WO2018187527A1

WO2018187527A1 - Method and kit for performing percutaneous dilational tracheostomy

Info

Publication number: WO2018187527A1
Application number: PCT/US2018/026174
Authority: WO
Inventors: Amr Salah Ibrahim Elsid OMAR
Original assignee: Hamad Medical Corporation; Hamad Medical Corporation Global Patent Trust
Priority date: 2017-04-07
Filing date: 2018-04-05
Publication date: 2018-10-11

Abstract

The method and kit for performing a percutaneous dilational tracheostomy utilize a puncturing wire (18) in addition to a tracheal tube (12) and bronchoscope (16). The puncturing wire (18) is inserted through the bronchoscope (16) and the bronchoscope (16) is used to select the location for the tracheostomy. The puncturing wire (18) has a sharp cutting end (20) for cutting a stoma in the patient's trachea at a selected location. The puncturing wire (18) may be pulled and positioned based on visual inspection of indicia (M1, M2, M3) marked thereon. The puncturing wire (18) serves to guide a dilator and tracheostomy tube into the trachea.

Description

METHOD AND KIT FOR PERFORMING PERCUTANEOUS DILATIONAL

TRACHEOSTOMY TECHNICAL FIELD

The disclosure of the present patent application relates generally to a surgical kit and method for performing a tracheostomy, and particularly to the usage of a puncturing wire for cutting a stoma in a patient's trachea from within the trachea at a selected location during a percutaneous dilational tracheostomy.

BACKGROUND ART

Percutaneous dilational tracheostomy (PDT), also referred to as bedside tracheostomy, is the placement of a tracheostomy tube in the trachea. PDT is considered a minimally invasive, bedside procedure that may be easily performed in the intensive care unit or at the patient's bedside (with continuous monitoring of the patient's vital signs).

In a typical PDT, the patient is positioned and prepped in the same manner as for a standard operative tracheostomy. A skin incision is made and a thin needle is entered percutaneously into the trachea. The tract between the skin and the tracheal lumen is serially dilated over a guidewire and stylet before a tracheostomy tube is advanced into the trachea.

In the typical PDT procedure, as described above, the trachea cannot be visualized during placement of the tracheostomy tube. As such, the patient is at risk of surgical error (such as the surgeon's choice of skin incision site as well as the incision itself), as well as major complications, such as bleeding, esophageal perforation, pneumothorax and conversion to surgical tracheostomy. The patient is further at risk of suffering minor complications, such as subcutaneous emphysema, air leakage from the inflatable cuff, puncture of the endotracheal tube or posterior tracheal wall, accidental detubation and hypotension.

It would be desirable to be able to minimize these risks during the PDT procedure. Thus, a method and kit for performing a percutaneous dilational tracheosotomy solving the aforementioned problems is desired.

DISCLOSURE

The method for performing a percutaneous dilational tracheostomy includes using a puncturing guide wire for cutting a stoma in a patient's trachea in a retrograde manner with visualization. The wire is configured to pass through a bronchoscope working channel to allow visualization of the trachea and facilitate precise puncturing of the trachea from the inside. The wire includes a sharp first or cutting end for puncturing the trachea and a curved, second end adapted for gripping by the medical practitioner external to the patient and the bronchoscope. The wire includes demarcations to identify various lengths of the wire from the second end, e.g., 20 cm., 15 cm., and 5 cm.

The puncturing wire is inserted through the bronchoscope and advanced through the bronchoscope until the first end reaches a desired point in the trachea, e.g., between the second and third tracheal rings. The bronchoscope can guide the wire to the desired puncturing position and provide support and/or stability for the wire to puncture the trachea. Once the guide wire is inserted into the trachea, the guide wire can serve to guide a dilator and a tracheostomy tube into the trachea.

A kit for performing a percutaneous dilational tracheostomy can include a tracheal tube with an inflatable cuff, a bronchoscope, and a puncturing wire. As described above, the puncturing wire has a distal end, which is adapted for gripping by the medical practitioner external to the patient and the bronchoscope, and a proximal end. The proximal end is sharp and defines a cutting end. The kit can further include at least one stomal dilator and a tracheal cannula.

These and other features of the present disclosure will become readily apparent upon further review of the following specification and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1 illustrates initial steps of a method for performing a percutaneous dilational tracheostomy, including an endotracheal tube being inserted into a trachea of a patient.

Fig. 2 illustrates further steps of the method for performing a percutaneous dilational tracheostomy, including a bronchoscope being inserted into the endotracheal tube.

Fig. 3 illustrates further steps of the method for performing a percutaneous dilational tracheostomy, including passage of a puncturing wire through the bronchoscope.

Fig. 4 shows a kit for performing a percutaneous dilational tracheostomy.

Similar reference characters denote corresponding features consistently throughout the attached drawings. BEST MODE(S)

A method for performing a percutaneous dilational tracheostomy is a percutaneous dilational tracheostomy (PDT) technique which uses a puncturing wire for cutting a patient's trachea from within the trachea. As shown in Fig. 1, a tracheal tube 12 is inserted in to the trachea. A cuff 14 of a tracheal tube 12 is deflated to position it just below the vocal cords and re-inflated to provide a good seal. As shown in Fig. 2, a bronchoscope 16 is positioned within the tube 12. As shown in Fig. 3, a puncturing wire 18 is inserted through the bronchoscope 16. The puncturing wire 18 has a distal end 22, which is adapted for gripping by the medical practitioner external to the patient and the bronchoscope 16, and a proximal end 20. The distal end can be curved and/or dull. The proximal end 20 is sharp and defines a cutting end. The patient's trachea is punctured by the cutting end 20 of the puncturing wire 18 at the selected location for the tracheostomy to create a stoma.

During the above procedure, the puncturing wire 18 is advanced through the bronchoscope 16 until the proximal end 20 reaches the selected location in the trachea. The bronchoscope 16 allows visualization of the trachea and provides support for the puncturing wire 18 during puncturing of the trachea. The tracheal puncture can be, e.g., between the second and third tracheal rings, and locating this site is performed under continuous bronchoscopic guidance. As shown in Fig. 3, once the proximal end of the puncturing wire 18 passes through the trachea and out of the skin, it can be retrieved by forceps F.

Preferably, as shown in Fig. 4, the puncturing wire 18 is marked with indicia and/or coloring to provide guidance for the medical practitioner. As a non-limiting example, for a conventional 90 cm long surgical wire, the first marking Ml could be positioned at a point 5 cm from distal end 22. The second marking M2 could be positioned at a point 15 cm from distal end 22. The third marking M3 could be positioned at a point 20 cm from distal tip 22. In order to increase visible distinction, markings M2 and M3 could be black, for example, and marking Ml could be red, for example. The wire can be pulled by forceps F until one or more of the markings appear. For example, once the 5 cm mark appears, the wire can be manipulated so that the soft distal end faces the tracheal bifurcation under bronchoscopic vision. The wire can then be pulled to the 10 cm mark. The puncturing wire 18 may be between approximately 90 cm and approximately 1.5 m. It should be understood that the puncturing wire 18 may be coated with a layer of polytetrafluoroethylene or any other suitable type of friction reducing material. The stoma is dilated with at least one dilator by passing over the wire 18. It should be understood that more than one dilator may be used. For example, a first, smaller dilator, such as a conventional 14-French dilator, may be passed over the proximal end 20 of the puncturing wire 18 and directed towards the trachea to dilate the skin and superficial tissues. An additional small skin incision may be made to facilitate dilator passage. This could then be followed by advancing a second, larger dilator over the puncturing wire 18. The at least one dilator may then be removed and a tracheostomy tube obturator along with a tracheostomy tube may be passed over the wire 18. Finally, endotracheal suction can be performed and ventilation established through the tracheostomy tube.

In order to perform the procedure described above, a kit 50 with all of the necessary components may be provided. As shown in Fig. 4, the kit for performing a percutaneous dilational tracheostomy 50 can include a tracheal tube 12 with an inflatable cuff 14, a bronchoscope 16, and a puncturing wire 18. As described above, the puncturing wire 18 has a distal end 22, which is adapted for gripping by the medical practitioner external to the patient and the bronchoscope 16, and a proximal end 20. The proximal end 20 is sharp and defines a cutting end. The kit 50 can further include at least one stomal dilator 26 and a tracheostomy tube or tracheal cannula 28.

It is to be understood that method for performing a percutaneous dilational tracheostomy is not limited to the specific embodiments described above, but encompasses any and all embodiments within the scope of the generic language of the following claims enabled by the embodiments described herein, or otherwise shown in the drawings or described above in terms sufficient to enable one of ordinary skill in the art to make and use the claimed subject matter.

Claims

1. A method for performing a percutaneous dilational tracheostomy, comprising the steps of:

inserting an endotracheal tube through the mouth and into the trachea of a patient; inserting a bronchoscope into the endotracheal tube;

inserting a puncturing wire through a channel of the bronchoscope, the puncturing wire having a sharp cutting end;

performing bronchoscopy on the patient to select a location for tracheostomy;

puncturing a trachea of the patient at the selected location for the tracheostomy with the sharp cutting end of the puncturing wire to create a stoma;

passing at least one dilator over the sharp cutting end of the wire for dilating the stoma; and

inserting a tracheostomy tube into the trachea through the stoma.

2. The method for performing a percutaneous dilational tracheostomy as recited in claim 1, further comprising pulling the sharp cutting end of the puncturing wire once the cutting end passes through the skin.

3. The method for performing a percutaneous dilational tracheostomy as recited in claim 2, wherein the sharp cutting end of the puncturing wire is pulled until one or more indicia marked on the puncturing wire are visualized.

4. The method for performing a percutaneous dilational tracheostomy as recited in claim 1, wherein the selected location is between the second third tracheal rings of the patient.

5. The method for performing a percutaneous dilational tracheostomy as recited in claim 1 , further comprising the step of removing the at least one dilator prior to inserting the tracheostomy tube.

6. The method for performing a percutaneous dilational tracheostomy as recited in claim 1, further comprising the step of inflating a cuff of the endotracheal tube just below the vocal cords of the patient.

7. A kit for performing a percutaneous dilational tracheostomy, comprising:

a tracheal tube with an inflatable cuff;

a bronchoscope; and

a puncturing wire having a sharp cutting end, wherein the puncturing wire is configured for removable insertion in the bronchoscope such that the sharp cutting end of the puncturing wire can cut a stoma through a patient's trachea at a selected site.

8. The kit for performing a percutaneous dilational tracheostomy as recited in claim 7, further comprising:

at least one stomal dilator; and

a tracheostomy tube.

9. The kit for performing a percutaneous dilational tracheostomy as recited in claim 7, wherein the puncturing wire further comprises a dull gripping end, wherein the dull gripping end defines a proximal end of the puncturing wire and the sharp cutting end defines a distal end of the puncturing wire, the sharp cutting end being adapted for cutting the patient' s trachea to form the stoma.

10. The kit for performing a percutaneous dilational tracheostomy as recited in claim

9, wherein the puncturing wire has a length between approximately 90 cm and approximately

I.5 m.

11. The kit for performing a percutaneous dilational tracheostomy as recited in claim 10, wherein the puncturing wire has an outer coating layer comprising a friction reducing material.

12. The kit for performing a percutaneous dilational tracheostomy as recited in claim

I I , wherein the friction reducing material comprises polytetrafluoroethylene.