# US 11,439,413 B2 · Epidural/subdural minimally invasive access tool

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- Number: US 11,439,413 B2
- Document ID: US11439413B2
- Status: Granted
- Kind: B2
- Application number: 16/764,520
- Filed: 2018-11-16
- Published: 2020-11-26
- Granted: 2022-09-13
- Earliest claimed: 2017-11-17
- Assignees: Icahn School of Medicine at Mount Sinai
- Applicants: Icahn School of Medicine at Mount Sinai
- Inventors: Joshua Bederson
- Web page: https://patentgrep.com/patent/US11439413B2

## CPC

- A61B 17/1739: {specially adapted for particular parts of the body}
- A61B 17/1695: {Trepans or craniotomes, i.e. specially adapted for drilling thin bones such as the skull}
- A61B 90/11: with guides for needles or instruments, e.g. arcuate slides or ball joints
- A61B 5/37: Intracranial electroencephalography [IC-EEG], e.g. electrocorticography [ECoG]
- A61B 2017/00991: {Telescopic means}
- A61B 2090/034: {abutting on parts of the device itself}
- A61B 2090/103: {Cranial plugs for access to brain}
- A61B 2090/508: {with releasable brake mechanisms}
- A61N 1/0539: {Anchoring of brain electrode systems, e.g. within burr hole}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

A cranial drill guide includes a housing and a drill guide sleeve assembly pivotally attached to the housing. The drill guide sleeve assembly has at least two degrees of freedom to allow the drill guide sleeve assembly to be moved to a first pivoted position for forming an angled burr hole through a cranial surface. The two degrees of freedom can comprise a pivoting motion of the drill guide sleeve assembly and an axial motion of a portion of the drill guide sleeve assembly.

## Claims

### Claim 1

A cranial drill guide comprising:
a housing; and
a drill guide sleeve assembly pivotally attached to the housing, the drill guide sleeve assembly having at least two degrees of freedom to allow the drill guide sleeve assembly to be moved to a first pivoted position for forming an angled burr hole through a cranial surface;
wherein the drill guide sleeve assembly comprises an outer sleeve and an inner sleeve, the outer sleeve being pivotally coupled to the housing about a first pivot axis, while the inner sleeve moves axially within the outer sleeve in response to the pivoting of the outer sleeve.

### Claim 2 (depends on 1)

The drill guide of claim 1, wherein the housing has a first side wall and a second side wall coupled to the first side wall with the drill guide sleeve assembly being disposed therebetween, wherein a cross member connects a bottom end of the first side wall to a bottom end of the second side wall with a pivot axis of the drill guide sleeve assembly being located above the bottom ends of the first side wall and the second side wall.

### Claim 3 (depends on 1)

The drill guide of claim 1, wherein the two degrees of freedom comprise a pivoting motion of the drill guide sleeve assembly and an axial motion of a portion of the drill guide sleeve assembly.

### Claim 4 (depends on 3)

The drill guide of claim 3, wherein pivoting of the drill guide sleeve assembly is translated into the axial motion of the portion of the drill guide sleeve assembly, wherein the pivoting and axial motion occur concurrently.

### Claim 5 (depends on 1)

The drill guide of claim 1, wherein the inner sleeve is free of direct attachment to the outer sleeve but rather, the inner sleeve is pivotally coupled to the housing.

### Claim 6 (depends on 1)

The drill guide of claim 1, further including a pair of pivotal linkages that are pivotally connected at a first end to the housing along a second pivot axis and at an opposite second end to the inner sleeve, whereby as the outer sleeve pivots about the first axis, the inner sleeve moves axially within the outer sleeve such that when the outer sleeve pivots in a first direction away from the housing, the inner sleeve is lowered within the outer sleeve, while when the outer sleeve pivots in an opposite second direction toward the housing, the inner sleeve is raised within the outer sleeve, wherein the second pivot axis is located above the first pivot axis.

### Claim 7 (depends on 6)

The drill guide of claim 6, wherein the outer sleeve includes a pair of open ended slots formed therein, wherein coupling members that attach the linkages to the inner sleeve pass through the slots and move therein as the drill guide sleeve assembly pivots between a storage position and the first pivoted position.

### Claim 8 (depends on 7)

The drill guide of claim 7, wherein in the first pivoted position, bottom ends of the inner sleeve and outer sleeve lie within or above a bottom plane of the housing, wherein the linkages are disposed external to the outer sleeve and the open ended slots are open at a top end of the outer sleeve.

### Claim 9 (depends on 1)

The drill guide of claim 1, wherein the housing includes a stabilizing element that extends radially outward therefrom, the stabilizing element having a through hole for receiving a fastener for detachably securing the drill guide to the cranial surface.

### Claim 10 (depends on 1)

The drill guide of claim 1, further including a base to which a bottom of the housing is rotatably mounted.

### Claim 11 (depends on 1)

The drill guide of claim 1, wherein the drill guide sleeve assembly moves between a storage position in which the drill guide sleeve assembly is contained within the housing in an upright position and the first pivoted position, wherein in the storage position, the inner sleeve extends a maximum distance above a top end of the outer sleeve and in the first pivoted position, the inner sleeve extends a minimum distance above the top end of the outer sleeve or lies below the top end of the outer sleeve.

### Claim 12 (depends on 1)

The drill guide of claim 1, wherein a bottom edge of each of the inner sleeve and the outer sleeve lies in more than one plane, the bottom edge of the outer sleeve having a flat portion and an upwardly sloped portion opposite the flat portion, each of the inner sleeve and the outer sleeve being oriented such that the upwardly sloped portion faces a pivot direction of the inner sleeve and the outer sleeve.

### Claim 13 (depends on 1)

The drill guide of claim 1, wherein the inner sleeve includes an inner lumen, the inner lumen having a variable diameter.

### Claim 14 (depends on 13)

The drill guide of claim 13, wherein the diameter of the inner lumen progressively decreases in a direction toward a bottom edge of the inner sleeve.

### Claim 15 (depends on 13)

The drill guide of claim 13, wherein the inner lumen includes a plurality of discrete sections each having at least one of a different shape and different size relative to the one or more other section.

### Claim 16 (depends on 15)

The drill guide of claim 15, wherein the inner lumen is constructed such that when the drill is fully inserted and the drill guide sleeve assembly is in a fully retracted position, a distal tip of the drill lies below a bottom edge of the inner sleeve.

### Claim 17 (depends on 16)

The drill guide of claim 16, wherein a bottom edge of the outer sleeve has a flat portion and an upwardly sloped portion opposite the flat portion, the distal tip of the drill lying above the flat portion but below the upwardly sloped portion.

### Claim 18

A cranial drill guide for guiding a drill comprising:
a housing;
a drill guide sleeve assembly pivotally attached to the housing, the drill guide sleeve assembly having at least two degrees of freedom to allow the drill guide sleeve assembly to be moved to a first pivoted position for forming an angled burr hole through a cranial surface; and
a depth adjustment mechanism that is part of the drill guide sleeve assembly and is configured to set a maximum insertion position for the drill within the drill guide sleeve assembly and thereby permit a depth of the angled burr hole to be controlled;
wherein the drill guide sleeve assembly comprises an outer sleeve, an inner sleeve, and a drill sleeve, the outer sleeve being pivotally coupled to the housing about a first pivot axis, while the inner sleeve and drill sleeve move axially within the outer sleeve in response to the pivoting of the outer sleeve.

### Claim 19 (depends on 18)

The drill guide of claim 18, wherein the outer sleeve, inner sleeve and drill sleeve are coaxial to one another with the inner sleeve disposed within an inner lumen of the outer sleeve and the drill sleeve is disposed within an inner lumen of the inner sleeve.

### Claim 20 (depends on 18)

The drill guide of claim 18, wherein the inner sleeve and the drill sleeve include engagement means that permits the drill sleeve to be fixedly coupled to the inner sleeve at a plurality of different axial positions with a top end of the drill sleeve being exposed above a top end of the inner sleeve across all of the plurality of different axial positions.

### Claim 21 (depends on 18)

The drill guide of claim 18, wherein the inner sleeve includes inner threads at a lower portion of the inner sleeve and the drill sleeve includes outer threads at a lower portion of the drill sleeve, the drill sleeve being threadingly coupled to the inner sleeve.

### Claim 22 (depends on 18)

The drill guide of claim 18, wherein the drill sleeve includes an inner lumen that extends along an entire length thereof, wherein the inner lumen includes a tapered end portion proximate a bottom end of the drill sleeve, the tapered end portion defining a stop for the drill.

### Claim 23 (depends on 22)

The drill guide of claim 22, wherein the tapered end comprises an inward taper such that a diameter of the inner lumen is less at the bottom end of the drill sleeve compared to a diameter of the inner lumen at an opposite top end of the drill sleeve, the diameter of the inner lumen being selected such that a body of the drill cannot pass therethrough, while a drill bit extending distally from the drill body passes therethrough.

### Claim 24 (depends on 22)

The drill guide of claim 22, wherein the drill guide sleeve assembly has a fully retracted position in which the drill guide sleeve assembly is configured to be positioned substantially perpendicular to the cranial surface and in the first pivoted position which comprises a fully extended position, the drill guide sleeve assembly is configured to be at an acute angle to the cranial surface, wherein in the fully retracted position, the inner sleeve and the drill sleeve is at a maximum raised position within the outer sleeve, while in the fully extended position, the inner sleeve and the drill sleeve is at a maximum lowered position within the outer sleeve, wherein a relative axial position of the drill sleeve and the inner sleeve in the maximum raised position is selected such that when a drill is fully inserted into the drill sleeve and contacts the stop, a drill bit of the drill is positioned proximate to a distalmost edge of a bottom end of the outer sleeve, while in the maximum lowered position, the drill bit extends below the outer sleeve and below the housing.

### Claim 25 (depends on 24)

The drill guide of claim 24, wherein in the maximum raised position and in the maximum lowered position, a top end of the drill sleeve extends and protrudes above both top ends of the inner sleeve and the outer sleeve.

### Claim 26 (depends on 18)

The drill guide of claim 18, wherein a bottom end of the outer sleeve includes an inwardly curved portion that is curved in a direction of a top end of the outer sleeve.

### Claim 27

A method for forming an angled burr hole through a cranial surface comprising the steps of:
positioning a cranial drill guide on the cranial surface, the drill guide having a pivotable drill guide sleeve assembly that is configured to receive a cranial drill;
inserting the cranial drill within the drill guide sleeve assembly; and
moving the drill guide sleeve assembly from a first position to a first pivoted position, while the cranial drill is inserted within the drill guide sleeve assembly, resulting in a drill bit of the drill being automatically advanced into the cranial surface to form the angled burr hole through the cranial surface.
