This document relates generally to instrument immobilizers, and more specifically, but not by way of limitation, to a low profile instrument immobilizer.
Neurosurgery sometimes involves inserting an electrode (for recording brain signals or providing stimulating pulses) or other instrument (for example, a catheter for fluid aspiration or drug infusion) through a burr hole or other entry portal into a subject's brain toward a target region of the brain. In certain applications, there is a need to secure the electrode or other instrument in place after it has been introduced, potentially for an extended period of time. Moreover, in certain applications, other equipment (such as a trajectory guide and any associated equipment) is mounted to the patient's skull about the burr hole.
For these and other reasons, which will become apparent upon reading the following detailed description and viewing the drawings that form a part thereof, the present inventors have recognized an unmet need for low profile instrument immobilizer devices, tools, and methods that reduce or avoid patient discomfort and also better retain instruments.
In the drawings, which are not necessarily drawn to scale, like numerals describe substantially similar components throughout the several views. Like numerals having different letter suffixes represent different instances of substantially similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.
In the following detailed description, reference is made to the accompanying drawings that form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural, logical and electrical changes may be made without departing from the scope of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims and their equivalents.
In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one. Furthermore, all publications, patents, and patent documents referred to in this document are incorporated by reference herein in their entirety, as though individually incorporated by reference. In the event of inconsistent usages between this documents and those documents so incorporated by reference, the usage in the incorporated reference(s) should be considered supplementary to that of this document; for irreconcilable inconsistencies, the usage in this document controls.
In this example, instrument immobilizer 100 includes a two-piece sliding cover including cover pieces 106A-B. Each cover piece 106A-B is sized and shaped to be inserted through a corresponding side slot 108A-B in an opposing side of hoop 102. Each piece of cover piece 106A-B also has a snap-fit or other catch 109A-B, such as a deformable tab, that engages a portion of hoop 102 when that cover piece 106A or 106B has been fully inserted. Catches 109A-B hold their corresponding cover piece 106A-B in place after it has been fully inserted. Alternatively, the instrument immobilizer includes a one-piece sliding cover that, in one example, the single cover piece substantially covers the circular center passage when fully inserted through a corresponding side slot.
As illustrated generally in
In this example, the access slot 606 extends across base 602, except for the presence of connecting member 608. The slot 606 permits access to the underlying burr hole or other entry portal, except for the obstruction of connecting member 608. Connecting member 608 provides a mechanical connection between two semicircular portions 602A-B of base 602. The semicircular portions 610A-B are separated by slot 606 and connecting member 608.
In this example, a latch 610 is eccentrically coupled to base 602 by coupling the latch to the base at a point offset from the center of the base. In the example of
In
In this example, instrument immobilizer 1000 includes a semicircular shaped clasp 1008. The clasp 1008 is coupled at a first end to one of the semicircular portions 1002A-B by a hinge 1010. At a second end, the clasp 1008 includes a fastener 1012. In this example, the fastener 1012 includes a male snap-fitting, for securing to a mating female receptacle 1100 (
In the example of
In this example, hoop 1702 defines a center passage therewithin, into which an insert 1706 is disposed. Insert 1706 includes at least one snap-fitting feature that allows insert 1706 to be snapped into hoop 1702. In one example, insert 1706 is inserted into the circular center passage of hoop 1702 such that insert 1706 rotates therewithin with respect to hoop 1702. In this example, the insert 1706 includes at least one detent disposed about the insert bottom surface and projecting to the side of the insert. The hoop 1702 includes a corresponding grooved surface disposed upon an intermediate surface therein. The at least one detent engages the grooved surface. This engagement prevents unwanted rotation of the insert 1706 with respect to the hoop 1702.
In
In one example, retaining members 1710A-B include respective mating couplings to hold the retaining members in engagement with each other. In one option, the mating couplings include snap-fit features to maintain engagement between the retaining members 1710A-B. In another example, at least one of the retaining members 1710A-B includes an engagement coupling that secures the at least one of the retaining members 1710A-B relative to insert 1706. In one option, the engagement coupling includes a “one-way” toothed surface disposed substantially upon the side slide rails of the insert 1706. Corresponding tabs are disposed along the bottom edge of the at least one of the retaining members 1710A-B. The tabs engage the toothed surface and thereby allow slidable movement of the at least one of the retaining members 1710A-B in one direction, typically toward the other retaining member. In another option, both retaining members 1710A-B have tabs that engage toothed surfaces on the rails. When retaining members 1710A-B contact each other, the tabs engaging the toothed rails maintain engagement between the retaining members 1710A-B. The retaining members 1710A-B do not disengage from each other because the tabs and teeth prevent sliding away in the other direction. If it is desirable to move the retaining members 1710A-B in a direction counter to that allowed by the tabs and teeth the retaining members 1710A-B are pulled out of engagement with the side rails, disengaged from each other and repositioned within the side slide rails.
In this example, hoop 1902 defines a center passage therewithin, into which a lid 1906 is disposed. Lid 1906 includes at least one snap-fitting feature that allows lid 1906 to be snapped into hoop 1902. In one example, lid 1906 rotates substantially within the circular center passage of hoop 1902. In another example, the lid 1906 includes at least one detent on its bottom surface, and the hoop 1902 includes a corresponding groove on or near its inner periphery. The at least one detent engages the groove. This prevents undesirable rotation of the lid 1906 with respect to the hoop 1902.
In this example, the lid 1906 includes a slot 1908. In one option, the slot 1908 has an arcuate geometry defined by the lid 1906 and extends across an angle of approximately 15 degrees. The slot 1908 extends from an outer edge 1920 of the lid 1906, tapering inward toward a center 1922 of the lid 1906. The slot includes at least one socket 1910.
The seat assembly also includes a collar 2514 coupled to the seat 2502 by the bridge 2506. In one example, the collar 2514 is suspended within the burr hole by the bridge 2506. In other words, the collar 2514 is suspended within a space 2516 defined by the inner surfaces of the seat 2502. In an alternative embodiment, the collar 2514 is disposed above or below the plane defined by the seat 2502. Optionally, where the collar 2514 is disposed below or above the seat 2502 at least the outer surface of the collar 2514 may have a greater circumference than the inner surface of the seat 2502. In another example, the bridge 2506 spans a distance between the seat 2502 and the collar 2514 substantially equal to the distance between the inner surface of the seat 2502 and the outer surface of the collar 2514. In one example, the collar 2514 is spaced from the seat 2502 so where the prongs 2504 are in an undeformed or deformed condition they do not contact the collar 2514. In an example, the collar 2514 defines a socket 2518 and is dimensioned and configured to retain an instrument immobilizer seated therein, for example instrument immobilizer insert 1706. In still another example, the seat assembly 2500 and instrument immobilizer insert 1706 are integral to each other.
An inner surface of the seat assembly 2800 defines an access lumen 2804. In one option, the access lumen 2804 is dimensioned and configured so an instrument immobilizer, for example, instrument immobilizer insert 1706 is capable of being disposed within the access lumen 2804. In yet another example, the seat assembly 2800 includes a collar 2806. In one option, the collar 2806 extends from the inner surface of the seat assembly 2800 and forms an annular ridge within the access lumen 2804. In another option, the collar 2806 is a discontinuous flange within the access lumen 2804. The collar 2806 is dimensioned and configured to couple with an instrument immobilizer such as instrument immobilizer insert 1706. In one example, the collar 2806 includes at least one snap fitting 2805 sized and shaped to engage with a corresponding projection, such as snap fitting 2807, on the instrument immobilizer insert 1706 to retain the insert 1706 in the collar 2806. The snap fitting 2805 defines a socket and is sized and shaped to receive the snap fitting 2807. In another example, the collar 2806 is dimensioned and configured to retain a variety of instrument immobilizer inserts, including, but not limited to, inserts configured like instrument immobilizers 100, 600, 1000, 1500, or 1900 and lid 2100.
In one option, when the seat assembly 2800 is inserted within the burr hole the seat assembly 2800 is substantially flush with the surface of the skull or disposed beneath the surface of the skull. In another option, when the instrument immobilizer insert 1706 is coupled to the seat assembly 2800 and the seat assembly 2800 is inserted within the burr hole, the insert 1706 is substantially flush with the surface of the skull or disposed beneath the surface of the skull. Optionally, the seat assembly 2800 and instrument immobilizer insert 1706 present no profile above the surface of the skull when inserted within the burr hole.
In another example, the seat assembly 2800 includes tool cavities 2808. In one option, the multiple tool cavities 2808 are formed in an end surface 2810 of the seat assembly 2800. In another option, the tool cavities 2808 are dimensioned and configured to receive the tines of a driving instrument. Optionally, the driving instrument is used to turn the threaded seat assembly 2800 and screw the seat assembly 2800 into the burr hole.
In another example, the flange 2903 includes tool cavities 2904. The tool cavities 2904 are dimensioned and configured to receive the tines of a driving instrument. Optionally, the driving instrument is used to turn the threaded seat assembly 2900 and screw the seat assembly 2900 into the burr hole. The flange 2903 serves as a depth stop as the seat assembly 2900 is driven into burr hole. In one option, the flange 2903 positions the seat assembly 2900 at a predetermined depth within the burr hole.
An inner surface of the seat assembly 3100A defines an access lumen 3111. In one example, an instrument immobilizer, for example, instrument immobilizer insert 1706 is coupled to the seat assembly 3100A and disposed above the access lumen 3111. In one option, the instrument immobilizer insert 1706 has an outer perimeter substantially corresponding to the outer perimeter of the seat assembly 3100A. As a result, the instrument immobilizer insert 1706 has an outer perimeter substantially corresponding to an inner perimeter of the burr hole 3103. Optionally, the instrument immobilizer insert 1706 has a diameter of about 14 millimeters.
Optionally, at least one of the seat assembly 3100 and the insert 1706 includes projections and/or sockets sized and shaped to couple the insert 1706 with the seat assembly 3100 by a snap fit. In one example, the instrument immobilizer insert 1706 includes projections, such as posts 3108, extending from one face of the insert 1706. In one option, the posts 3108 are dimensioned and configured to snugly fit within the tool cavities 3102. In another option, the posts 3108 include snap fittings 3110. In yet another option, the tool cavities 3102 include corresponding sockets 3112 dimensioned and configured to receive the snap fittings 3110. The snap fittings 3110 and sockets 3112 are dimensioned and configured to snugly couple the instrument immobilizer insert 1706 to the seat assembly 3100. In another example, the seat assembly 3100 is dimensioned and configured to snugly couple with a variety of instrument immobilizer inserts, including, but not limited to, inserts configured like instrument immobilizers 100, 600, 1000, 1500, or 1900 and lid 2100.
In another example, the seat assembly 3100B includes a cap 3120 sized and shaped to cover the instrument immobilizer insert 1706. At least one of the seat assembly 3100B and the cap 3120 includes projections and/or sockets sized and shaped to couple the cap 3120 with the seat assembly 3100B by a snap fit. In one option, the cap 3120 includes projections, such as posts 3108, extending from one face of the cap 3120. In one option, the posts 3108 are dimensioned and configured to snugly fit within tool cavities 3102. In another option, the posts 3108 include snap fittings 3110. In yet another option, the tool cavities 3102 include corresponding sockets 3112 dimensioned and configured to receive the snap fittings 3110. The snap fittings 3110 and sockets 3112 are dimensioned and configured to snugly couple the cap 3120 to the seat assembly 3100B.
Referring again to
In the above examples (aspects of which can be combined with each other), the components of instrument immobilizers 100, 600, 1000, 1500, 1700, 1900, lid 2100, and seat assemblies 2500, 2800, 2900, 3000, 3100 may be manufactured from molded plastic and are MRI compatible. The bone screws used for securing the instrument immobilizers may be manufactured from stainless steel. In one example, such bone screws include imaging fiducial markers integral or attachable thereto. Additionally, in other embodiments of the above examples the exit grooves are disposed at various locations (for example, at regular intervals) about the instrument immobilizers 100, 600, 1000, 1500, 1700, and 1900 to provide flexibility in the placement of the instruments when immobilized. Instrument immobilizers 100, 600, 1000, 1500, 1700, 1900, lid 2100, and seat assemblies 2500, 2800, 2900, 3000, 3100 are not limited to use in conjunction with skull burr holes in neurosurgery, but may be secured at other locations of a patient for securing an electrode or other surgical instrument (for example catheters used for aspiration or infusion), or about or within an entry portal in other objects into which an instrument has been introduced, and which requires immobilization. The above examples provide instrument immobilizers that are designed to advantageously provide a low-profile (e.g., small height) above or flush to the patient's skull. By way of example, but not by way of limitation, in one embodiment, instrument immobilizer 100 provides a height of less than about 0.1 inches, instrument immobilizer 600 provides a height of less than about 0.08 inches, instrument immobilizer 1000 provides a height of less than about 0.08 inches, instrument immobilizer 1500 provides a height of less than about 0.065 inches, instrument immobilizer 1700 provides a height of less than about 0.1 inches, instrument immobilizer 1900 and lid 2100 provide a height of less than about 0.1 inches, and seat assemblies 2500, 2800, 3100 and instrument immobilizer 1700 provide a height of 0.0 inches.
Several variations are possible. One example includes sliding the first cover piece through a slot in the instrument immobilizer base and sliding the second cover piece through another slot in the instrument immobilizer base. Another example includes grasping and/or retaining a portion of the instrument within a groove defined by the first and second cover piece.
Several variations are possible. One example includes retaining the latch against the instrument by engaging a portion of the latch to a mating portion of the instrument immobilizer base. In another example, a portion of the instrument is laterally positioned against the instrument immobilizer base, and the portion of the instrument is tucked under an overlying retaining member that holds the portion of the instrument against the instrument immobilizer base.
Several variations are possible. One example includes positioning a portion of the instrument laterally against the instrument immobilizer base, and tucking the instrument under a retaining member overlying the instrument and a groove. Another example includes snap-fitting the clasp to the instrument immobilizer base.
Several variations are possible. One example includes rotatably advancing the second base piece toward the instrument, where the second base piece is rotatably coupled with the surface. Another example includes snapping the first base piece together with the second base piece. In still another example, a portion of the instrument is positioned within a groove defined by one of the first base piece or the second base piece.
Several variations are possible. One example includes coupling an insert with an instrument immobilizer base. In another example, a portion of the instrument is received along edges of the first and second retaining member.
Several variations are possible. One example includes disposing a second instrument within a second tapered slot of the instrument immobilizer base, and moving the second instrument along the second tapered slot until the second instrument is grasped by the second tapered slot and immobilized. In another example, a portion of the instrument is received laterally along the instrument immobilizer base.
Several variations are possible. One example includes disposing an instrument within a passage of the instrument immobilizer. Another example includes advancing a first cover piece and a second cover piece (e.g. first and second cover pieces 1710A, 1710B) toward the instrument and engaging the first cover piece and the second cover piece against the instrument to immobilize the instrument therebetween. Yet another example includes deforming the seat to fit within the burr hole and releasing the seat so it expands and engages against the surface defining the burr hole. Optionally, deforming the seat is performed without deforming the collar. In another option, disposing the seat within the burr hole is performed prior to disposing the instrument immobilizer within the collar.
Several variations are possible. One example includes snap fitting the instrument immobilizer to the collar. Another example includes screwing the seat into the burr hole. Optionally, the outer perimeter of the seat includes threading. Yet another example includes coupling the instrument immobilizer to the collar of the seat after disposing the seat within the burr hole. Another option includes engaging a flange with an upper surface around the burr hole, wherein the flange extends radially from an outer perimeter of the seat.
Several variations are possible. One example includes snap fitting the instrument immobilizer to an end surface of the seat. Another example includes disposing a post having a snap fitting within a socket dimensioned and configured to receive the snap fitting. Yet another example includes screwing the seat into the burr hole where the outer perimeter of the seat includes threading. Optionally, coupling the instrument immobilizer to the seat is performed after disposing the seat within the burr hole.
Although the above examples have discussed immobilizing an electrode, these examples are also applicable to immobilizing any other instrument, including, but not limited to instruments for surgical, therapeutic, or diagnostic use, including use in non-medical fields where immobilization of an instrument is advantageous. Some examples of such other medical instruments include, by way of example, but not by way of limitation, a catheter (e.g., for aspiration or for infusion of a drug, cells, or another substance), a probe for measuring pressure, temperature, or some other parameter, a biopsy or other needle. Moreover, certain of the above examples that provide a cover for a burr hole or other entry portal may be useful for serving this function as well, even without securing and immobilizing an instrument. Further, in some of the examples above, the instrument immobilizers may be positioned within a burr hole using the seat assembly. Additionally, in other examples, an instrument immobilizer and the seat assembly may be made integral. Furthermore, in the above examples, one or more of such components may be coated, impregnated, or otherwise provided with a drug or other therapeutic agent for delivery to the site at which such component(s) are located. Examples of such agents include steroids or other anti-inflammatory agents, or anti-infection agents such as antibiotics or antiviral drugs.
It is to be understood that the above description is intended to be illustrative, and not restrictive. For example, the above-described embodiments may be used in combination with each other. Many other embodiments will be apparent to those of skill in the art upon reviewing the above description. The scope of the invention should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. In the appended claims, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.
This application is a Continuation-In-Part Application under 37 CFR §1.53(b) and 35 U.S.C. §111(a) of PCT/US2003/028966, filed Sep. 17, 2003 and published in English on Apr. 1, 2004 as WO 2004/026161 A2, which claimed priority under 35 U.S.C. §119(e) of U.S. Provisional Application Ser. No. 60/411,309, filed Sep. 17, 2002, which applications and publication are incorporated herein by reference.
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Number | Date | Country | |
---|---|---|---|
20050192594 A1 | Sep 2005 | US |
Number | Date | Country | |
---|---|---|---|
60411309 | Sep 2002 | US |
Number | Date | Country | |
---|---|---|---|
Parent | PCT/US03/28966 | Sep 2003 | US |
Child | 11005907 | US |