Device and method for guiding an instrument

Abstract

An instrument holder and method for aligning an instrument for use with an internal target in a subject, comprising a first layer; a second layer; and an instrument guide having an inlet point and an outlet point, the instrument guide being connected between the two layers and configured to guide the instrument from the inlet point to the outlet point, wherein the instrument holder is transparent to an imaging system, except that the first and second layers include markings visible to the imaging system.

Description

Technical Field

[0001] The present disclosure relates broadly to devices and methods for guiding the insertion of an instrument into a subject. Background Art

[0002] With the use of current technology, it is expected that minimally invasive techniques / surgery will enter the various parts of the subject. For example, percutaneous access to tissue, such as inserting a tool into the subject and removing tissue or performing any type of minimally invasive surgery. Some processes usually use a hollow needle to pierce the subject's skin, and insert the needle into the subject in a substantially accurate manner to collide with the target. In some processes, a guide wire is inserted through the hollow needle, and the wire guides the insertion of an endoscopic surgical instrument that can break and remove tissue. Similarly, other types of processes may need to insert a tool into the subject. Such processes may include biopsy, consultation, vertebroplasty, discectomy, and other acupuncture or tool puncture and intervention. Typically, imaging systems (e.g., X-rays, ultrasound, computed tomography (CT) scanning, magnetic resonance imaging (MRI)) are used to assist the above-mentioned technology. For example, some processes usually use C-arm perspectives to locate the target throughout the process.

[0003] Although it is recognized that minimally invasive techniques have benefits such as less trauma, less pain, less scarring, less risk of infection, and faster recovery compared to open incisions, it is also recognized that such minimally invasive techniques are often difficult to implement. Currently, the insertion process of a tool into a subject's body depends largely on the surgeon's experience in manipulating and aligning the tool. It should be understood that the tedious and time-consuming part of the manual process is the alignment and manipulation of the tool or needle.

[0004] Furthermore, during the use of minimally invasive techniques, prolonged procedure times generally increase the risk of perioperative complications for the subject. Furthermore, prolonged procedure times generally increase the health risks for the surgical staff due to exposure to radioactive imaging. Furthermore, it should be understood that prolonged procedure times place a burden on the hospital given that operating rooms are generally in constant demand.

[0005] Given the challenges faced by existing technologies such as those described above, robotic systems are being developed to facilitate or assist such procedures. For example, a number of automated robotic systems are currently being developed that are aided by image guidance systems and motorized needle insertion drivers. Robotic systems also encounter some of the limitations that current practitioners face when introducing instruments into a subject's body.

[0006] The current applicant's U.S. Patent Publication No. 2016 / 0206383, published on July 21, 2016 (the disclosure of which is incorporated herein by reference), describes systems and devices for guiding instruments.

[0007] It would be desirable to provide improved devices and methods for introducing instruments into a subject's body in view of current systems used by practitioners. Summary of the invention

[0008] One aspect of an embodiment of the present disclosure relates to an instrument holder for performing a procedure for aligning an instrument (e.g., a needle, a hollow needle, a tool, a wire) for accessing a target (e.g., a tumor, a kidney stone, an abscess, or other item) within a subject. The instrument holder can be any device that holds an instrument.

[0009] The instrument holder is configured to be supported by a rigid arm or an articulated arm and positioned so that the instrument can be inserted into the subject to hit a target.

[0010] The instrument support includes a first layer having an entry point for inserting the instrument and a second layer having an exit point for the instrument to exit from the support. The entry point and the exit point may both be located in the second layer.

[0011] The instrument includes a guide channel to guide the instrument to be connected between the entry point and the exit point.

[0012] The process is performed with the aid of an imaging system (e.g., C-arm, ultrasound, CT scan, MRI) that continuously displays the instrument and the target on a display. Alternatively, the imaging system (e.g., an X-ray machine) can display snapshots of the instrument and the target on a display. The first and second layers of the instrument support are provided with markings that can be seen on the display of the imaging system during the process. The markings can cover the entire layer. When aligned so that the instrument will collide with the target when inserted into the subject, the markings on the first layer are designed to form a predefined pattern with the markings on the second layer. Alternatively, the instrument inserted into the second layer can act as a marking on the second layer to align with the markings on the first layer.

[0013] The present disclosure may be applied to any method for referencing the position of an instrument to be used in conjunction with a medical imaging device.

[0014] Therefore, according to an exemplary embodiment of the present disclosure, there is provided an instrument support for aligning an instrument for entering a target within a subject, the instrument support comprising: a first layer; a second layer; an instrument guide having an entry point and an exit point, the instrument guide being connected between the first layer and the second layer and being configured to guide the instrument from the entry point to the exit point; wherein the first layer and the second layer comprise a first layer of markings and a second layer of markings visible to an imaging system; and wherein, when the first layer and the second layer are aligned so that the instrument will collide with the target, as seen on a display of the imaging system, the first layer of markings is designed to form a predefined pattern with the second layer of markings relative to the target.

[0015] In an exemplary embodiment of the present disclosure, the first layer of markings includes a first geometric shape, and the second layer of markings includes a second geometric shape different from the first geometric shape. Optionally, the first geometric shape includes a line, and the second geometric shape includes one or more pairs of arrows or arrowheads, and in the predefined pattern, the one or more pairs of arrows or arrowheads point to the line, which is located between the one or more pairs of arrows or arrowheads. Optionally, in the predefined pattern, there is a gap between the one or more pairs of arrows or arrowheads and the line. Alternatively, the first geometric shape includes a line representing a linear scale of a unit of measurement, and the second geometric shape includes a line, and in the predefined pattern, the line of the second geometric shape is aligned with the center line of the first geometric shape. Alternatively, the first geometric shape includes one or more pairs of arrows or arrowheads, and the second geometric shape includes two cross-shaped lines centered on the exit point, and in the predefined pattern, the one or more pairs of arrows or arrowheads point to the line of the second geometric shape, so that each line is located between the one or more pairs of arrows or arrowheads. Optionally, in the predefined pattern, there is a gap between the one or more pairs of arrows or arrowheads and the lines of the second geometric shape. Alternatively, the first geometric shape includes two or more groups of lines representing a linear scale of measurement units, and the second geometric shape includes two cross-shaped lines centered on the exit point, and in the predefined pattern, each line of the second geometric shape is aligned with the center line of each group of lines representing the linear scale of measurement units. Alternatively, the first layer of markings includes a cross centered on the entry point, and the second layer of markings includes a cross centered on the exit point, and in the predefined pattern, the crosses of the first layer of markings and the crosses of the second layer of markings coincide. Optionally, the instrument support also includes a protrusion extending from the second layer.

[0016] In an exemplary embodiment of the present disclosure, the instrument is a hollow needle. Alternatively, the instrument is an elongated tool. In an exemplary embodiment of the present disclosure, the instrument support includes a handle for assembling a positioning arm. Optionally, the handle is configured to enable the instrument support to rotate relative to the positioning arm. In an exemplary embodiment of the present disclosure, the first layer or the second layer includes an additional mark that is not part of the predefined pattern to identify the first layer or the second layer by a user during alignment. Optionally, the target is percutaneously positioned. In an exemplary embodiment of the present disclosure, the instrument support is transparent to the imaging system. Optionally, the instrument guide is perpendicular to the first layer and the second layer. In an exemplary embodiment of the present disclosure, the instrument guide forms a preselected angle with the first layer and the second layer.

[0017] According to an exemplary embodiment of the present disclosure, there is also provided a method for aligning an instrument with a target within a subject, the method comprising: providing an instrument support as described above on a positioning arm; positioning an imaging system to display the target and the instrument support on a display; and aligning the instrument support so that the first layer of markings and the second layer of markings form a predefined pattern on the display of the imaging system relative to the target.

[0018] In an exemplary embodiment of the present disclosure, the instrument is aligned to percutaneously access the target within the subject. Optionally, the positioning arm is an articulated arm positioned above the subject.

[0019] According to an exemplary embodiment of the present disclosure, there is also provided an instrument support for aligning an instrument for entering a target in a subject, the instrument support comprising: a first layer; a second layer, the second layer being connected to the first layer by a column; an instrument guide having an entry point and an exit point, the instrument guide being located within the second layer and configured to guide the instrument from the entry point to the exit point; wherein the first layer comprises markings forming a first layer of markings visible to an imaging system; and wherein, when the first layer and the second layer are aligned so that the instrument will collide with the target, as seen on a display of the imaging system, the first layer of markings is designed to form a predefined pattern with the instrument visible to the imaging system within the second layer relative to the target.

[0020] In an exemplary embodiment of the present disclosure, the first layer of markings includes a first geometric shape. Optionally, the first geometric shape includes a line representing a linear scale of a unit of measure, and in the predefined pattern, the instrument is aligned with the centerline of the first geometric shape. Alternatively, the first geometric shape includes one or more pairs of arrows or arrowheads, and in the predefined pattern, the one or more pairs of arrows or arrowheads point to the instrument, which is located between the one or more pairs of arrows or arrowheads. Optionally, in the predefined pattern, there is a gap between the one or more pairs of arrows or arrowheads and the instrument. Optionally, the instrument support also includes a protrusion extending from the second layer.

[0021] In an exemplary embodiment of the present disclosure, the instrument is a hollow needle. Alternatively, the instrument is an elongated tool. In an exemplary embodiment of the present disclosure, the instrument support includes a handle for assembling a positioning arm. Optionally, the handle is configured to enable the instrument support to rotate relative to the positioning arm. In an exemplary embodiment of the present disclosure, the first layer or the second layer includes an additional mark that is not part of the predefined pattern to identify the first layer or the second layer by a user during alignment. Optionally, the target is percutaneously positioned. In an exemplary embodiment of the present disclosure, the instrument support is transparent to the imaging system.

[0022] According to an exemplary embodiment of the present disclosure, there is also provided a method for aligning an instrument with a target within a subject, the method comprising: providing an instrument holder as described above on a positioning arm; inserting the instrument into the instrument holder; positioning an imaging system to display the target, the instrument holder and the instrument on a display; and aligning the instrument holder so that the first layer of markings and the instrument form a predefined pattern on the display of the imaging system relative to the target.

[0023] In an exemplary embodiment of the present disclosure, the instrument is aligned to percutaneously access the target within the subject. Optionally, the positioning arm is an articulated arm positioned above the subject. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The present disclosure will be understood and better appreciated through the following detailed description in conjunction with the accompanying drawings. The same structures, elements or components appearing in more than one figure are generally labeled with the same or similar numerals in all the figures in which they appear, wherein:

[0025] Figure 1A is a bottom perspective view of an instrument support according to an exemplary embodiment of the present disclosure;

[0026] Figure 1Bis a top perspective view of an instrument support according to an exemplary embodiment of the present disclosure;

[0027] Figure 2A is a bottom perspective view of a first alternative instrument support according to an exemplary embodiment of the present disclosure;

[0028] Figure 2B is a top perspective view of a first alternative instrument support according to an exemplary embodiment of the present disclosure;

[0029] Figure 2C is a top view of a first alternative instrument support according to an exemplary embodiment of the present disclosure;

[0030] Figure 3A is a side perspective view of a second alternative instrument support according to an exemplary embodiment of the present disclosure;

[0031] Figure 3B is a bottom view of a second alternative instrument support according to an exemplary embodiment of the present disclosure;

[0032] FIG. 3C to FIG. 3D is a diagram of a first example of markings on a second alternative instrument support according to an exemplary embodiment of the present disclosure, and Figure 3E is an illustration of a predefined pattern formed by exemplary markings on a second alternative instrument support;

[0033] Figure 3F to Figure 3G is a diagram of a second other example of markings on a second alternative instrument support according to an exemplary embodiment of the present disclosure, and Figure 3H is an illustration of a predefined pattern formed by exemplary markings on a second alternative instrument support;

[0034] Figure 4A is a bottom perspective view of a third alternative instrument support according to an exemplary embodiment of the present disclosure;

[0035] Figure 4B is a top perspective view of a third alternative instrument support according to an exemplary embodiment of the present disclosure;

[0036] Figure 4C is a top view of a third alternative instrument support according to an exemplary embodiment of the present disclosure;

[0037] FIG. 5A to FIG. 5G is a schematic diagram of a process of aligning an instrument support according to an exemplary embodiment of the present disclosure;

[0038] 6A to 6F is a schematic diagram of a first alternative process for aligning an instrument support according to another exemplary embodiment of the present disclosure; and

[0039] 7A to 7D is a schematic diagram of a second alternative process for aligning an instrument support according to an exemplary embodiment of the present disclosure.

[0040] Now with specific reference to the drawings in detail, it should be emphasized that the details shown are by way of example and for the purpose of illustrative discussion of the embodiments of the present disclosure. In this regard, the description with respect to the drawings makes it easy for those skilled in the art to understand how the embodiments of the present disclosure can be practiced.

[0041] Identical or repeated or equivalent or similar structures, elements or components appearing in one or more of the drawings are generally labeled with the same reference numerals, optionally with one or more additional letters to distinguish similar entities or variations of entities, and may not be repeatedly labeled and / or described. Reference to previously presented elements is implicit without further reference to the drawings or descriptions in which they appear.

[0042] The dimensions of the components and features shown in the figures are selected for convenience or clarity of expression and are not necessarily shown in scale or true perspective. For convenience or clarity, some elements or structures are not shown or are only partially and / or shown in different perspectives or from different viewpoints. DETAILED DESCRIPTION

[0043] Figure 1A is a bottom perspective view of an instrument support 100 according to an exemplary embodiment of the present disclosure, and Figure 1B 1 is a top perspective view of an instrument holder 100. The instrument holder 100 is used to hold an instrument 310 (e.g., Figure 3A and FIG. 4A to FIG. 4C In an exemplary embodiment of the present disclosure, the positioning arm 510 (e.g., FIG. 5A to FIG. 5G , 6A to 6F and 7A to 7D The instrument support 100 is supported by a rigid arm or an articulated arm (as shown) and is used to lock the instrument support 100 in a specific position and orientation above the subject so that the instrument 310 (e.g., a hollow needle or other type of probe) can be inserted into the instrument support and accurately guided into the subject. Optionally, the instrument support 100 includes a handle 135 to assemble the positioning arm 510. The handle 135 is held by the positioning arm 510 to keep the instrument support 100 stable or rotate relative to the positioning arm 510. The handle 135 can be a pair of spherical protrusions connected to the instrument support 100 at any part of the body of the instrument support 100 (including along the first layer 140 or the second layer 145). In addition, the instrument support 100 includes a three-dimensional marker to assist in aligning the instrument 310 to percutaneously enter the target. It will be understood that any number of markers can be used to form the three-dimensional marker.

[0044] In an exemplary embodiment of the present disclosure, in the imaging system 520 ( FIG. 5A to FIG. 5G , 6A to 6F and 7A to 7D ) (e.g., X-ray or C-arm), the imaging system 520 can see through the instrument support 100 and the subject's body to align the instrument 310 so that it is aimed at a desired point in the subject's body, such as aligning a hollow needle to reach a stone in the subject's kidney. Optionally, the instrument 310 is not transparent to the imaging system 520 so as to be viewed on a display of the imaging system 520. For example, the instrument support 100 can be made of plastic to make it transparent, and the instrument 310 can be made of metal to be opaque to the imaging system 520.

[0045] In an exemplary embodiment of the present disclosure, the instrument support 100 includes a first layer 140 and a second layer 145 connected together by an instrument guide 125, which is configured to hold an instrument 310 to enter a subject. The instrument guide is also adapted to prevent the instrument 310 from bending when penetrating the patient's skin. Optionally, the instrument guide 125 is perpendicular to the two layers (140, 145) or forms a preselected angle.

[0046] In an exemplary embodiment of the present disclosure, the first layer 140 includes an entry point 120 for inserting the instrument 310 into the first layer 140 and a first layer marker 105 (or multiple markers) that are opaque to the imaging system 520 to identify the first layer 140 and align it relative to the second layer 145. Optionally, the first layer marker 105 can be a line. In some embodiments of the present disclosure, the first layer 140, the second layer 145, and the instrument guide 125 are formed as a single mold. In some embodiments of the present disclosure, the instrument guide 125, the entry point 120, and the corresponding exit point 130 can all be located in a single plane and are not necessarily located between the handles 135.

[0047] In an exemplary embodiment of the present disclosure, the second layer 145 includes an exit point 130 for the instrument 310 to exit the instrument support 100, and includes one or more second layer markings 115 that are opaque to the imaging system 520 to enable the imaging system 520 to identify the second layer 145 and enable a user to align the second layer 145 relative to the first layer 140. Optionally, the second layer markings 115 include one or two pairs of arrows. Optionally, the one or two pairs of arrows are triangular and aligned so that their respective vertices face each other. Optionally, the instrument guide 125 guides the instrument 310 from the entry point 120 to the exit point 130 through the body of the instrument support 100 and optionally perpendicular to the first layer 140 and the second layer 145, or at a preselected angle.

[0048] In an exemplary embodiment of the present disclosure, when the first layer 140 and the second layer 145 are aligned so that the instrument will collide with the target 560 when inserted into the subject, as shown in the display 550 of the imaging system 520 (e.g., see Figure 5A and Figure 5B ) near the target 560, the first layer of markers 105 is designed to form a predefined pattern with the second layer of markers 115. Those skilled in the art will understand that the instrument can also penetrate, enter, touch, pierce, penetrate or otherwise interact with the target in a manner required by the practitioner for the relevant procedure.

[0049] In some embodiments of the present disclosure, additional transparent markings 108 that are not part of the predefined pattern are placed on the first layer 140 or the second layer 145 to enable a user of the instrument support 100 to better grip and / or view the instrument support 100 .

[0050] Figure 2A is a bottom perspective view of a first alternative instrument support 200 according to an exemplary embodiment of the present disclosure, Figure 2B is a top perspective view of a first alternative instrument holder 200, and Figure 2C 2 is a top view of a first alternative instrument holder 200. As in the instrument holder 100, the instrument holder 200 includes a handle 235 for holding the instrument holder 200 by the positioning arm 510 or rotating the instrument holder 200 relative to the positioning arm 510. The handle 235 can be a pair of spherical protrusions that form a part of the instrument holder 200 or are connected to the instrument holder 200 at any part of the body of the instrument holder 200 (including along the first layer 240 or the second layer 245). The instrument holder 200 also includes a first layer 240 and a second layer 245 connected by an instrument guide 225, which is configured to hold the instrument 310 to enter the subject. Optionally, the instrument guide 225 is perpendicular to the two layers (240, 245) or forms a preselected angle.

[0051] In an exemplary embodiment of the present disclosure, the body 260 of the instrument holder 200 connecting the first layer 240 and the second layer 245 includes an entry point 220 for inserting the instrument 310 into the instrument holder 200. Preferably, the distance between the first layer 240 and the second layer 245 is 5 to 10 centimeters, and ideally is about 6 centimeters.

[0052] In an exemplary embodiment of the present disclosure, the first layer 240 includes first layer markings 205 in the form of lines that represent a linear scale of a unit of measure (e.g., centimeters or inches). Preferably, the distance between the lines of the first layer markings 205 is 2 mm, where the total distance of the entire first layer markings 205 markings is 16 mm. Those skilled in the art will understand that the distance between the lines of the first layer markings 205 can be any distance as long as the imaging system can accurately distinguish the lines, and the distance between the lines of the first layer markings 205 should vary proportionally relative to the distance between the first layer 240 and the second layer 245. The first layer markings 205 (or multiple markings) are opaque to the imaging system to identify the first layer 240 and align it relative to the second layer 245. Optionally, the first layer markings 205 include one or more pairs of arrows 255. Optionally, the one or two pairs of arrows 255 are triangular and aligned so that their respective vertices face each other. Optionally, one or both pairs of arrows 255 are located above or below the centerline of the line representing the linear scale of the measurement unit such that the gap between the vertices of one or more pairs of arrows 255 are aligned with the centerline of the line representing the linear scale of the measurement unit.

[0053] In an exemplary embodiment of the present disclosure, the second layer 245 includes an exit point 230 from which the instrument 310 exits the instrument support 200, and includes a second layer marker 215 that is opaque to the imaging system 520 to enable the imaging system 520 to identify the second layer 245 and enable a user to align it relative to the first layer 240. Preferably, the second layer marker 215 is linear. The first layer marker 205 and the second layer marker 215 are formed of a material, such as a radiopaque material (e.g., a metallic material) that can be viewed on a display of the imaging system 520.

[0054] In an exemplary embodiment of the present disclosure, when the first layer 240 and the second layer 245 are aligned so that the instrument 310 will collide with the target 560 when inserted into the subject, as shown in the display 550 of the imaging system 520 (see Figure 6C ) near the target, the first layer of marks 205 is designed to form a predefined pattern with the second layer of marks 215. In the predefined pattern, the second layer of marks 215 will be aligned with the center line of the first layer of marks 205 (see Figure 2C). Preferably, the thickness of the line including the second layer markings 215 is different from the thickness of the line including the first layer markings 205 to assist the user in distinguishing the line including the first layer markings 205 and the second layer markings 215. Preferably, the line including the second layer markings 215 is narrower than the line including the first layer markings 205. Preferably, in the predefined pattern, the second layer markings 215 will be aligned between the one or two pairs of arrows 255 in the first layer markings 205. Preferably, in the predefined pattern, there is a gap between the second layer markings 215 and the vertices of the one or two pairs of arrows 255 in the first layer markings 205 to assist the user in aligning the first layer 240 and the second layer 245. Preferably, in the predefined pattern, the gap between the second layer markings 215 and the vertices of the one or two pairs of arrows 255 in the first layer markings 205 is 0.1 mm to 0.5 mm, and ideally is 0.2 mm.

[0055] In an exemplary embodiment of the present disclosure, there is a protrusion 250 extending from the second layer 245. Optionally, the protrusion 250 is perpendicular to the second layer 245 or forms a preselected angle with the second layer 245. Preferably, the protrusion 250 is located around the exit point 230, from which the instrument 310 exits the instrument support 200. The protrusion 250 reduces the distance between the exit point 230 of the instrument support 200 and the surface of the patient's skin to prevent the instrument 310 from bending when penetrating the patient's skin. Preferably, the protrusion 250 is rounded for safety in the case of contact with the patient's skin surface. Preferably, the protrusion 250 is between 2 mm and 10 mm, and ideally around 5 mm. Optionally, the instrument guide 225 guides the instrument 310 from the entry point 220 to the exit point 230 through the body 260 of the instrument support 200 and optionally perpendicular to the first layer 240 and the second layer 245, or at a preselected angle.

[0056] Figure 3A is a side perspective view of a second alternative instrument support 300 according to an exemplary embodiment of the present disclosure, and Figure 3B3 is a bottom view of a second alternative instrument holder 300. As in the previous embodiment, the instrument holder 300 includes a handle 335 to assemble the positioning arm 510. The handle 335 is used to hold the instrument holder 300 by the positioning arm 510 or rotate the instrument holder 300 relative to the positioning arm 510. The handle 335 can be a pair of spherical protrusions connected to the instrument holder 300 at any part of the body of the instrument holder 300 (including along the first layer 340 or the second layer 345). As in the previous embodiment, the instrument holder 300 also includes a first layer 340 and a second layer 345, which are connected together by an instrument guide 325 that is perpendicular to the two layers (340, 345) and is configured to hold the instrument 310 to enter the subject. Optionally, the first layer 340 includes an entry point 320 for inserting the instrument 310 into the first layer 340. Similarly, the first layer 340 includes a first layer marking 305 in the form of a cross centered at the entry point 320. Optionally, the first layer of markings 305 may include one or more pairs of arrows. Optionally, the one or more pairs of arrows are triangular and aligned so that their respective vertices face each other. Optionally, the first layer of markings 305 may include one or more sets of lines representing a linear scale of measurement units (e.g., centimeters or inches). Optionally, the first layer of markings 305 may additionally include numerical values ​​on one or more sets of lines representing a linear scale of measurement units to indicate the deviation of certain lines from a center line of the one or more sets of lines representing a linear scale of measurement units.

[0057] In an exemplary embodiment of the present disclosure, the second layer 345 includes an exit point 330 from which the instrument 310 exits the instrument support 300 to the second layer 345, and includes a second layer mark 315 in a cross shape, wherein the exit point 330 is located at the center of the cross-shaped second layer mark 315, so that the imaging system 520 can identify the second layer 345 and the user can align it relative to the first layer 340. The first layer mark 305 and the second layer mark 315 are formed of a material, such as a radiopaque material (e.g., a metal material) that can be viewed on a display of the imaging system 520. Optionally, the instrument guide 325 guides the instrument 310 from the entry point 320 to the exit point 330 through the body of the instrument support 300 that reaches the first layer 340 and the second layer 345. Optionally, the instrument guide 325 is perpendicular to the first layer 340 and the second layer 345 or forms a predetermined angle.

[0058] In an exemplary embodiment of the present disclosure, when the first layer 340 and the second layer 345 are aligned so that the instrument 310 will collide with the target 560 when inserted into the subject, as seen on the display 550 of the imaging system 520, the first layer markings 305 are designed to coincide with the second layer markings 315, forming a cross above the target.

[0059] Alternatively, when the first layer 340 and the second layer 345 are aligned so that the instrument 310 will collide with the target 560 when inserted into the subject, as viewed on the display 550 of the imaging system 520, the first layer of markings 305 is designed to form a predefined pattern with the second layer of markings 315. Optionally, in the predefined pattern, each line of the second layer of markings 315 will be aligned between one or more pairs of arrows of the first layer of markings 305, and there will be a gap between the line of the second layer of markings 315 and the top of the arrow or arrows of the first layer of markings 305. Optionally, in the predefined pattern, each line of the second layer of markings 315 will be aligned with the center line of each line of one or more groups of lines representing the linear scale of the unit of measurement of the first layer of markings 305.

[0060] FIG. 3C to FIG. 3D is an illustration of an example of marking on a second alternative instrument holder 300 according to an exemplary embodiment of the present disclosure, and Figure 3E is an illustration of a predefined pattern formed by exemplary markings on a second alternative instrument support 300 . Figure 3C is implemented as Figure 3A A first example of marking of the first layer marking 305 includes four pairs of triangular arrows, each pair of triangular arrows being aligned so that their respective vertices face each other in a radial arrangement. Figure 3D is a second example of a mark implemented as the second layer mark 315, which includes a crosshair mark. Figure 3E 5. In the process of aligning the device of the present disclosure, as seen on the display 550 of the imaging system 520, the first example and the second example ( Figure 3C , Figure 3D ) of the first layer mark 305 and the second layer mark 315. As can be seen, according to the first example and the second example, the lines of the crosshairs of the second layer mark 315 are aligned between each of the four pairs of arrows of the first layer mark 305.

[0061] Figure 3F to Figure 3G is an illustration of other examples of markings on a second alternative instrument support 300 according to an exemplary embodiment of the present disclosure, and Figure 3H is an illustration of a predefined pattern formed by exemplary markings on a second alternative instrument support 300 . Figure 3F is implemented as Figure 3A A third example of a marking of the first layer marking 305, which includes four pairs of triangular arrows, each pair of triangular arrows is aligned so that their respective vertices face each other in a radial arrangement and a square, wherein two groups of lines represent linear scales of measurement units on two adjacent sides of the square, and a midline of each of the two groups of lines represents a linear scale of measurement units aligned between vertices of the pair of triangular arrows located on at least two adjacent sides of the square. Figure 3G is a fourth example of a mark implemented as the second layer mark 315, which includes a crosshair mark. Figure 3H 5. In the process of aligning the device of the present disclosure, as seen on the display 550 of the imaging system 520, the third example and the fourth example ( Figure 3F and Figure 3G ) and a predefined pattern formed by the first layer mark 305 and the second layer mark 315. As can be seen, according to the third example and the fourth example, the line of the crosshair of the second layer mark 315 is between each of the four pairs of arrows of the first layer mark 305 and is aligned with the center line of each of the two groups of lines of the linear scale representing the measurement unit of the first layer mark 305.

[0062] Figure 4A is a bottom perspective view of a third alternative instrument support 400 according to an exemplary embodiment of the present disclosure, Figure 4B is a top perspective view of a third alternative instrument holder 400, and Figure 4C 4 is a top view of a third alternative instrument support 400. As in the previous embodiment, the instrument support 400 includes a handle 435 to assemble the positioning arm 510. The handle 435 is used to hold the instrument support 400 by the positioning arm 510 or rotate the instrument support 400 relative to the positioning arm 510. The handle 435 can be a pair of spherical protrusions connected to the instrument support 400 at any part of the body of the instrument support 400 (including along the first layer 440 or the second layer 445). As in the previous embodiment, the instrument support 400 also includes a first layer 440 and a second layer 445, which are connected together by a column 460. Preferably, there is a protrusion 450 extending from the second layer 445. Preferably, the protrusion 450 is rounded for safety in the case of contact with the patient's skin surface. Preferably, the protrusion 450 is 2 mm to 10 mm, and ideally is about 5 mm. Optionally, the protrusion 450 is perpendicular to the second layer 445 or forms a preselected angle with the second layer 445. Optionally, the pillar 460 is perpendicular to the two layers (440, 445). The pillar 460 can be any shape, including straight or circular.

[0063] In an exemplary embodiment of the present disclosure, the second layer 445 includes an entry point 420 for inserting the instrument 310, an exit point 430 for the instrument 310 to exit the instrument support 400, and an instrument guide 425 for guiding the instrument 310 from the entry point 420 to the exit point 430. The first layer 440 includes a first layer of markings 405. The first layer of markings 405 is formed of a material, such as a radiopaque material (e.g., a metallic material) that can be viewed on a display of the imaging system 520. Optionally, the first layer of markings 405 is in the form of a line of a linear scale representing a unit of measure (e.g., centimeters or inches). Optionally, the first layer of markings 405 also includes one or more pairs of arrows 455.

[0064] In an exemplary embodiment of the present disclosure, the instrument 310 is formed of a material, such as a radiopaque material (e.g., a metallic material) that can be viewed on a display of the imaging system 520. Once inserted into the instrument support 400, the instrument 310 enables the imaging system to identify the second layer 445 and enables the user to align it relative to the first layer 440. Preferably, the second layer 445 is aligned relative to the first layer 440 when the instrument 310 is aligned with the centerline of the first layer markings 405. Preferably, the second layer 445 is aligned relative to the first layer 440 when the instrument 310 is aligned between one or two pairs of arrows 455 in the first layer markings 405. Preferably, when the first layer 440 is aligned with the second layer 445, there is a gap between the instrument 310 and the apex of the one or two pairs of arrows 455 in the first layer markings 405. Preferably, the gap between the instrument 310 and the apex of the one or two pairs of arrows 455 in the first layer markings 405 is 0.1 mm to 0.5 mm, and ideally 0.2 mm.

[0065] In an exemplary embodiment of the present disclosure, the first layer mark and the second layer mark can be vice versa, and are not limited to arrows and lines or crosses. They can be any two-dimensional geometric shape, including but not limited to circle / semicircle, triangle, square, rectangle, polygon, ellipse, etc., as long as it can be appropriately used for alignment and matching.

[0066] In addition, the markers of the two layers can be aligned to establish a common axis that passes through all the markers. The markers can also align the instrument and target so that all three (markers, instrument, target) will be on the same axis. When the axis is established, the instrument is set to follow and move only along this axis.

[0067] FIG. 5A to FIG. 5G is a schematic diagram of a process of aligning an instrument support 100 according to an exemplary embodiment of the present disclosure. In an exemplary embodiment of the present disclosure, as Figure 5AAs shown, a subject 505 is placed on an operating table 530, wherein the instrument holder 100 is mounted on a positioning arm 510 above the subject 505. The positioning arm 510 is typically attached to the operating table 530, and the imaging system 520 is initially positioned at an angle α relative to the vertical. With the help of the imaging system 520, the practitioner views the display 550 and selects an angled plane relative to α (e.g., at an angle X) that will enable the instrument 310 to be optimally inserted to hit the target 560 (e.g., a kidney stone). In addition, the practitioner selects a puncture angle, tilting the instrument 310 in the selected angled plane to accurately hit the target 560.

[0068] In an exemplary embodiment of the present disclosure, the practitioner rotates the imaging system 520 to a desired angle (X+α) and views the instrument holder 100 as it appears on the display 550 .

[0069] like Figure 5B As shown, the practitioner uses the positioning arm 510 to align the first layer of markings 105 of the instrument support 100 to point to the target 560 and be centered at the second layer of markings 115. Optionally, the first layer of markings 105 is in the form of a line, and the second layer of markings 115 is in the form of two pairs of arrows. When the instrument support 100 is aligned with the selected plane, the line of the first layer of markings 105 will be centered between the arrows of the second layer of markings 115.

[0070] like Figure 5C As shown, the practitioner inserts an instrument 310 (eg, a hollow needle) into the instrument holder 100. Initially, the instrument 310 is not visible because it is perpendicular to the first layer of markings 105 and is not aligned to accurately pass through the target.

[0071] like Figure 5D As shown, the practitioner determines an entry point on the skin of the subject 505 and rotates the instrument 310 with the instrument holder 100 to align it with the entry point. The practitioner then inserts the instrument 310 approximately 3 mm into the skin of the subject 505 to establish the pivot point. Alternatively, the practitioner may stop the instrument 310 just above the entry point on the skin of the subject 505 and only insert the instrument at a later stage.

[0072] like Figure 5E As shown, the practitioner returns the imaging system 520 to the α degree position to verify that the instrument 310 is pointing toward the target. Alternatively, the instrument 310 or a virtual extension thereof may be identified as not passing through the target when viewed with the imaging system 520 from the α angle.

[0073] like Fig. 5FAs shown, the positioning arm 510 is moved forward or backward to tilt the instrument support 100 and the instrument 310 so that the instrument 310 will be aligned with the target 560, or so that the extension line of the instrument will be aligned with the target 560.

[0074] like Figure 5G As shown, once the instrument 310 is aligned with the target in 3D, the practitioner can view the display 550 and gently push the instrument 310 toward the target 560 until the instrument 310 hits the target 560. Optionally, the instrument can be used to fragment the target and / or vacuum it out of the patient.

[0075] 6A to 6F is a schematic diagram of a first alternative process for aligning the instrument support 200 according to an exemplary embodiment of the present disclosure. In an exemplary embodiment of the present disclosure, as Fig. 6A As shown, a subject 505 is placed on an operating table 530 , wherein an instrument holder 200 is mounted on a positioning arm 510 above the subject 505 .

[0076] The positioning arm 510 is typically attached to the operating table 530, and the imaging system 520 is initially positioned at an angle α relative to the vertical. With the help of the imaging system 520, the practitioner views the display 550 and selects an angled plane relative to α (e.g., at an angle X) that will allow the instrument 310 to be optimally inserted to hit the target 560 (e.g., a kidney stone). In addition, the practitioner selects a puncture angle, tilting the instrument 310 in the selected angled plane to accurately hit the target 560.

[0077] In an exemplary embodiment of the present disclosure, the practitioner rotates the imaging system 520 to the desired angle (X+α) and views the instrument support 200 as it appears on the display 550. Alternatively, if the instrument support 400 is mounted on the positioning arm 510, the practitioner rotates the imaging system 520 to the desired angle (X+α), inserts the instrument 310 into the instrument support 400, and views the instrument support 400 and the instrument 310 as they appear on the display 550.

[0078] The practitioner uses the imaging system 520 to take a snapshot that clearly shows the target 560, the first layer of markers 205 of the instrument support 200, and the second layer of markers 215 of the instrument support 200. Alternatively, if the instrument support 400 is used, the practitioner uses the imaging system 520 to take a snapshot that shows the target 560, the first layer of markers 405 of the instrument support 400, and the instrument 310 within the instrument support 400.

[0079] The practitioner reads the deviation of the second layer of markings 215 of the instrument holder 200 from the centerline of the first layer of markings 205 of the instrument holder 200 and the target 560. Alternatively, if the instrument holder 400 is used, the practitioner reads the deviation of the instrument 310 within the instrument holder 400 from the centerline of the first layer of markings 405 of the instrument holder 400.

[0080] like Figure 6B As shown, the practitioner can use the deviation as a guide to move the positioning arm 510 to align the second layer of markings 215 of the instrument support 200 to point to the target 560 and be centered on the first layer of markings 205. Optionally, the second layer of markings 215 is in the form of a line, and the first layer of markings 205 is in the form of a line of linear scale representing a unit of measurement (e.g., centimeters or inches). When the instrument support 200 is aligned with the selected plane, the line of the second layer of markings 215 will be centered on the centerline of the first layer of markings 205.

[0081] Alternatively, if the instrument holder 400 is used, the practitioner uses the deviation as a guide to move the positioning arm so that the instrument 310 is aligned within the instrument holder 400 to point to the target and be centered on the first layer of markings 405. Optionally, the first layer of markings 405 is in the form of a line representing a linear scale of units of measure (e.g., centimeters or inches). Optionally, the first layer of markings 405 also includes one or more pairs of arrows. When the instrument holder 400 is aligned with the selected plane, the instrument 310 within the instrument holder 400 will be centered on the centerline of the first layer of markings 405.

[0082] like Figure 6C As shown, the practitioner inserts instrument 310 (e.g., a hollow needle) into instrument holder 200, determines an entry point on the skin of subject 505, and rotates instrument 310 with instrument holder 200 to align it with the entry point. The practitioner then inserts instrument 310 approximately 3 mm into the skin of subject 505 to establish a pivot point. Alternatively, the practitioner may stop instrument 310 just above the entry point on the skin of subject 505 and insert only instrument 310 at a later stage.

[0083] like Fig.6D As shown, the practitioner returns the imaging system 520 to the α degree position to verify that the instrument 310 is pointing toward the target. Alternatively, the instrument 310 or a virtual extension thereof may be identified as not passing through the target when viewed with the imaging system 520 from the α angle.

[0084] like Fig. 6E As shown, the positioning arm 510 is moved forward or backward to tilt the instrument support 200 and the instrument 310 so that the instrument 310 will be aligned with the target 560, or so that the extension line of the instrument will be aligned with the target 560.

[0085] like Fig. 6F As shown, once the instrument 310 is aligned with the target in 3D, the practitioner can view the display 550 and gently push the instrument 310 toward the target 560 until the instrument 310 hits the target 560. Optionally, the instrument can be used to fragment the target and / or vacuum it out of the patient.

[0086] 7A to 7D is a schematic diagram of a second alternative process for aligning a second alternative instrument holder 300 according to an exemplary embodiment of the present disclosure. In an exemplary embodiment of the present disclosure, the practitioner selects a puncture angle, an insertion point 780 and marks the insertion point 780 on the skin of the subject 505. Fig. 7A A coordinate system 770 having axes relative to the insertion point 780 is shown. The axes include a cranial direction (head end), a caudal direction (rear end), a medial direction (center of the subject), and a lateral direction (outer end relative to the subject's entry point). In an exemplary embodiment of the present disclosure, the practitioner rotates the imaging system 520 in both the median plane (cranial-caudal) and the transverse plane (medial-lateral) to align with the insertion point 780 and the target 560 in the display 550. The practitioner also configures the positioning arm 510 on which the instrument holder 300 is mounted to align the instrument 310 toward the target 560. The positioning arm 510 is designed to have multiple degrees of freedom so that the instrument holder 300 can be oriented in any direction. Similarly, the articulated arm includes various locking knobs 790 to lock the elements of the positioning arm 510 and prevent them from moving before the instrument 310 is pushed into the body of the subject 505.

[0087] like Figure 7B As shown, the practitioner moves the positioning arm 510 to align the first layer of markings 305 with the second layer of markings 315 of the instrument holder 300, wherein the marked insertion point 780 and target 560 are made as accurate as possible.

[0088] like Figure 7C As shown, the practitioner can use the features of the positioning arm 510 to fine-tune the position of the instrument 310 relative to the target 560 and then lock the positioning arm 510 so that the instrument 310 can be held stable and not misaligned when the instrument 310 is pushed into the body of the subject 505 via the instrument holder 300.

[0089] like Fig.7D As shown, once the instrument support 300 and the instrument 310 are aligned, the practitioner can push the instrument 310 percutaneously to reach the target and treat it, for example, to extract a kidney stone or deliver a drug.

[0090] It should be understood that the above method and apparatus can change in many ways, including omitting or increasing steps, changing the order of steps and the type of the apparatus used. It should be understood that different features can be combined in different ways. Especially, in each embodiment of the present disclosure, all features shown above in a particular embodiment are not necessarily required. The further combination of the above features is also considered to be within the scope of some embodiments of the present disclosure.

[0091] It will be appreciated by those skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention is defined solely by the appended claims.

Claims

1. An instrument support for aligning an instrument for accessing a target in a subject, comprising: First floor; Second floor; an instrument guide having an entry point and an exit point, the instrument guide connected between the first layer and the second layer and configured to guide the instrument from the entry point to the exit point; wherein the first layer and the second layer include a first layer of markings and a second layer of markings visible to an imaging system; and wherein when the first layer and the second layer are aligned so that the instrument will collide with the target, the first layer of markings is designed to form a predefined pattern with the second layer of markings relative to the target as viewed on a display of the imaging system; Wherein the first layer of markings comprises a first geometric shape, the first geometric shape comprises one or more pairs of arrows or arrowheads, and the second layer of markings comprises a second geometric shape different from the first geometric shape, the second geometric shape comprises two cross-shaped lines centered on the exit point, and in the predefined pattern, the one or more pairs of arrows or arrowheads point to the lines of the second geometric shape so that each line is located between the one or more pairs of arrows or arrowheads. 2 . The instrument support of claim 1 , wherein in the predefined pattern, there are gaps between the one or more pairs of arrows or arrowheads and the lines of the second geometric shape. 3 . The instrument support of claim 1 , wherein the second geometric shape comprises two or more sets of lines representing a linear scale of units of measure. 4 . The instrument support of claim 1 , further comprising a protrusion extending from the second layer. The device holder according to claim 1 , wherein the device is a hollow needle. The instrument holder of claim 1 , wherein the instrument is an elongated tool.

7. The instrument support according to claim 1, wherein the instrument support includes a handle for mounting a positioning arm. 8 . The instrument support according to claim 7 , wherein the handle is configured to enable the instrument support to rotate relative to the positioning arm.

9. The instrument support of claim 1, wherein the first layer or the second layer includes an additional marking that is not part of the predefined pattern to identify the first layer or the second layer by a user during alignment.

10. The device holder of claim 1, wherein the target is located percutaneously.

11. The instrument support of claim 1, wherein the instrument support is transparent to the imaging system. 12 . The instrument support of claim 1 , wherein the instrument guide is perpendicular to the first layer and the second layer.

13. The instrument support of claim 1, wherein the instrument guide forms a preselected angle with the first layer and the second layer.

14. An instrument support for aligning an instrument for accessing a target in a subject, comprising: First floor; a second layer, the second layer being connected to the first layer via a column; an instrument guide having an entry point and an exit point, the instrument guide being located within the second layer and configured to guide the instrument from the entry point to the exit point; wherein the first layer includes markings forming a first layer of markings visible to an imaging system; and wherein when the first layer and the second layer are aligned so that the instrument will collide with the target, as viewed on a display of the imaging system, the first layer of markings is designed to form a predefined pattern with the instrument visible by the imaging system within the second layer relative to the target; The first layer of markings also includes a first geometric shape, which includes one or more pairs of arrows or arrowheads, and in the predefined pattern, the one or more pairs of arrows or arrowheads point to the instrument, and the instrument is located between the one or more pairs of arrows or arrowheads.

15. The instrument support of claim 14, wherein the first geometric shape includes a line representing a linear scale of units of measure, and in the predefined pattern, the instrument is aligned with a centerline of the first geometric shape.

16. The instrument holder of claim 14, wherein there is a gap between the one or more pairs of arrows or arrowheads and the instrument.

17. The instrument support of claim 14, further comprising a protrusion extending from the second layer.

18. The device holder of claim 14, wherein the device is a hollow needle.

19. The instrument holder of claim 14, wherein the instrument is an elongated tool.

20. The instrument support of claim 14, wherein the instrument support comprises a handle for mounting a positioning arm.

21. The instrument support of claim 20, wherein the handle is configured to enable the instrument support to rotate relative to the positioning arm.

22. The instrument support of claim 14, wherein the first layer or the second layer includes additional markings that are not part of the predefined pattern to identify the first layer or the second layer by a user during alignment.

23. The device support of claim 14, wherein the target is located percutaneously.

24. The instrument support of claim 14, wherein the instrument support is transparent to the imaging system.

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