阅读说明：本技术 外科手术引导系统、装置和方法 (Surgical guidance systems, devices, and methods ) 是由 苏博德·莫雷 阿施施·杰恩 蒂莫西·哈拉 比滕·凯瑟拉尼 萨米特·马利克 沙尔曼·卡帕迪亚 于 2018-05-22 设计创作，主要内容包括：一种引导装置,可以包括基部构件、联接至基部构件的支撑件、以及联接至支撑件的引导件。引导件可以相对于基部构件移动,并且可以包括从中延伸穿过的通孔。(A guide device may include a base member, a support coupled to the base member, and a guide coupled to the support. The guide may be movable relative to the base member and may include a through-hole extending therethrough.)

1. A guide device, comprising:

a base member;

a support coupled to the base member; and

a guide coupled to the support, wherein the guide is movable relative to the base member and includes a through-hole extending therethrough.

2. The guide device of claim 1, wherein the support comprises a spherical socket and the guide comprises a sphere.

3. Guide means according to any one of claims 1 or 2, wherein the ball is movably received within the support.

4. The guide device of any one of claims 2 or 3, wherein the guide comprises a radiopaque member extending around a circumference of the sphere.

5. The guide device of any one of claims 2-4, further comprising a lock, wherein in a locked configuration, the lock frictionally engages the ball.

6. The guide device of claim 1, wherein the support comprises at least one arm having a rail and the guide comprises a support bed movably coupled to the rail.

7. The guide device of claim 6, wherein the at least one arm is rotatable about a central axis of the base member and relative to the base member.

8. The guide device of claim 7, wherein the support bed is movable along the guide rail about an axis perpendicular to a central axis of the base member.

9. The guide device of any one of claims 6-8, wherein the support bed includes a radiopaque member extending around at least a portion of the support bed.

10. The guide device of any one of claims 6 to 9, wherein the support further comprises a support member received within and rotatable about a channel of the base member.

11. The guide device of any of the preceding claims, further comprising a plurality of tabs coupled to the base member.

12. The guide device of claim 11, wherein at least some of the plurality of tabs are deflectable toward a plane of the base member via a living hinge.

13. The guide device of at least one of claims 11 or 12, wherein at least some of the plurality of tabs include an adhesive thereon.

14. The guide device of any one of the preceding claims, the proximal opening of the through-hole of the guide being tapered.

15. The guide device of any one of the preceding claims, wherein the base comprises a C-ring or a plate.

Technical Field

Aspects of the present disclosure generally relate to medical devices and medical procedures. In particular, some aspects relate to surgical guidance systems, devices, and methods.

Background

Non-invasive surgical procedures enable medical professionals to treat internal areas of the body while minimizing the size of the physical opening in the external skin of the body. Many non-invasive procedures are designed for treating specific regions of the body, such as organs. For example, percutaneous nephrolithotomy (or "PCNL") is a procedure in which an object, such as a needle, is inserted through the skin and into the kidney to remove kidney stones. Precise needle placement is required to avoid damage to the kidney or surrounding tissue. Thus, medical imaging techniques (e.g., fluoroscopy) may be used during PCNL to locate the kidney and track the position of the needle relative to the located kidney. However, even with fluoroscopy, a medical professional must have detailed knowledge of the anatomy in and around the kidney to be able to visualize the kidney and surrounding tissue when the puncture is made through the skin. Thus, the step of accessing the kidney via a percutaneous puncture may require the medical professional to have significant experience and/or assistance from the radiologist to ensure the accurate location and angle of access to the kidney via the puncture in the skin. Furthermore, once access has been gained, the medical professional must ensure that the needle does not move accidentally in order to avoid injury to surrounding tissue.

The systems, devices, and methods of the present disclosure may correct or reduce some of the above-described challenges and/or address other aspects of the prior art.

Disclosure of Invention

Aspects of the present disclosure relate, inter alia, to systems, devices, and methods for surgical guidance. Each aspect disclosed herein may include one or more features described in connection with any other disclosed aspect.

In one example, the guide device may include a base member, a support coupled to the base member, and a guide coupled to the support. The guide may be movable relative to the base member and may include a through-hole extending therethrough.

Examples of the guiding means may include one or more of the following features. The support may comprise a ball socket and the guide may comprise a ball. The ball may be movably received within the support. The guide may include a radiopaque member extending around a circumference of the ball. The device may further comprise a locking element, and in the locked configuration, the locking element frictionally engages the ball. The support may include at least one arm having a rail, and the guide may include a support bed movably coupled to the rail. The at least one arm may be rotatable about a central axis of the base member and relative to the base member. The support bed may be movable along the guide rail about an axis perpendicular to the central axis of the base member. The support bed may include a radiopaque member extending around at least a portion of the support bed. The support may further comprise a support member received within and rotatable about the channel of the base member. The device may further include a plurality of tabs coupled to the base member. At least some of the plurality of tabs may be deflectable toward a plane of the base member via a living hinge. At least some of the plurality of tabs may include an adhesive thereon. The proximal opening of the through hole of the guide may be tapered. The base may comprise a C-ring or plate.

In another example, a method may include positioning a base member of a guide device at a site on a patient's skin. The method may further include adjusting an angular orientation of a guide movably coupled to the base member. The guide may comprise a ball received in the seat. Additionally, the method may include securing the base member to the skin of the patient and deploying the insertion device through the ball and into the patient.

Examples of the method may include one or more of the following features. The method may include confirming an orientation of the insertion device via a radiopaque member positioned on the ball. Securing the base member to the skin may include deflecting at least one tab coupled to the base member toward the skin of the patient. The method may further include frictionally engaging the ball via the lock to prevent movement of the ball relative to the seat.

In another example, a guide device may include a base member having a central axis, a seat coupled to the base member, and a ball rotatably received within the seat. The ball may include a radiopaque member around the circumference of the ball. The sphere may rotate about a sphere axis that is coaxial with the central axis or angled with respect to the central axis.

Examples of the guiding means may include one or more of the following features. The device may further comprise a locking element, and in the locked configuration, the locking element may frictionally engage the ball. A plurality of tabs may be coupled to the base member. At least some of the plurality of tabs may be deflectable toward a plane of the base member via a living hinge. At least some of the plurality of tabs may include an adhesive thereon.

Both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the features as claimed. As used herein, the terms "comprises," "comprising," "has," "having," or other variations thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. In addition, the term "exemplary" is used herein in the sense of "exemplary" rather than "ideal". As used herein, the terms "about," "substantially," and "approximately" refer to a range of values that are within +/-5% of the stated value.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects and together with the written description, serve to explain the principles of the disclosure.

Fig. 1 illustrates an exemplary guidance system including a base and an insertion device according to an aspect of the present disclosure;

FIG. 2 illustrates an exemplary guidance system including a base and an insertion device according to another aspect of the present disclosure;

FIG. 3 illustrates a further exemplary guidance system according to another aspect of the present disclosure, including a base and an insertion device;

FIG. 4 illustrates another exemplary guidance system including a base and an insertion device according to another aspect of the present disclosure;

FIGS. 5A-5C illustrate various alternative attachment mechanisms for the base of FIGS. 1-3; and is

Fig. 6A and 6B depict various alternative locking mechanisms for the base of fig. 1.

Detailed Description

Examples of the present disclosure relate to surgical guidance systems, devices, and methods for treating an internal body region of a subject. Such a surgical guidance system may include a base and at least one insertion device associated with the base that is inserted into an organ (e.g., a kidney) of a patient via a puncture in the patient's skin. In addition, such surgical guidance systems may help track the position of objects relative to the patient's body.

Reference will now be made in detail to the examples of the present disclosure described above and illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.

The terms "proximal" and "distal" are used herein to refer to the relative and directional positions of the components of an exemplary base or insertion device. As used herein, "proximal" refers to a location closer to the exterior of the patient's body or closer to the operator and/or medical professional using the base or insertion device. Conversely, "distal" refers to a location further from the operator and/or medical professional using the base or insertion device or closer to the interior of the patient's body.

Although aspects of the present disclosure are described with reference to a surgical guidance system incorporating medical imaging techniques for tracking the position of an insertion device (e.g., a needle) relative to a patient's kidney, the present disclosure is not so limited. Rather, any reference to a particular type of medical procedure (e.g., PCNL), insertion device (e.g., needle), treatment area (e.g., kidney), or medical imaging technique (e.g., fluoroscopy) is provided for convenience and is not intended to limit the present disclosure. Accordingly, the example surgical guidance systems, devices, and methods described herein may be used in or with any other suitable procedure, insertion device, treatment area, or imaging technique (medical or otherwise). For example, other energy emitting devices similar to a fluoroscope may be suitable for use with the devices and methods according to the present disclosure. Furthermore, while some of the arrangements described herein relate only to radiopaque materials used as imaging reference materials, other types of imaging reference materials may also be used in conjunction with other imaging systems (e.g., ultrasound, MRI, or CAT scanning devices).

As shown in fig. 1, the surgical guiding system includes a base 10 that includes a base member 12. The base member 12 may be a substantially flat disc, plate and/or ring. For example, the base member 12 shown in fig. 1 comprises a C-shaped plate that extends between about 220 ° and 260 °, or about 240 °, around the central axis C of the base 10. In other words, the base member 12 is a partial ring. The base member 12 includes a distally directed surface 14 that is movable along the patient's skin, as will be described in further detail below.

The base member 12 includes a plurality of tabs 16 that extend radially outward (e.g., away from the central axis) from the central axis C. As shown, the central axis C extends perpendicular to the plane of the distally directed surface 14. The three tabs 16 are equally spaced about the base member 12. Alternatively, more or fewer tabs 16 may be positioned about the base member 12, equally or unequally spaced. The tab 16 may be of any suitable shape. For example, as shown in FIG. 1, the tabs 16 are generally rectangular in shape. Other shapes may include square, circular, oval, triangular, polygonal, irregular, and combinations thereof. Further, in some arrangements, at least one tab 16 may have a shape that is different from the shape of at least another tab 16. As shown, each tab 16 may be generally planar and include a distally directed surface 18 that may be selectively secured to the patient's skin, as will be described in further detail below. Thus, the distally directed surface 18 may include an adhesive 20 or tape thereon. In another arrangement, only one or some of the tabs 16 may include adhesive 20 thereon. Alternatively, in some arrangements, no adhesive 20 is included on the tab 16. Rather, once positioned at the desired location on the patient's skin, the medical professional can tape or glue or otherwise secure one or more of the tabs 16 to the patient's skin.

Each tab 16 is coupled to the base member 12 via at least one flexible living hinge 22, thereby enabling movement of the tab 16 relative to the base member 12. For example, the living hinge 22 may include a connection between the tab 16 and the base member 12 having a thinned dimension, thereby enabling bending along the thinned portion. Thus, in a first configuration, as shown in fig. 1, each tab 16 may be bent upward in the direction of arrow a or away from the plane of the distally directed surface 14. In a second configuration (not shown), each tab 16 may be pushed or deflected downward in the direction of arrow B toward the plane of the distally directed surface 14, as will be described in further detail below. It should be understood that each tab 16 may be independently deflectable in the direction of arrow a or arrow B, such that only one or some tabs 16 may be deflected at any one given time.

As shown in fig. 1, the base 10 further includes a plurality of legs 24. For example, the base 10 includes three equally spaced legs 24 (only two of which are visible in the orientation of fig. 1). In other arrangements, more or fewer legs 24 may be positioned about the base 10, equally or unequally spaced about the central axis C. Each leg 24 may have any suitable shape, and pairs of adjacent legs 24 may define windows 26 to facilitate insertion/removal of various tools or devices (e.g., sheaths, needles, etc.) as desired. The width of each leg 22 (extending along a plane parallel to the plane of the distally-directed surface 14) has a dimension that is less than the length extending between the base member 12 and the support or abutment 28. In this way, window 26 may be sized to pass one or more tools therethrough if the medical professional determines that it is necessary or desirable. Thus, in some aspects, the legs 24 may have a length of between about 5mm and 25mm, or a length of about 20 mm. In addition, because the base member 12 is C-shaped, at least one window 26 is enlarged relative to at least one of the other windows 26. That is, the at least one window 26 is free of (e.g., does not include) the base member 12 along a bottom portion thereof. In this way, the base member 12 does not reduce the size of the window 26 and/or does not impede or interfere with the insertion/removal of tools through the base 10 along the patient's skin.

The seat 28 includes a spherical socket in which an inserter guide (e.g., a ball or sphere 30) is movably received. For example, the seat 28 may be contoured (not shown) (e.g., concave, cup-shaped, etc.) in a manner corresponding to the shape of the ball 30 to enable rotational movement of the ball 30 within the seat 28. In this way, the ball 30 can be rotated 360 ° around the central axis C. Furthermore, the ball 30 may set the angle to an angle α extending between the central axis C and the longitudinal axis N of the insertion device 40 received in the ball 30. For example, the angle α may be between about 10 ° and about 45 °, or about 35 °. It will be appreciated that the ball 30 may further rotate about an axis N, which may be coaxial or angled with respect to the central axis C in some arrangements. In some arrangements, a lubricating material may be located between the seat 28 and the ball 30 or on one or both of the seat or ball in order to reduce friction between the seat 28 and the ball 30. As shown, the seat 28 may include a lip or lip 32 that extends radially inward toward the central axis C to retain the ball 30 within the seat 28.

The seat 28 includes a channel 34 that extends through a portion (e.g., a radially outward side) of the seat, as shown in FIG. 1. A lock 36 is movably received within the channel 34 and can be selectively actuated to lock the ball 30 in a selected position. For example, the locking member 36 may include a push button mechanism. In a first configuration (e.g., a locked configuration), as shown in fig. 1, the spring (not shown) of the locking member 36 frictionally engages the ball 30, thereby preventing relative movement between the ball 30 and the seat 28. In a second configuration (not shown), the locking member 36 may be pressed or pushed radially inwardly in the direction of arrow D to release the spring force exerted by the spring of the locking member 36 to enable or allow the ball 30 to move freely within the seat 28. In some arrangements, the locking member 36 may include a spring-loaded button or push tab.

The ball 30 includes a through hole 38 through which an insertion device 40 may be advanced, as will be described in further detail below. The through bore 38 has a proximal entrance opening 42 and a diametrically opposed distal exit opening 44 (at

Not visible in the orientation of fig. 1). As shown, the access opening 40 may be tapered, conical, or otherwise funnel-shaped to facilitate passage of the insertion device 40 therethrough. Silicone, rubber, semi-rigid or elastomeric material may be lined or included in the through-hole 38 to frictionally engage the insertion device 40. Alternatively, the through-hole 38 may have a diameter sufficiently similar in size to the diameter of a portion of the insertion device 40 extending therethrough to frictionally grip the insertion device 40. In either arrangement, the insertion device 40 is securely positioned within the throughbore 38 and may be advanced upon application of a force greater than the frictional force holding the insertion device 40 within the throughbore 38. Additionally, a radiopaque member 46 is positioned on the ball 30. For example, the radiopaque member 46 may comprise a ring or wire of radiopaque material extending circumferentially around the hemisphere of the sphere 30. However, in some arrangements, the radiopaque member 46 may extend around less than the entire circumference of the sphere 30. Additionally, in some arrangements, the radiopaque member 46 may be discontinuous around the circumference of the sphere 30. Still further, in some arrangements, the radiopaque member 46 may be located on either side of a hemisphere of the sphere 30.

The exemplary insertion device 40 is shown in fig. 1 as having an elongated body or shaft 48 extending along an axis N between a distal end 50 and a proximal end 52. The insertion device 40 may be any type of elongate object such as a needle, cannula, catheter with one or more working channels, rigid or flexible barrel, or similar element. In some arrangements, the insertion device 40 is an 18 or 21 gauge insertion needle. The distal end 50 has a sharp or angled tip 54 that is constructed and arranged to facilitate penetration of body tissue (e.g., into and/or through the skin of a patient). At least a portion of the distal end 50 includes a radiopaque material to enhance visibility of the insertion device 40 via fluoroscopy. For example, in some arrangements, the entire shaft 48 may be radiopaque, while in other arrangements, one or more portions of the shaft 48 may be radiopaque.

The proximal end 52 has a hub or interface 56 that is engageable with a manipulation tool. For example, in some arrangements, the interface 56 includes a polygonal shape that is engageable with a forceps (not shown). However, in other arrangements, the proximal end 52 may assume any suitable shape, such as a rounded spherical shape, which may have a portion configured for use with forceps, such as the interface 56. Additionally or alternatively, the interface 56 may be held by the hand of a medical professional, as will be described in further detail below. In some aspects, the interface 56 may be coupled with a syringe (not shown) or the like for drawing and/or injecting fluid (e.g., urine), as will be described in further detail below. Optionally, the insertion device 40 may include a depth indicating slide 58 movably coupled to the shaft 48. For example, the slider 58 includes a central through hole 60 that surrounds the shaft 48. Silicone, rubber, semi-rigid or elastomeric material may be lined or included in the through-hole 60 to frictionally engage the shaft 48. Alternatively, the through-hole 60 may have a diameter sufficiently similar in size to the diameter of a portion of the insertion device 40 extending therethrough to frictionally grip the insertion device 40. In either arrangement, the insertion device 40 is securely positioned within the through-hole 60. In use, the slider 58 can be advanced along the shaft 48 to a position indicative of a maximum or preferred depth of insertion of the distal end 50 into the patient's tissue. The user may adjust the position of the slider 58 by applying a force greater than the frictional force holding the insertion device 40 within the through-hole 60 and advancing or retracting the slider 58 along the shaft 48. However, in some arrangements, the slide 58 may be omitted.

A surgical guidance system according to another aspect is shown in fig. 2. The system of fig. 2 is similar to the system of fig. 1, but with the base 10 replaced by a base 100. As shown, the base 100 includes a partial ring 112A and an insert 112B that together form a base member 112. In connecting the insert 112B to the partial ring 112A, the base 100 comprises a full 360 ° ring having a distally directed surface 114 that is movable along the patient's skin, as will be described in further detail below. In some arrangements, for example, the partial ring 112A extends between about 245 ° and about 305 ° about a central axis C of the base member 112 (along which the insertion device 40 extends in the orientation of fig. 2), or about 275 °. Additionally, in some arrangements, the insert 112B extends between about 55 ° and about 115 °, or about 85 °, around the central axis C of the base member 112. The insert 112B may be selectively coupled to and decoupled from the partial ring 112 in any suitable manner. In some arrangements, one or some portions of partial ring 112A may magnetically attract one or more portions of insert 112B. Additionally or alternatively, the partial ring 112A may include one or more insert connection portions 130 that define a groove for connecting (e.g., snap-fit connection, etc.) to a corresponding lip or extension 132 of the insert 112B.

Similar to the base member 12 of fig. 1, the base member 112 of fig. 2 includes a plurality of tabs 116 that extend radially outward (e.g., away from) the central axis C of the base member 112. As shown, the central axis C extends perpendicular to the plane of the distally directed surface 114. Similar to the base 12, the tabs 116 may have any suitable shape, number, arrangement, and/or spacing. In addition, each tab 116 may be generally planar and include a distally-directed surface 118 that may be selectively secured to the patient's skin, as will be described in further detail below (e.g., via an optional adhesive 120 or tape).

The base 100 further includes a support 122. As shown, at least a portion of the support 122 is received within a channel or track 124 of the partial ring 112A. Similar to the partial ring 112A, the support 122 may be C-shaped and extend between about 245 ° and about 305 ° about the central axis C, or about 275 °. The support 122 is rotatable about the central axis C to adjust the angular position of the insertion device 40. As shown, the support 122 includes an indicator 126. During rotation of the support 122, the indicator 126 is aligned with one of a plurality of angular scales 128 disposed about the base member 112. In this manner, the angular rotation of support 122, and thus insertion device 40 extending therethrough, is readily visible to the medical professional. Additionally, at least one of the support 122 and the base member 112 may include ratchet, notch, indent, or similarly shaped surfaces (not shown) such that rotation of the support 122 about the base member 112 causes tactile and/or audible feedback (e.g., a click) due to interference between the support 122 and the base member 112.

As shown in fig. 2, the support 122 further includes a pair of arms 134. The arm 134 is fixed relative to the support 122 so as to rotate therewith. As shown, each arm 134 includes a hemispherical shape with a rail 136. Each rail 136 may be coupled to a support or support bed 138. That is, the support bed 138 may include a track or lip 140 coupled to the rail 136 for movement therealong. Silicone, rubber, semi-rigid, and/or elastomeric materials may line or be included between lip 140 and rail 136 to frictionally retain support bed 138 at a desired position along rail 136. Alternatively, the lip 140 may be sized with dimensions sufficiently similar to those of the rail 136 to frictionally retain the support bed 138 at a desired location along the rail 136. The support bed 138 may be advanced or retracted along the rail 136 in the direction of arrows E and F upon application of a force greater than the frictional force holding the support bed 138 at a certain position along the rail 136. In this manner, the angular position of the support bed 138 relative to an axis G perpendicular to the central axis C may be adjusted. As shown, the support bed 138 includes a plurality of markings 142 that indicate the angle of adjustment of the support bed 138 relative to the axis G, and may be aligned with markings (not shown) on the arm 134.

The support bed 138 further includes an inserter guide support 144 having a through-hole 146 through which the inserter 40 can be advanced, as will be described in further detail below. The through-hole 146 extends between a proximal entry opening 148 and a diametrically opposed distal exit opening (not visible in the orientation of fig. 2). Similar to the ball 30 of fig. 1, the access opening 148 may be tapered, conical, or otherwise funnel-shaped to facilitate passage of the insertion device 40 therethrough. Additionally, silicone, rubber, semi-rigid and/or elastomeric materials may be lined or included in through-hole 146 to frictionally engage insertion device 40. Alternatively, the through-hole 146 may have a diameter sufficiently similar in size to the diameter of a portion of the insertion device 40 extending therethrough to frictionally grip the insertion device 40. In either arrangement, the insertion device 40 is securely positioned within the through-hole 146 and may be advanced upon application of a force greater than the frictional force holding the insertion device 40 within the through-hole 146. Additionally, a radiopaque member 152 may be positioned on the abutment 144. For example, radiopaque member 152 may comprise a ring or wire of radiopaque material extending circumferentially around at least a portion or all of abutment 144. In this arrangement, the insertion device 40 can rotate around the base member 112 and along the arms 134, which are always located at the center of the base member 112, thereby facilitating accurate insertion along a desired angle.

Additionally, in some arrangements, the radiopaque member 152 may be discontinuous around the circumference of the abutment 144.

A surgical guidance system according to another aspect is shown in fig. 3. The system of fig. 3 is similar to the system of fig. 1, but with the base 10 replaced by a base 200. The base 200 includes a base member 212 having a distally directed surface 214 that is movable along the patient's skin, as will be described in further detail below. The base member 212 may have any suitable shape (e.g., circular, elliptical, polygonal, irregular, combinations thereof, etc.). Further, the base member 212 may have a shape or size that varies along the length of the base member 212. The base member 212 includes a central through-hole 230 extending therethrough. Similar to the base member 12 of fig. 1, the base member 212 of fig. 3 includes a plurality of tabs 216 that extend radially outward (e.g., away from) the central axis C of the base member 212. As shown, the central axis C extends perpendicular to the plane of the distally directed surface 214. Similar to the base 12, the tabs 216 may have any suitable shape, number, arrangement, and/or spacing. In addition, each tab 216 may be generally planar and include a distally-directed surface 218 that may be selectively secured to the patient's skin, as will be described in further detail below (e.g., via an optional adhesive 220 or tape).

The base member 212 further includes a channel 222 extending within the through-hole 230 around the inner circumference of the base member 212. Alternatively, the channel 222 may extend around the outer circumference of the base member 212 without departing from the scope of the present disclosure. In either arrangement, the channel 222 may be sized to receive at least one protrusion 232 of the seat 234. For example, the seat 234 may include a pair of diametrically opposed projections 232, at least a portion 236 of which is received within and rotatable about the channel 222. Thus, the seat 234 may be rotated about the central axis C of the base 200 to adjust the angular position of the insertion device 40. As shown, the seat 234 may include an indicator 238 on at least one of the projections 232. During rotation of the mount 234, the indicator 238 is aligned with one of the plurality of angular scales 228 disposed about the base member 212. In this manner, angular rotation of the seat 234 about the central axis C, and thus the insertion device 40 extending therethrough, is readily visible to the medical professional. Additionally, at least one of the portion 236 and the channel 222 can include a ratchet, notch, indentation, or similarly shaped surface (not shown) such that rotation of the seat 234 about the base member 212 causes tactile and/or audible feedback (e.g., a click) due to interference therebetween.

As shown in fig. 3, the support 234 comprises a hemispherical frame having a pair of opposing legs 240. Each leg 240 is received by the coupling portion 242 of a respective one of the projections 232. For example, the coupling portion 242 includes at least one bracket, ring, tube, and/or cylinder in which the leg 240 is movably received. That is, the leg 240 is movable (e.g., slidable) relative to the coupling portion 242 to adjust the angle of the insertion device 40. For example, the legs 240 of the seat 234 may be selectively movable in the direction of arrow G (e.g., out of the page as shown in fig. 3) or in the direction of arrow H (e.g., into the page as shown in fig. 3) about an axis J extending perpendicular to the central axis C. Silicone, rubber, or semi-rigid or elastomeric material may be lined or included in coupling portion 242 to frictionally engage leg 240. Alternatively, coupling portion 242 may be of a sufficiently similar size as leg 240 extending therethrough so as to frictionally grip leg 240. In either arrangement, seat 234 is securely positioned within coupling portion 242 and may be advanced/retracted upon application of a force greater than the frictional force between leg 240 and coupling portion 242.

The base 200 further includes a ring 244 pivotably coupled to the seat 234. For example, the support 234 includes a pair of struts 246 extending between the legs 240. For example, a first strut 246 extends between the first ends of the legs 240, and a second strut 246 extends between the second ends of the legs 240 to form a hemispherical frame of the seat 234. Each strut 246 is pivotably coupled to the ring 244 via a shaft 248 extending therebetween. In this way, ring 244 is rotatable about axis K, which is perpendicular to central axis C and axis J.

The base 200 further includes an insertion device guide, such as a center support 250 within the ring 244. The central support 250 includes a through hole 252 through which the insertion device 40 can be advanced, as will be described in further detail below. Silicone, rubber, or semi-rigid or elastomeric material may be lined or included in through-hole 252 to frictionally engage insertion device 40. Alternatively, the through-hole 252 may have a diameter sufficiently similar in size to the diameter of a portion of the insertion device 40 extending therethrough to frictionally grip the insertion device 40. In either arrangement, the insertion device 40 is securely positioned within the through-hole 252 and may be advanced upon application of a force greater than the frictional force holding the insertion device 40 within the through-hole 252. Center support 250 is pivotably coupled to ring 244 via a shaft 254 extending therebetween. In this manner, the central support 250 and the insertion device 40 extending therethrough may pivot about an axis J extending perpendicular to the central axis C and the axis K. A radiopaque member 260 may be positioned on the central support 250. For example, radiopaque member 260 may comprise a ring or wire of radiopaque material extending circumferentially around at least a portion or all of central support 250. Additionally, in some arrangements, the radiopaque member 260 may be discontinuous around the circumference of the central support 250.

A surgical guidance system according to another aspect is shown in fig. 4. The system of fig. 4 includes a base 300 coupled to a bed 302 via an arm 304. For example, the bed 302 may include an operating table and/or a hospital bed on which a patient may be positioned for surgery, and is schematically illustrated in fig. 4. The arm 304 may extend between the bed 302 and the base 300 and may include any one or more of a strut, support, bracket, and/or linkage to facilitate supporting and mounting the base 300 to the bed 302. In some arrangements, a rack and pinion mechanism may couple bed 302 to arm 304.

The base 300 includes a base member 312 having a central through-hole 314 extending therethrough. The base member 312 is rotatably coupled to the arm 304 such that the base member 312 is rotatable about the central axis C of the base 300, for example in the direction of arrow L and/or arrow M. For example, the arm 304 may include a post (not shown) that is received within a track or channel (not shown) on a surface of the base member 312 facing the arm 304 (e.g., an underside or bottom of the base member 312). The channel may include a cut-out, notch, or the like, such that movement of the post of the arm 304 along the channel of the base member 312 provides tactile and/or audible feedback. As shown, the base member 312 includes an angular scale 316 disposed about the base member 312, while the arm 304 includes an indicator 318. During rotation of the base member 312, the indicator 318 is aligned with one of a plurality of angular scales 316 disposed about the base member 312. In this manner, the angular rotation of support base member 312 and, thus, insertion device 40 extending therethrough is readily visible to the medical professional.

The base 300 further includes a first linear adjuster 320 and a second linear adjuster 322 extending perpendicular to the first linear adjuster 320. The first linear adjuster 320 is fixedly mounted (e.g., non-movably mounted) to the base member 312, while the second linear adjuster 322 is movable (e.g., slides, translates, etc.) along the first linear adjuster 320 in a first direction N or a second direction O opposite the first direction N. For example, the first linear actuator 320 includes a central through-hole 324 within which a protrusion (not shown) of the second linear actuator 322 extends. The protrusion may include an enlarged portion (not shown) having a dimension (e.g., width) greater than a dimension (e.g., width) of the through-hole 324 to maintain the second linear actuator 322 coupled (e.g., movably coupled, slidably coupled, etc.) to the first linear actuator 320. The second linear adjuster 322 is rectangular and includes a first side surface 326, a second side surface 328, a first base surface 330, and a second base surface 332. A first base surface 330 and a second base surface 332 extend between opposite ends of the first and second side surfaces 326 and 328. In addition, the second linear adjuster 322 includes a central throughbore 334 extending through the first and second side surfaces 326 and 328. The insertion device guide support 336 is movably (e.g., slidably) coupled to the first side surface 326. The support 336 is movable along the second linear adjuster 322 in a first direction P and a second direction Q opposite the first direction P. Furthermore, the support 336 comprises a central through hole 338 through which the insertion device 40 extends. Silicone, rubber, semi-rigid and/or elastomeric materials may be lined or included in through-hole 338 to frictionally engage insertion device 40. Alternatively, the through-hole 338 may have a diameter sufficiently similar in size to the diameter of a portion of the insertion device 40 extending therethrough to frictionally grip the insertion device 40. In either arrangement, the insertion device 40 is securely positioned within the through-hole 338 and may be advanced upon application of a force greater than the frictional force holding the insertion device 40 within the through-hole 338. In use, the insertion device 40 is advanced to the second linear adjuster 322 until precise placement is determined, and then further advanced through the second linear adjuster 322 and the first linear actuator 320 to insert the insertion device 40.

In use, a medical professional can use any of base 10, base 100, base 200, or base 300 to align insertion device 40 with a desired treatment site (e.g., targeted calyx of a kidney). Optionally, the patient may be instructed to ingest a radiopaque contrast agent before or during a certain procedure (e.g., a PCNL procedure). Alternatively, one or more portions or structures of the patient (e.g., targeted renal calyces in the kidney) may be injected with a radiopaque contrast agent. In this way, targeted renal calyces or other structures can be visualized via fluoroscopy.

The medical professional may then move base 10, base 100, base 200, and/or base 300 relative to the patient's skin. For example, a medical professional may translate, slide, or otherwise move the respective distally-directed surfaces 14, 114, 214 of the base members 12, 112, 212 along the patient's skin. Alternatively, the medical professional may move base 312 over (e.g., over) the patient's body via arm 318. To determine the correct angle of insertion of the insertion device into the targeted renal calyx, the medical professional may adjust the insertion device 40 relative to the base 10, 100, 200, and/or 300 by means of a fluoroscopy device. For example, a medical professional may rotate the ball 30 within the seat 28 of the base 10 about the central axis C and/or position the ball 30 at an angle α relative to the central axis C (fig. 1); the support 122 may be rotated relative to the base member 112 and/or the position of the support bed 138 may be adjusted along the rails 136 about the axis G (fig. 2); the seat 234 can be adjusted about the central axis C relative to the base 212, the leg 240 about the axis J relative to the coupling portion 242, the ring 244 about the axis K, and the center support 250 about the axis J (fig. 3); or adjusting the base member 312 about the central axis C, adjusting the second linear adjuster 322 in directions N and/or O along the first linear adjuster 320, and/or adjusting the seat 336 in directions Q and/or P along the second linear adjuster 322 (fig. 4).

During adjustment of the insertion device 40 relative to the base 10, 100, 200, and/or 300, the medical professional can see the base 10, 100, 200, 300, the insertion device 40, and one or more radiopaque portions of the targeted renal calyx. For example, a medical professional may observe the location of the radiopaque rings 46, 152 and/or 260 relative to the insertion device 40 and the targeted renal calyx. Once the radiopaque rings 46, 152 and/or 260 are in line with the axis N of the insertion device 40 and the targeted calyx, the correct insertion angle is confirmed. At this point, the tabs 16, 116, and/or 216 may be deflected toward the plane of the distally directed surfaces 14, 114, and/or 214 to contact and adhere to the patient's skin via the adhesive 20, 120, and/or 220. Alternatively, the tabs 16, 116, and/or 216 may be secured to the patient's skin via one or more glues or tapes.

After confirming the proper insertion angle of the insertion device 40, the medical professional may rotate the C-arm of the fluoroscopy device to an angle that is perpendicular to the angle at which it was positioned when confirming the insertion angle of the insertion device 40. In this orientation, the fluoroscopy device is able to clearly see the insertion depth of the insertion device 40. After confirming the insertion angle and rotation of the C-arm of the fluoroscopy device, the insertion device 40 may be advanced (e.g., moved distally along axis N) through the through-holes 38, 148, 252, and/or 338 to penetrate the patient's skin and advance the tip 54 to a targeted site within the patient's body (e.g., to target the renal calyx). For example, a medical professional may grasp interface 56 (or any other available portion of insertion device 40) via a tool (e.g., forceps) or their hand in order to advance insertion device 40 distally toward the targeted renal calyx. The correct insertion depth of the insertion device 40 may be confirmed in any suitable manner, such as via visualization of one or more radiopaque portions of the insertion device 40, visually confirming urine flow through the needle, drawing urine through a syringe connected to the needle, or some combination of the above. A guidewire may be inserted through the shaft 48 and the shaft 48 may be removed over the guidewire. The guidewire may be left to guide instruments (e.g., dilation catheter, access sheath, lithotripsy device, retrieval device, etc.) required for PCNL procedures into the targeted renal calyx.

Fig. 5A-5C illustrate an alternative tab configuration for the base of fig. 1-3. For example, as shown in fig. 5A, the living hinge 22 of the base 10 in fig. 1 is replaced with a pivoting member 70 about which the tab 72 can pivot. To secure the tabs 72 of fig. 5A to the patient's skin, the tabs 72 are pivoted toward the patient's skin via the respective pivot members 70. Similar to the arrangement of fig. 1, the distal-facing surface of one or more tabs 72 includes an adhesive (not shown) thereon. Alternatively, as shown in fig. 5B, the living hinge 22 and tab 16 of the base 10 in fig. 1 are replaced with a living hinge 74 and leg 76. As shown, the legs 76 may raise the base member 12 from the patient's skin a distance equal to the length of the legs 76. To secure the legs 76 to the patient's skin, the base member 12 may be pressed distally, e.g., toward the patient's skin, to radially bend the legs 76 along the living hinges 74 away from the central axis C. Alternatively, any one or more of the legs 76 may be pushed or pulled radially outward away from the central axis C in order to bend the legs 76 along the living hinge 74. In some arrangements, one or more surfaces (e.g., the inner surface 78 of one or more legs 76) may include an adhesive (not shown) thereon. In yet another arrangement, as shown in fig. 5C, the tabs 16 of the base 10 in fig. 1 are replaced by a ring 80. In such an arrangement, the base member 12 may include one or more openings, windows, or apertures 82 extending therethrough. Each aperture 82 may be sized to pass an extension 84 of the ring 80 therethrough. For example, each aperture 82 may have a shape corresponding in size and arrangement to at least one extension 84 of the ring 80. Further, the distally directed surface of each extension 84 may include an adhesive (not shown) thereon. To secure the base 10 to the patient's skin, the ring 80 may be pressed distally, e.g., toward the patient's skin, to advance the extension 84 through the aperture 82.

Fig. 6A and 6B illustrate an alternative locking mechanism for fixing the position of the ball 30 of the base 10 in fig. 1. For example, as shown in fig. 6A, the locking member 36 of the base 10 in fig. 1 is replaced with a locking member 86. The locking member 86 includes a spring-loaded push button 88 housed in an outer housing 90. To unlock the position (e.g., angular orientation) of the ball 30 relative to the rest of the base 10, the push button 88 may be pressed towards the patient's skin for receipt in the outer housing 90. Once received therein, the ball 30 can be rotated relative to the outer housing 90. The exterior surface of the push button 88 may be tapered such that interference between the push button 88 and the outer housing 90 maintains the push button 88 therein until the push button 88 is pressed again (e.g., toward an overextended configuration, not shown) so as to allow the push button 88 to retract and move toward the locked configuration, as shown in fig. 6A. In another arrangement, as shown in fig. 6B, the locking member 36 of the base 10 in fig. 1 is replaced by a locking member 96. Locking element 96 includes a collet 94 positioned within a sleeve 96. As is known, the outer surface of the collet 94 and the inner surface of the sleeve 96 may be correspondingly threaded for engagement therebetween. To lock the position (e.g., angular orientation) of the ball 30 relative to the remainder of the base 10, the sleeve 96 may be rotated about the central axis C to compress the collet 94 and thereby frictionally engage the ball 30.

While the principles of the disclosure are described herein with reference to illustrative aspects for particular applications, it should be understood that the disclosure is not limited thereto. For example, while the slider 58 is shown and described in connection with the arrangement of fig. 1, the slider 58 may additionally be used in connection with any of the arrangements of fig. 2-4, 5A-5C, 6A, and 6B without departing from the scope of the present disclosure. Those skilled in the art and guided by the teachings herein provided will appreciate that other modifications, applications, aspects, and equivalents fall within the scope of the various aspects described herein. Accordingly, the disclosure should not be considered as limited by the foregoing description.