IP Library › Granted Patent US 12708412
Granted Patent B2
US 12708412 · App. 18/399,834 · Granted Aug 18, 2026

Bone fracture fixation device and related systems and methods

Inventors: Shannon M. Rush (San Jose, CA); Troy J. Boffeli (Woodbury, MN); Graham Hamilton (Concord, CA); Michael Lee (Johnston, IA); Jordan Grossman (Akron, OH); Mark Hardy (Lakewood, OH); Brogan McGuire (Johnston, IA)
Assignee: Surgical Design Innovations II, LLC
A61B17/7291A61B17/1624A61B2017/00477
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Quick Facts
Patent No.
US 12708412
App. No.
18/399,834
Filed
Dec 29, 2023
Granted
Aug 18, 2026
Kind
B2
Art Unit
3773
USPC
606/62
Abstract

The various embodiments disclosed herein relate to bone fixation devices, including intramedullary fixation or fusion devices. The various devices disclosed include an intermedullary device having a proximal member and a distal member that is articulable in relation to the proximal member. The proximal and distal members have ends that are movably coupled to form a joint that can be actuated to reduce a fracture and realign the bone after insertion of the device into the bone.

Claims (80)

1 . A bone fixation device comprising:

(a) a device body comprising:

(i) a proximal member comprising:

(A) a shaft lumen defined within the proximal member, wherein the shaft lumen is parallel to a longitudinal axis of the proximal member; and

(B) a drive slot defined with the proximal member, wherein the drive slot is transverse to the longitudinal axis of the proximal member;

(ii) a distal member comprising:

(A) a drive mechanism lumen defined within the distal member, wherein the drive mechanism lumen is parallel to a longitudinal axis of the distal member; and

(B) at least one fixation lumen defined within the distal member, wherein the at least one fixation lumen is transverse to the longitudinal axis of the distal member, wherein the at least one fixation lumen is in fluidic communication with the drive mechanism lumen;

(b) an adjustable joint formed between the proximal member and the distal member, wherein the proximal member and the distal member are movable radially and axially in relation to each other via the adjustable joint; and

(c) a drive mechanism operably coupled to the proximal and distal members, the drive mechanism comprising:

(i) a rotatable drive structure rotatably disposed within the drive mechanism lumen, wherein the rotatable drive structure comprises a rotatable engagement structure disposed at a proximal end of the rotatable drive structure; and

(ii) a linear drive shaft slidably disposed within the drive mechanism lumen, the linear drive shaft comprising:

(A) a stationary engagement structure disposed at a distal end of the linear drive shaft, wherein the stationary engagement structure is configured to couple with the rotatable engagement structure;

(B) at least one transverse lumen defined through the linear drive shaft, wherein the at least one transverse lumen is transverse to a longitudinal axis of the linear drive shaft, wherein the at least one transverse lumen is in fluidic communication with the at least one fixation lumen, wherein the at least one transverse lumen comprises first and second transverse lumens, wherein the first transverse lumen has a longitudinal axis that is transverse to a longitudinal axis of the second transverse lumen; and

(C) at least one protrusion disposed at a proximal end of the linear drive shaft, wherein the at least one protrusion is slidably disposed within the drive slot.

2 . The device of claim 1 , wherein rotation of the rotatable drive structure within the drive mechanism lumen causes the linear drive shaft to move axially within the drive mechanism lumen.

3 . The device of claim 1 , wherein the rotatable drive structure is threadably coupled to an inner surface of the drive mechanism lumen.

4 . The device of claim 1 , wherein the at least one fixation lumen comprises first and second fixation lumens, wherein the first fixation lumen has a longitudinal axis that is transverse to a longitudinal axis of the second fixation lumen.

5 . The device of claim 1 , wherein the at least one fixation lumen comprises threads defined in an inner wall of the at least one fixation lumen.

6 . The device of claim 1 , wherein the adjustable joint comprises:

(a) a distal face disposed at an angle ranging from 1 degree to 89 degrees in relation to the longitudinal axis of the proximal member; and

(b) a proximal face disposed at an angle corresponding to the angle of the distal face such that the proximal member is in slidable contact with the distal member.

7 . The device of claim 1 , wherein the linear drive shaft comprises a proximal section comprising a proximal section diameter and a distal section comprising a distal section diameter, wherein the distal section diameter is greater than the proximal section diameter.

8 . The device of claim 1 , wherein the at least one fixation lumen comprises threads defined in an inner wall of the at least one fixation lumen.

9 . A bone fixation device comprising:

(a) a device body comprising:

(i) a proximal member comprising:

(A) a shaft lumen defined within the proximal member, wherein the shaft lumen is parallel to a longitudinal axis of the proximal member; and

(B) a drive slot defined with the proximal member, wherein the drive slot is transverse to the longitudinal axis of the proximal member;

(ii) a distal member comprising:

(C) a drive mechanism lumen defined within the distal member, wherein the drive mechanism lumen is parallel to a longitudinal axis of the distal member; and

(D) at least one fixation lumen defined within the distal member, wherein the at least one fixation lumen is transverse to the longitudinal axis of the distal member, wherein the at least one fixation lumen is in fluidic communication with the drive mechanism lumen;

(b) an adjustable joint formed between the proximal member and the distal member, wherein the proximal member and the distal member are movable radially and axially in relation to each other via the adjustable joint; and

(c) a drive mechanism operably coupled to the proximal and distal members, the drive mechanism comprising:

(i) a rotatable drive structure rotatably disposed within the drive mechanism lumen, wherein the rotatable drive structure comprises a rotatable engagement structure disposed at a proximal end of the rotatable drive structure; and

(ii) a linear drive shaft slidably disposed within the drive mechanism lumen, the linear drive shaft comprising:

(A) a proximal section comprising a proximal section diameter and a distal section comprising a distal section diameter, wherein the distal section diameter is greater than the proximal section diameter;

(B) a stationary engagement structure disposed at a distal end of the linear drive shaft, wherein the stationary engagement structure is configured to couple with the rotatable engagement structure;

(C) at least one transverse lumen defined through the linear drive shaft, wherein the at least one transverse lumen is transverse to a longitudinal axis of the linear drive shaft, wherein the at least one transverse lumen is in fluidic communication with the at least one fixation lumen, wherein the at least one transverse lumen is defined in the distal section; and

(D) at least one protrusion disposed at a proximal end of the linear drive shaft, wherein the at least one protrusion is slidably disposed within the drive slot.

10 . The device of claim 9 , wherein rotation of the rotatable drive structure causes the linear drive shaft to move axially within the drive mechanism lumen.

11 . The device of claim 9 , wherein the rotatable drive structure is threadably coupled to an inner surface of the drive mechanism lumen.

12 . The device of claim 9 , wherein the at least one fixation lumen comprises first and second fixation lumens, wherein the first fixation lumen has a longitudinal axis that is transverse to a longitudinal axis of the second fixation lumen.

13 . A bone fixation device comprising:

(a) a device body comprising:

(i) a proximal member comprising:

(A) a shaft lumen defined within the proximal member, wherein the shaft lumen is parallel to a longitudinal axis of the proximal member; and

(B) a drive slot defined with the proximal member, wherein the drive slot is transverse to the longitudinal axis of the proximal member;

(ii) a distal member comprising:

(E) a drive mechanism lumen defined within the distal member, wherein the drive mechanism lumen is parallel to a longitudinal axis of the distal member; and

(F) at least one fixation lumen defined within the distal member, wherein the at least one fixation lumen is transverse to the longitudinal axis of the distal member, wherein the at least one fixation lumen is in fluidic communication with the drive mechanism lumen;

(b) an adjustable joint formed between the proximal member and the distal member, wherein the proximal member and the distal member are movable radially and axially in relation to each other via the adjustable joint;

(c) a drive mechanism operably coupled to the proximal and distal members, the drive mechanism comprising:

(i) a rotatable drive structure rotatably disposed within the drive mechanism lumen, wherein the rotatable drive structure comprises a rotatable engagement structure disposed at a proximal end of the rotatable drive structure; and

(ii) a linear drive shaft slidably disposed within the drive mechanism lumen, the linear drive shaft comprising:

(A) a stationary engagement structure disposed at a distal end of the linear drive shaft, wherein the stationary engagement structure is configured to couple with the rotatable engagement structure;

(B) at least one transverse lumen defined through the linear drive shaft, wherein the at least one transverse lumen is transverse to a longitudinal axis of the linear drive shaft, wherein the at least one transverse lumen is in fluidic communication with the at least one fixation lumen; and

(C) at least one protrusion disposed at a proximal end of the linear drive shaft, wherein the at least one protrusion is slidably disposed within the drive slot; and

(d) a removable cap, wherein the removable cap is removably coupleable to a distal opening defined in the distal member, wherein the distal opening is in fluidic communication with the drive mechanism lumen.

14 . A bone fixation device comprising:

(a) a device body comprising:

(i) a proximal member comprising:

(A) a proximal lumen defined within the proximal member, wherein the proximal lumen is parallel to a longitudinal axis of the proximal member; and

(B) a drive slot defined with the proximal member and in fluidic communication with the proximal lumen, wherein the drive slot is transverse to the longitudinal axis of the proximal member;

(ii) a distal member comprising:

(A) a distal lumen defined within the distal member, wherein the distal lumen is parallel to a longitudinal axis of the distal member, wherein the distal lumen is in fluidic communication with the proximal lumen; and

(B) at least one fixation lumen defined within the distal member, wherein the at least one fixation lumen is transverse to the longitudinal axis of the distal member, wherein the at least one fixation lumen is in fluidic communication with the distal lumen;

(b) a slidable joint formed between the proximal member and the distal member, wherein the distal member is movable radially and axially in relation to the proximal member via the slidable joint; and

(c) a drive mechanism operably coupled to the proximal and distal members, the drive mechanism comprising:

(i) a rotatable drive structure rotatably disposed within the distal lumen, wherein the rotatable drive structure comprises a first engagement structure disposed at a proximal end of the rotatable drive structure, wherein the first engagement structure comprises a substantially round protrusion extending proximally from the rotatable drive structure; and

(ii) a linear drive shaft slidably disposed within the proximal lumen and the distal lumen, the linear drive shaft comprising:

(A) a second engagement structure disposed at a distal end of the linear drive shaft, wherein the second engagement structure is operably coupled with the first engagement structure, wherein the second engagement structure comprises an engagement slot sized and shaped to receive the first engagement structure such that the first engagement structure is rotatable in relation to the linear drive shaft but is not moveable axially in relation to the linear drive shaft;

(B) at least one transverse lumen defined through the linear drive shaft, wherein the at least one transverse lumen is transverse to a longitudinal axis of the linear drive shaft, wherein the at least one transverse lumen is in fluidic communication with the at least one fixation lumen; and

(C) at least one radial protrusion disposed at a proximal end of the linear drive shaft, wherein the at least one radial protrusion is slidably disposed within the drive slot.

15 . The device of claim 14 , wherein the distal member is movable radially and axially in relation to the proximal member via the slidable joint between an aligned position in which the longitudinal axis of the distal member is substantially coaxial with the longitudinal axis of the proximal member and an articulate position in which the longitudinal axis of the distal member is non-coaxial and parallel with the longitudinal axis of the proximal member.

16 . The device of claim 14 , wherein rotation of the rotatable drive structure within the drive mechanism lumen causes the linear drive shaft to move axially within the distal lumen.

17 . The device of claim 14 , wherein the rotatable drive structure is threadably coupled to an inner surface of the distal lumen.

18 . The device of claim 14 , wherein the at least one fixation lumen comprises first and second fixation lumens, wherein the first fixation lumen has a longitudinal axis that is transverse to a longitudinal axis of the second fixation lumen.

19 . The device of claim 14 , wherein the at least one fixation lumen comprises threads defined in an inner wall of the at least one fixation lumen.

20 . The device of claim 14 , wherein the linear drive shaft comprises a proximal section comprising a proximal section diameter and a distal section comprising a distal section diameter, wherein the distal section diameter is greater than the proximal section diameter.