Vacuum-assisted stereotactic fixation system with patient-activated switch

• US 5,549,616 A
• Filed: 11/22/1994
• Issued: 08/27/1996
• Est. Priority Date: 11/02/1993
• Status: Expired due to Term

• Current Assignee: LOMA Linda University Medical Center (Mission Healthcare Services LLC)
• Original Assignee: LOMA Linda University Medical Center (Mission Healthcare Services LLC)
• Inventors: Lesyna, David A., Schulte, Reinhard W., Meinass, Helmut J., Wicks, William J.
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): Dawson, Glenn
• Application Number:
  US08/344,291
• Time in Patent Office: 644 Days
• Field of Search: 604/116, 604/164, 604/264, 606/1, 606/130
• US Class Current: 606/130
• CPC Class Codes: A61B 2017/00725 Calibration or performance testing
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2090/363 Use of fiducial points
• CPC Class Codes: A61B 2090/3983 Reference marker arrangements for use with image guided surgery
• CPC Class Codes: A61B 90/10 for stereotaxic surgery, e.g. frame-based stereotaxis
• CPC Class Codes: A61B 90/14 Fixators for body parts, e.g. skull clamps; Constructional details of fixators, e.g. pins
• CPC Class Codes: A61B 90/16 Bite blocks
• CPC Class Codes: A61N 2005/1097 Means for immobilizing the patient

Abstract

A stereotactic fixation apparatus provides for accurate and reproducible positioning of a patient'"'"'s skull during medical diagnostic and treatment procedures. The stereotactic fixation apparatus includes a mouthpiece having an acrylic impression formed as an impression of the patient'"'"'s upper teeth and hard palate. The mouthpiece is connected to a stereotactic frame, which in turn is releasable connected to an adaptor board on which the patient rests. Vacuum pressure is used to draw the acrylic impression firmly against the patient'"'"'s hard palate. Vacuum pressure is also used to hold the stereotactic frame on the adaptor board. The stereotactic fixation apparatus additionally includes a patient-activated safety release mechanism which allows the patient to disconnect the vacuum pressure and to dislodge the restraints of the mouthpiece and frame, as well as to disable the medical equipment used with the medical diagnostic or treatment procedure. A calibration phantom desirably is used with the stereotactic fixation apparatus to calibrate the orientation of the mouthpiece relative to the reference axes of the medical treatment device during each stage of the patient'"'"'s course.

Claims

1. A stereotactic fixation system for immobilizing a patient'"'"'s skull during a medical procedure involving a medical device, said system comprising:

a platform for supporting a portion of a patient;

a stereotactic fixation apparatus contacting said platform at least at one interface region;

a port adapted for connection to a source of vacuum, said port being in fluidic communication with said interface region, whereby the vacuum holds said stereotactic fixation apparatus against said platform when vacuum pressure is applied to said interface region through said port;

a first sensor positioned proximate to said interface region, said sensor generating a first input signal indicating the application or absence of a vacuum at said interface region;

a patient-activated switch having at least first and second operational states, said switch generating a second input signal when the switch is in one of said states; and

a controller which receives said first and second input signals from said first sensor and said patient-activated switch, respectively, said controller generating an output signal when said vacuum pressure is applied at said interface region and said patient-activated switch is in said first state, said output signal enabling the operation of the medical device.

2. The stereotactic fixation system of claim 1, wherein said stereotactic fixation apparatus comprises a mouthpiece attached to a stereotactic frame, said mouthpiece having a surface for contacting a patient'"'"'s hard palate and a port adapted for connection to the source of vacuum, said mouthpiece port located on the exterior of said mouthpiece, said mouthpiece being configured to provide a fluidic path between said surface and said port.

3. The stereotactic fixation system of claim 2 additionally comprising a second sensor positioned proximate to said fluidic path defined by said mouthpiece, said second sensor generating a third input signal indicating the application or absence of a vacuum in said fluidic path of said mouthpiece.

4. The stereotactic fixation system of claim 1, wherein said stereotactic fixation apparatus comprises a rigid face mask mounted to a frame, said face mask having a shape with conforms to the contours of the anterior features of the patient'"'"'s skull.

5. The stereotactic fixation system of claim 2, wherein said controller selectively generates a second output signal to disable the source of vacuum applied to said port of said mouthpiece and applied to said port at said interface region in response to said second input signal of the patient-activated switch when the switch is in said second state.

6. A method of interlocking the operation of a medical device with the operational state of a quick-release stereotactic fixation apparatus used to immobilize a patient'"'"'s skull, said stereotactic fixation apparatus having a patient-activated switch, said method comprising the steps of:

sensing pressure at an interface region between a portion of said stereotactic fixation apparatus and a platform which supports at least the patient'"'"'s skull;

determining whether vacuum pressure is applied at said interface region to hold said stereotactic fixation apparatus against said platform;

determining whether the patient-activated switch is in a selected state; and

generating a signal which enables the medical device when a vacuum is applied at said interface region and said patient-activated switch is in said selected state.