Fracture fixation device
10743925 ยท 2020-08-18
Assignee
Inventors
- Kevin T. Stone (Winona Lake, IN, US)
- Brian K. Berelsman (Warsaw, IN, US)
- Ryan A. Kaiser (Leesburg, IN, US)
Cpc classification
A61B2017/0414
HUMAN NECESSITIES
A61B17/7001
HUMAN NECESSITIES
A61B17/0487
HUMAN NECESSITIES
A61B17/683
HUMAN NECESSITIES
A61B17/7053
HUMAN NECESSITIES
A61B2017/0445
HUMAN NECESSITIES
A61B17/809
HUMAN NECESSITIES
A61B2017/0424
HUMAN NECESSITIES
A61B2017/0422
HUMAN NECESSITIES
A61B17/0401
HUMAN NECESSITIES
International classification
Abstract
Assemblies for securing fractured bone are provided. The assembly includes a first fixation element, a second fixation element, and an adjustable flexible member construct. The first fixation element having a male or a female sleeve is secured within a first portion of the fractured bone. The second fixation element having the other of the male or female sleeve telescopically received within the one of the male or female sleeve is secured within a second portion of the fractured bone. The adjustable flexible member construct extends between the first and second fixation elements and has at least one adjustable loop coupled to the first fixation element and the second fixation element and a pair of adjusting ends extending through an opening in the first fixation element. The pair of adjusting ends can be pulled to reduce a diameter of the adjustable loop and to compress fragments of the fractured bone.
Claims
1. A bone compression assembly, comprising: a first fixation element securable in a first bone portion; a second fixation element securable in a second bone portion; and an adjustable suture construct extending between the first fixation element and the second fixation element, the adjustable suture construct including a suture with a free end that extends longitudinally through a longitudinal passage in the suture to form an adjustable loop, wherein the adjustable suture construct is coupled to the first fixation element and the second fixation element such that, with the free end extending longitudinally through the longitudinal passage in the suture to form the adjustable loop, the free end can be pulled through the longitudinal passage to decrease a size of the adjustable loop for pulling the first fixation element and the second fixation element toward one another, wherein the first fixation element and the second fixation element each include external threading and are matable together via a keyed arrangement between the first fixation element and the second fixation element such that the first fixation element and the second fixation element can be simultaneously rotationally driven through bone.
2. The bone compression assembly of claim 1, wherein the free end is a first free end, the longitudinal passage is a first longitudinal passage, and the adjustable loop is a first adjustable loop, the suture further including a second free end that extends longitudinally through a second longitudinal passage in the suture to form a second adjustable loop.
3. The bone compression assembly of claim 2, wherein, with the first free end extending longitudinally through the first longitudinal passage in the suture to form the first adjustable loop and with the second free end extending longitudinally through the second longitudinal passage in the suture to form the second adjustable loop, the first free end can be pulled through the first longitudinal passage to decrease the size of the first adjustable loop without decreasing a size of the second adjustable loop and the second free end can be pulled through the second longitudinal passage to decrease the size of the second adjustable loop without decreasing the size of the first adjustable loop.
4. The bone compression assembly of claim 2, wherein the first longitudinal passage is separate from the second longitudinal passage in the suture.
5. The bone compression assembly of claim 2, wherein the first free end extends into the suture through a first aperture in the suture, longitudinally within the suture along the first longitudinal passage, and out of the suture through a fourth aperture in the suture to form the first adjustable loop, and wherein the second free end extends into the suture through a second aperture in the suture, longitudinally within the suture along the second longitudinal passage, and out of the suture through a third aperture in the suture to form the second adjustable loop, the first aperture, the second aperture, the third aperture, and the fourth aperture all being separate apertures in the suture.
6. The bone compression assembly of claim 5, wherein, with the first free end extending into the suture through the first aperture in the suture, longitudinally within the suture along the first longitudinal passage, and out of the suture through the fourth aperture in the suture to form the first adjustable loop and with the second free end extending into the suture through the second aperture in the suture, longitudinally within the suture along the second longitudinal passage, and out of the suture through the third aperture in the suture to form the second adjustable loop, the first free end can be pulled through the first longitudinal passage to decrease a size of the first adjustable loop without decreasing a size of the second adjustable loop and the second free end can be pulled through the second longitudinal passage to decrease a size of the second adjustable loop without decreasing a size of the first adjustable loop.
7. The bone compression assembly of claim 1, wherein the first fixation element includes at least a first hole, a second hole, and a third hole with a summit of the adjustable suture construct passing through the first hole and the second hole and with the free end of the adjustable suture construct passing through the third hole.
8. A bone compression assembly, comprising: a first fixation element securable in a first bone portion; a second fixation element securable in a second bone portion; and an adjustable suture construct including a suture with a free end that extends longitudinally through a longitudinal passage in the suture to form an adjustable loop, wherein the first fixation element is coupled to the second fixation element with the adjustable suture construct such that, with the free end extending longitudinally through the longitudinal passage in the suture to form the adjustable loop, the free end can be pulled through the longitudinal passage to decrease a size of the adjustable loop for pulling the first fixation element and the second fixation element toward one another, the first fixation element including a first sleeve member through which the adjustable suture construct extends to couple the first fixation element to the second fixation element, the second fixation element including a second sleeve member through which the adjustable suture construct extends to couple the first fixation element to the second fixation element, the first sleeve member and the second sleeve member being matable together via a keyed arrangement between the first sleeve member and the second sleeve member such that the first fixation element and the second fixation element can be simultaneously rotationally driven through bone.
9. The bone compression assembly of claim 8, wherein the free end is a first free end, the longitudinal passage is a first longitudinal passage, and the adjustable loop is a first adjustable loop, the suture further including a second free end that extends longitudinally through a second longitudinal passage in the suture to form a second adjustable loop.
10. The bone compression assembly of claim 9, wherein, with the first free end extending longitudinally through the first longitudinal passage in the suture to form the first adjustable loop and with the second free end extending longitudinally through the second longitudinal passage in the suture to form the second adjustable loop, the first free end can be pulled through the first longitudinal passage to decrease the size of the first adjustable loop without decreasing a size of the second adjustable loop and the second free end can be pulled through the second longitudinal passage to decrease the size of the second adjustable loop without decreasing the size of the first adjustable loop.
11. The bone compression assembly of claim 9, wherein the first longitudinal passage is separate from the second longitudinal passage in the suture.
12. The bone compression assembly of claim 9, wherein the first free end extends into the suture through a first aperture in the suture, longitudinally within the suture along the first longitudinal passage, and out of the suture through a fourth aperture in the suture to form the first adjustable loop, and wherein the second free end extends into the suture through a second aperture in the suture, longitudinally within the suture along the second longitudinal passage, and out of the suture through a third aperture in the suture to form the second adjustable loop, the first aperture, the second aperture, the third aperture, and the fourth aperture all being separate apertures in the suture.
13. The bone compression assembly of claim 12, wherein, with the first free end extending into the suture through the first aperture in the suture, longitudinally within the suture along the first longitudinal passage, and out of the suture through the fourth aperture in the suture to form the first adjustable loop and with the second free end extending into the suture through the second aperture in the suture, longitudinally within the suture along the second longitudinal passage, and out of the suture through the third aperture in the suture to form the second adjustable loop, the first free end can be pulled through the first longitudinal passage to decrease a size of the first adjustable loop without decreasing a size of the second adjustable loop and the second free end can be pulled through the second longitudinal passage to decrease a size of the second adjustable loop without decreasing a size of the first adjustable loop.
14. The bone compression assembly of claim 8, wherein the first fixation element includes at least a first hole, a second hole, and a third hole with a summit of the adjustable suture construct passing through the first hole and the second hole and with the free end of the adjustable suture construct passing through the third hole.
15. The bone compression assembly of claim 8, wherein at least one of the first fixation element and the second fixation element includes external threading.
16. The bone compression assembly of claim 15, wherein the first fixation element and the second fixation element include external threading.
17. A bone compression assembly, comprising: a first fixation element that includes external threading, the first fixation element securable in a first bone portion; a second fixation element that includes external threading, the second fixation element securable in a second bone portion; and an adjustable suture construct extending between the first fixation element and the second fixation element, the adjustable suture construct including a suture with a free end that extends longitudinally through a longitudinal passage in the suture to form an adjustable loop, wherein the adjustable suture construct is coupled to the first fixation element and the second fixation element such that, with the free end extending longitudinally through the longitudinal passage in the suture to form the adjustable loop, the free end can be pulled through the longitudinal passage to decrease a size of the adjustable loop for pulling the first fixation element and the second fixation element toward one another, wherein the first fixation element includes at least a first hole, a second hole, and a third hole with a summit of the adjustable suture construct passing through the first hole and the second hole and with the free end of the adjustable suture construct passing through the third hole.
18. The bone compression assembly of claim 17, wherein the free end is a first free end, the longitudinal passage is a first longitudinal passage; and the adjustable loop is a first adjustable loop, the suture further including a second free end that extends longitudinally through a second longitudinal passage in the suture to form a second adjustable loop.
19. The bone compression assembly of claim 18, wherein the second free end passes through a fourth hole in the first fixation element.
20. The bone compression assembly of claim 18, wherein the first longitudinal passage is separate from the second longitudinal passage in the suture.
21. The bone compression assembly of claim 18, wherein the first free end extends into the suture through a first aperture in the suture, longitudinally within the suture along the first longitudinal passage, and out of the suture through a fourth aperture in the suture to form the first adjustable loop, and wherein the second free end extends into the suture through a second aperture in the suture, longitudinally within the suture along the second longitudinal passage, and out of the suture through a third aperture in the suture to form the second adjustable loop, the first aperture, the second aperture, the third aperture, and the fourth aperture all being separate apertures in the suture.
Description
DRAWINGS
(1) The drawings described herein are for illustration purposes only and are not intended to limit the scope of the present disclosure in any way.
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DETAILED DESCRIPTION
(20) The following description is merely exemplary in nature and is not intended to limit the present disclosure, application, or uses. It should be understood that throughout the drawings, corresponding reference numerals indicate like or corresponding parts and features. While the present disclosure relates to fracture fixation, the apparatus and methods of the present teachings can be used with other orthopedic and non-orthopedic procedures as well.
(21) Referring to
(22) In various embodiments, the assembly 10, assembly 110, 210 as detailed later herein, or the adjustable flexible member construct 14 alone is used to compresses the respective fragments together and to affect healing at the compromised bone 16. Bones suitable for use with the present teachings include any bone in the body, such as the vertebrae, long bones of the arms, legs or fingers; curved bones, such as the ribs; flat bones, such as those of the wrist or feet, for example, and the like. Any bones of the legs, arms, torso, hands, feet, head, are suitable for use with the apparatus and methods of the present teachings.
(23) Referring to
(24) The frame lower surface 20 can include a flat surface or the lower surface 20 can be curved to accommodate the contour of the bone 16. The upper surface 22 of the frame 12 partially defines the openings 26A and 26B for the flexible member holders 24A and 24B, respectively. The flexible member holders 24A and 24B can be channels, a post, a pin, a hole, or other means by which to retain a flexible member on the frame 12. It is understood that the flexible member holders 24A and 24B need not be formed on the upper surface 22 and that the flexible member holders 24A and 24B can extend from the lower surface 20 and around the upper surface 22. As shown in
(25) Any of the flexible member holders 24A-24D can be open such that the adjustable flexible member construct 14 can be repeatedly manually placed and removed, or the flexible member holders 24A-24D can be closed such that the adjustable flexible member construct 14 is permanently housed therein and cannot be inadvertently removed without disassembling the adjustable flexible member construct 14. The flexible member holders 24A-240 can be sized to allow the adjustable flexible member construct 14 to freely slide therein. The flexible member holders 24A-24D can be pre-formed to be closed or can be initially provided as an open and subsequently crimped or pinched closed.
(26) In various embodiments, the flexible member holders 24A and 24B face each other or are opposed. This allows for the adjustable flexible member construct 14 to be disposed in a first flexible member holder, for example flexible member holder 24B, wrapped around the bone 16, and then be disposed in the other flexible member holder, for example flexible member holder 24A, and tightened when the flexible member construct 14 is engaged such that opposing force is applied to the opposing flexible member holder to provide compression.
(27) As shown in
(28) Referring to
(29) To form the adjustable flexible member construct 14, a first end 36 of the flexible member is passed through a first aperture 38 and through a longitudinal passage 40 and out a second aperture 42. A second end 44 is passed through the second aperture 42, through the longitudinal passage 40 and out the first aperture 38. In various embodiments, the first and second apertures 38 and 42 are formed during the braiding process as loose portions between pairs of fibers defining the flexible member 34. Passing the ends 36 and 44 through the apertures 38 and 42 forms loops 46 and 46. The longitudinal and parallel placement and advancement of the first and second ends 36 and 44 of the flexible member 34 within the longitudinal passage 40 resists the reverse relative movement of the first and second portions 48 and 50 of the flexible member 34 once it is tightened. A further discussion of the flexible member construct is provided in U.S. patent Ser. No. 11/541,506 filed on Sep. 29, 2006 entitled Method And Apparatus For Forming A Self-Locking Adjustable Suture Loop assigned to Biomet Sports Medicine, Inc., and the disclosure is incorporated by reference.
(30) The loops 46 and 46 define mounts or summits 52 and 52 of the adjustable flexible member construct 14 and are disposed opposite from the longitudinal passage 40 such that when the summit 52 is disposed in a first flexible member holder 24A and the longitudinal passage 40 is disposed in a second flexible member holder 24B, the summit 52 and the longitudinal passage 40 remain stationary with respect to the frame 12, while the overall diameter of the adjustable flexible member construct 14 is decreased to compress the bone fragments 18 and 18.
(31) The tensioning of the ends 36 and 44 cause relative translation of the sides of the flexible member 34 with respect to each other. Upon applying tension to the first and second ends 36 and 44 of the flexible member 34, the size of the loop(s) 46 is reduced to a desired size or load. The flexible member 34 locks without knots due to the tensioning placed on the first and second ends 36 and 44. At this point, additional tension causes the body of the flexible member defining the longitudinal passage 40 to constrict about the portions 48 and 50 of the flexible members within the longitudinal passage 40. This constriction reduces the diameter of the longitudinal passage 40, thus forming a mechanical interface between the exterior surfaces of the first and second portions 48 and 50, as well as the interior surface of the longitudinal passage 40. This constriction causes the adjustable flexible member to automatically lock in a reduced or smaller diameter position.
(32) In use, the assembly 10 is formed by coupling the adjustable flexible member construct 14 to the frame 12. The lower surface 20 is placed such that it abuts the bone fragments 18 and 18. In embodiments where at least one flexible member holder 24A or 24B is closed, the summit 52 is placed in the open flexible member holder 24B opposite the longitudinal passage 40 disposed in the opposing closed flexible member holder 24A. The flexible member free ends 36 and 44 are engaged and pulled in the direction of the arrow shown in
(33) Turning to
(34) The assembly 110 includes a frame or fixation plate 112 and an adjustable flexible member construct 114. The frame 112 includes a lower surface 120, an upper surface 122, and at least one flexible member holder, depicted as a post 124, thereon about which the adjustable flexible member construct 114 can be secured.
(35) The post 124 sits proud to the upper surface 122 of the frame. The post 124 can be centered on the frame 112, or the post 124 can be placed at an off-center point on the frame 112. The post 124 can be generally smooth and cylindrical as shown in
(36) The frame 112 can have a flat profile or the frame 112 can have a slightly curved profile, such as those shown in
(37) In use, the lower surface of the frame 112 is placed against the bone fragments 18 and 18. Either of the summit 52 or the longitudinal passage 40 of the adjustable flexible member construct 14 is disposed about the post 124. The other of the summit 52 or the longitudinal passage 40 is partially circled about the bone 16 and is disposed on the opposite side of the post 124. In embodiments where the post 124 includes the notch 126, the adjustable flexible member construct 14 can be disposed in the notch 126 during the wrapping process. The ends 36 and 44 of the adjustable flexible member construct 14 are engaged to reduce the diameter of the adjustable flexible member construct 14 about the bone 16 and thereby compress the bone fragments 18 and 18.
(38) Turning to
(39) As shown in
(40) The upper fixation element 200 and lower fixation element 202 are shown in connection with the fixation plate 112 where the grommet 206 is disposed in the opening 130 in the fixation plate 112. It is understood that the plate 112 can be used with either of the upper fixation element 200 or the lower fixation element 202. When used with the grommet 206, however, a portion of the bone fragment 18 may be reamed so as to provide a countersink 222 for receipt of at least the loop portion 218. In particular, the countersink 222 may be sized so as to allow a top surface 224 of the grommet 206 to lie flush with a top surface 226 of the fixation plate 112 after tightening.
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(42) With specific reference to
(43) Turning to
(44) With reference now to
(45) It should be understood that sleeves 230, 236 may be either integrally formed or separately formed and later secured to the set screw head 216 or screw tip 212, respectively. It should also be understood that the male-female telescoping arrangement may be reversed so as to provide the male portion at the set screw head 216 and the female portion at the screw tip 212. Additionally, the set screw head 216 and screw tip 212 may each have an external screw thread wherein the outer thread diameters may be similar, as shown, or may be provided with different diameter profiles to accommodate a particular fracture zone (e.g., the outer diameter of the set screw head 216 may be greater than the outer diameter of the screw tip 212). With either outer diameter arrangement, the assembly 210 is fixed in the bone fragments 18 and 18 such that the upper fixation element 200 is secured within the bone fragment 18 and the lower fixation element 202 is secured within the bone fragment 18, as will be described in more detail below with respect to
(46) The adjustable flexible member construct 14 may extend between the upper and lower fixation elements 200, 202, as described above. In particular, the adjustable flexible member construct 14 may have the longitudinal passage 40 passing through the eyelet structure 228 of the screw tip 212, while at least the summits 52, 52 may pass through a central plate 234 in the set screw head 216. For example, the central plate 234 may have a plurality of apertures 238 for receiving at least the summits 52, 52 and ends 36, 44, as shown. For example, the ends 36, 44 may pass through a first pair of apertures 240, while the summits 52, 52 may pass through a second pair of apertures 242 in the set screw head 216, as shown in
(47) As previously described, the ends 36, 44 may be engaged and pulled in the upward/outward direction such that the diameter of the loop 46 is reduced and the bone fragments 18 and 18 are compressed. The ends 36, 44 may be tied so as to resist the reverse relative movement of the first and second portions 48 and 50 of the flexible member 34 once it is tightened. While the adjustable flexible member construct 14 is shown as described with reference to
(48) With reference now to
(49) The present teachings further provide methods for securing the fractured or weakened bone 16 within a patient's body. The frame 12 is abutted against the fractured or weakened bone 16 such that the lower surface 20 sits against the bone. The frame 12 can be positioned to span across both sides of the fracture. The summit 52 or the longitudinal passage 40 is disposed in one of the flexible member holders 24A or 24B defined by the frame 12. The fractured or weakened bone 16 is then encircled by partially wrapping the adjustable flexible member construct 14 at least partially contained in the frame about the bone. The other of the summit 52 or the longitudinal passage 40 is fixed in the second, opposing flexible member holder 24B. In embodiments where a plurality of frames 12 or the plurality of flexible member holders 24A-24D are provided on the frame 12, the process can be repeated by employing several adjustable flexible member constructs 14 in various sets of flexible member holders, for example the set 24A/24C and the set 24B/24D of
(50) The ends 36 and 44 of the adjustable flexible member construct 14 are engaged or pulled to reduce the size of the loop 46 and to cause the summit 52 and the longitudinal passage to press against the respective opposed flexible member holders. This compresses the bone fragments 18 and 18 at the compromised site. In embodiments where the frame 12 is made of a rigid material, engaging the free ends 36 and 44 does not cause the frame 12 to stretch, lengthen, or otherwise increase in size, thereby allowing for tighter compression. In embodiments utilizing fasteners 32 or 132, the fasteners can be secured to the bone fragments, 18 and 18 before or after the adjustable flexible member construct 14 is reduced about the bone 16. The flexible member constructs allow additional tensioning of each individual flexible member construct independently, so as to avoid any laxity that may occur to a flexible member construct as others are tightened.
(51) In still further embodiments such as those shown in
(52) With reference now to
(53) After removal of the aimer, a longitudinal bore 262 of a cannulated bone cutting tool (e.g., drill 264) may be placed over the guide wire 260 to guide the bone cutting tool 264 as it is brought into engagement with the fractured bone 16, as shown in
(54) With reference now to
(55) Referring now to
(56) The description of the invention is merely exemplary in nature and, thus, variations that do not depart from the gist of the invention are intended to be within the scope of the invention. For example, any of the above mentioned surgical procedures is applicable to the repair of other body portions. For example, the procedures can be equally applied to orthopedic repair of wrists, fingers, legs, ankles, and other bones and also to non-orthopedic repairs. Such variations are not to be regarded as a departure from the spirit and scope of the invention.