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EP-4289466-B1 - SYSTEMS, APPARATUS, AND METHODS FOR PERFORMING A PERCUTANEOUS TRACHEOSTOMY

EP4289466B1EP 4289466 B1EP4289466 B1EP 4289466B1EP-4289466-B1

Inventors

  • TROPELLO, STEVEN P.
  • CAROLAN, Howard
  • GOLDWASSER, Elisabeth

Dates

Publication Date
20260506
Application Date
20190531

Claims (15)

  1. A system (100) for performing a percutaneous tracheostomy, comprising: an inflation assembly (110) including an elongated tube (112), an inflatable member (114), and a magnetic member (115), the elongated tube having a first end (111) , a second end (113), and defining a first lumen (116), the inflatable member coupled to the first end of the elongated tube, the inflatable member fluidically coupled to the first lumen such that the inflatable member can receive fluid via the first lumen, the magnetic member coupled to the first end of the elongated tube such that movement of the magnetic member can cause corresponding movement of the first end of the elongated tube; a guidewire assembly (120) including a guidewire (122) having a first end (121) and a second end (123), the first end of the guidewire including a coupling member (124), the coupling member configured to couple to the inflatable member such that translation of the elongated tube translates the guidewire assembly; and a tubular member (150) defining a second lumen, the second lumen configured to receive the inflation assembly (110) such that the inflation assembly is translatable within the second lumen.
  2. The system of claim 1, wherein the inflatable member is a first inflatable member, the tubular member including a second inflatable member (152) configured to transition between an uninflated and an inflated configuration, the second inflatable member configured to extend from an outer surface of the tubular member in the inflated configuration.
  3. The system of claim 2, wherein the second inflatable member (152) is configured to seal against an inner surface of a trachea in the inflated configuration.
  4. The system of claim 1, wherein the tubular member is configured such that a patient can be ventilated via the tubular member when the inflation assembly is disposed within and translated relative to the second lumen.
  5. The system of claim 1, wherein an outermost diameter of the inflation assembly is equal to or less than 50% of an inner diameter of the tubular member.
  6. The system of claim 1, wherein the inflation assembly includes a barrier member (195) coupled to the inflatable member and configured to be more resistant to being pierced than a sidewall of the inflatable member.
  7. The system of claim 6, wherein the barrier member has a first hardness and the sidewall of the inflatable member has a second hardness, the first hardness being greater than the second hardness.
  8. The system of claim 6, wherein a portion of the sidewall of the inflatable member has a first thickness and the barrier member has a second thickness, the second thickness being greater than the first thickness.
  9. The system of claim 1, wherein the inflatable member includes a first sidewall portion and a second sidewall portion opposite the first sidewall portion, the first sidewall portion configured to receive a needle therethrough and the second sidewall portion configured to be more resistant to being pierced by the needle than the first sidewall portion.
  10. The system of claim 1, wherein the inflation assembly includes a barrier member disposed on or coupled to the elongated tube, the barrier member is more resistant to puncturing or tearing than the inflatable member or a portion of the inflatable member.
  11. The system of claim 1, further comprising a needle (130) defining a third lumen (135) , the third lumen configured to receive the guidewire assembly.
  12. The system of claim 1, further comprising a fluid configured to be disposed within the inflatable member via the first lumen of the elongated tube such that a location of the inflatable member can be visualized via ultrasound.
  13. The system of claim 1, wherein the coupling member includes a shape memory material.
  14. The system of claim 1, wherein the coupling member is configured to transition between a first configuration for insertion and a second configuration for retention or coupling, the coupling member having a greater lateral extent relative to a central axis of the guidewire in the second configuration than in the first configuration such that the coupling member can expand to retain the guidewire relative to the inflatable member in the second configuration and such that the coupling member can fit inside a lumen of a needle in the first configuration, the coupling member being biased toward the second configuration such that, in the absence of external forces on the coupling member, the coupling member will assume the second configuration.
  15. The system of claim 14, wherein the first configuration of the coupling member is elongated such that the coupling member is shaped as a straight wire, and the second configuration of the coupling member corresponds to an unbiased shape or configuration that is a pigtail shape.

Description

Background Embodiments described herein relate to a system of claim 1. Some patients suffer from medical conditions that impair the patient's ability to breath. In such patients, a tracheostomy procedure may be beneficial. For some patients, percutaneous tracheostomy is a preferable procedure over open surgical tracheostomy because it is safer and less expensive. Some percutaneous tracheostomy techniques include the Ciaglia technique (serial or one-step dilation), the Griggs technique (wire forceps), and a translaryngeal tracheostomy (or Fantoni) technique. Generally, a percutaneous tracheostomy procedure requires safely puncturing the anterior trachea of a patient and inserting a guidewire using the Seldinger technique. Typically, the entry site used for the puncture and subsequent guidewire insertion is between the first and second or second and third tracheal rings. Identifying the ideal site for tracheal puncture, however, can be challenging. Advanced tools such as bronchoscopy and ultrasound have been used to improve upon physical exam landmarks. Bronchoscopes, like many advanced procedural tools, can be expensive, have issues with sterility, can malfunction, and often lack immediate availability. While ultrasound, unlike bronchoscopy, can identify tracheal rings, thyroid isthmus and proximal blood vessels to enable a safer needle insertion, ultrasound alone lacks the ability to visualize the posterior trachea and thus the patient can be at risk for posterior trachea wall damage. Without bronchoscopy, the damaged posterior wall cannot be accessed during dilatational percutaneous tracheostomy. Furthermore, standard bronchoscopes often inhibit adequate ventilation to the patient during a percutaneous tracheostomy procedure, raising additional risks for the patient. Thus, there is a need for systems, apparatus, and methods of performing a percutaneous tracheostomy which reduce risks to the patient and allows for the percutaneous tracheostomy to be quickly and easily performed. WO2017/216650 discloses an endotracheal tube for protecting the trachea and oesophagus from injury during the percutaneous dilatational tracheostomy procedure and bronchoscopy. The ET tube is fabricated with and without non-penetrable material piece. The ET tube has upper and lower portions. The upper portion of the ET tube is similar to cuffed endotracheal tubes and leads to a lower portion through proximal bevel. A short, thin cuff separates an upper portion from the lower portion. The lower portion is U-shaped, which provides bronchoscopic visualization of the anterior wall of trachea. The non-penetrable material covers the inner surface of the ET tube with non-penetrable material piece. This layer prevents the damage to respiratory canal during PDT procedure. A distal bevel of the ET facilitates induction of the ET tube into respiratory canal. Two radiopaque lines on the mid lateral sides of the tracheal tube help for locating right position of the tube. Summary In accordance with one aspect of the invention, there is provided a system for performing a percutaneous tracheostomy as defined by claim 1. Optional features are defined by the dependent claims. Brief Description of the Drawings FIG. 1 is a schematic illustration of a guidewire placement system, according to an embodiment.FIGS. 2A and 2B are schematic illustrations of a front view and a cross-sectional side view, respectively, of a portion of human anatomy.FIG. 2C is a schematic illustration of a cross-sectional side view of a portion of human anatomy engaged with a portion of the guidewire placement system of FIG. 1, according to an embodiment.FIGS. 3A-3M are schematic illustrations of a guidewire placement system in various stages of operation, according to an embodiment.FIG. 4 is a schematic illustration of a guidewire placement system, according to an embodiment.FIG. 5 is a schematic illustration of a guidewire placement system, according to an embodiment.FIG. 6 is a schematic illustration of a guidewire placement system, according to an embodiment.FIG. 7 is a flow chart of a method, according to an embodiment. Detailed Description It is disclosed but not claimed that a system includes an inflation assembly and a guidewire assembly. The inflation assembly can include an elongated tube, an inflatable member, and a magnetic member. The elongated tube can have a first end, a second end, and can define a lumen. The inflatable member can be coupled to the first end of the elongated tube and can be fluidically coupled to the lumen such that the inflatable member can receive fluid via the lumen. The magnetic member can be coupled to the first end of the elongated tube such that movement of the magnetic member can cause corresponding movement of the first end of the elongated tube. The guidewire assembly can include a guidewire having a first end and a second end. The first end of the guidewire assembly can include a coupling member, the coupling member configured to couple