Intraosteal ultrasound during surgical implantation

• US 6,579,244 B2
• Filed: 10/24/2002
• Issued: 06/17/2003
• Est. Priority Date: 10/24/2001
• Status: Expired due to Fees

• Current Assignee: Cutting Edge Surgical Incorporated
• Original Assignee: Cutting Edge Surgical Incorporated
• Inventors: Goodwin, Mark R.
• Primary Examiner(s): Lateef, Marvin M.
• Assistant Examiner(s): Jain, Ruby
• Application Number:
  US10/280,305
• Publication Number:
  US 20030078495A1
• Time in Patent Office: 236 Days
• Field of Search: 600/437, 600/561, 600/587, 600/559, 604/22, 606/99, 606/104, 606/90, 606/91, 606/53, 606/86, 310/334
• US Class Current: 600/561
• CPC Class Codes: A61B 17/1626 Control means; Display units
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 8/0858 involving measuring tissue layers, e.g. skin, interfaces
• CPC Class Codes: A61B 8/0875 for diagnosis of bone A61B5/4504 takes precedence
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/4405 Device being mounted on a trolley
• CPC Class Codes: A61B 8/463 characterised by displaying multiple images or images and diagnostic data on one display composite display in devices for short-range imaging with acoustic waves G01S7/52074
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for

Abstract

IntraOsteal UltraSound (IOUS) is the use of acoustical energyto facilitate “real-time” manipulation and navigation of a device for intraosseous placement of synthetic or biologic implants and to diagnose the condition of the tissue into which the implant is being placed. Representative applications include placement of synthetic or biologic implants, such as bone screws, through vertebral pedicles during spinal fusion surgery. Devices for use in the placement of the implants include a means for creating a lumen or channel into the bone at the desired site in combination with a probe for providing realtime feedback of differences in density of the tissue, typically differences in acoustical impedence between cancellous and cortical bone. The devices will also typically include means for monitoring the feedback such as a screen creating an image for the surgeon as he creates the channel, and/or an audible signal which different tissues are present. The system can also be used for diagnostic applications.

Claims

1. A method for guiding and placing an implant within a region of tissues characterized by defined differences in acoustical impedence comprising

introducing into the region a transducer and receiver for ultrasound or audio signals and

monitoring differences in acoustical impedence as the transducer and receiver are moved through the region.

2. The method of claim 1 wherein the region is bone and the tissues are cortical bone and cancellous bone.

3. The method of claim 1 wherein the region is a joint and the tissues are soft tissues such as ligaments, tendons or cartilage and bone.

4. The method of claim 1 wherein the method further comprises locating an implant in the region.

5. The method of claim 4 wherein the implant is a metal, ceramic, biological or polymeric implant.

6. The method of claim 5 wherein the implant is screw or pin.

7. The method of claim 6 wherein the implant is placed into spinal pedicles.

8. The method of claim 1 wherein the method is used to guide the placement of pedicle screws across a vertebral body during anterior spinal deformity corrective surgery.

9. The method of claim 1 wherein the ultrasound is used to measure or provide analysis of one or more factors or variables selected from the group consisting of Bone mineral density (BMD), Histology of bone, disease, water content, cartilage composition, lesions, vascular defects, neoplasms, and areas of avascular necrosis.

10. The method of claim 1 wherein the method is used to determine areas of bony non-union, fracture, or regions between bone.

11. A system for use in guiding and placing an implant within a region of tissues characterized by defined differences in acoustical impedence comprising

a transducer and receiver for ultrasound or audio signals and means for monitoring differences in acoustical impedence as the transducer and receiver are moved through the region.

12. The system of claim 11 wherein the region is bone and the tissues are cortical bone and cancellous bone, and the system produces a signal when differences in density between the cortical bone and the cancellous bone are detected.

13. The system of claim 11 wherein the device further includes means for cutting tissue or bone.

14. The system of claim 11 further comprising a sensor that detects changes in acoustical impedence.

15. The system claim 14 wherein the sensor produces a detectable signal when there is a change in acoustical impedence.