IP Library Granted Patent US 8,852,187
Granted Patent B2
US 8,852,187 · App. 13/371,012 · Granted Oct 7, 2014

Variable length device and method

Inventors: Scott Pool (Laguna Hills, CA); Stuart A. Green (Long Beach, CA); Edmund J. Roschak (Mission Viejo, CA)
Assignee: Ellipse Technologies, Inc.
A61B17/7216A61B19/026A61B2017/00411A61B2017/00845A61B2019/0272A61B19/0271A61B17/1725A61B17/921
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Quick Facts
Patent No.
US 8,852,187
App. No.
13/371,012
Filed
Feb 10, 2012
Granted
Oct 7, 2014
Kind
B2
Art Unit
3733
USPC
606/63
Abstract

A method for treating a fracture with a variable length nail is provided. The nail is configured for at least 5 mm of axial length change in each direction. An incision is made in proximity to a fractured bone and canal is cleared through the center of the bone. The variable length nail is inserted into the canal and a distraction shaft and a housing are secured to separate portions of the fractured bone. The incision is allowed or caused to close. An external adjustment device with at least one rotatable magnet is placed in proximity to the patient's skin. The external adjustment device is operated so that a magnetic field of the at least one rotatable magnet of the external adjustment device causes the rotatable permanent magnet of the variable length nail to rotate, causing either extension or retraction of the distraction shaft relative to the housing.

Claims (48)

1. A method for treating a complex fracture with a variable length nail comprising a housing and a distraction shaft, the housing containing a rotatable permanent magnet mechanically coupled to a lead screw, the lead screw interfacing with a nut such that rotation of the lead screw in a first direction causes the distraction shaft to axially retract within the housing and rotation of the lead screw in a second direction causes the distraction shaft to axially extend from the housing, the method comprising:

making a first hole or incision in the skin of the patient in proximity to a fractured long bone, wherein the fractured long bone was not purposely fractured and comprises at least several pieces of bone, and at least partially clearing a canal through the center of the long bone;

inserting the variable length nail into the canal and securing the housing and distraction shaft to separate portions of the fractured long bone;

causing or allowing the hole or incision to close;

determining after causing or allowing the hole or incision to close that the fractured long bone is a substantially incorrect length, wherein the determining includes determining whether the long bone is incorrectly substantially long, whether the long bone is incorrectly substantially short, or whether the long bone is substantially the correct length;

placing an external adjustment device in proximity to the patient's skin, the external adjustment device comprising at least one rotatable magnet; and

operating the external adjustment device in response to the determining that the fractured long bone is a substantially incorrect length so that a magnetic field of the at least one rotatable magnet causes the rotatable permanent magnet of the variable length nail to rotate, causing the distraction shaft to either retract into or extend out of the housing.

2. The method of claim 1 , further comprising:

operating the external adjustment device so that the distraction shaft retracts into the housing in order to apply compression between a plurality of sections of the fractured long bone.

3. The method of claim 1 , further comprising:

operating the external adjustment device so that the distraction shaft extends from the housing in order to perform a distraction of the bone and/or a fracture callus.

4. The method of claim 2 , further comprising:

operating the external adjustment device so that the distraction shaft extends from the housing in order to perform a distraction of the bone and/or a fracture callus.

5. The method of claim 3 , further comprising:

operating the external adjustment device so that the distraction shaft retracts into the housing in order to apply compression between a plurality of sections of the fractured long bone.

6. The method of claim 1 , further comprising:

operating the external adjustment device so that the distraction shaft and housing are cycled together and apart.

7. The method of claim 6 , wherein the total change of length during the cycling is between 5% and 60% of a nominal gap between a plurality of sections of bone.

8. The method of claim 7 , wherein the total change of length during the cycling is approximately 30% of the nominal gap between a plurality of sections of bone.

9. The method of claim 6 , wherein the distraction shaft and housing are cycled together and apart at a frequency of at least 30 cycles per minute.

10. The method of claim 6 , wherein the distraction shaft and housing are cycled together and apart for a cumulative time period of greater than 5 minutes per day and less than one hour per day.

11. The method of claim 10 , wherein the distraction shaft and housing are cycled together and apart for a cumulative time period of greater than 10 minutes per day and less than 60 minutes per day.

12. The method of claim 1 , wherein the rotation of the at least one rotatable magnet is cyclic.

13. The method of claim 1 , wherein the operating step is performed one day after the inserting step.

14. The method of claim 1 , wherein the operating step is performed at least one week after the insertion step.

15. The method of claim 1 , wherein the operating step is performed after the patient has at least partially recovered from a surgical procedure associated with the insertion step.

16. The method of claim 1 , wherein the operating step is performed at least one week after the patient has at least partially recovered from a surgical procedure associated with the insertion step.

17. A method for treating a complex fracture with a variable length nail comprising a housing and a distraction shaft, the housing containing a rotatable permanent magnet mechanically coupled to a lead screw, the lead screw interfacing with a nut such that rotation of the lead screw in a first direction causes the distraction shaft to axially retract within the housing and rotation of the lead screw in a second direction causes the distraction shaft to axially extend out of the housing, the method comprising:

making a first hole or incision in the skin of the patient in proximity to a fractured long bone, wherein the fractured long bone was not purposely fractured and comprises at least several pieces of bone, and at least partially clearing a canal through the center of the long bone;

inserting the variable length nail into the canal and securing the housing and distraction shaft to separate portions of the fractured long bone;

causing or allowing the hole or incision to close;

determining after causing or allowing the hole or incision to close that the quality of a fracture callus of the long bone is inadequate;

placing an external adjustment device in proximity to the patient's skin, the external adjustment device comprising at least one rotatable magnet; and

operating the external adjustment device in response to the determining that the quality of the fracture callus is inadequate so that a magnetic field of the at least one rotatable magnet causes the rotatable permanent magnet of the variable length nail to rotate, causing the distraction shaft to retract into the housing.

18. The method of claim 17 , further comprising:

determining after operating the external adjustment device that the quality of the fracture callus has improved;

placing the external adjustment device in proximity to the patient's skin; and

operating the external adjustment device causing the distraction shaft to extend from the housing in order to perform a distraction of the long bone.

19. A method for treating a complex fracture with a variable length nail comprising a housing and a distraction shaft, the housing containing a rotatable permanent magnet mechanically coupled to a lead screw, the lead screw interfacing with a nut such that rotation of the lead screw in a first direction causes the distraction shaft to axially retract within the housing and rotation of the lead screw in a second direction causes the distraction shaft to axially extend from the housing, the method comprising:

making a first hole or incision in the skin of the patient in proximity to a fractured long bone, wherein the fractured long bone was not purposely fractured and comprises at least several pieces of bone, and at least partially clearing a canal through the center of the long bone;

inserting a variable length nail into the canal and securing the housing and distraction shaft to separate portions of a fractured long bone;

causing or allowing the hole or incision to close;

determining after causing or allowing the hole or incision to close that the long bone is incorrectly substantially short;

placing an external adjustment device in proximity to the patient's skin, the external adjustment device comprising at least one rotatable magnet; and

operating the external adjustment device in response to the determining that the fractured long bone is incorrectly substantially short so that a magnetic field of the at least one rotatable magnet causes the rotatable permanent magnet of the variable length nail to rotate, causing the distraction shaft to retract out of the housing.

20. The method of claim 19 , further comprising:

determining after operating the external adjustment device that the fractured long bone is substantially a correct length; and

allowing the bone to consolidate.

Assignments (5)
SECURITY INTEREST Recorded Feb 28, 2020
From: NUVASIVE, INC.; NUVASIVE CLINICAL SERVICES MONITORING, INC.; NUVASIVE CLINICAL SERVICES, INC.; NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
To: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 052918/0595 →
NOTICE OF GRANT OF SECURITY INTEREST IN PATENTS Recorded Nov 16, 2016
From: NUVASIVE, INC.; IMPULSE MONITORING, INC.
To: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 040634/0404 →
CORRECTIVE ASSIGNMENT TO CORRECT THE NATURE OF CONVEYANCE FROM ASSIGNMENT TO MERGER AND CHANGE OF NAME, THE ASSIGNEE NAME, AND THE RECORDED DOCUMENT PREVIOUSLY RECORDED ON REEL 038272 FRAME 0865. ASSIGNOR(S) HEREBY CONFIRMS THE MERGER AND CHANGE OF NAME. Recorded Sep 7, 2016
From: ELLIPSE TECHNOLOGIES, INC.
To: NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Reel/Frame 039939/0418 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 13, 2016
From: ELLIPSE TECHNOLOGIES, INC.
To: NUVASIVE, INC.
Reel/Frame 038272/0865 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 26, 2012
From: POOL, SCOTT; GREEN, STUART A.; ROSCHAK, EDMUND J.
To: ELLIPSE TECHNOLOGIES, INC.
Reel/Frame 027928/0914 →
Continuity (3)
Provisional Application 61442658 · Feb 14, 2011
Provisional Application 61472055 · Apr 5, 2011
Related Publication 20120209269A1 · Aug 16, 2012