Source distribution unit for needle assembly

Abstract

A device for controlling a needle assembly (10) having a handle (14) connected to a hollow needle (30) and a core needle (36) penetrating the hollow needle. The device includes a retaining rod (18) and a connector (22) slidably mounted on the retaining rod, the connector being configured to be fixedly attached to the handle. The connector has a controller (110) that, in a first position, causes the connector to translate proximally a predetermined distance on the retaining rod, thereby translating the handle and hollow needle proximally by a predetermined distance and translating the core needle distally relative to the connector by a predetermined distance. In a second position, the controller causes the connector to translate proximally a predetermined distance on the retaining rod, thereby translating the handle, hollow needle, and core needle by a predetermined distance.

Description

[0001] Cross-reference to related applications This application claims the benefit of U.S. Provisional Patent Application 63 / 631,502, filed April 9, 2024, which is incorporated herein by reference.

[0002] Invention Field The present invention relates generally to endoscopic examination, and more particularly to an apparatus for endoscopic delivery of multiple implants or substances. Background of the Invention In endoscopic procedures, sources (such as implants or substances) can be placed inside a patient for a variety of potential therapeutic uses, such as for placing reference markers, for drug delivery, and for implanting radiotherapy seeds. For example, in the case of endoscopic examination in a radiotherapy setting such as Diffusing Alpha-emitters Radiation Therapy (DaRT) procedures, such sources are specifically categorized as radioactive seeds, which are implanted endoscopically into the tumor to kill it.

[0004] Accurate positioning of the source within the patient's body is extremely important, because even a small deviation from the target location can not only significantly reduce the effectiveness of the surgery, but may also lead to harmful side effects, such as damage to healthy tissue.

[0005] U.S. Patent 10,292,786 to Clancy et al. describes a reference object deployment system having a handle configured to actuate the system. The reference object may include one or more protrusions configured to engage one or more slots in a needle of the system. The needle may be configured to deliver multiple reference objects in a tandem, one at a time, to a target orientation.

[0006] McWeeney's U.S. Patent Application 2011 / 190662 describes a device for needle aspiration biopsy and delivery of diagnostic or therapeutic agents. The device includes a handle member having a proximal portion and a distal portion. A proximal handle member is disposed to the proximal portion of the handle member, and a distal handle member is disposed to the distal portion of the handle member. A sheath lumen is disposed within the handle member.

[0007] U.S. Patent Application 2015 / 0031935 by Wazer et al. describes a device for brachytherapy delivery in the treatment of cancer via radiotherapy. The device includes: a handle having a first handle actuator and a second handle actuator; an end effector; and a device shaft connecting the handle to the end effector. The end effector has a first adjacent staple cartridge and a second adjacent staple cartridge, each cartridge holding a set of staples.

[0008] Subramanian's U.S. Patent 10,589,071 describes a dual-balloon catheter comprising a catheter having a proximal end portion, a central portion, and a distal end portion. The catheter includes multiple lumens extending from the proximal end portion within the catheter and multiple inflatable balloons positioned in the central and / or distal end portions. Invention Overview Embodiments of the present invention provide a device for controlling a needle assembly having a handle coupled to a hollow needle and a hollow needle penetrating the hollow needle, the device comprising: Holder; A connector, slidably mounted on the retaining rod and configured to be fixedly attached to the handle, the connector having a controller, the controller: In the first position, the connector is moved proximally a predetermined distance on the retaining rod, causing the handle and the hollow pin to be moved proximally a predetermined distance relative to the connector, and the core pin to be moved distally a predetermined distance relative to the connector. In the second position, the connector is moved a predetermined distance on the retaining rod, so that the handle, the hollow needle, and the core needle are moved by the predetermined distance.

[0010] The component may have a static rod coupled to a sheath surrounding the hollow needle, and the device may also include another connector slidably mounted on a retaining rod, the other connector being configured to be fixedly connected to the static rod.

[0011] In the disclosed embodiment, the connector includes a rack and pinion, the pinion being coupled to a gear drive that retains the core needle within the hollow needle. In a first position, the rack and pinion are engaged, and in a second position, the rack and pinion are disengaged.

[0012] In a further disclosed embodiment, the device includes a support housing, wherein the support is configured to slide, and wherein a controller is configured to rotate the support housing to a first orientation and a second orientation, the first orientation placing the support in a first position and the second orientation placing the support in a second position. The support housing is rotatable about a hinge fixed to a retaining rod.

[0013] According to one embodiment of the present invention, a method for implanting at least one source into a patient is also provided, the method comprising: A hollow needle is provided, the hollow needle having a distal end of the needle and a lumen, the lumen being configured to receive the at least one source; Insert the core needle into the lumen; Insert the at least one source into the lumen; The hollow needle is inserted into the patient's body so that the distal end of the needle is located in a predetermined position within the patient's body; The needle is advanced through the lumen to contact the proximal end of the at least one source, thereby pushing the at least one source such that the distal end of the at least one source is aligned with the distal end of the needle; and After the core needle is advanced through the lumen to contact the proximal end of the at least one source, the hollow needle is withdrawn proximally while the core needle is held in place so that the at least one source enters the patient at the predetermined location.

[0014] According to one embodiment of the present invention, a method for controlling a needle assembly having a handle coupled to a hollow needle and a core needle penetrating the hollow needle is also provided, the method comprising: The connector is slidably mounted on the retaining rod; Securely attach the connector to the handle; and A controller having a first position and a second position is attached to the connector, wherein the controller: In the first position, the connector is moved proximally a predetermined distance on the retaining rod, causing the handle and the hollow pin to be moved proximally a predetermined distance relative to the connector, and the core pin to be moved distally a predetermined distance relative to the connector. In the second position, the connector is moved a given distance on the retaining rod, so that the handle, the hollow needle, and the core needle are moved a given distance.

[0015] This disclosure will be more fully understood from the following detailed description of embodiments thereof, taken in conjunction with the accompanying drawings, in which: Brief description of the attached diagram Figure 1A and Figure 1B This is a schematic diagram of a needle assembly and a source distribution unit that can be attached to the needle assembly according to an embodiment of the present invention; Figure 2 This is a schematic diagram of elements used by a needle assembly according to an embodiment of the present invention; and Figures 3A to 3CThese are different views of a handle connector mounted on a rod according to an embodiment of the present invention. Detailed Implementation

[0016] Overview In endoscopic procedures that kill tumors using implanted sources, including radioactive seeds, it is crucial to implant the seed as precisely as possible within the tumor to prevent damage to tissues outside the tumor. While physicians can perform implantation manually using a fine needle aspiration (FNA) / biopsy needle with a core, a high level of expertise is typically required for successful seed implantation, and even then, achieving the required precise seed positioning (typically within 4 mm) is challenging.

[0017] Embodiments of the present invention provide a source dispensing unit (SDU) attached to a needle assembly, such as a needle assembly for endoscopic procedures, and converting the assembly to semi-automatic operation. The SDU controls the position of three elements of the needle assembly attached to the SDU: the hollow needle, the sheath surrounding the hollow needle, and the core needle inserted into the hollow needle. The SDU enables independent manipulation of the sheath, needle, and core needle.

[0018] Independent manipulation allows for individual control of the needle, for example, for initial contact with the tumor. Independent manipulation also allows for controlled relative movement between the sheath, needle, and core needle, enabling the source to be translated to the distal end of the needle and then held in place via the core needle upon needle withdrawal.

[0019] The SDU includes a rigid rod, a connector for connecting to the component static rod, and a connector for connecting to the component handle, all slidably mounted on the rigid rod.

[0020] The connector connected to the component's static rod allows for independent adjustment of the sheath.

[0021] The connector connected to the component handle includes a rack and pinion assembly, and the connector has a controller for engaging or disengaging the rack and pinion. When the rack engages with the pinion, the core pin is effectively disengaged from the needle, and any translation of the pinion relative to the rack causes the core pin to translate independently of the needle. When the rack disengages from the pinion, the core pin is effectively engaged with the needle, such that any translation of the handle connector causes both the needle and the core pin to translate.

[0022] The needle assembly can be used to position multiple sources (already inserted into the hollow needle) to a desired orientation, such as a selected area of ​​a tumor. The SDU controller can then be activated to engage the rack and pinion, and when the rack and pinion are engaged, the handle connector can be translated proximally. As described below, this proximal translation of the handle connector retracts the hollow needle proximally from the source position, but translates the core needle distally relative to the needle, keeping the distal end of the core needle in place. Therefore, during needle retraction, the source contacting the distal end of the core needle remains in place.

[0023] In a typical procedure, the desired implantation source (e.g., a radioactive seed) is first loaded into a hollow needle to contact the core needle within the needle. A biocompatible plug (optionally formed of a substance such as glycerin or bone wax) can be inserted into the needle and applied to the most distal source to prevent the source from moving out of the needle and, in the case of a radioactive seed, to reduce radiation exposure from the source.

[0024] The physician can then insert the hollow needle into the patient, positioning the distal end of the needle in the desired position within the patient's body. The physician can then operate the SDU to advance the needle, thereby removing the plug and positioning the distal source at the needle tip—all without altering the needle's orientation. The physician then withdraws the hollow needle using the SDU as described above, repositioning the distal source within the patient's body. By using the SDU, the physician only needs one hand to perform the insertion and withdrawal of the needle.

[0025] During a single insertion procedure (i.e., one insertion and withdrawal of the needle), a physician can use an SDU to insert a single source into the patient, or alternatively, insert multiple sources sequentially (i.e., in a line). Inserting multiple consecutive sources provides radiation over a larger target area of ​​the tumor compared to a single source.

[0026] The following describes other actions of the SDU.

[0027] Detailed description In the following description, all directional references (e.g., up, down, upward, downward, left, right, top, bottom, above, below, vertical, and horizontal) are used for identification purposes only to aid the reader in understanding this disclosure and do not impose limitations, in particular, on the location, orientation, or use of embodiments of the invention.

[0028] Now for reference Figure 1A , Figure 1B and Figure 2 . Figure 1A This is a schematic diagram of a needle assembly 10 and a source distribution unit (SDU) 16 that can be attached to the needle assembly, according to an embodiment of the present invention. Figure 1B This is a schematic diagram of an SDU 16 attached to a pin assembly 10 according to an embodiment of the present invention. Figure 2This is a schematic diagram of the elements used in the needle assembly according to an embodiment of the present invention.

[0029] The needle assembly 10 can be used to implant multiple source endoscopes into a patient via a single needle for therapeutic purposes, such as placing reference markers, delivering drugs, and implanting radiotherapy seeds into organs of human patients, typically into tumors within organs. Figure 1A As shown, the needle assembly 10 includes a sheath-retaining static rod 12 and a handle 14, with the handle sliding about the static rod 12. The static rod 12 and handle 14 serve as the base for a source applicator, such that the rod and handle together are also referred to herein as applicator 13. An SDU 16 is configured to attach to the needle assembly, and Figure 1B The SDU is shown when attached to the pin assembly. (Example) Figure 1A As shown, when the SDU 16 is attached to the needle assembly 10, the core needle 36 (described further below) is inserted into the handle 14.

[0030] SDU 16 includes a rigid retaining rod 18 on which two connectors are configured to slide: a static rod connector 20, which is coupled to a static rod 12 of the needle assembly, and a handle connector 22, which is coupled to a handle 14. A proximal segment 18P of the rod 18 has a generally U-shaped cross-section, and a portion of the handle connector 22 is held within an opening in the U-shape of segment 18P, as described below. Both connectors have corresponding locks: a first lock 24 that locks the connector 20 to the rod 18 and a second lock 26 that locks the handle connector 22 to the rod. The handle connector 22 has a hole 17, the function of which is described below.

[0031] In endoscopic surgery, in addition to the applicator 13, the needle assembly 10 also includes a component kit 28 that is manipulated during the procedure, and details of this set of components are as follows: Figure 2 As shown in the image.

[0032] like Figure 2 As shown, kit 28 includes a generally cylindrical hollow needle 30, a generally cylindrical sheath 34, and a generally cylindrical core needle 36. The hollow needle 30 is configured to hold a plurality of sources 32, and the cylindrical sheath 34 surrounds the hollow needle. In a radiotherapy procedure, the sources 32 include radiotherapy seeds. The core needle 36 penetrates the hollow needle. The core needle 36, sheath 34, and needle 30 are all flexible elements; the sheath and needle are tubular, while the core needle is a solid, wire-like element. In one embodiment, the core needle 36 is formed of nitinol / stainless steel.

[0033] To construct the needle assembly 10, the kit 28 is attached to the applicator 13: the sheath 34 is fixedly attached to the static rod 12, and the hollow needle 30 is internally fixedly attached to the handle 14. (When attached, the kit 28 and the applicator 13 form the needle assembly 10.) Figure 1Aand Figure 1B A sheath 34 extending from the distal portion of rod 12 is shown. Figure 1A Also shown is a mandrel 36 that enters the proximal portion of the handle 14; as described above, in embodiments of the invention, the mandrel is inserted into the handle when the source dispensing unit 16 is attached to the applicator 13. The assembly of the mandrel 36 into the handle 14 is described below.

[0034] As described above, the static rod connector 20 is connected to the static rod 12 of the needle assembly, and after connection, and with the lock 24 unlocked, the connector can slide on the rod 18. Leaving the connector 20 unlocked and thus allowing it to slide freely on the rod 18 enables the needle 30 to move relative to the sheath 34; the needle and the core needle are connected to the handle 14. When the lock 24 is unlocked and the lock 26 of the handle connector 22 is locked, the needle and the core needle can be moved relative to the sheath by pushing the handle connector, causing the rod 18 to slide within the static rod connector 20.

[0035] Figures 3A to 3C This is a different illustration of a handle connector 22 mounted on a rod 18 according to an embodiment of the present invention. Figure 3A The figure shows a connector 22 on the rod 18, and also shows the outer container housing 40 of the connector. The figure also shows a mandrel 36 extending from the connector 22; as shown... Figure 1A As shown, the portion of the core needle 36 extending from the connector is inserted into the handle 14.

[0036] Figure 3B A portion of the housing 40 was removed to reveal the internal components of the connector and the structure of the rod 18. The internal components of the connector 22 include a gear drive assembly 44, which is housed within the assembly housing 46.

[0037] like Figure 3B and Figure 3C As shown, rod 18 includes a horizontal groove 50A, an inverted U-shaped groove 54A, and a hole 62A on its front side. Corresponding elements, namely a horizontal slit 50B, an inverted U-shaped groove 54B, and a hole 62B, are present on the back side of rod 18. The function of these elements of the rod is described below. A U-shaped opening 58 is also present in the upper portion of the front side of the rod; there are no elements corresponding to the opening 58 on the back side of the rod.

[0038] Figure 3C Handle connector 22 is shown, with a portion of housing 40 and component housing 46 removed to reveal the internal components of gear transmission assembly 44. Additionally, connector 22 and rod 18 are shown in exploded form, with the connector separated from the rod.

[0039] Component 44 includes a Luer connector 66, which is attached to the Luer connector 15 of the handle 14 (e.g., Figure 1A(As shown). Before using the procedure of device 10, the needle 36 is pre-assembled into the gear assembly 44, such that a portion passes through the connector 66 to be located in the channel 70 of the assembly, and that the distal end of the needle (the portion extending from the connector 66 shown in the figure) is positioned in a predetermined position within the hollow needle. The remainder of the needle is wound around a circular ratchet 74 having a pawl 74R connected to the wheel, and the end of the needle is secured to the wheel 74. The needle 36 is wound around the wheel 74 such that the counterclockwise rotation of the wheel about its axis 78 moves the needle distally within the hollow needle 30 in the direction of the handle 14 and the static rod 12. Figure 3C As shown, wheel 74 has numbers on its surface, and one of these numbers is visible through hole 17.

[0040] Gear 82 is coaxial with wheel 74, and is positioned behind the wheel so that it... Figure 3C Not visible in the center, the gear 82 is fixed to the wheel. Gear 82 meshes with another gear 86, which serves as the pinion of the rack and pinion assembly 90 and is also referred to herein as pinion 86. In addition to pinion 86, assembly 90 also includes a rack 94, which is held within a generally U-shaped rack support housing 98.

[0041] As described below, in the engaged state of device 10, pinion 86 engages with rack 94, i.e., meshes; in the disengaged state of device 10, pinion 86 does not mesh with rack. When rack 94 meshes with pinion 86, the translation of rack relative to pinion causes pinion to rotate, thereby rotating wheel 74, which in turn causes mandrel 36 to translate. When the translation of rack relative to pinion is distal, pinion 86 rotates clockwise, causing gear 82 and its attached wheel 74 to rotate counterclockwise. The counterclockwise rotation of wheel causes mandrel 36 to translate distally, and it should be understood that the size of rack and the amount of mandrel translation are equal. The distal translation of rack relative to pinion can be achieved by holding pinion in a fixed position and moving rack distally, or alternatively, by holding rack fixed and moving pinion proximally.

[0042] The support housing 98 is located in the opening of section 18P of the rod 18, and the hinge pin 102 passing through holes 62A and 62B of the housing 98 and the rod 18 allows the support housing to rotate in a vertical plane about the hinge pin. A protrusion 106 in the housing 98 moves within a U-shaped opening 58 and ensures that the housing remains in a vertical plane and does not rotate beyond the limits defined by the U-shaped opening. The controller 110 is configured to allow the operator of the device 10 to rotate the housing 98 between two states: an upper state where the rack 94 is engaged with the pinion 86; and a lower state where the rack is not engaged with the pinion.

[0043] like Figure 3C As shown, the housing 98 has two horizontal slits on its front surface: slit 114A and slit 118A, and two corresponding slits on its back surface: slit 114B and slit 118B. A first pin 122 passing through the rack 94 connects slits 114A and 114B, and a second pin 126 passing through the rack 94 connects slits 118A and 118B. When the device 10 is assembled, the first pin 122 is also located in the inverted U-shaped grooves 54A and 54B.

[0044] Pins 122 and 126 allow rack 94 to slide horizontally distally or proximally within the housing 98, within the boundaries defined by slits 114A and 118A (and their corresponding slits). Controller 110 is connected to pin 122 and can be used to actuate the sliding of rack 94 within housing 98 in a pawl-like manner, as described below.

[0045] Embodiments of the present invention allow the following actions to be performed on the needle element kit 28.

[0046] Needle settings Typically, to configure component 10, the distal ends of the sheath 34 and the hollow needle 30 should be aligned. For example... Figure 1B As shown, alignment can be achieved by initially connecting the static rod connector 20 to the static rod 12 and by connecting the handle connector 22 to the handle 14. After connection, the operator of the device can adjust the controller 110 so that the rack 94 does not engage with the pinion 96. Then, the two connectors can slide on the retaining rod 18 respectively, thereby allowing the rod 12 to slide relative to the handle 14. When the distal ends of the sheath and the hollow needle are aligned, the two connectors can be secured in place on the rod 18 using locks 24 and 26, thereby effectively locking the sheath 34 and the needle 30 together.

[0047] During the procedure, the needle 30 can be unlocked from the sheath 34 by unlocking lock 24. Then, by pushing handle connector 22, handle 14 and its attached needle 30 can be translated distally relative to the sheath.

[0048] Source location Multiple sources 32 can be positioned within the hollow needle 30 by sliding rack 94 in a ratchet-like manner and by using controller 110 to slide rack 94 distally and proximally within rack housing 98. Distal and proximal movement is achieved by using controller 110 to slide pin 122 between the distal and proximal ends of slits 114A (and slits 114B). When rack 94 translates distally, controller 110 also rotates rack housing 98, causing rack 94 to engage with pinion 86. When rack translates proximally, controller 110 rotates rack housing, disengaging rack 94 from pinion 86.

[0049] Because the rack engages with the pinion during the rack's distal translation, there is a corresponding distal translation of the mandrel 36, which can be used to position the source 32 to contact the mandrel. During the rack's proximal translation, there is no engagement, so the mandrel 36 does not move. The pawl 74R ensures that there is no unintentional proximal movement of the mandrel during the rack's proximal movement.

[0050] It should be understood that this action of pushing the needle distally occurs when the hollow needle is fixed, so that the source 32 can be pushed to align with the distal end of the needle.

[0051] In a typical procedure, a predetermined number of sources are initially inserted into the hollow needle to contact the distal end of the core needle. The distal end of the core needle is positioned such that the distal end of the most distal source is a predetermined distance from the distal end of the hollow needle. A biocompatible plug can be inserted into the needle and applied to the most distal source to prevent the source from moving out of the needle.

[0052] Once the user of device 10 has inserted the distal end of the hollow needle into the desired position within the patient's body, the user can use controller 110 as described above (i.e., by a back-and-forth ratchet motion) to advance the needle to expel the plug and prepare the device for needle withdrawal, as described below.

[0053] Needle withdrawal Using the above actions, source 32 can be positioned at the distal end of needle 30, and the user of device 10 can insert the needle until the distal end of the needle is in the desired orientation, such as the distal portion of a tumor. (Lock 24 of connector 20 should be locked on lever 18 to lock the needle's orientation.) At this point, lock 26 of connector 22 should be unlocked, and controller 110 can then be used to engage rack 94 and pinion 86. The user can then slide connector 22 proximally on lever 18, thereby translating handle 14 and its attached needle 30 proximally, i.e., withdrawing the needle from the distal end in the desired orientation. However, due to the engagement of rack and pinion, the proximal translation of connector 74 causes an equivalent distal translation of core needle 36 relative to the needle via rotation of wheel 74.

[0054] Since the distal end of the mandrel contacts the source, the distal translation of the mandrel 36 relative to the needle actively ensures that the source 32 remains in the desired position, as the distal end of the mandrel does not move relative to the desired position. The numbers on the face of the wheel 74, visible through the hole 17, provide the user with an indication of the number of sources 32 deployed.

[0055] Combined translation of needle and core needle It should be understood that when lock 24 is unlocked and lock 26 is locked and controller 110 is not engaged, handle connector 20 can slide freely on lever 18. Sliding causes needle 30 and core needle 36 to translate together distally or proximally.

[0056] It should be understood that the embodiments described above are illustrated by way of example, and the invention is not limited to those specifically shown and described above. Rather, the scope of the invention includes combinations and sub-combinations of the various features described above, as well as variations and modifications thereto that would occur to those skilled in the art upon reading the foregoing description and which are not disclosed in the prior art.

Claims

1. A device for controlling a needle assembly, the needle assembly having a handle coupled to a hollow needle and a core needle penetrating the hollow needle, the device comprising: Holder; A connector, slidably mounted on the retaining rod and configured to be fixedly attached to the handle, the connector having a controller, the controller: In the first position, the connector is moved proximally a predetermined distance on the retaining rod, causing the handle and the hollow pin to be moved proximally a predetermined distance relative to the connector, and the core pin to be moved distally a predetermined distance relative to the connector. In the second position, the connector is moved by the preset distance on the retaining rod, so that the handle, the hollow needle, and the core needle are moved by the preset distance.

2. The apparatus according to claim 1, wherein, The component has a static rod coupled to a sheath surrounding the hollow needle, and the device also includes another connector slidably mounted on the retaining rod and configured to be fixedly connected to the static rod.

3. The apparatus according to any one of claims 1-2, wherein, The connector includes a rack and a pinion, the pinion being connected to a gear drive that holds the core needle within the hollow needle.

4. The apparatus according to claim 3, wherein, In the first position, the rack and the pinion are engaged, and in the second position, the rack and the pinion are disengaged.

5. The device of claim 3, comprising a support housing, wherein the support is configured to slide, and wherein, The controller is configured to rotate the bracket housing to a first orientation and a second orientation, the first orientation placing the bracket in a first position and the second orientation placing the bracket in a second position.

6. The apparatus according to claim 5, wherein, The bracket housing rotates about a hinge fixed to the retaining rod.

7. A method for implanting at least one source into a patient, the method comprising: A hollow needle is provided, the hollow needle having a distal end of the needle and a lumen, the lumen being configured to receive the at least one source; Insert the core needle into the lumen; Insert the at least one source into the lumen; The hollow needle is inserted into the patient's body so that the distal end of the needle is located in a predetermined position within the patient's body; The needle is fed through the lumen to contact the proximal end of the at least one source, thereby pushing the at least one source so that the distal end of the at least one source is aligned with the distal end of the needle. and After the core needle is advanced through the lumen to contact the proximal end of the at least one source, the hollow needle is withdrawn proximally while the core needle is held in place so that the at least one source enters the patient at the predetermined location.

8. A method for controlling a needle assembly having a handle coupled to a hollow needle and a core needle penetrating the hollow needle, the method comprising: The connector is slidably mounted on the retaining rod; The connector is securely attached to the handle; and A controller having a first position and a second position is attached to the connector, wherein the controller: In the first position, the connector is moved proximally a predetermined distance on the retaining rod, causing the handle and the hollow pin to be moved proximally by the predetermined distance relative to the connector, and the core pin to be moved distally by the predetermined distance relative to the connector. In the second position, the connector is moved a given distance on the retaining rod, so that the handle, the hollow needle, and the core needle are moved by the given distance.

9. The method according to claim 8, wherein, The needle assembly has a static rod coupled to a sheath surrounding the hollow needle, and the method includes: Another connector is slidably mounted on the retaining rod; and, The other connector is fixedly connected to the static rod.

10. The method according to any one of claims 8-9, further comprising: The pinion in the rack and pinion of the connector is connected to a gear transmission device, which keeps the core needle inside the hollow needle.

11. The method according to claim 10, wherein, In the first position, the rack and the pinion are engaged, and in the second position, the rack and the pinion are disengaged.

12. The method of claim 10, the method comprising positioning a bracket within a bracket housing, wherein the bracket is configured to slide, and the method comprising configuring the controller to rotate the bracket housing to a first orientation and a second orientation, the first orientation placing the bracket in a first position and the second orientation placing the bracket in a second position.

13. The method according to claim 12, wherein, The bracket housing rotates about a hinge fixed to the retaining rod.

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