# US 9,039,615 B2 · Method and apparatus for directed device placement in the cerebral ventricles or other intracranial targets

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- Number: US 9,039,615 B2
- Document ID: US9039615B2
- Status: Granted
- Kind: B2
- Application number: 12/479,255
- Filed: 2009-06-05
- Published: 2009-12-10
- Granted: 2015-05-26
- Earliest claimed: 2008-06-06
- Assignees: Bedrock Inventions, LLC
- Applicants: Alexander C. Flint
- Inventors: Alexander C. Flint
- Web page: https://patentgrep.com/patent/US9039615B2

## CPC

- A61B 17/3423: {Access ports, e.g. toroid shape introducers for instruments or hands (access sites for liquids A61M39/0247)}
- A61B 8/0808: {for diagnosis of the brain}
- A61B 8/12: in body cavities or body tracts, e.g. by using catheters
- A61B 90/11: with guides for needles or instruments, e.g. arcuate slides or ball joints
- A61M 27/006: {Cerebrospinal drainage; Accessories therefor, e.g. valves}
- A61B 8/00: Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B 8/4209: {by using holders, e.g. positioning frames}
- A61B 2090/103: {Cranial plugs for access to brain}
- A61B 2090/378: {using ultrasound}
- A61M 2205/04: implanted
- A61M 2210/0693: Brain, cerebrum
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

Apparatus for directed cranial access to a site includes a guidepiece and a receptacle. The receptacle includes lower and upper parts. The guidepiece includes a body having a bore defining an alignment axis. The guidepiece is dimensioned to fit rotatably within the receptacle. The bore is dimensioned to accept an imaging device, and an adaptor is provided, dimensioned to accept a device to be placed at the site. The imaging device is inserted into the bore and the guidepiece is swiveled until the image shows that the axis is aligned along an optimal trajectory to the site, the guidepiece is locked, and the imaging device is withdrawn. Then the adaptor is inserted into the bore, and the device is inserted through the adaptor along the established trajectory to the site. After placement of the device, the adaptor, guidepiece, and receptacle are removed while the device is held in place.

## Claims

### Claim 1

A method for placing a device at an intracranial site, comprising:
providing apparatus including a guidepiece and a receptacle, wherein:
the receptacle comprises a lower part and an upper part, the lower receptacle part having a rim and a base and a hollow stem at the base adapted to be mounted in a hole in the skull, the upper receptacle part having a rim and an opening at the top, each part of the receptacle having an interior spherical surface, wherein the upper and lower receptacle parts can be joined at the rims to form an inner surface enclosing a generally spherical interior; and
the guidepiece comprises a body having a spherical outer surface and a lumen through the center thereof, defining an alignment axis, the guidepiece being dimensioned to fit rotatably within the receptacle interior, the lumen being configured and dimensioned to accept an imaging device therein;
providing an adaptor insertable within the guidepiece lumen, the adaptor having an adaptor bore, configured and dimensioned to accept a device to be placed at the site;
forming a hole in the skull;
assembling the apparatus and mounting the apparatus in the skull;
inserting an imaging device into the guidepiece lumen and activating imaging apparatus associated with the imaging device to generate an image of the intracranial contents;
swiveling the guidepiece, containing the imaging device therein, until the image shows that the alignment axis is aligned along an optimal trajectory to the site, and, while the alignment axis is aligned along the optimal trajectory to the site, tightening the receptacle to lock the guidepiece and establish the trajectory;
determining the distance along the trajectory to the site with reference to the image;
while the guidepiece remains locked in place, withdrawing the imaging device from the guidepiece lumen;
while the guidepiece remains locked in place, the imaging device having been removed therefrom, inserting the adaptor into the guidepiece lumen;
while the guidepiece remains locked in place with the adaptor in the lumen thereof, inserting the device to be placed at the site through the adaptor bore over the determined distance along the established trajectory to the site;
and withdrawing adaptor and the apparatus, leaving the device in place at the site.

### Claim 2 (depends on 1)

The method of claim 1 wherein the guidepiece body further comprises a bore through the center thereof, and a guide tube in the bore, wherein a lumen in the guide tube comprises the guidepiece lumen.

### Claim 3 (depends on 1)

The method of claim 1 wherein forming the hole in the skull comprises drilling a hole having a diameter less than about 12.5 mm.

### Claim 4 (depends on 3)

The method of claim 3 wherein forming the hole in the skull comprises drilling a hole having a diameter less than about 6.4 mm.

### Claim 5 (depends on 3)

The method of claim 3 wherein forming the hole in the skull comprises drilling a hole having a diameter in a range about 6 mm to about 8 mm.

### Claim 6 (depends on 1)

The method of claim 1 wherein forming the hole in the skull is carried out using a twist drill.

### Claim 7 (depends on 1)

The method of claim 1 wherein the stem is externally threaded, and wherein mounting the apparatus in the skull comprises screwing the stem into the hole in the skull, and wherein withdrawing the apparatus comprises unscrewing the stem from the hole in the skull and removing the upper receptacle part, the guide tube, and the lower receptacle part while preventing removal of the inserted device.

### Claim 8 (depends on 1)

The method of claim 1 wherein the rims of the receptacle parts are complementarily threaded, and wherein tightening the receptacle comprises screwing the upper receptacle part together with the lower receptacle part.

### Claim 9 (depends on 1)

The method of claim 1 wherein the imaging device comprises an ultrasound probe.

### Claim 10 (depends on 1)

The method of claim 1 wherein a width dimension of the imaging device is at least as great as the inner diameter of the stem.

### Claim 11 (depends on 1)

The method of claim 1 wherein the device to be inserted is marked with depth indicia to aid in inserting the device over the determined distance to the target.

### Claim 12 (depends on 1)

The method of claim 1 wherein the intracranial site comprises a cerebral ventricle, and the device to be placed at the site comprises a ventricular catheter.

### Claim 13 (depends on 12)

The method of claim 12, further comprising providing a stopper having an outer diameter narrow enough that it does not interfere with subsequent removal of the adaptor, and prior to withdrawing the apparatus and adaptor placing the stopper at the end of the catheter.

### Claim 14 (depends on 1)

The method of claim 1 wherein the device to be placed comprises a cerebrospinal fluid shunt.

### Claim 15 (depends on 14)

The method of claim 14 wherein the intracranial site comprises a cerebral ventricle, and the device to be placed at the site comprises a ventricular shunt.

### Claim 16 (depends on 14)

The method of claim 14, further comprising providing a stopper having an outer diameter narrow enough that it does not interfere with subsequent removal of the adaptor, and prior to withdrawing the apparatus and adaptor placing the stopper at the end of the shunt.