WO2018191121A1

WO2018191121A1 - Needle-orienting systems, devices, and methods thereof

Info

Publication number: WO2018191121A1
Application number: PCT/US2018/026499
Authority: WO
Inventors: Rodrigo Fernandez
Original assignee: C.R. Bard, Inc.
Priority date: 2017-04-13
Filing date: 2018-04-06
Publication date: 2018-10-18

Abstract

Provided herein is a device including, in some embodiments, a first longitudinal member, a second longitudinal member, an end piece fixed to an end of the second member configured for inserting the first member therethrough, and a slideable piece configured for inserting the second member therethrough. The end piece can include an end-piece through hole perpendicularly oriented to the second member configured for inserting the first member therethrough. The slideable piece can include a slideable-piece through hole configured for inserting the second member therethrough. The slideable piece can also include a clamping means for clamping the slideable piece in place on the second member. The slideable piece can also include a number of needle-angle through holes configured for inserting surgical needles therethrough. Each needle-angle through hole can be oriented to form a different acute angle with the second member and a complementary acute angle with the first member.

Description

NEEDLE-ORIENTING SYSTEMS, DEVICES, AND METHODS THEREOF

PRIORITY

[0001] This application claims the benefit of priority to U S Provisional Application

No. 62/485,318, filed April 13, 2017, which is incorporated by reference in its entirety into this application.

BACKGROUND

[0002] Percutaneous nephrolithotomy ("PCNL") is a minimally invasive surgical procedure primarily for removing kidney stones or other kidney obstructions from kidneys, wherein the stones or other obstructions are either too large or complex to be removed by other procedures. In a PCNL procedure, a tract to a patient's kidney is established with a needle through a patient's back guided by X-ray radiography. The tract is subsequently dilated with a dilator advanced over a guidewire in place of the needle, and a renal sheath is advanced over the dilator. Removal of the dilator leaves the renal sheath, which provides a portal for completion of the PCNL procedure. However, the PCNL procedure is not without difficulties such as correctly establishing a depth and an angle of the tract to the patient's kidney. Furthermore, the PCNL procedure is not without risks such as overexposure to X-rays. As such, the PCNL procedure and other procedures requiring needle tracts guided by X-ray radiography can benefit from reducing needle-placement errors and exposure to X-rays. Provided herein are needle-orienting systems, devices, and methods thereof that address the foregoing.

SUMMARY

[0003] Provided herein is a device including, in some embodiments, a first longitudinal member, a second longitudinal member, an end piece fixed to an end of the second member configured for inserting the first member therethrough, and a slideable piece configured for inserting the second member therethrough. The end piece can include an end-piece through hole perpendicularly oriented to the second member configured for inserting the first member therethrough. The slideable piece can include a slideable-piece through hole configured for inserting the second member therethrough. The slideable piece can also include a clamping means for clamping the slideable piece in place on the second member. The slideable piece can also include a number of needle-angle through holes configured for inserting surgical needles therethrough. Each needle-angle through hole of the number of needle-angle through holes can be oriented to form a different acute angle with the second member and a complementary acute angle with the first member.

[0004] Also provided herein is a system including, in some embodiments, a needle- orienting device and a needle-orienting coordinate system. The needle-orienting device can include a first, graduated longitudinal member for depth-based measurements; a second, non- graduated longitudinal member; an end piece fixed to an end of the second member; and a slideable piece for the second member. The end piece can include an end-piece through hole perpendicularly oriented to the second member configured for inserting the first member therethrough. The slideable piece can include a slideable-piece through hole configured for inserting the second member therethrough. The slideable piece can also include a clamping means for clamping the slideable piece in place on the second member. The slideable piece can also include a number of needle-angle through holes configured for inserting surgical needles therethrough. The number of needle-angle through holes can be oriented to form a corresponding number of different pairs of complementary acute angles in the needle-orienting device. Each different pair of complementary acute angles of the number of different pairs of complementary acute angles includes a first acute angle formed with the second member and a second acute angle formed with the first member. The needle-orienting coordinate system can include a first coordinate plane and a second coordinate plane perpendicularly oriented to the first coordinate plane. The first and second coordinate planes can include uniformly spaced longitudinal and transverse members of a sufficient radiodensity for visualization of the needle- orienting coordinate system in X-ray radiographs.

[0005] Also provided herein is a method including, in some embodiments, radiographically imaging a patient; determining a region of operative interest from X-ray radiographs; setting a depth setting on a needle-orienting device to correspond to a depth of the region of operative interest; inserting a surgical needle through the needle-orienting device; adjusting the needle to match the depth setting on the needle-orienting device; removing the needle from the needle-orienting device; placing the needle-orienting device over the region of operative interest; and inserting the needle into the patient to form a tract for a surgical procedure. Radiographically imaging the patient can include radiographically imaging the patient to produce the X-ray radiographs including a first X-ray radiograph and a second X-ray radiograph. The first X-ray radiograph can be in a coronal plane of the patient with a first coordinate plane superimposed thereon. The second X-ray radiograph can be in a sagittal plane of the patient with a second coordinate plane superimposed thereon. Determining the region of operative interest from the X-ray radiographs can include determining coronal-plane and sagittal -plane coordinates for the region of operative interest from the X-ray radiographs. Setting the depth setting on the needle-orienting device to correspond to the depth of the region of operative interest can include setting a first, graduated longitudinal member of the needle- orienting device to a depth setting corresponding to the sagittal -plane coordinates of the region of operative interest. Inserting the surgical needle through the needle-orienting device can include inserting the needle through a needle-angle through hole of a slideable piece mounted on a second longitudinal member of the needle-orienting device. Adjusting the needle to match the depth setting on the needle-orienting device can include adjusting a through-hole exit length of the needle with a needle stopper about a through -hole entrance length of the needle to match the depth setting of the first member. Removing the needle from the needle-orienting device can include removing the needle and the first member from the needle-orienting device. Removing the first member from the needle-orienting device can include removing the first member from an end-piece through hole of an end piece fixed to the second member. Placing the needle-orienting device over the region of operative interest can include placing the end- piece through hole over the coronal-plane coordinates for the region of operative interest. Inserting the needle into the patient to form the tract for the surgical procedure can include inserting the needle into the patient up to the needle stopper to form a tract for a surgical procedure.

[0006] These and other features of the concepts provided herein may be better understood with reference to the drawings, description, and appended claims.

DRAWINGS

[0007] FIG. 1 provides an image showing a needle-orienting system in accordance with some embodiments.

[0008] FIG. 2A provides a schematic illustrating a first view of a needle-orienting device in accordance with some embodiments.

[0009] FIG. 2B provides a schematic illustrating a second view of a needle-orienting device in accordance with some embodiments. [0010] FIG. 2C provides a schematic illustrating a third view of a needle-orienting device in accordance with some embodiments.

[0011] FIG. 3 provides a schematic illustrating a cross section of a slideable piece of a needle-orienting device in accordance with some embodiments.

[0012] FIG. 4 provides a schematic illustrating a needle-orienting coordinate system on a patient in accordance with some embodiments.

[0013] FIG. 5 provides a schematic illustrating an X-ray radiograph with a superimposed coordinate plane in accordance with some embodiments.

[0014] FIG. 6A provides a schematic illustrating a needle-orienting device on a patient in accordance with some embodiments.

[0015] FIG. 6B provides a schematic illustrating a needle-orienting device on a patient and a surgical needle through the needle-orienting device and in the patient in accordance with some embodiments.

DESCRIPTION

[0016] Before some particular embodiments are provided in greater detail, it should be understood that the particular embodiments provided herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment provided herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments provided herein.

[0017] Regarding terminology used herein, it should also be understood the terminology is for the purpose of describing some particular embodiments, and the terminology does not limit the scope of the concepts provided herein. Unless indicated otherwise, ordinal numbers (e.g., first, second, third, etc.) are used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, "first," "second," and "third" features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. It should also be understood that, unless indicated otherwise, any labels such as "left," "right," "front," "back," "top," "bottom," "forward," "reverse," "clockwise," "counter clockwise," "up," "down," or other similar terms such as "upper," "lower," "aft," "fore," "vertical," "horizontal," "proximal," "distal," and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. It should also be understood that the singular forms of "a," "an," and "the" include plural references unless the context clearly dictates otherwise.

[0018] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.

[0019] PCNL is a minimally invasive surgical procedure primarily for removing kidney stones or other kidney obstructions from kidneys, wherein the stones or other obstructions are either too large or complex to be removed by other procedures. In a PCNL procedure, a tract to a patient's kidney is established with a needle through a patient's back guided by X-ray radiography. The tract is subsequently dilated with a dilator advanced over a guidewire in place of the needle, and a renal sheath is advanced over the dilator. Removal of the dilator leaves the renal sheath, which provides a portal for completion of the PCNL procedure. However, the PCNL procedure is not without difficulties such as correctly establishing a depth and an angle of the tract to the patient's kidney. Furthermore, the PCNL procedure is not without risks such as overexposure to X-rays. As such, the PCNL procedure and other procedures requiring needle tracts guided by X-ray radiography can benefit from reducing needle-placement errors and exposure to X-rays. Provided herein are needle-orienting systems, devices, and methods thereof that address the foregoing.

[0020] FIG. 1 provides an image showing a needle-orienting system 100 in accordance with some embodiments. As shown, the needle-orienting system 100 can include a needle- orienting coordinate system 1 10 and a needle-orienting device 120.

[0021] The needle-orienting coordinate system 110 can include a first coordinate plane

112 and a second coordinate plane 1 14 perpendicularly oriented or orthogonal to the first coordinate plane 112. The first and second coordinate planes can include uniformly spaced longitudinal and transverse members of a sufficient radiodensity for visualization of the needle- orienting coordinate system in X-ray radiographs. The uniformly spaced longitudinal and transverse members can include a spacing common to each direction of the longitudinal and transverse directions. As shown, the needle-orienting coordinate system 1 10 configured in this way provides a rectangular or square coordinate system.

[0022] The longitudinal and transverse members of the needle-orienting coordinate system 110 can include a radiopaque material selected from a metal, a ceramic, a polymer, or a combination thereof having a sufficient radiodensity for visualization of the needle-orienting coordinate system 100 in X-ray radiographs. The combination can include a polymer with a radiopaque metal or ceramic dispersed throughout the polymer, and the polymer can be used to form the longitudinal and transverse members such as in a molding process (e.g., injection molding, compression molding, thermoforming, etc.) or coat the longitudinal and transverse members.

[0023] The needle-orienting system 100 can further include one or more needle stoppers such as needle stopper 262 of FIGS. 2A and 2C.

[0024] FIGS. 2A, 2B, and 2C provide schematics illustrating different views of the needle-orienting device 120 in accordance with some embodiments.

[0025] As shown, the needle-orienting device 120 can include a first assembly including a first longitudinal member 232, a second longitudinal member 242, an end piece 244 fixed to an end of the second member 242 configured for inserting the first member 232 therethrough, and a slideable piece 252 configured for inserting the second member 242 therethrough. The first member 232 can be graduated such as a graduated bar or rod for depth- based measurements. (See the graduated first member 232 of FIG. 2A, wherein an end portion of the first member 232 is graduated.) The second member 242 can be a non-graduated such as a non-graduated bar or rod. The end piece 244 can include an end-piece through hole perpendicularly oriented or orthogonal to the second member 242 configured for inserting the first member 232 therethrough. (See FIGS. 2A and 2C for the orthogonal orientation of the first member 232 in the end-piece through hole and the second member 242.) The slideable piece 252 can include a slideable-piece through hole configured for inserting the second member 242 therethrough. The slideable piece 252 can also include a clamping means for clamping the slideable piece 252 in place on the second member 242. The slideable piece 252 can also include a number of needle-angle through holes 254 configured for inserting surgical needles (e.g., needle N) therethrough. [0026] As shown in FIG. 2C, a central axis of the first member 232 or a first-member central axis can lie in a first plane (e.g., plane A of FIG. 2C) and a central axis of the second member 242 or a second-member central axis can lie in a second plane (e.g., plane B of FIG. 2C) different than the first plane. For example, the second plane can include at least one plane that does not intersect with the first plane. Such a plane as the at least one plane can be parallel with the first plane. In addition, the first-member central axis and central axes of the number of needle-angle through holes 254 can lie in a first plane (e.g., plane A of FIG. 2C), and the second-member central axis can lie in a second plane (e.g., plane B of FIG. 2C) different than the first plane. Again, the second plane can include at least one plane that does not intersect with the first plane. Such a plane as the at least one plane can be parallel with the first plane.

[0027] While the foregoing describes geometric relationships in the first assembly of the needle-orienting device 120, it should be understood that the foregoing also describes geometric relationships in a second assembly of the needle-orienting device 120 in which the first member 232 is removed from the first assembly. (See FIGS. 6A and 6B for an example of the second assembly of the needle-orienting device 120.) As such, a central axis of the end- piece through hole perpendicularly oriented to the second member 242 can lie in the first plane and the second-member central axis can lie in the second, different plane. In addition, the central axis of the end-piece through hole and the central axes of the number of needle-angle through holes 254 can lie in the first plane, and the second-member central axis can lie in the second, different plane.

[0028] The first member 232 of the first assembly of the needle-orienting device 120 can be graduated such as a graduated bar or rod for depth-based measurements. (See the graduated first member 232 of FIG. 2A, wherein an end portion of the first member 232 is graduated.) The first member 232 can be graduated in multiple units, submultiple units, or a combination of multiple and submultiple units corresponding to the spacing of the uniformly spaced longitudinal and transverse members of the needle-orienting coordinate system 110. For example, the spacing of the uniformly spaced longitudinal and transverse members can be in metric units such as centimeters, and the multiple units of the first member 232 can be, for example, centimeters (e.g., if the multiplier is unity), decimeters, etc., and the submultiple units of the first member 232 can be, for example, millimeters, micrometers, etc. Analogously, the spacing of the uniformly spaced longitudinal and transverse members can be in U.S. customary units such as inches, and the multiple units of the first member 232 can be, for example, inches (e.g., if the multiplier is unity), and the submultiple units of the first member 232 can be, for example, half inches, quarter inches, etc.

[0029] Depth-based measurements with the first member 232 of the needle-orienting device 120 can be controlled with a stopping means for stopping the first member 232 at a desired through-hole exit length when inserting the first member 232 through the end-piece through hole. As shown in FIGS. 2A and 2B, the stopping means can include a holed stopper 234 about a through-hole entrance length of the first member.

[0030] The second assembly of the needle-orienting device 120 is the first assembly of the needle-orienting device 120 without the first member 232. As such, the needle-orienting device 120 can include a second assembly including the second member 242, the end piece 244 fixed to a distal end of the second member 242 configured with the end-piece through hole for inserting the first member 232 therethrough, and the slideable piece 252 configured with the slideable-piece through hole for inserting the second member 242 therethrough. (See FIGS. 6A and 6B for an example of the second assembly of the needle-orienting device 120.)

[0031] The slideable piece 252 can be slideably mounted on the second member 242 such that the slideable piece can slide from a proximal end of the second member 242 to the opposite, distal end of the second member 242 including the fixed end piece 244. The slideable piece 252 can include a clamping means for clamping the slideable piece 252 in place on the second member 242. The clamping means can include a clamping screw 256 (e.g., a tommy bar screw) disposed in a clamping-screw through hole of the slideable piece 252. FIGS. 2A and 2B show two different configurations for the clamping screw 256 disposed in the clamping- screw through hole, a first configuration of which is in a top of the slideable piece 252 (see FIG. 2A), and a second configuration of which is in a side of the slideable piece 252 (see FIG. 2B). The second configuration can reduce crowding of components on the top side of the slideable piece 252 in some embodiments of the needle-orienting device 120. The clamping means can also include a clamping lever with an eccentric cam and a threaded stud disposed in a clamping-lever through hole of the slideable piece 252.

[0032] FIG. 3 provides a schematic illustrating a cross section of the slideable piece

252 of the needle-orienting device 100 in accordance with some embodiments.

[0033] As shown, the slideable piece 252 can include a number of needle-angle through holes 254 configured for inserting surgical needles (e.g., needle N of FIGS. 2A and 2C) therethrough. The number of needle-angle through holes 254 can include, but are not limited to, a first needle-angle through hole 254a oriented to form a 30° angle with the second member 242, a second needle-angle through hole 254b oriented to form a 45° angle with the second member 242, and a third needle-angle through hole 254c oriented to form a 60° angle with the second member 242. Any two or more of the number of needle-angle through holes 254 can intersect in a portion of the slideable piece 252. As shown in FIG. 3, the first needle-angle through hole 254a, the second needle-angle through hole 254b, and the third needle-angle through hole 254c intersect in a middle portion of the slideable piece 252.

[0034] Referring to FIG. 2A, each needle-angle through hole of the number of needle- angle through holes 254 can be oriented to form a different acute angle (e.g., zA in FIG. 2A) with the second member 242 and a complementary acute angle (e.g., zB in FIG. 2A) with the first member 232. In other words, the number of needle-angle through holes 254 can be oriented to form a corresponding number of different pairs of complementary acute angles (e.g., zA and zB in FIG. 2A) in the needle-orienting device 120. Each different pair of complementary acute angles of the number of different pairs of complementary acute angles includes a first acute angle (e g , ZA in FIG. 2A) formed with the second member 242 and a second acute angle (e.g., ZB in FIG. 2A) formed with the first member 232.

[0035] Again, the needle-orienting system 100 can include one or more needle stoppers such as the needle stopper 262 configured for stopping a surgical needle Nat a desired through- hole exit length upon insertion of the needle N through any of the number of needle-angle through holes 254. The needle stopper 262 can be configured for placement about a through- hole entrance length of the needle N.

[0036] FIGS. 4, 5, 6A, and 6B provide schematics illustrating various aspects of a method of the needle-orienting system 100 for orienting and inserting a surgical needle N into a patient to form a tract for a surgical procedure in accordance with some embodiments. FIG. 4 provides a schematic illustrating the needle-orienting coordinate system 110 on the patient in accordance with some embodiments. FIG. 5 provides a schematic illustrating an X-ray radiograph 500 with a superimposed coordinate plane (e.g., the second coordinate plane 114) in accordance with some embodiments. FIG. 6A provides a schematic illustrating the second assembly of the needle-orienting device 120 on the patient in accordance with some embodiments. FIG. 6B provides a schematic illustrating the second assembly of the needle- orienting device 120 on the patient and the needle N through the needle-orienting device 120 and in the patient in accordance with some embodiments.

[0037] As shown, the method can include radiographically imaging the patient; determining a region of operative interest from X-ray radiographs; setting a depth setting on the needle-orienting device 120 to correspond to a depth of the region of operative interest; inserting the surgical needle N through the needle-orienting device 120; adjusting the needle N to match the depth setting on the needle-orienting device 120; removing the needle Nfrom the needle-orienting device 120; placing the needle-orienting device 120 over the region of operative interest; and inserting the needle N into the patient to form the tract for the surgical procedure (e.g., PC L).

[0038] Prior to radiographically imaging the patient, the method can further include positioning the needle-orienting coordinate system 110 including the first coordinate plane 1 12 and the second coordinate plane 114 on the patient. (See FIG. 4.) Again, the first coordinate plane 1 12 and the second coordinate plane 1 14 can include uniformly spaced longitudinal and transverse members of a sufficient radiodensity for visualization of the needle-orienting coordinate system in the X-ray radiographs.

[0039] Radiographically imaging the patient can include radiographically imaging the patient to produce the X-ray radiographs including a first X-ray radiograph and a second X-ray radiograph. The first X-ray radiograph can be in a coronal plane of the patient with the first coordinate plane 1 12 superimposed thereon. (See FIG. 4 for the first coordinate plane 112 for superimposition in the coronal plane of the patient in the first X-ray radiograph.) The second X-ray radiograph can be in a sagittal plane of the patient with the second coordinate plane 1 14 superimposed thereon. (See FIG. 4 for the second coordinate plane 114 for superimposition in the sagittal plane of the patient in the second X-ray radiograph.) FIG. 5 provides a schematic illustrating the X-ray radiograph 500 corresponding to the second X-ray radiograph in the sagittal plane of the patient with the second coordinate plane 1 14 superimposed thereon.

[0040] Determining the region of operative interest from the X-ray radiographs can include determining coronal-plane and sagittal -plane coordinates for the region of operative interest from the X-ray radiographs. For example, the region of operative interest can be a kidney or a kidney stone or another kidney obstruction in the kidney of the patient. (See FIG. 5 for the sagittal -plane coordinates for a kidney stone S.) [0041] Setting the depth setting on the needle-orienting device 120 to correspond to the depth of the region of operative interest can include setting the first member 232 of the needle- orienting device 120 to a depth setting corresponding to the sagittal -plane coordinates of the region of operative interest.

[0042] Inserting the surgical needle N through the needle-orienting device 120 can include inserting the needle N through a needle-angle through hole (e.g., the first needle-angle through hole 254a, the second needle-angle through hole 254b, the third needle-angle through hole 254c, etc.) of the slideable piece 252 mounted on the second member 242 of the needle- orienting device 120.

[0043] Adjusting the needle Nto match the depth setting on the needle-orienting device

120 can include adjusting a through-hole exit length of the needleNwith a needle stopper (e.g., the needle stopper 262) about a through-hole entrance length of the needle Nto match the depth setting of the first member 232 (e.g., 2.5" as in FIG. 6B). Adjusting the through-hole exit length of the needle N to match the depth setting of the first member 232 can include sliding the slideable piece 252 toward or away from the first member 232 until a tip of the needle N nearly touches or touches a bottom of the first member 232. Subsequent to sliding the slideable piece 252 until the tip of the needle N nearly touches or touches the bottom of the first member 232, the method can further include clamping the slideable piece 252 in place on the second member 242 to lock the slideable piece 252 in position on the second member 242.

[0044] Removing the needle from the needle-orienting device can include removing the needle N and the first member 232 from the needle-orienting device 120.

[0045] Removing the first member 232 from the needle-orienting device 120 can include removing the first member 232 from the end-piece through hole of the end piece 244 fixed to the second member 242. Removing the first member 232 from the needle-orienting device 120 provides the second assembly of the needle-orienting device 120 shown in FIGS. 6 A and 6B.

[0046] Placing the needle-orienting device 120 over the region of operative interest can include placing the end-piece through hole of the end piece 244 over the coronal-plane coordinates for the region of operative interest. A mark M in FIGS. 6A and 6B indicates a mark made on the patient at the coronal-plane coordinates for the region of operative interest as determined from the first X-ray radiograph. [0047] Inserting the needle Ninto the patient to form the tract for the surgical procedure can include inserting the needle Ninto the patient up to the needle stopper 262 to form the tract for the surgical procedure (e.g., PCNL).

[0048] Subsequent to inserting the needle N into the patient to form the tract, the method can further include removing the needle stopper 262 about the through-hole entrance length of the needle N and removing the needle-orienting device 120 leaving the needle N in place in the tract. If the surgical procedure is PCNL, the tract can be subsequently dilated with a dilator advanced over a guidewire in place of the needle N, and a renal sheath can be advanced over the dilator. Removal of the dilator leaves the renal sheath, which provides a portal for completion of the PCNL procedure.

[0049] As such, provided herein is a device including, in some embodiments, a first longitudinal member, a second longitudinal member, an end piece fixed to an end of the second member configured for inserting the first member therethrough, and a slideable piece configured for inserting the second member therethrough. The end piece can include an end- piece through hole perpendicularly oriented to the second member configured for inserting the first member therethrough. The slideable piece can include a slideable-piece through hole configured for inserting the second member therethrough. The slideable piece can also include a clamping means for clamping the slideable piece in place on the second member. The slideable piece can also include a number of needle-angle through holes configured for inserting surgical needles therethrough. Each needle-angle through hole of the number of needle-angle through holes can be oriented to form a different acute angle with the second member and a complementary acute angle with the first member.

[0050] In such embodiments, a first-member central axis can lie in a first plane and a second-member central axis can lie in a second plane different than the first plane.

[0051] In such embodiments, a first-member central axis and central axes of the number of needle-angle through holes can lie in first plane, and a second-member central axis can lie in a second plane different than the first plane.

[0052] In such embodiments, the number of needle-angle through holes can intersect.

[0053] In such embodiments, the number of needle-angle through holes can include a first needle-angle through hole oriented to form a 30° angle with the second member, a second needle-angle through hole oriented to form a 45° angle with the second member, and a third needle-angle through hole oriented to form a 60° angle with the second member.

[0054] In such embodiments, the clamping means can include a clamping screw disposed in a clamping-screw through hole of the slideable piece. The clamping means can also include a clamping lever with a threaded stud disposed in a clamping-lever through hole of the slideable piece.

[0055] In such embodiments, the device can also include a stopping means for stopping the first member at a desired through-hole exit length when inserting the first member through the end-piece through hole. The stopping means can include a holed stopper about a through- hole entrance length of the first member.

[0056] Also provided herein is a system including, in some embodiments, a needle- orienting device and a needle-orienting coordinate system. The needle-orienting device can include a first, graduated longitudinal member for depth-based measurements; a second, non- graduated longitudinal member; an end piece fixed to an end of the second member; and a slideable piece for the second member. The end piece can include an end-piece through hole perpendicularly oriented to the second member configured for inserting the first member therethrough. The slideable piece can include a slideable-piece through hole configured for inserting the second member therethrough. The slideable piece can also include a clamping means for clamping the slideable piece in place on the second member. The slideable piece can also include a number of needle-angle through holes configured for inserting surgical needles therethrough. The number of needle-angle through holes can be oriented to form a corresponding number of different pairs of complementary acute angles in the needle-orienting device. Each different pair of complementary acute angles of the number of different pairs of complementary acute angles includes a first acute angle formed with the second member and a second acute angle formed with the first member. The needle-orienting coordinate system can include a first coordinate plane and a second coordinate plane perpendicularly oriented to the first coordinate plane. The first and second coordinate planes can include uniformly spaced longitudinal and transverse members of a sufficient radiodensity for visualization of the needle- orienting coordinate system in X-ray radiographs. [0057] In such embodiments, the first member can be graduated in multiple units, submultiple units, or a combination of multiple and submultiple units corresponding to spacing of the uniformly spaced longitudinal and transverse members.

[0058] In such embodiments, the longitudinal and transverse members can include a radiopaque material selected from a metal, a ceramic, a polymer, or a combination thereof having the sufficient radiodensity for visualization of the needle-orienting coordinate system in X-ray radiographs.

[0059] In such embodiments, a first-member central axis and central axes of the number of needle-angle through holes can lie in first plane, and a second-member central axis can lie in a second plane different than the first plane.

[0060] In such embodiments, the clamping means can include a clamping screw disposed in a clamping-screw through hole of the slideable piece.

[0061] In such embodiments, the system can further include a needle stopper configured for stopping a needle at a desired through-hole exit length upon insertion of the needle through any of the number of needle-angle through holes. The needle stopper can be configured for placement about a through-hole entrance length of the needle.

[0062] Also provided herein is a method including, in some embodiments, radiographically imaging a patient; determining a region of operative interest from X-ray radiographs; setting a depth setting on a needle-orienting device to correspond to a depth of the region of operative interest; inserting a surgical needle through the needle-orienting device; adjusting the needle to match the depth setting on the needle-orienting device; removing the needle from the needle-orienting device; placing the needle-orienting device over the region of operative interest; and inserting the needle into the patient to form a tract for a surgical procedure. Radiographically imaging the patient can include radiographically imaging the patient to produce the X-ray radiographs including a first X-ray radiograph and a second X-ray radiograph. The first X-ray radiograph can be in a coronal plane of the patient with a first coordinate plane superimposed thereon. The second X-ray radiograph can be in a sagittal plane of the patient with a second coordinate plane superimposed thereon.

[0063] Determining the region of operative interest from the X-ray radiographs can include determining coronal-plane and sagittal -plane coordinates for the region of operative interest from the X-ray radiographs. Setting the depth setting on the needle-orienting device to correspond to the depth of the region of operative interest can include setting a first, graduated longitudinal member of the needle-orienting device to a depth setting corresponding to the sagittal-plane coordinates of the region of operative interest. Inserting the surgical needle through the needle-orienting device can include inserting the needle through a needle-angle through hole of a slideable piece mounted on a second longitudinal member of the needle- orienting device. Adjusting the needle to match the depth setting on the needle-orienting device can include adjusting a through-hole exit length of the needle with a needle stopper about a through-hole entrance length of the needle to match the depth setting of the first member. Removing the needle from the needle-orienting device can include removing the needle and the first member from the needle-orienting device. Removing the first member from the needle-orienting device can include removing the first member from an end-piece through hole of an end piece fixed to the second member. Placing the needle-orienting device over the region of operative interest can include placing the end-piece through hole over the coronal- plane coordinates for the region of operative interest. Inserting the needle into the patient to form the tract for the surgical procedure can include inserting the needle into the patient up to the needle stopper to form a tract for a surgical procedure.

[0064] In such embodiments, the method can further include positioning a needle- orienting coordinate system including the first coordinate plane and the second coordinate plane on the patient. The first and second coordinate planes can include uniformly spaced longitudinal and transverse members of a sufficient radiodensity for visualization of the needle- orienting coordinate system in the X-ray radiographs.

[0065] In such embodiments, adjusting the through-hole exit length of the needle to match the depth setting of the first member includes sliding the slideable piece toward or away from the first member until a tip of the needle nearly touches or touches a bottom of the first member.

[0066] In such embodiments, the method can further include clamping the slideable piece in place on the second member to lock the slideable piece in position on the second member. [0067] In such embodiments, the method can further include removing the needle stopper about the through-hole entrance length of the needle and removing the needle-orienting device leaving the needle in place in the tract.

[0068] In such embodiments, the region of operative interest can be a kidney stone or another kidney obstruction in a kidney of the patient, and the surgical procedure can be percutaneous nephrolithotomy. Inserting the needle into the patient to form the tract for the percutaneous nephrolithotomy can include inserting the needle into a back of the patient up to the needle stopper.

[0069] While some particular embodiments have been provided herein, and while the particular embodiments have been provided in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts presented herein. Additional adaptations and/or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and/or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments provided herein without departing from the scope of the concepts provided herein.

Claims

CLAIMS What is claimed is:

1. A device, comprising:

a first longitudinal member;

a second longitudinal member;

an end piece fixed to an end of the second member including an end-piece through hole perpendicularly oriented to the second member configured for inserting the first member therethrough; and

a slideable piece including:

a slideable-piece through hole configured for inserting the second member therethrough,

a clamping means for clamping the slideable piece in place on the second member, and

a number of needle-angle through holes configured for inserting surgical needles therethrough,

wherein each needle-angle through hole of the number of needle-angle through holes is oriented to form a different acute angle with the second member and a complementary acute angle with the first member.

2. The device of claim 1, wherein a first-member central axis lies in a first plane and a second-member central axis lies in a second plane different than the first plane.

3. The device of claim 1, wherein:

a first-member central axis and central axes of the number of needle-angle through holes lie in first plane, and

a second-member central axis lies in a second plane different than the first plane.

4. The device of any claim of claims 1-3, wherein the number of needle-angle through holes intersect.

5. The device of any claim of claims 1-4, wherein the number of needle-angle through holes includes a first needle-angle through hole oriented to form a 30° angle with the second member, a second needle-angle through hole oriented to form a 45° angle with the second member, and a third needle-angle through hole oriented to form a 60° angle with the second member.

6. The device of any claim of claims 1-5, wherein the clamping means includes: a clamping screw disposed in a clamping-screw through hole of the slideable piece, or a clamping lever with a threaded stud disposed in a clamping-lever through hole of the slideable piece.

7. The device of any claim of claims 1-6, further comprising a stopping means for stopping the first member at a desired through-hole exit length when inserting the first member through the end-piece through hole.

8. The device of claim 7, wherein the stopping means includes a holed stopper about a through-hole entrance length of the first member.

9. A system, comprising:

a) a needle-orienting device including:

a first, graduated longitudinal member for depth-based measurements; a second, non-graduated longitudinal member;

a slideable piece including:

a slideable-piece through hole configured for inserting the second member therethrough;

a clamping means for clamping the slideable piece in place on the second member; and

a number of needle-angle through holes configured for inserting surgical needles therethrough oriented to form a corresponding number of different pairs of complementary acute angles in the needle-orienting device, wherein each different pair of complementary acute angles of the number of different pairs of complementary acute angles includes a first acute angle formed with the second member and a second acute angle formed with the first member; and

b) a needle-orienting coordinate system, including: a first coordinate plane; and

a second coordinate plane perpendicularly oriented to the first coordinate plane, wherein the first and second coordinate planes include uniformly spaced longitudinal and transverse members of a sufficient radiodensity for visualization of the needle-orienting coordinate system in X-ray radiographs.

10. The system of claim 9, wherein the first member is graduated in multiple units, submultiple units, or a combination of multiple and submultiple units corresponding to spacing of the uniformly spaced longitudinal and transverse members.

11. The system of either claim 9 or claim 10, wherein the longitudinal and transverse members include a radiopaque material selected from a metal, a ceramic, a polymer, or a combination thereof having the sufficient radiodensity for visualization of the needle- orienting coordinate system in X-ray radiographs.

12. The system of any claim of claims 9-11, wherein:

13. The system of any claim of claims 9-12, wherein the clamping means includes a clamping screw disposed in a clamping-screw through hole of the slideable piece.

14. The system of any claim of claims 9-13, further comprising:

c) a needle stopper configured for stopping a needle at a desired through-hole exit length upon insertion of the needle through any of the number of needle-angle through holes, wherein the needle stopper is configured for placement about a through-hole entrance length of the needle.

15. A method, comprising:

radiographically imaging a patient to produce X-ray radiographs, including:

a first X-ray radiograph in a coronal plane of a patient with a first coordinate plane superimposed thereon; and

a second X-ray radiograph in a sagittal plane of the patient with a second coordinate plane superimposed thereon; determining coronal-plane and sagittal-plane coordinates for a region of operative interest from the X-ray radiographs;

setting a first, graduated longitudinal member of a needle-orienting device to a depth setting corresponding to the sagittal-plane coordinates of the region of operative interest;

inserting a surgical needle through a needle-angle through hole of a slideable piece mounted on a second longitudinal member of the needle-orienting device; adjusting a through-hole exit length of the needle with a needle stopper about a through- hole entrance length of the needle to match the depth setting of the first member; removing the needle and the first member from the needle-orienting device,

wherein removing the first member from the needle-orienting device includes removing the first member from an end-piece through hole of an end piece fixed to the second member;

placing the end-piece through hole over the coronal-plane coordinates for the region of operative interest; and

inserting the needle into the patient up to the needle stopper to form a tract for a surgical procedure.

16. The method of claim 15, further comprising positioning a needle-orienting coordinate system including the first coordinate plane and the second coordinate plane on the patient, wherein the first and second coordinate planes include uniformly spaced longitudinal and transverse members of a sufficient radiodensity for visualization of the needle-orienting coordinate system in the X-ray radiographs.

17. The method of either claim 15 or claim 16, wherein adjusting the through-hole exit length of the needle to match the depth setting of the first member includes sliding the slideable piece toward or away from the first member until a tip of the needle nearly touches or touches a bottom of the first member.

18. The method of claim 17, further comprising clamping the slideable piece in place on the second member to lock the slideable piece in position on the second member.

19. The method of any claim of claims 15-18, further comprising:

removing the needle stopper about the through-hole entrance length of the needle; and removing the needle-orienting device leaving the needle in place in the tract.

20. The method of any claim of claims 15-19, wherein:

the region of operative interest is a kidney stone or another kidney obstruction in a kidney of the patient, and

the surgical procedure is percutaneous nephrolithotomy.