Guide for a medical device

Abstract

A guide for a medical device, the guide including a base defining a first side and a second side opposite from the first side. The first side is configured to be coupled to a patient. The base includes an aperture that extends through the first side and the second side and the aperture defines a central point and a central axis that extends through the aperture and the central point. The guide includes a protractor coupled to the base, the protractor has a first semicircular body including a first plurality of slots and a second semicircular body. The first semicircular body is configured to selectively couple the second semicircular body. The protractor includes a plurality of channels in radial alignment with the central point that are configured to receive the medical device. The plurality of channels is defined between the first semicircular body and the second semicircular body.

Description

Attorney Docket No. 093386-0012-W001GUIDE FOR A MEDICAL DEVICECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No.63 / 748,488, filed January 23, 2025, the entire contents of which are incorporated by reference herein.FIELD

[0002] Constructions, examples, and aspects described herein relate to, among other things, a guide for a medical device, such as needles used for biopsies.

[0100] BACKGROUND

[0003] Biopsies may require specific locations of tissue to be sampled.SUMMARY

[0003] The present disclosure provides, in one aspect, a guide for a medical device, the guide including a base defining a first side and a second side opposite from the first side. The first side is configured to be coupled to a patient. The base includes an aperture that extends through the first side and the second side and the aperture defines a central point and a central axis that extends through the aperture and the central point. The guide includes a protractor coupled to the base, the protractor has a first semicircular body including a first plurality of slots and a second semicircular body. The first semicircular body is configured to selectively couple the second semicircular body. The protractor includes a plurality of channels in radial alignment with the central point that are configured to receive the medical device. The plurality of channels are defined between the first semicircular body and the second semicircular body.

[0004] The present disclosure provides, in one aspect, a guide for a medical device, the guide including a base defining a first side and a second side opposite from the first side. The first side is configured to be coupled to a patient. The base includes a main body and an aperture that extends through the main body from the first side to the second side. The aperture defines aAttorney Docket No. 093386-0012-W001central point and a central axis that extends through the aperture and the central point. The base includes a pair of legs extending from the main body along a longitudinal axis that is perpendicular to the central axis. The guide includes a protractor coupled to the pair of legs. The protractor includes a first semicircular body and a second semicircular body. The first semicircular body is configured to selectively couple the second semicircular body. The protractor includes a plurality of channels defined between the first semicircular body and the second semicircular body.

[0005] The present disclosure provides, in one aspect, a method of preparing a guide for a medical device. The method includes coupling a first side of a base of the guide to a patient. The method includes pivoting a first semicircular body of a protractor relative to the base. The method includes pivoting a second semicircular body of the protractor relative to the base. The method includes aligning a protrusion extending from the first semicircular body with a recess defined in the second semicircular body that corresponds with the protrusion. The method includes coupling the protrusion with the recess. The method includes forming a plurality of channels defined between the first semicircular body and the second semicircular body in response to the first semicircular body being coupled to the second semicircular body. Each of the plurality of channels configured to receive the medical device.

[0006] Other aspects of the present disclosure will become apparent by consideration of the detailed description and accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0007] FIG. 1 is a perspective view of a guide for a medical device, according to a construction of the disclosure.

[0008] FIG. 2 is a perspective view of a base and a protractor for the guide of FIG. 1.

[0009] FIG. 3 is a perspective view of a base, according to another construction of the present disclosure.

[0010] FIG. 4 is a perspective view of a protractor, according to another construction of the present disclosure.Attorney Docket No. 093386-0012-W001

[0011] FIG. 5A is a front perspective view of a first body of an armature, according to another construction of the present disclosure.

[0012] FIG. 5B is a rear perspective view of the first body of the armature of FIG. 5 A.

[0013] FIG. 6 is a front perspective view of a second body of an armature.

[0014] FIG. 7 is a front perspective view of a guide in the open or unfolded position, according to another construction of the present disclosure.

[0015] FIG. 8 is a perspective view of a base and the protractor of FIG. 7.

[0016] FIG. 9 is a top view of the base and the protractor of FIG. 7.

[0017] FIG. 10 is an enlarged view of slots of a plurality of slots of a first semicircular body of the protractor of FIG. 7.

[0018] FIG. 11 is a side view of the base and the protractor of FIG. 7.

[0019] FIG. 12 is an enlarged view of grooves of the guide of FIG. 7.

[0020] FIG. 13 is a rear perspective view of the base and the protractor of FIG. 7.

[0021] FIG. 14 is a bottom view of the base and the protractor of FIG. 7.

[0022] FIG. 15 is an enlarged view of identifiers of a plurality of identifiers of the first semicircular body of the protractor of FIG. 7.

[0023] FIG. 16 is a perspective view of the base and the protractor of FIG. 7 in a collapsed or folded position.

[0024] FIG. 17 is a perspective view of the base and the protractor of FIG. 7 receiving the medical device.

[0025] FIG. 18 is a top schematic view of a portion of the protractor of FIG. 17.

[0026] FIG. 19 is a top view of the guide of FIG. 7 being aligned with a laser of a CT gantry.Attorney Docket No. 093386-0012-W001

[0027] FIG. 20 A is a schematic side view of the guide of FIG. 7 being aligned with the laser of the CT gantry.

[0028] FIG. 20B is a schematic side view of the guide of FIG. 7 being aligned with the laser of the CT gantry.

[0029] FIG. 21 is a top schematic view of a portion of the protractor of FIG. 7 in the collapsed or folded position with slots according to another construction of the present disclosure.DETAILED DESCRIPTION

[0030] Before any constructions of the disclosure are explained in detail, it is to be understood that the disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The disclosure is capable of other constructions and of being practiced or of being carried out in various ways.

[0031] The terms “substantially,” “essentially,” “approximately,” “about,” or any other version thereof, are defined as being close to as understood by one of ordinary skill in the art, and in one non-limiting embodiment the term is defined to be within 10%, in another embodiment within 5%, in another embodiment within 1% and in another embodiment within 0.5%. The term “one of,” without a more limiting modifier such as “only one of,” and when applied herein to two or more subsequently defined options such as “one of A and B” should be construed to mean an existence of any one of the options in the list alone (e.g., A alone or B alone) or any combination of two or more of the options in the list (e.g., A and B together).

[0032] A device or structure that is “configured” in a certain way is configured in at least that way but may also be configured in ways that are not listed.

[0033] The terms “coupled,” “coupling,” or “connected” as used herein can have several different meanings depending on the context in which these terms are used. For example, the terms coupled, coupling, or connected can have a mechanical or electrical connotation. For example, as used herein, the terms coupled, coupling, or connected can indicate that twoAttorney Docket No. 093386-0012-W001elements or devices are directly connected to one another or connected to one another through intermediate elements or devices via an electrical element, electrical signal or a mechanical element depending on the particular context.

[0034] In the foregoing specification, specific embodiments are described. However, one of ordinary skill in the art appreciates that various modifications and changes may be made without departing from the scope of the invention as set forth in the claims below. Accordingly, the specification and figures are to be regarded in an illustrative rather than a restrictive sense, and all such modifications are intended to be included within the scope of present teachings.

[0035] One of ordinary skill in the art appreciates that various modifications and changes can be made without departing from the scope of the invention as set forth in the claims below. The benefits, advantages, solutions to problems, and any element(s) that may cause any benefit, advantage, or solution to occur or become more pronounced are not to be construed as a critical, required, or essential features or elements of any or all the claims. The invention is defined solely by the appended claims including any amendments made during the pendency of this application and all equivalents of those claims as issued.

[0036] Moreover, in this document, relational terms such as first and second, top and bottom, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. The terms “comprises,” “comprising,” “has,” “having,” “includes,” “including,” “contains,” “containing,” or any other variation thereof, are intended to cover a nonexclusive inclusion, such that a process, method, article, or apparatus that comprises, has, includes, contains 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. An element proceeded by “comprises ...a,” “has ...a,” “includes ... a,” or “contains ...a” does not, without more constraints, preclude the existence of additional identical elements in the process, method, article, or apparatus that comprises, has, includes, contains the element. Unless the context of their usage unambiguously indicates otherwise, the articles “a,” “an,” and “the” should not be interpreted as meaning “one” or “only one.” Rather these articles should be interpreted as meaning “at least one” or “one or more.” Likewise, when the terms “the” or “said” are used toAttorney Docket No. 093386-0012-W001refer to a noun previously introduced by the indefinite article “a” or “an,” “the” and “said” mean “at least one” or “one or more” unless the usage unambiguously indicates otherwise.

[0037] FIGS. 1 and 2 illustrate a guide 100 for a medical device (e.g., a designated gauge needle) according to an embodiment of the present disclosure. Examples of the medical devices compatible with the guide 100 include, but are not limited to, biopsy needles (e.g., aspiration needles and coaxial needles) and other needles for diagnostic testing (e.g., vascular, biliary, lymphatic, urinary / renal access) and therapeutic procedures (eg., localized chemotherapy / radiotherapy injection, ablation needle placement, spinal augmentation needles). Other medical devices include a caliber dilator or catheter. The guide 100 provides rapid and accurate orientation of biopsy and procedural needles prior to placement into the body to minimize the amount of time and radiation necessary to accurately position the needle. With the aid of CT imaging guidance, the guide 100 enables a user to easily and precisely determine the azimuthal and equatorial angles of the trajectory of the needle before insertion which, combined with a needle of known length, provides the three-dimensional (3D) coordinates necessary to eliminate the guesswork of stereotactic needle placement, thus significantly reducing procedure time, radiation, complications, and patient discomfort.

[0038] The guide 100 includes a base 104 and a protractor 108 having an armature 112. The base 104, the protractor 108, and the armature 112 are configured to be assembled intraoperatively. In some embodiments, the base 104 is disc-shaped and includes a first side 116 and a second side 120. The first side 116 is configured to be coupled to a patient 122. In some constructions, the first side 116 includes an adhesive (e.g., a skin adhesive). The base 104 includes embedded markers 124. In the illustrated construction, the markers are radiopaque markers 124 (e.g., thin metallic wire or film). In other constructions, the markers 124 are visible on an MR. I (e.g., gadolinium or manganese impregnated ink). In the illustrated construction, the radiopaque markers 124 extend around a circumference of the base 104 and around a circumference of the aperture 128. The radiopaque markers 124 also include tick marks (e.g., at 3, 6, and 9 o'clock) on the second side 120 of the base 104. In some constructions, the radiopaque marker 124 is a continuous layer along an entirety of the base 104. The markers 124 act as fiducial markers visible under CT which ensure that the device / needle entry point is properly positioned. The markers 124 also ensure that the base 104 is aligned with a laserAttorney Docket No. 093386-0012-W001sightline within the CT gantry. In the illustrated construction, three of the radiopaque markers 124 are spaced approximately 90 degrees from one another. In other constructions, the radiopaque markers 124 includes less than three markers or greater than three markers. In other constructions, the markers of the radiopaque markers are spaced less than 90 degrees or more than 90 degrees from each other. In the illustrated construction, the base 104 defines a diameter DI that is approximately 1 centimeter. In other constructions, the diameter DI is less than 1 centimeter or greater than 1 centimeter. The base 104 includes an aperture 128 (e.g., a beveled or chamfered hole) that extends through the base 104 from the first side 116 to the second side 120. In the illustrated construction, the aperture 128 is centrally arranged on the base 104. The aperture 128 defines a central point Cl. The base 104 includes a slit 132 extending from the aperture 128 to an outer periphery of the base 104 (e.g., the 12 o'clock edge of the disc). The slit 132 is wide enough for a medical device (e.g., a designated gauge needle 134) to pivot within but allowing the base 104 to be removed from around the needle 134 after placement into the patient 122. The base 104 includes a pair of pegs 136 (FIG. 2) that are configured to interface with the protractor 108. In the illustrated construction, the pegs of the pair of pegs 136 extend from the base 104 between the first and second sides 116, 120 and are disposed 180 degrees relative to one another.

[0039] The protractor 108 includes radial spokes 140 with clips 144 on an end of the spokes 140 that attach to the pegs of the pair of pegs 136 of the base 104. In the illustrated construction, the clips 144 are made of ridged plastic. The interface between the pegs 136 and the clips 144 permits the protractor 108 to rotate in an altitudinal direction Al relative to the base 104. In some constructions, the pegs 136 and / or the clips 144 include ridges 146 (FIG. 2) such that the position of the protractor 108 can be fixed in the direction Al relative to the base 104. For instance, the position of the protractor 108 may need to be changed in cases where oblique CT gantry tilt is required. In the illustrated construction, the protractor 108 is semicircular and is constructed out of plastic. In other constructions, the protractor may be constructed from metal, wood, or a composite, etc. The protractor 108 defines a diameter D2. In the illustrated construction, the diameter D2 is approximately 11 centimeters. In other constructions, the diameter D2 is less than 11 centimeters or greater than 11 centimeters. The protractor 108 includes angular markings 150. In the illustrated construction, the angular markings 150 are placed in intervals along a circumference of the protractor 108 in a direction A2. The directionAttorney Docket No. 093386-0012-W001A2 is perpendicular to the direction Al . Tn some constructions, the angular markings 150 are disposed at 5-degree intervals in the direction A2. In some constructions, the intervals of the angular markings 150 are less than 5 degrees or greater than 5 degrees. In some constructions, the angular markings 150 are radiopaque markers. The protractor 108 defines a first channel 154 that extends through the protractor 108 and about the central point Cl. The protractor 108 defines a second channel 158 that extends through the protractor 108 and about the central point Cl. The second channel 158 is disposed nearer to the base 104 than the first channel 154.

[0040] The protractor 108 includes an armature 112 that is configured to slide in the first and second channels 154, 158. The armature 112 is coupled to the protractor 108 via a fastener 166 that extends through the armature 112 and the first channel 154 such that the armature 112 is slidably coupled to the protractor 108. In some constructions, the fastener 166 may be fastened such that the armature 112 is fixed along the direction A2. In some constructions, the armature 112 includes a clip 168 that provides a second coupling point of the armature 112 to the protractor 108. The armature 112 is coupled to the protractor 108 such that the armature 112 is disposed radially outward from the central point Cl. The fastener 166 and / or the clip 168 are configured to provide a friction fit between the armature 112 and the protractor 108 such that the armature 112 can be locked in a position in the direction A2. In the illustrated construction, the armature 112 includes a needle guide 170. In the illustrated construction, the needle guide 170 is defined by the armature 112. That is, the needle guide 170 is integrated with the armature 112. In other constructions, the needle guide 170 is a separate piece that is coupled to the armature 112. The needle guide 170 includes a groove 172 configured to receive the medical device (e.g., the needle 134). The groove 172 points toward the base 104 (e.g., the central point Cl). The groove 172 has a width specific to the gauge of the medical device (e.g., the needle 134).

[0041] The guide 100 can be sold as a prepackaged kit. The kit may include more than one armature 112, with each of the armatures having grooves 172 with different widths such that different sized medical devices can be accommodated. For instance, one of the armatures may accommodate a small gauge needle (e.g., a 22 gauge needle) for anesthesia followed by an armature with a larger gauge biopsy needle (e.g., a 16 gauge needle). The grooves 172 are compatible with needles between 26 gauge and 15 gauge. In other constructions, the grooves 172 are compatible with gauges above 26 gauge and below 26 gauge. Each of the components ofAttorney Docket No. 093386-0012-W001the guide 100 (e.g., the base 104, the protractor 108, and the armature 112) may be made of a transparent medical-grade plastic that has been sterilized. Each of the components of the guide 100 may be manufactured in a single injection molding for decreased cost and packaging.

[0042] FIG. 3 illustrates another construction of a base 200. The base 200 is similar to the base 104 and therefore only differences will be discussed. In the illustrated construction, the base 200 includes a countersunk hole 204.

[0043] FIG. 4 illustrates another construction of a protractor 300. The protractor 300 is similar to the protractor 108 and therefore only differences will be discussed. The protractor 300 includes the first channel 154, the second channel 158, and a third channel 304.

[0044] FIGS. 5A-6 illustrate another construction of an armature 400. The armature 400 includes a first body 404 (FIGS. 5A and 5B) and a second body 408 (FIG. 6). The first body 404 includes the groove 172 configured to receive the medical device. The first body 404 includes a first projection 412 and a second projection 416. The first projection 412 is configured to be received by the first channel 154 and the second projection 416 is configured to be received by the second channel 158. The first and second projections 412, 416 are each arcuately-shaped such that the projections 412, 416 slide in the first and second channels 154, 158. Each of the first and second projections 412, 416 include recesses 420. The second body 408 includes projections 424 configured to engage the recess 420 of the first and second projections 412, 416 such that the armature 400 is coupled to the protractor (e.g., the protractors, 108 and 300). The first and second bodies 404, 408 are coupled together with a portion of the protractor disposed between the bodies 404, 408.

[0045] FIG. 7 illustrates another construction of a guide 500 for a medical device (e.g., a designated gauge needle). The guide 500 includes a base 504, a protractor 508 coupled to the base 504, and a radiopaque marker 512 configured to be coupled to the base 504. In the illustrated construction, the radiopaque marker 512 defines a profile that matches the base 504. In the illustrated construction, the radiopaque marker 512 includes adhesive on each side such that one side of the radiopaque marker 512 is coupled to the base 504 and an opposite side of the radiopaque marker 512 is coupled to the patient.Attorney Docket No. 093386-0012-W001

[0046] FIGS. 8 and 9 illustrate the base 504 having a main body 516 defining a first side 520 and a second side 524 opposite from the first side 520. In the illustrated embodiment, the first side 520 receives the radiopaque marker 512 such that the first side 520 is coupled to the patient (e.g., a patient’s skin 526). The radiopaque marker 512 is visible under a CT (e.g., gadolinium or manganese impregnated ink). In the illustrated construction, the radiopaque marker 512 extends around a circumference of the base 504. In some constructions, the radiopaque marker 512 includes tick marks (e.g., at 3, 6, and 9 o'clock). In some constructions, the radiopaque marker 512 is a continuous layer along an entirety of the base 504. The radiopaque marker 512 act as fiducial marker visible under CT which ensure that the device / needle entry point is properly positioned. The base 504 includes an aperture 528 that extends through the main body 516. That is, the aperture 528 extends through the first side 520 and the second side 524. The aperture 528 defines the central point Cl, which is disposed in the center of the aperture 528, and a central axis Al that extends through the aperture 528 and the central point Cl. The aperture 528 is configured to receive the medical device. The main body 516 includes a chamfer 532 disposed on the second side 524. The base 504 includes a slit 536 defined in the main body 516. Specifically, the slit 536 extends from the aperture 528 to an outer perimeter 538 of the main body 516, the outer perimeter extending between the first and the second sides 520, 524. The base 504 includes a pair of legs 540 that extend from the main body 516. In the illustrated construction, the pair of legs 540 are disposed on opposite sides of the outer perimeter 538. In the illustrated construction, a leg of the pair of legs 540 is disposed 180 degrees from the other leg of the pair of legs 540. In other words, a leg of the pair of legs 540 is parallel to the other leg of the pair of legs 540. The pair of legs 540 extend along a longitudinal axis A2 that is perpendicular to the central axis Al.

[0047] With continued reference to FIGS. 8 and 9, the protractor 508 is coupled to the base 504. In the illustrated construction, the protractor 508 is coupled to the pair of legs 540. The protractor 508 includes a first semicircular body 544 and a second semicircular body 548, the first semicircular body 544 being disposed on an opposite side of a plane Pl from the second semicircular body 548. The plane Pl extends through the longitudinal axis A2 and is parallel to the central axis Al. In the illustrated construction, the first and the second semicircular bodies 544, 548 are similar in construction. The first semicircular body 544 is configured to selectively couple the second semicircular body 548. In the illustrated construction, the first and the secondAttorney Docket No. 093386-0012-W001semicircular bodies 544, 548 are each configured to be pivoted relative to the base 504 such that the first and the second semicircular bodies 544, 548 selectively couple to one another (see FIG.16). In the illustrated construction, the first and the second semicircular bodies 544, 548 are each folded relative to the base 504. The first semicircular body 544 and the second semicircular body 548 each define an outer edge El and an inner edge E2. The inner edge E2 is disposed radially closer to the base 504 than the outer edge El .

[0048] With continued reference to FIGS. 8 and 9, the first semicircular body 544 includes a first plurality of slots 552 that extend between the outer edge El and the inner edge E2. Each slot of the first plurality of slots 552 extends in a direction radially aligned with the central point Cl. In some constructions, each slot of the first plurality of slots 552 is angularly offset from adjacent slots of the first plurality of slots 552 by an angle between 1 degree and 10 degrees relative to the central point Cl. In the illustrated construction, each slot of the first plurality of slots 552 is angularly offset from adjacent slots of the first plurality of slots 552 by 2.5 degrees relative to the central point Cl. The first plurality of slots 552 defines an angular span SI. In the unfolded position as shown in FIGS. 8 and 9, the angular span SI is measured from a lateral axis A3 that is perpendicular to the central axis Al and the longitudinal axis A2. In the folded or collapsed position, the angular span SI is measured from the central axis Al (FIG. 16). In the illustrated construction, the angular span SI is approximately 120 degrees. In the illustrated construction, the angular span SI extends from -60 degrees to 60 degrees relative to the central axis Al. The first semicircular body 544 includes a protrusion 556 extending therefrom. In the illustrated construction, the protrusion 556 is spherical. The protrusion 556 contact or align with a corresponding feature on the second semicircular body 548. The first semicircular body 544 includes a recess 560 defined therein. The recess 560 receives a corresponding feature of the second semicircular body 548.

[0049] FIG. 10 illustrates slots of the first plurality of slots 552. Each of the slots 552 has fillets 561 between walls 562 such that the surface of each slot is smooth (i.e., no sharp corners on the interior of each respective slot). The fillets 561 help to guide the medical device from the outer edge El to the inner edge E2 without getting snagged.Attorney Docket No. 093386-0012-W001

[0050] Referring back to FIGS. 8 and 9, the second semicircular body 548 includes a second plurality of slots 564 that extend between the outer edge El and the inner edge E2. Each slot of the second plurality of slots 564 extends in a direction radially aligned with the central point Cl. In some constructions, each slot of the second plurality of slots 564 is angularly offset from adjacent slots of the second plurality of slots 564 by an angle between 1 -degree and 10 degrees relative to the central point Cl. In the illustrated construction, each slot of the second plurality of slots 564 is angularly offset from adjacent slots of the second plurality of slots 564 by 2.5 degrees relative to the central point Cl. The second plurality of slots 564 defines an angular span S2. In the unfolded position as shown in FIGS. 8 and 9, the angular span S2 is measured from the lateral axis A3. In the folded or collapsed position, the angular span S2 is measured from the central axis Al (FIG. 16). The angular span S2 matches the angular span SI relative to the longitudinal axis A2 (e g., the angular span is mirrored about the longitudinal axis A2).

[0051] With continued reference to FIGS. 8 and 9, the second semicircular body 548 includes a protrusion 568 extending therefrom. In the illustrated construction, the protrusion 568 is spherical. The protrusion 568 contacts or aligns with the recess 560 of the first semicircular body 544. The second semicircular body 548 includes a recess 572 defined therein. The recess 572 receives the protrusion 556 of the second semicircular body 548. Each respective protrusion and recess on the first and the second semicircular bodies 544, 548 are configured to align the first semicircular body 544 with the second semicircular body 548 when the first and the second semicircular bodies 544, 548 selectively couple to one another. In some constructions, the protrusions 556, 568 and the recesses 560, 572 are replaced with a locking mechanism such that the first and the second semicircular bodies 544, 548 can be locked with one another. For instance, the protrusions 556, 568 and the recesses 560, 572 can be replaced with a corresponding ball detent mechanism. In the illustrated construction, each slot of the slots 552, 564 is the same size and is configured to accommodate medical devices of different shapes and sizes. In other constructions, the size of the slots 552, 564 can be changed to accommodate different sizes of medical devices. In some construction, the gauge of needles that can be accommodated by the slots 552, 564 range from 10 gauge to 24 gauge. For instance, in one construction, the slots 552, 564 may be sized to accommodate a 16 gauge needle. In another construction, the slots 552, 564 may be sized to accommodate a 22 gauge needle. That is,Attorney Docket No. 093386-0012-W001multiple constructions of the guide 500 can be produced to accommodate different medical devices.

[0052] With reference to FIGS. 11 and 12, the guide 500 further includes a first groove 576 at least partially disposed between the base 504 and the first semicircular body 544. In the illustrated construction, the first groove 576 is a U-groove. The first groove 576 reduces the thickness of the material coupling the base 504 to the first semicircular body 544 such that the first semicircular body 544 can pivot about the first groove 576. The first semicircular body 544 defines a first thickness T1 measured in a direction parallel to the central axis Al in the unfolded position. In the illustrated construction, the thickness T1 is approximately 2.6 millimeters. The first semicircular body 544 includes an intermediate region 580 that is disposed next to the first groove 576. The intermediate region 580 defines a second thickness T2 measured in a direction parallel to the central axis Al in the unfolded position. In the illustrated construction, the thickness T2 is approximately 1.3 millimeters. In other words, the intermediate region 580 defines a thickness that is approximately half the thickness defined by other portions of the first semicircular body 544. Each leg of the pair of legs 540 defines a thickness T3 measured in a direction parallel to the central axis Al in the unfolded position. In the illustrated construction, the thickness T3 is approximately 1.3 millimeters. The first groove 576 defines a radius R1 of approximately 0.75 millimeters. On an opposite side of the guide 500 than the first groove 576, there is a second groove 584. In the illustrated construction, the second groove 584 is a rectangular groove. The first groove 576 and the second groove 584 are disposed on the same side of the plane Pl . A thickness T4 is defined between the grooves 576 and the second groove 584. In the illustrated construction, the thickness T4 is approximately 0.25 millimeters. Due to the geometry of the grooves 576, 584, and the reduced thickness of the guide 500, the first semicircular body 544 is configured to pivot about the first groove 576.

[0053] With reference to FIGS. 11 and 12, the guide 500 further includes a third groove 588 at least partially disposed between the base 504 and the second semicircular body 548. In the illustrated construction, the third groove 588 is a U-groove. The third groove 588 reduces a thickness of material coupling the base 504 to the second semicircular body 548 such that the second semicircular body 548 can pivot about the third groove 588. The second semicircular body 548 has a common thickness with the first semicircular body 544 (i.e., the thickness of theAttorney Docket No. 093386-0012-W001second semicircular body 548 is the same as the thickness Tl). The second semicircular body 548 includes an intermediate region 592 that is disposed next to the third groove 588. The intermediate region 592 has a common thickness with the intermediate region 580 (i.e., the thickness of the intermediate region 592 is the same as the thickness T2). The third groove 588 and the first groove 576 have a common radius (i.e., the radius of the third groove 588 is the same as the radius R1 of the first groove 576). On an opposite side of the guide 500 than the third groove 588, there is a fourth groove 596. In the illustrated construction, the fourth groove 596 is a rectangular groove. The third groove 588 and the fourth groove 596 are disposed on the same side of the plane Pl. A thickness defined between the grooves 588, 596 is common with the thickness defined between the grooves 576, 584 (i.e., the thickness defined between the grooves 588, 596 is the same as the thickness T4). Due to the geometry of the grooves 588, 596, and the reduced thickness of the guide 500, the second semicircular body 548 is configured to pivot about the third groove 588.

[0054] FIGS. 13-15 illustrate a side of the guide 500 that is opposite from the side with the slots 552, 564. The base 504 includes an optional integrated radiopaque marker 512. As discussed with respect to FIG. 7, some embodiments of the guide 500 include the radiopaque marker 512 that is separately coupled to the first side 520 of the base 504. In some constructions, as shown in FIGS. 13 and 14, the radiopaque marker 512 can be integrated within the base 504. Each of the first semicircular body 544 and the second semicircular body 548 includes an identifier of a plurality of identifiers 600 for each slot of the slots 552, 564.

[0055] With continued reference to FIGS. 13-15, in some constructions, at least one identifier of the plurality of identifiers 600 includes a first marker 604. In the illustrated construction, the first marker 604 is aligned with a corresponding slot of the plurality of slots 552, 564. The first marker 604 extends from the respective semicircular body in a direction radially aligned with the central point Cl. The first marker 604 defines a length LI in a direction aligned with a radial direction from the central point Cl.

[0056] With continued reference to FIGS. 13-15, in some constructions, at least one identifier of the plurality of identifiers 600 includes a slit 608 and a second marker 612. The slit 608 extends from the outer edge El and toward the inner edge E2. In the illustratedAttorney Docket No. 093386-0012-W001construction, the second marker 612 is aligned with a corresponding slot of the plurality of slots 552, 564. The second marker 612 extends from the respective semicircular body in a direction radially aligned with the central point Cl. The second marker 612 defines a length L2 in a direction aligned with a radial direction from the central point Cl.

[0057] With continued reference to FIGS. 13-15, in some constructions, at least one identifier of the plurality of identifiers 600 includes the slit 608 and a third marker 616. In the illustrated construction, the third marker 616 is aligned with a corresponding slot of the plurality of slots 552, 564. The third marker 616 extends from the respective semicircular body in a direction radially aligned with the central point Cl. The third marker 616 defines a length L3 in a direction aligned with a radial direction from the central point Cl.

[0058] With continued reference to FIGS. 13-15, in some constructions, at least one identifier of the plurality of identifiers 600 includes the slit 608 and a fourth marker 620. In the illustrated construction, the fourth marker 620 is aligned with a corresponding slot of the plurality of slots 552, 564. The fourth marker 620 extends from the respective semicircular body in a direction radially aligned with the central point Cl (FIG. 14). The fourth marker 620 defines a length L4 in a direction aligned with a radial direction from the central point Cl . In the illustrated construction, the magnitude of the length LI is less than a magnitude of the lengths L2, L3, and L4. The magnitude of the length L2 is greater than the magnitude of the length LI and less than the magnitudes of the lengths L3 and L4. The magnitude of the length L3 is greater than the magnitude of the lengths LI and L2 and less than the length L4. The magnitude of the length L4 is greater than the magnitude of the lengths LI, L2, and L3.

[0059] With continued reference to FIGS. 13-15, each of the first semicircular body 544 and the second semicircular body 548 includes a plurality of indicia 624 that indicate the angle relative to the lateral axis A3 in the unfolded position or open position (FIGS. 7-9) or the central axis Al in the folded position or collapsed position. In the illustrated constriction, the indicia 624 are numbers that correspond to the angle of the identifiers 600. In the illustrated construction, the fourth marker 620 corresponds to the lateral axis A3 in the unfolded position or the central axis Al in the folded position. In the illustrated construction, the third marker 616 corresponds to a 10-degree increment from the lateral axis A3 in the unfolded position or theAttorney Docket No. 093386-0012-W001central axis Al in the folded position. In the illustrated construction, the second marker 612 corresponds to a 5-degree increment between the third markers 616. In the illustrated construction, the first marker 604 corresponds to a 2.5-degree increment between the second marker 612 and the third marker 616.

[0060] FIG. 16 illustrates the protractor 508 in the folded position or the collapsed position. In the folded position, the first semicircular body 544 and the second semicircular body 548 face each other. In the illustrated construction, the plane Pl is disposed between the first semicircular body 544 and the second semicircular body 548. In the folded position, the first semicircular body 544 couples to the second semicircular body 548. That is, the protrusions 556, 568 selectively couples or aligns with the recesses 572, 560 respectively. As shown in FIG. 16, a gap 626 is defined between the first semicircular body 544 and the second semicircular body 548. The protractor 508 includes a plurality of channels 628 that are in radial alignment with the central point Cl. In the illustrated construction, the plurality of channels 628 are disposed in the gap 626. The plurality of channels 628 are defined between the first and the second semicircular bodies 544, 548. In some constructions, the plurality of channels 628 is defined between the first plurality of slots 552 of the first semicircular body 544 and the second semicircular body 548. In some constructions, the plurality of channels 628 is defined between the second plurality of slots 564 of the second semicircular body 548 and the first semicircular body 544. In some constructions, the plurality of channels 628 is defined between the first plurality of slots 552 and the second plurality of slots 564. The first semicircular body 544 and the second semicircular body 548 are selectively coupled to one another because the first and the second semicircular bodies 544, 548 contact one another when a force is applied to bring the bodies 544, 548 together at the plane Pl. However, the first and the second semicircular bodies 544, 548 do not remain coupled to one another after the force is removed.

[0061] FIG. 17 illustrates the protractor 508 in the folded position with the medical device (e.g., the needle 134). In some constructions, the needle 134 is placed into a channel of the plurality of channels 628. That is, the first and the second semicircular bodies 544, 548 are selectively coupled to one another to form the plurality of channels 628 and then the needle 134 is guided through a channel of the plurality of channels 628. In other constructions, the needle 134 is rested in a slot of one of slots 552, 564 of the first and the second semicircular bodies 544,Attorney Docket No. 093386-0012-W001548 prior to the first and the second semicircular bodies 544, 548 being coupled to one another. In the illustrated construction, the base 504 and the protractor 508 are constructed of a single piece (i.e., a monolithic construction). In the illustrated construction, the base 504 and the protractor 508 are constructed by injection molding. In the illustrated construction, the base 504 and the protractor 508 are formed from a single piece of polypropylene.

[0062] FIG. 18 illustrates a schematic view of a portion of the protractor 508 in the folded position. In the folded position, the first plurality of slots 552 and the second plurality of slots 564 face one another with the plane Pl disposed therebetween. As shown in FIG. 18, the first plurality of slots 552 are aligned with the second plurality of slots 564 in a direction perpendicular to the plane Pl. As such, each channel of the plurality of channels 628 is defined between a slot of the first plurality of slots 552 and a slot of the second plurality of slots 564.

[0063] FIGS. 19-20B illustrate the method of using the guide 500. The guide 500 is provided in a sterile bag (not shown) in the unfolded position. The guide 500 is removed from the sterile bag and a protective film coupled to the adhesive on the radiopaque marker 512 is removed. The central point Cl of the aperture 528 is aligned with an entry point 632 of the patient. The longitudinal axis A2 of the pair of legs 540 is aligned with the laser sightline of the computed tomography (CT) gantry. Specifically, the laser sight defines a first axis A4 and a second axis A5. Depending on the desired location of the medical device, the longitudinal axis A2 is aligned with either the first axis A4 or the second axis A5. In the illustrated embodiment, the longitudinal axis A2 is aligned with the first axis A4, and the guide 500 is coupled to the patient, as shown in FIG. 19. Specifically, the first side 520 of the base 504 is coupled to the skin 526 of the patient.

[0064] With continued reference to FIGS. 19-20B, after coupling the first side 520 of the base 504 to the patient, the first semicircular body 544 is pivoted or folded relative to the base 504 and the second semicircular body 548 is pivoted or folded relative to the base 504. In the illustrated embodiment, the first semicircular body 544 is pivoted about the first groove 576. In the illustrated embodiment, the second semicircular body 548 is pivoted about the third groove 588. The first and the second semicircular bodies 544, 548 are pivoted toward each other with the plurality of slots 552, 564 in a facing relationship with the plane Pl. In the illustratedAttorney Docket No. 093386-0012-W001construction, the protrusion 556 is aligned with the recess 572 and the protrusion 568 is aligned with the recess 560. After the first and the second semicircular bodies 544, 548 are in a facing relationship, the needle 134 can either be inserted into a slot of the slots 552, 564 (e.g., prior to the first and the second semicircular bodies 544, 548 being coupled to one another) or into a channel of the plurality of channels 628 (e.g., after the first and the second semicircular bodies 544, 548 are coupled to one another). The needle 134 is held within a channel of the plurality of channels 628 because the needle 134 is sandwiched between the first semicircular body 544 and the second semicircular body 548. That is, the user can pinch the first and the second semicircular bodies 544, 548 such that the friction force between the first and the second semicircular bodies 544, 548 and the needle 134 controls positioning of the needle 134. For instance, the first and the second semicircular bodies 544, 548 can be held with a force that prevents the needle 134 from moving in a channel of the channels 628. The first and the second semicircular bodies 544, 548 can be held with a force that permits the needle 134 to move within the channel of the plurality of channels 132 toward the central point Cl.

[0065] With reference to FIGS. 20A and 20B, the plurality of channels 628 are also aligned with either the first axis A4 or the second axis A5. In FIG. 20A, the plurality of channels 628 are aligned with the first axis A4. In FIG. 20A, the first axis A4 is oriented perpendicular to the patient’s skin 526 and the longitudinal axis A2 (extending in and out of the page) is aligned with the first axis A4. However, in other embodiments, the first axis A4 is not perpendicular to the patient’s skin 526. As shown in FIG. 20B, the first axis A4 is disposed at an angle that is not perpendicular to the patient’s skin 526. Accordingly, the plurality of channels 628 at the outer edge El are oriented to be aligned with the first axis A4 that is not perpendicular to the patient’s skin 526 and the longitudinal axis A2 (extending in and out of the page) is aligned with the first axis A4. The first and the second semicircular bodies 544, 548 are not oriented perpendicular to the base 504. In other words, the first and the second semicircular bodies 544, 548 are capable of orientations other than being arranged perpendicular to the base 504.

[0066] FIG. 21 is a schematic view of another construction of a first plurality of slots 700 and a second plurality of slots 704. In the illustrated construction, the first semicircular body 544 includes the first plurality of slots 700 and not the first plurality of slots 552. That is, the first plurality of slots 700 is interchangeable with the first plurality of slots 552. In the illustratedAttorney Docket No. 093386-0012-W001construction, the second semicircular body 548 includes the second plurality of slots 704 and not the second plurality of slots 564. That is, the second plurality of slots 704 is interchangeable with the second plurality of slots 564. In the illustrated construction, the first semicircular body 544 includes protrusions 708 disposed between adjacent slots of the first plurality of slots 700. In the illustrated construction, the second semicircular body 548 includes protrusions 712 disposed between adjacent slots of the second plurality of slots 704. The first plurality of slots 700 are offset from the second plurality of slots 704 in a direction perpendicular to the plane Pl. As such, each channel of the plurality of channels 628 is defined between a slot of the first plurality of slots 700 of the first semicircular body 544 and the protrusion 712 of the second semicircular body 548, or is defined between a slot of the second plurality of slots 704 of the second semicircular body 548 and the protrusion 708 of the first semicircular body 544. In the illustrated constriction, the needle 134 is disposed between one of the protrusions 708 and one of the second plurality of slots 704.

Claims

1. Attorney Docket No. 093386-0012-W001CLAIMSWhat is claimed is:

1. A guide for a medical device, the guide comprising:a base defining a first side and a second side opposite from the first side, the first side configured to be coupled to a patient, the base including an aperture that extends through the first side and the second side, the aperture defining a central point and a central axis that extends through the aperture and the central point; anda protractor coupled to the base, the protractor includinga first semicircular body including a first plurality of slots,a second semicircular body,wherein the first semicircular body is configured to selectively couple the second semicircular body, wherein the protractor includes a plurality of channels in radial alignment with the central point that are configured to receive the medical device, the plurality of channels defined between the first semicircular body and the second semicircular body.

2. The guide of claim 1, wherein the second semicircular body includes a second plurality of slots, wherein the plurality of channels are defined between the first and the second plurality of slots.

3. The guide of claim 1, wherein each of the plurality of channels is angularly offset from adjacent channels of the plurality of channels by 2.5 degrees relative to the central point.

4. The guide of claim 1, wherein the first semicircular body includes an identifier for each channel of the plurality of channels, wherein the identifier includes: (i) a first marker, or (ii) a slit and a second marker, or (iii) a slit and a third marker, wherein each of the first marker, the second marker, and the third marker are different from one another.Attorney Docket No. 093386-0012-W0015. The guide of claim 1 , further comprising a first groove at least partially disposed between the base and the first semicircular body and a second groove at least partially disposed between the base and the second semicircular body,wherein the first semicircular body is configured to pivot about the first groove and the second semicircular body is configured to pivot about the second groove.

6. The guide of claim 1, wherein the plurality of channels defines an angular span measured from the central axis, wherein the angular span extends from -60 degrees to 60 degrees relative to the central axis when the first semicircular body couples to the second semicircular body.Attorney Docket No. 093386-0012-W0017. A guide for a medical device, the guide comprising:a base defining a first side and a second side opposite from the first side, the first side configured to be coupled to a patient, the base includinga main body,an aperture that extends through the main body from the first side to the second side, the aperture defining a central point and a central axis that extends through the aperture and the central point, anda pair of legs extending from the main body along a longitudinal axis that is perpendicular to the central axis; anda protractor coupled to the pair of legs, the protractor includinga first semicircular body, anda second semicircular body,wherein the first semicircular body is configured to selectively couple the second semicircular body, wherein the protractor includes a plurality of channels defined between the first semicircular body and the second semicircular body.

8. The guide of claim 7, wherein the first semicircular body includes a protrusion extending therefrom, wherein the second semicircular body includes a recess configured to receive the protrusion when the first semicircular body couples to the second semicircular body.

9. The guide of claim 8, wherein the protrusion is a first protrusion and the recess is a first recess, wherein the second semicircular body includes a second protrusion extending therefrom and wherein the first semicircular body includes a second recess configured to receive the second protrusion when the first semicircular body couples to the second semicircular body.

10. The guide of claim 7, wherein the first semicircular body defines an outer edge and an inner edge, the inner edge being disposed radially closer to the base than the outer edge, wherein the first semicircular body includes a plurality of slots extending from the outer edge to the inner edge in a direction radially aligned with the central point.Attorney Docket No. 093386-0012-W00111. The guide of claim 10, wherein the first semicircular body includes a plurality of indicators corresponding to at least a portion of the plurality of slots, the plurality of indicators indicating an angle of the plurality of channels relative to the central point, wherein the plurality of indicators are disposed on an opposite side of the first semicircular body than the plurality of slots.

12. The guide of claim 10, wherein the plurality of channels is defined between the plurality of slots and the second semicircular body.

13. The guide of claim 7, further comprising a first groove at least partially disposed between a leg of the pair of legs and the first semicircular body, and wherein the first semicircular body is configured to pivot about the first groove.

14. The guide of claim 7, wherein the first semicircular body and the second semicircular body are configured to be pivoted relative to the base.

15. The guide of claim 7, wherein the base and the protractor are formed from a single piece of polypropylene.Attorney Docket No. 093386-0012-W00116. A method of preparing a guide for a medical device, the method comprising:coupling a first side of a base of the guide to a patient;pivoting a first semicircular body of a protractor relative to the base;pivoting a second semicircular body of the protractor relative to the base;aligning a protrusion extending from the first semicircular body with a recess defined in the second semicircular body that corresponds with the protrusion;coupling the protrusion with the recess; andforming a plurality of channels defined between the first semicircular body and the second semicircular body in response to the first semicircular body being coupled to the second semicircular body, each of the plurality of channels configured to receive the medical device.

17. The method according to claim 16, wherein during the step of pivoting the first semicircular body, the first semicircular body is pivoted about a first groove disposed between the base and the first semicircular body.

18. The method according to claim 17, wherein during the step of pivoting the second semicircular body, the second semicircular body is pivoted about a second groove disposed between the base and the second semicircular body.

19. The method according to claim 18, wherein the protrusion is a first protrusion, wherein the second semicircular body includes a second protrusion extending therefrom, wherein the recess is a first recess, wherein the first semicircular body includes a second recess defined therein, the method further comprising aligning the second protrusion with the second recess.

20. The method according to claim 16, further comprisingaligning a pair of legs that extend from the base with a first axis defined by a laser of a computed tomography gantry; andaligning the plurality of channels at outer edges of the first semicircular body and the second semicircular body with the first axis.

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