Minimally invasive actuable bone fixation devices

• US 7,914,533 B2
• Filed: 11/30/2006
• Issued: 03/29/2011
• Est. Priority Date: 05/18/2005
• Status: Active Grant

• Current Assignee: Arthrex Incorporated
• Original Assignee: Sonoma Orthopedic Products Incorporated (Arthrex Incorporated)
• Inventors: Mazur, Kai U., Saravia, Heber, Nelson, Charles L.
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): MERENE, JAN CHRISTOP L
• Application Number:
  US11/565,534
• Publication Number:
  US 20070233105A1
• Time in Patent Office: 1,580 Days
• Field of Search: 606 62- 68, 606/86.R, 606300-331
• US Class Current: 606/64
• CPC Class Codes: A61B 17/7208 Flexible pins, e.g. ENDER pins
• CPC Class Codes: A61B 17/7241 the nail having separate elements through which screws pass
• CPC Class Codes: A61B 17/7266 with fingers moving radially outwardly
• CPC Class Codes: A61B 17/7275 with expanding cylindrical parts
• CPC Class Codes: A61B 17/7291 for small bones, e.g. in the foot, ankle, hand or wrist
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive

Abstract

Apparatus for bone reinforcement, fixation and treatment of diseased or fractured bones including a supporting structure optionally coated with therapeutic agent is provided. The supporting structure or device may be collapsible upon deployment at the surgical site, and include fixation features such as anchors to securely position in place once deployed. Bone cement or other material may be provided to alternatively secure the positioned supporting structure for treatment. A lockable bone fixation device is described that comprises: a sleeve adapted to be positioned in a space formed in a bone; a guidewire adapted to guide movement of the sleeve; and an actuable lock adapted to secure the sleeve within the space of the bone from an end of the device.

Claims

1. A method for treatment of an elongate bone, an intermedullary space extending along an axis of the bone, the bone having a fracture, the method comprising;

forming an access opening traversing the intermedullary space at a placement angle to the axis of the bone;

inserting a first end of a bone fixation device into the access opening, the bone fixation device having a flexible sleeve extending between the first end and a second end along a sleeve axis;

advancing the bone fixation device from the access opening into the intermedullary space by flexing the sleeve in a plane along the sleeve axis;

rigidly affixing a section of the bone fixation device to the bone adjacent the access opening, wherein the section spans the placement angle and rigidly supports the sleeve within the intramedullary space;

locking the bone fixation device within the intramedullary space by rotating an actuator of the bone fixation device, the actuator oriented along the access opening and coupled with the second end of the sleeve by the section so that the actuator rotates about an axis of the access opening disposed at the placement angle to the axis of the bone wherein an elongate structure extends from the actuator and around the placement angle, the elongate structure having sufficient flexibility to transfer movement from the actuator to the sleeve when the placement angle is at least within a range of at least 30 to 45 degrees,

and wherein the locking of the bone fixation device imposes an axial load on bearing surfaces disposed along the sleeve so as to stiffens the bone fixation device;

deploying a plurality of teeth, with the elongate element and in response to rotating of the actuator, from an un-deployed configuration to a deployed configuration, the teeth in the un-deployed configuration disposed within an outer surface of the sleeve, the teeth in the deployed configuration extending radially outwardly from the outer surface of the sleeve through apertures in the sleeve and securing the sleeve within the intermedullary space of the bone.

2. The method of claim 1, wherein the elongate structure rotates about the axis of the access opening adjacent the actuator and transmits rotation around the placement angle so as to rotate about the sleeve axis within the intermedullary space during deployment, the rotation of the elongate structure urging the plurality of teeth radially outwardly, and wherein the placement angle is within a range from 30 to 45 degrees.

3. The method of claim 2, further comprising advancing a guidewire through the access opening and into the intermedullary space so that a bend of the guidewire extends around the placement angle between the access opening and the intermedullary space, a guidewire lumen extending axially within the bone fixation device;

and

wherein the bone fixation device is advanced axially while the guidewire is disposed within the guidewire lumen so that the guidewire axially guides the sleeve of the bone fixation device from the access opening, around the placement angle, and into the intermedullary space.

4. The method of claim 1, wherein the sleeve flexes sufficiently so that the lockable bone fixation device conforms anatomically to the bone, wherein flexing of the sleeve is accommodated by the bearing surfaces disposed along the length of the sleeve, and wherein rotation of the actuator imposes the axial load on the bearing surfaces so as to stiffen the lockable fixation device when the teeth are in the deployed configuration such that fixation of the fracture is effected.

5. The method of claim 1 wherein each tooth comprises a flexible structure and deploying the teeth bends the teeth radially from the un-deployed configuration to the deployed configuration, the bending of the teeth induced by threaded coupling of the actuator near the second end of the sleeve such that axial motion of the elongate structure is transmitted along the flexible sleeve to the teeth disposed at the first end.

6. The method of claim 1, further comprising removing the bone fixation device from the intermedullary space by articulation of the actuator so as to withdraw the teeth into the sleeve.

7. The method of claim 1, wherein the bone comprises a radius bone, and wherein the access aperture is formed through a laterally oriented bony protuberance of the radius bone so as to access the intermedullary space within the radius bone.

8. The method of claim 1, wherein each tooth is included in an associated anchoring segment, the anchoring segments comprising annular bodies from which the teeth extend, the annular bodies of the anchoring segments being separated axially and disposed within the sleeve, the sleeve having a cut extending circumferentially therethrough so as to flex axially between the annular bodies when the bone fixation device is inserted from the access opening into the intermedullary space, the annular bodies being urged axially by rotating of the actuator when deploying the teeth.

9. The method of claim 1 wherein the sleeve comprises a spiral cut through the sleeve and the sleeve flexes laterally in all directions when the device is advanced at the placement angle.

10. The method of claim 1 wherein the section comprises a universal joint with the elongate extending therethrough, and further comprising flexing of the universal joint to correspond to the placement angle during insertion of the sleeve, and locking the universal joint so that the section rigidly supports the sleeve within the intramedullary space.