Compression closure devices and methods of using the same

Abstract

A sternal device may include at least one anchor component that engages a sternum or a portion thereof. The sternal device may further include at least one deformable component configured to transition between an axially-extended conformation and an axially-retracted conformation.

Description

COMPRESSION CLOSURE DEVICES AND METHODS OF USING THE SAMECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application Serial No. 63 / 529,586 entitled “Superelastic Sternal Closure Devices and Methods of Using the Same” and filed July 28, 2023, which is hereby incorporated herein by reference in its entirety for all purposes.STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

[0002] Not applicable.BACKGROUND

[0003] The sternum, also called the “breastbone,” is a long, generally flat bone located centrally in a person’s chest. The sternum generally protects the heart and lungs. A sternotomy is a surgical procedure in which a patient’s sternum or a portion of the sternum is divided laterally, for example, using a sternal saw. A sternotomy, for example, may be performed to provide access to the heart, thymus, or lungs, such as for a heart transplant, a lung transplant, a biopsy of removal of certain thoracic tumors, a corrective procedure for congenital heart defects, or a coronary artery bypass procedure.

[0004] Multiple variations of sternotomies exist, for example, a median sternotomy (e.g., in which the sternum is divided laterally along a medial line thereof), an inverse “T” — type sternotomy (e.g., in which an upper portion of the sternum is divided from a lower portion of the sternum, and the upper portion is divided laterally), a partial upper “L” — type sternotomy (e.g., in which a “L”-shaped is used to divide an upper corner from the remainder of the sternum), and a manubriotomy (e.g., in which the manubrium portion of the sternum is divided laterally).

[0005] Upon completion of the underlying procedure, it is necessary to repair or reconstruct the divided sternum. For example, wires, cable ties, or tie bands have been used, conventionally, to provide fixation and stability of the sternum following a sternotomy procedure to enable fusion of the sternum. However, fixation by metal sternal wire(s) may not offer robust stability in questionable bone quality. Nonetheless, plastic, metal, or polyetheretherketone (PEEK) cable ties have been used to avoid suchlimitations. Such fixation devices (e.g., cable ties) generally statically stabilize the sternum during the healing process. However, although offering improved efficacy over metal sternal wires, bone resorption, implant migration, or implant loosening may cause loss of initial stability. Likewise, plates made from, for example, stainless steel or titanium have also been employed to provide fixation of the sternum, but are also static and suffer from many of the same shortcomings.

[0006] As such, there is a need for a sternal fixation device that combines the low-profile provided by wires and cable ties while still providing dynamic, long-term compression and stability.BRIEF SUMMARY

[0007] Embodiments of sternal devices and methods of using the same are disclosed herein.

[0008] For example, in some embodiments disclosed herein a sternal device comprising at least one anchor component configured to engage a sternum or a portion thereof, and at least one deformable component configured to transition between an axially-extended conformation and an axially-retracted conformation.

[0009] Also for example, in some embodiments disclosed herein is a sternal device. The sternal device may comprise at least one anchor component configured to engage a sternum or a portion thereof. The sternal device may further comprise at least one deformable component configured to transition between an axially-extended conformation and an axially-retracted conformation.

[0010] Also, in some embodiments disclosed herein is a method for repair or reconstruction of bones. The method may comprise providing a sternal device comprising one or more anchor components and one or more deformable components. The method may also comprise engaging the sternal device with the sternum of a patient. The method may also comprise allowing the deformable component to transition from the axially-extended conformation into the axially-retracted conformation so as to apply a compressive force to the sternum.

[0011] Embodiments described herein comprise a combination of features and characteristics intended to address various shortcomings associated with certain prior devices, systems, and methods for fracture repair or reconstruction. The foregoing outlines, broadly, the features and technical characteristics of the various disclosedembodiments. The various characteristics and features described above, as well as others, will be readily understood to those skilled in the art upon reading the following detailed description, and by referring to the accompanying drawings. It should be appreciated that the conception and the specific embodiments disclosed herein are not limiting and may be modified or used to design other structures for carrying out the various embodiments. It should also be realized that such equivalent constructions do not depart from the spirit and scope of the principles disclosed herein. Although the embodiments disclosed here may be described in connection with sternal devices, the devices disclosed and claimed herein may be used to repair and reconstruct other bones.BRIEF DESCRIPTION OF THE DRAWINGS

[0012] For a detailed description of various exemplary embodiments, reference will now be made to the accompanying drawings in which various embodiments and implementations of a sternal device are illustrated.

[0013] Figure 1 is a top view of a first embodiment of sternal device according to the disclosure herein;

[0014] Figure 2 is a bottom view of the first embodiment of sternal device according to the disclosure herein;

[0015] Figure 3 is a side view of the first embodiment of sternal device according to the disclosure herein;

[0016] Figure 4 is an end view of the first embodiment of sternal device according to the disclosure herein;

[0017] Figure 5 is a perspective view of the first embodiment of sternal device according to the disclosure herein;

[0018] Figure 6 is a perspective view of the first embodiment of sternal device according to the disclosure herein;

[0019] Figure 7 is a perspective view of the first embodiment of sternal device according to the disclosure herein;

[0020] Figure 8 is a perspective view of a second embodiment of sternal device according to the disclosure herein;

[0021] Figure 9 is a perspective view of the second embodiment of sternal device according to the disclosure herein;

[0022] Figure 10 is a perspective view of the second embodiment of sternal device according to the disclosure herein;

[0023] Figure 11 is a perspective view of a third embodiment of sternal device according to the disclosure herein;

[0024] Figure 12 is a perspective view of the third embodiment of sternal device according to the disclosure herein;

[0025] Figure 13 is a perspective view of the third embodiment of sternal device according to the disclosure herein;

[0026] Figure 14 is a perspective view of the third embodiment of sternal device according to the disclosure herein;

[0027] Figure 15 is a top view of the third embodiment of sternal device according to the disclosure herein;

[0028] Figure 16 is a top view of the third embodiment of sternal device according to the disclosure herein;

[0029] Figure 17 is a top view of a fourth embodiment of sternal device according to the disclosure herein;

[0030] Figure 18 is a perspective view of the fourth embodiment of sternal device according to the disclosure herein;

[0031] Figure 19 is a top view of the fourth embodiment of sternal device according to the disclosure herein;

[0032] Figure 20 is a perspective view of a fifth embodiment of sternal device according to the disclosure herein;

[0033] Figure 21 is a top view of the fifth embodiment of sternal device according to the disclosure herein;

[0034] Figure 22 is a side view of the fifth embodiment of sternal device according to the disclosure herein;

[0035] Figure 23 is a perspective view of a sixth embodiment of sternal device according to the disclosure herein;

[0036] Figure 24 is a top view of the sixth embodiment of sternal device according to the disclosure herein;

[0037] Figure 25 is a side view of the sixth embodiment of sternal device according to the disclosure herein;

[0038] Figure 26 is a perspective view of a seventh embodiment of sternal device according to the disclosure herein;

[0039] Figure 27 is a top view of the seventh embodiment of sternal device according to the disclosure herein;

[0040] Figure 28 is a side view of the seventh embodiment of sternal device according to the disclosure herein;

[0041] Figure 29 is a perspective view of an eighth embodiment of sternal device according to the disclosure herein;

[0042] Figure 30 is a side view of the eighth embodiment of sternal device according to the disclosure herein;

[0043] Figure 31 is a top view of the eighth embodiment of sternal device according to the disclosure herein;

[0044] Figure 32 is a perspective view of a ninth embodiment of sternal device according to the disclosure herein;

[0045] Figure 33 is a top view of the ninth embodiment of sternal device according to the disclosure herein;

[0046] Figure 34 is a side view of the ninth embodiment of sternal device according to the disclosure herein;

[0047] Figure 35 is a top view of a tenth embodiment of sternal device according to the disclosure herein;

[0048] Figure 36 is a second top view of the tenth embodiment of sternal device according to the disclosure herein;

[0049] Figure 37 is a front view of a sternal device in a deployed state according to one or more embodiments herein;

[0050] Figure 38 is a front view of a sternal device in a deployed state according to one or more embodiments herein;

[0051] Figure 39 is a front view of a sternal device in a deployed state according to one or more embodiments herein;

[0052] Figure 40 is a front view of a sternal device in a deployed state according to one or more embodiments herein;

[0053] Figure 41 is a front view of a sternal device in a deployed state according to one or more embodiments herein;

[0054] Figure 42 is a front view of a sternal device in a deployed state according to one or more embodiments herein;

[0055] Figure 43 is a perspective view of a sternal device in a deployed state according to one or more embodiments herein;

[0056] Figure 44 is a perspective view of a sternal device in a deployed state according to one or more embodiments herein;

[0057] Figure 45 is a perspective view of a sternal device in a deployed state according to one or more embodiments herein;

[0058] Figure 46 is a perspective view of a sternal device in a deployed state according to one or more embodiments herein;

[0059] Figure 47 is a front view of a sternal device in a deployed state according to one or more embodiments herein;

[0060] Figure 48 is a front view of a sternal device in a deployed state according to one or more embodiments herein;

[0061] Figure 49 is a front view of a sternal device in a deployed state according to one or more embodiments herein;

[0062] Figure 50 is a perspective view of a sternal device in a deployed state according to one or more embodiments herein; and

[0063] Figure 51 is a perspective view of a sternal device in a deployed state according to one or more embodiments herein.DETAILED DESCRIPTION

[0064] The following discussion is directed to various exemplary embodiments. However, one of ordinary skill in the art will understand that the examples disclosed herein have broad application, and that the discussion of any embodiment is meant only to be exemplary of that embodiment, and not intended to suggest that the scope of the disclosure, including the claims, is limited to that embodiment.

[0065] The figures are not necessarily to scale. Certain features and components herein may be shown exaggerated in scale or in somewhat schematic form and some details of conventional elements may not be shown in interest of clarity and conciseness.

[0066] In the following discussion and in the claims, the terms “including” and “comprising” are used in an open-ended fashion, and thus should be interpreted to mean “including, but not limited to... .” Also, the term “couple” or “couples” is intended to meaneither an indirect or direct connection. Thus, if a first component couples to a second component, that connection may be through a direct connection of the two components, or through an indirect connection that is established via another component. In addition, as used herein, the terms “axial” and “axially” generally mean along or parallel to a given axis (e.g. , central axis of a body or a port), while the terms “radial” and “radially” generally mean perpendicular to the given axis. For instance, an axial distance refers to a distance measured along or parallel to the axis, and a radial distance means a distance measured perpendicular to the axis. As used herein, the terms “approximately,” “about,” “substantially,” and the like mean within 20% (i.e., plus or minus 20%) of the recited value, and alternatively, within 10% (i.e., plus or minus 10%) of the recited value. Thus, for example, a recited angle of “about 80 degrees” refers to an angle ranging from 64 degrees to 96 degrees, and alternatively ranging from 72 degrees to 88 degrees.

[0067] Unless the context dictates the contrary, all ranges set forth herein should be interpreted as being inclusive of their endpoints, and open-ended ranges should be interpreted to include only commercially practical values. Similarly, all lists of values should be considered as inclusive of intermediate values unless the context indicates the contrary.

[0068] Disclosed herein is a closure device configured to provide dynamic, long-term compression and stability for the repair and reconstruction of bone segments. Although the embodiments disclosed herein may be described with respect to using sternal disclosures, the disclosed subject matter may be applicable to the repair and reconstruction of other bones. In various embodiments as will be disclosed, the sternal devices generally include at least one deformable component and at least one anchor component. For example, the disclosed sternal devices provide a low-profile means of dynamic, long-term compression and stability.

[0069] Generally, the at least one deformable component is configured to provide tension to the at least one anchor component such that the at least anchor component applies a compressive force to a patient’s sternum. More particularly, the deformable component may be generally configured to be deformable between an axially-retracted conformation, relative to a longitudinal axis, and an axially-extended conformation, relative to the longitudinal axis. Moreover, the deformable component may also exhibit a tendency, when in the axially-extended conformation, to return to the axially-retracted conformation. Also, the one or more anchor components may be generally configuredto be engaged with respect to the sternum such that the forces applied by the deformable component are applied to the one or more portions of the sternum. For example, in various embodiments, each of the one or more anchor components may be configured to be wrapped around the sternum, to be hooked to a portion of the sternum, or to be fixed to a portion of the sternum, such as via an acceptable fastener, for example, a surgical screw.

[0070] In some embodiments, the deformable component may be made from a suitable shape memory material, for example, a shape memory material suitable for surgical applications, for example, a medical grade shape memory allow. For example, in some embodiments, the shape memory material may be medical grade Nitinol.

[0071] Nitinol is a metal alloy made of approximately half nickel and half titanium, for example, from about 40% to about 60% nickel, by weight, and about 40% to about 60% titanium, by weight. Nitinol may be characterized as exhibiting a phase transformation, for example, such that the molecular arrangement of Nitinol varies according to its temperature. At lower temperatures, the crystalline architecture of Nitinol resembles an accordion making it relatively unstable, malleable, and weak. This is referred to as the martensitic phase of Nitinol (e.g., martensite). At higher temperatures, the crystalline structure of Nitinol is rearranged into a cubic form making it contracted, rigid, and strong. This is referred to as the austenitic phase of Nitinol (e.g., austenite). The temperature range at which Nitinol transforms from the martensitic phase into austenitic phase can be adjusted and manipulated through manufacturing processes. For example, during manufacturing, a Nitinol device may undergo heat treatments that “program” the temperature ranges that yield the transition between the martensitic and austenitic phases. For example, when a Nitinol device is heated, the treatments dictate the temperatures associated with the phase transformation from martensite to austenite (Austenite Start temperature or As) and the end of the transformation (Austenite Finish temperature or Af). In addition, when a Nitinol device is cooled, the treatments dictate the beginning of the phase transformation from austenite to martensite (Martensite Start temperature or Ms) and the end of the transformation (Martensite Finish temperature or Mf).

[0072] In addition to the aforementioned phase transformation, Nitinol exhibits shape memory and superelastic / pseudoelastic characteristics. With regards to shape memory, a Nitinol device can be designed to transform from one shape to another when exposedto heat. For example, prior to heat treating, the Nitinol device may be cooled, and thus become malleable in the martensite material phase and shaped into a particular form that imparts internal residual stresses. Heat treatment can then be applied, which sets or “bakes” this established shape into the memory of the implant. Then, when the Nitinol device is heated through its transformation temperature range, the device will revert to its predetermined final shape as it undergoes the phase transformation to Austenite.

[0073] Compared to most other metals, Nitinol can withstand a large amount of strain, for example up to 8%, and still recover its original shape. The superelastic characteristic is exhibited when a deformable component made of Nitinol is warmed through its transformation temperature range but is constrained and prevented from returning to its original shape. While constrained in a deformed shape, as is the case when a deformable component made of Nitinol is implanted, continuous exposure to sufficient heat allows the implant to behave like an elastic spring. This superelastic effect thus may be used to maintaining tension applied to the one or more anchor components and, thereby, compression of the sternum, a long-term compressive force between portions of the sternal over a large displacement range.

[0074] In various embodiments, a deformable component made from Nitinol may be characterized as thermally-activated or Superelastic. The transition temperature ranges of these types of implants vary and can be classified as either heat-activated or body temperature-activated. Heat-activated Nitinol bone staples have an austenite start temperature (As) and austenite finish temperature (Af) above body temperature. These implants are implanted, for example, in the sternum in the malleable martensitic phase and are exposed to an external heat via electrocautery or bi-polar electrical resistance to convert the implant from martensite to austenite, and thus, promote shape change that creates compression between portions of the sternum being joined. Compression is maintained through the superelastic effect as the implant is constrained by the sternum. A deformable component made from Nitinol that is temperature-activated may have a transition temperature range that is slightly lower than body temperature. Since the Asmay be at or below room temperature, these implants may utilize freezer storage to prevent premature transition. These implants may be placed with respect to the sternum while still in a frozen state, and then compress the portions of the sternum through the shape memory effect as they warm to body temperature. Compression is againmaintained through the superelastic effect as the implant is constrained in an axially- extended conformation by the sternum.

[0075] A deformable component that is superelastic may have an austenite finish temperature (Af) for these implants is significantly below room temperature, for example 10 to -20 degrees C, thus freezer storage to maintain an initial shape in the martensite material phase may not be sufficient, as implants may begin to deflect before placement with respect to the sternum. Thus, in some instances, external constraint devices may be used to mechanically extend the deformable component prior to or during placement with respect to the sternum. Upon release of the constraining tool, the superelastic effect is transferred from the tool to the bone to achieve compression of the portions of the sternum.

[0076] Additionally, in some embodiment embodiments, one or more of the at least one anchor components may also be made from a shape memory material, for example, a shape memory material suitable for surgical applications, for example, a medical grade shape memory allow. For example, in some embodiments, the shape memory material may be medical grade Nitinol. Additionally or alternatively, in one or more embodiments, one or more of the at least one anchor components may comprise (e.g., be made from) surgical grade stainless steel, ceramic materials, tungsten carbide, titanium, polyetheretherketone (PEEK), and combinations thereof.

[0077] Accordingly, disclosed herein are various embodiments of a sternal device.

[0078] Referring now to Figures 1 , 2, 3, 4, 5, 6, and 7, a first embodiment of a sternal device 100 is shown. Figures 1 , 2, 3, 4, and 5 illustrate a top view, a bottom view, an end view, a side view, and a perspective view, respectively, of the sternal device 100 in an undeployed, axially-retracted conformation. Figure 6 illustrates the sternal device 100 in an axially-extended conformation, as deployed. Figure 7 illustrates the sternal device 100 in an axially-retracted conformation, as deployed.

[0079] As shown in the embodiment of Figures 1 , 2, 3, 4, 5, 6, and 7, the sternal device 100 includes a plurality of, for example, four (4), anchor components 110 integrated with a deformable component 120. Although the embodiment of Figures 1 , 2, 3, 4, 5, 6, and 7 includes four anchor components 110, in some embodiments a sternal device may similarly in 2, 6, 8, or 10 anchor components. In the embodiment of Figures 1-7, generally, each of the four (4) anchor components 110 comprises a leg and the deformable component 120 comprises a bridge that extends between a first group oflegs (first leg 111a and third leg 111c) and a second group of legs (second leg 111 b and fourth leg 111 d). Each of the first leg 111a and the third leg 111c extends from the deformable component 120 at a first end 120a and, likewise, each of the second leg 111 b and the fourth leg 111 d extends from the deformable component 120 at a second end 120b.

[0080] Referring to Figure 5, the sternal device 100 may be defined with respect to a central axis 102 passing through the geometric center of the deformable component 120 and centered between the legs. In addition, the sternal device 100 may be defined with respect to each of a first latitudinal axis 104a and a second latitudinal axis 104b. The first latitudinal axis 104a generally extends between the deformable component 120 and a connection point for each of the first leg 111 a and the third leg 111 c. Likewise, the second latitudinal axis 104b generally extends between the deformable component 120 and a connection point for each of the second leg 111 b and the fourth leg 11 1 d. In this embodiment, the central axis 102, the first latitudinal axis 104a, and the second latitudinal axis 104b lie in a common place, which may also be referred to herein as the “reference plane.”

[0081] Each of the first leg 111 a, the second leg 111 b, the third leg 111 c, and the fourth leg 111 d has a central axis 112a, 112b, 112c, 112d, respectively, laterally spaced apart from central axis 105, a first or fixed end fixably attached to and integral with the corresponding end 110a, 1 10b of the sternal device 100, and a second or free or distal end. For purposes of clarity and further explanation, each axis 112a, 112b, 112c, 112d may also simply be referred to as axis 112. In this embodiment, the central axis 112 of each of the first leg 111 a, the second leg 111 b, the third leg 111 c, and the fourth leg 111 d is a linear, longitudinal that intersects the first latitudinal axis 104a or the second latitudinal axis 104b.

[0082] As best shown in Figure 5, in an undeployed state, each anchor component 110 (for example, the first leg 111 a, the second leg 111 b, the third leg 111 c, and the fourth leg 111d) is oriented substantially parallel to the reference place. Referring to Figure 6 and 7, when deployed, each anchor component 110 (for example, the first leg 111 a, the second leg 111 b, the third leg 111 c, and the fourth leg 11 1 d) is oriented at a leg angle a measured between the corresponding axis 112 and the reference plane. In embodiments described herein, leg angle a of each leg ranges from about 90 degrees to about 60 degrees, additionally or alternatively, from about 90 degreesto about 75 degrees, additionally or alternatively, from about 90 degrees to about 80 degrees. In embodiments where the leg angles a are less than 90 degrees, the distal ends of the legs of opposing legs are disposed relatively closer together and, thus the legs may be referred to herein as “inwardly biased.” In various, the leg angles a of any two or more legs may be the same or different. In the embodiment illustrated in Figure 6 and 7, each leg angle a is an acute angle between 90 degrees and 80 degrees, such that the legs are inwardly biased, and each leg angle a is approximately the same.

[0083] In various embodiments, each leg may be characterized with respect to a crosssection taken in a plane oriented perpendicular to the corresponding axis 135. In cross-section, an outer surface of each of the legs may be characterized as defining a non-rectangular outer shape or profile. In the embodiment of Figures 1-7, the outer surface of each leg comprises a cylindrical surface extending axially (relative to corresponding axis 112) and, thus, the profile at cross-section is circular. In some embodiments, the cylindrical radial outer surface of the legs may be advantageous as the cylindrical geometry can more fully fill the drilled hole, as compared to a rectangular prismatic geometry, and thus, offers the potential for enhanced bending strength and fixation within the bone segments. More specifically, rectangular cross-sectional dimensions of legs having a rectangular prismatic shape are limited as the sharp corners of the cross-section contact the cylindrical inner surface of the bone defined by the drilled hole, and any increases in one of the cross-sectional dimensions of the rectangular cross-section may result in sufficient interference between the legs and bone segments to restrict insertion of the legs into the bone segments.

[0084] Although the legs illustrated in the embodiment of Figures 1 , 2, 3, 4, 5, 6, and 7 have cylindrical outer surfaces defining circular profiles in cross-sections taken perpendicular to axes 112, in other embodiments, the legs may have outer surfaces with other geometries that define other non-rectangular profiles in cross-sections taken perpendicular to the central axes of the legs, such as polygons, semi-circular, or elliptical cross-sections.

[0085] In the embodiment of Figure 1 -7, the outer surface of each leg also comprises a leg taper 1 15 disposed at the distal end of each leg. The leg taper 115 may have an angle 0 measured from central axis 1 12 of each leg. For example, the outer surface of each leg or a portion thereof may be characterized as frustoconical andcharacterized by a non-zero leg taper angle 0. In embodiments described herein, the leg taper angle 0 may range from 0 degrees to about 2.5 degrees, additionally or alternatively, from about 0.075 degrees to about 1.5 degrees, or, additionally or alternatively, from about 0.125 degrees to about 1 .25 degrees. In some applications, a non-zero taper angle 0 may advantageously facilitate a wedging fit between the legs and a cylindrically shaped drilled hole, which may enhance the retention of the implant with the bone segments. In addition, non-zero taper angles 0 may allow a narrower tip, which may aid in insertion of the leg into holes, while allowing an increased diameter at the fixed ends of the legs to increase the bending strength at the joints between the legs and the deformable component. For example, one or more bevels may be provided along the outer surface on each leg, for example, along the sides of legs that face away from each other

[0086] Referring still to Figures 1-7, each of the legs may comprise one or more serrations 118 axially spaced (relative to corresponding axis 112) along outer surface on the inside of each leg, for example, along the sides of legs that face toward each other. In this embodiment, each serration 118 is defined by a sloped surface 118a that slopes radially inward toward the corresponding axis 112 moving axially toward the distal end of each corresponding leg, and an upward facing shoulder 118b extending radially inward from the sloped surface toward axis 1 12 of the corresponding leg. In the embodiment of Figures 1 , 2, 3, 4, 5, 6 and 7, the sloped surface 118a on the inside of each leg at the distal end thereof and the bevel on the outside of each leg collectively define the tapered tips at the distal end of each leg.

[0087] As illustrated in the embodiment of Figures 1-7, the deformable component 120 is configured such that a portion of the deformable component 120 may be deformed, for example, such that the sternal device 100 may have both a first, contracted state and a second, expanded state. For example, referring to Figures 5, the deformable component 120 is configured to deform such that the sternal device 100 expands or contracts in a direction parallel to the central axis 105. Referring to Figure 6, the deformable component 120 is shown in a deformed state such that the sternal device 100 moves into the axially-extended conformation. Also, referring to Figure 7, the deformable component 120 may exhibit a tendency or bias toward the undeformed state such that the sternal device 100 exhibits a tendency to return to the axially contracted conformation.

[0088] More particularly, referring again to Figure 5, the deformable component 120 may comprise a first deformable bridge 122 and a second deformable bridge 124. In Figure 5, the deformable component, particularly, both the first deformable bridge 122 and the second deformable bridge 124 are shown in the undeformed state. As shown (and as also seen in Figure 3), both the first deformable bridge 122 and the second deformable bridge 124 exhibit a curvature in a second reference plane parallel to the central axis 105 and perpendicular to the previously-referenced reference plane. In general, a central axis associated with the first deformable bridge 122 and / or the second deformable bridge 124 may have a constant or variable radius of curvature measured in the second reference plane from a point. In embodiments described herein, the radius of curvature of the central axis associated with the first deformable bridge 122 and / or the second deformable bridge 124 about 0 mm (i.e., linear) to about 200 mm, alternatively range from about 25 mm to about 150 mm, and more alternatively range from about 50 mm to about 100 mm. It should be appreciated that the radius of curvature of the central axis associated with the first deformable bridge 122 and / or the second deformable bridge 124 can vary along its length between ends 120a, 120b or, alternatively, can be constant along its length between ends 120a, 120b.

[0089] Referring to Figure 7, in comparison to Figure 6, the first deformable bridge 122 and / or the second deformable bridge 124 may deform via a decrease in the curvature associated with the first deformable bridge 122 and / or the second deformable bridge 124. For example, when deformed the first deformable bridge 122 and / or the second deformable bridge 124 may be flattened, such that the distance between the ends 120a, 120b increases.

[0090] Referring again to Figure 5, in some embodiments the first deformable bridge 122 and the second deformable bridge 124 may together form a “diamond”-shape. As can be seen in Figure 5 (also, Figures 1 and 2) the first deformable bridge 122 and second deformable bridge may be bowed or splayed away from each other at a midpoint between the first end 120a and the second end 120b. Not intending to be bound by theory, in some embodiments the bow splay may provide working-room to sever the first deformable bridge 122 and the second deformable bridge 124 in the event of an emergency surgical procedure in which access to the chest cavity is required.

[0091] Generally, each of the first deformable bridge 122 and the second deformable bridge 124 may be characterized as having a radially outer surface extending axially along the length thereof, respectively, generally substantially from first end 120a to the second end 120b. In addition, each of the first deformable bridge 122 and the second deformable bridge 124 may be characterized with respect to a cross-section taken in a plane oriented perpendicular to its length. In cross-section, the outer surface of each of the first deformable bridge 122 and the second deformable bridge 124 defines a non-rectangular outer shape or profile. In this embodiment, the profile at the crosssection is generally elliptically-shaped. In particular, the outer surface of each of the first deformable bridge 122 and the second deformable bridge 124 includes a flat upper surface, a flat lower surface, and a pair of rounded edges extending from flat upper surface to the flat lower surface. The flat upper surface and flat lower surface 114 are generally oriented parallel to each other and to the reference plane. As previously described, the first deformable bridge 122 and / or the second deformable bridge 124 exhibit a curvature in the second reference plane and, thus, the flat upper surface of each of the first deformable bridge 122 and the second deformable bridge 124 comprises a convex surface, whereas the lower flat surface comprises a concave surface.

[0092] In this embodiment, the cross-sectional area of the of each of the first deformable bridge 122 and the second deformable bridge 124 in any plane oriented perpendicular to its length is equal to or greater than the cross-sectional area of each leg taken in any plane oriented perpendicular to axis 112. In embodiments described herein, the ratio of (i) the cross-sectional area of each of the first deformable bridge 122 and the second deformable bridge 124 in any plane oriented perpendicular to its length to (ii) the cross-sectional area of each leg in any plane oriented perpendicular to the axis of the leg (e.g., axis 112) is 10.0 to 1.0, additionally or alternatively, about 2.5 to 1.0 or, additionally or alternatively, about 1.5 to 1.0.

[0093] Referring again to Figures 1-7, the sternal device 100 comprises a first lateral component 132 disposed toward the first end 120a of the deformable component and a second lateral component 134 disposed toward the second end 120b of the deformable component 120b. Generally, each of the first lateral component 132 and the second lateral component 134 may extend perpendicular to the central axis, forexample, parallel to the first latitudinal axis 104a and the second latitudinal axis 104b, respectively.

[0094] As shown best in Figure 5, the first deformable bridge 122 and the second deformable bridge 124 each extend between the first lateral component 132 and the second lateral component 134, for example, such that a first end of each of the first deformable bridge 122 and the second deformable bridge 124 is fixed to and integrated with the first lateral component 132 and, likewise, such that a second end of each of the first deformable bridge 122 and the second deformable bridge 124 is fixed to and integrated with the second lateral component 134.

[0095] As similarly discussed with respect to the first deformable bridge 122 and the second deformable bridge 124, the first lateral component 132 and the second lateral component 134 may be characterized as having a radially outer surface extending axially along the length thereof, respectively (e.g., generally in the direction of the lateral axes 104a, 104b). In addition, each of the first lateral component 132 and the second lateral component 134 has a cross-section taken in a plane oriented perpendicular to its length, for example, perpendicular to the lateral axes 104a, 104b, respectively. In cross-section, the outer surface of each of the first lateral component 132 and the second lateral component 134 defines a non-rectangular outer shape or profile. In this embodiment, the profile at cross-section is generally oval or elliptical in shape.

[0096] As described above, legs, first deformable bridge 122, second deformable bridge 124, first lateral component 132, and second lateral component 134 may have different cross-sectional geometries. Generally, to smoothly blend the various components together, the sternal device 100 may include smoothly curved concave transitional surfaces at the intersection of various components. In some embodiments, the transitional surfaces may be effective to reduce bending stress concentrations and may be used to grip sternal device 100 with a surgical insertion or retaining tool.

[0097] In this embodiment, sternal device 100 is made of a Nitinol material, and thus, can be heat treated and programed, as discussed above, to have shape memory and superelastic / pseudoelastic characteristics such that sternal device 100 may be classified as a superelastic shape memory implant, and may transform from one shape to another when exposed to heat.

[0098] Referring now to Figures 8, 9, and 10, another embodiment of a sternal device 800 is shown. Figure 8 illustrate the sternal device 800 in an axially-extended conformation and Figure 9 illustrates an axially-retracted conformation.

[0099] As shown in the embodiments of Figures 8 and 9, the sternal device 800 includes two anchor components 810 and a deformable component 820. In the embodiment of Figures 8 and 9, a first anchor component 810 is incorporated with the deformable component 820 and a second anchor component 810 is configured to be engaged with the deformable component 120. Additionally, Figure 10 illustrates the second anchor component 810 separate, for example, from the deformable component 820 which, as noted above, is integral with the first anchor component 10.

[0100] As illustrated in the embodiment of Figures 8, 9, and 10, the first and second anchor components 810 are configured to engage a sternum by via a hook or grapple structure. In use, the hook structure of the anchor components 810 are generally configured to hook or wrap partially around the edges of the sternum, or into drilled or punched holes of the sternum such that the sternum can be pulled together (e.g., toward each other).

[0101] As illustrated in the embodiment of Figures 8, 9, and 10, the deformable component 820 is configured such that a portion of the deformable component 820 may be deformed laterally, for example, in a direction perpendicular to the direction of expansion or contraction, thereby allowing the deformable component 820 to expand or contract. For example, as shown in Figure 8, the deformation of the deformable component 820 allows the deformable component to move into the axially-extended conformation. Also, as shown in Figure 9, the deformable component 820 may exhibit a tendency for a portion of the deformable component 820 to take on a serpentine or undulating pattern in a direction perpendicular to the direction of expansion or contraction, for example, such that the deformable component 820 exhibits a tendency to return to the axially contracted conformation.

[0102] In some embodiments, one or more of the at least one anchor components 810 may be configured to be selectively engaged to the deformable component 820. For example, in various embodiments the deformable component 820 and one or more of the at least one anchor components 810 may comprise any suitable combination of mating or interlocking structures. For example, in the embodiment of Figures 8, 9, and 10, the deformable component 820 and one or more of the at least one anchorcomponents 810 comprise a “zip-tie” engagement structure. More particularly, the one or more of the at least one anchor components 810 comprise a linear ratchet gear rack and the deformable component 820 comprises a pawl, cleat, or other structure configured to engage the ratchet gear rack.

[0103] Referring to Figure 10, the deformable component 820 and one or more of the at least one anchor components 810 may comprise separate structure, enabling the deformable component 820 and the one or more of the at least one anchor components 810 to be joined together during placement of the sternal device 800 with respect to the sternum.

[0104] Referring now to Figures 11 , 12, 13, 14, 15, and 16, another embodiment of a sternal device 1100 is shown. Figure 11 illustrates the sternal device 1100 in an axially- extended conformation, Figures 14 and 16 illustrate an axially-retracted conformation, and figures 12, 13, and 15 illustrate intermediate conformations.

[0105] AS shown in the embodiments of Figures 11-16, the sternal device 1100 includes two anchor components 1 110 and a deformable component 1120. In the embodiment of Figures 11-16, the deformable component 1120 is an independent structure from the anchor components 1 110, and a first and second anchor component 11 10 are each configured to be engaged with the deformable component 1120.

[0106] AS illustrated in the embodiment of Figures 11-16, and as similarly disclosed with respect to Figures 8-10, the first and second anchor components 11 10 are configured to engage a sternum by via a hook or grapple structure.

[0107] AS also illustrated in the embodiment of Figures 11-16, and as similarly disclosed with respect to Figures 8-10, the deformable component 1120 is configured such that a portion of the deformable component 1120 may be deformed laterally, for example, in a direction perpendicular to the direction of expansion or contraction, thereby allowing the deformable component 1120 to expand or contract. For example, the deformation of the deformable component 1120 allows the deformable component to move into the axially-extended conformation and the deformable component 1120 may exhibit a tendency for a portion of the deformable component 1120 to take on a serpentine or undulating pattern in a direction perpendicular to the direction of expansion or contraction, for example, such that the deformable component 1120 exhibits a tendency to return to the axially contracted conformation.

[0108] Finally, and again as similarly disclosed with respect to Figures 8-10, the deformable component 1120 and the anchor components 1110 comprise a “zip-tie” engagement structure.

[0109] Referring now to Figures 17, 18, and 19, another embodiment of a sternal device 1700 is shown. Figure 17 illustrates the sternal device 300 in an intermediate conformation, for example, between the axially-extended and axially-retracted conformations and Figures 18 and 19 illustrate the anchor components 1710 of the sternal device of Figure 17.

[0110] AS shown in the embodiment of Figure 17, the sternal device 300 includes two anchor components 1710 and a deformable component 1720. In the embodiment of Figure 17, the deformable component 1720 is an independent structure from the anchor components 1710, and a first and second anchor component 1710 are each configured to be engaged with the deformable component 1720.[oom] As illustrated in the embodiment of Figures 17-19, the first and second anchor components 1710 are configured to engage a sternum by via a suitable fastener. For example, in the embodiment of Figures 17-19, the first and second anchor components each include a plurality of holes suitable to receive a surgical screw, for example, such that the first and second anchor components may be secured with respect to the sternum. Additionally or alternatively, in some embodiments any suitable fastener may be employed, for example, a surgical staple. An example of a suitable surgical staple is disclosed in International Application No. PCT / US2021040544 published as WO / 2022 / 010920 and entitled “ORTHOPEDIC COMPRESSION IMPLANTS AND DEVICES FOR INSTALLING AND RETAINING SAME,” which is incorporated herein by reference in its entirety.

[0112] As also illustrated in the embodiment of Figures 17-19, and as similarly disclosed with respect to Figures 8-10, the deformable component 1720 is configured such that a portion of the deformable component 1720 may be deformed laterally, for example, in a direction perpendicular to the direction of expansion or contraction, thereby allowing the deformable component 1720 to expand or contract. For example, the deformation of the deformable component 1720 allows the deformable component to move into the axially-extended conformation and the deformable component 1720 may exhibit a tendency for a portion of the deformable component 1720 to take on a serpentine or undulating pattern in a direction perpendicular to the direction ofexpansion or contraction, for example, such that the deformable component 1720 exhibits a tendency to return to the axially contracted conformation.

[0113] Finally, and again as similarly disclosed with respect to Figures 8-10, the deformable component 1720 and the anchor components 1710 comprise a “zip-tie” engagement structure.

[0114] Referring now to Figures 20, 21 , and 22, another embodiment of a sternal device 2000 is shown. Figures 13-15 illustrate the sternal device 2000 in an axially-retracted conformations.

[0115] As shown in the embodiment of Figures 20-22, the sternal device 2000 includes a single anchor component 2010 and a deformable component 2020. In the embodiment of Figures 20-22, the deformable component 2020 is integrated with the anchor components 2010 and the anchor component 2010 is configured to be engaged with the deformable component 2020.

[0116] As illustrated in the embodiment of Figures 20-22, the anchor component 2010 is configured to engage a sternum by being wrapped around the sternum. For example, in the embodiment of Figures 20-22, in use, the sternal device may be wrapped around the sternum and the anchor component 2010 engaged with the deformable component 2020.

[0117] AS also illustrated in the embodiment of Figures 20-22, and as similarly disclosed with respect to Figures 8-10, the deformable component 2020 is configured such that a portion of the deformable component 2020 may be deformed laterally, for example, in a direction perpendicular to the direction of expansion or contraction, thereby allowing the deformable component 2020 to expand or contract. For example, the deformation of the deformable component 2020 allows the deformable component to move into the axially-extended conformation and the deformable component 2020 may exhibit a tendency for a portion of the deformable component 2020 to take on a serpentine or undulating pattern in a direction perpendicular to the direction of expansion or contraction, for example, such that the deformable component 2020 exhibits a tendency to return to the axially contracted conformation.

[0118] Finally, and again as similarly disclosed with respect to Figures 810-15, the deformable component 2020 and the anchor components 2010 comprise a “zip-tie” engagement structure.

[0119] Referring now to Figures 23, 24, and 25, another embodiment of a sternal device 2300 is shown. Figures 23-25 illustrate the sternal device 2300 in an axially-retracted conformations.

[0120] The embodiment of Figures 23-25 illustrates an embodiment similar to the embodiment of Figures 20-22. For example, as shown in the embodiment of Figures 23-25, the sternal device 2300 includes a single anchor component 2310 and a deformable component 2320. In the embodiment of Figures 23-25, the deformable component 2320 is integrated with the anchor components 2310 and the anchor component 2310 is configured to be engaged with the deformable component 2320.

[0121] Additionally, the embodiment of Figures 23-25 illustrates an alternative embodiment of a deformable component, for example, as shown in Figures 23-25. As similarly disclosed with respect to various other embodiments, the deformable component 2320 of is configured such that a portion of the deformable component 2320 may be deformed laterally, for example, in a direction perpendicular to the direction of expansion or contraction, thereby allowing the deformable component 2320 to expand or contract. For example, the deformation of the deformable component 2320 allows the deformable component to move into the axially-extended conformation and the deformable component 2320 may exhibit a tendency for a portion of the deformable component 2320 to take on a serpentine or undulating pattern in a direction perpendicular to the direction of expansion or contraction, for example, such that the deformable component 2320 exhibits a tendency to return to the axially contracted conformation.

[0122] Referring now to Figures 26, 27, and 28, another embodiment of a sternal device 2600 is shown. Figures 26-28 illustrate the sternal device 2600 in an axially-retracted conformations.

[0123] As shown in the embodiment of Figures 26-28, the sternal device 2600 includes a single anchor component 2610 and a deformable component 2620. In the embodiment of Figures 26-21 , the deformable component 2620 is integrated with the anchor components 2610 and the anchor component 2610 is configured to be engaged with the deformable component 2620.

[0124] As illustrated in the embodiment of Figures 26-28, the anchor component 2610 is configured to engage a sternum by being wrapped around the sternum. For example, in the embodiment of Figures 26-28, in use, the sternal device may bewrapped around the sternum and the anchor component 2610 engaged with the deformable component 2620.

[0125] AS also illustrated in the embodiment of Figures 26-28, and as similarly disclosed with respect to Figures 8-10, the deformable component 2620 is configured such that a portion of the deformable component 2620 may be deformed laterally, for example, in a direction perpendicular to the direction of expansion or contraction, thereby allowing the deformable component 2620 to expand or contract. For example, the deformation of the deformable component 2620 allows the deformable component to move into the axially-extended conformation and the deformable component 2620 may exhibit a tendency for a portion of the deformable component 2620 to take on a serpentine or undulating pattern in a direction perpendicular to the direction of expansion or contraction, for example, such that the deformable component 2620 exhibits a tendency to return to the axially contracted conformation.

[0126] In the embodiment of Figures 26-28, the anchor component 2610 may be configured to be selectively engaged to the deformable component 2620. For example, in various embodiments the deformable component 2620 and the anchor component 2610 comprise combination of mating or interlocking structures. For example, and more particularly, the anchor component 2610 comprises a plurality of linearly-arranged holes and the deformable component 2620 comprises a peg or other structure configured to engage one of the holes in the anchor component 2610.

[0127] Referring now to Figures 29, 30, and 31 , another embodiment of a sternal device 700 is shown. Figures 29-31 illustrate the sternal device 2900 in an axially-extended conformations.

[0128] As shown in the embodiment of Figures 29-31 , the sternal device 2900 includes a single anchor component 2910 and a deformable component 2920. In the embodiment of Figures 29-31 , the deformable component 2920 is independent from the anchor component 2910 and the anchor component 2910 is configured to be engaged with the deformable component 2920.

[0129] As illustrated in the embodiment of Figures 29-31 , the anchor component 2910 is configured to engage a sternum by being wrapped around the sternum. For example, in the embodiment of Figures 29-31 , in use, the sternal device may be wrapped around the sternum and the anchor component 2910 engaged with the deformable component 2920.

[0130] As also illustrated in the embodiment of Figures 29-31 , the deformable component 2920 is configured as a deformable, surgical staple 2920. In some embodiments, the deformable, surgical staple 2920 may be deformable over the length thereof, for example, such that distance between the terminal ends of the staple vary between the axially-retracted and axially-extended conformations.

[0131] In the embodiment of Figures 29-31 , the anchor component 2910 may be configured to be engaged with the deformable component 2920. For example, in the embodiment of Figures 29-31 , the anchor component 2910 comprises one or more holes in each end thereof, such that the deformable staple may be received into a hole within each end of the anchor component 2910, for example, so as to hold the respective ends of the anchor component with respect to each other. In the embodiment of Figures 29- 31 , the anchor component 2910 is configured such that the deformable surgical staple 2920 may also be received into the sternum; for example, the deformable surgical staple may extend through the holes in the anchor component 2910 and be secured within holes in the sternum.

[0132] Referring now to Figures 32, 33, and 34, another embodiment of a sternal device 3200 is shown. Figures 32-34 illustrate the sternal device 3200 in an axially-extended conformations.

[0133] AS shown in the embodiment of Figures 32-34, and as similarly disclosed with respect to Figures 22-24, the sternal device 3200 includes a single anchor component 3210 and a deformable component 3220. In the embodiment of Figures 32-34, the deformable component 3220 is independent from the anchor component 3210 and the anchor component 3210 is configured to be engaged with the deformable component 3220.

[0134] AS illustrated in the embodiment of Figures 32-34, and as similarly disclosed with respect to Figures 29-31 , the anchor component 3210 is configured to engage a sternum by being wrapped around the sternum. For example, in the embodiment of Figures 32-34, in use, the sternal device may be wrapped around the sternum and the anchor component 3210 engaged with the deformable component 3220.

[0135] AS also illustrated in the embodiment of Figures 32-34, the deformable component 3220 is configured as a deformable, surgical staple 3220. In some embodiments, the deformable, surgical staple 3220 may be deformable over thelength thereof, for example, such that distance between the terminal ends of the staple vary between the axially-retracted and axially-extended conformations.

[0136] In the embodiment of Figures 32-34, the anchor component 3210 may be configured to be engaged with the deformable component 3220. For example, in the embodiment of Figures 32-34, the anchor component 3210 comprises one or more holes in each end thereof, such that the deformable staple may be received into a hole within each end of the anchor component 3210, for example, so as to hold the respective ends of the anchor component with respect to each other. In the embodiment of Figures 32- 34, the anchor component 3210 is configured such that the deformable surgical staple 3220 is not received into the sternum; for example, the deformable surgical staple may extend through the holes in the anchor component 3210 and extend generally parallel to the surface of the sternum.

[0137] Referring now to Figures 35 and 36, another embodiment of a sternal device 3500 is shown. Figure 35 illustrates the sternal device 3500 in an axially-extended conformation and Figure 36 illustrates the sternal device 3500 in an axially-retracted conformation.

[0138] As shown in the embodiment of Figures 35-36, the sternal device 3500 includes two anchor components 3510 and three deformable components 3520. In the embodiment of Figures 35-36, the deformable components 3520 are independent structures from the two anchor components 3510, and a first and second anchor component 3510 are each configured to be engaged with the plurality of deformable components 3520.

[0139] AS illustrated in the embodiment of Figures 35-36, the first and second anchor components 3510 are configured to engage a sternum by via a suitable fastener. For example, in the embodiment of Figures 35-36, the first and second anchor components 3510 each include a plurality of holes suitable to receive a surgical screw, for example, such that the first and second anchor components may be secured with respect to the sternum. Additionally or alternatively, in some embodiments any suitable fastener may be employed, for example, a surgical staple.

[0140] AS also illustrated in the embodiment of Figures 35-36, the deformable components 3520 are configured as deformable, surgical staples 3520. In some embodiments, the deformable, surgical staple 3520 may be deformable over thelength thereof, for example, such that distance between the terminal ends of the staple vary between the axially-retracted and axially-extended conformations.

[0141] In the embodiment of Figures 35-36, the plurality of anchor components 3510 may be configured to be engaged with the deformable component 3520. For example, in the embodiment of Figures 35-36, the anchor component 3510 comprises a plurality of holes along one edge thereof, such that the deformable staple may be received into a hole within each the two anchor components 3510, for example, so as to hold the two anchor components with respect to each other. In the embodiment of Figures 35-36, each of the anchor components 3510 is configured such that the deformable surgical staple 3220 is not received into the sternum; for example, the deformable surgical staple may extend through the holes in the anchor component 3510 and extend generally parallel to the surface of the sternum.

[0142] In use, a sternal device, for example, as disclosed with respect to one or more of the embodiments and / or figures herein, may be employed in the performance of a medical procedure (e.g., a surgical procedure). For example, in some embodiments a sternal device may be employed in the performance of a sternotomy to provide closure of a surgically divided sternum.

[0143] In some embodiments, a method of using a sternal device in the performance of a surgical procedure may include the step of providing a sternal device, for example, including at least one anchor component and at least one deformable component. In some embodiments, the deformable component may be provided in an axially-extended conformation. Additionally, in an embodiment, such as where the one or more anchor component are formed from a shape memory and / or superelastic material, for example, Nitinol, the one or more anchor components may also be provided in an extended conformation.

[0144] In some embodiments, a method of using a sternal device in the performance of a surgical procedure may also include the step of positioning the one or more anchor components with respect to the sternum of the patient. For example, in various embodiments, the anchor components may be hooked onto the sternum, wrapped around or partially around the sternum, fastening the anchor component in place with respect to the sternum or a portion thereof (e.g., via surgical screws or staples), or combinations thereof.

[0145] In some embodiments, a method of using a sternal device in the performance of a surgical procedure may also include the step of engaging the one or more deformable components with the one or more anchor components, for example, as disclosed with respect to the various embodiments herein.

[0146] In some embodiments, a method of using a sternal device in the performance of a surgical procedure may also include the step of allowing the deformable component to transition from the axially-extended conformation into the axially-retracted conformation and, as such, thereby applying a compressive force to the sternum. For example, Figures 37-51 illustrate various embodiments of a sternal device as employed in the context of a surgical procedure.

[0147] In some particular embodiments, and referring to the embodiment of Figures 1- 7, the surgical use of sternal device 100 may utilize the shape memory characteristics of Nitinol to impart compressive loads across a sternotomy site, for examples, to apply compression across a break or fracture, to aid and enable fusion. In the manner previously described, sternal device 100 can be made of Nitinol and programed though deformation and heat treatment, such that the shape memory of the Nitinol material causes opposing legs to be biased toward each other, for example, by decreasing leg angle a (e.g. distal ends move inward toward each other) and / or causes the first deformable bridge 122 and the second deformable bridge 124 to return to an initial state (e.g., where the first deformable bridge 122 and the second deformable bridge 124 spread laterally) so as to draw the first end 120a and the second end 120b together (e.g., toward each other), in response to heating of sternal device 100. Such heating of sternal device 100 may be accomplished with an external source (e.g. , heat- activated), or as sternal device 100 is brought to room temperature or body temperature (e.g., body temperature-activated). In addition, in some embodiments, the shape transformation may have already occurred and an external tool may be used to restrain the deformation of sternal device 100. For example, in some embodiments, the external tool may apply forces to the first deformable bridge 122 and the second deformable bridge 124 to elastically flex the deformable component such that the first end 120a and second end 120 are forced apart. Additionally or alternatively, in some embodiments, the legs may be constrained with axes 1 12 oriented parallel and perpendicular to the reference plane so as to be inserted into holes in bone segments. The legs may be advanced into the holes until a lower surface deformable component120 is pressed into contact (or approximate contact) with the sternum. The external tool may be removed, thereby releasing the strain energy of the elastically deformed sternal device 100 and allowing the legs to apply compression across the sternum to draw a break or fracture together.

[0148] While exemplary embodiments have been shown and described, modifications thereof can be made by one skilled in the art without departing from the scope or teachings herein. The embodiments described herein are exemplary only and are not limiting. Many variations and modifications of the systems, apparatus, and processes described herein are possible and are within the scope of the disclosure. Accordingly, the scope of protection is not limited to the embodiments described herein, but is only limited by the claims that follow, the scope of which shall include all equivalents of the subject matter of the claims. Unless expressly stated otherwise, the steps in a method claim may be performed in any order. The recitation of identifiers such as (a), (b), (c) or (1 ), (2), (3) before steps in a method claim are not intended to and do not specify a particular order to the steps, but rather are used to simplify subsequent reference to such steps.

Claims

CLAIMSWhat is claimed is:1 . A sternal device comprising: at least one anchor component configured to engage a sternum or a portion thereof; and at least one deformable component configured to transition between an axially- extended conformation and an axially-retracted conformation.

2. The sternal device of claim 1 , wherein the at least one anchor component is integral with the at least one deformable component3. The sternal device of claim 1 , wherein the at least one anchor component comprises a plurality of legs.

4. The sternal device of claim 3, wherein the at least one anchor component comprises a first leg, a second leg, a third leg, and a fourth leg.

5. The sternal device of claim 4, wherein the deformable component comprises a first deformable bridge and a second deformable bridge.

6. There sternal device of claim 5, wherein the first deformable bridge and the second deformable bridge are configured to deform by decreasing a curvature associated with each of the first deformable bridge and the second deformable bridge.

7. The sternal device of claim 5, wherein the deformable component further comprises a first lateral component and a second lateral component, wherein each of the first deformable bridge and the second deformable bridge extend between the first lateral component and the second lateral component.

8. The sternal device of claim 7, wherein the first leg is fixably attached to a first end of the first lateral component, the second leg is fixably attached to a first end of thesecond lateral component, the third leg is fixably attached to a second end of the first lateral component, and the fourth leg is fixably attached to a second end of the second lateral component.

9. The sternal device of claim 8, wherein each of the first leg, the second leg, the third leg, and the fourth leg is configured to be deformed such that a longitudinal axis of each leg form an angle of at least 70° and not more than 90° with respect to a reference plane that includes a central axis, a first lateral axis extending axially along the first lateral component, and a second lateral axis extending axially along the second lateral component.

10. The sternal device of claim 1 , wherein 9 is at least 80° and not more than 90°.11 . The sternal device of claim 1 , wherein, in the axially-retracted conformation, the deformable component exhibits a serpentine or undulating pattern.

12. The sternal device of claim 11 , wherein, in the axially-extended conformation, the serpentine or undulating pattern is lessened.

13. The sternal device of claim 1 , wherein the sternal device is formed from a shape memory material.

14. The sternal device of claim 1 , wherein the sternal device is formed from a superelastic material.

15. The sternal device of claim 1 , wherein the sternal device is formed from Nitinol.

16. A method comprising: providing a sternal device comprising one or more anchor components and one or more deformable components; engaging the sternal device with the sternum of a patient; andallowing the deformable component to transition from an axially-extended conformation into an axially-retracted conformation so as to apply a compressive force to the sternum.

17. The method of claim 16, wherein engaging the sternal device with the sternum of the patient is performed as part of a sternotomy.

18. The method of claim 16, wherein the one or more anchor component comprises a first leg, a second leg, a third leg, and a fourth leg, and wherein the deformable component comprises a first deformable bridge and a second deformable bridge.

19. The method of claim 18, wherein the deformable component further comprises a first lateral component and a second lateral component, wherein each of the first deformable bridge and the second deformable bridge extend between the first lateral component and the second lateral component.

20. The method of claim 19, wherein the first leg is fixably attached to a first end of the first lateral component, the second leg is fixably attached to a first end of the second lateral component, the third leg is fixably attached to a second end of the first lateral component, and the fourth leg is fixably attached to a second end of the second lateral component, and wherein each of the first leg, the second leg, the third leg, and the fourth leg is configured to be deformed such that a longitudinal axis of each leg form an angle of at least 70° and not more than 90° with respect to a reference plane that includes a central axis, a first lateral axis extending axially along the first lateral component, and a second lateral axis extending axially along the second lateral component.21 . A method for comprising compression to a bone, the method comprising: providing a bone compression device comprising at least two anchor components and one or more deformable components; engaging the bone compression device with a bone of a patient; and allowing the deformable component to transition from the axially-extended conformation into the axially-retracted conformation so as to apply a compressive force to the bone.

22. The method of claim 21 , wherein the at least two anchor component comprise a first leg, a second leg, a third leg, and a fourth leg, and wherein the deformable component comprises a first deformable bridge and a second deformable bridge.

23. The method of claim 22, wherein the deformable component further comprises a first lateral component and a second lateral component, wherein each of the first deformable bridge and the second deformable bridge extend between the first lateral component and the second lateral component.

24. The method of claim 23, wherein the first leg is fixably attached to a first end of the first lateral component, the second leg is fixably attached to a first end of the second lateral component, the third leg is fixably attached to a second end of the first lateral component, and the fourth leg is fixably attached to a second end of the second lateral component, and wherein each of the first leg, the second leg, the third leg, and the fourth leg is configured to be deformed such that a longitudinal axis of each leg form an angle of at least 70° and not more than 90° with respect to a reference plane that includes a central axis, a first lateral axis extending axially along the first lateral component, and a second lateral axis extending axially along the second lateral component.

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