GB2563484A

GB2563484A - System for inserting a tracheal cannula into a tracheostomy

Info

Publication number: GB2563484A
Application number: GB1806182.0A
Authority: GB
Inventors: Ramdohr Bastian
Original assignee: Primed Halberstadt Medizintechnik GmbH
Current assignee: Primed Halberstadt Medizintechnik GmbH
Priority date: 2017-04-15
Filing date: 2018-04-16
Publication date: 2018-12-19
Anticipated expiration: 2038-04-16
Also published as: DE202017002009U1; NL1042813A; CZ31835U1; GB2563484B; PL71175Y1; DE202018001767U1; PL127226U1; SE542940C2; ES1211738Y; GB201806182D0; ES1211738U; FR3065163B3; FR3065163A3; NL1042813B1; SE1850396A1

Abstract

A system for inserting a tracheal cannula into a tracheostomy, comprises: a tracheal cannula 5; and an insertion aid 1 that includes a handle 2, a curved body 3 and a tip 4. A bayonet closure system 6, provides a releasably coupling between the insertion aid 1 and the tracheal cannula 5, with the bayonet system 6 comprising a bayonet ring 10 connected to insertion aid 1 and a bayonet attachment 11 connected to tracheal cannula 5. Bayonet ring 10 may include three or four closure arrangements 14 for making a form-fitting connection with three or four contours 16 of the bayonet attachment 11. Bayonet ring 10 may comprise a lug 15, where bayonet ring 10 is mounted on the insertion aid 1 allowing rotation of bayonet ring 10 about the longitudinal axis of the insertion aid 1 through lug 15 engaging in a groove 13, thereby securing against displacement of bayonet ring 10 along the longitudinal axis of the insertion aid 1. At a patient facing end of tracheal cannula 5, there may be a transitional region 12, where the tracheal cannula wall thickness decreases to provide an atraumatic transition for insertion of the cannula 5 into a tracheostomy.

Description

System for inserting a tracheal cannula into a tracheostomy

The invention relates to a system for inserting a tracheal cannula into a tracheostomy, comprising an insertion aid and a tracheal cannula.

In the event for example of a need for long-term ventilation after an accident, an operation, a neurological disease that damages the swallowing reflex, radiotherapy to the neck or head, or in the case of laryngeal paralysis, it may be necessary to perform a minimally invasive procedure during which access to the windpipe is created through the soft tissues of the neck - also called a tracheostomy. This medical procedure is also carried out for example as the means of choice in the prior art when the upper airways are displaced, if it is impossible to put in a breathing tube. A tracheotomy is also usual in the case of patients whose larynx has been completely removed.

It is likewise known from the prior art to push a so-called tracheal cannula through a tracheostomy and into the windpipe and to secure it there, wherein the tracheostomy is held open by this tracheal cannula. A tracheal cannula of this kind is usually a flexible to rigid, short, curved tube that enables or facilitates breathing. If a treatment of this kind with a tracheal cannula is continued over a relatively long period, it is also usual to replace the tracheal cannula regularly.

Tracheal cannulas differ for example in respect of their type of material. For cannulas of this kind, materials such as silicone or other plastics or metals such as silver or nickel silver are usually used. A further distinction between the cannulas may be made in dependence on their length, internal diameter (lumen), shape and function. The length and lumen of the cannula are usually adapted to the size of the tracheostomy of the patient. Depending on the mode of functioning of the tracheal cannulas, a distinction may be made between blockable and non-blockable cannulas.

When for example the tracheal cannula is inserted for the first time, it is necessary to insert the tracheal cannula into the tracheostomy with the help of an insertion aid.

An insertion aid is required in particular in cases where the tracheal wall cannot be inspected through the stoma.

DE 10 2005 021 470 A1 discloses an insertion aid for percutaneous tracheostomy or a device for putting a tracheal cannula into a tracheostomy, wherein the insertion aid has a shaft that may be guided through the tracheal cannula and a conical tip connected to the shaft. In order to reduce the risk of injury when the tracheal cannula is put in and to facilitate putting in, it is proposed that the insertion aid should have a conical tip that may be put into a first condition, with a small base diameter, and a second condition, with a large base diameter.

It is provided for the conical tip to be made from a resilient material that, if appropriate forces are applied, can be stretched into the condition with a large base diameter, and that shrinks again when the forces decrease.

For the purpose of applying these appropriate forces, a displacement body is provided that has a larger diameter than the central longitudinal bore of the conical tip in the condition not under load. This displacement body may be displaced into the region of the conical tip and withdrawn again, and in the pushed-in position it has the effect of widening the conical tip to give the condition with a large base diameter.

DE 10 2006 029 599 A1 describes a device having a guide catheter for putting a tracheal cannula into a tracheostomy. In order to provide a device for putting a tracheal cannula into a tracheostomy which prevents injury by the distal end surface of the cannula and which is suitable for use with very flexible cannulas, cannulas of narrow internal diameter and/or of large wall thickness, it is proposed that the guide catheter should have a shield that is mounted in the vicinity of the distal end of the guide catheter and is made from a flexible material and has substantially the shape of a distally oriented conical tip.

It is further disclosed that the tube of the guide catheter runs through the axis of this tip, with a base external diameter that, in a first condition, corresponds at least to the external diameter of the tracheal cannula and, in a second condition, is smaller than the internal diameter of the tracheal cannula as a result of deformation and may thus be withdrawn back through the tracheal cannula.

DE 20 2010 002 803 U1 discloses a device for putting a cannula or tracheal cannula into a tracheostomy. It is provided for the obturator that is inserted into the tracheal cannula to have a conical tip that takes a form having a sliding shield such that the sliding shield projects beyond the edge of the tracheal cannula and thus blunts the cannula edge. The sliding shield is sufficiently flexible that, once the tracheal cannula has been positioned with the obturator, the obturator itself can be withdrawn from the tracheal cannula with the sliding shield. The sliding shield functions as an insertion aid and, as a result of its flexible wall, prevents the tracheal cannula edge from being able to cause injury. Because of the particular materials of the sliding shield and the particular coating of the sliding shield, insertion is facilitated if it is wetted with liquid.

EP 1 281 414 A1 discloses an introducing device for a medical tube such as a tracheal cannula, wherein the introducing device is tubular and has a duct extending over its entire length. The introducing device has a tubular first end that protrudes at a patient side of the tracheal cannula to be inserted, by a distance of at least twice the external diameter of the tracheal cannula. The second end of the tracheal cannula to be inserted is secured in the region of a conical coupling adjoined by a handle element, for manipulating the introducing device. It is provided for a guide wire to be guidable through the duct that extends over the entire length of the introducing device.

It is further disclosed that, at least in its curved midsection, the introducing device is made partly from a plastics material having a metal insert, and that the handle takes a form that is substantially straight and cylindrical with gripping ribs.

WO 2015/078427 A1 discloses an insertion aid for inserting a tracheal cannula into a tracheostomy, which comprises a handle, a body and a tip. The tip takes an atraumatic form having a through-hole for a guide wire such that injuries to the patient when the tracheal cannula is put in are avoided.

The body of the insertion aid takes a curved form and is arranged between the handle and the tip. In the described embodiment, the curved body does not take the form of a hollow body but as a solid body with no cavities. For a guide wire that, in an insertion phase of the tracheal cannula, is conventionally arranged in a cavity in the insertion aid, there is provided in the solid body with no cavities an external groove which receives this guide wire along the solid body.

Here, the free end of the groove is formed such that it opens into the through-holes in the handle and the tip.

It is also disclosed that the body and the handle are made of a hard material such as metal or hard plastics, while the tip is made from a soft material such as a soft plastics.

The disadvantages of the known prior art are seen in particular in the fact that the tracheal cannula can be displaced along the insertion aid as it is inserted into the tracheostomy, as a result of the forces arising during this process. Moreover, in some cases large forces are required for removing the insertion aid after the tracheal cannula has been inserted, which may result in considerable stress for the patient, together with a risk of injury.

Thus, there is a need for a simple, improved solution for a system for inserting a tracheal cannula into a tracheostomy.

The object of the invention is to provide a system for inserting a tracheal cannula into a tracheostomy by means of which putting a tracheal cannula into the tracheostomy is simplified and facilitated, and by means of which at the same time the risk of injury to the patient when the tracheal cannula is put in is reduced.

Moreover, reliable and easily releasable securing of the tracheal cannula on the system for inserting a tracheal cannula into a tracheostomy is to be achieved.

The object is achieved by subject matter having the features of Claim 1 of the independent claims. Further developments are provided in dependent Claims 2 to 10.

The system according to the invention for inserting a tracheal cannula into a tracheostomy includes an insertion aid and a tracheal cannula, which may be positioned in a tracheostomy of a patient using this insertion aid.

The insertion aid includes a handle, a curved body and a tip, which are mechanically firmly connected to one another. In a particular embodiment, the handle and the curved body are made from a single part, such as a hard plastics, a metal or a combination of two materials (metal and plastics). In a further embodiment, the tip is also a constituent part of this one part. A one-part construction of this kind results in better strength in the insert aid and reduces the complexity of assembly before the insertion aid is used.

The handle of the insertion aid takes a substantially cylindrical form with a throughhole. For the purpose of improving manipulation, the handle may have a noncylindrical shape, grip elements or grip recesses, or a coating on plastics.

The curved body adjoining the handle is preferably given a round cross-section, and has a diameter that corresponds to or is smaller than the internal diameter of the tracheal cannula associated with the system.

The curved body has a curvature that is suitable for putting the tracheal cannula in, and takes a form having a through-hole that extends in the longitudinal direction of the body.

A tip is arranged at a second end, not connected to the handle, of the curved body. This tip has a first and a second region. The first region of the tip takes a conical form, wherein the diameter of the first region increases in the direction of the curved body, to a maximum diameter of the tip. The second region of the tip takes a cylindrical form and has a diameter that corresponds to the maximum diameter of the tip. The tip is constructed to have a through-hole that extends over both regions.

The system for inserting a tracheal cannula into a tracheostomy is suitable and ready for use with a guide wire known from the prior art, as a result of the through-holes in the handle, in the curved body and in the tip.

The tracheal cannula associated with the system takes a form at its proximal end facing the patient such that the material thickness of the tracheal cannula decreases in part, at least in a transitional region. It is provided for the tracheal cannula to be received or positioned on the insertion aid oriented such that the end of the transitional region of the tracheal cannula lies in the region of the second region of the tip, that is to say in the cylindrical part of the tip. With this orientation, no edge that could result in injuries to the patient when the tracheal cannula is inserted into the tracheostomy is produced.

Optimum positioning of the tracheal cannula on the insertion aid is achieved if, as viewed from the external, proximal end of the tip in the direction of the curved body, a constant increase in the diameter can be seen until the maximum diameter of the tracheal cannula, that is to say its external diameter, is reached. This constant increase in the diameter thus extends over the first conical region of the tip and the transitional region of the tracheal cannula.

For the purpose of positioning and holding the tracheal cannula on the insertion aid there is provided a closure system that is arranged in a region between the handle and the curved body. The closure system takes a form such that it can receive the distal end, remote from the patient, of the tracheal cannula and immobilise it firmly. In this way, the tracheal cannula is secured during insertion into a tracheostomy, to prevent displacement along the curved body.

It is provided for the closure system to take the form of a so-called bayonet closure system. This bayonet closure system or bayonet closure provides a rapidly producible and easily releasable mechanical connection between two cylindrical parts, such as the system for inserting a tracheal cannula into a tracheostomy, called the insertion aid for short, and the tracheal cannula.

It is provided for a bayonet ring to be mounted on the insertion aid as a constituent part of the bayonet closure system, wherein this bayonet ring engages form-fittingly in a peripheral hollow on the surface of the insertion aid, in a region between the handle and the curved body, by means of at least one, preferably three or four, lugs that are arranged on the inside of the bayonet ring. In this way, the bayonet ring is mounted such that it can rotate about the longitudinal axis of the insertion aid. This bayonet ring is thus prevented in an effective manner from being displaced along the longitudinal axis of the insertion aid by the form-fitting engagement.

Before a tracheal cannula is inserted into the tracheostomy of a patient, the tracheal cannula is pushed over the tip and onto the curved body of the insertion aid. The tracheal cannulas provided for the system that is described have a further constituent part of the bayonet closure system, suitable for coupling to a bayonet ring of a bayonet closure, at their distal end, remote from the patient.

By means of this bayonet attachment, once the tracheal cannula has been pushed onto the insertion aid it is mechanically secured with the aid of the bayonet ring, which as a result of being rotated in a first direction engages form-fittingly in the bayonet attachment by means of its closure arrangements, and in this way the tracheal cannula is prevented in an effective manner from being displaced in the direction of the longitudinal axis of the insertion aid.

Once the tracheal cannula has been put into the tracheostomy of the patient, the form-fitting connection of the tracheal cannula is released from the insertion aid by rotating the bayonet ring in a second direction opposed to the first direction. Then, the insertion aid can be withdrawn from the tracheal cannula that has been positioned in the patient.

For the purpose of ensuring functioning of the arranged bayonet closure system, the latter has for example two closure arrangements or claws that are arranged opposite one another in the bayonet ring and, when the bayonet closure is closed, engage form-fittingly in and latch into two corresponding contours arranged on the bayonet attachment. In an alternative embodiment, three closure arrangements that are mounted offset from one another by 120 degrees, with their corresponding three contours, or four closure arrangements that are mounted offset from one another by 90 degrees, with their corresponding four contours, may be used in the bayonet closure system.

Because, in one embodiment, the tip of the system has at no point a diameter greater than the internal diameter of the tracheal cannula, withdrawal may be performed with little exertion of force. Thus, no appreciable stress on the patient as a result of removing the insertion aid is to be expected either.

Even if, in a further embodiment, the greatest diameter of the tip is selected such that it is slightly larger than the internal diameter of the tracheal cannula, it is still possible to withdraw the insertion aid from the tracheal cannula easily, because there are no edges or obstacles inside the tracheal cannula to be overcome.

The disclosed system is particularly suitable for the first time a tracheal cannula is inserted into a newly made, not yet stable tracheostomy that has been created by percutaneous dilational tracheotomy.

The atraumatic transition of the system in the region between the tip and the patent end of the tracheal cannula is particularly advantageous.

Further details, features and advantages of embodiments of the invention will become apparent from the description below of exemplary embodiments, given with reference to the associated drawings. In the drawings:

Fig. 1 shows an illustration of the system for inserting a tracheal cannula into a tracheostomy, in a side view,

Fig. 2 shows an illustration of the system for inserting a tracheal cannula into a tracheostomy, in a perspective view,

Fig. 3 shows an illustration of the system for inserting a tracheal cannula into a tracheostomy, in a sectional view,

Fig. 4 shows a partial region of the system, on a larger scale, of the region of the bayonet ring, in a sectional view, and

Fig. 5 shows a magnified illustration of the system for inserting a tracheal cannula into a tracheostomy (insertion aid), in the region of the bayonet closure system, in a perspective view.

Figure 1 represents an illustration of the system for inserting a tracheal cannula 5 into a tracheostomy, in a side view. The system includes the insertion aid 1 with the following regions: handle 2, curved body 3 and tip 4. The system further includes the tracheal cannula 5, which is arranged on the insertion aid 1, in particular over the region of the curved body 3. For the purpose of securing the tracheal cannula 5, a closure system 6 is arranged in the region between the handle 2 and the curved body 3.

In the embodiment of the closure system 6 shown in Figure 1, this closure system is shown in the form of a bayonet closure with a bayonet ring 10. For the purpose of coupling the tracheal cannula 5 to the bayonet ring 10, the tracheal cannula 5 has a bayonet attachment 11. At an end of the tracheal cannula 5 facing the patient, the transitional region 12 is illustrated, in which the wall thickness of the tracheal cannula 5 decreases. In one example, the wall thickness at the end of the tracheal cannula 5 is only approximately 0.3 mm.

Readily visible in Figure 1 is the atraumatic transition of the system, in the form of the conical line of the tip 4 and the transitional region 12.

Figure 2 represents an illustration of the system for inserting a tracheal cannula 5 into a tracheostomy, in a perspective view. The elements of the system for inserting a tracheal cannula 5 into a tracheostomy that have already been explained in connection with Figure 1 can be seen in this illustration as well.

Figure 3 illustrates the system for inserting a tracheal cannula into a tracheostomy 5, in a perspective view. The insertion aid includes the handle 2, the curved body 3 and the tip 4, wherein all the constituent parts 2, 3, 4 of the insertion aid are provided with associated through-holes. In this way, it is possible to utilise the system with a guide wire known from the prior art, which is not illustrated in Figure 3.

As shown in Figure 3, the end of the tracheal cannula 5 that is remote from the patient is formed with a bayonet attachment 11 that can be coupled to the bayonet ring 10. For this purpose, the bayonet ring 10 is mounted on the insertion aid 1 such that it can rotate about the longitudinal axis of the insertion aid 1 in a groove 13, and is secured to prevent displacement along the longitudinal axis of the insertion aid 1 by means of this groove 13. For this purpose, the bayonet ring 10 has for example a plurality of lugs 15 that are formed such that the lugs 15 are fitted form-fittingly into the peripheral groove 13 and, when the bayonet ring 10 is rotated in relation to the handle 2 of the insertion aid 1, the lugs 15 can move inside the groove 13.

As a result of rotating this bayonet ring 10 in a first direction, it engages form-fittingly in the contours 16 of the bayonet attachment 11 by means of its closure arrangements 14, and in an effective manner prevents the tracheal cannula 5 from being displaced in the direction of the longitudinal axis of the insertion aid 1. The closure arrangements 14 and the contours 16 are not illustrated in detail in Figure 3.

Figure 3 illustrates the transitional region 12, which tapers within the material thickness of the tracheal cannula 5, and which ends in the region of the cylindrical region of the tip 4, thus providing an atraumatic transition of the system for inserting a tracheal cannula 5 into a tracheostomy.

Figure 4 shows a partial region of the system, with the region around the bayonet ring 10 on a larger scale, in a sectional view. In this illustration, the groove 13 in which the bayonet ring 10 is rotatably mounted by means of its lugs 15 is readily visible. Further visible, in the upper region of the illustration, is a closure arrangement 14 that engages form-fittingly in a contour 16 of the bayonet attachment 11 as a result of rotating the bayonet ring 10.

Figure 5 shows a magnified illustration of the system for inserting a tracheal cannula 1 into a tracheostomy, in the region of the bayonet closure system 6, in a perspective view. In the example of Figure 5, two of three lugs 15 that are arranged offset from one another on the inside of the bayonet ring 10, for example at an angle of 120 degrees, are illustrated. The third lug 15 is hidden as a result of the manner of the perspective illustration.

As an alternative, it is also possible for two opposing lugs 15, or four lugs 15 arranged in the bayonet ring 10 in each case offset from one another for example at an angle of 90 degrees, to be used.

As a further alternative, only one lug 15 is used, wherein the lug 15 may run peripherally or extends over only part of the inner surface of the bayonet ring 10, as illustrated in Figure 5 in the example having three lugs 15.

The three lugs 15 shown in Figure 5, which are arranged in a peripheral hollow or in the groove 13 in the handle 2 (not illustrated in Figure 5), make it possible to mount the bayonet ring 10 such that it can rotate on the handle 2 of the insertion aid 1.

Figure 5 illustrates by way of example four contours 16 arranged on the bayonet attachment 11. As an alternative, it is also possible for two or three contours 16 to be arranged. In the illustration, two opposing contours 16 are formed in an L shape and thus each form an abutment for the closure arrangements 14 when the bayonet closure system 6 is closed. The two contours 16 formed in an L shape are located in the upper and lower region of the bayonet attachment 11 in Figure 5.

In the example of Figure 5, the bayonet ring 10 has four closure arrangements 14 or claws that are arranged on the inside of the bayonet ring 10, in each case offset from one another by 90 degrees. The number of closure arrangements 14 can also vary, wherein the number of closure arrangements 14 must match the number of contours 16.

As a result of rotating this bayonet ring 10 in a first direction, it engages form-fittingly in the contours 16 of the bayonet attachment 11 by means of its closure arrangements 14, and in an effective manner prevents the tracheal cannula 5 from being displaced in the direction of the longitudinal axis of the insertion aid 1.

Once the tracheal cannula 5 has been inserted into a tracheostomy of a patient, the bayonet closure system 6 is opened by rotating the bayonet ring 10 in the opposite direction, wherein the form fit between the contours 16 of the bayonet attachment 11 and the closure arrangements 14 of the bayonet ring 10 is disengaged. The handle 2 of the insertion aid 1 can thus easily be removed, wherein the tracheal cannula 5 remains in the tracheostomy of the patient.

List of reference numerals

Insertion aid

Handle

Curved body

Tip

Tracheal cannula

Closure system (bayonet closure system)

Through-hole in handle

Through-hole in body

Through-hole in tip

Bayonet ring

Bayonet attachment

Transitional region

Groove

Closure arrangement (claw)

Lug

Contour

Claims

1. A system for inserting a tracheal cannula into a tracheostomy, comprising an insertion aid (1) and a tracheal cannula (5), characterised in that the insertion aid (1) has a handle (2), a curved body (3) and a tip (4), and in that there is arranged on the insertion aid (1), in a region between the handle (2) and the curved body (3), a closure system (6) that may form-fittingly couple the tracheal cannula (5) to the insertion aid (1) and easily release it therefrom, in that the closure system (6) is a bayonet closure system having a bayonet attachment (11) and a bayonet ring (10), wherein the bayonet attachment (11) is connected to the tracheal cannula (5) and the bayonet ring (10) is connected to the insertion aid (1).

2. A system according to Claim 1, characterised in that the handle (2) and the curved body (3) are made in a single piece.

3. A system according to Claim 1 or 2, characterised in that the tip (4) has a first conical and a second cylindrical region.

4. A system according to one of Claims 1 to 3, characterised in that a plurality of contours (16) are arranged on the bayonet attachment (11) and a plurality of closure arrangements (14) are arranged on an inner side of the bayonet ring (10).

5. A system according to one of Claims 1 to 4, characterised in that the bayonet attachment (11) is arranged at an end of the tracheal cannula (5) that is remote from a patient.

6. A system according to one of Claims 1 to 5, characterised in that the bayonet ring (10) has at least one lug (15) and is mounted on the insertion aid (1) such that it can rotate about the longitudinal axis of the insertion aid (1) by means of a groove (13) in which the at least one lug (15) engages, and is arranged to be secured against displacement along the longitudinal axis of the insertion aid (1) by the groove (13).

7. A system according to one of Claims 1 to 6, characterised in that the tracheal cannula (5) has, at an end facing the patient, a transitional region (12) in which the wall thickness of the tracheal cannula 5 decreases.

8. A system according to one of Claims 1 to 7, characterised in that the bayonet ring (10) has three or four closure arrangements (14) for making a form-fitting connection with three or four contours (16) of the bayonet attachment (11).

9. A system according to one of Claims 1 to 8, characterised in that the closure arrangements (14) and the contours (16) are in each case arranged offset from one another at an angle of 120 degrees or 90 degrees.

10. A system according to one of Claims 1 to 9, characterised in that at least one contour (16) has an abutment for a closure arrangement (14).