Patent Description:
Some devices in the art employ features that attempt to improve device targeting and placement. These devices use a pivoting housing to stably hold a device for insertion. However, the housings generally do not have inherent imaging capabilities. As a result, the devices require the use of a separate imaging device, such as an ultrasound probe, to be used for the selection of a desired direction of insertion. The ultrasound probe must then be removed before the device can be inserted, and the operator is unable to visualize the device insertion without using another imaging device. <CIT> discloses a robotic manipulator to manipulate the orientation of end effectors such as surgical tools under computer control, while strictly limiting undesired motions.

<CIT> discloses a cranial interface component suitable to be at least partially secured into a burr hole that may operate in conjunction with a computer platform system. While the fixation device of the cranial interface is moved, position, angle, and rotation data relative to the fixation device are collected for each image to generate a three-dimensional model.

There is a need in the art for better devices for accurate localization and intervention of targets within a patient. Further, there is a need for true "point of care" navigation that can continuously update imaging to reflect dynamic changes of the target location being imaged. The present invention meets this need.

The guide according to the invention is defined in claim <NUM>. The guide allows accurate insertion of medical devices during stereotactic surgical procedures. The methods of use disclosed are not claimed.

The present disclosure further provides fixation devices, locking assemblies, and methods for using the same. The fixation devices are capable of accurate insertion of medical devices by providing detection means of a patient's internal anatomy and localizing a desired target. The devices are capable of at least partially locking into position to maintain accuracy.

In one aspect, the present disclosure relates to a fixation device comprising: an elongate body having a proximal end opening, a distal end opening, and a lumen connecting the proximal and distal end openings; at least one emission means at a distal end region of the elongate body; and at least one receiving means for receiving at least some emissions from said emission means.

In one embodiment, the elongate body lumen is sized suitably for an instrument, tool, implant, or biological material to pass therethrough. In one embodiment, the elongate body lumen is sized suitably for an inserted instrument, tool, implant, or biological material to rotate. In one embodiment, the elongate body lumen has a cross-section that is circular, elliptical, polygonal, or keyed. In one embodiment, the elongate body lumen may be centered or off-center in the elongate body.

In one embodiment, the emission means are selected from the group consisting of: ultrasonic transducers, optical sensors, thermal sensors, electromagnetic sensors, photoelectric transducers, laser diodes, radio transducers, Doppler, x-ray, particle sensors, chemical sensors, and piezoelectric sensors. In one embodiment, the ultrasonic transducers are either piezoelectric ultrasonic transducers or capacitive ultrasonic transducers. In one embodiment, the distal end region of the elongate body is composed of a material which is at least partially transmissive to said emission.

In one embodiment, the device further comprises: a grommet having a proximal end opening, a distal end opening, and a lumen connecting the proximal and distal end openings; and at least one locking member; wherein the grommet lumen is sized such that the elongate body of the fixation device can pass through the grommet lumen and be at least partially locked into place by the at least one locking member.

In one embodiment, the grommet comprises one or more materials selected from the group consisting of: metals, ceramics, and polymers. In one embodiment, the grommet comprises one or more materials selected from the group consisting of: stainless steel, cobalt, titanium, aluminum oxide, zirconia, calcium phosphate, silicon, polyethylene, polyvinyl chloride, polyurethane, and polylactide.

In one embodiment, the device further comprises: a cup having a base member and perimeter sidewalls forming an open top, wherein the base member includes at least one opening, and at least one locking member; wherein the cup is sized such that the distal end region of the elongate body of the fixation device can be at least partially locked into place within the cup by the at least one locking member.

In one embodiment, the cup comprises one or more materials selected from the group consisting of: metals, ceramics, and polymers. In one embodiment, wherein the cup comprises one or more materials selected from the group consisting of: stainless steel, cobalt, titanium, aluminum oxide, zirconia, calcium phosphate, silicon, polyethylene, polyvinyl chloride, polyurethane, and polylactide. In one embodiment, the at least one locking member is selected from the group consisting of: a screw, a bolt, a pin, an adhesive, and a clamp. In one embodiment, the at least one locking member is engaged mechanically, electro-mechanically, magnetically, or adhesively.

In one embodiment, the device further comprises an anchoring patch comprising: a flexible substrate having a first and a second surface; and a rigid housing positioned within the flexible substrate; wherein the housing is dimensioned to engage the devices disclosed.

In one embodiment, the flexible substrate comprises a material selected from the group consisting of plastics, polymers, metals, and gels. In one embodiment, the device further comprises an adhesive material on at least a portion of the first surface of the flexible substrate.

In one embodiment, the device further comprises a first angled shim housing having a space at its center and a cranial burr anchor, wherein the first angled shim housing is attached to the cranial burr anchor, wherein the fixation device fits within and is rotatable within the space of the first angled shim housing, and the first angled shim housing is rotatable about the cranial burr anchor.

In one embodiment, the device further comprises a second angled shim housing, wherein the second angled shim housing is attached between the first angled shim housing and the cranial burr anchor, and wherein the second angled shim housing is rotatable about the first angled shim housing and the cranial burr anchor.

In one embodiment, the device further comprises a lever attachment having a lumen attached to and continuous with the lumen of the fixation device, wherein the lumen of the lever attachment is sized to accept a medical instrument.

In one embodiment, the device further comprises a rotatable housing, a cranial burr anchor, and a lever attachment having a lumen connected to the proximal end opening of the fixation device, wherein the rotatable housing is attached to the cranial burr anchor, wherein the fixation device is encased and rotatable within the rotatable housing, wherein the rotatable housing is rotatable about the cranial burr anchor, and wherein the lumen of the lever attachment is sized to accept a medical instrument.

In one embodiment, the device further comprises a cranial interface component having at least two angular rails, an anterior-posterior angle control component having at least two angular rails, a lateral angle control component having a space at its center, and a lever attachment having a lumen connected to the proximal opening of the fixation device, wherein the anterior-posterior angle control component is movable along the at least two angular rails of the cranial interface component, wherein the lateral angle control component is movable along the at least two angular rails of the anterior-posterior angle control component, wherein the fixation device fits within and is rotatable within the space of the lateral angle control component, and wherein the lumen of the lever attachment is sized to accept a medical instrument.

In one embodiment, the device further comprises a hemispherical cap having a first track and a hemispherical cranial burr anchor having a second track, wherein the first track spans the diameter of the hemispherical cap, wherein the second track spans the diameter of the hemispherical cranial burr anchor, wherein the hemispherical cap is movable along the second track, wherein the fixation device is movable along the first track, and wherein the first track and the second track are perpendicular to each other.

In another aspect, the present disclosure relates to a method, not forming part of the claimed invention, of localizing and interacting with a target site within a patient's anatomy, comprising the steps of: attaching the device disclosed to the patient's body near the target site; generating emissions using the attached device; receiving the emissions from the attached device; adjusting the orientation of the attached device to aim the attached device at the target site; at least partially locking the attached device; determining a target site first boundary having a minimum depth and a target site second boundary having a maximum depth; and inserting medical devices through the lumen of the attached device to interact with the target site such that the medical devices pass the minimum depth but do not exceed the maximum depth.

In another aspect, the present disclosure relates to a method, not forming part of the claimed invention, for accurate insertion of an external ventricular drain (EVD), comprising the steps of: inserting the device disclosed into a burr hole in a patient's skull; imaging a region within the patient's brain using the attached device; aligning the lumen of the attached device with a desired site of drainage; at least partially locking the attached device in place; determining a desired site of drainage first boundary having a minimum depth and a desired site of drainage second boundary having a maximum depth; and guiding an EVD through the lumen of the attached device into the desired site of drainage for draining such that the EVD passes the minimum depth but does not exceed the maximum depth. In one embodiment, an ultrasonic reflective strip is attached to the EVD.

In another aspect, the present disclosure relates to a method, not forming part of the claimed invention, for accurate insertion of a medical device to a target site, comprising the steps of: affixing an anchoring patch having a flexible substrate and a rigid housing onto a patient at a desired site of insertion of a medical device; engaging the device to the rigid housing of the anchoring patch; aligning the lumen of the attached device with the target site; at least partially locking the attached device in place; determining a target site first boundary having a minimum depth and a target site second boundary having a maximum depth; and guiding the medical device through the lumen of the attached device to the target site such that the medical device passes the minimum depth but does not exceed the maximum depth.

In one embodiment, the medical device is selected from the group consisting of: catheters, microforceps, microscalpels, biopsy needles, radiofrequency ablation probes, cryoablation probes, suturing instruments, and syringes. In one embodiment, an ultrasonic reflective strip is attached to the medical device.

In another aspect, the present disclosure relates to a method, not forming part of the claimed invention, of stereotactic mapping; comprising the steps of: attaching at least two devices of the present disclosure to a patient's body; generating emissions using at least one of the attached devices; and receiving the emissions using at least one of the attached devices.

In another aspect, the present disclosure relates to a method, not forming part of the claimed invention, of using a fixation device to insert a ventricular catheter into a subject's brain, comprising the steps of: marking the skin at Kocher's point above a subject's skull; making an incision at the marked skin; perforating the skull; inserting a fixation device having ultrasonic transducers; aligning the ultrasonic transducers to capture a cross-sectional ultrasound image of the brain and the positional, angular, and rotational orientation of the ultrasonic transducers; actuating the ultrasonic transducers; acquiring a series of ultrasonic images of the brain and associated positional, angular, and rotational orientation of the ultrasonic transducers during actuation; assembling the ultrasonic images into a 3D reconstruction of the brain ventricles using the associated positional, angular, and rotational orientation of the ultrasonic transducers; performing an automatic segmentation of the 3D reconstruction to isolate an anatomy of interest; acquiring the positional, angular, and rotational orientation of the anatomy of interest; aligning the fixation device to target the anatomy of interest; fixing the alignment of the fixation device relative to the skull; inserting a catheter and ventricular drain through the fixation device into the anatomy of interest; and removing the fixation device over the catheter and ventricular drain.

In another aspect, the present disclosure relates to a fixation device comprising: an elongate body having a proximal end opening, a distal end opening, and a lumen connecting the proximal and distal end openings; a first angled shim housing having a space at its center; and a cranial burr anchor; wherein the first angled shim housing is attached to the cranial burr anchor, wherein the elongate body fits within and is rotatable within the space of the first angled shim housing, and wherein the first angled shim housing is rotatable about the cranial burr anchor.

In another aspect, the present disclosure relates to a fixation device comprising: an elongate body having a proximal end opening, a distal end opening, and a lumen connecting the proximal and distal end openings; a first angled shim housing having a space at its center; a second angled shim housing; and a cranial burr anchor; wherein the first angled shim housing is attached to the second angled shim housing, wherein the second angled shim housing is attached to the cranial burr anchor, wherein the elongate body fits within and is rotatable within the space of the first angled shim housing, wherein the first angled shim housing is rotatable about the second angled shim housing, and wherein the second angled shim housing is rotatable about the cranial burr anchor.

In another aspect, the present disclosure relates to a fixation device comprising: an elongate body having a proximal end opening, a distal end opening, and a lumen connecting the proximal and distal end openings; a first angled shim housing having a space at its center; a lever attachment having a lumen; and a cranial burr anchor; wherein the lever attachment is attached to the first angled shim housing, wherein the first angled shim housing is attached to the cranial burr anchor, wherein the lumen of the elongate body is attached to and continuous with the lumen of the lever attachment, wherein the elongate body fits within and is rotatable within the space of the first angled shim housing, and wherein the first angled shim housing is rotatable about the cranial burr anchor.

In another aspect, the present disclosure relates to a fixation device comprising: an elongate body having a proximal end opening, a distal end opening, and a lumen connecting the proximal and distal end openings; a rotatable housing; a cranial burr anchor; and a lever attachment having a lumen attached to and continuous with the lumen of the elongate body; wherein the rotatable housing is attached to the cranial burr anchor, wherein the elongate body is encased and rotatable within the rotatable housing, wherein the rotatable housing is rotatable about the cranial burr anchor, and wherein the lumen of the lever attachment is sized to accept a medical instrument.

In another aspect, the present disclosure relates to a fixation device comprising: an elongate body having a proximal end opening, a distal end opening, and a lumen connecting the proximal and distal end openings; a cranial interface component having at least two angular rails; an anterior-posterior angle control component having at least two angular rails; a lateral angle control component having a space at its center; and a lever attachment having a lumen attached to and continuous with the lumen of the elongate body; wherein the anterior-posterior angle control component is movable along the at least two angular rails of the cranial interface component, wherein the lateral angle control component is movable along the at least two angular rails of the anterior-posterior angle control component, wherein the elongate body fits within and is rotatable within the space of the lateral angle control component, and wherein the lumen of the lever attachment is sized to accept a medical instrument.

In another aspect, the present disclosure relates to a fixation device comprising: an elongate body having a proximal end opening, a distal end opening, and a lumen connecting the proximal and distal end openings; a hemispherical cap having a first track; and a hemispherical cranial burr anchor having a second track; wherein the first track spans the diameter of the hemispherical cap, wherein the second track spans the diameter of the hemispherical cranial burr anchor, wherein the hemispherical cap is movable along the second track, wherein the elongate body is movable along the first track, and wherein the first track and the second track are perpendicular to each other.

In another aspect, the present disclosure relates to a kit comprising: the device of the present invention; a hair clipper; a tape measure; a surgical marking implement; skin preparation material; a scalpel; and a drilling instrument.

In one embodiment, the kit further comprises display equipment. In one embodiment, the kit further comprises a portable power source.

In another aspect, the present disclosure relates to a kit comprising: a guide; a power source; a hair clipper; a tape measure; a surgical marking implement; skin preparation material; a scalpel; and a drilling instrument.

In one embodiment, the kit further comprises at least one emission means and at least one receiving means for receiving at least some emissions from said emission means. In one embodiment, the kit further comprises display equipment. In one embodiment, the kit further comprises a portable power source.

The following detailed description of preferred embodiments will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the disclosure, there are shown in the drawings embodiments which are presently preferred. It should be understood, however, that the invention is not limited to the precise arrangements, geometry, and instrumentalities of the embodiments shown in the drawings.

The present disclosure provides fixation devices, locking assemblies, and methods for using the same. The fixation devices disclosed are capable of accurate insertion of medical devices by providing detection means of a patient's internal anatomy to localize a desired target. The devices are capable of at least partially locking into position to maintain accuracy.

It is to be understood that the figures and descriptions have been simplified to illustrate elements that are relevant for a clear understanding of the present disclosure, while eliminating, for the purpose of clarity, many other elements found in typical medical devices. Those of ordinary skill in the art may recognize that other elements and/or steps are desirable and/or required in implementing the present disclosure. However, because such elements and steps are well known in the art, and because they do not facilitate a better understanding, a discussion of such elements and steps is not provided herein. The disclosure herein is directed to all such variations and modifications to such elements and methods known to those skilled in the art.

Unless defined elsewhere, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

As used herein, each of the following terms has the meaning associated with it in this section.

"About" as used herein when referring to a measurable value such as an amount, a temporal duration, and the like, is meant to encompass variations of ±<NUM>%, ±<NUM>%, ±<NUM>%, ±<NUM>%, and ±<NUM>% from the specified value, as such variations are appropriate.

As used herein, "imaging" may include ultrasonic imaging, be it one dimensional, two dimensional, three dimensional, or real-time three dimensional imaging (4D). Two dimensional images may be generated by one dimensional transducer arrays (e.g., linear arrays or arrays having a single row of elements). Three dimensional images may be produced by two dimensional arrays (e.g., those arrays with elements arranged in an n by n planar configuration) or by mechanically reciprocated, one dimensional transducer arrays. The term "imaging" also includes optical imaging, tomography, including optical coherence tomography (OCT), radiographic imaging, photoacoustic imaging, and thermography.

The terms "patient," "subject," "individual," and the like are used interchangeably herein, and refer to any animal, or cells thereof whether in vitro or in situ, amenable to the methods described herein. In certain non-limiting embodiments, the patient, subject or individual is a human.

As used herein, "sonolucent" is defined as a property wherein a material is capable of transmitting ultrasound pulses without introducing significant interference, such that an acceptable acoustic response can be obtained from the body structure(s) of interest.

Throughout this disclosure, various aspects can be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the disclosure.

For example, description of a range such as from <NUM> to <NUM> should be considered to have specifically disclosed subranges such as from <NUM> to <NUM>, from <NUM> to <NUM>, from <NUM> to <NUM>, from <NUM> to <NUM>, from <NUM> to <NUM>, from <NUM> to <NUM>, etc., as well as individual numbers within that range, for example, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and any whole and partial increments there between.

The present disclosure provides fixation devices, locking assemblies, and methods for using the same. The fixation devices are capable of accurate insertion of medical devices by providing detection means of a patient's internal anatomy and localizing a desired target. The devices are capable of at least partially locking into position to maintain accuracy.

Referring now to <FIG>, an exemplary fixation device <NUM> is depicted. Fixation device <NUM> comprises elongate body <NUM>, lumen <NUM>, proximal end opening <NUM>, distal end opening <NUM>, and a plurality of transducers <NUM>. Elongate body <NUM> can have any suitable shape. In one embodiment, elongate body <NUM> is cylindrical. There are no limitations to the particular sizes and dimensions elongate body <NUM> may have. Elongate body <NUM> can be made from any suitable material. For example, elongate body <NUM> can comprise silicones, plastics, polymers, metals, and the like. In one embodiment, elongate body <NUM> comprises a sonolucent material throughout. In one embodiment, elongate body <NUM> comprises a sonolucent material only at its distal end.

Elongate body <NUM> comprises lumen <NUM> and transducers <NUM>. Lumen <NUM> extends through the entire length of elongate body <NUM> and connects proximal opening <NUM> and distal opening <NUM>. Lumen <NUM> can have any suitable diameter. In one embodiment, lumen <NUM> has a diameter of at least <NUM>. In one embodiment, lumen <NUM> has a diameter of <NUM>. In various embodiments, lumen <NUM> has a diameter between <NUM> and <NUM>. In one embodiment, lumen <NUM> is dimensioned to fit a catheter.

Transducers <NUM> can be any suitable device capable of emitting energy, receiving energy, or both energy emission and reception. In various embodiments, elongate body <NUM> comprises one, two, three, four, or more transducers <NUM>. Elongate body <NUM> may also comprise combinations of different transducers <NUM>. For example, elongate body <NUM> may comprise a combination of emitting transducers and receiving transducers, or a combination of transducers that respond to different types of energy. Non-limiting examples of types of transducers suitable for use with the present invention include: ultrasonic transducers, optical sensors, thermal sensors, electromagnetic sensors, photoelectric transducers, laser diodes, radio transducers, Doppler, x-ray, particle sensors, chemical sensors, piezoelectric sensors, and the like.

Lumen <NUM> can have any suitable cross-section, such as a cross-section that is circular, elliptical, polygonal, or keyed. Lumen <NUM> may be centered or off-center in fixation device <NUM>. Lumen <NUM> of fixation device <NUM> is amenable to guiding any various types of medical devices. For example, lumen <NUM> may accommodate additional probes or instruments appropriate for any given medical procedure. Non-limiting examples of additional components include catheters, microforceps, microscalpels, biopsy needles, radiofrequency ablation probes, cryoablation probes, suturing instruments, syringes, and the like. In some embodiments, lumen <NUM> comprises a circular cross-section and is sized and dimensioned to permit an inserted instrument to rotate.

Referring now to <FIG>, a top-down view of an exemplary grommet locking assembly <NUM> is depicted. Grommet locking assembly <NUM> comprises grommet <NUM>, fixation device <NUM>, fulcrum <NUM>, and locking member <NUM>. Referring now to <FIG>, an isometric view of an exemplary grommet locking assembly <NUM> is depicted. Grommet <NUM> fits within an opening on a patient to provide access to the interior of a patient's anatomy.

In various embodiments, the exterior surface of grommet <NUM> can comprise features to enhance the fit of grommet <NUM> within a patient, such as ridges, flanges, threads, barbs, and the like. Grommet <NUM> can be made from any suitable biocompatible material, such as stainless steel, cobalt, titanium, aluminum oxide, zirconia, calcium phosphate, silicon, polyethylene, polyvinyl chloride, polyurethane, polylactide, and the like. In one embodiment, grommet <NUM> comprises a sonolucent material throughout. In one embodiment, grommet <NUM> comprises a sonolucent material only at its distal end.

Grommet <NUM> can have any suitable shape. Non-limiting examples of grommet <NUM> shapes include cylinders, cubes, cuboids, and the like. There are no limitations to the particular sizes and dimensions grommet <NUM> may have.

Grommet <NUM> comprises a lumen that extends through the entire length of grommet <NUM>. Within the lumen, grommet <NUM> comprises a plurality of fulcrums <NUM>. For example, in one exemplary embodiment, grommet <NUM> comprises at least two fulcrums <NUM>. Fulcrums <NUM> attach to the lumen of grommet <NUM> and to the exterior surface of fixation device <NUM>. Fulcrums <NUM> may be made from any suitable material. In one embodiment, fulcrums <NUM> are made from a pliable material, such as a biocompatible rubber, polymer, or gel. Fulcrums <NUM> secure fixation device <NUM> to grommet <NUM> while providing fixation device <NUM> with the ability to move independently from grommet <NUM>. For example, pliable fulcrums <NUM> are deformable to allow fixation device <NUM> to be oriented within grommet <NUM>. Fixation device <NUM> can be oriented by angling to any degree. In one embodiment, fixation device <NUM> can be oriented by angling up to <NUM> degrees from vertical. In another embodiment, fixation device <NUM> can be oriented by angling by up to <NUM> degrees from vertical. In one embodiment, instead of fulcrums <NUM>, fixation device <NUM> is attached to grommet <NUM> by a pliable membrane.

Grommet <NUM> further comprises at least one locking member <NUM>. Locking member <NUM> can be any suitable locking member, including but not limited to: a screw, a bolt, a pin, an adhesive, and a clamp. For example, in one exemplary embodiment, a grommet locking assembly <NUM> may comprise locking members <NUM> that are screws that pass through grommet <NUM> to contact fixation device <NUM>. The screws may be screwed in or out of grommet <NUM> to vary and lock the orientation of fixation device <NUM>. In other embodiments, the locking member <NUM> may be mechanical, electro-mechanical, magnetic, or adhesive.

Referring now to <FIG>, a side view cross section of an exemplary cup locking assembly <NUM> is depicted. Cup locking assembly <NUM> comprises fixation device <NUM> and cup <NUM>. Fixation device <NUM> further comprises ball adapter <NUM>. Cup <NUM> fits within an opening on a patient to provide access to the interior of a patient's anatomy.

In various embodiments, the exterior surface of cup <NUM> can comprise features to enhance the fit of cup <NUM> within a patient, such as ridges, flanges, threads, barbs, and the like. Cup <NUM> can be made from any suitable biocompatible material, such as stainless steel, cobalt, titanium, aluminum oxide, zirconia, calcium phosphate, silicon, polyethylene, polyvinyl chloride, polyurethane, polylactide, and the like. In one embodiment, cup <NUM> comprises a sonolucent material throughout. In one embodiment, cup <NUM> comprises a sonolucent material only at its distal end.

Cup <NUM> comprises a base member and perimeter sidewalls forming an open top. The base member comprises at least one opening <NUM>. Cup <NUM> can have any suitable shape. In some embodiments, cup <NUM> has the shape of a conical frustum with wide diameter facing away from the patient and a narrow diameter facing towards the patient. Cup <NUM> can have any suitable dimensions. For example, cup <NUM> can have a height of <NUM> to <NUM>, and a diameter of <NUM> to <NUM>.

The interior of cup <NUM> is dimensioned to fit ball adapter <NUM> of fixation device <NUM>. Ball adapter <NUM> is able to rotate freely within cup <NUM>, like a ball joint, to provide fixation device <NUM> with an orientation. Fixation device <NUM> can be oriented by angling to any degree. In one embodiment, fixation device <NUM> can be oriented by angling up to <NUM> degrees from vertical. In another embodiment, fixation device <NUM> can be oriented by angling up to <NUM> degrees from vertical.

Cup <NUM> further comprises locking member <NUM>. Locking member <NUM> can be any suitable locking member, including but not limited to: a screw, a bolt, a pin, an adhesive, and a clamp. For example, in one embodiment, locking member <NUM> is a screw. The screw may be screwed in or out of cup <NUM> such that when the screw contacts ball adapter <NUM>, the screw arrests the movement of ball adapter <NUM>, thereby locking the orientation of fixation device <NUM>. In other embodiments, the locking member <NUM> may be mechanical, electro-mechanical, magnetic, or adhesive.

In various embodiments, the present disclosure relates to fixation devices having fixed degrees of freedom for precise movement. Referring now to <FIG> and <FIG>, an exemplary single shim <NUM> Degrees of Freedom (DoF) fixation device <NUM> is depicted. Device <NUM> comprises anchor <NUM>, rotating shim <NUM>, and rotating transducer housing <NUM>. Anchor <NUM> is secured within a burr hole, such as that of a skull depicted in <FIG> and <FIG>. Rotating shim <NUM> fits within anchor <NUM>. In various embodiments, rotating shim <NUM> comprises an angle, wherein the angle can be any suitable angle between <NUM> and <NUM> degrees. Rotating shim <NUM> comprises a space at its center for accepting rotating transducer housing <NUM>. Transducer housing <NUM> comprises at least one ultrasonic transducer and at least one aperture for accepting a medical instrument <NUM>. The first DoF of device <NUM> is the vertical travel of medical instrument <NUM>. The second DoF is the rotation of transducer housing <NUM>. The third DoF is the rotation of shim <NUM>.

Referring now to <FIG>, an exemplary double shim <NUM> DoF fixation device <NUM> is depicted. Device <NUM> comprises anchor <NUM>, a first rotating shim <NUM>, a second rotating shim <NUM>, and a rotating transducer housing <NUM>. Similarly to the components of device <NUM>, anchor <NUM> secures within a burr hole, wherein anchor <NUM> holds a first rotating shim <NUM>. The second rotating shim <NUM> fits on top of the first rotating shim <NUM>, and the second rotating shim <NUM> comprises a space at its center for accepting rotating transducer housing <NUM>. In various embodiments, transducer housing <NUM> comprises at least one ultrasonic transducer and at least one aperture for accepting a medical instrument <NUM>. The first rotating shim <NUM> and the second rotating shim <NUM> each comprise an angle, wherein the angle can be any suitable angle between <NUM> and <NUM> degrees. In various embodiments, the first rotating shim <NUM> can have the same angle or a different angle than the second rotating shim <NUM>. The first DoF of device <NUM> is the vertical travel of medical instrument <NUM>. The second DoF of device <NUM> is the rotation of transducer housing <NUM>. The third DoF of device <NUM> is the rotation of first shim <NUM>, second shim <NUM>, or both.

Referring now to <FIG>, an exemplary single shim <NUM> DoF fixation device <NUM> is depicted. Device <NUM> comprises anchor <NUM>, rotating shim <NUM>, transducer housing <NUM>, and lever <NUM>. As described elsewhere herein, anchor <NUM> secures within a burr hole. Rotating shim <NUM> fits within anchor <NUM>. In various embodiments, rotating shim <NUM> comprises an angle, wherein the angle can be any suitable angle between <NUM> and <NUM> degrees. Rotating shim <NUM> comprises a space at its center for accepting transducer housing <NUM>. Transducer housing <NUM> comprises at least one ultrasonic transducer and a lever housing, whereupon lever <NUM> actuates. The lever housing may comprise regularly spaced markings to indicate the relative position of lever <NUM>. In various embodiments, lever <NUM> may be angled between <NUM> and <NUM> degrees from vertical. Lever <NUM> comprises at least one aperture for accepting a medical instrument <NUM>. The first DoF of device <NUM> is the vertical travel of medical instrument <NUM>. The second DoF of device <NUM> is the angulation of lever <NUM>. The third DoF of device <NUM> is the rotation of transducer housing <NUM>. The fourth DoF of device <NUM> is the rotation of shim <NUM>.

Referring now to <FIG>, an exemplary levered <NUM> DoF fixation device <NUM> is depicted. Device <NUM> comprises anchor <NUM>, rotatable housing <NUM>, transducer housing <NUM>, and lever <NUM>. As described elsewhere herein, anchor <NUM> secures within a burr hole, and articulating component <NUM> fits within anchor <NUM>. Rotatable housing <NUM> comprises a space at its center for accepting transducer housing <NUM>. Transducer housing <NUM> comprises at least one ultrasonic transducer and a lever housing, whereupon lever <NUM> actuates. The lever housing may comprise regularly spaced markings to indicate the relative position of lever <NUM>. In various embodiments, lever <NUM> may be angled between <NUM> and <NUM> degrees from vertical. Lever <NUM> comprises at least one aperture for accepting a medical instrument <NUM>. The first DoF of device <NUM> is the vertical travel of medical instrument <NUM>. The second DoF of device <NUM> is the angulation of lever <NUM>. The third DoF of device <NUM> is the rotation of transducer housing <NUM>.

Referring now to <FIG> and <FIG>, an exemplary <NUM> DoF fixation device <NUM> is depicted. Device <NUM> comprises cranial interface component <NUM>, anterior-posterior angle control <NUM>, lateral angle control <NUM>, transducer housing <NUM>, and lever <NUM>. Cranial interface component <NUM> is at least partially secured into a burr hole. Cranial interface component <NUM> features a frame and at least two angular rails for guiding the movement of anterior-posterior angle control <NUM>. Anterior-posterior angle control <NUM> in turn comprises at least two angular rails for guiding the movement of lateral angle control <NUM>. Lateral angle control <NUM> comprises a space at its center for accepting transducer housing <NUM>. Transducer housing <NUM> comprises at least one ultrasonic transducer located within a conical region that fits within cranial interface component <NUM>, wherein the conical region serves as a pivot point while the orientation of transducer housing <NUM> is adjusted. Transducer housing <NUM> comprises a lever housing, whereupon lever <NUM> actuates. The lever housing may comprise regularly spaced markings to indicate the relative position of lever <NUM>. In various embodiments, lever <NUM> may be angled between <NUM> and <NUM> degrees from vertical. Lever <NUM> comprises at least one aperture for accepting a medical instrument <NUM>. The first DoF of device <NUM> is the vertical travel of medical instrument <NUM>. The second DoF of device <NUM> is the angulation of lever <NUM>. The third DoF of device <NUM> is the rotation of transducer housing <NUM>. The fourth DoF of device <NUM> is the angulation of lateral angle control <NUM>. The fifth DoF of device <NUM> is the angulation of anterior-posterior angle control <NUM>.

Referring now to <FIG>, an exemplary compact <NUM> DoF fixation device <NUM> is depicted. Device <NUM> comprises anchor <NUM>, hemispheric cap <NUM>, and transducer housing <NUM>. Anchor <NUM> is at least partially secured into a burr hole and comprises a hemispheric top with track <NUM> on its surface, track <NUM> spanning the diameter of anchor <NUM>. Hemispheric cap <NUM> sits on top of anchor <NUM> and moves along track <NUM>. Hemispheric cap <NUM> comprises track <NUM> on its surface, track <NUM> being perpendicular to track <NUM> and spanning the diameter of hemispheric cap <NUM>. Both anchor <NUM> and hemispheric cap <NUM> comprise an open space at their centers to fit transducer housing <NUM>. Transducer housing <NUM> sits on top of hemispheric cap <NUM> and moves along track <NUM>. Transducer housing <NUM> comprises at least one ultrasonic transducer and at least one aperture for accepting a medical instrument <NUM>.

In various embodiments, the fixation devices may be sterilized or autoclaved. In certain embodiments, the fixation devices of the present devices may be partially disposable. For example, certain components enclosing transducers <NUM> and any associated circuitry and electronics may be detachable and cleaned between uses, while other components may be discarded and replaced between uses.

The fixation devices can be combined with additional components to facilitate their use in various applications. The additional components may include features that help automate the use of the fixation devices, such as actuators for mechanical movement and adjustment of the fixation device. The actuators may comprise position sensors to record positional orientations of the fixation device. For example, the fixation devices may further include encoders, multi-degree of freedom mems devices (e.g., Bosch BNO055 <NUM> degrees of freedom absolute orientation sensor), or any other suitable device for sensing, communicating, and recording data relating to the position, angle, and rotation of the transducer. In some embodiments, the position, angle, and rotation data may be mapped to a specific image set to correspond to the orientation of the fixation device when the image set was taken. The position, angle, and rotation data may be used to generate a 3D map from a series of image sets, to calculate volume rendering, to determine orientation parameters for a particular angle of entry, and the like. In certain embodiments, the sensing, communicating, and recording may be activated and deactivated by a remote switch, such that a user may choose when to begin and when to terminate the collection of location data. The remote switch enables a user to capture data in an efficient manner. The positional data may, for example, be later conveyed to the actuators such that a fixation device may quickly reacquire the positional orientation needed to find a target site, with subsequent emissions from the transducers to confirm accurate targeting.

In one embodiment, the additional component is an anchoring patch. For example, as depicted in <FIG>, cup locking assembly <NUM> may be adhered to anchoring patch <NUM> to form fixation device patch <NUM>. Fixation device patch <NUM> is useful in applications where guided accurate insertion of medical instruments is required but the surrounding tissue is too soft to secure a cup locking assembly <NUM>. As shown in <FIG>, anchoring patch <NUM> provides cup locking assembly <NUM> with a stable substrate to anchor into. Cup locking assembly <NUM> is then able to image, for example, the interior of the calf between the tibia and the fibula and accurately insert medical instrument <NUM> as depicted in <FIG>.

Anchoring patch <NUM> may be made from any suitable material, including plastics, polymers, metals, gels, and the like. In one embodiment, anchoring patch <NUM> may be flexible. In another embodiment, anchoring patch <NUM> may be rigid. Anchoring patch <NUM> may comprise an adhesive on the surface that contacts a patient. Cup locking assembly <NUM> may be adhered to anchoring patch <NUM> in any suitable way, such as by an adhesive or by friction. In one embodiment, anchoring patch <NUM> may comprise a rigid housing having features such as screw threads, clips, latches, and the like to connect to cup locking assembly <NUM>.

The devices of the present invention operates in conjunction with a computer platform system, such as a local or remote executable software platform, or as a hosted internet or network program or portal. In certain embodiments, portions of the system may be computer operated, or in other embodiments, the entire system may be computer operated. As contemplated herein, any computing device as would be understood by those skilled in the art may be used with the system, including desktop or mobile devices, laptops, desktops, tablets, smartphones or other wireless digital/cellular phones, televisions or other thin client devices as would be understood by those skilled in the art.

The computer platform is fully capable of sending and interpreting device emissions signals as described herein throughout. For example, the computer platform can be configured to control emissions parameters such as frequency, intensity, amplitude, period, wavelength, pulsing, and the like, depending on the emissions type. The computer platform can also be configured to control the actuation of the device, such as angulation and partial locking. The computer platform can be configured to record received emissions signals, and subsequently interpret the emissions. For example, the computer platform may be configured to interpret the emissions as images and subsequently transmit the images to a digital display. The computer platform may further perform automated calculations based on the received emissions to output data such as density, distance, temperature, composition, imaging, and the like, depending on the type of emissions received. The computer platform may further provide a means to communicate the received emissions and data outputs, such as by projecting one or more static and moving images on a screen, emitting one or more auditory signals, presenting one or more digital readouts, providing one or more light indicators, providing one or more tactile responses (such as vibrations), and the like. In some embodiments, the computer platform communicates received emissions signals and data outputs in real time, such that an operator may adjust the use of the device in response to the real time communication. For example, in response to a stronger received emission, the computer platform may output a more intense light indicator, a louder auditory signal, or a more vigorous tactile response to an operator, such that the operator may adjust the device to receive a stronger signal or the operator may partially lock the device in a position that registers the strongest signal. In a further example, the computer platform may display image overlays to represent an inserted medical device in relation to a displayed ultrasound image or volume rendering (3D reconstruction) on screen.

In some embodiments, the computer platform is integrated into the devices. For example, in some embodiments, at least one component of the computer platform described elsewhere herein is incorporated into a fixation device, such as emissions parameter controlling means, emissions recording and interpretation means, communication means for the received emissions and data outputs, and one or more features for displaying the received emissions, data, and images. Fixation devices having at least one integrated computer platform component may be operable as a self-contained unit, such that additional computer platform components apart from the device itself are not necessary. Self-contained units provide a convenient means of using the devices by performing a plurality of functions related to the devices. Self-contained units may be swappable and disposable, improving portability and decreasing the risk of contamination.

The computer operable component(s) may reside entirely on a single computing device, or may reside on a central server and run on any number of end-user devices via a communications network. The computing devices may include at least one processor, standard input and output devices, as well as all hardware and software typically found on computing devices for storing data and running programs, and for sending and receiving data over a network, if needed. If a central server is used, it may be one server or, more preferably, a combination of scalable servers, providing functionality as a network mainframe server, a web server, a mail server and central database server, all maintained and managed by an administrator or operator of the system. The computing device(s) may also be connected directly or via a network to remote databases, such as for additional storage backup, and to allow for the communication of files, email, software, and any other data formats between two or more computing devices. There are no limitations to the number, type or connectivity of the databases utilized by the system. The communications network can be a wide area network and may be any suitable networked system understood by those having ordinary skill in the art, such as, for example, an open, wide area network (e.g., the internet), an electronic network, an optical network, a wireless network, a physically secure network or virtual private network, and any combinations thereof. The communications network may also include any intermediate nodes, such as gateways, routers, bridges, internet service provider networks, public-switched telephone networks, proxy servers, firewalls, and the like, such that the communications network may be suitable for the transmission of information items and other data throughout the system.

The software may also include standard reporting mechanisms, such as generating a printable results report, or an electronic results report that can be transmitted to any communicatively connected computing device, such as a generated email message or file attachment. Likewise, particular results of the aforementioned system can trigger an alert signal, such as the generation of an alert email, text or phone call, to alert a manager, expert, researcher, or other professional of the particular results. Further embodiments of such mechanisms are described elsewhere herein or may standard systems understood by those skilled in the art.

The present disclosure provides methods for using the fixation device and locking assemblies disclosed. The methods of using the fixation device and locking assemblies provide accurate insertion of various medical devices by providing detection means of a patient's internal anatomy and at least partially locking the orientation and position of the fixation device.

In one embodiment, a single fixation device with transducers having energy emission means and energy reception means is used to provide detection means of a patient's internal anatomy for the accurate insertion of medical devices. Referring now to <FIG>, an exemplary method <NUM> begins with step <NUM> of attaching a single fixation device to the patient's body near a target site within the patient's anatomy. In step <NUM>, the single fixation device generates emissions, and in step <NUM>, at least some emissions are received by the single fixation device to determine the location of the target site within the patient's anatomy. In step <NUM>, the orientation of the single fixation device is adjusted such that the lumen of the fixation device is pointed at the target site, and in step <NUM>, the single fixation device is at least partially locked. In step <NUM>, a target site first boundary having a minimum depth is determined, and a target site second boundary having a maximum depth is determined. Finally, in step <NUM>, medical devices may then be accurately inserted through the single fixation device lumen to interact with the target site as needed, wherein the medical devices pass the minimum depth but do not exceed the maximum depth.

Referring now to <FIG>, the method step of determining a target site first boundary and a target site second boundary is depicted. In <FIG>, a plurality of emissions <NUM> are emitted from fixation device <NUM> in the direction of target site <NUM>. In <FIG>, at least a portion of the plurality of emissions <NUM> are reflected back and received by fixation device <NUM>. For example, reflected emission <NUM> indicates the depth of a fat-muscle boundary interface. Reflected emission <NUM> indicates the depth of the target site first boundary having a minimum depth, which is the location of the target site that is closest to fixation device <NUM>. Reflected emission <NUM> indicates the depth of the target site second boundary having a maximum depth, which is the location of the target site that is furthest from fixation device <NUM>. Medical device <NUM> may then be inserted into target site <NUM> with accuracy by passing the minimum depth and not exceeding the maximum depth.

In some embodiments, depth of insertion may be determined by measuring the length of medical device <NUM> as it passes through fixation device <NUM>. Medical device <NUM> will have reached the correct depth once the measured length is between the minimum depth and the maximum depth. In other embodiments, depth of insertion may be determined using a medical device having an ultrasonic reflective material. For example, a medical device having an ultrasonic reflective material at its distal end can have its distance from fixation device <NUM> continually monitored such that the medical device will have reached the correct depth once fixation device <NUM> detects that the ultrasonic reflective material is located between the minimum depth and the maximum depth.

In one embodiment, one or more fixation devices are used to provide detection means of a patient's internal anatomy for the accurate insertion of medical devices. For example, one or more fixation devices are attached to the exterior of a patient's body near a target site within the patient's anatomy. In one embodiment, the transducers of the one or more fixation devices may comprise both energy emission means and energy reception means. In another embodiment, at least one fixation device comprises transducers with emission means while the remaining fixation devices comprise transducers with reception means. In another embodiment, at least one fixation device comprises transducers with reception means while the remaining fixation devices comprise transducers with emission means.

In one embodiment, one or more fixation devices are used to map the internal anatomy of a patient in three dimensions. The fixation devices are useful in stereotactic mapping and stereotactic surgery. For example, one or more fixation devices are attached to the exterior of a patient's body, whereupon energy emission and reception determines the internal anatomy of the patient and maps it in three dimensions. The mapping data can be interpreted using a coordinate system, and surgery may be performed upon precise coordinates using the devices and methods disclosed.

In one embodiment, the present disclosure provides methods for inserting an external ventricular drain (EVD) into a patient using a fixation device and a grommet locking assembly. The grommet locking assembly may be inserted into a burr hole in the skull, preferably at Kocher's point (<FIG>), approximately <NUM> along the sagittal axis as measured from the nasion and <NUM> laterally towards the right or left ear. The grommet locking assembly spans the thickness <NUM> of the skull (<FIG>). Ultrasound imaging is performed using the ultrasonic transducers located in the fixation device to determine the brain's anatomy, including location and depth. An operator may vary the orientation of the fixation device such that the fixation device is aimed at the right lateral ventricle, preferably the frontal horn of the right lateral ventricle. The operator may then at least partially lock the fixation device in place by actuating the at least one locking member so that the grommet locking assembly maintains the aim of the fixation device at the frontal horn of the right lateral ventricle. An operator may then determine a first boundary of the right lateral ventricle closest to the fixation device having a minimum depth and a second boundary of the right lateral ventricle furthest from the fixation device having a maximum depth. The operator may then insert a drainage catheter into the frontal horn of the right lateral ventricle by guiding the catheter into the lumen of the at least partially locked fixation device such that the drainage catheter passes the minimum depth but does not exceed the maximum depth. In one embodiment, the drainage catheter may be fitted with an ultrasonic reflective strip for enhanced visualization of the catheter.

In another embodiment, the present disclosure provides methods for inserting an EVD into a patient using a fixation device and a cup locking assembly. For example, a cup may be first inserted into a burr hole in the skull, preferably at Kocher's point (<FIG>), approximately <NUM> along the sagittal axis as measured from the nasion and <NUM> laterally towards the right or left ear. The cup spans the thickness <NUM> of the skull (<FIG>). The fixation device with ball adapter is then inserted into the cup, and ultrasound imaging is performed using the ultrasonic transducers located in the fixation device to determine the brain's anatomy, including location and depth. An operator may vary the orientation of the fixation device such that the fixation device is aimed at the right lateral ventricle, preferably the frontal horn of the right lateral ventricle. The operator may then at least partially lock the fixation device in place by actuating the at least one locking member so that the cup locking assembly maintains the aim of the fixation device at the frontal horn of the right lateral ventricle. An operator may then determine a first boundary of the right lateral ventricle closest to the fixation device having a minimum depth and a second boundary of the right lateral ventricle furthest from the fixation device having a maximum depth. The operator may then insert a drainage catheter into the frontal horn of the right lateral ventricle by guiding the catheter into the lumen of the at least partially locked fixation device such that the drainage catheter passes the minimum depth but does not exceed the maximum depth. In one embodiment, the drainage catheter may be fitted with an ultrasonic reflective strip for enhanced visualization of the catheter.

In certain embodiments, the present disclosure provides methods of using the fixation devices in conjunction with imaging software, wherein the imaging software acquires ultrasound images of the body to form real-time three dimensional display models from the reconstruction of gathered image data sets (<FIG>, <FIG>). The ultrasound transducer portion of a fixation device is controllably moved to image the anatomy of the body (<FIG>). While the fixation device is moved, position, angle, and rotation data relative to the fixation device are collected for each image (such as via a mems sensor) to generate a three-dimensional model. The combination of the 3D data and the position, angle, and rotation data allows a physician to determine the ideal trajectory and stopping point of an inserted medical instrument into the body. Upon selection of target coordinates, the computer, attached by either wired or wireless means to the fixation device, will calculate the correct orientation of the individual components of the fixation device, assuring precise and efficient placement of the medical instrument. In some embodiments, the fixation device further comprises one or more motors, such that the computer may further automatically adjust the orientation of the fixation device to match the selected target coordinates.

In some embodiments, the methods of using the fixation devices in conjunction with imaging software are suitable for placing ventricular catheters. As described elsewhere herein, the fixation devices incorporate at least one ultrasound transducer component capable of selectively moving its sonic energy wave front. In some embodiments, the sonic energy wave front can be moved in a pivoting manner such that the axis of rotation is parallel to the face of the transmission surface. The sonic energy wave front is moved along, and normal to, a given plane face such as the sagittal or coronal planes of the brain, wherein "normal" is referred to in the geometric sense as perpendicular to a line tangential to the skull. The sonic energy wave front can also be rotated about a fixed axis that is generally oriented in an axial direction, normal to the ultrasound transducer transmission face; rotating in this manner causes the sonic energy wave front to cross the sagittal plane, the coronal plane, or both. As the transducer is either pivoted or spun about an axis of rotation, encoders mounted in the fixation devices are capable of providing real-time positional (rotational and angular information) of the transducer's position. The positional information of the transducer face angle, referenced from a starting zero position, is combined with the associated image pixel data acquired at that specific point of data collection in space and time. In some embodiments, the fixation devices also provide real-time positional data of the inserted medical instruments.

It should be appreciated that movement of the transducers to capture imaging and positional data is not limited to a single rotation. For example, the transducers may be actuated in a single sweeping direction. The transducers may also be actuated in more than once rotation, or more than one sweeping direction. The transducers may also be actuated in a combination of one or more rotations and one or more sweeping directions. Using a sweeping actuation, volumetric image formation can be obtained by sequential anterior to posterior translation of a transducer relative to a subject. In the context of imaging a brain, a sweep of the transducer may be performed in the sagittal plane to render a three dimensional image of a desired structure. If, for instance, an object of interest is not represented in the sagittal sweep, the transducer can be translated along the coronal plane and a repeated anterior to posterior sweep of the transducer can be made to obtain the volumetric image of the desired structure.

Referring now to <FIG>, an exemplary method <NUM> of using a fixation device to insert a ventricular catheter is depicted. Method <NUM> begins with step <NUM>, wherein the skin is marked at Kocher's point above a subject's skull. Typically, Kocher's point is located with reference to the point between the subject's pupils, known as the nasion. A <NUM> line is drawn from the nasion along the skull in a posterior direction to the occiput. At the endpoint of the <NUM> line, a <NUM> line is drawn laterally towards the left or right ear. The endpoint of the <NUM> line is roughly Kocher's point. In step <NUM>, an incision is made at the marked skin. The incision is preferable large enough to accommodate a fixation device. Hemostasis should be established. To provide easier access to the skull, the skin may be spread with a retraction device. In step <NUM>, the skull is perforated. The skull may be perforated using any suitable drill bit. In some embodiments, it is recommended not to exceed <NUM> RPM when drilling. In step <NUM>, a fixation device of the present disclosure having ultrasonic transducers is inserted into the skull perforation. In step <NUM>, the ultrasonic transducers are aligned to capture a cross-sectional ultrasound image of the brain with the positional, angular, and rotational orientation of the ultrasonic transducers. In step <NUM>, the ultrasonic transducers are actuated. In step <NUM>, a series of ultrasonic images of the brain and associated positional, angular, and rotational orientation of the ultrasonic transducers are acquired during actuation. Typically, anechoic regions visible in the ultrasonic images represent the brain ventricles. In step <NUM>, the ultrasonic images are assembled to form a 3D reconstruction of the brain ventricles using the associated positional, angular, and rotational orientation of the ultrasonic transducers. In step <NUM>, an automatic segmentation of the 3D reconstruction is performed to isolate an anatomy of interest. The 3D reconstruction and segmentation views can be displayed from multiple angles, such as from a sagittal, coronal, and axial plane view, as well as a 3D view. Any suitable software can be used to generate the views, such as Osirix, ITK-Snap, 3D-Slicer, and Mimics. In step <NUM>, the positional, angular, and rotational orientation of the anatomy of interest are acquired. The location can be confirmed on the 3D reconstruction and segmentation views. In step <NUM>, the fixation device is aligned to target the anatomy of interest. In step <NUM>, the alignment of the fixation device is fixed relative to the skull. In step <NUM>, a catheter and ventricular drain are inserted through the fixation device into the anatomy of interest. In some embodiments, the ultrasonic transducers may be activated to monitor the entry of the catheter and ventricular drain. For example, out-of-plane imaging using the ultrasonic transducers can verify accurate catheter and ventricular drain insertion. In step <NUM>, the fixation device is removed over the catheter and ventricular drain.

With reference now to <FIG>, a anchor bolt <NUM> with raised pillars <NUM> is shown according to one embodiment. The anchor bolt <NUM> includes a threaded portion <NUM> that is designed to screw the anchor bolt <NUM> into a perforation formed in a patient's skull. A top portion <NUM> of the anchor bolt <NUM> is configured to connect to and anchor a PID guide and an ultrasound probe assembly. The anchor bolt, PID guide and ultrasound probe assembly can be considered components of a PID system. The threaded portion <NUM> and top portion <NUM> are separated by raised pillars <NUM> to form an opening <NUM> and allow for access to a treatment device, such as an EVD. In certain embodiments, the opening <NUM> can be used to access and fixate the EVD while the PID guide is being removed (see for example the method 500B described below). As shown in the alternative embodiment of <FIG>, the bolt anchor <NUM> can include a base <NUM> having multiple spikes <NUM> for improved fixation to the skull. In certain embodiments, the spikes <NUM> are disposed circumferentially or in pairs about the center opening of the bolt anchor <NUM>. In certain embodiments, holes <NUM> are formed in the base <NUM> for the insertion of bone screws that can thread into the scull. In certain embodiments, the holes <NUM> are disposed circumferentially or in pairs about the center opening, or are alternating between spikes in the base <NUM>. In one embodiment, an anchor bolt includes a circumferential bone attachment portion, a circumferential raised attachment portion, and a pillar member forming an opening therebetween. In one embodiment, the pillar member includes a plurality of separated pillar members. In one embodiment, the skull attachment portion includes a threaded surface.

With reference now to <FIG>, an ultrasound probe assembly <NUM> having a retractable ultrasound probe <NUM> is shown according to one embodiment. The ultrasound probe assembly <NUM> includes a housing <NUM>, an ultrasound probe <NUM> and a guide tube <NUM>. In certain embodiments, the probe <NUM> is retracted and deployed using a proximal dial mechanism <NUM>. During a procedure, the proximal dial mechanism <NUM> can be used to retract the probe <NUM> from the burr hole. A proximal dial mechanism <NUM> can also be used for fine adjustment of the probe <NUM> once inserted from the PID guide onto the dura. This allows for contact with the dura and image optimization. In one embodiment, a series of gears <NUM> is disposed at the base of the probe <NUM> that will allow for the probe <NUM> to be adjusted perpendicular to the probe housing or the dura surface, such as by the proximal dial mechanism <NUM> or a separate mechanism. Otherwise, if the adjustment were direct (i.e. along the trajectory of the probe), this may cause the probe to make contact with the inner table of the skull. According to the embodiment shown, the EVD <NUM> is placed from the center <NUM> of the ultrasound probe assembly <NUM> via the EVD guide tube <NUM> extending through the middle of the ultrasound probe assembly <NUM>. This embodiment minimizes the risks associated with the EVD being placed from an offset and angled approach, instead allowing a more direct advancement towards the target treatment location. This embodiment further minimizes the risk of angulation of the PID causing contact with the inner or outer table of the skull. The central axis of the guide tube forms an acute angle with the ultrasound transducer as shown in <FIG>. As shown specifically with reference to <FIG>, when the probe is retracted, it is also moved off to the side to allow the EVD to advance from the center of the probe assembly. This will translate to the EVD entering in the middle of the burr hole thus minimizing the risk of the EVD making contact with the inner or outer tables of the skull. In one embodiment, an ultrasound probe assembly includes a housing forming a guide tube extending therethrough, a retractable ultrasound probe, and a distal attachment portion. In one embodiment, the ultrasound probe is configured to move towards a central axis of the guide tube during extension. In one embodiment, the ultrasound probe is configured to move away from a central axis of the guide tube during retraction. In one embodiment, the ultrasound probe assembly includes a retractable ultrasound probe that moves along a first axis, and a guide tube having a central axis, where the first axis and the central axis are non-parallel. In one embodiment, the first axis and the central axis intersect to form an acute angle. In one embodiment, the first axis and the central axis intersect to form an angle of less than <NUM> degrees. In one embodiment, the ultrasound probe assembly includes a proximal control configured to retract and extend the probe. In one embodiment, the ultrasound probe assembly includes a control configured to move a tip of the probe along a lateral plane. In one embodiment, the retractable probe assembly includes a linear encoder. In one embodiment, the retractable probe assembly includes a magnetic encoder.

Advantageously, embodiments of the ultrasound probe can overcome the limited space for both ultrasound probe and EVD to occupy the typically <NUM> hole left by the drill. This avoids the safety implications of vectors that displace the EVD from the intended location which could impose a safety risk to the patient. Further, The hole that is produced by the drill is typically not symmetric, and there are fragments of bone that are left after removal of the bone pad. This limits the rotation and angulation of the probe and could interfere with the trajectory of the EVD if a bone fragment displaced the EVD in route to target. The embodiment described above allows the EVD to enter in the middle of the burr hole, avoiding this safety issue.

With reference now to <FIG> and <FIG>, in one embodiment, a linear encoder <NUM> will read the EVD <NUM> (or an EVD stylet) as it is inserted and advanced through the EVD guide tube <NUM>. In certain embodiments, the EVD or an EVD stylet is encoded with magnetic tape. In certain embodiments, the linear encoder <NUM> is a magnetic encoder that will read linear magnetic tape as it passes through the probe assembly to give the user real time information of the location of the EVD <NUM> as it advances towards the target. This can be represented on the user interface in coordination with the 3D rendered ventricles. Linear encoders <NUM> and rotary encoders <NUM> can also be positioned on the PID guide <NUM> for precision motion control, as shown in <FIG> according to one embodiment. The linear encoders <NUM> respond to motion along a path, while the rotary encoders <NUM> respond to rotational motion. In certain embodiments, the encoder determines a position (or direction) based on the scale it is detecting (e.g. a magnetic tape) and outputs a signal indicating the position (or direction), in either analog or digital format, to a controller. The encoders may use optical, magnetic, capacitive or inductive principles to generate an output signal. In one embodiment, the encoders are magnetic linear and rotary encoders that use magnetic tape to determine position. In one embodiment, a guide includes an opening, a first portion configured to attach to the circumferential raised attachment portion of the anchor bolt, a second portion configured to attach to the distal attachment portion of the ultrasound probe assembly, and a first and second encoder. In one embodiment, the guide includes a coronal plane adjustment mechanism. In one embodiment, the guide includes a sagittal plane adjustment mechanism. In one embodiment, the first encoder is a coronal encoder. In one embodiment, the second encoder is a sagittal encoder. In one embodiment, the first encoder is a linear encoder. In one embodiment, the second encoder is a rotary encoder.

With reference now to <FIG>, a flowchart of an exemplary method 500A of positioning a PID system for insertion of an EVD is shown according to one embodiment. First, to mark the skin <NUM>, a point is located between the pupils in the midline (Nasion), and a <NUM> line is drawn from the Nasion along the skull heading posterior to the occiput (see for example <FIG>). From this line (midline), a point is located <NUM> lateral and marked. An incision is made <NUM> large enough to accommodate the device at Kocher's point. Hemostasis should be obtained, then the skin can be spread with a retraction device (see for example <FIG>). Then, the skull is perforated with a power drill <NUM>, such as a <NUM>-<NUM> twist drill. In certain embodiments, the drill has a non-clogging geometry (e.g. fluted surfaces) to remove bone chips from the hole, as well a non-skid tip (see e.g. Acra Cut Smart Drill Model <NUM>-<NUM>). Next, the pillared anchor bolt <NUM> is threaded into the hole and secured to the scull <NUM>. Various embodiments of either the threaded anchor bolt <NUM> (<FIG>) or the spiked pillared anchor bolt <NUM>' (<FIG>) described above can be used. The PID guide <NUM> is then be inserted and connected to the pillared anchor bolt <NUM>, aligning the PID guide <NUM> in the coronal plane, towards the ear and locking into place on the pillared anchor bolt <NUM> with a locking pin/bolt portion of the PDI guide <NUM> (<FIG>). As shown in <FIG>, an encoder based PID guide <NUM>' and spiked pillared anchor bolt <NUM>' can be used. The PID guide <NUM> and anchor bolt <NUM> assembly is shown in <FIG>. Next, insert the ultrasound transducer of the ultrasound probe assembly <NUM> containing a second 9dof is inserted into the locked PID guide <NUM>, <NUM> (<FIG>). As shown in <FIG>, an encoder based PID guide <NUM>' can be used. When desired, the ultrasound probe assembly <NUM> can also be inserted directly into an anchor bolt <NUM> for imaging the target treatment area as shown in <FIG>. The fully assembled PID system is shown in <FIG>. A fully assembled PID system with an encoder based PID guide <NUM>' is shown in <FIG>. Next the depth of the transducer should be adjusted to make contact with the Dura using the twist knob <NUM> at the bottom of the ultrasound probe assembly <NUM>, <NUM>. As illustrated in <FIG>, tilt the transducer into the ideal coronal orientation where the right anterior horn of the lateral ventricle is in the central portion of the real time image by adjusting the angle of the green portion of the PID guide <NUM>. Next, perform a preliminary sweep of the PID in the sagittal direction to confirm proper sagittal orientation <NUM> (<FIG>). Confirm the lateral ventricle is located in the center of the ultrasound image <NUM>. Once satisfied with the sagittal orientation, press the "scan button" and sweep in the sagittal anterior-posterior direction until the unit has captured the predetermined number of images at the designated angular increments <NUM>. The capture portion of the scan will complete automatically and the unit will automatically create a 3D reconstruction of the scanned image sequence. This form of auto-segmentation provides a significant advantage over conventional systems. Auto-segmentation applied to the PID system is Updated in real time, and the interaction between the 3D model of the ventricle and the PID/avatar which too is updated in real time (<FIG>) provides a significant advantage over conventional systems. Dominant images and supportive images can be interchanged with a sign-in process that alters the user interface based upon user's present preferences (see <FIG>) the software/user interface will allow the user to determine target location and depth prior to EVD insertion (malpositioned catheters shown in <FIG>). By using the information from the 9dof, encoder and electromagnetic positioning device located on the PID, an avatar (overlay) image of the PID is projected over the <NUM>D image of the reconstructed lateral ventricle (<FIG>). The position of the avatar overlay correlates in real time to the position of the actual PID and as a result, the trajectory of the EVD. Utilizing the avatar representation allows the practitioner to move the PID guide into final align with the target at which time the PID is then locked into place in real time. Thus, the image capture and positioning process can be summarized in one embodiment as including the steps of determining the position of the transducer/PID using 2d scanning, sweeping the transducer form anterior to posterior, auto-segmenting the region of interest (e.g. the ventricle) using positioning data from the 9dof/encoder/electromagnetic device. Movement of the PID/transducer will update the region of interest model (e.g. the 3d ventricle). This 3D real time updates with the movement of the transducer and will simultaneous update the position of the PID/avatar within the user interface.

With refence now to <FIG>, a flowchart of an exemplary method 500B of placing an EVD is shown according to one embodiment. A distance D from the transducer face <NUM> to the entrance opening of the EVD guide <NUM> is determined <NUM> (<FIG>). This distance D is constant (i.e. the PID will move up and down a few mm with rotation of the dial, but will move as a unit). The distance D' from the transducer to the anterior horn of the ipsilateral ventricle is determined (<FIG>), and added to the distance D from the transducer face <NUM> to the entrance opening of the EVD guide <NUM>, <NUM>. Next, the distance from transducer to target D' added to the distance from the opening of the EVD guide on the PID D is determined and marked M on the EVD <NUM> as measured from the functional tip of the EVD (<FIG>) <NUM>. The transducer is switched on to provide out of plane imaging of the EVD entering the ventricle (<FIG>). The EVD <NUM> is then inserted up to the mark M <NUM> (<FIG>). The practitioner can also confirm proper placement (<FIG>) <NUM> with real time ultrasound image guidance information. Next, the practitioner can grab the EVD <NUM> with non-penetrating forceps <NUM> through the opening in the pillared anchor bolt <NUM> and subgaleal tunnel of EVD <NUM>, <NUM> (<FIG>). Once the EVD <NUM> is secure, the practitioner removes the ultrasound probe assembly <NUM> over the EVD <NUM>, <NUM>. Next, with the EVD still secure (<FIG>), the PID guide <NUM> is removed over the EVD <NUM>, <NUM> (<FIG>). Finally, the pillared bolt <NUM> can be removed over the EVD <NUM>, <NUM> (<FIG>).

In one embodiment, a method for imaging a region of interest includes the steps of perforating a bone, inserting an anchor bolt into the perforation, connecting a guide onto the anchor bolt, connecting an ultrasound probe assembly including an ultrasound transducer onto the guide, adjusting the depth of the ultrasound transducer, performing a sweep of the region of interest to confirm proper orientation; and retracting the ultrasound transducer.

In one embodiment, a method for imaging a region of interest includes the steps of perforating a bone, inserting an anchor bolt into the perforation, connecting a guide onto the anchor bolt, connecting an ultrasound probe assembly including an ultrasound transducer onto the guide, adjusting the depth of the ultrasound transducer, tilting the ultrasound transducer into a coronal orientation where the right anterior horn of the lateral ventricle is in the central portion of the real time image by performing a preliminary sweep in a sagittal direction to confirm proper sagittal orientation, confirming a lateral ventricle is located in a center of an ultrasound image; and sweeping in a sagittal anterior-posterior direction.

In one embodiment, a method for placing a catheter includes the steps of performing the steps of the method for imaging a region of interest; inserting a catheter; and confirming proper placement with a real time ultrasound image. In one embodiment, the method includes the steps of immobilizing the catheter through an opening in the anchor bolt; and removing the ultrasound probe assembly, guide and anchor bolt over the catheter.

An important aspect of embodiments described herein that separates this system and method from conventional systems and methods is the absence of a need for a specialized CT scan or MRI that must be obtained prior to "matching" with surface landmarks. For example, if a patient was previously admitted to an outside hospital where they had a CT scan or MRI, and it was not obtained with the protocol and equipment of the patient's current hospital, the medical professionals at the current hospital would have to repeat the CT scan or MRI according to the protocol and equipment of the patient's current hospital. Once the CT scan or MRI is obtained with the special protocol, the patient is then "matched" using surface landmarks. This entire process is very time consuming, spanning several hours, and the CT scanner and traditional navigation equipment are very expensive. The instant devices, methods and systems described throughout the embodiments combine the imaging, 3D segmentation and navigation steps into one single step that would take less than <NUM> minutes total. It is easy to understand that if the patient is in extremis, time is of the essence. Additionally, patients are often too sick to travel outside of the ICU and a compact localized and bedside solution provides a great benefit. The ultrasound can obtain 2D images with coordinate data which will allow for segmentation of the 2D images into a 3D structure. The rendered image of the ventricle is what the practitioner will use to determine the path of the EVD. The patient interface device will then be moved into the proper position and the ultrasound probe removed. This will allow for the EVD to be inserted and advanced to the proper location. The software can allow the ultrasound images that are acquired to be "fused" with a CT scan that the patient likely will have prior to admission to the ICU or transferred from another hospital. In one embodiment, the disclosure provides improved methods for accurate biopsies. For example, a fixation device patch may be adhered to the soft tissue near the desired sample site. Emissions from the fixation device transducers determine the patient's internal anatomy, including structure depth. An operator may vary the orientation of the fixation device such that the fixation device is aimed at the desired sample site. The operator may then at least partially lock the fixation device in place by actuating the at least one locking member so that the fixation device maintains its aim at the desired sample site. The operator may then accurately direct a biopsy needle into the sample site by guiding the biopsy needle into the lumen of the locked fixation device. In one embodiment, the biopsy needle may be fitted with an ultrasonic reflective strip for enhanced visualization of the catheter.

The present disclosure also includes a kit comprising components useful within the methods and instructional material that describes, for instance, the method of using the fixation devices and locking assemblies as described elsewhere herein. The kit may comprise components and materials useful for performing the methods disclosed.

For instance, the kit may comprise a fixation device, a grommet locking assembly, a cup locking assembly, and catheters. In other embodiments, the kit may include separately the transducer components and the locking assemblies, such that the transducer components may be sterilized and reusable, while the locking assemblies may be sterilized and reusable or discarded and replaced. In other embodiments, the kit may further comprise software and electronic equipment to convert received waves into images. The software and electronic equipment may be presented in a compact form for portable use.

In certain embodiments, the kit comprises instructional material. Instructional material may include a publication, a recording, a diagram, or any other medium of expression which can be used to communicate the usefulness of the device described herein. The instructional material of the kit may, for example, be affixed to a package which contains one or more instruments which may be necessary for the desired procedure. Alternatively, the instructional material may be shipped separately from the package, or may be accessible electronically via a communications network, such as the Internet.

Claim 1:
A guide (<NUM>) for accurate insertion of medical devices during stereotactic surgical procedures comprising:
an opening;
a first portion configured to attach to a circumferential raised attachment portion of an anchor bolt (<NUM>);
a second portion configured to attach to a distal attachment portion of an ultrasound probe assembly (<NUM>);
and a first (<NUM>) and second (<NUM>) encoder; wherein the first encoder is configured to determine a position based on motion of the first encoder along a first path and to output a first signal indicating the position to a controller,
the second encoder is configured to determine a position based on motion of the second encoder along a second path and to output a second signal indicating the position to a controller,
and movement along the first and second paths will update a model of a region of interest in real time based on the positioning data provided by the first and second output signals from the first and second encoders.