used, including but not limited to various endoscopic or laparoscopic cannulas.

[0058] It should also be understood that the detailed description set forth above is merely exemplary in nature, and variations that do not depart from the gist and / or spirit of the claimed subject matter are intended to be within the scope of the claims. These variations should not be considered as departing from the spirit and scope of the claimed subject matter.

Claims

1. A catheter assembly, comprising: a catheter defining a lumen therein, a wall of the catheter defining an opening therein at a distal end of the catheter; a flexible needle capable of being disposed in the lumen; and a biasing mechanism comprising a bevel located within the lumen and a curved stylet coaxially disposed within the flexible needle, the bevel having an inclined surface adjacent the opening forming a distal end of the lumen, wherein the bevel and the curved stylet are configured to cooperate to deflect the flexible needle out of the lumen through the opening when the flexible needle is advanced through the distal end of the catheter, wherein when the flexible needle extends to the distal end of the catheter, the bevel pushes the flexible needle at a first offset angle to the axis of the lumen, and when the flexible needle extends beyond the distal end of the catheter to sample an eccentric tissue area, the curved stylet pushes the flexible needle away from the bevel and increasingly away from the axis of the lumen at a second offset angle, and The second offset angle is greater than the first offset angle.

2. The catheter assembly of claim 1, wherein the bevel defines an offset from the axis of the lumen within a range of 5 to 25 degrees. 3 . The catheter assembly of claim 1 , wherein an amount of curvature of the curved stylet is proportional to a length that the curved stylet extends beyond the distal end of the catheter. The catheter assembly of claim 1 , wherein the curved stylet is further configured to be removed from the lumen. The catheter assembly of claim 1 , wherein the curved stylet is made of a shape memory alloy.

6. A system for sampling a targeted tissue region, the system comprising: Handle assembly; as well as A catheter assembly, the catheter assembly being operably coupled to the handle assembly, the catheter assembly being configured to be inserted into a body cavity toward a target tissue region to be sampled, the catheter assembly comprising: a catheter defining a lumen therein, a wall of the catheter defining an opening therein at a distal end of the catheter; a flexible needle capable of being disposed in the lumen; and a biasing mechanism comprising a bevel located within the lumen and a curved stylet coaxially disposed within the flexible needle, the bevel having an inclined surface adjacent the opening forming a distal end of the lumen, wherein the bevel and the curved stylet are configured to cooperate to deflect the flexible needle out of the lumen through the opening when the flexible needle is advanced through the distal end of the catheter, wherein when the flexible needle extends to the distal end of the catheter, the bevel pushes the flexible needle at a first offset angle to the axis of the lumen, and when the flexible needle extends beyond the distal end of the catheter to sample an eccentric tissue area, the curved stylet pushes the flexible needle away from the bevel and increasingly away from the axis of the lumen at a second offset angle, and The second offset angle is greater than the first offset angle.

7. The system of claim 6, wherein the curved stylet is further configured to be removed from the lumen using the handle assembly, the system further comprising: A vacuum device is operatively coupled to the flexible needle via the handle assembly with the curved stylet removed from the lumen.

8. The system of claim 7, wherein the handle assembly is configured to torque the catheter.

Images