Patent Grant
11510665
Several medical procedures require the fastening of one bone to another bone. Some such procedures include fixation of acromioclavicular separations due to coracoclavicular ligament disruptions, fixation of dorsal distal radioulnar ligament disruptions, stabilization of the first and second metatarsals for hallux valgus reconstruction, and stabilization of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.
One aspect provided herein is a suture-button system comprising: a suture strand; a primary button having a plurality of primary apertures and a primary threaded portion, wherein the suture strand is inserted through a first and second primary aperture of the plurality of primary apertures; a secondary button having a plurality of secondary apertures, wherein the suture strand is inserted through a first and second secondary aperture of the plurality of secondary apertures, such that at least one targeted tissue of a subject is clamped between a distal surface of the primary button and a proximal surface of the secondary button upon applying a tension to the suture strand; and a lock having a secondary threaded portion, wherein the secondary threaded portion is removably coupled to the primary threaded portion, wherein coupling the secondary threaded portion of the lock to the threaded portion prevents the suture strand from translating through the plurality of primary apertures, thereby securing the clamping of the targeted tissue.
In some embodiments, the plurality of primary apertures comprises 2, 3, 4, or 5 primary apertures. In some embodiments, the plurality of primary apertures are equally spaced on the primary button. In some embodiments, the plurality of primary apertures are equally spaced on the primary button in a circular array. In some embodiments, the plurality of primary apertures are equally spaced on the primary button in a circular array about the primary threaded portion. In some embodiments, the plurality of primary apertures are equally spaced on the primary button in a circular array about a center axis of the secondary button. In some embodiments, a proximal surface of the primary button comprises a countersink. In some embodiments, the primary threaded portion comprises a female threaded portion. In some embodiments, the secondary threaded portion comprises a male threaded portion. In some embodiments, the primary threaded portion comprises a male threaded portion. In some embodiments, the secondary threaded portion comprises a female threaded portion. In some embodiments, the plurality of secondary apertures comprises 2, 3, 4, or 5 secondary apertures. In some embodiments, a distal surface of the secondary button comprises a channel connecting two or more of the plurality of secondary apertures. In some embodiments, one or more edges of the secondary button are rounded or chamfered. In some embodiments, an aspect ratio between the length and width of the secondary button is about 1:1 to about 4:1. In some embodiments, the lock comprises a head and wherein the secondary threaded portion extends from the head. In some embodiments, a distal surface of the head is tapered outwards from a center axis of the lock. In some embodiments, the distal surface of the head is tapered outwards from a center axis of the lock by about 20° to about 89°. In some embodiments, the suture strand is a #1 size suture, a #2 size suture, a #3 size suture, a #4 size suture, a #5 size suture, a #6 size suture, or a #7 size suture. In some embodiments, the suture strand has a length of about 100 mm to about 1,200 mm. In some embodiments, the system comprises 2, 3, 4, 5, 6 or more suture strands. In some embodiments, the system comprises a first suture strand and a second suture strand, wherein at least a portion of the first suture strand passes within at least a portion of the second suture strand to form a suture bundle. In some embodiments, the portion of the first suture strand that passes within the second suture strand is a mesial portion of the first suture. In some embodiments, the portion of the second suture strand through which the first suture strand passes is a mesial portion of the second suture. In some embodiments, the lock comprises a driver feature, an alignment feature, or both. In some embodiments, the driver feature is opposite the secondary threaded portion. In some embodiments, the driver feature and the alignment feature are generally concentric. In some embodiments, the driver feature is proximal to the alignment feature. In some embodiments, a maximum inner diameter of the driver feature is greater than a maximum inner diameter of the alignment feature. In some embodiments, the driver feature comprises a Philips driver feature, a flathead driver feature, a torx driver feature, a hex driver feature, or a square socket feature. In some embodiments, the alignment feature has a cross sectional shape comprising a circle, a triangle, a square, a pentagon, a hexagon, an octagon, or any combination thereof. In some embodiments, the system further comprises a lock driver comprising a driving feature that is configured to rotate the lock relative to the primary button. In some embodiments, the lock driver further comprises an aligning feature configured to align the lock driver to the alignment feature of the lock. In some embodiments, the alignment feature is distal to the driving feature. In some embodiments, at least a portion of the lock extends beyond a distal face of the primary button when the primary button is coupled to the lock. In some embodiments, a distal face of the primary button extends beyond a distal face of the lock when the primary button is coupled to the lock. In some embodiments, wherein at least one end of the suture strand is coupled to a terminator. In some embodiments: the system comprises two suture strands, wherein the plurality of primary apertures comprises four primary apertures; the plurality of secondary apertures comprises two secondary apertures; a first suture strand is inserted through a first primary aperture, through a first secondary aperture, through a second secondary aperture, and through a second primary aperture; and a second suture strand is inserted through a third primary aperture, through the first secondary aperture, through the second secondary aperture, and through a fourth primary aperture. In some embodiments: the system comprises two suture strands, wherein the plurality of primary apertures comprises four primary apertures; the plurality of secondary apertures comprises two secondary apertures; a first suture strand is inserted through a first primary aperture, through a first secondary aperture, through a second secondary aperture, and through a second primary aperture; and a second suture strand is inserted through a third primary aperture, through the second secondary aperture, through the first secondary aperture, and through a fourth primary aperture; In some embodiments, the first primary aperture and the second primary aperture are adjacent. In some embodiments, the first primary aperture and the second primary aperture are nonadjacent. In some embodiments, the system further comprises a tightening tool comprising: a threaded rod; a knob coupled to a proximal end of the threaded rod; a collar coupled to the threaded rod; an arm spinner between the knob and the collar, wherein the arm spinner comprises an aperture accepting the threaded rod; and a handle comprising a cavity, wherein at least a portion of the cavity comprises a threaded feature configured to couple to the threaded rod, wherein the lock comprises the driver feature, and wherein a distal portion of the handle comprises a tensioning feature configured to rotate the driving feature of the lock. In some embodiments, the arm spinner further comprises a terminator channel accepting the terminator. In some embodiments, the arm spinner comprises 1, 2, 3, 4, 5, 6, or more terminator channels. In some embodiments, the knob is coupled to the proximal end of the threaded rod by a pin, an adhesive, a fastener, a press-fit, a weld, or any combination thereof. In some embodiments, the collar is coupled to the threaded rod by a pin, an adhesive, a fastener, a press-fit, a weld, or any combination thereof. In some embodiments, the lock further comprises the alignment feature, and wherein the distal portion of the handle further comprises a tensioning alignment feature that couples to the alignment feature. In some embodiments, the arm spinner rotates freely about the threaded rod, the knob, or both. In some embodiments, rotating the knob and the threaded rod in a first direction with respect with to the handle translates the spinner proximally from the handle. In some embodiments, rotating the knob and the threaded rod in a second direction opposite the first direction translates the spinner distally to the handle. In some embodiments, rotating the handle in a first direction tightens the lock against the primary button.
Another aspect provided herein is a suture-button system comprising: one or more a suture strands; a primary button having a plurality of primary apertures, and a primary threaded portion; a secondary button having a plurality of secondary apertures; and a lock having a secondary threaded portion, wherein the secondary threaded portion is removably coupled to the primary threaded portion; wherein each primary aperture has one or more of the plurality of sutures strands inserted therethrough, wherein each secondary aperture has one or more of the plurality of sutures strands inserted therethrough, and wherein coupling the secondary threaded portion of the lock to the threaded portion prevents each of the plurality of suture strands from translating through one or more of the plurality of first button apertures. In some embodiments, the plurality of primary apertures comprises 2, 3, 4, or 5 primary apertures. In some embodiments, the plurality of primary apertures are equally spaced on the primary button. In some embodiments, the plurality of primary apertures are equally spaced on the primary button in a circular array. In some embodiments, the plurality of primary apertures are equally spaced on the primary button in a circular array about the primary threaded portion. In some embodiments, the plurality of primary apertures are equally spaced on the primary button in a circular array about a center axis of the secondary button. In some embodiments, a proximal surface of the primary button comprises a countersink. In some embodiments, the primary threaded portion comprises a female threaded portion. In some embodiments, the secondary threaded portion comprises a male threaded portion. In some embodiments, the primary threaded portion comprises a male threaded portion. In some embodiments, the secondary threaded portion comprises a female threaded portion. In some embodiments, the plurality of secondary apertures comprises 2, 3, 4, or 5 secondary apertures. In some embodiments, a distal surface of the secondary button comprises a channel connecting two or more of the plurality of secondary apertures. In some embodiments, one or more edges of the secondary button are rounded or chamfered. In some embodiments, an aspect ratio between the length and width of the secondary button is about 1:1 so about 4:1. In some embodiments, the lock comprises a head and wherein the secondary threaded portion extends from the head. In some embodiments, a distal surface of the head is tapered outwards from a center axis of the lock. In some embodiments, the distal surface of the head is tapered outwards from a center of the lock by about 20° to about 89°. In some embodiments, the lock comprises a driver feature, an alignment feature, or both. In some embodiments, the driver feature is opposite the secondary threaded portion. In some embodiments, the driver feature and the alignment feature are generally concentric. In some embodiments, the driver feature is proximal to the alignment feature. In some embodiments, a maximum inner diameter of the driver feature is greater than a maximum inner diameter of the alignment feature. In some embodiments, the driver feature comprises a Philips driver feature, a flathead driver feature, a torx driver feature, a hex driver feature, or a square socket feature. In some embodiments, the alignment feature has a cross sectional shape comprising a circle, a triangle, a square, a pentagon, a hexagon, an octagon, or any combination thereof. In some embodiments, they system further comprises a lock driver comprising a driving feature that is configured to rotate the lock about the primary button. In some embodiments, the lock driver further comprises an aligning feature configured to align the lock driver to the alignment feature of the lock. In some embodiments, the alignment feature is distal to the driving feature. In some embodiments, at least a portion of the lock extends beyond a distal face of the primary button when the primary button is coupled to the lock. In some embodiments, a distal face of the primary button extends beyond a distal face of the lock when the primary button is coupled to the lock. In some embodiments: the plurality of primary apertures comprises two primary apertures; the plurality of secondary apertures comprises two secondary apertures; the one or more suture strands consists of one suture strand; and the one suture strand is inserted through a first primary aperture, through a first secondary aperture, through a second secondary aperture, and through a second primary aperture. In some embodiments: the plurality of primary apertures comprises four primary apertures; the plurality of secondary apertures comprises two secondary apertures; the one or more a suture strands consists of two suture strands; a first suture strand is inserted through a first primary aperture, through a first secondary aperture, through a second secondary aperture, and through a second primary aperture; and a second suture strand is inserted through a third primary aperture, through the first secondary aperture, through the second secondary aperture, and through a fourth primary aperture; In some embodiments: the plurality of primary apertures comprises four primary apertures; the plurality of secondary apertures comprises two secondary apertures; the one or more a suture strands consists of two suture strands; a first suture strand is inserted through a first primary aperture, through a first secondary aperture, through a second secondary aperture, and through a second primary aperture; and a second suture strand is inserted through a third primary aperture, through the second secondary aperture, through the first secondary aperture, and through a fourth primary aperture; In some embodiments, the first primary aperture and the second primary aperture are adjacent. In some embodiments, the first primary aperture and the second primary aperture are nonadjacent. In some embodiments, the system further comprises a tightening tool comprising: a threaded rod; a knob coupled to a proximal end of the threaded rod; a collar coupled to the threaded rod; an arm spinner between the knob and the tensioning collar, wherein the arm spinner comprises an aperture accepting the threaded rod; and a handle comprising a cavity, wherein at least a portion of the cavity comprises a threaded feature configured to couple to the threaded rod, wherein the lock comprises the driver feature, and wherein a distal portion of the handle comprises a tensioning feature configured to rotate the driving feature of the lock. In some embodiments, the arm spinner further comprises a terminator channel accepting the terminator. In some embodiments, the arm spinner comprises 1, 2, 3, 4, 5, 6, or more terminator channels. In some embodiments, the knob is coupled to the proximal end of the threaded rod by a pin, an adhesive, a fastener, a press-fit, a weld, or any combination thereof. In some embodiments, the collar is coupled to the threaded rod by a pin, an adhesive, a fastener, a press-fit, a weld, or any combination thereof. In some embodiments, the lock further comprises the alignment feature, and wherein the distal portion of the handle further comprises a tensioning alignment feature that couples to the alignment feature. In some embodiments, the arm spinner rotates freely about the threaded rod, the knob, or both. In some embodiments, rotating the knob and the threaded rod in a first direction with respect with to the handle translates the spinner proximally from the handle. In some embodiments, rotating the knob and the threaded rod in a second direction opposite the first direction translates the spinner distally towards the handle. In some embodiments, rotating the handle in a first direction tightens the lock against the primary button. In some embodiments, the suture is a #1 size suture, a #2 size suture, a #3 size suture, a #4 size suture, a #5 size suture, a #6 size suture, or a #7 size suture. In some embodiments, the suture has a length of about 100 mm to about 1,200 mm. In some embodiments, the system comprise 2, 3, 4, 5, 6 or more suture strands. In some embodiments, the system comprise a first suture strand and a second suture strand, wherein at least a portion of the first suture strand passes within at least a portion of the second suture strand to form a suture bundle 170. In some embodiments, the portion of the first suture strand that passes within the second suture strand is a mesial portion of the first suture. In some embodiments, the portion of the second suture strand through which the first suture strand passes is a mesial portion of the second suture.
Another aspect provided herein is a suture-button assembly comprising: two or more suture-button systems; and an insertion plate comprising a plurality of insertion plate apertures, each insertion plate aperture accepting at least one suture strand. In some embodiments, the plurality of insertion plate apertures comprises 2, 3, 4, 5, 6, or more insertion plate apertures. In some embodiments, the assembly further comprises an insertion screw, wherein the insertion plate further comprises a screw hole; configured to removable couple to the insertion screw. In some embodiments, the screw hole is positioned between two of the plurality of insertion plate apertures. In some embodiments, the insertion screw comprises a first portion configured to removably couple to the screw hole and a second portion configured to attach to a bone of a patient.
Another aspect provided herein is a method of assembling a suture button, the method comprising: providing the suture-button system of any one or more embodiments described herein, wherein: the plurality of primary apertures comprises a first primary aperture and a second primary aperture; the plurality of secondary apertures comprises a first secondary aperture and a second secondary aperture; and the one or more a suture strands consists of one suture strand; inserting the one suture strand through the first primary aperture; inserting the one suture strand through the first secondary aperture; inserting the one suture strand through the second secondary aperture; and inserting the one suture strand through the second primary aperture. In some embodiments, the method further comprises inserting the secondary button through a hole in a bone or tissue. In some embodiments, the method further comprises rotating the secondary button after its insertion through the hole in the bone or tissue such that a proximal face of the secondary button lies against the bone or tissue. In some embodiments, the method further comprises coupling the secondary threaded portion of the lock with the primary threaded portion of the primary button to prevent the suture strand from translating through the first primary aperture and the second primary aperture. In some embodiments, the method further comprises providing the tightening tool of any one or more embodiments described herein. In some embodiments, the secondary threaded portion and the primary threaded portion are coupled by the tightening tool. In some embodiments, the method further comprises tightening the suture strand with respect to the primary button, the secondary button, or both, with the tightening tool.
Another aspect provided herein is a method of assembling a suture button, the method comprising: providing the suture-button system of any one or more embodiments described herein, wherein: the plurality of primary apertures comprises a first primary aperture, a second primary aperture, a third primary aperture, and a fourth primary aperture; the plurality of secondary apertures comprises a first secondary aperture and a second secondary aperture; and the one or more a suture strands consists of a first suture strand and a second suture strand; inserting the first suture strand through the first primary aperture; inserting the first suture strand through the first secondary aperture; inserting the first suture strand through the second secondary aperture; inserting the first suture strand through the second primary aperture; inserting the second suture strand through the third primary aperture; inserting the second suture strand through the first secondary aperture; inserting the second suture strand through the second secondary aperture; and inserting the second suture strand through the fourth primary aperture. In some embodiments, the method further comprises inserting the secondary button through a hole in a bone or tissue. In some embodiments, the method further comprises rotating the secondary button after its insertion through the hole in the bone or tissue such that a proximal face of the secondary button lies against the bone or tissue. In some embodiments, the method further comprises coupling the secondary threaded portion of the lock with the primary threaded portion of the primary button to prevent the first suture strand and the second suture strand from translating through the plurality of primary apertures. In some embodiments, the method further comprises providing the tightening tool of any one or more embodiments described herein. In some embodiments, the secondary threaded portion and the primary threaded portion are coupled by the tightening tool. In some embodiments, the method further comprises tightening the first suture strand and the second suture strand with respect to the primary button, the secondary button, or both, with the tightening tool.
Another aspect provided herein is a method of assembling a suture button, the method comprising: providing the suture-button system of any one or more embodiments described herein, wherein: the plurality of primary apertures comprises a first primary aperture, a second primary aperture, a third primary aperture, and a fourth primary aperture; the plurality of secondary apertures comprises a first secondary aperture and a second secondary aperture; and the one or more a suture strands consists of a first suture strand and a second suture strand; inserting the first suture strand through the first primary aperture; inserting the first suture strand through the first secondary aperture; inserting the first suture strand through the second secondary aperture; inserting the first suture strand through the second primary aperture; inserting the second suture strand through the third primary aperture; inserting the second suture strand through the second secondary aperture; inserting the second suture strand through the first secondary aperture; and inserting the second suture strand through the fourth primary aperture. In some embodiments, the method further comprises inserting the secondary button through a hole in a bone or tissue. In some embodiments, the method further comprises rotating the secondary button after its insertion through the hole in the bone or tissue such that a proximal face of the secondary button lies against the bone or tissue. In some embodiments, the method further comprises coupling the secondary threaded portion of the lock with the primary threaded portion of the primary button to prevent the first suture strand and the second suture strand from translating through the plurality of primary apertures. In some embodiments, the method further comprises providing the tightening tool of any one or more embodiments described herein. In some embodiments, the secondary threaded portion and the primary threaded portion are coupled by the tightening tool. In some embodiments, the method further comprises tightening the first suture strand and the second suture strand with respect to the primary button, the secondary button, or both, with the tightening tool.
The novel features of the disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the disclosure are utilized, and the accompanying drawings of which:
Potential applications of the devices, systems, and methods herein include but are not limited to fixation of acromioclavicular separations due to coracoclavicular ligament disruptions, fixation of dorsal distal radioulnar ligament disruptions, stabilization of the first and second metatarsals for hallux valgus reconstruction, and stabilization of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.
Suture-Button Systems
One aspect provided herein per
In some embodiments, the suture strand 130 is a standard suture. In some embodiments, the suture strand 130 is a medical grade suture. In some embodiments, the suture is a #1 size suture, a #2 size suture, a #3 size suture, a #4 size suture, a #5 size suture, a #6 size suture, or a #7 size suture. In some embodiments, the suture strand 130 has a length of about 100 mm to about 1,200 mm. In some embodiments, the system 100 comprises 2, 3, 4, 5, 6 or more suture strands 130. As disclosed herein, the terms suture and suture strands are used interchangeably.
In some embodiments, per
In some embodiments, per
In some embodiments, tension applied to one or more suture loops adjusts the distance between the primary and secondary buttons. In some embodiments, tension applied to one or more suture loops brings the primary and secondary buttons closer together. In some embodiments, tension applied to one or more suture loops provides a clamping pressure or force about a bone or tissue located between the primary and secondary buttons. In some embodiments, tension is applied by tightening the one or more suture loops. In some embodiments, the one or more suture loops are tightened by pulling on the one or more suture loops. In some embodiments, the one or more suture loops are pulled in a proximal direction relative to the primary button.
In some embodiments, per
In some embodiments, per
As shown in
In some embodiments, one or more outer edges of the primary button 110 are rounded or chamfered. In some embodiments, one or more edges of the apertures 111 on a distal face of the primary button 110 are rounded or chamfered. In some embodiments, one or more edges of the primary apertures 111 on a proximal face of the primary button 110 are rounded or chamfered. In some embodiments, one or more edges of the primary button 110 are rounded or chamfered. In some embodiments, the rounded or chamfered edges reduce and/or prevent damage to a portion of suture strand 130 passing thereover.
As shown in
In some embodiments, the primary button 110 has a width of about 3 mm to about 12 mm. In some embodiments, the primary button 110 has a length of about 3 mm to about 12 mm. In some embodiments, the primary button 110 has a diameter of about 3 mm to about 12 mm. In some embodiments, the primary button 110 has a thickness of about 0.5 mm to about 3 mm. In some embodiments, the secondary button 120 has a width of about 2 mm to about 7 mm. In some embodiments, the secondary button 120 has a length of about 7 mm to about 20 mm. In some embodiments, the secondary button 120 has a thickness of about 0.5 mm to about 3 mm.
Further per
In some embodiments, a distance between the centers 121A, 121B of a first secondary aperture 121 and a second secondary aperture 121 is greater than a distance between the centers of at least one pair of opposing primary apertures 111. In some embodiments, a distance between the centers 121A, 121B of the first secondary aperture 121 and the second secondary aperture 121 is less than a distance between the centers of at least one pair of opposing primary apertures 111. In some embodiments, a distance between the centers 121A, 121B of the first secondary aperture 121 and the second secondary aperture 121 is equal to a distance between the centers of at least one pair of opposing primary apertures 111. In some embodiments, a distance between the centers 121A, 121B of the first secondary aperture 121 and the second secondary aperture 121 is greater than a distance between the centers of at least one pair of adjacent primary apertures 111. In some embodiments, a distance between the centers 121A, 121B of the first secondary aperture 121 and the second secondary aperture 121 is less than a distance between the centers of at least one pair of adjacent primary apertures 111. In some embodiments, a distance between the centers 121A, 121B of the first secondary aperture 121 and the second secondary aperture 121 is equal to a distance between the centers of at least one pair of adjacent primary apertures 111.
Per
As shown per
In some embodiments, per
Further per
In some embodiments of a first suture-button system 100A, per
Per
Per
In some embodiments, rotating the lock 140 in a first direction relative to the primary button inserts the secondary threaded portion 141 of the lock 140 distally through the primary threaded portion 113 of the primary button 110, so as to compress at least a portion of each of the plurality of suture strands 130 located between the distal face 145 of the head 144 and the primary button proximal face 113. In some embodiments, rotating the lock 140 in a second direction relative to the primary button, opposite the first direction, translates the secondary threaded portion 141 of the lock 140 proximally through the primary threaded portion 113 of the primary button 110, so as to enable each of the plurality of suture strands 130 to translate through the plurality of primary apertures 111.
In some embodiments, per
In some embodiments, per
In some embodiments, per
In some embodiments, per
In some embodiments, applying tension between two ends of each of the one or more suture strands 130 reduces a distance between the primary button 110 and the secondary button 120. In some embodiments, applying tension between two ends of each of the one or more suture strands 130 reduces a distance between the distal surface of the primary button 110 and a proximal surface of the secondary button 110. In some embodiments, applying tension between two ends of each of the one or more suture strands 130 provides a clamping force between the distal surface of the primary button 110 and a proximal surface of the secondary button 110. In some embodiments, applying tension between two ends of each of the one or more suture strands 130 increases a clamping pressure that the primary button 110 and the secondary button 110 apply to a target tissue therebetween. In some embodiments, applying tension between two ends of each of the one or more suture strands 130 increases a clamping pressure that the distal surface of the primary button 110 and the proximal surface secondary button 110 apply to a target tissue therebetween.
In some embodiments, the target tissue comprises two or more portions of a bone, a muscle tissue, an epithelial tissue, a connective, tissue, a nervous tissue, or any combination thereof. In some embodiments, two or more of the following are clamped together between the primary button 110 and the secondary button 110: a bone, a muscle tissue, an epithelial tissue, a connective, tissue, a nervous tissue, or any combination thereof. In some embodiments, upon tensioning of the suture strands 130, the primary button 110 and the secondary button 120 clamp a bone to: another bone, a muscle tissue, an epithelial tissue, a connective, tissue, a nervous tissue, or any combination thereof. In some embodiments, upon tensioning of the suture strands 130, the primary button 110 and the secondary button 120 clamp a muscle tissue to: bone, another muscle tissue, an epithelial tissue, a connective, tissue, a nervous tissue, or any combination thereof. In some embodiments, upon tensioning of the suture strands 130, the primary button 110 and the secondary button 120 clamp an epithelial tissue to: bone, muscle tissue, another epithelial tissue, a connective, tissue, a nervous tissue, or any combination thereof. In some embodiments, upon tensioning of the suture strands 130, the primary button 110 and the secondary button 120 clamp a connective tissue to: bone, muscle tissue, epithelial tissue, another connective, tissue, a nervous tissue, or any combination thereof. In some embodiments, upon tensioning of the suture strands 130, the primary button 110 and the secondary button 120 clamp a nervous tissue to: bone, muscle tissue, epithelial tissue, connective, tissue, another nervous tissue, or any combination thereof.
Suture-Button Assemblies
Another aspect provided herein, per
In some embodiments, the assembly further comprises an insertion screw 160. In some embodiments, insertion screw 160 is configured to be removably coupled with the screw hole 152. In some embodiments, the insertion screw 160 comprises a first portion 161, a second portion 162 configured to attach to a bone of a patient, and a third portion 163 having length and/or diameter greater than a greatest length or diameter of the screw hole 152. In some embodiments, the third portion 163 prevents the first portion 161 from passing through the screw hole 152 after the second portion 162 has been inserted therethrough. In some embodiments, the second portion comprises a threaded feature configured to attach to the bone of the patient.
Method of Assembling a First Suture Button System
Another aspect provided herein is a method of assembling a first suture button system 100. In some embodiments, the method comprises: providing a first suture-button system 100 wherein the primary button 110 comprises a first primary aperture 111 and a second primary aperture 111, wherein the secondary button 120 comprises a first secondary aperture 121 and a second secondary aperture 121, and wherein the first suture button system comprises one suture strand 130. In some embodiments, the method comprises inserting the suture strand 130 through the first primary aperture 111, inserting the one suture strand 130 through the first secondary aperture 121, inserting the one suture strand 130 through the second secondary aperture 121, and inserting the one suture strand 130 through the second primary aperture 111. In some embodiments, one or more of the steps of inserting the suture strand 130 through the first primary aperture 111, through the first secondary aperture 121, through the second secondary aperture 121, and through the second primary aperture 111 are performed simultaneously. In some embodiments, the method further comprises coupling the two ends of the suture strand 130 together. In some embodiments, the method further comprises coupling the two ends of the suture strand 130 by tying the two ends of the suture strand 130 together. In some embodiments, the method further comprises coupling the two ends of the suture strand 130 with a terminator.
In some embodiments, the method further comprises inserting the secondary button 120 through a hole in a proximal surface of a bone or tissue of a patient, and tightening the suture such that the primary button 110 and the secondary button 120 are tightly pressed against opposing surfaces of the bone. In some embodiments, the secondary button 120 is inserted through a bone or tissue hole extending through at least one bone. In some embodiments, the bone or tissue hole is a tunnel, channel, passageway, or any combination thereof. In some embodiments, the secondary button 120 is attached to an insertion needle 220 via one or more insertion suture 210 loops. In some embodiments, the insertion suture 210 loops may be formed by passing an insertion suture 210 through one or more secondary apertures 121 in the secondary button 120 and attaching both free ends of the one or more insertion suture strands 210 to the insertion needle 220. In some embodiments, the free ends of the one or more insertion suture strands 210 are attached to the insertion needle 220 via crimping. In some embodiments, the insertion needle 220 may be inserted through said bone or tissue hole on a first side of the bone or tissue, and received on a second side, such that the secondary button 120 is pulled through the hole in its most narrow configuration. In some embodiments, the secondary button 120, after passing through the bone or tissue hole in its most narrow configuration, is then pivoted such that it lies flat against the bone or tissue. In some embodiments, the secondary button 120 lies against the bone or tissue on its length 120A. In some embodiments, the primary button 110 and secondary button 120 are disposed on either side of the bone or tissue hole with the suture 130 extending through the bone or tissue hole. In some embodiments, the insertion needle 220 is disconnected from the secondary button by cutting and removing the insertion suture 210. In some embodiments, the suture strand 130 is tightened, such that the primary and secondary buttons apply a clamping force or pressure on a first and second side of a bone or tissue.
As described herein, tightening the suture includes applying a tension to the coupled ends of the suture 130. In some embodiments, pulling the coupled ends of the suture 130 applies tension to the suture. In some embodiments, pulling the coupled ends of the suture 130 in a proximal direction applies tension to the suture. In some embodiments, the tightening is performed by hand. In some embodiments, the tightening is performed by the lock driver described herein. In some embodiments, the tightening is performed by rotating the tightening tool 190 herein. In some embodiments, the tightening comprises inserting the suture strand loop 130 within the terminator channels 192A of the spinner 192, coupling the tensioning feature 195A and the driver feature of the lock 140, and rotating the knob 191 with respect to the handle 193. In some embodiments, the tightening comprises inserting the suture strand loop 130 within the terminator channels 192A of the spinner 192, coupling the tensioning feature 195A and the driver feature of the lock 140, rotating the knob 191 with respect to the handle 193, and rotating the tightening tool 190 with respect to the driving feature of the lock 140. In some embodiments, rotating the knob 191 in a first direction translates the spinner 192 and terminator channels 192A proximally from the handle 193, thereby tightening the suture strand 130. In some embodiments, rotating the knob 191 in a second direction translates the spinner 192 and terminator channels 192A distally to the handle 193, thereby loosening the suture strand 130, and decreasing the tension. In some embodiments, once the desired tension is reached the lock 140 is tightened against the primary button 110 such that the suture is locked in place therebetween. In some embodiments, the lock 140 is loosened against the primary button 110 to enable readjustment of the tension of the suture strand, wherein the lock 140 is subsequently tightened against the primary button 110 once the desired tension is reached. In some embodiments, the method further comprises trimming the loose ends of the suture.
Method of Assembling a Second Suture Button System
Further provided herein, per
In some embodiments, the method comprises: inserting the first suture strand 130 through the first primary aperture 111; inserting the first suture strand 130 through the first secondary aperture 121; inserting the first suture strand 130 through the second secondary aperture 121; inserting the first suture strand 130 through the second primary aperture 111; inserting the second suture strand 130 through the third primary aperture 111; inserting the second suture strand 130 through the first secondary aperture 121; inserting the second suture strand 130 through the second secondary aperture 121; and inserting the second suture strand 130 through the fourth primary aperture 111. In some embodiments, one or more of the inserting the first suture strand 130 through the first primary aperture 111, inserting the first suture strand 130 through the first secondary aperture 121, inserting the first suture strand 130 through the second secondary aperture 121, inserting the first suture strand 130 through the second primary aperture 111, inserting the second suture strand 130 through the third primary aperture 111, inserting the second suture strand 130 through the first secondary aperture 121, inserting the second suture strand 130 through the second secondary aperture 121, and inserting the second suture strand 130 through the fourth primary aperture 111 are performed simultaneously.
In some embodiments, the method comprises: inserting the first suture strand 130 through the first primary aperture 111; inserting the first suture strand 130 through the first secondary aperture 121; inserting the first suture strand 130 through the second secondary aperture 121; inserting the first suture strand 130 through the second primary aperture 111; inserting the second suture strand 130 through the third primary aperture 111; inserting the second suture strand 130 through the second secondary aperture 121; inserting the second suture strand 130 through the first secondary aperture 121; and inserting the second suture strand 130 through the fourth primary aperture 111. In some embodiments, one or more of the inserting the first suture strand 130 through the first primary aperture 111, inserting the first suture strand 130 through the first secondary aperture 121, inserting the first suture strand 130 through the second secondary aperture 121, inserting the first suture strand 130 through the second primary aperture 111, inserting the second suture strand 130 through the third primary aperture 111, inserting the second suture strand 130 through the second secondary aperture 121, inserting the second suture strand 130 through the first secondary aperture 121, and inserting the second suture strand 130 through the fourth primary aperture 111 are performed simultaneously.
Per
In some embodiments, the method further comprises inserting the secondary button 120 through a hole in a bone or tissue of a patient, as described herein, and tightening the sutures such that the primary button 110 and the secondary button 120 are tightly pressed against respective surfaces of the bone or tissue. In some embodiments, the tightening is performed by hand. In some embodiments, the tightening is performed by the lock driver as described herein. In some embodiments, the tightening is performed by the tightening tool as described herein.
In some embodiments, once the desired tension is reached, the lock 140 is tightened against the primary button 110 such that the sutures are locked in place therebetween. In some embodiments, the method further comprises trimming the loose ends of the sutures.
Method of Assembling a Suture Button Assembly
Provided herein, per
In some embodiments, the method comprises inserting each of a plurality of suture strands 130 through one or more of the secondary apertures 121 of the secondary button 120 of a first suture button system 100, inserting each of a plurality of suture strands 130 through one or more of the secondary apertures 121 of the secondary button 120 of a second suture button system 100, inserting each of a plurality of suture strands 130 of the first suture button system 100 through a first insertion plate aperture 151 of the insertion plate 150, inserting each of a plurality of suture strands 130 of the second suture button system 100 through a second insertion plate aperture 151 of the insertion plate 150, inserting each of a plurality of suture strands 130 through one or more of the primary apertures 111 of the primary button 110 of a first suture button system 100, and inserting each of a plurality of suture strands 130 through one or more of the primary apertures 111 of the primary button 110 of a second suture button system 100.
In some embodiments, the method further comprises inserting the insertion screw 160 into the insertion hole 152 of the insertion plate 150. In some embodiments, the method further comprises screwing the insertion screw 160 into a bone or tissue of a patient. In some embodiments, screwing the insertion screw 160 into a bone or tissue of a patient temporarily fixates the plate to the bone or tissue of the patient while the suture-button system is deployed.
Terms and Definitions
Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs.
As used herein, the singular forms “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. Any reference to “or” herein is intended to encompass “and/or” unless otherwise stated.
As used herein, the term “about” in some cases refers to an amount that is approximately the stated amount.
As used herein, the term “about” refers to an amount that is near the stated amount by 10%, 5%, or 1%, including increments therein.
As used herein, the term “about” in reference to a percentage refers to an amount that is greater or less the stated percentage by 10%, 5%, or 1%, including increments therein.
As used herein, the term “generally” refers to a geometric relationship between two or more elements within tolerances of 10%, 5%, or 1%, including increments therein.
As used herein, the phrases “at least one”, “one or more”, and “and/or” are open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions “at least one of A, B and C”, “at least one of A, B, or C”, “one or more of A, B, and C”, “one or more of A, B, or C” and “A, B, and/or C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together.
The following illustrative examples are representative of embodiments of the systems, and methods described herein and are not meant to be limiting in any way.
In one example of an ankle syndesmosis repair, suture-button assembly is used, wherein the secondary button rests on the tibia and the primary button rests on the fibula. The plate of the suture-button assembly is placed on the fibula across a fracture, so that one suture-button system is deployed on either side of the fracture. The insertion screw is used to temporarily fixate the plate to the fibula while the suture-button system is deployed.
While preferred embodiments of the present disclosure have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the disclosure. It should be understood that various alternatives to the embodiments of the disclosure described herein may be employed in practicing the disclosure.
This application is a continuation of International Application No. PCT/US2021/023101, filed Mar. 19, 2021, which claims the benefit of U.S. Provisional Application No. 63/002,272, filed Mar. 30, 2020, both of which are hereby incorporated by reference in their entirety herein.
| Number | Name | Date | Kind |
|---|---|---|---|
| 3845575 | Boden | Nov 1974 | A |
| 3953144 | Boden | Apr 1976 | A |
| 6185798 | Ton | Feb 2001 | B1 |
| 6585730 | Foerster | Jul 2003 | B1 |
| 7637926 | Foerster et al. | Dec 2009 | B2 |
| 8100923 | Paraschac et al. | Jan 2012 | B2 |
| 8162978 | Lombardo et al. | Apr 2012 | B2 |
| 8371004 | Huber et al. | Feb 2013 | B2 |
| 8409252 | Lombardo et al. | Apr 2013 | B2 |
| 8652173 | Mansmann | Feb 2014 | B2 |
| 9168034 | Lombardo et al. | Oct 2015 | B2 |
| 9226742 | Wolf et al. | Jan 2016 | B2 |
| 9241706 | Paraschac et al. | Jan 2016 | B2 |
| 9463010 | Gittings et al. | Oct 2016 | B2 |
| 10076377 | Bonutti et al. | Sep 2018 | B2 |
| 20030195563 | Foerster | Oct 2003 | A1 |
| 20060265010 | Paraschac et al. | Nov 2006 | A1 |
| 20060282119 | Perchik | Dec 2006 | A1 |
| 20070060922 | Dreyfuss | Mar 2007 | A1 |
| 20070213770 | Dreyfuss | Sep 2007 | A1 |
| 20070276437 | Call et al. | Nov 2007 | A1 |
| 20080051836 | Foerster et al. | Feb 2008 | A1 |
| 20080294204 | Chirico et al. | Nov 2008 | A1 |
| 20090012522 | Lob | Jan 2009 | A1 |
| 20090292321 | Collette | Nov 2009 | A1 |
| 20100004683 | Hoof et al. | Jan 2010 | A1 |
| 20110004242 | Stchur | Jan 2011 | A1 |
| 20110166599 | Jervis et al. | Jul 2011 | A1 |
| 20130030479 | Regauer | Jan 2013 | A1 |
| 20130144334 | Bouduban et al. | Jun 2013 | A1 |
| 20130197578 | Gregoire et al. | Aug 2013 | A1 |
| 20140081323 | Hawkins | Mar 2014 | A1 |
| 20140257294 | Gedet et al. | Sep 2014 | A1 |
| 20160030035 | Zajac et al. | Feb 2016 | A1 |
| 20160089131 | Wade | Mar 2016 | A1 |
| 20170065273 | Hart et al. | Mar 2017 | A1 |
| 20170189007 | Burkhart et al. | Jul 2017 | A1 |
| 20180249998 | Chavan | Sep 2018 | A1 |
| 20190038275 | Clark et al. | Feb 2019 | A1 |
| 20190175223 | Nguyen | Jun 2019 | A1 |
| 20190380747 | Fischer et al. | Dec 2019 | A1 |
| 20200077999 | Bowman et al. | Mar 2020 | A1 |
| 20220054122 | Bowman et al. | Feb 2022 | A1 |
| 20220192655 | Bowman et al. | Jun 2022 | A1 |
| Number | Date | Country |
|---|---|---|
| 3235471 | Oct 2017 | EP |
| WO-2020056029 | Mar 2020 | WO |
| WO-2021202123 | Oct 2021 | WO |
| WO-2022039991 | Feb 2022 | WO |
| Entry |
|---|
| U.S. Appl. No. 16/569,752, filed Sep. 13, 2019, Allowed. |
| U.S. Appl. No. 17/654,170, filed Mar. 9, 2022, Pending. |
| U.S. Appl. No. 17/401,263, filed Aug. 12, 2021, Pending. |
| PCT/US2019/050659 International Search Report dated Dec. 31, 2019. |
| PCT/US2021/023101 International Search Report and Written Opinion dated Jun. 24, 2021. |
| PCT/US2021/045506 International Search Report and Written Opinion dated Jan. 31, 2022. |
| U.S. Appl. No. 17/651,747, filed Feb. 18, 2022. |
| Number | Date | Country | |
|---|---|---|---|
| 20220167963 A1 | Jun 2022 | US |
| Number | Date | Country | |
|---|---|---|---|
| 63002272 | Mar 2020 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2021/023101 | Mar 2021 | US |
| Child | 17651747 | US |
