WO2024147757A1

WO2024147757A1 - A medical device for aligning an instrument

Info

Publication number: WO2024147757A1
Application number: PCT/SG2023/050011
Authority: WO
Inventors: Guohua Zeng; Qing Hui Wu; Jian Ping CHAI; Teck Kheng Lee; Soo Leong FOO
Original assignee: Invivo Medical Pte. Ltd.
Priority date: 2023-01-05
Filing date: 2023-01-05
Publication date: 2024-07-11

Abstract

The present disclosure generally relates to an apparatus and a method for aligning an instrument, such as a needle, relative to a plane for insertion into the body of a subject. The present disclosure provides a medical device having a needle holding device and an adjustment mechanism for allowing a main body of the medical device to be aligned to the plane. The medical device comprises a main body, an adjustment mechanism and a guide limiter. Said adjustment mechanism comprises a knob; a screw connected to the knob; a receiver for receiving the screw, the receiver having a pivot at its bottom section; and a vertical gap formed between said receiver and a lateral extension of a main body of the medical device.

Description

A MEDICAL DEVICE FOR ALIGNING AN INSTRUMENT

FIELD OF THE DISCLOSURE

[0001] The present disclosure generally relates to an apparatus and method for guiding an instrument for insertion into the body of a subject. In particular, the present disclosure relates to a medical device having a needle holding device and an alignment component.

BACKGROUND OF THE DISCLOSURE

[0002] With the use of current technologies, minimally invasive techniques or procedures are desired for accessing parts of subjects. For example, percutaneous access to the tissue such as a minimally invasive procedure to insert a tool into the body of the subject and remove tissue or to perform any type of procedure. Some procedures typically use a hollow needle to puncture the skin of a subject, and the needle is then inserted in a substantially precise manner into the subject to collide with the target. In some procedures, a guide wire is inserted through the hollow needle, and the wire guides the insertion of endoscopic surgical instruments that can fragment and remove tissue. Similarly, other types of procedures may require the insertion of a tool into the body of a subject. Such procedures include biopsies, interrogation, vertebroplasty, discectomy, and other needle or tool puncturing. Techniques, such as those described above, typically are performed with the aid of imaging systems (e.g. x-ray, ultrasound, magnetic resonance imaging or MRI). For example, some processes use a C-arm fluoroscopy throughout the process to locate the target.

[0003] While it has been recognized that minimally invasive techniques offer benefits such as less pain, smaller scars, less risk of infection and faster recovery, as compared to open incisions, it has also been recognized that such invasive techniques are typically difficult to perform. Currently, the insertion process of a tool into the body of a subject is significantly dependent on the experience of the surgeon to manipulate and align the needle. It is recognized that the tedious and time-consuming part of the manual procedure is the alignment and manipulation of the needle or the tool.

[0004] Furthermore, prolonged procedural time during usage of minimally invasive techniques likely increases the risk of perioperative complications of subjects. In addition, prolonged procedural time increases the health risk of surgical crews as well as the patient due to exposure to radioactive imaging. Furthermore, prolonged procedural time imposes a burden on hospitals given that operating theatres are typically in constant demand. [0005] In view of the challenges described above, robotic systems have been developed to facilitate or assist in such procedures. For example, a number of automated robotic system aided by image guiding system and motorized needle insertion driver is currently in development. However, robotic systems also encounter some of the limitations that current practitioners face when guiding an instrument into the body of a subject.

[0006] A United States patent application 14/915,112 (published as US 2016/0206383 Al on 21 July 2016), the disclosure of which is incorporated herein by reference describes a system and apparatus for guiding an instrument. In addition, PCT application No. PCT/SG2020/050558 by the current applicant and published as WO/2021/066752 on 8 April 2021, the disclosure of which is incorporated herein by reference describes an instrument holder for aligning an instrument and method of using the same.

[0007] In view of the above limitations and challenges, it is desirable to provide an improved apparatus and method for guiding an instrument into the body of a subject that minimizes the risk of exposure to radiation experienced by patients and/ or practitioners.

SUMMARY

[0008] An aspect of an embodiment of the disclosure, relates to an instrument holder for performing a process of aligning an instrument (e.g. a needle, hollow needle, tool, wire) used to access a target (e.g. a tumour, kidney stone or other item) within a subject. The instrument holder may be any device that holds an instrument. The alignment may be achieved or facilitated by means of an adjustment mechanism described herein.

[0009] There is provided a medical device for aligning an instrument with a respect to a plane, for accessing a target within a subject, comprising a main body comprising a lateral extension, an adjustment mechanism, comprising a knob, a screw connected to the knob, a receiver for receiving the screw, the receiver having a pivot at its bottom section and a vertical gap formed between said receiver and the lateral extension. The medical device may further comprise a guide limiter connecting the bottom side of the main body and the bottom side of the receiver. The target may be located percutaneously.

[0010] The medical device disclosed herein may further comprise an indicator, in contact with the knob, having markings thereon, to indicate the degree of rotation of the knob. Optionally, wherein said indicator may comprise a ring having markings thereon, to indicate the degree of rotation of the knob. When the knob of the medical device disclosed herein is rotated, the screw’s rotation may change the vertical gap and consequently the main body rotates about the pivot, said rotation may be limited by the guide limiter, allowing the main body to be aligned with the plane. The vertical gap may change from a first distance to a second distance, at the second distance, the main body is aligned with the plane. When the vertical gap is at the second distance and the main body is not aligned with the plane, the knob may be further rotated thereby changing the distance of the vertical gap to a third distance, a fourth distance or a fifth distance. The change in the distance of the vertical gap of the adjustment mechanism from the first distance to the second distance corresponds to the rotation of the screw by a first turning angle.

[0011] The medical device disclosed herein may further comprise a second adjustment mechanism comprising a second knob and a second screw connected to the second knob, said second knob and second screw are positioned at the lateral side of the main body. When the second knob is rotated the second screw’s rotation displaces the main body laterally such that the instrument collides with the target.

[0012] The plane used as a basis for adjustment described above may be perpendicular relative to an incoming radiation path from an imaging system. Advantageously, the adjustment performed may minimize use or avoid continuous use of the imaging system thereby minimizing risk of exposure to the radiation from the imaging system.

[0013] The change in the distance of the vertical gap of the adjustment mechanism from the first distance to the second distance corresponds to the rotation of the screw by a first turning angle.

[0014] The medical device described herein may include the receiver, said receiver may comprise a clevis. The receiver may further comprise a clevis pivot and a clevis pin.

[0015] The instrument used in the present disclosure may be a hollow needle.

[0016] The medical device described herein may optionally further comprise a handle to fit a positioning arm. Further, optionally, the medical device described may further comprise an instrument holder to secure the instrument. Said instrument holder may be transparent to the imaging system.

[0017] There is provided a method for aligning an instrument to a target within a subject, comprising providing a medical device described in the present disclosure, activating an imaging system to show on a display the target and the instrument holder, and rotating the knob of the adjustment mechanism causing the main body of the medical device to rotate the main body about the pivot, said rotation is limited by the guide limiter thereby aligning the main body with the plane. Optionally, the method may further comprise deactivating the imaging system before rotating the knob. The rotation of the knob may rotate the screw thereby changing the distance of the vertical gap and consequently causing the main body to rotate about the pivot. The plane may be perpendicular relative to an incoming radiation path from the imaging system.

[0018] Optionally, the method may further include rotating a second knob of a second adjustment mechanism to cause the main body to displace laterally such that the instrument collides with the target.

[0019] Upon rotating the knob, the distance of the vertical gap may change from a first distance to a second distance and said change corresponds to the rotation of the screw by a first turning angle.

[0020] The disclosure can be applied to any method for referencing a position of a tool to be used in conjunction with a medical imaging device.

BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The present disclosure will be understood and better appreciated from the following detailed description taken in conjunction with the drawings. Identical structures, elements or parts, which appear in more than one figure, are generally labelled with the same or similar number in all the figures in which they appear, wherein:

[0022] FIG. 1A is a perspective view of the medical device, in accordance with an embodiment of the disclosure;

[0023] FIG. IB is a side view of the medical device according to an embodiment of the disclosure, viewed from the proximal end;

[0024] FIG. 1C is a schematic illustration of the medical device, according to an embodiment of the present disclosure, viewed from the proximal end, similar as that shown in FIG. IB, except that different parts of the main body are also depicted;

[0025] FIG. ID is a schematic illustration of a perspective view of the medical device, in accordance with an embodiment of the present disclosure, showing the main body, the first adjustment mechanism and the second adjustment mechanism described in FIG. 1C; [0026] FIG. 2A is a side view of an instrument holder of the medical device, according to an embodiment of the disclosure;

[0027] FIG. 2B shows first layer markings and second layer markings of the instrument holder of the medical device in accordance with an embodiment of the disclosure;

[0028] FIG. 3 illustrates a method for aligning the medical device using the first adjustment mechanism according to an embodiment of the disclosure; and

[0029] FIG. 4 illustrates a method for aligning the medical device using the first adjustment mechanism and the second adjustment mechanism according to an embodiment of the disclosure.

[0030] With specific reference to the drawings in detail, it is important to note that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the disclosure. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the disclosure may be practiced.

[0031] Identical or duplicate or equivalent or similar structures, elements, or parts that appear in one or more drawings are generally labelled with the same reference numeral, optionally with an additional letter or letters to distinguish between similar entities or variants of entities, and may not be repeatedly labelled and/or described. References to previously presented elements are implied without necessarily further citing the drawing or description in which they appear.

[0032] Dimensions of components and features shown in the figures are chosen for convenience or clarity of presentation and are not necessarily shown to scale or true perspective. For convenience or clarity, some elements or structures are not shown or shown only partially and/or with different perspective or from different point of views.

DETAILED DESCRIPTION

[0033] FIG. 1A is a perspective view of a medical device 100 according to an exemplary embodiment of the present disclosure. The medical device 100 may be used for aligning an instrument for accessing a target 128 within a subject. In some embodiments, the subject is a patient undergoing a surgery or a surgical treatment. In some embodiments, the target is located percutaneously. The medical device 100 includes a main body 130, a first adjustment mechanism. In some embodiments, the main body 130 includes a lateral extension 131 (see Fig. 1C). In some embodiments, the medical device disclosed herein may optionally include a second adjustment mechanism. In some embodiments, the first adjustment mechanism may allow the main body 130 of the device 100 to be tilted causing the main body to be aligned with a plane thereby allowing the instrument to be aligned with that plane. In some embodiments, the second adjustment mechanism allows the main body 130 of the device 100 to be displaced laterally. In some embodiments, the medical device 100 may further include a third adjustment mechanism to allow the device or the instrument to be displaced towards distal end or proximal end of the medical device. The combination of the first adjustment mechanism and the second adjustment mechanism advantageously provides synergistic effect in allowing more flexibility to the medical device to be positioned in an ideal or desirable position. Said combination may further include the third adjustment mechanism. In some embodiments, the medical device 100 may include an articulated arm (not shown).

[0034] Referring to FIG. 1A, the medical device 100 has a distal end 120’ and a proximal end 160’, the main body 130 being positioned between the proximal end 160’ and the distal end 120’. In some embodiments, the first adjustment mechanism may include a first knob 140. In some embodiments, the second adjustment mechanism may include a second knob 150. In some embodiments, the third adjustment mechanism may include a third knob 160. In some embodiments, the medical device 100 may further include an instrument holder 120 at the distal end 120’ of the medical device 100. The instrument holder 120 serves to hold an instrument 110. The instrument 110 may be a needle, a wire and other suitable instrument. In some embodiments, the needle may be a hollow needle. In some embodiments, instrument 110 may include an outer needle (not shown) and an inner needle (not shown), the inner needle is extendable along a certain axis for example axis 145. It is to be appreciated that in such an embodiment, the outer needle is a hollow needle. In some embodiments, instrument 110 may include the outer needle and inner needle, each of the outer and inner needles is hollow and further comprises a wire substantially enclosed within the inner needle. When the first knob 140 of the first adjustment mechanism is rotated for example clockwise, the main body 130 may be tilted for example to be aligned with a plane. It is to be understood that the terms “aligned” and “parallel” may be used interchangeably as they have the same meaning. In such an embodiment, the medical device 100 may be considered to comprise a co-planing component. In some embodiments, the plane may be surface of the patient’s skin where the instrument is to be inserted. Further, it can be appreciated that the rotation of the first knob may be also anti -clockwise. In addition to the adjustment of the medical device 100 by the first knob 140, the medical device 100 may be further adjusted by the second adjustment mechanism, for example by rotating the second knob 150 clockwise or anticlockwise. Further, the medical device 100 may be further adjusted by the third adjustment mechanism, for example by rotating the third knob 160 clockwise or anticlockwise. In some embodiments, the positioning of the medical device 100 may be performed by rotating the second knob 150, followed by the first knob 140 and the third knob 160. This cycle may be repeated in no particular order. In some embodiments, the adjustment using the third knob 160 may not be necessary. In an exemplary embodiment, the medical device 100 may be adjusted by rotating the first knob 140 and rotating the second knob 150. In another exemplary embodiment, the medical device 100 may be adjusted by rotating the first knob 140, rotating the second knob 150 and rotating the first knob 140 again for final alignment. In an exemplary embodiment, the medical device 100 may be adjusted by rotating the first knob 140, rotating the second knob 150 and rotating the third knob 160.

[0035] As will be described further below, in some embodiments, it is to be appreciated that the medical device 100 further comprises the following components: a shaft (161) to displace the medical device in the distal or proximal direction along axis 137 when the third knob 160 is rotated. In some embodiments, the medical device 100 may further include a cam lock (162), a handle (163) for a practitioner to orientate the medical device, a socket screw (170), a socket lock (169), fingers (171), a pivot pin (172), a finger lock (173), a collet (168), a clamp (167), a guide remover (166), a slider (165), and end stopper (164).

[0036] Referring now to FIG. IB, the medical device 100 is viewed along a fourth axis 137 from the proximal end 160’ of the medical device 100. As can be seen from this schematic drawing, the first adjustment mechanism may include a first knob 140, a first screw 141 connected to the first knob 140 that is configured to rotate as the first knob 140 is rotated and a receiver 142 for receiving the first screw 141. In some embodiments, the first adjustment mechanism may further include a vertical gap 136 formed between the receiver 142 and the lateral expansion 131. In some embodiments, the medical device 100 may further include a guide limiter 144 connecting the bottom side of the main body and the bottom side of the receiver. In some embodiments, the receiver 142 has a pivot 143 at the bottom section of the receiver 142. In some embodiments, the receiver 142 may include a clevis 149 as will be further described in Fig. 1C. In some embodiments, in addition to the clevis 149, the receiver 142 may include a clevis pin 143 allowing the receiver 142 to pivot about said clevis pin 143. In some embodiments, the first adjustment mechanism may further include an indicator that can be provided in the form of ring 148 in contact with the first knob 140. In some embodiments, the ring 148 may be a dial ring. In some embodiments, the ring or dial ring 148 comprises markings thereon to indicate the degree of rotation of the first knob 140.

[0037] In some embodiments, when the first knob 140 is rotated about a first axis 145 or a third axis 146 by a user in a clockwise direction, the first screw 141 correspondingly rotates clockwise. The rotation of the first screw 141 may cause change in the distance of the vertical gap 136 from a first state or position to a second state or position. In an exemplary embodiment, the clockwise rotation may shorten the distance of the vertical gap and the anticlockwise rotation may widen the vertical gap. In some embodiments, the change in distance of the vertical gap 136 may cause the main body 130 and thus the medical device 100 to tilt or rotate about the fourth axis 137. The rotation may be restricted by the guide limiter 144 allowing precise adjustment of the main body 130 thus the medical device 100. In some embodiments, the guide limiter 144 has a thickness allowing “elastic deformation” of the guide limiter. The guide limiter may, preferably, made of a material that allows for such elastic deformation. For clarity, when the first knob 140 is first rotated clockwise to change the distance of the vertical gap 136 from the first position to the second position causing the main body 130 to tilt, when the first knob 140 is rotated in opposite direction of the first rotation (anticlockwise), the distance of the vertical gap 136 may return from the second position to the first position thus causing the main body 130 to return to its original position. The extent of the rotation of the first knob 140 may be indicated by the markings present in the dial ring 148 for reference by the user or operator. If further adjustment of the medical device 100 is necessary, the first knob 140 may be rotated further. Further rotation of the first knob 140 may further change the distance of the vertical gap 136. Consequently, the change of the vertical distance 136 may exert a pressure on a section of the main body 130 of the medical device 100 causing the main body to rotate correspondingly in response to the applied or exerted pressure. The guide limiter 144 limits further rotation of the main body 130.

[0038] FIG. 1C is a schematic illustration of the medical device 100 viewed from the proximal end along the fourth axis 137 similar as that shown in FIG. IB, except that different parts of the main body 130 are also shown including top side 134, bottom side 135, proximal section 132 and distal section 133. FIG. ID is a schematic illustration of a perspective view of the medical device 100 showing the main body 130, the first adjustment mechanism and the second adjustment mechanism shown in FIG. 1C.

[0039] In FIG. IB, the term “a” denotes “arm” referring to a perpendicular distance from an axis 146 (‘third axis’) cutting through the centre of the first knob 140 to an axis 147 (‘fifth axis’) cutting through the guide limiter 144 and both axes 146 and 147 are parallel to the first axis 145. The unit for “a” is usually expressed in millimetres. The term “r” denotes “radius” referring to a vertical distance from the guide limiter 144 to the bottom side of the first knob 140. The unit for “r” is typically expressed in millimetres. The term “c” denotes “clevis’ nominal extension” or “clevis’ length” referring to a distance from the bottom side of the first knob 140 to centre of the clevis pin 143. The unit for “c” is typically expressed in millimetres. [0040] In some embodiments, when the first knob 140 is rotated by a first knob turning angle Ok, the main body 130 may be tilted by a corresponding co-plane angle 0c. A further rotation of the first knob by the same turning angle 0k (total rotation of the first knob is 20k) will result in the main body 130 to be tilted further by 0_C thus total rotation of the main body 130 is 20_c. It is to be understood that if the rotation of the first knob 140 above is clockwise by 0k (denoted as being rotated by +0k), it may be possible that the first knob 140 is rotated anticlockwise by 0k (denoted as being rotated by - 0k). Consequently, the clockwise rotation of the first knob 140 by +0k will tilt the main body 130 by +0_C. Similarly, anticlockwise rotation of the first knob 140 by - 0k will tilt the main body 130 by - 0c. In some embodiments, the first knob turning angle may be a function of the various parameters of the device for example the dimensions of the clevis and so forth, as will be described below.

[0041] As will be described below, the medical device 100 may include an instrument holder 120 mounted at the distal end 120’ of the medical device 100. The instrument holder 120 may include a first layer 121 having markings 124 thereon and a second layer 122 having second markings 125 thereon. Referring now to FIG. 2A, the term “dm” denotes “marker distance” referring to a distance between markers found on the first layer 121 and markers found on the second layer 122 of the instrument holder 120. The unit for “dm” is usually expressed in millimetres. “X_m” in FIG. 2B, denotes “marking distance” referring to a distance between the adjacent lines used in the scale of the markings in the first layer 121 and the second layer 122 of the instrument holder 120 as will be described below. The unit for “X_m” is usually expressed in millimetres. Pitch abbreviated as “p” (not shown) refers to a distance between the two adjacent grooves in the first screw 141 and may be expressed in threads/inch or threads/mm.

[0042] In some embodiments, the first knob turning angle 0k may be dependent on one or more parameters selected from the group consisting of arm (a), radius (r), clevis’ nominal extension (c), marker distance (dm), marking distance (Xm) and pitch (p). Consequently, in some embodiments, the first knob turning angle 0k may be estimated from one or more parameters above. In some embodiments, the first knob turning angle may be estimated or calculated by using the following equation (i):

[0043] In some embodiments, when further adjustment may be required, for example when the main body or the medical device is not aligned to the plane after the first adjustment i.e. first rotation of the first knob 140, the first knob 140 may be further rotated in the same direction as the first rotation (clockwise or anticlockwise) such that the distance of the vertical gap 136 further changes from the second position to a third position, the second position to a fourth position, from a third position to the fourth position, from the third position to a fifth position, or from the fourth position to the fifth position. It is to be understood that a further rotation of the first knob 140 may exert different pressure to the main body.

[0044] As can be appreciated, the first adjustment mechanism may allow the main body 130 of the medical device 100 to be tilted or rotated by a certain co-plane angle 0_c (see FIG. 1C). The rotation may cause the main body to be aligned with the plane. In some embodiments, such adjustment may cause the instrument 100 held by the instrument holder 120 to collide with a target.

[0045] In some embodiments, the medical device 100 may further include the second adjustment mechanism comprising the second knob 150 can be rotated about a second axis 155 (see FIGS. 1A and IB). The second screw 151 is connected to the second knob 150. As described previously, the second adjustment mechanism allows the main body 130 of the device 100 to be displaced laterally. When the second knob 150 is rotated, the second screw 151 will likewise rotate as it exerts a pressure on the main body 130 by pulling or pushing a section of the main body 130. Such pulling or pushing action may be generated by the rotation of the second screw having an expanded tip (not shown) received by a second receiver (not shown) placed inside the main body 130. The second receiver may comprise a recess (not shown) that fits or is complementary to the shape of the expanded tip of the second screw. The lateral displacement may be adjusted such that the extent of rotation of the second knob 150 will correspond to a predefined lateral displacement. In some embodiments, the lateral displacement may be measured by markings 152 present in the main body 130. In some embodiments, such markings may be present at the top side 134 of the main body 130. In some embodiments, the first axis 145 may be positioned perpendicularly with respect to the second axis 155. The angle between the first axis 145 and the second axis 155 is about 90°. In some embodiments, the third axis 137 may be positioned perpendicularly with respect to the first axis 145 and the second axis 155. The angle between the first axis 145 and the third axis 137 is about 90°. The angle between the second axis 155 and the third axis 137 is about 90°.

[0046] In some embodiments, positioning the instrument holder 120 may be performed under an imaging system (for example using X-ray or C-arm) that can see through the instrument holder 120 and the body of the subject to align the instrument 110 to be pointed at a desired point within the body of the subject, for example aligning a hollow needle to reach a stone within the subject’s kidney. Advantageously, the imaging system may only be used only at the beginning of the procedure that is to estimate the location of the desired point or target with respect to the position of the instrument. Once the estimate is approximated, the imaging system may be switched off or inactivated so as to minimize the risk of exposure of the radiation originating from the imaging system. In some embodiments, the imaging system may be used continuously during the adjustment of the instrument. In some embodiments, the imaging system may be used intermittently. As described above, since the duration of the imaging process is reduced, the risk of radiation of exposure may be minimized.

[0047] In some embodiments, when the positioning the instrument holder 120 is performed under the imaging system, said imaging system may generate a radiation to the body of the subject. Said incoming radiation path from the imaging system forms a second plane. When the main body 130 of the medical device 100 is tilted to be aligned to the plane, this plane is perpendicular relative to the second plane that is forming a 90° angle with the incoming radiation path from the imaging system.

[0048] In some embodiments, the first knob 140 may be rotated to cause the main body 130 be substantially positioned in a plane parallel to the incoming radiation path from the imaging system. Consequently, the instrument holder 120 and thus the instrument 110 may be also positioned in a plane parallel to the incoming radiation path from the imaging system. Advantageously, during the adjustment process, second markings 125 of the second layer 122 in the instrument holder 120 may be substantially stationary as the position of the medical device 100 is being adjusted by first adjustment mechanism, second adjustment mechanism or third adjustment mechanism.

[0049] In accordance with some embodiments of the present disclosure, the instrument holder 120 includes a first layer 121 and a second layer 122 connected together by an instrument guide 123 (see FIGS. 1A and 2A). The instrument holder 120 is configured to hold the instrument 110 for access to the subject. As used herein, the instrument guide may also be termed as “connecting guide”. The connecting or instrument guide 123 advantageously prevents or minimizes bending of the instrument 110 when penetrating the skin of a patient. The connecting or instrument guide 123 is perpendicular to the two layers (see FIG. 2A) or forms a preselected angle. In some embodiments, the instrument holder 120 is transparent to the imaging system. In some embodiments, the instrument holder 120 further comprises a handle to fit a positioning arm (not shown).

[0050] In some embodiments, the first layer 121 includes an entry point (not shown) for inserting the instrument 110 to the first layer 121. In some embodiments, the first layer comprises a first layer marking 124 (refer to FIG. 2B) that is non-transparent to the imaging system to identify the first layer 121 and align it relative to the second layer 122. In some embodiments, the first layer marking 124 may be a line or a set of lines. When the first layer marking 124 is a set of lines, the first layer marking 124 includes a middle line. In some embodiments, the first layer markings comprise lines representing linear graduations of a unit of measure (for example in centimetre, millimetre or inch). The distance between the lines of the first layer marking 124 is 0.5, 1, 1.5, 2, 3, or 4 millimetres. It is to be understood that the distance between the lines of the first layer marking 124 may be adjusted to any distance provided that the imaging system can accurately differentiate the lines, and that the distance between the lines of the first layer marking 124 should change proportionately with the distance between the first layer 121 and the second layer 122. Optionally, the first layer marking 124 may further comprise one or more pairs of arrows or arrow heads 126 having their respective vertices facing one another (see FIG. 2B). When the first layer marking 124 comprises one or more pairs of arrows or arrow heads 126, a gap may be formed between vertices of the arrow heads. When the first layer markings 124 comprises lines representing linear graduations of a unit of measure and one or more pairs of arrows or arrow heads, the one or two pairs of arrows or arrow heads 126 are situated above or below the middle line of the lines representing linear graduations of the unit of measure.

[0051] In some embodiments, the first layer 121, the second layer 122 and the connecting or instrument guide 123 are formed as a single mould.

[0052] In some embodiments, the second layer includes an exit point (not shown) from which the instrument 110 exits the instrument holder 120. In some embodiments, the second layer includes the second layer markings 125 that are non-transparent to the imaging system so as to enable the imaging system to identify the second layer and enable the user to align the second layer to the first layer. In some embodiment, the second layer marking 125 is in the shape of a line. In some embodiments, as mentioned above, the second layer marking 125 is stationary or maintains its position as the medical device 100 is adjusted.

[0053] In some embodiments, the first layer marking 124 and the second layer marking 125 are formed from a material such as a radio-opaque material that can be seen on the display of the imaging system. Non-limiting example of the radio-opaque material includes a metallic material.

[0054] In an exemplary embodiment of the disclosure, the first layer marking 124 is designed to form a predefined pattern with the second layer marking 125 when viewed on a display (see FIG. 3) of the imaging system near the target when aligning the first layer and the second layer so that the instrument 110 will collide with the target (or desired point) 128 when inserted into the subject.

[0055] In some embodiments, in the predefined pattern, the second layer marking 125 will align at the middle line of the first layer marking 124 (see FIG. 3(c)). Preferably, the line in the second layer marking 125 is of a different thickness from the lines in the first layer marking 124 to assist the user in differentiating the lines in the first layer marking 124 and in the second layer marking 125. In some embodiments, the line of the second layer marking 125 is narrower than the lines of the first layer marking 124. In some embodiment, in the predefined pattern, the second layer marking 125 will align between the one or two pairs of arrows 126 in the first layer marking 124. In some embodiments, in the predefined pattern, there is a gap between the second layer marking 125 and the vertices of the one or two pairs of arrows 126 in the first layer marking 124 to assist the user in aligning the first layer 121 and the second layer 122. In some embodiments, in the predefined pattern, the gap between the second layer marking 125 and the vertices of the one or two pairs of arrows 126 in the first layer marking 124 is between 0.1 and 0.5 millimetres, and preferably 0.2 millimetres.

[0056] In an exemplary embodiment of the disclosure, a protuberance (not shown) may be provided extending from the second layer 122. Optionally, the protuberance is perpendicular to the second layer 122 or forms a preselected angle with the second layer 122. In some embodiments, the protuberance is located around the exit point (not shown) from which the instrument 110 exits the instrument holder 120. The protuberance advantageously reduces the distance between the exit point of the instrument holder 120 and the skin surface of a patient to prevent bending of the instrument 110 when penetrating the skin of a patient. Preferably, the protuberance is rounded for safety in case of contact with the skin surface of a patient. Preferably, the protuberance is between 2 to 10 millimetres. In some embodiments, the protuberance is around 5 millimetres. Optionally, the connecting or instrument guide 123 guides the instrument 110 from the entry point (not shown) to the exit point through the body (not shown) of the instrument holder 120 and optionally perpendicular to the first layer 121 and second layer 122, or at a preselected angle.

[0057] FIGS. 3 and 4 are schematic illustrations of a process of aligning the instrument holder 120 or medical device 100 having instrument holder 120 mounted at its distal end 120’, according to an exemplary embodiment of the disclosure. In some embodiments, the subject is positioned on a surgical table (not shown) with the medical device 100 above the subject. The instrument holder may be optionally mounted on a positioning arm or an articulated arm 127 to allow more flexibility or further adjustment of the medical device 100. In some embodiments, the positioning arm 127 is attached to the surgical table (not shown) and an imaging system (not shown) is initially positioned at an angle a relative to the vertical. With the assistance of the imaging system (not shown), the practitioner views the display and selects an angled plane relative to the initial angle, which will enable optimal insertion of the instrument 110 to hit the target 128 (e.g. a kidney stone). Additionally, the practitioner selects a puncture angle for tilting the instrument 110 in the selected angled plane to accurately hit the target 128. In some embodiments, a coarse positioning may be used when a practitioner positions the device 100 near or above the target. In some embodiments, the coarse positioning may be assisted by the use of imaging system.

[0058] In some embodiments, when the instrument holder 120 is aligned with the selected plane, the line of the second layer marking 125 will be centred between the arrows of the first layer marking 124. In some embodiments, when the instrument holder 120 is aligned with the selected plane, the line of the second layer marking 125 aligns or is substantially superimposed to the middle line of the first layer marking 124.

[0059] In some embodiments, there is provided a method for aligning an instrument to a target within a subject using a medical device disclosed in the present disclosure.

[0060] In some embodiments, the method comprising providing a medical device 100 as disclosed herein. The method further comprises positioning an imaging system to show on a display the target and the instrument holder 120 and adjusting a first adjustment mechanism to position the instrument in a plane parallel relative to an incoming radiation path from the imaging system.

[0061] In some embodiments, the method further comprising adjusting a second adjustment mechanism to displace the device laterally and position the instrument such that the target is aligned with the plane defined by the first alignment component.

[0062] Referring to FIG. 3, the medical device 100 may be positioned near or above the target. A pointer (or the second layer marking) 125 may be then aligned to the target. This step may be referred to as a coarse positioning of the device. Depending on the position of the pointer 125 with respect to the markings (for example first layer markings 124) shown by the instrument holder 120, the coarse positioning may be repeated. For clarity, when the pointer 125 is found out of the adjustment range as shown in position (a) or (b) in FIG. 3, the coarse positioning may be repeated under the X-ray. Referring to position (a)(i), when the pointer 125 is off scale to right by two marks, to align the instrument 110, the first knob 140 is to be rotated anticlockwise by two marks, followed by confirming the alignment. The rotation may be performed when the X-ray emitting device is switched off. Referring to position (a)(ii) in FIG. 3, when the pointer 125 is off scale to right by one mark, to align the instrument 110, the first knob 140 is to be rotated anticlockwise by one mark, followed by confirming the alignment. The rotation may be performed when the X-ray emitting device is switched off.

[0063] Referring to position (b)(i) in FIG. 3, when the pointer 125 is off scale to left by two marks, to align the instrument 110, the first knob 140 is to be rotated clockwise by two marks, followed by confirming the alignment. The rotation may be performed when the X-ray emitting device is switched off. Referring to position (b)(ii), when the pointer 125 is off scale to left by one mark, to align the instrument 110, the first knob 140 is to be rotated clockwise by one mark, followed by confirming the alignment. The rotation may be performed when the X-ray emitting device is switched off.

[0064] Referring to position (c) in FIG. 3, since the pointer 125 aligns with the target, no further adjustment is required.

[0065] FIG. 4 illustrates a process for aligning the instrument 110 using the first adjustment mechanism and the second adjustment mechanism described in the present disclosure. As can be seen in position (a)(i), the pointer 125 is off scale to left by two marks. As previously described, to align the instrument 110, the first knob 140 is to be rotated clockwise by two marks. At position (a)(i), which corresponds to position (b)(i), the main body 130 of the medical device 100 is not aligned with a surface or a plane (in this case is the skin of the patient or subject). The rotation of the first knob 140 causes the main body 130 to be aligned with that plane. In some embodiments, such first alignment allows the main body 130 to be substantially perpendicular relative to the incoming X-ray (see position (b)(ii) of FIG. 4).

[0066] After the first alignment, the user will determine if the pointer 125 collides the target 127. If the pointer 125 does not collide the target 127 (as can be seen from position (a)(ii) in FIG. 4), the user rotates the second knob 150 causing the pointer 125 to be aligned with the target 127 (see position (a)(iii) of FIG. 4). The final position of the device 100 with respect to the patient or subject can be seen from position (b)(iii) in FIG. 4. In some embodiments, the first alignment may be performed when the X-ray emitting device is switched off. In some embodiments, the second alignment may be performed when the X-ray emitting device is switched off. In some embodiments, the first alignment and the second alignment may be performed when the X-ray emitting device is switched off.

[0067] Table 1 below lists the various parts of the components of the medical device 100 disclosed in the present disclosure. Hence, in some embodiments, it is to be appreciated that the medical device 100 further comprises the following components: a shaft (161) extendable along axis 137 for further adjustment of the device 100, shaft 161 can be secured by a cam lock (162). Device 100 may further comprise a handle (163) for operator or practitioner to orientate device 100 in operational configuration. Device 100 may further comprise a pair of socket lock (169) and a pair of socket screw (170) to secure and fasten instrument guide 120. Device 100 may include fingers (171) around distal end 120’ of device 100, the fingers are extendable along axis 137. Device 100 may further include a pivot pin (172) and a finger lock (173) for securing fingers 171. Device 100 further includes a collet (168), a clamp (167) to secure main body 130. Device 100 may include a guide remover (166), a slider (165) that is extendable along axis 137, and an end stopper (164).

[0068] Table 1. Parts of the medical device 100 in accordance with an embodiment of the present disclosure.

[0069] It should be appreciated that the above-described methods and apparatus may be varied in many ways, including omitting or adding steps, changing the order of steps and the type of devices used. It should be appreciated that different features may be combined in different ways. In particular, not all the features shown above in a particular embodiment are necessary in every embodiment of the disclosure. Further combinations of the above features are also considered to be within the scope of some embodiments of the disclosure.

[0070] It will be appreciated by persons 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 only by the claims, which follow.

Claims

1. A medical device for aligning an instrument with respect to a plane, for accessing a target within a subject, comprising: a main body comprising a lateral extension; an adjustment mechanism, comprising: a knob; a screw connected to the knob; a receiver for receiving the screw, the receiver having a pivot at its bottom section; and a vertical gap formed between said receiver and the lateral extension; a guide limiter connecting the bottom side of the main body and the bottom side of the receiver.

2. The medical device according to claim 1, further comprising an indicator, in contact with the knob, having markings thereon, to indicate the degree of rotation of the knob.

3. The medical device according to claim 2, wherein said indicator comprises a ring having markings thereon, to indicate the degree of rotation of the knob.

4. The medical device according to any one of claims 1-3, wherein when the knob is rotated, the screw’s rotation changes the vertical gap and consequently the main body rotates about the pivot, said rotation is limited by the guide limiter, allowing the main body to be aligned with the plane.

5. The medical device according to claim 4, wherein the vertical gap changes from a first distance to a second distance, wherein at the second distance, the main body is aligned with the plane.

6. The medical device according to claim 5, wherein when the vertical gap is at the second distance and the main body is not aligned with the plane, the knob is further rotated thereby changing the distance of the vertical gap to a third distance, a fourth distance or a fifth distance.

7. The medical device according to any one of claims 1-6, further comprising: a second adjustment mechanism comprising a second knob and a second screw connected to the second knob, said second knob and second screw are positioned at the lateral side of the main body.

8. The medical device according to claim 7, wherein when the second knob is rotated the second screw’s rotation displaces the main body laterally such that the instrument collides with the target.

9. The medical device according to any one of claims 1-8, wherein the plane is perpendicular relative to an incoming radiation path from an imaging system.

10. The medical device according to claim 9, wherein the adjustment minimizes continuous use of the imaging system.

11. The medical device according to any one of claims 5-10, wherein change in the distance of the vertical gap from the first distance to the second distance corresponds to the rotation of the screw by a first turning angle.

12. The medical device according to any one of claims 1-11, wherein the receiver comprises a clevis.

13. The medical device according to claim 12, wherein the receiver further comprising a clevis pivot and a clevis pin.

14. The medical device according to any one of claims 1-13, wherein the instrument is a hollow needle.

15. The medical device according to any one of claims 1-14, further comprising a handle to fit a positioning arm.

16. The medical device according to any one of claims 1-15, wherein the target is located percutaneously.

17. The medical device according to any one of claims 1-16, further comprising an instrument holder to secure the instrument.

18. The medical device according to claim 17, wherein the instrument holder is transparent to the imaging system.

19. A method for aligning an instrument to a target within a subject, comprising: providing a medical device according to any one of claims 1-18; activating an imaging system to show on a display the target and the instrument holder; and rotating the knob of the adjustment mechanism causing the main body of the medical device to rotate the main body about the pivot, said rotation is limited by the guide limiter thereby aligning the main body with the plane.

20. The method of claim 19, wherein step (ii) further comprising (ii-a) deactivating the imaging system before proceeding to step (iii).

21. The method of claim 19 or 20, wherein the rotation of the knob rotates the screw thereby changing the distance of the vertical gap and consequently causing the main body to rotate about the pivot.

22. The method of any one of claims 19-21, wherein said plane is perpendicular relative to an incoming radiation path from the imaging system.

23. The method of any one of claims 19-22, further comprising (iv) rotating a second knob of a second adjustment mechanism to cause the main body to displace laterally such that the instrument collides with the target.

24. The method of any one of claims 21-23, wherein upon rotating the knob, the distance of the vertical gap changes from a first distance to a second distance and said change corresponds to the rotation of the screw by a first turning angle.