Variable pitch flexible needle

Abstract

To provide improved flexible tube assemblies, flexible needle assemblies, systems, methods of fabricating a flexible tube, and methods of fabricating a flexible needle.SOLUTION: A flexible tube assembly 100 includes: a flexible tube having a proximal end 104 with a proximal strain relief section 106, and a distal end 108 with a distal strain relief section 110, the proximal strain relief section being located between the proximal end and the distal strain relief section, the distal strain relief section being located between the distal end and the proximal strain relief section, the distal end defining an opening 112 therein, at least a portion of at least one of the proximal strain relief section and the distal strain relief section defining therein a spiral cut with a continuously variable pitch; and tubing disposed in an airtight manner over an exterior surface of the flexible tube, at least the portion of the at least one of the proximal strain relief section and the distal strain relief section defining therein the spiral cut with a continuously variable pitch.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] [Related Application] The subject matter disclosed in this application relates to the subject matter disclosed in U.S. Patent Application No. 13 / 778,049, filed on February 26, 2013 and published on August 29, 2013 as U.S. Patent Application Publication No. 2013 / 0225997, entitled "Lung Biopsy Needle", the entire contents of which are incorporated herein by reference.

[0002] The disclosed embodiments relate to flexible needles for biopsying tissue and / or delivering fluid, medicine or other substances to a target area.

Background Art

[0003] The description in this section is merely to provide background information related to the present disclosure and may not constitute prior art.

[0004] Early diagnosis of potential cancerous tissue is an important step in cancer treatment because the earlier the cancerous tissue can be treated, the higher the patient's chance of survival. Typical diagnostic procedures involve biopsying the tissue at the target site. In the case of the lungs, lung cancer can be difficult to diagnose because it is difficult to access the airways near the target area. The target area may exist as a lung nodule, a small tissue mass in the lungs, which can range in size between 5 and 25 mm. Biopsies are usually performed on this tissue mass to determine whether the tissue therein is cancerous or, if not, whether it is diseased or not.

[0005] Existing systems are typically limited in smaller peripheral airways, which can be difficult to access pulmonary nodules and may be too narrow to accommodate larger catheters and biopsy devices. Furthermore, biopsy needles are usually straight and relatively inflexible. Consequently, biopsy needles may restrict the articulation of the bronchoscope or become difficult to pass through the working channel of the bronchoscope if the bronchoscope is articulated around a narrow corner. In some cases, the needle material may bend inelastically, which can result in needle bending that is difficult to control. Moreover, straight biopsy needles obtain samples along the needle axis throughout the needle's reciprocating cycle. Consequently, obtaining multiple samples from different regions of a single nodule, for example, can be difficult and may require repeated repositioning of the bronchoscope or guide sheath.

[0006] Conventional flexible needle technology can help facilitate better access to target areas such as lymph nodes by enabling a larger endoscopic angle. Needle flexibility is typically achieved through a spiral hole created by laser cutting the needle wall along its length at its distal end. The laser-cut portion of the flexible needle is usually covered with a thin film of heat-shrinkable material to prevent the formation of an opening pathway (hereinafter referred to as a "shunt") between the inside and outside of the needle wall throughout the entire needle wall, and to allow tissue aspiration by vacuum along its entire length from the tip of the needle.

[0007] The heat-shrinkable material can be subjected to compressive or tensile stress while achieving high needle angle formation due to improved flexibility. Such stress is greatest at both ends where the laser-cut section ends and the needle tube is not flexible (i.e., solid), as the heat shrinkage must pass through the laser-cut section to avoid shunt formation and ensure proper covering. The high stress at the end of the laser cut can lead to cracking or splitting of the heat shrinkage, which can help form a shunt and lead to loss of vacuum, potentially negatively affecting the needle's ability to aspirate tissue. [Overview of the project]

[0008] The disclosed embodiments include a flexible tube assembly, a flexible needle assembly, a system, a method for manufacturing a flexible tube, and a method for manufacturing a flexible needle.

[0009] In a non-limiting exemplary embodiment, the flexible tube assembly includes a flexible tube having a proximal end with a proximal strain relief portion and a distal end with a distal strain relief portion, wherein the proximal strain relief portion is located between the proximal end and the distal strain relief portion, and the distal end defines an opening in the flexible tube, and at least a portion of at least one of the proximal strain relief portion and the distal strain relief portion defines a spiral cut having a continuously variable pitch in the flexible tube, and a group of tubes airtightly disposed on the outer surface of the flexible tube, wherein at least a portion of at least one of the proximal strain relief portion and the distal strain relief portion defines a spiral cut having a continuously variable pitch in the tube.

[0010] In another non-limiting exemplary embodiment, the flexible needle assembly is a flexible needle having a proximal end with a proximal strain relief portion, a distal end with a distal strain relief portion, and an intermediate portion disposed between the proximal and distal ends, wherein the proximal strain relief portion is located between the proximal and intermediate portions, the distal end defines a tip configured to penetrate tissue, and the proximal strain relief portion has a first pitch value between first The flexible needle comprises a spiral cut having a continuously variable pitch that changes up to a second pitch value greater than the first pitch value, a middle section having a spiral cut having a pitch substantially constant with the second pitch value, and a distal strain relief section having a spiral cut having a continuously variable pitch that changes from the second pitch value to a third pitch value greater than the second pitch value, and tubes hermetically disposed on the outer surface of the flexible needle from the proximal end to the distal end.

[0011] In another, non-limiting exemplary embodiment, the system includes a sheath and a flexible tube assembly disposed in the sheath, the flexible tube having a proximal end with a proximal strain relief section and a distal end with a distal strain relief section, the proximal strain relief section being located between the proximal end and the distal strain relief section, the distal end defining an opening in the flexible tube assembly, and at least a portion of at least one of the proximal strain relief section and the distal strain relief section defining a spiral cut having a continuously variable pitch in the flexible tube assembly; a set of tubes hermetically disposed on the outer surface of the flexible tube, the set of tubes having at least a portion of at least one of the proximal strain relief section and the distal strain relief section defining a spiral cut having a continuously variable pitch in the flexible tube assembly; and a medical device operably connected to the flexible tube.

[0012] In another non-limiting exemplary embodiment, a method for manufacturing a flexible tube assembly includes the steps of: providing a flexible tube having a proximal end having a proximal strain relief portion and a distal end having a distal strain relief portion, wherein the proximal strain relief portion is located between the proximal end and the distal strain relief portion, and the distal strain relief portion is located between the distal end and the proximal strain relief portion, with the distal end defining an opening in the middle; defining a spiral cut having a continuously variable pitch in at least a portion of at least one of the proximal strain relief portion and the distal strain relief portion; and hermetically arranging the tubes on the outer surface of the flexible tube, wherein at least a portion of at least one of the proximal strain relief portion and the distal strain relief portion defines a spiral cut having a continuously variable pitch in the middle.

[0013] In another non-limiting exemplary embodiment, a method for manufacturing a flexible needle assembly includes the steps of providing a flexible needle having a proximal end with a proximal strain relief portion, a distal end with a distal strain relief portion, and an intermediate portion disposed between the proximal and distal ends, wherein the proximal strain relief portion is located between the proximal end and the intermediate portion, and the distal end is located between the distal end and the intermediate portion, and the distal end defines a tip configured to penetrate tissue, and providing a first pitch to the proximal strain relief portion The process includes defining a spiral cut having a continuously variable pitch that changes from a pitch value to a second pitch value greater than a first pitch value; defining a spiral cut having a substantially constant pitch with a second pitch value in the intermediate portion; defining a spiral cut having a continuously variable pitch that changes from a second pitch value to a third pitch value greater than the second pitch value in the distal strain relaxation portion; and airtightly arranging tubes on the outer surface of the flexible needle from the proximal end to the distal end.

[0014] Further features, advantages, and application areas will become apparent from the descriptions provided herein. It should be understood that the descriptions and examples are intended for illustrative purposes only and are not intended to limit the scope of this disclosure.

[0015] The drawings described herein are for illustrative purposes only and are not intended to limit the scope of this disclosure. The elements in the drawings are not necessarily to a specific scale and are primarily intended to illustrate the principles of the disclosed embodiments. [Brief explanation of the drawing]

[0016] [Figure 1] This is a perspective view of a partial schematic embodiment of an exemplary flexible tube assembly. [Figure 2A] This is a partial schematic representation of an embodiment of a flexible pipe assembly and a side view with a portion cut out. [Figure 2B] A partial schematic and a cut-out side plan view of another embodiment of the flexible tube assembly. [Figure 2C] A partial schematic and a cut-out side plan view of another embodiment of the flexible tube assembly. [Figure 2D] A partial schematic and a cut-out side plan view of another embodiment of the flexible tube assembly. [Figure 3A] A partial schematic and a cut-out side plan view of another embodiment of the flexible tube assembly. [Figure 3B] A partial schematic and a cut-out side plan view of another embodiment of the flexible tube assembly. [Figure 4] This is a partial schematic and a cut-out side plan view of another embodiment of a flexible tube assembly configured as a flexible needle assembly. [Figure 5] This is a partial schematic and a cut-out side view of an embodiment of a flexible needle assembly. [Figure 6A] This is a flowchart illustrating an exemplary method for manufacturing a flexible tube assembly. [Figure 6B] Figure 6A illustrates the details of the flowchart. [Figure 7A] This is a flowchart illustrating an exemplary method for manufacturing a flexible needle assembly. [Figure 7B] Figure 7A illustrates the details of the flowchart. [Figure 8] An example of a handle that can be used to operate and control an embodiment of the flexible needle assembly described herein. [Figure 9] A perspective view in a partially schematic form of a system including the flexible tube assembly of FIG. 1.

DETAILED DESCRIPTION OF THE INVENTION

[0017] The following description is merely exemplary in nature and is not intended to limit the present disclosure, application, or use.

[0018] Hereinafter, various embodiments of a flexible tube assembly, a flexible needle assembly, and a transbronchial needle aspiration system, as well as their related components and parts, will be described with reference to the accompanying drawings. The technical terms used in the description presented herein are not intended to be construed in a limiting or restrictive manner. Rather, the technical terms are merely used in conjunction with a detailed description of embodiments of assemblies, systems, methods, and related components. Furthermore, embodiments can include several novel features, and no single one of these features solely bears the desired characteristics or is considered essential for the implementation of the disclosed embodiments described herein. For example, references may be made herein to the use of terms such as "lung," "airway," "nodule," etc. in the embodiments described herein, but these terms are broad and the embodiments described can be used non-limitingly and, unless otherwise indicated, can be used to access other blood vessels, pathways, lumens, body cavities, tissues, and organs present in humans and animals. For example, lumens such as those of the gastrointestinal tract system (i.e., the intestines) can be accessed by the embodiments described herein.

[0019] Turning now to FIG. 1 and viewing it generally, an exemplary non-limiting embodiment of a flexible tube assembly 100 is shown. As discussed herein, embodiments of this flexible tube assembly 100 and other embodiments described herein can be used in conjunction with existing systems and methods for seeking, navigating to, and biopsying a target region (e.g., a lung nodule, a lymph node), and / or for delivering a fluid, a medicament, or other substance to the target region. By use of embodiments in which the flexible tube assembly 100 is embodied as a flexible needle, it becomes possible to biopsy tissue and cells over a considerably wider area and over a broader range of angles than existing systems, and in certain embodiments, to allow for greater articulation of a bronchoscope or endoscope so as to access highly intricate regions of anatomical structures. Thus, use of such embodiments can achieve improved sample quality, improved diagnostic yield, and reduced misdiagnosis results (i.e., false positives or false negatives). Although a bronchoscope is mentioned herein, it is noted that other endoscopes can be used (such as a gastric endoscope and a colonoscope). Thus, the embodiments described herein can be used to explore, navigate to, and biopsy other lumens.

[0020] Looking still more generally and still to FIG. 1, in a non-limiting exemplary embodiment of the flexible tube assembly 100, the flexible tube 102 has a proximal end 104 having a proximal strain relief 106 and a distal end 108 having a distal strain relief 110. The proximal strain relief 106 is positioned between the proximal end 104 and the distal strain relief 110, and the distal strain relief 110 is positioned between the distal end 108 and the proximal strain relief 106. The distal end 108 defines an opening 112 therein. At least a portion of at least the proximal strain relief 106 and / or the distal strain relief 110 defines a spiral cut (not shown in FIG. 1) having a continuously variable pitch therein. The tubing 114 is disposed airtight on the outer surface of the flexible tube 102 from at least a portion of at least one of the proximal strain relief and the distal strain relief that defines a spiral cut having a continuously variable pitch therein.

[0021] An overview is presented here; further details are shown below without limitation, using non-limiting examples.

[0022] Referring further to Figure 1, the tube 102 may be made from any suitable material and, if desired, may have any size for a particular application. In view of non-limiting examples, the tube 102 may be made from metal, or metal alloys such as stainless steel, other stainless steels, such as American Iron and Steel Institute ("AISI") Type 304 stainless steel, plastic, or nitinol. Similarly, non-limiting examples, the tube 102 may be made from hypotube. In such embodiments, the tube 102 may be 19-gauge hypotube, 20-gauge hypotube, 21-gauge hypotube, 22-gauge hypotube, 25-gauge hypotube, 27-gauge hypotube, etc., depending on the size and flexibility constraints of the particular application. In such embodiments, the hypotube is preferably configured to be relatively smooth, at least along its proximal portion, so that when introduced into a device such as a lumen catheter, for example, non-limitingly, the hypotube can slide, rotate, or otherwise move relatively freely along the lumen.

[0023] Furthermore, referring to Figure 1, in various embodiments, the tubing 114 includes heat shrink tubing. In such embodiments, the heat shrink tubing 114 is airtightly disposed on the outer surface of the flexible tube 102 from at least a portion of the proximal strain relief section 106 and / or distal strain relief section 110, which define a spiral cut having a continuously variable pitch therein. That is, in such embodiments, the heat shrink tubing 114 covers the entire spiral cut wherever it is defined, and the heat shrink tubing 114 extends beyond the ends of the spiral cut. Therefore, the heat shrinkable tubes 114 can help prevent shunt formation, help enable vacuum aspiration of tissue from the needle tip through the entire length of the flexible tube assembly 100 (in embodiments where the flexible tube assembly 100 is a flexible needle assembly), and in some other embodiments, can also help transport fluids, pharmaceuticals, or other substances to the area of ​​interest and deliver them through the opening 112 through the entire length of the flexible tube assembly 100. The heat shrinkable tubes 114 can also act as electrical insulators in embodiments where the flexible tube 102 functions as an electrode.

[0024] It will be understood that the flexibility of the flexible tube 102 may be adjusted for specific applications if desired. Flexibility can be altered, for example, by modifying the wall thickness of the flexible tube 102, the material used within it, and the spacing, pitch, and angle between lines in the spiral cut. In some embodiments, the lines in the spiral cut are cut to a thickness in the range of approximately 0.0010 to 0.0025 inches, and preferably between 0.0015 to 0.0020 inches. It will be understood that the spiral cut can have any pitch value suitable for providing the desired flexibility for a given application. A higher pitch value results in less flexibility of the tube 102 than a lower pitch value, and a lower pitch value results in greater flexibility of the tube 102 than a higher pitch value. In some embodiments, the spiral-cut portion may have a high pitch value of 0.120 or 0.150, and in some embodiments, the spiral-cut portion may have a low pitch value of 0.040, 0.060, or 0.080 for specific applications, if desired.

[0025] It will be understood that several embodiments of the flexible tube assembly 100 may be suitable for a variety of applications, if desired. Referring to Figures 2A-2D in view of non-limiting examples, in some embodiments, flexibility may only be desirable in a portion of the flexible tube assembly 100. In some of these embodiments, the spiral cut 116 may only be defined at the proximal strain relief portion 106 (Figures 2A and 2B) or the distal strain relief portion 110 (Figures 2C and 2D), depending on whether flexibility is desired. In some of these embodiments, the pitch value of the spiral cut 116 may decrease continuously as the spiral cut 116 moves from the proximal end 104 to the distal end 108 (Figures 2A and 2C). In such embodiments, the lines in the spiral cut 116 continuously approach, and the tube 102 becomes more flexible as the spiral cut 116 moves from the proximal end 104 to the distal end 108. In some other embodiments of these, the pitch value of the spiral cut 116 can increase continuously as the spiral cut 116 moves from the proximal end 104 to the distal end 108 (Figures 2B and 2D). In such embodiments, the lines in the spiral cut 116 move continuously further apart, and the pipe 102 becomes less flexible as the spiral cut 116 moves from the proximal end 104 to the distal end 108.

[0026] In some other embodiments, flexibility may be desirable in more than one portion of the flexible tube assembly 100. In such embodiments, the spiral cut 116 may be defined in both the proximal strain relief section 106 and the distal strain relief section 110. In some of these embodiments, referring hereby to Figures 3A and 3B, the proximal strain relief section 106 and the distal strain relief section 110 are adjacent. In these embodiments, the proximal strain relief section 106 defines a spiral cut 116 having a continuously variable pitch that changes continuously from a pitch value PV1 adjacent to the proximal end 104 to a pitch value PV2 at an intermediate position between the proximal end 104 and the distal end 108, which is different from pitch value PV1. Similarly, the distal strain relief section 110 defines a spiral cut 116 having a continuously variable pitch that changes continuously from a pitch value PV2 at an intermediate position between the proximal end 104 and the distal end 108 to a pitch value different from pitch value PV2.

[0027] As shown in Figure 3A, in one such embodiment, pitch value PV1 is greater than pitch value PV2, and pitch value PV3 is less than pitch value PV2. That is, the pitch value of the spiral cut 116 decreases continuously as the spiral cut 116 moves from the proximal end 104 to the distal end 108. The lines in the spiral cut 116 move continuously closer to each other, and the pipe 102 becomes more flexible as the spiral cut 116 moves from the proximal end 104 to the distal end 108, with the pipe 102 being most flexible at the end of the spiral cut 116 near the distal end 108.

[0028] As shown in Figure 3B, in this other embodiment, pitch value PV1 is greater than pitch value PV2, and pitch value PV3 is greater than pitch value PV2. That is, the pitch value of the spiral cut 116 continuously decreases as the spiral cut 116 moves from the proximal end 104 towards the distal end 108, towards an intermediate position between the proximal end 104 and the distal end 108. The pitch value of the spiral cut 116 continuously increases as the spiral cut 116 moves from the proximal end 104 towards the distal end 108, away from an intermediate position between the proximal end 104 and the distal end 108. The lines of the spiral cut 116 are closest to each other at an intermediate position between the proximal end 104 and the distal end 108, and the pipe 102 is most flexible at an intermediate position between the proximal end 104 and the distal end 108.

[0029] Referring further to Figure 4, in some embodiments, the flexible tube 102 has an intermediate portion 118 located midway between the proximal end 104 and the distal end 108. In some such embodiments, the intermediate portion 118 defines a spiral cut in which a substantially constant pitch having a pitch value PV2 is defined. In some embodiments, pitch value PV1 is greater than pitch value PV2, and pitch value PV3 is greater than pitch value PV2. That is, the pitch value of the spiral cut 116 decreases continuously as the spiral cut 116 moves toward the intermediate portion 118, in the direction from the proximal end 104 to the distal end 108. The pitch value of the spiral cut 116 increases continuously as the spiral cut 116 moves toward the intermediate portion 118, in the direction from the proximal end 104 to the distal end 108. The lines of the spiral cut 116 are closest to each other in the intermediate portion 118, and the tube 102 is most flexible in the intermediate portion 118.

[0030] In some embodiments, the distal end 108 defines a sharp tip 120 configured to penetrate tissue. In such embodiments, the flexible tube assembly 100 is preferably configured as a flexible needle. In some embodiments, the flexible tube assembly 100 (configured as a flexible needle in this case) can be connected to a bronchoscope or endoscope. As is well known, the drive portion of a bronchoscope or endoscope is inherently the most flexible in its application. By positioning the intermediate portion 118 within the drive portion of a bronchoscope or endoscope, the flexible tube assembly 100 (configured as a flexible needle) can contribute to the flexibility of the bronchoscope or endoscope. Thus, the flexible tube assembly 100 (configured as a flexible needle) can contribute to the ability of the bronchoscope or endoscope to reach and aspirate tissue from a target area that may be difficult to reach, such as lymph nodes.

[0031] Therefore, it will be understood that the length of the proximal strain relief section 106, the length of the distal strain relief section 110, the pitch value of the spiral cut 116 in the proximal strain relief section 106, and the pitch value of the spiral cut 116 in the distal strain relief section 110 can be selected as desired to provide flexibility for a specific application.

[0032] Referring further to Figure 5, the exemplary flexible needle assembly 500 is a representative example of the flexible needle application of the flexible tube assembly 100 (configured as a flexible needle) shown in Figure 4 and above. As indicated by similar reference numbers, the details of the components described above do not need to be repeated in order to understand the subject matter disclosed.

[0033] In a non-limiting exemplary embodiment of the flexible needle assembly 500, the flexible needle 102 (i.e., the needle application of the flexible tube 102 described above) has a proximal end 104 with a proximal strain relief section 106, a distal end 108 with a distal strain relief section 110, and an intermediate section 118 positioned between the proximal end 104 and the distal end 108. The proximal strain relief section 106 is located between the proximal end 104 and the intermediate section 118, and the distal strain relief section 110 is located between the distal end 108 and the intermediate section 118. The distal end 108 defines a sharp tip 120 configured to penetrate tissue. The proximal strain relief section 106 defines a spiral cut 116 having a continuously variable pitch that changes from a pitch value PV1 to a pitch value PV2 greater than pitch value PV1. The intermediate section 118 defines a spiral cut 116 having a substantially constant pitch with a pitch value PV2. The distal strain relief section 110 defines a spiral cut 116 having a continuously variable pitch that changes from a pitch value PV2 to a pitch value PV3 greater than PV2. The tubes 114 are airtightly arranged on the outer surface of the flexible needle 102 from the proximal end 104 to the distal end 108. In various embodiments, the tubes 114 include heat shrink tubing.

[0034] In some embodiments, the flexible needle assembly 500 can be advanced into the peripheral airway and easily penetrate into the lung parenchyma. In some embodiments, the flexible needle assembly 500 can penetrate tissue to a depth of at least 15 mm. In various embodiments, it will be understood that the flexible needle assembly 500 can penetrate tissue to a depth of up to approximately 40 mm. In some embodiments, the distal end 108 of the flexible needle assembly 500 can be articulated, thus allowing it to bend more than 90 degrees relative to the more proximal portion. In some embodiments, and when inserted into the working channel of a bronchoscope (such as the Olympus BF-PL80™ bronchoscope), the flexible needle assembly 500 can be articulated by at least 130 degrees, with its sharp tip 120 fitting snugly with the end of the bronchoscope. Due to its relatively low profile, embodiments of the flexible needle assembly 500 can be miniaturized in conjunction with a catheter or guide sheath to fit into working channels as small as 2.0 mm or smaller (such as those of a bronchoscope). For example, certain embodiments of the flexible needle assembly 500 can be used with a small guide sheath having a minimum inner diameter of 1.7 mm.

[0035] The flexible needle 102 is preferably flexible, so that the scope (such as a bronchoscope or endoscope) to which the flexible needle 102 is connected can achieve a sufficiently large angle to aspirate tissue from the target area. In view of an unrestricted example, sampling tissue from a lymph node involves bending the bronchoscope by approximately 90 degrees. The flexible needle 102 is flexible as discussed above, but it also has sufficient column strength to push axially and transmit sufficient force, and as a result, the flexible needle 102 can push out tissue.

[0036] The embodiments described herein may be used with any suitable visualization device, such as an ultrasound system or a navigation system. Because the flexible needle assembly 500 can articulate, bend, and / or bend to a greater extent than a straight, non-flexible needle, and independently of any angles or articulations that the bronchoscope or endoscope may simultaneously have, the use of the flexible needle assembly 500 can make access to a target area in the lung or other tissue easier and simpler. This makes it possible, for example, to biopsy tissue at a near-perpendicular angle from the bronchoscope. Furthermore, the flexible needle assembly 500 can bend in the region between the sharp tip 120 and any protective guide sheath or the distal end of a catheter. In other words, the flexibility of the flexible needle assembly 500 reduces the possibility of puncturing the working channel of the bronchoscope. The increased flexibility also reduces, for example, the radial force exerted by the distal end 108 of the flexible needle assembly 500 during navigation from the working channel of the bronchoscope, although this is not limited to the extent necessary.

[0037] Ultrasound has been found to be a suitable system for visualization because ultrasound has a relatively deep penetration depth (at least 40 mm), but other systems can also be used. In some configurations, if desired, a helical ultrasound probe can be used to provide improved visualization than an ultrasound probe that enables visualization in all directions, not just a single plane. Other systems for locating and navigating target tissues such as pulmonary nodules and lymph nodes may include the use of bronchoscopy with optical channels, X-ray diagnostics, optical coherence tomography, and magnetic resonance imaging. Any other suitable navigation system can also be used, including commercially available systems that use X-ray computed tomography for visualization assistance (e.g., BfNavi® system sold by Olympus and i-Logic® system sold by SuperDimension, but not limited to these). In embodiments in which plastic material is used for the flexible needle 102, it will be understood that some of the navigation systems listed above, such as X-ray, may not be applicable.

[0038] The above context of flexibility and column strength involves the interaction between the pitch value and gauge of the spiral cut 116 and the material of the flexible needle 102. With respect to flexibility and pitch value, it will be understood that the lower the pitch value (i.e., the closer the spacing of the lines of the spiral cut 116), the more flexible the portion of the flexible needle 102 will be. In various embodiments, the middle portion 118 corresponds to the portion of the scope (such as a bronchoscope or endoscope) connected to the flexible needle 102, which has the highest degree of flexibility. Similarly, in various embodiments, the distal end 108 has a lower degree of flexibility (in other words, the distal end 108 is more rigid) than the middle portion 118, which helps the sharp tip 120 penetrate tissue.

[0039] Therefore, in some embodiments, the pitch value of the proximal strain relief section 106 may begin toward the proximal end 104 with a pitch value PV1 of approximately 0.120 or 0.150, and continuously decrease toward the pitch value PV2 at the intermediate section 118. Conversely, the pitch value of the distal strain relief section 110 may begin with the pitch value PV2 at the intermediate section 118 and end toward the distal end 108 with a pitch value PV3 of approximately 0.120 or 0.150. It is understood that pitch is conventionally used to indicate the length of one rotation. The pitch values ​​associated with the proximal strain relief section 106 and the distal strain relief section 110 may be assumed to be a series of pitches that gradually increase or decrease according to the conventional definition of pitch value, or as used in this application, and it will also be understood that this pitch value may effectively be an integral pitch.

[0040] In such embodiments, the pitch value PV2 in the intermediate section 118 is substantially constant and smaller than the pitch values ​​PV1 and PV3. As described above, in some embodiments, the pitch values ​​PV1 and PV3 can be equal to values ​​such as about 0.120 or 0.150. Since the intermediate section 118 passes through the portion of the scope (such as a bronchoscope or endoscope) connected to the flexible needle 102 with the highest degree of flexibility, in various embodiments, it is preferable that the substantially constant pitch value PV2 is smaller than the pitch values ​​PV1 and PV3. In some embodiments, the pitch value PV2 can be, as desired, to a degree such as about 0.040, 0.060, or 0.080 for a particular application.

[0041] It will be understood that the tubes 114 are under compressive or tensile stress due to the spiral cut 116 and the large angle formation of the flexible needles 102, which is achieved by the improved flexibility provided by the selection of material and gauge. It will be further understood that the stress is greatest at both ends (i.e., the proximal end 104 and the distal end 108) where the spiral cut 116 ends and the flexible needles 102 become non-flexible (solid). It will be understood that excessively high stress at the end of the spiral cut 116 (for example, if the flexible needle 102 is too flexible at both ends of the spiral cut 116) may cause the tubes 114 to tear or crack, which may contribute to the formation of a shunt and the resulting loss of vacuum, and consequently may adversely affect the ability of the flexible needle assembly 500 to aspirate tissue.

[0042] Therefore, the pitch values ​​at the ends of the spiral cuts 116 in the proximal strain relief section 106 and the distal strain relief section 110 are selected to be sufficiently high to provide a suitably low amount of flexibility (or, conversely, a suitable amount of stiffness) in order to reduce strain on the pipes 114, thereby helping to protect the pipes 114. Local stresses on the pipes 114 at the proximal end 104 and distal end 108 are reduced by the creation of a stress relaxation transition zone (i.e., the proximal strain relief section 106 and the distal strain relief section 110) between the flexible portion (i.e., the intermediate portion 118) and the uncut (solid) portion of the needle 102 beyond the end of the spiral cut 116. As the continuously variable pitch of the spiral cut 116, which gradually increases, moves away from the intermediate portion 118 (which is provided to improve needle flexibility) towards the proximal end 104 and distal end 108, the continuously variable pitch has the effect of distributing the stress differences over a longer area, while simultaneously gradually reducing this stress to a lower level. As a result, the continuously variable pitch of the spiral cut 116 in the proximal strain relief portion 106 and distal strain relief portion 110 can help reduce stress concentration due to high strain, and therefore can help reduce strain on the pipes 114, thereby helping to protect the pipes 114.

[0043] It will be understood that the length of the stress relaxation transition region (i.e., the proximal strain relaxation section 106 and the distal strain relaxation section 110) can vary in gradual changes in length and pitch values ​​depending on the desired amount of flexibility of the flexible needle 102. That is, a stiffer needle does not require as much strain relaxation as a highly flexible needle. Therefore, the appropriate amount of strain relaxation depends on the needle and can therefore be adjusted.

[0044] Regarding the strength of the column, in some embodiments, a pitch value PV2 of about 0.050 in the intermediate section 118 may correlate with the selection of a highly flexible needle. In some other embodiments, a pitch value PV2 of about 0.080 in the intermediate section 118 may correlate with the selection of a moderately flexible needle. In some other embodiments, a pitch value PV2 of about 0.110 in the intermediate section 118 may correlate with the selection of a lowly flexible needle. However, it will be understood that the flexibility, gauge, and type of the flexible needle can be selected as desired for a particular application. Thus, it will be further understood that the selection of a substantially constant pitch value PV2 in the intermediate section 118 can help adjust the flexibility of the flexible needle assembly 500 to meet the flexibility requirements of the scope (such as a bronchoscope or endoscope) connected to the flexible needle assembly 500.

[0045] In some embodiments, the imaging system may be desirable to enhance the visibility of the sharp tip 120, and in particular, to increase the echo brightness of the flexible needle assembly 500 in the vicinity of the sharp tip 120. If desired in such cases, the flexible needle 102 may include echo enhancement features in the vicinity of the distal end 108. In view of non-limiting examples, in some embodiments, the flexible needle 102 has an intermediate portion 118 and distal In the region that includes the strain relaxation section 110, the scribe line 122 can be defined.

[0046] The following is a series of flowcharts illustrating the implementation. For ease of understanding, the first flowchart represents the implementation by the embodiment, and subsequent flowcharts represent alternative implementations and / or extensions of the first flowchart, either as the construction of operations on partial components or operations on additional components to one or more previously presented flowcharts. Those skilled in the art will understand that the style of representation used herein (i.e., beginning with the representation of the implementation by the embodiment, and thereafter providing additions to and / or further details in the subsequent flowcharts) generally allows for a quick and easy understanding of the implementation of various methods.

[0047] Referring here to Figure 6A, an exemplary method 600 for manufacturing a flexible tube assembly is presented. It will be understood that embodiments of Method 600 may be suitable for non-limiting the fabrication of various embodiments of the flexible tube assembly 100 (Figures 1, 2A-2D, 3A, 3B, and 4). Method 600 begins with block 602. In block 604, a flexible tube is provided having a proximal end with a proximal strain relief section and a distal end with a distal strain relief section, the proximal strain relief section being located between the proximal end and the distal strain relief section, and the distal end defining an opening in the middle. In block 606, a spiral cut having a continuously variable pitch is defined in at least a portion of at least one of the proximal strain relief section and the distal strain relief section. In block 608, the tubing is airtightly arranged on the outer surface of the flexible tubing, and at least a portion of at least one of the proximal strain relief section and the distal strain relief section defines a spiral cut having a continuously variable pitch. Method 600 ends in block 610.

[0048] In various embodiments, the definition of the spiral cut having a continuously variable pitch in block 606 in at least a portion of at least one of the proximal strain relief section and the distal strain relief section can be performed by a laser cutting process.

[0049] In various embodiments, and with further reference to Figure 6B, the arrangement of airtight tubing on the outer surface of the flexible tube from the proximal end to the distal end in block 608 may include the arrangement of airtight heat-shrinkable tubing on the outer surface of the flexible tube from the proximal end to the distal end in block 612.

[0050] Referring here to Figure 7A, an exemplary method 700 for manufacturing a flexible needle assembly is presented. It will be understood that embodiments of Method 700 may be suitable for non-limitingly manufacturing various embodiments of a flexible tube assembly 100, which are configured as a flexible needle assembly (Figure 4) and a flexible needle assembly 500 (Figure 5). Method 700 begins in block 702. In block 704, a flexible needle is provided having a proximal end with a proximal strain relief portion and a distal end with a distal strain relief portion, and an intermediate portion disposed between the proximal and distal ends, the proximal strain relief portion being located between the proximal end and the intermediate portion, the distal strain relief portion being located between the distal end and the intermediate portion, and the distal end defining a tip configured to penetrate tissue. In block 706, a spiral cut having a continuously variable pitch that changes from a first pitch value to a second pitch value greater than the first pitch value is defined in the proximal strain relief portion. In block 708, the spiral cut is defined in an intermediate section having a substantially constant pitch with a second pitch value. In block 710, the spiral cut is defined in a distal strain-relaxing section having a continuously variable pitch that ranges from a second pitch value to a third pitch value greater than the second pitch value. In block 712, the tubes are airtightly arranged on the outer surface of the flexible needle from the proximal end to the distal end. Method 700 ends in block 714.

[0051] In various embodiments, the definition of the spiral cuts in blocks 706, 708, and 710 can be carried out by a laser cutting process.

[0052] In various embodiments, and with further reference to Figure 7B, the arrangement of airtight tubing on the outer surface of the flexible needle from the proximal end to the distal end in block 712 may include the arrangement of airtight heat-shrinkable tubing on the outer surface of the flexible needle from the proximal end to the distal end in block 716.

[0053] Referring now to Figure 8, an exemplary handle 1701 can be used to operate and control an embodiment of the flexible needle assembly 500 described herein. The handle 1701 is suitably connected to a catheter 1700 having a flexible needle hypotubule inside, and the handle 1701 can control the extension of the flexible needle assembly 500 from the catheter 1700.

[0054] In some other embodiments, and with reference to Figure 9 thereafter, an exemplary system 1000 is presented. In various embodiments, and in view in general terms, the system 1000 includes a flexible tube assembly 100 and a medical device 1002 operably connected to the flexible tube 102.

[0055] Viewed as examples rather than limitations, in various embodiments, the system 1000 includes a sheath 1004. The flexible tube assembly 100 is disposed within the sheath 1004. In various embodiments, the sheath 1004 is made from a material suitable for medical use in the body, such as plastic or PTFE.

[0056] As discussed above, and in various embodiments of the flexible tube assembly 100, the flexible tube 102 has a proximal end 104 having a proximal strain relief section 106, and a distal end 108 having a distal strain relief section 110. The proximal strain relief section 106 is located between the proximal end 104 and the distal strain relief section 110, and the distal strain relief section 110 is located between the distal end 108 and the proximal strain relief section 106. The distal end 108 defines an opening 112 inside. At least a portion of the proximal strain relief section 106 and / or the distal strain relief section 110 defines a spiral cut (not shown in Figure 9) having a continuously variable pitch inside. The tubes 114 are airtightly disposed on the outer surface of the flexible tube 102 from at least a portion of at least one of the proximal strain relief section and the distal strain relief section, which define a spiral cut having a continuously variable pitch inside.

[0057] The medical device 1002 is operably connected to the flexible tube 102. In various embodiments, the medical device 1002 may include a diagnostic medical device having a diagnostic mode, or a therapeutic medical device having a treatment mode.

[0058] In some embodiments, where the medical device 1002 includes a diagnostic medical device having a diagnostic mode, the system 1000 may be configured to aspirate a sample from a site of interest. In such embodiments, the flexible tube 102 is configured as a flexible needle (for example, in the manner discussed above with reference to Figures 4 and 5). Similarly, in such embodiments, the diagnostic medical device 1002 appropriately includes a vacuum source such as a syringe or a vacuum pump.

[0059] As discussed above, in some other embodiments, the medical device 1002 may include a therapeutic medical device having a treatment mode. In some such embodiments, the therapeutic medical device may include a fluid source, such as a syringe or pump. In such embodiments, the fluid may include pharmaceuticals, saline solution, and the like.

[0060] In some other such embodiments, the system 1000 can be configured for use in tissue ablation. In such embodiments, the flexible tube 102 is configured as an electrode, and the therapeutic medical device includes a power source. The system 1000 may be configured as a monopole system, in which case the flexible tube 102 is the monopole electrode, and a conductive plate (not shown) placed under the patient functions as another electrode. Alternatively, the system 1000 may be configured as a bipolar system, in which case the flexible tube 102 is the primary electrode, and a secondary electrode (not shown) is placed near the tissue to be ablated.

[0061] This description of the biopsy systems, apparatus, and methods described herein for use in the lungs and for use against pulmonary nodules is not limited, and these embodiments will be understood to be usable for biopsy, navigation, and exploration of target areas in other locations in the patient, including the stomach, endoscopy, or other suitable locations. Similarly, a bronchoscope is not required, and other suitable apparatus, which can be adapted to the embodiments described herein, may also be used, including, non-limitingly, various endoscopes or laparoscopic cannulas.

[0062] The embodiments for carrying out the invention described above are essentially illustrative, and it will be further understood that any modifications that do not deviate from the spirit and / or intent of the subject matter of the claims are intended to be within the scope of the claims. Such modifications will not be considered to deviate from the spirit and scope of the subject matter of the claims. [Explanation of symbols]

[0063] 100 Flexible Tube Assembly 102 Flexible tube, flexible needle 104 Proximal end 106 Proximal strain relief area 108 Distal end 110 Distal strain relief section 112 Opening 114 Pipes, heat shrinkable tubes 116 Spiral Cut 118 Middle part 120 Tip 122 Scribeline 500 Flexible Needle Assembly

Claims

1. A flexible tube assembly, A flexible tube having a proximal end adjacent to a proximal strain relief portion and a distal end adjacent to a distal strain relief portion, wherein the proximal strain relief portion is directly connected to the distal strain relief portion, thereby the proximal strain relief portion and the distal strain relief portion are adjacent, the proximal strain relief portion extends from a proximal position adjacent to the proximal end toward the distal strain relief portion, the distal strain relief portion extends from a distal position adjacent to the distal end toward the proximal strain relief portion, and the distal end comprises a flexible tube defining an opening inside. The proximal strain relief portion has a spiral cut having a first continuously variable pitch that decreases continuously from a first pitch value at a position adjacent to the proximal end to a second pitch value different from the first pitch value. The distal strain relief portion has a spiral cut having a second continuously variable pitch that continuously decreases from a first pitch value at a position adjacent to the distal end to a second pitch value different from the first pitch value, and the distal strain relief portion is provided with a scribe line. The heat shrink tube is further provided, which is airtightly disposed on the outer surface of at least one of the proximal strain relief portion and the distal strain relief portion, having the spiral cut, The first continuously variable pitch is connected to the second continuously variable pitch continuously and without interruption. Flexible pipe assembly.

2. The flexible tube assembly according to claim 1, wherein the distal end defines a tip that is configured to penetrate tissue.

3. It is a system, Sheath and, A flexible tube assembly disposed in the sheath, wherein the flexible tube assembly is A flexible tube having a proximal end adjacent to a proximal strain relief portion and a distal end adjacent to a distal strain relief portion, wherein the proximal strain relief portion is directly connected to the distal strain relief portion, thereby the proximal strain relief portion and the distal strain relief portion are adjacent, the proximal strain relief portion extends from a proximal position adjacent to the proximal end toward the distal strain relief portion, the distal strain relief portion extends from a distal position adjacent to the distal end toward the proximal strain relief portion, and the distal end comprises a flexible tube with an opening defined therein. The proximal strain relief portion has a spiral cut having a first continuously variable pitch that decreases continuously from a first pitch value at a position adjacent to the proximal end to a second pitch value different from the first pitch value. The distal strain relief section has a spiral cut having a second continuously variable pitch that decreases continuously from a first pitch value at a position adjacent to the distal end to a second pitch value different from the first pitch value, and the distal strain relief section is provided with a scribe line. The heat shrink tube further includes the spiral cut having a continuously variable pitch, which is airtightly disposed on the outer surface of at least one of the proximal strain relief portion and the distal strain relief portion. Flexible tube assembly and A medical device is operably connected to the aforementioned flexible tube. Equipped with, The first continuously variable pitch is connected to the second continuously variable pitch continuously and without interruption. system.

4. The system according to claim 3, wherein the medical device includes a diagnostic medical device.

5. The aforementioned flexible tube is configured as a flexible needle, The diagnostic medical device includes a vacuum source. The system according to claim 4.

6. The system according to claim 5, wherein the vacuum source includes a device selected from a syringe and a vacuum pump.

7. The system according to claim 3, wherein the medical device includes a therapeutic medical device.

8. The system according to claim 7, wherein the therapeutic medical device includes a fluid source.

9. The aforementioned flexible tube is configured as an electrode, The aforementioned therapeutic medical device includes a power source, The system according to claim 7.

10. A flexible tube assembly, A flexible tube having a proximal end adjacent to a proximal strain relief portion and a distal end adjacent to a distal strain relief portion, wherein the proximal strain relief portion is located between the proximal end and the distal strain relief portion, the distal end defines an opening in the middle, the proximal strain relief portion has a spiral cut having a continuously variable pitch that changes from a first pitch value to a second pitch value smaller than the first pitch value, and the distal strain relief portion has a continuously variable pitch that changes from the second pitch value to a first pitch value larger than the second pitch value, A heat shrink tube having the spiral cut having a continuously variable pitch, hermetically disposed on the outer surface of at least one part of the proximal strain relief portion and the distal strain relief portion, Equipped with, The flexible tube defines a scribe line in at least the region including the distal strain relief portion. Flexible pipe assembly.

11. A flexible needle assembly, A flexible needle having a proximal end adjacent to a proximal strain relief portion, a distal end adjacent to a distal strain relief portion, and an intermediate portion disposed between the proximal end and the distal end, wherein the proximal strain relief portion is located between the proximal end and the intermediate portion, the distal end is located between the distal end and the intermediate portion, the distal end defines a tip configured to penetrate tissue, the proximal strain relief portion has a spiral cut having a continuously variable pitch that changes from a first pitch value to a second pitch value smaller than the first pitch value, the intermediate portion has the spiral cut having a pitch constant with the second pitch value, and the distal strain relief portion has the spiral cut having a continuously variable pitch that changes from a second pitch value to a third pitch value larger than the second pitch value, A heat-shrinkable tube is airtightly disposed on the outer surface of the flexible needle from the proximal end to the distal end, Equipped with, The flexible needle defines a scribe line in a region including at least the distal strain relief portion. Flexible needle assembly.

12. It is a system, Sheath and, A flexible tube assembly disposed in the sheath, wherein the flexible tube assembly is A flexible tube having a proximal end adjacent to a proximal strain relief portion and a distal end adjacent to a distal strain relief portion, wherein the proximal strain relief portion is located between the proximal end and the distal strain relief portion, the distal end defines an opening in the middle, the proximal strain relief portion has a spiral cut having a continuously variable pitch that changes from a first pitch value to a second pitch value smaller than the first pitch value, and the distal strain relief portion has a continuously variable pitch that changes from the second pitch value to a first pitch value larger than the second pitch value, A heat shrink tube having the spiral cut having a continuously variable pitch, hermetically disposed on the outer surface of at least one part of the proximal strain relief portion and the distal strain relief portion, A flexible tube assembly, A medical device is operably connected to the aforementioned flexible tube. Equipped with, The flexible tube defines a scribe line in at least the region including the distal strain relief portion. system.

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