Mesoconus suture button
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- ACUMED
- Filing Date
- 2021-09-08
- Publication Date
- 2026-05-26
Smart Images
Figure 0007865949000001 
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Abstract
Description
Technical Field
[0001] Claims of Priority This application claims the priority and the benefit of U.S. Application No. 17 / 016,807, filed on September 10, 2020. The entire disclosure of this U.S. application is incorporated herein by reference.
[0002] This application generally relates to surgical techniques for holding two bones together. In particular, the present application provides a suture button that enables a surgeon or any other appropriate healthcare provider to more easily and effectively perform suture button techniques, such as for repairing ligamentous injuries of the ankle.
Background Art
[0003] In various cases, a patient may suffer an injury that requires fixing a first bone, i.e., the proximal bone, to a second bone, i.e., the distal bone, to assist in the patient's recovery from the injury. An injury to the ankle joint can be one such type of injury. The ankle joint is composed of two bones, the tibia and the fibula, and is held together by the distal tibiofibular ligamentous connection. In some cases, for example, after an ankle injury, the ligamentous connection may be torn, leaving a gap between the tibia and the fibula. If it is found to be torn or unstable, it is necessary to repair the ligament injury in order to prevent ankle instability and subsequently reduce the risk of developing osteoarthritis of the ankle joint.
[0004] One method of fixing the proximal bone to the distal bone is suture button technology. Suture button technology involves deploying a bone fixation structure that includes a first button coupled to a second button by a suture. The suture can be tensioned to fix the proximal bone to the distal bone. For example, to repair a ligament injury, suture button technology involves two buttons that hold the fibula (e.g., the proximal bone) and the tibia (e.g., the distal bone) together, and a suture that connects the two buttons through perforated bone holes in the fibula and the tibia. The buttons are typically positioned in place using a needle and pull-through suture or a button insertion instrument.
[0005] However, the buttons commonly used in suture buttoning techniques have several drawbacks. The suture must be secured using a button that applies pressure to the mesial bone, while also allowing tension to be applied to the ends of the suture to increase the tension between the mesial and distal bone buttons. As tension is applied to the suture, it inevitably moves, or slides, between the two buttons. However, common mesial bone buttons can sometimes be configured in a way that creates unintended friction between the button and the suture. For example, a common mesial bone button may have multiple individual openings used for different parts of the suture, i.e., both ends. These individual openings can restrict the movement of the suture, potentially causing friction. In other cases, a common mesial bone button may have suture openings of a size that similarly restricts the suture and causes friction. Excessive friction can cause the suture to break, potentially requiring the surgeon to redo the procedure or leading to the suture's function deteriorating before the patient has fully recovered. Unintended levels of friction can also make the procedure more difficult for the surgeon. For example, the suture may catch on the edge while the surgeon is applying tension to it.
[0006] In addition to the above, conventional mesial buttons may extend unintended from the mesium after installation. This may increase patient discomfort compared to when the height of the mesial button is more closely aligned with the height of the mesium.
[0007] Buttons used to apply pressure to the lateral bone may need to be adjusted after being inserted through a bone hole to prevent them from returning through the bone hole. Adjusting a lateral bone button may require unfolding the button from the button insertion device, which changes its orientation. However, generally, such unfolding may require forcibly separating the lateral bone button from the insertion device to give it enough space to change its orientation. In some cases, such as when the lateral bone button is pressed by tissue (e.g., skin) and hinders its orientation during the change, the required amount of space may make it difficult to unfold the lateral bone button easily and effectively.
[0008] In addition to the above, the lateral bone button is used to attach the suture that connects the lateral bone button to the mesial bone button. As tension is applied to the suture to set the lateral bone button and mesial bone button, the suture will inevitably move relative to the lateral bone button. A typical lateral bone button may cause friction between the lateral bone button and the suture that is greater than desired. For example, many typical lateral bone buttons include at least two holes through which the suture passes and moves, and friction occurs between each hole and the suture. With such a typical configuration having at least two holes, the suture may wrap around or twist itself when it is loaded into or unloaded from the button insertion device.
[0009] Therefore, a button that addresses the above-mentioned shortcomings is desired. In addition, a button that addresses the above-mentioned shortcomings is desired. [Overview of the Initiative]
[0010] The suture buttons, systems, and methods disclosed herein relate generally to surgical techniques for holding two bones together. In particular, suture buttons are disclosed that enable surgeons and all other appropriate healthcare providers to more easily and effectively perform suture button techniques, such as for repairing ligamentous joint injuries of the ankle. A first suture button is disclosed, configured to contact the nearest bone (e.g., the fibula) as part of a suture button technique to fix a mesial bone to a distal bone. A second suture button is disclosed, configured to contact the furthest bone (e.g., the tibia) as part of a suture button technique to fix a mesial bone to a distal bone. When a surgeon performs a suture button technique to repair a ligamentous joint injury, they can use the first suture button and the second suture button provided. Alternatively, the surgeon may use the first suture button provided with another appropriate suture button or anchor, or the second suture button provided with another appropriate suture button or anchor.
[0011] Throughout this disclosure, the first suture button will be referred to as the fibular button and the second suture button as the tibial button, but it will be obvious that the first suture button and the second suture button provided may be used to fix together multiple bones other than the fibula and tibia.
[0012] In view of the technical features described herein, and in combination with any other embodiments unless otherwise specified, a first embodiment of the disclosure of this application, a suture button assisting in the fixation of two bones includes, but is not limited to, a head and a pulley peg. The head of the suture button includes an upper surface, a lower surface, and a first opening extending through the head from the upper surface to the lower surface. The pulley peg extends from a first end to a second end. Each end of the pulley peg is connected to or integrated with the lower surface of the head so as to form a second opening between the pulley peg and the lower surface of the head.
[0013] In a second aspect of the disclosure of this application, which can be combined with any other aspect (e.g., the first aspect) unless otherwise specified, the cross-section of the first opening is circular.
[0014] In a third aspect of the disclosure of this application, which can be combined with any other aspect (e.g., the first aspect) unless otherwise specified, the cross-section of the first opening is tablet-shaped.
[0015] In a fourth aspect of the disclosure of this application, which can be combined with any other aspect (e.g., the first and third aspects) unless otherwise specified, the tablet-shaped cross section of the first opening has a first length that is longer than the second length, and the plane extending through the first and second ends of the pulley peg is substantially perpendicular to the first length.
[0016] In a fifth aspect of the disclosure of this application, which can be combined with any other aspect (e.g., the first to fourth aspects) unless otherwise specified, the top surface includes a chamfered surface leading to the first opening.
[0017] In a sixth aspect of the disclosure of this application, which can be combined with any other aspect (e.g., the first to fifth aspects) unless otherwise specified, the lower surface includes a chamfered surface leading to the first opening.
[0018] In a seventh aspect of the disclosure of this application, which can be combined with any other aspect (e.g., the first to sixth aspects) unless otherwise specified, the pulley peg includes at least one flat surface near each of the first and second ends.
[0019] In an eighth aspect of the disclosure of this application, which can be combined with any other aspect (e.g., the first to seventh aspects) unless otherwise specified, the first and second ends of the pulley peg closest to the first opening are rounded.
[0020] In the ninth aspect of the disclosure of this application, which can be combined with any other aspect (e.g., aspects 1 through 8) unless otherwise specified, the pulley peg is a single, seamless member.
[0021] In a tenth aspect of the disclosure of this application, which can be combined with any other aspect (for example, aspects 1 to 9) unless otherwise specified, the portion of the pulley peg furthest from the bottom surface is rounded.
[0022] In an eleventh aspect of the disclosure of this application, which can be combined with any other aspect (e.g., aspects 1 to 10) unless otherwise specified, the system includes a first suture button or anchor, a second suture button connected to the first suture button or anchor by suture thread, and a button inserter for deploying the first suture button or anchor and the second suture button. The second suture button includes a head and a pulley peg. The head has an upper surface, a lower surface, and a first opening extending through the head from the upper surface to the lower surface. The pulley peg extends from a first end to a second end, with each of the first and second ends connected to the lower surface of the head to form a second opening between the pulley peg and the lower surface of the head. The central portion of the suture is passed through the second opening and positioned, and each end of the suture is passed through the first opening and positioned, and tension is applied to the ends of the suture, thereby creating tension between the first suture button or anchor and the second suture button after deployment from the button insertion device.
[0023] In a twelfth aspect of the disclosure of this application, which can be combined with any other aspect (e.g., the eleventh aspect) unless otherwise specified, the suture comprises one suture strand.
[0024] In a thirteenth aspect of the disclosure of this application, which can be combined with any other aspect (e.g., the eleventh aspect) unless otherwise specified, the suture comprises a plurality of suture strands.
[0025] In a 14th aspect of the disclosure of the present application that can be combined with any other optional aspect (e.g., aspects 11 to 13) unless otherwise specified, the suture includes an adjustable loop or a non-adjustable loop.
[0026] In a 15th aspect of the disclosure of the present application that can be combined with any other optional aspect (e.g., aspects 1 to 14) unless otherwise specified, the size of the first opening is set such that a plurality of strands of the suture passing through the first opening can enter.
[0027] In a 16th aspect of the disclosure of the present application that can be combined with any other optional aspect (e.g., aspects 1 to 15) unless otherwise specified, the pulley peg has a first width between the first and second ends of the pulley peg, and the head has a second width that exceeds the first width.
[0028] In a 17th aspect of the disclosure of the present application that can be combined with any other optional aspect (e.g., aspects 1 to 16) unless otherwise specified, the innermost part of the pulley peg and the inner part of the head forming the first opening share a continuous surface.
[0029] In an 18th aspect of the disclosure of the present application, which can be combined with any other optional aspect (e.g., aspects 1 to 17) unless otherwise specified, a method of fixing two bones to each other includes forming a bone hole penetrating through the first bone and the second bone, and inserting a first suture button or anchor through the bone hole by a button insertion instrument, the insertion being such that the first suture button or anchor exits from the other side of the bone hole. The first suture button or anchor is connected to the pulley peg of the second suture button by a suture thread. The second suture button includes a head and a pulley peg. The head has an upper surface, a lower surface, and a first opening extending through the head from the upper surface to the lower surface. The pulley peg extends from a first end to a second end, and each of the first and second ends is connected to or integrated with the lower surface of the head so as to form a second opening between the pulley peg and the lower surface of the head. The central portion of the suture thread is passed through and disposed in the second opening, and the end portions of the suture thread are passed through and disposed in the first opening. The method may further include the step of deploying the first suture button or anchor and the second suture button from the button insertion instrument. Tension may be applied to the end portions of the suture thread such that the first suture button or anchor abuts against the second bone and the second suture button abuts against the first bone. Thereafter, the suture thread may be fixed.
[0030] In a 19th aspect of the disclosure of the present application, which can be combined with any other optional aspect (e.g., the 18th aspect) unless otherwise specified, the pulley peg is disposed within the bone hole after tension is applied to the end portions of the suture thread.
[0031] In a 20th aspect of the disclosure of the present application, which can be combined with any other optional aspect (e.g., the 18th and 19th aspects) unless otherwise specified, the tensioned and fixed suture thread is completely within the bone hole.
[0032] Additional features and advantages of the disclosed methods and apparatus will be described in the following detailed description and figures and will be apparent therefrom. The features and advantages described herein are not exhaustive, and many additional features and advantages will be apparent to those skilled in the art in consideration of the figures and description. Furthermore, it should be noted that the language used herein has been chosen primarily for readability and explanatory purposes and does not limit the scope of the subject matter of the invention. [Brief explanation of the drawing]
[0033] [Figure 1A] A perspective view of a fibular button having a head with a circular opening, according to one aspect of the present disclosure, is shown. [Figure 1B] A perspective view of a fibular button having a head with a circular opening, according to one aspect of the present disclosure, is shown.
[0034] [Figure 1C] A perspective view of a fibular button having a pulley peg with a rounded end, according to one aspect of the present disclosure, is shown.
[0035] [Figure 1D] The image shows a perspective view of a fibular button according to one aspect of the present disclosure, having a head, wherein a chamfered surface on the upper surface of the head connects to an opening in the head.
[0036] [Figure 1E] The image shows a perspective view of a fibular button according to one aspect of the present disclosure, having a head, wherein a chamfered surface on the underside of the head connects to an opening in the head.
[0037] [Figure 2A] The image shows a cross-sectional side view of a fibular button having a rounded pulley peg according to one aspect of the present disclosure. [Figure 2B] The image shows a cross-sectional side view of a fibular button having a rounded pulley peg according to one aspect of the present disclosure.
[0038] [Figure 2C] The image shows a cross-sectional side view of a fibular button having a pulley peg without a rounded edge, according to one aspect of the present disclosure.
[0039] [Figure 3A] A perspective view of a tibial button according to one aspect of this disclosure is shown. [Figure 3B] A top view of a tibial button according to one aspect of this disclosure is shown.
[0040] [Figure 3C] A side view of a tibial button having an angled insertion end according to one aspect of the present disclosure is shown. [Figure 3D] A side view of a tibial button having an insertion end with a different angle, according to one aspect of the present disclosure, is shown.
[0041] [Figure 3E] The image shows a side view of a tibial button having an off-center opening according to one aspect of the present disclosure.
[0042] [Figure 4A] A side view is shown of an example of a system including a button insertion device, a suture button, and sutures, relating to one aspect of the present disclosure. [Figure 4B] A side view of another example of a system including a button insertion device, a suture button, and sutures relating to one aspect of the present disclosure is shown.
[0043] [Figure 5A] A partial top view of an example of a button insertion device in which a fibular button is loaded, relating to one aspect of this disclosure, is shown.
[0044] [Figure 5B] This shows a cross-sectional front view of an example of the insertion tip of a button insertion device according to one aspect of the present disclosure.
[0045] [Figure 6A]This shows a perspective lateral view of a tibial button loaded onto the insertion tip of a button insertion device according to one aspect of the present disclosure. [Figure 6B] This shows a perspective lateral view of a tibial button loaded onto the insertion tip of a button insertion device according to one aspect of the present disclosure.
[0046] [Figure 6C] Figure 6B shows a perspective side view of the button insertion device of the tibial button, according to one aspect of the present disclosure. [Figure 6D] Figure 6B shows a perspective side view of the button insertion device of the tibial button, according to one aspect of the present disclosure.
[0047] [Figure 7] One aspect of the present disclosure shows a button insertion device in which a fibular button and a tibial button are loaded and positioned through a bone hole to advance the tibial button to the other side of the bone hole.
[0048] [Figure 8] An embodiment of this disclosure shows a set fibular button and a tibial button that fix two bones together. [Modes for carrying out the invention]
[0049] The suture buttons, systems, and methods disclosed herein relate generally to surgical techniques for holding two bones together. In particular, suture buttons are disclosed that enable surgeons and all other appropriate healthcare providers to perform suture button techniques more easily and effectively, such as for repairing ligamentous joint injuries of the ankle. In one example, a button insertion device can be used by the surgeon to deploy the button. In such an example, the first suture button disclosed herein is configured to abut against the proximal bone as part of a bone fixation structure. The second suture button disclosed herein is configured to be fed through bone holes formed in the proximal and distal bones and then abut against the distal bone as part of a bone fixation structure. Throughout this disclosure, the first suture button is referred to as the fibular button and the second suture button as the tibial button, but it is naturally understood that the first suture button and the second suture button provided may be used to fix together any two bones other than the fibula and tibia.
[0050] When a surgeon performs the suture buttoning technique to repair ligamentous joint damage, etc., the provided fibular button and the provided tibial button can be used. Alternatively, the surgeon may use the provided fibular button with another suitable suture button or anchor, or the provided tibial button with another suitable suture button or anchor.
[0051] In some cases, using the provided fibular button configuration, the provided fibular button includes a wide space through which the suture can pass without contacting the metal part of the fibular button, thereby reducing friction between the fibular button and the suture during installation compared to a typical mesoconus button. The provided fibular button may include a head and a pulley peg extending from the head. The head includes one opening, and the space between the pulley peg and the head is a second opening. The size of each opening is set so that multiple strands of suture can move freely through the opening. The suture can move more freely through the larger space, which reduces friction between parts of the suture and friction between the suture and the fibular button. The provided fibular button may further include various curved, smooth, or chamfered surfaces to further reduce friction.
[0052] In some cases, the size of the fibular button pulley peg is set so that the pulley peg can be inserted into a bone hole. Inserting the pulley peg into a bone hole is useful for more secure locking of the fibular button in place than if it were simply placed on the bone surface. Also, inserting the pulley peg into a bone hole allows the fibular button to have a smoother ridge relative to the proximal bone than a typical proximal button. In addition, once the pulley peg is in place, its position within the bone hole allows the tensioned suture to be secured inside the bone rather than on the bone surface where the suture would be more exposed to other tissues. Therefore, using this fibular button can help reduce the irritation or discomfort that may arise for the patient from a previously placed button or suture protruding from one of the patient's bones. Furthermore, using this fibular button can help protect the tensioned suture from future breakage. In addition, by keeping the tensioned suture within the bone, the risk of the surgeon cutting the tensioned suture is eliminated, while the free end of the suture can be cut to bring its height to the level of the fibular button.
[0053] The provided tibial button configuration reduces friction between the tibial button and the suture during installation compared to conventional distal buttons. For example, the provided tibial button includes one large opening through which the suture passes. This single large opening reduces the number of potential contact points between the tibial button and the suture compared to conventional buttons that include multiple openings for the suture. The tibial button may also include various curved, smooth, and chamfered surfaces to further reduce friction. The provided tibial button is further useful in preventing the suture from wrapping around itself when loading the tibial button into or unloading it from the button insertion device, by guiding the suture to only one side of the device.
[0054] The tibial buttons provided may also be configured to prevent rotation or lateral translation when loaded into a button insertion device. The provided button insertion system can assist in facilitating the rotation of the tibial button as it is deployed from the button insertion device. The tibial button includes a chamfered end facing the suture that connects the tibial button to a second button (e.g., a fibular button) when loaded into the button insertion device. In addition to the tension from the suture, the tibial button naturally tilts to rotate in the direction the chamfered end is facing, thus facilitating its rotation in that direction. Furthermore, to deploy the tibial button, the button insertion device may include an extrusion rod that extends slightly beyond the tip of the button insertion device to push the tibial button out from the tip where the tibial button is loaded. The rotation-facilitating aspect of the button insertion system allows the tibial button to rotate near the tip of the button insertion device, using little space between them.
[0055] The proximity of the tibial button to the button insertion device and the manner in which the tibial button is assisted in its rotation generate a strong rotational force that helps the tibial button overcome the reaction force of tissues (e.g., skin) that can press the tibial button. Furthermore, each of the above manners helps to increase the ease of deploying the tibial button compared to at least some common button insertion systems by assisting the tibial button to reliably change its orientation, i.e., rotate, in the desired or intended direction. Further effects of the fibular button and the tibial button provided will become clear from the following description of the figures.
[0056] Figures 1A and 1B show perspective views of example fibular button 100A. Example fibular button 100A includes a button head 102 and a pulley peg 108 extending from the button head 102. An opening 114 is formed between the button head 102 and the pulley peg 108. The button head 102 includes an upper surface 104 and a lower surface 110. In various embodiments, the upper surface 104 may be rounded to help prevent damage to surrounding tissue when the fibular button 100A is placed in a patient. In some embodiments, the lower surface 110 may be flat as shown. The button head 102 also includes an opening 106 extending through the button head 102 from the upper surface 104 to the lower surface 110. The size of the opening 106 is set so that multiple strands of suture material moving through the opening 106 can be inserted into the opening 106. In some cases, the size of the opening 106 may be made sufficiently large so that a knot of suture can be placed within the opening 106. The top surface 104 may include a chamfered surface 116 connected to the opening 106. The chamfered surface 116 can help reduce friction between the button head 102 and the suture moving through the opening 106. In various cases, the cross-section of the opening 106 may be circular, as shown in the illustration.
[0057] In various embodiments, the pulley peg 108 extends from a first end 120 to a second end 122. The first end 120 and the second end 122 may be connected to or integrated with the lower surface 110 of the button head 102. In some cases, the pulley peg 108 may include a flat surface 118 at each of its ends 120 and 122. The flat surface 118 can help guide the suture through the opening 106. In some cases, the pulley peg 108 may include a flat surface 112 at each of its ends 120 and 122. In other cases, the pulley peg 108 may include a curved surface 124 at each of its ends 120 and 122, as illustrated in Figure 1C as part of fibular button example 100B. The curved surface 124 can help reduce friction between the pulley peg 108 and the suture that moves toward and through the opening 106.
[0058] In various cases, the cross-section of the opening 106 may be a suitable cross-section other than circular. For example, the cross-section of the opening 106 may be pill-shaped, rectangular with rounded corners, oval, or any other suitable shape. Figure 1D shows an example 100C of a fibular button having a button head 102 with an opening 130 having an elongated cross-section, i.e., pill-shaped. The pill-shaped cross-section of the opening 130 can help reduce friction between multiple suture strands and / or between multiple suture strands and the button head 102 by providing additional space for the sutures to move freely. For example, the ends of one or more suture strands can move through the opening 130 with the rest of the strand outside the outermost boundary of the pulley peg 108. In other words, the ends of one or more suture strands do not need to move inward toward a central opening (e.g., opening 106) which could cause friction between the parts of one or more suture strands. In addition, the tablet-shaped opening 130 can be made sufficiently large so that a suture knot can be placed inside the tablet-shaped opening 130.
[0059] In various cases, the tablet-shaped opening 130 may be substantially perpendicular to the pulley peg 108, as illustrated. In other words, the tablet-shaped opening 130 includes a long end and a short end, and the plane extending through the central portion of the two ends 120 and 122 of the pulley peg 108 is substantially perpendicular to the long end. This substantially perpendicular configuration allows the pulley peg 108 to be narrower than if the ends 120 and 122 of the pulley peg 108 were off the long end of the opening 130. Narrowing the width allows the pulley peg 108 to fit into narrower bone holes.
[0060] In various cases, the innermost part of the pulley peg 108 and the inner part of the button head 102 (for example, the part forming the opening 130) share a continuous surface 132. In other words, the inner surface of the button head 102 forming the opening 130 is directly continuous with the inside of the pulley peg 108. This is in contrast to the space on the lower surface 110 that exists between the opening 130 and the ends 120 and 122 of the pulley peg 108. Eliminating this space between the opening 130 and the ends 120 and 122 of the pulley peg 108 is useful in eliminating edges that may increase friction between the suture and the fibular button 100C.
[0061] In some embodiments, the underside of the button head of the fibular button provided may include a chamfered surface that leads to an opening in the button head. For example, Figure 1E shows an example 100D of a fibular button in which the underside 110 of the button head 102 includes a chamfered surface 140 that leads to an opening 130. The chamfered surface 140 can help reduce friction between the button head 102 and the suture moving through the opening 130.
[0062] Figures 2A and 2B show side views of example fibular button 100A, respectively, rotated 90 degrees relative to each other. As will be described in more detail later, the pulley peg 108 is configured to secure sutures (e.g., multiple suture strands and / or multiple portions of one suture strand). For example, in Figure 2B, the free ends of the suture strands can enter from one side of the opening 114 and exit from the other side of the opening 114 so that the pulley peg 108 secures the suture strands when both free ends of the suture strands are pulled away from the fibular button 100A. In other embodiments of the present disclosure, the pulley peg 108 may take on other suitable shapes extending outward from the bottom surface 110, allowing one or more suture strands to be secured by the pulley peg 108. For example, Figure 2C shows example fibular button 200 including a pulley peg 208. The pulley peg includes two legs 202A and 202B connected by a crossbar 204. In some cases, the legs 202A, 202B and the crossbar 204 may be a single, integrated part. In other cases, the crossbar 204 may be connected to both legs 202A and 202B.
[0063] Examples of fibular buttons 100A, 100B, or 100C may be constructed from any suitable medical-grade material that can be in long-term contact with biological material. For example, fibular buttons 100A, 100B, or 100C may be constructed from nitinol.
[0064] Figures 3A, 3B, and 3C show perspective, top, and side views, respectively, of an example tibial button 300A. The tibial button 300A includes a support portion 302 having an opening 308. The support portion 302 may include a curved surface to reduce friction between the suture and the support portion 302 during the installation of the tibial button 300A. In addition, the inclusion of one opening 308 in the support portion 302 for the suture strand to move during the installation of the tibial button 300A can help reduce friction between the suture and the tibial button 300A compared to a typical suture button having multiple openings used for different suture strands or different parts of a single suture strand. A wing 304 extends from the support portion 302 to the tip 310 of the tibial button 300A. A wing 306 extends from the support portion 302 to the chamfered end 312 of the tibial button 300A. Wings 304 and 306 may have various appropriate lengths relative to the support 302.
[0065] In various cases, the wing 306 may be configured to engage with the tip of the button insertion device so that the wing 306 does not slide or otherwise separate from the tip of the button insertion device until the tibial button 300A is deployed. For example, the wing 306 may include recesses 314A, 314B. The wing 306 may include recesses 314A, 314B on one side or on both sides (e.g., the opposite side not shown). One or more portions of the wing 306 that do not have recesses may correspond to one or more recesses on the tip of the button insertion device so that lateral movement of the tibial button relative to the button insertion device (e.g., movement perpendicular to the long axis of the tibial button 300A) is prevented when the wing 306 slides within the tip of the button insertion device.
[0066] The chamfered end 312 of the wing 306 includes a chamfered face at an angle 316. In various examples, the angle 316 may be equal to 30 degrees. In other examples, the wing 306 may be chamfered at another suitable angle 316, such as 15 to 60 degrees. For example, Figure 3D shows example 300B of a tibial button having a wing 306 with a chamfered end 312 at an angle 316 of 45 degrees. The effects that the chamfered end 312 can have on the tibial button disclosed herein will be described in more detail with reference to Figures 6A to 6D.
[0067] In various examples, such as those illustrated in Figures 3A-3D, the support portion 302 and the opening 308 passing through the support portion 302 may be positioned in the center between the wings 304 and 306. In other examples, the support portion 302 and / or the opening 308 may be offset from the center between the wings 304 and 306. For example, Figure 3E shows example 300C of a tibial button having a support portion 302 and an opening 308 with a centerline offset from the axis 320 of the wings 304 and 306. The centerlines of the support portion 302 and the opening 308 may be offset toward the longer side of the wing 306 (e.g., the longer side due to the chamfered end 312) to assist in the rotation and positioning of the tibial button 300C during installation. This will be described in more detail later. In other examples, the opening 308 may be off-center while the support portion 302 is centered. In some cases, the support 302 and the opening 308 may be centered along the axis 320 such that the lengths of wing 304 and wing 306 are equal. In other cases, the support 302 and / or the opening 308 may be off-center along the axis 320. If the support 302 is off-center along the axis 320, the length of either wing 304 or wing 306 may be longer than the length of the other.
[0068] Examples of tibial buttons 300A, 300B, or 300C may be constructed from any suitable medical-grade material that can be in long-term contact with biomaterials. For example, fibular buttons 300A, 300B, or 300C may be constructed from nitinol.
[0069] The following disclosures describe fibular button example 100A and tibial button example 300A. However, the following disclosures may also be applied to fibular button examples 100B and 100C and tibial button examples 300B and 300C, and any other appropriate fibular and / or tibial buttons shall not be inconsistent with this disclosure.
[0070] In some cases, the provided fibular button 100A and / or the provided tibial button 300A may be used in conjunction with a needle and pull-out suture procedure. In other cases, the fibular button 100A and / or tibial button 300A may be used with a button insertion device for deploying the fibular button 100A and / or tibial button 300A for placement in the patient. The fibular button 100A may be used together with the tibial button 300A in a surgical procedure. Alternatively, the fibular button 100A and the tibial button 300A may be used independently of each other in a surgical procedure. For example, the fibular button 100A may be used with a different suitable anchor or suture button than the tibial button 300A. In another case, the tibial button 300A may be used with a different suitable anchor or suture button than the fibular button 100A.
[0071] Figure 4A shows an example 400 of a button insertion device that can be used with the fibular button 100A and / or tibial button 300A and method disclosed herein. The example 400 of the button insertion device may include a handle 402, a support projection 404, a trigger 406, a shaft 414, an extrusion rod 408, an elastic member 412 (e.g., a spring), and a button deployment section 430. The button deployment section 430 may include a suture bollard 410 and a button post 416. In this example, the tibial button 300A is removably engaged with the shaft 414. For example, a portion of the tibial button 300A may be positioned so that the button 300A is constrained with respect to rotation and lateral directions, with respect to the tibia within an insertion tip 432 at the end of the shaft 414. This will be described in more detail with reference to Figures 6A to 6D. In the loaded configuration of the illustrated example of the button insertion device 400, the tibial button 300A can be fixed in place along the long axis of the button insertion device 400 by the tension of the suture 418. In some examples, the extrusion rod 408 extends from the button deployment section 430 through the inside of the shaft 414 and contacts the tibial button 300A.
[0072] The suture 418 may be made of a flexible material, for example, a suture or a suture tape. In some cases, the suture 418 may be a single strand of suture arranged to connect the fibula button 100A to the tibial button 300A. In other cases, the suture 418 may be multiple strands of suture arranged to connect the fibula button 100A to the tibial button 300A. In at least one case, the suture 418 may be an adjustable loop or a non-adjustable loop. In at least one case, the combination of the suture 418, the tibial button 300A and the fibula button 100A may be an adjustable knotless button / loop structure. The knotless button / loop structure may be a self-locking structure.
[0073] In the loaded configuration of example 400 of the button insertion device, the fibular button 100A can be held close to the button post 416 by the tension of the suture 418. The suture 418 can be wrapped around the suture bollard 410 before deployment. An surgeon or any other appropriate healthcare provider can use example 400 of the button insertion device to insert the tibial button 300A through the tunnels of the first and second bones (e.g., fibula and tibia), and the tibial button 300A can be deployed by moving the trigger 406 in the direction of the illustrated arrow. The fibular button 100A can be deployed by translating the button insertion device 400 away from the patient. The deployed fibular button 100A and tibial button 300A can then be secured by applying tension to the suture 418 to set them in place.
[0074] As an alternative to the button insertion device 400, Figure 4B shows an example of a button insertion device 440 that can be used with the fibular button 100A and / or tibial button 300A and method disclosed herein. The example of the button insertion device 440 includes a handle 442, a support projection 444, a trigger 446, an internal rod 508 (Figure 5), an elastic member 512 (Figure 5), a shaft 452, and a button deployment section 530 (Figure 5). The button deployment section 530 may include a suture bollard 448 and a button post 450. In this example, the tibial button 300A is removably engaged with the insertion end 432 of the shaft 414 in the same or similar manner as using the example of the button insertion device 400 described above. The example of the button insertion device 440 is configured similarly to the example of the button insertion device 400. The user can deploy the tibial button 300A by moving the trigger 446 by pulling the trigger 446 in the direction of the illustrated arrow. The fibula button 100A can be deployed by moving the button insertion device 440 in a parallel direction away from the patient.
[0075] Figure 5A shows a partial top view of example 440 of a button insertion device. Example 100 of a fibular button is held in place by the tension of a suture 418 against a button post 450. In some examples, the button post 450 includes two separate posts as shown, with a suitable space between them for use with a pulley peg 108. This allows the suture 418 to be secured by the pulley peg 108 while also allowing the free end of the suture 418 to be pulled through the opening 106.
[0076] Figure 5B shows a cross-sectional front view of example 432 of the insertion tip of a button insertion device 400 or 440. The insertion tip 432 may include a slit 502 between a first end 504A and a second end 504B. When the tibial button 300A is placed in the slit 502, rotation of the tibial button 300A around its long axis is prevented. In some cases, the first end 504A may include a recess 506. The recess 506 may correspond to a portion of the tibial button 300A that does not have a recess (see, for example, Figure 3A), so that the wings 306 of the tibial button 300A can be inserted into the insertion tip 432. That is, it may be aligned with a portion that does not have a recess. For example, the shape of the recess 506 may be a round cross-section, a square cross-section, or any other appropriate shape as shown. Therefore, the portion of the tibial button 300A's wing 306 that does not have a recess is positioned within the recess 506 of the insertion tip 432, preventing the tibial button 300A from moving laterally along the short axis of the button insertion device 400 or 440. In cases where the wing 306 of the tibial button 300A includes recesses 314A and 314B on both sides, the second end 504B of the insertion tip 432 may also include a recess. In addition, the recess 506 of the insertion tip 432 prevents the tibial button 300A from rotating around its short axis.
[0077] It is obvious that button insertion devices 400 and 440 are merely examples of button insertion devices that can be used to deploy the fibular button 100A and / or tibial button 300A. Any suitable button insertion device that does not contradict the effect of the fibular button 100A and / or tibial button 300A as described herein may be used to deploy the fibular button 100A and / or tibial button 300A.
[0078] Figures 6A and 6B show perspective side views of interchangeable configurations of a tibial button 300A loaded into the insertion tip 432 of a button insertion device (e.g., button insertion device 400). In configuration 600A shown in Figure 6A, the tibial button 300A is positioned within the insertion tip 432 such that the chamfered end 312 faces a first direction (e.g., towards the top of the page). In configuration 600B shown in Figure 6B, the tibial button 300A is positioned within the insertion tip 432 such that the chamfered end 312 faces the opposite direction (e.g., towards the bottom of the page). In each of configurations 600A and 600B, the chamfered end 312 faces towards the suture 418. Facing the suture 418 with the chamfered end 312 helps to facilitate the rotation of the tibial button 300A in the desired direction and positioning after it has been unfolded. For example, in configuration 600A, when the tibial button 300A is deployed, it rotates in the direction of arrow 602. Conversely, in configuration 600B, when the tibial button 300A is deployed, it rotates in the direction of arrow 604.
[0079] In either configuration 600A or configuration 600B, the configuration of the tibial button 300A allows the suture 418 to be located on the side of the insertion tip 432 and the button insertion instrument shaft, preventing the suture 418 from wrapping around the button insertion instrument shaft or the tibial button 300A itself. In addition, the tibial button 300A and the insertion tip 432 may be configured such that a gap 606 remains between the tibial button 300A and the insertion tip 432 when the tibial button 300A is fully inserted. The gap 606 is radiotransmitting and therefore can be visualized by X-ray. The gap 606 can help the surgeon determine how far the button insertion instrument must be inserted before deploying the tibial button 300A.
[0080] Figures 6C and 6D further illustrate configuration 600B to show an example of a tibial button 300A that rotates and positions itself when deployed. Figure 6C shows that the extrusion rod 408 of example button insertion device 400 moves in parallel to push the tibial button 300A out of the insertion tip 432. For example, the extrusion rod 408 can be moved in parallel by moving the trigger 406 of the button insertion device 400. In various cases, fully pressing the trigger 406 allows the extrusion rod 408 to extend beyond the end face of the insertion tip 432, thereby helping to ensure that the tibial button 300A is completely separated from the button insertion device 400 and completely pushed out from the insertion tip 432. Ensuring that the tibial button 300A is completely separated from the button insertion device 400 allows for easier deployment when it is necessary to press against tissue (e.g., skin) to install the tibial button 300A. In addition, the end face of the extrusion rod 408 that abuts against the tibial button 300A may be flat as shown in the figure, so that it abuts only the closest part of the chamfered end 312. The space between the flat end face of the extrusion rod 408 and the chamfered end 312 of the tibial button 300A provides space for the tibial button 300A to rotate, or turn.
[0081] Once the tibial button 300A is fully pushed out from the insertion tip 432, the tension of the suture 418 causes the tibial button 300A to rotate toward the suture 418 (for example, in the direction of arrow 604). Minimizing contact between the chamfered surface 312 of the tibial button 300A and the extrusion rod 408 is useful in facilitating the rotation of the tibial button 300A toward the suture 418. Facilitating the rotation of the tibial button 300A in a desired or intended direction helps reduce the complications that may arise during the surgical procedure if the tibial button 300A rotates in an unintended direction (which could potentially cause the suture 418 to become entangled or trapped). Furthermore, the ease of rotation provided in this disclosure allows the tibial button 300A to rotate very close to the insertion tip 432, thereby improving the ease of deploying the tibial button 300A. Figure 6D shows the rotated tibial button 300A.
[0082] As described, fibular button 100A and tibial button 300A can be used as part of a suture-button technique to fix two bones together. For example, an ankle ligament repair method (with or without an ankle fracture) may include drilling bone holes through the patient's fibula and tibia. The tibial button 300A and fibular button 100A can be loaded into a button insertion device (e.g., button insertion device 400). The surgeon can then feed the tibial button 300A through the bone hole using the button insertion device. Figure 7 shows the tibial button 300A being fed through bone holes 706 in the fibular bone 702 and tibia bone 704 using the button insertion device 400. The tibial button 300A is joined to the fibular button 100A by suture 418. Subsequently, the surgeon can deploy the tibial button 300A and the fibular button 100A by moving the trigger 406 of the button insertion device 400 and then moving the button insertion device 400 in a parallel manner away from the patient. In some cases, the tibial button 300A may be deployed first, and then the fibular button 100A may be deployed after the tibial button 300A has been positioned in place.
[0083] When deployed, the tibial button 300A rotates as described above and contacts the surface of the tibia bone 704. The surgeon can withdraw the button insertion device 400 from the bone hole 706. The surgeon can apply tension to the suture 418 (e.g., tighten the adjustable structure) to position the fibular button 100A and fix it to the lateral surface of the fibular bone 702. After the tibial button 300A and fibular button 100A are in place, the suture 418 can be secured by knots or by a knotless button-loop structure. The free end of the suture 418 can be cut off to remove excess material. Figure 8 shows the installed fibular button 100A and tibial button 300A joined by the suture 418, fixing the fibular bone 702 to the tibia bone 704. The pulley peg 108 of the fibular button 100A is entirely within the bone hole 706, which allows only the button head 102 of the fibular button 100A to protrude from the surface of the fibular bone 702. In some cases, the knot of the suture 418 can be placed within the opening 106 of the fibular button 100A.
[0084] The examples and embodiments disclosed herein should be construed as illustrative only and in no way limit the scope of this disclosure. It will be apparent to those skilled in the art that modifications can be made to the details of the embodiments described above without departing from the basic principles described. In other words, various modifications and improvements to the embodiments specifically disclosed above are within the scope of the appended claims. For example, any suitable combination of features of the various embodiments described is contemplated.
Claims
1. A head having a rounded upper surface, a flat lower surface, and a first opening, wherein the first opening extends through the head from the upper surface to the lower surface, A pulley peg extending from a first end to a second end, wherein each of the first and second ends is connected to the flat lower surface of the head such that a second opening is formed between the pulley peg and the flat lower surface of the head, A suture button that assists in fixing two bones, A sewn button, wherein the first opening has a rounded rectangular cross-section consisting of two parallel lines of equal length and two semicircles.
2. The suture button according to claim 1, wherein the first end and the second end of the pulley peg are perpendicular to the length.
3. The suture button according to claim 1, wherein the suture button includes a chamfered surface between the curved upper surface and the first opening.
4. The suture button according to claim 1, wherein the suture button includes a chamfered surface between the flat lower surface and the first opening.
5. The suture button according to claim 1, wherein the pulley peg includes at least one flat surface at each of the first and second ends.
6. The stitching button according to claim 1, wherein the first end and the second end of the pulley peg closest to the first opening are rounded.
7. The suture button according to claim 1, wherein the pulley peg is a single, seamless component.
8. The stitching button according to claim 7, wherein the portion of the pulley peg furthest from the lower surface is rounded.