EXTERNAL FIXATOR SYSTEM
20170215923 · 2017-08-03
Inventors
- Manoj Kumar Singh (Mahwah, NJ, US)
- Yves Stephane Crozet (Ramsey, NJ, US)
- Vinzenz Andreas Burgherr (Bern, CH)
- Mark Thomas Dahl (Afton, MN, US)
Cpc classification
A61B17/66
HUMAN NECESSITIES
A61B17/62
HUMAN NECESSITIES
A61B17/6425
HUMAN NECESSITIES
International classification
A61B17/62
HUMAN NECESSITIES
A61B17/64
HUMAN NECESSITIES
Abstract
An external fixation frame for correcting a bone deformity includes a first fixation ring and a second fixation ring. A posterior adjustable length strut couples a posterior portion of the first fixation ring to a posterior portion of the second fixation ring and has universal joint. Medial and lateral adjustable length struts couples medial and lateral portions of the first fixation ring to medial and lateral portions of the second fixation ring respectively, each of the medial and lateral adjustable length struts including a constrained hinge joint. The fixation frame also includes a half ring hingedly coupled to the second fixation ring, and an anterior adjustable length strut coupling an anterior portion of the first fixation ring to the half ring.
Claims
1. (canceled)
2. An external fixation frame comprising: a top fixation ring; a U-shaped bottom fixation ring having an intermediate portion, a first elongate portion extending from the intermediate portion to a first free end portion, and a second elongate portion extending from the intermediate portion to a second free end portion; at least four struts coupling the top fixation ring to the bottom fixation ring, each strut including a threaded rod; a half ring having a first end portion and a second end portion connected by an arcuate portion; a first hinge member coupled to the first free end portion of the bottom fixation ring and extending away from a top surface of the bottom fixation ring, the first hinge member including a first aperture therethrough; a second hinge member coupled to the second free end portion of the bottom fixation ring and extending away from the top surface of the bottom fixation ring, the second hinge member including a second aperture therethrough; a first fastener coupling the first end portion of the half ring to the first hinge member, the first fastener extending through the first aperture of the first hinge member; and a second fastener coupling the second end portion of the half ring to the second hinge member, the second fastener extending through the second aperture of the second hinge member, wherein the half ring is rotatable about an axis defined by the first and second fasteners.
3. The external fixation frame of claim 2, wherein the first and second hinge members each extend orthogonally to the top surface of the bottom fixation ring.
4. The external fixation frame of claim 3, wherein the first and second fasteners each extend orthogonally to the first and second hinge members.
5. The external fixation frame of claim 2, wherein the axis defined by the first and second fasteners is positioned in a plane parallel to the top surface of the bottom fixation ring.
6. The external fixation frame of claim 2, further comprising: a third hinge member coupled to the first end portion of the half ring, the first fastener extending through a third aperture in the third hinge member; and a fourth hinge member coupled to the second end portion of the half ring, the second fastener extending through a fourth aperture in the fourth hinge member.
7. The external fixation frame of claim 2, wherein each of the at least four struts is an adjustable length telescopic strut that includes a cylindrical body portion coupled to the bottom fixation ring, the threaded rod coaxially received within the cylindrical body portion.
8. The external fixation frame of claim 2, further comprising: at least one bone fastener having a first end operably coupled to the first elongate portion of the bottom fixation ring and a second end operably coupled to the second elongate portion of the bottom fixation ring.
9. The external fixation frame of claim 2, further comprising a rocker member coupled to the bottom fixation ring and positioned distal to the bottom fixation ring.
10. The external fixation frame of claim 9, wherein the rocker member includes a textured bottom ground-contacting surface.
11. The external fixation frame of claim 9, wherein the rocker member includes a curved body portion with at least one connecting element projecting proximally from the curved body portion and configured to mate with an aperture in the bottom fixation ring in order to couple the rocker member to the bottom fixation ring.
12. The external fixation frame of claim 11, wherein the at least one connecting element comprises: a main body portion extending through an aperture in the curved body portion of the rocker member; and a distal flange extending distally of the main body portion, the distal flange configured to contact a corresponding shoulder portion of the aperture in the curved body portion.
13. The external fixation frame of claim 9, wherein the rocker member includes a first rocker portion coupled to the first elongate portion of the bottom fixation ring and a second rocker portion coupled to the second elongate portion of the bottom fixation ring.
14. The external fixation frame of claim 13, wherein the first and second rocker portions are each positioned a spaced distance in a distal direction from bottom surface of the bottom fixation ring.
15. An external fixation frame comprising: a top fixation ring; a U-shaped bottom fixation ring having an intermediate portion, a first elongate portion extending from the intermediate portion to a first free end portion, and a second elongate portion extending from the intermediate portion to a second free end portion; at least four struts coupling the top fixation ring to the bottom fixation ring, each strut including a threaded rod; a half ring having a first end portion and a second end portion connected by an arcuate portion; a first hinge member coupled to the first free end portion of the bottom fixation ring and extending orthogonal to and away from a top surface of the bottom fixation ring, the first hinge member including a first aperture therethrough; a second hinge member coupled to the second free end portion of the bottom fixation ring and extending orthogonal to and away from the top surface of the bottom fixation ring, the second hinge member including a second aperture therethrough; a first fastener coupling the first end portion of the half ring to the first hinge member, the first fastener extending through the first aperture of the first hinge member and extending orthogonally to the first hinge member; and a second fastener coupling the second end portion of the half ring to the second hinge member, the second fastener extending through the second aperture of the second hinge member and extending orthogonally to the second hinge member, wherein the half ring is rotatable about an axis defined by the first and second fasteners, the axis being positioned in a plane parallel to the top surface of the bottom fixation ring.
16. The external fixation frame of claim 15, wherein each of the at least four struts is an adjustable length telescopic strut that includes a cylindrical body portion coupled to the bottom fixation ring, the threaded rod coaxially received within the cylindrical body portion.
17. The external fixation frame of claim 15, further comprising a rocker member coupled to the bottom fixation ring and positioned distal to the bottom fixation ring.
18. The external fixation frame of claim 17, wherein the rocker member includes a textured bottom ground-contacting surface.
19. The external fixation frame of claim 17, wherein the rocker member includes a first rocker portion coupled to the first elongate portion of the bottom fixation ring and a second rocker portion coupled to the second elongate portion of the bottom fixation ring.
20. The external fixation frame of claim 19, wherein the first and second rocker portions are each positioned a spaced distance in a distal direction from bottom surface of the bottom fixation ring.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] Preferred embodiments of the invention are described in the following with reference to the drawings, which are for the purpose of illustrating the present preferred embodiments of the invention and not for the purpose of limiting the same.
[0013] A more complete appreciation of the subject matter of the present invention and the various advantages thereof can be realized by reference to the following detailed description in which reference is made to the accompanying drawings in which:
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DETAILED DESCRIPTION
[0040] As used herein, the term “proximal” means a direction closer to the heart of a patient and the term “distal” means a direction farther away from the heart of a patient. The term “anterior” means towards the front part of the body or the face and the term “posterior” means towards the back of the body. The term “medial” means toward the midline of the body and the term “lateral” means away from the midline of the body.
[0041] Referring to
[0042]
[0043] In the present embodiment there is an upper fixation plate 1 in connection with the lower leg L and a lower fixation plate 2 in connection with the foot F. The lower fixation plate 2 comprises also a rolling structure 20 to enable a user to walk around.
[0044] Adjustable length struts 3 each include a length adjusting mechanism 32 having a threaded strut 33 and a non-rotating strut 34 having an internal thread along at least a portion of a length thereof in which the threaded strut 33 engages. Struts 3 include a first end region 30 and a second end region 31 in which the struts 3 are coupled to the respective fixation plates. In the present embodiment the struts 3 are connected to the upper fixation plate 1 by means of an actuation unit 4 and to the lower fixation plate 2 by means of a clamping element 4′. It is also possible to use an actuation unit 4 to connect the strut 3 to the upper fixation plate 1 as well as to the lower fixation plate 2. The actuation unit 4 is preferably provided to actuate the length-adjusting strut in order to adjust its length.
[0045] The actuation unit 4 is preferably in a fixed connection with fixation plates 1, 2 as shown in
[0046]
[0047] The outer sleeve 5 extends along a middle axis M as shown in
[0048] In
[0049] When the outer sleeve 5 is inserted into the opening 10 the shoulder 11 is preferably in contact with flange 55. The shaft section 54 of the outer sleeve 5 extends through the first section 13 of the opening 10 and the bearing section 52 extends into the section 14. The outer sleeve 5 is fixed to the fixation plate 1, 2 by means of nut 56 which retracts the outer sleeve 55 relative to fixation plate 1, 2 such that flange 55 comes in contact with the shoulder 11.
[0050] From
[0051] The actuation element 6 of actuation unit 4 preferably extends along the middle axis M and comprises mainly a shaft section 60 which extends through the opening 50 of the outer sleeve and a connection section 61 which is in connection with strut 3. The actuation element 6 can be actuated, i.e. rotated, by means of a tool 67 shown in
[0052] The actuation element 6 is borne by means of a ball bearing 9 in the outer sleeve 5. In the present embodiment, the ball bearing 9 is provided by means of the shaft section 61 and the bearing section 52. A separate ball bearing is also possible, but a ball bearing which is provided according to the embodiment of
[0053] As shown in
[0054] Between the outer sleeve 5 and the actuation element 6 there is arranged a feedback unit 7 as shown in
[0055] There are a plurality of chambers 71 arranged which are preferably distributed evenly around the perimeter of the through opening 50 of the outer sleeve 5. In the present embodiment, eight chambers 71 are arranged such that each chamber is located approximately 45° from a neighboring chamber, but it is also possible to arrange more or less than eight chambers. The number of chambers preferably depends on the application. Preferably, each time the actuation element is rotated such that the spring-loaded ball moves from one chamber 71 and into a neighboring chamber 71, adjustable length strut is lengthened 1 mm. Each time the actuation element is rotated such that the spring-loaded ball moves from one chamber 71 and into a neighboring chamber 71, adjustable length strut may be lengthened between 0.1 mm to 1 mm.
[0056] It is important for the adjustable length strut to not be lengthened so easily or inadvertently such that accidental injury may be caused. Osteogenesis generally occurs over a considerable length of time and lengthening and/or angulation adjustment between adjacent bone fragments should only be done in a prescribed manner. Therefore, chambers 71 are preferably deep enough to securedly house at least a portion of the spring loaded ball 70 and a spring constant k of the spring is sufficient enough to force the ball against side walls in the respective chambers such that preferably only intended actuation of the actuation unit causes the actuation unit to actuate.
[0057] With regard to the embodiment as shown in
[0058] The strut 3 with its end region is in a fixed connection with the actuation element 6. In the present embodiment, there is a Cardan (universal) joint 62 arranged between the strut 3 and the actuation element 6 in order to compensate angular differences between the strut 3 and the actuation element 6. Furthermore the actuation element 6 comprises an opening 63 in which the strut 3 extends as shown in
[0059] Upon rotation of the actuation element 6, the strut will also be rotated and its length will be adjusted according to the degree of rotation. The feedback unit 7 then provides the user with an acoustic as well as with a haptic feedback due to its mechanical structure as outlined above.
[0060] Upon rotation of the actuation element 6, the strut will also be rotated and its length will be adjusted according to the degree of rotation. The feedback unit 7 then provides the user with an acoustic as well as with a haptic feedback due to its mechanical structure as outlined above.
[0061] The arrangement of the feedback unit 7 as mentioned herein has the advantage that in terms of dimension a very compact structure can be achieved. Thereby the overall weight can be significantly reduced and it is preferably more convenient for the patient to use such a structure.
[0062] As shown in
[0063]
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[0065] As illustrated in
[0066] The half-ring 113 is best illustrated in
[0067] The half-ring 113 may also include hinges 1320 at the ends of the main portion 1300. The hinges 1320 may include a first hinge portion 1322 and a second hinge portion 1324. The first hinge portion 1322 may be coupled to the half-ring 113, for example by an adhesive, or may alternately be integral with the half-ring. As illustrated in
[0068] The first hinge portion 1322 may also include a textured surface and an aperture to accept a fastener. The aperture preferably is unthreaded. The fastener may be, for example, a screw 1326 with a first portion of the screw shaft unthreaded and a second portion of the screw shaft threaded. The second hinge portion 1324 may be of a generally similar structure to the first hinge portion 1322, having a textured surface and an aperture to accept a fastener. Preferably, the aperture is internally threaded.
[0069] The second hinge portion 1324 may also include a connecting portion 1325. The connecting portion 1325 may, for example, be cylindrical and configured to pass through an aperture 10 in the bottom fixation ring 2. The connecting portion 1325 may also be threaded to mate with a locking nut or other fastener to secure the second hinge portion 1324 in a fixed relation to the bottom fixation ring 2.
[0070] The screw 1326 may be inserted through the unthreaded aperture in the first hinge portion. Preferably the unthreaded aperture is large enough that the shaft of the screw 1326 can move freely through the aperture. The threaded portion of the screw 1326 is then inserted through the threaded aperture in the second hinge portion 1324. The threaded aperture is preferably dimensioned such that the screw 1326 must be rotated to pass through the threaded aperture. As the screw 1326 is rotated, the second hinge portion 1324 is drawn toward the first hinge portion 1322. When fully inserted, the unthreaded portion of the screw 1326 generally is located at the unthreaded aperture of the first hinge portion 1322 and the threaded portion of the screw is engaged with the threaded aperture of the second hinge portion 1324. In this position, the first hinge portion 1322 and second hinge portion 1324 are frictionally engaged such that rotation of the first hinge portion relative to the second hinge portion about the screw 1326 is resisted. In the embodiment in which one or both of the hinge portions 1322, 1324 include textured surfaces, such as ridges, the engagement of the textured surfaces may provide additional resistance against rotation. A nut may also be threaded onto any portion of the screw 1326 that extends beyond the aperture in the second hinge portion 1324 to help prevent unintentional rotation of the screw 1326 when in the fully threaded, locked position.
[0071] The bottom fixation ring 102 is illustrated in
[0072] Rolling structure, or rocker 120, is illustrated in
[0073] The main body 1200 of the rocker 120 may include one or more connecting pins 1205 (three connecting pins illustrated in
[0074] Although only one rocker 120 is illustrated in
[0075] As discussed above, multiple struts may be used to connect components of the fixation system and to allow for various types of movement and positioning between the components. In the illustrated embodiment, at least three different types of struts are used, including universal hinge struts 103a, constrained hinge struts 103b and half-ring struts 103c.
[0076] Now referring to
[0077] The actuation unit 104a may be substantially similar to the actuation unit 4 described above, including a ball and spring mechanism to provide auditory and/or tactile feedback. In the illustrated embodiment, universal hinge strut 103a includes a universal joint 162a near the connecting element 104a′. This is in contrast to the strut 3 described above, in which the universal joint 62 is positioned closer to the actuation element 4. The internal mechanisms described with relation to strut 3, however, generally apply with equal force to the universal hinge strut 103a. The universal hinge strut 103a may also include a quick-release mechanism 135a. Generally, the quick-release mechanism 135a has a locked position and an unlocked position. In the locked position, the threaded strut 133a can move into or out of the non-rotating strut 134a only by rotation of the threaded strut into the non-rotating strut. In the unlocked position, the threaded strut 133a may be moved into or out of the non-rotating strut 134a without rotation of the threaded strut, such that a user may quickly move the threaded strut into the non-rotating strut. This mechanism is more fully described in U.S. patent application Ser. No. 13/592,832, titled “Bone Transport External Fixation Frame.”
[0078] Now referring to
[0079] The actuation unit 104b may be substantially similar to the actuation unit 4 described above, including a ball and spring mechanism to provide auditory and/or tactile feedback. In the illustrated embodiment, constrained hinge strut 103b includes a constrained joint 168b near the connecting element 104b′. The constrained hinge strut 103b may also include a quick-release mechanism 135b.
[0080] Constrained hinge joint 168 is shown in more detail in
[0081] The first hinge portion 1422 may also include a textured surface and an aperture to accept a fastener. The aperture preferably is unthreaded. The fastener may be, for example, a screw 1426 with a first portion of the screw shaft unthreaded and a second portion of the screw shaft threaded. The second hinge portion 1424 may be of a generally similar structure to the first hinge portion 1422, having a textured surface and an aperture to accept a fastener. Preferably, the aperture is internally threaded.
[0082] The screw 1426 may be inserted through the unthreaded aperture in the first hinge portion. Preferably the unthreaded aperture is large enough that the shaft of the screw 1426 can move freely through the aperture. The threaded portion of the screw 1426 is then inserted through the threaded aperture in the second hinge portion 1424. The threaded aperture is preferably dimensioned such that the screw 1426 must be rotated to pass through the threaded aperture. As the screw 1426 is rotated, the second hinge portion 1424 is drawn toward the first hinge portion 1422. When fully inserted, the unthreaded portion of the screw 1426 generally is located at the unthreaded aperture of the first hinge portion 1422 and the threaded portion of the screw is engaged with the threaded aperture of the second hinge portion 1424. In this position, the first hinge portion 1422 and second hinge portion 1424 are frictionally engaged such that rotation of the first hinge portion relative to the second hinge portion about the screw 1426 is resisted. In the embodiment in which one or both of the hinge portions 1422, 1424 include textured surfaces, such as ridges, the engagement of the textured surfaces may provide additional resistance against rotation. A nut may also be threaded onto any portion of the screw 1426 that extends beyond the aperture in the second hinge portion 1424 to help prevent unintentional rotation of the screw 1426 when in the fully threaded, locked position.
[0083] The constrained hinge strut 103b may also include an aperture 169b. The aperture 169b accepts a K-wire or other bone fastener that travels into the bone. The connection of the K-wire with the bone and the aperture 169b of the constrained hinge strut 103b lines the axis of the constrained hinge joint 168b with the anatomic joint axis.
[0084] Now referring back to
[0085] Now referring to
[0086] Half-ring strut 103c includes a length adjusting mechanism having a threaded strut 133c and a non-rotating strut 134c having an internal thread along at least a portion of a length thereof in which the threaded strut 133c engages. Half-ring strut 103c may be connected to the upper fixation plate 101 by means of an actuation unit 104c and to the half-ring 113 by means of a connecting element 104c′. The actuation unit 104c is preferably provided to actuate the length-adjusting strut in order to adjust its length.
[0087] The actuation unit 104c may be substantially similar to the actuation unit 4 described above, including a ball and spring mechanism to provide auditory and/or tactile feedback. In the illustrated embodiment, half-ring strut 103c includes a constrained 168c near the connecting element 104c′ and a universal joint 162c near the actuation unit 104c. The half-ring strut 103c may also include a quick-release mechanism 135c.
[0088] A similar embodiment of half-ring strut 103c is illustrated in
[0089]
[0090] In one embodiment of the fixation device, one universal hinge strut 103a fixes the top fixation plate 101 to the bottom fixation plate 102 at a posterior side of the device. Two constrained hinge joints 103b fix the top fixation plate 101 to the bottom fixation plate 102 at the medial and lateral sides of the device. A half-ring 113 is fixed at the anterior end of the bottom fixation plate 102, and a half-ring strut 103c fixes the half-ring 113 to an anterior portion of the top fixation plate 101. Each of the struts 103a-c may be increased or decreased in length as described above. The universal hinge strut 103a allows for top fixation ring 101 to move relative to the bottom fixation ring 102 with rotation about three axes. The constrained hinge strut 103b allows for the top fixation ring 101 to move relative to the bottom fixation ring 102 with rotation about a single axis. The half-ring 113 is constrained to rotation about one axis of rotation due to the hinges 1320 connecting the half-ring to the bottom fixation ring 102. The axis about which the half-ring rotates may be an axis that extends through the center of hinges 1320. The half-ring strut 103c allows the top fixation ring 101 to be rotated about three axes with respect to the half-ring 113, due to the universal joint 168c of the half-ring strut. This configuration allows the half-ring 113 to be assembled in multiple locations and positions on the distal portion of the foot ring, the half-ring having a lockable hinge. The combination of the features above allows for increased control of the foot and ankle in order to properly return it to an anatomic and functional position. The device also limits and/or avoids the possibility of changing of motor struts during treatment. In addition, the half-ring 113 provides added strength to the frame itself, as described above, by bridging the two free ends of the bottom fixation ring 102.
[0091] Now referring to
[0092] The bottom fixation ring 102 may also include one or more foot compression modules 200, as illustrated in
[0093] Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims. For examples, components of one embodiment described herein may be combined with components of another embodiment described herein without departing from the scope of the invention.