Managing patient airways remains a major concern in intensive care units (“ICU”) for patients that need assistance breathing. A tracheostomy is a medical procedure for providing an air passage to help a patient breathe when the usual rout for breathing is obstructed or impaired. The tracheostomy procedure may provide certain benefits. For example, patient comfort may be an immediate benefit because sedation and analgesic demands may be significantly reduced. In another example, the tracheostomy procedure is associated with improving the ability to wean a patient from mechanical ventilation, and thus can decrease the length of the patient's ICU stay.
A tracheostomy procedure may either be an operative tracheostomy or a percutaneous tracheostomy. An operative tracheostomy procedure is a surgical procedure that involves dissection and incision of the trachea under direct vision. A percutaneous dilational tracheostomy (“PDT”), also referred to as a bedside tracheostomy, is the placement of a tracheostomy tube without direct surgical visualization of the trachea, and is a minimally invasive procedure that may be easily performed in the ICU or at the patient's bedside. Accordingly, a PDT offers numerous advantages compared to an operative tracheostomy. For instance, it requires less time to perform a PDT, it is less expensive, and it may typically be performed sooner because an operating room is not required. Additionally, overall complications may be less frequent for PDT when compared to operative tracheostomies.
However, PDT has an increased risk of anterior tracheal injury and posterior tracheal wall perforation. The major complications encountered from PDT are bleeding, false track, esophageal perforation, pneumothorax, and conversion to surgical tracheostomy. The minor complications may include bleeding, subcutaneous emphysema, air leakage cuff, puncturing of the endotracheal tube or posterior tracheal wall, accidental detubation, and hypotension. Accordingly, the PDT procedure may be improved.
The present disclosure generally relates to a percutaneous dilational tracheostomy (“PDT”). In particular, the present disclosure provides a kit and method for performing a PDT including puncturing a patient's trachea from within the patient's trachea with a puncturing wire that includes an inner core and an outer sheath.
In light of the disclosures herein, and without limiting the scope of the invention in any way, in a first aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, a method of performing a percutaneous dilational tracheostomy (“PDT”) includes inserting a tracheal tube including an inflatable cuff through a mouth and into a trachea of a patient; inserting a bronchoscope into the tracheal tube; inserting a puncturing wire through a channel of the bronchoscope. The puncturing wire includes a sharp cutting end opposite a dull gripping end. The method also includes puncturing the trachea of the patient with the sharp cutting end of the puncturing wire from within the trachea at a selected location to create a stoma; passing at least one dilator over the sharp cutting end of the puncturing wire for dilating the stoma; inserting a tracheostomy tube into the trachea through the stoma; and removing the puncturing wire from the patient.
In a second aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the method further includes pulling the sharp cutting end of the puncturing wire once the sharp cutting end passes through at least the trachea or skin of the patient. The pulling advances a portion of the puncturing wire out of the patient.
In a third aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the puncturing wire includes multiple markings, and the sharp cutting end is pulled until at least one of the multiple markings appears outside of the patient.
In a fourth aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the method further includes manipulating the puncturing wire once a marking nearest the dull gripping end of the multiple markings appears outside of the patient, wherein the manipulating includes positioning the puncturing wire such that the dull gripping end faces a tracheal bifurcation of the patient.
In a fifth aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the method further includes, after the puncturing wire is manipulated, advancing the puncturing wire into the patient until the next adjacent marking to the marking nearest the dull gripping end is near the skin of the patient.
In a sixth aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the selected location is between the second and third tracheal rings of the patient.
In a seventh aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, puncturing the trachea of the patient includes providing support to the sharp cutting end with the bronchoscope when the sharp cutting end punctures the trachea.
In an eighth aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the puncturing wire includes an inner core at least partially enclosed by an outer sheath. The inner core includes the sharp cutting end, and the outer sheath includes the dull gripping end opposite the sharp cutting end.
In a ninth aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the method further includes inflating the inflatable cuff of the tracheal tube at a position just below the vocal chords of the patient.
In a tenth aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, a kit for performing a PDT includes a bronchoscope including a channel, a tracheal tube, and a puncturing wire. The tracheal tube includes an insertion end and a free end with an inflatable cuff near the insertion end, and the tracheal tube is adapted to receive the bronchoscope. The puncturing wire includes a sharp cutting end and a dull gripping end, and is adapted to be removably inserted in the channel of the bronchoscope. The sharp cutting end is adapted to cut a stoma through a trachea of a patient from within the trachea at a selected site.
In an eleventh aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the kit further includes at least one stomal dilator and a tracheostomy tube.
In a twelfth aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the at least one stomal dilator includes a 14-French dilator.
In a thirteenth aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the puncturing wire is coated in a friction-reducing material.
In a fourteenth aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the friction-reducing material includes polytetrafluoroethylene.
In a fifteenth aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the puncturing wire has a length between approximately 90 cm and approximately 1.5 m.
In a sixteenth aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the puncturing wire includes at least one marking.
In a seventeenth aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, each of the at least one marking is a color or an indentation.
In a eighteenth aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the puncturing wire includes multiple markings including a first marking positioned approximately 5 cm from the dull gripping end, a second marking positioned approximately 15 cm from the dull gripping end, and a third marking positioned approximately 20 cm from the dull gripping end.
In a nineteenth aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the first marking is a first color, the second marking is a second color, and the third marking is a third color, and wherein the first color is different than at least one of the second color and the third color.
In a twentieth aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the puncturing wire includes an inner core at least partially enclosed by an outer sheath. The inner core includes the sharp cutting end, and the outer sheath includes the dull gripping end opposite the sharp cutting end.
The present disclosure generally relates to a percutaneous dilational tracheostomy (“PDT”), also referred to as a bedside tracheostomy. In particular, the present disclosure provides a kit and method for performing a PDT including puncturing a patient's trachea from within the patient's trachea with a puncturing wire that includes a sharp cutting end and a dull gripping end. Early tracheostomy procedures reduce the incidence and severity of laryngeal injuries and sinusitis, improve the weaning of patient's off of mechanical ventilation, and shorten a patient's ICU stay. Thus, early tracheostomy using the disclosed kits and methods can allow medical professionals to quickly obtain these benefits to decrease the length of a patient's overall hospital stay. Accordingly, by decreasing patients' ICU stays and overall hospital stays, hospital resources such as beds become available more quickly for incoming patients.
Additionally, the presently disclosed methods require less training and may minimize the experience needed to perform the procedure with the disclosed kit. Moreover, the disclosed methods may be performed by two medical professionals instead of three, as required when performing a conventional PDT. Further, the disclosed kits and methods may decrease the PDT procedure time and decrease the risk of stoma misplacement, false track, puncturing the posterior of the trachea or the tracheal tube, and of components being entrapped in the tracheal tube. Accordingly, the present disclosure may improve a medical facility's quality of care in a cost-effective manner by decreasing the incidence of tracheostomy complications, decreasing the tracheostomy procedure time, and reducing patients' post-procedural ICU stay.
Before describing an example PDT procedure utilizing the provided kits and methods, the flexible puncturing wire 18 component will be described. As depicted in
In various examples of the present disclosure, the puncturing wire 18 may have one or more markings, such as markings M1, M2, and M3 depicted in
The markings may be any suitable indication to a medical professional that a specific portion of the puncturing wire 18 is before the medical professional. For instance, the markings M1, M2, and M3 may be colors or indentations in the puncturing wire 18. In some examples in which the markings are colors, one or more of the markings may be a different color than one or more of the other markings to increase the visible distinction between the markings. For instance, the marking M1 may be red and the markings M2 and M3 may be black. In another instance, the marking M1 may be red, the marking M2 may be blue, and the marking M3 may be black.
In some aspects of the present disclosure, the puncturing wire 18 may be constructed of an inner core 30 (
The outer sheath 40 may protect the inner core 30 from external conditions, for example, frictional forces with a bronchoscope channel, and may provide additional durability and strength to the inner core 30 to prevent it from breaking. The outer sheath 40 may also provide extra rigidity, and accordingly strength, to the puncturing wire 50 to assist the puncturing wire 50 in puncturing a patient's trachea from within the trachea. In some instances, the outer sheath 40 may be coated with a layer of friction reducing material, such as polytetrafluoroethylene, to increase the ability of the puncturing wire 50 to slide within a bronchoscope channel or a patient's insides (e.g., the patient's air passage) during a procedure. In various aspects, the outer sheath 40 may be constructed in a way, and of a material, that makes the outer sheath 40 resistant to kinking. Accordingly, the puncturing wire 50 in such examples may be flexible to bend without its outer sheath 40 kinking, as depicted by the various configurations of the gripping end 22 of the puncturing wire 50 in
The procedure may begin, as depicted in
As depicted in
As further depicted in
Once the sharp cutting end 20 passes out of the skin, it may be retrieved by a forceps F or other suitable tool to prevent accidental lacerations of the medical professional by the sharp cutting end 20. A medical professional may then pull the puncturing wire 18 using the forceps F to advance the puncturing wire 18 out of the bronchoscope 16 and even further to a certain point. For instance, the medical professional may pull the puncturing wire 18 such that the marking M3 appears out of the patient's skin, the marking M2 appears, and then may stop when the marking M1 appears. At this point in the procedure, the medical professional may manipulate the puncturing wire 18 so that the gripping end 22 faces the patient's tracheal bifurcation. The medical professional may do so by using the bronchoscope 16 to position the gripping end 22. The medical professional may then advance the puncturing wire 18 back into the patient a certain amount. For instance, the medical professional may advance the puncturing wire 18 until the marking M2 is near the patient's skin, for example, when the marking M2 is just outside the patient or just within the patient.
Next in the procedure, a medical professional may then dilate the stoma with at least one dilator by passing the dilator over the puncturing wire 18. In some instances, an additional skin incision may be made to facilitate dilator passage if the stoma created by the sharp cutting end 20 is not sufficient. In some examples, more than one dilator may be used. For instance, a medical professional may pass a first, smaller dilator, such as a conventional 14-French dilator, over the puncturing wire 18 towards the patient's trachea to dilate the patient's skin and superficial tissues. The medical professional may then pass a second, larger dilator over the puncturing wire 18.
A medical professional may then remove the one or more dilators and may pass a tracheostomy tube obturator and a tracheostomy tube over the puncturing wire 18 to insert into the patient. The medical professional may then remove the puncturing wire 18 by pulling it all the way out of the patient. The medical professional may then perform endotracheal suction and establish ventilation for the patient through the tracheostomy tube. Accordingly, the disclosed PDT technique eliminates the need for a trocar and any complications that may result from using a trocar.
At step 510, the patient's trachea and skin are punctured with the sharp cutting end of the puncturing wire (e.g., the sharp cutting end 20 or 34) from within the trachea at a selected location to create a stoma. At step 512, at least one dilator is passed over the sharp cutting end of the puncturing wire for dilating the stoma. At step 514, a tracheostomy tube is inserted into the trachea through the stoma. At step 516, the puncturing wire is removed from the patient. At step 518, the example method 500 ends.
In other aspects of the present disclosure, the example kit 60 may additionally, or alternatively to the puncturing wire 18, include a puncturing wire 50. As described above, the puncturing wire 50 includes an inner core 30 at least partially enclosed by an outer sheath 40. The inner core 30 includes a sharp cutting end 34 and the outer sheath includes a dull gripping end 42 opposite the sharp cutting end 34 of the inner core 30. The puncturing wire 50 is constructed to be advanced through a channel in the bronchoscope 16 and the sharp cutting end 34 of the puncturing wire 50 is constructed to puncture a patient's trachea and skin from within the patient's trachea. In such other aspects, the kit 60 may also include at least one stomal dilator 26 and a tracheostomy tube 28.
Without further elaboration, it is believed that one skilled in the art can use the preceding description to utilize the claimed inventions to their fullest extent. The examples and embodiments disclosed herein are to be construed as merely illustrative and not a limitation of the scope of the present disclosure in any way. It will be apparent to those having skill in the art that changes may be made to the details of the above-described embodiments without departing from the underlying principles discussed. In other words, various modifications and improvements of the embodiments specifically disclosed in the description above are within the scope of the appended claims. For example, any suitable combination of features of the various embodiments described is contemplated. The scope of the invention is therefore defined by the following claims.
The present application is a continuation-in-part of PCT Patent Application No. PCT/US2018/026174 filed on Apr. 5, 2018, which claims priority to and the benefit of U.S. Provisional Application 62/483,317 filed on Apr. 7, 2017. The present application further claims priority to and the benefit of U.S. Provisional Application 62/744,999 filed on Oct. 12, 2018. The entirety of each are incorporated herein by reference.
Number | Date | Country | |
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62483317 | Apr 2017 | US | |
62744999 | Oct 2018 | US |
Number | Date | Country | |
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Parent | PCT/US2018/026174 | Apr 2018 | US |
Child | 16593644 | US |