Bone treatment systems and methods for introducing an abrading structure to abrade bone

• US 7,682,378 B2
• Filed: 11/10/2005
• Issued: 03/23/2010
• Est. Priority Date: 11/10/2004
• Status: Active Grant

• Current Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Original Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Inventors: Shadduck, John H., Truckai, Csaba
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): MERENE, JAN CHRISTOP L
• Application Number:
  US11/271,498
• Publication Number:
  US 20060229625A1
• Time in Patent Office: 1,594 Days
• Field of Search: 606/79, 606/84, 606/246, 606/249, 606/279, 606/86.R, 606/92, 606/93, 606/94, 606/95
• US Class Current: 606/279
• CPC Class Codes: A61B 17/1615 Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material
• CPC Class Codes: A61B 17/1617 with mobile or detachable parts
• CPC Class Codes: A61B 17/1631 Special drive shafts, e.g. flexible shafts A61B17/1642, A61B17/164 take precedence
• CPC Class Codes: A61B 17/1642 for producing a curved bore
• CPC Class Codes: A61B 17/1668 for the upper femur A61B17/164 takes precedence
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61M 1/842 rotating continuously rotating surgical cutting instruments A61B17/32002

Abstract

The invention provides instruments and methods for prophylactic treatment of an osteoporotic vertebral body or for treating a vertebral compression fracture (VCF). In one exemplary method, a probe system uses a high speed rotational elastomeric cutter having an optional expandable abrasive surface for abrading or cutting at least one path or region within vertebral cancellous bone. Irrigation and aspiration sources are included in the probe system for removing abraded bone debris. In one embodiment, the high speed rotational abrader uses a tissue-selective abrading surface that abrades or cuts bone but does not cut soft tissue. In another embodiment, an expandable abrading surface allows the treatment of bone with low pressures to create paths or spaces without explosive expansion forces known in prior art balloon procedures that are designed to crush and compact cancellous bone in a vertebra. After the creation of a path or space, an in-situ hardenable bone cement volume is introduced into each path or space to support the vertebra.

Claims

1. A method of treating bone, comprising:

introducing a rotatable elastomeric abrading structure into an interior of a bone, wherein the elastomeric abrading structure is rotatable within a selected speed range that cuts bone and does not cut soft tissue, is a generally solid cylindrical structure and has a channel therethrough for aspirating debris from or delivering a fluid to the bone;

rotating the elastomeric abrading structure to cut at least one of cancellous bone and cortical bone;

increasing an outer diameter of the generally solid cylindrical structure from a first generally cylindrical shape to a second generally cylindrical shape;

rotating the elastomeric abrading structure to cut through a plurality of locations in a cortical wall of the bone to create a weakened region, wherein the elastomeric abrading structure does not cut soft tissue adjacent the cortical wall and wherein cutting through the cortical wall is performed from the interior of the bone to the exterior of the bone; and

introducing a bone fill material into the bone and thereby elevating a vertebral endplate.

2. The method of treating bone of claim 1, wherein rotating the abrading structure is accomplished at from 500 to 400,000 rpm.

3. The method of treating bone of claim 1, wherein rotating the abrading structure is accomplished at from 5,000 to 100,000 rpm.

4. The method of treating bone of claim 1, wherein introducing the abrading structure is accomplished with said abrading structure in the first shape.

5. The method of treating bone of claim 1, further comprising flowing a fluid into the interior of the bone through the channel passing through an interior of the abrading structure.

6. The method of treating bone of claim 1, further comprising aspirating debris from the interior of the bone through the channel passing through an interior of the abrading structure.

7. The method of treating bone of claim 1, further comprising axially moving the abrading structure while rotating to form an elongated path along a guide wire.

8. The method of claim 1, further comprising the step of introducing a guide wire into the interior of the bone and wherein the step of introducing the abrading structure further comprises introducing the abrading structure along the guide wire, the guide wire being strung through the channel in the abrading structure.

9. The method of claim 8, further comprising the step of infusing a fluid into the interior of the bone, the fluid traveling through the channel of the abrading structure.

10. The method of claim 9, wherein the step of rotating the abrading structure further comprises rotating while the abrading structure is on the guide wire.

11. The method of claim 1, further comprising the step of controllably moving the abrading structure from the first shape to the second shape by using a pull rod to compress the generally solid cylindrical structure.