The present invention relates generally to an orthopaedic fixation apparatus and the method for using the apparatus. More specifically, the present invention relates to an orthopaedic fixation apparatus that can be attached to the body of a patient during surgery.
During certain surgical procedures, separated opposing portions of the skeletal system, for example, pieces of a surgically separated or fractured bone, are placed into alignment with one another to facilitate proper healing. The bone pieces are held securely to one another with the aid of a fixation device. If subsequent surgery is required, the fixation device should preferably be capable of being opened easily without harm to the patient and quickly in case of an emergency.
Conventional fixation devices include plates that extend across a surgical incision or a fracture and that are held in place against movement by bone screws. Conventional fixation devices also include wires that extend across a surgical incision or a fracture and that are threaded into holes drilled or otherwise formed in the adjacent bone pieces. Such fixation devices may become loosened, cause injury, or cause the surgical incision or the bone fracture to heal improperly or to separate. For example, a wire is typically tied in knots and may become untwisted as a result of movement by the patient. Also, such fixation devices may be difficult and time consuming to remove if there is a need for future access via surgery to the injury site.
The present invention is directed to an orthopaedic fixation apparatus and a method for using the apparatus and, more particularly, to an orthopaedic fixation apparatus that can be attached to the body of patient or subject treatment during surgery.
In accordance with an embodiment of the present invention, an orthopaedic fixation apparatus comprises a first retainer section positionable against the body of a patient and a second retainer section positionable against the body of a patient. The first retainer section includes a first opening extending through the first retainer section. The second retainer section includes a second opening extending through the second retainer section. The second retainer section is separable from the first retainer section. The orthopaedic fixation apparatus also comprises a first fastener insertable into the first opening and a second fastener insertable into the second opening. The first fastener has a shank portion configured and dimensioned to pass through the first opening. The first fastener also has a head portion configured and dimensioned to prevent the head portion from passing through the first opening. The second fastener similarly has a shank portion configured and dimensioned to pass through the second opening. The second fastener also has a head portion configured and dimensioned to prevent the head portion from passing through the second opening. The orthopaedic fixation apparatus further comprises a retention member engageable with the first fastener and with the second fastener. The retention member is elongated and flexible. The retention member is also configured and dimensioned to contact and extend at least partially around the head portion of the first fastener and to extend from the head portion of the first fastener to the head portion of the second fastener and to contact and to extend at least partially around the head portion of the second fastener all when the shank portion of the first fastener is disposed in the first opening and the shank portion of the second fastener is disposed in the second opening.
In accordance with another embodiment of the present invention, an orthopaedic fixation apparatus comprises a first retainer section positionable against the body of a patient and a second retainer section positionable against the body of a patient. The first retainer section includes a first opening extending through the first retainer section. The second retainer section includes a second opening extending through the second retainer section. The second retainer section is separable from the first retainer section. The orthopaedic fixation apparatus also comprises a first fastener insertable into the first opening and a second fastener insertable into the second opening. The first fastener has a shank portion configured and dimensioned to pass through the first opening. The first fastener also has a head portion configured and dimensioned to prevent the head portion from passing through the first opening. The second fastener has a shank portion configured and dimensioned to pass through the second opening. The second fastener also has a head portion configured and dimensioned to prevent the head portion from passing through the second opening. The orthopaedic fixation apparatus further comprises a retention member engageable with the first fastener and the second fastener. The retention member is a relatively rigid and plastically deformable loop of material. The retention member is also configured and dimensioned to contact and extend at least partially around the head portion of the first fastener and to extend from the head portion of the first fastener to the head portion of the second fastener and to contact and to extend at least partially around the head portion of the second fastener when the shank portion of the first fastener is disposed in the first opening and the shank portion of the second fastener is disposed in the second opening.
In accordance with a further embodiment of the present invention, an orthopaedic fixation apparatus comprises a retainer assembly including a first retainer section positionable against the body of a patient and a second retainer section positionable against the body of a patient. The first retainer section includes a first opening extending through the first retainer section. The second retainer section includes a second opening extending through the second retainer section. The second retainer section is spaced apart from the first retainer section. The retainer assembly also includes a first laterally extending wall connecting the first retainer section and the second retainer section and a second laterally extending wall connecting the first retainer section and the second retainer section. The second laterally extending wall is spaced apart from the first laterally extending wall. A first fastener is insertable into the first opening. The first fastener has a shank portion configured and dimensioned to pass through the first opening. The first fastener also has a head portion configured and dimensioned to prevent the head portion from passing through the first opening. A second fastener is insertable into the second opening. The second fastener has a shank portion configured and dimensioned to pass through the second opening. The second fastener also has a head portion configured and dimensioned to prevent the head portion from passing through the second opening. The first and second laterally extending walls are relatively rigid and plastically deformable to cause the first retainer section to move toward the second retainer section.
In accordance with yet another embodiment of the present invention, a method of implanting an orthopaedic fixation apparatus to join two pieces of bone comprises the steps of positioning a first retainer section of the orthopaedic fixation apparatus against a first piece of bone and positioning a second retainer section of the orthopaedic fixation apparatus against a second piece of bone. The method also comprises the step of inserting a shank portion of a first fastener through a first opening in the first retainer section and into the first piece of bone to attach the first retainer section to the first piece of bone. The first fastener has a head portion configured and dimensioned to prevent the head portion from passing through the first opening when the shank portion of the first fastener is inserted through the first opening. The method further comprises the step of inserting a shank portion of a second fastener through a second opening in the second retainer section and into the second piece of bone to attach the second retainer section to the second piece of bone. The second fastener has a head portion configured and dimensioned to prevent the head portion from passing through the second opening when the shank portion of the second fastener is inserted through the second opening. The method yet further comprises the step of engaging an elongated flexible retention member of the orthopaedic fixation apparatus with the head portion of the first fastener and with the head portion of the second fastener to hold the first retainer section and the first bone piece in a desired position relative to the second retainer section and the second bone piece. The retention member contacts and extends at least partially around the head portion of the first fastener and extends from the head portion of the first fastener to the head portion of the second fastener and contacts and extends at least partially around the head portion of the second fastener, all when the shank portion of the first fastener is inserted through the first opening into the first piece of bone and the shank portion of the second fastener is inserted through the second opening into the second piece of bone.
In accordance with yet a further embodiment of the present invention, a method of implanting an orthopaedic fixation apparatus to join two pieces of bone comprises the steps of positioning a first retainer section of the orthopaedic fixation apparatus against a first piece of bone and positioning a second retainer section of the orthopaedic fixation apparatus against a second piece of bone. The method also comprises the step of inserting a shank portion of a first fastener through a first opening in the first retainer section and into the first piece of bone to attach the first retainer section to the first piece of bone. The first fastener has a head portion configured and dimensioned to prevent the head portion from passing through the first opening when the shank portion of the first fastener is inserted through the first opening. The method further comprises the step of inserting a shank portion of a second fastener through a second opening in the second retainer section and into the second piece of bone to attach the second retainer section to the second piece of bone. The second fastener has a head portion configured and dimensioned to prevent the head portion from passing through the second opening when the shank portion of the second fastener is inserted through the second opening. The method yet further comprising the step of engaging a retention member of the orthopaedic fixation apparatus with the head portion of the first fastener and with the head portion of the second fastener to hold the first retainer section and the first bone piece in a desired position relative to the second retainer section and the second bone piece. The retention member is a substantially rigid and plastically deformable loop of material. The retention member (a) contacts and extends at least partially around the head portion of the first fastener and (b) extends from the head portion of the first fastener to the head portion of the second fastener and (c) contacts and extends at least partially around the head portion of the second fastener, all when the shank portion of the first fastener is inserted through the first opening into the first piece of bone and the shank portion of the second fastener is inserted through the second opening into the second piece of bone.
In accordance with yet a further embodiment of the present invention, a method of implanting an orthopaedic fixation apparatus to join two pieces of bone comprises the steps of positioning a first retainer section of the orthopaedic fixation apparatus against a first piece of bone and positioning a second retainer section of the orthopaedic fixation apparatus against a second piece of bone. The method also comprises inserting a shank portion of a first fastener through a first opening in the first retainer section and into the first piece of bone to attach the first retainer section to the first piece of bone. The first fastener has a head portion configured and dimensioned to prevent the head portion from passing through the first opening when the shank portion of the first fastener is inserted through the first opening. The method further comprises the step of inserting a shank portion of a second fastener through a second opening in the second retainer section and into the second piece of bone to attach the second retainer section to the second piece of bone. The second fastener has a head portion configured and dimensioned to prevent the head portion from passing through the second opening when the shank portion of the second fastener is inserted through the second opening. The method still further comprises the step of deforming first and second laterally extending walls of the orthopaedic fixation apparatus to hold the first retainer section and the first bone piece in a desired position relative to the second retainer section and the second bone piece. The first laterally extending wall of the orthopaedic fixation apparatus connects the first retainer section and the second retainer section. The second laterally extending wall of the orthopaedic fixation apparatus connects the first retainer section and the second retainer section. The second laterally extending wall is spaced apart from the first laterally extending wall.
In accordance with still yet a further embodiment of the present invention, an orthopaedic fixation device comprises a first retainer section positionable against the body of a patient. The first retainer section includes at least one opening extending through the first retainer section within which a fastener is receivable. A first engaging element is located on the first retainer section. The orthopaedic fixation device also comprises a second retainer section positionable against the body of a patient. The second retainer section includes at least one opening extending through the second retainer section within which a fastener is receivable. A second engaging element is located on the second retainer section. The first and second retainer sections are separable one from another in one state, and also are connectable by interengagement of the first and second engaging elements in another state. The first and second engaging elements when engaged with each other hold the first and second retainer sections against movement relative to each other along at least one line of force acting upon the first and second retainer sections when connected.
In accordance with a still further embodiment of the present invention, an orthopaedic fixation apparatus comprises a cleat and an elongated flexible retention member. The cleat includes a recess and a resiliently biased arm adjacent to the recess. The retention member is configured and dimensioned to be received lengthwise in the recess. The arm extends at least partially into the recess and cooperates with the recess to hold the retention member against longitudinal movement when the retention member extends along the recess adjacent to the arm.
The foregoing and other features and advantages of the present invention will become apparent to those skilled in the art to which the present invention relates upon reading the following description with reference to the accompanying drawings, in which:
Various embodiments of an orthopaedic fixation apparatus and methods for applying the apparatus are described below. The embodiments of the present invention are described in relation to an orthopaedic fixation apparatus for use on specific patient anatomy, for example, the sternum, the calcaneus bone, and the olecranon bone. Nonetheless, it will be appreciated that embodiments of the present invention could be employed across a variety of medical applications or procedures in which closure of a gap between two opposing anatomical structures is desired.
The first retainer section 14 is disposed on the left portion, S1, of the sternum. The first retainer section 14 is elongated and has an upper or anterior surface 40 and a lower or posterior surface 42 (
Multiple fastener openings 48, which may hereafter be referred to as first fastener openings, extend entirely through the first retainer section 14 from the anterior surface 40 to the posterior surface 42. The anterior surface 40 surrounding each fastener opening 48 includes an annular beveled surface area 96 to provide a countersink for each fastener opening. The fastener openings 48 are arranged in a closely spaced, longitudinally extending array adjacent the left edge 44 of the first retainer section, as viewed in
More particularly, the right edge 46 of the first retainer section 14 includes an upper or anterior edge portion 50 and a lower or posterior edge portion 52. The anterior edge portion 50 is defined by an inwardly-facing or rightward-facing wall 54. The anterior edge portion 50 and the wall 54 are elongated and extend for the length of the first retainer section 14. Along its length, the anterior edge portion 50 includes rounded tabs 56. The rounded tabs 56 are longitudinally spaced apart from one another and are separated by substantially straight portions 58 of the anterior edge portion 50. The straight portions 58 of the anterior edge portion 50 are disposed relatively closer to the left edge 44 of the first retainer section 14. The rounded tabs 56 are disposed relatively farther from the left edge 44 of the first retainer section 14. The rounded tabs 56 are also spaced apart from the fastener openings 48. The posterior edge portion 52 is defined by an inwardly-facing or rightward-facing wall 60. The posterior edge portion 52 and the wall 60 are elongated and extend for the length of the first retainer section 14. Along its length, the posterior edge portion 52 includes rounded recesses 62. The rounded recesses 62 are longitudinally spaced apart from one another and are separated by substantially straight portions 64 of the posterior edge portion 52. The straight portions 64 of the posterior edge portion 52 are disposed relatively farther from the left edge 44 of the first retainer section 14. The rounded recesses 62 are disposed relatively closer to the left edge 44 of the first retainer section 14. The rounded tabs 56 of the anterior edge portion 50 are positioned along the length of the first retainer section 14 so as to be aligned with the straight portions 64 of the posterior edge portion 52. Similarly, the rounded recesses 62 of the posterior edge portion 52 are positioned along the length of the first retainer section 14 so as to be aligned with the straight portions 58 of the anterior edge portion 50.
The second retainer section 16 is separate and distinct from the first retainer section 14 such that the first and second retainer sections are two separate components of the orthopaedic fixation apparatus 10, which can be implanted and otherwise handled independently of one another. The second retainer section 16 is shown in
Multiple fastener openings 74, which may hereafter be referred to as second fastener openings, extend entirely through the second retainer section 16 from the anterior surface 66 to the posterior surface 68. The anterior surface 66 surrounding each fastener opening 74 includes an annular beveled surface area 98 to provide a countersink for each fastener opening. The fastener openings 74 are arranged in a closely spaced, longitudinally extending array adjacent the right edge 70 of the second retainer section, as viewed in
More particularly, the left edge 72 of the second retainer section 16 includes an upper or anterior edge portion 76 and a lower or posterior edge portion 78. The posterior edge portion 78 is defined by an inwardly-facing or leftward-facing wall 86. The posterior edge portion 78 and the wall 86 are elongated and extend for the length of the second retainer section 16. Along its length, the posterior edge portion 78 includes rounded tabs 80. The rounded tabs 80 are longitudinally spaced apart from one another and are separated by substantially straight portions 88 of the posterior edge portion 78. The straight portions 88 of the posterior edge portion 78 are disposed relatively closer to the right edge 70 of the second retainer section 16. The rounded tabs 80 are disposed relatively farther from the right edge 70 of the second retainer section 16. The rounded tabs 80 are also spaced apart from the fastener openings 74. The anterior edge portion 76 is defined by an inwardly-facing or leftward-facing wall 84. The anterior edge portion 76 and the wall 84 are elongated and extend for the length of the second retainer section 16. Along its length, the anterior edge portion 76 includes rounded recesses 82. The rounded recesses 82 are longitudinally spaced apart from one another and are separated by substantially straight portions 90 of the anterior edge portion 76. The straight portions 90 of the anterior edge portion 76 are disposed relatively farther from the right edge 70 of the second retainer section 16. The rounded recesses 82 are disposed relatively closer to the right edge 70 of the second retainer section 16. The rounded tabs 80 of the posterior edge portion 78 are positioned along the length of the second retainer section 16 so as to be aligned with the straight portions 90 of the anterior edge portion 76. Similarly, the rounded recesses 82 of the anterior edge portion 76 are positioned along the length of the second retainer section 16 so as to be aligned with the straight portions 88 of the posterior edge portion 78.
As can be seen in
The rounded tabs 56 of the anterior edge portion 50 of the first retainer section 14 are not only shaped and dimensioned so as to fit into the rounded recesses 82 of the anterior edge portion 76 of the second retainer section 16, the rounded tabs 56 are also dimensioned in a posterior-to-anterior direction to fit closely against anterior surfaces 92 of the second retainer section adjacent to and anterior to the straight portions 88 of the posterior edge portion 78 of the second retainer section. Similarly, the rounded tabs 80 of the posterior edge portion 78 of the second retainer section 16 are not only shaped and dimensioned so to fit into the rounded recesses 62 of the posterior edge portion 52 of the first retainer section 14, the rounded tabs 80 are also dimensioned in a posterior-to-anterior direction to fit closely against posterior surfaces 94 of the first retainer section adjacent to and posterior to the straight portions 58 of the anterior edge portion 50 of the first retainer section. More particularly, when the first and second retainer sections 14 and 16 are spaced apart from one another or are in an open position, as shown, for example, in
To enable the first retainer section 14 to be secured to the left portion, S1, of the sternum, the fastener openings 48 in the first retainer section are shaped and dimensioned to receive bone screws or threaded fasteners 18. Likewise, to enable the second retainer section 16 to be secured to the right portion, S2, of the sternum, the fastener openings 74 in the second retainer section are shaped and dimensioned to receive bone screws or threaded fasteners 20. As can be seen in
Each of the fasteners 18 and 20, which may hereafter be referred to as post screws, is formed of a biocompatible material that can withstand stresses imparted to the fastener when implanted in a patient's sternum and secured to other components of the orthopaedic fixation apparatus 10, as described below. Suitable materials may include metals, such as titanium and stainless steel, and metal alloys. Each of the fasteners 18 and 20 has a head portion 104 and a shank portion 106. Head portion 104 includes a neck 108, a tapered collar 110, a reduced-diameter post 112 and a cap 114. The neck 108 abuts and is joined at one end to the shank portion 106. The tapered collar 110 abuts and is joined to the opposite end of the neck 108. Adjacent the neck 108, the collar 110 has an outer diameter that is the same as the outer diameter as the neck. The outer diameter of the collar 110 increases along the length of the collar with increasing distance from the neck 108. At the end of the collar 110 opposite the neck 108, the post 112 abuts and is joined to the collar.
The post 112 has an outer diameter that is smaller than the outer diameter of the adjacent end of the collar 110. The outer diameter of the post 112 may also be smaller than the opposite, smaller-diameter end of the collar 110 and/or smaller than the outer diameter of the neck 108. At the end of the post 112 opposite the collar 110, the cap 114 abuts and is joined to the post. The cap 114 has an outer diameter that is larger than the outer diameter of the post 112. As a result of the post 112 having a smaller outer diameter than both the cap 114 and the adjacent end of the collar 110, a recess 118 is formed between the cap and the collar. The overall length of the head portion is designated X1 in
At the end of the cap 114 opposite the post 112, a tool-receiving recess 116 is formed in the end surface 115 of the cap. The tool-receiving recess 116 may shaped as a pair of intersecting slots, as shown in
The head portion 104 of each fastener 18, 20 is configured and dimensioned to prevent the head portion from passing through an associated fastener opening 48, 74. Specifically, the collar 110 of each head portion 104 has an outer diameter at its larger end opposite the associated neck 108 that is larger than the diameter of the associated fastener opening 48, 74. The outer surface of the collar 110 is tapered to match the match the slope of the beveled surface area 96, 98 surrounding the associated fastener opening 48, 74. As a result, the collar 110 can seat against the beveled surface area 96, 98 of the associated fastener opening 48, 74 so that head portion 104 is drawn tightly against the corresponding first or second retainer section 14, 16 and the first or second retainer section 14, 16 is drawn tightly against the sternum when the fastener 18, 20 is screwed into the sternum. The post 112 and the cap 114 of the fastener 18, 20 will then project above the anterior surface 40 or 66 of the associated first or second retainer section 14 or 16. The post 112 and cap 114 will facilitate securing the first retainer section 14 to the second retainer section 16, as will be explained below.
Although many of the fastener openings 48 in the first retainer section 14 receive first fasteners 18 to attach the first retainer section to the left portion, S1, of the sternum, one fastener opening 48, which is at an end of the array of fastener openings 48, receives a different fastener 130. Similarly, although many of the fastener openings 74 in the second retainer section 16 receive second fasteners 20 to attach the second retainer section to the right portion, S2, of the sternum, one fastener opening 74, which is at an end of the array of fastener openings 74, receives a different fastener 132. For reasons that will be explained below, the fastener opening 48 that receives the fastener 130 is located adjacent one end of the first retainer section 14, while the fastener opening 74 that receives the fastener 132 is at the opposite end of the second retainer section 16. As can be seen in
Each of the fasteners 130 and 132, which may hereafter be referred to as lock screws, is formed of a biocompatible material that can withstand stresses imparted to the fastener when implanted in a patient's sternum and secured to other components of the orthopaedic fixation apparatus 10, as described below. Suitable materials may include metals, such as titanium and stainless steel, and metal alloys. Each of the fasteners 130 and 132 has a head portion 134 and a shank portion 136. Head portion 134 includes a reduced-diameter post 142 and a cap 144. The reduced-diameter post 142 abuts and is joined at one end to the shank portion 136. The reduced-diameter post 142 has a cylindrical outer surface with a diameter that is smaller than the diameter of the adjacent end of the shank portion 136. At the end of the reduced-diameter post 142 opposite the shank portion 136, the cap 144 abuts and is joined to the post. The cap 144 has an outer diameter that is larger than the outer diameter of the post 142. As a result of the post 142 having a smaller outer diameter than both the cap 144 and the adjacent end of the shank portion 136, a recess 146 is formed between the cap and the shank portion. In addition, a hole or passage 148 is formed in and extends entirely through the post 142. The overall length of the head portion is designated X2 in
At the end of the cap 144 opposite the post 142, a tool-receiving recess 150 is formed in the end surface 145 of the cap. The tool-receiving recess 150 may shaped as a pair of intersecting slots, as shown in
The head portion 134 of each fastener 130, 132 is configured and dimensioned to prevent the head portion from passing through an associated fastener opening 48, 74. Specifically, the cap 144 of each head portion 134 has an outer diameter that is larger than the diameter of the associated fastener opening 48, 74. Nonetheless, as there is no structure corresponding to the collar 110 of fasteners 18, 20, the head portion 134 of the fasteners 130, 132 will not seat against the beveled surface area 96, 98 of the associated fastener opening 48, 74 so that head portion 134 is drawn tightly against the first or second retainer section 14, 16 and the first or second retainer section 14, 16 is drawn tightly against the sternum when the fastener 18, 20 is screwed into the sternum. Instead, the surgeon or other user of the orthopaedic fixation apparatus 10 must visually or otherwise ensure that the shank portion 136 of the fastener 130, 132 is screwed into the sternum a distance such that the post 142 and cap 144 remain and project above the anterior surface 40 or 66 of the associated first or second retainer section 14 or 16 surrounding the fastener opening 48, 74. The post 142 and cap 144 will facilitate securing the first retainer section 14 to the second retainer section 16, as will be explained below.
Certain of the fastener openings 48 in the first retainer section 14 may optionally receive a yet further different fastener 160 to attach the first retainer section to the left portion, S1, of the sternum. Similarly, certain of the fastener openings 74 in the second retainer section 16 may optionally receive a yet further different fastener 162 to attach the second retainer section to the right portion, S2, of the sternum. As can be seen in
Each of the fasteners 160 and 162, which may hereafter be referred to as pan head screws, is formed of a biocompatible material that can withstand stresses imparted to the fastener when implanted in a patient's sternum and secured to other components of the orthopaedic fixation apparatus 10, as described below. Suitable materials may include metals, such as titanium and stainless steel, and metal alloys. Each of the fasteners 160 and 162 has a head portion 164 and a shank portion 166. Head portion 164 includes a reduced-diameter post 172 and a cap 174. The reduced-diameter post 172 abuts and is joined at one end to the shank portion 166. The reduced-diameter post 172 has a cylindrical outer surface with a diameter that is smaller than the diameter of the adjacent end of the shank portion 166. At the end of the reduced-diameter post 172 opposite the shank portion 166, the cap 174 abuts and is joined to the post. The cap 174 has a tapered outer surface. Adjacent the post 172, the cap 174 has an outer diameter that is the same as the outer diameter as the post. The outer diameter of the cap 174 increases along the length of the cap with increasing distance from the post 172. The overall length of the head portion is designated X3 in
At the end of the cap 174 opposite the post 172, a tool-receiving recess 176 is formed in the end surface 175 of the cap. The tool-receiving recess 176 may shaped as a pair of intersecting slots, like the tool receiving recesses 116 and 150, but the tool-receiving recess 176 may also be shaped as a single slot, a hexagonal socket, a six-pointed star socket, or any other shape that can accept a tool to screw the fastener 160, 162 into a bone. The shank portion 166 of the fastener 160, 162 has an outer threaded surface 178. The shank portion tapers along its length from its end adjacent the post 172 of the head portion 164 to its opposite end or tip.
The head portion 164 of each fastener 160, 162 is configured and dimensioned to prevent the head portion from passing through an associated fastener opening 48, 74. Specifically, the cap 174 of each head portion 164 has an outer diameter at its larger end opposite the associated post 172 that is larger than the diameter of the diameter of the associated fastener opening 48, 74. In addition, the outer surface of the cap 174 is tapered to match the match the slope of the beveled surface area 96, 98 surrounding the associated fastener opening 48, 74. As a result, the cap 174 can seat against the beveled surface area 96, 98 of the associated fastener opening 48, 74 so that head portion 164 is drawn tightly against the corresponding first or second retainer section 14, 16 and the corresponding first or second retainer section 14, 16 is drawn tightly against the sternum when the fastener 160, 162 is screwed into the sternum. When the outer surface of the cap 174 is fully seated against the beveled surface area 96, 98 of the associated fastener opening 48, 74, the end of the cap in which the tool-receiving recess 176 is formed will be flush or level with the anterior surface 40, 66 of the associated first or second retainer section 14, 16.
When the first and second retainer sections 14 and 16 are implanted in the left and right sternum portions S1 and S2, respectively, the retention member 22 is used to hold the left and right sternum portions in a desired position relative to one another to facilitate or promote healing of the sternum. The retention member 22 may also be used to draw together the left and right sternum portions S1 and S2, respectively, into a desired position relative to one another. In the embodiment of
In the embodiment of
Although cable 24 is shown as engaging the fasteners in a “ziz-zag” pattern, in which the cable extends across the gap between the first and second retainer sections 14 and 16 after extending partway around each fastener 18, 20, the cable may extend from one retainer section to the other retainer section after engaging two or more fasteners in a single retainer section. Other patterns of engagement, symmetric or asymmetric, may be used to engage the cable 24 with the fasteners 18, 20 and thus draw together the first and second retainer sections 14 and 16 and/or hold the first and second retainer sections in a desired position relative to one another. For example a criss-cross pattern of the cable 24 is possible. In addition, while the orthopaedic fixation apparatus 10 is shown in
The left and right sternum portions S1 and S2 and the implanted first and second retainer sections 14 and 16 may be moved together through direct manipulation by a surgeon, by pulling or applying tension to the cable 24, by applying force to the first and second retainer sections with a tool, or by another other technique or combination of techniques, as deemed appropriate by, for example, the surgeon. To hold the left and right sternum portions S1 and S2 and the implanted first and second retainer sections 14 and 16 in a desired position relative to one another, the cable 24 is drawn tightly against the fasteners 18, 20, 130, and 132 contacted by the cable and is then held, secured or locked against movement relative to the fasteners. As an example of a technique to hold or lock the cable 24 against such movement, the end portions 196 and 198 of the cable 24 can be wound one or more complete or partial turns around the fasteners 130 and 132 in the first and second retainer sections 14 and 16, respectively. The end portions 196 and 198 of the cable 24 may then further be twisted around an adjacent portion of the cable that extends toward the other of the first and second retainer sections. As another example, one or both of the fasteners 130 and 132 can be screwed an additional partial turn or more into the sternum so that one or both of the end portions 196 and 198 is pinched between an anterior surface 40, 66 of the first or second retainer section 14, 16 and an edge of the fastener adjacent the passage 148 in the fastener through which the end portion of the cable 24 extends. Other techniques and mechanisms for holding or locking the cable 24 against movement are described below.
In use, the orthopaedic fixation apparatus 10 is implanted to close a gap created in a patient's sternum when the sternum is surgically divided into a left sternum portion S1 and a right sternum portion S2 in order to gain access to an organ in the patient's chest cavity. The first retainer section 14 is disposed on the left portion, S1, of the sternum, and the second retainer section 16 is disposed on the right portion S2 of the sternum. The first retainer section 14 is secured to the tissue of the sternum with first fasteners 18, 130 and, optionally, 160. The shank portions 106, 136, and 166 of the first fasteners 18, 130, and 160, respectively, pass through the fastener openings 48 in the first retainer section 14. The head portions 104 and 164 of the first fasteners 18 and 160, respectively, do not pass through the fastener openings 48 but rather engage the anterior surface 40 of the first retainer section 14 to secure the first retainer section to the left portion S1 of the sternum. Similarly, the second retainer section 16 is secured to the tissue of the sternum with second fasteners 20, 132 and, optionally, 162. The shank portions 106, 136, and 166 of the second fasteners 20, 132, and 162, respectively, pass through the fastener openings 74 in the second retainer section 16. The head portions 104 and 164 of the second fasteners 20 and 162, respectively, do not pass through the fastener openings 74 but rather engage the anterior surface 66 of the second retainer section 16 to secure the second retainer section to the right portion S2 of the sternum.
After the first and second retainer sections 14 and 16 are secured to the left sternum portion S1 and right sternum portion S2, respectively, the left and right sternum portions S1 and S2 and the implanted first and second retainer sections 14 and 16 may be moved together. This movement may be accomplished through direct manipulation by a surgeon, by engaging the cable 24 with the fasteners 18, 20, 130, and 132 and pulling or applying tension to the cable 24, by applying force to the first and second retainer sections with a tool, or by another other technique or combination of techniques, as deemed appropriate by, for example, the surgeon. Although the friction fit of the rounded tabs 56, 80 of the retainer 12 helps to hold the first and second retainer sections 14 and 16 together once the left and right retainer sections are at least partially engaged with each other, the rounded shape of the tabs 56, 80 of retainer 12 also allows the first and second retainer sections 14 and 16 to be moved apart more easily if adjustment is needed in the fit of the first and second retainer sections or if re-entry to the sternal cavity is needed. If it has not already been done, the cable 24 of the retention member 22 is engaged with the fasteners 18, 20, 130, and 132 to secure the first and second retainer sections in position. The cable 24 is then drawn tightly against the fasteners 18, 20, 130, and 132 contacted by the cable and is held, secured or locked against movement relative to the fasteners so as to hold the left and right sternum portions S1 and S2 and the implanted first and second retainer sections 14 and 16 in a desired position relative to one another.
The first and second retainer sections 14 and 16 may vary in length in order to span most or substantially all of the length of the body B of the sternum and possibly the length of both the manubrium M and the xyphoid process XP or to span only a portion of the length of the body of the sternum. As shown, for example, in
The first retainer sections 214 are disposed on the left portion, S1, of the sternum, and the second retainer sections 216 are disposed on the right portion S2 of the sternum. The first retainer sections 214 are secured to the tissue of the sternum with first fasteners 18, 130 and, optionally, 160. The shank portions 106, 136, and 166 of the first fasteners 18, 130, and 160, respectively, pass through fastener openings 248 in the first retainer sections 214. Like the fastener openings 48 of the orthopaedic fixation apparatus 10, the fastener openings 248, which may hereafter be referred to as first fastener openings, extend entirely through the first retainer section 214 from an anterior surface 240 to a posterior surface 242 of the first retainer section. The head portions 104 and 164 of the first fasteners 18 and 160, respectively, do not pass through the fastener openings 248 but rather engage the anterior surface 240 of the first retainer sections 214 to secure the first retainer sections to the left portion S1 of the sternum. Similarly, the second retainer sections 216 are secured to the tissue of the sternum with second fasteners 20, 132 and, optionally, 162. The shank portions 106, 136, and 166 of the second fasteners 20, 132, and 162, respectively, pass through fastener openings 274 in the second retainer section 216. Like the fastener openings 74 of the orthopaedic fixation apparatus 10, the fastener openings 274, which may hereafter be referred to as second fastener openings, extend entirely through the second retainer section 216 from an anterior surface 266 to a posterior surface 268 of the first retainer section. The head portions 104 and 164 of the second fasteners 20 and 162, respectively, do not pass through the fastener openings 274 but rather engage the anterior surface 266 of the second retainer section 216 to secure the second retainer section to the right portion S2 of the sternum.
The anterior surface 240 surrounding each fastener opening 248 in the first retainer sections 214 includes an annular beveled surface area 296 to provide a countersink for the fastener opening. Similarly, the posterior surface 242 surrounding each fastener opening 248 in the first retainer sections 214 includes an annular beveled surface area 297 to provide a countersink for the fastener opening. In a like manner, both the anterior surface 266 and the posterior surface 268 surrounding each fastener opening 274 in the second retainer sections 216 include annular beveled surface areas 298 and 299 to provide countersinks for the fastener opening. By having the annular beveled surfaces 296, 297, 298, and 299 surrounding the fastener openings 248 and 274 in both the anterior and posterior surfaces 240, 266, 242, and 268 of each of the first and second retainer sections 214 and 216, each of the first and second retainer sections 214 and 216 may be used on either left sternum portion S1 or the right sternum portion by simply turning the retainer section over and reversing the anterior and posterior surfaces.
Like the orthopaedic fixation apparatus 10, the orthopaedic fixation apparatus 200 includes a retention member 22 that engages at least one fastener received in each of the first and second retainer sections 214 and 216. The retention member 22 includes a cable 24 that engages the fasteners 18, 20, 130, and 132 received in both the first and second retainer sections 214 and 216 in an alternating or zig-zag pattern, as shown in
As previously noted, the first and second retainer sections 214 and 216 illustrated in
To hold the left and right sternum portions S1 and S2 and the implanted first and second retainer sections 214 and 216 in a desired position relative to one another, the cable 24 is drawn tightly against the fasteners 18, 20, 130, and 132 contacted by the cable and is then held, secured or locked against movement relative to the fasteners. As an example of a technique to hold or lock the cable 24 against such movement, the end portions 196 and 198 of the cable 24 can be wound one or more complete or partial turns around the fasteners 130 and 132 in the first and second retainer sections 214 and 216, respectively. The end portions 196 and 198 of the cable 24 may then further be twisted around an adjacent portion of the cable that extends toward the other of the first and second retainer sections. As another example, illustrated in
As a further example,
In yet a further example of a technique to hold or lock the cable 24 against movement relative to the fasteners 18, 20, 130, and 132,
When the cable cleat 202 is included in the orthopaedic fixation apparatus 200′, as shown in
The cable cleat 202 of
The double cable cleat 202″ allows twice as many teeth 210 to engage a single cable 24 of a single retention member 22, thereby providing greater retaining force against a greater tension in the cable, or, as shown in
The cable cleat 202 and the double cable cleat 202″ can be disposed relatively close to a retainer 212 or a retainer 12 or can be disposed relatively far from a retainer, as is the case with respect to the retainer 212 implanted in the manubrium M of the orthopaedic fixation apparatus 200″ of
In another embodiment of the present invention, as illustrated in
As shown in
The loop or band 350 may be formed of any biocompatible material, such as titanium, that can withstand stresses imparted to the loop or band when implanted in a patient's sternum and secured to other components of the orthopaedic fixation apparatus 300. The material of which the loop or band is formed must also be sufficiently rigid to retain its initial shape, such as the shape shown in
A loop or band 350 is shown installed in its initial condition as part of an orthopaedic fixation apparatus 300 in
In use, the orthopaedic fixation apparatus 300 is implanted to close a gap created in a patient's sternum when the sternum is surgically divided into a left sternum portion S1 and a right sternum portion S2 in order to gain access to an organ in the patient's chest cavity. As shown in
After the first and second retainer sections 214 and 216 are secured to the left sternum portion S1 and right sternum portion S2, respectively, using the first and second fasteners 160 and 162, respectively, the left and right sternum portions S1 and S2 and the implanted first and second retainer sections 214 and 216 may be moved together. This movement may be accomplished through direct manipulation by a surgeon, by applying force to the first and second retainer sections with a tool, or by another other technique or combination of techniques, as deemed appropriate by, for example, the surgeon. The friction fit of the tabs 256, 280 of the retainer 212 helps to hold the left and right retainer sections 214 and 216 together once the left and right retainer sections are at least partially engaged with each other. A loop or band 350 is then installed to secure together the left and right retainer sections 214 and 216 of each retainer 212. One first fastener 18 is inserted into the central opening 355 in the loop or band 350 adjacent one of the end portions 354. One second fastener 20 is inserted into the central opening 355 in the loop or band 350 adjacent the other of the end portions 354. During the insertion process, the loop or band 350 is cammed over the tapered collars 110 of the fasteners 18, 20 from the necks 108 of the fasteners. The rounded edges of the anterior surface 356 of the loop or band 350 and the tapered shape of the collars 110 of the fasteners 18, 20 facilitates the camming motion. After passing over the collars of the fasteners 18, 20, the loop or band 350 snaps into the grooves 118 of the fasteners 18, 20 and closely contacts at least a portion of the surfaces of the posts 112 of the fasteners 18, 20. The shank portions 106 of the fasteners 18, 20 may be inserted into the appropriate fastener openings 248 and 274 and screwed into the sternum either before or after the loop or band 350 is cammed over the collars 110 of the fasteners. More particularly, the process of screwing the fasteners 18, 20 into the tissue of the sternum may provide the force necessary to cause the loop or band 350 to cam over the collars 110 of the fasteners. The fasteners 18, 20 are screwed into the sternum to a depth such that the tapered outer surface of the collars 110 of the fasteners contact and seat on the beveled surface areas 296 and 298 (
In the orthopaedic fixation apparatus 10 of
The orthopaedic fixation apparatus 400 comprises a retainer 412, which includes a first retainer section 414 and a second retainer section 416 that are spaced apart from each other. One end portion 411 of the first retainer section 414 is joined to an end portion 413 of the second retainer section 416 by a first substantially straight, laterally-extending wall 402. The opposite end portion 415 of the first retainer section 414 is joined to another end portion 417 of the second retainer section 416 by a second substantially straight, laterally-extending wall 404. The first laterally-extending wall 402 is spaced apart from the second laterally-extending wall 404. The first and second retainer sections 414 and 416 and the first and second laterally-extending walls 402 and 404 thus together form a unitary retainer assembly 410. As shown, the first and second retainer sections 414 and 416 and the first and second laterally-extending walls 402 and 404 are formed as one piece, although they could be formed as separate components and subsequently joined together to form the retainer assembly 410. Also, as a result of the spacing between the first and second retainer sections 414 and 416 and the spacing between the first and second laterally-extending walls 402 and 404, the first and second retainer sections and the first and second laterally-extending walls together define a central opening 408 in the retainer assembly 410.
The first retainer section 414 has an upper or anterior surface 440 and a lower or posterior surface 442. The second retainer section 416 has an upper or anterior surface 466 and a lower or posterior surface 468. Three fastener openings 448, which may hereafter be referred to as first fastener openings, extend entirely through the first retainer section 414 from the anterior surface 440 to the posterior surface 442. The anterior surface 440 surrounding each fastener opening 448 includes an annular beveled surface area 496 to provide a countersink for each fastener opening. Three fastener openings 474, which may hereafter be referred to as second fastener openings, extend entirely through the second retainer section 416 from the anterior surface 466 to the posterior surface 468. The anterior surface 466 surrounding each fastener opening 474 includes an annular beveled surface area 498 to provide a countersink for each fastener opening. As shown, two of the three fastener openings 448 in the first retainer section 414 receive a fastener 160. Similarly, two of the three fastener openings 474 in the second retainer section 416 receive a fastener 160. Alternatively, each of the three fastener openings 448 in the first retainer section 414 and each of the three fastener openings 474 in the second retainer section 416 may receive a fastener 160, 162. The beveled surface areas 496, 498 allow the fasteners 160, 162 to seat in the fastener openings 448, 474 of the first and second retainer sections 414, 416, while the end surfaces of the caps 174 of the fasteners are substantially flush or level with the anterior surfaces 440, 466 of the first and second retainer sections.
Each of the first and second laterally-extending walls 402 and 404 of the retainer assembly 410 includes a compressible bend zone. In the initial condition of the retainer assembly 410, as shown in
When the retainer assembly 410 is initially installed or implanted with fasteners 160 inserted into the fastener openings 448 and 474 of first and second retainer sections 414 and 416, respectively, and screwed into the sternum, the retainer assembly 410 has the shape and dimensions indicated in
In use, the orthopaedic fixation apparatus 400 is implanted to close a gap created in a patient's sternum when the sternum is surgically divided into a left sternum portion S1 and a right sternum portion S2 in order to gain access to an organ in the patient's chest cavity. As shown in
After the first and second retainer sections 414 and 416 are secured to the left sternum portion S1 and right sternum portion S2, respectively, using the first and second fasteners 160 and 162, respectively, the left and right sternum portions S1 and S2 and the implanted first and second retainer sections 414 and 416 may be moved together. This movement may be accomplished by applying force directed outwardly of the central opening 408 to the first and second laterally-extending walls 402 and 404 of the retainer assembly 410 with a tool, by applying force directed inwardly of the central opening 408 to the first and second retainer sections 414 and 416 with a tool, or by another other technique or combination of techniques, as deemed appropriate by, for example, the surgeon. The selected technique causes plastic deformation or distraction of the first and second laterally-extending walls 402 and 404 and effectively produces a bend at the compression zones or bend zones of the substantially straight, laterally-extending walls 402 and 404 so that each of the laterally-extending walls assumes a flattened V shape. As the deformation of the first and second laterally-extending walls 402 and 404 of the retainer assembly 410 is permanent, the first and second retainer sections 414 and 416 and the left and right portions S1 and S2 of the sternum are thus held, secured or locked in the desired position relative to one another.
Although the orthopaedic fixation apparatuses 10, 200, 300, and 400 are described above as being used to close a surgical incision in a patient’ sternum, the orthopaedic fixation apparatuses 10, 200, 300, and 400 may be used in other orthopaedic situations. For example, the orthopaedic fixation apparatuses 10, 200, 300, and 400 may be used to reduce and fix a fracture in a bone. The bone may be a rib, a radius, a calcaneus, a mandible, or any other bone, whether fractured or surgically incised. The orthopaedic fixation apparatuses 10, 200, 300, and 400 may also be used to reduce a gap between two adjacent bones that has been increased by injury or accident to a size in excess of a naturally occurring gap or that is excessive in size in comparison to a typical gap, as assessed from a medical standpoint.
The outer dimensions of the first and second retainer sections 14, 16, 214, 216, 414, and 416 may be selected as appropriate to address the length of the gap that is to be reduced and the width of the gap. For example, the retainer 12 (
Materials that can be used for the first and second retainer sections 14, 16, 214, 216, 414, and 416, the retention members 22, and the first and second fasteners 18, 20, 130, 132, 160, 162 include any material that is biocompatible and can withstand stresses that are imparted to the retainer sections, retention members, and fasteners during and after implantation in a patient. Suitable materials include but are not limited to, metals, for example, titanium and stainless steel, for example 316L stainless steel, and metal alloys. In addition, ceramics and polymers may also be used depending upon the particular component and the desired dimensions and properties, such as strength, rigidity, and biocompatibility, of the retainer sections, retention members, and/or fasteners. For example, the elongated flexible retention member 24 may be a braided stainless steel or braided polymer fiber. The polymer may be a thermoplastic or thermoset polymer. Suitable thermoplastic and thermoset materials that can be used for the elongated flexible retention member 24 or other components include, but are not limited to, polyester, polyetherimide, polycarbonate, polyamide, latex, silicone, polyurethane, polyolefin, polyvinyl chloride (PVC), ethylene vinyl acetate (EVA), ethylene methylacrylate (EMA), ethylene ethylacrylate (EEA), styrene butadiene styrene (SBS), and ethylene propylene diene rubber (EPDM), and blends and copolymers thereof. The first and second retainer sections 14, 16, 214, 216, 414, and 416 may be rigid or may have a limited degree of flexibility to fit the contour a patient's sternum. For example, first and second retainer sections 14, 16, 214, 216, 414, and 416 may be made thin using titanium to produce a streamlined yet rigid retainer section. As another alternative, the first and second retainer sections 14, 16, 214, 216, 414, and 416 may have curved posterior and/or anterior surfaces 42, 40, 68, 66, 242, 240, 270, 268, 442, 440, 470, and 478 to fit the contour a patient's sternum. In some circumstances, it may be desirable that certain of the first and second retainer sections 14, 16, 214, 216, 414, and 416, the retention members 22, and the first and second fasteners 18, 20, 130, 132, 160, 162 be made of a biodegradable material that dissolves within the body.
From the above description of the invention, those skilled in the art will perceive improvements, changes and modifications. Such improvements, changes, and/or modifications within the skill of the art are intended to be covered by the appended claims.
This application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/730,822, filed Nov. 28, 2012, the entirety of which is hereby incorporated by reference for all purposes.
Number | Date | Country | |
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61730822 | Nov 2012 | US |