GB2610046A

GB2610046A - Tracheostomy apparatus and devices

Info

Publication number: GB2610046A
Application number: GB2209355.3A
Authority: GB
Inventors: Steven Veasey Neil; John Woosnam Christopher; Thomas Jeffrey Andrew; Bateman Timothy
Original assignee: Smiths Medical International Ltd
Current assignee: Smiths Medical International Ltd
Priority date: 2021-07-02
Filing date: 2022-06-24
Publication date: 2023-02-22
Also published as: GB202109625D0; GB202209355D0

Abstract

A reinforcement device 1 for use in percutaneous tracheostomy, the device insertable into the trachea via the nose or mouth, with a patient end 12 of the device being located at a region where instruments (20, Fig 2) – such as a cannula, needle, dilator etc. - enter the trachea during formation of the tracheostomy. The reinforcement device thus helps reduce collapse or radial compression of the trachea during formation of the tracheostomy. The reinforcement device may be configured as a tube, with at least the patient end of the tube reinforced, such as by a helical wire 13. A longitudinal slot 14 may extend along the anterior side of the patient end of the reinforcement tube, so that tracheostomy instruments can enter the tube via the slot and the tube can subsequently be withdrawn (Fig 2). The tube may be armoured (302, Fig 3) along its posterior side in the region of the slot to resist needle penetration. Radiation emitters (402, Fig 4), such as LEDs, may be provided close to the patient end to emit radiation visible externally of the patient through neck tissue.

Description

TRACHEOSTOMY APPARATUS AND DEVICES

This invention relates to tracheostomy apparatus of the kind including instruments for accessing the trachea through neck tissue.

The invention is more particularly concerned with tracheostomy apparatus for use in the percutaneous technique for inserting a tracheostomy tube.

The Seldinger percutaneous technique for inserting a tracheostomy tube involves inserting an assembly of a tight-fitting cannula on a needle through the skin and underlying neck tissue between adjacent tracheal cartilage rings so that the tip of the needle and cannula locate in the trachea. Some means for detecting insertion, such as a loss-of-resistance syringe could be attached to the hub of the needle. The needle is then removed, leaving the cannula in position to provide a track into the trachea. A guidewire is inserted through the cannula into the trachea following which the cannula is slid out along the guidewire, which is left in position. The next step is to slide a 14 gauge pre-dilator along the guidewire to expand the puncture site slightly so that it can receive a guiding catheter. A dilator, or a series of dilators of increasing diameter, is then slid along the guiding catheter to enlarge the opening sufficiently to receive the tracheostomy tube.

This technique is generally preferred over the alternative cut-down technique because it can be performed at the bedside, creates less trauma and is quicker healing. However, the percutaneous technique has been contra-indicated for children yotinger than sixteen because their softer tracheal tissue and cartilage rings can allow the trachea to collapse during the dilation step.

It is an object of the present invention to provide alternative medico-surgical apparatus and a device for use in the apparatus.

According to one aspect of the present invention there is provided tracheostomy apparatus of the above-specified kind, characterised in that the apparatus further includes a reinforcement device insertable into the trachea via the nose or mouth to the region where the instruments enter the trachea such that the reinforcement device helps reduce collapse of the trachea during access of the instruments to the trachea.

The reinforcement device preferably includes a tube reinforced along at least its patient end. The tube may be reinforced by a circumferential reinforcement, such as a helical wire. The tube preferably includes a longitudinal slot along its patient end on its anterior side so that the instruments can enter the tube via the slot and the tube can subsequently be withdrawn. The reinforcement tube may be armoured along its posterior side in the region of the slot to resist needle penetration. The reinforcement device may include one or more radiation emitters close to its patient end to emit radiation visible externally of the patient through neck tissue. Preferably the reinforcement device includes a plurality of radiation emitters spaced longitudinally of one another.

According to another aspect of the present invention there is provided tracheostomy apparatus including instruments for accessing the trachea through neck tissue, characterised in that the apparatus includes a reinforcement tube adapted for insertion into the trachea via the nose or mouth so that the patient end of the tube locates in the region where the instruments enter the trachea, that at least the patient end of the tube is reinforced to help reduce collapse of the trachea during access of the instruments to the trachea, and that the tube has a longitudinal slot along its patient end on its anterior side so that the instruments can enter the tube via the slot and the tube can be subsequently withdrawn.

According to a further aspect of the present invention there is provided a reinforcement device or tube for use in apparatus according to the above one or other aspect of the present invention.

According to a fourth aspect of the present invention there is provided a kit for use in a method of forming a tracheostomy including one or more instruments for forming a tracheostomy opening, a reinforcement tube having a patient end at least reinforced against collapsing radially and having a longitudinal slot at the patient end on its anterior side and opening at the tip of the reinforced tube, at least one dilator and a tracheostomy tube, the method including the steps of inserting the reinforcement tube via the mouth or nose so that its patient end locates in the trachea in the region of the desired tracheostomy, forming an opening to the trachea through neck tissue with the instrument or instruments such that they extend into the slot, dilating the opening with the dilator, the reinforcement tube reducing collapse of the trachea caused by pressure applied during the steps of forming an opening and dilating the opening, and subsequently withdrawing the reinforcing tube such that its slot enables it to slide over any inserted instrument or dilator, and subsequently insetting the tracheostomy tube.

Tracheostomy apparatus, a reinforcement device, and a method of forming a tracheostomy in a paediatric patient will now be described, by way of example, with reference to the accompanying drawings, in which: Figure 1 is a perspective view of a reinforcement tube being a part of the apparatus; Figure 2 illustrates use of the apparatus; Figure 3 is a perspective view of a part of first modified form of the reinforcement tube; and Figure 4 is a perspective view of a part of a second modified form of the reinforcement tube.

The apparatus comprises a conventional set of instruments used to make an opening into the trachea through neck tissue of a paediatric patient and for introducing a tracheostomy tube with the addition of a novel reinforcement device for reinforcing the trachea during the procedure.

There is no need to illustrate or explain in detail the conventional instruments but these would typically include a scalpel, a needle mounted on a loss-of-resistance syringe, a guidevvire, a pre-dilation catheter, one or more dilators and the tracheostomy tube mounted on an obturator or introducer. Alternative dilation instruments could be provided such as a balloon dilator or Griggs forceps. The needle is used to make the initial penetration of the trachea. Even though the needle is mounted on a loss-of-resistance syringe, which provides an indication when the tip of the needle penetrates the trachea, there is still some risk the tip of the needle will be inserted too far and cause damage to the posterior wall of the trachea, especially in the case of a paediatric patient with a small diameter trachea. Subsequent stages of enlarging the trachea by dilation involve a certain amount of force being applied to the anterior wall of the trachea, which in normal use could cause the trachea to collapse. The additional reinforcement device is in the form of a reinforcement tube 1 insertable in the trachea. The purpose of the reinforcement tube is to reinforce the trachea internally so as to prevent it being damaged during the tracheostomy procedure.

The reinforcement tube is a form of a modified endotracheal tube 1 in that its rear or machine end 10 locates externally of the mouth or nose and its forward or patient end 11 extends a short distance below or beyond the site of the proposed tracheostomy. The tube is made of a flexible plastics material and is reinforced against radially compression at least along a region 12 at its patient end adapted to extend along either side of (above and below) the site of the tracheostomy. The reinforcement tube 1 may be reinforced by a circumferential (including helical) member along its entire length or just along its patient end region 12. The reinforcement of the tube could take various different forms. In one form the reinforcement is a helical wire 13 of a stiff material, such as a metal, ceramic or hard plastics, the dimensions, pitch and nature of the wire being sufficient to prevent any significant radial compression of the tube along the reinforced region. Alternatively, the reinforcement may be provided by thickened regions of the wall of the tube. The external diameter of the reinforcement tube 1 at least along its patient end region 12 is selected to be a relatively close fit within the trachea so that when the trachea is compressed during the tracheostomy procedure it cannot be deflected very far before contacting the supporting reinforcement tube, which thereby limits further compression. Alternative reinforcements could instead be used such as a series of annular rings, a mesh or a stiff sleeve attached to or embedded in the wall of the tube at its patient end.

The patient end 11 of the reinforcement tube 1 is bevelled and a longitudinal slot 14 extends along the anterior side of the tube. The slot 14 opens at the bevelled patient end 11 and extends rearwardly such that, in use, the site of the tracheostomy is located about half way along the length of the slot. The width of the slot 14 is preferably about half the external diameter of the tube 1, such that the slot subtends an angle of about 600 at the centre of the tube. The slot 14 may be formed by cutting through the turns of the reinforcement 13 along the length of the slot and subsequently heat forming or overmoulding over the cut ends of the reinforcement so that they do not form exposed sharp edges. Alternatively, the reinforcement 13 could be added after forming the tube and its patient end slot. In a further alternative arrangement the reinforced patient end could be formed separately from the main shaft of the tube and subsequently joined with the shaft. In such an arrangement the patient end could be made entirely of a stiff material resistant to compression, such as a hard plastics, a metal or ceramic.

The reinforcement tube 1 is preferably used to provide ventilation of the patient during the tracheostomy procedure. The reinforcement tube 1 preferably, but optionally, includes a conventional inflatable sealing cuff 15 on its outer surface just rearwardly of the rear end of the slot 14. In addition to confining gas flow in the trachea along the bore of the tube 1 the sealing cuff 15 helps anchor the patient end 11 centrally in the trachea and prevents displacement during the tracheostomy procedure.

In use, the reinforcement tube 1 is inserted first in the usual way for an endotracheal tube, such as by using a laryngoscope, such that the patient end tip 11 of the tube locates just below the proposed site of the tracheostomy. A conventional percutaneous tracheostomy procedure is then started with the needle and cannula 20 being inserted through neck tissue, between adjacent tracheal rings "TR"in the manner shown in Figure 2. The slot 14 in the reinforcement tube 1 allows for excessive insertion of the needle and cannula 20 without it puncturing wall material of the tube. The slot 14 also allows the guidewire (not shown) and predilator to be subsequently inserted and pass through the slot and out of the open patient end 11 of the tube 1. The stoma can then be dilated by any conventional technique, such as by a series of dilators of increasing diameters, a single stage dilator, a balloon dilator or Griggs forceps. The reinforcement tube 1 remains in place during the dilation stage and ensures that the trachea does not collapse under the pressure applied. It also helps reduce damage to the tracheal rings "TR". Once the stoma has been dilated the reinforcement tube 1 is pulled rearvvardly so that the tracheostomy tube can be inserted. The slot 14 ensures that the reinforcement tube 1 can be pulled rearwardly of the trachea without being held by the inserted instruments.

In order further to reduce the risk that the needle mounted on the loss-of-resistance syringe might damage the posterior wall of the trachea if over-inserted the reinforcement tube 301 could be armoured with a shield 302 that resists penetration by the needle on its posterior wall, opposite the slot 314 as shown in Figure 3. The shield 302 could take the form of a plate of a hard material such as a metal, ceramic or hard plastics, or it could be in the form of a tightly woven mesh of a ballistic material such as an aramid fibre.

It is important to ensure that the tracheostomy procedure is performed in line with the slot in the patient end of the reinforcing tube. Figure 4 shows an arrangement where the tube 401 includes several lamps 402, such as LEDs, on the posterior wall of the tube opposite the slot 414 and located to radiate visible light through the slot. The lamps 402 need to be bright enough to be visible externally through the neck tissue. By using three lamps 402 as shown it is possible to see the orientation of the reinforcement tube and to use the central lamp as the guide for making the incision into the trachea.

The present invention is not limited to paediatric tracheostomy apparatus but could have application in apparatus for other patients with insubstantial or damaged neck tissue.

Claims

CLAIMS1. Tracheostomy apparatus including instruments (20) for accessing the trachea through neck tissue, characterised in that the apparatus further includes a reinforcement device (1, 301, 401) insertable into the trachea via the nose or mouth to the region where the instruments enter the trachea such that the reinforcement device helps reduce collapse of the trachea during access of the instruments (20) to the trachea.
2. Apparatus according to Claim 1, characterised in that the reinforcement device includes a tube (1, 301, 401) reinforced along at least its patient end (12).
3. Apparatus according to Claim 2, characterised in that the tube (1, 301, 401) is reinforced by a circumferential reinforcement (13).
4. Apparatus according to Claim 3, characterised in that the tube (1, 301, 401) is reinforced by a helical wire (13).
5. Apparatus according to any one of Claims 2 to 4, characterised in that the tube (1, 301, 401) includes a longitudinal slot (14, 314, 414) along its patient end (12) on its anterior side so that the instruments (20) can enter the tube via the slot and the tube can subsequently be withdrawn.
6. Apparatus according to Claim 5, characterised in that the reinforcement tube (301) is armoured along its posterior side in the region of the slot (314) to resist needle penetration.
7. Apparatus according to any one of the preceding claims, characterised in that the reinforcement device (401) includes one or more radiation emitters (402) close to its patient end to emit radiation visible externally of the patient through neck tissue.
8. Apparatus according to Claim 7, characterised in that the reinforcement device (401) includes a plurality of radiation emitters (402) spaced longitudinally of one another.
9. Tracheostomy apparatus including instruments for accessing the trachea through neck tissue, characterised in that the apparatus includes a reinforcement tube (1, 301, 401) adapted for insertion into the trachea via the nose or mouth so that the patient end (12) of the tube locates in the region where the instruments enter the trachea, that at least the patient end of the tube is reinforced (13) to help reduce collapse of the trachea during access of the instruments (20) to the trachea, and that the tube has a longitudinal slot (14, 314, 414) along its patient end on its anterior side so that the instruments can enter the tube via the slot and the tube can be subsequently withdrawn.
1(1 A reinforcement device or tube (1, 301, 401) for use in apparatus according to any one of the preceding claims.
11. A kit for use in a method of forming a tracheostomy including one or more instruments (20) for forming a tracheostomy opening, a reinforcement tube (1, 301, 401) having a patient end (11, 12) at least reinforced (13) against collapsing radially and having a longitudinal slot (14, 314, 414) at the patient end on its anterior side and opening at the tip of the reinforced tube, at least one dilator and a tracheostomy tube, the method including the steps of inserting the reinforcement tube (1, 301, 401) via the mouth or nose so that its patient end (11, 12) locates in the trachea in the region of the desired tracheostomy, forming an opening to the trachea through neck tissue with the instrument or instruments (20) such that they extend into the slot (14, 314, 414), dilating the opening with the dilator, the reinforcement tube (1, 301, 401) reducing collapse of the trachea caused by pressure applied during the steps of forming an opening and dilating the opening, and subsequently withdrawing the reinforcing tube (1, 301, 401) such that its slot (14, 314, 414) enables it to slide over any inserted instrument or dilator, and subsequently inserting the tracheostomy tube.