Reinforced bridge superelastic bone compression staple and inserter system

Abstract

The invention is a staple comprising a bridge member having a top surface and an opposing bottom surface defining a thickness between and two lateral edges defining a width therebetween and either the thickness or the width includes a center flared area, such as a “diamond-like” shape meaning that it has a v-shape on opposing lateral edges flanked by opposing fillets to form an inserter mount area and the staple has a pair of legs spaced apart along the axis and each joined at a rounded flared shoulder to the bridge member. In a four-legged version the bridge has a waist.

Claims

1. A staple, comprising: a bridge member having a top surface and an opposing bottom surface defining a thickness between and defining a first edge face and a second opposing edge face to define a width between them and the bridge member having a long axis and the first edge face and the second edge face each having a complex curve along the axis so as to form a diamond-like shape widened area between waist areas; and at least one pair of a first leg having a first leg width and a second leg having a second leg width and being spaced apart along the long axis and each leg being joined to the bridge member at a shoulder having a width which is larger than the first leg width and the second leg width.

2. A staple as set forth in claim 1 wherein the superelastic material is Nitinol.

3. A staple as set forth in claim 2, wherein the bridge thickness between the top surface and the bottom surface is constant.

4. A staple inserter system comprising: a staple, comprising: a bridge member having a top surface and an opposing bottom surface defining a thickness between and defining a first edge face and a second opposing edge face to define a bridge width between them and the bridge member having a long axis and the first edge face and the second edge face each having a complex curve along the axis so as to form a diamond-like widened area between two waist areas; at least one pair of legs with a first leg having a first leg width and a second leg having a second leg width and being spaced apart along the long axis and each leg being joined to the bridge member at a shoulder having a width which is larger than the first leg width and the second leg width; and an inserter that constrains the diamond-like widened area on the bridge of the staple.

5. A staple as set forth in claim 4, wherein at least one of the pair of the legs include an engagement feature.

6. A staple as set forth in claim 4, wherein both legs of the pair of legs includes an engagement feature.

7. A staple as set forth in claim 6, wherein the engagement feature is a plurality of ridges.

8. A staple as set forth in claim 4, wherein the diamond-like widened area includes two opposing rounded v-shapes at a center along the long axis of the bridge member.

9. A staple, comprising: a superelastic material which includes a bridge member extending along an bridge axis between a first end and a second end defining a bridge length and having a top surface and a bottom surface separated by a thickness defining a first face and a second opposing face which defines a bridge shape having a width which varies along the length and whereby the bridge shape is bilaterally symmetric between the first end and second end about a midplane transverse to the bridge axis and the bridge shape has a maximum width at the mid-point to and includes opposing v-shaped apexes and a minimum width n between the first end and the midplane and a minimum width n between the midplane and the second end whereby the minimum width n is greater than 20% less than the width at the midplane; and with at least one pair of a first leg having a first leg width and a second leg having a second leg width joined to the bridge member at the first end and the second end.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 shows a top perspective view of the staple with the legs in a converging state and in accordance with the present invention;

(2) FIG. 2 shows a top view of the staple of FIG. 5;

(3) FIG. 3 shows a first side view of the staple of FIG. 2 with a cross section of the narrow section of the bridge as shown in FIG. 2;

(4) FIG. 4 shows a second side view of the staple of FIG. 2 with a cross section of the thickened section of the bridge as shown in FIG. 2;

(5) FIG. 5 shows a side view of the staple of FIG. 1;

(6) FIG. 6 shows a bottom side perspective of the staple of FIG. 1;

(7) FIG. 7 shows a bottom detail view of the staple of FIG. 1;

(8) FIG. 8 shows a side view of the staple of FIG. 1;

(9) FIG. 9 shows a bottom perspective view of a staple in the activated state with the legs in parallel position and having shoulder optimization in accordance with the present invention;

(10) FIG. 10 shows a bottom perspective view of a staple in the activated state with the legs in parallel position and having bridge and shoulder optimization in accordance with the present invention;

(11) FIG. 11 shows side perspective of a drill guide body for the implantation of a four-legged staple in accordance with the present invention;

(12) FIG. 12 shows a side perspective view of a staple inserter loaded with a four-legged staple for use in the drill guide body and with the inserter system of the present invention;

(13) FIG. 13 shows a side perspective view of an inserter staple cartridge member loaded with a two-legged staple in an activated state ready for use with the inserter system of the present invention;

(14) FIG. 14 shows a full side view of the activator member for use with the inserter system of the present invention loaded with a two-legged staple in accordance with the present invention;

(15) FIG. 15 shows a side perspective detailed view of a further embodiment of the inserted staple cartridge member loaded with a two-legged staple and of the inserted system of the present invention;

(16) FIG. 16 shows a side perspective view of an inserter staple cartridge member of FIG. 15 loaded with a two-legged staple with the rails of the inserter truncated in order to show the groove members on the inside of the rails to guide the diamond bridge of the staple;

(17) FIG. 17 shows an alternative inserter staple cartridge member with truncated legs and loaded with a four-legged staple for use with the inserter system of the present invention;

(18) FIG. 18 shows a bottom side perspective of a four-legged staple in accordance with the present invention;

(19) FIG. 19 shows a side view of the staple of FIG. 18;

(20) FIG. 20 shows a bottom view of the staple of FIG. 18; and

(21) FIG. 21 shows a top view of the staple of FIG. 18.

DETAILED DESCRIPTION OF THE INVENTION

(22) The present invention relates to a room temperature superelastic Nitinol bone compression staple 10. The staple 10 has two or more legs 12 that will engage bones or bone segments through the cortical surfaces. The legs 12 are spaced apart from each other and joined together by bridge member 14 that extends across the area between legs at either end of the bridge member 14. As shown, the legs are joined to transitional areas 16 or shoulders which flare outward in width compared to the width of the leg and of the bridge to which they join and fold or curve at an angle of from 75° to 90°, and preferably from 85° to 90° relative to a long axis of the bridge member 14 to form a hood shape as can be seen in FIGS. 6-8.

(23) The bridge member 14 has a top surface 20 and a bottom surface 22 which have corresponding shapes so that they are separated by a constant thickness for at least a portion, and preferably for at least 50%, and more preferably for at least 75% or even 90% of the surface area and further has a complex curving configuration. It extends along an axis preferably in a straight profile, but with a topography that can curve in either of two dimensions (i.e. length and width) or in both of two transverse directions. The shape includes two side edges 24, which have the complex curving shape (which looks somewhat like a curly bracket “{”) of the present invention.

(24) The bridge member 14 includes a thickened or reinforced area 40 provided by a flare or swelling of material such as to form an edge member with a profile that is a serpentine or a half diamond shape with fillets or concave curves 42 on either side of a node, v-shape or bump 44. The opposing edge members flare at the same point along the length of the bridge to form symmetrical profiles. The result is the formation of a partial diamond 46 flanked by two narrower straits 48 that widen again into the shoulder area. This reinforcement serves to inhibit the potential for failure at the bridge.

(25) The surfaces extending between the side edges 24 forming the top or outer surface 20 and the bottom or inner surface of the bridge 22 curve along the axis, in a shape that may define a portion of a circle, and they curve as well in a direction transverse to the axis. Preferably the bridge curves along the length. It is also possible that the bridge curves along the width. In this instance, both curves are convex relative to the bottom surface and can be the same or different radius curves. Preferably, the curves have the same inner radius dimensions so that the bridge member defines portions of spheres on the outer and inner surfaces and the radius is between 10-100 mm, and optimally is 50 mm +/−10 mm.

(26) The legs 12 also have a regular shape. While this can be a rectangle, they can form other polygons in cross section. The legs may also include features 30 to help hold the legs in the bone, such as texturing, or ridges or barbs that help to hold the legs in position. Preferably, the surfaces of the legs that include this feature are opposing surfaces, such as surfaces that face an opposing leg as shown in the detail of FIG. 6. These ridges may include a series of spaced parallel ridges or alternating areas which in cross-section extend away from the base surface of the leg and return the base surface of the leg. Alternatively, the legs may include a series of grooves cut into the surface, or the legs may have a surface treatment, such as knurling, or cross-hatching. If they have ridges, the ridges may cover a portion of the vertical surface, such as 10-90%, and preferably from 25-50%. The ridges are lower profile than barbs, (for example only 0.25-2, and preferably 1+/−0.25 mm in height from the surface of the leg in order to permit earlier staple re-orientation and increased bone growth after removal.

(27) a pair of opposing legs, either one or two legs may include these features. The legs have a cross-sectional configuration that provides for improved resistance to breaking as well as increased compressive forces, such as a polygonal shape that is not square. One preferred configuration is a rectangle. The staple may have two opposing legs, spaced apart from each other along the axis of the bridge member, or on one side it may have two legs, and one on the other, or optionally, it may have four legs which are situated to form a rectangle which circumscribes the bridge member. The staple is provided having a range of different bridge widths ranging from 10 mm to 25 mm and various leg lengths in the same range of length, so as to accommodate different fixation procedures in the forefoot, midfoot, rearfoot and hand.

(28) FIGS. 18-21 illustrate a four-legged version 111 of the staple of the present invention. This staple has a bridge 122 which joins four legs 112 which may include the ridges 120 of the two-legged version of the staple. This version of the staple includes the hooded shoulder members or flares 116 which join each of the legs to the bridge which has a central inward curve to accommodate the sliding relationship with the inserter rails that have opposing convex curves to capture the inward curves of the bridge member. Thus, the bridge has a central waist area 123 that functions to interact with the inverse curved surfaces of the inserter rails to guide the staple along that length. FIG. 20 shows the complex topography which forms the reinforcing attributes of the shoulder members.

(29) FIGS. 9 and 10 illustrate finite element analysis that demonstrates the advantages of the staple 10, 10′ of the present invention. FIG. 9 only having the flared optimized shoulders 16′ as a transition between the bridge 14′ and the legs 12′, while FIG. 10 also includes the diamond area 44.

(30) The staple system of the present invention also comprises a companion four-legged staple 111, shown on a further embodiment of the inserter cartridge 80 in FIG. 12 as well as in FIGS. 17 and 18 that illustrate the hooded shoulder feature and curving bridge member of the present invention on a multi-legged staple member. The inserter cartridge 80 fits on an inserter body and activator member 70 with handle 60 and used with a drill guide assembly 150 having a variation of the turn member 174′. This version is also shown with an additional component 228 that inserts into a bore in the drill guide and has arms that secure and stabilize the inserter during the implantation of the staple into the pre-drilled bores. The four-legged staple includes legs 112 and a bridge member 114 that may also include the bridge optimization of the present invention.

(31) FIGS. 13 and 16 illustrate how the nodes 44 or diamond member 40 of the bridge 14 of the staple 10 of the present invention are constrained and guided along the length of the inserter in mating surfaces such as in a recess, i.e., a slot 332 or a groove '332 formed on the side legs 320 of a staple cartridge 310 on an embodiment of the staple inserter 300 where internal surfaces 334 interface with the area between the fillets 42 and the nodes 44 of the bridge member to secure the staple 10 in the staple inserter cartridge 310 and while the staple legs 12 are held by the end of the staple cartridge 310. In the four-legged version the staple bridge may include the concave surfaces while the cartridge legs include convexly rounded surfaces that hold the waist. FIG. 16 illustrates a further embodiment of the staple inserter and staple cartridge assembly 300′ in which the cartridge has a close-pin type capture mechanism for the staple 10, and a collar 350 that holds the cartridge 310′ to the inserter 300′.

(32) FIGS. 17-21 illustrate a four-legged version of the invention having the enhanced bridge and shoulder configuration.

(33) FIGS. 12-14 illustrate a drill guide body 200 having a handle 210 and extensions 212 that include grooves 214 that receive drill guide members for a four-legged staple 226 or for a two-legged staple 228 as shown in FIGS. 13 and 14.

(34) Preferably, the staple is fabricated by machining a Nitinol blank to form a staple in the closed (converging legs) shape and the resulting staple is mechanically deformed during use to “load” the staple, meaning to induce the superelastic shape memory properties to compress bone segments and facilitate osteosynthesis. In this state, the staple has legs extending at a substantially transverse direction to the axis of the bridge in order to allow the staple to be inserted into pre-drilled pilot holes in the bone.

(35) Optimally, the staple is supplied pre-assembled and pre-loaded into a parallel leg configuration on an inserter 110 or introducer in a sterile procedure pack containing disposable instrumentation. In this instance, the inserter 110 has a pair of pivoting handles 120 that are squeezed together to expand a pair of arm member bearing cylindrical holders that bias the staple legs open when the handles are engaged together.