Biopsy needle for accessing peripheral pulmonary nodules

Abstract

Medical devices and methods of making and using the medical devices are disclosed. An exemplary 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 access a periphery of a patient's lung, and the elongated body may have a first portion, a second portion, and a puncturing end. 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 extends distally from 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 that is different from the wall thickness of the second portion of the needle.

Description

Technical Field

[0001] The present invention relates to medical devices, as well as methods of manufacturing and / or using medical devices. More specifically, the present invention relates to biopsy needles.

Background Art

[0002] For medical use, such as for the lungs, a wide variety of medical devices have been developed. Some of these devices include catheters, stents, diagnostic tools, etc., and further include delivery devices and / or systems used to deliver such devices. These devices are manufactured by any one of a variety of different manufacturing methods and can be used according to any one of a variety of methods. Well-known medical devices, delivery systems, and methods each have certain advantages and disadvantages. There is a continuing need to provide alternative medical devices and delivery devices, as well as alternative methods for manufacturing and using medical devices and delivery devices.

Summary of the Invention

[0003] The present invention provides alternatives for the design, materials, manufacturing methods, and usage methods of medical devices. In a first aspect, a lung biopsy needle may include a proximal end, a distal end, and an elongate body extending between the proximal end and the distal end. The elongate body may have a first portion, a second portion, and a piercing end. The first portion may have a first level of flexibility. The second portion may have a second level of flexibility that is higher 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. The second level of flexibility of the second portion may be constant along the length of the second portion. The second portion of the elongate body may be distal to the distal end of the first portion of the elongate body.

[0004] Additionally or alternatively, in a second aspect, the first level of flexibility may be from 3.0 lbf / in (5.25×10 2 N / m) to 4.0 lbf / in (7.00×10 2The second flexibility level can be between N / m and 0.1 lbf / in (0.18 × 10 2 N / m) to 1.0 lbf / in (1.75 × 10 2 It can be between N / m.

[0005] Additionally or alternatively, in a third embodiment, the elongated body may include a transition section extending between the distal end of a first portion and the proximal end of a second portion, the transition section having a level of flexibility that gradually transitions along its length from a first level of flexibility to a second level of flexibility.

[0006] In addition or alternatively, in a fourth embodiment, the elongated body may be provided with a lumen extending from its proximal end to the starting point of the puncture end, the lumen may have a certain diameter. In addition or alternatively, in a fifth embodiment, the first portion of the elongated body may have a first outer diameter that is constant along the length 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 the length from the proximal end to the distal end of the second portion, the second outer diameter may be smaller than the first outer diameter.

[0007] In addition or alternatively, in a sixth embodiment, the first part may have a longitudinal axis concentric with the longitudinal axis of the second part. In addition or alternatively, in a seventh embodiment, the first portion may have a first wall thickness that is constant along a first length 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 thinner than the first wall thickness and constant along a second length from a first end of the second portion to a second end of the second portion.

[0008] Additionally or alternatively, in the eighth embodiment, the elongated body may include a transition section extending between the distal end of the first portion and the proximal end of the second portion, the transition section having a wall thickness that gradually changes along its length from a first wall thickness to a second wall thickness.

[0009] Additionally or alternatively, in the ninth embodiment, 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 5 inches (12.7 cm) and 10 inches (25.4 cm).

[0010] In addition or alternatively, in a tenth embodiment, the elongated body may include a transition section having a length between the distal end of the first portion and the proximal end of the second portion, the length of which may be between 0.1 inches (0.25 cm) and 1.0 inch (2.54 cm).

[0011] In addition or alternatively, in an eleventh embodiment, a method for manufacturing a lung biopsy needle may include the steps of: selecting an elongated tube having a first wall thickness over a length from a first end of the elongated tube to a second end of the elongated tube; and adjusting the wall thickness of the distal end of the elongated tube, extending distally from the proximal end of the elongated tube having the first wall thickness, to a second wall thickness that is thinner than the first wall thickness.

[0012] In addition or alternatively, in a twelfth embodiment, the method may further include the step of adjusting the wall thickness of the transition section such that the wall thickness of the transition section gradually decreases from a first wall thickness to a second wall thickness over the length of the transition section.

[0013] In addition or alternatively, in a thirteenth embodiment, the step of adjusting the wall thickness of the distal end of the elongated tube may include the step of removing material from the distal end in order to reduce the outer diameter of the distal end from a first outer diameter of the proximal end to a second outer diameter.

[0014] In addition or alternatively, in a 14th embodiment, the step of removing material from the distal portion may include the step of grinding the distal portion. Additionally or alternatively, in a fifteenth embodiment, the distal portion may have a certain wall thickness.

[0015] Additionally or alternatively, in a 16th embodiment, the lumen of the elongated tube may have a certain diameter. In addition or alternatively, in the 17th embodiment, the distal portion of the elongated tube may have a certain level of flexibility along the length of the distal portion from a first end to a second end.

[0016] In addition or alternatively, in the 18th embodiment, a method for collecting a tissue sample from a patient's lung may include the steps of: identifying a pathway in the airway to a tissue sampling site; introducing a flexible needle into the airway along the pathway, the flexible needle having a first portion having a first length and a first wall thickness, a second portion having a second length and a second wall thickness thinner than the first wall thickness, and a puncture end having a proximal end at the distal end of the second portion; navigating the flexible needle through the pathway to guide the puncture end of the flexible needle to a tissue sampling site; and collecting a tissue sample from the tissue sampling site.

[0017] In addition or alternatively, in the 19th embodiment, the method may further include the step of inserting a flexible needle into the lumen of a catheter. In addition or alternatively, in a 20th embodiment, the flexible needle may have a certain inner diameter.

[0018] The above summaries of some embodiments do not describe each of the disclosed embodiments or any embodiment of the present invention. The following drawings and detailed description illustrate those embodiments more specifically.

[0019] The present invention can be more fully understood by considering the following detailed description in relation to the attached drawings. [Brief explanation of the drawing]

[0020] [Figure 1] Plan view of an exemplary biopsy tool for accessing peripheral lung nodules. [Figure 2] A perspective view showing an example biopsy needle. [Figure 3] Figure 2 is a side view showing an example biopsy needle. [Figure 4]End view showing an exemplary biopsy needle of FIG. 2. [Figure 5] Cross-sectional view showing an exemplary biopsy needle of FIG. 2, taken along line 5-5 of FIG. 4. [Figure 6] Flow diagram showing an exemplary method of manufacturing a biopsy needle. [Figure 7] Flow diagram showing an exemplary method of using a biopsy needle. **DETAILED DESCRIPTION OF THE INVENTION**

[0021] The present invention is capable of various modifications and alternative forms, and specific examples thereof are shown in the drawings and will be described in detail below. However, it should be understood that the present invention is not intended to be limited to the specific embodiments described. Rather, the present invention encompasses all modifications, equivalents, and alternatives within the spirit and scope of the present invention.

[0022] For the terms defined below, these definitions shall apply unless different definitions are provided elsewhere in the claims or in the specification. In this specification, all numerical values are considered to be modified by the term "about", whether or not explicitly stated. The term "about" generally refers to a range of numbers that those skilled in the art would consider to be equivalent to the recited value (i.e., having the same effect or result). In many cases, the term "about" may include numbers rounded to the nearest significant digit value.

[0023] Numerical ranges described by endpoints include all numbers within that range (e.g., 1 - 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. Also, as used in this specification and the appended claims, the term "or" generally includes "and / or" unless the context clearly dictates otherwise.

[0024] It should be noted that expressions such as "one embodiment," "several embodiments," and "other embodiments" in this specification mean that the described embodiments may include one or more specific features, structures, and / or characteristics. However, such descriptions do not necessarily mean that those specific features, structures, and / or characteristics are included in all embodiments. Furthermore, if a specific feature, structure, and / or characteristic is described in relation to one embodiment, it should be understood that such feature, structure, and / or characteristic may be used in relation to other embodiments, regardless of whether it is explicitly stated or not, unless it is explicitly stated that this would be contrary to the description.

[0025] The following detailed description should be interpreted with reference to the drawings, in which similar structures in different drawings are numbered the same. These drawings are not necessarily to scale and illustrate exemplary embodiments, and are not intended to limit the scope of the invention.

[0026] The global lung cancer epidemic, coupled with the increased adoption of lung cancer screening, may be contributing to a rise in the number of suspected solitary pulmonary nodules (SPNs) detected by chest computed tomography (CT) scans or other scans. Suspected SPNs, typically located in the periphery of the lung, can be difficult to access and diagnose using current bronchoscopy techniques, which are primarily designed for the central airways. Peripheral pulmonary nodules, or SPNs, can be round masses up to 3 centimeters (cm) in size, potentially benign or malignant. When an SPN is identified, it may be necessary to diagnose it by biopsy. Typically, fine-needle aspiration (FNA) may be used to access and biopsy identified SPNs, either through a transbronchial approach via the patient's throat or oral cavity, or through a transthoracic approach via the patient's pleural cavity. Generally, the transbronchial approach is sometimes preferred over the transthoracic approach because it allows access to the subcutaneous tissue nodule (SPN) through the existing pulmonary airway without puncturing living tissue. However, since SPNs are often located in the deep periphery of the lung, reaching them through the pulmonary airway can be difficult or impossible, and therefore it may be necessary to access them using the transthoracic approach by puncturing the patient's thoracic cavity. Because the transthoracic approach may require a longer recovery time than the transbronchial approach, it is sometimes considered more invasive, and therefore it is desirable to provide a device configured to navigate the tortuous pathways in the deep periphery of the pulmonary airway. Such a device may enable physicians to collect biopsy samples from SPNs in the deep periphery of the lung that were previously inaccessible via the transbronchial approach. Although this invention describes pulmonary nodules, the methods and devices described herein are expected to be applicable to other anatomical sites, such as the gastrointestinal tract, urinary tract, and gynecological tract, without the intention of limiting them.

[0027] Figure 1 shows a plan view of an exemplary biopsy system 10 advanced through the trachea T ​​and bronchial tree BT to a peripheral nodule 12 in the lung L. In some cases, the nodule, or lesion 12, may be located in the deep peripheral region of the lung, and access may be difficult due to the tortuous pathways of the airways in the peripheral region of the lung.

[0028] Figure 1 shows a biopsy system 10 reaching a peripheral nodule 12. However, typical biopsy systems used with bronchoscopy in a transbronchial approach cannot access SPNs located deep in the periphery of the lung due to the tortuosity of the airways in the deep periphery. While biopsy systems may use needles of various gauges, including those between 17 and 27 gauges (though this is not intended to be limiting), a 25 gauge needle has been found to be a suitable size for attempting to access SPNs in the periphery of the lung. A 25 gauge needle may have an inner diameter of approximately 0.0120 inches (0.0305 cm) and an outer diameter of approximately 0.0203 inches (0.0516 cm). Therefore, a 25 gauge needle can provide a favorable balance of stiffness and flexibility necessary to pass through the airways of the lung, while also providing an inner diameter that facilitates proper sample collection by the needle once it reaches the SPN. Even so, it has been found that the distal end of a 25-gauge needle may be too rigid to navigate the deep peripheral airways of the lung. Furthermore, while a 27-gauge needle may have a more flexible distal end than a 25-gauge needle, it may not have the necessary proximal rigidity to pass through the deep peripheral airways of the lung, and / or may not have a properly sized bore to ensure that a sample is reliably taken from the subcutaneous tissue (SPN) if it reaches the SPN (for example, to ensure that a sufficient sample is taken from the SPN to perform the required tests on the sample) (for example, the bore may be too small). The needle according to the present invention addresses such requirements by providing a needle having proximal rigidity suitable for passing through the deep periphery of the lung, distal flexibility suitable for navigating the deep periphery of the lung, and an appropriate inner diameter (e.g., a sufficiently large inner diameter) for ensuring that an appropriate sample is taken from the SPN when the needle is positioned in the SPN (e.g., for ensuring that a sufficient sample is taken from the SPN to perform the required tests on the sample).

[0029] Figure 2 shows a perspective view of a needle 20 configured to traverse the meandering airway pathways in the deep periphery of a patient's lung while maintaining axial strength to allow insertion to a target site. The needle 20 may have a proximal end 22 and a distal end 24, with an elongated body 26 extending between the proximal end 22 and the distal end 24. To facilitate navigation to the periphery of a patient's lung, the needle 20 or the elongated body 26 of the needle 20 may have one or more different flexures along its length.

[0030] The elongated body 26 may have one or more parts. If the elongated body may have two or more parts, the elongated body 26 may have at least a first part 28 and a second part 30. Furthermore, although not required, the elongated body may have a transition part 32 and / or a tip part 34 (e.g., a piercing end, a puncture end, a beveled end, or other tip).

[0031] Figure 3 is a side view of the needle 20. As shown in Figure 3, the second portion 30 of the elongated body 26 may extend distally from the first portion 28 of the elongated body 26, and in some cases the second portion 30 (e.g., the distal portion) may be the entire distal portion of the first portion 28 (e.g., the proximal portion), although 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. If the elongated body 26 includes a transition portion 32, as in the needle 20 of Figure 3, 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 transition portion 32, and the transition portion 32 may extend from the distal end of the first portion 28 to the proximal end of the second portion 30. The second portion 30 may extend distally from the distal end of the transition portion 32. If the elongated body 26 includes a tip portion 34, the second portion 30 may extend from the distal end of the transition portion to the proximal end of the tip portion 34, and the tip portion 34 may extend from the distal end of the second portion 30 to the distal end 24 of the needle 20.

[0032] Each part of the elongated body 26 may have the same or different lengths as the other parts of the elongated body. The length of the elongated body 26 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 depending on the application of the needle 20. For example, the elongated body 26 may have lengths between approximately 40 inches (101.6 cm) and 100 inches (254.0 cm), between 50 inches (127.0 cm) and 90 inches (228.6 cm), between 60 inches (152.4 cm) and 80 inches (203.2 cm), between 65 inches (165.1 cm) and 70 inches (177.8 cm), and / or different lengths less than 40 inches (101.6 cm) or greater than 100 inches (254.0 cm). The length of the first portion 28 of the elongated body 26, extending from the proximal end to the distal end of the first portion 28, can be any length depending on the application of the needle 20. For example, the first portion 28 of the elongated body 26 may have lengths between approximately 30 inches (76.2 cm) and 90 inches (228.6 cm), between 40 inches (101.6 cm) and 80 inches (203.2 cm), between 50 inches (127.0 cm) and 70 inches (177.8 cm), between 55 inches (139.7 cm) and 60 inches (152.4 cm), and / or different lengths less than 30 inches (76.2 cm) or greater than 90 inches (228.6 cm). The length of the second portion 30 of the elongated body, extending from the proximal end to the distal end of the second portion 30, can be any length depending on the application of the needle 20. For example, the second portion 30 of the elongated body 26 may have lengths between approximately 2 inches (5.08 cm) and 20 inches (50.8 cm), between 4 inches (10.16 cm) and 16 inches (40.64 cm), between 6 inches (15.24 cm) and 12 inches (30.48 cm), between 7 inches (17.78 cm) and 10 inches (25.4 cm), and / or different lengths less than 2 inches (5.08 cm) or greater than 20 inches (50.8 cm). The lengths of the transition portion 32 and the tip portion 34 may vary, but the transition portion 32 has lengths between approximately 0.1 inches (0.25 cm) and 2 inches (5.08 cm), while the tip portion 34 has lengths between approximately 0.They can have a length of less than 1 inch (0.25 cm), and in some cases, typically less than 0.5 inches (1.27 cm).

[0033] In some cases, as disclosed herein, the needle 20 may be configured to travel through the airways in the deep periphery of the patient's lungs to reach a pulmonary nodule or nodule within the lung. In such cases, the needle 20 may have an overall length between 50 inches (127.0 cm) and 80 inches (203.2 cm) (e.g., 66 inches (167.64 cm) or about 66 inches (167.64 cm), or any other length), and the first part 28 of the needle 20 may have a length between 50 inches (127.0 cm) and 60 inches (152.4 cm) (e.g., 56 inches (142.24 cm) or about 56 inches (142.24 cm), or any other length), and the second part The 30 section can be between 8 inches (20.32 cm) and 12 inches (30.48 cm) in length (e.g., 9.5 inches (24.13 cm) or approximately 9.5 inches (24.13 cm), or any other length), the transition section 32 can be between approximately 0.4 inches (1.016 cm) and 0.6 inches (1.524 cm) in length (e.g., 0.5 inches (1.27 cm) or an approximate value thereof, or any other length), and the tip section 34 may be less than approximately 0.5 inches (1.27 cm) in length.

[0034] Figure 3 shows an example configuration of a needle 20 including a first section 28, a second section 30, a transition section 32, and a tip section 34, but one or more of these sections can be removed from the needle 20, and further / or one or more sections can be added to the needle 20. For example, in some cases the needle 20 may not include the transition section 32. Alternatively or additionally, the needle 20 may include one or more additional elongations and / or one or more additional transition sections (similar to one or both of the first section 28 and the second section 30, for example). In an example of an elongated body including one or more additional elongations, the first section 28 and the second section 30 may be two of the most distal elongations, and / or the second section 30 may be the most distal elongation. In some cases, additional elongated and / or transitional sections may facilitate the addition of one or more portions of the elongated body 26 having different flexibility (e.g., flexibility level) than the other portions of the elongated body 26, in which case these additional portions may be used to increase or decrease the flexibility / rigidity of the needle 20 in a local area in order to facilitate access to specific anatomical structures of the patient and / or to facilitate use with auxiliary medical devices (e.g., scopes or other medical devices).

[0035] As shown in Figure 3, 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 a predetermined amount. This predetermined amount is between approximately 0.001 inches (0.0025 cm) and 0.007 inches (0.0178 cm), between approximately 0.002 inches (0.0051 cm) and 0.006 inches (0.0152 cm), between approximately 0.003 inches (0.0076 cm) and 0.005 inches (0.0127 cm), or approximately 0.004 inches (0.0102 cm), or a larger or smaller amount. Furthermore, in some cases, the first outer diameter OD1 of the first portion 28 of the elongated body 26 may be constant along the length from the proximal end to the distal end of the first portion 28, although this is not required. Similarly, in some cases, the second outer diameter OD2 of the second portion 30 of the elongated body 26 may be constant along the length from the proximal end to the distal end of the second portion 30, although this is not required. The relative outer diameters of the first portion 28 and the second portion 30 may facilitate the imparting of a different flexibility to the second portion 30 than that of the first portion 28.

[0036] If the needle 20 includes a transition section 32, the transition section 32 may have an outer diameter that tapers from approximately a first outer diameter OD1 of the first portion 28 to approximately a second outer diameter OD2 of the second portion 30. In some cases, the taper of the outer diameter of the transition section 32 may have a constant slope. Alternatively, the outer diameter of the transition section 32 may have two or more different slopes, and / or the transition section 32 may have an outer diameter that decreases in stages from the first outer diameter OD1 to the second outer diameter OD2, and / or the outer diameter of the transition section 32 may transition in any other form from the first outer diameter OD1 to the second outer diameter OD2.

[0037] Figure 4 is an elevation view of the distal end of the needle 20 shown in Figures 2 and 3. The needle 20 has an elongated body 26, a transition section 32 extending from a first section 28 to a second section 30, and a second section 30 extending to a tip section 34, which may be the most distal part of the elongated body 26. Furthermore, the elongated body 26 can define a lumen 36 having a diameter defined by the inner diameter of the elongated body 26 (one or more).

[0038] Figure 5 is a cross-sectional view of the needle 20 along the line 5-5 in Figure 4. 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. Furthermore, in some cases, the first inner diameter ID1 of the first portion 28 of the elongated body 26 may be constant along the length from the proximal end to the distal end of the first portion 28, although this is not required. Similarly, in some cases, the second inner diameter ID2 of the second portion 30 of the elongated body 26 may be constant along the length from the proximal end to the distal end of the second portion 30, although this is not required. If a transition portion 32 is present, it may have an inner diameter that may be constant along the length 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 may be the same as any other portion between the proximal end 22 of the needle and the proximal end 34, so that the elongated body 26 may have a constant inner diameter from the proximal end 22 of the needle to the proximal end of the tip portion 34. On the other hand, it is conceivable that one or more portions of the elongated body 26 may have an inner diameter that varies along that portion and / or an inner diameter that differs from one or more other portions of the elongated body 26.

[0039] Figure 5 shows a lumen 36 extending from the proximal end 22 of the needle 20 to the distal end of the second portion 30 and opening outward from the tip 34. The lumen 36 may have a constant diameter along the length of the needle, defined by the inner diameter of the elongated body 26. In some cases, the lumen 36 may have a longitudinal axis along the first longitudinal axis LA1 of the first portion 28 and the second longitudinal axis LA2 of the second portion 30. In one example, the first longitudinal axis LA1 may be concentric with the second longitudinal axis LA2, although this is not required.

[0040] The wall thickness of the elongated body 26 can be determined by subtracting the inner diameter of the elongated body 26 from the outer diameter of the elongated body 26. In some cases, for example, 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 can be determined in conjunction with the material properties of the material of the elongated body to 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).

[0041] As shown in Figure 5, the first portion 28 of the elongated body 26 may have a first wall thickness WT1 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 equal to the second outer diameter OD2 minus the second inner diameter ID2. If 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, similar to how the outer diameter of the transition portion 32 transitions from the first outer diameter OD1 to the second outer diameter OD2. If the elongated body 26 includes additional elongated portions, these additional elongated portions may have different wall thicknesses, similar to the first wall thickness WT1 and / or the second wall thickness WT2, but this is not required.

[0042] In the example of Figure 5, the first portion 28 of the elongated body 26 may have a constant wall thickness WT1 that imparts a certain degree of flexibility to the first portion 28. However, the first portion 28 of the elongated body 26 may have a wall thickness that varies along its length, and therefore may have flexibility that varies along its length depending on the desired proximal rigidity or flexibility. In the example of Figure 5, the second portion 30 of the elongated body 26 may have a constant wall thickness WT2 that imparts a certain degree of flexibility to the second portion. However, the second portion 30 of the elongated body 26 may have a wall thickness that varies along its length, and therefore may have flexibility that varies along its length depending on the desired distal rigidity or flexibility.

[0043] In one example of a needle 20 configured to reach the SPN in the deep peripheral part of the lung by passing through the pulmonary airway, the elongated body may have a first portion 28 having a first wall thickness WT1 (e.g., the wall thickness of a 25 gauge needle) between approximately 0.0069 inches (0.0175 cm) and 0.0091 inches (0.0231 cm), and a second portion 30 having a second wall thickness WT2 between approximately 0.0029 inches (0.0074 cm) and 0.0051 inches (0.013 cm), and may have a constant inner diameter (e.g., the inner diameter of a 25 gauge needle) between approximately 0.0119 inches (0.0302 cm) and 0.0121 inches (0.0307 cm). The needle 20 configured in this way can be given the proximal rigidity or flexibility necessary to pass through the deep peripheral airways of the lung, while maintaining an inner diameter (e.g., the dimensions of the lumen 36) sized to reliably collect a suitable sample of SPN, i.e., a nodule, located deep within the lung, and can also be provided with the distal rigidity or flexibility necessary to pass through the tortuous pathways deep within the lung (for example, the distal rigidity or flexibility of the needle 20 is reduced without sacrificing the dimensions of the lumen 36, so that the same amount of sample can be collected from the SPN as in other situations, without reducing the outer diameter or wall thickness of the second portion 30 of the needle 20).

[0044] Furthermore, the first portion 28 and the second portion 30 of the needle 20 having the dimensional configuration described in the paragraph above can be monolithically formed from a single piece of material. When such a needle 20 is made of cobalt-chromium, the first portion 28 of the needle 20 may have a flexibility of approximately 3.6 lbf / in (630.45 N / m), and the second portion 30 of the needle 20 may have a flexibility of approximately 0.9 lbf / in (157.61 N / m) (for example, a 75% increase in flexibility compared to the first portion 28). In this case, the flexibility of each portion 28, 30 of the needle 20 can be measured by a three-point bending test, which is common in the flexibility measurement industry. If the first portion 28 and the second portion 30 of the needle 20 are formed monolithically (for example, monolithically from biocompatible stainless steel (e.g., cobalt-chromium or other stainless steel)), then the needle 20 may have advantages, though not limited to, compared to typical needles used to insert into the airways of the lungs (e.g., needles with a standard 25 gauge cobalt-chromium distal portion, needles with a standard 25 gauge 300 series stainless steel distal portion, needles with a 25 gauge cobalt-chromium distal portion with a spiral cut (e.g., 0.120 inch (0.3048 cm) pitch to 0.200 inch (0.508 cm) pitch), including increased distal flexibility while maintaining proximal rigidity and the amount of sample that can be collected by the needle, and reduced material and manufacturing costs.

[0045] The needle 20 disclosed herein can be manufactured by one or more manufacturing techniques. Method 100 shown in Figure 6 presents an exemplary method for manufacturing the 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 described above or a different first wall thickness), and / or a specified gauge (e.g., 25 gauge or other gauge). In some cases, the selected elongated tube may have a first wall thickness between approximately 0.0069 inches (0.0175 cm) and 0.0091 inches (0.0231 cm) (e.g., with a first outer diameter between approximately 0.0190 inches (0.0483 cm) and 0.0210 inches (0.0533 cm) and an inner diameter between approximately 0.0119 inches (0.0302 cm) and 0.0121 inches (0.0307 cm)).

[0046] The selected slender tube may be a pre-formed needle with a tip (e.g., a puncture end, a penetrating end, a pointed end, or other tip). Alternatively, the selected slender tube may be a raw tube with a tip added to the distal end of the selected needle.

[0047] The selected slender tube may be formed from any desired material. For example, the selected slender tube may be formed entirely or at least partially from biocompatible stainless steel (e.g., cobalt-chromium or other biocompatible stainless steel). In some cases, the slender tube may be a monolithic tube or may be formed from two or more materials joined together.

[0048] Once an elongated tube is selected, the wall thickness of the distal end of the elongated tube will be adjusted to a second wall thickness that is thinner than the first wall thickness (for example, the second wall thickness WT2 described above or a different second wall thickness). The adjusted second wall thickness can be of any dimension. In some cases, the adjusted wall thickness may be between approximately 0.0029 inches (0.0074 cm) and 0.0051 inches (0.013 cm) (for example, when the second outer diameter is between approximately 0.0150 inches (0.0381 cm) and 0.0170 inches (0.0432 cm), and the inner diameter is between approximately 0.0119 inches (0.0302 cm) and 0.0121 inches (0.0307 cm). When such an elongated tube is formed, and that tube is made of cobalt-chromium, the flexibility or stiffness of the proximal part, as measured by a standard three-point bending test, may be approximately 3.6 lbf / in (630.45 N / m), and the flexibility or stiffness of the distal part may be approximately 0.9 lbf / in (157.61 N / m).

[0049] The distal portion of the selected slender tube may be the part of the slender tube that extends distally from the proximal portion of the slender tube. In some cases, the distal portion of the selected slender tube may extend proximal from the distal end of the slender tube, or from the proximal end of the tip of the slender tube, for a distance between approximately 8 inches (20.32 cm) and approximately 12 inches (30.48 cm). In one example, the distal portion of the selected slender tube may be the second portion 30 of the slender body 26 described above.

[0050] In some cases, the second wall thickness of the distal end of an elongated tube may be constant along the length of the distal end. Such a constant wall thickness may consequently give the distal end a certain flexibility along its length, facilitating passage through the meandering pathways deep within the periphery of the lung.

[0051] In some cases, method 100 may include adjusting the wall thickness of a transition section of a selected elongated tube (e.g., the transition section 32 of the elongated body 26 described above or a different transition section). Adding a transition section to a selected elongated tube may increase the stability of the tube and reduce the likelihood that the distal section with the adjusted second wall thickness will break off from the proximal section with the first wall thickness, compared to an elongated tube without a transition section (e.g., an elongated tube having a shoulder between a proximal section with a first wall thickness and a distal section with a second wall thickness).

[0052] When a transition is formed in a selected elongated tube, the transition may have a wall thickness that gradually decreases from a first wall thickness to a second wall thickness along the length of the transition. In one example, the transition may have a wall thickness that gradually changes from a first wall thickness to a second wall thickness along a length of approximately 0.400 inches (1.016 cm) to approximately 0.600 inches (1.524 cm). In some cases, the length of the transition is about 100 times greater than the difference between the first and second wall thicknesses, although this is not mandatory.

[0053] The wall thickness of a selected slender tube can be adjusted in any way. In some cases, the wall thickness of a selected slender tube may be adjusted by removing material from the outer diameter of the slender tube (e.g., from the distal and / or transitional portions). Alternatively or additionally, adjusting the wall thickness of the distal portion of a slender tube relative to the proximal portion of the slender tube may, but are not limited to, include adding material to the slender tube (e.g., from the proximal and / or transitional portions) by typical tube forming techniques, including extrusion, drawing, and / or other techniques, and / or manipulating the relative dimensions of the wall thickness of the slender tube portions in any way.

[0054] Any removal technique can be used to remove material from the outer diameter of an elongated tube in order to adjust the wall thickness of the distal portion. For example, the distal portion of a selected elongated tube can be ground to a desired outer diameter to form a wall thickness with the desired flexibility. Other removal techniques may be used as needed, and these techniques may include, but are not limited to, milling, turning, honing, lapping, planning, and / or other removal techniques.

[0055] The needle formed by Method 100 can take various forms, having a distal elongated portion that has lower flexibility than the more proximal elongated portion. In one example, the needle formed by Method 100 may have a tip (e.g., tip 34 or other tip), a distal portion extending proximal from the tip (e.g., a second portion 30 or other distal portion), and a proximal portion extending proximal from the distal portion (e.g., a first portion 28 or other proximal portion). In this case, the distal portion has higher flexibility than 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 section (e.g., transition section 32 or other transition section) between the proximal and distal portions, in which case the transition section has flexibility that gradually transitions from the flexibility of the proximal portion to the flexibility of the distal portion, and has the same inner diameter as the distal and proximal portions, and is formed monolithically with the distal and proximal portions. On the other hand, other configurations are envisioned, including needles composed of two or more materials, and / or needles having one or more portions on the proximal side of the proximal portion.

[0056] Figure 7 shows a method 200 using a flexible needle (e.g., needle 20 or other needle) in a procedure for taking a tissue sample from a patient's lung. Method 200 may include a step 202 of identifying a pathway in the airway to the tissue sample site. The pathway in the airway can be identified by any method. For example, the pathway can be identified by the same or a different CT scan that may be used to identify the SPN or other nodules (e.g., the target site). Alternatively, one or more other scan or imaging techniques may be used to identify a pathway through the pulmonary airway to the target site. Once the pathway is identified, a flexible needle (e.g., needle 20 or other needle with a constant inner diameter) can be introduced into the airway along the identified pathway 204. Introducing the flexible needle into the pathway may include inserting the flexible needle into the lumen of a catheter and / or the lumen of a bronchoscope. A flexible needle may include a first portion (e.g., a first portion 28 or another first portion) having a length having a first wall thickness (e.g., the first wall thickness WT1 described above or a different wall thickness), a second portion (e.g., a second portion 30 or another second portion) having a length having a second wall thickness thinner than the first wall thickness (e.g., the second wall thickness WT2 described above or a different wall thickness), and a tip portion (e.g., a tip portion 34 having a puncture end, a penetrating end, a sharp end, or another tip portion) having a proximal end at the distal end of the second portion.

[0057] After inserting the flexible needle into the identified pathway, Method 200 may include step 206 of navigating the flexible needle through the identified pathway to a target sample site (e.g., SPN or other nodule). Once the target sample site is reached, Method 200 may include step 208 of collecting a tissue sample from the tissue sample site (e.g., SPN or other nodule). In some cases, the sample can be collected by engaging the tip of the flexible needle with the SPN or nodule or other tissue, and by drawing a syringe connected to the flexible needle to draw the sample into the lumen of the needle while aspirating through the lumen of the flexible needle. After the sample has been collected, the sample and / or the flexible needle can be withdrawn from the patient and it can be confirmed that the sample is of SPN or nodule origin. If it cannot be confirmed that the sample is of SPN or nodule origin, Method 200 can be repeated.

[0058] As described above with respect to needle 20, the flexible needle can have a constant inner diameter, or diameter, of its lumen, which is configured to facilitate the collection of appropriate sample dimensions from SPN or other nodules while having a distal end with increased flexibility. In such a configured flexible needle, the inner diameter, or lumen diameter, of the flexible needle allows for a larger vacuum force within the needle lumen, which responds better to pulling the syringe, compared to the vacuum force that can be obtained by a needle in which the wall thickness and inner diameter of the distal end of the needle are reduced to increase flexibility at the distal end.

[0059] The specific material of needle 20 may be as described above, but needle 20 may include any material generally associated with medical devices. For simplicity, the following description refers to needle 20. However, this is not to limit the devices and methods described herein, and this description may be applied to other similar systems and / or components of systems or devices disclosed herein.

[0060] The needle 20 may be made of metal, metal alloy, polymer (some examples thereof are disclosed below), metal-polymer composites, ceramics, composites thereof, etc., or other suitable materials. Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylenetetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethane (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., DSM Engineering ARNITEL® (available from Plastics), ether-based or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalate and / or other polyester elastomers such as HYTREL® (available from DuPont), polyamides (e.g., DURETHAN® (available from Bayer) or CRISTAMID® (available from ElfAtochem), elastic polyamides, block polyamides / ethers, polyether block amides (PEBA, available under trade names such as PEBAX®), ethylene vinyl acetate copolymer (EVA), silico Polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low-density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly-p-phenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, (EMS American)This may include nylon-12, perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS50A), polycarbonates, ions, biocompatible polymers, other suitable materials, or mixtures, composites, copolymers, polymer-metal composites, etc. In some embodiments, the polymer may be blended with liquid crystal polymer (LCP). For example, the mixture may contain up to about 6% LCP.

[0061] Some examples of suitable metals and metal alloys include stainless steel such as 304V, 304L, and 316LV stainless steel; mild steel; nickel-titanium alloys such as linear elastic and / or superelastic Nitinol; nickel-chromium-molybdenum alloys (e.g., UNS:N06625 such as INCONEL® 625, UNS:N06022 such as HASTELLOY® C-22®, UNS:N10276 such as HASTELLOY® C276®, and other HASTELLOY® alloys, etc.); nickel-copper alloys (e.g., UNS:N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, etc.); nickel-cobalt- This includes other nickel alloys such as chromium-molybdenum alloys (e.g., UNS:R30035, such as MP35-N®), nickel-molybdenum alloys (e.g., UNS:N10665, such as HASTELLOY® ALLOYB2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, such as ELGILOY® and PHYNOX®); platinum-rich stainless steel; titanium; composites thereof; and equivalents; or any other suitable material.

[0062] As suggested herein, some commercially available nickel-titanium alloys, or nitinol alloys, are classified as "linearly elastic" or "non-hyperelastic," which may be chemically similar to conventional shape-memory and hyperelastic types, but may exhibit unique and useful mechanical properties. Linearly elastic and / or non-hyperelastic nitinol can be distinguished from hyperelastic nitinol by the absence of a substantial "hyperelastic plateau" or "stagnation region" in the stress / strain curve, as exhibited by hyperelastic nitinol. Instead, in linearly elastic and / or non-hyperelastic nitinol, as the recoverable strain increases, the stress continues to increase in a generally linear relationship, or not necessarily perfectly linear but somewhat linear relationship, or at least more linear than the hyperelastic plateau and / or stagnation region sometimes seen in hyperelastic nitinol, until plastic deformation begins. Therefore, for the purposes of this invention, linearly elastic and / or non-superelastic nitinol may also be referred to as "generally" linearly elastic and / or non-superelastic nitinol.

[0063] In some cases, linear elastic and / or non-hyperelastic nitinol can be distinguished from hyperelastic nitinol by the fact that linear elastic and / or non-hyperelastic nitinol can tolerate a strain of up to about 2–5% while remaining largely elastic (e.g., before plastic deformation), while hyperelastic nitinol can tolerate a strain of up to about 8% before plastic deformation. Both of these materials can be distinguished from other linear elastic materials, such as stainless steel (which can also be distinguished by its composition), which can tolerate only about 0.2–0.44% strain before plastic deformation.

[0064] In some embodiments, linear elastic and / or non-hyperelastic nickel-titanium alloys are alloys that do not exhibit any martensite / austenite phase transitions detectable by differential scanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA) over a wide temperature range. For example, in some embodiments, the linear elastic and / or non-hyperelastic nickel-titanium alloy may not exhibit a martensite / austenite phase transition detectable by DSC and DMTA analysis in the range of about -60°C to about 120°C. Therefore, the mechanical bending properties of such materials may be hardly affected by temperature over this extremely wide temperature range. In some embodiments, the mechanical bending properties of linear elastic and / or non-hyperelastic nickel-titanium alloys at ambient or room temperature are substantially the same as those at body temperature, for example, in that they do not exhibit a hyperelastic plateau and / or stagnation region. In other words, over a wide temperature range, linearly elastic and / or non-superelastic nickel-titanium alloys maintain their linearly elastic and / or non-superelastic properties and / or characteristics.

[0065] In some embodiments, linearly elastic and / or non-superelastic nickel-titanium alloys can have nickel in the range of about 50 to about 60 wt%, with the remainder being essentially titanium. In some embodiments, the composition is in the range of about 54 to about 57 wt% nickel. An example of a suitable nickel-titanium alloy is the FHP-NT alloy, commercially available from Furukawa Technomaterials Co., Ltd. (Kanagawa, Japan). Several examples of nickel-titanium alloys are disclosed in U.S. Patent No. 5,238004 and No. 6,508803, which are incorporated herein by reference. Other suitable materials may include ULTANIUM® (available from Neo-Metrics) and GUMMETAL® (available from Toyota). In some other embodiments, superelastic alloys, such as superelastic nitinol, can be used to obtain desired properties.

[0066] In at least some embodiments, some or all of the needle 20 may be doped with, composed of, or otherwise incorporate an X-ray opaque material. The X-ray opaque material is understood to be a material capable of producing a relatively bright image on a fluoroscopy screen or in other imaging techniques during a medical procedure. This relatively bright image helps the user of the needle 20 to locate its position. Some examples of X-ray opaque materials include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymer materials with added X-ray opaque fillers, etc. Furthermore, other X-ray opaque marker bands and / or coils may be incorporated into the design of the needle 20 to achieve the same effect.

[0067] In some embodiments, the needle 20 is given a certain degree of magnetic resonance imaging (MRI) suitability. For example, the needle 20 or some parts or components thereof may be made of a material that does not distort the image too much and does not produce many artifacts (i.e., missing images). For example, some ferromagnetic materials may be unsuitable because they can produce artifacts in MRI images. The needle 20 or some parts thereof may also include and / or be made of a material that can be imaged by an MRI device. Some materials exhibiting these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003 such as ELGILOY® and PHYNOX®), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035 such as MP35-N®), nitinol, and equivalents.

[0068] It should be understood that the present invention is, in many respects, merely illustrative. Details can be modified without departing from the scope of the invention, particularly with respect to shape, dimensions, and arrangement of steps. This may include, to the extent appropriate, using any feature of one exemplary embodiment in other embodiments. The scope of the invention is, of course, defined by the language expressing the appended claims.

Claims

1. It is a lung biopsy needle, It has a monolithic, elongated body, The elongated body includes a first portion which includes the proximal end of the monolithically formed elongated body, and the first portion is 5.25 × 10 ２ N / m to 7.00 × 10 ２ It is formed from a material having first material properties that impart a first flexibility level between N / m to the first portion, The elongated body includes a second portion distal to the first portion, the second portion having a different flexibility level from the first portion, 0.18 × 10 ２ From N / m to 1.75 × 10 ２ It is formed from a material having a second material property that imparts a second flexibility level between N / m to the second portion, The elongated body includes a transition portion provided between the first portion and the second portion, The transition section has a flexibility level that gradually changes along the longitudinal direction of the transition section from the first flexibility level to the second flexibility level. A lung biopsy needle, wherein the first material properties described above are different from the second material properties described above.

2. The lung biopsy needle according to claim 1, wherein the monolithically formed elongated body is provided with a lumen, the lumen having a constant diameter and extending from the proximal end to the distal end.

3. The lung biopsy needle according to claim 2, wherein the outer diameter of the monolithically formed elongated body changes between the proximal end and the distal end.

4. The lung biopsy needle according to claim 1, wherein the first portion has a first wall thickness, and the second portion has a second wall thickness different from the first wall thickness, and the difference in wall thickness contributes to the difference in flexibility levels between the first portion and the second portion.

5. The lung biopsy needle according to claim 1, wherein the first portion has a first outer diameter that is constant along the length extending from the proximal end to the distal end of the first portion, and the second portion has a second outer diameter that is constant along the length extending from the proximal end to the distal end of the second portion and is smaller than the first outer diameter.

6. The lung biopsy needle according to claim 1, wherein the length of the second portion of the monolithically formed elongated body is between 0.2032 m and 0.3048 m.

7. The lung biopsy needle according to claim 1, wherein the monolithically formed elongated body comprises the transition portion, the transition portion having a length extending between the first portion and the second portion, and the length of the transition portion is between 0.00254 m and 0.0254 m.

8. The first flexibility level is 5.25 × 10 ２ N / m to 7.00 × 10 ２ The second flexibility level is between N / m and 0.18 × 10 ２ From N / m to 1.75 × 10 ２ A lung biopsy needle according to claim 1, wherein the value is between N / m.

9. It is a lung biopsy needle, It has a monolithic, elongated body, The elongated body includes a first portion including a proximal end of the monolithically formed elongated body, the first portion having a first wall thickness and being formed of a material having a first material property imparting a first level of flexibility to the first portion between 5.25×10 ２ N / m and 7.00×10 ２ N / m, The elongated body includes a second portion distal to the first portion, the second portion having a second wall thickness different from the first wall thickness, and a different flexibility level of 0.18 × 10⁻¹⁰. ２ From N / m to 1.75 × 10 ２ It is formed from a material having a second material property that imparts a second flexibility level between N / m to the second portion, The first material properties differ from the second material properties, The elongated body includes a transition portion provided between the first portion and the second portion, The lung biopsy needle has a transition section having a flexibility level that gradually changes along the longitudinal direction of the transition section from the first flexibility level to the second flexibility level.

10. The lung biopsy needle according to claim 9, wherein the monolithically formed elongated body is provided with a lumen, the lumen having a constant diameter and extending from the proximal end to the distal end.

11. The lung biopsy needle according to claim 10, wherein the outer diameter of the monolithically formed elongated body changes between the proximal end and the distal end.

12. The lung biopsy needle according to claim 9, wherein the first portion has a central longitudinal axis, and the central longitudinal axis is concentric with the central longitudinal axis of the second portion.

13. The lung biopsy needle according to claim 9, wherein the length of the second portion of the monolithically formed elongated body is between 0.2032 m and 0.3048 m.

14. The lung biopsy needle according to claim 9, wherein the monolithically formed elongated body includes a transition portion, the 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 is between 0.00254 m and 0.0254 m.

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