Frameless stereotactic guidance of medical procedures

• US 20060212044A1
• Filed: 04/07/2006
• Published: 09/21/2006
• Est. Priority Date: 10/02/2003
• Status: Active Grant

• Current Assignee: University of Florida Research Foundation, Incorporated (State University System of Florida)
• Original Assignee: University of Florida Research Foundation, Incorporated (State University System of Florida)
• Inventors: Friedman, William Allen, Bova, Frank Joseph
• Granted Patent: US 7,651,506 B2
• Time in Patent Office: Days
• US Class Current: 606/130
• CPC Class Codes: A61B 2017/3405 using mechanical guide means
• CPC Class Codes: A61B 2034/105 Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2034/108 Computer aided selection or customisation of medical implants or cutting guides
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2055 Optical tracking systems
• CPC Class Codes: A61B 2034/2072 Reference field transducer attached to an instrument or patient
• CPC Class Codes: A61B 2034/256 having a database of accessory information, e.g. including context sensitive help or scientific articles
• CPC Class Codes: A61B 2090/3983 Reference marker arrangements for use with image guided surgery
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 90/10 for stereotaxic surgery, e.g. frame-based stereotaxis
• CPC Class Codes: A61B 90/11 with guides for needles or instruments, e.g. arcuate slides or ball joints
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing

Abstract

Devices, methods and systems for frameless guidance of image-based medical procedures such as stereotactic radiotherapy and surgery. Devices including custom fitting subject-specific articles include contoured surfaces that provide spatial reference to the location of target regions within the subject. The devices are attached exclusive of fasteners anchored to the tissue of the subject and reside on the front of a head of the subject when attached. The devices and articles can be fabricated using computer-directed fabrication technology.

Claims

1. A device for guiding medical procedures, comprising:

a subject-specific article comprising at least one reference contour dimensioned to follow a contour of a first exterior surface portion of the head of a subject to be treated,

said article rigidly attachable to said first surface portion exclusive of fasteners anchored to tissue of said subject underlying said article upon attachment, wherein said article upon attachment exclusively resides on a front of a head of said subject,

said article providing a customized spatially unambiguous reference for alignment of a preplanned medical procedure to one or more target regions associated with said head of said subject.

2. The device of claim 1, wherein said article upon attachment exclusively contacts non-opposing exterior points of said head of said subject.

3. The device of claim 1, wherein said first surface portion comprises a surface portion selected from the group consisting of the nose, the eye socket, and the eyebrow ridge.

4. The device of claim 1, wherein said article includes at least one opening for access to a second surface portion, further comprising a probe guide emerging from said opening.

5. The device of claim 4, wherein an angle of said probe guide emerging from said opening is adjustable.

6. The device of claim 4, wherein said probe guide is oriented at a predetermined angle with respect to said article for guidance to said opening or embedded regions under said opening aligned with said probe guide.

7. The device of claim 6, further comprising at least one structure for directing a biopsy or incision depth attached to said article.

8. The device of claim 1, wherein said article includes at least one opening for access to a second surface portion, further comprising at least one surface along a periphery of said opening for attachment of a custom skin clip or retractor.

9. The device of claim 1, wherein said article includes a structure for attachment to a stereotactic phantom device.

10. A method for guiding a medical procedure, comprising the steps of:

providing a subject-specific article comprising at least one reference contour dimensioned to follow a contour of a first exterior surface portion of the head of a subject to be treated, said article rigidly attachable to said first surface portion exclusive of fasteners anchored to tissue of said subject underlying said article upon attachment, wherein said article upon attachment exclusively resides on a front of a head of said subject, said article providing a customized spatially unambiguous reference for alignment of a preplanned medical procedure to one or more target regions associated with said head said subject;

attaching said article to said head of said subject; and

performing a medical procedure on said target region, guided at least in part by said article.

11. The method of claim 10, further comprising the step of:

checking for proper alignment of said article upon attachment to said subject using a stereotactic phantom device procedure before performing said medical procedure on said target region.

12. A system for performing a medical procedure, comprising:

a subject-specific article comprising at least one reference contour dimensioned to follow a contour of a first exterior surface portion of the head of a subject to be treated, said article rigidly attachable to said first surface portion exclusive of fasteners anchored to tissue of said subject underlying said article upon attachment, wherein said article upon attachment exclusively resides on a front of said head of said subject, said article providing a customized spatially unambiguous reference for alignment of a preplanned medical procedure to one or more target regions associated with said head of said subject; and

a therapeutic, diagnostic or surgical device, wherein said device is guided to said target region at least in part by said subject-specific article.

13. The system of claim 12, wherein said subject-specific article further comprises a plurality of external reference markers.

14. The system of claim 13, wherein said reference markers are optical markers.

15. The system of claim 14, wherein said article includes at least one opening for access to a second surface portion, further comprising a probe guide emerging from said opening.

16. A system for forming a device comprising a subject specific article comprising at least one reference contour for guiding a medical procedure, comprising:

computing structure for providing 3-dimensional data representing a subject-specific article comprising a reference contour dimensioned to replicate a contour of an exterior surface portion of the head of a subject to be treated, said article attachable to a first surface portion exclusive of fasteners anchored to tissue of said subject underlying said article upon attachment, wherein said article upon attachment exclusively resides on a front of said head of said subject; and

a machine for forming said device from said 3-dimensional data.

17. The system of claim 16, wherein said contour of said subject to be treated is computed from a 3-dimensional planning image of said subject.

18. The system of claim 16, wherein said machine is a rapid prototyping machine.