Surgery – Respiratory method or device – Means placed in body opening to facilitate insertion of...
Reexamination Certificate
1997-06-03
2003-06-10
Lewis, Aaron J. (Department: 3761)
Surgery
Respiratory method or device
Means placed in body opening to facilitate insertion of...
C128S207290, C128S207140
Reexamination Certificate
active
06575158
ABSTRACT:
FIELD OF THE INVENTION
The field of this invention relates to endotracheal tube guides and their use in related tracheostomy procedures.
BACKGROUND OF THE INVENTION
Prior to delivery to the operating room, certain types of trauma patients are frequently intubated with endotracheal tubes (ETs) which are inserted into the trachea via a guide. Several issued U.S. patents deal with techniques of insertion of guides and ETs. Such patents are U.S. Pat. Nos. 4,672,960; 5,507,279; 5,235,970; 3,957,055; 4,892,095; and 4,655,214. Various designs of ETs have been used, as well as guides for such tubes. Of general interest in the area of ET and guide construction are U.S. Pat. Nos. 4,685,457; 5,329,921; 4,683,879; 4,919,126; 3,605,751; 5,119,811; 5,429,127; 5,353,787; and 5,546,936.
Thus, while guides have been used to insert ETs, when the patient is delivered to the operating room for surgery, the ET is typically removed as an incision is made in the trachea for insertion of the tracheal tube. The guide for the ET has already been removed prior to delivery of the patient to the operating room as part of the insertion procedure for the ET. Accordingly, in the past, if difficulties developed with the access to the trachea for insertion of the tracheal tube, it became necessary to reinsert the ET to prevent a decrease in oxygen saturation in the patient which could potentially lead to cardiac and brain damage, irreversible organ failure, or death.
Prior designs of airway guides have been sufficiently bulky so as to prevent their continuing use as a guide should reintubation with an ET be required during the tracheostomy procedure. Without the guide in place after removal of the ET during a tracheostomy procedure, there exists a risk that the ET will not be smoothly reinsertable into the patient after it has originally been withdrawn. This can occur because of inflammation caused by trauma which has been exacerbated with time and other conditions such that the initial removal of the guide for the ET, followed by removal of the ET during the tracheostomy, will preclude a quick reinsertion of the ET guide, followed by the ET, in a timely manner into the patient's trachea.
Accordingly, to address the potential risks to some patients where difficulty is encountered in the tracheostomy procedure, the apparatus and method of the present invention have been devised. The objective of the invention is to provide a guide having a suitable distal profile so as to facilitate the subsequent tracheostomy procedure without undue obstruction in the trachea. With the provision of such an airway guide, a procedure of the present invention has been developed so that the guide may be left in the trachea after removal of the ET at the onset of the tracheostomy procedure. A further object of the apparatus and method of the invention is to provide a guide made of a material with a low coefficient of friction such that on its own and/or in conjunction with body fluids, it can facilitate a rapid reinsertion of the ET. Yet another object of the invention is to provide a design for the guide which facilitates its sterilization for reuse.
Some prior designs (Eschmann) have incorporated a composite structure for the guide. In this design, the interior of the guide is made from a core made of a woven material, coated with a plastic material. However, in use, the plastic coating developed cracks which exposed the woven substrate and made sterilization of such designs a questionable procedure. Guides or stylets made with or without a lumen and having a constant cross-sectional area have also been employed, using polyvinylchloride (PVC). Accordingly, another object of the present invention is to provide a guide made from preferably a unitary material which has good lubricity and which can be reliably sterilized, yet at the same time be simply fabricated or molded into the desired shape so it can remain in place without getting in the way during a tracheostomy.
SUMMARY OF THE INVENTION
An ET guide is provided which is preferably made of polytetrafluoroethylene (PTFE), also known as Teflon®. The distal end has a reduced profile so that the guide can be left in place, with the ET removed in the operating room just prior to a tracheostomy. If for any reason problems are encountered in the tracheostomy procedure, the guide of the present invention, having been left in after the removal of the ET, can facilitate a reinsertion of the ET to avoid danger to the patient from a decrease in oxygen saturation. At the same time, the reduced distal profile allows the guide to remain in place during the tracheostomy procedure without obstructing the area of the incision for the tracheostomy. The guide can remain in place until the tracheostomy is successfully concluded, at which point it can be optionally removed. Leaving the guide in position as the tracheostomy is being conducted facilitates reinsertion of the ET which is routinely taken out in the operating room prior to the onset of the tracheostomy. In the preferred design, the guide has a circular cross-section until its distal end, which is a reduced-thickness, flattened segment of a predetermined length at the distal portion of the guide.
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Singer et al., An Endoscopic Technique for Restoration of Voice After Laryngectomy, Annals of Otology, Rhinology and Laryngectomy, Nov./Dec. 1980, vol. 89, No. 6.
Chelly Jacques
Katz Jeffrey
Smith Thomas
Duane Morris LLP
Lewis Aaron J.
The Board of Regents of the University of Texas System
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