The present invention relates generally to surgical stabilization of flail chest, chest wall bone fractures after trauma and/or the correction of chest wall deformities. More particularly, the invention relates to severe chest wall trauma and complex deformities of the anterior chest wall that need to be stabilized and/or corrected surgically by means of chest wall remodeling and surgical stabilization.
Flail chest is a life-threatening medical condition that occurs when a segment of the rib cage breaks due to trauma and becomes detached from the rest of the chest wall.
What is needed is a flail chest stabilization device that implants to a patient's body without connecting to a muscle, a rib or any surrounding tissue.
To address the needs in the art, a flail chest stabilization device is provided that includes a pair of lateral bridges, a pair of main stabilization bars, a screw and slider-element connector assembly, and a slider introducer tool, where the slider introducer tool positions the slider-element, where the main stabilization bars are connected by the screw and slider connector assembly to the lateral bridges, where the stabilization bars are in a parallel configuration or crossed configuration.
According to one aspect of the invention, the main stabilization bar is thicker in a center region relative to each end region, where the thicker center region imparts a central stabilization force that is greater than an end stabilization force.
In another aspect of the invention, the main stabilization bar includes a T-shape slot or a linear shape slot at each end. In one aspect, the slider-element further includes a spoiler block configured to limit a range of travel for the slider-element within the stabilization bar T-shape slot, where the screw and slider element assembly are moveably engaged with the T-shape slot or the linear shape slot.
In a further aspect, the invention includes a middle stabilization bar connected to the lateral bridges, where the middle stabilization bar is configured to provide antero-posterior stabilization. In one aspect, the middle stabilization bar includes a single thickness from end to end, where the middle stabilization bar has a plurality multiple threaded holes, or slots on each the end. In a further aspect, the middle stabilization bar is configured to impart a force that goes from front to back of a rib cage, where the imparted force flattens asymmetric deformities or stabilizes fractured bones. In another aspect, the middle bar is connected to the lateral bridges by lateral secondary mini-bridges, where the lateral secondary mini-bridges are connected to the lateral bridges by the screw and slider-element connector assembly, where the middle stabilization bar is connected to the secondary mini-bridge by a threaded screw.
In yet another aspect of the invention, the flail chest stabilization device implants to a patient's body without connecting to a muscle, a rib or any surrounding tissue.
According to one aspect of the invention, the lateral bridges include a flat or curved profile. In one aspect, the invention further includes a superior parallel stabilization bar, where the main stabilization bars are connected to the curved lateral in the crossed configuration, where the superior parallel stabilizer bar is connected to the flat lateral bridges, where the flat lateral bridges are further connected to the main stabilization bars.
According to another aspect of the invention, the slider introducer tool is positioned under the main stabilization bar during a surgical procedure.
The current invention is a device for the stabilization of flail chest, including multiple chest wall bone fractures and/or the correction of deformities of the anterior chest wall.
The system according to the current invention is different because it avoids fixation of the implants to the patient's body parts (muscles, ribs and surrounding tissues) as the system fixates by its own. The fixation method is original (sliders, bridges and screws). Also the possibility of crossed main stabilization bars with original curved bridges are innovative. The crossed stabilization bars can be combined to a superior parallel stabilization bars, thus the fixation system requires a combined curved-straight bridges.
This is a system comprised of main stabilization bars that can be parallel or crossed and are fixed laterally by bridges.
The main stabilization bar is thicker in the center where mayor forces are required and thinner in both ends where less stabilization forces are required.
There are two models of main stabilization bars, with (T shape slot) or without horizontal slot depending on the model of slider to be used.
The main lateral bridges are fixed by means of sliders and screws. There are two model of sliders, with and without spoiler. The slider with spoiler is intended to be used with the main stabilization bar that has T shaped slots.
In certain complex thoracic deformities or extremely severe chest trauma with sternal fractures that need mixed stabilization forces (anterior and posterior forces) a novel three bars system in which the middle bar and the lateral bridges provide combined antero-posterior stabilization has been designed.
In this specific variant, the middle bar has the same thickness from end to end and has a fixation method comprised of multiple threaded holes on each end. This middle bar is used to apply a force that goes from front to back in order to flatten asymmetric deformities or stabilize fractured bones such as the sternum. In order to fix this middle bar, two lateral secondary mini-bridges are fixed to the middle bar by means of one or two screws. Screws are placed into the threaded holes located at the end of the middle bar. The main bridges are used as an anchor for the middle bar fixation by means of the secondary mini-bridges.
Special original and innovative instrumentation has been designed for the delivery and placement of the sliders called “sliders introducers” that need to be placed under the main stabilization bar during the surgical procedure.
Turning now to the figures, one embodiment of a flail chest stabilization device 100 is provided in
According to another aspect of the invention, the slider introducer tool 108 is positioned under the main stabilization bar 104 during a surgical procedure, where there are two different model of slider introducers, a left handed and a right handed. The slider introducer tool engages the slider-element 106A by inserting an introducer tip 110 into a slider-element port 112, as shown in
In a further embodiment,
In yet another aspect of the invention, the flail chest stabilization device implants to a patient's body without connecting to a muscle, a rib or any surrounding tissue.
The present invention has now been described in accordance with several exemplary embodiments, which are intended to be illustrative in all aspects, rather than restrictive. Thus, the present invention is capable of many variations in detailed implementation, which may be derived from the description contained herein by a person of ordinary skill in the art. For example, one embodiment provides a structural implant that will reshape and or stabilize the surgical remodeling of complex congenital chest wall deformities such as Currarino Syndrome, Pectus Arquatum, Poland Syndrome, Pectus Excavatum and Pectus Carinatum in all its variants and Jeune Syndrome and any variant of congenital or acquired chest wall deformity. A further embodiment provides a structural implant that will stabilize and or replace the chest wall after the surgical reconstruction and or stabilization following massive resection of chest wall sections due to chest wall tumors.
All such variations are considered to be within the scope and spirit of the present invention as defined by the following claims and their legal equivalents.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2019/058924 | 4/9/2019 | WO |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO2019/197391 | 10/17/2019 | WO | A |
| Number | Name | Date | Kind |
|---|---|---|---|
| 6669697 | Pisharodi | Dec 2003 | B1 |
| 9833269 | Park | Dec 2017 | B2 |
| 9872708 | Park | Jan 2018 | B2 |
| 10531901 | Su | Jan 2020 | B2 |
| 10835293 | Pisharodi | Nov 2020 | B2 |
| 20040117016 | Abramson | Jun 2004 | A1 |
| 20110251540 | Notrica | Oct 2011 | A1 |
| 20170156759 | Park | Jun 2017 | A1 |
| 20180310973 | Son | Nov 2018 | A1 |
| 20190314072 | Uemura | Oct 2019 | A1 |
| Number | Date | Country |
|---|---|---|
| 106691565 | May 2017 | CN |
| 101037957 | May 2011 | KR |
| 1018524440000 | Apr 2018 | KR |
| WO-2017023147 | Feb 2017 | WO |
| Entry |
|---|
| Translation of CN106691565. |
| Translation WO2017023147 A1. |
| Number | Date | Country | |
|---|---|---|---|
| 20210022782 A1 | Jan 2021 | US |
| Number | Date | Country | |
|---|---|---|---|
| 62655532 | Apr 2018 | US | |
| 62699486 | Jul 2018 | US |