Biopsy needle for accessing peripheral lung nodules

Abstract

This invention discloses a medical device and a method of manufacturing and using the medical device. An example medical device may include a lung biopsy needle having a proximal end, a distal end, and an elongated body extending between the proximal and distal ends. The needle may be configured to approach the periphery of a patient's lung, and the elongated portion may have a first portion, a second portion, and a puncture tip. The first portion may have a first flexibility, and the second portion may have a second flexibility that is more flexible than the first flexibility. The second portion may extend distally to the first portion, and the second flexibility may be constant along the length of the second portion. The first portion of the needle may have a wall thickness different from the wall thickness of the second portion of the needle.

Description

[0001] This application is a divisional application of application number 201880018183.6, filed on March 9, 2018, entitled "Biopsy needle for proximal pulmonary nodules".

[0002] Cross-references to related applications

[0003] This disclosure claims the benefit and priority of U.S. Provisional Patent Application Serial No. 62 / 472,128, filed March 16, 2017, the contents of which are incorporated herein by reference. Technical Field

[0004] This disclosure pertains to medical devices and methods for manufacturing and / or using medical devices. More particularly, this disclosure pertains to biopsy needles. Background Technology

[0005] A wide variety of medical devices have been developed for medical applications, such as lung use. Some of these devices include catheters, stents, diagnostic tools, and delivery devices and / or systems for delivering such devices. These devices are manufactured using any of a variety of different manufacturing methods and can be used according to any of these methods. Each known medical device, delivery system, and method has its own advantages and disadvantages. There is a continuing need for alternative medical devices and delivery devices, as well as alternative methods for manufacturing and using medical devices and delivery devices. Summary of the Invention

[0006] This disclosure provides designs, materials, manufacturing methods, and alternative uses for medical devices. In a first aspect, a lung biopsy needle may include a proximal end, a distal end, and an elongated body extending between the proximal and distal ends, wherein the elongated body may have a first portion, a second portion, and a puncture tip, the first portion may have a first level of flexibility, and the second portion may have a second level of flexibility that is more flexible than the first level of flexibility, the second portion may have a length extending between a first end and a second end of the second portion, and the second level of flexibility of the second portion may be constant along the length of the second portion, and the second portion of the elongated body may be located distal to the distal end of the first portion of the elongated body.

[0007] Alternatively or additionally, in the second aspect, the first flexibility level may be between 3.0 lbf / in and 4.0 lbf / in and the second flexibility level may be between 0.1 lbf / in and 1.0 lbf / in.

[0008] Additionally or alternatively, in a third aspect, the elongated body may have a transition portion extending between the distal end of the first portion and the proximal end of the second portion, and the transition portion may have a flexibility level that gradually transitions from a first flexibility level to a second flexibility level along its length.

[0009] Additionally or alternatively, in a fourth aspect, the elongated body may include a lumen extending from the proximal end to the origin of the puncture tip, and the lumen may have a constant diameter.

[0010] Additionally or alternatively, in a fifth aspect, the first portion of the elongated body may have a first outer diameter that is constant along a length extending from the proximal end to the distal end of the first portion; and the second portion of the elongated body may have a second outer diameter that is constant along a length extending from the proximal end to the distal end of the second portion; and the second outer diameter may be smaller than the first outer diameter.

[0011] Additionally or alternatively, in the sixth aspect, the first part may have a central longitudinal axis coaxial with the central longitudinal axis of the second part.

[0012] Additionally or alternatively, in the seventh aspect, the first portion may have a first wall thickness that is constant along a first length extending from a first end of the first portion to a second end of the first portion; and the second portion may have a second wall thickness that is less than the first wall thickness and is constant along a second length extending from a first end of the second portion to a second end of the second portion.

[0013] Additionally or alternatively, in the eighth aspect, the elongated body may have a transition portion extending between the distal end of the first portion and the proximal end of the second portion, and the transition portion may have a wall thickness that gradually transitions from a first wall thickness to a second wall thickness along its length.

[0014] Additionally or alternatively, in the ninth aspect, the length of the second portion of the elongated body extending from the proximal end of the second portion to the distal end of the second portion may be between five inches and ten inches.

[0015] Additionally or alternatively, in the tenth aspect, the elongated body may include a transition portion having a length extending between the distal end of the first portion and the proximal end of the second portion, and the length of the transition portion may be between 0.1 inches and 1.0 inches.

[0016] Additionally or alternatively, in the eleventh aspect, the method of manufacturing a lung biopsy needle may include selecting an elongated tube having a first wall thickness that extends from a first end of the elongated tube to a second end of the elongated tube; adjusting the wall thickness of a distal portion of the elongated tube to a second wall thickness less than the first wall thickness, the distal portion of the elongated tube extending distal to the proximal portion of the elongated tube having the first wall thickness.

[0017] Additionally or alternatively, in the twelfth aspect, the method may further include adjusting the wall thickness of the transition portion such that the wall thickness of the transition portion gradually decreases from a first wall thickness to a second wall thickness along the length of the transition portion.

[0018] Additionally or alternatively, in the thirteenth aspect, adjusting the wall thickness of the distal portion of the elongated tube may include removing material from the distal portion to reduce the outer diameter of the distal portion from a first outer diameter of the proximal portion to a second outer diameter.

[0019] Additionally or alternatively, in the fourteenth aspect, removing material from the distal portion may include grinding the distal portion.

[0020] Additionally or alternatively, in the fifteenth aspect, the distal portion may have a constant wall thickness.

[0021] Additionally or alternatively, in the sixteenth aspect, the lumen of the slender tube may have a constant diameter.

[0022] Additionally or alternatively, in the seventeenth aspect, the length of the distal portion of the elongated tube extending along the distal portion from the first end of the distal portion to the second end of the distal portion has a constant level of flexibility.

[0023] Additionally or alternatively, in the eighteenth aspect, a method for obtaining a tissue sample from a patient's lung may include identifying a path in an airway leading to a tissue sample site; introducing a flexible needle along the path into the airway, wherein the flexible needle may include a first portion having a first length having a first wall thickness; a second portion having a second length having a second wall thickness less than the first wall thickness; and having a proximal puncture tip at a distal end of the second portion; navigating the flexible needle through the path to guide the puncture tip of the flexible needle to the tissue sample site; and obtaining a tissue sample from the tissue sample site.

[0024] Additionally or alternatively, in the nineteenth aspect, the method may also include inserting a flexible needle into the lumen of a catheter.

[0025] Additionally or alternatively, in the twentieth aspect, the flexible needle may have a constant inner diameter.

[0026] The above summary of some embodiments is not intended to describe every disclosed embodiment or every implementation of the invention. These embodiments are illustrated more specifically by the following drawings and detailed description. Attached Figure Description

[0027] This disclosure can be more fully understood by considering the following specific embodiments in conjunction with the accompanying drawings, wherein:

[0028] Figure 1 A plan view of a biopsy tool for a lung nodule close to the surrounding tissue;

[0029] Figure 2 A three-dimensional view of an example biopsy needle;

[0030] Figure 3 for Figure 2 A side view of an example biopsy needle;

[0031] Figure 4 for Figure 2 The end view of the instance biopsy needle in the image;

[0032] Figure 5 for Figure 2 Example biopsy needle edge Figure 4 The sectional view taken from line 5-5 in the middle;

[0033] Figure 6 A flowchart illustrating an example method for manufacturing a biopsy needle; and

[0034] Figure 7 This is a flowchart of an example method using a biopsy needle.

[0035] While various modifications and alternatives may be made to this disclosure, details have been shown by examples in the figures and will be described in detail. However, it should be understood that the invention is not intended to be limited to the specific embodiments described. Rather, the invention covers all modifications, equivalents, and alternatives falling within the spirit and scope of this disclosure. Detailed Implementation

[0036] For the purposes of the terms defined below, these definitions shall apply unless otherwise defined in the claims or elsewhere in this specification.

[0037] In this document, all numerical values ​​are assumed to be modified by the term "about," whether explicitly indicated or not. The term "about" generally refers to a range of numbers that a person skilled in the art would consider equivalent to the stated value (i.e., having the same function or result). In many cases, the term "about" may include numbers rounded to the nearest significant figure.

[0038] The range of values ​​expressed by the endpoints includes all numbers within that range (for example, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0039] As used in this specification and the appended claims, the singular forms “a” and “the” include plural references unless the context clearly indicates otherwise. As used in this specification and the appended claims, the term “or” is generally used to include its meaning of “and / or” unless the context clearly indicates otherwise.

[0040] It should be noted that references to "one embodiment," "some embodiments," or "other embodiments" in the specification indicate that the described embodiments may include one or more specific features, structures, and / or characteristics. However, such expressions do not necessarily imply that all embodiments include that specific feature, structure, and / or characteristic. Furthermore, whether explicitly described or not, when a specific feature, structure, and / or characteristic is described in connection with an embodiment, it should be understood that such feature, structure, and / or characteristic may also be used in other embodiments, unless explicitly stated otherwise.

[0041] The following detailed description should be read with reference to the accompanying drawings, in which similar structures in different drawings are numbered the same. The drawings (which are not necessarily drawn to scale) illustrate exemplary embodiments and are not intended to limit the scope of this disclosure.

[0042] The global spread of lung cancer, combined with the adoption of lung tumor screening, has led to an increase in the number of suspicious solitary pulmonary nodules (SPNs) visible on chest computed tomography (CT) scans or other scans. Suspicious SPNs (which are often located in the periphery of the lung) may be difficult to approach and diagnose using current bronchoscopic techniques designed primarily for the central airway. Peripheral pulmonary nodules, or SPNs, may be round masses measuring up to 3 cm in mass and can be benign or malignant. When an SPN is identified, a biopsy may be required for diagnosis. Typically, fine-needle aspiration (FNA) can be used to approach and obtain a biopsy from an identified SPN via a transbronchial approach through the patient's throat or mouth, or via a transthoracic approach through the patient's chest cavity. Generally, the transbronchial approach is advantageous over the transthoracic approach because access to the SPN can be achieved through the existing airways of the lung without perforating body tissue. However, because SPNs are typically located in the deep periphery of the lungs, reaching them via the lung airways can be difficult or impossible, potentially requiring a transthoracic approach involving puncture of the patient's pleural cavity. Since the transthoracic approach is considered more invasive than the transbronchial approach and may require more recovery time, it is desirable to provide a device configured to navigate a tortuous path through the deep or distal periphery of the lung airways. Such a device would allow physicians to obtain biopsy samples from SPNs located in the deep or distal periphery of the patient's lungs via the transbronchial approach, SPNs that were previously inaccessible via the transbronchial approach. While this disclosure is described with respect to pulmonary nodules, it is conceivable that the methods and devices described herein can be applied to other parts of the anatomy, such as, but not limited to, the gastrointestinal tract, urinary tract, gynecological, etc.

[0043] Figure 1 A plan view of an example biopsy system 10 is shown, advancing through the trachea T ​​and bronchial tree BT to a peripheral nodule 12 within the lung L. In some cases, the nodule or lesion 12 may be located in the deep peripheral region of the lung, which may be difficult to access due to the tortuous path of the airways in the peripheral region of the lung.

[0044] although Figure 1 A biopsy system 10 for reaching the peripheral nodule 12 is described, but due to the tortuous nature of the airways in the deep periphery of the lung, typical biopsy systems used transbronchialally with bronchoscopy cannot access the SPN located in the deep periphery of the lung. Although various sizes of needles are available for biopsy systems, including but not limited to needles between 17 (17) and 27 (27) sizes, it has been found that a 25 (25) gauge needle may be the preferred size for attempting to access the SPN in the periphery of the lung. Because a 25 (25) gauge needle can have an inner diameter of about 0.0120 inches and an outer diameter of about 0.0203 inches, it provides an optimal balance between rigidity and flexibility required to traverse the airways of the lung, while also providing an inner diameter size that facilitates obtaining a sufficient sample (once the needle reaches the SPN). Even so, it has been found that the distal end of a 25 (25) gauge needle may be too rigid to navigate through the airways in the deep periphery of the lung. Additionally, while a 27 (27) gauge needle may have a more flexible distal end than a 25 (25) gauge needle, a 27 (27) gauge needle may not have the proximal rigidity required to traverse the deep periphery of the lung and / or may not have a sufficiently large inner diameter (e.g., the inner diameter may be too small) to reliably obtain a sample from the SPN (e.g., to reliably obtain a sufficient sample from the SPN to perform the required tests on the sample), if the SPN is reached. The disclosed needle addresses this need by providing a needle with proximal rigidity suitable for traversing the deep periphery of the lung, distal flexibility suitable for navigation through the deep periphery of the lung, and a suitable inner diameter (e.g., a sufficiently large inner diameter) for reliably obtaining a sufficient sample from the SPN once the needle is positioned there (e.g., to reliably obtain a sufficient sample from the SPN to perform the required tests on the sample).

[0045] Figure 2 A perspective view of needle 20 is depicted, configured to traverse a tortuous path through the deep peripheral airways of a patient's lungs while maintaining axial strength to allow insertion to a target location. Needle 20 may have a proximal end 22 and a distal end 24, and an elongated body 26 extending between the proximal end 22 and the distal end 24. To facilitate navigation to the periphery of the patient's lungs, needle 20 or the elongated body 26 of needle 20 may have one or more different types of flexibility along its length.

[0046] The elongated body 26 may have one or more portions. Where the elongated body may have more than one portion, the elongated body 26 may have at least a first portion 28 and a second portion 30. Additionally, although not strictly necessary, the elongated body may have a transition portion 32 and / or a tip portion 34 (e.g., a penetrating tip, a piercing tip, an angled tip, or other tip).

[0047] Figure 3 This is a side view of needle 20. (Example) Figure 3 As shown, the second portion 30 of the elongated body 26 may extend distally to the first portion 28 of the elongated body 26, and in some cases, the second portion 30 (e.g., the distal portion) may be completely distal to the first portion 28 (e.g., the proximal portion), but this is not always necessary. In one example, the first portion 28 of the elongated body 26 may extend from the proximal end 22 of the needle 20 to the proximal end of the second portion 30. When the elongated body 26 includes a transition portion 32, as... Figure 3 In the needle 20, a first portion 28 of the elongated body 26 extends from the proximal end 22 of the needle 20 to the proximal end of the transition portion 32, and the transition portion 32 extends from the distal end of the first portion 28 to the proximal end of the second portion 30. The second portion 30 extends distally from the distal end of the transition portion 32. When the elongated body 26 includes a tip portion 34, the second portion 30 extends from the distal end of the transition portion to the proximal end of the tip portion 34, and the tip portion 34 extends from the distal end of the second portion 30 to the distal end 24 of the needle 20.

[0048] Each portion of the elongated body 26 may have the same or different length as another portion of the elongated body. Depending on the application of the needle 20, the length of the elongated body 26 extending between the proximal end 22 (e.g., the first end) and the distal end 24 (e.g., the second end) of the needle 20 may be any length. For example, the length of the elongated body 26 may be between about forty (40) inches and one hundred (100) inches, fifty (50) inches and ninety (90) inches, sixty (60) inches and eighty (80) inches, sixty-five (65) inches and seventy (70) inches, and / or less than forty (40) inches or greater than one hundred (100) inches. Depending on the application of the needle 20, the length of the first portion 28 extending between the proximal and distal ends of the first portion 28 of the elongated body 26 may be any length. For example, the length of the first portion 28 of the elongated body 26 may be between about thirty (30) inches and ninety (90) inches, forty (40) inches and eighty (80) inches, fifty (50) inches and seventy (70) inches, fifty-five (55) inches and sixty (60) inches, and / or less than thirty (30) inches or greater than ninety (90) inches. Depending on the application of the needle 20, the length of the second portion 30 extending between the proximal and distal ends of the elongated body 26 may be any length. For example, the length of the second portion 30 of the elongated body 26 may be between about two (2) inches and twenty (20) inches, four (4) inches and sixteen (16) inches, six (6) inches and twelve (12) inches, seven (7) inches and ten (10) inches, and / or less than two (2) inches or greater than twenty (20) inches. Although the lengths of the transition portion 32 and the tip portion 34 can vary, the transition portion 32 has a length between about 0.1 inches and two (2) inches, while the tip portion 34 may have a length of less than about one inch, and in some cases is typically less than half an inch.

[0049] In some cases, as disclosed herein, needle 20 may be configured to travel through airways deep or distal to the patient’s lungs to reach nodules on or within the lungs. In such cases, the total length of needle 20 may be between fifty (50) inches and eighty (80) inches (e.g., or about sixty-six (66) inches or any other length), the length of the first portion 28 of needle 20 may be between fifty (50) inches and sixty (60) inches (e.g., or about 56 inches or any other length), the length of the second portion 30 may be between eight (8) inches and twelve (12) inches (e.g., or about 9.5 inches or any other length), the transition portion 32 may be between about 0.4 inches and 0.6 inches (e.g., or about 0.5 inches or any other length), and the length of the tip portion 34 may be less than about 0.5 inches.

[0050] although Figure 3 A typical configuration of needle 20 is depicted, comprising a first portion 28, a second portion 30, a transition portion 32, and a tip portion 34, but one or more of these portions may be removed from needle 20 and / or one or more portions may be added to needle 20. For example, in some cases, needle 20 may not include transition portion 32. Alternatively or separately, needle 20 may include one or more additional elongated portions (e.g., similar to one or both of the first portion 28 and the second portion 30) and / or one or more additional transition portions. In one instance where the elongated body includes one or more additional elongated portions, the first portion 28 and the second portion 30 may be the two most distal elongated portions, and / or the second portion 30 may be the most distal elongated portion. In some cases, the additional elongated portions and / or transition portions may facilitate the addition of one or more portions of the elongated body 26 having a different flexibility (e.g., level of flexibility) than another portion of the elongated body 26, wherein the additional portions may be used to increase or decrease the flexibility / rigidity in a local area of ​​needle 20 to facilitate access to specific anatomical structures of the patient and / or to facilitate use with assistive medical devices (e.g., endoscopes or other medical devices).

[0051] like Figure 3 As shown, the first portion 28 of the elongated body 26 may have a first outer diameter OD1, and the second portion 30 of the elongated body 26 may have a second outer diameter OD2. The second outer diameter OD2 may be smaller than the first outer diameter OD1. In one example, the second outer diameter OD2 may be smaller than the first outer diameter OD1 by approximately 0.001 inches to 0.007 inches, approximately 0.002 inches to 0.006 inches, approximately 0.003 inches to 0.005 inches, approximately 0.004 inches, or larger or smaller. Additionally, in some cases, the first outer diameter OD1 of the first portion 28 of the elongated body 26 may be constant along its length from the proximal end to the distal end of the first portion 28, but this is not mandatory. Similarly, in some cases, the second outer diameter OD2 of the second portion 30 of the elongated body 26 may be constant along its length from the proximal end to the distal end of the second portion 30, but this is not mandatory. The relative outer diameters of the first part 28 and the second part 30 can facilitate providing the second part 30 with a flexibility that differs from that of the first part 28.

[0052] The transition portion 32 (when included in the needle 20) may have an outer diameter that tapers from about a first outer diameter OD1 of the first portion 28 to about a second outer diameter OD2 of the second portion 30. In some cases, the taper of the outer diameter of the transition portion 32 may have a constant slope. Alternatively, the outer diameter of the transition portion 32 may have two or more different slopes, the transition portion 32 may have an outer diameter that decreases in a stepwise manner from the first outer diameter OD1 to the second outer diameter OD2, and / or the outer diameter of the transition portion 32 may transition from the first outer diameter OD1 to the second outer diameter OD2 in any other way.

[0053] Figure 4 for Figure 2 and Figure 3 The diagram shows a distal view of the needle 20. The needle 20 depicts an elongated body 26, wherein a transition portion 32 extends from a first portion 28 to a second portion 30, and the second portion 30 extends to a tip portion 34, which may be the most distal portion of the elongated body 26. Additionally, the elongated body 26 may define a lumen 36 having a diameter defined by the inner diameter of the elongated body 26.

[0054] Figure 5 For needle 20 along Figure 4 The cross-sectional view is taken from line 5-5. The first portion 28 of the elongated body 26 may have a first inner diameter ID1, and the second portion 30 of the elongated body 26 may have a second inner diameter ID2. The second inner diameter ID2 may be equal to the first inner diameter ID1. Additionally, in some cases, the first inner diameter ID1 of the first portion 28 of the elongated body 26 may have a constant length extending from the proximal end to the distal end of the first portion 28, but this is not mandatory. Similarly, in some cases, the second inner diameter ID2 of the second portion 30 of the elongated body 26 may have a constant length extending from the proximal end to the distal end of the second portion 30, but this is not mandatory. When present, the transition portion 32 may have an inner diameter with a constant length extending from the proximal end to the distal end of the transition portion 32. In some cases, the inner diameters of the first portion 28, the second portion 30, and the transition portion 32, together with any other portions extending between the proximal end 22 of the needle 20 and the proximal end of the tip portion 34, may be the same, such that the elongated body 26 may have a constant inner diameter extending from the proximal end 22 of the needle to the proximal end of the tip portion 34. However, it is conceivable that one or more portions of the elongated body 26 may have an inner diameter that changes along that portion, and / or an inner diameter different from that of one or more other portions of the elongated body 26.

[0055] Figure 5A lumen 36 is shown extending from the proximal end 22 of the needle 20 to the distal end of the second portion 30 and exiting the tip portion 34. The lumen 36 may have a constant diameter along the length of the needle, as defined by the inner diameter of the elongated body 26. In some cases, the lumen 36 may have a central longitudinal axis along a first longitudinal axis LA1 of the first portion 28 and a second longitudinal axis LA2 of the second portion 30. In one example, the first longitudinal axis LA1 may be coaxial with the second longitudinal axis LA2, but this is not mandatory.

[0056] The wall thickness of the elongated body 26 can be determined by subtracting the inner diameter of the elongated body 26 from its outer diameter. In some cases, when the elongated body 26 or at least the first portion 28 and the second portion 30 of the elongated body 26 are formed of the same material, the wall thickness of the elongated body 26, together with the material properties of the material of the elongated body, can determine the flexibility of the elongated body 26 and / or the flexibility of each portion of the elongated body 26 (e.g., the first portion 28, the second portion 30, the transition portion 32, the tip portion 34, and / or other portions of the elongated body 26).

[0057] like Figure 5 As shown, the first portion 28 of the elongated body 26 may have a first wall thickness WT1, which is equal to the first outer diameter OD1 minus the first inner diameter ID1. The second portion 30 of the elongated body 26 may have a second wall thickness WT2, which is equal to the second outer diameter OD2 minus the second inner diameter ID2. When the elongated body 26 includes a transition portion 32, the transition portion 32 may have a wall thickness that transitions from the first wall thickness WT1 to the second wall thickness WT2 in a manner similar to how the outer diameter of the transition portion 32 transitions from the first outer diameter OD1 to the second outer diameter OD2. Additional elongated portions (when included in the elongated body 26) may have wall thicknesses similar to or different from the first wall thickness WT1 and / or the second wall thickness WT2, but this is not mandatory.

[0058] exist Figure 5 In one example, the first portion 28 of the elongated body 26 may have a constant wall thickness WT1, thereby imparting constant flexibility to the first portion 28. However, depending on the desired proximal rigidity or flexibility, the first portion 28 of the elongated body 26 may have a wall thickness varying along its length, and thus a flexibility varying along its length. Figure 5 In one example, the second portion 30 of the elongated body 26 may have a constant wall thickness WT2, thereby giving the second portion constant flexibility. However, depending on the desired distal rigidity or flexibility, the second portion 30 of the elongated body 26 may have a wall thickness that varies along its length, and thus a flexibility that varies along its length.

[0059] In one example where the needle 20 is configured to reach the SPN in the deep periphery of the lung and traverse the lung airway to reach the SPN, the elongated body may have a first portion 28 with a first wall thickness WT1 between about 0.0069 inches and 0.0091 inches (e.g., the wall thickness of a 25 (25) gauge needle), a second portion 30 with a second wall thickness WT2 between about 0.0029 inches and 0.0051 inches, and a constant inner diameter between about 0.0119 inches and 0.0121 inches (e.g., the inner diameter of a 25 (25) gauge needle). The needle 20 of this configuration can provide the proximal rigidity or flexibility required to traverse the airway through the deep periphery of the lung, and the distal rigidity or flexibility required to traverse the tortuous path through the deep periphery of the lung, while maintaining the size of the inner diameter (e.g., the size of the lumen 36) to reliably obtain sufficient sample from SPNs or nodules located in the deep periphery of the lung (e.g., the distal rigidity or flexibility of the needle 20 is reduced, but the size of the lumen 36 is not sacrificed, so that the same amount of sample can be obtained from the SPN as in other ways, but without reducing the outer diameter or wall thickness of the second part 30 of the needle 20).

[0060] Additionally, the first portion 28 and the second portion 30 of the needle 20, having the dimensional configuration discussed in the previous paragraphs, can be formed monolithically from a single piece of material. When such a needle 20 is constructed of cobalt-chromium, the first portion 28 of the needle 20 can have a flexibility of about 3.6 lbf / in, and the second portion 30 of the needle 20 can have a flexibility of about 0.9 lbf / in (e.g., a 75% increase in flexibility compared to the first portion 28), wherein the flexibility of each portion 28, 30 of the needle 20 can be measured by a three-point bending test commonly used in industry to measure flexibility. When the first portion 28 and the second portion 30 of the needle 20 are monolithically formed (e.g., monolithically formed from biocompatible stainless steel (e.g., cobalt-chromium or other stainless steels)), the needle 20 may have advantages over typical needles that traverse the lung airways (e.g., needles with a distal portion of standard 25 gauge cobalt-chromium, standard 25 gauge 300 series stainless steel, 25 gauge cobalt-chromium with helical cuts (e.g., 120-inch to 200-inch pitch), and 25 gauge nitinol needles), including but not limited to maintaining proximal rigidity and sample volume obtainable from the needle while increasing distal flexibility and reducing material and manufacturing costs.

[0061] The needle 20 disclosed herein can be manufactured using one or more manufacturing techniques. Figure 6Method 100 shown provides an example method for manufacturing needle 20. Method 100 may include selecting an elongated tube 102. The selected elongated tube may have a first wall thickness (e.g., the first wall thickness WT1 discussed above or a different first wall thickness) and / or a specified specification (e.g., specification number 25 or other specifications). In some cases, the selected elongated tube may have a first wall thickness between about 0.0069 inches and 0.0091 inches (e.g., a first outer diameter between about 0.0190 inches and 0.0210 inches, and an inner diameter between about 0.0119 inches and 0.0121 inches).

[0062] The selected elongated tube may be a pre-formed needle with a pointed portion (e.g., a puncture tip, a penetrating tip, a sharp point, or other pointed portion). Alternatively, the selected elongated tube may be a raw tube with the pointed portion added to the distal end of the selected needle.

[0063] The selected elongated tube can be formed from any desired material. In one example, the selected elongated tube may be formed integrally or at least partially from biocompatible stainless steel (e.g., cobalt-chromium or other biocompatible stainless steel). In some cases, the elongated tube may be a monolithic tube or may be formed from two or more materials integrally joined together.

[0064] Once the elongated tube is selected, the wall thickness of the distal portion can be adjusted to a second wall thickness 104 less than the first wall thickness (e.g., the second wall thickness WT2 discussed above or a different second wall thickness). The adjusted second wall thickness can be of any size. In some cases, the adjusted wall thickness can be between about 0.0029 inches and 0.0051 inches (e.g., a second outer diameter between about 0.0150 inches and 0.0170 inches, and an inner diameter between about 0.0119 inches and 0.0121 inches). When this elongated tube is formed and is made of cobalt-chromium, the flexibility or stiffness of the proximal portion can be about 3.6 lbf / in and the flexibility or stiffness of the distal portion can be about 0.9 lbf / in, as measured by a standard 3-point bending test.

[0065] The distal portion of the selected elongated tube may be the portion of the elongated tube that extends distally from the proximal portion of the elongated tube. In some cases, the distal portion of the selected elongated tube may extend proximally from the distal end of the elongated tube or from the proximal end of the tip portion of the elongated tube by a distance between approximately eight (8) inches and approximately twelve (12) inches. In one example, the distal portion of the selected elongated tube may be the second portion 30 of the elongated body 26 discussed above.

[0066] In some cases, the second wall thickness of the distal portion of the slender tube can be constant along the length of the distal portion. This constant wall thickness can result in the distal portion having a constant flexibility along its length to facilitate a tortuous path across the deep periphery of the lung.

[0067] In some cases, method 100 may include adjusting the wall thickness of a transition portion of the selected elongated tube (e.g., transition portion 32 of the elongated body 26 discussed above, or different transition portions). Adding a transition portion to the selected elongated tube increases tube stability and reduces the likelihood of the distal portion with the adjusted second wall thickness breaking off from the proximal portion with the first wall thickness, compared to such elongated tubes without a transition portion (e.g., elongated tubes with a shoulder between a proximal portion having a first wall thickness and a distal portion having a second wall thickness).

[0068] When a transition portion is formed in the selected elongated tube, the transition portion may have a wall thickness that gradually decreases from a first wall thickness to a second wall thickness over its length. In one example, the transition portion may have a wall thickness that gradually transitions from the first wall thickness to the second wall thickness over a length of about 0.400 inches to about 0.600 inches. In some cases, the length of the transition portion is about one hundred (100) times the difference between the first and second wall thicknesses, but this is not mandatory.

[0069] The wall thickness of the selected elongated tube can be adjusted in any way. In some cases, the wall thickness of the selected elongated tube can be adjusted by removing material from the outer diameter of the elongated tube (e.g., from the distal portion and / or transition portion). Alternatively or additionally, adjusting the wall thickness of the distal portion of the elongated tube relative to the proximal portion of the elongated tube may include adding material to the elongated tube (e.g., to the proximal portion and / or transition portion) and / or otherwise manipulating the relative dimensions of the wall thickness of the elongated tube portion by typical tube forming techniques (including, but not limited to, extrusion, stretching, and / or other techniques).

[0070] When material is removed from the outer diameter of an elongated tube to adjust the wall thickness of the distal portion, any removal technique can be used. In one example, the distal portion of the selected elongated tube may be ground to the desired outer diameter to form a wall thickness with desired flexibility. Other removal techniques may be used as needed, including but not limited to milling, turning, boring, finishing, planning, and / or other removal techniques.

[0071] The needle formed according to method 100 can take various forms in which the flexibility of the most distal elongated portion is less than that of the more proximal elongated portion. In one example, the needle formed according to method 100 may have a pointed portion (e.g., pointed portion 34 or other pointed portions), a distal portion extending proximally from the pointed portion (e.g., second portion 30 or other distal portions), and a proximal portion extending proximally from the distal portion (e.g., first portion 28 or other proximal portions), wherein the flexibility of the distal portion is greater than that of the proximal portion, the distal and proximal portions have a constant inner diameter from the proximal end of the proximal portion to the distal end of the distal portion, and the distal and proximal portions are formed monolithically. In some cases, the formed needle may have a transition portion (e.g., transition portion 32 or other transition portion) between the proximal and distal portions, wherein the transition portion has a flexibility that gradually transitions from approximately the flexibility of the proximal portion to the flexibility of the distal portion, has the same inner diameter as the distal and proximal portions, and is formed monolithically with the distal and proximal portions. However, other constructions may be considered, including needles constructed from two or more materials and / or needles having one or more portions proximal to the proximal portion.

[0072] Figure 7 A method 200 is illustrated for obtaining a tissue sample from a patient's lungs during a surgical procedure using a flexible needle (e.g., needle 20 or other needles). Method 200 may include identifying a path 202 in the airway leading to a tissue sample site. The path in the airway can be identified in any manner. In one instance, the path may be identified in the same or different CT scans used to identify SPNs or other nodules (e.g., target sites). Alternatively, one or more other scanning or imaging techniques may be used to identify the path through the lung airway to the target site. Once the path is identified, a flexible needle (e.g., needle 20 or other needles with a constant inner diameter) may be introduced into the airway along the identified path 204. Introducing the flexible needle into the path may include inserting the flexible needle into the lumen of a catheter and / or the lumen of a bronchoscope. The flexible needle may include a first portion (e.g., first portion 28 or other first portions) having a length of a first wall thickness (e.g., the first wall thickness WT1 discussed above or a different wall thickness), a second portion (e.g., second portion 30 or other second portions) having a length of a second wall thickness less than the first wall thickness (e.g., the second wall thickness WT2 discussed above or a different wall thickness), and a tip portion having a proximal end at the distal end of the second portion (e.g., a tip portion 34 having a puncture tip, a penetrating tip, a sharp tip, or other tip portion).

[0073] After the flexible needle is inserted into the identified path, method 200 may include navigating the flexible needle through the identified path to a target sample site (e.g., to an SPN or other nodule). Once the target sample site is reached, the method may include obtaining a tissue sample 208 from the tissue sample site (e.g., from an SPN or other nodule). In some cases, the sample may be obtained by engaging the tip portion of the flexible needle with the SPN or nodule or other tissue, and while the tip portion is engaged, withdrawing a syringe that is in communication with the flexible needle to create a vacuum through the lumen of the flexible needle and aspirate the sample into the lumen of the needle. After obtaining the sample, the sample and / or the flexible needle may be withdrawn from the patient, and the sample may be confirmed as derived from an SPN or nodule. If the sample is confirmed to be from a non-SPN or nodule, then method 200 may be repeated.

[0074] As discussed above regarding needle 20, the flexible needle may have a constant inner diameter or diameter of its lumen, configured to facilitate obtaining sufficient sample size from SPNs or other nodules, while having a distal end with increased flexibility. In such a configuration of flexible needle, the inner diameter or diameter of the flexible needle lumen allows for a greater vacuum force within the needle lumen (compared to the vacuum force obtained by a needle with a reduced wall thickness at the distal end and a reduced inner diameter at the distal end to increase distal flexibility) to better collect samples in response to syringe withdrawal.

[0075] While the specific materials of needle 20 have been discussed above, needle 20 may include any materials commonly associated with medical devices. For the sake of brevity, the following discussion refers to needle 20. However, this is not intended to limit the devices and methods described herein, as the discussion can be applied to other similar systems and / or components of the systems or devices disclosed herein.

[0076] The needle 20 may be made of metal, metal alloy, polymer (some examples of which are disclosed below), metal-polymer composite, ceramic, combinations thereof, or other suitable materials. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), and polyoxymethylene (POM, for example, available from DuPont). Polyether block esters, polyurethanes (e.g., Polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), and polyether esters (e.g., available from DSM Engineering Plastics) ), ether-based or ester-based copolymers (e.g., butene / poly(alkylene ether) phthalates and / or other polyester elastomers, such as those available from DuPont). ), polyamides (e.g., those available from Bayer) Or it may be obtained from Elf Atochem ), elastic polyamide, block polyamide / ether, polyether block amide (PEBA, for example, can be traded under name) Obtained), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low-density polyethylene (e.g., Polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polybutylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene ether (PPO), poly(p-phenylene terephthalamide) (e.g., Polysulfone, nylon, nylon-12 (such as those available from EMS American Grilon) Perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer / metal composites, etc. In some embodiments, the polymer may be blended with a liquid crystal polymer (LCP). For example, the blend may contain up to about 6% LCP.

[0077] Some examples of suitable metals and metal alloys include stainless steels (such as 304V, 304L, and 316LV stainless steels), mild steels, nickel-titanium alloys (such as linearly elastic and / or hyperelastic nickel-titanium alloys), and other nickel alloys (such as nickel-chromium-molybdenum alloys (e.g., UNS:N06625, such as...)). 625; UNS: N06022, such as UNS:N10276, such as other Alloys, etc.), nickel-copper alloys (e.g., UNS:N04400, such as...) 400 400 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035, such as...). (etc.), nickel-molybdenum alloys (e.g., UNS:N10665, such as...) Other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten alloys or tungsten alloys, cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, such as...). (etc.), platinum-rich stainless steel, titanium, combinations thereof, or any other suitable material.

[0078] As mentioned herein, within the family of commercially available nickel-titanium or nitinol alloys, there is a category referred to as "linear elastic" or "non-hyperelastic," which, while chemically similar to common shape memory and hyperelastic types, can exhibit unique and beneficial mechanical properties. The difference between linear elastic and / or non-hyperelastic nitinol and hyperelastic nitinol lies in the fact that linear elastic and / or non-hyperelastic nitinol does not possess a substantial "superelastic plateau" or "flag region" in its stress / strain curve, whereas hyperelastic nitinol does. Conversely, in linear elastic and / or non-hyperelastic nitinol, as recoverable strain increases, stress continues to increase in a generally linear, or slightly linear, but not necessarily perfectly linear, relationship until plastic deformation begins, or at least in a more linear relationship than the superelastic plateau and / or flag region exhibited in hyperelastic nitinol. Thus, for the purposes of this disclosure, linear elastic and / or non-hyperelastic nitinol may also be referred to as "generally" linear elastic and / or non-hyperelastic nitinol.

[0079] In some cases, the difference between linear elastic and / or non-hyperelastic nitinol and hyperelastic nitinol can also be that linear elastic and / or non-hyperelastic nitinol can withstand up to about 2-5% strain while maintaining approximately elasticity (e.g., before plastic deformation), while hyperelastic nitinol can withstand up to about 8% strain before plastic deformation. Both materials can be distinguished from other linear elastic materials such as stainless steel (which can also be distinguished based on their composition), other linear elastic materials can only withstand about 0.2 to 0.44% strain before plastic deformation.

[0080] In some embodiments, linear elastic and / or non-hyperelastic nickel-titanium alloys are alloys that do not exhibit any martensitic / austenitic phase transformations detectable by differential scanning calorimetry (DSC) and dynamic thermal metallography (DMTA) over a wide temperature range. For example, in some embodiments, martensitic / austenitic phase transformations of linear elastic and / or non-hyperelastic nickel-titanium alloys are not detectable by differential scanning calorimetry (DSC) and dynamic thermal metallography (DMTA) in a range from approximately -60°C to approximately 120°C. Therefore, the mechanical bending properties of such materials are generally unaffected by temperature over this very wide temperature range. In some embodiments, the mechanical bending properties of linear elastic and / or non-hyperelastic nickel-titanium alloys at ambient temperature or room temperature are substantially the same as their mechanical properties at body temperature; for example, neither exhibits a hyperelastic plateau and / or marked area. In other words, linear elastic and / or non-hyperelastic nickel-titanium alloys retain their linear elastic and / or non-hyperelastic properties and / or performance over a wide temperature range.

[0081] In some embodiments, the linearly elastic and / or non-hyperelastic nickel-titanium alloy may contain about 50 to about 60 wt% nickel, with the remainder being substantially titanium. In some embodiments, the composition contains about 54 to about 57 wt% nickel. An example of a suitable nickel-titanium alloy is the FHP-NT alloy, commercially available from Furukawa Techno Material Co., Kanagawa Prefecture, Japan. Some examples of nickel-titanium alloys are disclosed in U.S. Patent Nos. 5,238,004 and 6,508,803, which are incorporated herein by reference. Other suitable materials may include ULTANIUM. TM (Available from Neo-Metrics) and GUM METAL TM (Available from Toyota). In some other embodiments, superelastic alloys, such as superelastic nitinol, can be used to achieve the desired properties.

[0082] In at least some embodiments, the needle 20 may be partially or entirely doped with, made of, or otherwise comprised of a radiopaque material. A radiopaque material should be understood as one capable of producing a relatively bright image on a fluorescent screen or other imaging technique during medical procedures. This relatively bright image helps the user of the needle 20 determine its location. Some examples of radiopaque materials include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials carrying radiopaque fillers, etc. Furthermore, other radiopaque marking strips and / or coils may be incorporated into the design of the needle 20 to achieve the same result.

[0083] In some embodiments, the needle 20 is endowed with a degree of magnetic resonance imaging (MRI) compatibility. For example, the needle 20, or parts thereof, may be made of a material that substantially does not distort the image or generate a large number of artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may be unsuitable because they may produce artifacts on MRI images. The needle 20 or parts thereof may also comprise and / or be made of materials that an MRI machine can image. Some materials exhibiting these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, etc.). (etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035, such as...) (etc.), nickel-titanium, etc., and others.

[0084] It should be understood that this disclosure is illustrative in many respects. Variations in detail may be made without departing from the scope of this disclosure, particularly in terms of shape, size, and arrangement of steps. To the extent appropriate, this may include using any of the features of one exemplary embodiment in other embodiments. The scope of the invention is, of course, defined by the language of the appended claims.

Claims

1. A biopsy needle, comprising: An elongated body formed from monomers, the elongated body comprising: A first portion having a proximal end of an elongated body formed from the monomer, the first portion having a first flexibility, and In the second portion distal to the first portion, the second portion has a second flexibility different from that of the first portion. The wall thickness of the first portion is between 0.0069 inches and 0.0091 inches, and the wall thickness of the second portion is between 0.0029 inches and 0.0051 inches.

2. The biopsy needle of claim 1, wherein the elongated body formed by the monomer has a lumen extending from the proximal end to the distal end, the lumen having a constant diameter.

3. The biopsy needle according to claim 2, wherein the outer diameter of the elongated body formed by the monomer varies between the proximal end and the distal end.

4. The biopsy needle according to claim 1, wherein the first portion has a central longitudinal axis coaxial with the central longitudinal axis of the second portion.

5. The biopsy needle of claim 1, wherein the first portion has a first outer diameter, and the second portion has a second outer diameter different from the first outer diameter.

6. The biopsy needle of claim 1, wherein the first portion has a central longitudinal axis coaxial with the central longitudinal axis of the second portion.

7. The biopsy needle of claim 1, wherein the length of the second portion of the elongated body formed by the monomer is between 5 inches and 10 inches.

8. The biopsy needle of claim 1, wherein the elongated body formed by the monomer has a transition portion extending between the distal end of the first portion and the proximal end of the second portion, the transition portion having a length between 0.1 inches and 1.0 inches.

9. The biopsy needle of claim 1, wherein the first flexibility is between 3.0 lbf / in and 4.0 lbf / in and the second flexibility is between 0.1 lbf / in and 1.0 lbf / in.

10. The biopsy needle of claim 1, wherein the length of the second portion of the elongated body formed by the monomer is between 5 inches and 10 inches.

11. The biopsy needle of claim 1, wherein the elongated body formed by the monomer has a transition portion extending between the distal end of the first portion and the proximal end of the second portion, the transition portion having a length between 0.1 inches and 1.0 inches.

12. The biopsy needle of claim 1, wherein the material is configured to plastically deform when subjected to strain of up to 8%.

13. A biopsy needle, comprising: An elongated body formed from monomers, the elongated body comprising: A first portion having a proximal end of an elongated body formed from the monomer, the first portion having a first wall thickness between 0.0069 inches and 0.0091 inches, and The second portion is located on the far side of the first portion, and the second portion has a second wall thickness between 0.0029 inches and 0.0051 inches.

14. The biopsy needle of claim 13, wherein the elongated body formed by the monomer includes a lumen extending from the proximal end to the distal end, and the lumen has a constant diameter.

15. The biopsy needle of claim 14, wherein the outer diameter of the elongated body formed by the monomer varies between the proximal end and the distal end.

16. The biopsy needle of claim 13, wherein the first portion has a central longitudinal axis coaxial with the central longitudinal axis of the second portion.

17. The biopsy needle of claim 13, wherein the length of the second portion of the elongated body formed by the monomer is between 5 inches and 10 inches.

18. The biopsy needle of claim 13, wherein the elongated body formed by the monomer has a transition portion extending between the distal end of the first portion and the proximal end of the second portion, the transition portion having a length between 0.1 inches and 1.0 inches.

19. The biopsy needle of claim 13, wherein the first portion has a central longitudinal axis coaxial with the central longitudinal axis of the second portion.

20. The biopsy needle of claim 13, wherein the length of the second portion of the elongated body formed by the monomer is between 5 inches and 10 inches.

21. The biopsy needle of claim 13, wherein the elongated body formed by the monomer has a transition portion extending between the distal end of the first portion and the proximal end of the second portion, the transition portion having a length between 0.1 inches and 1.0 inches.

22. The biopsy needle of claim 13, wherein the material is configured to plastically deform when subjected to strain of up to 8%.

23. A biopsy needle, comprising: An elongated body formed from monomers, the elongated body comprising: A first portion having a proximal end of an elongated body formed from the monomer, the first portion having a first outer diameter and a first wall thickness between 0.0069 inches and 0.0091 inches, and In the second portion distal to the first portion, the second portion has a second outer diameter different from the first outer diameter, and a second wall thickness between 0.0029 inches and 0.0051 inches. The elongated body formed by the monomer includes a lumen extending from the proximal end to the distal end, and the lumen has a constant diameter.

24. The biopsy needle of claim 23, wherein the first portion has a central longitudinal axis coaxial with the central longitudinal axis of the second portion.

25. The biopsy needle of claim 23, wherein the length of the second portion of the elongated body formed by the monomer is between 5 inches and 10 inches.

26. The biopsy needle of claim 23, wherein the elongated body formed by the monomer has a transition portion extending between the distal end of the first portion and the proximal end of the second portion, the transition portion having a length between 0.1 inches and 1.0 inches.

27. The biopsy needle of claim 23, wherein the material is configured to plastically deform when subjected to strain of up to 8%.

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