System, method and apparatus for sternal closure

Surgery – Instruments – Suture retaining means

Reexamination Certificate

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C606S075000

Reexamination Certificate

active

06302899

ABSTRACT:

FIELD OF THE INVENTION
The present invention is related to the closure of hard or soft tissue that has been separated. More specifically, the present invention is related to the closure of a sternum with the use of wire sutures inserted through grommets and placed into the sternum.
BACKGROUND OF THE INVENTION
There are various circumstances in which separated tissue of a patient needs to be brought together so it can heal. Tissue is defined as bone, muscle or fascia that has been divided to gain access the thoracic cavity, mediastinum, or abdomen. For instance, in chest surgery, many times the sternum is separated so a surgeon can again gain access to the chest cavity and organs, muscle and tissue therein. After the surgeon has finished his procedure regarding the chest cavity, the sternum needs to be closed. Key to the healing process of the sternum is the proper stabilization and contact of the two severed sides together. Heretofore, there have been many techniques used to bring the separated sides of the sternum together and maintain them in contact so the healing process can occur. However, these techniques generally limit the movement the patient can experience without damaging or affecting the healing sternum. Furthermore, the process of introducing tools to bring the separated sides of the sternum together can itself create risk or cause damage to the sternum.
The present invention provides for bringing the separate sides of the sternum together while minimizing damage to them and maintaining them while also allowing some flexibility and movement by the patient without disturbing the healing process.
SUMMARY OF THE INVENTION
The present invention pertains to a system for closing together a first side of a sternum and a second side of the sternum of a patient. The system comprises a first grommet to be disposed in the first side. The system comprises a second grommet adapted to be disposed in the second side. The system comprises a mechanism for placing a grommet into the sternum. The placing mechanism is adapted to hold the grommet for placement in the sternum. The system comprises a first wire suture for insertion through the first and second grommets. The system comprises a stop mechanism for allowing the placing mechanism to place a grommet into the sternum only in a desired location of the patient and any other portion of the patient is protected from damage by the placing mechanism during operation.
The present invention pertains to a grommet. The grommet comprises a first portion adapted to engage hard or soft tissue and be seated in the hard or soft tissue. The first portion has a hollow channel extending through it. The grommet comprises a second portion which slides into the first portion through the hollow channel and forms a friction fit with the first portion. The second portion has a hollow channel extending through it.
The present invention pertains to an approximator. The approximator comprises a mechanism for engaging the ends of a wire suture. The approximator comprises a mechanism for tensioning the wire suture. The engaging mechanism is connected to the tensioning mechanism. The approximator comprises a torque limiter in contact with the tensioning mechanism which limits the tension the tensioning mechanism can apply to the wire suture.
The present invention pertains to a drill stop mechanism. The drill stop mechanism comprises a bottom plate adapted to fit underneath hard or soft tissue to stop an object from penetrating past the bottom plate. The drill stop mechanism comprises a mechanism for holding the bottom plate in place about the hard or soft tissue.
The present invention pertains to a grommet placement tool. The grommet placement tool comprises a handle. The grommet placement tool comprises an elongate portion extending from the handle which engages and holds a grommet which is to be inserted into hard or soft tissue.
The present invention pertains to a method of threading a wire suture through a hole in a sternum. The method comprises the steps of inserting a wire passer through the hole so it extends in and through the hole and beneath the sternum. Then there is the step of inserting a wire suture into the wire passer from beneath the sternum.
The present invention pertains to a method of bringing together a first side of a sternum and a second side of the sternum The method comprises the steps of placing a drill stop mechanism under the first side of the sternum. Then there is the step of introducing an object into the first side of the sternum over where the drill stop mechanism is located so the object strikes the drill stop mechanism after it has passed through the first side of the sternum. Next there is the step of removing the object from the first side of the sternum so a hole remains in the sternum. Then there is the step of placing a first grommet in the hole. Next there is the step of placing a second grommet in a hole in the second side of the sternum. Then there is the step of introducing a wire suture into the first and second grommets. Next there is the step of drawing the ends of the wire suture which extend from the first and second grommets together so the first and second sides of the sternum come together. Then there is the step of crimping the ends of the wire suture.
The present invention pertains to a grommet for tissue. The grommet comprises a first portion that is adapted to fix to the bottom of the tissue. The grommet comprises a second portion adapted to fit to the top of the tissue. Preferably, the first portion is threaded and self-tapping and the second portion is adapted to form a friction fit with a hole in the tissue. The second portion has a rim which seats on the top of the surface of the tissue.
The present invention pertains to a method for placing a grommet into a sternum. The method comprises the steps of forming a hole in the sternum. Then there is the step of placing a first portion of the grommet at the bottom of the sternum in the hole. Next there is the step of placing a second portion of the sternum at the top of the sternum in the hole.
The present invention pertains to a method of protecting a patient when forming a hole in the patient. The method comprises the steps of placing a stop mechanism below a portion of the patient where the hole is going to be formed but above the tissue of the patient which is not to have the hole extend into it. Then there is the step of creating the hole.


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R. Labitzke, G. Schrammt, U. Witzel, P. Quisthout, “Sleeve-Rope Closure” of the Median Sternotomy after Open Heart Operations, Thorac, cardiovasc. Surgeon 31 (1983) 127-128, ©Georg Thieme Verlag Stuttgart, New York, pp. 127-128.

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