Low profile staple and methods for using same

Information

  • Patent Grant
  • 12318086
  • Patent Number
    12,318,086
  • Date Filed
    Friday, February 23, 2024
    a year ago
  • Date Issued
    Tuesday, June 3, 2025
    a month ago
Abstract
According to particular embodiments, the present staple includes a low-profile bridge and has the capacity for high sustained compression. In some embodiments, the staple includes a bridge with a continuous cross-section, legs with teeth cut therein (e.g., opposed to protruding from, as discussed herein), and legs including an angle of about 24 degrees.
Description
BACKGROUND

Generally, surgical staples are used in some orthopedic indications for holding two bone segments together. Typically, segments of the same bone are separated (e.g., broken, fractured, etc.) and legs of a staple are inserted into each bone segment to compress ends of two (or more) segments of a broken bone together to promote healing of the bone (e.g., such that the bone segments heal back together).


As will be understood, staples can compress bone segments together based on stored strain profiles of the staples. At minimum, such compression can limit the distance between broken bone segments, thereby possibly helping reduce bone healing time by eliminating gaps that need to be filled by the bones/body when healing. Further, such compression may help increase/speed bone growth.


As will also be understood, space within a body is limited and lower profile staples are desirable. However, in creating a low-profile staple (e.g., a staple that has minimum rise above the surface of a bone when the staple is fully inserted), the amount of stored strain (e.g., amount of compression the staple can impart when inserted) may be limited do to certain design constraints. Further, such low-profile staples may include localized strain concentrations (at corners and the like), which may increase risk of fatigue failure.


Therefore, there exists a need for a low profile surgical staple and has the capacity for high sustained compression and that minimizes localized strain concentrations.


BRIEF SUMMARY OF THE DISCLOSURE

Briefly described, and according to one embodiment, aspects of the present disclosure generally relate to an improved low profile staple with high sustained compression and improved fatigue performance (e.g., minimized localized strain concentrations).


According to particular embodiments, a staple includes: A) a bridge with a substantially continuous cross-section along at least 80% of a length of the bridge, a substantially smooth top surface, and a width that is greater than a thickness of the bridge; and B) one or more legs integrally formed with the bridge, each of the one or more legs forming an angle of greater than approximately 20 degrees with at least one other leg of the one or more legs. In some embodiments, the staple described above (or anywhere else herein), wherein: A) each of the one or more legs includes a proximal end and a distal end and each distal end includes a wedge-shaped tip; B) each of the one or more legs includes an inner surface and a plurality of teeth, wherein each of the plurality of teeth are cut out of a respective leg such that a point of each tooth lies substantially in the same plane as the inner surface of the respective leg; C) a midpoint of each of the one or more legs is located approximately at a midpoint of the width of the bridge; D) the staple includes at least one radius for transitioning from an outer edge of the bridge to a surface of a particular leg of the one or more legs; E) the staple includes a sloping portion from the substantially smooth top surface of the bridge to an outer surface of at least one of the one or more legs; F) each of a first subset of the plurality of teeth of a first leg of the one or more legs includes a first angle; G) each of s second subset of the plurality of teeth of the first leg includes a second angle, wherein the second angle is less than the first angle; H) the staple includes nitinol; I) the length of the bridge is at least 8.00 mm; J) a radius of the length of the bridge is at least 11.00 mm; K) the length of the bridge is at least 18.00 mm; and/or L) the radius of the length of the bridge is at least 31.00 mm.


According to a first aspect, a method of using a surgical staple includes: A) deforming a staple from a first position to a second position for inserting the staple into tissue of a patient, wherein: 1) the staple includes: a) a bridge with a substantially continuous cross-section along at least 80% of a length of the bridge, a smooth top surface, and a width that is greater than a thickness of the bridge; and b) one or more legs integrally formed with the bridge; 2) in the first position, each of the one or more legs form an angle of greater than approximately 20 degrees with at least one other leg of the one or more legs; 3) in the second position, each of the one or more legs are substantially parallel with the at least one other leg of the one or more legs and strain is distributed substantially evenly throughout the bridge; and 4) the staple, when inserted into the tissue of the patient exerts compressive force on the tissue of the patient. In some aspects, the method described above (or elsewhere herein), wherein: A) each of the one or more legs includes a proximal end and a distal end and each distal end includes a wedge-shaped tip; B) each of the one or more legs including an inner surface and a plurality of teeth; C) each of the plurality of teeth are cut out of a respective leg such that a point of each tooth lies substantially in the same plane as the inner surface of the respective leg; D) a midpoint of each of the one or more legs is located approximately at a midpoint of the width of the bridge; E) the staple includes at least one radius for transitioning from an outer edge of the bridge to a surface of a particular leg of the one or more legs; F) the staple includes a sloping portion from the smooth top surface of the bridge to an outer surface of at least one of the one or more legs; G) each of a first subset of the plurality of teeth of a first leg of the one or more legs includes a first angle; H) each of a second subset of the plurality of teeth of the first leg includes a second angle, wherein the second angle is less than the first angle; I) the staple includes nitinol; J) the length of the bridge is at least 8.00 mm; K) a radius of the length of the bridge is at least 11.00 mm; L) the length of the bridge is at least 18.00 mm; and/or I) the radius of the length of the bridge is at least 31.00 mm.


These and other aspects, features, and benefits of the claimed invention(s) will become apparent from the following detailed written description of the disclosed embodiments and aspects taken in conjunction with the following drawings, although variations and modifications thereto may be effected without departing from the spirit and scope of the novel concepts of the disclosure.





BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate one or more embodiments and/or aspects of the disclosure and, together with the written description, serve to explain the principles of the disclosure. Wherever possible, the same reference numbers are used throughout the drawings to refer to the same or like elements of an embodiment, and wherein:



FIG. 1 illustrates a perspective view of a staple, according to one embodiment of the present disclosure.



FIG. 2 illustrates a top view of a staple, according to one embodiment of the present disclosure.



FIG. 3 illustrates a side view of a staple, according to one embodiment of the present disclosure.



FIG. 4 illustrates a bottom view of a staple, according to one embodiment of the present disclosure.



FIG. 5 illustrates a front view of a staple, according to one embodiment of the present disclosure.



FIG. 6 illustrates a front view of a staple, according to one embodiment of the present disclosure.



FIG. 7 illustrates a front view of a staple, according to one embodiment of the present disclosure.



FIG. 8 illustrates a cross sectional view of the bridge shown in FIG. 7, according to one embodiment of the present disclosure.



FIG. 9 is a perspective view of an exemplary low profile staple, according to one embodiment of the present disclosure.



FIG. 10 is a front view of an exemplary low profile staple, according to one embodiment of the present disclosure.



FIG. 11 is a back view of an exemplary low profile staple, according to one embodiment of the present disclosure.



FIG. 12 is a side view of an exemplary low profile staple, according to one embodiment of the present disclosure.



FIG. 13 is a side view of an exemplary low profile staple, according to one embodiment of the present disclosure.



FIG. 14 is a top view of an exemplary low profile staple, according to one embodiment of the present disclosure.



FIG. 15 is a bottom view of an exemplary low profile staple, according to one embodiment of the present disclosure.



FIG. 16 is a perspective view of an exemplary low profile staple, according to one embodiment of the present disclosure.



FIG. 17 is a front view of an exemplary low profile staple, according to one embodiment of the present disclosure.



FIG. 18 is a back view of an exemplary low profile staple, according to one embodiment of the present disclosure.



FIG. 19 is a side view of an exemplary low profile staple, according to one embodiment of the present disclosure.



FIG. 20 is a side view of an exemplary low profile staple, according to one embodiment of the present disclosure.



FIG. 21 is a top view of an exemplary low profile staple, according to one embodiment of the present disclosure.



FIG. 22 is a bottom view of an exemplary low profile staple, according to one embodiment of the present disclosure.





DETAILED DESCRIPTION

For the purpose of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will, nevertheless, be understood that no limitation of the scope of the disclosure is thereby intended; any alterations and further modifications of the described or illustrated embodiments and any further applications of the principles of the disclosure as illustrated therein are contemplated as would normally occur to one skilled in the art to which the disclosure relates. All limitations of scope should be determined in accordance with and as expressed in the claims.


Whether a term is capitalized is not considered definitive or limiting of the meaning of a term. As used in this document, a capitalized term shall have the same meaning as an uncapitalized term, unless the context of the usage specifically indicates that a more restrictive meaning for the capitalized term is intended. However, the capitalization or lack thereof within the remainder of this document is not intended to be necessarily limiting unless the context clearly indicates that such limitation is intended.


Overview

According to particular embodiments, the present staple includes a low-profile bridge that has the capacity for high sustained compression and improved fatigue performance (e.g., minimized localized strain concentrations). In some embodiments, the staple includes a bridge with a continuous cross-section, legs with teeth cut therein (e.g., opposed to protruding from, as discussed herein), and legs with an angle of about 24 degrees (e.g., 12 degrees from vertical).


Some existing staples may include bridges with a discontinuous cross-section, which may limit the arch/radius of the bridge and likewise limit the angle at which the legs are positioned. As will be understood, the amount of compression a staple can impart on bone segments is related to the arch/radius of the bridge and angle in which the legs are positioned. In general, the greater the angle of the legs from vertical, the greater sustained compression the staple can impart on bone segments.


For example, a particular bone staple is manufactured with an arched bridge of a particular radius and legs of a particular angle from vertical. Continuing with this example, for insertion into one or more bone segments, the staple is deformed such that the bridge is substantially flattened/straightened from its resting arched position and the legs are substantially parallel/perpendicular to the substantially flattened bridge (e.g., the legs are at 0 degrees from vertical or are vertical). In this position, in this example, the staple stores strain as the bridge and legs attempt to return to their original position. As will be understood, the amount of stored strain is related to the arch/radius of the bridge and the angle of the legs. Therefore, the greater the arch/radius of the bridge and the greater the angle of the legs, the more stored strain in the staple and the more potential sustained compression force the staple can impart on bone segments upon insertion.


As will be recognized by one of ordinary skill in the art, the staples disclosed herein have a number of advantages over previously designed staples. First, various embodiments of the staples disclosed herein have a bridge with a continuous, low profile cross-section. Such a cross-section enables the bridge to have more stored strain and minimized localized strain than a bridge with a discontinuous cross-section (e.g., facets, different cross-sections in various portions of the bridge, etc.).


Second, some embodiments of the staples disclosed herein include teeth that are cut out of the legs (opposed to protruding therefrom). In these embodiments (and others), the legs may be wider/thicker than other staples, but have a similar structure for the teeth. As will be understood, wider/thicker legs may result in increased stiffness as compared to staples with less wide/thick legs. As will also be understood, stiff legs (along with a constant-cross section bridge) may help distribute stored strain of a particular staple substantially evenly along the bridge portion, minimizing or eliminating stress concentrations at the interface of the legs and bridge (or at corners or surface features of a non-continuous cross-section bridge).


Third, a combination of the above elements and advantages may result in a staple that is lower profile (along the entire bridge), has higher sustained compression (and higher compression force on a patient's tissue) for longer periods of time (compared to other staples), and a staple that has high durability (lower fatigue failure/improved fatigue performance) than other staples.


As will be understood, the exemplary staples discussed herein may be manufactured from any suitable material, including, but not limited to stainless steel, titanium, nitinol, biocompatible materials, and/or combinations of any of the previously mentioned materials.


Various aspects of the instant staple will be discussed in the following sections.


Exemplary Staple

Referring now to the figures, for the purposes of example and explanation of the fundamental processes and components of the disclosed staple, reference is made to FIG. 1, which illustrates an exemplary staple 100, according to one embodiment of the present disclosure. In various embodiments, the staple 100 includes a bridge 108 and two legs (104a, 104b). The staple 100 size (bridge×leg length) may be greater than, less than or equal to about 8 mm×8 mm, 10 mm×10 mm, 12 mm×12 mm, 14 mm×14 mm, 18 mm×18 mm, 18 mm×20 mm, 20 mm×18 mm, 20 mm×22 mm, or 26 mm×20 mm.


In particular embodiments, the bridge 108 has a first end 110a and a second end 110b and includes a substantially constant cross-section between the first end 110a and the second end 110b (as further discussed in relation to FIG. 8). In at least one embodiment, the bridge 108 is substantially smooth across a top surface (e.g., between ends 110a and 110b). In some embodiments, the bridge 108 includes one or more particular radii, which will be further discussed regarding FIG. 5.


In various embodiments, the staple 100 includes legs 104a and 104b that are integrally formed with the bridge 108. In some embodiments, the legs 104a and 104b may be generally straight from a proximal end (112a, 112b) to a distal end (114a, 114b) and may have a generally rectangular cross-section. In some embodiments, the legs (104a, 104b) may have any suitable shape (e.g. generally cylindrical, serpentine, obround, oval, tubular, etc.).


As shown in the embodiment of FIG. 1, each of the legs 104a and 104b include a distal end (114a, 114b). As shown, each of the distal ends 114a and 114b are formed into a wedge-like shape for easier insertion of a staple leg into tissue (e.g., bone). The distal ends 114a and 114b may form any suitable shape (e.g., points, rounded edges, blocked edges, etc.).


In various embodiments, the staple 100 may have a plurality of teeth 120 cut into the legs 104a and 104b. In some embodiments, the teeth 120 may be located on the internal face of the legs (104a, 104b). In various embodiments, the teeth 120 may extend along the entire length of the legs 104a and 104b. In some embodiments, the teeth 120 may extend along a partial length of the legs 104a and 104b. In various embodiments, the teeth 120 may be wedge-shaped, curved, straight or any combination thereof. As will be understood, a staple may include two or more legs (e.g., three, four, etc.) and each leg may have a different (or the same) number of teeth. In further embodiments, each staple leg may have different sized or shaped teeth (e.g., a staple with four legs may include teeth of a first shape along an inner pair of legs and teeth of a second shape long an outer pair of legs).



FIG. 2 is a top view of a staple, according to one embodiment of the present disclosure. In various embodiments, the top of the staple 100 includes the bridge 108, which may be curved between two ends 110a and 110b (curvature not shown in FIG. 2), with a smooth top surface and low profile cross-section that is substantially constant throughout the entire bridge 108.


In some embodiments, the bridge 108 includes a length 120 that may be greater than, less than or equal to about 8 mm to 35 mm. In particular embodiments, the bridge 108 has a length 120 that may be greater than, less than or equal to about 8.82 mm, 10.82 mm, 12.82 mm, 14.83 mm, 19.11 mm, 21.11 mm, or 27.12 mm.



FIG. 3 is a side view of a staple, according to one embodiment of the present disclosure. In the embodiment shown, the staple 100 includes a bridge 108 having an end 110 and a leg 104. In various embodiments, the bridge 108 is smooth and with a low-profile geometry that enables more curvature of the bridge, which may create greater sustained compression when the staple is inserted into tissue (as further discussed herein). In some embodiments, the top and bottom portion of the bridge 108 is generally arched in shape.


In various embodiments, the staple 100 may have a leg 104 connected to the bottom portion of bridge 108 near the proximal end 112 of the leg 104. In some embodiments, there is a transitional area that is sloped from the proximal end 112 of the leg 104 to the bridge 108. In some embodiments, this transitional area may have a radius that may be greater than, less than, or equal to about 1.00 mm. In at least one embodiment, the staple includes a shoulder 140 that transitions from the width of the bridge 108 to the depth 145 of the leg 104.


In some embodiments, the shoulder 140 may have one or more radii that may be greater than, less than, or equal to about 0.50 mm to 1.50 mm. In particular embodiments, the shoulder 140 has one or more radii that may be greater than, less than, or equal to about 0.50 mm, 1.00 mm, 1.50 mm, 2.00 mm, or 2.50 mm.


In some embodiments, the leg 104 may have a depth 145 that may be greater than, less than, or equal to about 1.00 mm to 3.00 mm. In particular embodiments, the leg 104 has a depth 145 that may be greater than, less than, or equal to about 1.5 mm, 2 mm, 2.5 mm, etc.



FIG. 4 is a bottom view of a staple, according to one embodiment of the present disclosure. As depicted, the staple 100 includes a bridge 108 having two ends (110a, 110b) and legs (104a, 104b).


In various embodiments, the staple 100 includes a first shoulder 140a and a second shoulder 140b. As shown, the width of the bridge 150 is greater than a depth of the legs 104a and 104b (as described in relation to FIG. 3). As such, the first shoulder 140a and second shoulder 140b transition from the width of the bridge 150 to the depth of the legs 104a and 104b.


In some embodiments, midpoints of the legs 104a and 104b are located at a midpoint of the bridge 108 (e.g., the legs are positioned along a centerline of the bridge). In these embodiments (and others), the shoulders 140a and 140b include a slope, arch, or other transition from each edge of the bridge 108 to an edge of each of the legs 104a and 104b. In particular embodiments, the transition from the width of the bridge 108 to the depth of the legs 104a and 104b is substantially gradual and constant (e.g., a gradual slope or a constant radius arch). In some embodiments, the slope includes more than one slope of varying pitch or multiple arches of varying radii.


In some embodiments, the bridge 108 includes a width 150 that may be greater than, less than, or equal to about 1.00 mm to 5.00 mm. In particular embodiments, the bridge 108 has a width 150 that may be greater than, less than, or equal to about 3.80 mm and/or 4.80 mm.



FIG. 5 is a front view of a staple, according to one embodiment of the present disclosure. In various embodiments, the staple 100 may have a bridge component 108 having two ends (110a, 110b) and legs (104a, 104b).


As discussed herein, according to particular embodiments, the bridge 108 is smooth with a constant radius across a top surface of the entire bridge (e.g., between ends 110a and 110b). As shown in FIG. 5, the bridge 108 includes a top radius 116 and a bottom radius 118, with a transition between the two.


In some embodiments, the bridge 108 may have a top radius 116 that may be greater than, less than, or equal to about 8.00 mm to 60.00 mm. In particular embodiments, the bridge 108 has a top radius 116 that may be greater than, less than, or equal to about 11.24 mm, 16.06 mm, 20.88 mm, 25.69 mm, 31.75 mm, 36.56 mm, and/or 51.01 mm.


According to at least one embodiment, the bridge 108 may have a bottom radius 118 that may be greater than, less than, or equal to a range from about 8.00 mm to 60.00 mm. In particular embodiments, the bridge 108 may have a bottom radius 118 that may be greater than, less than, or equal to about 10.24 mm, 14.98 mm, 19.71 mm, 24.44 mm, 30.33 mm, 35.06 mm, and/or 49.26 mm.


In some embodiments, the curvature of the bridge (along with other features) may help distribute strain substantially equally long the length of the bridge. In at least one embodiment, the curvature of the bridge may help distribute strain equally between the legs (104a, 104b), shoulders (140a, 140b) and the bridge 108.


In various embodiments, the bridge 108 first end 110a includes a first shoulder 140a and the second end 110b includes a second shoulder 140b.


In various embodiments, the staple 100 legs (104a, 104b) extend downward from the bridge 108 and have smooth outer surfaces with a plurality of teeth 120 found in the inner surfaces. In various embodiments, each leg has a proximal (112a, 112b) and distal end, wherein the distal ends (114a, 114b) include bone penetrating features.


In one embodiment, the legs 104a and 104b have a particular length 155 as measured from the bottom of leg to the top of the bridge 108. In the embodiment shown, the legs 104a and 104b have substantially the same length. In some embodiments, legs 104a and 104b may have different lengths, depending on the application of the staple 100.


In some embodiments, the legs (104a, 104b) may have a length 155 greater than, less than, or equal to about 9.00 mm to 24.00 mm. In particular embodiments, the legs (104a, 104b) have a length greater than, less than, or equal to about 9.48 mm, 11.62 mm, 13.77 mm, 15.90 mm, 20.23 mm, 20.41 mm, 22.19 mm, 22.33 mm, or 24.93 mm.


In one or more embodiments, the legs (104a, 104b) may have a width 175 that may be greater than, less than, or equal to 1.00 mm to 3.00 mm. In particular embodiments, the legs (104a, 104b) have a width 175 that may be greater than, less than, or equal to 1.50 mm or 2.00 mm.


Turning now to FIG. 6, a front view of a staple is shown, according to one embodiment of the present disclosure. Reference lines 170 and 180 are shown in FIG. 6 to help explain how the teeth 120 are created and the angle of the leg 104b from vertical, respectively.


According to at least one embodiment, the teeth 120 are cut into the legs (104a, 104b). Stated another way, in a particular embodiment, the ends (e.g., sharpest points) of the teeth 120 lie in the same plane as an inner surface of a leg. The plane of the inner surface of leg 104b is shown approximately as reference line 170. In some embodiments, the legs (104a, 104b) of staple 100 may have a various number of teeth 120 that may be greater than, less than, or equal to about 4, 6, 8, 10, 14, 16, or 18. The number of teeth included in the staple 100 may depend on the length of the legs of the staple 100 (e.g., a staple with longer legs may have more teeth).


In at least one embodiment, for the set of teeth 120, generally all of the teeth may be at 60 degrees. In particular embodiments, a tooth at the distal end of the legs is at an angle other than 60 degrees, such as for example, tooth 190 is at 45 degrees. In further embodiments, each tooth or a subset of teeth 120 may include any suitable angle or angles, including but not limited to about 20 to 85 degrees.


In some embodiments, each of the teeth 120 may have a depth 192 that may be greater than, less than, or equal to about 0.01 to 1.00 mm, 0.36 mm, 0.41 mm, 0.46 mm, 0.51 mm, 0.56 mm, or 0.58 mm.


As will be understood from discussions herein, all of the teeth 120 of the staple 100 may be substantially the same shape, depth, etc. In particular embodiments, the number of teeth, the size and depth of the teeth, etc. may vary along the length of the leg. In one embodiment, a leg may include a number of teeth near a distal end of a first depth and a number of teeth near a proximal end of a second depth, where the second depth is less than the first depth. In this embodiment (and others), the staple has larger teeth at the bottom of the staple and smaller teeth near the bridge of the staple.


In various embodiments, the legs (104a, 104b) are at an acute angle 185 of about 12 degrees from vertical (e.g., the angle between the legs is about 24 degrees), as indicated by reference line 180. In particular embodiments, the acute angle 185 may be any suitable angle within a range of about 10 to 15 degrees (e.g., the angle between the legs may be greater than 20 degrees). As will be understood from discussions herein, the angle of the legs 185 from vertical may be, in at least one embodiment, substantially similar to an angle measured from a horizontal line from the highest point on the bridge 108 (horizontal line not shown) to the end of the bridge 110a or 110b.



FIG. 7 is a front view of a staple 100, according to one embodiment of the present disclosure. FIG. 7 shows a section line, A-A, which indicates a cross-section of the bridge 108. As shown, the section line A-A passes through an approximate midpoint of the bridge 108. As further discussed herein, the bridge 108, in particular embodiments, includes a constant cross-section. As such, although the section line A-A passes through a midpoint of the bridge 108, it should be understood that this cross section represents any cross section of the bridge 108. The cross-section will be further discussed below in relation to FIG. 8.



FIG. 8 is a cross sectional view of the bridge 108 as indicated by section line A-A shown in FIG. 7, according to one embodiment of the present disclosure. As depicted, the staple 100 includes a low-profile bridge 108. In various embodiments, the bridge 108 includes a continuous radius with a smooth top surface. In at least one embodiment, the radius of the bridge cross section top surface is about 3.00-4.00 mm. In a particular embodiment, the radius of the bridge cross section top surface is about 3.38 mm or 3.86 mm.


As shown in FIG. 8, the bridge 108 includes a particular thickness 195. In some embodiments, the bridge 108 includes a thickness 195 that may be greater than, less than, or equal to about 1.00 mm to 3.00 mm. In particular embodiments, the bridge 108 has a thickness 195 that may be greater than, less than, or equal to about 1.02 mm, 1.10 mm, 1.19 mm, 1.27 mm, 1.44 mm, 1.52 mm or 1.77 mm.



FIGS. 9-22 show additional embodiments and features of exemplary staples discussed herein.


Exemplary Manufacturing Methods

The exemplary staples described herein may be manufactured in any suitable way. In at least one embodiment, a staple (e.g., staple 100 discussed herein) is produced from a solid piece of metal via a combination of wire EDM and grinding. In these embodiments (and others), the staple is a substantially uniform piece of material with each component or portion integrally connected.


In alternate embodiments, exemplary staples described herein may be produced by any other suitable manufacturing techniques, such as 3D printing.


CONCLUSION

While various aspects have been described in the context of a preferred embodiment, additional aspects, features, and methodologies of the claimed inventions will be readily discernible from the description herein, by those of ordinary skill in the art. Many embodiments and adaptations of the disclosure and claimed inventions other than those herein described, as well as many variations, modifications, and equivalent arrangements and methodologies, will be apparent from or reasonably suggested by the disclosure and the foregoing description thereof, without departing from the substance or scope of the claims. Furthermore, any sequence(s) and/or temporal order of steps of various processes described and claimed herein are those considered to be the best mode contemplated for carrying out the claimed inventions. It should also be understood that, although steps of various processes may be shown and described as being in a preferred sequence or temporal order, the steps of any such processes are not limited to being carried out in any particular sequence or order, absent a specific indication of such to achieve a particular intended result. In most cases, the steps of such processes may be carried out in a variety of different sequences and orders, while still falling within the scope of the claimed inventions. In addition, some steps may be carried out simultaneously, contemporaneously, or in synchronization with other steps.


The embodiments were chosen and described in order to explain the principles of the claimed inventions and their practical application so as to enable others skilled in the art to utilize the inventions and various embodiments and with various modifications as are suited to the particular use contemplated. Alternative embodiments will become apparent to those skilled in the art to which the claimed inventions pertain without departing from their spirit and scope. Accordingly, the scope of the claimed inventions is defined by the appended claims rather than the foregoing description and the exemplary embodiments described therein.

Claims
  • 1. A staple comprising: a bridge bottom surface comprising: a first edge, a second edge, and a bridge width therebetween;a first end and a second end; anda centerline running between the first end and the second end and bisecting the bridge width; andtwo legs, each comprising: a proximal end;a distal end comprising a bone penetrating feature;a length between the proximal end and the distal end of between 8 mm to 20 mm;an inner surface comprising a plurality of wedge-shaped teeth cut into the inner surface at a first depth of between 0.30 mm and 60 mm;an outer surface opposite the inner surface;a front surface orthogonal to the inner surface and the outer surface;a back surface opposite the front surface; anda rectangular cross-section defined by: a width between the inner surface and the outer surface of between 1.5 mm and 2.0 mm; anda second depth between the front surface and the back surface, wherein: the rectangular cross-section comprises a midpoint of the width and the second depth;the midpoint of each of the two legs is coupled to the bridge bottom surface along the centerline;the staple is configured to be positioned in a strained position and an unstrained position; andthe two legs are at an acute angle when the staple is in the unstrained position.
  • 2. The staple of claim 1, wherein the acute angle is 24 degrees when the staple is in the unstrained position.
  • 3. The staple of claim 2, wherein the staple further comprises curved transitions from the bridge bottom surface to the inner surface of each of the two legs.
  • 4. The staple of claim 3, wherein each of the plurality of wedge-shaped teeth are cut into the inner surface at an angle.
  • 5. The staple of claim 4, wherein the angle is 60 degrees.
  • 6. The staple of claim 4, wherein the angle varies for two or more of the plurality of wedge-shaped teeth.
  • 7. The staple of claim 4, wherein: the inner surface of each of the two legs defines a plane; andan end of each of the plurality of wedge-shaped teeth is in the plane.
  • 8. A staple comprising: a bridge bottom surface comprising: a first edge, a second edge, and a bridge width therebetween;a first end and a second end; anda centerline running between the first end and the second end and bisecting the bridge width; andtwo legs, each comprising: a proximal end;a distal end comprising a bone penetrating feature;an inner surface comprising a plurality of wedge-shaped teeth cut into the inner surface at a first depth of between 0.30 mm and 60 mm;an outer surface opposite the inner surface;a front surface orthogonal to the inner surface and the outer surface;a back surface opposite the front surface; anda rectangular cross-section defined by: a width between the inner surface and the outer surface of between 1.5 mm and 2.0 mm; anda second depth between the front surface and the back surface, wherein: the rectangular cross-section comprises a midpoint of the width and the second depth;the midpoint of each of the two legs is coupled to the bridge bottom surface along the centerline; andthe two legs are parallel when the staple is in a strained position.
  • 9. The staple of claim 8, wherein: the staple is configured to be positioned in the strained position and an unstrained position; andthe two legs are at an acute angle in the unstrained position.
  • 10. The staple of claim 9, wherein the acute angle is 24 degrees when the staple is in the unstrained position.
  • 11. The staple of claim 10, wherein the staple further comprises curved transitions from the bridge bottom surface to the inner surface of each of the two legs.
  • 12. The staple of claim 11, wherein the staple further comprises a length of 8 mm to 20 mm between the proximal end and the distal end of each of the two legs.
  • 13. The staple of claim 12, wherein each of the plurality of wedge-shaped teeth are cut into the inner surface at an angle.
  • 14. The staple of claim 13, wherein the angle is 60 degrees.
  • 15. The staple of claim 13, wherein the angle varies for two or more of the plurality of wedge-shaped teeth.
  • 16. The staple of claim 13, wherein: the inner surface of each of the two legs defines a plane; andan end of each of the plurality of wedge-shaped teeth is in the plane.
  • 17. A method comprising: inserting a staple into tissue of a patient, wherein: the staple comprises: a bridge bottom surface comprising: a first edge, a second edge, and a bridge width therebetween;a first end and a second end; anda centerline running between the first end and the second end and bisecting the bridge width; andtwo legs, each comprising: a proximal end;a distal end comprising a bone penetrating feature;a length between the proximal end and the distal end of between 8 mm to 20 mm;an inner surface comprising a plurality of wedge-shaped teeth cut into the inner surface at a first depth of between 0.30 mm and 60 mm;an outer surface opposite the inner surface;a front surface orthogonal to the inner surface and the outer surface;a back surface opposite the front surface; anda rectangular cross-section defined by: a width between the inner surface and the outer surface of between 1.5 mm and 2.0 mm; and a second depth between the front surface and the back surface;the rectangular cross-section comprises a midpoint of the width and the second depth;the midpoint of each of the two legs is coupled to the bridge bottom surface along the centerline;the staple is configured to be positioned in a strained position and an unstrained position;the two legs are at an acute angle when the staple is in the unstrained position; andcausing the staple to transition from the strained position to the unstrained position, thereby compressing the tissue of the patient.
  • 18. The method of claim 17, wherein each of the plurality of wedge-shaped teeth are cut into the inner surface at an angle.
  • 19. The method of claim 18, wherein: the inner surface of each of the two legs defines a plane; andan end of each of the plurality of wedge-shaped teeth is in the plane.
CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No. 17/306,147, filed May 3, 2021, entitled “LOW PROFILE STAPLE AND METHODS FOR USING SAME”, which is a continuation of U.S. patent application Ser. No. 16/393,489, filed Apr. 24, 2019, now U.S. Pat. No. 11,020,110, entitled “LOW PROFILE STAPLE AND METHODS FOR USING SAME,” which is a continuation of, and claims the benefit of and priority to, U.S. patent application Ser. No. 16/058,638, filed Aug. 8, 2018, now U.S. U.S. Pat. No. 10,307,156, entitled “LOW PROFILE STAPLE AND METHODS FOR USING SAME,” each of which are incorporated herein by reference in their entireties.

US Referenced Citations (122)
Number Name Date Kind
262635 Adams Aug 1882 A
2632356 Thiel Mar 1953 A
2867807 Anstett Jan 1959 A
D193140 Brown Jul 1962 S
3499359 Yrjanainen Mar 1970 A
3611708 Moore Oct 1971 A
D227976 Gerald Jul 1973 S
3969975 Krol Jul 1976 A
4269180 Dall May 1981 A
4402445 Green Sep 1983 A
4454875 Pratt Jun 1984 A
D281814 Pratt Dec 1985 S
4570623 Ellison Feb 1986 A
D286442 Korthoff Oct 1986 S
4983176 Cushman Jan 1991 A
5366479 McGarry Nov 1994 A
5454814 Comte Oct 1995 A
5662655 Laboureau et al. Sep 1997 A
6187009 Herzog et al. Feb 2001 B1
D574956 Grim Aug 2008 S
D586915 Grim et al. Feb 2009 S
7722610 Mola et al. May 2010 B2
D625417 Fox Oct 2010 S
D625591 MacDonald et al. Oct 2010 S
D691720 Cheney Oct 2013 S
D705930 Cheney May 2014 S
D706927 Cheney Jun 2014 S
D707357 Cheney Jun 2014 S
D717951 Cheney Nov 2014 S
9095338 Taylor Aug 2015 B2
9402624 Scott et al. Aug 2016 B1
D773665 Cheney et al. Dec 2016 S
D773666 Cheney Dec 2016 S
D775336 Shelton Dec 2016 S
D777329 Montoya Jan 2017 S
D780311 Cheney Feb 2017 S
D782674 Nering Mar 2017 S
9675395 Averous et al. Jun 2017 B2
D804666 Guo et al. Dec 2017 S
10085743 Roedl Oct 2018 B2
10117647 Cheney Nov 2018 B2
10307156 Blair Jun 2019 B1
D857199 Cheney et al. Aug 2019 S
10383625 Pirela-Cruz Aug 2019 B1
D870284 Hollis et al. Dec 2019 S
10568627 Guo et al. Feb 2020 B2
10610218 Palmer et al. Apr 2020 B2
D883482 Majors May 2020 S
D886299 Cundiff Jun 2020 S
D891618 Cheney Jul 2020 S
D892331 Hollis et al. Aug 2020 S
D895113 Blair Sep 2020 S
11020110 Blair Jun 2021 B1
11116499 Blair et al. Sep 2021 B1
11179149 Hartegen Nov 2021 B2
11317951 Hollis May 2022 B2
D957636 Blair Jul 2022 S
D960371 Hollis Aug 2022 S
D961081 Sayger Aug 2022 S
D988856 D'Ascanio Jun 2023 S
11911025 Blair Feb 2024 B1
20060058802 Kofoed Mar 2006 A1
20060233628 Lee Oct 2006 A1
20070270906 Molz Nov 2007 A1
20080161808 Fox Jul 2008 A1
20080167666 Fiere Jul 2008 A1
20080319443 Focht Dec 2008 A1
20090062800 Shano Mar 2009 A1
20100063506 Fox Mar 2010 A1
20110118842 Bernard May 2011 A1
20130030437 Fox Jan 2013 A1
20130123863 Hollis May 2013 A1
20130184768 Mciff Jul 2013 A1
20130231667 Taylor Sep 2013 A1
20130267956 Terrill Oct 2013 A1
20140018809 Allen Jan 2014 A1
20140097228 Taylor Apr 2014 A1
20140276830 Cheney Sep 2014 A1
20140277516 Miller Sep 2014 A1
20140309639 Averous Oct 2014 A1
20140358187 Taber Dec 2014 A1
20150133940 Palmer May 2015 A1
20150282819 Austin Oct 2015 A1
20150313592 Coillard-Lavirotte Nov 2015 A1
20160000434 Cocaign Jan 2016 A1
20160030039 Seavey Feb 2016 A1
20160066907 Cheney Mar 2016 A1
20160135808 Anderson May 2016 A1
20160199060 Morgan Jul 2016 A1
20160235460 Wahl Aug 2016 A1
20160338697 Biedermann Nov 2016 A1
20170065275 Cheney Mar 2017 A1
20170181779 Leither Jun 2017 A1
20170202552 Coleman Jul 2017 A1
20170252036 Palmer Sep 2017 A1
20170311948 Morgan Nov 2017 A1
20180008263 Goldstein Jan 2018 A1
20180153551 Jianxin Jun 2018 A1
20180271521 Wahl Sep 2018 A1
20180353172 Hartdegen Dec 2018 A1
20190000451 Majors Jan 2019 A1
20190046182 Krumme Feb 2019 A1
20190046183 Hartdegen Feb 2019 A1
20190105040 Gordon Apr 2019 A1
20190117219 Ritz Apr 2019 A1
20190150921 Fonte May 2019 A1
20190154070 Kargenian May 2019 A1
20190192140 Ducharme Jun 2019 A1
20190192160 Stamp Jun 2019 A1
20190357951 Rogers Nov 2019 A1
20200000465 Maclure Jan 2020 A1
20200038076 Amis Feb 2020 A1
20200197005 Daniel Jun 2020 A1
20200229813 Seykora Jul 2020 A1
20210228206 Cheney Jul 2021 A1
20210298748 Campbell Sep 2021 A1
20210386422 Maclure Dec 2021 A1
20220117599 Fein Apr 2022 A1
20220338869 Kobayashi Oct 2022 A1
20230255623 Ritz Aug 2023 A1
20230258214 Wang Aug 2023 A1
20230270435 Fox Aug 2023 A1
Foreign Referenced Citations (16)
Number Date Country
19966 Jun 1955 CA
50730 Jan 1983 CA
132677 Jun 2010 CA
303149448 Apr 2015 CN
304907199 Nov 2018 CN
2874166 Feb 2006 FR
3008302 Jan 2015 FR
1035018 Dec 1986 GB
6014567 Jun 2017 GB
D1132991 Feb 2002 JP
D1504138 Aug 2014 JP
300967753.0000 Aug 2018 KR
2015026357 Feb 2015 WO
2017207922 Dec 2017 WO
2018148284 Aug 2018 WO
2019226248 Nov 2019 WO
Non-Patent Literature Citations (3)
Entry
DePuy Synthes, BME Elite Continuous Compression Implant Product Overview. DePuy Synthes, 2017. Pamphlet.
Stryker, EasyClip Osteosynthesis Compression Staples. Stryker GMBH, Switzerland, 2015. Pamphlet.
Wright, Fuseforce Fixation System Surgical Technique. Wright Medical Group N.V., Oct. 25, 2018. Pamphlet.
Continuations (3)
Number Date Country
Parent 17306147 May 2021 US
Child 18585745 US
Parent 16393489 Apr 2019 US
Child 17306147 US
Parent 16058638 Aug 2018 US
Child 16393489 US