# Patent

## Title
Surgical navigation

## Abstract

A method of surgical navigation into the brain includes establishing a trajectory through the skull into the brain to a target, drilling a hole in the skull using a drill, and verifying the trajectory of the drilled hole during drilling using image guidance. A surgical navigation system includes a cannulated drill, a cannulated access member, and a coupling member for coupling the access member to the drill and for maintaining alignment of the cannulations in the drill and the access member. The access member is movable relative to the coupling member such that the access member can be secured to tissue while the coupling member maintains the alignment of the cannulations. A surgical kit includes a cannulated drill, a cannulated access member, a coupling member for coupling the access member to the drill, and a probe for receipt within the cannulated drill.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation of U.S. patent application Ser. No. 13/773,181 filed on Feb. 21, 2013, which is a continuation of U.S. patent application Ser. No. 12/525,492 filed on Jan. 6, 2010, now U.S. Pat. No. 8,394,099 issued on Mar. 12, 2013, which claims benefit of International Patent Application No. PCT/US2008/052790 filed on Feb. 1, 2008, which claims benefit of: (1.) U.S. Patent Application No. 60/942,261 filed on Jun. 6, 2007, and (2.) U.S. Patent Application No. 60/887,719 filed on Feb. 1, 2007. The entire disclosures of each of the above applications are incorporated herein by reference.


FIELD
The present disclosure relates to surgical navigation.
SUMMARY
This section provides a general summary of the disclosure, and is not a comprehensive disclosure of its full scope or all of its features.
A method of surgical navigation into the brain includes establishing a trajectory through the skull into the brain to a target, drilling a hole in the skull using a drill, and verifying the trajectory of the drilled hole during drilling using image guidance.
Embodiments of this aspect may include one or more of the following features. The image guidance is provided by a probe received by the drill. The probe is received in a lumen defined by the drill. The method includes placing an access member in the drilled hole, and verifying the trajectory of the access member during placement. The access member is placed using the drill, and the trajectory is verified using the probe received by the drill.
A surgical navigation system includes a cannulated drill, a cannulated access member, and a coupling member for coupling the access member to the drill and for maintaining alignment of the cannulations in the drill and the access member. The access member is movable relative to the coupling member such that the access member can be secured to tissue while the coupling member maintains the alignment of the cannulations.
Embodiments of this aspect may include one or more of the following features. The system includes a probe for receipt within the cannulated
A surgical kit includes a cannulated drill, a cannulated access member, a coupling member for coupling the access member to the drill, and a probe for receipt within the cannulated drill. Embodiments of this aspect may also include a drill bit, a medical device, and/or a robot arm.
Further areas of applicability will become apparent from the description provided herein. The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.



DRAWINGS
The drawings described herein are for illustrative purposes only of selected embodiments and not all possible implementations, and are not intended to limit the scope of the present disclosure.
FIG. 1 is an illustration of a cannulated drill being used to place an access member in the skull under navigation guidance.
FIG. 2 is a partial cross-sectional view of the access member.
FIG. 3 is a side view of a coupling member that couples the access member to the cannulated drill.
FIG. 4 shows the cannulated drill being used to drill a hole in a skull.
FIG. 5 shows the access member being used to position a medical device at a target site within the brain.
FIG. 6 illustrates an exemplary disposable kit containing components of the system.
FIG. 7 illustrates a robot arm supporting the cannulated drill.



Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings.
DETAILED DESCRIPTION
Example embodiments will now be described more fully with reference to the accompanying drawings.
Referring to FIG. 1, an image-guided trajectory system 10 includes an access member 12 for establishing a set trajectory to a target site, a cannulated drill 14, and a coupling member rod 16 that couples the access member 12 to the cannulated drill 14 during securement of the access member 12 to a patient's skull 20. Also shown in FIG. 1 is a probe 18, for example, a BrainLab Probe (available from BrainLab Cranial Navigation System) or an Integra Probe (available from Integra LifeSciences), received within the drill 14 and extending about half-way down the length of the drill 14. The probe 18 is coupled to an image guidance system 19, for example, a BrainLab image guidance system or an Integra image guidance system, which tracks the trajectory of the probe 18 relative to images of a patient's brain. The receipt of the probe 18 within the cannulated drill 14 during securement of the access member 12 to the skull 20 insures that the access member 12 establishes the desired trajectory to a target site.
Referring to FIG. 2, the access member 12 includes a main body 22 defining an internal lumen 24, and a clamping member 26 defining an internal lumen 28 aligned with lumen 24. The main body 22 has a distal portion 30 with a threaded region 32 that engages the skull bone to secure the access member to the skull 20. Surrounding the distal portion 30 is a depth stop 34 that sets the depth to which the access member 12 is insertable into the skull. The main body 22 has a proximal portion 36 with two outwardly extending wings 38 that can be engaged by the operator's hand and turned to thread the access member 12 into the skull.
The clamping member 26 has a threaded extension 40 that is received by the proximal portion 36 of the main body 24 and is rotatable relative to the main body 24. The clamping member 26 acts on a collet 42 located within proximal portion 36 such that rotation of the clamping member 26 causes the collet 42 to clamp onto and release the rod 16 (FIG. 3) received in the lumens 24 and 28.
Referring to FIG. 4, prior to securing the access member 12 to the skull 20, the operator uses the cannulated drill 14 to drill a pilot hole 60 in the skull 20. Using a drill bit 62 and with the probe 18 received within the drill 14, the operator drills the pilot hole 60 under image guidance such that the pilot hole 60 is aligned with a desired preplanned trajectory to a target set within the brain. Surrounding the drill bit 62 is a movable depth stop 64 that sets the depth to which the drill bit 62 is insertable into the skull.
After drilling the pilot hole, the operator replaces the drill bit 62 with the rod 16 and attached access member 12, a shown in FIG. 1. The rod 16 extends about 3.5 cm into the drill 14 and about 3.5 cm into the access member 12 to axially align the drill 14 and the access member 12. The operator places the access member 12 against the entrance to the pilot hole 60 and uses the probe 18 to align the access member 12 along the desired trajectory to the target site. The operator then loosens the collet 26 such that the access member 12 can be rotated relative to the rod 16 to advance the access member 12 into the skull 20. While the rod remains attached to the drill 14 and remains within the lumens 24, 28 during rotation of the access member 12, the rod 16 need not move, that is, is not rotated, during the advancement of the access member 12. While applying a force to the wings 38 to thread the access member 12 into the skull 20, the operator verifies the alignment of the access member 12 along the trajectory using probe 18 positioned within drill 14.
The operator then removes the drill 14 and rod 16 from the access member 12. Referring to FIG. 5, the access member 12 now establishes a set trajectory for introduction of various medical devices 70, e.g., ventriculostomy catheters, other directed catheters for convection therapy, epilepsy depth electrodes, thermocoagulation probes, lesioning probes, stereotactic needles, and ablative probes, to the target site 72. The operator need only control the depth of advancement of the medical device, which, in many cases, can be predetermined using navigation software.
To further increase the accuracy of the device placement through the access member 12, the drill 14 can directly hold the access member after securement of the access member to the skull 20, and the medical device can be passed through the drill and the access member to the target site.
A cannulated drill is available from Stryker (4200 Cordless Driver 2), and can be used with a step down chuck for holding the drill bit 62 and the rod 16.
The various components of the image-guided trajectory system 10 can be sold as kits 80 (FIG. 6), either disposable or non disposable, including one or more components of the system 10. For example, the cannulated drill 14, the access member 12, the coupling member 16, and the drill bit 62 can be packaged together for sale as a disposable kit. Alternatively, any combination of one or more of the four components can be packaged together for sale as a disposable kit, for example, just the access member 12, the coupling member 16, and the drill bit 62 can be packaged together, the access member 12 and the coupling member 16 can be packaged together, etc. The probe 18 can also be included in any of the various combinations of disposable kits described above, for example, a disposable kit can include the probe 18, drill 14, access member 12, and coupling member 16. Furthermore, one or more medical devices 70 can be included in any of the various combinations of disposable kits, including kits with the probe 18. All of the components need not be disposable. The various components can be sold as a system with the image guidance system 19.
Referring to FIG. 7, the cannulated drill 14 can be supported during use by a robot arm 82, for example, a BrainLab robot arm. The robot arm 82 can be manipulated to fix the position of the cannulated drill 14 in a selected axis. The robot arm 82 is preferably supported by a device 84, for example, a Mayfield head holder, used to fixate the head. The robot arm 82 can be included in any of the kit configurations described above.
The foregoing description of the embodiments has been provided for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosure. Individual elements or features of a particular embodiment are generally not limited to that particular embodiment, but, where applicable, are interchangeable and can be used in a selected embodiment, even if not specifically shown or described. The same may also be varied in many ways. Such variations are not to be regarded as a departure from the disclosure, and all such modifications are intended to be included within the scope of the disclosure.

## Claims

1. A system comprising:
a coupling rod; and
an access member having,
a main body defining a first lumen extending from a proximal end to a distal end of the main body, the proximal end having a first coupling region and the distal end having a second coupling region;
a clamping member coupled to the first coupling region and defining a second lumen aligned with the first lumen; and
a collet at the proximal end of the main body configured to secure the coupling rod received in the first and second lumens, the collet (i) is caused to clamp down on the coupling rod by the clamping member when the access member is tightened onto the clamping member, and (ii) releases the coupling rod when the access member is loosened from the clamping member;
wherein the second coupling region is configured to be coupled to a bone of a patient and the proximal end is configured to receive a medical device through the second lumen of the clamping member and the first lumen of the main body;
wherein the access member, while coupled to the clamping member, is movable relative to the clamping member to secure the access member to the bone of a patient while the clamping member and the coupling rod maintain alignment of the first lumen and the second lumen.

2. The system of claim 1, wherein the access member further includes a depth stop positioned on the main body and configured for setting a depth to which the access member is insertable into the bone of the patient.

3. The system of claim 1, wherein the second coupling region is an external threaded region configured to be threadably received within the bone of the patient.

4. The system of claim 1, wherein the proximal end of the main body includes two outwardly extending wings for facilitating advancing of the access member into the bone of the patient.

5. The system of claim 1, wherein the clamping member has an externally threaded extension and is threadably coupled to an internal thread of the first coupling region of the main body, wherein the clamping member is rotatable relative to the main body.

6. The system of claim 1, further comprising a cannulated drill configured to receive the coupling rod to maintain an alignment of a cannulation in the cannulated drill and the first and second lumens.

7. The system of claim 6, further comprising a probe configured to be disposed within the cannulated drill and configured to guide alignment of the access member to a target in the patient.

8. The system of claim 6, further comprising a robot arm configured to fix a position of the cannulated drill in a selected axis.

9. The system of claim 6, further comprising a drill bit configured to be attached to the cannulated drill and configured for drilling a pilot hole into the bone.

10. The system of claim 1, further comprising the medical device.

11. The system of claim 10, wherein the medical device comprises a ventriculostomy catheter, convertion therapy catheter, epilepsy depth electrode, thermocoagulation probe, lesioning probe, stereotactic needle or ablative probe.

12. A system comprising:
a cannulated drill;
a coupling rod; and
an access member having,
a body extending from a proximal end to a distal end and defining a first lumen extending therethrough;
a first coupling mechanism at the proximal end configured to receive and secure the coupling rod received in the first lumen; and
a second coupling at the distal end configured to be coupled to a bone of a patient and defining a second lumen aligned with the first lumen;
wherein the first lumen and the second lumen are is configured to receive and guide a medical device to the patient,
wherein the coupling rod is received within the cannulated drill, the first lumen, and the second lumen;
wherein the first coupling mechanism couples the access member to the cannulated drill with the coupling rod;
wherein the access member, while coupled to the first coupling mechanism, is movable relative to the first coupling mechanism to secure the access member to the bone of the patient while the first coupling mechanism and the coupling rod maintain alignment of the first lumen and the second lumen.

13. The system of claim 12, wherein a first coupling mechanism includes a clamping member coupled to the proximal end.

14. The system of claim 13, further comprising a collet at the proximal end of the body configured to secure the coupling rod received in the first and second lumens, the collet (i) is caused to clamp down on the coupling rod by the clamping member when the access member is tightened onto the clamping member, and (ii) releases the coupling rod when the access member is loosened from the clamping member.

15. The system of claim 12, wherein the second coupling includes an external threaded region configured to be threadably received within the bone of the patient.

16. The system of claim 15, wherein the access member further includes a depth stop positioned on the body adjacent to the external threaded region configured for setting a depth to which the access member is threadably inserted into the bone of the patient.

17. The system of claim 16, wherein the proximal end of the body includes two outwardly extending wings configured to facilitate advancing the access member into the bone of the patient.

18. The system of claim 12, further comprising:
the cannulated drill configured to receive the coupling rod to maintain an alignment of a cannulation in the cannulated drill and the first and second lumens.

19. A system comprising:
a coupling rod; and
an access member having,
a main body extending from a proximal end to a distal end and defining a first lumen extending therethrough;
a bone engaging coupling at the distal end of the main body configured to be coupled to a bone of a patient;
a depth stop positioned on the main body adjacent to the bone engaging coupling configured to set a depth to which the access member is insertable into the bone of the patient;
a clamping member extending from the proximal end and defining a second lumen aligned with the first lumen; and
a collet at the proximal end of the main body configured to secure the coupling rod received in the first and second lumens, the collet (i) is caused to clamp down on the coupling rod by the clamping member when the access member is tightened onto the clamping member, and (ii) releases the coupling rod when the access member is loosened from the clamping member;
wherein upon the coupling rod being received in the first and second lumens, the clamping member is configured to rotate and secure the coupling rod in the first and second lumens with the collet;
wherein the access member, while coupled to the clamping member, is movable relative to the clamping member to secure the access member to the bone of a patient while the clamping member and the coupling rod maintain alignment of the first lumen and the second lumen.

20. The system of claim 19 further comprising:
a cannulated drill configured to receive the coupling rod; and
a trackable probe configured to be received by the cannulated drill;
wherein a cannulation of the cannulated drill is tracked by way of the trackable probe to maintain an alignment of the cannulation in the cannulated drill with the first and second lumens using the coupling rod and aligning a trajectory of a medical device with the trackable probe.