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US 2011/0257652 A1Published application
Intramedullary fixation device and methods for bone fixation and stabilization
AssigneeArrowhead Medical Device Technologies, LLC
InventorScott Richard Roman
Life of this patent
Estimating the term…
Abstract
An internal intramedullary fixation device for the stabilization of bone in arthrodesis and fractures of the foot and hand is disclosed. During implantation in the medullary canal of each bone, the device grasps the edges of the canal, stabilizing the bone (internally) during the natural healing process.
Claims68
An intramedullary fixation device used in bone fixation and stabilization, comprising:
- an arrowhead-shaped distal head comprising a distal end having a sharp point, the distal head having first, second, third, and fourth outwardly facing side surfaces forming a pyramidal shape, the first and third side surfaces being opposed from each other and forming a first angle, and the second and fourth side surfaces being opposed from each other and forming a second angle, the second angle being different than the first angle, each of the first and third side surfaces having a proximally projecting edge forming a tip of a barb, the barbs being configured to engage tissue and inhibit rotational movement and inhibit axial movement of the distal head in a proximal direction;
- an arrowhead-shaped proximal head comprising a proximal end having a sharp point, the proximal head having fifth, sixth, seventh, and eighth outwardly facing side surfaces, the fifth and seventh side surfaces being opposed from each other and forming a third angle, and the sixth and eighth side surfaces being opposed from each other and forming a fourth angle, the third angle being different than the fourth angle, each of the fifth and seventh side surfaces having a distally projecting edge forming a tip of a barb, the barbs being configured to engage tissue and inhibit rotational movement and inhibit axial movement of the proximal head in a distal direction;
- and
- a rigid body extending between and connecting the distal head and the proximal head, the body having a rigidity sufficient to withstand bending loading applied by the phalanges.
1 more element
The intramedullary fixation device of claim 13, wherein the first portion has a length less than a length of the second portion.
An intramedullary fixation device used in bone fixation and stabilization, comprising:
- an arrowhead-shaped distal head having first, second, third, and fourth outwardly facing side surfaces forming a pyramidal shape, the first and third side surfaces being opposed from each other and forming a first angle, and the second and fourth side surfaces being opposed from each other and forming a second angle, each of the first and third side surfaces having a proximally projecting edge forming a tip of a barb, the barbs being configured to engage tissue and inhibit movement of the distal head in a proximal direction, and wherein the second and fourth side surfaces lack proximal edges forming barbs,
- an arrowhead-shaped proximal head having fifth, sixth, seventh, and eighth outwardly facing side surfaces, the fifth and seventh side surfaces being opposed from each other and forming a third angle, and the sixth and eighth side surfaces being opposed from each other and forming a fourth angle, each of the fifth and seventh side surfaces having a distally projecting edge forming a tip of a barb, the barbs being configured to engage tissue and inhibit movement of the proximal head in a distal direction, and wherein the sixth and eighth side surfaces lack proximal edges forming barbs;
- and
- a cylindrical body extending between and connecting the distal head and the proximal head, the cylindrical body having a rigidity sufficient to withstand bending loading applied by the phalanges.
1 more element
An intramedullary fixation device used in bone fixation and stabilization, comprising:
- an arrowhead-shaped distal head comprising a distal end having a sharp point, the distal head having first, second, third, and fourth outwardly facing side surfaces forming a pyramidal shape, the first and third side surfaces being opposed from each other and forming a first angle, and the second and fourth side surfaces being opposed from each other and forming a second angle, the second angle being different than the first angle,
- each of the first and third side surfaces having a proximally projecting edge forming a tip of a barb, the distal head also comprising a first undercut and a second undercut, each of the first and second undercuts having a depth such that the barb tips are disposed proximal of the respective undercut, the barbs being configured to engage tissue and inhibit movement of the distal head in a proximal direction;
- an arrowhead-shaped proximal head comprising a proximal end having a sharp point, the proximal head having fifth, sixth, seventh, and eighth outwardly facing side surfaces, the fifth and seventh side surfaces being opposed from each other and forming a third angle, and the sixth and eighth side surfaces being opposed from each other and forming a fourth angle, the third angle being different than the fourth angle,
- each of the fifth and seventh side surfaces having a distally projecting edge forming a tip of a barb, the proximal head also comprising a third undercut and a fourth undercut, each of the third and fourth undercuts having a depth such that the barb tips are disposed distal of the respective undercut, the barbs being configured to engage tissue and inhibit movement of the proximal head in a distal direction;
- and
- a rigid body extending between and connecting the distal head and the proximal head, the body having a rigidity sufficient to withstand bending loading applied by the phalanges, the body comprising a main portion, a distal neck portion, and a proximal neck portion, the distal and proximal neck portions having a cross-sectional area smaller than a cross-section area of the main portion, the distal neck portion supporting the distal head and the proximal neck portion supporting the proximal head, the distal neck intersecting with the first and second undercuts in the distal head and the proximal neck intersecting with the third and fourth undercuts in the proximal head.
3 more elements
A kit for bone fixation and stabilization, comprising:
- an intramedullary fixation device, comprising:
- an arrowhead-shaped distal head having first, second, third, and fourth outwardly facing side surfaces forming a pyramidal shape, the first and third side surfaces being opposed from each other and forming a first angle, and the second and fourth side surfaces being opposed from each other and forming a second angle, each of the first and third side surfaces having a proximally projecting edge forming a tip of a barb, the barbs being configured to engage tissue and inhibit movement of the distal head in a proximal direction, and wherein the second and fourth side surfaces lack barbs,
- an arrowhead-shaped proximal head having fifth, sixth, seventh, and eighth outwardly facing side surfaces, the fifth and seventh side surfaces being opposed from each other and forming a third angle, and the sixth and eighth side surfaces being opposed from each other and forming a fourth angle, each of the fifth and seventh side surfaces having a distally projecting edge forming a tip of a barb, the barbs being configured to engage tissue and inhibit movement of the proximal head in a distal direction, and wherein the sixth and eighth side surfaces lack barbs;
- and
- a cylindrical body extending between and connecting the distal head and the proximal head, the cylindrical body having a rigidity sufficient to withstand bending loading applied by the phalanges;
- and
- insertion forceps configured to securably grasp the intramedullary fixation device, the insertion forceps comprising:
- a first nose piece having a first recess formed therein, the first recess being sized to receive a portion of the cylindrical body of the intramedullary fixation device;
- a second nose piece having a second recess formed therein, the second recess being sized to receive a portion of the cylindrical body of the intramedullary fixation device, the first and second nose pieces being cooperatively arranged to securely grip the cylindrical body of the intramedullary fixation device sufficiently to prevent rotation and axial displacement under normal insertion conditions.
6 more elements
A method comprising:
- grasping an intramedullary fixation device that comprises:
- an arrowhead-shaped distal head having first, second, third, and fourth outwardly facing side surfaces forming a pyramidal shape, the first and third side surfaces being opposed from each other and forming a first angle, and the second and fourth side surfaces being opposed from each other and forming a second angle, each of the first and third side surfaces having a proximally projecting edge forming a tip of a barb, the barbs being configured to engage tissue and inhibit movement of the distal head in a proximal direction, and wherein the second and fourth side surfaces lack proximal edges forming barbs,
- an arrowhead-shaped proximal head having fifth, sixth, seventh, and eighth outwardly facing side surfaces, the fifth and seventh side surfaces being opposed from each other and forming a third angle, and the sixth and eighth side surfaces being opposed from each other and forming a fourth angle, each of the fifth and seventh side surfaces having a distally projecting edge forming a tip of a barb, the barbs being configured to engage tissue and inhibit movement of the proximal head in a distal direction, and wherein the sixth and eighth side surfaces lack proximal edges forming barbs;
- and
- a cylindrical body extending between and connecting the distal head and the proximal head, the cylindrical body having a rigidity sufficient to withstand bending loading applied by the phalanges.
- introducing a proximal end of the device into an intramedullary canal of a first bone element;
- introducing a distal end of the device into an intramedullary canal of a second bone element;
- releasing the intramedullary fixation device;
- and
- pressing the first and second bone elements together.
7 more elements
An intramedullary fixation device used in bone fixation and stabilization, comprising:
- an arrowhead-shaped distal head comprising a distal end having a sharp distal point, the distal head having distal first, second, and third outwardly facing side surfaces converging toward and intersecting at the distal point, the distal first outwardly facing surface having a maximum width greater than a maximum width of the distal second outwardly facing surface, at least one of the distal first, second, and third outwardly facing surfaces having a proximally projecting edge forming a tip of a barb, the barb being configured to engage tissue and inhibit rotational movement and inhibit axial movement of the distal head in a proximal direction;
- an arrowhead-shaped proximal head comprising a proximal end having a sharp proximal point, the proximal head having proximal first, second, and third outwardly facing side surfaces converging toward and intersecting at the proximal point, the proximal first outwardly facing surface having a maximum width greater than a maximum width of the proximal second outwardly facing surface, at least one of the proximal first, second, and third outwardly facing surfaces having a distally projecting edge forming a tip of a barb, the barb being configured to engage tissue and inhibit rotational movement and inhibit axial movement of the proximal head in a distal direction;
- and
- a rigid body extending between and connecting the distal head and the proximal head, the body having a rigidity sufficient to withstand bending loading applied by the phalanges.
1 more element
A kit for bone fixation and stabilization, comprising:
- an intramedullary fixation device, comprising:
- an arrowhead-shaped distal head comprising a distal end having a sharp distal point, the distal head having distal first, second, and third outwardly facing side surfaces converging toward and intersecting at the distal point, the distal first outwardly facing surface having a maximum width greater than a maximum width of the distal second outwardly facing surface, at least one of the distal first, second, and third outwardly facing surfaces having a proximally projecting edge forming a tip of a barb, the barb being configured to engage tissue and inhibit rotational movement and inhibit axial movement of the distal head in a proximal direction;
- an arrowhead-shaped proximal head comprising a proximal end having a sharp proximal point, the proximal head having proximal first, second, and third outwardly facing side surfaces converging toward and intersecting at the proximal point, the proximal first outwardly facing surface having a maximum width greater than a maximum width of the proximal second outwardly facing surface, at least one of the proximal first, second, and third outwardly facing surfaces having a distally projecting edge forming a tip of a barb, the barb being configured to engage tissue and inhibit rotational movement and inhibit axial movement of the proximal head in a distal direction;
- and
- a rigid body extending between and connecting the distal head and the proximal head, the body having a rigidity sufficient to withstand bending loading applied by the phalanges;
- and
- insertion forceps configured to securably grasp the intramedullary fixation device, the insertion forceps comprising:
- a first nose piece having a first recess formed therein, the first recess being sized to receive a portion of the cylindrical body of the intramedullary fixation device;
- a second nose piece having a second recess formed therein, the second recess being sized to receive a portion of the cylindrical body of the intramedullary fixation device, the first and second nose pieces being cooperatively arranged to securely grip the cylindrical body of the intramedullary fixation device sufficiently to prevent rotation and axial displacement under normal insertion conditions.
6 more elements
A method comprising:
- grasping an intramedullary fixation device that comprises:
- an arrowhead-shaped distal head comprising a distal end having a sharp distal point, the distal head having distal first, second, and third outwardly facing side surfaces converging toward and intersecting at the distal point, the distal first outwardly facing surface having a maximum width greater than a maximum width of the distal second outwardly facing surface, at least one of the distal first, second, and third outwardly facing surfaces having a proximally projecting edge forming a tip of a barb, the barb being configured to engage tissue and inhibit rotational movement and inhibit axial movement of the distal head in a proximal direction;
- an arrowhead-shaped proximal head comprising a proximal end having a sharp proximal point, the proximal head having proximal first, second, and third outwardly facing side surfaces converging toward and intersecting at the proximal point, the proximal first outwardly facing surface having a maximum width greater than a maximum width of the proximal second outwardly facing surface, at least one of the proximal first, second, and third outwardly facing surfaces having a distally projecting edge forming a tip of a barb, the barb being configured to engage tissue and inhibit rotational movement and inhibit axial movement of the proximal head in a distal direction;
- and
- a cylindrical body extending between and connecting the distal head and the proximal head, the cylindrical body having a rigidity sufficient to withstand bending loading applied by the phalanges.
- introducing a proximal end of the device into an intramedullary canal of a first bone element;
- introducing a distal end of the device into an intramedullary canal of a second bone element;
- releasing the intramedullary fixation device;
- and
- pressing the first and second bone elements together.
7 more elements
Dependencies are inferred from the claim text.