A needle having an intermittent spiral cut section and an uninterrupted spiral cut section adjacent to each other.

Abstract

To provide a needle with helical cuts comprising contiguous interrupted and uninterrupted sections.SOLUTION: Disclosed embodiments include apparatuses, systems and methods for sampling a targeted region of tissue in a body using a flexible needle, where the flexible needle includes a plurality of interrupted cuts and an uninterrupted cut extending continuously from uninterrupted cuts in order to reduce localized strain on the flexible needle. In an illustrative embodiment, an apparatus includes a flexible needle; the flexible needle includes a proximal end, a distal end including a needle tip, and a shaft extending between the proximal end and the distal end and including a flexible portion; the flexible portion includes an interrupted cut section including a plurality of interrupted cuts in the shaft following a first helical pattern, and an uninterrupted cut section including an uninterrupted cut in the shaft following a second helical pattern, where the uninterrupted cut extends continuously from an end of a first terminal cut at a first end of the interrupted cut section.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Application No. 63 / 251,299, filed October 1, 2021, the entire contents of which are incorporated herein.

[0002] The disclosed embodiments relate to flexible needles and the formation thereof. [Background technology]

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

[0004] Long, flexible needles can be very useful for obtaining tissue samples from within the body. These needles can be inserted through a catheter or other lumen to reach structures within the body and obtain tissue samples from targeted areas of the tissue, potentially avoiding more invasive procedures for obtaining the sample.

[0005] While such needles should have a certain degree of flexibility, such as the ability to bend and adjust to curves and angles, allowing them to navigate a potentially tortuous path to the target site, they also require sufficient column strength to allow the needle to be pushed into place and inserted into the target site. One method for creating such flexible needles is to cut notches into the needle wall. However, such notches can make the needle too flexible or can create localized stresses at the ends of the notches. Summary of the Invention [Means for solving the problem]

[0006] Disclosed embodiments include devices, systems, and methods involving flexible needles that include a plurality of interrupted cuts and continuous cuts extending from the continuous cuts to reduce local strain on the flexible needle.

[0007] In one illustrative, non-limiting embodiment, the device has a flexible needle having a proximal end, a distal end including a needle tip, and a shaft extending between the proximal and distal ends, the shaft including a flexible portion, the flexible portion including an intermittent cut section including a plurality of intermittent cuts in the shaft following a first helical pattern, and an intermittent cut section including one intermittent cut in the shaft following a second helical pattern, the intermittent cuts extending continuously from an end of a first terminal cut at a first end of the intermittent cut section.

[0008] In another illustrative, non-limiting embodiment, a system for sampling a target site of tissue includes: an insertion system configured to receive an elongate instrument into a proximal end of a lumen and to carry the distal end of the lumen into the body toward the target site of tissue to be sampled; a flexible needle assembly configured to be inserted into the body through the lumen, the flexible needle assembly having a flexible needle having a proximal end, a distal end including a needle tip, and a shaft extending between the proximal and distal ends, the shaft including a flexible portion, the flexible portion having an intermittent cut section including a plurality of intermittent cuts in the shaft that follow a first helical pattern and an intermittent cut section including one intermittent cut in the shaft that follows a second helical pattern, the intermittent cuts extending continuously from an end of a first terminal cut at a first end of the intermittent cut section; and a handle assembly configured to engage the proximal end of the flexible needle and control movement of the flexible needle.

[0009] In another illustrative, non-limiting embodiment, a method includes creating a needle shaft having a proximal end and a distal end including a needle tip; forming a plurality of intermittent cuts through a wall of the shaft, the plurality of intermittent cuts following a first spiral pattern; and forming a plurality of uninterrupted cuts in the shaft through a wall of the shaft, the uninterrupted cuts extending continuously from an end of a first terminal cut at a first end of the plurality of intermittent cuts and the uninterrupted cuts following a second spiral pattern.

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

[0011] The drawings described below are for purposes of illustration only and are not intended to limit the scope of the present disclosure in any way. The components in the drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the disclosed embodiments. [Brief explanation of the drawings]

[0012] [Figure 1] 1 is a side view, partially cut away, of a flexible needle having an interrupted notch that continues into an uninterrupted notch. FIG. [Figure 2] 1 is a side view, partially cut away, of a flexible needle having an interrupted notch that continues into an uninterrupted notch. FIG. [Figure 3] 1 is a side view, partially cut away, of a flexible needle having an interrupted notch that continues into an uninterrupted notch. FIG. [Figure 4] 1 is a side view, partially cut away, of a flexible needle having an interrupted notch that continues into an uninterrupted notch. FIG. [Figure 5] 1 is a side view, partially cut away, of a flexible needle having an interrupted notch that continues into an uninterrupted notch. FIG. [Figure 6A]1 is a side view, partially cut away, of a flexible needle having an interrupted notch that continues into an uninterrupted notch. FIG. [Figure 6B] 1 is a side view, partially cut away, of a flexible needle having an interrupted notch that continues into an uninterrupted notch. FIG. [Figure 7] 1 is a side view, partially cut away, of a flexible needle having an interrupted notch that continues into an uninterrupted notch. FIG. [Figure 8] 1 is a side view, partially cut away, of a flexible needle having an interrupted notch that continues into an uninterrupted notch. FIG. [Figure 9] 10A-10C are side views of various shapes of intermittent cuts. [Figure 10] 10A-10C are side views of various shapes of intermittent cuts. [Figure 11] 10A-10C are side views of various shapes of intermittent cuts. [Figure 12] 10A-10C are side views of various shapes of intermittent cuts. [Figure 13] 10A-10C are side views of various shapes of intermittent cuts. [Figure 14] 10A-10C are side views of various shapes of intermittent cuts. [Figure 15] FIG. 1 is a side view of an insertion system including a flexible needle assembly. [Figure 16] FIG. 1 is a perspective view of the head of an insertion system through which a flexible needle can be extended. [Figure 17] 1 is a flowchart of an exemplary method for preparing a flexible needle. [Figure 18] 1 is a schematic diagram showing an example of an intermittent cutting pattern and a table showing example values ​​of its parameters. DETAILED DESCRIPTION OF THE INVENTION

[0013] The following description is merely exemplary in nature and is not intended to limit the present disclosure, its application, or uses. The terms used in the description herein are not intended to be construed as limiting or restrictive. The terms are used merely in the context of detailed descriptions of embodiments of devices, systems, methods, and related components. Furthermore, while the embodiments may include several novel features, none of them alone is considered to be a cause of desirable attributes or essential to the practice of the disclosure of the embodiments described herein.

[0014] By way of introduction and overview, and not by way of limitation, in various embodiments, a device includes a flexible needle. The flexible needle has a shaft extending from a proximal end to a distal end, with a needle tip extending from the distal end. The shaft has a flexible portion including an intermittent cut section and an uninterrupted cut section. The intermittent cut section has a series of intermittent cuts in the shaft, each of the cuts forming the series of cuts following a first helical pattern. The first helical pattern can have a constant pitch or a variable pitch. The uninterrupted cut section has uninterrupted cuts in the shaft following a second helical pattern. The uninterrupted cuts extend continuously from the end of the first terminal cut at a first end of the intermittent cut section. The continuous cut section extending from the end of the interrupted cut section redistributes stress on the first end of the interrupted cut section, helping to prevent deformation, bending, or breakage of the needle shaft along the flexible portion. While the interrupted cuts provide adequate flexibility and column strength for extending the needle from the catheter along a tortuous path, many existing needles use only the interrupted cut pattern due to stress concentrations that occur at the transition between the interrupted cut section and the uncut needle section. One of the goals of the needle configuration disclosed herein is to position the interrupted cut adjacent to the end of the interrupted cut, thereby mitigating the occurrence of such stress concentrations at the end while still benefiting from the increased column strength provided by the interrupted cut.

[0015] It will be appreciated that the use of continuous cuts has been considered preferable over the use of interrupted cuts due to the potential for localized stress or strain. For example, U.S. Patent Application Publication No. 2013 / 0225997 states that "continuous patterns are more desirable than interrupted patterns due to their superior fatigue resistance and flexural properties." See U.S. Patent Application Publication No. 2013 / 0225997, particularly paragraph 0084. In various embodiments, continuous cuts extending from a series of continuous cuts distribute localized stress and strain, thereby mitigating fatigue and other concerns.

[0016] The flexible needle is coupled to a handle and can be used with an insertion system to secure a tissue sample from a target site within the body.

[0017] Having provided a general overview, details of various embodiments will now be described by way of non-limiting, illustrative examples only.

[0018] 1, the flexible needle 100 includes a shaft 110 extending from a proximal end 112 to a distal end 114. In various embodiments, a needle tip 116 extends from the distal end 114 and defines an opening 118 that can be used, for example, to obtain or retrieve a tissue sample or to inject a substance at a predetermined location, as described further below.

[0019] In various embodiments, shaft 110 includes a flexible portion 120. Flexible portion 120 includes an intermittent cut section 130 having a plurality of intermittent cuts 132. Flexible portion 120 also includes an uninterrupted cut section 140 having a single uninterrupted cut 142. In various embodiments, both intermittent cuts 132 and uninterrupted cut 142 can be formed by a laser cutting a cut through a wall 150 of shaft 110.

[0020] 2, it can be seen that the multiple interrupted cuts 132 and the single uninterrupted cut 142 follow helical patterns 232, 242, respectively. In various embodiments, the first helical pattern 232 of the interrupted cuts 132 is disposed at a first pitch angle α relative to the central axis 201 of the shaft 110, and the second helical pattern 242 of the uninterrupted cuts 142 is disposed at a second pitch angle α relative to the central axis 201 of the shaft 110. It will be appreciated that a smaller pitch angle provides a larger opening that allows for greater bending per unit length of the shaft 110 and generally provides greater flexibility compared to a larger pitch angle. It will also be appreciated that the flexibility provided by the interrupted cuts 132 is less than an uninterrupted cut of the same pitch angle, because the gaps in the interrupted cuts 132 are more resistant to bending than the cuts themselves. One advantage of interrupted cuts over uninterrupted cuts is higher column strength, so that for many applications, such as when applying force through the beveled section of the needle to remove it from a sample collection device, interrupted cuts provide a reasonable combination of flexibility and column strength. However, it has been observed that in conventional needle designs, stress concentrations occur at the transition from the interrupted spiral cut section directly to the uncut needle section, which can lead to needle failure (e.g., mechanical failure at the transition point).

[0021] As used herein, the term "intermittent cuts" refers to a cut pattern that includes a plurality of through cuts (e.g., that may be formed by laser cutting) that traverse a certain number of degrees radially around the needle until interrupted by a certain number of degrees of uncut sections. In various embodiments, for example, the intermittent cuts can include a cut pattern having a first cut that traverses a certain number of degrees radially around the needle, moving 115 degrees (i.e., approximately 2 radians) before being interrupted by a first uncut section at 29 degrees (i.e., approximately 0.5 radians), followed by a second cut following the same helical path, again moving 115 degrees before being interrupted by a second uncut section at 29 degrees, and so on.

[0022] In various embodiments, the uninterrupted cut 142 extends continuously from the end 262 of the first terminal cut 260 at the end of the interrupted cut 132. As previously noted, without the uninterrupted cut 142 extending continuously from the end 262 of the first terminal cut 260, stresses and strains applied along the uninterrupted cut section 140 may be localized at the end 262 of the first terminal cut 260. The localized stresses and strains may cause undesirable deformation of the shaft 110, potentially leading to bending, cracking, and / or breakage of the shaft 110. In various embodiments of the flexible needle 100, the uninterrupted cut 142 absorbs and distributes the stresses and strains applied to the first terminal cut 260. The presence of the uninterrupted notch 142 at the end of the interrupted notch 132 adjacent to the end 262 of the first terminal notch 260 significantly reduces the degree of localization of this undesirable stress, thereby preventing needle breakage as seen in needles of conventional designs.

[0023] 2, where the second pitch angle of the uninterrupted cut section 140 is greater than the first pitch angle of the intermittent cut section 130, the uninterrupted cut section 140 may be less flexible than the intermittent cut section 130, as previously described. However, the uninterrupted cut section 140 may still be more flexible than the uncut section of the shaft 110. Thus, the uninterrupted cut section 140 provides greater stiffness to the shaft 110 while providing greater flexibility than the uncut section for dissipating stresses and strains applied to the end 262 of the intermittent cut section 130 of the shaft 110.

[0024] 1 , the intermittent cut section 130 is disposed along the shaft 110 between the distal end 114 and the uninterrupted cut section 140. In this configuration, where the intermittent cut section 130 has a first pitch angle α that is less than the second pitch angle of the uninterrupted cut section 140, the flexible needle 100 is more flexible toward the distal end 114 of the shaft 110 than along the uninterrupted cut section 140. However, in other embodiments, it may be desirable for the shaft 110 to be more rigid toward the distal end 114 of the shaft. Looking further at FIG. 3 , in various embodiments, the flexible needle 300 includes a flexible portion 320 having an uninterrupted cut section 340 disposed between the distal end 314 of the flexible needle 300 and the intermittent cut section 330. In such an embodiment, when the cut sections 330, 340 have the same pitch angle as the cut sections 130, 140, as in the flexible needle 100 of Figures 1 and 2, the uninterrupted cut section 340 positioned closer to the distal end 314 will increase the stiffness of the flexible needle 300 towards the distal end 314.

[0025] In various embodiments, it may be desirable to include more than two cut sections to create a flexible needle with varying flexibility along its length. Further referring to FIG. 4 , the flexible needle 400 includes a flexible portion 420 having three cut sections 430, 440, and 450. Similar to the embodiment of FIG. 1 , the uninterrupted cut section 440 extends continuously from the intermittent cut section 430 adjacent the distal end 414 of the flexible needle 400. However, the flexible needle 400 also includes a second intermittent cut section 450 extending continuously from an end 472 of the uninterrupted cut section 462 opposite the end 463 extending from the first terminal cut 460 of the first intermittent cut section 430. The second intermittent cut section 450 can include a third helical pattern 473 having a third pitch angle γ. The third helical pattern 473 may be the same as or different from the first helical pattern 433 of the first intermittent cut section 430 having a first pitch angle α and / or the second helical pattern 443 of the uninterrupted cut section 440 having a second pitch angle β. The additional intermittent cut sections can provide a desired degree of flexibility to the flexible needle 400 rearward of the uninterrupted cut section 440. The pitch angles a, β, and γ can be varied for sections 430, 440, and 450 to provide a desired level of flexibility in each of the sections 430, 440, and 450.

[0026] As discussed with reference to Figure 4, in various embodiments, it may be desirable to include one uninterrupted cut section 440 between two intermittent cut sections 430, 450. In various other embodiments, it may be desirable to include an intermittent cut section between two intermittent cut sections. In such embodiments, a flexible, yet relatively stiff section may be provided in the flexible needle near the distal end of the flexible needle, while another uninterrupted cut section may be included adjacent to that section to distribute stress on the intermittent cut section.

[0027] 5, the flexible needle 500 includes a flexible portion 520 having three cut sections 530, 540, and 550. An interrupted cut section 540 extends continuously from the uninterrupted cut section 530 adjacent the distal end 514 of the flexible needle 500. The flexible needle 500 also includes a second interrupted cut section 550 extending continuously from an end 572 opposite the second terminal cut 570 of the interrupted cut section 540. As described with reference to FIG. 4, the pitch angle of the helical pattern of each of the cut sections 530, 540, and 550 can be configured and / or varied to provide a desired level of flexibility and / or relative flexibility for each of the cut sections 530, 540, and 550 compared to the flexibility of the other sections, as described in more detail below.

[0028] 6A, 6B, 7, and 8, the pitch angle of the helical pattern of the cut sections can be varied to provide a desired level of flexibility for each cut section. Further referring to FIG. 6A, the flexible needle 600 includes an intermittent cut section 630 and an uninterrupted cut section 640 extending continuously therefrom, as previously described with reference to FIGS. 1 and 2. In the example of FIGS. 1 and 2, the intermittent cut section 130 and the uninterrupted cut section 140 have helical patterns 232, 242 with different pitch angles α and β, respectively. In the example of FIG. 6A, the cut sections 630, 640 have the same helical patterns 632, 642 with the same pitch angle δ. It will be appreciated that the intermittent cut section 630 has the same pitch angle δ as the uninterrupted cut section 640, but is less flexible due to the uninterrupted cuts. In any event, the pitch angles of the various cutting sections may be different or the same to provide a level of flexibility for various applications.

[0029] 6B, it will be appreciated that the pitch angle can be fixed or alternatively variable in one or more cut sections. Flexible needle 601 includes intermittent cut sections 631, where the pitch angle varies, for example, from δ to δ. * to, and further δ ** to δ and then again to δ. In the uninterrupted cut section, the pitch angle changes from δ to δ' to δ". There is no restriction on the magnitude of the pitch angle, and the pitch angle can be changed and / or variable anywhere in either the intermittent cut section or the intermittent cut section.

[0030] As discussed with reference to Figures 7 and 8, when more than two cut sections are provided, the pitch angles can be the same or can vary, as desired. Further referring to Figure 7, the flexible needle 700 has three cut sections 730, 740, 750, of which the first intermittent cut section 730 has a first helical pattern 732, the first uninterrupted cut section 740 has a second helical pattern 742, and the second intermittent cut section 750 has a third helical pattern 752. Each of the helical patterns 732, 742, 752 can have different or the same pitch angles ε, ζ, and η, respectively. 8 , the flexible needle 800 includes three cut sections 830, 840, and 850, where the first uninterrupted cut section 830 has a first helical pattern 832, the first intermittent cut section 840 has a second helical pattern 842, and the second uninterrupted cut section 850 has a third helical pattern 852. Each of the helical patterns 832, 842, and 852 can have different or the same pitch angles θ, ι, and κ, respectively. Various embodiments are not limited by the number of cut sections, the relative positioning of the intermittent and uninterrupted cut sections, or the pitch angle of the helical pattern followed by the cuts. These configurations can be varied to provide different levels of flexibility along the shaft of the flexible needle for desired applications.

[0031] Further review of FIGS. 9 through 14 reveals that the cuts can be of various shapes. Differences in cut shape, as well as differences in pitch angle, can affect the relative flexibility or column strength of the cut sections. Further review of FIG. 9 reveals that the continuous cuts (not shown) and the intermittent cuts 900 can be linear across the entire surface of the shaft 905. It will be appreciated that the gaps 910 between the intermittent cuts 900 can be aligned. If the gaps 910 are offset, stiff portions of the shaft 905 may resist bending of the shaft 905, potentially reducing the flexibility provided by the intermittent cuts 900. Comparing FIGS. 9 and 10 reveals that in various embodiments, the gaps 910, 1010 between the intermittent cut sections 900, 1000 can vary in size. It will be appreciated that a smaller size of the gaps 910, 1010 increases the flexibility of the shaft 905.

[0032] 11, the notch 1100, whether linear or not, can have rounded ends 1110. The rounded ends 1110 help distribute stress and strain across the surface of the shaft 1105 at the ends of the notch 1100. The size of the rounded ends can vary to achieve the desired distribution of stress or strain across the surface of the shaft 1105. Similar to forming the notch itself as previously described, holes can be laser drilled into the surface of the shaft 1105.

[0033] In addition to, or instead of, the straight cuts described with reference to Figures 9-11, the intermittent cuts can be made in shapes other than straight cuts. Further, with reference to Figures 12-14, in various embodiments, sinusoidal cuts 1200 (Figure 12), jigsaw cuts (Figure 13), and zigzag cuts (Figure 14) can be used. These non-straight cuts can be more conducive to the propagation of stress and strain across the surface of the shaft than straight cuts and / or may provide less additional flexibility than straight cuts.

[0034] Flexible needle embodiments can be used with an insertion system to obtain a sample of a target site in body tissue. Continuing with FIG. 15 , an insertion system 1500 includes a control interface 1502 having a port 1504 configured to accept an elongated instrument, such as a flexible needle 1510 (shown in phantom inserted through the insertion system 1500). The control interface 1502 controls an insertion mechanism 1520 that directs an insertion tube 1522 mechanically and / or electrically to a target site in tissue 1530 for sample collection by a distal end 1540 of the flexible needle 1510. In various embodiments, the flexible needle 1510 is coupled to a handle 1550 that can be used to manipulate the flexible needle 1510. For example, the handle 1550 can be used to facilitate insertion of the flexible needle 1510 into the insertion tool 1500 and / or to manipulate the flexible needle 1510 to obtain a sample of a target site in tissue 1530.

[0035] In various embodiments, the insertion system 1500 can include an imaging system, as described in more detail below. The imaging system can cooperate with a display 1560 that displays imaging data 1562 of the target site in the tissue 1530 and / or the distal end 1540 of the flexible needle 1510, thereby assisting the operator in manipulating the insertion tool 1500 and flexible needle 1510 to obtain a sample. In various embodiments, the imaging data 1562 includes ultrasound imaging data, visual data, or other imaging data that can be used to visualize the sample collection process.

[0036] Continuing with FIG. 16 , the head 1600 of the insertion system 1500 ( FIG. 15 ) includes an imaging transducer 1610, such as an ultrasound transducer or a camera. In various embodiments, the head 1600 is disposed at the distal end of an insertion tube 1522. The head 1600 may also include an exit 1620 through which an elongated instrument, such as a flexible needle 1510 carried through the insertion tube 1522, can exit the head 1600. In various embodiments, the elongated instrument can be carried within a sheath 1630 extending through the insertion tube 1522. The imaging transducer 1610 collects imaging data that can be provided to an operator, such as via a display 1560 ( ​​FIG. 15 ), to assist the operator in guiding the distal end 1540 of the flexible needle 1510 to a target site in the tissue 1530 and / or to engage the flexible needle 1510 with a target site in the tissue 1530 to secure a sample.

[0037] 15 and 16, it can be seen that the flexible needle 1510 follows a tortuous path through the insertion system 1500 and beyond to reach its desired target. Providing a tailored level of flexibility at various points along the length of the flexible needle 1510 may be important to enable the flexible needle to reach the desired location. At the same time, having a consistent level of column strength and stiffness may also be important to push the flexible needle 1510 to the desired location. The use of interrupted cut sections that continue into uninterrupted cut sections distributes stress and strain while allowing a selected level of flexibility, avoiding undesirable deformation or structural failure of the flexible needle.

[0038] 17, a method 1700 for forming a flexible needle is illustrated. Method 1700 begins at block 1705. At block 1710, a needle shaft is created, the needle having a proximal end and a distal end including a needle tip. At block 1720, a plurality of interrupted cuts are formed through the wall of the shaft, where the plurality of interrupted cuts follow a first spiral pattern. At block 1730, interrupted cuts are formed in the shaft through the wall of the shaft, where the interrupted cuts extend continuously from the end of the first terminal cut at a first end of the plurality of interrupted cuts, where the interrupted cuts follow a second spiral pattern. Method 1700 stops at block 1735.

[0039] Turning now to FIG. 18, shown is a schematic diagram of an example intermittent slot pattern and a table of example parameter values ​​for that example. In Example 1, the intermittent slot pattern includes individual slots (a series of slots or a sequence of slots) that follow a spiral path around the needle, moving radially 115 degrees (i.e., approximately 2 radians) until they are interrupted by a 29-degree (i.e., approximately 0.5 radians) individual unslotted section, at which point a new individual slot begins following the same spiral path as before, moving a new 115 degrees, and then being interrupted by a new 29-degree unslotted section. This sequence can continue for the entire length of the unslotted section. As shown in FIG. 18, Example 1 includes approximately 2.5 slots per revolution with a 115 / 29 spiral slot pattern. All values ​​shown in FIG. 18 for Examples 1-7 are in inches.

[0040] It will be understood that the flexible needle devices described herein, and the systems and methods using the flexible needle devices described herein, can be used in a number of applications. While the example systems are described for securing samples from target tissue sites, the flexible needles can be used for depositing substances, obtaining or withdrawing fluid samples, or for a variety of other applications.

[0041] At times herein, one or more components may be referred to as being "configured for," "configured by," "configurable to," "operable / function to," "adapted," "capable," "matched to," etc. Those skilled in the art will understand that such language (e.g., "configured to") generally encompasses enabled components and / or disabled and / or standby components, unless the context requires otherwise.

[0042] While specific embodiments of the present subject matter described herein have been shown and described, it will be apparent to those skilled in the art that, based on the teachings herein, modifications and variations can be made without departing from the subject matter herein, and that the broader aspects thereof, and thus the appended claims, are intended to encompass within their scope all such modifications and variations, so long as they are within the true spirit and scope of the subject matter described herein. Those skilled in the art will understand that the terms used herein, and particularly the terms used in the appended claims (e.g., the body of the appended claims), are generally intended to be "open" terms (e.g., the term "including" should be interpreted as "including, but not limited to," the term "having" should be interpreted as "having at least," the term "including" should be interpreted as "including, but not limited to," etc.). Furthermore, those skilled in the art will understand that if a specific number of recited elements in a claim is intended, that intention will be explicitly recited in the claim, and that, absent such recitation, no such intention is intended. As an aid to understanding, for example, the following appended claims may use the limiting phrases "at least one" and "one or more" in the introductory portion of a claim. However, the use of such phrases should not be construed as implying that the indefinite article "a" or "an" in the introductory portion of a claim limits the claim having such a phrase to having only that one recitation. This is true even if the same claim also contains the introductory phrase "one or more" or "at least one" and an indefinite article such as "a" or "one" (e.g., "a" should typically mean "at least one" or "one or more"), and even if a definite article is used in the introductory portion of a claim.Furthermore, even when a claim is explicitly recited with a specific number introductory phrase, those skilled in the art will understand that such a phrase should typically be interpreted as meaning at least the recited number (e.g., "two items," when recited by itself without any other modifier, typically means at least two items or two or more items). Furthermore, when formulaic phrases such as "at least one of A, B, and C" are used, the interpretation is generally intended to be the meaning that one skilled in the art would understand as a matter of custom (e.g., "a system having any one of A, B, and C" includes, but is not limited to, systems having A only, B only, C only, A and B together, A and C together, B and C together, and / or A, B, and C together). Furthermore, those skilled in the art will understand that alternative words and / or phrases, whether in the specification, claims, or drawings, which typically have two or more alternative words, should be understood to contemplate the possibility of including either term, either term, or both terms, unless the context requires otherwise. For example, the phrase "A or B" is typically understood to include the possibilities of "A" or "B" or "A and B."

[0043] While the disclosed subject matter has been described in exemplary embodiments, those skilled in the art will recognize that various modifications could be made therein without departing from the scope of the claimed subject matter, as set forth in the claims. [Additional note 1] Equipped with a flexible needle, The flexible needle a proximal end; a distal end including a needle tip; a shaft extending between the proximal end and the distal end, the shaft including a flexible portion; and The flexible portion is an intermittent cut section including a plurality of intermittent cuts in the shaft following a first spiral pattern; a continuous cut section including a continuous cut portion of the shaft that follows a second helical pattern; and The apparatus wherein the uninterrupted cut extends continuously from an end of a first terminal cut at a first end of the interrupted cut section. [Additional note 2] the intermittent cut section is disposed adjacent the distal end; 2. The device of claim 1, wherein the continuous cutting section is disposed between the intermittent cutting section and the proximal end. [Additional note 3] the continuous cut section is disposed adjacent the distal end; 2. The device of claim 1, wherein the intermittent cutting section is disposed between the non-intermittent cutting section and the proximal end. [Additional note 4] 10. The device of claim 1, wherein a first pitch angle of the first spiral pattern of the intermittent cut section is smaller than a second pitch angle of the second spiral pattern of the uninterrupted cut section. [Additional note 5] 10. The apparatus of claim 1, wherein the first pitch angle of the first spiral pattern of the intermittent cut section has a pitch angle selected from a fixed pitch angle and a variable pitch angle. [Additional note 6] 10. The apparatus of claim 1, wherein the second pitch angle of the second spiral pattern of the intermittent cut section has a pitch angle selected from a fixed pitch angle and a variable pitch angle. [Additional note 7] 2. The device of claim 1, wherein the plurality of intermittent cuts includes a plurality of linear cuts. [Additional note 8] The device described in Appendix 1, wherein the plurality of intermittent cuts include a plurality of non-linear cuts including at least one cut pattern selected from a sinusoidal cut pattern, a jigsaw cut pattern, and a zigzag cut pattern. [Additional note 9] 10. The device of claim 1, wherein at least a portion of the intermittent cuts terminate in a circular hole formed in the shaft. [Additional Note 10] an additional uninterrupted cut section including additional uninterrupted cuts on the shaft following a third helical pattern having a third pitch angle, the additional uninterrupted cut section extending from a second end of a second terminal cut of the plurality of intermittent cuts at an end of the intermittent cut section opposite the first terminal cut; an additional intermittent cut section including an additional plurality of intermittent cuts on the shaft following a fourth helical pattern having a fourth pitch angle, the additional intermittent cut section extending from an end of the uninterrupted cuts opposite the end of the first terminal cut; further comprising at least one additional cut section selected from Item 1. The device of item 1. [Additional Note 11] 1. A system for sampling a target site of tissue, comprising: an insertion system configured to receive an elongate instrument in the proximal end of the lumen and to carry the distal end of the lumen into the body toward a target tissue site from which a sample is to be taken; a flexible needle assembly configured to be insertable into the body through the lumen, -having a flexible needle, The flexible needle a proximal end; a distal end including a needle tip; a shaft extending between said proximal end and said distal end and including a flexible portion; and The flexible portion is an intermittent cut section having a plurality of intermittent cuts in the shaft following a first spiral pattern; an uninterrupted cut section including uninterrupted cuts in the shaft that follow a second helical pattern, the uninterrupted cuts extending continuously from an end of a first terminal cut at a first end of the uninterrupted cut section; a flexible needle assembly including: a handle assembly configured to engage a proximal end of the flexible needle and control movement of the flexible needle; A system comprising: [Additional Note 12] the intermittent cut section is disposed adjacent the distal end; 12. The system of claim 11, wherein the continuous cutting section is disposed between the intermittent cutting section and the proximal end. [Additional Note 13] the continuous cut section is disposed adjacent the distal end; 12. The system of claim 11, wherein the intermittent cutting section is disposed between the non-intermittent cutting section and the proximal end. [Additional Note 14] 12. The system of claim 11, wherein a first pitch angle of the first spiral pattern of the intermittent cut section is smaller than a second pitch angle of the second spiral pattern of the uninterrupted cut section. [Additional Note 15] 12. The system of claim 11, wherein the first pitch angle of the first spiral pattern of the intermittent cut section has a pitch angle selected from a fixed pitch angle and a variable pitch angle. [Additional Note 16] 12. The system of claim 11, wherein the second pitch angle of the second spiral pattern of the intermittent cut section has a pitch angle selected from a fixed pitch angle and a variable pitch angle. [Additional Note 17] 12. The system of claim 11, wherein the plurality of intermittent cuts includes a plurality of linear cuts. [Additional Note 18] 12. The system of claim 11, wherein the plurality of intermittent cuts includes a plurality of non-linear cuts including at least one cut pattern selected from a sinusoidal cut pattern, a jigsaw cut pattern, and a zigzag cut pattern. [Additional Note 19] 12. The system of claim 11, wherein at least a portion of the intermittent cuts terminate in a circular hole formed in the shaft. [Additional Note 20] an additional uninterrupted cut section including one additional uninterrupted cut of the shaft following a third helical pattern having a third pitch angle, the additional uninterrupted cut section extending from a second end of a second terminal cut of the plurality of intermittent cuts at an end of the intermittent cut section opposite the first terminal cut; an additional interrupted cut section including an additional plurality of interrupted cuts on the shaft following a fourth helical pattern having a fourth pitch angle, the additional interrupted cut section extending from an end of the uninterrupted cut section opposite an end of the first terminal cut section; The system of claim 11, further comprising at least one additional cutting section selected from: [Additional Note 21] 12. The system of claim 11, wherein the insertion system further comprises an imaging probe attachable to the distal end of the lumen for monitoring the position of the needle relative to the target tissue site from which the sample is to be taken. [Additional Note 22] forming a needle shaft having a proximal end and a distal end including a needle tip; forming a plurality of interrupted cuts through a wall of the shaft, the plurality of interrupted cuts following a first spiral pattern; forming uninterrupted cuts in the shaft through the wall of the shaft, the uninterrupted cuts extending continuously from an end of a first terminal cut at a first end of a plurality of interrupted cuts, the uninterrupted cuts following a second spiral pattern; A method comprising: [Additional note 23] 23. The method of claim 22, further comprising forming an intermittent cut section between the distal end and the uninterrupted cut section. [Additional note 24] 23. The method of claim 22, further comprising forming an uninterrupted cut section between the distal end and the interrupted cut section. [Additional note 25] 23. The method of claim 22, further comprising forming a plurality of the interrupted cuts in the first spiral pattern at a first pitch angle, and forming the uninterrupted cuts in the second spiral pattern at a second pitch angle. [Additional note 26] 23. The method of claim 22, further comprising forming the plurality of intermittent cuts in the first spiral pattern at a pitch angle selected from a fixed pitch angle and a variable pitch angle. [Additional note 27] 23. The method of claim 22, further comprising forming the uninterrupted cuts in the second spiral pattern at a pitch angle selected from a fixed pitch angle and a variable pitch angle. [Additional note 28] 23. The method of claim 22, wherein forming the plurality of intermittent cuts further comprises forming a plurality of linear cuts. [Additional note 29] 23. The method of claim 22, wherein the step of forming the plurality of intermittent cuts further includes the step of forming a plurality of non-linear cuts using at least one cut pattern selected from a sinusoidal cut pattern, a jigsaw cut pattern, and a zigzag cut pattern. [Additional note 30] 23. The method of claim 22, further comprising forming a circular hole at at least one end of each of the plurality of interrupted cuts. [Additional note 31] forming an additional uninterrupted cut section including an additional uninterrupted cut on the shaft following a third helical pattern having a third pitch angle, the additional uninterrupted cut section extending from a second end of the second terminal cut at an end of the interrupted cut section opposite the first terminal cut; forming an additional intermittent cut section including a plurality of additional intermittent cuts on the shaft following a fourth helical pattern having a fourth pitch angle, the additional intermittent cut section extending from an end of the uninterrupted cuts opposite the end of the first terminal cut; 23. The method of claim 22, further comprising forming at least one additional cut section selected from: [Explanation of symbols]

[0044] 100 flexible needle, 110 shaft, 112 proximal end, 114 distal end, 116 needle tip, 118 opening, 120 flexible portion, 130 interrupted cut section, 132 interrupted cut, 140 uninterrupted cut section, 142 uninterrupted cut, 260 first terminal cut, 262 end, 300 flexible needle, 320 flexible portion, 340 uninterrupted cut section, 400 flexible needle, 414 distal end, 430, 440, 450 cut section, 460 first terminal cut, 462 uninterrupted cut, 472 end, 473 third spiral pattern, 500 flexible needle, 520 flexible portion, 530, 540, 550 cut section, 570 Second terminal cut section, 572 End, 600 Flexible needle, 630 Intermittent cut section, 632 Spiral pattern, 640 Cut section, 642 Spiral pattern, 700 Flexible needle, 730 First intermittent cut section, 732 Second spiral pattern, 750 Second intermittent cut section, 800 Flexible needle, 830 First intermittent cut section, 840 First intermittent cut section, 850 Second intermittent cut section, 852 Third spiral pattern, 900, 1000 Intermittent cut section, 905 Shaft, 910 Gap, 1110 Rounded end, 1500 Insertion system, insertion tool, 1502 Control interface, 1510 Flexible needle, 1522 Insertion tube, 1530 Tissue, 1540 Distal end, 1550 handle, 1560 display, 1562 imaging data, 1600 head, 1610 imaging transducer, 1700 method, 1710 block

Claims

1. Equipped with a flexible needle, The flexible needle a proximal end; a distal end including a needle tip; a shaft extending between the proximal end and the distal end, the shaft including a flexible portion; and The flexible portion is an intermittent cut section including a plurality of individual cuts in the shaft forming a series of cuts following a first spiral pattern; an uninterrupted cut section including an uninterrupted cut portion of the shaft that follows a second helical pattern; and The apparatus wherein the uninterrupted cut extends continuously from an end of a first terminal cut at a first end of the interrupted cut section.

2. the intermittent cut section is disposed adjacent the distal end; The device of claim 1 , wherein the uninterrupted cut section is disposed between the interrupted cut section and the proximal end.

3. the continuous cut section is disposed adjacent the distal end; The device of claim 1 , wherein the intermittent cutting section is disposed between the uninterrupted cutting section and the proximal end.

4. The apparatus of claim 1 , wherein a first pitch angle of the first spiral pattern of the intermittent cut section is less than a second pitch angle of the second spiral pattern of the uninterrupted cut section.

5. The apparatus of claim 1 , wherein a first pitch angle of the first helical pattern of the intermittent cut section has a pitch angle selected from a fixed pitch angle and a variable pitch angle.

6. 2. The apparatus of claim 1, wherein a second pitch angle of the second spiral pattern of the uninterrupted cut section has a pitch angle selected from a fixed pitch angle and a variable pitch angle.

7. The device described in claim 1, wherein the plurality of individual cut portions of the intermittent cut section include a plurality of linear cut portions.

8. The device described in claim 1, wherein the plurality of individual cut portions of the intermittent cut section include a plurality of non-linear cut portions including at least one cut pattern selected from a sinusoidal cut pattern, a jigsaw cut pattern, and a zigzag cut pattern.

9. The device of claim 1 , wherein at least some of the individual cuts in the intermittent cut section terminate in round holes formed in the shaft.

10. an additional uninterrupted cut section including an additional uninterrupted cut of the shaft following a third helical pattern having a third pitch angle, the additional uninterrupted cut section extending from a second end of a second terminal cut of the intermittent cut section at an end opposite the first terminal cut of the intermittent cut section; an additional intermittent cut section including an additional plurality of intermittent cuts on the shaft following a fourth helical pattern having a fourth pitch angle, the additional intermittent cut section extending from an end of the uninterrupted cuts opposite the end of the first terminal cut; further comprising at least one additional cut section selected from 10. The apparatus of claim 1.

11. 1. A system for sampling a target site of tissue, comprising: an insertion system configured to receive an elongate instrument in the proximal end of the lumen and to carry the distal end of the lumen into the body toward a target tissue site from which a sample will be taken; a flexible needle assembly configured for insertion into the body through the lumen, - has a flexible needle, The flexible needle a proximal end; a distal end including a needle tip; a shaft extending between the proximal end and the distal end and including a flexible portion; and The flexible portion is an intermittent cut section having a plurality of intermittent cuts in the shaft following a first spiral pattern; an uninterrupted cut section including uninterrupted cuts in the shaft following a second spiral pattern, the uninterrupted cuts extending continuously from an end of a first terminal cut at a first end of the uninterrupted cut section; a flexible needle assembly including: a handle assembly configured to engage a proximal end of the flexible needle and control movement of the flexible needle; Equipped with the intermittent cut section is disposed adjacent the distal end; The uninterrupted cut section is disposed between the intermittent cut section and the proximal end.

12. the continuous cut section is disposed adjacent the distal end; The system of claim 11 , wherein the intermittent cut section is disposed between the uninterrupted cut section and the proximal end.

13. The system of claim 11 , wherein a first pitch angle of the first spiral pattern of the intermittent cut section is less than a second pitch angle of the second spiral pattern of the uninterrupted cut section.

14. The system of claim 11 , wherein a first pitch angle of the first spiral pattern of the intermittent cut section has a pitch angle selected from a fixed pitch angle and a variable pitch angle.

15. The system of claim 11 , wherein a second pitch angle of the second spiral pattern of the uninterrupted cut section has a pitch angle selected from a fixed pitch angle and a variable pitch angle.

16. The system of claim 11 , wherein the plurality of intermittent cuts comprises a plurality of linear cuts.

17. 12. The system of claim 11, wherein the plurality of intermittent cuts comprises a plurality of non-linear cuts comprising at least one cut pattern selected from a sinusoidal cut pattern, a jigsaw cut pattern, and a zigzag cut pattern.

18. The system of claim 11 , wherein at least a portion of the interrupted cuts terminate in a circular hole formed in the shaft.

19. an additional uninterrupted cut section including one additional uninterrupted cut of the shaft following a third helical pattern having a third pitch angle, the additional uninterrupted cut section extending from a second end of a second terminal cut of the plurality of intermittent cuts at an end of the intermittent cut section opposite the first terminal cut; an additional interrupted cut section including an additional plurality of interrupted cuts on the shaft following a fourth helical pattern having a fourth pitch angle, the additional interrupted cut section extending from an end of the uninterrupted cut section opposite an end of the first terminal cut section; The system of claim 11 , further comprising at least one additional cutting section selected from:

20. 12. The system of claim 11, wherein the insertion system further comprises an imaging probe mountable to the distal end of the lumen for monitoring the position of the flexible needle relative to a target tissue site from which a sample is to be taken.

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