US-12616509-B2 - Sternum fixation device and method

US12616509B2US 12616509 B2US12616509 B2US 12616509B2US-12616509-B2

Abstract

An apparatus and technique for infernally securing a plurality of bone segments together. The device incorporates a plate-like structure stabilizing the fracture and integrated fasteners to attach straps circumscribing the bone segments.

Inventors

Louis A. Houff

Assignees

CIRCUMFIX SOLUTIONS, INC.

Dates

Publication Date: 20260505
Application Date: 20240207

Claims (19)

1 . A bone plate assembly, comprising: a plate having a plurality of apertures formed through a thickness of the plate, with a first aperture and a second aperture of the plurality of apertures being positioned proximal to lateral edges on opposing sides of the plate; and a locking fastener having a first end and a second end opposite the first end, wherein the locking fastener is configured to be positioned around a portion of a bone, wherein the first end is configured to be inserted through the first aperture of the plurality of apertures, wherein the second end is configured to be inserted through the second aperture of the plurality of apertures, wherein the first end and the second end are each configured to be locked into the plate, and wherein the first aperture and the second aperture each comprise a fastener attachment that allows movement of the locking fastener in an insertion direction and that resists movement of the locking fastener in a direction opposite the insertion direction.
2 . The bone plate assembly of claim 1 , wherein the first end and the second end of the locking fastener are separately tensionable.
3 . The bone plate assembly of claim 1 , wherein the locking fastener is flexible.
4 . The bone plate assembly of claim 1 , wherein the fastener attachment at the first aperture comprises a base slot and an exit slot, wherein the base slot is configured to accommodate entry of either of the first end or the second end of the locking fastener into the fastener attachment to accept and secure the locking fastener, and wherein the exit slot is configured to allow either of the first end or the second end of the locking fastener to exit the fastener attachment.
5 . The bone plate assembly of claim 1 , further comprising: at least one locking nut configured to be positioned over at least one of the plurality of apertures and having a hollow core configured to allow either of the first end or the second end of the locking fastener to pass through the hollow core in a first direction, wherein the locking fastener comprises ribs configured to engage an interior surface of the hollow core, thereby resisting movement of the locking fastener in a direction opposite the first direction.
6 . The bone plate assembly of claim 5 , wherein the at least one locking nut comprises a first locking nut and a second locking nut, wherein the first locking nut is configured to be inserted over the first end of the locking fastener until the first locking nut reaches a surface of the plate, and wherein the second locking nut is configured to be inserted over the second end of the locking fastener until the second locking nut reaches the surface of the plate.
7 . The bone plate assembly of claim 1 , wherein the locking fastener is configured to be passed behind a sternum through an intercostal space on each side of the sternum.
8 . The bone plate assembly of claim 1 , wherein the first end and the second end of the locking fastener are each textured.
9 . The bone plate assembly of claim 1 , wherein the first end and the second end of the locking fastener are each tapered.
10 . The bone plate assembly of claim 1 , wherein the first end and the second end of the locking fastener are configured to be received by a ratcheting fastener.
11 . The bone plate assembly of claim 1 , wherein the first end and the second end of the locking fastener are configured to be fitted with a cardiac needle.
12 . The bone plate assembly of claim 1 , wherein the locking fastener is cannulated and comprises a cannulation.
13 . The bone plate assembly of claim 12 , wherein the cannulation comprises a channel configured to receive a guide wire.
14 . The bone plate assembly of claim 13 , wherein the guide wire comprises a stop configured to resist movement into the locking fastener.
15 . A bone plate assembly, comprising: a plate having a plurality of apertures formed through a thickness of the plate, with a first aperture and a second aperture of the plurality of apertures being positioned proximal to lateral edges on opposing sides of the plate; a locking fastener having a first end and a second end opposite the first end; and a locking nut configured to be positioned over the first aperture and having a hollow core configured to allow the first end of the locking fastener to pass through the hollow core in a first direction, wherein the locking fastener is configured to be positioned around a portion of a bone, the first end is configured to be inserted through the first aperture, the second end is configured to be inserted through the second aperture, the first end is configured to be locked into the plate using the locking nut, and the locking fastener is configured to engage an interior surface of the hollow core to resist movement of the locking fastener in a direction opposite the first direction.
16 . A bone plate assembly, comprising: a plate having a plurality of apertures formed through a thickness of the plate, with a first aperture and a second aperture of the plurality of apertures being positioned proximal to lateral edges on opposing sides of the plate; and a locking fastener comprising a first end and a second end opposite the first end, wherein the locking fastener is cannulated and comprises a cannulation, wherein the locking fastener is configured to be positioned around a portion of a bone, the first end is configured to be inserted through the first aperture of the plurality of apertures, the second end is configured to be inserted through the second aperture of the plurality of apertures, and the first end and the second end are each configured to be locked into the plate.
17 . The bone plate assembly of claim 16 , wherein the cannulation comprises a channel configured to receive a guide wire.
18 . The bone plate assembly of claim 16 , wherein the guide wire comprises a stop configured to resist movement into the locking fastener.
19 . A bone plate assembly, comprising: a plate having a plurality of apertures formed through a thickness of the plate, with a first aperture and a second aperture of the plurality of apertures being positioned proximal to lateral edges on opposing sides of the plate; and a locking fastener having a first end and a second end opposite the first end, wherein the first end and the second end of the locking fastener are configured to be fitted with a cardiac needle, wherein the locking fastener is configured to be positioned around a portion of a bone, the first end is configured to be inserted through the first aperture of the plurality of apertures, the second end is configured to be inserted through the second aperture of the plurality of apertures, the first end and the second end are each configured to be locked into the plate.

Description

CROSS-REFERENCE TO RELATED APPLICATION This application is a continuation of U.S. patent application Ser. No. 17/591,483, filed Feb. 2, 2022, which is a continuation of U.S. patent application Ser. No. 16/208,707, filed Dec. 4, 2018, and issued as U.S. Pat. No. 11,241,264, which is a divisional of U.S. patent application Ser. No. 14/178,107, filed Feb. 11, 2014, and issued as U.S. Pat. No. 10,154,864, that claims the benefit of provisional of U.S. Provisional Application No. 61/801,005, filed Mar. 15, 2013, all of which are incorporated herein in their entireties. FIELD OF THE INVENTION This invention relates to an implantable sternum fixation device to secure and aid in the healing of a surgically cut or fractured sternum. BACKGROUND OF THE INVENTION Over the last 30 years Open Reduction Internal Fixation (ORIF) with Rigid Internal Fixation (RIF) has become accepted as the standard of care for treating many types of fractures helping patients painlessly return to pre-injury function earlier and more reliably than conventional treatment methods such as casting, bracing, interosseous wiring and cerclage wiring. In addition, when properly applied RIF improves the reestablishment of pre-fracture anatomical bone alignment promoting more reliable infection free healing. Besides the proven benefits in trauma care, ORIF is an acceptable method of repositioning bones in elective procedures and repairing bones surgically cut or fractured when necessary to gain surgical access to perform a primary procedure. Such is the case in open-heart surgery where the sternum is surgically cut to gain access to cardiovascular structures contained within the chest wall. In such cases the sternum is surgically cut along the midline of the long axis of the bone separating the sternum and the associated rib cage in half sections left and right. The standard method for reconstructing the surgically cut sternum is the placement of stainless steel wires circumferentially (cerclage) around the sternum segments and compressing together by twisting the wires tight to hold the surgically cut bone ends together approximating the pre-cut anatomical position of the sternum and chest wall. In most cases wire fixation has proven to be a successful and cost effective method of repairing the cut sternum with minimal reports of infection and non-union. The literature describes complication rates (infection and/or non-union) as high as 8%. Patients that incur complications, however, can endure significant pain and resolving their issues has proven difficult, time consuming, and expensive. Patients with certain underlying health issues are predisposed to complications and a delayed healing response. For instance, perhaps most significantly, certain cardiovascular patients with multiple health issues including, as examples, COPD, diabetes, and/or suppressed immune response that may delay or prevent healing, exhibit a propensity for post-operative infection, hardware failure and/or nonunion of the sternum. Other factors, such as age, poor diet, smoking, alcohol abuse and/or drug use, can also adversely affect healing. Many of these patients exhibit diseased bone that is weak and may lack sufficient cortical density and thickness. Over the years, numerous attempts have been made to improve a method for fixing the sternum, but most devices are designed to address the sternum after complications have arisen and are not intended to prevent complications by providing an improved primary solution. Furthermore, many of the commonly marketed products tend to be over engineered, complicated and time-consuming to implant. There are also a host of devices that do not appropriately address the complexities of the human anatomy and the demands such fixation must address in clinical application. Those devices tend to offer little to no benefit over wire fixation and may lead to unexpected and unintended complications beyond what is known from wire fixation. The sternum is a flat bone with a thin cortex shell (dense outer bone layer). Cortical density and thickness are important factors with screw fixation techniques as they provide resistance against pullout when screws are tightened as purchase is achieved by the threads compacting and resting in bone. Cortical density and thickness are also important factors in cerclage wire fixation as stability relies on wires compressing directly against the cortex to maintain secure fixation. An implant construct must provide and maintain sufficient stabilization for a duration long enough to allow bone healing to occur. If healing does not occur within an acceptable timeframe hardware loosening often leading to hardware failure becomes an increasing risk. This principle also applies to sternum fixation. In the patient population prone to delayed healing and increased risk of complication, cerclage wire fixation may be contraindicated. In such cases, fixation failure occurs due to broken or loosened wires. In some instances,